Wrongful Life

There have been recent discussions in the lay media about a growing trend of litigation cases focused not on the “right to live,” but rather on the “right to die.” These cases have involved patients who received aggressive treatment, despite having documentation of their wishes not to receive such aggressive treatment. Although unsettling, it is not surprising that this issue has arisen, given the national conversations about the exorbitant cost of care at the end of life in the United States, and the frequency with which patients do not receive end-of-life care that is concordant with their wishes.

These conversations have spurred providers and patients to discuss and document their wishes, via advanced care directives and/or POLST orders (Physicians Orders for Life Sustaining Treatment). There is now even a national day devoted to advanced care decision making (National Healthcare Decisions Day).

Also on The Hospital Leader…

Follow You, Follow Me by Tracy Cardin, ACNP-BC, SFHM

SHM Movers & Shakers, Hospital Silos & JHM Research in HM News by Felicia Steele
 

Wrongful Life

There have been recent discussions in the lay media about a growing trend of litigation cases focused not on the “right to live,” but rather on the “right to die.” These cases have involved patients who received aggressive treatment, despite having documentation of their wishes not to receive such aggressive treatment. Although unsettling, it is not surprising that this issue has arisen, given the national conversations about the exorbitant cost of care at the end of life in the United States, and the frequency with which patients do not receive end-of-life care that is concordant with their wishes.

These conversations have spurred providers and patients to discuss and document their wishes, via advanced care directives and/or POLST orders (Physicians Orders for Life Sustaining Treatment). There is now even a national day devoted to advanced care decision making (National Healthcare Decisions Day).

Also on The Hospital Leader…

Follow You, Follow Me by Tracy Cardin, ACNP-BC, SFHM

SHM Movers & Shakers, Hospital Silos & JHM Research in HM News by Felicia Steele
 

Wrongful Life

There have been recent discussions in the lay media about a growing trend of litigation cases focused not on the “right to live,” but rather on the “right to die.” These cases have involved patients who received aggressive treatment, despite having documentation of their wishes not to receive such aggressive treatment. Although unsettling, it is not surprising that this issue has arisen, given the national conversations about the exorbitant cost of care at the end of life in the United States, and the frequency with which patients do not receive end-of-life care that is concordant with their wishes.

These conversations have spurred providers and patients to discuss and document their wishes, via advanced care directives and/or POLST orders (Physicians Orders for Life Sustaining Treatment). There is now even a national day devoted to advanced care decision making (National Healthcare Decisions Day).

Also on The Hospital Leader…

Follow You, Follow Me by Tracy Cardin, ACNP-BC, SFHM

SHM Movers & Shakers, Hospital Silos & JHM Research in HM News by Felicia Steele
 

The ability to perform activities of daily living (ADLs), commonly called functional status, is central to older adults’ quality of life (QOL) and independence.^1,2 Understanding functional status is key to improving outcomes for older adults. In community-dwelling older adults with difficulty performing basic ADLs, practical interventions, including physical and occupational therapy, can improve functioning and prevent functional decline.^3,4 Understanding function also is important for delivering patient-centered care, including individualizing cancer screening,⁵ evaluating how patients will tolerate interventions,^6-9 and helping patients and families determine the need for long-term services and supports.

For these reasons, assessing functional status is a cornerstone of geriatrics practice. However, most older adults are cared for in primary care settings where routine measurement of functional status is uncommon.^10,11 Although policy leaders have long noted this gap and the obstacle it poses to improving the quality and outcomes of care for older adults, many health care systems have been slow to incorporate measurement of functional status into routine patient care.^12-14

Over the past several years, the VA has been a leader in the efforts to address this barrier by implementing routine, standardized measurement of functional status in primary care clinics. Initially, the VA encouraged, but did not require, measurement of functional status among older adults, but the implementation barriers and facilitators were not formally assessed.¹⁵ In a postimplementation evaluation, the authors found that a relatively small number of medical centers implemented functional measures. Moreover, the level of implementation seemed to vary across sites. Some sites were collecting complete measures on all eligible older patients, while other sites were collecting measures less consistently.¹⁵

As part of a national VA initiative to learn how best to implement standardized functional status measurement, the authors are conducting a qualitative study, including a formal assessment of barriers and facilitators to implementing functional assessments in VA primary care clinics. In the current project, which serves as formative work for this larger ongoing study, the authors identified and described current processes for measuring functional status in VA primary care patient aligned care team (PACT) and Geriatric (GeriPACT) clinics.

Methods

A rapid qualitative analysis approach was used, which included semistructured interviews with primary care stakeholders and rapid data analysis to summarize each clinic’s approach to measuring functional status and develop process maps for each clinic (eFigures 1, 2, 3, and 4 ). Interviews and analyses were conducted by a team consisting of a geriatrician clinician-researcher, a medical anthropologist, and a research coordinator. The institutional review boards of the San Francisco VAMC and the University of California, San Francisco approved the study.

Sampling Strategy

In order to identify VAMCs with varying approaches to assessing functional status in older patients who attended primary care appointments, the study used a criterion sampling approach.^16,17 First, national “health factors” data were extracted from the VA Corporate Data Warehouse (CDW). Health factors are patient data collected through screening tools called clinical reminders, which prompt clinic staff and providers to enter data into checkbox-formatted templates. The study then identified medical centers that collected health factors data from patients aged ≥ 65 years (157 of 165 medical centers). A keyword search identified health factors related to the Katz ADL (bathing, dressing, transferring, toileting, and eating), and Lawton Instrumental ADL (IADL) Scale (using the telephone, shopping, preparing food, housekeeping, doing laundry, using transportation, managing medications, and managing finances).^18,19 Health factors that were not collected during a primary care appointment were excluded.

Of the original 157 medical centers, 139 met these initial inclusion criteria. Among these 139 medical centers, 66 centers did not collect complete data on these 5 ADLs and 8 IADLs (eg, only ADLs or only IADLs, or only certain ADLs or IADLs).

Two medical centers were selected in each of the following 3 categories: (1) routinely used clinical reminders to collect standardized data on the Katz ADL and the Lawton IADL Scale; (2) routinely used clinical reminders to collect functional status data but collected partial information; and (3) did not use a clinical reminder to collect functional status data. To ensure that these 6 medical centers were geographically representative, the sample included at least 1 site from each of the 5 VA regions: 1 North Atlantic, 1 Southeast, 1 Midwest, 2 Continental (1 from the northern Continental region and 1 from the southern), and 1 Pacific. Three sites that included GeriPACTs also were sampled.

Primary care PACT and GeriPACT members from these 6 medical centers were recruited to participate. These PACT members included individuals who can assess function or use functional status information to inform patient care, including front-line nursing staff (licensed practical nurses [LPNs], and registered nurses [RNs]), primary care providers (medical doctors [MDs] and nurse practitioners [NPs]), and social workers (SWs).

Local bargaining units, nurse managers, and clinic directors provided lists of all clinic staff. All members of each group then received recruitment e-mails. Phone interviews were scheduled with interested participants. In several cases, a snowball sampling approach was used to increase enrollment numbers by asking interview participants to recommend colleagues who might be interested in participating.¹⁷

Data Collection

Telephone interviews were conducted between March 2016 and October 2016 using semistructured guides developed from the project aims and from related literature in implementation science.^20,21 Interview domains included clinic structure, team member roles and responsibilities, current practices for collecting functional status data, and opinions on barriers and facilitators to assessing and recording functional status (Appendix:

Data Analysis

Rapid analysis, a team-based qualitative approach was used to engage efficiently and systematically with the data.^22,23 This approach allowed results to be analyzed more quickly than in traditional qualitative analysis in order to inform intervention design and develop implementation strategies.²³ Rapid analysis typically includes organization of interview data into summary templates, followed by a matrix analysis, which was used to create process maps.²⁴

Summary Templates

Summary templates were developed from the interview guides by shortening each question into a representative code. The project team then read the transcripts and summarized key points in the appropriate section of the template. This process, known as data reduction, is used to organize and highlight material so conclusions can be drawn from the data easily.²² In order to maintain rigor and trustworthiness, one team member conducted the interview, and a different team member created the interview summary. All team members reviewed each summary and met regularly to discuss results.

The summary templates were converted into matrix analyses, a method of displaying data to identify relationships, including commonalities and differences.²⁴ The matrixes were organized by stakeholder group and clinic in order to compare functional status assessment and documentation workflows across clinics.

Process Maps

Finally, the team used the matrix data to create process maps for each clinic of when, where, and by whom functional status information was assessed and documented. These maps were created using Microsoft Visio (Redmond, WA). The maps integrated perspectives from all participants to give an overview of the process for collecting functional status data in each clinic setting. To ensure accuracy, participants at each site received process maps to solicit feedback and validation.

Results

Forty-six participants at 6 medical centers (20 MDs and NPs, 19 RNs and LPNs, and 7 SWs) from 9 primary care clinics provided samples and interviews. The study team identified 3 general approaches to functional status assessment: (1) Routine collection of functional status data via a standardized clinical reminder; (2) Routine collection of functional status data via methods other than a clinical reminder (eg, a previsit telephone screen or electronic note template); and (3) Ad hoc approaches to measuring functional status (ie, no standard or routine approach to assessing or documenting functional status). The study team selected 4 clinics (2 PACTs and 2 GeriPACTs) clinics to serve as examples of the 3 identified approaches.

The processes for functional status assessment in each of 4 clinics are summarized in the following detailed descriptions (Table).

Clinic 1

Clinic 1 is a GeriPACT clinic that routinely assesses and documents functional status for all patients (efigure 1, available at feprac.com). The clinic’s current process includes 4 elements: (1) a patient questionnaire; (2) an annual clinical reminder administered by an RN; (3) a primary care provider (PCP) assessment; and (4) a postvisit SW assessment if referred by the PCP.

All newly referred patients are mailed a paper questionnaire that includes questions about their medical history and functional status. The patient is asked to bring the completed questionnaire to the first appointment. The clinic RN completes this form for returning patients at every visit during patient intake.

Second, the clinic uses an annual functional status clinical reminder for patients aged ≥ 75 years. The reminder includes questions about a patient’s ability to perform ADLs and IADLs with 3 to 4 response options for each question. If the clinical reminder is due at the time of a patient appointment, the RN fills out the reminder using information from the paper questionnaire. The RN also records this functional status in the nursing intake note. The RN may elect to designate the PCP as a cosigner for the nursing intake note especially if there are concerns about or changes in the patient’s functional status.

Third, the RN brings the paper form to the PCP, who often uses the questionnaire to guide the patient history. The PCP then uses the questionnaire and patient history to complete a functional status template within their visit note. The PCP also may use this information to inform patient care (eg, to make referrals to physical or occupational therapy).

Finally, the PCP might refer the patient to SW. The SW may be able to see the patient immediately after the PCP appointment, but if not, the SW follows up with a phone call to complete further functional status assessment and eligibility forms.

In addition to the above assessments by individual team members, the PACT has an interdisciplinary team huddle at the end of each clinic to discuss any issues or concerns about specific patients. The huddles often focus on issues related to functional status.

Clinic 2

Clinic 2 is a primary care PACT clinic that routinely assesses and documents functional status (eFigure 2, available at fedprac.com). The clinic process includes 3 steps: an annual clinical reminder for patients aged ≥ 75 years; a PCP assessment; and a postvisit SW assessment if referred by the PCP.

First, patients see an LPN for the intake process. During intake, the LPN records vitals and completes relevant clinical reminders. Similar to Clinic 1, Clinic 2 requires an annual functional status clinical reminder that includes ADLs and IADLs for patients aged ≥ 75 years. Patient information from the intake and clinical reminders are recorded by the LPN in a preventative medicine note in the electronic health record. This note is printed and handed to the PCP.

The PCP may review the preventative medicine note prior to completing the patient history and physical, including the functional status clinical reminder when applicable. If the PCP follows up on any functional issues identified by the LPN or completes further assessment of patient function, he or she may use this information to refer the patient to services or to place a SW consult; the PCP’s functional assessment is documented in a free-form visit note.

When the SW receives a consult, a chart review for social history, demographic information, and previous functional status assessments is conducted. The SW then calls the patient to administer functional and cognitive assessments over the phone and refers the patient to appropriate services based on eligibility.

Clinic 3

Clinic 3 is a GeriPACT clinic where functional status information is routinely collected for all new patients but may or may not be collected for returning patients (eFigure 3, available at fedprac.com). The process for new patients includes a previsit SW assessment; an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit SW assessment if referred by the provider. The process for returning patients is similar but omits the previsit social work assessment. New patients complete a comprehensive questionnaire with a SW before their first clinic visit. The questionnaire is completed by phone and involves an extensive social and medical history, including an assessment of ADLs and IADLs. This assessment is recorded in a free-form social work note.

Next, both new and returning patients see an LPN who completes the intake process, including vitals and clinical reminders. Clinic 3 does not have a clinical reminder for functional status. However, the LPN could elect to ask about ADLs or IADLs if the patient brings up a functional issue related to the chief symptom or if the LPN observes something that indicates possible functional impairment, such as difficulty walking or a disheveled appearance. If discussed, this information is recorded in the LPN intake note, and the LPN also could verbally inform the PCP of the patient’s functional status. The RN is not formally involved in intake or functional status assessment in this clinic.

Finally, the patient sees the PCP, who may or may not have reviewed the LPN note. The PCP may assess functional status at his or her discretion, but there was no required assessment. The PCP could complete an optional functional status assessment template included in the PCP visit note. The PCP can refer the patient to services or to SW for further evaluation.

Clinic 4

Clinic 4 is a primary care PACT clinic that does not routinely measure functional status (eFigure 4, available at fedprac.com). The approach includes an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit social worker assessment if referred by the provider. These steps are very similar to those of clinic 3, but they do not include a previsit SW assessment for new patients.

Although not represented within the 4 clinics described in this article, the content of functional status clinical reminders differed across the 9 clinics in the larger sample. Clinical reminders differed across several domains, including the type of question stems (scripted questions for each ADL vs categories for each activity); response options (eg, dichotomous vs ≥ 3 options), and the presence of free-text boxes to allow staff to enter any additional notes.

Discussion

Approaches to assessing and documenting functional status varied widely. Whereas some clinics primarily used informal approaches to assessing and documenting functional status (ie, neither routine nor standardized), others used a routine, standardized clinical reminder, and some combined several standardized approaches to measuring function. The study team identified variability across several domains of the functional status assessment process, including documentation, workflow, and clinical reminder content.

Approaches to functional assessment differed between GeriPACT and PACT clinics. Consistent with the central role that functional status assessment plays in geriatrics practice, GeriPACTs tended to employ a routine, multidisciplinary approach to measuring functional status. This approach included standardized functional assessments by multiple primary care team members, including LPNs, SWs, and PCPs. In contrast, when PACTs completed standardized functional status assessment, it was generally carried out by a single team member (typically an LPN). The PCPs in PACTs used a nonroutine approach to assess functional status in which they performed detailed functional assessments for certain high-risk patients and referred a subset for further SW evaluation.

These processes are consistent with research showing that standardized functional status data are seldom collected routinely in nongeriatric primary care settings.¹¹ Reports by PCPs that they did not always assess functional status also are consistent with previous research demonstrating that clinicians are not always aware of their patients’ functional ability.¹⁰

In addition to highlighting differences between GeriPACT and PACTs, the identified processes illustrate the variability in documentation, clinic workflow, and clinical reminder content across all clinics. Approaches to documentation included checkbox-formatted clinical reminders with and without associated nursing notes, patient questionnaires, and templated PCP and SW notes. Clinics employed varying approaches to collect functional status information and to ensure that those data were shared with the team. Clinic staff assessed functional status at different times during the clinical encounter. Clinics used several approaches to share this information with team members, including warm handoffs from LPNs to PCPs, interdisciplinary team huddles, and electronic signoffs. Finally, clinical reminder content varied between clinics, with differences in the wording of ADL and IADL questions as well as in the number and type of response options.

This variability highlights the challenges inherent in developing a routine, standardized approach to measuring functional status that can be adapted across primary care settings. Such an approach must be both flexible enough to accommodate variation in workflow and structured enough to capture accurate data that can be used to guide clinical decisions. Capturing accurate, standardized data in CDW also will inform efforts to improve population health by allowing VHA leaders to understand the scope of disability among older veterans and plan for service needs and interventions.

Whereas the larger qualitative study will identify the specific barriers and facilitators to developing and implementing such an approach, current clinic processes present here offer hints as to which features may be important. For example, several clinics collected functional status information before the visit by telephone or questionnaire. Therefore, it will be important to choose a functional status assessment instrument that is validated for both telephone and in-person use. Similarly, some clinics had structured clinical reminders with categoric response options, whereas others included free-text boxes. Incorporating both categoric responses (to ensure accurate data) as well as free-text (to allow for additional notes about a patient’s specific circumstances that may influence service needs) may be one approach.

Limitations

This study’s approach to identifying clinic processes had several limitations. First, the authors did not send process maps to clinic directors for verification. However, speaking with PACT members who carry out clinic processes is likely the most accurate way to identify practice. Second, the results may not be generalizable to all VA primary care settings. Due to resource limitations and project scope, community-based outpatient clinics (CBOCs) were not included. Compared with clinics based in medical centers, CBOCs may have different staffing levels, practice models, and needs regarding implementation of functional status assessment.

Although 46 participants from 9 clinics were interviewed, there are likely additional approaches to measuring functional status that are not represented within this sample. In addition, 3 of the 4 clinics included are affiliated with academic institutions, and all 4 are located in large cities. Efforts to include rural VAMCs were not successful. Finally, clinic-level characteristics were not reported, which may impact clinic processes. Although study participants were asked about clinic characteristics, they were often unsure or only able to provide rough estimates. In the ongoing qualitative study, the authors will attempt to collect more reliable data about these clinic-level characteristics and to examine the potential role these characteristics may play as barriers or facilitators to implementing routine assessment of functional status in primary care settings.

Conclusion

VA primary care clinics had widely varying approaches for assessing and documenting functional status. This work along with a larger ongoing qualitative study that includes interviews with veterans will directly inform the design and implementation of a standardized, patient-centered approach to functional assessment that can be adapted across varied primary care settings. Implementing standardized functional status measurement will allow the VA to serve veterans better by using functional status information to refer patients to appropriate services and to deliver patient-centered care with the potential to improve patient function and quality of life.

The ability to perform activities of daily living (ADLs), commonly called functional status, is central to older adults’ quality of life (QOL) and independence.^1,2 Understanding functional status is key to improving outcomes for older adults. In community-dwelling older adults with difficulty performing basic ADLs, practical interventions, including physical and occupational therapy, can improve functioning and prevent functional decline.^3,4 Understanding function also is important for delivering patient-centered care, including individualizing cancer screening,⁵ evaluating how patients will tolerate interventions,^6-9 and helping patients and families determine the need for long-term services and supports.

For these reasons, assessing functional status is a cornerstone of geriatrics practice. However, most older adults are cared for in primary care settings where routine measurement of functional status is uncommon.^10,11 Although policy leaders have long noted this gap and the obstacle it poses to improving the quality and outcomes of care for older adults, many health care systems have been slow to incorporate measurement of functional status into routine patient care.^12-14

Over the past several years, the VA has been a leader in the efforts to address this barrier by implementing routine, standardized measurement of functional status in primary care clinics. Initially, the VA encouraged, but did not require, measurement of functional status among older adults, but the implementation barriers and facilitators were not formally assessed.¹⁵ In a postimplementation evaluation, the authors found that a relatively small number of medical centers implemented functional measures. Moreover, the level of implementation seemed to vary across sites. Some sites were collecting complete measures on all eligible older patients, while other sites were collecting measures less consistently.¹⁵

As part of a national VA initiative to learn how best to implement standardized functional status measurement, the authors are conducting a qualitative study, including a formal assessment of barriers and facilitators to implementing functional assessments in VA primary care clinics. In the current project, which serves as formative work for this larger ongoing study, the authors identified and described current processes for measuring functional status in VA primary care patient aligned care team (PACT) and Geriatric (GeriPACT) clinics.

Methods

A rapid qualitative analysis approach was used, which included semistructured interviews with primary care stakeholders and rapid data analysis to summarize each clinic’s approach to measuring functional status and develop process maps for each clinic (eFigures 1, 2, 3, and 4 ). Interviews and analyses were conducted by a team consisting of a geriatrician clinician-researcher, a medical anthropologist, and a research coordinator. The institutional review boards of the San Francisco VAMC and the University of California, San Francisco approved the study.

Sampling Strategy

In order to identify VAMCs with varying approaches to assessing functional status in older patients who attended primary care appointments, the study used a criterion sampling approach.^16,17 First, national “health factors” data were extracted from the VA Corporate Data Warehouse (CDW). Health factors are patient data collected through screening tools called clinical reminders, which prompt clinic staff and providers to enter data into checkbox-formatted templates. The study then identified medical centers that collected health factors data from patients aged ≥ 65 years (157 of 165 medical centers). A keyword search identified health factors related to the Katz ADL (bathing, dressing, transferring, toileting, and eating), and Lawton Instrumental ADL (IADL) Scale (using the telephone, shopping, preparing food, housekeeping, doing laundry, using transportation, managing medications, and managing finances).^18,19 Health factors that were not collected during a primary care appointment were excluded.

Of the original 157 medical centers, 139 met these initial inclusion criteria. Among these 139 medical centers, 66 centers did not collect complete data on these 5 ADLs and 8 IADLs (eg, only ADLs or only IADLs, or only certain ADLs or IADLs).

Two medical centers were selected in each of the following 3 categories: (1) routinely used clinical reminders to collect standardized data on the Katz ADL and the Lawton IADL Scale; (2) routinely used clinical reminders to collect functional status data but collected partial information; and (3) did not use a clinical reminder to collect functional status data. To ensure that these 6 medical centers were geographically representative, the sample included at least 1 site from each of the 5 VA regions: 1 North Atlantic, 1 Southeast, 1 Midwest, 2 Continental (1 from the northern Continental region and 1 from the southern), and 1 Pacific. Three sites that included GeriPACTs also were sampled.

Primary care PACT and GeriPACT members from these 6 medical centers were recruited to participate. These PACT members included individuals who can assess function or use functional status information to inform patient care, including front-line nursing staff (licensed practical nurses [LPNs], and registered nurses [RNs]), primary care providers (medical doctors [MDs] and nurse practitioners [NPs]), and social workers (SWs).

Local bargaining units, nurse managers, and clinic directors provided lists of all clinic staff. All members of each group then received recruitment e-mails. Phone interviews were scheduled with interested participants. In several cases, a snowball sampling approach was used to increase enrollment numbers by asking interview participants to recommend colleagues who might be interested in participating.¹⁷

Data Collection

Telephone interviews were conducted between March 2016 and October 2016 using semistructured guides developed from the project aims and from related literature in implementation science.^20,21 Interview domains included clinic structure, team member roles and responsibilities, current practices for collecting functional status data, and opinions on barriers and facilitators to assessing and recording functional status (Appendix:

Data Analysis

Rapid analysis, a team-based qualitative approach was used to engage efficiently and systematically with the data.^22,23 This approach allowed results to be analyzed more quickly than in traditional qualitative analysis in order to inform intervention design and develop implementation strategies.²³ Rapid analysis typically includes organization of interview data into summary templates, followed by a matrix analysis, which was used to create process maps.²⁴

Summary Templates

Summary templates were developed from the interview guides by shortening each question into a representative code. The project team then read the transcripts and summarized key points in the appropriate section of the template. This process, known as data reduction, is used to organize and highlight material so conclusions can be drawn from the data easily.²² In order to maintain rigor and trustworthiness, one team member conducted the interview, and a different team member created the interview summary. All team members reviewed each summary and met regularly to discuss results.

The summary templates were converted into matrix analyses, a method of displaying data to identify relationships, including commonalities and differences.²⁴ The matrixes were organized by stakeholder group and clinic in order to compare functional status assessment and documentation workflows across clinics.

Process Maps

Finally, the team used the matrix data to create process maps for each clinic of when, where, and by whom functional status information was assessed and documented. These maps were created using Microsoft Visio (Redmond, WA). The maps integrated perspectives from all participants to give an overview of the process for collecting functional status data in each clinic setting. To ensure accuracy, participants at each site received process maps to solicit feedback and validation.

