Access to specialized services has been a consistently complex problem for many integrated health care systems, including the Veterans Health Administration (VHA). About two-thirds of veterans experience significant barriers when trying to obtain medical care.¹ While these problems partly mirror difficulties that nonveterans face as well, there is a unique obligation toward those who put life and health at risk during their military service.²

To better meet demands, the VHA expanded personnel and clinic infrastructure with more providers and a network of community-based outpatient clinics (CBOC) that created more openings for clinic visits.³ Yet regional variability remains a significant problem for primary and even more so for specialty medical services.

Recent data show that more than one-fifth of all veterans live in areas with low population density and shortages of health care providers.⁴ The data point at a special problem in this context because these veterans often face long travel times to centers offering specialty services. The introduction of electronic consults functions as an alternative venue to obtain expert input but amounts to only 2% of total consult volume.⁵ A more interactive approach with face-to-face teleconferencing, case discussions, and special training led by expert clinicians has further improved access in such underserved areas and played a key role in the success of the VHA hepatitis C treatment initiative.⁶

Despite its clearly proven role and success, these e-consults come with some conceptual shortcomings. A key caveat is the lack of direct patient involvement. Obtaining information from the source rather than relying on symptoms documented by a third person can be essential in approaching medical problems. Experts may be able to tease out the often essential details of a history when making a diagnosis. A direct contact adds an additional, perhaps less tangible, component to the interaction that relies on verbal and nonverbal components of personal interactions and plays an important role in treatment success. Prior studies strongly link credibility of and trust in a provider as well as the related treatment success to such aspects of communication.^7,8

Gastroenterology Telemedicine Services

The George E. Wahlen VA Medical Center in Salt Lake City, Utah, draws from a large catchment area that extends from the southern border of Utah to the neighboring states of Idaho, Wyoming, Nevada, and Montana. Large stretches of this territory are remote with population densities well below 5 persons per square mile. The authors therefore devised a specialty outreach program relying on telemedicine for patients with gastrointestinal and liver diseases and present the initial experience with the implementation of this program.

Phase 1: Finding the Champions

Prior studies clearly emphasized that most successful telemedicine clinics relied on key persons (“champions”) promoting the idea and carrying the additional logistic and time issues required to start and maintain the new program^.9,10 Thus we created a small team that defined and refined goals, identified target groups, and worked out the logistics. Based on prior experiences, we focused initially on veterans with more chronic and likely functional disorders, such as diarrhea, constipation, dyspepsia, or nausea. The team also planned to accept patients with chronic liver disorders or abnormal test results that required further clarification. By consensus, the group excluded acute problems and bleeding as well as disorders with pain as primary manifestations. The underlying assumption was that a direct physical examination was less critical in most of these cases.

Phase 2: Outreach

Clinic managers and medical directors of the affiliated CBOC were informed of the planned telemedicine clinic. Also, we identified local champions who could function as point persons and assist in the organization of visits. One member of the team personally visited key sites to discuss needs and opportunities with CBOC personnel during a routine staff meeting. The goal was to introduce the program, the key personnel, to explain criteria for appropriate candidates that may benefit from telemedicine consults, and to agree on a referral pathway. Finally, we emphasized that the consultant would always defer to the referring provider or patient and honor their requests.

Phase 3: Identifying Appropriate Patients

The team planned for and has since used 4 different pathways to identify possible candidates for telemedicine visits. The consult triaging process with telemedicine is an option that is brought up with patients if their travel to the facility exceeds 100 miles. Similarly, the team reviews procedural requests to optimize diagnostic yields and limit patient burden. For example, if endoscopic testing is requested to address chronic abdominal pain or other concerns that had already prompted a similar request with negative results, then the team will ask for feedback and recommend a telemedicine consultation prior to performing the procedure. Telemedicine also is offered for follow-up encounters to veterans seen in the facility for clinical or procedural evaluations if they live ≥ 40 miles away. The 2 other pathways are requests from referring providers or patients that specifically ask for telemedicine visits.

Phase 4: Implementation

Since rolling out the program in November 2016, video visits have been used for more than 150 clinic encounters. Within the first 12 months, 124 patients were seen at least once using telemedicine links. Of 144 visits, 54 (38%) were follow-up visits; the rest constituted initial consultations. Focusing on initial encounters only, veterans specifically asked for a telemedicine visit in 16 cases (17.8%). One-third of these referrals was specifically marked as a telemedicine visit by the primary care provider. In the remaining cases, the triaging personnel brought up the possibility of a telemedicine interaction and requested feedback from the referring provider.

Veterans resided in many different areas within and outside of the facility’s immediate referral area (Figure). 

Beyond obtaining contextual data and information about the specific clinical manifestations, the rationale for these encounters was a detailed discussion of the problem and treatment options available. Ablative therapy in Barrett esophagus best exemplifies the potential relevance of such an encounter: Although conceptually appealing to decrease cancer risk, the approach requires a significant commitment typically involving repeated sessions of radiofrequency ablation followed by intense endoscopic surveillance. With travel distances of several hundred miles in these cases, these encounters provide relevant information to patients and the opportunity to make informed decisions without the burden and cost of a long trip.

A shift in telemedicine encounters will likely occur that will increasingly rely on access from home computers or handheld devices. However, the initial phase of this program relied on connections through a CBOC. Coordination between 2 sites adds a level of complexity to ensure availability of space and videoconferencing equipment. To limit the logistic burden and improve cost-effectiveness, the authors did not expect or request the presence of the primary or another independent provider. Instead, the team communicated with a locally designated point person who coordinated the remote encounters and assisted in implementing some of the suggested next steps. Prior site visits and communications with referring providers had established channels of communication to define concerns or highlight findings. The same channels also allowed the team to direct its attention to specific aspects of the physical examination to support or rule out a presumptive diagnosis.

If additional testing was suggested, Telemedicine Services generally ordered the appropriate assessments unless veterans requested relying on local resources better known to personnel at the remote site. The most common diagnostic steps recommended were laboratory tests (n = 21; 14.6%), endoscopic procedures (n = 18; 12.5%), and radiologic studies (n = 17; 11.8%) (Table 2).

Discussion

The initial implementation of a specialty telemedicine clinic taught us several lessons that will not only guide this program expansion, but also may be relevant for others introducing telemedicine into their specialty clinics. At first glance, videoconferencing with patients resembles more conventional clinic encounters. However, it adds another angle as many steps from scheduling a visit to implementing recommendations rely on different members at the remote site. Thus, the success of such a program depends on establishing a true partnership with the teams at the various satellite sites. It also requires ongoing feedback from all team members and fine-tuning to effectively integrate it into the routine operations of both sites.

Feedback about the program has been very positive with comments often asking for an expansion beyond gastroenterology. Concerns largely were limited to scheduling problems that may become less relevant if the new telehealth initiative moves forward and enables health care providers to directly connect with computers or handheld devices at the patient’s home. Prior studies demonstrated that most individuals have access to such technology and accept it as a viable or even attractive option for medical encounters.^11,12

For some, remaining in the comfort of their own home is not only more convenient, but also adds a sense of security, further adding to its appeal.¹³ As suggested by the economist Richard Thaler, simple nudges may be required to increase use and perhaps utility of telemedicine or e-consults.¹⁴ At this stage, it is the active choice of the referral or triaging provider to consider telemedicine as an option. To facilitate deviation from the established routine, we plan to revise the consult requests by using a drop-down menu option that brings up e-consult, telemedicine, or clinic visit as alternatives and requires an active choice rather than defaulting to conventional face-to-face visits.

Despite an overall successful launch of the specialty telemedicine clinic, several conceptual questions require additional in-depth assessments. While video visits indeed include the literal face time that characterizes normal clinic visits, does this translate into the “face value” that may contribute to treatment success? If detailed information about physical findings is needed, remote encounters require a third person at the distant site to complete this step, which may not only be a logistic burden, but also could influence the perceived utility and affect outcomes.

Previously published studies have demonstrated the effectiveness of video-based interactions and allow providers to address these points to some degree. Remote encounters have established roles in mental healthcare that is less dependent on physical findings.¹⁵ Distance monitoring of devices or biomarkers, such as blood sugar levels or blood pressure, are becoming routine and often are combined with corrective interventions.^16-18

Recently completed trials showed satisfaction did not differ from conventional clinic encounters when telemedicine encounters were used to manage chronic headaches or provide postoperative follow-up after urologic surgery.^19,20 For gastroenterology, telemedicine outreach after hospitalizations not only improved care, but also lowered rates of testing after discharge.²¹ In patients with inflammatory bowel disease, a group that was not targeted during this initial phase, proactive and close follow-up with remote technology can decrease the need for hospitalization.²²

These data are consistent with encouraging feedback received. Nonetheless, it is important to assess whether this approach is superior to established and cheaper alternatives, most notably simple telephone interactions. Video-linkage obviously allows nonverbal elements of communication, which play an important role in patient preference and satisfaction, treatment implementation, and impact.^7,8,23-25 Providers described patients as more focused and engaged compared with telephone interactions and valued the ability to incorporate body language in their assessment.²⁶

Telemedicine clinics offered by specialty providers may not improve access as defined by wait times only, which would require adding more clinical time and personnel. However, it can lower barriers to care imposed by long distances between rural areas and facilities with specialized expertise. Even if a remote encounter concludes with the recommendation to visit the clinic for more detailed testing or treatment, explaining the need for such steps and involving the patient in the decision-making process may affect adherence.

Conclusion

Although the experiences of the team at George E. Wahlen VA Medical Center support the use of telemedicine in specialty clinics, the next phase of the project needs to address the utility of this approach and define the perceived value and potential problems of telemedicine. Obtaining this insight will require complex data sets with feedback from patients and referring and consulting providers. As trade-offs will likely vary between different diseases or symptoms, such studies will provide a better definition of clinical scenarios best suited for remote encounters. In addition, they may provide approximate values for distance or efforts that may make the cost of a direct clinic visit worth it, thereby defining boundary-condition.

Access to specialized services has been a consistently complex problem for many integrated health care systems, including the Veterans Health Administration (VHA). About two-thirds of veterans experience significant barriers when trying to obtain medical care.¹ While these problems partly mirror difficulties that nonveterans face as well, there is a unique obligation toward those who put life and health at risk during their military service.²

To better meet demands, the VHA expanded personnel and clinic infrastructure with more providers and a network of community-based outpatient clinics (CBOC) that created more openings for clinic visits.³ Yet regional variability remains a significant problem for primary and even more so for specialty medical services.

