Evidence exists that physicians consider what may be called “social” or “nonmedical” factors (lack of social support or barriers to access) in hospital admission decision-making and that patients are hospitalized even in the absence of a level of medical acuity warranting admission.^1-3 Although hospitalization is associated with the risk of adverse events (AEs),⁴ whether this risk is related to the medical acuity of admission remains unclear. Our study sought to quantify the AEs experienced by patients hospitalized without definite medical acuity compared with those experienced by patients hospitalized with a definite medically appropriate indication for admission.

Setting and Database Used for Analysis

This study was conducted at an urban, safety-net, public teaching hospital. At our site, calls for medical admissions are always answered by a hospital medicine attending physician (“triage physician”) who works collaboratively with the referring physician to facilitate appropriate disposition. Many of these discussions occur via telephone, but the triage physician may also assess the patient directly if needed. This study involved 24 triage physicians who directly assessed the patient in 65% of the cases.

At the time of each admission call, the triage physician logs the following information into a central triage database: date and time of call, patient location, reason for admission, assessment of appropriateness for medical floor, contributing factors to admission decision-making, and patient disposition.

Admission Appropriateness Group Designation

To be considered for inclusion in this study, calls must have originated from the emergency department and resulted in admission to the general medicine floor on either a resident teaching or hospitalist service from February 1, 2018 to June 1, 2018. This time frame was selected to avoid the start of a new academic cycle in late June that may confound AE rates.

The designation of appropriateness was determined by the triage physician’s logged response to triage database questions at the time of the admission call. Of the 748 admissions meeting inclusion criteria, 513 (68.6%) were considered definitely appropriate on the basis of the triage physician’s response to the question “Based ONLY on the medical reason for hospitalization, in your opinion, how appropriate is this admission to the medicine floor service?” Furthermore, 169 (22.6%) were considered without definite medical acuity on the basis of the triage physician’s indication that “severity of medical problems alone may not require inpatient hospitalization” (Appendix Figure 1).

Study Design

Following a retrospective cohort study design, we systematically sampled 150 admissions from those “admitted without definite medical acuity” to create the exposure group and 150 from the “definitely medically appropriate” admissions to create the nonexposure group. Our sampling method involved selecting every third record until reaching the target sample size. This method and group sizes were determined prior to beginning data collection. Given the expected incidence of 33% AEs in the unexposed group (consistent with previous reports of AEs using the trigger tool⁵), we anticipated that a total sample size of 300 would be appropriate to capture a relative risk of at least 1.5 with 80% power and 95% confidence level.

Chart review was performed to capture patient demographics, admission characteristics, and hospitalization outcomes. We captured emergency severity index (ESI)⁶, a validated, reliable triage assessment score assigned by our emergency department, as a measurement of acute illness and calculated the Charlson comorbidity index (CCI)⁷ as a measurement of chronic comorbidity.

Identification of Adverse Events

We measured AEs by using the Institute for Healthcare Improvement Global Trigger Tool,^8,9 which is estimated to identify up to 10 times more AEs than other methods, such as voluntary reporting.⁵ This protocol includes 28 triggers in the Cares and Medication Modules that serve as indicators that an AE may have occurred. The presence of a trigger is not necessarily an AE but a clue for further analysis. Two investigators (AS and CS) independently systematically searched for the presence of triggers within each patient chart. Trigger identification prompted in-depth analysis to confirm the occurrence of an AE and to characterize its severity by using the National Coordinating Council for Medication Error Reporting and Prevention categorization.¹⁰ An AE was coded when independent reviewers identified evidence of a preventable or nonpreventable “noxious and unintended event occurring in association with medical care.”⁹ By definition, any AEs identified were patient harms. Findings were reviewed weekly to ensure agreement, and discrepancies were adjudicated by a third investigator (MB).

All study data were collected by using REDCap electronic data capture tools hosted at the University of Washington.¹¹ The University of Washington Institutional Review Board granted approval for this study.

Study Outcome and Statistical Analysis

The primary outcome was AEs per group with results calculated in three ways: AEs per 1,000 patient-days, AEs per 100 admissions, and percent of admissions with an AE. The risk ratio (RR) for the percent of admissions with an AE and the incidence rate ratio (IRR) for AEs per 1,000 patient-days were calculated for the comparison of significance.

Other data were analyzed by using Pearson’s chi square for categorical data, Student t test for normally distributed quantitative data, and Wilcoxon rank-sum (Mann–Whitney) for the length of stay (due to skew). Analyses were conducted using STATA (version 15.1, College Station, TX).

This work follows standards for reporting observational students as outlined in the STROBE statement.¹²

Patient Demographics

Both groups were predominantly white/non-Hispanic, male, and English-speaking (Table 1). More patients without definite medical acuity were covered by public insurance (78.9% vs 69.8%, P = .010) and discharged to homelessness (34.8% vs 22.6%, P = .041).

Measures of Illness

Patients considered definitely medically appropriate had lower ESI scores, indicative of more acute presentation, than those without definite medical acuity (2.73 [95% CI 2.64-2.81] vs 2.87 [95% CI 2.78-2.95], P = .026). There was no difference in CCI scores (Table 1).

Reason for Admission and Outcomes

Admissions considered definitely medically appropriate more frequently had an identified diagnosis/syndrome (66% vs 53%) or objective measurement (8.7% vs 2.7%) listed as the reason for admission, whereas patients admitted without definite medical acuity more freuqently had undifferentiated symptoms (34.7% vs 24%) or other/disposition (6% vs 1.3%) listed. The most common factors that triage physicians cited as contributing to the decision to admit patients without definite medical acuity included homelessness (34%), lack of outpatient social support (32%), and substance use disorder (25%). More details are available in Appendix Tables 1 and 2.

Admissions without definite medical acuity were longer than those with definite medical acuity (6.6 vs 6.0 days, P = .038), but there was no difference in emergency department readmissions within 48 hours or hospital readmissions within 30 days (Table 1).

Adverse Events

We identified 76 AEs in 41 admissions without definite medical acuity (range 0-10 AEs per admission) and 63 AEs in 44 definitely medically appropriate admissions (range 0-4 AEs per admission). The percentage of admissions with AE (27.3% vs 29.3%; RR 0.93, 95% CI 0.65-1.34, P = .70) and the rate of AE/1,000 patient-days (76.8 vs 70.4; IRR 1.09, 95% CI 0.77-1.55, P = .61) did not show statistically significant differences. The distribution of AE severity was similar between the two groups (Table 2). Most identified AEs caused temporary harm to the patient and were rated at severity levels E or F. Severe AEs, including at least one level I (patient death), occurred in both groups. The complete listing of positive triggers leading to adverse event identification by group and severity is available in Appendix Table 3.

By using a robust, standardized method, we found that patients admitted without definite medical acuity experienced the same number of inpatient AEs as patients admitted for definitely medically appropriate reasons. While the groups were relatively similar overall in terms of demographics and chronic comorbidity, we found evidence of social vulnerability in the group admitted without definite medical acuity in the form of increased rates of homelessness, triage physician concern regarding the lack of outpatient social support, and disposition-related reasons for admission. That both groups suffered harm―including patient death―while admitted to the hospital is striking, in particular for those patients who were admitted because of the lack of suitable outpatient options.

The potential limitations to the generalizability of this work include the single-site, safety-net setting and the use of individual physician determination of admission appropriateness. The proportion of admissions without definite medical acuity reported here is similar to that reported by previously published admission decision-making studies,^2,3 and the rate of AEs observed is similar to rates measured in other studies using the trigger tool methodology.^5,13 These similarities suggest some commonality across settings. Our study treats triage physician assessment as the marker of difference in defining the two groups and is an inherently subjective assessment that is reflective of real-world, holistic decision-making. Notably, the triage physician assessment was corroborated by corresponding differences in the ESI score, an acute triage assessment completed by a clinician outside of our team.

This study adds foundational knowledge to the risk/benefit discussion surrounding the decision to admit. Physician admission decisions are likely influenced by concern for the safety of vulnerable patients. Our results suggest that considering the risk of hospitalization itself in this decision-making remains important.

Evidence exists that physicians consider what may be called “social” or “nonmedical” factors (lack of social support or barriers to access) in hospital admission decision-making and that patients are hospitalized even in the absence of a level of medical acuity warranting admission.^1-3 Although hospitalization is associated with the risk of adverse events (AEs),⁴ whether this risk is related to the medical acuity of admission remains unclear. Our study sought to quantify the AEs experienced by patients hospitalized without definite medical acuity compared with those experienced by patients hospitalized with a definite medically appropriate indication for admission.

Setting and Database Used for Analysis

This study was conducted at an urban, safety-net, public teaching hospital. At our site, calls for medical admissions are always answered by a hospital medicine attending physician (“triage physician”) who works collaboratively with the referring physician to facilitate appropriate disposition. Many of these discussions occur via telephone, but the triage physician may also assess the patient directly if needed. This study involved 24 triage physicians who directly assessed the patient in 65% of the cases.

At the time of each admission call, the triage physician logs the following information into a central triage database: date and time of call, patient location, reason for admission, assessment of appropriateness for medical floor, contributing factors to admission decision-making, and patient disposition.

Admission Appropriateness Group Designation

To be considered for inclusion in this study, calls must have originated from the emergency department and resulted in admission to the general medicine floor on either a resident teaching or hospitalist service from February 1, 2018 to June 1, 2018. This time frame was selected to avoid the start of a new academic cycle in late June that may confound AE rates.

The designation of appropriateness was determined by the triage physician’s logged response to triage database questions at the time of the admission call. Of the 748 admissions meeting inclusion criteria, 513 (68.6%) were considered definitely appropriate on the basis of the triage physician’s response to the question “Based ONLY on the medical reason for hospitalization, in your opinion, how appropriate is this admission to the medicine floor service?” Furthermore, 169 (22.6%) were considered without definite medical acuity on the basis of the triage physician’s indication that “severity of medical problems alone may not require inpatient hospitalization” (Appendix Figure 1).

Study Design

Following a retrospective cohort study design, we systematically sampled 150 admissions from those “admitted without definite medical acuity” to create the exposure group and 150 from the “definitely medically appropriate” admissions to create the nonexposure group. Our sampling method involved selecting every third record until reaching the target sample size. This method and group sizes were determined prior to beginning data collection. Given the expected incidence of 33% AEs in the unexposed group (consistent with previous reports of AEs using the trigger tool⁵), we anticipated that a total sample size of 300 would be appropriate to capture a relative risk of at least 1.5 with 80% power and 95% confidence level.

Chart review was performed to capture patient demographics, admission characteristics, and hospitalization outcomes. We captured emergency severity index (ESI)⁶, a validated, reliable triage assessment score assigned by our emergency department, as a measurement of acute illness and calculated the Charlson comorbidity index (CCI)⁷ as a measurement of chronic comorbidity.

Identification of Adverse Events

We measured AEs by using the Institute for Healthcare Improvement Global Trigger Tool,^8,9 which is estimated to identify up to 10 times more AEs than other methods, such as voluntary reporting.⁵ This protocol includes 28 triggers in the Cares and Medication Modules that serve as indicators that an AE may have occurred. The presence of a trigger is not necessarily an AE but a clue for further analysis. Two investigators (AS and CS) independently systematically searched for the presence of triggers within each patient chart. Trigger identification prompted in-depth analysis to confirm the occurrence of an AE and to characterize its severity by using the National Coordinating Council for Medication Error Reporting and Prevention categorization.¹⁰ An AE was coded when independent reviewers identified evidence of a preventable or nonpreventable “noxious and unintended event occurring in association with medical care.”⁹ By definition, any AEs identified were patient harms. Findings were reviewed weekly to ensure agreement, and discrepancies were adjudicated by a third investigator (MB).

All study data were collected by using REDCap electronic data capture tools hosted at the University of Washington.¹¹ The University of Washington Institutional Review Board granted approval for this study.

Study Outcome and Statistical Analysis

The primary outcome was AEs per group with results calculated in three ways: AEs per 1,000 patient-days, AEs per 100 admissions, and percent of admissions with an AE. The risk ratio (RR) for the percent of admissions with an AE and the incidence rate ratio (IRR) for AEs per 1,000 patient-days were calculated for the comparison of significance.

Other data were analyzed by using Pearson’s chi square for categorical data, Student t test for normally distributed quantitative data, and Wilcoxon rank-sum (Mann–Whitney) for the length of stay (due to skew). Analyses were conducted using STATA (version 15.1, College Station, TX).

This work follows standards for reporting observational students as outlined in the STROBE statement.¹²

Patient Demographics

Both groups were predominantly white/non-Hispanic, male, and English-speaking (Table 1). More patients without definite medical acuity were covered by public insurance (78.9% vs 69.8%, P = .010) and discharged to homelessness (34.8% vs 22.6%, P = .041).