Results

Forty-six participants at 6 medical centers (20 MDs and NPs, 19 RNs and LPNs, and 7 SWs) from 9 primary care clinics provided samples and interviews. The study team identified 3 general approaches to functional status assessment: (1) Routine collection of functional status data via a standardized clinical reminder; (2) Routine collection of functional status data via methods other than a clinical reminder (eg, a previsit telephone screen or electronic note template); and (3) Ad hoc approaches to measuring functional status (ie, no standard or routine approach to assessing or documenting functional status). The study team selected 4 clinics (2 PACTs and 2 GeriPACTs) clinics to serve as examples of the 3 identified approaches.

The processes for functional status assessment in each of 4 clinics are summarized in the following detailed descriptions (Table).

Clinic 1

Clinic 1 is a GeriPACT clinic that routinely assesses and documents functional status for all patients (efigure 1, available at feprac.com). The clinic’s current process includes 4 elements: (1) a patient questionnaire; (2) an annual clinical reminder administered by an RN; (3) a primary care provider (PCP) assessment; and (4) a postvisit SW assessment if referred by the PCP.

All newly referred patients are mailed a paper questionnaire that includes questions about their medical history and functional status. The patient is asked to bring the completed questionnaire to the first appointment. The clinic RN completes this form for returning patients at every visit during patient intake.

Second, the clinic uses an annual functional status clinical reminder for patients aged ≥ 75 years. The reminder includes questions about a patient’s ability to perform ADLs and IADLs with 3 to 4 response options for each question. If the clinical reminder is due at the time of a patient appointment, the RN fills out the reminder using information from the paper questionnaire. The RN also records this functional status in the nursing intake note. The RN may elect to designate the PCP as a cosigner for the nursing intake note especially if there are concerns about or changes in the patient’s functional status.

Third, the RN brings the paper form to the PCP, who often uses the questionnaire to guide the patient history. The PCP then uses the questionnaire and patient history to complete a functional status template within their visit note. The PCP also may use this information to inform patient care (eg, to make referrals to physical or occupational therapy).

Finally, the PCP might refer the patient to SW. The SW may be able to see the patient immediately after the PCP appointment, but if not, the SW follows up with a phone call to complete further functional status assessment and eligibility forms.

In addition to the above assessments by individual team members, the PACT has an interdisciplinary team huddle at the end of each clinic to discuss any issues or concerns about specific patients. The huddles often focus on issues related to functional status.

Clinic 2

Clinic 2 is a primary care PACT clinic that routinely assesses and documents functional status (eFigure 2, available at fedprac.com). The clinic process includes 3 steps: an annual clinical reminder for patients aged ≥ 75 years; a PCP assessment; and a postvisit SW assessment if referred by the PCP.

First, patients see an LPN for the intake process. During intake, the LPN records vitals and completes relevant clinical reminders. Similar to Clinic 1, Clinic 2 requires an annual functional status clinical reminder that includes ADLs and IADLs for patients aged ≥ 75 years. Patient information from the intake and clinical reminders are recorded by the LPN in a preventative medicine note in the electronic health record. This note is printed and handed to the PCP.

The PCP may review the preventative medicine note prior to completing the patient history and physical, including the functional status clinical reminder when applicable. If the PCP follows up on any functional issues identified by the LPN or completes further assessment of patient function, he or she may use this information to refer the patient to services or to place a SW consult; the PCP’s functional assessment is documented in a free-form visit note.

When the SW receives a consult, a chart review for social history, demographic information, and previous functional status assessments is conducted. The SW then calls the patient to administer functional and cognitive assessments over the phone and refers the patient to appropriate services based on eligibility.

Clinic 3

Clinic 3 is a GeriPACT clinic where functional status information is routinely collected for all new patients but may or may not be collected for returning patients (eFigure 3, available at fedprac.com). The process for new patients includes a previsit SW assessment; an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit SW assessment if referred by the provider. The process for returning patients is similar but omits the previsit social work assessment. New patients complete a comprehensive questionnaire with a SW before their first clinic visit. The questionnaire is completed by phone and involves an extensive social and medical history, including an assessment of ADLs and IADLs. This assessment is recorded in a free-form social work note.

Next, both new and returning patients see an LPN who completes the intake process, including vitals and clinical reminders. Clinic 3 does not have a clinical reminder for functional status. However, the LPN could elect to ask about ADLs or IADLs if the patient brings up a functional issue related to the chief symptom or if the LPN observes something that indicates possible functional impairment, such as difficulty walking or a disheveled appearance. If discussed, this information is recorded in the LPN intake note, and the LPN also could verbally inform the PCP of the patient’s functional status. The RN is not formally involved in intake or functional status assessment in this clinic.

Finally, the patient sees the PCP, who may or may not have reviewed the LPN note. The PCP may assess functional status at his or her discretion, but there was no required assessment. The PCP could complete an optional functional status assessment template included in the PCP visit note. The PCP can refer the patient to services or to SW for further evaluation.

Clinic 4

Clinic 4 is a primary care PACT clinic that does not routinely measure functional status (eFigure 4, available at fedprac.com). The approach includes an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit social worker assessment if referred by the provider. These steps are very similar to those of clinic 3, but they do not include a previsit SW assessment for new patients.

Although not represented within the 4 clinics described in this article, the content of functional status clinical reminders differed across the 9 clinics in the larger sample. Clinical reminders differed across several domains, including the type of question stems (scripted questions for each ADL vs categories for each activity); response options (eg, dichotomous vs ≥ 3 options), and the presence of free-text boxes to allow staff to enter any additional notes.

Discussion

Approaches to assessing and documenting functional status varied widely. Whereas some clinics primarily used informal approaches to assessing and documenting functional status (ie, neither routine nor standardized), others used a routine, standardized clinical reminder, and some combined several standardized approaches to measuring function. The study team identified variability across several domains of the functional status assessment process, including documentation, workflow, and clinical reminder content.

Approaches to functional assessment differed between GeriPACT and PACT clinics. Consistent with the central role that functional status assessment plays in geriatrics practice, GeriPACTs tended to employ a routine, multidisciplinary approach to measuring functional status. This approach included standardized functional assessments by multiple primary care team members, including LPNs, SWs, and PCPs. In contrast, when PACTs completed standardized functional status assessment, it was generally carried out by a single team member (typically an LPN). The PCPs in PACTs used a nonroutine approach to assess functional status in which they performed detailed functional assessments for certain high-risk patients and referred a subset for further SW evaluation.

These processes are consistent with research showing that standardized functional status data are seldom collected routinely in nongeriatric primary care settings.¹¹ Reports by PCPs that they did not always assess functional status also are consistent with previous research demonstrating that clinicians are not always aware of their patients’ functional ability.¹⁰

In addition to highlighting differences between GeriPACT and PACTs, the identified processes illustrate the variability in documentation, clinic workflow, and clinical reminder content across all clinics. Approaches to documentation included checkbox-formatted clinical reminders with and without associated nursing notes, patient questionnaires, and templated PCP and SW notes. Clinics employed varying approaches to collect functional status information and to ensure that those data were shared with the team. Clinic staff assessed functional status at different times during the clinical encounter. Clinics used several approaches to share this information with team members, including warm handoffs from LPNs to PCPs, interdisciplinary team huddles, and electronic signoffs. Finally, clinical reminder content varied between clinics, with differences in the wording of ADL and IADL questions as well as in the number and type of response options.

This variability highlights the challenges inherent in developing a routine, standardized approach to measuring functional status that can be adapted across primary care settings. Such an approach must be both flexible enough to accommodate variation in workflow and structured enough to capture accurate data that can be used to guide clinical decisions. Capturing accurate, standardized data in CDW also will inform efforts to improve population health by allowing VHA leaders to understand the scope of disability among older veterans and plan for service needs and interventions.

Whereas the larger qualitative study will identify the specific barriers and facilitators to developing and implementing such an approach, current clinic processes present here offer hints as to which features may be important. For example, several clinics collected functional status information before the visit by telephone or questionnaire. Therefore, it will be important to choose a functional status assessment instrument that is validated for both telephone and in-person use. Similarly, some clinics had structured clinical reminders with categoric response options, whereas others included free-text boxes. Incorporating both categoric responses (to ensure accurate data) as well as free-text (to allow for additional notes about a patient’s specific circumstances that may influence service needs) may be one approach.

Limitations

This study’s approach to identifying clinic processes had several limitations. First, the authors did not send process maps to clinic directors for verification. However, speaking with PACT members who carry out clinic processes is likely the most accurate way to identify practice. Second, the results may not be generalizable to all VA primary care settings. Due to resource limitations and project scope, community-based outpatient clinics (CBOCs) were not included. Compared with clinics based in medical centers, CBOCs may have different staffing levels, practice models, and needs regarding implementation of functional status assessment.

Although 46 participants from 9 clinics were interviewed, there are likely additional approaches to measuring functional status that are not represented within this sample. In addition, 3 of the 4 clinics included are affiliated with academic institutions, and all 4 are located in large cities. Efforts to include rural VAMCs were not successful. Finally, clinic-level characteristics were not reported, which may impact clinic processes. Although study participants were asked about clinic characteristics, they were often unsure or only able to provide rough estimates. In the ongoing qualitative study, the authors will attempt to collect more reliable data about these clinic-level characteristics and to examine the potential role these characteristics may play as barriers or facilitators to implementing routine assessment of functional status in primary care settings.

Conclusion

VA primary care clinics had widely varying approaches for assessing and documenting functional status. This work along with a larger ongoing qualitative study that includes interviews with veterans will directly inform the design and implementation of a standardized, patient-centered approach to functional assessment that can be adapted across varied primary care settings. Implementing standardized functional status measurement will allow the VA to serve veterans better by using functional status information to refer patients to appropriate services and to deliver patient-centered care with the potential to improve patient function and quality of life.

The ability to perform activities of daily living (ADLs), commonly called functional status, is central to older adults’ quality of life (QOL) and independence.^1,2 Understanding functional status is key to improving outcomes for older adults. In community-dwelling older adults with difficulty performing basic ADLs, practical interventions, including physical and occupational therapy, can improve functioning and prevent functional decline.^3,4 Understanding function also is important for delivering patient-centered care, including individualizing cancer screening,⁵ evaluating how patients will tolerate interventions,^6-9 and helping patients and families determine the need for long-term services and supports.

For these reasons, assessing functional status is a cornerstone of geriatrics practice. However, most older adults are cared for in primary care settings where routine measurement of functional status is uncommon.^10,11 Although policy leaders have long noted this gap and the obstacle it poses to improving the quality and outcomes of care for older adults, many health care systems have been slow to incorporate measurement of functional status into routine patient care.^12-14

Over the past several years, the VA has been a leader in the efforts to address this barrier by implementing routine, standardized measurement of functional status in primary care clinics. Initially, the VA encouraged, but did not require, measurement of functional status among older adults, but the implementation barriers and facilitators were not formally assessed.¹⁵ In a postimplementation evaluation, the authors found that a relatively small number of medical centers implemented functional measures. Moreover, the level of implementation seemed to vary across sites. Some sites were collecting complete measures on all eligible older patients, while other sites were collecting measures less consistently.¹⁵

As part of a national VA initiative to learn how best to implement standardized functional status measurement, the authors are conducting a qualitative study, including a formal assessment of barriers and facilitators to implementing functional assessments in VA primary care clinics. In the current project, which serves as formative work for this larger ongoing study, the authors identified and described current processes for measuring functional status in VA primary care patient aligned care team (PACT) and Geriatric (GeriPACT) clinics.

Methods

A rapid qualitative analysis approach was used, which included semistructured interviews with primary care stakeholders and rapid data analysis to summarize each clinic’s approach to measuring functional status and develop process maps for each clinic (eFigures 1, 2, 3, and 4 ). Interviews and analyses were conducted by a team consisting of a geriatrician clinician-researcher, a medical anthropologist, and a research coordinator. The institutional review boards of the San Francisco VAMC and the University of California, San Francisco approved the study.

Sampling Strategy

In order to identify VAMCs with varying approaches to assessing functional status in older patients who attended primary care appointments, the study used a criterion sampling approach.^16,17 First, national “health factors” data were extracted from the VA Corporate Data Warehouse (CDW). Health factors are patient data collected through screening tools called clinical reminders, which prompt clinic staff and providers to enter data into checkbox-formatted templates. The study then identified medical centers that collected health factors data from patients aged ≥ 65 years (157 of 165 medical centers). A keyword search identified health factors related to the Katz ADL (bathing, dressing, transferring, toileting, and eating), and Lawton Instrumental ADL (IADL) Scale (using the telephone, shopping, preparing food, housekeeping, doing laundry, using transportation, managing medications, and managing finances).^18,19 Health factors that were not collected during a primary care appointment were excluded.

Of the original 157 medical centers, 139 met these initial inclusion criteria. Among these 139 medical centers, 66 centers did not collect complete data on these 5 ADLs and 8 IADLs (eg, only ADLs or only IADLs, or only certain ADLs or IADLs).

Two medical centers were selected in each of the following 3 categories: (1) routinely used clinical reminders to collect standardized data on the Katz ADL and the Lawton IADL Scale; (2) routinely used clinical reminders to collect functional status data but collected partial information; and (3) did not use a clinical reminder to collect functional status data. To ensure that these 6 medical centers were geographically representative, the sample included at least 1 site from each of the 5 VA regions: 1 North Atlantic, 1 Southeast, 1 Midwest, 2 Continental (1 from the northern Continental region and 1 from the southern), and 1 Pacific. Three sites that included GeriPACTs also were sampled.

Primary care PACT and GeriPACT members from these 6 medical centers were recruited to participate. These PACT members included individuals who can assess function or use functional status information to inform patient care, including front-line nursing staff (licensed practical nurses [LPNs], and registered nurses [RNs]), primary care providers (medical doctors [MDs] and nurse practitioners [NPs]), and social workers (SWs).

Local bargaining units, nurse managers, and clinic directors provided lists of all clinic staff. All members of each group then received recruitment e-mails. Phone interviews were scheduled with interested participants. In several cases, a snowball sampling approach was used to increase enrollment numbers by asking interview participants to recommend colleagues who might be interested in participating.¹⁷

Data Collection

Telephone interviews were conducted between March 2016 and October 2016 using semistructured guides developed from the project aims and from related literature in implementation science.^20,21 Interview domains included clinic structure, team member roles and responsibilities, current practices for collecting functional status data, and opinions on barriers and facilitators to assessing and recording functional status (Appendix:

Data Analysis

Rapid analysis, a team-based qualitative approach was used to engage efficiently and systematically with the data.^22,23 This approach allowed results to be analyzed more quickly than in traditional qualitative analysis in order to inform intervention design and develop implementation strategies.²³ Rapid analysis typically includes organization of interview data into summary templates, followed by a matrix analysis, which was used to create process maps.²⁴

Summary Templates

Summary templates were developed from the interview guides by shortening each question into a representative code. The project team then read the transcripts and summarized key points in the appropriate section of the template. This process, known as data reduction, is used to organize and highlight material so conclusions can be drawn from the data easily.²² In order to maintain rigor and trustworthiness, one team member conducted the interview, and a different team member created the interview summary. All team members reviewed each summary and met regularly to discuss results.

The summary templates were converted into matrix analyses, a method of displaying data to identify relationships, including commonalities and differences.²⁴ The matrixes were organized by stakeholder group and clinic in order to compare functional status assessment and documentation workflows across clinics.

Process Maps

Finally, the team used the matrix data to create process maps for each clinic of when, where, and by whom functional status information was assessed and documented. These maps were created using Microsoft Visio (Redmond, WA). The maps integrated perspectives from all participants to give an overview of the process for collecting functional status data in each clinic setting. To ensure accuracy, participants at each site received process maps to solicit feedback and validation.

Results

Forty-six participants at 6 medical centers (20 MDs and NPs, 19 RNs and LPNs, and 7 SWs) from 9 primary care clinics provided samples and interviews. The study team identified 3 general approaches to functional status assessment: (1) Routine collection of functional status data via a standardized clinical reminder; (2) Routine collection of functional status data via methods other than a clinical reminder (eg, a previsit telephone screen or electronic note template); and (3) Ad hoc approaches to measuring functional status (ie, no standard or routine approach to assessing or documenting functional status). The study team selected 4 clinics (2 PACTs and 2 GeriPACTs) clinics to serve as examples of the 3 identified approaches.

The processes for functional status assessment in each of 4 clinics are summarized in the following detailed descriptions (Table).

Clinic 1

Clinic 1 is a GeriPACT clinic that routinely assesses and documents functional status for all patients (efigure 1, available at feprac.com). The clinic’s current process includes 4 elements: (1) a patient questionnaire; (2) an annual clinical reminder administered by an RN; (3) a primary care provider (PCP) assessment; and (4) a postvisit SW assessment if referred by the PCP.

All newly referred patients are mailed a paper questionnaire that includes questions about their medical history and functional status. The patient is asked to bring the completed questionnaire to the first appointment. The clinic RN completes this form for returning patients at every visit during patient intake.

Second, the clinic uses an annual functional status clinical reminder for patients aged ≥ 75 years. The reminder includes questions about a patient’s ability to perform ADLs and IADLs with 3 to 4 response options for each question. If the clinical reminder is due at the time of a patient appointment, the RN fills out the reminder using information from the paper questionnaire. The RN also records this functional status in the nursing intake note. The RN may elect to designate the PCP as a cosigner for the nursing intake note especially if there are concerns about or changes in the patient’s functional status.

Third, the RN brings the paper form to the PCP, who often uses the questionnaire to guide the patient history. The PCP then uses the questionnaire and patient history to complete a functional status template within their visit note. The PCP also may use this information to inform patient care (eg, to make referrals to physical or occupational therapy).

Finally, the PCP might refer the patient to SW. The SW may be able to see the patient immediately after the PCP appointment, but if not, the SW follows up with a phone call to complete further functional status assessment and eligibility forms.

In addition to the above assessments by individual team members, the PACT has an interdisciplinary team huddle at the end of each clinic to discuss any issues or concerns about specific patients. The huddles often focus on issues related to functional status.

Clinic 2

Clinic 2 is a primary care PACT clinic that routinely assesses and documents functional status (eFigure 2, available at fedprac.com). The clinic process includes 3 steps: an annual clinical reminder for patients aged ≥ 75 years; a PCP assessment; and a postvisit SW assessment if referred by the PCP.

First, patients see an LPN for the intake process. During intake, the LPN records vitals and completes relevant clinical reminders. Similar to Clinic 1, Clinic 2 requires an annual functional status clinical reminder that includes ADLs and IADLs for patients aged ≥ 75 years. Patient information from the intake and clinical reminders are recorded by the LPN in a preventative medicine note in the electronic health record. This note is printed and handed to the PCP.

The PCP may review the preventative medicine note prior to completing the patient history and physical, including the functional status clinical reminder when applicable. If the PCP follows up on any functional issues identified by the LPN or completes further assessment of patient function, he or she may use this information to refer the patient to services or to place a SW consult; the PCP’s functional assessment is documented in a free-form visit note.

When the SW receives a consult, a chart review for social history, demographic information, and previous functional status assessments is conducted. The SW then calls the patient to administer functional and cognitive assessments over the phone and refers the patient to appropriate services based on eligibility.

Clinic 3

Clinic 3 is a GeriPACT clinic where functional status information is routinely collected for all new patients but may or may not be collected for returning patients (eFigure 3, available at fedprac.com). The process for new patients includes a previsit SW assessment; an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit SW assessment if referred by the provider. The process for returning patients is similar but omits the previsit social work assessment. New patients complete a comprehensive questionnaire with a SW before their first clinic visit. The questionnaire is completed by phone and involves an extensive social and medical history, including an assessment of ADLs and IADLs. This assessment is recorded in a free-form social work note.

Next, both new and returning patients see an LPN who completes the intake process, including vitals and clinical reminders. Clinic 3 does not have a clinical reminder for functional status. However, the LPN could elect to ask about ADLs or IADLs if the patient brings up a functional issue related to the chief symptom or if the LPN observes something that indicates possible functional impairment, such as difficulty walking or a disheveled appearance. If discussed, this information is recorded in the LPN intake note, and the LPN also could verbally inform the PCP of the patient’s functional status. The RN is not formally involved in intake or functional status assessment in this clinic.

Finally, the patient sees the PCP, who may or may not have reviewed the LPN note. The PCP may assess functional status at his or her discretion, but there was no required assessment. The PCP could complete an optional functional status assessment template included in the PCP visit note. The PCP can refer the patient to services or to SW for further evaluation.

Clinic 4

Clinic 4 is a primary care PACT clinic that does not routinely measure functional status (eFigure 4, available at fedprac.com). The approach includes an informal LPN screening (ie, not based on a standardized clinical reminder); a PCP assessment; and a postvisit social worker assessment if referred by the provider. These steps are very similar to those of clinic 3, but they do not include a previsit SW assessment for new patients.

Although not represented within the 4 clinics described in this article, the content of functional status clinical reminders differed across the 9 clinics in the larger sample. Clinical reminders differed across several domains, including the type of question stems (scripted questions for each ADL vs categories for each activity); response options (eg, dichotomous vs ≥ 3 options), and the presence of free-text boxes to allow staff to enter any additional notes.

Discussion

Approaches to assessing and documenting functional status varied widely. Whereas some clinics primarily used informal approaches to assessing and documenting functional status (ie, neither routine nor standardized), others used a routine, standardized clinical reminder, and some combined several standardized approaches to measuring function. The study team identified variability across several domains of the functional status assessment process, including documentation, workflow, and clinical reminder content.

Approaches to functional assessment differed between GeriPACT and PACT clinics. Consistent with the central role that functional status assessment plays in geriatrics practice, GeriPACTs tended to employ a routine, multidisciplinary approach to measuring functional status. This approach included standardized functional assessments by multiple primary care team members, including LPNs, SWs, and PCPs. In contrast, when PACTs completed standardized functional status assessment, it was generally carried out by a single team member (typically an LPN). The PCPs in PACTs used a nonroutine approach to assess functional status in which they performed detailed functional assessments for certain high-risk patients and referred a subset for further SW evaluation.

These processes are consistent with research showing that standardized functional status data are seldom collected routinely in nongeriatric primary care settings.¹¹ Reports by PCPs that they did not always assess functional status also are consistent with previous research demonstrating that clinicians are not always aware of their patients’ functional ability.¹⁰

In addition to highlighting differences between GeriPACT and PACTs, the identified processes illustrate the variability in documentation, clinic workflow, and clinical reminder content across all clinics. Approaches to documentation included checkbox-formatted clinical reminders with and without associated nursing notes, patient questionnaires, and templated PCP and SW notes. Clinics employed varying approaches to collect functional status information and to ensure that those data were shared with the team. Clinic staff assessed functional status at different times during the clinical encounter. Clinics used several approaches to share this information with team members, including warm handoffs from LPNs to PCPs, interdisciplinary team huddles, and electronic signoffs. Finally, clinical reminder content varied between clinics, with differences in the wording of ADL and IADL questions as well as in the number and type of response options.

This variability highlights the challenges inherent in developing a routine, standardized approach to measuring functional status that can be adapted across primary care settings. Such an approach must be both flexible enough to accommodate variation in workflow and structured enough to capture accurate data that can be used to guide clinical decisions. Capturing accurate, standardized data in CDW also will inform efforts to improve population health by allowing VHA leaders to understand the scope of disability among older veterans and plan for service needs and interventions.

Whereas the larger qualitative study will identify the specific barriers and facilitators to developing and implementing such an approach, current clinic processes present here offer hints as to which features may be important. For example, several clinics collected functional status information before the visit by telephone or questionnaire. Therefore, it will be important to choose a functional status assessment instrument that is validated for both telephone and in-person use. Similarly, some clinics had structured clinical reminders with categoric response options, whereas others included free-text boxes. Incorporating both categoric responses (to ensure accurate data) as well as free-text (to allow for additional notes about a patient’s specific circumstances that may influence service needs) may be one approach.