Recent data show that more than one-fifth of all veterans live in areas with low population density and shortages of health care providers.⁴ The data point at a special problem in this context because these veterans often face long travel times to centers offering specialty services. The introduction of electronic consults functions as an alternative venue to obtain expert input but amounts to only 2% of total consult volume.⁵ A more interactive approach with face-to-face teleconferencing, case discussions, and special training led by expert clinicians has further improved access in such underserved areas and played a key role in the success of the VHA hepatitis C treatment initiative.⁶

Despite its clearly proven role and success, these e-consults come with some conceptual shortcomings. A key caveat is the lack of direct patient involvement. Obtaining information from the source rather than relying on symptoms documented by a third person can be essential in approaching medical problems. Experts may be able to tease out the often essential details of a history when making a diagnosis. A direct contact adds an additional, perhaps less tangible, component to the interaction that relies on verbal and nonverbal components of personal interactions and plays an important role in treatment success. Prior studies strongly link credibility of and trust in a provider as well as the related treatment success to such aspects of communication.^7,8

Gastroenterology Telemedicine Services

The George E. Wahlen VA Medical Center in Salt Lake City, Utah, draws from a large catchment area that extends from the southern border of Utah to the neighboring states of Idaho, Wyoming, Nevada, and Montana. Large stretches of this territory are remote with population densities well below 5 persons per square mile. The authors therefore devised a specialty outreach program relying on telemedicine for patients with gastrointestinal and liver diseases and present the initial experience with the implementation of this program.

Phase 1: Finding the Champions

Prior studies clearly emphasized that most successful telemedicine clinics relied on key persons (“champions”) promoting the idea and carrying the additional logistic and time issues required to start and maintain the new program^.9,10 Thus we created a small team that defined and refined goals, identified target groups, and worked out the logistics. Based on prior experiences, we focused initially on veterans with more chronic and likely functional disorders, such as diarrhea, constipation, dyspepsia, or nausea. The team also planned to accept patients with chronic liver disorders or abnormal test results that required further clarification. By consensus, the group excluded acute problems and bleeding as well as disorders with pain as primary manifestations. The underlying assumption was that a direct physical examination was less critical in most of these cases.

Phase 2: Outreach

Clinic managers and medical directors of the affiliated CBOC were informed of the planned telemedicine clinic. Also, we identified local champions who could function as point persons and assist in the organization of visits. One member of the team personally visited key sites to discuss needs and opportunities with CBOC personnel during a routine staff meeting. The goal was to introduce the program, the key personnel, to explain criteria for appropriate candidates that may benefit from telemedicine consults, and to agree on a referral pathway. Finally, we emphasized that the consultant would always defer to the referring provider or patient and honor their requests.

Phase 3: Identifying Appropriate Patients

The team planned for and has since used 4 different pathways to identify possible candidates for telemedicine visits. The consult triaging process with telemedicine is an option that is brought up with patients if their travel to the facility exceeds 100 miles. Similarly, the team reviews procedural requests to optimize diagnostic yields and limit patient burden. For example, if endoscopic testing is requested to address chronic abdominal pain or other concerns that had already prompted a similar request with negative results, then the team will ask for feedback and recommend a telemedicine consultation prior to performing the procedure. Telemedicine also is offered for follow-up encounters to veterans seen in the facility for clinical or procedural evaluations if they live ≥ 40 miles away. The 2 other pathways are requests from referring providers or patients that specifically ask for telemedicine visits.

Phase 4: Implementation

Since rolling out the program in November 2016, video visits have been used for more than 150 clinic encounters. Within the first 12 months, 124 patients were seen at least once using telemedicine links. Of 144 visits, 54 (38%) were follow-up visits; the rest constituted initial consultations. Focusing on initial encounters only, veterans specifically asked for a telemedicine visit in 16 cases (17.8%). One-third of these referrals was specifically marked as a telemedicine visit by the primary care provider. In the remaining cases, the triaging personnel brought up the possibility of a telemedicine interaction and requested feedback from the referring provider.

Veterans resided in many different areas within and outside of the facility’s immediate referral area (Figure). 

Beyond obtaining contextual data and information about the specific clinical manifestations, the rationale for these encounters was a detailed discussion of the problem and treatment options available. Ablative therapy in Barrett esophagus best exemplifies the potential relevance of such an encounter: Although conceptually appealing to decrease cancer risk, the approach requires a significant commitment typically involving repeated sessions of radiofrequency ablation followed by intense endoscopic surveillance. With travel distances of several hundred miles in these cases, these encounters provide relevant information to patients and the opportunity to make informed decisions without the burden and cost of a long trip.

A shift in telemedicine encounters will likely occur that will increasingly rely on access from home computers or handheld devices. However, the initial phase of this program relied on connections through a CBOC. Coordination between 2 sites adds a level of complexity to ensure availability of space and videoconferencing equipment. To limit the logistic burden and improve cost-effectiveness, the authors did not expect or request the presence of the primary or another independent provider. Instead, the team communicated with a locally designated point person who coordinated the remote encounters and assisted in implementing some of the suggested next steps. Prior site visits and communications with referring providers had established channels of communication to define concerns or highlight findings. The same channels also allowed the team to direct its attention to specific aspects of the physical examination to support or rule out a presumptive diagnosis.

If additional testing was suggested, Telemedicine Services generally ordered the appropriate assessments unless veterans requested relying on local resources better known to personnel at the remote site. The most common diagnostic steps recommended were laboratory tests (n = 21; 14.6%), endoscopic procedures (n = 18; 12.5%), and radiologic studies (n = 17; 11.8%) (Table 2).

Discussion

The initial implementation of a specialty telemedicine clinic taught us several lessons that will not only guide this program expansion, but also may be relevant for others introducing telemedicine into their specialty clinics. At first glance, videoconferencing with patients resembles more conventional clinic encounters. However, it adds another angle as many steps from scheduling a visit to implementing recommendations rely on different members at the remote site. Thus, the success of such a program depends on establishing a true partnership with the teams at the various satellite sites. It also requires ongoing feedback from all team members and fine-tuning to effectively integrate it into the routine operations of both sites.

Feedback about the program has been very positive with comments often asking for an expansion beyond gastroenterology. Concerns largely were limited to scheduling problems that may become less relevant if the new telehealth initiative moves forward and enables health care providers to directly connect with computers or handheld devices at the patient’s home. Prior studies demonstrated that most individuals have access to such technology and accept it as a viable or even attractive option for medical encounters.^11,12

For some, remaining in the comfort of their own home is not only more convenient, but also adds a sense of security, further adding to its appeal.¹³ As suggested by the economist Richard Thaler, simple nudges may be required to increase use and perhaps utility of telemedicine or e-consults.¹⁴ At this stage, it is the active choice of the referral or triaging provider to consider telemedicine as an option. To facilitate deviation from the established routine, we plan to revise the consult requests by using a drop-down menu option that brings up e-consult, telemedicine, or clinic visit as alternatives and requires an active choice rather than defaulting to conventional face-to-face visits.

Despite an overall successful launch of the specialty telemedicine clinic, several conceptual questions require additional in-depth assessments. While video visits indeed include the literal face time that characterizes normal clinic visits, does this translate into the “face value” that may contribute to treatment success? If detailed information about physical findings is needed, remote encounters require a third person at the distant site to complete this step, which may not only be a logistic burden, but also could influence the perceived utility and affect outcomes.

Previously published studies have demonstrated the effectiveness of video-based interactions and allow providers to address these points to some degree. Remote encounters have established roles in mental healthcare that is less dependent on physical findings.¹⁵ Distance monitoring of devices or biomarkers, such as blood sugar levels or blood pressure, are becoming routine and often are combined with corrective interventions.^16-18

Recently completed trials showed satisfaction did not differ from conventional clinic encounters when telemedicine encounters were used to manage chronic headaches or provide postoperative follow-up after urologic surgery.^19,20 For gastroenterology, telemedicine outreach after hospitalizations not only improved care, but also lowered rates of testing after discharge.²¹ In patients with inflammatory bowel disease, a group that was not targeted during this initial phase, proactive and close follow-up with remote technology can decrease the need for hospitalization.²²

These data are consistent with encouraging feedback received. Nonetheless, it is important to assess whether this approach is superior to established and cheaper alternatives, most notably simple telephone interactions. Video-linkage obviously allows nonverbal elements of communication, which play an important role in patient preference and satisfaction, treatment implementation, and impact.^7,8,23-25 Providers described patients as more focused and engaged compared with telephone interactions and valued the ability to incorporate body language in their assessment.²⁶

Telemedicine clinics offered by specialty providers may not improve access as defined by wait times only, which would require adding more clinical time and personnel. However, it can lower barriers to care imposed by long distances between rural areas and facilities with specialized expertise. Even if a remote encounter concludes with the recommendation to visit the clinic for more detailed testing or treatment, explaining the need for such steps and involving the patient in the decision-making process may affect adherence.

Conclusion

Although the experiences of the team at George E. Wahlen VA Medical Center support the use of telemedicine in specialty clinics, the next phase of the project needs to address the utility of this approach and define the perceived value and potential problems of telemedicine. Obtaining this insight will require complex data sets with feedback from patients and referring and consulting providers. As trade-offs will likely vary between different diseases or symptoms, such studies will provide a better definition of clinical scenarios best suited for remote encounters. In addition, they may provide approximate values for distance or efforts that may make the cost of a direct clinic visit worth it, thereby defining boundary-condition.

Access to specialized services has been a consistently complex problem for many integrated health care systems, including the Veterans Health Administration (VHA). About two-thirds of veterans experience significant barriers when trying to obtain medical care.¹ While these problems partly mirror difficulties that nonveterans face as well, there is a unique obligation toward those who put life and health at risk during their military service.²

To better meet demands, the VHA expanded personnel and clinic infrastructure with more providers and a network of community-based outpatient clinics (CBOC) that created more openings for clinic visits.³ Yet regional variability remains a significant problem for primary and even more so for specialty medical services.

Recent data show that more than one-fifth of all veterans live in areas with low population density and shortages of health care providers.⁴ The data point at a special problem in this context because these veterans often face long travel times to centers offering specialty services. The introduction of electronic consults functions as an alternative venue to obtain expert input but amounts to only 2% of total consult volume.⁵ A more interactive approach with face-to-face teleconferencing, case discussions, and special training led by expert clinicians has further improved access in such underserved areas and played a key role in the success of the VHA hepatitis C treatment initiative.⁶

Despite its clearly proven role and success, these e-consults come with some conceptual shortcomings. A key caveat is the lack of direct patient involvement. Obtaining information from the source rather than relying on symptoms documented by a third person can be essential in approaching medical problems. Experts may be able to tease out the often essential details of a history when making a diagnosis. A direct contact adds an additional, perhaps less tangible, component to the interaction that relies on verbal and nonverbal components of personal interactions and plays an important role in treatment success. Prior studies strongly link credibility of and trust in a provider as well as the related treatment success to such aspects of communication.^7,8

Gastroenterology Telemedicine Services

The George E. Wahlen VA Medical Center in Salt Lake City, Utah, draws from a large catchment area that extends from the southern border of Utah to the neighboring states of Idaho, Wyoming, Nevada, and Montana. Large stretches of this territory are remote with population densities well below 5 persons per square mile. The authors therefore devised a specialty outreach program relying on telemedicine for patients with gastrointestinal and liver diseases and present the initial experience with the implementation of this program.

Phase 1: Finding the Champions

Prior studies clearly emphasized that most successful telemedicine clinics relied on key persons (“champions”) promoting the idea and carrying the additional logistic and time issues required to start and maintain the new program^.9,10 Thus we created a small team that defined and refined goals, identified target groups, and worked out the logistics. Based on prior experiences, we focused initially on veterans with more chronic and likely functional disorders, such as diarrhea, constipation, dyspepsia, or nausea. The team also planned to accept patients with chronic liver disorders or abnormal test results that required further clarification. By consensus, the group excluded acute problems and bleeding as well as disorders with pain as primary manifestations. The underlying assumption was that a direct physical examination was less critical in most of these cases.