Measures of Illness

Patients considered definitely medically appropriate had lower ESI scores, indicative of more acute presentation, than those without definite medical acuity (2.73 [95% CI 2.64-2.81] vs 2.87 [95% CI 2.78-2.95], P = .026). There was no difference in CCI scores (Table 1).

Reason for Admission and Outcomes

Admissions considered definitely medically appropriate more frequently had an identified diagnosis/syndrome (66% vs 53%) or objective measurement (8.7% vs 2.7%) listed as the reason for admission, whereas patients admitted without definite medical acuity more freuqently had undifferentiated symptoms (34.7% vs 24%) or other/disposition (6% vs 1.3%) listed. The most common factors that triage physicians cited as contributing to the decision to admit patients without definite medical acuity included homelessness (34%), lack of outpatient social support (32%), and substance use disorder (25%). More details are available in Appendix Tables 1 and 2.

Admissions without definite medical acuity were longer than those with definite medical acuity (6.6 vs 6.0 days, P = .038), but there was no difference in emergency department readmissions within 48 hours or hospital readmissions within 30 days (Table 1).

Adverse Events

We identified 76 AEs in 41 admissions without definite medical acuity (range 0-10 AEs per admission) and 63 AEs in 44 definitely medically appropriate admissions (range 0-4 AEs per admission). The percentage of admissions with AE (27.3% vs 29.3%; RR 0.93, 95% CI 0.65-1.34, P = .70) and the rate of AE/1,000 patient-days (76.8 vs 70.4; IRR 1.09, 95% CI 0.77-1.55, P = .61) did not show statistically significant differences. The distribution of AE severity was similar between the two groups (Table 2). Most identified AEs caused temporary harm to the patient and were rated at severity levels E or F. Severe AEs, including at least one level I (patient death), occurred in both groups. The complete listing of positive triggers leading to adverse event identification by group and severity is available in Appendix Table 3.

By using a robust, standardized method, we found that patients admitted without definite medical acuity experienced the same number of inpatient AEs as patients admitted for definitely medically appropriate reasons. While the groups were relatively similar overall in terms of demographics and chronic comorbidity, we found evidence of social vulnerability in the group admitted without definite medical acuity in the form of increased rates of homelessness, triage physician concern regarding the lack of outpatient social support, and disposition-related reasons for admission. That both groups suffered harm―including patient death―while admitted to the hospital is striking, in particular for those patients who were admitted because of the lack of suitable outpatient options.

The potential limitations to the generalizability of this work include the single-site, safety-net setting and the use of individual physician determination of admission appropriateness. The proportion of admissions without definite medical acuity reported here is similar to that reported by previously published admission decision-making studies,^2,3 and the rate of AEs observed is similar to rates measured in other studies using the trigger tool methodology.^5,13 These similarities suggest some commonality across settings. Our study treats triage physician assessment as the marker of difference in defining the two groups and is an inherently subjective assessment that is reflective of real-world, holistic decision-making. Notably, the triage physician assessment was corroborated by corresponding differences in the ESI score, an acute triage assessment completed by a clinician outside of our team.

This study adds foundational knowledge to the risk/benefit discussion surrounding the decision to admit. Physician admission decisions are likely influenced by concern for the safety of vulnerable patients. Our results suggest that considering the risk of hospitalization itself in this decision-making remains important.

Evidence exists that physicians consider what may be called “social” or “nonmedical” factors (lack of social support or barriers to access) in hospital admission decision-making and that patients are hospitalized even in the absence of a level of medical acuity warranting admission.^1-3 Although hospitalization is associated with the risk of adverse events (AEs),⁴ whether this risk is related to the medical acuity of admission remains unclear. Our study sought to quantify the AEs experienced by patients hospitalized without definite medical acuity compared with those experienced by patients hospitalized with a definite medically appropriate indication for admission.

Setting and Database Used for Analysis

This study was conducted at an urban, safety-net, public teaching hospital. At our site, calls for medical admissions are always answered by a hospital medicine attending physician (“triage physician”) who works collaboratively with the referring physician to facilitate appropriate disposition. Many of these discussions occur via telephone, but the triage physician may also assess the patient directly if needed. This study involved 24 triage physicians who directly assessed the patient in 65% of the cases.

At the time of each admission call, the triage physician logs the following information into a central triage database: date and time of call, patient location, reason for admission, assessment of appropriateness for medical floor, contributing factors to admission decision-making, and patient disposition.

Admission Appropriateness Group Designation

To be considered for inclusion in this study, calls must have originated from the emergency department and resulted in admission to the general medicine floor on either a resident teaching or hospitalist service from February 1, 2018 to June 1, 2018. This time frame was selected to avoid the start of a new academic cycle in late June that may confound AE rates.

The designation of appropriateness was determined by the triage physician’s logged response to triage database questions at the time of the admission call. Of the 748 admissions meeting inclusion criteria, 513 (68.6%) were considered definitely appropriate on the basis of the triage physician’s response to the question “Based ONLY on the medical reason for hospitalization, in your opinion, how appropriate is this admission to the medicine floor service?” Furthermore, 169 (22.6%) were considered without definite medical acuity on the basis of the triage physician’s indication that “severity of medical problems alone may not require inpatient hospitalization” (Appendix Figure 1).

Study Design

Following a retrospective cohort study design, we systematically sampled 150 admissions from those “admitted without definite medical acuity” to create the exposure group and 150 from the “definitely medically appropriate” admissions to create the nonexposure group. Our sampling method involved selecting every third record until reaching the target sample size. This method and group sizes were determined prior to beginning data collection. Given the expected incidence of 33% AEs in the unexposed group (consistent with previous reports of AEs using the trigger tool⁵), we anticipated that a total sample size of 300 would be appropriate to capture a relative risk of at least 1.5 with 80% power and 95% confidence level.

Chart review was performed to capture patient demographics, admission characteristics, and hospitalization outcomes. We captured emergency severity index (ESI)⁶, a validated, reliable triage assessment score assigned by our emergency department, as a measurement of acute illness and calculated the Charlson comorbidity index (CCI)⁷ as a measurement of chronic comorbidity.

Identification of Adverse Events

We measured AEs by using the Institute for Healthcare Improvement Global Trigger Tool,^8,9 which is estimated to identify up to 10 times more AEs than other methods, such as voluntary reporting.⁵ This protocol includes 28 triggers in the Cares and Medication Modules that serve as indicators that an AE may have occurred. The presence of a trigger is not necessarily an AE but a clue for further analysis. Two investigators (AS and CS) independently systematically searched for the presence of triggers within each patient chart. Trigger identification prompted in-depth analysis to confirm the occurrence of an AE and to characterize its severity by using the National Coordinating Council for Medication Error Reporting and Prevention categorization.¹⁰ An AE was coded when independent reviewers identified evidence of a preventable or nonpreventable “noxious and unintended event occurring in association with medical care.”⁹ By definition, any AEs identified were patient harms. Findings were reviewed weekly to ensure agreement, and discrepancies were adjudicated by a third investigator (MB).

All study data were collected by using REDCap electronic data capture tools hosted at the University of Washington.¹¹ The University of Washington Institutional Review Board granted approval for this study.

Study Outcome and Statistical Analysis

The primary outcome was AEs per group with results calculated in three ways: AEs per 1,000 patient-days, AEs per 100 admissions, and percent of admissions with an AE. The risk ratio (RR) for the percent of admissions with an AE and the incidence rate ratio (IRR) for AEs per 1,000 patient-days were calculated for the comparison of significance.

Other data were analyzed by using Pearson’s chi square for categorical data, Student t test for normally distributed quantitative data, and Wilcoxon rank-sum (Mann–Whitney) for the length of stay (due to skew). Analyses were conducted using STATA (version 15.1, College Station, TX).

This work follows standards for reporting observational students as outlined in the STROBE statement.¹²

Patient Demographics

Both groups were predominantly white/non-Hispanic, male, and English-speaking (Table 1). More patients without definite medical acuity were covered by public insurance (78.9% vs 69.8%, P = .010) and discharged to homelessness (34.8% vs 22.6%, P = .041).

Measures of Illness

Patients considered definitely medically appropriate had lower ESI scores, indicative of more acute presentation, than those without definite medical acuity (2.73 [95% CI 2.64-2.81] vs 2.87 [95% CI 2.78-2.95], P = .026). There was no difference in CCI scores (Table 1).

Reason for Admission and Outcomes

Admissions considered definitely medically appropriate more frequently had an identified diagnosis/syndrome (66% vs 53%) or objective measurement (8.7% vs 2.7%) listed as the reason for admission, whereas patients admitted without definite medical acuity more freuqently had undifferentiated symptoms (34.7% vs 24%) or other/disposition (6% vs 1.3%) listed. The most common factors that triage physicians cited as contributing to the decision to admit patients without definite medical acuity included homelessness (34%), lack of outpatient social support (32%), and substance use disorder (25%). More details are available in Appendix Tables 1 and 2.

Admissions without definite medical acuity were longer than those with definite medical acuity (6.6 vs 6.0 days, P = .038), but there was no difference in emergency department readmissions within 48 hours or hospital readmissions within 30 days (Table 1).

Adverse Events

We identified 76 AEs in 41 admissions without definite medical acuity (range 0-10 AEs per admission) and 63 AEs in 44 definitely medically appropriate admissions (range 0-4 AEs per admission). The percentage of admissions with AE (27.3% vs 29.3%; RR 0.93, 95% CI 0.65-1.34, P = .70) and the rate of AE/1,000 patient-days (76.8 vs 70.4; IRR 1.09, 95% CI 0.77-1.55, P = .61) did not show statistically significant differences. The distribution of AE severity was similar between the two groups (Table 2). Most identified AEs caused temporary harm to the patient and were rated at severity levels E or F. Severe AEs, including at least one level I (patient death), occurred in both groups. The complete listing of positive triggers leading to adverse event identification by group and severity is available in Appendix Table 3.

By using a robust, standardized method, we found that patients admitted without definite medical acuity experienced the same number of inpatient AEs as patients admitted for definitely medically appropriate reasons. While the groups were relatively similar overall in terms of demographics and chronic comorbidity, we found evidence of social vulnerability in the group admitted without definite medical acuity in the form of increased rates of homelessness, triage physician concern regarding the lack of outpatient social support, and disposition-related reasons for admission. That both groups suffered harm―including patient death―while admitted to the hospital is striking, in particular for those patients who were admitted because of the lack of suitable outpatient options.

The potential limitations to the generalizability of this work include the single-site, safety-net setting and the use of individual physician determination of admission appropriateness. The proportion of admissions without definite medical acuity reported here is similar to that reported by previously published admission decision-making studies,^2,3 and the rate of AEs observed is similar to rates measured in other studies using the trigger tool methodology.^5,13 These similarities suggest some commonality across settings. Our study treats triage physician assessment as the marker of difference in defining the two groups and is an inherently subjective assessment that is reflective of real-world, holistic decision-making. Notably, the triage physician assessment was corroborated by corresponding differences in the ESI score, an acute triage assessment completed by a clinician outside of our team.

This study adds foundational knowledge to the risk/benefit discussion surrounding the decision to admit. Physician admission decisions are likely influenced by concern for the safety of vulnerable patients. Our results suggest that considering the risk of hospitalization itself in this decision-making remains important.

As you review the electronic health record before rounds in the morning, you notice a red exclamation mark in the chart of a patient who was admitted two days ago for an acute chronic obstructive pulmonary disease (COPD) exacerbation. The patient’s respiratory rate (RR) this morning is recorded at 24 breaths per minute (bpm). His RR last evening was 16 bpm and he remains on two liters per minute of supplemental oxygen. No one has notified you that he is getting worse, but you stop by the room to confirm that he is clinically stable.

During rounds, the resident states “The respiratory rate is recorded as 24 bpm, which is high, but I never trust the respiratory rate.” You silently agree and confirm your mistrust of the recorded RR.

Elevated RR has been associated with numerous poor outcomes, including mortality after myocardial infarction¹ and death and readmission after acute COPD exacerbation.² Furthermore, RR is used in models to predict mortality and intensive care unit admission,³ as well as in models to identify and predict mortality from sepsis.⁴ Recorded RRs are frequency inaccurate,⁵ and medical staff lack confidence in recorded RR values.⁶ Based on this evidence, you feel justified in your mistrust of recorded RR values. You might even believe that until a high-tech RR monitoring system is invented and implemented at your hospital, human error will forever prevent you from knowing your patients’ true RRs.

However, there is hope. In this issue of the Journal of Hospital Medicine, Keshvani et al.⁷ describe a successful quality improvement project where they employed plan–do–study–act methodology in a single inpatient unit to improve the accuracy of recorded RR. Before their project, only 36% of RR measurements were accurate, and there was considerable heterogeneity in the RR measurement technique. To address this problem, an interdisciplinary team of patient care assistants (PCAs), nurses, physicians, and hospital administration developed a plan to identify barriers, improve workflow, and educate stakeholders in RR recording.