Limitations

This study’s approach to identifying clinic processes had several limitations. First, the authors did not send process maps to clinic directors for verification. However, speaking with PACT members who carry out clinic processes is likely the most accurate way to identify practice. Second, the results may not be generalizable to all VA primary care settings. Due to resource limitations and project scope, community-based outpatient clinics (CBOCs) were not included. Compared with clinics based in medical centers, CBOCs may have different staffing levels, practice models, and needs regarding implementation of functional status assessment.

Although 46 participants from 9 clinics were interviewed, there are likely additional approaches to measuring functional status that are not represented within this sample. In addition, 3 of the 4 clinics included are affiliated with academic institutions, and all 4 are located in large cities. Efforts to include rural VAMCs were not successful. Finally, clinic-level characteristics were not reported, which may impact clinic processes. Although study participants were asked about clinic characteristics, they were often unsure or only able to provide rough estimates. In the ongoing qualitative study, the authors will attempt to collect more reliable data about these clinic-level characteristics and to examine the potential role these characteristics may play as barriers or facilitators to implementing routine assessment of functional status in primary care settings.

Conclusion

VA primary care clinics had widely varying approaches for assessing and documenting functional status. This work along with a larger ongoing qualitative study that includes interviews with veterans will directly inform the design and implementation of a standardized, patient-centered approach to functional assessment that can be adapted across varied primary care settings. Implementing standardized functional status measurement will allow the VA to serve veterans better by using functional status information to refer patients to appropriate services and to deliver patient-centered care with the potential to improve patient function and quality of life.

Woman dies following cervical cone biopsy: $4.25M award  

A 46-year-old woman underwent a cervical cone biopsy at a Veterans Administration (VA) hospital on July 18. Following the test, significant bleeding occurred. The gynecologic surgeon attempted to control the hemorrhage by injecting ferric subsulfate (Monsel’s) solution into the patient’s vagina. The bleeding abated, but the patient went into hypovolemic shock. During emergency laparotomy, a uterine perforation and injuries to both uterine arteries were detected. A hysterectomy was performed to stop the hemorrhage. The patient improved at first, but developed sepsis, small-bowel necrosis, and other complications. A bowel resection procedure was performed on July 26. She died on September 5.

ESTATE'S CLAIM:
The surgeon’s actions were negligent. She removed too much tissue during the biopsy, injured the vaginal and uterine walls, and failed to timely diagnose and appropriately treat the injuries. The ferric subsulfate solution entered the abdominal cavity via the perforation, causing peritonitis and bowel injuries. A pathology report from the bowel resection surgery informed the surgeon that the bowel was not properly reconnected after the damaged portion was removed, but this condition was neither detected intraoperatively nor treated postoperatively.

DEFENDANTS' DEFENSE:
The surgeon moved for summary judgment, countering that, as a federal employee, she was exempt from personal liability for the services performed as an employee of the VA. That motion was denied. She then argued that injury to the vaginal/uterine wall is a known complication of the biopsy procedure.

VERDICT:
A $4.25 million Illinois verdict was returned in federal court.

Related article:
Reducing maternal mortality in the United States—Let’s get organized!

Needle stick not reported to patient

A woman delivered a baby assisted by an on-call ObGyn. When the baby developed fetal tachycardia, the ObGyn recommended expediting delivery and discussed various options and the risks of each option. The mother chose a vaginal forceps delivery. During the procedure, the mother experienced a 3rd-degree perineal laceration and a few minor lacerations, which were repaired. The mother was in pain, so the ObGyn performed a revision repair. During the procedure, the ObGyn accidentally stuck himself with a clean needle. He replaced the needle and changed his glove. The mother reported instant pain relief following revision and was discharged. After the needle incident, the ObGyn’s thumb became red and swollen, so he took antibiotics.

Two days after discharge, the patient reported to the ObGyn’s office with fever, pain, and a foul odor emanating from the surgery site. She was given the diagnosis of pelvic incisional cellulitis and was taken to the operating room for exploration and debridement. The patient developed septic shock and necrotizing fasciitis. She was placed on a ventilator and underwent 13 surgeries.

PATIENTS' CLAIM:
The ObGyn was negligent. The patient claimed breach of duty: the ObGyn did not disclose that his thumb was swollen and that he took antibiotics.

PHYSICIANS' DEFENSE:
There was no breach of duty. He did not feel the need to concern the patient about an injury to himself that did not affect her.

VERDICT:
A Kansas defense verdict was returned.

Related article:
2017 Update on infectious disease

Catheter removal, air embolism: $3.5M settlement

A 44-year-old woman underwent gynecologic surgery on April 22. She developed a rectovaginal fistula and other complications. Intravenous antibiotics were required and parenteral nutrition was delivered through a central venous catheter. On May 22, after a hospital nurse removed the catheter, an air embolism developed, causing a brain injury. The patient has a mental disability and residual leg tremors.

PATIENTS' CLAIM:
Because of the surgeon’s negligence during surgery, a fistula developed. The nurse negligently removed the catheter, causing the embolism.

DEFENDANTS' DEFENSE:
The case settled during the trial.

VERDICT:
A $3.5 million Illinois settlement was reached, including payments of $1 million from the surgeon and $2.5 million from the hospital.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Woman dies following cervical cone biopsy: $4.25M award  

A 46-year-old woman underwent a cervical cone biopsy at a Veterans Administration (VA) hospital on July 18. Following the test, significant bleeding occurred. The gynecologic surgeon attempted to control the hemorrhage by injecting ferric subsulfate (Monsel’s) solution into the patient’s vagina. The bleeding abated, but the patient went into hypovolemic shock. During emergency laparotomy, a uterine perforation and injuries to both uterine arteries were detected. A hysterectomy was performed to stop the hemorrhage. The patient improved at first, but developed sepsis, small-bowel necrosis, and other complications. A bowel resection procedure was performed on July 26. She died on September 5.

ESTATE'S CLAIM:
The surgeon’s actions were negligent. She removed too much tissue during the biopsy, injured the vaginal and uterine walls, and failed to timely diagnose and appropriately treat the injuries. The ferric subsulfate solution entered the abdominal cavity via the perforation, causing peritonitis and bowel injuries. A pathology report from the bowel resection surgery informed the surgeon that the bowel was not properly reconnected after the damaged portion was removed, but this condition was neither detected intraoperatively nor treated postoperatively.

DEFENDANTS' DEFENSE:
The surgeon moved for summary judgment, countering that, as a federal employee, she was exempt from personal liability for the services performed as an employee of the VA. That motion was denied. She then argued that injury to the vaginal/uterine wall is a known complication of the biopsy procedure.

VERDICT:
A $4.25 million Illinois verdict was returned in federal court.

Related article:
Reducing maternal mortality in the United States—Let’s get organized!

Needle stick not reported to patient

A woman delivered a baby assisted by an on-call ObGyn. When the baby developed fetal tachycardia, the ObGyn recommended expediting delivery and discussed various options and the risks of each option. The mother chose a vaginal forceps delivery. During the procedure, the mother experienced a 3rd-degree perineal laceration and a few minor lacerations, which were repaired. The mother was in pain, so the ObGyn performed a revision repair. During the procedure, the ObGyn accidentally stuck himself with a clean needle. He replaced the needle and changed his glove. The mother reported instant pain relief following revision and was discharged. After the needle incident, the ObGyn’s thumb became red and swollen, so he took antibiotics.

Two days after discharge, the patient reported to the ObGyn’s office with fever, pain, and a foul odor emanating from the surgery site. She was given the diagnosis of pelvic incisional cellulitis and was taken to the operating room for exploration and debridement. The patient developed septic shock and necrotizing fasciitis. She was placed on a ventilator and underwent 13 surgeries.

PATIENTS' CLAIM:
The ObGyn was negligent. The patient claimed breach of duty: the ObGyn did not disclose that his thumb was swollen and that he took antibiotics.

PHYSICIANS' DEFENSE:
There was no breach of duty. He did not feel the need to concern the patient about an injury to himself that did not affect her.

VERDICT:
A Kansas defense verdict was returned.

Related article:
2017 Update on infectious disease

Catheter removal, air embolism: $3.5M settlement

A 44-year-old woman underwent gynecologic surgery on April 22. She developed a rectovaginal fistula and other complications. Intravenous antibiotics were required and parenteral nutrition was delivered through a central venous catheter. On May 22, after a hospital nurse removed the catheter, an air embolism developed, causing a brain injury. The patient has a mental disability and residual leg tremors.

PATIENTS' CLAIM:
Because of the surgeon’s negligence during surgery, a fistula developed. The nurse negligently removed the catheter, causing the embolism.

DEFENDANTS' DEFENSE:
The case settled during the trial.

VERDICT:
A $3.5 million Illinois settlement was reached, including payments of $1 million from the surgeon and $2.5 million from the hospital.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Woman dies following cervical cone biopsy: $4.25M award  

A 46-year-old woman underwent a cervical cone biopsy at a Veterans Administration (VA) hospital on July 18. Following the test, significant bleeding occurred. The gynecologic surgeon attempted to control the hemorrhage by injecting ferric subsulfate (Monsel’s) solution into the patient’s vagina. The bleeding abated, but the patient went into hypovolemic shock. During emergency laparotomy, a uterine perforation and injuries to both uterine arteries were detected. A hysterectomy was performed to stop the hemorrhage. The patient improved at first, but developed sepsis, small-bowel necrosis, and other complications. A bowel resection procedure was performed on July 26. She died on September 5.

ESTATE'S CLAIM:
The surgeon’s actions were negligent. She removed too much tissue during the biopsy, injured the vaginal and uterine walls, and failed to timely diagnose and appropriately treat the injuries. The ferric subsulfate solution entered the abdominal cavity via the perforation, causing peritonitis and bowel injuries. A pathology report from the bowel resection surgery informed the surgeon that the bowel was not properly reconnected after the damaged portion was removed, but this condition was neither detected intraoperatively nor treated postoperatively.

DEFENDANTS' DEFENSE:
The surgeon moved for summary judgment, countering that, as a federal employee, she was exempt from personal liability for the services performed as an employee of the VA. That motion was denied. She then argued that injury to the vaginal/uterine wall is a known complication of the biopsy procedure.

VERDICT:
A $4.25 million Illinois verdict was returned in federal court.

Related article:
Reducing maternal mortality in the United States—Let’s get organized!

Needle stick not reported to patient

A woman delivered a baby assisted by an on-call ObGyn. When the baby developed fetal tachycardia, the ObGyn recommended expediting delivery and discussed various options and the risks of each option. The mother chose a vaginal forceps delivery. During the procedure, the mother experienced a 3rd-degree perineal laceration and a few minor lacerations, which were repaired. The mother was in pain, so the ObGyn performed a revision repair. During the procedure, the ObGyn accidentally stuck himself with a clean needle. He replaced the needle and changed his glove. The mother reported instant pain relief following revision and was discharged. After the needle incident, the ObGyn’s thumb became red and swollen, so he took antibiotics.

Two days after discharge, the patient reported to the ObGyn’s office with fever, pain, and a foul odor emanating from the surgery site. She was given the diagnosis of pelvic incisional cellulitis and was taken to the operating room for exploration and debridement. The patient developed septic shock and necrotizing fasciitis. She was placed on a ventilator and underwent 13 surgeries.

PATIENTS' CLAIM:
The ObGyn was negligent. The patient claimed breach of duty: the ObGyn did not disclose that his thumb was swollen and that he took antibiotics.

PHYSICIANS' DEFENSE:
There was no breach of duty. He did not feel the need to concern the patient about an injury to himself that did not affect her.

VERDICT:
A Kansas defense verdict was returned.

Related article:
2017 Update on infectious disease

Catheter removal, air embolism: $3.5M settlement

A 44-year-old woman underwent gynecologic surgery on April 22. She developed a rectovaginal fistula and other complications. Intravenous antibiotics were required and parenteral nutrition was delivered through a central venous catheter. On May 22, after a hospital nurse removed the catheter, an air embolism developed, causing a brain injury. The patient has a mental disability and residual leg tremors.

PATIENTS' CLAIM:
Because of the surgeon’s negligence during surgery, a fistula developed. The nurse negligently removed the catheter, causing the embolism.

DEFENDANTS' DEFENSE:
The case settled during the trial.

VERDICT:
A $3.5 million Illinois settlement was reached, including payments of $1 million from the surgeon and $2.5 million from the hospital.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

I recently received a group text from a friend voicing her frustration that her neighbor had acquired chickens, and she shared a photo of some roaming freely in the front yard. Naturally, my response was related to the potential infectious disease exposure and infections. Another friend chimed in “fresh eggs, and these are free range chickens. They don’t get sick. ... Many people in my area have chickens.” Unbeknownst to my friends, they had helped me select the ID Consult topic for this month.

Nontyphoidal Salmonella bacteria are associated with a wide spectrum of infections which range from asymptomatic gastrointestinal carriage to bacteremia, meningitis, osteomyelitis, and focal infections. Invasive disease is seen most often in children younger than 5 years of age, persons aged 65 years or older, and individuals with hemoglobinopathies including sickle cell disease and those with immunodeficiencies. Annually, the Centers for Disease Control and Prevention estimates that nontyphoidal salmonellosis is responsible for 1.2 million illnesses, 23,000 hospitalizations, and 450 deaths in the United States. Gastroenteritis is the most common manifestation of the disease and is characterized by abdominal cramps, diarrhea, and fever that develops 12-72 hours after exposure. It is usually self-limited. As previously reported in this column (June, 2017), Salmonella is one of the top two foodborne pathogens in the United States, and most outbreaks have been associated with consumption of contaminated food. But wait, contaminated food is not the only cause of some of our most recent outbreaks.

JasonJiron/Thinkstock

Live poultry-associated salmonellosis (LPAS)

LPAS was first reported in the 1950s. More recent epidemiologic data was published by C. Basler et al. (Emerging Infect Dis. 2016;22[10]:1705-11). LPAS was defined as two or more culture confirmed human Salmonella infections with a combination of epidemiologic, laboratory, or traceback evidence linking illnesses to contact with live poultry. From 1990 to 2014, a total of 53 LPAS outbreaks in the United States were documented and associated with 2,630 illnesses, 387 hospitalizations, and 5 deaths. The median outbreak size involved 26 cases (range, 4-363) and 77% (41 of 53) were multistate. The median age of the patients was 9 years (range, less than 1 to 92 years), and 31% were aged 5 years or younger. Exposure to chicks and ducklings was reported in 85% and 38%, respectively. High-risk practices included keeping poultry inside of the home (46%), snuggling baby birds (49%), and kissing baby birds (13%). The median time from purchase of poultry to onset of illness was 17 days (range, 1-672), and 66% reported onset of illness less than 30 days after purchase. Almost 52% reported owning poultry for less than 1 year.

The number of outbreaks continued to increase. From 1990 to 2005, there were a total of 17 outbreaks, compared with 36 between 2006 and 2014. Historically, outbreaks occurred in children around Easter when brightly colored dyed chicks were purchased. In the above review, 80% of outbreaks began in February, March, or April with an average duration of 4.9 months (range, 1-12).

Salmonella isolates

Backyard flocks and LPAS

More recently outbreaks have been associated with backyard flocks occurring year round and affecting both adults and children in contrast to seasonal peaks. The first multistate backyard flock outbreak was documented in 2007. Currently, the CDC is investigating 10 separate multistate outbreaks that began on Jan. 4, 2017. It involves 48 states, 961 infected individuals, 215 hospitalizations, and 1 death. At least 5 salmonella serotypes have been isolated.

What about the hatcheries?

It’s estimated that 50 million live poultry are sold annually. Birds are shipped within 24 hours after hatching via the U.S. Postal Service in boxes containing up to 100 chicks. Delivery occurs within 72 hours of hatching. Approximately 20 mail order hatcheries provide the majority of poultry sold to the general public. The National Poultry Improvement Plan (NPIP) is a voluntary state and federal testing and certification program whose goal is to eliminate poultry disease from breeder flocks to prevent egg-transmitted and hatchery-disseminated diseases. All hatcheries may participate. They also may participate in the voluntary Salmonella monitoring program. Note participation is not mandatory.

Preventing future outbreaks: patient/parental education is mandatory

1. Make sure your parents know about the association of Salmonella and live poultry. Reinforce these are farm animals, not pets. Purchase birds from hatcheries that participate in NPIP and the Salmonella monitoring programs.

2. Chicks, ducklings, or other live poultry should not be taken to schools, day care facilities, or nursing homes. Poultry should not be allowed in the home or in areas where food or drink is being prepared or consumed.

3. Poultry should not be snuggled, kissed, or allowed to touch one’s mouth. Hand washing with soap and water should occur after touching live poultry or any object touched in areas where they live or roam.

4. Contact with live poultry should be avoided in those at risk for developing serious infections including persons aged 5 years or younger, 65 years or older, immunocompromised individuals, and those with hemoglobinopathies.

5. All equipment used to care for live birds should be washed outdoors. Owners should have designated shoes when caring for poultry which should never be worn inside the home.

Hopefully, the next time you see a patient with fever and diarrhea you will recall this topic and ask about their contact with live poultry.

Additional resources to facilitate discussions can be found at www.cdc.gov/salmonella.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.

I recently received a group text from a friend voicing her frustration that her neighbor had acquired chickens, and she shared a photo of some roaming freely in the front yard. Naturally, my response was related to the potential infectious disease exposure and infections. Another friend chimed in “fresh eggs, and these are free range chickens. They don’t get sick. ... Many people in my area have chickens.” Unbeknownst to my friends, they had helped me select the ID Consult topic for this month.

Nontyphoidal Salmonella bacteria are associated with a wide spectrum of infections which range from asymptomatic gastrointestinal carriage to bacteremia, meningitis, osteomyelitis, and focal infections. Invasive disease is seen most often in children younger than 5 years of age, persons aged 65 years or older, and individuals with hemoglobinopathies including sickle cell disease and those with immunodeficiencies. Annually, the Centers for Disease Control and Prevention estimates that nontyphoidal salmonellosis is responsible for 1.2 million illnesses, 23,000 hospitalizations, and 450 deaths in the United States. Gastroenteritis is the most common manifestation of the disease and is characterized by abdominal cramps, diarrhea, and fever that develops 12-72 hours after exposure. It is usually self-limited. As previously reported in this column (June, 2017), Salmonella is one of the top two foodborne pathogens in the United States, and most outbreaks have been associated with consumption of contaminated food. But wait, contaminated food is not the only cause of some of our most recent outbreaks.

JasonJiron/Thinkstock

Live poultry-associated salmonellosis (LPAS)

LPAS was first reported in the 1950s. More recent epidemiologic data was published by C. Basler et al. (Emerging Infect Dis. 2016;22[10]:1705-11). LPAS was defined as two or more culture confirmed human Salmonella infections with a combination of epidemiologic, laboratory, or traceback evidence linking illnesses to contact with live poultry. From 1990 to 2014, a total of 53 LPAS outbreaks in the United States were documented and associated with 2,630 illnesses, 387 hospitalizations, and 5 deaths. The median outbreak size involved 26 cases (range, 4-363) and 77% (41 of 53) were multistate. The median age of the patients was 9 years (range, less than 1 to 92 years), and 31% were aged 5 years or younger. Exposure to chicks and ducklings was reported in 85% and 38%, respectively. High-risk practices included keeping poultry inside of the home (46%), snuggling baby birds (49%), and kissing baby birds (13%). The median time from purchase of poultry to onset of illness was 17 days (range, 1-672), and 66% reported onset of illness less than 30 days after purchase. Almost 52% reported owning poultry for less than 1 year.

The number of outbreaks continued to increase. From 1990 to 2005, there were a total of 17 outbreaks, compared with 36 between 2006 and 2014. Historically, outbreaks occurred in children around Easter when brightly colored dyed chicks were purchased. In the above review, 80% of outbreaks began in February, March, or April with an average duration of 4.9 months (range, 1-12).

Salmonella isolates

Backyard flocks and LPAS

More recently outbreaks have been associated with backyard flocks occurring year round and affecting both adults and children in contrast to seasonal peaks. The first multistate backyard flock outbreak was documented in 2007. Currently, the CDC is investigating 10 separate multistate outbreaks that began on Jan. 4, 2017. It involves 48 states, 961 infected individuals, 215 hospitalizations, and 1 death. At least 5 salmonella serotypes have been isolated.

What about the hatcheries?

It’s estimated that 50 million live poultry are sold annually. Birds are shipped within 24 hours after hatching via the U.S. Postal Service in boxes containing up to 100 chicks. Delivery occurs within 72 hours of hatching. Approximately 20 mail order hatcheries provide the majority of poultry sold to the general public. The National Poultry Improvement Plan (NPIP) is a voluntary state and federal testing and certification program whose goal is to eliminate poultry disease from breeder flocks to prevent egg-transmitted and hatchery-disseminated diseases. All hatcheries may participate. They also may participate in the voluntary Salmonella monitoring program. Note participation is not mandatory.

Preventing future outbreaks: patient/parental education is mandatory

1. Make sure your parents know about the association of Salmonella and live poultry. Reinforce these are farm animals, not pets. Purchase birds from hatcheries that participate in NPIP and the Salmonella monitoring programs.

2. Chicks, ducklings, or other live poultry should not be taken to schools, day care facilities, or nursing homes. Poultry should not be allowed in the home or in areas where food or drink is being prepared or consumed.

3. Poultry should not be snuggled, kissed, or allowed to touch one’s mouth. Hand washing with soap and water should occur after touching live poultry or any object touched in areas where they live or roam.

4. Contact with live poultry should be avoided in those at risk for developing serious infections including persons aged 5 years or younger, 65 years or older, immunocompromised individuals, and those with hemoglobinopathies.

5. All equipment used to care for live birds should be washed outdoors. Owners should have designated shoes when caring for poultry which should never be worn inside the home.

Hopefully, the next time you see a patient with fever and diarrhea you will recall this topic and ask about their contact with live poultry.

Additional resources to facilitate discussions can be found at www.cdc.gov/salmonella.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.

I recently received a group text from a friend voicing her frustration that her neighbor had acquired chickens, and she shared a photo of some roaming freely in the front yard. Naturally, my response was related to the potential infectious disease exposure and infections. Another friend chimed in “fresh eggs, and these are free range chickens. They don’t get sick. ... Many people in my area have chickens.” Unbeknownst to my friends, they had helped me select the ID Consult topic for this month.

Nontyphoidal Salmonella bacteria are associated with a wide spectrum of infections which range from asymptomatic gastrointestinal carriage to bacteremia, meningitis, osteomyelitis, and focal infections. Invasive disease is seen most often in children younger than 5 years of age, persons aged 65 years or older, and individuals with hemoglobinopathies including sickle cell disease and those with immunodeficiencies. Annually, the Centers for Disease Control and Prevention estimates that nontyphoidal salmonellosis is responsible for 1.2 million illnesses, 23,000 hospitalizations, and 450 deaths in the United States. Gastroenteritis is the most common manifestation of the disease and is characterized by abdominal cramps, diarrhea, and fever that develops 12-72 hours after exposure. It is usually self-limited. As previously reported in this column (June, 2017), Salmonella is one of the top two foodborne pathogens in the United States, and most outbreaks have been associated with consumption of contaminated food. But wait, contaminated food is not the only cause of some of our most recent outbreaks.

JasonJiron/Thinkstock

Live poultry-associated salmonellosis (LPAS)

LPAS was first reported in the 1950s. More recent epidemiologic data was published by C. Basler et al. (Emerging Infect Dis. 2016;22[10]:1705-11). LPAS was defined as two or more culture confirmed human Salmonella infections with a combination of epidemiologic, laboratory, or traceback evidence linking illnesses to contact with live poultry. From 1990 to 2014, a total of 53 LPAS outbreaks in the United States were documented and associated with 2,630 illnesses, 387 hospitalizations, and 5 deaths. The median outbreak size involved 26 cases (range, 4-363) and 77% (41 of 53) were multistate. The median age of the patients was 9 years (range, less than 1 to 92 years), and 31% were aged 5 years or younger. Exposure to chicks and ducklings was reported in 85% and 38%, respectively. High-risk practices included keeping poultry inside of the home (46%), snuggling baby birds (49%), and kissing baby birds (13%). The median time from purchase of poultry to onset of illness was 17 days (range, 1-672), and 66% reported onset of illness less than 30 days after purchase. Almost 52% reported owning poultry for less than 1 year.

