Study Overview

Objective. To determine if there is an additive benefit of weight loss for pain and functioning in patients with established symptomatic osteoarthritis (OA) of the knee.

Design. Cohort study.

Setting and participants. Participants living in Australia who had completed the Osteoarthritis Healthy Weight For Life program (OAHWFL), a program run by Prima Health Solutions on behalf of participating health funds in Australia and New Zealand; its full cost is borne by the insurance/health care fund. Patients in the program are invited to enroll based on age (≥ 50) and claims data indicating knee OA; patients wishing to enroll must obtain a referral from their doctor confirming weight and height and radiographic or arthroscopic diagnosis of knee OA. Participants in the program had a body mass index (BMI) > 28 kg/m² and met 1986 American College of Rheumatology clinical criteria for knee OA. Further, participants were deemed to clinically require referral to orthopedic surgeon and were surgical candidates by medical opinion.

Intervention. The OAHWFL program is a specialized knee and hip OA management program that focuses on weight loss, utilizing a portion-controlled eating plan with meal replacements, an activity plan, a personalized online tracker, and personal support. It is delivered remotely via phone, texts, email, message board, and mail. The 18-week program consists of 3 phases. During the first 6-week phase, participants were instructed to consume a nutritionally complete very low calorie meal replacement (KicStart, Prima Health Solutions) for 2 meals per day with controlled portions and “free foods” (eg, berries and leafy greens). During the second 6-week phase, participants were transitioned off the meal replacements onto a portion-controlled meal plan, with 1 meal replacement per day. In the final phase, participants consumed portion-controlled whole foods for all 3 meals. All phases included recommendations for moderate aerobic exercise 3 times per week for an increasing time period and intensity, online healthy eating and lifestyle education, and telephone motivation and support at predetermined intervals and on demand.

Main outcome measure. The main outcome measure was percentage of body weight lost from baseline to 18 weeks. Additionally, the validated Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire was administered to all participants. The 5 KOOS subscales (pain, other symptoms, function in daily living, function in recreation, and knee-related quality of life) were co-primary outcomes. The validated Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) function score was derived from KOOS. The dose-response relationship was assessed using weight change categories (< 2.5%, 2.5–5.0%, 5.1–7.5%, 7.6%–10%, and > 10%) and change in KOOS scores.

Main results. At the time of analysis, 3827 persons with knee or hip OA were approved by their doctor to participate. Of these 155 had not yet started the program, 728 were undergoing the program, and 846 had discontinued or were lost to follow-up. Of the 2098 who completed the program, 715 were excluded because of incomplete data or OA of the hip, leaving 1383 participants. Overall the baseline mean weight was 95.12 ± 17.2 kg with a mean BMI of 34.39 ± 5.17. Average age was 64 ± 8.7.

94.2% (1304 participants) had a greater than 2.5% reduction in body weight at the end of 18 weeks. 31.1% lost ≥ 10% body weight, 22.9% lost between 7.5 and 10%, 24% lost between 5 and 7.5%, 16.1% lost between 2.5–5%, and 5.7% of participants lost ≤ 2.5%. The greatest amount of weight loss was associated with the greatest improvement of both KOOS and WOMAC scores, with a significant dose-response relationship between weight loss and knee OA symptoms. This persisted in regression analysis adjusted for baseline KOOS and weight, sex, and age. Those with the largest weight loss improved their KOOS scores by 16.17 ± 16.1. The second highest weight loss group has an improvement in KOOS scores by 13.3 ± 15.1, then next highest 12.0 ± 17.1, followed by 9.9 ± 16.8 and finally an improvement of 6.1 ± 13.0 in the weight loss of ≤ 2.5% cohort.

Conclusion. This study showed a relationship between weight loss and improvement in knee OA pain and functioning, with greater weight loss resulting in greater improvement in both categories. Those who were better functioning at the commencement of the study required less weight loss to reach a meaningful improvement in functioning and pain compared to those who started with worse functional status. The OAHWFL intervention was shown to be an effective method of weight loss over an 18-month period.

Commentary

OA is the most common form of arthritis in the United States and the incidence has been rising. A recent study conducted by the Mayo Clinic found OA to be the second most common reason for ambulatory primary care visits, second only to dermatologic complaints [1].It is estimated that the average direct cost of OA per patient is $2600 per year [2], with job-related costs of $3.4 to $13.2 billion per year [3]. Knee replacements alone amounted to $28.5 billion in 2009 [4]. Aside from the financial burden of OA is its impact on quality of life. While genetic predisposition is important in disease pathogenesis, there are well established modifiable risk factors for OA. Among these is maintenance of a healthy weight and physical activity, both of which were addressed in this study.

There is high-quality evidence that weight loss improves the symptoms of knee OA [5]. The current study evaluated whether a dietary intervention for knee OA would be effective in a real-world setting, outside the controlled conditions of a randomized trial. Short-term weight loss did provide pain relief and increase functioning; however, the study does not report weight trajectory after cessation of the intervention. It would be more meaningful to know how many of the participants maintained weight loss after a longer period of time. In addition, it is unclear if the gain in function and pain control was from the weight loss or regular physical activity. A control group that participated in the physical activity without significant weight loss would have strengthened the association between weight loss and KOOS and WOMAC measures.

Though this study took place in a community setting and was tested in both rural and urban settings, the results may not be generalizable to patients who are not already motivated to lose weight, as patients self-nominated themselves to enroll in the program. This study also made use of meal supplements, which were supplied at no cost to patients. Without dedicated funding to supply the meal replacements in addition to the support program, it would be difficult to replicate these results. However, some insurance carriers will cover similar programs that provide validated methods for weight loss, which may be a feasible alternative. Other limitations to the study included lack of a control group, reliance on self-reported weight loss data, and that persons who discontinued the program were not included in the analysis.

Applications for Clinical Practice

Body mechanics and increased inflammation associated with obesity both contribute to worsening of knee OA. The dose-response relationship shown in this study of weight loss in overweight or obese people with OA of the knee is encouraging. Previous studies have shown a clear relationship between weight loss and improvement in pain. The most well-known is perhaps the 4-pound weight rule, which states that for every pound of weight lost, there is a 4-pound reduction in the load exerted on the knee for each step taken [5].Concrete examples of the benefits of weight loss that providers can share with their patients makes discussion about weight loss tangible. Further, the study teased out that those with better physical functioning at the start of the study required less weight loss to achieve gains in pain reduction and functional status. As the hazards of obesity continue to come to light, more community-based weight loss programs are becoming available. Most of the participants in this study successfully lost weight using a community-based approach, highlighting the usefulness of these programs. Weight loss in a community setting is a challenge to all providers. Knowing which patients will benefit the most from a weight loss program can help direct providers to personalized recommendations.

—Christina Downey, MD,
Geisinger Medical Center, Danville, PA.

Study Overview

Objective. To determine if there is an additive benefit of weight loss for pain and functioning in patients with established symptomatic osteoarthritis (OA) of the knee.

Design. Cohort study.

Setting and participants. Participants living in Australia who had completed the Osteoarthritis Healthy Weight For Life program (OAHWFL), a program run by Prima Health Solutions on behalf of participating health funds in Australia and New Zealand; its full cost is borne by the insurance/health care fund. Patients in the program are invited to enroll based on age (≥ 50) and claims data indicating knee OA; patients wishing to enroll must obtain a referral from their doctor confirming weight and height and radiographic or arthroscopic diagnosis of knee OA. Participants in the program had a body mass index (BMI) > 28 kg/m² and met 1986 American College of Rheumatology clinical criteria for knee OA. Further, participants were deemed to clinically require referral to orthopedic surgeon and were surgical candidates by medical opinion.

Intervention. The OAHWFL program is a specialized knee and hip OA management program that focuses on weight loss, utilizing a portion-controlled eating plan with meal replacements, an activity plan, a personalized online tracker, and personal support. It is delivered remotely via phone, texts, email, message board, and mail. The 18-week program consists of 3 phases. During the first 6-week phase, participants were instructed to consume a nutritionally complete very low calorie meal replacement (KicStart, Prima Health Solutions) for 2 meals per day with controlled portions and “free foods” (eg, berries and leafy greens). During the second 6-week phase, participants were transitioned off the meal replacements onto a portion-controlled meal plan, with 1 meal replacement per day. In the final phase, participants consumed portion-controlled whole foods for all 3 meals. All phases included recommendations for moderate aerobic exercise 3 times per week for an increasing time period and intensity, online healthy eating and lifestyle education, and telephone motivation and support at predetermined intervals and on demand.

Main outcome measure. The main outcome measure was percentage of body weight lost from baseline to 18 weeks. Additionally, the validated Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire was administered to all participants. The 5 KOOS subscales (pain, other symptoms, function in daily living, function in recreation, and knee-related quality of life) were co-primary outcomes. The validated Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) function score was derived from KOOS. The dose-response relationship was assessed using weight change categories (< 2.5%, 2.5–5.0%, 5.1–7.5%, 7.6%–10%, and > 10%) and change in KOOS scores.

Main results. At the time of analysis, 3827 persons with knee or hip OA were approved by their doctor to participate. Of these 155 had not yet started the program, 728 were undergoing the program, and 846 had discontinued or were lost to follow-up. Of the 2098 who completed the program, 715 were excluded because of incomplete data or OA of the hip, leaving 1383 participants. Overall the baseline mean weight was 95.12 ± 17.2 kg with a mean BMI of 34.39 ± 5.17. Average age was 64 ± 8.7.

94.2% (1304 participants) had a greater than 2.5% reduction in body weight at the end of 18 weeks. 31.1% lost ≥ 10% body weight, 22.9% lost between 7.5 and 10%, 24% lost between 5 and 7.5%, 16.1% lost between 2.5–5%, and 5.7% of participants lost ≤ 2.5%. The greatest amount of weight loss was associated with the greatest improvement of both KOOS and WOMAC scores, with a significant dose-response relationship between weight loss and knee OA symptoms. This persisted in regression analysis adjusted for baseline KOOS and weight, sex, and age. Those with the largest weight loss improved their KOOS scores by 16.17 ± 16.1. The second highest weight loss group has an improvement in KOOS scores by 13.3 ± 15.1, then next highest 12.0 ± 17.1, followed by 9.9 ± 16.8 and finally an improvement of 6.1 ± 13.0 in the weight loss of ≤ 2.5% cohort.

Conclusion. This study showed a relationship between weight loss and improvement in knee OA pain and functioning, with greater weight loss resulting in greater improvement in both categories. Those who were better functioning at the commencement of the study required less weight loss to reach a meaningful improvement in functioning and pain compared to those who started with worse functional status. The OAHWFL intervention was shown to be an effective method of weight loss over an 18-month period.

Commentary

OA is the most common form of arthritis in the United States and the incidence has been rising. A recent study conducted by the Mayo Clinic found OA to be the second most common reason for ambulatory primary care visits, second only to dermatologic complaints [1].It is estimated that the average direct cost of OA per patient is $2600 per year [2], with job-related costs of $3.4 to $13.2 billion per year [3]. Knee replacements alone amounted to $28.5 billion in 2009 [4]. Aside from the financial burden of OA is its impact on quality of life. While genetic predisposition is important in disease pathogenesis, there are well established modifiable risk factors for OA. Among these is maintenance of a healthy weight and physical activity, both of which were addressed in this study.