The authors created a low-cost, “low-tech” intervention that consisted of training and educating PCAs on the correct technique and the importance of RR measurement, modifying workflow to incorporate RR measurement into a 30-second period of automated blood pressure measurement, and adding stopwatches to the vital sign carts. The RR measurements obtained by PCAs were compared with the RR measurements obtained by trained team members to assess for accuracy. PCA-obtained RR measurements were also compared with two control units, both before and after the intervention. Secondary outcomes included time to complete vital sign measurements and the incidence of systemic inflammatory response syndrome (SIRS) specifically due to tachypnea. The authors hypothesized that improved RR accuracy would reduce the number of falsely elevated RRs and could reduce the rate of SIRS.

The intervention improved the accuracy of PCA-obtained RRs from 36% to 58% and decreased the median RR from 18 to 14 breaths per minute. The implementation also resulted in a more normal distribution of RR in the intervention unit compared with the control unit. Interestingly, this intervention did not increase the time spent in obtaining vital signs—in fact, the time to complete vital signs decreased from a median of 2:26 to 1:55 minutes. In addition, tachypnea-specific SIRS incidence was reduced by 7.8% per hospitalization. An important implication of this finding is that reducing the false-positive rate of SIRS could possibly decrease unnecessary testing, medical interventions, and alert fatigue.

This project shows that meaningful interventions need not be expensive or overly technologic to have very real clinical effects. It would be very easy for a system to advocate for funding to purchase advanced monitors that purport to remove human error from the situation rather than trying first to improve human performance. Certainly, there is a role for advanced technologies—but improvement need not wait for, or be completely predicated on, these new technologies. The first barrier often expressed when evaluating a potential improvement initiative is that “we don’t have time for that”. This project demonstrates that innovations to improve care can also benefit the care team and improve workflow. Certainly, this project is not definitive and should be replicated elsewhere, but it is an important first step.

In an era where technology is expanding rapidly and the pace of innovation is breathtaking, we have an obligation to ensure that we are getting the basics right. Further, we must not take core tasks—such as vital signs, physical examination, and medication reconciliation—for granted, nor should we accept that they are as they will be. We discuss and debate the merits of advanced imaging, artificial intelligence, and machine learning­—which are certainly exciting advances—but we must occasionally pause, breathe, and examine our practice to make sure that we do not overlook things that are truly vital to our patients’ care.

Disclosures

The authors have nothing to disclose.

As you review the electronic health record before rounds in the morning, you notice a red exclamation mark in the chart of a patient who was admitted two days ago for an acute chronic obstructive pulmonary disease (COPD) exacerbation. The patient’s respiratory rate (RR) this morning is recorded at 24 breaths per minute (bpm). His RR last evening was 16 bpm and he remains on two liters per minute of supplemental oxygen. No one has notified you that he is getting worse, but you stop by the room to confirm that he is clinically stable.

During rounds, the resident states “The respiratory rate is recorded as 24 bpm, which is high, but I never trust the respiratory rate.” You silently agree and confirm your mistrust of the recorded RR.

Elevated RR has been associated with numerous poor outcomes, including mortality after myocardial infarction¹ and death and readmission after acute COPD exacerbation.² Furthermore, RR is used in models to predict mortality and intensive care unit admission,³ as well as in models to identify and predict mortality from sepsis.⁴ Recorded RRs are frequency inaccurate,⁵ and medical staff lack confidence in recorded RR values.⁶ Based on this evidence, you feel justified in your mistrust of recorded RR values. You might even believe that until a high-tech RR monitoring system is invented and implemented at your hospital, human error will forever prevent you from knowing your patients’ true RRs.

However, there is hope. In this issue of the Journal of Hospital Medicine, Keshvani et al.⁷ describe a successful quality improvement project where they employed plan–do–study–act methodology in a single inpatient unit to improve the accuracy of recorded RR. Before their project, only 36% of RR measurements were accurate, and there was considerable heterogeneity in the RR measurement technique. To address this problem, an interdisciplinary team of patient care assistants (PCAs), nurses, physicians, and hospital administration developed a plan to identify barriers, improve workflow, and educate stakeholders in RR recording.

The authors created a low-cost, “low-tech” intervention that consisted of training and educating PCAs on the correct technique and the importance of RR measurement, modifying workflow to incorporate RR measurement into a 30-second period of automated blood pressure measurement, and adding stopwatches to the vital sign carts. The RR measurements obtained by PCAs were compared with the RR measurements obtained by trained team members to assess for accuracy. PCA-obtained RR measurements were also compared with two control units, both before and after the intervention. Secondary outcomes included time to complete vital sign measurements and the incidence of systemic inflammatory response syndrome (SIRS) specifically due to tachypnea. The authors hypothesized that improved RR accuracy would reduce the number of falsely elevated RRs and could reduce the rate of SIRS.

The intervention improved the accuracy of PCA-obtained RRs from 36% to 58% and decreased the median RR from 18 to 14 breaths per minute. The implementation also resulted in a more normal distribution of RR in the intervention unit compared with the control unit. Interestingly, this intervention did not increase the time spent in obtaining vital signs—in fact, the time to complete vital signs decreased from a median of 2:26 to 1:55 minutes. In addition, tachypnea-specific SIRS incidence was reduced by 7.8% per hospitalization. An important implication of this finding is that reducing the false-positive rate of SIRS could possibly decrease unnecessary testing, medical interventions, and alert fatigue.

This project shows that meaningful interventions need not be expensive or overly technologic to have very real clinical effects. It would be very easy for a system to advocate for funding to purchase advanced monitors that purport to remove human error from the situation rather than trying first to improve human performance. Certainly, there is a role for advanced technologies—but improvement need not wait for, or be completely predicated on, these new technologies. The first barrier often expressed when evaluating a potential improvement initiative is that “we don’t have time for that”. This project demonstrates that innovations to improve care can also benefit the care team and improve workflow. Certainly, this project is not definitive and should be replicated elsewhere, but it is an important first step.

In an era where technology is expanding rapidly and the pace of innovation is breathtaking, we have an obligation to ensure that we are getting the basics right. Further, we must not take core tasks—such as vital signs, physical examination, and medication reconciliation—for granted, nor should we accept that they are as they will be. We discuss and debate the merits of advanced imaging, artificial intelligence, and machine learning­—which are certainly exciting advances—but we must occasionally pause, breathe, and examine our practice to make sure that we do not overlook things that are truly vital to our patients’ care.

Disclosures

The authors have nothing to disclose.

As you review the electronic health record before rounds in the morning, you notice a red exclamation mark in the chart of a patient who was admitted two days ago for an acute chronic obstructive pulmonary disease (COPD) exacerbation. The patient’s respiratory rate (RR) this morning is recorded at 24 breaths per minute (bpm). His RR last evening was 16 bpm and he remains on two liters per minute of supplemental oxygen. No one has notified you that he is getting worse, but you stop by the room to confirm that he is clinically stable.

During rounds, the resident states “The respiratory rate is recorded as 24 bpm, which is high, but I never trust the respiratory rate.” You silently agree and confirm your mistrust of the recorded RR.

Elevated RR has been associated with numerous poor outcomes, including mortality after myocardial infarction¹ and death and readmission after acute COPD exacerbation.² Furthermore, RR is used in models to predict mortality and intensive care unit admission,³ as well as in models to identify and predict mortality from sepsis.⁴ Recorded RRs are frequency inaccurate,⁵ and medical staff lack confidence in recorded RR values.⁶ Based on this evidence, you feel justified in your mistrust of recorded RR values. You might even believe that until a high-tech RR monitoring system is invented and implemented at your hospital, human error will forever prevent you from knowing your patients’ true RRs.

However, there is hope. In this issue of the Journal of Hospital Medicine, Keshvani et al.⁷ describe a successful quality improvement project where they employed plan–do–study–act methodology in a single inpatient unit to improve the accuracy of recorded RR. Before their project, only 36% of RR measurements were accurate, and there was considerable heterogeneity in the RR measurement technique. To address this problem, an interdisciplinary team of patient care assistants (PCAs), nurses, physicians, and hospital administration developed a plan to identify barriers, improve workflow, and educate stakeholders in RR recording.

The authors created a low-cost, “low-tech” intervention that consisted of training and educating PCAs on the correct technique and the importance of RR measurement, modifying workflow to incorporate RR measurement into a 30-second period of automated blood pressure measurement, and adding stopwatches to the vital sign carts. The RR measurements obtained by PCAs were compared with the RR measurements obtained by trained team members to assess for accuracy. PCA-obtained RR measurements were also compared with two control units, both before and after the intervention. Secondary outcomes included time to complete vital sign measurements and the incidence of systemic inflammatory response syndrome (SIRS) specifically due to tachypnea. The authors hypothesized that improved RR accuracy would reduce the number of falsely elevated RRs and could reduce the rate of SIRS.

The intervention improved the accuracy of PCA-obtained RRs from 36% to 58% and decreased the median RR from 18 to 14 breaths per minute. The implementation also resulted in a more normal distribution of RR in the intervention unit compared with the control unit. Interestingly, this intervention did not increase the time spent in obtaining vital signs—in fact, the time to complete vital signs decreased from a median of 2:26 to 1:55 minutes. In addition, tachypnea-specific SIRS incidence was reduced by 7.8% per hospitalization. An important implication of this finding is that reducing the false-positive rate of SIRS could possibly decrease unnecessary testing, medical interventions, and alert fatigue.

This project shows that meaningful interventions need not be expensive or overly technologic to have very real clinical effects. It would be very easy for a system to advocate for funding to purchase advanced monitors that purport to remove human error from the situation rather than trying first to improve human performance. Certainly, there is a role for advanced technologies—but improvement need not wait for, or be completely predicated on, these new technologies. The first barrier often expressed when evaluating a potential improvement initiative is that “we don’t have time for that”. This project demonstrates that innovations to improve care can also benefit the care team and improve workflow. Certainly, this project is not definitive and should be replicated elsewhere, but it is an important first step.

In an era where technology is expanding rapidly and the pace of innovation is breathtaking, we have an obligation to ensure that we are getting the basics right. Further, we must not take core tasks—such as vital signs, physical examination, and medication reconciliation—for granted, nor should we accept that they are as they will be. We discuss and debate the merits of advanced imaging, artificial intelligence, and machine learning­—which are certainly exciting advances—but we must occasionally pause, breathe, and examine our practice to make sure that we do not overlook things that are truly vital to our patients’ care.

Disclosures

The authors have nothing to disclose.

Pediatric herpes zoster declined by 72% in the years following introduction of routine varicella vaccination, with the rates in vaccinated children 78% lower than those in unvaccinated children.

KatarzynaBialasiewicz/Thinkstock

The benefit became largely apparent after children received the second vaccination in the recommended series, and persisted throughout childhood, Sheila Weinmann, PhD, of Kaiser Permanente Northern California, Oakland, and colleagues said.*

The analysis included 6.37 million children in the Kaiser Permanente database, 50% of whom were vaccinated for all or some of the study period stretching from 2003 to 2014. Overall, the crude lab-confirmed herpes zoster (HZ) incidence rate was 74/100,000 person-years. When stratified by vaccine status, the crude rate of HZ among vaccinated children was 78% lower than among unvaccinated children (38 vs. 170 cases per 100,000 person years).

Herpes zoster was more common among girls than boys and up to six times more common in immunosuppressed children than in nonimmunosuppressed children.

The authors also found that unvaccinated children benefited from the high rate of vaccination around them. Although the HZ rate was always lower among vaccinated children, the rate among unvaccinated children fell sharply after 2007.

“The trend of decreasing HZ incidence among children who were unvaccinated is likely due to a lack of primary VZV [varicella-zoster virus] infection resulting from herd immunity in a highly vaccinated population,” Dr. Weinmann and her associates said.

There was some variability among age groups, especially among the youngest who were not fully vaccinated.

“In the group aged 1-2 years, the confirmation-adjusted HZ rate among children who were vaccinated was 70% higher than among those who were unvaccinated,” the authors said. In the “older groups, HZ rates were significantly higher in children who were unvaccinated than in those who were vaccinated,” the researchers noted.

The highest incidence was among vaccinated 1-year-olds, who had a 140% higher risk of HZ than did unvaccinated 1-year-olds. But this risk elevation disappeared by age 2 years. For everyone else, aged 2-17 years, the rate of HZ remained significantly lower in vaccinated children.

“Among the small number of children vaccinated at 11 months of age (for whom the vaccine is not recommended), the HZ incidence rate was significantly higher than in children vaccinated at 1 year of age and older. Similarly, children who contract wild-type varicella infection at younger than 1 year of age also have a higher risk of HZ (relative risk, 13.5). The immature adaptive T-cell response in children less than 1 year of age appears less able to contain VZV as a latent infection, compared with older children.

“Our findings for 11-month-olds who were vaccinated should be interpreted with caution because this population included only three cases of HZ and could have included children participating in a prelicensure study with a vaccine formulation different from Varivax,” Dr. Weinmann and her associates said.