The number of outbreaks continued to increase. From 1990 to 2005, there were a total of 17 outbreaks, compared with 36 between 2006 and 2014. Historically, outbreaks occurred in children around Easter when brightly colored dyed chicks were purchased. In the above review, 80% of outbreaks began in February, March, or April with an average duration of 4.9 months (range, 1-12).

Salmonella isolates

Backyard flocks and LPAS

More recently outbreaks have been associated with backyard flocks occurring year round and affecting both adults and children in contrast to seasonal peaks. The first multistate backyard flock outbreak was documented in 2007. Currently, the CDC is investigating 10 separate multistate outbreaks that began on Jan. 4, 2017. It involves 48 states, 961 infected individuals, 215 hospitalizations, and 1 death. At least 5 salmonella serotypes have been isolated.

What about the hatcheries?

It’s estimated that 50 million live poultry are sold annually. Birds are shipped within 24 hours after hatching via the U.S. Postal Service in boxes containing up to 100 chicks. Delivery occurs within 72 hours of hatching. Approximately 20 mail order hatcheries provide the majority of poultry sold to the general public. The National Poultry Improvement Plan (NPIP) is a voluntary state and federal testing and certification program whose goal is to eliminate poultry disease from breeder flocks to prevent egg-transmitted and hatchery-disseminated diseases. All hatcheries may participate. They also may participate in the voluntary Salmonella monitoring program. Note participation is not mandatory.

Preventing future outbreaks: patient/parental education is mandatory

1. Make sure your parents know about the association of Salmonella and live poultry. Reinforce these are farm animals, not pets. Purchase birds from hatcheries that participate in NPIP and the Salmonella monitoring programs.

2. Chicks, ducklings, or other live poultry should not be taken to schools, day care facilities, or nursing homes. Poultry should not be allowed in the home or in areas where food or drink is being prepared or consumed.

3. Poultry should not be snuggled, kissed, or allowed to touch one’s mouth. Hand washing with soap and water should occur after touching live poultry or any object touched in areas where they live or roam.

4. Contact with live poultry should be avoided in those at risk for developing serious infections including persons aged 5 years or younger, 65 years or older, immunocompromised individuals, and those with hemoglobinopathies.

5. All equipment used to care for live birds should be washed outdoors. Owners should have designated shoes when caring for poultry which should never be worn inside the home.

Hopefully, the next time you see a patient with fever and diarrhea you will recall this topic and ask about their contact with live poultry.

Additional resources to facilitate discussions can be found at www.cdc.gov/salmonella.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.

Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.

Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).

The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.

The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.

The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.

However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.

The researchers had no financial conflicts to disclose.

Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.

Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).

The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.

The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.

The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.

However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.

The researchers had no financial conflicts to disclose.

Adjuvant chemotherapy was associated with improved overall survival rates at 3 years in patients who had surgery for gastroesophageal cancer, based on retrospective data from more than 10,000 adults.

Preoperative chemoradiotherapy and resection has shown benefits in patients with gastroesophageal adenocarcinoma, but the potential benefits of adjuvant chemotherapy (AC) after surgery in these patients has not been well studied, wrote Ali A. El Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (JAMA Oncol. 2017 Sep 21. doi: 10.1001/jamaoncol.2017.2805).

The researchers reviewed data from 10,086 patients in the National Cancer Database during 2006-2013. Of these, 814 (8%) received adjuvant chemotherapy after surgery and 9,272 (94%) received no additional intervention beyond postoperative observation. The average age of the patients was 61 years, and 88% were men.

The average survival rates at 3 years after surgery were 40 months for the adjuvant group and 34 months for the observation group (hazard ratio, 0.79). The overall survival rates in the adjuvant group were 94%, 54%, and 38% at 1,3, and 5 years, respectively, compared with rates of 88%, 47%, and 34%, in the observation group.

The findings were limited in part by the retrospective nature of the study, the researchers said. In addition, “the estimated effect of AC on overall survival is subject to selection bias and immortal time bias given that the study was observational,” they noted.

However, the results support the addition of chemotherapy for gastroesophageal surgery patients, and “provide compelling motivation to explore the potential benefit of adjuvant chemotherapy in a randomized clinical trial,” they said. “A two-arm phase 2 trial design using recurrence-free survival as a primary endpoint is an appealing first step,” they added.

The researchers had no financial conflicts to disclose.

Performance of 6 bedside procedures (paracentesis, thoracentesis, lumbar puncture, arthrocentesis, central venous catheter [CVC] placement, and arterial line placement) are considered core competencies for hospitalists.¹ Yet, the American Board of Internal Medicine (ABIM) no longer requires demonstration of manual competency for bedside procedures, and graduates may enter the workforce with minimal or no experience performing such procedures.² As such, the burden falls on hospital privileging committees to ensure providers have the necessary training and experience to competently perform invasive procedures before granting institutional privileges to perform them.³ Although recommendations for privileging to perform certain surgical procedures have been proposed,^4,5 there are no widely accepted guidelines for initial or ongoing privileging of common invasive bedside procedures performed by hospitalists, and current privileging practices vary significantly.

In 2015, the Society of Hospital Medicine (SHM) set up a Point-of-Care Ultrasound (POCUS) Task Force to draft evidence-based guidelines on the use of ultrasound to perform bedside procedures. The recommendations for certification of competency in ultrasound-guided procedures may guide institutional privileging. The purpose of this study was to better understand current hospital privileging practices for invasive bedside procedures both with and without ultrasound guidance and how current practices are perceived by experts.

Study Design, Setting, and Participants

After approval by the University of Texas Health Science Center at San Antonio Institutional Review Board, we conducted a survey of hospital privileging processes for bedside procedures from a convenience sample of hospitalist procedure experts on the SHM POCUS Task Force. All 21 hospitalists on the task force were invited to participate, including the authors of this article. These hospitalists represent 21 unique institutions, and all have clinical, educational, and/or research expertise in ultrasound-guided bedside procedures.

Survey Design

A 26-question, electronic survey on privileging for bedside procedures was conducted (Appendix A). Twenty questions addressed procedures in general, such as minimum numbers of procedures required and use of simulation. Six questions focused on the use of ultrasound guidance. To provide context, many questions were framed to assess a privileging process being drafted by the task force. Answers were either multiple choice or free text.

Data Collection and Analysis

All members of the task force were invited to complete the survey by e-mail during November 2016. A reminder e-mail was sent on the day after initial distribution. No compensation was offered, and participation was not required. Survey results were compiled electronically through Research Electronic Data Capture, or “REDCap”^TM (Nashville, Tennessee), and data analysis was performed with Stata version 14 (College Station, Texas). Means of current and recommended minimum thresholds were calculated by excluding responses of “I don’t know,” and responses of “no minimum number threshold” were coded as 0.

The survey response rate was 100% (21 of 21). All experts were hospitalists, but 2 also identified themselves as intensivists. Experts practiced in a variety of hospital settings, including private university hospitals (43%), public university hospitals (19%), Veterans Affairs teaching hospitals (14%), community teaching hospitals (14%), and community nonteaching hospitals (10%). Most hospitals (90%) were teaching hospitals for internal medicine trainees. All experts have personally performed bedside procedures on a regular basis, and most (86%) had leadership roles in teaching procedures to students, residents, fellows, physician assistants, nurse practitioners, and/or physicians. Approximately half (57%) were involved in granting privileges for bedside procedures at their institutions.

Our survey identified 3 distinct differences between hospitalist procedure experts’ recommendations and their own hospitals’ current privileging practices. First, whereas experts recommended ultrasound guidance for thoracentesis, paracentesis, and CVC placement, it is rarely a current requirement. Second, experts recommend requiring minimum numbers of procedures for both initial and ongoing privileging even though such minimums are not currently required at half of their hospitals. Third, recommended minimum numbers were generally higher than those currently in place.

The routine use of ultrasound guidance for thoracentesis, paracentesis, and CVC placement is likely a result of increased adoption based on the literature showing clinical benefits.^6-9 Thus, the expert recommendations for required use of ultrasound guidance for these procedures seems both appropriate and feasible. The procedure minimums identified in our study are similar to prior ABIM guidelines when manual competency was required for board certification in internal medicine and are comparable to recent minimums proposed by the Society of Critical Care Medicine, both of which recommended a minimum of 5 to 10 per procedure.^10,11 Nevertheless, no commonly agreed-upon minimum number of procedures currently exists for certification of competency, and the variability seen in the experts’ responses further supports the idea that no specific number will guarantee competence. Thus, while requiring minimum numbers of procedures was generally considered necessary by our experts, minimums alone were also considered insufficient for initial privileging because most recommended that direct observation and simulation should be part of an initial privileging process.

These findings encourage more rigorous requirements for both initial and ongoing privileging of procedures. Nevertheless, our findings were rarely unanimous. The most frequently cited reason for disagreement on our findings was feasibility and capacity for direct observation, and the absence of ultrasound equipment or simulators, particularly in resource-limited clinical environments.

Our study has several strengths and limitations. One strength is the recruitment of study experts specifically composed of hospitalist procedure experts from diverse geographic and hospital settings. Yet, we acknowledge that our findings may not be generalizable to other specialties. Another strength is we obtained 100% participation from the experts surveyed. Weaknesses of this study include the relatively small number of experts who are likely to be biased in favor of both the use of ultrasound guidance and higher standards for privileging. We also relied on self-reported data about privileging processes rather than direct observation of those practices. Finally, questions were framed in the context of only 1 possible privileging pathway, and experts may respond differently to a different framing.

Our findings may guide the development of more standardized frameworks for initial and ongoing privileging of hospitalists for invasive bedside procedures. In particular, additional privileging requirements may include the routine use of ultrasound guidance for paracentesis, thoracentesis, and CVC insertion; simulation preceding direct observation of manual skills if possible; and higher required minimums of procedures for both initial and ongoing privileging. The goal of a standardized framework for privileging should be directed at improving the quality and safety of bedside procedures but must consider feasibility in diverse clinical settings where hospitalists work.

Acknowledgments

The authors thank the hospitalists on the SHM POCUS Task Force who provided data about their institutions’ privileging processes and requirements. They are also grateful to Loretta M. Grikis, MLS, AHIP, at the White River Junction Veterans Affairs Medical Center for her assistance as a medical librarian.

Disclosure

Brian P. Lucas (U.S. Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Dartmouth SYNERGY, and the National Institutes of Health National Center for Advancing Translational Sciences [UL1TR001086]). Nilam Soni (U.S. Department of Veterans Affairs and Quality Enhancement Research Initiative Partnered Evaluation Initiative grant [HX002263-01A1]). The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the U.S. Government.

Performance of 6 bedside procedures (paracentesis, thoracentesis, lumbar puncture, arthrocentesis, central venous catheter [CVC] placement, and arterial line placement) are considered core competencies for hospitalists.¹ Yet, the American Board of Internal Medicine (ABIM) no longer requires demonstration of manual competency for bedside procedures, and graduates may enter the workforce with minimal or no experience performing such procedures.² As such, the burden falls on hospital privileging committees to ensure providers have the necessary training and experience to competently perform invasive procedures before granting institutional privileges to perform them.³ Although recommendations for privileging to perform certain surgical procedures have been proposed,^4,5 there are no widely accepted guidelines for initial or ongoing privileging of common invasive bedside procedures performed by hospitalists, and current privileging practices vary significantly.

In 2015, the Society of Hospital Medicine (SHM) set up a Point-of-Care Ultrasound (POCUS) Task Force to draft evidence-based guidelines on the use of ultrasound to perform bedside procedures. The recommendations for certification of competency in ultrasound-guided procedures may guide institutional privileging. The purpose of this study was to better understand current hospital privileging practices for invasive bedside procedures both with and without ultrasound guidance and how current practices are perceived by experts.

Study Design, Setting, and Participants

After approval by the University of Texas Health Science Center at San Antonio Institutional Review Board, we conducted a survey of hospital privileging processes for bedside procedures from a convenience sample of hospitalist procedure experts on the SHM POCUS Task Force. All 21 hospitalists on the task force were invited to participate, including the authors of this article. These hospitalists represent 21 unique institutions, and all have clinical, educational, and/or research expertise in ultrasound-guided bedside procedures.

Survey Design

A 26-question, electronic survey on privileging for bedside procedures was conducted (Appendix A). Twenty questions addressed procedures in general, such as minimum numbers of procedures required and use of simulation. Six questions focused on the use of ultrasound guidance. To provide context, many questions were framed to assess a privileging process being drafted by the task force. Answers were either multiple choice or free text.

Data Collection and Analysis

All members of the task force were invited to complete the survey by e-mail during November 2016. A reminder e-mail was sent on the day after initial distribution. No compensation was offered, and participation was not required. Survey results were compiled electronically through Research Electronic Data Capture, or “REDCap”^TM (Nashville, Tennessee), and data analysis was performed with Stata version 14 (College Station, Texas). Means of current and recommended minimum thresholds were calculated by excluding responses of “I don’t know,” and responses of “no minimum number threshold” were coded as 0.

The survey response rate was 100% (21 of 21). All experts were hospitalists, but 2 also identified themselves as intensivists. Experts practiced in a variety of hospital settings, including private university hospitals (43%), public university hospitals (19%), Veterans Affairs teaching hospitals (14%), community teaching hospitals (14%), and community nonteaching hospitals (10%). Most hospitals (90%) were teaching hospitals for internal medicine trainees. All experts have personally performed bedside procedures on a regular basis, and most (86%) had leadership roles in teaching procedures to students, residents, fellows, physician assistants, nurse practitioners, and/or physicians. Approximately half (57%) were involved in granting privileges for bedside procedures at their institutions.

Our survey identified 3 distinct differences between hospitalist procedure experts’ recommendations and their own hospitals’ current privileging practices. First, whereas experts recommended ultrasound guidance for thoracentesis, paracentesis, and CVC placement, it is rarely a current requirement. Second, experts recommend requiring minimum numbers of procedures for both initial and ongoing privileging even though such minimums are not currently required at half of their hospitals. Third, recommended minimum numbers were generally higher than those currently in place.

The routine use of ultrasound guidance for thoracentesis, paracentesis, and CVC placement is likely a result of increased adoption based on the literature showing clinical benefits.^6-9 Thus, the expert recommendations for required use of ultrasound guidance for these procedures seems both appropriate and feasible. The procedure minimums identified in our study are similar to prior ABIM guidelines when manual competency was required for board certification in internal medicine and are comparable to recent minimums proposed by the Society of Critical Care Medicine, both of which recommended a minimum of 5 to 10 per procedure.^10,11 Nevertheless, no commonly agreed-upon minimum number of procedures currently exists for certification of competency, and the variability seen in the experts’ responses further supports the idea that no specific number will guarantee competence. Thus, while requiring minimum numbers of procedures was generally considered necessary by our experts, minimums alone were also considered insufficient for initial privileging because most recommended that direct observation and simulation should be part of an initial privileging process.

These findings encourage more rigorous requirements for both initial and ongoing privileging of procedures. Nevertheless, our findings were rarely unanimous. The most frequently cited reason for disagreement on our findings was feasibility and capacity for direct observation, and the absence of ultrasound equipment or simulators, particularly in resource-limited clinical environments.

Our study has several strengths and limitations. One strength is the recruitment of study experts specifically composed of hospitalist procedure experts from diverse geographic and hospital settings. Yet, we acknowledge that our findings may not be generalizable to other specialties. Another strength is we obtained 100% participation from the experts surveyed. Weaknesses of this study include the relatively small number of experts who are likely to be biased in favor of both the use of ultrasound guidance and higher standards for privileging. We also relied on self-reported data about privileging processes rather than direct observation of those practices. Finally, questions were framed in the context of only 1 possible privileging pathway, and experts may respond differently to a different framing.

Our findings may guide the development of more standardized frameworks for initial and ongoing privileging of hospitalists for invasive bedside procedures. In particular, additional privileging requirements may include the routine use of ultrasound guidance for paracentesis, thoracentesis, and CVC insertion; simulation preceding direct observation of manual skills if possible; and higher required minimums of procedures for both initial and ongoing privileging. The goal of a standardized framework for privileging should be directed at improving the quality and safety of bedside procedures but must consider feasibility in diverse clinical settings where hospitalists work.

Acknowledgments

The authors thank the hospitalists on the SHM POCUS Task Force who provided data about their institutions’ privileging processes and requirements. They are also grateful to Loretta M. Grikis, MLS, AHIP, at the White River Junction Veterans Affairs Medical Center for her assistance as a medical librarian.

Disclosure

Brian P. Lucas (U.S. Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Dartmouth SYNERGY, and the National Institutes of Health National Center for Advancing Translational Sciences [UL1TR001086]). Nilam Soni (U.S. Department of Veterans Affairs and Quality Enhancement Research Initiative Partnered Evaluation Initiative grant [HX002263-01A1]). The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the U.S. Government.

Performance of 6 bedside procedures (paracentesis, thoracentesis, lumbar puncture, arthrocentesis, central venous catheter [CVC] placement, and arterial line placement) are considered core competencies for hospitalists.¹ Yet, the American Board of Internal Medicine (ABIM) no longer requires demonstration of manual competency for bedside procedures, and graduates may enter the workforce with minimal or no experience performing such procedures.² As such, the burden falls on hospital privileging committees to ensure providers have the necessary training and experience to competently perform invasive procedures before granting institutional privileges to perform them.³ Although recommendations for privileging to perform certain surgical procedures have been proposed,^4,5 there are no widely accepted guidelines for initial or ongoing privileging of common invasive bedside procedures performed by hospitalists, and current privileging practices vary significantly.

In 2015, the Society of Hospital Medicine (SHM) set up a Point-of-Care Ultrasound (POCUS) Task Force to draft evidence-based guidelines on the use of ultrasound to perform bedside procedures. The recommendations for certification of competency in ultrasound-guided procedures may guide institutional privileging. The purpose of this study was to better understand current hospital privileging practices for invasive bedside procedures both with and without ultrasound guidance and how current practices are perceived by experts.

Study Design, Setting, and Participants

After approval by the University of Texas Health Science Center at San Antonio Institutional Review Board, we conducted a survey of hospital privileging processes for bedside procedures from a convenience sample of hospitalist procedure experts on the SHM POCUS Task Force. All 21 hospitalists on the task force were invited to participate, including the authors of this article. These hospitalists represent 21 unique institutions, and all have clinical, educational, and/or research expertise in ultrasound-guided bedside procedures.

Survey Design

A 26-question, electronic survey on privileging for bedside procedures was conducted (Appendix A). Twenty questions addressed procedures in general, such as minimum numbers of procedures required and use of simulation. Six questions focused on the use of ultrasound guidance. To provide context, many questions were framed to assess a privileging process being drafted by the task force. Answers were either multiple choice or free text.

Data Collection and Analysis

All members of the task force were invited to complete the survey by e-mail during November 2016. A reminder e-mail was sent on the day after initial distribution. No compensation was offered, and participation was not required. Survey results were compiled electronically through Research Electronic Data Capture, or “REDCap”^TM (Nashville, Tennessee), and data analysis was performed with Stata version 14 (College Station, Texas). Means of current and recommended minimum thresholds were calculated by excluding responses of “I don’t know,” and responses of “no minimum number threshold” were coded as 0.

The survey response rate was 100% (21 of 21). All experts were hospitalists, but 2 also identified themselves as intensivists. Experts practiced in a variety of hospital settings, including private university hospitals (43%), public university hospitals (19%), Veterans Affairs teaching hospitals (14%), community teaching hospitals (14%), and community nonteaching hospitals (10%). Most hospitals (90%) were teaching hospitals for internal medicine trainees. All experts have personally performed bedside procedures on a regular basis, and most (86%) had leadership roles in teaching procedures to students, residents, fellows, physician assistants, nurse practitioners, and/or physicians. Approximately half (57%) were involved in granting privileges for bedside procedures at their institutions.

Our survey identified 3 distinct differences between hospitalist procedure experts’ recommendations and their own hospitals’ current privileging practices. First, whereas experts recommended ultrasound guidance for thoracentesis, paracentesis, and CVC placement, it is rarely a current requirement. Second, experts recommend requiring minimum numbers of procedures for both initial and ongoing privileging even though such minimums are not currently required at half of their hospitals. Third, recommended minimum numbers were generally higher than those currently in place.

The routine use of ultrasound guidance for thoracentesis, paracentesis, and CVC placement is likely a result of increased adoption based on the literature showing clinical benefits.^6-9 Thus, the expert recommendations for required use of ultrasound guidance for these procedures seems both appropriate and feasible. The procedure minimums identified in our study are similar to prior ABIM guidelines when manual competency was required for board certification in internal medicine and are comparable to recent minimums proposed by the Society of Critical Care Medicine, both of which recommended a minimum of 5 to 10 per procedure.^10,11 Nevertheless, no commonly agreed-upon minimum number of procedures currently exists for certification of competency, and the variability seen in the experts’ responses further supports the idea that no specific number will guarantee competence. Thus, while requiring minimum numbers of procedures was generally considered necessary by our experts, minimums alone were also considered insufficient for initial privileging because most recommended that direct observation and simulation should be part of an initial privileging process.

These findings encourage more rigorous requirements for both initial and ongoing privileging of procedures. Nevertheless, our findings were rarely unanimous. The most frequently cited reason for disagreement on our findings was feasibility and capacity for direct observation, and the absence of ultrasound equipment or simulators, particularly in resource-limited clinical environments.

Our study has several strengths and limitations. One strength is the recruitment of study experts specifically composed of hospitalist procedure experts from diverse geographic and hospital settings. Yet, we acknowledge that our findings may not be generalizable to other specialties. Another strength is we obtained 100% participation from the experts surveyed. Weaknesses of this study include the relatively small number of experts who are likely to be biased in favor of both the use of ultrasound guidance and higher standards for privileging. We also relied on self-reported data about privileging processes rather than direct observation of those practices. Finally, questions were framed in the context of only 1 possible privileging pathway, and experts may respond differently to a different framing.

Our findings may guide the development of more standardized frameworks for initial and ongoing privileging of hospitalists for invasive bedside procedures. In particular, additional privileging requirements may include the routine use of ultrasound guidance for paracentesis, thoracentesis, and CVC insertion; simulation preceding direct observation of manual skills if possible; and higher required minimums of procedures for both initial and ongoing privileging. The goal of a standardized framework for privileging should be directed at improving the quality and safety of bedside procedures but must consider feasibility in diverse clinical settings where hospitalists work.

Acknowledgments

The authors thank the hospitalists on the SHM POCUS Task Force who provided data about their institutions’ privileging processes and requirements. They are also grateful to Loretta M. Grikis, MLS, AHIP, at the White River Junction Veterans Affairs Medical Center for her assistance as a medical librarian.

Disclosure

Brian P. Lucas (U.S. Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Dartmouth SYNERGY, and the National Institutes of Health National Center for Advancing Translational Sciences [UL1TR001086]). Nilam Soni (U.S. Department of Veterans Affairs and Quality Enhancement Research Initiative Partnered Evaluation Initiative grant [HX002263-01A1]). The contents of this publication do not represent the views of the U.S. Department of Veterans Affairs or the U.S. Government.

In this issue of the Journal of Hospital Medicine, Ellimoottil and colleagues examine characteristics of readmissions identified as planned by the planned readmission algorithm developed for the Center for Medicare & Medicaid Services (CMS) by using Medicare claims data from 131 hospitals in Michigan.¹ They found that a substantial portion of readmissions currently classified as planned by the algorithm appear to be nonelective, as defined by the presence of a charge by an emergency medicine physician or an admission type of emergent or urgent, making those hospitalizations unlikely to be planned. They suggest that the algorithm could be modified to exclude such cases from the planned designation.