Phase 2: Outreach

Clinic managers and medical directors of the affiliated CBOC were informed of the planned telemedicine clinic. Also, we identified local champions who could function as point persons and assist in the organization of visits. One member of the team personally visited key sites to discuss needs and opportunities with CBOC personnel during a routine staff meeting. The goal was to introduce the program, the key personnel, to explain criteria for appropriate candidates that may benefit from telemedicine consults, and to agree on a referral pathway. Finally, we emphasized that the consultant would always defer to the referring provider or patient and honor their requests.

Phase 3: Identifying Appropriate Patients

The team planned for and has since used 4 different pathways to identify possible candidates for telemedicine visits. The consult triaging process with telemedicine is an option that is brought up with patients if their travel to the facility exceeds 100 miles. Similarly, the team reviews procedural requests to optimize diagnostic yields and limit patient burden. For example, if endoscopic testing is requested to address chronic abdominal pain or other concerns that had already prompted a similar request with negative results, then the team will ask for feedback and recommend a telemedicine consultation prior to performing the procedure. Telemedicine also is offered for follow-up encounters to veterans seen in the facility for clinical or procedural evaluations if they live ≥ 40 miles away. The 2 other pathways are requests from referring providers or patients that specifically ask for telemedicine visits.

Phase 4: Implementation

Since rolling out the program in November 2016, video visits have been used for more than 150 clinic encounters. Within the first 12 months, 124 patients were seen at least once using telemedicine links. Of 144 visits, 54 (38%) were follow-up visits; the rest constituted initial consultations. Focusing on initial encounters only, veterans specifically asked for a telemedicine visit in 16 cases (17.8%). One-third of these referrals was specifically marked as a telemedicine visit by the primary care provider. In the remaining cases, the triaging personnel brought up the possibility of a telemedicine interaction and requested feedback from the referring provider.

Veterans resided in many different areas within and outside of the facility’s immediate referral area (Figure). 

Beyond obtaining contextual data and information about the specific clinical manifestations, the rationale for these encounters was a detailed discussion of the problem and treatment options available. Ablative therapy in Barrett esophagus best exemplifies the potential relevance of such an encounter: Although conceptually appealing to decrease cancer risk, the approach requires a significant commitment typically involving repeated sessions of radiofrequency ablation followed by intense endoscopic surveillance. With travel distances of several hundred miles in these cases, these encounters provide relevant information to patients and the opportunity to make informed decisions without the burden and cost of a long trip.

A shift in telemedicine encounters will likely occur that will increasingly rely on access from home computers or handheld devices. However, the initial phase of this program relied on connections through a CBOC. Coordination between 2 sites adds a level of complexity to ensure availability of space and videoconferencing equipment. To limit the logistic burden and improve cost-effectiveness, the authors did not expect or request the presence of the primary or another independent provider. Instead, the team communicated with a locally designated point person who coordinated the remote encounters and assisted in implementing some of the suggested next steps. Prior site visits and communications with referring providers had established channels of communication to define concerns or highlight findings. The same channels also allowed the team to direct its attention to specific aspects of the physical examination to support or rule out a presumptive diagnosis.

If additional testing was suggested, Telemedicine Services generally ordered the appropriate assessments unless veterans requested relying on local resources better known to personnel at the remote site. The most common diagnostic steps recommended were laboratory tests (n = 21; 14.6%), endoscopic procedures (n = 18; 12.5%), and radiologic studies (n = 17; 11.8%) (Table 2).

Discussion

The initial implementation of a specialty telemedicine clinic taught us several lessons that will not only guide this program expansion, but also may be relevant for others introducing telemedicine into their specialty clinics. At first glance, videoconferencing with patients resembles more conventional clinic encounters. However, it adds another angle as many steps from scheduling a visit to implementing recommendations rely on different members at the remote site. Thus, the success of such a program depends on establishing a true partnership with the teams at the various satellite sites. It also requires ongoing feedback from all team members and fine-tuning to effectively integrate it into the routine operations of both sites.

Feedback about the program has been very positive with comments often asking for an expansion beyond gastroenterology. Concerns largely were limited to scheduling problems that may become less relevant if the new telehealth initiative moves forward and enables health care providers to directly connect with computers or handheld devices at the patient’s home. Prior studies demonstrated that most individuals have access to such technology and accept it as a viable or even attractive option for medical encounters.^11,12

For some, remaining in the comfort of their own home is not only more convenient, but also adds a sense of security, further adding to its appeal.¹³ As suggested by the economist Richard Thaler, simple nudges may be required to increase use and perhaps utility of telemedicine or e-consults.¹⁴ At this stage, it is the active choice of the referral or triaging provider to consider telemedicine as an option. To facilitate deviation from the established routine, we plan to revise the consult requests by using a drop-down menu option that brings up e-consult, telemedicine, or clinic visit as alternatives and requires an active choice rather than defaulting to conventional face-to-face visits.

Despite an overall successful launch of the specialty telemedicine clinic, several conceptual questions require additional in-depth assessments. While video visits indeed include the literal face time that characterizes normal clinic visits, does this translate into the “face value” that may contribute to treatment success? If detailed information about physical findings is needed, remote encounters require a third person at the distant site to complete this step, which may not only be a logistic burden, but also could influence the perceived utility and affect outcomes.

Previously published studies have demonstrated the effectiveness of video-based interactions and allow providers to address these points to some degree. Remote encounters have established roles in mental healthcare that is less dependent on physical findings.¹⁵ Distance monitoring of devices or biomarkers, such as blood sugar levels or blood pressure, are becoming routine and often are combined with corrective interventions.^16-18

Recently completed trials showed satisfaction did not differ from conventional clinic encounters when telemedicine encounters were used to manage chronic headaches or provide postoperative follow-up after urologic surgery.^19,20 For gastroenterology, telemedicine outreach after hospitalizations not only improved care, but also lowered rates of testing after discharge.²¹ In patients with inflammatory bowel disease, a group that was not targeted during this initial phase, proactive and close follow-up with remote technology can decrease the need for hospitalization.²²

These data are consistent with encouraging feedback received. Nonetheless, it is important to assess whether this approach is superior to established and cheaper alternatives, most notably simple telephone interactions. Video-linkage obviously allows nonverbal elements of communication, which play an important role in patient preference and satisfaction, treatment implementation, and impact.^7,8,23-25 Providers described patients as more focused and engaged compared with telephone interactions and valued the ability to incorporate body language in their assessment.²⁶

Telemedicine clinics offered by specialty providers may not improve access as defined by wait times only, which would require adding more clinical time and personnel. However, it can lower barriers to care imposed by long distances between rural areas and facilities with specialized expertise. Even if a remote encounter concludes with the recommendation to visit the clinic for more detailed testing or treatment, explaining the need for such steps and involving the patient in the decision-making process may affect adherence.

Conclusion

Although the experiences of the team at George E. Wahlen VA Medical Center support the use of telemedicine in specialty clinics, the next phase of the project needs to address the utility of this approach and define the perceived value and potential problems of telemedicine. Obtaining this insight will require complex data sets with feedback from patients and referring and consulting providers. As trade-offs will likely vary between different diseases or symptoms, such studies will provide a better definition of clinical scenarios best suited for remote encounters. In addition, they may provide approximate values for distance or efforts that may make the cost of a direct clinic visit worth it, thereby defining boundary-condition.

Lab mouse

New research suggests the FOXM1 protein plays an important role in acute myeloid leukemia (AML) progression, and targeting FOXM1 could improve AML treatment.

With a retrospective study, researchers showed that overexpression of FOXM1 was associated with increased resistance to chemotherapy and inferior overall survival.

Subsequent preclinical research showed that ixazomib inhibits FOXM1, exhibits antileukemic activity, and sensitizes AML cells to chemotherapy.

Irum Khan, MD, of the University of Illinois in Chicago, and her colleagues reported these findings in JCI Insight.

Previous research showed that AML patients with NPM1 mutations have a higher rate of remission with chemotherapy, and the NPM1 protein affects the location and activity of FOXM1. NPM1 keeps FOXM1 in the nucleus where it can activate other cancer-promoting genes.

When the NPM1 gene is mutated, FOXM1 migrates out of the nucleus and into the cell’s cytoplasm, where it can’t interact with DNA. This may explain why AML patients with NPM1 mutations have a better response to chemotherapy and are less likely to relapse.

With the current research, Dr Khan and her colleagues further explored the role of FOXM1 in AML.

Retrospective analysis

The multicenter, retrospective study began with data from 111 adults with AML. They had intermediate-risk cytogenetics and a median age of 61.

Eighty-eight patients received induction with cytarabine and an anthracycline, and 80 achieved a complete remission with or without count recovery.

FOXM1 expression data were available for 74 of these patients. Fifty patients achieved remission with 1 cycle of induction, and 24 required more than 1 cycle.

“[Patients] with FOXM1 present in the nucleus of their cancer cells had worse treatment outcomes, higher rates of chemotherapy resistance, and lower survival rates compared to patients without FOXM1 present in the nucleus,” Dr Khan said.

The patients who failed their first line of induction had a more than 2-fold increase in the percentage of nuclei expressing FOXM1 in their bone marrow (P=0.004). And the average nuclear intensity of FOXM1 was significantly higher in the patients who failed their first line of induction (P=0.02).

The percentage of FOXM1-positive nuclei and the average nuclear intensity of FOXM1 both significantly predicted resistance to first-line chemotherapy. The odds ratio was 1.80 for a 10% increase in FOXM1-positive nuclei (P=0.005) and 2.5 for a 0.1 unit increase in nuclear intensity (P=0.02).

A multivariate analysis showed that the FOXM1 nuclear/cytoplasmic (N:C) ratio and nuclear FOXM1 intensity predicted inferior overall survival in a single institution. (Institutions were analyzed separately for survival). The hazard ratio was 4.7 for every 0.1 unit increase in N:C ratio (P=0.03) and 4.27 for every 0.1 unit increase in nuclear intensity (P=0.06).

Confirming the role of FOXM1

The researchers set out to confirm the role of FOXM1 via experiments in mice.

The team induced a FLT3-ITD-driven myeloproliferative neoplasm in a FOXM1-overexpressing transgenic mouse model.

These mice had more residual disease after treatment with cytarabine than control mice with normal levels of FOXM1.

“Our finding suggests that overexpression of FOXM1 directly induces chemoresistance, which matches what we saw in our analysis of patients’ FOXM1 levels and their treatment outcomes,” Dr Khan said.

Targeting FOXM1 with ixazomib

Next, the researchers showed they could produce a therapeutic response by inhibiting FOXM1 in AML. The team used ixazomib, which was shown to suppress FOXM1.

There was a 2-fold increase in apoptosis when AML patient cells were treated with ixazomib (compared to DMSO).

Ixazomib also exhibited antitumor activity in a xenograft model of AML (HL-60 cells) and reduced leukemic burden in an orthotopic model of AML (KG-1 cells).