Dr. Weinmann and her associates reported no relevant financial disclosures. The study was supported by the Centers for Disease Control and Prevention.

msullivan@mdedge.com

SOURCE: Weinmann S et al. Pediatrics. 2019 Jun 10. doi: 10.1542/peds.2018-2917.

* This article was updated 6/14/2019

Pediatric herpes zoster declined by 72% in the years following introduction of routine varicella vaccination, with the rates in vaccinated children 78% lower than those in unvaccinated children.

KatarzynaBialasiewicz/Thinkstock

The benefit became largely apparent after children received the second vaccination in the recommended series, and persisted throughout childhood, Sheila Weinmann, PhD, of Kaiser Permanente Northern California, Oakland, and colleagues said.*

The analysis included 6.37 million children in the Kaiser Permanente database, 50% of whom were vaccinated for all or some of the study period stretching from 2003 to 2014. Overall, the crude lab-confirmed herpes zoster (HZ) incidence rate was 74/100,000 person-years. When stratified by vaccine status, the crude rate of HZ among vaccinated children was 78% lower than among unvaccinated children (38 vs. 170 cases per 100,000 person years).

Herpes zoster was more common among girls than boys and up to six times more common in immunosuppressed children than in nonimmunosuppressed children.

The authors also found that unvaccinated children benefited from the high rate of vaccination around them. Although the HZ rate was always lower among vaccinated children, the rate among unvaccinated children fell sharply after 2007.

“The trend of decreasing HZ incidence among children who were unvaccinated is likely due to a lack of primary VZV [varicella-zoster virus] infection resulting from herd immunity in a highly vaccinated population,” Dr. Weinmann and her associates said.

There was some variability among age groups, especially among the youngest who were not fully vaccinated.

“In the group aged 1-2 years, the confirmation-adjusted HZ rate among children who were vaccinated was 70% higher than among those who were unvaccinated,” the authors said. In the “older groups, HZ rates were significantly higher in children who were unvaccinated than in those who were vaccinated,” the researchers noted.

The highest incidence was among vaccinated 1-year-olds, who had a 140% higher risk of HZ than did unvaccinated 1-year-olds. But this risk elevation disappeared by age 2 years. For everyone else, aged 2-17 years, the rate of HZ remained significantly lower in vaccinated children.

“Among the small number of children vaccinated at 11 months of age (for whom the vaccine is not recommended), the HZ incidence rate was significantly higher than in children vaccinated at 1 year of age and older. Similarly, children who contract wild-type varicella infection at younger than 1 year of age also have a higher risk of HZ (relative risk, 13.5). The immature adaptive T-cell response in children less than 1 year of age appears less able to contain VZV as a latent infection, compared with older children.

“Our findings for 11-month-olds who were vaccinated should be interpreted with caution because this population included only three cases of HZ and could have included children participating in a prelicensure study with a vaccine formulation different from Varivax,” Dr. Weinmann and her associates said.

Dr. Weinmann and her associates reported no relevant financial disclosures. The study was supported by the Centers for Disease Control and Prevention.

msullivan@mdedge.com

SOURCE: Weinmann S et al. Pediatrics. 2019 Jun 10. doi: 10.1542/peds.2018-2917.

* This article was updated 6/14/2019

Pediatric herpes zoster declined by 72% in the years following introduction of routine varicella vaccination, with the rates in vaccinated children 78% lower than those in unvaccinated children.

KatarzynaBialasiewicz/Thinkstock

The benefit became largely apparent after children received the second vaccination in the recommended series, and persisted throughout childhood, Sheila Weinmann, PhD, of Kaiser Permanente Northern California, Oakland, and colleagues said.*

The analysis included 6.37 million children in the Kaiser Permanente database, 50% of whom were vaccinated for all or some of the study period stretching from 2003 to 2014. Overall, the crude lab-confirmed herpes zoster (HZ) incidence rate was 74/100,000 person-years. When stratified by vaccine status, the crude rate of HZ among vaccinated children was 78% lower than among unvaccinated children (38 vs. 170 cases per 100,000 person years).

Herpes zoster was more common among girls than boys and up to six times more common in immunosuppressed children than in nonimmunosuppressed children.

The authors also found that unvaccinated children benefited from the high rate of vaccination around them. Although the HZ rate was always lower among vaccinated children, the rate among unvaccinated children fell sharply after 2007.

“The trend of decreasing HZ incidence among children who were unvaccinated is likely due to a lack of primary VZV [varicella-zoster virus] infection resulting from herd immunity in a highly vaccinated population,” Dr. Weinmann and her associates said.

There was some variability among age groups, especially among the youngest who were not fully vaccinated.

“In the group aged 1-2 years, the confirmation-adjusted HZ rate among children who were vaccinated was 70% higher than among those who were unvaccinated,” the authors said. In the “older groups, HZ rates were significantly higher in children who were unvaccinated than in those who were vaccinated,” the researchers noted.

The highest incidence was among vaccinated 1-year-olds, who had a 140% higher risk of HZ than did unvaccinated 1-year-olds. But this risk elevation disappeared by age 2 years. For everyone else, aged 2-17 years, the rate of HZ remained significantly lower in vaccinated children.

“Among the small number of children vaccinated at 11 months of age (for whom the vaccine is not recommended), the HZ incidence rate was significantly higher than in children vaccinated at 1 year of age and older. Similarly, children who contract wild-type varicella infection at younger than 1 year of age also have a higher risk of HZ (relative risk, 13.5). The immature adaptive T-cell response in children less than 1 year of age appears less able to contain VZV as a latent infection, compared with older children.

“Our findings for 11-month-olds who were vaccinated should be interpreted with caution because this population included only three cases of HZ and could have included children participating in a prelicensure study with a vaccine formulation different from Varivax,” Dr. Weinmann and her associates said.

Dr. Weinmann and her associates reported no relevant financial disclosures. The study was supported by the Centers for Disease Control and Prevention.

msullivan@mdedge.com

SOURCE: Weinmann S et al. Pediatrics. 2019 Jun 10. doi: 10.1542/peds.2018-2917.

* This article was updated 6/14/2019

A 46-year-old man with no significant medical history presents to the emergency department (ED) with right flank pain and nausea. CT reveals a 5-mm ureteral stone with no obstruction or hydronephrosis. You are planning to start him on IV ketorolac for pain. What is the most appropriate dose?

Ketorolac tromethamine is a highly effective NSAID. As a nonopiate analgesic, it is often the first choice for the treatment of acute pain in the flank, abdomen, musculoskeletal system, or head.² While it is not associated with euphoria, withdrawal effects, or respiratory depression (like its opiate analgesic counterparts), ketorolac carries an FDA black-box warning for gastrointestinal, cardiovascular, renal, and bleeding risks.³

NSAIDs are known to have a “ceiling dose” at which maximum analgesic benefit is achieved; higher doses will not provide further pain relief. Higher doses of ketorolac may be used when the anti-inflammatory effects of NSAIDs are desired, but they are likely to cause more adverse effects.⁴ Available data describe the ceiling dose of ketorolac as 10 mg across dosage forms—yet the majority of research and most health care providers in current practice use higher doses (20 to 60 mg).^4,5 The FDA-approved labeling provides for a maximum dose of 60 mg/d.³

In one recent study, ketorolac was prescribed above its ceiling dose in at least 97% of patients who received IV doses and at least 96% of those who received intramuscular (IM) doses in a US ED.⁶ If 10 mg of ketorolac is an effective analgesic dose, current practice exceeds the label recommendation to use the lowest effective dose. This study sought to determine the comparative efficacy of 3 different doses of IV ketorolac for acute pain management in an ED.

STUDY SUMMARY

10 mg of ketorolac is enough for pain

This randomized double-blind trial evaluated the effectiveness of ketorolac in 240 adult patients (ages 18 to 65) presenting to an ED with acute flank, abdominal, musculoskeletal, or headache pain.¹ Acute pain was defined as onset within the past 30 days.

Patients were randomly assigned to receive either 10, 15, or 30 mg of IV ketorolac in 10 mL of normal saline. A pharmacist prepared the medication in identical syringes, which were delivered in a blinded manner to the nurses caring for the patients. Pain (measured using a 0-to-10 scale), vital signs, and adverse effects were assessed at baseline and at 15, 30, 60, 90, and 120 minutes. If patients were still in pain at 30 minutes, IV morphine (0.1 mg/kg) was offered. The primary outcome was a numerical pain score at 30 minutes after ketorolac administration; secondary outcomes included the occurrence of adverse events and the use of rescue medication (morphine).

The treatment groups were similar in terms of demographics and baseline vital signs. Mean age was 39 to 42. Across the 3 groups, 36% to 40% of patients had abdominal pain, 26% to 39% had flank pain, 20% to 26% had musculoskeletal pain, and 1% to 11% had headache pain. Patients had experienced pain for an average of 1.5 to 3.5 days.

Continue to: Baseline pain scores...

Baseline pain scores were similar for all 3 groups (7.5-7.8 on a 10-point scale). In the intention-to-treat analysis, all 3 doses of ketorolac decreased pain significantly at 30 minutes, with no difference between the groups: mean pain scores postintervention were 5.1 for the 10- and 15-mg group and 4.8 for the 30-mg group. There was no difference between the groups at any other time intervals. There was also no difference between groups in the number of patients who needed rescue medication at 30 minutes (4 patients in the 10-mg group, 3 patients in the 15-mg group, and 4 patients in the 30-mg group). In addition, adverse events (eg, dizziness, nausea, headache, itching, flushing) did not differ between the groups.

WHAT’S NEW

10 mg is just as effective as 30 mg

This trial confirms that a low dose of IV ketorolac is just as effective as higher doses for acute pain control.

CAVEATS

2-hour limit; no look at long-term effects

It isn’t known whether the higher dose would have provided greater pain relief beyond the 120 minutes evaluated in this trial, or if alternative dosage forms (oral or IM) would result in different outcomes. This study was not designed to compare serious long-term adverse effects such as bleeding, renal impairment, or cardiovascular events. Additionally, this study was not powered to look at specific therapeutic indications or anti-inflammatory response.

CHALLENGES TO IMPLEMENTATION

10-mg single-dose vial not readily available

Ketorolac tromethamine for injection is available in the United States in 15-, 30-, and 60-mg single-dose vials. Because a 10-mg dose is not available as a single-dose vial, it would need to be specially prepared (as it was in this study). However, this study should reassure providers that using the lowest available dose (eg, 15 mg IV if that is what is available) will relieve acute pain as well as higher doses will. CR

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[1]:41-42).

A 46-year-old man with no significant medical history presents to the emergency department (ED) with right flank pain and nausea. CT reveals a 5-mm ureteral stone with no obstruction or hydronephrosis. You are planning to start him on IV ketorolac for pain. What is the most appropriate dose?

Ketorolac tromethamine is a highly effective NSAID. As a nonopiate analgesic, it is often the first choice for the treatment of acute pain in the flank, abdomen, musculoskeletal system, or head.² While it is not associated with euphoria, withdrawal effects, or respiratory depression (like its opiate analgesic counterparts), ketorolac carries an FDA black-box warning for gastrointestinal, cardiovascular, renal, and bleeding risks.³

NSAIDs are known to have a “ceiling dose” at which maximum analgesic benefit is achieved; higher doses will not provide further pain relief. Higher doses of ketorolac may be used when the anti-inflammatory effects of NSAIDs are desired, but they are likely to cause more adverse effects.⁴ Available data describe the ceiling dose of ketorolac as 10 mg across dosage forms—yet the majority of research and most health care providers in current practice use higher doses (20 to 60 mg).^4,5 The FDA-approved labeling provides for a maximum dose of 60 mg/d.³

In one recent study, ketorolac was prescribed above its ceiling dose in at least 97% of patients who received IV doses and at least 96% of those who received intramuscular (IM) doses in a US ED.⁶ If 10 mg of ketorolac is an effective analgesic dose, current practice exceeds the label recommendation to use the lowest effective dose. This study sought to determine the comparative efficacy of 3 different doses of IV ketorolac for acute pain management in an ED.

STUDY SUMMARY

10 mg of ketorolac is enough for pain

This randomized double-blind trial evaluated the effectiveness of ketorolac in 240 adult patients (ages 18 to 65) presenting to an ED with acute flank, abdominal, musculoskeletal, or headache pain.¹ Acute pain was defined as onset within the past 30 days.

Patients were randomly assigned to receive either 10, 15, or 30 mg of IV ketorolac in 10 mL of normal saline. A pharmacist prepared the medication in identical syringes, which were delivered in a blinded manner to the nurses caring for the patients. Pain (measured using a 0-to-10 scale), vital signs, and adverse effects were assessed at baseline and at 15, 30, 60, 90, and 120 minutes. If patients were still in pain at 30 minutes, IV morphine (0.1 mg/kg) was offered. The primary outcome was a numerical pain score at 30 minutes after ketorolac administration; secondary outcomes included the occurrence of adverse events and the use of rescue medication (morphine).