To determine whether modifying the algorithm as recommended is a good idea, it is helpful to examine the origins of the existing planned readmission algorithm. The algorithm originated as a consequence of hospital accountability measures for readmissions and was developed by this author in collaboration with colleagues at Yale University and elsewhere.² Readmission measures have been controversial in part because clearly some (undetermined) fraction of readmissions is unavoidable. Many commentators have asked that readmission measures therefore capture only avoidable or related readmissions. Avoidable readmissions are those that could have been prevented by members of the healthcare system through actions taken during or after hospitalization, such as patient counseling, communication among team members, and guideline-concordant medical care. Related readmissions are those directly stemming from the index admission. However, reliably and accurately defining such events has proven elusive. One study, for instance, found the rate of physician-assessed preventability in published studies ranged from 9% to 48%.³ The challenge is even greater in trying to determine preventability using just claims data, without physician review of charts. Imagine, for instance, a patient with heart failure who is readmitted with heart failure exacerbation. The readmission preceded by a large fast-food meal is likely preventable; although even in this case, some would argue the healthcare system should not be held accountable for a readmission if the patient had been properly counseled about avoiding salty food. The one preceded by progressively worsening systolic function in a patient who reliably takes medications, weighs herself daily, and watches her diet is likely not. But both appear identical in claims. Related is also a difficult concept to operationalize. A recently hospitalized patient readmitted with pneumonia might have acquired it in the hospital (related) or from her grandchild 2 weeks later (unrelated). Again, both appear identical in claims.

In the ideal world, clinicians would be held accountable only for preventable readmissions. In practice, that has not proven to be possible.

Instead, the CMS readmission measures omit readmissions that are thought to be planned in advance: necessary and intentional readmissions. Defining a planned readmission is conceptually easier than defining a preventable readmission, yet even this is not always straightforward. The clearest case might be a person with a longstanding plan to have an elective surgery (say, a hip replacement) who is briefly admitted with something minor enough not to delay a subsequent admission for the scheduled surgery. Other patients are admitted with acute problems that require follow-up hospitalization (for instance, an acute myocardial infarction that requires a coronary artery bypass graft 2 weeks later).⁴ More ambiguous are patients who are sent home on a course of treatment with a plan for rehospitalization if it fails; for instance, a patient with gangrene is sent home on intravenous antibiotics but fails to improve and is rehospitalized for an amputation. Is that readmission planned or unplanned? Reasonable people might disagree.

Nonetheless, assuming it is desirable to at least try to identify and remove planned readmissions from measures, there are a number of ways in which one might do so. Perhaps the simplest would be to classify each hospitalization as planned or not on the UB-04 claim form. Such a process would be very feasible but also subject to gaming or coding variability. Given that there is some ambiguity and no standard about what types of readmissions are planned and that current policy provides incentives to reduce unplanned readmission rates, hospitals might vary in the cases to which they would apply such a code. This approach, therefore, has not been favored by payers to date. An alternative is to prospectively flag admissions that are expected to result in planned readmissions. In fiscal year 2014, the CMS implemented this option for newborns and patients with acute myocardial infarction by creating new discharge status codes of “discharged to [location] with a planned acute care hospital inpatient readmission.” Institutions can flag discharges that they know at the time of discharge will be followed by a readmission, such as a newborn who requires a repeat hospitalization for repair of a congenital anomaly.⁵ There is no time span required for the planned readmission to qualify. However, the difficulty in broadening the applicability of this option to all discharges lies in identification and matching; there also remains a possibility for gaming. The code does not specify when the readmission is expected nor for what diagnosis or procedure. How, then, do we know if the subsequent readmission is the one anticipated? Unexpected readmissions may still occur in the interim. Conversely, what if the discharging clinicians don’t know about an anticipated planned procedure? What would stop hospitals from labeling every discharge as expected to be followed by a planned readmission? These considerations have largely prevented the CMS from asking hospitals to apply the new code widely or from applying the code to identify planned readmissions.

Instead, the existing algorithm attempts to identify procedures that might be done on an elective basis and assumes readmissions with these procedures are planned if paired with a nonurgent diagnosis. Ellimoottil and colleagues attempt to verify whether this is accurate using a creative approach of seeking emergency department (ED) charges and admission type of emergent or urgent, and they found that roughly half of planned readmissions are, in fact, likely unplanned. This figure agrees closely with the original chart review validation of the algorithm. In particular, they found that some procedures, such as percutaneous cardiac interventions, appear to be paired regularly with a nonurgent principal diagnosis, such as coronary artery disease, even when done on an urgent basis.

This validation was performed prior to the availability of version 4.0 of the planned readmission algorithm, which removes several high-frequency procedures from the potentially planned readmission list (including cardiac devices and diagnostic cardiac catheterizations) that were very frequently mischaracterized as planned in the original chart validation.⁶ At least 8 such cases were also identified in this validation according to the table. Therefore, the misclassification rate of the current algorithm version is probably less than that reported in this article. Nonetheless, percutaneous transluminal coronary angioplasty remains on the planned procedure list in version 4.0 and appears to account for a substantial error rate, and it is likely that the authors’ approach would improve the accuracy even of the newer version of the algorithm.

The advantages of the suggested modifications are that they do not require chart review and could be readily adopted by the CMS. Although seeking ED charges for Medicare is somewhat cumbersome in that they are recorded in a different data set than the inpatient hospitalizations, there is no absolute barrier to adding this step to the algorithm, and doing so has substantial face validity. That said, identifying ED visits is not straightforward because nonemergency services can be provided in the ED (ie, critical care or observation care) and because facilities and providers have different billing requirements, producing different estimates depending on the data set used.⁷ Including admission type would be easier, but it would be less conservative and likely less accurate, as this field has not been validated and is not typically audited. Nonetheless, adding the presence of ED charges seems likely to improve the accuracy of the algorithm. As the CMS continues to refine the planned readmission algorithm, these proposed changes would be very reasonable to study with chart validation and, if valid, to consider adopting.

Disclosure 

Dr. Horwitz reports grants from Center for Medicare & Medicaid Services, grants from Agency for Healthcare Research and Quality, during the conduct of the study.

In this issue of the Journal of Hospital Medicine, Ellimoottil and colleagues examine characteristics of readmissions identified as planned by the planned readmission algorithm developed for the Center for Medicare & Medicaid Services (CMS) by using Medicare claims data from 131 hospitals in Michigan.¹ They found that a substantial portion of readmissions currently classified as planned by the algorithm appear to be nonelective, as defined by the presence of a charge by an emergency medicine physician or an admission type of emergent or urgent, making those hospitalizations unlikely to be planned. They suggest that the algorithm could be modified to exclude such cases from the planned designation.

To determine whether modifying the algorithm as recommended is a good idea, it is helpful to examine the origins of the existing planned readmission algorithm. The algorithm originated as a consequence of hospital accountability measures for readmissions and was developed by this author in collaboration with colleagues at Yale University and elsewhere.² Readmission measures have been controversial in part because clearly some (undetermined) fraction of readmissions is unavoidable. Many commentators have asked that readmission measures therefore capture only avoidable or related readmissions. Avoidable readmissions are those that could have been prevented by members of the healthcare system through actions taken during or after hospitalization, such as patient counseling, communication among team members, and guideline-concordant medical care. Related readmissions are those directly stemming from the index admission. However, reliably and accurately defining such events has proven elusive. One study, for instance, found the rate of physician-assessed preventability in published studies ranged from 9% to 48%.³ The challenge is even greater in trying to determine preventability using just claims data, without physician review of charts. Imagine, for instance, a patient with heart failure who is readmitted with heart failure exacerbation. The readmission preceded by a large fast-food meal is likely preventable; although even in this case, some would argue the healthcare system should not be held accountable for a readmission if the patient had been properly counseled about avoiding salty food. The one preceded by progressively worsening systolic function in a patient who reliably takes medications, weighs herself daily, and watches her diet is likely not. But both appear identical in claims. Related is also a difficult concept to operationalize. A recently hospitalized patient readmitted with pneumonia might have acquired it in the hospital (related) or from her grandchild 2 weeks later (unrelated). Again, both appear identical in claims.

In the ideal world, clinicians would be held accountable only for preventable readmissions. In practice, that has not proven to be possible.

Instead, the CMS readmission measures omit readmissions that are thought to be planned in advance: necessary and intentional readmissions. Defining a planned readmission is conceptually easier than defining a preventable readmission, yet even this is not always straightforward. The clearest case might be a person with a longstanding plan to have an elective surgery (say, a hip replacement) who is briefly admitted with something minor enough not to delay a subsequent admission for the scheduled surgery. Other patients are admitted with acute problems that require follow-up hospitalization (for instance, an acute myocardial infarction that requires a coronary artery bypass graft 2 weeks later).⁴ More ambiguous are patients who are sent home on a course of treatment with a plan for rehospitalization if it fails; for instance, a patient with gangrene is sent home on intravenous antibiotics but fails to improve and is rehospitalized for an amputation. Is that readmission planned or unplanned? Reasonable people might disagree.

Nonetheless, assuming it is desirable to at least try to identify and remove planned readmissions from measures, there are a number of ways in which one might do so. Perhaps the simplest would be to classify each hospitalization as planned or not on the UB-04 claim form. Such a process would be very feasible but also subject to gaming or coding variability. Given that there is some ambiguity and no standard about what types of readmissions are planned and that current policy provides incentives to reduce unplanned readmission rates, hospitals might vary in the cases to which they would apply such a code. This approach, therefore, has not been favored by payers to date. An alternative is to prospectively flag admissions that are expected to result in planned readmissions. In fiscal year 2014, the CMS implemented this option for newborns and patients with acute myocardial infarction by creating new discharge status codes of “discharged to [location] with a planned acute care hospital inpatient readmission.” Institutions can flag discharges that they know at the time of discharge will be followed by a readmission, such as a newborn who requires a repeat hospitalization for repair of a congenital anomaly.⁵ There is no time span required for the planned readmission to qualify. However, the difficulty in broadening the applicability of this option to all discharges lies in identification and matching; there also remains a possibility for gaming. The code does not specify when the readmission is expected nor for what diagnosis or procedure. How, then, do we know if the subsequent readmission is the one anticipated? Unexpected readmissions may still occur in the interim. Conversely, what if the discharging clinicians don’t know about an anticipated planned procedure? What would stop hospitals from labeling every discharge as expected to be followed by a planned readmission? These considerations have largely prevented the CMS from asking hospitals to apply the new code widely or from applying the code to identify planned readmissions.

Instead, the existing algorithm attempts to identify procedures that might be done on an elective basis and assumes readmissions with these procedures are planned if paired with a nonurgent diagnosis. Ellimoottil and colleagues attempt to verify whether this is accurate using a creative approach of seeking emergency department (ED) charges and admission type of emergent or urgent, and they found that roughly half of planned readmissions are, in fact, likely unplanned. This figure agrees closely with the original chart review validation of the algorithm. In particular, they found that some procedures, such as percutaneous cardiac interventions, appear to be paired regularly with a nonurgent principal diagnosis, such as coronary artery disease, even when done on an urgent basis.

This validation was performed prior to the availability of version 4.0 of the planned readmission algorithm, which removes several high-frequency procedures from the potentially planned readmission list (including cardiac devices and diagnostic cardiac catheterizations) that were very frequently mischaracterized as planned in the original chart validation.⁶ At least 8 such cases were also identified in this validation according to the table. Therefore, the misclassification rate of the current algorithm version is probably less than that reported in this article. Nonetheless, percutaneous transluminal coronary angioplasty remains on the planned procedure list in version 4.0 and appears to account for a substantial error rate, and it is likely that the authors’ approach would improve the accuracy even of the newer version of the algorithm.

The advantages of the suggested modifications are that they do not require chart review and could be readily adopted by the CMS. Although seeking ED charges for Medicare is somewhat cumbersome in that they are recorded in a different data set than the inpatient hospitalizations, there is no absolute barrier to adding this step to the algorithm, and doing so has substantial face validity. That said, identifying ED visits is not straightforward because nonemergency services can be provided in the ED (ie, critical care or observation care) and because facilities and providers have different billing requirements, producing different estimates depending on the data set used.⁷ Including admission type would be easier, but it would be less conservative and likely less accurate, as this field has not been validated and is not typically audited. Nonetheless, adding the presence of ED charges seems likely to improve the accuracy of the algorithm. As the CMS continues to refine the planned readmission algorithm, these proposed changes would be very reasonable to study with chart validation and, if valid, to consider adopting.

Disclosure 

Dr. Horwitz reports grants from Center for Medicare & Medicaid Services, grants from Agency for Healthcare Research and Quality, during the conduct of the study.

In this issue of the Journal of Hospital Medicine, Ellimoottil and colleagues examine characteristics of readmissions identified as planned by the planned readmission algorithm developed for the Center for Medicare & Medicaid Services (CMS) by using Medicare claims data from 131 hospitals in Michigan.¹ They found that a substantial portion of readmissions currently classified as planned by the algorithm appear to be nonelective, as defined by the presence of a charge by an emergency medicine physician or an admission type of emergent or urgent, making those hospitalizations unlikely to be planned. They suggest that the algorithm could be modified to exclude such cases from the planned designation.

To determine whether modifying the algorithm as recommended is a good idea, it is helpful to examine the origins of the existing planned readmission algorithm. The algorithm originated as a consequence of hospital accountability measures for readmissions and was developed by this author in collaboration with colleagues at Yale University and elsewhere.² Readmission measures have been controversial in part because clearly some (undetermined) fraction of readmissions is unavoidable. Many commentators have asked that readmission measures therefore capture only avoidable or related readmissions. Avoidable readmissions are those that could have been prevented by members of the healthcare system through actions taken during or after hospitalization, such as patient counseling, communication among team members, and guideline-concordant medical care. Related readmissions are those directly stemming from the index admission. However, reliably and accurately defining such events has proven elusive. One study, for instance, found the rate of physician-assessed preventability in published studies ranged from 9% to 48%.³ The challenge is even greater in trying to determine preventability using just claims data, without physician review of charts. Imagine, for instance, a patient with heart failure who is readmitted with heart failure exacerbation. The readmission preceded by a large fast-food meal is likely preventable; although even in this case, some would argue the healthcare system should not be held accountable for a readmission if the patient had been properly counseled about avoiding salty food. The one preceded by progressively worsening systolic function in a patient who reliably takes medications, weighs herself daily, and watches her diet is likely not. But both appear identical in claims. Related is also a difficult concept to operationalize. A recently hospitalized patient readmitted with pneumonia might have acquired it in the hospital (related) or from her grandchild 2 weeks later (unrelated). Again, both appear identical in claims.

In the ideal world, clinicians would be held accountable only for preventable readmissions. In practice, that has not proven to be possible.

Instead, the CMS readmission measures omit readmissions that are thought to be planned in advance: necessary and intentional readmissions. Defining a planned readmission is conceptually easier than defining a preventable readmission, yet even this is not always straightforward. The clearest case might be a person with a longstanding plan to have an elective surgery (say, a hip replacement) who is briefly admitted with something minor enough not to delay a subsequent admission for the scheduled surgery. Other patients are admitted with acute problems that require follow-up hospitalization (for instance, an acute myocardial infarction that requires a coronary artery bypass graft 2 weeks later).⁴ More ambiguous are patients who are sent home on a course of treatment with a plan for rehospitalization if it fails; for instance, a patient with gangrene is sent home on intravenous antibiotics but fails to improve and is rehospitalized for an amputation. Is that readmission planned or unplanned? Reasonable people might disagree.

Nonetheless, assuming it is desirable to at least try to identify and remove planned readmissions from measures, there are a number of ways in which one might do so. Perhaps the simplest would be to classify each hospitalization as planned or not on the UB-04 claim form. Such a process would be very feasible but also subject to gaming or coding variability. Given that there is some ambiguity and no standard about what types of readmissions are planned and that current policy provides incentives to reduce unplanned readmission rates, hospitals might vary in the cases to which they would apply such a code. This approach, therefore, has not been favored by payers to date. An alternative is to prospectively flag admissions that are expected to result in planned readmissions. In fiscal year 2014, the CMS implemented this option for newborns and patients with acute myocardial infarction by creating new discharge status codes of “discharged to [location] with a planned acute care hospital inpatient readmission.” Institutions can flag discharges that they know at the time of discharge will be followed by a readmission, such as a newborn who requires a repeat hospitalization for repair of a congenital anomaly.⁵ There is no time span required for the planned readmission to qualify. However, the difficulty in broadening the applicability of this option to all discharges lies in identification and matching; there also remains a possibility for gaming. The code does not specify when the readmission is expected nor for what diagnosis or procedure. How, then, do we know if the subsequent readmission is the one anticipated? Unexpected readmissions may still occur in the interim. Conversely, what if the discharging clinicians don’t know about an anticipated planned procedure? What would stop hospitals from labeling every discharge as expected to be followed by a planned readmission? These considerations have largely prevented the CMS from asking hospitals to apply the new code widely or from applying the code to identify planned readmissions.

Instead, the existing algorithm attempts to identify procedures that might be done on an elective basis and assumes readmissions with these procedures are planned if paired with a nonurgent diagnosis. Ellimoottil and colleagues attempt to verify whether this is accurate using a creative approach of seeking emergency department (ED) charges and admission type of emergent or urgent, and they found that roughly half of planned readmissions are, in fact, likely unplanned. This figure agrees closely with the original chart review validation of the algorithm. In particular, they found that some procedures, such as percutaneous cardiac interventions, appear to be paired regularly with a nonurgent principal diagnosis, such as coronary artery disease, even when done on an urgent basis.

This validation was performed prior to the availability of version 4.0 of the planned readmission algorithm, which removes several high-frequency procedures from the potentially planned readmission list (including cardiac devices and diagnostic cardiac catheterizations) that were very frequently mischaracterized as planned in the original chart validation.⁶ At least 8 such cases were also identified in this validation according to the table. Therefore, the misclassification rate of the current algorithm version is probably less than that reported in this article. Nonetheless, percutaneous transluminal coronary angioplasty remains on the planned procedure list in version 4.0 and appears to account for a substantial error rate, and it is likely that the authors’ approach would improve the accuracy even of the newer version of the algorithm.

The advantages of the suggested modifications are that they do not require chart review and could be readily adopted by the CMS. Although seeking ED charges for Medicare is somewhat cumbersome in that they are recorded in a different data set than the inpatient hospitalizations, there is no absolute barrier to adding this step to the algorithm, and doing so has substantial face validity. That said, identifying ED visits is not straightforward because nonemergency services can be provided in the ED (ie, critical care or observation care) and because facilities and providers have different billing requirements, producing different estimates depending on the data set used.⁷ Including admission type would be easier, but it would be less conservative and likely less accurate, as this field has not been validated and is not typically audited. Nonetheless, adding the presence of ED charges seems likely to improve the accuracy of the algorithm. As the CMS continues to refine the planned readmission algorithm, these proposed changes would be very reasonable to study with chart validation and, if valid, to consider adopting.

Disclosure 

Dr. Horwitz reports grants from Center for Medicare & Medicaid Services, grants from Agency for Healthcare Research and Quality, during the conduct of the study.

“Unnecessary noise is the most cruel abuse of care which can be inflicted on either the sick or the well.”

–Florence Nightingale¹

Motivated by the “unsustainable” rise in noise pollution and its “direct, as well as cumulative, adverse health effects,” an expert World Health Organization (WHO) task force composed the Guidelines for Community Noise, outlining specific noise recommendations for public settings, including hospitals.² In ward settings, these guidelines mandate that background noise (which is defined as unwanted sound) levels average <35 decibels (dB; ie, a typical library) during the day, average <30 dB at night, and peak no higher than 40 dB (ie, a normal conversation), a level sufficient to awaken someone from sleep.

Since the publication of these guidelines in 1999, substantial new research has added to our understanding of hospital noise levels. Recent research has demonstrated that few, if any, hospitals comply with WHO noise recommendations.³ Moreover, since 1960, hospital sound levels have risen ~4 dB per decade; based on the logarithmic decibel scale, if this trend continues, this translates to a 528% increase in loudness by 2020.³

The overwhelming majority of research on hospital noise has focused on the intensive care unit (ICU), where beeping machines and busy staff often push peak nighttime noise levels over 80 dB (ie, a kitchen blender).⁴ When evaluated during sleep, noise in the ICU causes frequent arousals and awakenings. When noise is combined with other factors, such as bright light and patient care interactions, poor sleep quality invariably results.⁴

While it has been known for years that critically ill patients experience markedly fragmented and nonrestorative sleep,⁵ poor sleep has recently gained attention due to its potential role as a modifiable risk factor for delirium and its associated consequences, including prolonged length of stay and long-lasting neuropsychological and physical impairments.⁶ Due to this interest, numerous interventions have been attempted,⁷ including multicomponent bundles to promote sleep,⁸ which have been shown to reduce delirium in the ICU.^9-12 Therefore, efforts to promote sleep in the ICU, including interventions to minimize nighttime noise, are recommended in Society of Critical Care Medicine clinical practice guidelines¹³ and are listed as a top 5 research priority by an expert panel of ICU delirium researchers.¹⁴

In contrast to the ICU, there has been little attention paid to noise in other patient care areas. Existing studies in non-ICU ward settings suggest that excessive noise is common,³ similar to the ICU, and that patients experience poor sleep, with noise being a significant disruptor of sleep.^5,15,16 Such poor sleep is thought to contribute to uncontrolled pain, labile blood pressure, and dissatisfaction with care.^16,17

In this issue of the Journal of Hospital Medicine, Jaiswal and colleagues¹⁸ report on an important study evaluating sound and light levels in both non-ICU and ICU settings within a busy tertiary-care hospital. In 8 general ward, 8 telemetry, and 8 ICU patient rooms, the investigators used meters to record sound and light levels for 24 to 72 hours. In each of these locations, they detected average hourly sound levels ranging from 45 to 54 dB, 47 to 55 dB, and 56 to 60 dB, respectively, with ICUs consistently registering the highest hourly sound levels. Notably, all locations exceeded WHO noise limits at all hours of the day. As a novel measure, the investigators evaluated sound level changes (SLCs), or the difference between peak and background sound levels, based on research suggesting that dramatic SLCs (≥17.5 dB) are more disruptive than constant loud noise.¹⁹ The authors observed that SLCs ≥17.5 dB occur predominantly during daytime hours and, interestingly, at a similar rate in the wards versus the ICU.

Importantly, the authors do not link their findings with patient sleep or other patient outcomes but instead focus on employing rigorous methods to gather continuous recordings. By measuring light levels, the authors bring attention to an issue often considered less disruptive to sleep than noise.^6,10,20 Similar to prior research,²¹ Jaiswal and colleagues demonstrate low levels of light at night, with no substantial difference between non-ICU and ICU settings. As a key finding, the authors bring attention to low levels of light during daytime hours, particularly in the morning, when levels range from 22 to 101 lux in the wards and 16 to 39 lux in the ICU. While the optimal timing and brightness of light exposure remains unknown, it is well established that ambient light is the most potent cue for circadian rhythms, with levels >100 lux necessary to suppress melatonin, the key hormone involved in circadian entrainment. Hence, the levels of morning light observed in this study were likely insufficient to maintain healthy circadian rhythms. When exposed to abnormal light levels and factors such as noise, stress, and medications, hospitalized patients are at risk for circadian rhythm misalignment, which can disrupt sleep and trigger a complex molecular cascade, leading to end-organ dysfunction including depressed immunity, glucose dysregulation, arrhythmias, and delirium.^22-24

What are the major takeaway messages from this study? First, it confirms that sound levels are not only high in the ICU but also in non-ICU wards. As hospital ratings and reimbursements now rely on favorable patient ratings, future noise-reduction efforts will surely expand more vigorously across patient care areas.²⁵ Second, SLCs and daytime recordings must be included in efforts to understand and improve sleep and circadian rhythms in hospitalized patients. Finally, this study provides a sobering reminder of the challenge of meeting WHO guidelines and facilitating an optimal healing environment for patients. Sadly, hospital sound levels continue to rise, and quiet-time interventions consistently fail to lower noise to levels anywhere near WHO limits.²⁶ Hence, to make any progress, hospitals of the future must entertain novel design modifications (eg, sound-absorbing walls and alternative room layouts), fix common sources of noise pollution (eg, ventilation systems and alarms), and critically evaluate and update interventions aimed at improving sleep and aligning circadian rhythms for hospitalized patients.²⁷

Acknowledgments

B.B.K. is currently supported by a grant through the University of California, Los Angeles Clinical Translational Research Institute and the National Institutes of Health’s National Center for Advancing Translational Sciences (UL1TR000124).