There is high-quality evidence that weight loss improves the symptoms of knee OA [5]. The current study evaluated whether a dietary intervention for knee OA would be effective in a real-world setting, outside the controlled conditions of a randomized trial. Short-term weight loss did provide pain relief and increase functioning; however, the study does not report weight trajectory after cessation of the intervention. It would be more meaningful to know how many of the participants maintained weight loss after a longer period of time. In addition, it is unclear if the gain in function and pain control was from the weight loss or regular physical activity. A control group that participated in the physical activity without significant weight loss would have strengthened the association between weight loss and KOOS and WOMAC measures.

Though this study took place in a community setting and was tested in both rural and urban settings, the results may not be generalizable to patients who are not already motivated to lose weight, as patients self-nominated themselves to enroll in the program. This study also made use of meal supplements, which were supplied at no cost to patients. Without dedicated funding to supply the meal replacements in addition to the support program, it would be difficult to replicate these results. However, some insurance carriers will cover similar programs that provide validated methods for weight loss, which may be a feasible alternative. Other limitations to the study included lack of a control group, reliance on self-reported weight loss data, and that persons who discontinued the program were not included in the analysis.

Applications for Clinical Practice

Body mechanics and increased inflammation associated with obesity both contribute to worsening of knee OA. The dose-response relationship shown in this study of weight loss in overweight or obese people with OA of the knee is encouraging. Previous studies have shown a clear relationship between weight loss and improvement in pain. The most well-known is perhaps the 4-pound weight rule, which states that for every pound of weight lost, there is a 4-pound reduction in the load exerted on the knee for each step taken [5].Concrete examples of the benefits of weight loss that providers can share with their patients makes discussion about weight loss tangible. Further, the study teased out that those with better physical functioning at the start of the study required less weight loss to achieve gains in pain reduction and functional status. As the hazards of obesity continue to come to light, more community-based weight loss programs are becoming available. Most of the participants in this study successfully lost weight using a community-based approach, highlighting the usefulness of these programs. Weight loss in a community setting is a challenge to all providers. Knowing which patients will benefit the most from a weight loss program can help direct providers to personalized recommendations.

—Christina Downey, MD,
Geisinger Medical Center, Danville, PA.

Study Overview

Objective. To determine if there is an additive benefit of weight loss for pain and functioning in patients with established symptomatic osteoarthritis (OA) of the knee.

Design. Cohort study.

Setting and participants. Participants living in Australia who had completed the Osteoarthritis Healthy Weight For Life program (OAHWFL), a program run by Prima Health Solutions on behalf of participating health funds in Australia and New Zealand; its full cost is borne by the insurance/health care fund. Patients in the program are invited to enroll based on age (≥ 50) and claims data indicating knee OA; patients wishing to enroll must obtain a referral from their doctor confirming weight and height and radiographic or arthroscopic diagnosis of knee OA. Participants in the program had a body mass index (BMI) > 28 kg/m² and met 1986 American College of Rheumatology clinical criteria for knee OA. Further, participants were deemed to clinically require referral to orthopedic surgeon and were surgical candidates by medical opinion.

Intervention. The OAHWFL program is a specialized knee and hip OA management program that focuses on weight loss, utilizing a portion-controlled eating plan with meal replacements, an activity plan, a personalized online tracker, and personal support. It is delivered remotely via phone, texts, email, message board, and mail. The 18-week program consists of 3 phases. During the first 6-week phase, participants were instructed to consume a nutritionally complete very low calorie meal replacement (KicStart, Prima Health Solutions) for 2 meals per day with controlled portions and “free foods” (eg, berries and leafy greens). During the second 6-week phase, participants were transitioned off the meal replacements onto a portion-controlled meal plan, with 1 meal replacement per day. In the final phase, participants consumed portion-controlled whole foods for all 3 meals. All phases included recommendations for moderate aerobic exercise 3 times per week for an increasing time period and intensity, online healthy eating and lifestyle education, and telephone motivation and support at predetermined intervals and on demand.

Main outcome measure. The main outcome measure was percentage of body weight lost from baseline to 18 weeks. Additionally, the validated Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire was administered to all participants. The 5 KOOS subscales (pain, other symptoms, function in daily living, function in recreation, and knee-related quality of life) were co-primary outcomes. The validated Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) function score was derived from KOOS. The dose-response relationship was assessed using weight change categories (< 2.5%, 2.5–5.0%, 5.1–7.5%, 7.6%–10%, and > 10%) and change in KOOS scores.

Main results. At the time of analysis, 3827 persons with knee or hip OA were approved by their doctor to participate. Of these 155 had not yet started the program, 728 were undergoing the program, and 846 had discontinued or were lost to follow-up. Of the 2098 who completed the program, 715 were excluded because of incomplete data or OA of the hip, leaving 1383 participants. Overall the baseline mean weight was 95.12 ± 17.2 kg with a mean BMI of 34.39 ± 5.17. Average age was 64 ± 8.7.

94.2% (1304 participants) had a greater than 2.5% reduction in body weight at the end of 18 weeks. 31.1% lost ≥ 10% body weight, 22.9% lost between 7.5 and 10%, 24% lost between 5 and 7.5%, 16.1% lost between 2.5–5%, and 5.7% of participants lost ≤ 2.5%. The greatest amount of weight loss was associated with the greatest improvement of both KOOS and WOMAC scores, with a significant dose-response relationship between weight loss and knee OA symptoms. This persisted in regression analysis adjusted for baseline KOOS and weight, sex, and age. Those with the largest weight loss improved their KOOS scores by 16.17 ± 16.1. The second highest weight loss group has an improvement in KOOS scores by 13.3 ± 15.1, then next highest 12.0 ± 17.1, followed by 9.9 ± 16.8 and finally an improvement of 6.1 ± 13.0 in the weight loss of ≤ 2.5% cohort.

Conclusion. This study showed a relationship between weight loss and improvement in knee OA pain and functioning, with greater weight loss resulting in greater improvement in both categories. Those who were better functioning at the commencement of the study required less weight loss to reach a meaningful improvement in functioning and pain compared to those who started with worse functional status. The OAHWFL intervention was shown to be an effective method of weight loss over an 18-month period.

Commentary

OA is the most common form of arthritis in the United States and the incidence has been rising. A recent study conducted by the Mayo Clinic found OA to be the second most common reason for ambulatory primary care visits, second only to dermatologic complaints [1].It is estimated that the average direct cost of OA per patient is $2600 per year [2], with job-related costs of $3.4 to $13.2 billion per year [3]. Knee replacements alone amounted to $28.5 billion in 2009 [4]. Aside from the financial burden of OA is its impact on quality of life. While genetic predisposition is important in disease pathogenesis, there are well established modifiable risk factors for OA. Among these is maintenance of a healthy weight and physical activity, both of which were addressed in this study.

There is high-quality evidence that weight loss improves the symptoms of knee OA [5]. The current study evaluated whether a dietary intervention for knee OA would be effective in a real-world setting, outside the controlled conditions of a randomized trial. Short-term weight loss did provide pain relief and increase functioning; however, the study does not report weight trajectory after cessation of the intervention. It would be more meaningful to know how many of the participants maintained weight loss after a longer period of time. In addition, it is unclear if the gain in function and pain control was from the weight loss or regular physical activity. A control group that participated in the physical activity without significant weight loss would have strengthened the association between weight loss and KOOS and WOMAC measures.

Though this study took place in a community setting and was tested in both rural and urban settings, the results may not be generalizable to patients who are not already motivated to lose weight, as patients self-nominated themselves to enroll in the program. This study also made use of meal supplements, which were supplied at no cost to patients. Without dedicated funding to supply the meal replacements in addition to the support program, it would be difficult to replicate these results. However, some insurance carriers will cover similar programs that provide validated methods for weight loss, which may be a feasible alternative. Other limitations to the study included lack of a control group, reliance on self-reported weight loss data, and that persons who discontinued the program were not included in the analysis.

Applications for Clinical Practice

Body mechanics and increased inflammation associated with obesity both contribute to worsening of knee OA. The dose-response relationship shown in this study of weight loss in overweight or obese people with OA of the knee is encouraging. Previous studies have shown a clear relationship between weight loss and improvement in pain. The most well-known is perhaps the 4-pound weight rule, which states that for every pound of weight lost, there is a 4-pound reduction in the load exerted on the knee for each step taken [5].Concrete examples of the benefits of weight loss that providers can share with their patients makes discussion about weight loss tangible. Further, the study teased out that those with better physical functioning at the start of the study required less weight loss to achieve gains in pain reduction and functional status. As the hazards of obesity continue to come to light, more community-based weight loss programs are becoming available. Most of the participants in this study successfully lost weight using a community-based approach, highlighting the usefulness of these programs. Weight loss in a community setting is a challenge to all providers. Knowing which patients will benefit the most from a weight loss program can help direct providers to personalized recommendations.

—Christina Downey, MD,
Geisinger Medical Center, Danville, PA.

Start earning free CME credits today at www.shmconsults.com.

Start earning free CME credits today at www.shmconsults.com.

Start earning free CME credits today at www.shmconsults.com.

Appropriate Use of Targeted Oral Anticoagulants to Prevent Stroke in Patients with Nonvalvular Atrial Fibrillation

This activity includes thorough discussions on initial management of patients with nonvalvular atrial fibrillation (NVAF), appropriate situations for oral anticoagulation in the presence of NVAF, appropriate choice of oral anticoagulant, reversal of oral anticoagulation, and guidelines for oral anticoagulation and stroke prevention in NVAF patients and special-population NVAF patients.

Four modules addressing various aspects of anticoagulation/thrombosis have been updated and include:

• Target-Specific Oral Anticoagulants for Stroke Prophylaxis in Patients with NVAF
• Management of Postoperative Atrial Fibrillation
• Perioperative Bridging of Anticoagulant Therapy
• Perioperative Management of Anticoagulation

Appropriate Use of Targeted Oral Anticoagulants to Prevent Stroke in Patients with Nonvalvular Atrial Fibrillation

This activity includes thorough discussions on initial management of patients with nonvalvular atrial fibrillation (NVAF), appropriate situations for oral anticoagulation in the presence of NVAF, appropriate choice of oral anticoagulant, reversal of oral anticoagulation, and guidelines for oral anticoagulation and stroke prevention in NVAF patients and special-population NVAF patients.

Four modules addressing various aspects of anticoagulation/thrombosis have been updated and include:

• Target-Specific Oral Anticoagulants for Stroke Prophylaxis in Patients with NVAF
• Management of Postoperative Atrial Fibrillation
• Perioperative Bridging of Anticoagulant Therapy
• Perioperative Management of Anticoagulation

Appropriate Use of Targeted Oral Anticoagulants to Prevent Stroke in Patients with Nonvalvular Atrial Fibrillation

This activity includes thorough discussions on initial management of patients with nonvalvular atrial fibrillation (NVAF), appropriate situations for oral anticoagulation in the presence of NVAF, appropriate choice of oral anticoagulant, reversal of oral anticoagulation, and guidelines for oral anticoagulation and stroke prevention in NVAF patients and special-population NVAF patients.