Finally, the researchers found that ixazomib sensitized AML cells to chemotherapy. The team observed synergistic activity between ixazomib and cytarabine or 5-azacitidine.

“There is a real unmet need for new ways to get around the resistance to chemotherapy that patients who don’t have this beneficial [NPM1] mutation often face,” Dr Khan said.

“Drugs that suppress FOXM1 in combination with the standard treatment, such as ixazomib, should result in better outcomes, but clinical trials will ultimately be needed to prove this theory.”

This research was supported by grants from the National Institutes of Health and Takeda.

Lab mouse

New research suggests the FOXM1 protein plays an important role in acute myeloid leukemia (AML) progression, and targeting FOXM1 could improve AML treatment.

With a retrospective study, researchers showed that overexpression of FOXM1 was associated with increased resistance to chemotherapy and inferior overall survival.

Subsequent preclinical research showed that ixazomib inhibits FOXM1, exhibits antileukemic activity, and sensitizes AML cells to chemotherapy.

Irum Khan, MD, of the University of Illinois in Chicago, and her colleagues reported these findings in JCI Insight.

Previous research showed that AML patients with NPM1 mutations have a higher rate of remission with chemotherapy, and the NPM1 protein affects the location and activity of FOXM1. NPM1 keeps FOXM1 in the nucleus where it can activate other cancer-promoting genes.

When the NPM1 gene is mutated, FOXM1 migrates out of the nucleus and into the cell’s cytoplasm, where it can’t interact with DNA. This may explain why AML patients with NPM1 mutations have a better response to chemotherapy and are less likely to relapse.

With the current research, Dr Khan and her colleagues further explored the role of FOXM1 in AML.

Retrospective analysis

The multicenter, retrospective study began with data from 111 adults with AML. They had intermediate-risk cytogenetics and a median age of 61.

Eighty-eight patients received induction with cytarabine and an anthracycline, and 80 achieved a complete remission with or without count recovery.

FOXM1 expression data were available for 74 of these patients. Fifty patients achieved remission with 1 cycle of induction, and 24 required more than 1 cycle.

“[Patients] with FOXM1 present in the nucleus of their cancer cells had worse treatment outcomes, higher rates of chemotherapy resistance, and lower survival rates compared to patients without FOXM1 present in the nucleus,” Dr Khan said.

The patients who failed their first line of induction had a more than 2-fold increase in the percentage of nuclei expressing FOXM1 in their bone marrow (P=0.004). And the average nuclear intensity of FOXM1 was significantly higher in the patients who failed their first line of induction (P=0.02).

The percentage of FOXM1-positive nuclei and the average nuclear intensity of FOXM1 both significantly predicted resistance to first-line chemotherapy. The odds ratio was 1.80 for a 10% increase in FOXM1-positive nuclei (P=0.005) and 2.5 for a 0.1 unit increase in nuclear intensity (P=0.02).

A multivariate analysis showed that the FOXM1 nuclear/cytoplasmic (N:C) ratio and nuclear FOXM1 intensity predicted inferior overall survival in a single institution. (Institutions were analyzed separately for survival). The hazard ratio was 4.7 for every 0.1 unit increase in N:C ratio (P=0.03) and 4.27 for every 0.1 unit increase in nuclear intensity (P=0.06).

Confirming the role of FOXM1

The researchers set out to confirm the role of FOXM1 via experiments in mice.

The team induced a FLT3-ITD-driven myeloproliferative neoplasm in a FOXM1-overexpressing transgenic mouse model.

These mice had more residual disease after treatment with cytarabine than control mice with normal levels of FOXM1.

“Our finding suggests that overexpression of FOXM1 directly induces chemoresistance, which matches what we saw in our analysis of patients’ FOXM1 levels and their treatment outcomes,” Dr Khan said.

Targeting FOXM1 with ixazomib

Next, the researchers showed they could produce a therapeutic response by inhibiting FOXM1 in AML. The team used ixazomib, which was shown to suppress FOXM1.

There was a 2-fold increase in apoptosis when AML patient cells were treated with ixazomib (compared to DMSO).

Ixazomib also exhibited antitumor activity in a xenograft model of AML (HL-60 cells) and reduced leukemic burden in an orthotopic model of AML (KG-1 cells).

Finally, the researchers found that ixazomib sensitized AML cells to chemotherapy. The team observed synergistic activity between ixazomib and cytarabine or 5-azacitidine.

“There is a real unmet need for new ways to get around the resistance to chemotherapy that patients who don’t have this beneficial [NPM1] mutation often face,” Dr Khan said.

“Drugs that suppress FOXM1 in combination with the standard treatment, such as ixazomib, should result in better outcomes, but clinical trials will ultimately be needed to prove this theory.”

This research was supported by grants from the National Institutes of Health and Takeda.

Lab mouse

New research suggests the FOXM1 protein plays an important role in acute myeloid leukemia (AML) progression, and targeting FOXM1 could improve AML treatment.

With a retrospective study, researchers showed that overexpression of FOXM1 was associated with increased resistance to chemotherapy and inferior overall survival.

Subsequent preclinical research showed that ixazomib inhibits FOXM1, exhibits antileukemic activity, and sensitizes AML cells to chemotherapy.

Irum Khan, MD, of the University of Illinois in Chicago, and her colleagues reported these findings in JCI Insight.

Previous research showed that AML patients with NPM1 mutations have a higher rate of remission with chemotherapy, and the NPM1 protein affects the location and activity of FOXM1. NPM1 keeps FOXM1 in the nucleus where it can activate other cancer-promoting genes.

When the NPM1 gene is mutated, FOXM1 migrates out of the nucleus and into the cell’s cytoplasm, where it can’t interact with DNA. This may explain why AML patients with NPM1 mutations have a better response to chemotherapy and are less likely to relapse.

With the current research, Dr Khan and her colleagues further explored the role of FOXM1 in AML.

Retrospective analysis

The multicenter, retrospective study began with data from 111 adults with AML. They had intermediate-risk cytogenetics and a median age of 61.

Eighty-eight patients received induction with cytarabine and an anthracycline, and 80 achieved a complete remission with or without count recovery.

FOXM1 expression data were available for 74 of these patients. Fifty patients achieved remission with 1 cycle of induction, and 24 required more than 1 cycle.

“[Patients] with FOXM1 present in the nucleus of their cancer cells had worse treatment outcomes, higher rates of chemotherapy resistance, and lower survival rates compared to patients without FOXM1 present in the nucleus,” Dr Khan said.

The patients who failed their first line of induction had a more than 2-fold increase in the percentage of nuclei expressing FOXM1 in their bone marrow (P=0.004). And the average nuclear intensity of FOXM1 was significantly higher in the patients who failed their first line of induction (P=0.02).

The percentage of FOXM1-positive nuclei and the average nuclear intensity of FOXM1 both significantly predicted resistance to first-line chemotherapy. The odds ratio was 1.80 for a 10% increase in FOXM1-positive nuclei (P=0.005) and 2.5 for a 0.1 unit increase in nuclear intensity (P=0.02).

A multivariate analysis showed that the FOXM1 nuclear/cytoplasmic (N:C) ratio and nuclear FOXM1 intensity predicted inferior overall survival in a single institution. (Institutions were analyzed separately for survival). The hazard ratio was 4.7 for every 0.1 unit increase in N:C ratio (P=0.03) and 4.27 for every 0.1 unit increase in nuclear intensity (P=0.06).

Confirming the role of FOXM1

The researchers set out to confirm the role of FOXM1 via experiments in mice.

The team induced a FLT3-ITD-driven myeloproliferative neoplasm in a FOXM1-overexpressing transgenic mouse model.

These mice had more residual disease after treatment with cytarabine than control mice with normal levels of FOXM1.

“Our finding suggests that overexpression of FOXM1 directly induces chemoresistance, which matches what we saw in our analysis of patients’ FOXM1 levels and their treatment outcomes,” Dr Khan said.

Targeting FOXM1 with ixazomib

Next, the researchers showed they could produce a therapeutic response by inhibiting FOXM1 in AML. The team used ixazomib, which was shown to suppress FOXM1.

There was a 2-fold increase in apoptosis when AML patient cells were treated with ixazomib (compared to DMSO).

Ixazomib also exhibited antitumor activity in a xenograft model of AML (HL-60 cells) and reduced leukemic burden in an orthotopic model of AML (KG-1 cells).

Finally, the researchers found that ixazomib sensitized AML cells to chemotherapy. The team observed synergistic activity between ixazomib and cytarabine or 5-azacitidine.

“There is a real unmet need for new ways to get around the resistance to chemotherapy that patients who don’t have this beneficial [NPM1] mutation often face,” Dr Khan said.

“Drugs that suppress FOXM1 in combination with the standard treatment, such as ixazomib, should result in better outcomes, but clinical trials will ultimately be needed to prove this theory.”

This research was supported by grants from the National Institutes of Health and Takeda.

Micrograph showing CLL

Patients with chronic lymphocytic leukemia (CLL) should be routinely monitored for melanoma, according to researchers.

A study of 470 CLL patients showed they have a significantly higher risk of invasive melanoma than the general population.

Most of the melanomas reported in this study were detected via routine surveillance, and most were discovered before they reached an advanced stage.

Clive Zent, MD, of Wilmot Cancer Institute at the University of Rochester Medical Center in Rochester, New York, and his colleagues described this study in Leukemia Research.

The researchers analyzed data on 470 CLL patients followed for 2849 person-years. Eighteen of these patients developed 22 melanomas. This included 14 cases of invasive melanoma in 13 patients.

The rate of invasive melanoma was significantly higher in this CLL cohort than the rate observed in the age- and sex-matched general population. The standardized incidence ratio was 6.32.

“We do not for sure know why CLL patients are more susceptible to melanoma, but the most likely cause is a suppressed immune system,” Dr Zent noted.

“Normally, in people with healthy immune systems, malignant skin cells might be detected and destroyed before they become a problem. But in CLL patients, failure of this control system increases the rate at which cancer cells can grow into tumors and also the likelihood that they will become invasive or spread to distant sites.”

Detection and management

Fifteen of the 22 melanomas (68.2%) in the CLL cohort were detected via surveillance in a dermatology clinic, and 2 (9.1%) were detected at the CLL/lymphoma clinic.

Three cases of melanoma (14.3%) were detected within the first year of a patient’s CLL diagnosis.

Seven melanomas (33.3%) were detected at pathologic stage 0, 8 (38.1%) at stage I, 2 (9.5%) at stage II, 3 (14.3%) at stage III, and 1 (4.8%) at stage IV. Detailed data were not available for the remaining case.

Melanomas were managed with wide local excision (n=19), sentinel node biopsies (n=6), Mohs surgery (n=1), drugs (n=2), palliative care (n=1), and comfort care (n=1).

The 4 patients who received drugs, palliative care, or comfort care had advanced melanoma.

The patient who received palliative care was still alive at 2.4 years of follow-up. The patient who received comfort care died of metastatic melanoma 1.4 years after diagnosis.

The third patient with advanced melanoma received 2 cycles of dacarbazine and palliative radiation to lung and brain metastases. This patient died 3.6 years after melanoma diagnosis.