The treatment groups were similar in terms of demographics and baseline vital signs. Mean age was 39 to 42. Across the 3 groups, 36% to 40% of patients had abdominal pain, 26% to 39% had flank pain, 20% to 26% had musculoskeletal pain, and 1% to 11% had headache pain. Patients had experienced pain for an average of 1.5 to 3.5 days.

Continue to: Baseline pain scores...

Baseline pain scores were similar for all 3 groups (7.5-7.8 on a 10-point scale). In the intention-to-treat analysis, all 3 doses of ketorolac decreased pain significantly at 30 minutes, with no difference between the groups: mean pain scores postintervention were 5.1 for the 10- and 15-mg group and 4.8 for the 30-mg group. There was no difference between the groups at any other time intervals. There was also no difference between groups in the number of patients who needed rescue medication at 30 minutes (4 patients in the 10-mg group, 3 patients in the 15-mg group, and 4 patients in the 30-mg group). In addition, adverse events (eg, dizziness, nausea, headache, itching, flushing) did not differ between the groups.

WHAT’S NEW

10 mg is just as effective as 30 mg

This trial confirms that a low dose of IV ketorolac is just as effective as higher doses for acute pain control.

CAVEATS

2-hour limit; no look at long-term effects

It isn’t known whether the higher dose would have provided greater pain relief beyond the 120 minutes evaluated in this trial, or if alternative dosage forms (oral or IM) would result in different outcomes. This study was not designed to compare serious long-term adverse effects such as bleeding, renal impairment, or cardiovascular events. Additionally, this study was not powered to look at specific therapeutic indications or anti-inflammatory response.

CHALLENGES TO IMPLEMENTATION

10-mg single-dose vial not readily available

Ketorolac tromethamine for injection is available in the United States in 15-, 30-, and 60-mg single-dose vials. Because a 10-mg dose is not available as a single-dose vial, it would need to be specially prepared (as it was in this study). However, this study should reassure providers that using the lowest available dose (eg, 15 mg IV if that is what is available) will relieve acute pain as well as higher doses will. CR

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[1]:41-42).

A 46-year-old man with no significant medical history presents to the emergency department (ED) with right flank pain and nausea. CT reveals a 5-mm ureteral stone with no obstruction or hydronephrosis. You are planning to start him on IV ketorolac for pain. What is the most appropriate dose?

Ketorolac tromethamine is a highly effective NSAID. As a nonopiate analgesic, it is often the first choice for the treatment of acute pain in the flank, abdomen, musculoskeletal system, or head.² While it is not associated with euphoria, withdrawal effects, or respiratory depression (like its opiate analgesic counterparts), ketorolac carries an FDA black-box warning for gastrointestinal, cardiovascular, renal, and bleeding risks.³

NSAIDs are known to have a “ceiling dose” at which maximum analgesic benefit is achieved; higher doses will not provide further pain relief. Higher doses of ketorolac may be used when the anti-inflammatory effects of NSAIDs are desired, but they are likely to cause more adverse effects.⁴ Available data describe the ceiling dose of ketorolac as 10 mg across dosage forms—yet the majority of research and most health care providers in current practice use higher doses (20 to 60 mg).^4,5 The FDA-approved labeling provides for a maximum dose of 60 mg/d.³

In one recent study, ketorolac was prescribed above its ceiling dose in at least 97% of patients who received IV doses and at least 96% of those who received intramuscular (IM) doses in a US ED.⁶ If 10 mg of ketorolac is an effective analgesic dose, current practice exceeds the label recommendation to use the lowest effective dose. This study sought to determine the comparative efficacy of 3 different doses of IV ketorolac for acute pain management in an ED.

STUDY SUMMARY

10 mg of ketorolac is enough for pain

This randomized double-blind trial evaluated the effectiveness of ketorolac in 240 adult patients (ages 18 to 65) presenting to an ED with acute flank, abdominal, musculoskeletal, or headache pain.¹ Acute pain was defined as onset within the past 30 days.

Patients were randomly assigned to receive either 10, 15, or 30 mg of IV ketorolac in 10 mL of normal saline. A pharmacist prepared the medication in identical syringes, which were delivered in a blinded manner to the nurses caring for the patients. Pain (measured using a 0-to-10 scale), vital signs, and adverse effects were assessed at baseline and at 15, 30, 60, 90, and 120 minutes. If patients were still in pain at 30 minutes, IV morphine (0.1 mg/kg) was offered. The primary outcome was a numerical pain score at 30 minutes after ketorolac administration; secondary outcomes included the occurrence of adverse events and the use of rescue medication (morphine).

The treatment groups were similar in terms of demographics and baseline vital signs. Mean age was 39 to 42. Across the 3 groups, 36% to 40% of patients had abdominal pain, 26% to 39% had flank pain, 20% to 26% had musculoskeletal pain, and 1% to 11% had headache pain. Patients had experienced pain for an average of 1.5 to 3.5 days.

Continue to: Baseline pain scores...

Baseline pain scores were similar for all 3 groups (7.5-7.8 on a 10-point scale). In the intention-to-treat analysis, all 3 doses of ketorolac decreased pain significantly at 30 minutes, with no difference between the groups: mean pain scores postintervention were 5.1 for the 10- and 15-mg group and 4.8 for the 30-mg group. There was no difference between the groups at any other time intervals. There was also no difference between groups in the number of patients who needed rescue medication at 30 minutes (4 patients in the 10-mg group, 3 patients in the 15-mg group, and 4 patients in the 30-mg group). In addition, adverse events (eg, dizziness, nausea, headache, itching, flushing) did not differ between the groups.

WHAT’S NEW

10 mg is just as effective as 30 mg

This trial confirms that a low dose of IV ketorolac is just as effective as higher doses for acute pain control.

CAVEATS

2-hour limit; no look at long-term effects

It isn’t known whether the higher dose would have provided greater pain relief beyond the 120 minutes evaluated in this trial, or if alternative dosage forms (oral or IM) would result in different outcomes. This study was not designed to compare serious long-term adverse effects such as bleeding, renal impairment, or cardiovascular events. Additionally, this study was not powered to look at specific therapeutic indications or anti-inflammatory response.

CHALLENGES TO IMPLEMENTATION

10-mg single-dose vial not readily available

Ketorolac tromethamine for injection is available in the United States in 15-, 30-, and 60-mg single-dose vials. Because a 10-mg dose is not available as a single-dose vial, it would need to be specially prepared (as it was in this study). However, this study should reassure providers that using the lowest available dose (eg, 15 mg IV if that is what is available) will relieve acute pain as well as higher doses will. CR

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2019. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2019;68[1]:41-42).

The estimated prevalence of obstructive sleep apnea in North and South America stands at 170 million, results from a novel epidemiologic analysis showed.

“I would not have thought that there are 170 million people in the Americas with clinically important sleep apnea based on our conservative estimates,” the study’s first author, Atul Malhotra, MD, said in an interview in advance of the annual meeting of the Associated Professional Sleep Societies. “Even if we restrict the conversation to moderate to severe sleep apnea, we still see 81 million people afflicted in the Americas alone. We have recently estimated almost 1 billion patients afflicted with OSA worldwide.”

In an effort to estimate the Americas’ prevalence of adult OSA using existing data from epidemiologic studies, Dr. Malhotra, director of sleep medicine at the University of California, San Diego, senior author Adam V. Benjafield, PhD, and their colleagues contacted authors of important analyses on the topic following an exhaustive review of the literature. For countries where no measurement had been made, they used publicly available data to obtain estimates of age, sex, race, and body mass index. Next, they developed an algorithm to match countries without prevalence estimates with countries from which OSA epidemiologic studies exist. “The situation was complicated given the variable age of the existing studies, the differences in technology used (e.g., nasal pressure vs. thermistor), the changing scoring criteria, and other sources of variability,” the researchers wrote in their abstract.

Dr. Malhotra reported on data from 38 of 40 countries in the Americas. Drawing from American Academy of Sleep Medicine 2012 criteria and using what they characterized as a “somewhat conservative” approach, the researchers estimated the prevalence of adult OSA in the Americas to be 170 million, or 37% of the population. In addition, they estimate that 81 million adults, or 18% of the population, suffer from moderate to severe OSA based on an apnea hypopnea index of 15 or more per hour. The countries with the greatest burden of OSA are the United States (54 million), Brazil (49 million), and Colombia (11 million).

“The findings will hopefully help to raise awareness about the disease but also encourage a strategic conversation regarding how best to address this large burden,” Dr. Malhotra said. “We are unaware of prior efforts to estimate OSA prevalence on a large scale.”

He acknowledged certain limitations of the study, including that the methods, equipment, definitions, and criteria used in existing studies in the medial literature varied widely. “We did our best to harmonize these methods across studies but obviously we can’t change the equipment that was used in previous studies,” he said. “Thus, we view our findings as an estimate requiring further efforts to corroborate.”

The research stemmed from an academic/industry partnership with ResMed, which provided a donation the UCSD Sleep Medicine Center. Dr. Malhotra reported having no financial disclosures. Dr. Benjafield is an employee of ResMed, a medical equipment company that specializes in sleep-related breathing devices.

dbrunk@mdedge.com

SOURCE: Malhotra A et al. SLEEP 2019, Abstract 0477.

The estimated prevalence of obstructive sleep apnea in North and South America stands at 170 million, results from a novel epidemiologic analysis showed.

“I would not have thought that there are 170 million people in the Americas with clinically important sleep apnea based on our conservative estimates,” the study’s first author, Atul Malhotra, MD, said in an interview in advance of the annual meeting of the Associated Professional Sleep Societies. “Even if we restrict the conversation to moderate to severe sleep apnea, we still see 81 million people afflicted in the Americas alone. We have recently estimated almost 1 billion patients afflicted with OSA worldwide.”

In an effort to estimate the Americas’ prevalence of adult OSA using existing data from epidemiologic studies, Dr. Malhotra, director of sleep medicine at the University of California, San Diego, senior author Adam V. Benjafield, PhD, and their colleagues contacted authors of important analyses on the topic following an exhaustive review of the literature. For countries where no measurement had been made, they used publicly available data to obtain estimates of age, sex, race, and body mass index. Next, they developed an algorithm to match countries without prevalence estimates with countries from which OSA epidemiologic studies exist. “The situation was complicated given the variable age of the existing studies, the differences in technology used (e.g., nasal pressure vs. thermistor), the changing scoring criteria, and other sources of variability,” the researchers wrote in their abstract.

Dr. Malhotra reported on data from 38 of 40 countries in the Americas. Drawing from American Academy of Sleep Medicine 2012 criteria and using what they characterized as a “somewhat conservative” approach, the researchers estimated the prevalence of adult OSA in the Americas to be 170 million, or 37% of the population. In addition, they estimate that 81 million adults, or 18% of the population, suffer from moderate to severe OSA based on an apnea hypopnea index of 15 or more per hour. The countries with the greatest burden of OSA are the United States (54 million), Brazil (49 million), and Colombia (11 million).

“The findings will hopefully help to raise awareness about the disease but also encourage a strategic conversation regarding how best to address this large burden,” Dr. Malhotra said. “We are unaware of prior efforts to estimate OSA prevalence on a large scale.”

He acknowledged certain limitations of the study, including that the methods, equipment, definitions, and criteria used in existing studies in the medial literature varied widely. “We did our best to harmonize these methods across studies but obviously we can’t change the equipment that was used in previous studies,” he said. “Thus, we view our findings as an estimate requiring further efforts to corroborate.”

The research stemmed from an academic/industry partnership with ResMed, which provided a donation the UCSD Sleep Medicine Center. Dr. Malhotra reported having no financial disclosures. Dr. Benjafield is an employee of ResMed, a medical equipment company that specializes in sleep-related breathing devices.

dbrunk@mdedge.com

SOURCE: Malhotra A et al. SLEEP 2019, Abstract 0477.

The estimated prevalence of obstructive sleep apnea in North and South America stands at 170 million, results from a novel epidemiologic analysis showed.

“I would not have thought that there are 170 million people in the Americas with clinically important sleep apnea based on our conservative estimates,” the study’s first author, Atul Malhotra, MD, said in an interview in advance of the annual meeting of the Associated Professional Sleep Societies. “Even if we restrict the conversation to moderate to severe sleep apnea, we still see 81 million people afflicted in the Americas alone. We have recently estimated almost 1 billion patients afflicted with OSA worldwide.”

In an effort to estimate the Americas’ prevalence of adult OSA using existing data from epidemiologic studies, Dr. Malhotra, director of sleep medicine at the University of California, San Diego, senior author Adam V. Benjafield, PhD, and their colleagues contacted authors of important analyses on the topic following an exhaustive review of the literature. For countries where no measurement had been made, they used publicly available data to obtain estimates of age, sex, race, and body mass index. Next, they developed an algorithm to match countries without prevalence estimates with countries from which OSA epidemiologic studies exist. “The situation was complicated given the variable age of the existing studies, the differences in technology used (e.g., nasal pressure vs. thermistor), the changing scoring criteria, and other sources of variability,” the researchers wrote in their abstract.