Disclosure

The authors have nothing to disclose.

“Unnecessary noise is the most cruel abuse of care which can be inflicted on either the sick or the well.”

–Florence Nightingale¹

Motivated by the “unsustainable” rise in noise pollution and its “direct, as well as cumulative, adverse health effects,” an expert World Health Organization (WHO) task force composed the Guidelines for Community Noise, outlining specific noise recommendations for public settings, including hospitals.² In ward settings, these guidelines mandate that background noise (which is defined as unwanted sound) levels average <35 decibels (dB; ie, a typical library) during the day, average <30 dB at night, and peak no higher than 40 dB (ie, a normal conversation), a level sufficient to awaken someone from sleep.

Since the publication of these guidelines in 1999, substantial new research has added to our understanding of hospital noise levels. Recent research has demonstrated that few, if any, hospitals comply with WHO noise recommendations.³ Moreover, since 1960, hospital sound levels have risen ~4 dB per decade; based on the logarithmic decibel scale, if this trend continues, this translates to a 528% increase in loudness by 2020.³

The overwhelming majority of research on hospital noise has focused on the intensive care unit (ICU), where beeping machines and busy staff often push peak nighttime noise levels over 80 dB (ie, a kitchen blender).⁴ When evaluated during sleep, noise in the ICU causes frequent arousals and awakenings. When noise is combined with other factors, such as bright light and patient care interactions, poor sleep quality invariably results.⁴

While it has been known for years that critically ill patients experience markedly fragmented and nonrestorative sleep,⁵ poor sleep has recently gained attention due to its potential role as a modifiable risk factor for delirium and its associated consequences, including prolonged length of stay and long-lasting neuropsychological and physical impairments.⁶ Due to this interest, numerous interventions have been attempted,⁷ including multicomponent bundles to promote sleep,⁸ which have been shown to reduce delirium in the ICU.^9-12 Therefore, efforts to promote sleep in the ICU, including interventions to minimize nighttime noise, are recommended in Society of Critical Care Medicine clinical practice guidelines¹³ and are listed as a top 5 research priority by an expert panel of ICU delirium researchers.¹⁴

In contrast to the ICU, there has been little attention paid to noise in other patient care areas. Existing studies in non-ICU ward settings suggest that excessive noise is common,³ similar to the ICU, and that patients experience poor sleep, with noise being a significant disruptor of sleep.^5,15,16 Such poor sleep is thought to contribute to uncontrolled pain, labile blood pressure, and dissatisfaction with care.^16,17

In this issue of the Journal of Hospital Medicine, Jaiswal and colleagues¹⁸ report on an important study evaluating sound and light levels in both non-ICU and ICU settings within a busy tertiary-care hospital. In 8 general ward, 8 telemetry, and 8 ICU patient rooms, the investigators used meters to record sound and light levels for 24 to 72 hours. In each of these locations, they detected average hourly sound levels ranging from 45 to 54 dB, 47 to 55 dB, and 56 to 60 dB, respectively, with ICUs consistently registering the highest hourly sound levels. Notably, all locations exceeded WHO noise limits at all hours of the day. As a novel measure, the investigators evaluated sound level changes (SLCs), or the difference between peak and background sound levels, based on research suggesting that dramatic SLCs (≥17.5 dB) are more disruptive than constant loud noise.¹⁹ The authors observed that SLCs ≥17.5 dB occur predominantly during daytime hours and, interestingly, at a similar rate in the wards versus the ICU.

Importantly, the authors do not link their findings with patient sleep or other patient outcomes but instead focus on employing rigorous methods to gather continuous recordings. By measuring light levels, the authors bring attention to an issue often considered less disruptive to sleep than noise.^6,10,20 Similar to prior research,²¹ Jaiswal and colleagues demonstrate low levels of light at night, with no substantial difference between non-ICU and ICU settings. As a key finding, the authors bring attention to low levels of light during daytime hours, particularly in the morning, when levels range from 22 to 101 lux in the wards and 16 to 39 lux in the ICU. While the optimal timing and brightness of light exposure remains unknown, it is well established that ambient light is the most potent cue for circadian rhythms, with levels >100 lux necessary to suppress melatonin, the key hormone involved in circadian entrainment. Hence, the levels of morning light observed in this study were likely insufficient to maintain healthy circadian rhythms. When exposed to abnormal light levels and factors such as noise, stress, and medications, hospitalized patients are at risk for circadian rhythm misalignment, which can disrupt sleep and trigger a complex molecular cascade, leading to end-organ dysfunction including depressed immunity, glucose dysregulation, arrhythmias, and delirium.^22-24

What are the major takeaway messages from this study? First, it confirms that sound levels are not only high in the ICU but also in non-ICU wards. As hospital ratings and reimbursements now rely on favorable patient ratings, future noise-reduction efforts will surely expand more vigorously across patient care areas.²⁵ Second, SLCs and daytime recordings must be included in efforts to understand and improve sleep and circadian rhythms in hospitalized patients. Finally, this study provides a sobering reminder of the challenge of meeting WHO guidelines and facilitating an optimal healing environment for patients. Sadly, hospital sound levels continue to rise, and quiet-time interventions consistently fail to lower noise to levels anywhere near WHO limits.²⁶ Hence, to make any progress, hospitals of the future must entertain novel design modifications (eg, sound-absorbing walls and alternative room layouts), fix common sources of noise pollution (eg, ventilation systems and alarms), and critically evaluate and update interventions aimed at improving sleep and aligning circadian rhythms for hospitalized patients.²⁷

Acknowledgments

B.B.K. is currently supported by a grant through the University of California, Los Angeles Clinical Translational Research Institute and the National Institutes of Health’s National Center for Advancing Translational Sciences (UL1TR000124).

Disclosure

The authors have nothing to disclose.

“Unnecessary noise is the most cruel abuse of care which can be inflicted on either the sick or the well.”

–Florence Nightingale¹

Motivated by the “unsustainable” rise in noise pollution and its “direct, as well as cumulative, adverse health effects,” an expert World Health Organization (WHO) task force composed the Guidelines for Community Noise, outlining specific noise recommendations for public settings, including hospitals.² In ward settings, these guidelines mandate that background noise (which is defined as unwanted sound) levels average <35 decibels (dB; ie, a typical library) during the day, average <30 dB at night, and peak no higher than 40 dB (ie, a normal conversation), a level sufficient to awaken someone from sleep.

Since the publication of these guidelines in 1999, substantial new research has added to our understanding of hospital noise levels. Recent research has demonstrated that few, if any, hospitals comply with WHO noise recommendations.³ Moreover, since 1960, hospital sound levels have risen ~4 dB per decade; based on the logarithmic decibel scale, if this trend continues, this translates to a 528% increase in loudness by 2020.³

The overwhelming majority of research on hospital noise has focused on the intensive care unit (ICU), where beeping machines and busy staff often push peak nighttime noise levels over 80 dB (ie, a kitchen blender).⁴ When evaluated during sleep, noise in the ICU causes frequent arousals and awakenings. When noise is combined with other factors, such as bright light and patient care interactions, poor sleep quality invariably results.⁴

While it has been known for years that critically ill patients experience markedly fragmented and nonrestorative sleep,⁵ poor sleep has recently gained attention due to its potential role as a modifiable risk factor for delirium and its associated consequences, including prolonged length of stay and long-lasting neuropsychological and physical impairments.⁶ Due to this interest, numerous interventions have been attempted,⁷ including multicomponent bundles to promote sleep,⁸ which have been shown to reduce delirium in the ICU.^9-12 Therefore, efforts to promote sleep in the ICU, including interventions to minimize nighttime noise, are recommended in Society of Critical Care Medicine clinical practice guidelines¹³ and are listed as a top 5 research priority by an expert panel of ICU delirium researchers.¹⁴

In contrast to the ICU, there has been little attention paid to noise in other patient care areas. Existing studies in non-ICU ward settings suggest that excessive noise is common,³ similar to the ICU, and that patients experience poor sleep, with noise being a significant disruptor of sleep.^5,15,16 Such poor sleep is thought to contribute to uncontrolled pain, labile blood pressure, and dissatisfaction with care.^16,17

In this issue of the Journal of Hospital Medicine, Jaiswal and colleagues¹⁸ report on an important study evaluating sound and light levels in both non-ICU and ICU settings within a busy tertiary-care hospital. In 8 general ward, 8 telemetry, and 8 ICU patient rooms, the investigators used meters to record sound and light levels for 24 to 72 hours. In each of these locations, they detected average hourly sound levels ranging from 45 to 54 dB, 47 to 55 dB, and 56 to 60 dB, respectively, with ICUs consistently registering the highest hourly sound levels. Notably, all locations exceeded WHO noise limits at all hours of the day. As a novel measure, the investigators evaluated sound level changes (SLCs), or the difference between peak and background sound levels, based on research suggesting that dramatic SLCs (≥17.5 dB) are more disruptive than constant loud noise.¹⁹ The authors observed that SLCs ≥17.5 dB occur predominantly during daytime hours and, interestingly, at a similar rate in the wards versus the ICU.

Importantly, the authors do not link their findings with patient sleep or other patient outcomes but instead focus on employing rigorous methods to gather continuous recordings. By measuring light levels, the authors bring attention to an issue often considered less disruptive to sleep than noise.^6,10,20 Similar to prior research,²¹ Jaiswal and colleagues demonstrate low levels of light at night, with no substantial difference between non-ICU and ICU settings. As a key finding, the authors bring attention to low levels of light during daytime hours, particularly in the morning, when levels range from 22 to 101 lux in the wards and 16 to 39 lux in the ICU. While the optimal timing and brightness of light exposure remains unknown, it is well established that ambient light is the most potent cue for circadian rhythms, with levels >100 lux necessary to suppress melatonin, the key hormone involved in circadian entrainment. Hence, the levels of morning light observed in this study were likely insufficient to maintain healthy circadian rhythms. When exposed to abnormal light levels and factors such as noise, stress, and medications, hospitalized patients are at risk for circadian rhythm misalignment, which can disrupt sleep and trigger a complex molecular cascade, leading to end-organ dysfunction including depressed immunity, glucose dysregulation, arrhythmias, and delirium.^22-24

What are the major takeaway messages from this study? First, it confirms that sound levels are not only high in the ICU but also in non-ICU wards. As hospital ratings and reimbursements now rely on favorable patient ratings, future noise-reduction efforts will surely expand more vigorously across patient care areas.²⁵ Second, SLCs and daytime recordings must be included in efforts to understand and improve sleep and circadian rhythms in hospitalized patients. Finally, this study provides a sobering reminder of the challenge of meeting WHO guidelines and facilitating an optimal healing environment for patients. Sadly, hospital sound levels continue to rise, and quiet-time interventions consistently fail to lower noise to levels anywhere near WHO limits.²⁶ Hence, to make any progress, hospitals of the future must entertain novel design modifications (eg, sound-absorbing walls and alternative room layouts), fix common sources of noise pollution (eg, ventilation systems and alarms), and critically evaluate and update interventions aimed at improving sleep and aligning circadian rhythms for hospitalized patients.²⁷

Acknowledgments

B.B.K. is currently supported by a grant through the University of California, Los Angeles Clinical Translational Research Institute and the National Institutes of Health’s National Center for Advancing Translational Sciences (UL1TR000124).

Disclosure

The authors have nothing to disclose.

Peripheral intravenous catheters (PIVCs) are the most frequently used vascular access devices (VADs) in all patient populations and practice settings. Because of its invasive nature and the fact that PIVCs are placed and medications are administered directly into the bloodstream, vascular access is risky. There are multiple factors to consider when placing a PIVC, the least of which is determining the most appropriate device for the patient based on the prescribed therapy.

VAD planning and assessment needs to occur at the first patient encounter so that the most appropriate device is selected and it aligns with the duration of the treatment, minimizes the number of unnecessary VADs placed, and preserves veins for any future needs. The level of the clinician’s expertise, coupled with challenging environments of care, add to the complexity of what most perceive to be a “simple” procedure—placing a PIVC. For these reasons, it’s imperative that clinicians are competent in the use and placement of VADs to ensure safe patient care.

Carr and colleagues¹ performed a notable scoping review to determine the existence of tools, clinical prediction rules, and algorithms (TRAs) that would support decision-making for the use of PIVCs and promote first-time insertion success (FTIS). They refined their search strategy to studies that described the use or development of any TRA regarding PIVC insertion in hospitalized adult patients.

The team identified 36 references for screening and based on their inclusion and exclusion criteria, were left with 13 studies in the final review. Inclusion criteria included TRAs for PIVC insertion in hospitalized adult patients using a traditional insertion approach, which was defined as “an assessment and/or insertion with touch and feel, therefore, without vessel locating technology such as ultrasound and/or near infrared technology.” ¹ Of note is that some of the exclusion criteria included pediatric studies, TRAs focused on postinsertion assessment, studies that examined VADs other than PIVCs, and studies in which vascular visualization techniques were used.

In general, the authors were unable to find reported evidence that the study recommendations were adopted in clinical practice or to what degree any TRA had on the success of a PIVC insertion. As a result, they were unable to determine what, if any, clinical value the TRAs had.

The review of the studies, however, identified 3 variables that had an impact on PIVC insertion success: patient, clinician, and product characteristics. Vein characteristics, such as the number, size, and location of veins, and patients’ clinical conditions, such as diabetes, sickle cell anemia, and intravenous drug abuse, were noted as predictors of PIVC insertion success. In 7 papers, the primary focus was on patients with a history of difficult intravenous access (DIVA). The definition of DIVA varied from time to insertion of the PIVC to the number of failed attempts, ranging from 1 to 3 or more attempts.

Clinician variables, such as specialty nurse certification, years of experience, and self-reporting skill level, were associated with successful insertions, and clinicians who predicted FTIS were likely to have FTIS. Product variables included PIVC gauge size and the number of vein options and the relationship with successful first attempts.

Limitations noted by the researchers were a lack of sufficient published evidence for TRAs for PIVC insertion and standardized definitions for DIVA and expert inserters. The number of variables and the dearth of standardized terms may also influence the ability to adopt any TRAs.

While the purpose of the research was to identify TRAs that could guide clinical practice for the use of PIVCs and successful insertions, the authors make an important point that dwell time was not considered. While a TRA may lead to a successful insertion, it may not transcend the intended life of the PIVC or the duration of the therapy. Therefore, TRAs should embed steps that ensure the appropriate device is selected at the start of the patient’s treatment.

The authors identified a need for undertaking and providing research in a critical area of patient care and safety. This article increases awareness of issues related to PIVCs and the impact they have on patient care. FTIS rates vary and the implications of their use are many. Patient satisfaction, no delay in treatment, vein preservation, a decreased risk of complications, and the cost of labor and products are factors to consider. Tools to improve patient outcomes related to device insertion, care, and management need to be developed and validated. The authors also note that future TRAs should integrate the use of ultrasound and vascular visualization technologies.

In a complex, challenging healthcare environment, tools and guidance that enhance practice do not only help clinicians; they have a positive impact on patient care. The need for research, so that gaps in knowledge and science can be bridged, is clear. Gaps must be identified, research conducted, and TRAs developed and adopted to enhance patient outcomes.

Disclosure

The author reports no conflicts of interest.

Peripheral intravenous catheters (PIVCs) are the most frequently used vascular access devices (VADs) in all patient populations and practice settings. Because of its invasive nature and the fact that PIVCs are placed and medications are administered directly into the bloodstream, vascular access is risky. There are multiple factors to consider when placing a PIVC, the least of which is determining the most appropriate device for the patient based on the prescribed therapy.

VAD planning and assessment needs to occur at the first patient encounter so that the most appropriate device is selected and it aligns with the duration of the treatment, minimizes the number of unnecessary VADs placed, and preserves veins for any future needs. The level of the clinician’s expertise, coupled with challenging environments of care, add to the complexity of what most perceive to be a “simple” procedure—placing a PIVC. For these reasons, it’s imperative that clinicians are competent in the use and placement of VADs to ensure safe patient care.

Carr and colleagues¹ performed a notable scoping review to determine the existence of tools, clinical prediction rules, and algorithms (TRAs) that would support decision-making for the use of PIVCs and promote first-time insertion success (FTIS). They refined their search strategy to studies that described the use or development of any TRA regarding PIVC insertion in hospitalized adult patients.

The team identified 36 references for screening and based on their inclusion and exclusion criteria, were left with 13 studies in the final review. Inclusion criteria included TRAs for PIVC insertion in hospitalized adult patients using a traditional insertion approach, which was defined as “an assessment and/or insertion with touch and feel, therefore, without vessel locating technology such as ultrasound and/or near infrared technology.” ¹ Of note is that some of the exclusion criteria included pediatric studies, TRAs focused on postinsertion assessment, studies that examined VADs other than PIVCs, and studies in which vascular visualization techniques were used.

In general, the authors were unable to find reported evidence that the study recommendations were adopted in clinical practice or to what degree any TRA had on the success of a PIVC insertion. As a result, they were unable to determine what, if any, clinical value the TRAs had.

The review of the studies, however, identified 3 variables that had an impact on PIVC insertion success: patient, clinician, and product characteristics. Vein characteristics, such as the number, size, and location of veins, and patients’ clinical conditions, such as diabetes, sickle cell anemia, and intravenous drug abuse, were noted as predictors of PIVC insertion success. In 7 papers, the primary focus was on patients with a history of difficult intravenous access (DIVA). The definition of DIVA varied from time to insertion of the PIVC to the number of failed attempts, ranging from 1 to 3 or more attempts.

Clinician variables, such as specialty nurse certification, years of experience, and self-reporting skill level, were associated with successful insertions, and clinicians who predicted FTIS were likely to have FTIS. Product variables included PIVC gauge size and the number of vein options and the relationship with successful first attempts.

Limitations noted by the researchers were a lack of sufficient published evidence for TRAs for PIVC insertion and standardized definitions for DIVA and expert inserters. The number of variables and the dearth of standardized terms may also influence the ability to adopt any TRAs.

While the purpose of the research was to identify TRAs that could guide clinical practice for the use of PIVCs and successful insertions, the authors make an important point that dwell time was not considered. While a TRA may lead to a successful insertion, it may not transcend the intended life of the PIVC or the duration of the therapy. Therefore, TRAs should embed steps that ensure the appropriate device is selected at the start of the patient’s treatment.

The authors identified a need for undertaking and providing research in a critical area of patient care and safety. This article increases awareness of issues related to PIVCs and the impact they have on patient care. FTIS rates vary and the implications of their use are many. Patient satisfaction, no delay in treatment, vein preservation, a decreased risk of complications, and the cost of labor and products are factors to consider. Tools to improve patient outcomes related to device insertion, care, and management need to be developed and validated. The authors also note that future TRAs should integrate the use of ultrasound and vascular visualization technologies.

In a complex, challenging healthcare environment, tools and guidance that enhance practice do not only help clinicians; they have a positive impact on patient care. The need for research, so that gaps in knowledge and science can be bridged, is clear. Gaps must be identified, research conducted, and TRAs developed and adopted to enhance patient outcomes.

Disclosure

The author reports no conflicts of interest.

Peripheral intravenous catheters (PIVCs) are the most frequently used vascular access devices (VADs) in all patient populations and practice settings. Because of its invasive nature and the fact that PIVCs are placed and medications are administered directly into the bloodstream, vascular access is risky. There are multiple factors to consider when placing a PIVC, the least of which is determining the most appropriate device for the patient based on the prescribed therapy.

VAD planning and assessment needs to occur at the first patient encounter so that the most appropriate device is selected and it aligns with the duration of the treatment, minimizes the number of unnecessary VADs placed, and preserves veins for any future needs. The level of the clinician’s expertise, coupled with challenging environments of care, add to the complexity of what most perceive to be a “simple” procedure—placing a PIVC. For these reasons, it’s imperative that clinicians are competent in the use and placement of VADs to ensure safe patient care.

Carr and colleagues¹ performed a notable scoping review to determine the existence of tools, clinical prediction rules, and algorithms (TRAs) that would support decision-making for the use of PIVCs and promote first-time insertion success (FTIS). They refined their search strategy to studies that described the use or development of any TRA regarding PIVC insertion in hospitalized adult patients.

The team identified 36 references for screening and based on their inclusion and exclusion criteria, were left with 13 studies in the final review. Inclusion criteria included TRAs for PIVC insertion in hospitalized adult patients using a traditional insertion approach, which was defined as “an assessment and/or insertion with touch and feel, therefore, without vessel locating technology such as ultrasound and/or near infrared technology.” ¹ Of note is that some of the exclusion criteria included pediatric studies, TRAs focused on postinsertion assessment, studies that examined VADs other than PIVCs, and studies in which vascular visualization techniques were used.

In general, the authors were unable to find reported evidence that the study recommendations were adopted in clinical practice or to what degree any TRA had on the success of a PIVC insertion. As a result, they were unable to determine what, if any, clinical value the TRAs had.

The review of the studies, however, identified 3 variables that had an impact on PIVC insertion success: patient, clinician, and product characteristics. Vein characteristics, such as the number, size, and location of veins, and patients’ clinical conditions, such as diabetes, sickle cell anemia, and intravenous drug abuse, were noted as predictors of PIVC insertion success. In 7 papers, the primary focus was on patients with a history of difficult intravenous access (DIVA). The definition of DIVA varied from time to insertion of the PIVC to the number of failed attempts, ranging from 1 to 3 or more attempts.

Clinician variables, such as specialty nurse certification, years of experience, and self-reporting skill level, were associated with successful insertions, and clinicians who predicted FTIS were likely to have FTIS. Product variables included PIVC gauge size and the number of vein options and the relationship with successful first attempts.

Limitations noted by the researchers were a lack of sufficient published evidence for TRAs for PIVC insertion and standardized definitions for DIVA and expert inserters. The number of variables and the dearth of standardized terms may also influence the ability to adopt any TRAs.

While the purpose of the research was to identify TRAs that could guide clinical practice for the use of PIVCs and successful insertions, the authors make an important point that dwell time was not considered. While a TRA may lead to a successful insertion, it may not transcend the intended life of the PIVC or the duration of the therapy. Therefore, TRAs should embed steps that ensure the appropriate device is selected at the start of the patient’s treatment.

The authors identified a need for undertaking and providing research in a critical area of patient care and safety. This article increases awareness of issues related to PIVCs and the impact they have on patient care. FTIS rates vary and the implications of their use are many. Patient satisfaction, no delay in treatment, vein preservation, a decreased risk of complications, and the cost of labor and products are factors to consider. Tools to improve patient outcomes related to device insertion, care, and management need to be developed and validated. The authors also note that future TRAs should integrate the use of ultrasound and vascular visualization technologies.

In a complex, challenging healthcare environment, tools and guidance that enhance practice do not only help clinicians; they have a positive impact on patient care. The need for research, so that gaps in knowledge and science can be bridged, is clear. Gaps must be identified, research conducted, and TRAs developed and adopted to enhance patient outcomes.

Disclosure

The author reports no conflicts of interest.

Up to a billion peripheral intravenous catheters (PIVCs) are inserted annually; therefore, the importance of this invasive device in modern medicine cannot be argued.¹ The insertion of a PIVC is a clinical procedure undertaken by a range of clinical staff and in a variety of patient populations and settings. In many clinical environments (for example, the emergency department [ED]), PIVCs are the predominant first-choice vascular access device (VAD).^2,3 Researchers in one study estimated over 25 million PIVCs are used in French EDs each year,³ and intravenous therapy is the leading ED treatment in the United States.⁴

First-time insertion success (FTIS) for PIVCs has been reported at 18% to 98% in adult populations.^5,6 The variability of FTIS likely reflects not just a variety of clinician groups and patient populations but also the absence of uniform approaches to PIVC insertion. Terms frequently used to describe or formalize a pattern of care or a clinical procedure include the following: diagnostic and prognostic tools and/or plans, frameworks, predictive assessment tools, prediction models, rules, decision-making rules, scores, scales, risk factors, risk algorithms, and algorithms.^7-12 In this paper, we use the terms tools, clinical prediction rules, and algorithms (TRAs) to review such frameworks that have been reported in the context of promoting FTIS for PIVCs.