Four modules addressing various aspects of anticoagulation/thrombosis have been updated and include:

• Target-Specific Oral Anticoagulants for Stroke Prophylaxis in Patients with NVAF
• Management of Postoperative Atrial Fibrillation
• Perioperative Bridging of Anticoagulant Therapy
• Perioperative Management of Anticoagulation

Finger prick

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Xprecia Stride Coagulation Analyzer from Siemens Healthcare Diagnostics.

This hand-held, portable coagulation analyzer is designed to deliver prothrombin time/international normalized ratio (PT/INR) testing for point-of-care (POC) monitoring and management of oral anticoagulation therapy with the vitamin K antagonist warfarin.

The Xprecia Stride Coagulation Analyzer is the first POC PT/INR device cleared by the FDA based on the new rules published in March 2016.

The analyzer uses fresh capillary whole blood, and results are expressed as INR. The Xprecia Stride Coagulation Analyzer utilizes the same Dade® Innovin® reagent used by Siemens Healthineers central lab analyzers to minimize any potential for variability.

Research has shown the performance of the Xprecia Stride Coagulation Analyzer to be equivalent to a reference laboratory hemostasis system,* with results available within minutes.

According to Siemens, the Xprecia Stride Coagulation Analyzer includes a number of innovations and features not found on most other POC analyzers.

The Xprecia Stride Coagulation Analyzer has a touchscreen interface with step-by-step instructions that help guide the user.

To further enhance usability, the analyzer features simple icons and animation in a color display more commonly found in mobile devices than medical instruments.

The Xprecia Stride Coagulation Analyzer is no bigger than a smartphone and weighs just 10.5 oz, so it can be held at virtually any angle and brought directly to the patient’s finger for blood sample collection.

The analyzer has an integrated barcode scanner intended to simplify data capture and improve patient workflow. The scanner offers patient and operator ID entry.

The Xprecia Stride Coagulation Analyzer has an operator lockout feature that restricts the analyzer’s use to trained staff only.

And the analyzer includes a first-of-its kind test strip eject button that allows the user to eject a used test strip and easily dispose of it without touching it, minimizing potential biohazard exposure.

For more information on the Xprecia Stride Coagulation Analyzer, visit www.siemens.com/xprecia.

*White Paper, Fernando R, Jacobson AK, Kennedy S, Lessard C, Olson K, Scribner A, “PT/INR Test Performance of the Xprecia Stride Coagulation Analyzer Demonstrates Equivalency with Established Laboratory Hemostasis and Point-of-care Methods.”

Finger prick

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Xprecia Stride Coagulation Analyzer from Siemens Healthcare Diagnostics.

This hand-held, portable coagulation analyzer is designed to deliver prothrombin time/international normalized ratio (PT/INR) testing for point-of-care (POC) monitoring and management of oral anticoagulation therapy with the vitamin K antagonist warfarin.

The Xprecia Stride Coagulation Analyzer is the first POC PT/INR device cleared by the FDA based on the new rules published in March 2016.

The analyzer uses fresh capillary whole blood, and results are expressed as INR. The Xprecia Stride Coagulation Analyzer utilizes the same Dade® Innovin® reagent used by Siemens Healthineers central lab analyzers to minimize any potential for variability.

Research has shown the performance of the Xprecia Stride Coagulation Analyzer to be equivalent to a reference laboratory hemostasis system,* with results available within minutes.

According to Siemens, the Xprecia Stride Coagulation Analyzer includes a number of innovations and features not found on most other POC analyzers.

The Xprecia Stride Coagulation Analyzer has a touchscreen interface with step-by-step instructions that help guide the user.

To further enhance usability, the analyzer features simple icons and animation in a color display more commonly found in mobile devices than medical instruments.

The Xprecia Stride Coagulation Analyzer is no bigger than a smartphone and weighs just 10.5 oz, so it can be held at virtually any angle and brought directly to the patient’s finger for blood sample collection.

The analyzer has an integrated barcode scanner intended to simplify data capture and improve patient workflow. The scanner offers patient and operator ID entry.

The Xprecia Stride Coagulation Analyzer has an operator lockout feature that restricts the analyzer’s use to trained staff only.

And the analyzer includes a first-of-its kind test strip eject button that allows the user to eject a used test strip and easily dispose of it without touching it, minimizing potential biohazard exposure.

For more information on the Xprecia Stride Coagulation Analyzer, visit www.siemens.com/xprecia.

*White Paper, Fernando R, Jacobson AK, Kennedy S, Lessard C, Olson K, Scribner A, “PT/INR Test Performance of the Xprecia Stride Coagulation Analyzer Demonstrates Equivalency with Established Laboratory Hemostasis and Point-of-care Methods.”

Finger prick

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Xprecia Stride Coagulation Analyzer from Siemens Healthcare Diagnostics.

This hand-held, portable coagulation analyzer is designed to deliver prothrombin time/international normalized ratio (PT/INR) testing for point-of-care (POC) monitoring and management of oral anticoagulation therapy with the vitamin K antagonist warfarin.

The Xprecia Stride Coagulation Analyzer is the first POC PT/INR device cleared by the FDA based on the new rules published in March 2016.

The analyzer uses fresh capillary whole blood, and results are expressed as INR. The Xprecia Stride Coagulation Analyzer utilizes the same Dade® Innovin® reagent used by Siemens Healthineers central lab analyzers to minimize any potential for variability.

Research has shown the performance of the Xprecia Stride Coagulation Analyzer to be equivalent to a reference laboratory hemostasis system,* with results available within minutes.

According to Siemens, the Xprecia Stride Coagulation Analyzer includes a number of innovations and features not found on most other POC analyzers.

The Xprecia Stride Coagulation Analyzer has a touchscreen interface with step-by-step instructions that help guide the user.

To further enhance usability, the analyzer features simple icons and animation in a color display more commonly found in mobile devices than medical instruments.

The Xprecia Stride Coagulation Analyzer is no bigger than a smartphone and weighs just 10.5 oz, so it can be held at virtually any angle and brought directly to the patient’s finger for blood sample collection.

The analyzer has an integrated barcode scanner intended to simplify data capture and improve patient workflow. The scanner offers patient and operator ID entry.

The Xprecia Stride Coagulation Analyzer has an operator lockout feature that restricts the analyzer’s use to trained staff only.

And the analyzer includes a first-of-its kind test strip eject button that allows the user to eject a used test strip and easily dispose of it without touching it, minimizing potential biohazard exposure.

For more information on the Xprecia Stride Coagulation Analyzer, visit www.siemens.com/xprecia.

*White Paper, Fernando R, Jacobson AK, Kennedy S, Lessard C, Olson K, Scribner A, “PT/INR Test Performance of the Xprecia Stride Coagulation Analyzer Demonstrates Equivalency with Established Laboratory Hemostasis and Point-of-care Methods.”

The diagnosis

Gastrografin swallow (Figure C) demonstrated rupture of the distal esophagus, with leakage of gastrografin into the mediastinum (arrow). Upper gastrointestinal endoscopy confirmed rupture of the left posterolateral wall of the distal esophagus consistent with Boerhaave’s syndrome (Figure D), and a self-expanding covered metal stent was placed.

Broad-spectrum antibiotics and nasogastric feeding were commenced, and the left pleural effusion drained with a tube thoracostomy. Unfortunately, despite initial improvement, the patient subsequently deteriorated and died 30 days after admission.

Boerhaave’s is a rare clinical entity defined as spontaneous esophageal rupture, excluding perforations resulting from foreign bodies or iatrogenic instrumentation.

Mackler’s triad of vomiting, lower chest pain, and subcutaneous emphysema is the classical presentation but is seen in only a minority of cases; thus, diagnostic errors are common.² Importantly, the chest radiograph is almost always abnormal, with pleural effusions or pneumomediastinum often seen.³ Surgical repair is the definitive treatment, but in patients considered unfit for surgery, conservative or endoscopic management is advocated. Mortality remains greater than 30%, and rises sharply if diagnosis is delayed^,2 emphasizing the importance of awareness of this unusual diagnosis.

References

1. Lucendo, A.J., Fringal-Ruiz, A.B., Rodriguez, B. Boerhaave’s syndrome as the primary manifestation of adult eosinophilic esophagitis. (Two case reports and a review of the literature.) Dis Esophagus. 2011 Feb;24:E11-5.

2. Brauer, R.B., Liebermann-Meffert, D., Stein, H.J., et al. Boerhaave’s syndrome: Analysis of the literature and report of 18 new cases. Dis Esophagus. 1997 Jan;10:64-8.

3. Pate, J.W., Walker, W.A., Cole, F.H. Jr, et al. Spontaneous rupture of the esophagus: a 30-year experience. Ann Thorac Surg. 1989 May;47:689-92.

The diagnosis

Gastrografin swallow (Figure C) demonstrated rupture of the distal esophagus, with leakage of gastrografin into the mediastinum (arrow). Upper gastrointestinal endoscopy confirmed rupture of the left posterolateral wall of the distal esophagus consistent with Boerhaave’s syndrome (Figure D), and a self-expanding covered metal stent was placed.

Broad-spectrum antibiotics and nasogastric feeding were commenced, and the left pleural effusion drained with a tube thoracostomy. Unfortunately, despite initial improvement, the patient subsequently deteriorated and died 30 days after admission.

Boerhaave’s is a rare clinical entity defined as spontaneous esophageal rupture, excluding perforations resulting from foreign bodies or iatrogenic instrumentation.

Mackler’s triad of vomiting, lower chest pain, and subcutaneous emphysema is the classical presentation but is seen in only a minority of cases; thus, diagnostic errors are common.² Importantly, the chest radiograph is almost always abnormal, with pleural effusions or pneumomediastinum often seen.³ Surgical repair is the definitive treatment, but in patients considered unfit for surgery, conservative or endoscopic management is advocated. Mortality remains greater than 30%, and rises sharply if diagnosis is delayed^,2 emphasizing the importance of awareness of this unusual diagnosis.

References

1. Lucendo, A.J., Fringal-Ruiz, A.B., Rodriguez, B. Boerhaave’s syndrome as the primary manifestation of adult eosinophilic esophagitis. (Two case reports and a review of the literature.) Dis Esophagus. 2011 Feb;24:E11-5.

2. Brauer, R.B., Liebermann-Meffert, D., Stein, H.J., et al. Boerhaave’s syndrome: Analysis of the literature and report of 18 new cases. Dis Esophagus. 1997 Jan;10:64-8.

3. Pate, J.W., Walker, W.A., Cole, F.H. Jr, et al. Spontaneous rupture of the esophagus: a 30-year experience. Ann Thorac Surg. 1989 May;47:689-92.

The diagnosis

Gastrografin swallow (Figure C) demonstrated rupture of the distal esophagus, with leakage of gastrografin into the mediastinum (arrow). Upper gastrointestinal endoscopy confirmed rupture of the left posterolateral wall of the distal esophagus consistent with Boerhaave’s syndrome (Figure D), and a self-expanding covered metal stent was placed.

Broad-spectrum antibiotics and nasogastric feeding were commenced, and the left pleural effusion drained with a tube thoracostomy. Unfortunately, despite initial improvement, the patient subsequently deteriorated and died 30 days after admission.