Dr. Malhotra reported on data from 38 of 40 countries in the Americas. Drawing from American Academy of Sleep Medicine 2012 criteria and using what they characterized as a “somewhat conservative” approach, the researchers estimated the prevalence of adult OSA in the Americas to be 170 million, or 37% of the population. In addition, they estimate that 81 million adults, or 18% of the population, suffer from moderate to severe OSA based on an apnea hypopnea index of 15 or more per hour. The countries with the greatest burden of OSA are the United States (54 million), Brazil (49 million), and Colombia (11 million).

“The findings will hopefully help to raise awareness about the disease but also encourage a strategic conversation regarding how best to address this large burden,” Dr. Malhotra said. “We are unaware of prior efforts to estimate OSA prevalence on a large scale.”

He acknowledged certain limitations of the study, including that the methods, equipment, definitions, and criteria used in existing studies in the medial literature varied widely. “We did our best to harmonize these methods across studies but obviously we can’t change the equipment that was used in previous studies,” he said. “Thus, we view our findings as an estimate requiring further efforts to corroborate.”

The research stemmed from an academic/industry partnership with ResMed, which provided a donation the UCSD Sleep Medicine Center. Dr. Malhotra reported having no financial disclosures. Dr. Benjafield is an employee of ResMed, a medical equipment company that specializes in sleep-related breathing devices.

dbrunk@mdedge.com

SOURCE: Malhotra A et al. SLEEP 2019, Abstract 0477.

The monoclonal antibody teplizumab may delay the onset of type 1 diabetes in individuals at high risk, according to research presented at the annual scientific sessions of the American Diabetes Association.

In this study, 76 first-degree relatives of individuals with type 1 diabetes – who did not themselves have the disease but were considered at high risk because of antibodies and abnormal glucose tolerance tests – were randomized to a single two-week outpatient course of intravenous teplizumab or saline placebo. The patients, of whom 72% were 18 years of age or younger, were followed for a median of 745 days and had twice-yearly oral glucose tolerance testing.

Overall, 43% of the 44 patients who received teplizumab were diagnosed with type 1 diabetes during the course of the study, compared with 72% of the 32 who received the placebo. The treatment was associated with a 59% reduction in the hazard ratio for type 1 diabetes, even after adjusting for age, the results of a second oral glucose-tolerance testing before randomization, or the presence of anti-GAD65 antibodies.

The median time to diagnosis was 48.4 months in the teplizumab group and 24.4 months in the placebo group. The greatest effect was seen in the first year after randomization, during which only 7% of the teplizumab group were diagnosed with type 1 diabetes, compared with 44% of the placebo group. The findings were published simultaneously in the New England Journal of Medicine.

“The delay of progression to type 1 diabetes is of clinical importance, particularly for children, in whom the diagnosis is associated with adverse outcomes, and given the challenges of daily management of the condition,” said Dr. Kevan C. Herold, professor of immunobiology and medicine at Yale University, New Haven, Conn., and coauthors.

There were significantly more adverse events in the teplizumab group, compared with placebo, with three-quarters of the 20 grade 3 adverse events being lymphopenia during the first 30 days. In all but one participant, however, the lymphopenia resolved by day 45. Participants receiving teplizumab also reported a higher incidence of dermatologic adverse events, such as a spontaneously-resolving rash that was experienced by just over one-third of the group.

The researchers also looked for evidence of T-cell unresponsiveness, which has been previously seen in patients with new-onset type 1 diabetes who received treatment with teplizumab. They noted an increase in a particular type of CD8+ T cell associated with T-cell unresponsiveness at months 3 and 6 in participants treated with teplizumab.

Teplizumab is an Fc receptor-nonbinding monoclonal antibody that has been shown to reduce the loss of beta-cell function in patients with type 1 diabetes (Diabetes. 2013 Nov;62(11):3766-74).

The study was supported by the National Institutes of Health, the Juvenile Diabetes Research Foundation, and the American Diabetes Association, with the study drug and additional site monitoring provided by MacroGenics. Eight authors declared grants, personal fees, and other support from private industry, with one also declaring income and stock options from MacroGenics.

SOURCE: Herold K et al. NEJM. 2019 Jun 9. doi: 10.1056/NEJMoa1902226*

*Correction, 6/9/2019: An earlier version of this story misstated the doi number for the journal article. The number is 10.1056/NEJMoa1902226.

The monoclonal antibody teplizumab may delay the onset of type 1 diabetes in individuals at high risk, according to research presented at the annual scientific sessions of the American Diabetes Association.

In this study, 76 first-degree relatives of individuals with type 1 diabetes – who did not themselves have the disease but were considered at high risk because of antibodies and abnormal glucose tolerance tests – were randomized to a single two-week outpatient course of intravenous teplizumab or saline placebo. The patients, of whom 72% were 18 years of age or younger, were followed for a median of 745 days and had twice-yearly oral glucose tolerance testing.

Overall, 43% of the 44 patients who received teplizumab were diagnosed with type 1 diabetes during the course of the study, compared with 72% of the 32 who received the placebo. The treatment was associated with a 59% reduction in the hazard ratio for type 1 diabetes, even after adjusting for age, the results of a second oral glucose-tolerance testing before randomization, or the presence of anti-GAD65 antibodies.

The median time to diagnosis was 48.4 months in the teplizumab group and 24.4 months in the placebo group. The greatest effect was seen in the first year after randomization, during which only 7% of the teplizumab group were diagnosed with type 1 diabetes, compared with 44% of the placebo group. The findings were published simultaneously in the New England Journal of Medicine.

“The delay of progression to type 1 diabetes is of clinical importance, particularly for children, in whom the diagnosis is associated with adverse outcomes, and given the challenges of daily management of the condition,” said Dr. Kevan C. Herold, professor of immunobiology and medicine at Yale University, New Haven, Conn., and coauthors.

There were significantly more adverse events in the teplizumab group, compared with placebo, with three-quarters of the 20 grade 3 adverse events being lymphopenia during the first 30 days. In all but one participant, however, the lymphopenia resolved by day 45. Participants receiving teplizumab also reported a higher incidence of dermatologic adverse events, such as a spontaneously-resolving rash that was experienced by just over one-third of the group.

The researchers also looked for evidence of T-cell unresponsiveness, which has been previously seen in patients with new-onset type 1 diabetes who received treatment with teplizumab. They noted an increase in a particular type of CD8+ T cell associated with T-cell unresponsiveness at months 3 and 6 in participants treated with teplizumab.

Teplizumab is an Fc receptor-nonbinding monoclonal antibody that has been shown to reduce the loss of beta-cell function in patients with type 1 diabetes (Diabetes. 2013 Nov;62(11):3766-74).

The study was supported by the National Institutes of Health, the Juvenile Diabetes Research Foundation, and the American Diabetes Association, with the study drug and additional site monitoring provided by MacroGenics. Eight authors declared grants, personal fees, and other support from private industry, with one also declaring income and stock options from MacroGenics.

SOURCE: Herold K et al. NEJM. 2019 Jun 9. doi: 10.1056/NEJMoa1902226*

*Correction, 6/9/2019: An earlier version of this story misstated the doi number for the journal article. The number is 10.1056/NEJMoa1902226.

The monoclonal antibody teplizumab may delay the onset of type 1 diabetes in individuals at high risk, according to research presented at the annual scientific sessions of the American Diabetes Association.

In this study, 76 first-degree relatives of individuals with type 1 diabetes – who did not themselves have the disease but were considered at high risk because of antibodies and abnormal glucose tolerance tests – were randomized to a single two-week outpatient course of intravenous teplizumab or saline placebo. The patients, of whom 72% were 18 years of age or younger, were followed for a median of 745 days and had twice-yearly oral glucose tolerance testing.

Overall, 43% of the 44 patients who received teplizumab were diagnosed with type 1 diabetes during the course of the study, compared with 72% of the 32 who received the placebo. The treatment was associated with a 59% reduction in the hazard ratio for type 1 diabetes, even after adjusting for age, the results of a second oral glucose-tolerance testing before randomization, or the presence of anti-GAD65 antibodies.

The median time to diagnosis was 48.4 months in the teplizumab group and 24.4 months in the placebo group. The greatest effect was seen in the first year after randomization, during which only 7% of the teplizumab group were diagnosed with type 1 diabetes, compared with 44% of the placebo group. The findings were published simultaneously in the New England Journal of Medicine.

“The delay of progression to type 1 diabetes is of clinical importance, particularly for children, in whom the diagnosis is associated with adverse outcomes, and given the challenges of daily management of the condition,” said Dr. Kevan C. Herold, professor of immunobiology and medicine at Yale University, New Haven, Conn., and coauthors.

There were significantly more adverse events in the teplizumab group, compared with placebo, with three-quarters of the 20 grade 3 adverse events being lymphopenia during the first 30 days. In all but one participant, however, the lymphopenia resolved by day 45. Participants receiving teplizumab also reported a higher incidence of dermatologic adverse events, such as a spontaneously-resolving rash that was experienced by just over one-third of the group.

The researchers also looked for evidence of T-cell unresponsiveness, which has been previously seen in patients with new-onset type 1 diabetes who received treatment with teplizumab. They noted an increase in a particular type of CD8+ T cell associated with T-cell unresponsiveness at months 3 and 6 in participants treated with teplizumab.

Teplizumab is an Fc receptor-nonbinding monoclonal antibody that has been shown to reduce the loss of beta-cell function in patients with type 1 diabetes (Diabetes. 2013 Nov;62(11):3766-74).

The study was supported by the National Institutes of Health, the Juvenile Diabetes Research Foundation, and the American Diabetes Association, with the study drug and additional site monitoring provided by MacroGenics. Eight authors declared grants, personal fees, and other support from private industry, with one also declaring income and stock options from MacroGenics.

SOURCE: Herold K et al. NEJM. 2019 Jun 9. doi: 10.1056/NEJMoa1902226*

*Correction, 6/9/2019: An earlier version of this story misstated the doi number for the journal article. The number is 10.1056/NEJMoa1902226.

FORT LAUDERDALE, FLA. — A multicenter pilot study of a prophylactic regimen for both matched sibling donor and unrelated donor bone marrow transplantation in adults with severe sickle cell disease has found similar overall and event-free survival rates between the two approaches, exceeding 90% and 85%, respectively, at one year, according to preliminary results presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

The results have led to a Phase 2 single-arm, multicenter trial, known as STRIDE , to evaluate a reduced toxicity preparative regimen consisting of busulfan (13.2 mg/kg), fludarabine (175   mg/m ² ) and antithymocyte globulin (ATG, 6 mg/kg) and cyclosporine or tacrolimus and methotrexate for graft-vs-host disease (GVHD) prophylaxis in adults with sickle cell disease (SCD), said Lakshmanan Krishnamurti, MD, of Children’s Healthcare of Atlanta/Emory University. “The data are similar with 91% overall survival and 86% event-free survival,” he said.

The pilot study, published recently ( Am J Hematol. 2019;94:446-54 ), indicated the effectiveness of non-myeloablative conditioning in SCD patients with matched-sibling bone marrow transplant (BMT), with a higher intensity regimen of busulfan/fludarabine/ATG effective in unrelated donor BMT for other conditions, Dr. Krishnamurti said.

The pilot study also found that three-year event-free survival (EFS) of 82%, and statistically significant improvements in pain and health-related quality of life.

STRIDE is the first comparative study of BMT vs. standard of care in severe SCD, Dr. Krishnamurti added. The primary endpoint is overall survival at two years after biologic assignment, with longer-term outcomes including survival at three to 10 years post-hematopoietic stem cell transplantation (HSCT), and impact of BMT on sickle-related events, organ function, health-related quality of life and chronic pain.  

The pilot study included 22 patients between the ages of 17 and 36 who had BMT at eight centers. Seventeen patients received marrow from a sibling-matched donor and five patients received marrow from an unrelated donor. 

Dr. Krishnamurti referenced a recent study out of France that showed chimerism levels after transplant may be a determining physiological factor for outcomes (Haematologica. doi:10.3324/haematol.2018.213207 ). “So if chimerism is stable, somewhere in the 25% to 50% or better range, and hemoglobin levels are improved, this decrease hemolysis,” he said. “This is very important in understanding how to manage these patients.”

That study showed that rates of chronic GVHD up to 10 years post-transplant have steadily improved over the past three decades in patients with SCD who’ve had BMT, Dr. Krishnamurti noted. “But chronic GVHD is higher in patients age 16 to 30 vs. patients 15 and younger,” he said, “so that’s the reason to consider transplantation sooner in patients who have a matched sibling donor.”