The purpose of this systematic scoping review was to investigate what PIVC decision-making approaches exist to facilitate FTIS of PIVCs in adult hospitalized patients. Our intention was to systematically synthesize the research on TRAs, to review significant associations identified with these TRAs, and to critique TRA validity and reliability.

Scoping Review

We selected a scoping review method that, by definition, maps the evidence to identify gaps,^13,14 set research agendas, and identify implications for decision making. This allowed a targeted approach to answering our 3 research questions:

• What published clinical TRAs exist to facilitate PIVC insertion in adults?
• What clinical, patient and/or product variables have been identified using TRAs as having significant associations with FTIS for PIVCs in adult patients?
• What is the reported reliability, validity, responsiveness, clinical feasibility, and utility of existing TRAs for PIVC insertion in adults?

Our aim was to identify the amount, variety and essential qualities of TRA literature rather than to critically appraise and evaluate the effectiveness of TRAs, a process reserved for systematic review and meta-analysis of interventional studies.^13,14 We followed scoping review guidelines published by members and collaborators of the Joanna Briggs Institute, an internationally recognized leader in research synthesis, evidence use, and implementation. The guidance is based on 5 steps: (i) scoping review objective and question, (ii) background of the topic to support scoping review, (iii) study selection, (iv) charting the results, and (v) collating and summarizing results.¹⁵ Clinicometric assessment of a TRA or any clinical prediction rule requires 4 specific phases: (i) development (identification of predictors from data), (ii) validation (testing the rule in a separate population for reliability), (iii) impact analysis or responsiveness (How clinically useful is the rule in the clinical setting? Is it resource heavy or light? Is it cost effective?), and (iv) implementation and adoption (uptake into clinical practice).¹⁶

Search Strategy

We included studies that described the use or development of any TRA regarding PIVC insertion in the adult hospitalized population.

Inclusion Criteria

Studies were included if they were published in the English Language, included TRAs for PIVC insertion in adult hospital patients, and prospectively assessed a clinical category of patient for PIVC insertion using a traditional approach. We defined a traditional PIVC insertion approach as an assessment and/or insertion with touch and feel, therefore, without vessel-locating technology such as ultrasound and/or near infrared technology.

Exclusion Criteria

Exclusion criteria included pediatric studies, authors’ personal (nonresearch) experience of tools, TRAs focused on postinsertion assessment of the cannula (such as phlebitis, infiltration, and/or dressing failure), and papers with a focus on VADs other than PIVCs. We excluded studies using PIVC ultrasound and/or near infrared technology because these are not standard in all insertions and greatly change the information available for pre-insertion assessment as well as the likelihood of insertion success.

In June 2016, a systematic search of the Cochrane library, Ovid Medline® In-process & Other Non-Indexed Citations and Ovid MEDLINE(R) <1946 to Present>, EBSCO CINAHL databases, and Google Scholar with specific keywords to identify publications that identified or defined TRAs was undertaken. Medical subject headings were created with assistance from a research librarian using tailored functions within individual databases. With key search terms, we limited studies to those related to our inclusion criteria. See Appendix 1 for our search strategy for Medline and CINAHL.

We used Covidence, a web-based application specifically designed for systematic reviews to screen and evaluate eligible publications.¹⁷ Two authors (PJC and NSH) screened the initial retrieved searches based upon the predetermined inclusion and exclusion criteria.

Data Extraction

A paper template was developed and used by 2 reviewers (P.J.C. and N.S.H.). Data included the following: study sample, aim(s), design, setting and country in which the study took place, clinical and patient variables, and how the TRAs were developed and tested. Studies were categorized by TRA type. We also sought to identify if clinical trial registration (where appropriate) was evidenced, in addition to evidence of protocol publication and what standardized reporting guidelines were used (such as those outlined by the EQUATOR Network).¹⁸

Data Synthesis

Formal meta-analysis was beyond the scope and intention of this review. However, we provide the FTIS rate and the ranges of odds ratios (ORs) with 95% confidence intervals (CIs) for certain independent predictors.

Thirty-six references were imported for screening against title and abstract content, with 11 studies excluded and 25 studies assessed for full-text eligibility (see Figure, PRISMA Flowchart). We then excluded a further 12 studies (6 did not meet inclusion criteria, 2 were focused on the prehospital setting, 2 were personal correspondence and focused on another type of VAD, 1 was a protocol to establish a TRA, and 1 was a framework for all device types), leaving 13 studies included in the final review (see Figure). These studies presented data on 4 tools,^19-22 4 predictive models^3,23-25 (of which 3 present receiver operating characteristic/area under the curve scores),^3,23,24 2 framed as risk factor studies,^26,27 and 1 of each of the following: a scale,²⁸ a score,²⁹ and an estimation of the incidence report rate (Table 1).³⁰ Seven studies had “difficult” or “difficulty” in their title as a term to use to describe insertion failure.^{3,19,24-27,30} One study was titled exclusively for the nursing profession,²⁰ 5 studies were reported in medical journals,^{3,24,26,29,30} and 6 were reported in nursing journals,^19-22,25,27 with the remainder published in a vascular access journal.^23,28

General Characteristics of Included Studies

One TRA which was registered as a clinical trial²⁴ involved a standardized reporting tool as is recommended by the EQUATOR Network.¹⁸

Nine of the 13 papers reported that TRA components were chosen based on identified predictors of successful insertion from observational data^{3,19,23-28,30}, with 5 papers using multivariate logistic regression to identify independent predictors.^3,23,24,26,2 At least 4330 insertion attempts on patients were reported. Seven papers reported FTIS, which ranged from 61%-90%.^3,23-27,30

Two clinical settings accounted for 10 of the 13 included studies. We identified 5 papers from the ED setting^{3,23,26,29,30} and 5 studies specific to cancer settings.^19-22,28 Two ED papers identified clinical predictors of insertion difficulty, with 1 identifying an existing medical diagnosis (such as sickle cell disease, diabetes, or intravenous drug abuse) and the other reporting a pragmatic patient self-report of difficulty.^26,30 Three studies focused on patient-exclusive variables (such as vein characteristics)^19,21,28 and some with a combined clinician and patient focus.^{3,23-25,27,30}Relatively few studies reported interobserver measurements to describe the reliability of clinical assessments made.^3,19,21,28 Webster et al. in Australia assessed interrater reliability of a vein assessment tool (VAT) and found high agreement (kappa 0.83 for medical imaging nurses and 0.93 for oncology nurses).²¹ Wells compared reliability with Altman’s K scores obtained from a different VAT when compared with the Deciding on Intravenous Access tool and found good agreement.²² Vein deterioration was proposed as a variable for inclusion when developing an assessment tool within an oncological context.³¹ In Spain, de la Torre and colleagues²⁸ demonstrated good interrater agreement (with kappa, 0.77) for the Venous International Assessment (VIA) tool. The VIA offers a grading system scale to predict the patient’s declining vessel size while undergoing chemotherapy via peripheral veins with PIVCs. Grade I suggests little or no insertion failure, whereas a Grade V should predict insertion failure.

Patient Variables

Vein characteristics were significant independent factors associated with insertion success in a number of studies.^{3,19,23,24,27,28} These included the number of veins, descriptive quality (eg, small, medium, large), size, location, visible veins, and palpable veins. Other factors appear to be patient specific (such as chronic conditions), including diabetes (OR, 2.1 [adjusted to identify demographic risk factors]; 95% CI, 1.3-3.4), sickle cell disease (OR, 3.5; 95% CI, 1.4-4.8), and intravenous drug abuse (OR, 2.4; 95% CI, 1.1-5.3).²⁶ It is unclear if a consistent relationship between weight classification and insertion outcomes exists. Despite a finding that BMI was not independently associated with insertion difficulty,²⁶ one study reports that BMI was independently associated with insertion failure (BMI <18.5 [OR, 2.24; 95% CI, 1.07-4.67], BMI >30 [OR, 1.98; 95% CI, 1.9-3.60])³ and another reports emaciated patients were associated with greater failure when compared to normal weight patients (OR, 0.07; 95% CI, 0.02-0.34).²³ Consequently, extremes of BMI appear to be associated with insertion outcomes despite 1 study reporting no significant association with BMI as an independent factor of insertion failure.²⁶ A history of difficult intravenous access (DIVA) was reported in 1 study and independently associated with insertion failure (OR, 3.86; 95% CI, 2.39-6.25; see Table 2). DIVA appears to be the motivating factor in the title of 7 studies. When defined, the definitions of DIVA are heterogeneous and varied and include the following: >1 minute to insert a PIVC and requiring >1 attempt²⁷; 2 failed attempts³⁰; 3 or more PIVC attempts.²⁶ In the remaining 4 studies, variables associated with difficulty are identified and, therefore, TRAs to target those in future with predicted difficulty prior to any attempts are proposed.^3,19,24,25

Clinician Variables

Specialist nurse certification, years of experience, and self-report skill level (P < 0.001) appear to be significantly associated with successful insertions.²⁵ This is in part validated in another study reporting greater procedural inserting PIVCs as an independent predictor of success (OR, 4.404; 95% CI, 1.61-12-06; see Table 2).²³ Two studies involved simple pragmatic percentage cut offs for PIVCs: likelihood of use²⁹ and likelihood of insertion success.²³ One paper using a cross-sectional design that surveyed ED clinicians suggested if the clinician’s predicted likelihood of the patient needing a PIVC was >80%, this was a reasonable trigger for PIVC insertion.²⁹ The other, in a self-report cohort study, reported that a clinician’s likelihood estimation of PIVC FTIS prior to insertion is independently associated with FTIS (OR, 1.06; 95% CI, 1.04-1.07).²³

Product Variables

In this review, higher failure rates were identified in smaller sizes (22-24 g).²⁶ One study revealed gauge size was significantly associated with a failed first attempt in a univariate analysis (OR, 0.44; 95% CI, 0.34-0.58), but this was not retained in a multivariate model.²⁴ Matching the PIVC size with vein assessment is considered in the VIA tool.²⁸ It suggests a large PIVC (18 g) can be considered in patients with at least 6 vein options; smaller PIVCs of 22 to 24 g are recommended when 3 or fewer veins are found.²⁸ One paper describes a greater proportion of success between PIVC brands.²⁵

The published evidence for TRAs for PIVCs is limited, with few studies using 2 or more reliability, validity, responsiveness, clinical feasibility, or utility measurements in their development. There is a clear need to assess the clinical utility and clinical feasibility of these approaches so they can be externally validated prior to clinical adoption.¹⁶ For this reason, a validated TRA is likely required but must be appropriate for the capability of the healthcare services to use it. We suggest the consistent absence of all of these phases is owing to the variety of healthcare practitioners who are responsible for the insertion, the care and surveillance of peripheral cannulae, and the fragmentation of clinical approaches that exist.³²

Previously, a comprehensive systematic review on the subject of PIVCs found that the presence of a visible and/or palpable vein is usually associated with FTIS.³³ This current review found evidence of simple scores or cutoff percentage estimates in 2 TRA reports to predict either appropriate PIVC insertion or FTIS.^23,29 If such methods are supported by future experimental trials, then such simple approaches could initiate huge clinical return, particularly given that idle or unused PIVCs are of substantial clinical concern.^34-36 PIVCs transcend a variety of clinical environments with excessive use identified in the ED, where it may be performed for blood sampling alone and, hence, are labeled as “just in case” PIVCs and contribute to the term “idle PIVC.”^23,34 Therefore, a clinical indication to perform PIVC insertion in the first instance must be embedded into any TRA; for example, clinical deterioration is likely and the risks are outweighed by benefit, intravenous fluids and/or medicines are required, and/or diagnostic or clinical procedures are requested (such as contrast scans or procedural sedation).

In the majority of papers reviewed, researchers described how to categorize patients into levels of anticipated and predicted difficulty, but none offered corresponding detailed recommendations for strategies to increase insertion success, such as insertion with ultrasound or vascular access expert. Hypothetically, adopting a TRA may assist with the early identification of difficult to cannulate patients who may require a more expert vascular access clinician. However, in this review, we identify that a uniform definition for DIVA is lacking. Both Webster et al.²¹ and Wells²² suggest that an expert inserter is required if difficult access is identified by their tools, but there is no clear description of the qualities of an expert inserter in the literature.³⁷ Recently, consensus recommendations for the definition of vascular access specialist add to discussions about defining vascular access as an interdisciplinary specialist role.³⁸ This is supported by other publications that highlight the association between PIVC procedural experience and increased insertion success.^6,23,39-41With regards to products, PIVC gauge size may or may not be significantly associated with insertion success. For identifying a relationship of PIVC gauge with vein quality, both the vein diameter and description will help with the clinical interpretation of results. For example, it may be the case that bigger veins are easier to insert a PIVC and, thus, larger PIVCs are inserted. The opposite can occur when the veins are small and poorly visualized; hence, one may select a small gauge catheter. This argument is supported by Prottengeier et al.⁴² in a prehospital study that excluded PIVC size in a multivariate analysis because of confounding. However, gauge size is very likely to influence postinsertion complications. Prospective studies are contradictory and suggest 16 to 18 g PIVCs are more likely to contribute to superficial thrombus,⁴³ phlebitis, and, thus, device failure, in contrast to others reporting more frequent dislodgement with smaller 22 g PIVCs.^6,44Finally, the studies included did not assess survival times of the inserted PIVCs, given postinsertion failure in the hospitalized patient is prevalent⁴⁵ and, importantly, modifiable.⁴⁶ A TRA may yield initial insertion success, but if postinsertion the PIVC fails because of a modifiable reason that the TRA has not acknowledged, then it may be of negligible overall benefit. Therefore, TRAs for PIVC insertion need calibration, further development, and ongoing refinement prior to external validation testing.²⁴ Future research should also examine the role of TRAs in settings where ultrasound or other insertion technology is routinely used.

This review identifies a clinically significant gap in vascular access science. The findings of this review support recent work on vessel health and preservation^47-49 and appropriate device insertion.⁵⁰ It also points to the need for further research on the development and testing of an appropriate clinical TRA to improve vascular access outcomes in clinical practice.

Acknowledgments

The authors thank Ms. Kylie Black and Mr. Simon Lewis, who are medical research librarians at The University of Western Australia.

Disclosure

 Mr. Carr has received “speakers bureau” payment form CareFusion in 2013 and Becton Dickinson (BD) in 2014 for lectures on the subject of vascular access. He received a grant from CareFusion (facilitated by his institution at the time) to attend a scientific meeting on vascular access in the USA in 2012. Griffith University has received unrestricted investigator initiated research or educational grants on Marie Cooke’s behalf from product manufacturers: Baxter; Becton, Dickinson and Company; Centurion Medical Products and Entrotech Lifesciences. Griffith University has received unrestricted investigator initiated research or educational grants on Claire M. Rickard’s behalf from product manufacturers: 3M; Adhezion Biomedical, AngioDynamics; Bard, Baxter; B.Braun; Becton, Dickinson and Company; Centurion Medical Products; Cook Medical; Entrotech, Flomedical; ICU Medical; Medtronic; Smiths Medical, Teleflex. Griffith University has received consultancy payments on Claire M. Rickard’s behalf from product manufacturers: 3M, Bard; BBraun, BD, ResQDevices, Smiths Medical. Dr. Higgins and Dr. Rippey have nothing to disclose. All of the aforementioned have not biased or influenced this review.

All authors have made substantial contributions with this review. Each author has contributed to drafting and editing the manuscript and approves the final version for publishing.

Up to a billion peripheral intravenous catheters (PIVCs) are inserted annually; therefore, the importance of this invasive device in modern medicine cannot be argued.¹ The insertion of a PIVC is a clinical procedure undertaken by a range of clinical staff and in a variety of patient populations and settings. In many clinical environments (for example, the emergency department [ED]), PIVCs are the predominant first-choice vascular access device (VAD).^2,3 Researchers in one study estimated over 25 million PIVCs are used in French EDs each year,³ and intravenous therapy is the leading ED treatment in the United States.⁴

First-time insertion success (FTIS) for PIVCs has been reported at 18% to 98% in adult populations.^5,6 The variability of FTIS likely reflects not just a variety of clinician groups and patient populations but also the absence of uniform approaches to PIVC insertion. Terms frequently used to describe or formalize a pattern of care or a clinical procedure include the following: diagnostic and prognostic tools and/or plans, frameworks, predictive assessment tools, prediction models, rules, decision-making rules, scores, scales, risk factors, risk algorithms, and algorithms.^7-12 In this paper, we use the terms tools, clinical prediction rules, and algorithms (TRAs) to review such frameworks that have been reported in the context of promoting FTIS for PIVCs.

The purpose of this systematic scoping review was to investigate what PIVC decision-making approaches exist to facilitate FTIS of PIVCs in adult hospitalized patients. Our intention was to systematically synthesize the research on TRAs, to review significant associations identified with these TRAs, and to critique TRA validity and reliability.

Scoping Review

We selected a scoping review method that, by definition, maps the evidence to identify gaps,^13,14 set research agendas, and identify implications for decision making. This allowed a targeted approach to answering our 3 research questions:

• What published clinical TRAs exist to facilitate PIVC insertion in adults?
• What clinical, patient and/or product variables have been identified using TRAs as having significant associations with FTIS for PIVCs in adult patients?
• What is the reported reliability, validity, responsiveness, clinical feasibility, and utility of existing TRAs for PIVC insertion in adults?

Our aim was to identify the amount, variety and essential qualities of TRA literature rather than to critically appraise and evaluate the effectiveness of TRAs, a process reserved for systematic review and meta-analysis of interventional studies.^13,14 We followed scoping review guidelines published by members and collaborators of the Joanna Briggs Institute, an internationally recognized leader in research synthesis, evidence use, and implementation. The guidance is based on 5 steps: (i) scoping review objective and question, (ii) background of the topic to support scoping review, (iii) study selection, (iv) charting the results, and (v) collating and summarizing results.¹⁵ Clinicometric assessment of a TRA or any clinical prediction rule requires 4 specific phases: (i) development (identification of predictors from data), (ii) validation (testing the rule in a separate population for reliability), (iii) impact analysis or responsiveness (How clinically useful is the rule in the clinical setting? Is it resource heavy or light? Is it cost effective?), and (iv) implementation and adoption (uptake into clinical practice).¹⁶

Search Strategy

We included studies that described the use or development of any TRA regarding PIVC insertion in the adult hospitalized population.

Inclusion Criteria

Studies were included if they were published in the English Language, included TRAs for PIVC insertion in adult hospital patients, and prospectively assessed a clinical category of patient for PIVC insertion using a traditional approach. We defined a traditional PIVC insertion approach as an assessment and/or insertion with touch and feel, therefore, without vessel-locating technology such as ultrasound and/or near infrared technology.

Exclusion Criteria

Exclusion criteria included pediatric studies, authors’ personal (nonresearch) experience of tools, TRAs focused on postinsertion assessment of the cannula (such as phlebitis, infiltration, and/or dressing failure), and papers with a focus on VADs other than PIVCs. We excluded studies using PIVC ultrasound and/or near infrared technology because these are not standard in all insertions and greatly change the information available for pre-insertion assessment as well as the likelihood of insertion success.

In June 2016, a systematic search of the Cochrane library, Ovid Medline® In-process & Other Non-Indexed Citations and Ovid MEDLINE(R) <1946 to Present>, EBSCO CINAHL databases, and Google Scholar with specific keywords to identify publications that identified or defined TRAs was undertaken. Medical subject headings were created with assistance from a research librarian using tailored functions within individual databases. With key search terms, we limited studies to those related to our inclusion criteria. See Appendix 1 for our search strategy for Medline and CINAHL.

We used Covidence, a web-based application specifically designed for systematic reviews to screen and evaluate eligible publications.¹⁷ Two authors (PJC and NSH) screened the initial retrieved searches based upon the predetermined inclusion and exclusion criteria.

Data Extraction

A paper template was developed and used by 2 reviewers (P.J.C. and N.S.H.). Data included the following: study sample, aim(s), design, setting and country in which the study took place, clinical and patient variables, and how the TRAs were developed and tested. Studies were categorized by TRA type. We also sought to identify if clinical trial registration (where appropriate) was evidenced, in addition to evidence of protocol publication and what standardized reporting guidelines were used (such as those outlined by the EQUATOR Network).¹⁸

Data Synthesis

Formal meta-analysis was beyond the scope and intention of this review. However, we provide the FTIS rate and the ranges of odds ratios (ORs) with 95% confidence intervals (CIs) for certain independent predictors.

Thirty-six references were imported for screening against title and abstract content, with 11 studies excluded and 25 studies assessed for full-text eligibility (see Figure, PRISMA Flowchart). We then excluded a further 12 studies (6 did not meet inclusion criteria, 2 were focused on the prehospital setting, 2 were personal correspondence and focused on another type of VAD, 1 was a protocol to establish a TRA, and 1 was a framework for all device types), leaving 13 studies included in the final review (see Figure). These studies presented data on 4 tools,^19-22 4 predictive models^3,23-25 (of which 3 present receiver operating characteristic/area under the curve scores),^3,23,24 2 framed as risk factor studies,^26,27 and 1 of each of the following: a scale,²⁸ a score,²⁹ and an estimation of the incidence report rate (Table 1).³⁰ Seven studies had “difficult” or “difficulty” in their title as a term to use to describe insertion failure.^{3,19,24-27,30} One study was titled exclusively for the nursing profession,²⁰ 5 studies were reported in medical journals,^{3,24,26,29,30} and 6 were reported in nursing journals,^19-22,25,27 with the remainder published in a vascular access journal.^23,28

General Characteristics of Included Studies

One TRA which was registered as a clinical trial²⁴ involved a standardized reporting tool as is recommended by the EQUATOR Network.¹⁸

Nine of the 13 papers reported that TRA components were chosen based on identified predictors of successful insertion from observational data^{3,19,23-28,30}, with 5 papers using multivariate logistic regression to identify independent predictors.^3,23,24,26,2 At least 4330 insertion attempts on patients were reported. Seven papers reported FTIS, which ranged from 61%-90%.^3,23-27,30

Two clinical settings accounted for 10 of the 13 included studies. We identified 5 papers from the ED setting^{3,23,26,29,30} and 5 studies specific to cancer settings.^19-22,28 Two ED papers identified clinical predictors of insertion difficulty, with 1 identifying an existing medical diagnosis (such as sickle cell disease, diabetes, or intravenous drug abuse) and the other reporting a pragmatic patient self-report of difficulty.^26,30 Three studies focused on patient-exclusive variables (such as vein characteristics)^19,21,28 and some with a combined clinician and patient focus.^{3,23-25,27,30}Relatively few studies reported interobserver measurements to describe the reliability of clinical assessments made.^3,19,21,28 Webster et al. in Australia assessed interrater reliability of a vein assessment tool (VAT) and found high agreement (kappa 0.83 for medical imaging nurses and 0.93 for oncology nurses).²¹ Wells compared reliability with Altman’s K scores obtained from a different VAT when compared with the Deciding on Intravenous Access tool and found good agreement.²² Vein deterioration was proposed as a variable for inclusion when developing an assessment tool within an oncological context.³¹ In Spain, de la Torre and colleagues²⁸ demonstrated good interrater agreement (with kappa, 0.77) for the Venous International Assessment (VIA) tool. The VIA offers a grading system scale to predict the patient’s declining vessel size while undergoing chemotherapy via peripheral veins with PIVCs. Grade I suggests little or no insertion failure, whereas a Grade V should predict insertion failure.