Boerhaave’s is a rare clinical entity defined as spontaneous esophageal rupture, excluding perforations resulting from foreign bodies or iatrogenic instrumentation.

Mackler’s triad of vomiting, lower chest pain, and subcutaneous emphysema is the classical presentation but is seen in only a minority of cases; thus, diagnostic errors are common.² Importantly, the chest radiograph is almost always abnormal, with pleural effusions or pneumomediastinum often seen.³ Surgical repair is the definitive treatment, but in patients considered unfit for surgery, conservative or endoscopic management is advocated. Mortality remains greater than 30%, and rises sharply if diagnosis is delayed^,2 emphasizing the importance of awareness of this unusual diagnosis.

References

1. Lucendo, A.J., Fringal-Ruiz, A.B., Rodriguez, B. Boerhaave’s syndrome as the primary manifestation of adult eosinophilic esophagitis. (Two case reports and a review of the literature.) Dis Esophagus. 2011 Feb;24:E11-5.

2. Brauer, R.B., Liebermann-Meffert, D., Stein, H.J., et al. Boerhaave’s syndrome: Analysis of the literature and report of 18 new cases. Dis Esophagus. 1997 Jan;10:64-8.

3. Pate, J.W., Walker, W.A., Cole, F.H. Jr, et al. Spontaneous rupture of the esophagus: a 30-year experience. Ann Thorac Surg. 1989 May;47:689-92.

The Joint Council of Pediatric Hospital Medicine (JCPHM), successor to the Strategic Planning (STP) Committee, recently recommended submitting a petition for two-year pediatric hospital medicine (PHM) fellowship certification to the American Board of Pediatrics (ABP), which was completed in 2014. In December 2015, the ABP Board of Directors voted to (1) approve the proposal for a two-year PHM fellowship incorporating scholarly activity with the provision that entrustable professional activities (EPAs) be used as the framework for assessing competencies and (2) not require those who achieve and maintain PHM certification to maintain general pediatrics certification. The proposal for certification of a two-year PHM fellowship will now be submitted to the American Board of Medical Specialties (ABMS). Concerns regarding the formal certification of PHM as an ABMS-recognized subspecialty have been raised by many stakeholders, including community pediatric hospitalists, pediatric residency program directors, and med-peds physicians.

We feel that the “first, do no harm” guiding principle seems to have been forgotten by the ABP as it attempts to formalize the training of pediatric hospitalists. In December 2015, the ABP voted in favor of a two-year ACGME-accredited PHM fellowship. The intent was to “assure the best care of hospitalized children,” “assure the public,” “accelerate improvements and innovation in quality improvement,” and “raise the level of care of all hospitalized children by establishing best practices in clinical care.” To be clear, these goals are shared by all of us (although there is no indication that the public is seeking additional assurance). Prior to launching broad-scale, time-intensive, and financially costly initiatives, we should ensure that our efforts would achieve—rather than obstruct—their intended aims. In addition to a lack of evidence supporting that subspecialty certification will advance our path toward achieving these goals, there are numerous reasons a required PHM fellowship is unnecessary and potentially even harmful to the hospitalist workforce. The negative unintended consequences need to be weighed heavily.

We have found no data to support that children would receive inferior inpatient care from pediatric hospitalists due to lack of formal certification. Hospital medicine physicians are paving the way in quality improvement, high-value care, medical education, palliative care, and global health, supported in part through training in various non-accredited hospital medicine fellowships. There is nothing stopping pediatric hospitalists from establishing and disseminating best practices in clinical care. Hospitalists are already making strides in providing high-quality care at low costs, as demonstrated by the abundant PHM scholarly work described in the ABP application to the ABMS. The alleged problem of needing to build trust within the community is yet to be demonstrated, as we have leaders at local, regional, and national levels. The chief medical officer of the Centers for Medicare & Medicaid Services is a hospitalist as is our surgeon general. Hospital medicine is the fastest-growing specialty in the history of medicine,1 and we should seek to propel rather than fetter our future colleagues.

Below are our reasons for opposing this formal certification.

We already have a fellowship system.

As we all know, advanced training opportunities already exist for those interested in pursuing extra research and quality improvement training. Similar to other pediatric subspecialty fellowships, these PHM fellowships are undersubscribed (20% of PHM fellowships did not fill in 2016),2 with the majority of graduating pediatric residents transitioning to hospitalists opting not to pursue fellowship training. We should continue to let graduating pediatric residents vote with their feet without the undue influence of subspecialty certification.

Subspecialization has opportunity costs that may reduce the PHM pipeline.

Even if we assume an adequate number of fellowship programs could be developed and funded, our fear is that the decision to turn PHM into an accredited subspecialty could paradoxically reduce the pipeline of inpatient providers. Residency is already a three- to four-year endeavor (pediatrics and med-peds) that is poorly compensated and time-intensive. In the absence of evidence supporting the value of additional training, tacking on another two years seems unreasonable in the face of the student loan debt crisis, reduced compensation, and lost time for career advancement. These are significant opportunity costs. While most specialties lead to a significant pay raise to compensate for the added training time, pediatrics remains the lowest-paid physician specialty.3 Should PHM follow the trend of most pediatric subspecialties, pursuit of fellowship training would be a negative financial decision for residency graduates.4 For the health system, increasing debt-to-income ratios runs the risk of creating a medical education bubble market.5

More than 25% of med-peds graduates pursue careers in hospital medicine, a percentage that continues to grow, accounting for more than 100 new hospitalists per year.6 As a result, med-peds-trained hospitalists constitute more than 10% of the pediatric hospitalist workforce.6 Requiring PHM fellowship training may reduce this crucial pipeline of practitioners. In a 2014 unpublished survey of 225 med-peds practitioners, 78% of residents and 96% of attendings responded that they would not consider pursuing an ACGME-accredited PHM fellowship.7 This is compounded by a lack of parity with the practice of adult hospital medicine both in compensation and required training and is heightened by the fact that the training in question does not incorporate care for adult patients. There is clear consensus by 96% of med-peds hospitalists that the creation of an ACGME-certified PHM subspecialty will negatively affect the likelihood of med-peds providers pursuing PHM.7

Certification will pose a potential risk to specific patient populations.

We are also concerned that a reduced PHM workforce could disproportionately impact young adults with special healthcare needs and those children cared for in rural or community-based hospitals. Med-peds training equips providers to care for children with chronic diseases that then transition into adulthood; more than 25% provide care for young adults with special healthcare needs.6 With the increasing number of children with chronic health conditions surviving into adulthood,8 med-peds hospitalists serve essential roles in providing care and coordination for this vulnerable population. Furthermore, hospital medicine groups in medical systems that cannot support a full-time categorical pediatric hospitalist tend to employ med-peds physicians or family practitioners. Concerns with PHM certification are thus extended to those family medicine physicians who practice PHM.

Pediatric residency trains pediatricians in inpatient care.

We feel that the decision to move forward on PHM subspecialty certification calls into question the value of pediatric residency training. There is no evidence that clinical inpatient training in pediatrics residency is inadequate. If one leaves residency trained to do anything, it is practicing hospital medicine. A significant portion of residency takes place inpatient, both on wards and in the intensive care units. The 2009 ABP Foundation–funded study of PHM reported that 94% of pediatric hospitalist respondents rated their training in general clinical skills during residency as fully adequate, 85% rated their training in communication skills as fully adequate, and 73% did not believe any additional training beyond residency should be required.9 With respect to med-peds graduates, more than 90% feel equipped to care for children and adults upon residency completion.10 If the ABMS carries forward with this decision, the only clinical work one would be “certified” to do after residency is primary care. However, after completion of residency training, most of us feel at least as comfortable, if not more comfortable, caring for children in the inpatient setting.

Primary care should require subspecialty certification as well.

Furthermore, the decision to create a certified subspecialty begs the question as to why fellowship should not be mandated for those entering the field of primary care. Does the field of primary care not require research to move it forward? Does the field of primary care not require providers who can adeptly apply quality improvement methodologies to improve primary-care delivery? Does the public not require the same type of assurance? By these measures, primary care should require subspecialty certification as well. These arguments could easily be construed as an indictment of residency training.

The target should be residency training.

The PHM ABMS application describes a clinical curriculum consisting of eight core clinical rotations in various settings. That small number emphasizes the fact that extra clinical training is really not needed and that we do not require a complete overhaul of the current training system. The skills in question for the accredited PHM fellowship include communication, negotiation, leadership, quality improvement, pain management, sedation, procedures, transport, billing/coding, autonomous decision making, and scholarly practice. Are most of these not skills that we should foster in all practicing pediatricians? If graduating pediatric residents lack competence in core pediatric skills (e.g., communication, pain management, autonomous decision making), we should target improvements in residency education rather than require years of further training. Pediatrics residency training already requires training in quality improvement and is incorporating “tracks” that target areas of perceived deficiency. Those physicians who actually require specialized hospital-based skills (e.g., sedation, procedures, and transport) could receive core training during residency (e.g., through PHM tracks or electives) and further hone these skills through faculty development efforts. While non-PhD researchers may benefit from additional training in research methodologies, this training comes at the expense of time spent caring for patients on the wards and should not be required training for the majority of pediatric hospitalists pursuing purely clinical roles.

Broad-based support for a PHM subspecialty has not been demonstrated.

While approximately 40 pediatric hospitalists originated the PHM certification petition, we have not seen clear support for subspecialty certification from the community. PHM certification runs the risk of alienating the general pediatrics community, as many outpatient pediatricians continue to care for their patients in the inpatient setting. Furthermore, at tertiary-care medical centers, pediatric subspecialists often serve as hospitalists, yet this stakeholder group has not entered into this conversation. Importantly, the Association of Pediatric Program Directors (APPD) did not endorse this proposal. Many of the APPD members were quite concerned about the harm this certification could cause. While the APA Board and the AAP Board of Directors support PHM subspecialty certification, it is not clear that the rank-and-file members do. The Society of Hospital Medicine did not support or oppose certification. In an era of controversy surrounding certification requirements, prior to making a decision that will alter the direction of an entire field and impact all future residency graduates interested in entering that field, we should ensure there is broad-based support for this decision.

An alternative path has already been established and validated.

A more prudent, cost-effective, and universally acceptable approach would be to follow in the footsteps of the American Board of Internal Medicine (ABIM) and American Board of Family Medicine (ABFM) in establishing a Focused Practice in Pediatric Hospital Medicine program. This approach respects the unique body of knowledge required of those who care for hospitalized children while maintaining the required flexibility to nurture and help to mature existing training pipelines. Core hospital medicine skills should be further honed through residency curricular changes and faculty development efforts, while hospital-based physicians interested in developing niche skills could still do so via already existing fellowships.

When it comes to pediatric hospital medicine, first, do no harm.

Pediatric hospitalists are inpatient generalists by training and clinical approach. Our practices vary from large academic medical centers with every imaginable subspecialty consult service available to remote rural settings that require hospitalists to possess unique and specific skills. Some pediatric hospitalists participate in newborn care, some perform sedations, and some perform a variety of diagnostic and therapeutic procedures. The current system is meeting the needs of the vast majority of our PHM community. Changes to the residency curriculum that are already under way can address any clinical and quality improvement gaps. More than enough PHM fellowships are available to those who choose to pursue them. The public is not requesting reassurance, and the field is already advancing at a rapid rate both clinically and scholarly. Subspecialty recognition is not necessary and will likely lead to negative unintended consequences. Given the financial constraints on our current system and the need for pediatric hospitalists to be stewards of high-value care, we should make collective decisions that will clearly benefit our patients and health system. As medical professionals, our priority should always be first, do no harm.