The fourth patient received ipilimumab for the melanoma while also receiving ibrutinib to treat her CLL. When the ipilimumab failed, the patient proceeded to pembrolizumab and achieved a near-complete response within 3 months. Then, an intensely hypermetabolic abdominal node was detected and successfully treated with radiation.

The patient continued on pembrolizumab, and her melanoma was in sustained remission at last follow-up, after 23 cycles of pembrolizumab. Her CLL was still responding to ibrutinib at that point as well.

Based on these data, Dr Zent and his colleagues recommend routine melanoma screening for CLL patients. The team believes such surveillance might decrease morbidity and mortality in these patients, although more research is needed to confirm this theory.

Micrograph showing CLL

Patients with chronic lymphocytic leukemia (CLL) should be routinely monitored for melanoma, according to researchers.

A study of 470 CLL patients showed they have a significantly higher risk of invasive melanoma than the general population.

Most of the melanomas reported in this study were detected via routine surveillance, and most were discovered before they reached an advanced stage.

Clive Zent, MD, of Wilmot Cancer Institute at the University of Rochester Medical Center in Rochester, New York, and his colleagues described this study in Leukemia Research.

The researchers analyzed data on 470 CLL patients followed for 2849 person-years. Eighteen of these patients developed 22 melanomas. This included 14 cases of invasive melanoma in 13 patients.

The rate of invasive melanoma was significantly higher in this CLL cohort than the rate observed in the age- and sex-matched general population. The standardized incidence ratio was 6.32.

“We do not for sure know why CLL patients are more susceptible to melanoma, but the most likely cause is a suppressed immune system,” Dr Zent noted.

“Normally, in people with healthy immune systems, malignant skin cells might be detected and destroyed before they become a problem. But in CLL patients, failure of this control system increases the rate at which cancer cells can grow into tumors and also the likelihood that they will become invasive or spread to distant sites.”

Detection and management

Fifteen of the 22 melanomas (68.2%) in the CLL cohort were detected via surveillance in a dermatology clinic, and 2 (9.1%) were detected at the CLL/lymphoma clinic.

Three cases of melanoma (14.3%) were detected within the first year of a patient’s CLL diagnosis.

Seven melanomas (33.3%) were detected at pathologic stage 0, 8 (38.1%) at stage I, 2 (9.5%) at stage II, 3 (14.3%) at stage III, and 1 (4.8%) at stage IV. Detailed data were not available for the remaining case.

Melanomas were managed with wide local excision (n=19), sentinel node biopsies (n=6), Mohs surgery (n=1), drugs (n=2), palliative care (n=1), and comfort care (n=1).

The 4 patients who received drugs, palliative care, or comfort care had advanced melanoma.

The patient who received palliative care was still alive at 2.4 years of follow-up. The patient who received comfort care died of metastatic melanoma 1.4 years after diagnosis.

The third patient with advanced melanoma received 2 cycles of dacarbazine and palliative radiation to lung and brain metastases. This patient died 3.6 years after melanoma diagnosis.

The fourth patient received ipilimumab for the melanoma while also receiving ibrutinib to treat her CLL. When the ipilimumab failed, the patient proceeded to pembrolizumab and achieved a near-complete response within 3 months. Then, an intensely hypermetabolic abdominal node was detected and successfully treated with radiation.

The patient continued on pembrolizumab, and her melanoma was in sustained remission at last follow-up, after 23 cycles of pembrolizumab. Her CLL was still responding to ibrutinib at that point as well.

Based on these data, Dr Zent and his colleagues recommend routine melanoma screening for CLL patients. The team believes such surveillance might decrease morbidity and mortality in these patients, although more research is needed to confirm this theory.

Micrograph showing CLL

Patients with chronic lymphocytic leukemia (CLL) should be routinely monitored for melanoma, according to researchers.

A study of 470 CLL patients showed they have a significantly higher risk of invasive melanoma than the general population.

Most of the melanomas reported in this study were detected via routine surveillance, and most were discovered before they reached an advanced stage.

Clive Zent, MD, of Wilmot Cancer Institute at the University of Rochester Medical Center in Rochester, New York, and his colleagues described this study in Leukemia Research.

The researchers analyzed data on 470 CLL patients followed for 2849 person-years. Eighteen of these patients developed 22 melanomas. This included 14 cases of invasive melanoma in 13 patients.

The rate of invasive melanoma was significantly higher in this CLL cohort than the rate observed in the age- and sex-matched general population. The standardized incidence ratio was 6.32.

“We do not for sure know why CLL patients are more susceptible to melanoma, but the most likely cause is a suppressed immune system,” Dr Zent noted.

“Normally, in people with healthy immune systems, malignant skin cells might be detected and destroyed before they become a problem. But in CLL patients, failure of this control system increases the rate at which cancer cells can grow into tumors and also the likelihood that they will become invasive or spread to distant sites.”

Detection and management

Fifteen of the 22 melanomas (68.2%) in the CLL cohort were detected via surveillance in a dermatology clinic, and 2 (9.1%) were detected at the CLL/lymphoma clinic.

Three cases of melanoma (14.3%) were detected within the first year of a patient’s CLL diagnosis.

Seven melanomas (33.3%) were detected at pathologic stage 0, 8 (38.1%) at stage I, 2 (9.5%) at stage II, 3 (14.3%) at stage III, and 1 (4.8%) at stage IV. Detailed data were not available for the remaining case.

Melanomas were managed with wide local excision (n=19), sentinel node biopsies (n=6), Mohs surgery (n=1), drugs (n=2), palliative care (n=1), and comfort care (n=1).

The 4 patients who received drugs, palliative care, or comfort care had advanced melanoma.

The patient who received palliative care was still alive at 2.4 years of follow-up. The patient who received comfort care died of metastatic melanoma 1.4 years after diagnosis.

The third patient with advanced melanoma received 2 cycles of dacarbazine and palliative radiation to lung and brain metastases. This patient died 3.6 years after melanoma diagnosis.

The fourth patient received ipilimumab for the melanoma while also receiving ibrutinib to treat her CLL. When the ipilimumab failed, the patient proceeded to pembrolizumab and achieved a near-complete response within 3 months. Then, an intensely hypermetabolic abdominal node was detected and successfully treated with radiation.

The patient continued on pembrolizumab, and her melanoma was in sustained remission at last follow-up, after 23 cycles of pembrolizumab. Her CLL was still responding to ibrutinib at that point as well.

Based on these data, Dr Zent and his colleagues recommend routine melanoma screening for CLL patients. The team believes such surveillance might decrease morbidity and mortality in these patients, although more research is needed to confirm this theory.

Clinical question: In patients with infective endocarditis, does a vegetation size greater than 10 mm impart a greater embolic risk?

Background: A vegetation size greater than 10 mm has historically been used as the cutoff for increased risk of embolization in infective endocarditis, and this cutoff forms a key part of the American Heart Association guidelines for early surgical intervention. However, this cutoff is derived primarily from observational data from small studies.

Study design: Meta-analysis of observational studies and randomized clinical trials.

Dr. Winters is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Clinical question: In patients with infective endocarditis, does a vegetation size greater than 10 mm impart a greater embolic risk?

Background: A vegetation size greater than 10 mm has historically been used as the cutoff for increased risk of embolization in infective endocarditis, and this cutoff forms a key part of the American Heart Association guidelines for early surgical intervention. However, this cutoff is derived primarily from observational data from small studies.

Study design: Meta-analysis of observational studies and randomized clinical trials.

Dr. Winters is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Clinical question: In patients with infective endocarditis, does a vegetation size greater than 10 mm impart a greater embolic risk?

Background: A vegetation size greater than 10 mm has historically been used as the cutoff for increased risk of embolization in infective endocarditis, and this cutoff forms a key part of the American Heart Association guidelines for early surgical intervention. However, this cutoff is derived primarily from observational data from small studies.

Study design: Meta-analysis of observational studies and randomized clinical trials.

Dr. Winters is a hospitalist at Beth Israel Deaconess Medical Center, and instructor in medicine, Harvard Medical School, Boston.

Combining the vascular endothelial growth factor (VEGF) receptor–targeting tyrosine kinase inhibitor apatinib with oral etoposide in people with platinum resistant or refractory ovarian cancer has shown promising efficacy and manageable toxicity in a Phase 2 study.

Angiogenesis was a “hallmark” process in cancer, and antiangiogenic therapy, including anti-VEGF antibodies and multireceptor tyrosine kinase inhibitors, has been shown to be an attractive therapeutic strategy for ovarian cancer.

“Increasing evidence suggests that the combination of antiangiogenic therapy and single-agent chemotherapy improves the outcome of platinum-resistant ovarian cancer,” Chun-Yan Lan, MD, of the Collaborative Innovation Center for Cancer Medicine at Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues wrote in Lancet Oncology.

The investigators chose apatinib because it has shown encouraging antitumor activities and tolerable toxicities in several malignant tumors and was available in mainland China, they said.

The single-arm prospective study enrolled 35 women aged 18-70 years with heavily pretreated ovarian cancer that was refractory to platinum (defined as progression during the initial platinum-based treatment) or resistant to platinum (defined as progression within 6 months after the last platinum treatment).

Women were treated with apatinib at an initial dose of 500 mg once daily on a continuous basis and with oral etoposide at a dose of 50 mg once daily on days 1-14 of a 21-day cycle. Oral etoposide was administered for a maximum of six cycles. Dose modifications, including dose interruptions, were allowed in order to manage adverse events.

Treatment was continued until disease progression, patient withdrawal, or unacceptable toxic effects. The primary endpoint of the study was the proportion of patients achieving an objective response according to Response Evaluation Criteria in Solid Tumors (RECIST). The study authors analyzed efficacy data using three populations: intention-to-treat, per-protocol, and safety populations.

Results showed that 19 of 35 patients achieved an objective response (54%; 95% confidence interval, 36.6%-71.2%) in an intention-to-treat analysis. In the per-protocol population, 19 of 31 patients (61%; 95% CI, 42.2%-78.2%) achieved an objective response.

Median progression-free survival was 8.1 months (interquartile range, 4.3-14.6; 95% CI, 2.8-13.4), and the median duration of response was 7.4 months (IQR, 4.0-13.0; 95% CI, 2.3-12.0).

The most common grade 3 or 4 adverse events reported were neutropenia (n = 17), fatigue (n = 11), anemia n = 10), and mucositis (n = 8). Serious adverse events were reported in two patients who were admitted to the hospital.

Dose reductions were required in 82% (n = 28) of 34 patients on apatinib and 77% (n = 26) for etoposide. The authors said they would suggest future studies use a lower starting dose of apatinib and give etoposide for 10 days rather than 14.

“Our study showed that the combination therapy of apatinib with oral etoposide shows promising efficacy and manageable toxicities in patients with platinum-resistant or platinum-refractory recurrent ovarian cancer and further study in phase 3 trials is warranted,” the study authors concluded.

They said that a strength of their study was that both apatinib and oral etoposide were able to be given orally without the need for hospital admission or an infusion pump, factors that could improve adherence and cost effectiveness for patients.

However, they noted that one limitation was that it was a single-arm study with no control group, which meant the selection bias could not be ruled out.