Patient Variables

Vein characteristics were significant independent factors associated with insertion success in a number of studies.^{3,19,23,24,27,28} These included the number of veins, descriptive quality (eg, small, medium, large), size, location, visible veins, and palpable veins. Other factors appear to be patient specific (such as chronic conditions), including diabetes (OR, 2.1 [adjusted to identify demographic risk factors]; 95% CI, 1.3-3.4), sickle cell disease (OR, 3.5; 95% CI, 1.4-4.8), and intravenous drug abuse (OR, 2.4; 95% CI, 1.1-5.3).²⁶ It is unclear if a consistent relationship between weight classification and insertion outcomes exists. Despite a finding that BMI was not independently associated with insertion difficulty,²⁶ one study reports that BMI was independently associated with insertion failure (BMI <18.5 [OR, 2.24; 95% CI, 1.07-4.67], BMI >30 [OR, 1.98; 95% CI, 1.9-3.60])³ and another reports emaciated patients were associated with greater failure when compared to normal weight patients (OR, 0.07; 95% CI, 0.02-0.34).²³ Consequently, extremes of BMI appear to be associated with insertion outcomes despite 1 study reporting no significant association with BMI as an independent factor of insertion failure.²⁶ A history of difficult intravenous access (DIVA) was reported in 1 study and independently associated with insertion failure (OR, 3.86; 95% CI, 2.39-6.25; see Table 2). DIVA appears to be the motivating factor in the title of 7 studies. When defined, the definitions of DIVA are heterogeneous and varied and include the following: >1 minute to insert a PIVC and requiring >1 attempt²⁷; 2 failed attempts³⁰; 3 or more PIVC attempts.²⁶ In the remaining 4 studies, variables associated with difficulty are identified and, therefore, TRAs to target those in future with predicted difficulty prior to any attempts are proposed.^3,19,24,25

Clinician Variables

Specialist nurse certification, years of experience, and self-report skill level (P < 0.001) appear to be significantly associated with successful insertions.²⁵ This is in part validated in another study reporting greater procedural inserting PIVCs as an independent predictor of success (OR, 4.404; 95% CI, 1.61-12-06; see Table 2).²³ Two studies involved simple pragmatic percentage cut offs for PIVCs: likelihood of use²⁹ and likelihood of insertion success.²³ One paper using a cross-sectional design that surveyed ED clinicians suggested if the clinician’s predicted likelihood of the patient needing a PIVC was >80%, this was a reasonable trigger for PIVC insertion.²⁹ The other, in a self-report cohort study, reported that a clinician’s likelihood estimation of PIVC FTIS prior to insertion is independently associated with FTIS (OR, 1.06; 95% CI, 1.04-1.07).²³

Product Variables

In this review, higher failure rates were identified in smaller sizes (22-24 g).²⁶ One study revealed gauge size was significantly associated with a failed first attempt in a univariate analysis (OR, 0.44; 95% CI, 0.34-0.58), but this was not retained in a multivariate model.²⁴ Matching the PIVC size with vein assessment is considered in the VIA tool.²⁸ It suggests a large PIVC (18 g) can be considered in patients with at least 6 vein options; smaller PIVCs of 22 to 24 g are recommended when 3 or fewer veins are found.²⁸ One paper describes a greater proportion of success between PIVC brands.²⁵

The published evidence for TRAs for PIVCs is limited, with few studies using 2 or more reliability, validity, responsiveness, clinical feasibility, or utility measurements in their development. There is a clear need to assess the clinical utility and clinical feasibility of these approaches so they can be externally validated prior to clinical adoption.¹⁶ For this reason, a validated TRA is likely required but must be appropriate for the capability of the healthcare services to use it. We suggest the consistent absence of all of these phases is owing to the variety of healthcare practitioners who are responsible for the insertion, the care and surveillance of peripheral cannulae, and the fragmentation of clinical approaches that exist.³²

Previously, a comprehensive systematic review on the subject of PIVCs found that the presence of a visible and/or palpable vein is usually associated with FTIS.³³ This current review found evidence of simple scores or cutoff percentage estimates in 2 TRA reports to predict either appropriate PIVC insertion or FTIS.^23,29 If such methods are supported by future experimental trials, then such simple approaches could initiate huge clinical return, particularly given that idle or unused PIVCs are of substantial clinical concern.^34-36 PIVCs transcend a variety of clinical environments with excessive use identified in the ED, where it may be performed for blood sampling alone and, hence, are labeled as “just in case” PIVCs and contribute to the term “idle PIVC.”^23,34 Therefore, a clinical indication to perform PIVC insertion in the first instance must be embedded into any TRA; for example, clinical deterioration is likely and the risks are outweighed by benefit, intravenous fluids and/or medicines are required, and/or diagnostic or clinical procedures are requested (such as contrast scans or procedural sedation).

In the majority of papers reviewed, researchers described how to categorize patients into levels of anticipated and predicted difficulty, but none offered corresponding detailed recommendations for strategies to increase insertion success, such as insertion with ultrasound or vascular access expert. Hypothetically, adopting a TRA may assist with the early identification of difficult to cannulate patients who may require a more expert vascular access clinician. However, in this review, we identify that a uniform definition for DIVA is lacking. Both Webster et al.²¹ and Wells²² suggest that an expert inserter is required if difficult access is identified by their tools, but there is no clear description of the qualities of an expert inserter in the literature.³⁷ Recently, consensus recommendations for the definition of vascular access specialist add to discussions about defining vascular access as an interdisciplinary specialist role.³⁸ This is supported by other publications that highlight the association between PIVC procedural experience and increased insertion success.^6,23,39-41With regards to products, PIVC gauge size may or may not be significantly associated with insertion success. For identifying a relationship of PIVC gauge with vein quality, both the vein diameter and description will help with the clinical interpretation of results. For example, it may be the case that bigger veins are easier to insert a PIVC and, thus, larger PIVCs are inserted. The opposite can occur when the veins are small and poorly visualized; hence, one may select a small gauge catheter. This argument is supported by Prottengeier et al.⁴² in a prehospital study that excluded PIVC size in a multivariate analysis because of confounding. However, gauge size is very likely to influence postinsertion complications. Prospective studies are contradictory and suggest 16 to 18 g PIVCs are more likely to contribute to superficial thrombus,⁴³ phlebitis, and, thus, device failure, in contrast to others reporting more frequent dislodgement with smaller 22 g PIVCs.^6,44Finally, the studies included did not assess survival times of the inserted PIVCs, given postinsertion failure in the hospitalized patient is prevalent⁴⁵ and, importantly, modifiable.⁴⁶ A TRA may yield initial insertion success, but if postinsertion the PIVC fails because of a modifiable reason that the TRA has not acknowledged, then it may be of negligible overall benefit. Therefore, TRAs for PIVC insertion need calibration, further development, and ongoing refinement prior to external validation testing.²⁴ Future research should also examine the role of TRAs in settings where ultrasound or other insertion technology is routinely used.

This review identifies a clinically significant gap in vascular access science. The findings of this review support recent work on vessel health and preservation^47-49 and appropriate device insertion.⁵⁰ It also points to the need for further research on the development and testing of an appropriate clinical TRA to improve vascular access outcomes in clinical practice.

Acknowledgments

The authors thank Ms. Kylie Black and Mr. Simon Lewis, who are medical research librarians at The University of Western Australia.

Disclosure

 Mr. Carr has received “speakers bureau” payment form CareFusion in 2013 and Becton Dickinson (BD) in 2014 for lectures on the subject of vascular access. He received a grant from CareFusion (facilitated by his institution at the time) to attend a scientific meeting on vascular access in the USA in 2012. Griffith University has received unrestricted investigator initiated research or educational grants on Marie Cooke’s behalf from product manufacturers: Baxter; Becton, Dickinson and Company; Centurion Medical Products and Entrotech Lifesciences. Griffith University has received unrestricted investigator initiated research or educational grants on Claire M. Rickard’s behalf from product manufacturers: 3M; Adhezion Biomedical, AngioDynamics; Bard, Baxter; B.Braun; Becton, Dickinson and Company; Centurion Medical Products; Cook Medical; Entrotech, Flomedical; ICU Medical; Medtronic; Smiths Medical, Teleflex. Griffith University has received consultancy payments on Claire M. Rickard’s behalf from product manufacturers: 3M, Bard; BBraun, BD, ResQDevices, Smiths Medical. Dr. Higgins and Dr. Rippey have nothing to disclose. All of the aforementioned have not biased or influenced this review.

All authors have made substantial contributions with this review. Each author has contributed to drafting and editing the manuscript and approves the final version for publishing.

Up to a billion peripheral intravenous catheters (PIVCs) are inserted annually; therefore, the importance of this invasive device in modern medicine cannot be argued.¹ The insertion of a PIVC is a clinical procedure undertaken by a range of clinical staff and in a variety of patient populations and settings. In many clinical environments (for example, the emergency department [ED]), PIVCs are the predominant first-choice vascular access device (VAD).^2,3 Researchers in one study estimated over 25 million PIVCs are used in French EDs each year,³ and intravenous therapy is the leading ED treatment in the United States.⁴

First-time insertion success (FTIS) for PIVCs has been reported at 18% to 98% in adult populations.^5,6 The variability of FTIS likely reflects not just a variety of clinician groups and patient populations but also the absence of uniform approaches to PIVC insertion. Terms frequently used to describe or formalize a pattern of care or a clinical procedure include the following: diagnostic and prognostic tools and/or plans, frameworks, predictive assessment tools, prediction models, rules, decision-making rules, scores, scales, risk factors, risk algorithms, and algorithms.^7-12 In this paper, we use the terms tools, clinical prediction rules, and algorithms (TRAs) to review such frameworks that have been reported in the context of promoting FTIS for PIVCs.

The purpose of this systematic scoping review was to investigate what PIVC decision-making approaches exist to facilitate FTIS of PIVCs in adult hospitalized patients. Our intention was to systematically synthesize the research on TRAs, to review significant associations identified with these TRAs, and to critique TRA validity and reliability.

Scoping Review

We selected a scoping review method that, by definition, maps the evidence to identify gaps,^13,14 set research agendas, and identify implications for decision making. This allowed a targeted approach to answering our 3 research questions:

• What published clinical TRAs exist to facilitate PIVC insertion in adults?
• What clinical, patient and/or product variables have been identified using TRAs as having significant associations with FTIS for PIVCs in adult patients?
• What is the reported reliability, validity, responsiveness, clinical feasibility, and utility of existing TRAs for PIVC insertion in adults?

Our aim was to identify the amount, variety and essential qualities of TRA literature rather than to critically appraise and evaluate the effectiveness of TRAs, a process reserved for systematic review and meta-analysis of interventional studies.^13,14 We followed scoping review guidelines published by members and collaborators of the Joanna Briggs Institute, an internationally recognized leader in research synthesis, evidence use, and implementation. The guidance is based on 5 steps: (i) scoping review objective and question, (ii) background of the topic to support scoping review, (iii) study selection, (iv) charting the results, and (v) collating and summarizing results.¹⁵ Clinicometric assessment of a TRA or any clinical prediction rule requires 4 specific phases: (i) development (identification of predictors from data), (ii) validation (testing the rule in a separate population for reliability), (iii) impact analysis or responsiveness (How clinically useful is the rule in the clinical setting? Is it resource heavy or light? Is it cost effective?), and (iv) implementation and adoption (uptake into clinical practice).¹⁶

Search Strategy

We included studies that described the use or development of any TRA regarding PIVC insertion in the adult hospitalized population.

Inclusion Criteria

Studies were included if they were published in the English Language, included TRAs for PIVC insertion in adult hospital patients, and prospectively assessed a clinical category of patient for PIVC insertion using a traditional approach. We defined a traditional PIVC insertion approach as an assessment and/or insertion with touch and feel, therefore, without vessel-locating technology such as ultrasound and/or near infrared technology.

Exclusion Criteria

Exclusion criteria included pediatric studies, authors’ personal (nonresearch) experience of tools, TRAs focused on postinsertion assessment of the cannula (such as phlebitis, infiltration, and/or dressing failure), and papers with a focus on VADs other than PIVCs. We excluded studies using PIVC ultrasound and/or near infrared technology because these are not standard in all insertions and greatly change the information available for pre-insertion assessment as well as the likelihood of insertion success.

In June 2016, a systematic search of the Cochrane library, Ovid Medline® In-process & Other Non-Indexed Citations and Ovid MEDLINE(R) <1946 to Present>, EBSCO CINAHL databases, and Google Scholar with specific keywords to identify publications that identified or defined TRAs was undertaken. Medical subject headings were created with assistance from a research librarian using tailored functions within individual databases. With key search terms, we limited studies to those related to our inclusion criteria. See Appendix 1 for our search strategy for Medline and CINAHL.

We used Covidence, a web-based application specifically designed for systematic reviews to screen and evaluate eligible publications.¹⁷ Two authors (PJC and NSH) screened the initial retrieved searches based upon the predetermined inclusion and exclusion criteria.

Data Extraction

A paper template was developed and used by 2 reviewers (P.J.C. and N.S.H.). Data included the following: study sample, aim(s), design, setting and country in which the study took place, clinical and patient variables, and how the TRAs were developed and tested. Studies were categorized by TRA type. We also sought to identify if clinical trial registration (where appropriate) was evidenced, in addition to evidence of protocol publication and what standardized reporting guidelines were used (such as those outlined by the EQUATOR Network).¹⁸

Data Synthesis

Formal meta-analysis was beyond the scope and intention of this review. However, we provide the FTIS rate and the ranges of odds ratios (ORs) with 95% confidence intervals (CIs) for certain independent predictors.

Thirty-six references were imported for screening against title and abstract content, with 11 studies excluded and 25 studies assessed for full-text eligibility (see Figure, PRISMA Flowchart). We then excluded a further 12 studies (6 did not meet inclusion criteria, 2 were focused on the prehospital setting, 2 were personal correspondence and focused on another type of VAD, 1 was a protocol to establish a TRA, and 1 was a framework for all device types), leaving 13 studies included in the final review (see Figure). These studies presented data on 4 tools,^19-22 4 predictive models^3,23-25 (of which 3 present receiver operating characteristic/area under the curve scores),^3,23,24 2 framed as risk factor studies,^26,27 and 1 of each of the following: a scale,²⁸ a score,²⁹ and an estimation of the incidence report rate (Table 1).³⁰ Seven studies had “difficult” or “difficulty” in their title as a term to use to describe insertion failure.^{3,19,24-27,30} One study was titled exclusively for the nursing profession,²⁰ 5 studies were reported in medical journals,^{3,24,26,29,30} and 6 were reported in nursing journals,^19-22,25,27 with the remainder published in a vascular access journal.^23,28

General Characteristics of Included Studies

One TRA which was registered as a clinical trial²⁴ involved a standardized reporting tool as is recommended by the EQUATOR Network.¹⁸

Nine of the 13 papers reported that TRA components were chosen based on identified predictors of successful insertion from observational data^{3,19,23-28,30}, with 5 papers using multivariate logistic regression to identify independent predictors.^3,23,24,26,2 At least 4330 insertion attempts on patients were reported. Seven papers reported FTIS, which ranged from 61%-90%.^3,23-27,30

Two clinical settings accounted for 10 of the 13 included studies. We identified 5 papers from the ED setting^{3,23,26,29,30} and 5 studies specific to cancer settings.^19-22,28 Two ED papers identified clinical predictors of insertion difficulty, with 1 identifying an existing medical diagnosis (such as sickle cell disease, diabetes, or intravenous drug abuse) and the other reporting a pragmatic patient self-report of difficulty.^26,30 Three studies focused on patient-exclusive variables (such as vein characteristics)^19,21,28 and some with a combined clinician and patient focus.^{3,23-25,27,30}Relatively few studies reported interobserver measurements to describe the reliability of clinical assessments made.^3,19,21,28 Webster et al. in Australia assessed interrater reliability of a vein assessment tool (VAT) and found high agreement (kappa 0.83 for medical imaging nurses and 0.93 for oncology nurses).²¹ Wells compared reliability with Altman’s K scores obtained from a different VAT when compared with the Deciding on Intravenous Access tool and found good agreement.²² Vein deterioration was proposed as a variable for inclusion when developing an assessment tool within an oncological context.³¹ In Spain, de la Torre and colleagues²⁸ demonstrated good interrater agreement (with kappa, 0.77) for the Venous International Assessment (VIA) tool. The VIA offers a grading system scale to predict the patient’s declining vessel size while undergoing chemotherapy via peripheral veins with PIVCs. Grade I suggests little or no insertion failure, whereas a Grade V should predict insertion failure.

Patient Variables

Vein characteristics were significant independent factors associated with insertion success in a number of studies.^{3,19,23,24,27,28} These included the number of veins, descriptive quality (eg, small, medium, large), size, location, visible veins, and palpable veins. Other factors appear to be patient specific (such as chronic conditions), including diabetes (OR, 2.1 [adjusted to identify demographic risk factors]; 95% CI, 1.3-3.4), sickle cell disease (OR, 3.5; 95% CI, 1.4-4.8), and intravenous drug abuse (OR, 2.4; 95% CI, 1.1-5.3).²⁶ It is unclear if a consistent relationship between weight classification and insertion outcomes exists. Despite a finding that BMI was not independently associated with insertion difficulty,²⁶ one study reports that BMI was independently associated with insertion failure (BMI <18.5 [OR, 2.24; 95% CI, 1.07-4.67], BMI >30 [OR, 1.98; 95% CI, 1.9-3.60])³ and another reports emaciated patients were associated with greater failure when compared to normal weight patients (OR, 0.07; 95% CI, 0.02-0.34).²³ Consequently, extremes of BMI appear to be associated with insertion outcomes despite 1 study reporting no significant association with BMI as an independent factor of insertion failure.²⁶ A history of difficult intravenous access (DIVA) was reported in 1 study and independently associated with insertion failure (OR, 3.86; 95% CI, 2.39-6.25; see Table 2). DIVA appears to be the motivating factor in the title of 7 studies. When defined, the definitions of DIVA are heterogeneous and varied and include the following: >1 minute to insert a PIVC and requiring >1 attempt²⁷; 2 failed attempts³⁰; 3 or more PIVC attempts.²⁶ In the remaining 4 studies, variables associated with difficulty are identified and, therefore, TRAs to target those in future with predicted difficulty prior to any attempts are proposed.^3,19,24,25

Clinician Variables

Specialist nurse certification, years of experience, and self-report skill level (P < 0.001) appear to be significantly associated with successful insertions.²⁵ This is in part validated in another study reporting greater procedural inserting PIVCs as an independent predictor of success (OR, 4.404; 95% CI, 1.61-12-06; see Table 2).²³ Two studies involved simple pragmatic percentage cut offs for PIVCs: likelihood of use²⁹ and likelihood of insertion success.²³ One paper using a cross-sectional design that surveyed ED clinicians suggested if the clinician’s predicted likelihood of the patient needing a PIVC was >80%, this was a reasonable trigger for PIVC insertion.²⁹ The other, in a self-report cohort study, reported that a clinician’s likelihood estimation of PIVC FTIS prior to insertion is independently associated with FTIS (OR, 1.06; 95% CI, 1.04-1.07).²³

Product Variables

In this review, higher failure rates were identified in smaller sizes (22-24 g).²⁶ One study revealed gauge size was significantly associated with a failed first attempt in a univariate analysis (OR, 0.44; 95% CI, 0.34-0.58), but this was not retained in a multivariate model.²⁴ Matching the PIVC size with vein assessment is considered in the VIA tool.²⁸ It suggests a large PIVC (18 g) can be considered in patients with at least 6 vein options; smaller PIVCs of 22 to 24 g are recommended when 3 or fewer veins are found.²⁸ One paper describes a greater proportion of success between PIVC brands.²⁵

The published evidence for TRAs for PIVCs is limited, with few studies using 2 or more reliability, validity, responsiveness, clinical feasibility, or utility measurements in their development. There is a clear need to assess the clinical utility and clinical feasibility of these approaches so they can be externally validated prior to clinical adoption.¹⁶ For this reason, a validated TRA is likely required but must be appropriate for the capability of the healthcare services to use it. We suggest the consistent absence of all of these phases is owing to the variety of healthcare practitioners who are responsible for the insertion, the care and surveillance of peripheral cannulae, and the fragmentation of clinical approaches that exist.³²

Previously, a comprehensive systematic review on the subject of PIVCs found that the presence of a visible and/or palpable vein is usually associated with FTIS.³³ This current review found evidence of simple scores or cutoff percentage estimates in 2 TRA reports to predict either appropriate PIVC insertion or FTIS.^23,29 If such methods are supported by future experimental trials, then such simple approaches could initiate huge clinical return, particularly given that idle or unused PIVCs are of substantial clinical concern.^34-36 PIVCs transcend a variety of clinical environments with excessive use identified in the ED, where it may be performed for blood sampling alone and, hence, are labeled as “just in case” PIVCs and contribute to the term “idle PIVC.”^23,34 Therefore, a clinical indication to perform PIVC insertion in the first instance must be embedded into any TRA; for example, clinical deterioration is likely and the risks are outweighed by benefit, intravenous fluids and/or medicines are required, and/or diagnostic or clinical procedures are requested (such as contrast scans or procedural sedation).

In the majority of papers reviewed, researchers described how to categorize patients into levels of anticipated and predicted difficulty, but none offered corresponding detailed recommendations for strategies to increase insertion success, such as insertion with ultrasound or vascular access expert. Hypothetically, adopting a TRA may assist with the early identification of difficult to cannulate patients who may require a more expert vascular access clinician. However, in this review, we identify that a uniform definition for DIVA is lacking. Both Webster et al.²¹ and Wells²² suggest that an expert inserter is required if difficult access is identified by their tools, but there is no clear description of the qualities of an expert inserter in the literature.³⁷ Recently, consensus recommendations for the definition of vascular access specialist add to discussions about defining vascular access as an interdisciplinary specialist role.³⁸ This is supported by other publications that highlight the association between PIVC procedural experience and increased insertion success.^6,23,39-41With regards to products, PIVC gauge size may or may not be significantly associated with insertion success. For identifying a relationship of PIVC gauge with vein quality, both the vein diameter and description will help with the clinical interpretation of results. For example, it may be the case that bigger veins are easier to insert a PIVC and, thus, larger PIVCs are inserted. The opposite can occur when the veins are small and poorly visualized; hence, one may select a small gauge catheter. This argument is supported by Prottengeier et al.⁴² in a prehospital study that excluded PIVC size in a multivariate analysis because of confounding. However, gauge size is very likely to influence postinsertion complications. Prospective studies are contradictory and suggest 16 to 18 g PIVCs are more likely to contribute to superficial thrombus,⁴³ phlebitis, and, thus, device failure, in contrast to others reporting more frequent dislodgement with smaller 22 g PIVCs.^6,44Finally, the studies included did not assess survival times of the inserted PIVCs, given postinsertion failure in the hospitalized patient is prevalent⁴⁵ and, importantly, modifiable.⁴⁶ A TRA may yield initial insertion success, but if postinsertion the PIVC fails because of a modifiable reason that the TRA has not acknowledged, then it may be of negligible overall benefit. Therefore, TRAs for PIVC insertion need calibration, further development, and ongoing refinement prior to external validation testing.²⁴ Future research should also examine the role of TRAs in settings where ultrasound or other insertion technology is routinely used.

This review identifies a clinically significant gap in vascular access science. The findings of this review support recent work on vessel health and preservation^47-49 and appropriate device insertion.⁵⁰ It also points to the need for further research on the development and testing of an appropriate clinical TRA to improve vascular access outcomes in clinical practice.

Acknowledgments

The authors thank Ms. Kylie Black and Mr. Simon Lewis, who are medical research librarians at The University of Western Australia.

Disclosure

 Mr. Carr has received “speakers bureau” payment form CareFusion in 2013 and Becton Dickinson (BD) in 2014 for lectures on the subject of vascular access. He received a grant from CareFusion (facilitated by his institution at the time) to attend a scientific meeting on vascular access in the USA in 2012. Griffith University has received unrestricted investigator initiated research or educational grants on Marie Cooke’s behalf from product manufacturers: Baxter; Becton, Dickinson and Company; Centurion Medical Products and Entrotech Lifesciences. Griffith University has received unrestricted investigator initiated research or educational grants on Claire M. Rickard’s behalf from product manufacturers: 3M; Adhezion Biomedical, AngioDynamics; Bard, Baxter; B.Braun; Becton, Dickinson and Company; Centurion Medical Products; Cook Medical; Entrotech, Flomedical; ICU Medical; Medtronic; Smiths Medical, Teleflex. Griffith University has received consultancy payments on Claire M. Rickard’s behalf from product manufacturers: 3M, Bard; BBraun, BD, ResQDevices, Smiths Medical. Dr. Higgins and Dr. Rippey have nothing to disclose. All of the aforementioned have not biased or influenced this review.

All authors have made substantial contributions with this review. Each author has contributed to drafting and editing the manuscript and approves the final version for publishing.