Weijen W. Chang, MD, is chief of the Division of Pediatric Hospital Medicine at Baystate Children’s Hospital and associate professor of pediatrics at the University of Massachusetts Medical School.

Leonard Samuel Feldman, MD, is director of the Medicine-Pediatrics Urban Health Residency Program and associate professor of medicine and pediatrics at Johns Hopkins School of Medicine.

Bradley Monash, MD, is associate chief of medicine at University of California, San Francisco and assistant clinical professor of medicine and pediatrics at UCSF School of Medicine.

Archna Eniasivam, MD, is assistant clinical professor of medicine at UCSF School of Medicine.

References

1. Chen C, Eagle S. “Should Pediatric HM Pursue Subspecialty Certification, Required Fellowship Training?” The Hospitalist. July 31, 2012
2. Results and Data: Specialties Matching Service 2016 Appointment Year. National Resident Matching Program website. Accessed May 15, 2016.
3. Medscape Pediatrician Compensation Report 2015. Medscape website.  Accessed April 29, 2016.
4. Rochlin JM, Simon HK. Does fellowship pay: what is the long-term financial impact of subspecialty training in pediatrics? Pediatrics. 2001;127(2):254-260.
5. Asch DA, Nicholson S, Vujicic M. Are we in a medical education bubble market? N Engl J Med. 2013;369(21):1973-1975.
6. O’Toole JK, Friedland AR, Gonzaga AM, et al. The practice patterns of recently graduated internal medicine-pediatric hospitalists. Hosp Pediatr. 2015;5(6):309-314.
7. Society of Hospital Medicine: Survey of Med-Peds Physicians about PHM Certification. May 2014 (unpublished).
8. Goodman DM, Hall M, Levin A, et al. Adults with chronic health conditions originating in childhood: inpatient experience in children’s hospitals. Pediatrics. 2011;128(1):5-13.
9. Freed GL, Dunham KM, Research Advisory Committee of the American Board of P. Pediatric hospitalists: training, current practice, and career goals. J Hosp Med. 2009;4(3):179-186.
10. Donnelly MJ, Lubrano L, Radabaugh CL, Lukela MP, Friedland AR, Ruch-Ross HS. The med-peds hospitalist workforce: results from the American Academy of Pediatrics Workforce Survey. Hosp Pediatr. 2015;5(11):574-579.

The Joint Council of Pediatric Hospital Medicine (JCPHM), successor to the Strategic Planning (STP) Committee, recently recommended submitting a petition for two-year pediatric hospital medicine (PHM) fellowship certification to the American Board of Pediatrics (ABP), which was completed in 2014. In December 2015, the ABP Board of Directors voted to (1) approve the proposal for a two-year PHM fellowship incorporating scholarly activity with the provision that entrustable professional activities (EPAs) be used as the framework for assessing competencies and (2) not require those who achieve and maintain PHM certification to maintain general pediatrics certification. The proposal for certification of a two-year PHM fellowship will now be submitted to the American Board of Medical Specialties (ABMS). Concerns regarding the formal certification of PHM as an ABMS-recognized subspecialty have been raised by many stakeholders, including community pediatric hospitalists, pediatric residency program directors, and med-peds physicians.

We feel that the “first, do no harm” guiding principle seems to have been forgotten by the ABP as it attempts to formalize the training of pediatric hospitalists. In December 2015, the ABP voted in favor of a two-year ACGME-accredited PHM fellowship. The intent was to “assure the best care of hospitalized children,” “assure the public,” “accelerate improvements and innovation in quality improvement,” and “raise the level of care of all hospitalized children by establishing best practices in clinical care.” To be clear, these goals are shared by all of us (although there is no indication that the public is seeking additional assurance). Prior to launching broad-scale, time-intensive, and financially costly initiatives, we should ensure that our efforts would achieve—rather than obstruct—their intended aims. In addition to a lack of evidence supporting that subspecialty certification will advance our path toward achieving these goals, there are numerous reasons a required PHM fellowship is unnecessary and potentially even harmful to the hospitalist workforce. The negative unintended consequences need to be weighed heavily.

We have found no data to support that children would receive inferior inpatient care from pediatric hospitalists due to lack of formal certification. Hospital medicine physicians are paving the way in quality improvement, high-value care, medical education, palliative care, and global health, supported in part through training in various non-accredited hospital medicine fellowships. There is nothing stopping pediatric hospitalists from establishing and disseminating best practices in clinical care. Hospitalists are already making strides in providing high-quality care at low costs, as demonstrated by the abundant PHM scholarly work described in the ABP application to the ABMS. The alleged problem of needing to build trust within the community is yet to be demonstrated, as we have leaders at local, regional, and national levels. The chief medical officer of the Centers for Medicare & Medicaid Services is a hospitalist as is our surgeon general. Hospital medicine is the fastest-growing specialty in the history of medicine,1 and we should seek to propel rather than fetter our future colleagues.

Below are our reasons for opposing this formal certification.

We already have a fellowship system.

As we all know, advanced training opportunities already exist for those interested in pursuing extra research and quality improvement training. Similar to other pediatric subspecialty fellowships, these PHM fellowships are undersubscribed (20% of PHM fellowships did not fill in 2016),2 with the majority of graduating pediatric residents transitioning to hospitalists opting not to pursue fellowship training. We should continue to let graduating pediatric residents vote with their feet without the undue influence of subspecialty certification.

Subspecialization has opportunity costs that may reduce the PHM pipeline.

Even if we assume an adequate number of fellowship programs could be developed and funded, our fear is that the decision to turn PHM into an accredited subspecialty could paradoxically reduce the pipeline of inpatient providers. Residency is already a three- to four-year endeavor (pediatrics and med-peds) that is poorly compensated and time-intensive. In the absence of evidence supporting the value of additional training, tacking on another two years seems unreasonable in the face of the student loan debt crisis, reduced compensation, and lost time for career advancement. These are significant opportunity costs. While most specialties lead to a significant pay raise to compensate for the added training time, pediatrics remains the lowest-paid physician specialty.3 Should PHM follow the trend of most pediatric subspecialties, pursuit of fellowship training would be a negative financial decision for residency graduates.4 For the health system, increasing debt-to-income ratios runs the risk of creating a medical education bubble market.5

More than 25% of med-peds graduates pursue careers in hospital medicine, a percentage that continues to grow, accounting for more than 100 new hospitalists per year.6 As a result, med-peds-trained hospitalists constitute more than 10% of the pediatric hospitalist workforce.6 Requiring PHM fellowship training may reduce this crucial pipeline of practitioners. In a 2014 unpublished survey of 225 med-peds practitioners, 78% of residents and 96% of attendings responded that they would not consider pursuing an ACGME-accredited PHM fellowship.7 This is compounded by a lack of parity with the practice of adult hospital medicine both in compensation and required training and is heightened by the fact that the training in question does not incorporate care for adult patients. There is clear consensus by 96% of med-peds hospitalists that the creation of an ACGME-certified PHM subspecialty will negatively affect the likelihood of med-peds providers pursuing PHM.7

Certification will pose a potential risk to specific patient populations.

We are also concerned that a reduced PHM workforce could disproportionately impact young adults with special healthcare needs and those children cared for in rural or community-based hospitals. Med-peds training equips providers to care for children with chronic diseases that then transition into adulthood; more than 25% provide care for young adults with special healthcare needs.6 With the increasing number of children with chronic health conditions surviving into adulthood,8 med-peds hospitalists serve essential roles in providing care and coordination for this vulnerable population. Furthermore, hospital medicine groups in medical systems that cannot support a full-time categorical pediatric hospitalist tend to employ med-peds physicians or family practitioners. Concerns with PHM certification are thus extended to those family medicine physicians who practice PHM.

Pediatric residency trains pediatricians in inpatient care.

We feel that the decision to move forward on PHM subspecialty certification calls into question the value of pediatric residency training. There is no evidence that clinical inpatient training in pediatrics residency is inadequate. If one leaves residency trained to do anything, it is practicing hospital medicine. A significant portion of residency takes place inpatient, both on wards and in the intensive care units. The 2009 ABP Foundation–funded study of PHM reported that 94% of pediatric hospitalist respondents rated their training in general clinical skills during residency as fully adequate, 85% rated their training in communication skills as fully adequate, and 73% did not believe any additional training beyond residency should be required.9 With respect to med-peds graduates, more than 90% feel equipped to care for children and adults upon residency completion.10 If the ABMS carries forward with this decision, the only clinical work one would be “certified” to do after residency is primary care. However, after completion of residency training, most of us feel at least as comfortable, if not more comfortable, caring for children in the inpatient setting.

Primary care should require subspecialty certification as well.

Furthermore, the decision to create a certified subspecialty begs the question as to why fellowship should not be mandated for those entering the field of primary care. Does the field of primary care not require research to move it forward? Does the field of primary care not require providers who can adeptly apply quality improvement methodologies to improve primary-care delivery? Does the public not require the same type of assurance? By these measures, primary care should require subspecialty certification as well. These arguments could easily be construed as an indictment of residency training.

The target should be residency training.

The PHM ABMS application describes a clinical curriculum consisting of eight core clinical rotations in various settings. That small number emphasizes the fact that extra clinical training is really not needed and that we do not require a complete overhaul of the current training system. The skills in question for the accredited PHM fellowship include communication, negotiation, leadership, quality improvement, pain management, sedation, procedures, transport, billing/coding, autonomous decision making, and scholarly practice. Are most of these not skills that we should foster in all practicing pediatricians? If graduating pediatric residents lack competence in core pediatric skills (e.g., communication, pain management, autonomous decision making), we should target improvements in residency education rather than require years of further training. Pediatrics residency training already requires training in quality improvement and is incorporating “tracks” that target areas of perceived deficiency. Those physicians who actually require specialized hospital-based skills (e.g., sedation, procedures, and transport) could receive core training during residency (e.g., through PHM tracks or electives) and further hone these skills through faculty development efforts. While non-PhD researchers may benefit from additional training in research methodologies, this training comes at the expense of time spent caring for patients on the wards and should not be required training for the majority of pediatric hospitalists pursuing purely clinical roles.

Broad-based support for a PHM subspecialty has not been demonstrated.

While approximately 40 pediatric hospitalists originated the PHM certification petition, we have not seen clear support for subspecialty certification from the community. PHM certification runs the risk of alienating the general pediatrics community, as many outpatient pediatricians continue to care for their patients in the inpatient setting. Furthermore, at tertiary-care medical centers, pediatric subspecialists often serve as hospitalists, yet this stakeholder group has not entered into this conversation. Importantly, the Association of Pediatric Program Directors (APPD) did not endorse this proposal. Many of the APPD members were quite concerned about the harm this certification could cause. While the APA Board and the AAP Board of Directors support PHM subspecialty certification, it is not clear that the rank-and-file members do. The Society of Hospital Medicine did not support or oppose certification. In an era of controversy surrounding certification requirements, prior to making a decision that will alter the direction of an entire field and impact all future residency graduates interested in entering that field, we should ensure there is broad-based support for this decision.