Source: Lan CY et al. Lancet Oncol. 2018 Aug 3. doi: 10.1016/ S1470-2045(18)30349-8.

Combining the vascular endothelial growth factor (VEGF) receptor–targeting tyrosine kinase inhibitor apatinib with oral etoposide in people with platinum resistant or refractory ovarian cancer has shown promising efficacy and manageable toxicity in a Phase 2 study.

Angiogenesis was a “hallmark” process in cancer, and antiangiogenic therapy, including anti-VEGF antibodies and multireceptor tyrosine kinase inhibitors, has been shown to be an attractive therapeutic strategy for ovarian cancer.

“Increasing evidence suggests that the combination of antiangiogenic therapy and single-agent chemotherapy improves the outcome of platinum-resistant ovarian cancer,” Chun-Yan Lan, MD, of the Collaborative Innovation Center for Cancer Medicine at Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues wrote in Lancet Oncology.

The investigators chose apatinib because it has shown encouraging antitumor activities and tolerable toxicities in several malignant tumors and was available in mainland China, they said.

The single-arm prospective study enrolled 35 women aged 18-70 years with heavily pretreated ovarian cancer that was refractory to platinum (defined as progression during the initial platinum-based treatment) or resistant to platinum (defined as progression within 6 months after the last platinum treatment).

Women were treated with apatinib at an initial dose of 500 mg once daily on a continuous basis and with oral etoposide at a dose of 50 mg once daily on days 1-14 of a 21-day cycle. Oral etoposide was administered for a maximum of six cycles. Dose modifications, including dose interruptions, were allowed in order to manage adverse events.

Treatment was continued until disease progression, patient withdrawal, or unacceptable toxic effects. The primary endpoint of the study was the proportion of patients achieving an objective response according to Response Evaluation Criteria in Solid Tumors (RECIST). The study authors analyzed efficacy data using three populations: intention-to-treat, per-protocol, and safety populations.

Results showed that 19 of 35 patients achieved an objective response (54%; 95% confidence interval, 36.6%-71.2%) in an intention-to-treat analysis. In the per-protocol population, 19 of 31 patients (61%; 95% CI, 42.2%-78.2%) achieved an objective response.

Median progression-free survival was 8.1 months (interquartile range, 4.3-14.6; 95% CI, 2.8-13.4), and the median duration of response was 7.4 months (IQR, 4.0-13.0; 95% CI, 2.3-12.0).

The most common grade 3 or 4 adverse events reported were neutropenia (n = 17), fatigue (n = 11), anemia n = 10), and mucositis (n = 8). Serious adverse events were reported in two patients who were admitted to the hospital.

Dose reductions were required in 82% (n = 28) of 34 patients on apatinib and 77% (n = 26) for etoposide. The authors said they would suggest future studies use a lower starting dose of apatinib and give etoposide for 10 days rather than 14.

“Our study showed that the combination therapy of apatinib with oral etoposide shows promising efficacy and manageable toxicities in patients with platinum-resistant or platinum-refractory recurrent ovarian cancer and further study in phase 3 trials is warranted,” the study authors concluded.

They said that a strength of their study was that both apatinib and oral etoposide were able to be given orally without the need for hospital admission or an infusion pump, factors that could improve adherence and cost effectiveness for patients.

However, they noted that one limitation was that it was a single-arm study with no control group, which meant the selection bias could not be ruled out.

Source: Lan CY et al. Lancet Oncol. 2018 Aug 3. doi: 10.1016/ S1470-2045(18)30349-8.

Combining the vascular endothelial growth factor (VEGF) receptor–targeting tyrosine kinase inhibitor apatinib with oral etoposide in people with platinum resistant or refractory ovarian cancer has shown promising efficacy and manageable toxicity in a Phase 2 study.

Angiogenesis was a “hallmark” process in cancer, and antiangiogenic therapy, including anti-VEGF antibodies and multireceptor tyrosine kinase inhibitors, has been shown to be an attractive therapeutic strategy for ovarian cancer.

“Increasing evidence suggests that the combination of antiangiogenic therapy and single-agent chemotherapy improves the outcome of platinum-resistant ovarian cancer,” Chun-Yan Lan, MD, of the Collaborative Innovation Center for Cancer Medicine at Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues wrote in Lancet Oncology.

The investigators chose apatinib because it has shown encouraging antitumor activities and tolerable toxicities in several malignant tumors and was available in mainland China, they said.

The single-arm prospective study enrolled 35 women aged 18-70 years with heavily pretreated ovarian cancer that was refractory to platinum (defined as progression during the initial platinum-based treatment) or resistant to platinum (defined as progression within 6 months after the last platinum treatment).

Women were treated with apatinib at an initial dose of 500 mg once daily on a continuous basis and with oral etoposide at a dose of 50 mg once daily on days 1-14 of a 21-day cycle. Oral etoposide was administered for a maximum of six cycles. Dose modifications, including dose interruptions, were allowed in order to manage adverse events.

Treatment was continued until disease progression, patient withdrawal, or unacceptable toxic effects. The primary endpoint of the study was the proportion of patients achieving an objective response according to Response Evaluation Criteria in Solid Tumors (RECIST). The study authors analyzed efficacy data using three populations: intention-to-treat, per-protocol, and safety populations.

Results showed that 19 of 35 patients achieved an objective response (54%; 95% confidence interval, 36.6%-71.2%) in an intention-to-treat analysis. In the per-protocol population, 19 of 31 patients (61%; 95% CI, 42.2%-78.2%) achieved an objective response.

Median progression-free survival was 8.1 months (interquartile range, 4.3-14.6; 95% CI, 2.8-13.4), and the median duration of response was 7.4 months (IQR, 4.0-13.0; 95% CI, 2.3-12.0).

The most common grade 3 or 4 adverse events reported were neutropenia (n = 17), fatigue (n = 11), anemia n = 10), and mucositis (n = 8). Serious adverse events were reported in two patients who were admitted to the hospital.

Dose reductions were required in 82% (n = 28) of 34 patients on apatinib and 77% (n = 26) for etoposide. The authors said they would suggest future studies use a lower starting dose of apatinib and give etoposide for 10 days rather than 14.

“Our study showed that the combination therapy of apatinib with oral etoposide shows promising efficacy and manageable toxicities in patients with platinum-resistant or platinum-refractory recurrent ovarian cancer and further study in phase 3 trials is warranted,” the study authors concluded.

They said that a strength of their study was that both apatinib and oral etoposide were able to be given orally without the need for hospital admission or an infusion pump, factors that could improve adherence and cost effectiveness for patients.

However, they noted that one limitation was that it was a single-arm study with no control group, which meant the selection bias could not be ruled out.

Source: Lan CY et al. Lancet Oncol. 2018 Aug 3. doi: 10.1016/ S1470-2045(18)30349-8.

NEW ORLEANS – A national practice transformation initiative aimed at increasing laggardly adult immunization rates and reducing health disparities has scored an impressive success in a pilot project carried out in seven rural southwestern Georgia counties.

Bruce Jancin/MDedge News

“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.

The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.

The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.

The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.

“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.

She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.

“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.

Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.

“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.

It wasn’t easy at first, Dr. Ferguson recalled.

“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.

Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.

“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.

A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”

Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.

“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”

She reported having no financial conflicts regarding her presentation or the adult immunization initiative.

bjancin@mdedge.com
 

NEW ORLEANS – A national practice transformation initiative aimed at increasing laggardly adult immunization rates and reducing health disparities has scored an impressive success in a pilot project carried out in seven rural southwestern Georgia counties.

Bruce Jancin/MDedge News

“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.

The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.

The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.

The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.

“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.

She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.

“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.

Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.

“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.

It wasn’t easy at first, Dr. Ferguson recalled.

“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.

Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.

“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.

A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”

Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.

“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”

She reported having no financial conflicts regarding her presentation or the adult immunization initiative.

bjancin@mdedge.com
 

NEW ORLEANS – A national practice transformation initiative aimed at increasing laggardly adult immunization rates and reducing health disparities has scored an impressive success in a pilot project carried out in seven rural southwestern Georgia counties.

Bruce Jancin/MDedge News

“We saw increases of 52%-93% in our pneumococcal vaccination rates in our nine adult medicine clinics,” Frances E. Ferguson, MD, said at the annual meeting of the American College of Physicians.

The project, conducted through the ACP’s quality improvement program, known as Quality Connect, with funding from the Centers for Disease Control and Prevention, has as its ultimate goal making adult immunization standard practice across the country in general internal medicine and primary care. One of the initial pilot projects was conducted at Albany (Ga.) Area Primary Health Care, a federally qualified community health center with 28 service delivery sites in seven mainly rural southwestern Georgia counties. The majority of the center’s patients are at or below the poverty level. The lessons learned from this and other successful local projects will be disseminated nationally, according to Dr. Ferguson, a general internist at the health center.

The project utilizes the ACP Quality Connect “Plan, Do, Study, Act” approach to implementing constructive changes in medical practice, coupled with an abundance of resources readily available from the nonprofit Immunization Action Coalition, which has been funded by the CDC for more than 20 years.

The coalition’s website includes easily downloadable and custom-modifiable standing orders, plain-language information handouts on pneumococcal pneumonia and other vaccine-preventable illnesses and possible vaccine side effects for patients to read in the waiting room before their office visit, concise CDC-standardized talking points for providers to use in convincing patients to get vaccinated, as well as a detailed 10-point action plan for medical practice leadership to make it all happen.

“You don’t have to reinvent the wheel with this. You just go to their website,” Dr. Ferguson explained.

She cited her personal experience as representative of that of her fellow general internists who got on board with the project’s goal. As of April 2016, just before rollout of the pilot project, Dr. Ferguson’s pneumococcal vaccination rate stood at 22.5%. One month into the project, her vaccination rate had zoomed to 60%. When the formal pilot project ended in February 2017, her rate was 88.2%, an absolute 65.7% increase in 10 months. And since the pilot project’s conclusion, adult pneumococcal vaccination rates across Albany Area Primary Health Care have continued to climb.

“We have continued to improve because our champions are still in place, and our standing orders are, too,” she noted.

Standing orders are at the core of the project’s success, according to Dr. Ferguson. They provide nurses with the legal authority to determine if a patient is eligible for a vaccine and to go ahead and give it before seeing the physician.

“The most important thing for me is that nurses are an essential and invaluable asset to your practice, especially when you empower them to function fully within the scope of their practice. They can do amazing things. I just feel like the nurses are the winners here. We are winners because of our nurses,” she said.

It wasn’t easy at first, Dr. Ferguson recalled.

“We had pushback from nurses because they were afraid to do anything without the doctor directly telling them to do it. And we had physicians who didn’t want to have standing orders because they didn’t want anybody to do anything until they told them to. But we managed to get all that straightened out in the first month,” according to the internist.

Other keys to the program’s success included designating champions of the project at every clinic. Often this was the director of nursing, who was appointed to be in charge of the standing orders program. This “champions” concept is detailed in the ACP Quality Connect website. The champion – Dr. Ferguson was one – gets staff buy in on promoting the importance of immunizations, teaches strategies, and engages in community outreach.