The French study shows that BMT with sibling-matched donors has excellent outcomes in young children, Dr. Krishnamurti said. “Outcomes for adults with transplantation is becoming similar to that in children,” he added. “Age is an important predictor of outcomes and the risk for progressive morbidity-impaired quality of life and risk of mortality still exists in adults with sickle cell disease.”

The bottom line, he said, is that patients and caregivers must be given the opportunity to consider transplantation as an option at younger ages.

Dr. Krishnamurti did not disclose any financial relationships.

SOURCE: Krishnamurti L et al. FSCDR 2019

FORT LAUDERDALE, FLA. — A multicenter pilot study of a prophylactic regimen for both matched sibling donor and unrelated donor bone marrow transplantation in adults with severe sickle cell disease has found similar overall and event-free survival rates between the two approaches, exceeding 90% and 85%, respectively, at one year, according to preliminary results presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

The results have led to a Phase 2 single-arm, multicenter trial, known as STRIDE , to evaluate a reduced toxicity preparative regimen consisting of busulfan (13.2 mg/kg), fludarabine (175   mg/m ² ) and antithymocyte globulin (ATG, 6 mg/kg) and cyclosporine or tacrolimus and methotrexate for graft-vs-host disease (GVHD) prophylaxis in adults with sickle cell disease (SCD), said Lakshmanan Krishnamurti, MD, of Children’s Healthcare of Atlanta/Emory University. “The data are similar with 91% overall survival and 86% event-free survival,” he said.

The pilot study, published recently ( Am J Hematol. 2019;94:446-54 ), indicated the effectiveness of non-myeloablative conditioning in SCD patients with matched-sibling bone marrow transplant (BMT), with a higher intensity regimen of busulfan/fludarabine/ATG effective in unrelated donor BMT for other conditions, Dr. Krishnamurti said.

The pilot study also found that three-year event-free survival (EFS) of 82%, and statistically significant improvements in pain and health-related quality of life.

STRIDE is the first comparative study of BMT vs. standard of care in severe SCD, Dr. Krishnamurti added. The primary endpoint is overall survival at two years after biologic assignment, with longer-term outcomes including survival at three to 10 years post-hematopoietic stem cell transplantation (HSCT), and impact of BMT on sickle-related events, organ function, health-related quality of life and chronic pain.  

The pilot study included 22 patients between the ages of 17 and 36 who had BMT at eight centers. Seventeen patients received marrow from a sibling-matched donor and five patients received marrow from an unrelated donor. 

Dr. Krishnamurti referenced a recent study out of France that showed chimerism levels after transplant may be a determining physiological factor for outcomes (Haematologica. doi:10.3324/haematol.2018.213207 ). “So if chimerism is stable, somewhere in the 25% to 50% or better range, and hemoglobin levels are improved, this decrease hemolysis,” he said. “This is very important in understanding how to manage these patients.”

That study showed that rates of chronic GVHD up to 10 years post-transplant have steadily improved over the past three decades in patients with SCD who’ve had BMT, Dr. Krishnamurti noted. “But chronic GVHD is higher in patients age 16 to 30 vs. patients 15 and younger,” he said, “so that’s the reason to consider transplantation sooner in patients who have a matched sibling donor.”

The French study shows that BMT with sibling-matched donors has excellent outcomes in young children, Dr. Krishnamurti said. “Outcomes for adults with transplantation is becoming similar to that in children,” he added. “Age is an important predictor of outcomes and the risk for progressive morbidity-impaired quality of life and risk of mortality still exists in adults with sickle cell disease.”

The bottom line, he said, is that patients and caregivers must be given the opportunity to consider transplantation as an option at younger ages.

Dr. Krishnamurti did not disclose any financial relationships.

SOURCE: Krishnamurti L et al. FSCDR 2019

FORT LAUDERDALE, FLA. — A multicenter pilot study of a prophylactic regimen for both matched sibling donor and unrelated donor bone marrow transplantation in adults with severe sickle cell disease has found similar overall and event-free survival rates between the two approaches, exceeding 90% and 85%, respectively, at one year, according to preliminary results presented at the annual meeting of the Foundation for Sickle Cell Disease Research.

The results have led to a Phase 2 single-arm, multicenter trial, known as STRIDE , to evaluate a reduced toxicity preparative regimen consisting of busulfan (13.2 mg/kg), fludarabine (175   mg/m ² ) and antithymocyte globulin (ATG, 6 mg/kg) and cyclosporine or tacrolimus and methotrexate for graft-vs-host disease (GVHD) prophylaxis in adults with sickle cell disease (SCD), said Lakshmanan Krishnamurti, MD, of Children’s Healthcare of Atlanta/Emory University. “The data are similar with 91% overall survival and 86% event-free survival,” he said.

The pilot study, published recently ( Am J Hematol. 2019;94:446-54 ), indicated the effectiveness of non-myeloablative conditioning in SCD patients with matched-sibling bone marrow transplant (BMT), with a higher intensity regimen of busulfan/fludarabine/ATG effective in unrelated donor BMT for other conditions, Dr. Krishnamurti said.

The pilot study also found that three-year event-free survival (EFS) of 82%, and statistically significant improvements in pain and health-related quality of life.

STRIDE is the first comparative study of BMT vs. standard of care in severe SCD, Dr. Krishnamurti added. The primary endpoint is overall survival at two years after biologic assignment, with longer-term outcomes including survival at three to 10 years post-hematopoietic stem cell transplantation (HSCT), and impact of BMT on sickle-related events, organ function, health-related quality of life and chronic pain.  

The pilot study included 22 patients between the ages of 17 and 36 who had BMT at eight centers. Seventeen patients received marrow from a sibling-matched donor and five patients received marrow from an unrelated donor. 

Dr. Krishnamurti referenced a recent study out of France that showed chimerism levels after transplant may be a determining physiological factor for outcomes (Haematologica. doi:10.3324/haematol.2018.213207 ). “So if chimerism is stable, somewhere in the 25% to 50% or better range, and hemoglobin levels are improved, this decrease hemolysis,” he said. “This is very important in understanding how to manage these patients.”

That study showed that rates of chronic GVHD up to 10 years post-transplant have steadily improved over the past three decades in patients with SCD who’ve had BMT, Dr. Krishnamurti noted. “But chronic GVHD is higher in patients age 16 to 30 vs. patients 15 and younger,” he said, “so that’s the reason to consider transplantation sooner in patients who have a matched sibling donor.”

The French study shows that BMT with sibling-matched donors has excellent outcomes in young children, Dr. Krishnamurti said. “Outcomes for adults with transplantation is becoming similar to that in children,” he added. “Age is an important predictor of outcomes and the risk for progressive morbidity-impaired quality of life and risk of mortality still exists in adults with sickle cell disease.”

The bottom line, he said, is that patients and caregivers must be given the opportunity to consider transplantation as an option at younger ages.

Dr. Krishnamurti did not disclose any financial relationships.

SOURCE: Krishnamurti L et al. FSCDR 2019

The introduction of separate payment for the immediate postpartum implantation of long-acting reversible contraception was associated with increased use and a slow-down in the number of short-interval births in patients covered by South Carolina’s Medicaid program.

Immediate postpartum long-acting reversible contraception (IPP-LARC) is recommended to reduce the incidence of short pregnancy intervals – pregnancies within 6-24 months of each other. The global payment for hospital labor and delivery, however, may act as a disincentive to providing IPP-LARC, according to Maria W. Steenland of Brown University, Providence, R.I., and co-authors.

They looked at inpatient Medicaid claims data for 242,825 childbirth hospitalizations in South Carolina from 2010-2017; during that time the state Medicaid program began to provide an additional payment for IPP-LARC.

At the start of the study, just 0.07% of women received an IPP-LARC. After the change in reimbursement policy in March 2012, there was a steady 0.07 percentage point monthly increase in their use in adults and 0.1 percentage point increase per month in adolescents. In December 2017, 5.65% of adults and 10.48% of adolescents received an IPP-LARC (JAMA. 2019; doi: 10.1001/jama.2019.6854).

There was a corresponding, significant change in the trend of short-interval births among adolescents. Before the policy change, adolescent short-interval births had been increasing, but by March 2016 – 4 years after the payment change – the adolescent short-interval birth rate was 5.28 percentage points lower than what was expected had the increasing trend continued.

There was no significant change in the trend for short-interval births among adults.

“These findings suggest that IPP-LARC reimbursement could increase immediate postpartum contraceptive options and help adolescents avoid short-interval births,” the authors wrote, noting that as of February 2018, 36 other states’ Medicaid programs had began separately reimbursing for IPP-LARC.

They also raised the possibility that there may have been confounding due to other events that occurred at the same time as the policy changes.

The study was supported by the Eric M. Mindich Research Fund and one author was supported by National Institutes of Health. No conflicts of interest were declared.

SOURCE: Steenland M et al. JAMA 2019, DOI:10.1001/jama.2019.6854.

The introduction of separate payment for the immediate postpartum implantation of long-acting reversible contraception was associated with increased use and a slow-down in the number of short-interval births in patients covered by South Carolina’s Medicaid program.

Immediate postpartum long-acting reversible contraception (IPP-LARC) is recommended to reduce the incidence of short pregnancy intervals – pregnancies within 6-24 months of each other. The global payment for hospital labor and delivery, however, may act as a disincentive to providing IPP-LARC, according to Maria W. Steenland of Brown University, Providence, R.I., and co-authors.

They looked at inpatient Medicaid claims data for 242,825 childbirth hospitalizations in South Carolina from 2010-2017; during that time the state Medicaid program began to provide an additional payment for IPP-LARC.

At the start of the study, just 0.07% of women received an IPP-LARC. After the change in reimbursement policy in March 2012, there was a steady 0.07 percentage point monthly increase in their use in adults and 0.1 percentage point increase per month in adolescents. In December 2017, 5.65% of adults and 10.48% of adolescents received an IPP-LARC (JAMA. 2019; doi: 10.1001/jama.2019.6854).

There was a corresponding, significant change in the trend of short-interval births among adolescents. Before the policy change, adolescent short-interval births had been increasing, but by March 2016 – 4 years after the payment change – the adolescent short-interval birth rate was 5.28 percentage points lower than what was expected had the increasing trend continued.

There was no significant change in the trend for short-interval births among adults.

“These findings suggest that IPP-LARC reimbursement could increase immediate postpartum contraceptive options and help adolescents avoid short-interval births,” the authors wrote, noting that as of February 2018, 36 other states’ Medicaid programs had began separately reimbursing for IPP-LARC.

They also raised the possibility that there may have been confounding due to other events that occurred at the same time as the policy changes.

The study was supported by the Eric M. Mindich Research Fund and one author was supported by National Institutes of Health. No conflicts of interest were declared.

SOURCE: Steenland M et al. JAMA 2019, DOI:10.1001/jama.2019.6854.

The introduction of separate payment for the immediate postpartum implantation of long-acting reversible contraception was associated with increased use and a slow-down in the number of short-interval births in patients covered by South Carolina’s Medicaid program.

Immediate postpartum long-acting reversible contraception (IPP-LARC) is recommended to reduce the incidence of short pregnancy intervals – pregnancies within 6-24 months of each other. The global payment for hospital labor and delivery, however, may act as a disincentive to providing IPP-LARC, according to Maria W. Steenland of Brown University, Providence, R.I., and co-authors.

They looked at inpatient Medicaid claims data for 242,825 childbirth hospitalizations in South Carolina from 2010-2017; during that time the state Medicaid program began to provide an additional payment for IPP-LARC.

At the start of the study, just 0.07% of women received an IPP-LARC. After the change in reimbursement policy in March 2012, there was a steady 0.07 percentage point monthly increase in their use in adults and 0.1 percentage point increase per month in adolescents. In December 2017, 5.65% of adults and 10.48% of adolescents received an IPP-LARC (JAMA. 2019; doi: 10.1001/jama.2019.6854).

There was a corresponding, significant change in the trend of short-interval births among adolescents. Before the policy change, adolescent short-interval births had been increasing, but by March 2016 – 4 years after the payment change – the adolescent short-interval birth rate was 5.28 percentage points lower than what was expected had the increasing trend continued.

There was no significant change in the trend for short-interval births among adults.

“These findings suggest that IPP-LARC reimbursement could increase immediate postpartum contraceptive options and help adolescents avoid short-interval births,” the authors wrote, noting that as of February 2018, 36 other states’ Medicaid programs had began separately reimbursing for IPP-LARC.

They also raised the possibility that there may have been confounding due to other events that occurred at the same time as the policy changes.

The study was supported by the Eric M. Mindich Research Fund and one author was supported by National Institutes of Health. No conflicts of interest were declared.

SOURCE: Steenland M et al. JAMA 2019, DOI:10.1001/jama.2019.6854.

SAN FRANCISCO – Seventy-percent of type 2 diabetes patients who lost more than 33 pounds on a liquid diet over a few months, and kept it off, were free of the disease at 2 years, according to United Kingdom investigators.