An alternative path has already been established and validated.

A more prudent, cost-effective, and universally acceptable approach would be to follow in the footsteps of the American Board of Internal Medicine (ABIM) and American Board of Family Medicine (ABFM) in establishing a Focused Practice in Pediatric Hospital Medicine program. This approach respects the unique body of knowledge required of those who care for hospitalized children while maintaining the required flexibility to nurture and help to mature existing training pipelines. Core hospital medicine skills should be further honed through residency curricular changes and faculty development efforts, while hospital-based physicians interested in developing niche skills could still do so via already existing fellowships.

When it comes to pediatric hospital medicine, first, do no harm.

Pediatric hospitalists are inpatient generalists by training and clinical approach. Our practices vary from large academic medical centers with every imaginable subspecialty consult service available to remote rural settings that require hospitalists to possess unique and specific skills. Some pediatric hospitalists participate in newborn care, some perform sedations, and some perform a variety of diagnostic and therapeutic procedures. The current system is meeting the needs of the vast majority of our PHM community. Changes to the residency curriculum that are already under way can address any clinical and quality improvement gaps. More than enough PHM fellowships are available to those who choose to pursue them. The public is not requesting reassurance, and the field is already advancing at a rapid rate both clinically and scholarly. Subspecialty recognition is not necessary and will likely lead to negative unintended consequences. Given the financial constraints on our current system and the need for pediatric hospitalists to be stewards of high-value care, we should make collective decisions that will clearly benefit our patients and health system. As medical professionals, our priority should always be first, do no harm.

Weijen W. Chang, MD, is chief of the Division of Pediatric Hospital Medicine at Baystate Children’s Hospital and associate professor of pediatrics at the University of Massachusetts Medical School.

Leonard Samuel Feldman, MD, is director of the Medicine-Pediatrics Urban Health Residency Program and associate professor of medicine and pediatrics at Johns Hopkins School of Medicine.

Bradley Monash, MD, is associate chief of medicine at University of California, San Francisco and assistant clinical professor of medicine and pediatrics at UCSF School of Medicine.

Archna Eniasivam, MD, is assistant clinical professor of medicine at UCSF School of Medicine.

References

1. Chen C, Eagle S. “Should Pediatric HM Pursue Subspecialty Certification, Required Fellowship Training?” The Hospitalist. July 31, 2012
2. Results and Data: Specialties Matching Service 2016 Appointment Year. National Resident Matching Program website. Accessed May 15, 2016.
3. Medscape Pediatrician Compensation Report 2015. Medscape website.  Accessed April 29, 2016.
4. Rochlin JM, Simon HK. Does fellowship pay: what is the long-term financial impact of subspecialty training in pediatrics? Pediatrics. 2001;127(2):254-260.
5. Asch DA, Nicholson S, Vujicic M. Are we in a medical education bubble market? N Engl J Med. 2013;369(21):1973-1975.
6. O’Toole JK, Friedland AR, Gonzaga AM, et al. The practice patterns of recently graduated internal medicine-pediatric hospitalists. Hosp Pediatr. 2015;5(6):309-314.
7. Society of Hospital Medicine: Survey of Med-Peds Physicians about PHM Certification. May 2014 (unpublished).
8. Goodman DM, Hall M, Levin A, et al. Adults with chronic health conditions originating in childhood: inpatient experience in children’s hospitals. Pediatrics. 2011;128(1):5-13.
9. Freed GL, Dunham KM, Research Advisory Committee of the American Board of P. Pediatric hospitalists: training, current practice, and career goals. J Hosp Med. 2009;4(3):179-186.
10. Donnelly MJ, Lubrano L, Radabaugh CL, Lukela MP, Friedland AR, Ruch-Ross HS. The med-peds hospitalist workforce: results from the American Academy of Pediatrics Workforce Survey. Hosp Pediatr. 2015;5(11):574-579.

The Joint Council of Pediatric Hospital Medicine (JCPHM), successor to the Strategic Planning (STP) Committee, recently recommended submitting a petition for two-year pediatric hospital medicine (PHM) fellowship certification to the American Board of Pediatrics (ABP), which was completed in 2014. In December 2015, the ABP Board of Directors voted to (1) approve the proposal for a two-year PHM fellowship incorporating scholarly activity with the provision that entrustable professional activities (EPAs) be used as the framework for assessing competencies and (2) not require those who achieve and maintain PHM certification to maintain general pediatrics certification. The proposal for certification of a two-year PHM fellowship will now be submitted to the American Board of Medical Specialties (ABMS). Concerns regarding the formal certification of PHM as an ABMS-recognized subspecialty have been raised by many stakeholders, including community pediatric hospitalists, pediatric residency program directors, and med-peds physicians.

We feel that the “first, do no harm” guiding principle seems to have been forgotten by the ABP as it attempts to formalize the training of pediatric hospitalists. In December 2015, the ABP voted in favor of a two-year ACGME-accredited PHM fellowship. The intent was to “assure the best care of hospitalized children,” “assure the public,” “accelerate improvements and innovation in quality improvement,” and “raise the level of care of all hospitalized children by establishing best practices in clinical care.” To be clear, these goals are shared by all of us (although there is no indication that the public is seeking additional assurance). Prior to launching broad-scale, time-intensive, and financially costly initiatives, we should ensure that our efforts would achieve—rather than obstruct—their intended aims. In addition to a lack of evidence supporting that subspecialty certification will advance our path toward achieving these goals, there are numerous reasons a required PHM fellowship is unnecessary and potentially even harmful to the hospitalist workforce. The negative unintended consequences need to be weighed heavily.

We have found no data to support that children would receive inferior inpatient care from pediatric hospitalists due to lack of formal certification. Hospital medicine physicians are paving the way in quality improvement, high-value care, medical education, palliative care, and global health, supported in part through training in various non-accredited hospital medicine fellowships. There is nothing stopping pediatric hospitalists from establishing and disseminating best practices in clinical care. Hospitalists are already making strides in providing high-quality care at low costs, as demonstrated by the abundant PHM scholarly work described in the ABP application to the ABMS. The alleged problem of needing to build trust within the community is yet to be demonstrated, as we have leaders at local, regional, and national levels. The chief medical officer of the Centers for Medicare & Medicaid Services is a hospitalist as is our surgeon general. Hospital medicine is the fastest-growing specialty in the history of medicine,1 and we should seek to propel rather than fetter our future colleagues.

Below are our reasons for opposing this formal certification.

We already have a fellowship system.

As we all know, advanced training opportunities already exist for those interested in pursuing extra research and quality improvement training. Similar to other pediatric subspecialty fellowships, these PHM fellowships are undersubscribed (20% of PHM fellowships did not fill in 2016),2 with the majority of graduating pediatric residents transitioning to hospitalists opting not to pursue fellowship training. We should continue to let graduating pediatric residents vote with their feet without the undue influence of subspecialty certification.

Subspecialization has opportunity costs that may reduce the PHM pipeline.

Even if we assume an adequate number of fellowship programs could be developed and funded, our fear is that the decision to turn PHM into an accredited subspecialty could paradoxically reduce the pipeline of inpatient providers. Residency is already a three- to four-year endeavor (pediatrics and med-peds) that is poorly compensated and time-intensive. In the absence of evidence supporting the value of additional training, tacking on another two years seems unreasonable in the face of the student loan debt crisis, reduced compensation, and lost time for career advancement. These are significant opportunity costs. While most specialties lead to a significant pay raise to compensate for the added training time, pediatrics remains the lowest-paid physician specialty.3 Should PHM follow the trend of most pediatric subspecialties, pursuit of fellowship training would be a negative financial decision for residency graduates.4 For the health system, increasing debt-to-income ratios runs the risk of creating a medical education bubble market.5

More than 25% of med-peds graduates pursue careers in hospital medicine, a percentage that continues to grow, accounting for more than 100 new hospitalists per year.6 As a result, med-peds-trained hospitalists constitute more than 10% of the pediatric hospitalist workforce.6 Requiring PHM fellowship training may reduce this crucial pipeline of practitioners. In a 2014 unpublished survey of 225 med-peds practitioners, 78% of residents and 96% of attendings responded that they would not consider pursuing an ACGME-accredited PHM fellowship.7 This is compounded by a lack of parity with the practice of adult hospital medicine both in compensation and required training and is heightened by the fact that the training in question does not incorporate care for adult patients. There is clear consensus by 96% of med-peds hospitalists that the creation of an ACGME-certified PHM subspecialty will negatively affect the likelihood of med-peds providers pursuing PHM.7

Certification will pose a potential risk to specific patient populations.

We are also concerned that a reduced PHM workforce could disproportionately impact young adults with special healthcare needs and those children cared for in rural or community-based hospitals. Med-peds training equips providers to care for children with chronic diseases that then transition into adulthood; more than 25% provide care for young adults with special healthcare needs.6 With the increasing number of children with chronic health conditions surviving into adulthood,8 med-peds hospitalists serve essential roles in providing care and coordination for this vulnerable population. Furthermore, hospital medicine groups in medical systems that cannot support a full-time categorical pediatric hospitalist tend to employ med-peds physicians or family practitioners. Concerns with PHM certification are thus extended to those family medicine physicians who practice PHM.

Pediatric residency trains pediatricians in inpatient care.

We feel that the decision to move forward on PHM subspecialty certification calls into question the value of pediatric residency training. There is no evidence that clinical inpatient training in pediatrics residency is inadequate. If one leaves residency trained to do anything, it is practicing hospital medicine. A significant portion of residency takes place inpatient, both on wards and in the intensive care units. The 2009 ABP Foundation–funded study of PHM reported that 94% of pediatric hospitalist respondents rated their training in general clinical skills during residency as fully adequate, 85% rated their training in communication skills as fully adequate, and 73% did not believe any additional training beyond residency should be required.9 With respect to med-peds graduates, more than 90% feel equipped to care for children and adults upon residency completion.10 If the ABMS carries forward with this decision, the only clinical work one would be “certified” to do after residency is primary care. However, after completion of residency training, most of us feel at least as comfortable, if not more comfortable, caring for children in the inpatient setting.

Primary care should require subspecialty certification as well.

Furthermore, the decision to create a certified subspecialty begs the question as to why fellowship should not be mandated for those entering the field of primary care. Does the field of primary care not require research to move it forward? Does the field of primary care not require providers who can adeptly apply quality improvement methodologies to improve primary-care delivery? Does the public not require the same type of assurance? By these measures, primary care should require subspecialty certification as well. These arguments could easily be construed as an indictment of residency training.

The target should be residency training.