“They lead the practice in the quality improvement project. We found that was very important, to have someone at each site who could keep the fire under the staff, keep the project going even when it’s very busy and everybody’s running around. There has to be someone there who’s encouraging people to remember to keep giving immunizations in spite of everything that’s going on that day,” she explained.

A central principle of successful quality improvement programs is accurate performance data gathering and dissemination. “Doctors are very competitive people,” Dr. Ferguson observed. “When I tell you you’re not doing as well as your colleagues and I can show you a graph that shows how far you are lagging behind, you get the fire under you and get moving.”

Audience members were agog at the community health center’s stratospheric vaccination rates. What about all the vaccine skeptics? they asked.

“I think for us it’s a matter of trust,” she replied. “We are a community health center and many of our patients and our providers have been with us for a long time. The nursing staff live in those communities, so the patients know them well. The CDC’s cards with talking points are a big help. I take the time to talk to patients and explain how the vaccine is going to build an army of immunologic protection. There are always going to be the diehards who say, ‘My cousin’s foot fell off when he got the pneumonia vaccine,’ though. You can’t get past those people. There’s just nothing you can say to them that will change their mind.”

She reported having no financial conflicts regarding her presentation or the adult immunization initiative.

bjancin@mdedge.com
 

Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).

Courtesy Health Subcommittee

As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.

The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.

So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.

“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”

Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.

Courtesy Health Subcommittee

The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”

The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.

AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”

The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”

Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.

The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.

The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”

Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”

gtwachtman@mdedge.com

Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).

Courtesy Health Subcommittee

As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.

The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.

So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.

“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”

Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.

Courtesy Health Subcommittee

The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”

The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.

AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”

The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”

Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.

The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.

The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”

Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”

gtwachtman@mdedge.com

Doctors have expressed their displeasure at the lack of response by the Centers for Medicare & Medicaid Services to launch physician-focused advanced alternative payment models (APMs).

Courtesy Health Subcommittee

As part of the MACRA law, Congress created a process by which physicians could seek to implement specialty-specific APMs that they had developed and tested. The purpose was to provide more avenues for specialist participation in the Quality Payment Program’s APM track.

The process goes like this: Doctors create and implement an APM that focuses on providing value-based care in their particular specialty arena. They submit the program and early outcomes to the Physician-Focused Payment Model Technical Advisory Committee or PTAC. The committee reviews the APM and, if it has merit, forwards it to the CMS. The CMS can either approve the APM or ask for additional testing.

So far, PTAC has sent at least 10 APMs to the CMS. To date, not a single one has been approved or even tested on a limited scale.

“Physicians want to be engaged and involved in this process,” David Barbe, MD, immediate past president of the American Medical Association, told members of the House Energy and Commerce Health Subcommittee during a July 26 hearing. “PTAC was created for that very reason. They have received dozens of proposals that come from the ground level. Physicians that are practicing know what will work in their practices and perhaps in their specialty. And yet, none of these have been adopted by CMS or really, we think, given serious consideration.”

Frank Opelka, MD, medical director for quality and health policy at the American College of Surgeons, noted that a proposal they had submitted to PTAC appears to be the one that has gotten furthest along in the process.

Courtesy Health Subcommittee

The model was “accepted in a letter by the Secretary for consideration by the [CMS Innovation Center],” Dr. Opelka testified at the hearing. “The innovation center had a few conference calls with us and one 2-hour in-person meeting on a product that we’d developed that took almost 5 years in the making. There are no resources and no capability in the innovation center to complete a design and then to create an implementation and have a sandbox or pilot area in which to test. The PTAC has done a fantastic job. The Secretary vetted us. I think [ours was] the only one that went from the Secretary and was recommended to the innovation center and it died in there because [the Center] is just not wired to really innovate and we really need to turn that on.”

The CMS issued a letter on June 13 essentially rejecting eight of the models that PTAC recommended. The AMA asked the agency to reconsider at least four of the proposals in a June 21 letter.

AMA leadership does not think that the CMS gave serious consideration to any of the PTAC recommendations, Dr. Barbe said. “These span from very focused proposals in GI medicine to reduce rehospitalization in Crohn’s patients all the way up to the end-stage renal disease that could have very broad effect on improving care and reducing cost for dialysis patients. We think there is great opportunity there if CMS will listen to us.”

The AMA is “especially concerned because the statute to reform Medicare physician payment provided only 6 years of bonus payments to facilitate physicians’ migration to APMs,” according to the group’s letter to the CMS. “We are approaching the 3-year mark for the initial implementation and there is still not a robust APM pathway for physicians.”

Dr. Barbe also expressed concern that physicians’ taste for innovation could wane, given 3 years without successful implementation or testing of a physician-focused APM.

The CMS “seems to be interested in coming up with ideas on their own and I think that’s not only reinventing the wheel potentially, but it is not taking advantage of some very creative and innovated proposals that have come forward,” Dr. Barbe said.

The AMA recognizes “that the APMs recommended by PTAC needed some refinement. Data and pilot test experience likely would help in addressing some of the concerns raised by both PTAC and HHS,” according to the letter. “PTAC has indicated in its recommendations to HHS that it felt the issues it had identified could be resolved with assistance from CMS. Moreover, PTAC concluded that the positive attributes of the APM proposals outweigh the concerns they had identified, but the department does not seem to agree.”

Dr. Opelka, in his written testimony to the subcommittee, suggested that “it may be invaluable to commission a study on these challenges, including CMS’ ability to measure the true quality of care provided by physicians of all specialties, the availability of cost measures that are meaningful and actionable in concert with these quality measures, physicians’ ability to access patient health information when they need it and in a standardized predictable format, and the availability of APMs that grant physicians of all specialties the opportunity to be creative in using their expertise to increase quality and value of care to the patient.”

gtwachtman@mdedge.com

Comedy can be about pushing the limits of topics explored and questioning societal norms. For those comedians bold enough to push hard, the result can be societal pushback. As just one example, consider the arrest of George Carlin by Milwaukee police for allegedly violating public obscenity laws for uttering those seven naughty words not to be said on television (the charge was subsequently dismissed).

David Sedaris is a present-day boundary pusher. His sources of humor have ranged from his early life growing up in a family with five siblings to the challenges of getting older with aging parents, and from American attitudes about race to his own ambivalence about guns.

Pushback against his humor has come from both ends of the political spectrum. “I don’t know which is worse: a far-right audience or a far-left audience. Each of them is a hand around my throat slowly choking the life out of me,” Mr. Sedaris said in an interview with The Economist correspondent Anne McElvoy.

Mr. Sedaris’s take on the oddities of everyday life are side splitting to some, to the tune of millions of book sales and accolades as a giant of humor – and deeply offensive to others.

His career in making people laugh began in art school with monologues on the paintings of fellow students. What has followed is a life of keeping his eyes and ears open, and a notebook at the ready to record the goings-on of daily life.

Often, something bad can happen that can prove to be funny, at least in hindsight, Mr. Sedaris explains. He cites the example of his medical examination for a kidney stone that went sideways, with him ending up in the hospital’s waiting area clad only in his underwear.

“The thought came that someday, this will be funny to me. Today it’s not, but someday it will be,” Mr. Sedaris says.

Such humor seems global. Laughs at his stories may come at different parts, based on the language and cultural interpretations. But the basic premise of the story can hit home in far-flung places.

The path to the humor in his stories can prove perilous. “It’s so hard to talk about race in the United States. ... The audience thinks: ‘Wait a minute, if I laugh at this, does it mean I’m racist?’ You can feel them getting snagged there, so oftentimes I just leave that element out of the story because I want the story to move,” Mr. Sedaris says.

Does that mean humor has a limit that should not be crossed? Not to Mr. Sedaris.

Click here to listen to the interview.

Comedy can be about pushing the limits of topics explored and questioning societal norms. For those comedians bold enough to push hard, the result can be societal pushback. As just one example, consider the arrest of George Carlin by Milwaukee police for allegedly violating public obscenity laws for uttering those seven naughty words not to be said on television (the charge was subsequently dismissed).

David Sedaris is a present-day boundary pusher. His sources of humor have ranged from his early life growing up in a family with five siblings to the challenges of getting older with aging parents, and from American attitudes about race to his own ambivalence about guns.

Pushback against his humor has come from both ends of the political spectrum. “I don’t know which is worse: a far-right audience or a far-left audience. Each of them is a hand around my throat slowly choking the life out of me,” Mr. Sedaris said in an interview with The Economist correspondent Anne McElvoy.

Mr. Sedaris’s take on the oddities of everyday life are side splitting to some, to the tune of millions of book sales and accolades as a giant of humor – and deeply offensive to others.

His career in making people laugh began in art school with monologues on the paintings of fellow students. What has followed is a life of keeping his eyes and ears open, and a notebook at the ready to record the goings-on of daily life.

Often, something bad can happen that can prove to be funny, at least in hindsight, Mr. Sedaris explains. He cites the example of his medical examination for a kidney stone that went sideways, with him ending up in the hospital’s waiting area clad only in his underwear.

“The thought came that someday, this will be funny to me. Today it’s not, but someday it will be,” Mr. Sedaris says.

Such humor seems global. Laughs at his stories may come at different parts, based on the language and cultural interpretations. But the basic premise of the story can hit home in far-flung places.

The path to the humor in his stories can prove perilous. “It’s so hard to talk about race in the United States. ... The audience thinks: ‘Wait a minute, if I laugh at this, does it mean I’m racist?’ You can feel them getting snagged there, so oftentimes I just leave that element out of the story because I want the story to move,” Mr. Sedaris says.

Does that mean humor has a limit that should not be crossed? Not to Mr. Sedaris.

Click here to listen to the interview.

Comedy can be about pushing the limits of topics explored and questioning societal norms. For those comedians bold enough to push hard, the result can be societal pushback. As just one example, consider the arrest of George Carlin by Milwaukee police for allegedly violating public obscenity laws for uttering those seven naughty words not to be said on television (the charge was subsequently dismissed).

David Sedaris is a present-day boundary pusher. His sources of humor have ranged from his early life growing up in a family with five siblings to the challenges of getting older with aging parents, and from American attitudes about race to his own ambivalence about guns.

Pushback against his humor has come from both ends of the political spectrum. “I don’t know which is worse: a far-right audience or a far-left audience. Each of them is a hand around my throat slowly choking the life out of me,” Mr. Sedaris said in an interview with The Economist correspondent Anne McElvoy.

Mr. Sedaris’s take on the oddities of everyday life are side splitting to some, to the tune of millions of book sales and accolades as a giant of humor – and deeply offensive to others.

His career in making people laugh began in art school with monologues on the paintings of fellow students. What has followed is a life of keeping his eyes and ears open, and a notebook at the ready to record the goings-on of daily life.

Often, something bad can happen that can prove to be funny, at least in hindsight, Mr. Sedaris explains. He cites the example of his medical examination for a kidney stone that went sideways, with him ending up in the hospital’s waiting area clad only in his underwear.

“The thought came that someday, this will be funny to me. Today it’s not, but someday it will be,” Mr. Sedaris says.

Such humor seems global. Laughs at his stories may come at different parts, based on the language and cultural interpretations. But the basic premise of the story can hit home in far-flung places.