M. Alexander Otto/MDedge News

The odds of remission – meaning a hemoglobin A1c below 6.5% on repeat testing, off all medications – were directly related to the amount of weight patients lost; 60% of subjects who lost 22-33 pounds were free of type 2 disease at 2 years, versus 29% who lost 11-21 pounds, and 5% who lost less than 11 pounds.

“If people lose” around 30 pounds “and keep it off for 2 years, there’s a two-thirds chance of them escaping type 2 [diabetes]. People want to understand their options, and this is an option. This is very good news for people with diabetes,” said senior investigator Roy Taylor, MD, a professor of medicine and metabolism at the University of Newcastle, Newcastle upon Tyne, England, who presented the findings of the Diabetes Remission Clinical Trial (DiRECT) at the annual scientific sessions of the American Diabetes Association (Lancet Diabetes Endocrinol. 2019 May;7(5):344-355).

A subgroup analysis he also presented found that beta cell function rebounds rapidly after weight loss and is pretty much normal at 2 years, so long as people keep the weight off.


The study is rooted in previous work by Dr. Taylor and his colleagues that found that very low-calorie diets normalized fasting plasma glucose in just 7 days in patients with type 2 diabetes due to a rapid fall in liver fat content and subsequent restoration of insulin sensitivity. That and other findings suggested that fast weight loss – instead of the traditional gradual approach – might help.

He and his team randomized 149 volunteers from primary care practices in the United Kingdom to standard care, and 149 others to rapid weight loss; more than a quarter of the patients who were asked agreed to participate.

aotto@mdedge.com
 

SOURCE: Zhyzhneuskaya SV et al., ADA 2019 abstract 66-OR

SAN FRANCISCO – Seventy-percent of type 2 diabetes patients who lost more than 33 pounds on a liquid diet over a few months, and kept it off, were free of the disease at 2 years, according to United Kingdom investigators.

M. Alexander Otto/MDedge News

The odds of remission – meaning a hemoglobin A1c below 6.5% on repeat testing, off all medications – were directly related to the amount of weight patients lost; 60% of subjects who lost 22-33 pounds were free of type 2 disease at 2 years, versus 29% who lost 11-21 pounds, and 5% who lost less than 11 pounds.

“If people lose” around 30 pounds “and keep it off for 2 years, there’s a two-thirds chance of them escaping type 2 [diabetes]. People want to understand their options, and this is an option. This is very good news for people with diabetes,” said senior investigator Roy Taylor, MD, a professor of medicine and metabolism at the University of Newcastle, Newcastle upon Tyne, England, who presented the findings of the Diabetes Remission Clinical Trial (DiRECT) at the annual scientific sessions of the American Diabetes Association (Lancet Diabetes Endocrinol. 2019 May;7(5):344-355).

A subgroup analysis he also presented found that beta cell function rebounds rapidly after weight loss and is pretty much normal at 2 years, so long as people keep the weight off.


The study is rooted in previous work by Dr. Taylor and his colleagues that found that very low-calorie diets normalized fasting plasma glucose in just 7 days in patients with type 2 diabetes due to a rapid fall in liver fat content and subsequent restoration of insulin sensitivity. That and other findings suggested that fast weight loss – instead of the traditional gradual approach – might help.

He and his team randomized 149 volunteers from primary care practices in the United Kingdom to standard care, and 149 others to rapid weight loss; more than a quarter of the patients who were asked agreed to participate.

aotto@mdedge.com
 

SOURCE: Zhyzhneuskaya SV et al., ADA 2019 abstract 66-OR

SAN FRANCISCO – Seventy-percent of type 2 diabetes patients who lost more than 33 pounds on a liquid diet over a few months, and kept it off, were free of the disease at 2 years, according to United Kingdom investigators.

M. Alexander Otto/MDedge News

The odds of remission – meaning a hemoglobin A1c below 6.5% on repeat testing, off all medications – were directly related to the amount of weight patients lost; 60% of subjects who lost 22-33 pounds were free of type 2 disease at 2 years, versus 29% who lost 11-21 pounds, and 5% who lost less than 11 pounds.

“If people lose” around 30 pounds “and keep it off for 2 years, there’s a two-thirds chance of them escaping type 2 [diabetes]. People want to understand their options, and this is an option. This is very good news for people with diabetes,” said senior investigator Roy Taylor, MD, a professor of medicine and metabolism at the University of Newcastle, Newcastle upon Tyne, England, who presented the findings of the Diabetes Remission Clinical Trial (DiRECT) at the annual scientific sessions of the American Diabetes Association (Lancet Diabetes Endocrinol. 2019 May;7(5):344-355).

A subgroup analysis he also presented found that beta cell function rebounds rapidly after weight loss and is pretty much normal at 2 years, so long as people keep the weight off.


The study is rooted in previous work by Dr. Taylor and his colleagues that found that very low-calorie diets normalized fasting plasma glucose in just 7 days in patients with type 2 diabetes due to a rapid fall in liver fat content and subsequent restoration of insulin sensitivity. That and other findings suggested that fast weight loss – instead of the traditional gradual approach – might help.

He and his team randomized 149 volunteers from primary care practices in the United Kingdom to standard care, and 149 others to rapid weight loss; more than a quarter of the patients who were asked agreed to participate.

aotto@mdedge.com
 

SOURCE: Zhyzhneuskaya SV et al., ADA 2019 abstract 66-OR

SEATTLE – Finding a balance between maintaining patient privacy and preventing self-harm is crucial in multiple sclerosis patients at risk for suicide.

“There are some situations where concern for a patient’s safety overrides [confidentiality],” Lauren Sankary, an attorney and neuroethics fellow at the Cleveland Clinic, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “I want to empower you to feel confident to break confidentiality when it makes sense based on your professional judgment.”

It’s not clear whether suicide is more common in patients with MS. A systematic review from 2012 found that most studies reviewed documented a higher rate of suicide in patients with MS, compared with the general population (J Psychosom Res. 2012 Dec;73(6):411-7) while a report from 2017 noted that rates of suicidal intent were elevated in MS (Mult Scler. 2017 Jun;23(7):923-927). Conversely, a French study from 2017 found that excess suicide risk may not be true for MS patients (Mult Scler. 2017 May;23(6):864-871).

When considering breaking confidentiality to seek help for a patient, Ms. Sankary said, “the ethical tension is that on the one hand, disclosing protected health information may protect patient safety. But on the other hand, it may threaten the therapeutic relationship. It’s a true ethical dilemma, and part of what’s difficult is figuring out in which situations are we willing to accept these tradeoffs.”

Consider professional ethical guidelines, federal and local laws, and clinical protocols in the decision making process, she advised.

On the federal level, HIPAA allows the breaking of confidentiality when it “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”

The U.S. Department of Health & Human Services’ Office of Civil Rights notes that “HIPAA permits a covered health care provider to notify a patient’s family members of a serious and imminent threat to the health or safety of the patient or others if those family members are in a position to lessen or avert the threat. Thus, to the extent that a provider determines that there is a serious and imminent threat of a patient physically harming self or others, HIPAA would permit the provider to warn the appropriate person(s) of the threat, consistent with his or her professional ethical obligations and State law requirements.”

Confidential information cannot be disclosed to just anyone, however. HIPAA notes that it must be disclosed only to “a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.”

HIPAA doesn’t require medical professionals to report suicide risk, Ms. Sankary said, but some states require certain professionals to do so. And some states require certain professionals to alert parents if children are suicidal.

The laws mainly affect mental health professionals but may extend to physicians and nurses, according to the National Conference of State Legislators. For example, New Jersey professionals in several fields have a duty to warn in certain situations, including the risk of self-harm.

The American Medical Association’s Code of Medical Ethics suggests physicians must “inform the patient when there has been a significant infringement on privacy of which the patient would otherwise not be aware,” Ms. Sankary said.

Ms. Sankary reported no relevant disclosures.

SEATTLE – Finding a balance between maintaining patient privacy and preventing self-harm is crucial in multiple sclerosis patients at risk for suicide.

“There are some situations where concern for a patient’s safety overrides [confidentiality],” Lauren Sankary, an attorney and neuroethics fellow at the Cleveland Clinic, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “I want to empower you to feel confident to break confidentiality when it makes sense based on your professional judgment.”

It’s not clear whether suicide is more common in patients with MS. A systematic review from 2012 found that most studies reviewed documented a higher rate of suicide in patients with MS, compared with the general population (J Psychosom Res. 2012 Dec;73(6):411-7) while a report from 2017 noted that rates of suicidal intent were elevated in MS (Mult Scler. 2017 Jun;23(7):923-927). Conversely, a French study from 2017 found that excess suicide risk may not be true for MS patients (Mult Scler. 2017 May;23(6):864-871).

When considering breaking confidentiality to seek help for a patient, Ms. Sankary said, “the ethical tension is that on the one hand, disclosing protected health information may protect patient safety. But on the other hand, it may threaten the therapeutic relationship. It’s a true ethical dilemma, and part of what’s difficult is figuring out in which situations are we willing to accept these tradeoffs.”

Consider professional ethical guidelines, federal and local laws, and clinical protocols in the decision making process, she advised.

On the federal level, HIPAA allows the breaking of confidentiality when it “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”

The U.S. Department of Health & Human Services’ Office of Civil Rights notes that “HIPAA permits a covered health care provider to notify a patient’s family members of a serious and imminent threat to the health or safety of the patient or others if those family members are in a position to lessen or avert the threat. Thus, to the extent that a provider determines that there is a serious and imminent threat of a patient physically harming self or others, HIPAA would permit the provider to warn the appropriate person(s) of the threat, consistent with his or her professional ethical obligations and State law requirements.”

Confidential information cannot be disclosed to just anyone, however. HIPAA notes that it must be disclosed only to “a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.”

HIPAA doesn’t require medical professionals to report suicide risk, Ms. Sankary said, but some states require certain professionals to do so. And some states require certain professionals to alert parents if children are suicidal.

The laws mainly affect mental health professionals but may extend to physicians and nurses, according to the National Conference of State Legislators. For example, New Jersey professionals in several fields have a duty to warn in certain situations, including the risk of self-harm.

The American Medical Association’s Code of Medical Ethics suggests physicians must “inform the patient when there has been a significant infringement on privacy of which the patient would otherwise not be aware,” Ms. Sankary said.

Ms. Sankary reported no relevant disclosures.

SEATTLE – Finding a balance between maintaining patient privacy and preventing self-harm is crucial in multiple sclerosis patients at risk for suicide.

“There are some situations where concern for a patient’s safety overrides [confidentiality],” Lauren Sankary, an attorney and neuroethics fellow at the Cleveland Clinic, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “I want to empower you to feel confident to break confidentiality when it makes sense based on your professional judgment.”

It’s not clear whether suicide is more common in patients with MS. A systematic review from 2012 found that most studies reviewed documented a higher rate of suicide in patients with MS, compared with the general population (J Psychosom Res. 2012 Dec;73(6):411-7) while a report from 2017 noted that rates of suicidal intent were elevated in MS (Mult Scler. 2017 Jun;23(7):923-927). Conversely, a French study from 2017 found that excess suicide risk may not be true for MS patients (Mult Scler. 2017 May;23(6):864-871).

When considering breaking confidentiality to seek help for a patient, Ms. Sankary said, “the ethical tension is that on the one hand, disclosing protected health information may protect patient safety. But on the other hand, it may threaten the therapeutic relationship. It’s a true ethical dilemma, and part of what’s difficult is figuring out in which situations are we willing to accept these tradeoffs.”

Consider professional ethical guidelines, federal and local laws, and clinical protocols in the decision making process, she advised.

On the federal level, HIPAA allows the breaking of confidentiality when it “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”

The U.S. Department of Health & Human Services’ Office of Civil Rights notes that “HIPAA permits a covered health care provider to notify a patient’s family members of a serious and imminent threat to the health or safety of the patient or others if those family members are in a position to lessen or avert the threat. Thus, to the extent that a provider determines that there is a serious and imminent threat of a patient physically harming self or others, HIPAA would permit the provider to warn the appropriate person(s) of the threat, consistent with his or her professional ethical obligations and State law requirements.”

Confidential information cannot be disclosed to just anyone, however. HIPAA notes that it must be disclosed only to “a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.”

HIPAA doesn’t require medical professionals to report suicide risk, Ms. Sankary said, but some states require certain professionals to do so. And some states require certain professionals to alert parents if children are suicidal.

The laws mainly affect mental health professionals but may extend to physicians and nurses, according to the National Conference of State Legislators. For example, New Jersey professionals in several fields have a duty to warn in certain situations, including the risk of self-harm.

The American Medical Association’s Code of Medical Ethics suggests physicians must “inform the patient when there has been a significant infringement on privacy of which the patient would otherwise not be aware,” Ms. Sankary said.

Ms. Sankary reported no relevant disclosures.