The PHM ABMS application describes a clinical curriculum consisting of eight core clinical rotations in various settings. That small number emphasizes the fact that extra clinical training is really not needed and that we do not require a complete overhaul of the current training system. The skills in question for the accredited PHM fellowship include communication, negotiation, leadership, quality improvement, pain management, sedation, procedures, transport, billing/coding, autonomous decision making, and scholarly practice. Are most of these not skills that we should foster in all practicing pediatricians? If graduating pediatric residents lack competence in core pediatric skills (e.g., communication, pain management, autonomous decision making), we should target improvements in residency education rather than require years of further training. Pediatrics residency training already requires training in quality improvement and is incorporating “tracks” that target areas of perceived deficiency. Those physicians who actually require specialized hospital-based skills (e.g., sedation, procedures, and transport) could receive core training during residency (e.g., through PHM tracks or electives) and further hone these skills through faculty development efforts. While non-PhD researchers may benefit from additional training in research methodologies, this training comes at the expense of time spent caring for patients on the wards and should not be required training for the majority of pediatric hospitalists pursuing purely clinical roles.

Broad-based support for a PHM subspecialty has not been demonstrated.

While approximately 40 pediatric hospitalists originated the PHM certification petition, we have not seen clear support for subspecialty certification from the community. PHM certification runs the risk of alienating the general pediatrics community, as many outpatient pediatricians continue to care for their patients in the inpatient setting. Furthermore, at tertiary-care medical centers, pediatric subspecialists often serve as hospitalists, yet this stakeholder group has not entered into this conversation. Importantly, the Association of Pediatric Program Directors (APPD) did not endorse this proposal. Many of the APPD members were quite concerned about the harm this certification could cause. While the APA Board and the AAP Board of Directors support PHM subspecialty certification, it is not clear that the rank-and-file members do. The Society of Hospital Medicine did not support or oppose certification. In an era of controversy surrounding certification requirements, prior to making a decision that will alter the direction of an entire field and impact all future residency graduates interested in entering that field, we should ensure there is broad-based support for this decision.

An alternative path has already been established and validated.

A more prudent, cost-effective, and universally acceptable approach would be to follow in the footsteps of the American Board of Internal Medicine (ABIM) and American Board of Family Medicine (ABFM) in establishing a Focused Practice in Pediatric Hospital Medicine program. This approach respects the unique body of knowledge required of those who care for hospitalized children while maintaining the required flexibility to nurture and help to mature existing training pipelines. Core hospital medicine skills should be further honed through residency curricular changes and faculty development efforts, while hospital-based physicians interested in developing niche skills could still do so via already existing fellowships.

When it comes to pediatric hospital medicine, first, do no harm.

Pediatric hospitalists are inpatient generalists by training and clinical approach. Our practices vary from large academic medical centers with every imaginable subspecialty consult service available to remote rural settings that require hospitalists to possess unique and specific skills. Some pediatric hospitalists participate in newborn care, some perform sedations, and some perform a variety of diagnostic and therapeutic procedures. The current system is meeting the needs of the vast majority of our PHM community. Changes to the residency curriculum that are already under way can address any clinical and quality improvement gaps. More than enough PHM fellowships are available to those who choose to pursue them. The public is not requesting reassurance, and the field is already advancing at a rapid rate both clinically and scholarly. Subspecialty recognition is not necessary and will likely lead to negative unintended consequences. Given the financial constraints on our current system and the need for pediatric hospitalists to be stewards of high-value care, we should make collective decisions that will clearly benefit our patients and health system. As medical professionals, our priority should always be first, do no harm.

Weijen W. Chang, MD, is chief of the Division of Pediatric Hospital Medicine at Baystate Children’s Hospital and associate professor of pediatrics at the University of Massachusetts Medical School.

Leonard Samuel Feldman, MD, is director of the Medicine-Pediatrics Urban Health Residency Program and associate professor of medicine and pediatrics at Johns Hopkins School of Medicine.

Bradley Monash, MD, is associate chief of medicine at University of California, San Francisco and assistant clinical professor of medicine and pediatrics at UCSF School of Medicine.

Archna Eniasivam, MD, is assistant clinical professor of medicine at UCSF School of Medicine.

References

1. Chen C, Eagle S. “Should Pediatric HM Pursue Subspecialty Certification, Required Fellowship Training?” The Hospitalist. July 31, 2012
2. Results and Data: Specialties Matching Service 2016 Appointment Year. National Resident Matching Program website. Accessed May 15, 2016.
3. Medscape Pediatrician Compensation Report 2015. Medscape website.  Accessed April 29, 2016.
4. Rochlin JM, Simon HK. Does fellowship pay: what is the long-term financial impact of subspecialty training in pediatrics? Pediatrics. 2001;127(2):254-260.
5. Asch DA, Nicholson S, Vujicic M. Are we in a medical education bubble market? N Engl J Med. 2013;369(21):1973-1975.
6. O’Toole JK, Friedland AR, Gonzaga AM, et al. The practice patterns of recently graduated internal medicine-pediatric hospitalists. Hosp Pediatr. 2015;5(6):309-314.
7. Society of Hospital Medicine: Survey of Med-Peds Physicians about PHM Certification. May 2014 (unpublished).
8. Goodman DM, Hall M, Levin A, et al. Adults with chronic health conditions originating in childhood: inpatient experience in children’s hospitals. Pediatrics. 2011;128(1):5-13.
9. Freed GL, Dunham KM, Research Advisory Committee of the American Board of P. Pediatric hospitalists: training, current practice, and career goals. J Hosp Med. 2009;4(3):179-186.
10. Donnelly MJ, Lubrano L, Radabaugh CL, Lukela MP, Friedland AR, Ruch-Ross HS. The med-peds hospitalist workforce: results from the American Academy of Pediatrics Workforce Survey. Hosp Pediatr. 2015;5(11):574-579.

Nurse converses with patient
Photo courtesy of NCI

NEW YORK—Two presentations at the NCCN 11th Annual Congress: Hematologic Malignancies addressed the importance of supportive care in the treatment of patients with T-cell lymphomas and multiple myeloma.

Erin Kopp, ACNP-BC, of City of Hope Comprehensive Cancer Center in Duarte, California, reminded the audience that supportive care is not palliative care.

Supportive care “complements critical care so that the patient doesn’t have to stop treatment,” she said.

Kopp focused primarily on cutaneous T-cell lymphoma (CTCL) in her presentation, with some recommendations for managing tumor lysis syndrome in patients undergoing therapy for peripheral T-cell lymphoma (PTCL).

And Kathleen Colson, RN, of the Dana-Farber Cancer Institute in Boston, Massachusetts, discussed supportive care for patients with multiple myeloma (MM).

T-cell lymphomas

Most T-cell lymphoma patients will require multiple treatment regimens over their lifetimes, Kopp said. And each type of therapy brings different treatment-related toxicities, which in turn require distinct supportive care measures to manage them.

Topical steroids, for example, may cause skin-thinning, stretch marks, skin irritation, and may be absorbed systemically when a high-potency formulation is used. So the lowest potency steroid that provides the maximum efficacy should be utilized. Practitioners should assess systemic effects if high-potency steroids are utilized.

Topical nitrogen mustard can darken the skin, which often occurs as the lesions resolve, Kopp said. She cautioned that patients experiencing hyperpigmentation often stop treatment without telling their physicians. 

So Kopp recommends appropriate patient education to go along with the treatment. With nitrogen mustard, this includes applying a thin layer only to the affected areas and refrigerating the topical ointment to increase soothing. 

Topical retinoids may cause redness, itching, warmth, swelling, burning, scaling or other irritation. They also increase the patients’ sensitivity to light. Kopp indicated that for the first week, topical retinoids should be applied once every other day and then titrated as tolerated.

Phototherapy with PUVA or narrowband-UVB may also cause itching, in addition to skin burn, nausea, and other side effects.

“Do not underestimate emollients,” Kopp said, for relief of pruritus. And skin baths with bleach significantly decrease infections that may result from treatment.

Systemic therapy with retinoids, interferon, cytotoxic agents, monoclonal antibodies, and HDAC inhibitors may also cause distinct reactions. For example, the retinoid bexarotene may cause primary hypothyroidism and major lipid abnormalities. Therefore, TSH, free T4, and triglycerides should be monitored every 8 weeks.

Cytotoxic agents such as pralatrexate and methotrexate significantly increase the risk for infection.

Monoclonal antibodies can reactivate previous viral infection, induce tumor lysis syndrome (TLS), and cause progressive multifocal leukoencephalopathy.

HDAC inhibitors such as vorinostat and romidepsin may cause QT prolongation and myelosuppression, among other side effects.

Practitioners need to assess symptoms and side effects thoroughly and often and provide options for supportive care management.

PTCL is an under recognized risk for TLS, Kopp said.

“It should be addressed aggressively,” she added, with monitoring and correction of electrolyte imbalance.

Patients should be rigorously hydrated, and allopurinol should be administered 2-3 days prior to treatment and adjusted based on the patient response and uric acid level.

Multiple myeloma

Colson described supportive care as “keeping all the pieces together.” MM itself can result in a broad spectrum of clinical manifestations, including renal compromise, neuropathy, infection, hypercalcemia, bone pain, lytic lesions, and anemia. 

To preserve renal health, patients should drink plenty of water and avoid certain medications, such as IV contrast and nonsteroidal anti-inflammatory drugs. 

Peripheral neuropathy can be a side effect of treatment or be caused by the disease itself. Bortezomib-related neuropathy can be reduced with weekly instead of twice weekly dosing and with subcutaneous administration.

Duration of higher doses of thalidomide treatment also impacts neuropathy. Carfilzomib and pomalidomide have a lower incidence of neuropathy. 

Myeloma patients have a 15-fold increased risk of recurrent infection because white blood cell production is decreased and the normal immune role of plasma cells is lost.

Supportive therapy includes antibiotics and IVIG therapy. In addition, Colson said pneumonia and influenza vaccines should be considered, as well as prophylaxis for Pneumocystis carinii, herpes zoster, and fungal infections.

Hypercalcemia results from increased bone deterioration. Symptoms include loss of appetite, fatigue, vomiting, muscle weakness, confusion, constipation, increased thirst, and increased urine output. Supportive measures are adequate hydration, furosemide, bisphosphonates, and steroids.

Supportive therapy for bone pain includes bisphosphonates, radiation, pain medication, kyphoplasty, and vertebroplasty. Bisphosphonates, such as pamidronate and zoledronic acid, inhibit bone destruction and are recommended for all myeloma patients with bone disease. However, patients should be monitored for renal dysfunction and osteonecrosis of the jaw when taking bisphosphonates.

And Colson advises, “Hold bisphosphonate therapy if the patient needs a root canal or extraction.” Additionally, dental implants are not recommended for MM patients.

Anemia is another common presenting symptom of myeloma and may also be a result of decreased kidney function. Colson said the use of red blood cell supplements may be used with caution to ameliorate the symptom. Red blood cell transfusion may be considered and a reduction in the medication dose may be required.

MM is a hypercoagulable disease, and measures should be taken to avoid deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients should wear anti-embolism stockings, exercise regularly, take low-dose aspirin, and move about frequently instead of sitting for long periods. Immunomodulatory medications may be adjusted to reduce the risk of a blot clot forming.

Infusion-related reactions are also a risk of therapy, and symptoms of a reaction need to be managed immediately and appropriately, with antihistamines, corticosteroids, interruption of the infusion, slowing of the infusion rate after symptom resolution, and permanent discontinuation in the case of grade 4 reactions.

The potential for longer survival exists, Colson said, due to appropriate supportive care measures.