The path to the humor in his stories can prove perilous. “It’s so hard to talk about race in the United States. ... The audience thinks: ‘Wait a minute, if I laugh at this, does it mean I’m racist?’ You can feel them getting snagged there, so oftentimes I just leave that element out of the story because I want the story to move,” Mr. Sedaris says.

Does that mean humor has a limit that should not be crossed? Not to Mr. Sedaris.

Click here to listen to the interview.

Established criteria for identifying inflammatory back pain in people with ankylosing spondylitis do not perform well in identifying axial involvement in people with psoriatic arthritis and neither does clinical judgment, a study shows.

feellife/Thinkstock

Radiology data from these patients showed that 27 with baseline x-rays fulfilled the New York radiographic criteria for AS, and 45 had radiographic sacroiliitis not satisfying NY criteria (excluding grade 1) and/or syndesmophytes. Nine out of 31 patients with no axial disease on x-ray had evidence of axial disease on MRI. Eighteen out of 54 patients had axial involvement without back pain.

Results showed that agreement (kappa coefficient) between rheumatologist judgment of IBP and IBP criteria in patients with back pain was moderate and was highest for the Calin criteria (0.70; 95% confidence interval, 0.56-0.85), followed by the ASAS criteria (0.61; 95% CI, 0.46-0.76) and the Rudwaleit criteria (0.59; 95% CI, 0.44-0.74).

When x-ray or MRI change was considered “gold standard” for axial involvement for all patients, the specificity was high for rheumatologist judgment of IBP as well as Calin, Rudwaleit, and ASAS criteria, but their sensitivity was low, the researchers reported.

When the investigators compared positive likelihood ratios (LRs) for the presence of back pain, the Rudwaleit criteria (2.17) performed the best in ruling in axial disease, whereas the LRs were 1.75 for Calin and 1.86 for ASAS criteria. Rheumatologist-reported back pain (0.68) performed the best for ruling out axial disease when comparing negative LRs.

“The low positive LRs of the Calin, Rudwaleit, and ASAS criteria as well as that of rheumatologist report of back pain or judgment of IBP for [axial] PsA defined as any axial radiological change found in our study suggests that none of these criteria performed well in detecting axial disease in patients with PsA,” the study authors wrote.

The authors also conducted an exploratory analysis within patients with PsA with back involvement (defined by x-rays or MRI) and compared those with back pain (n = 36) or without (n = 18). The back pain group had a significantly higher Bath Ankylosing Spondylitis Disease Activity Index score (5.72 vs. 4.27), a finding that the authors said they expected because it is a patient-reported measure.

The back pain group also had a lower prevalence of human leukocyte antigen-B*38 (2.78 vs. 27.78), a finding that the authors said was interesting but would need to be replicated in future studies.

The prevalence of HLA-B*27, HLA-B*08, and HLA-C*06 was similar between patients with and without back pain, indicating “that the two groups are largely similar and hence, for the purpose of defining axial disease in PsA, symptoms (back pain) may not be important.”

“The findings of this study suggest that rheumatologist-judged IBP or the criteria for IBP developed for AS may not perform well when ascertaining axial involvement in PsA,” the study authors concluded.

“Moreover, patients with axial radiological changes without back pain were similar to those with back pain. ... In order to stratify patients with poorer prognosis, rheumatologists should consider conducting axial imaging in all patients with PsA regardless of the presence or the nature of back pain,” they added.

The study was funded by the University of Toronto Psoriatic Arthritis Program, which is supported by the Krembil Foundation.

SOURCE: Yap KS et al. Ann Rheum Dis. 2018 Aug 4. doi: 10.1136/annrheumdis-2018-213334.

Established criteria for identifying inflammatory back pain in people with ankylosing spondylitis do not perform well in identifying axial involvement in people with psoriatic arthritis and neither does clinical judgment, a study shows.

feellife/Thinkstock

Radiology data from these patients showed that 27 with baseline x-rays fulfilled the New York radiographic criteria for AS, and 45 had radiographic sacroiliitis not satisfying NY criteria (excluding grade 1) and/or syndesmophytes. Nine out of 31 patients with no axial disease on x-ray had evidence of axial disease on MRI. Eighteen out of 54 patients had axial involvement without back pain.

Results showed that agreement (kappa coefficient) between rheumatologist judgment of IBP and IBP criteria in patients with back pain was moderate and was highest for the Calin criteria (0.70; 95% confidence interval, 0.56-0.85), followed by the ASAS criteria (0.61; 95% CI, 0.46-0.76) and the Rudwaleit criteria (0.59; 95% CI, 0.44-0.74).

When x-ray or MRI change was considered “gold standard” for axial involvement for all patients, the specificity was high for rheumatologist judgment of IBP as well as Calin, Rudwaleit, and ASAS criteria, but their sensitivity was low, the researchers reported.

When the investigators compared positive likelihood ratios (LRs) for the presence of back pain, the Rudwaleit criteria (2.17) performed the best in ruling in axial disease, whereas the LRs were 1.75 for Calin and 1.86 for ASAS criteria. Rheumatologist-reported back pain (0.68) performed the best for ruling out axial disease when comparing negative LRs.

“The low positive LRs of the Calin, Rudwaleit, and ASAS criteria as well as that of rheumatologist report of back pain or judgment of IBP for [axial] PsA defined as any axial radiological change found in our study suggests that none of these criteria performed well in detecting axial disease in patients with PsA,” the study authors wrote.

The authors also conducted an exploratory analysis within patients with PsA with back involvement (defined by x-rays or MRI) and compared those with back pain (n = 36) or without (n = 18). The back pain group had a significantly higher Bath Ankylosing Spondylitis Disease Activity Index score (5.72 vs. 4.27), a finding that the authors said they expected because it is a patient-reported measure.

The back pain group also had a lower prevalence of human leukocyte antigen-B*38 (2.78 vs. 27.78), a finding that the authors said was interesting but would need to be replicated in future studies.

The prevalence of HLA-B*27, HLA-B*08, and HLA-C*06 was similar between patients with and without back pain, indicating “that the two groups are largely similar and hence, for the purpose of defining axial disease in PsA, symptoms (back pain) may not be important.”

“The findings of this study suggest that rheumatologist-judged IBP or the criteria for IBP developed for AS may not perform well when ascertaining axial involvement in PsA,” the study authors concluded.

“Moreover, patients with axial radiological changes without back pain were similar to those with back pain. ... In order to stratify patients with poorer prognosis, rheumatologists should consider conducting axial imaging in all patients with PsA regardless of the presence or the nature of back pain,” they added.

The study was funded by the University of Toronto Psoriatic Arthritis Program, which is supported by the Krembil Foundation.

SOURCE: Yap KS et al. Ann Rheum Dis. 2018 Aug 4. doi: 10.1136/annrheumdis-2018-213334.

Established criteria for identifying inflammatory back pain in people with ankylosing spondylitis do not perform well in identifying axial involvement in people with psoriatic arthritis and neither does clinical judgment, a study shows.

feellife/Thinkstock

Radiology data from these patients showed that 27 with baseline x-rays fulfilled the New York radiographic criteria for AS, and 45 had radiographic sacroiliitis not satisfying NY criteria (excluding grade 1) and/or syndesmophytes. Nine out of 31 patients with no axial disease on x-ray had evidence of axial disease on MRI. Eighteen out of 54 patients had axial involvement without back pain.

Results showed that agreement (kappa coefficient) between rheumatologist judgment of IBP and IBP criteria in patients with back pain was moderate and was highest for the Calin criteria (0.70; 95% confidence interval, 0.56-0.85), followed by the ASAS criteria (0.61; 95% CI, 0.46-0.76) and the Rudwaleit criteria (0.59; 95% CI, 0.44-0.74).

When x-ray or MRI change was considered “gold standard” for axial involvement for all patients, the specificity was high for rheumatologist judgment of IBP as well as Calin, Rudwaleit, and ASAS criteria, but their sensitivity was low, the researchers reported.

When the investigators compared positive likelihood ratios (LRs) for the presence of back pain, the Rudwaleit criteria (2.17) performed the best in ruling in axial disease, whereas the LRs were 1.75 for Calin and 1.86 for ASAS criteria. Rheumatologist-reported back pain (0.68) performed the best for ruling out axial disease when comparing negative LRs.

“The low positive LRs of the Calin, Rudwaleit, and ASAS criteria as well as that of rheumatologist report of back pain or judgment of IBP for [axial] PsA defined as any axial radiological change found in our study suggests that none of these criteria performed well in detecting axial disease in patients with PsA,” the study authors wrote.

The authors also conducted an exploratory analysis within patients with PsA with back involvement (defined by x-rays or MRI) and compared those with back pain (n = 36) or without (n = 18). The back pain group had a significantly higher Bath Ankylosing Spondylitis Disease Activity Index score (5.72 vs. 4.27), a finding that the authors said they expected because it is a patient-reported measure.

The back pain group also had a lower prevalence of human leukocyte antigen-B*38 (2.78 vs. 27.78), a finding that the authors said was interesting but would need to be replicated in future studies.

The prevalence of HLA-B*27, HLA-B*08, and HLA-C*06 was similar between patients with and without back pain, indicating “that the two groups are largely similar and hence, for the purpose of defining axial disease in PsA, symptoms (back pain) may not be important.”

“The findings of this study suggest that rheumatologist-judged IBP or the criteria for IBP developed for AS may not perform well when ascertaining axial involvement in PsA,” the study authors concluded.

“Moreover, patients with axial radiological changes without back pain were similar to those with back pain. ... In order to stratify patients with poorer prognosis, rheumatologists should consider conducting axial imaging in all patients with PsA regardless of the presence or the nature of back pain,” they added.

The study was funded by the University of Toronto Psoriatic Arthritis Program, which is supported by the Krembil Foundation.

SOURCE: Yap KS et al. Ann Rheum Dis. 2018 Aug 4. doi: 10.1136/annrheumdis-2018-213334.

Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.

Courtesy Janssen Biotech

The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.

The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.

Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.

Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.

cpalmer@mdedge.com

Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.

Courtesy Janssen Biotech

The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.

The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.

Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.

Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.

cpalmer@mdedge.com

Janssen has applied to the Food and Drug Administration and the European Medicines Agency to allow splitting of the first infusion of daratumumab (Darzalex) in multiple myeloma patients over 2 consecutive days.

Courtesy Janssen Biotech

The goal is to improve the treatment experience for patients and physicians, according to the announcement from Janssen.

The regulatory submissions are based on the global, multi-arm, phase 1b MMY1001 study (NCT01998971). The study evaluated daratumumab in combination with various other treatments in 240 patients with multiple myeloma. It found that both the safety profile and the pharmacokinetics concentrations seen with either single dosing or split dosing were similar.

Daratumumab is the first approved monoclonal antibody that targets CD38, which is expressed across multiple myeloma cells regardless of disease stage. Daratumumab is currently approved for treatment of multiple myeloma in both the United States and the European Union either as monotherapy or in conjunction with other treatments.

Daratumumab is known to sometimes cause severe/serious infusion reactions, such as anaphylactic reactions; interfere with serological testing; and cause neutropenia or thrombocytopenia.

cpalmer@mdedge.com