Nurse converses with patient
Photo courtesy of NCI

NEW YORK—Two presentations at the NCCN 11th Annual Congress: Hematologic Malignancies addressed the importance of supportive care in the treatment of patients with T-cell lymphomas and multiple myeloma.

Erin Kopp, ACNP-BC, of City of Hope Comprehensive Cancer Center in Duarte, California, reminded the audience that supportive care is not palliative care.

Supportive care “complements critical care so that the patient doesn’t have to stop treatment,” she said.

Kopp focused primarily on cutaneous T-cell lymphoma (CTCL) in her presentation, with some recommendations for managing tumor lysis syndrome in patients undergoing therapy for peripheral T-cell lymphoma (PTCL).

And Kathleen Colson, RN, of the Dana-Farber Cancer Institute in Boston, Massachusetts, discussed supportive care for patients with multiple myeloma (MM).

T-cell lymphomas

Most T-cell lymphoma patients will require multiple treatment regimens over their lifetimes, Kopp said. And each type of therapy brings different treatment-related toxicities, which in turn require distinct supportive care measures to manage them.

Topical steroids, for example, may cause skin-thinning, stretch marks, skin irritation, and may be absorbed systemically when a high-potency formulation is used. So the lowest potency steroid that provides the maximum efficacy should be utilized. Practitioners should assess systemic effects if high-potency steroids are utilized.

Topical nitrogen mustard can darken the skin, which often occurs as the lesions resolve, Kopp said. She cautioned that patients experiencing hyperpigmentation often stop treatment without telling their physicians. 

So Kopp recommends appropriate patient education to go along with the treatment. With nitrogen mustard, this includes applying a thin layer only to the affected areas and refrigerating the topical ointment to increase soothing. 

Topical retinoids may cause redness, itching, warmth, swelling, burning, scaling or other irritation. They also increase the patients’ sensitivity to light. Kopp indicated that for the first week, topical retinoids should be applied once every other day and then titrated as tolerated.

Phototherapy with PUVA or narrowband-UVB may also cause itching, in addition to skin burn, nausea, and other side effects.

“Do not underestimate emollients,” Kopp said, for relief of pruritus. And skin baths with bleach significantly decrease infections that may result from treatment.

Systemic therapy with retinoids, interferon, cytotoxic agents, monoclonal antibodies, and HDAC inhibitors may also cause distinct reactions. For example, the retinoid bexarotene may cause primary hypothyroidism and major lipid abnormalities. Therefore, TSH, free T4, and triglycerides should be monitored every 8 weeks.

Cytotoxic agents such as pralatrexate and methotrexate significantly increase the risk for infection.

Monoclonal antibodies can reactivate previous viral infection, induce tumor lysis syndrome (TLS), and cause progressive multifocal leukoencephalopathy.

HDAC inhibitors such as vorinostat and romidepsin may cause QT prolongation and myelosuppression, among other side effects.

Practitioners need to assess symptoms and side effects thoroughly and often and provide options for supportive care management.

PTCL is an under recognized risk for TLS, Kopp said.

“It should be addressed aggressively,” she added, with monitoring and correction of electrolyte imbalance.

Patients should be rigorously hydrated, and allopurinol should be administered 2-3 days prior to treatment and adjusted based on the patient response and uric acid level.

Multiple myeloma

Colson described supportive care as “keeping all the pieces together.” MM itself can result in a broad spectrum of clinical manifestations, including renal compromise, neuropathy, infection, hypercalcemia, bone pain, lytic lesions, and anemia. 

To preserve renal health, patients should drink plenty of water and avoid certain medications, such as IV contrast and nonsteroidal anti-inflammatory drugs. 

Peripheral neuropathy can be a side effect of treatment or be caused by the disease itself. Bortezomib-related neuropathy can be reduced with weekly instead of twice weekly dosing and with subcutaneous administration.

Duration of higher doses of thalidomide treatment also impacts neuropathy. Carfilzomib and pomalidomide have a lower incidence of neuropathy. 

Myeloma patients have a 15-fold increased risk of recurrent infection because white blood cell production is decreased and the normal immune role of plasma cells is lost.

Supportive therapy includes antibiotics and IVIG therapy. In addition, Colson said pneumonia and influenza vaccines should be considered, as well as prophylaxis for Pneumocystis carinii, herpes zoster, and fungal infections.

Hypercalcemia results from increased bone deterioration. Symptoms include loss of appetite, fatigue, vomiting, muscle weakness, confusion, constipation, increased thirst, and increased urine output. Supportive measures are adequate hydration, furosemide, bisphosphonates, and steroids.

Supportive therapy for bone pain includes bisphosphonates, radiation, pain medication, kyphoplasty, and vertebroplasty. Bisphosphonates, such as pamidronate and zoledronic acid, inhibit bone destruction and are recommended for all myeloma patients with bone disease. However, patients should be monitored for renal dysfunction and osteonecrosis of the jaw when taking bisphosphonates.

And Colson advises, “Hold bisphosphonate therapy if the patient needs a root canal or extraction.” Additionally, dental implants are not recommended for MM patients.

Anemia is another common presenting symptom of myeloma and may also be a result of decreased kidney function. Colson said the use of red blood cell supplements may be used with caution to ameliorate the symptom. Red blood cell transfusion may be considered and a reduction in the medication dose may be required.

MM is a hypercoagulable disease, and measures should be taken to avoid deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients should wear anti-embolism stockings, exercise regularly, take low-dose aspirin, and move about frequently instead of sitting for long periods. Immunomodulatory medications may be adjusted to reduce the risk of a blot clot forming.

Infusion-related reactions are also a risk of therapy, and symptoms of a reaction need to be managed immediately and appropriately, with antihistamines, corticosteroids, interruption of the infusion, slowing of the infusion rate after symptom resolution, and permanent discontinuation in the case of grade 4 reactions.

The potential for longer survival exists, Colson said, due to appropriate supportive care measures.

Nurse converses with patient
Photo courtesy of NCI

NEW YORK—Two presentations at the NCCN 11th Annual Congress: Hematologic Malignancies addressed the importance of supportive care in the treatment of patients with T-cell lymphomas and multiple myeloma.

Erin Kopp, ACNP-BC, of City of Hope Comprehensive Cancer Center in Duarte, California, reminded the audience that supportive care is not palliative care.

Supportive care “complements critical care so that the patient doesn’t have to stop treatment,” she said.

Kopp focused primarily on cutaneous T-cell lymphoma (CTCL) in her presentation, with some recommendations for managing tumor lysis syndrome in patients undergoing therapy for peripheral T-cell lymphoma (PTCL).

And Kathleen Colson, RN, of the Dana-Farber Cancer Institute in Boston, Massachusetts, discussed supportive care for patients with multiple myeloma (MM).

T-cell lymphomas

Most T-cell lymphoma patients will require multiple treatment regimens over their lifetimes, Kopp said. And each type of therapy brings different treatment-related toxicities, which in turn require distinct supportive care measures to manage them.

Topical steroids, for example, may cause skin-thinning, stretch marks, skin irritation, and may be absorbed systemically when a high-potency formulation is used. So the lowest potency steroid that provides the maximum efficacy should be utilized. Practitioners should assess systemic effects if high-potency steroids are utilized.

Topical nitrogen mustard can darken the skin, which often occurs as the lesions resolve, Kopp said. She cautioned that patients experiencing hyperpigmentation often stop treatment without telling their physicians. 

So Kopp recommends appropriate patient education to go along with the treatment. With nitrogen mustard, this includes applying a thin layer only to the affected areas and refrigerating the topical ointment to increase soothing. 

Topical retinoids may cause redness, itching, warmth, swelling, burning, scaling or other irritation. They also increase the patients’ sensitivity to light. Kopp indicated that for the first week, topical retinoids should be applied once every other day and then titrated as tolerated.

Phototherapy with PUVA or narrowband-UVB may also cause itching, in addition to skin burn, nausea, and other side effects.

“Do not underestimate emollients,” Kopp said, for relief of pruritus. And skin baths with bleach significantly decrease infections that may result from treatment.

Systemic therapy with retinoids, interferon, cytotoxic agents, monoclonal antibodies, and HDAC inhibitors may also cause distinct reactions. For example, the retinoid bexarotene may cause primary hypothyroidism and major lipid abnormalities. Therefore, TSH, free T4, and triglycerides should be monitored every 8 weeks.

Cytotoxic agents such as pralatrexate and methotrexate significantly increase the risk for infection.

Monoclonal antibodies can reactivate previous viral infection, induce tumor lysis syndrome (TLS), and cause progressive multifocal leukoencephalopathy.

HDAC inhibitors such as vorinostat and romidepsin may cause QT prolongation and myelosuppression, among other side effects.

Practitioners need to assess symptoms and side effects thoroughly and often and provide options for supportive care management.

PTCL is an under recognized risk for TLS, Kopp said.

“It should be addressed aggressively,” she added, with monitoring and correction of electrolyte imbalance.

Patients should be rigorously hydrated, and allopurinol should be administered 2-3 days prior to treatment and adjusted based on the patient response and uric acid level.

Multiple myeloma

Colson described supportive care as “keeping all the pieces together.” MM itself can result in a broad spectrum of clinical manifestations, including renal compromise, neuropathy, infection, hypercalcemia, bone pain, lytic lesions, and anemia. 

To preserve renal health, patients should drink plenty of water and avoid certain medications, such as IV contrast and nonsteroidal anti-inflammatory drugs. 

Peripheral neuropathy can be a side effect of treatment or be caused by the disease itself. Bortezomib-related neuropathy can be reduced with weekly instead of twice weekly dosing and with subcutaneous administration.

Duration of higher doses of thalidomide treatment also impacts neuropathy. Carfilzomib and pomalidomide have a lower incidence of neuropathy. 

Myeloma patients have a 15-fold increased risk of recurrent infection because white blood cell production is decreased and the normal immune role of plasma cells is lost.

Supportive therapy includes antibiotics and IVIG therapy. In addition, Colson said pneumonia and influenza vaccines should be considered, as well as prophylaxis for Pneumocystis carinii, herpes zoster, and fungal infections.

Hypercalcemia results from increased bone deterioration. Symptoms include loss of appetite, fatigue, vomiting, muscle weakness, confusion, constipation, increased thirst, and increased urine output. Supportive measures are adequate hydration, furosemide, bisphosphonates, and steroids.

Supportive therapy for bone pain includes bisphosphonates, radiation, pain medication, kyphoplasty, and vertebroplasty. Bisphosphonates, such as pamidronate and zoledronic acid, inhibit bone destruction and are recommended for all myeloma patients with bone disease. However, patients should be monitored for renal dysfunction and osteonecrosis of the jaw when taking bisphosphonates.

And Colson advises, “Hold bisphosphonate therapy if the patient needs a root canal or extraction.” Additionally, dental implants are not recommended for MM patients.

Anemia is another common presenting symptom of myeloma and may also be a result of decreased kidney function. Colson said the use of red blood cell supplements may be used with caution to ameliorate the symptom. Red blood cell transfusion may be considered and a reduction in the medication dose may be required.

MM is a hypercoagulable disease, and measures should be taken to avoid deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients should wear anti-embolism stockings, exercise regularly, take low-dose aspirin, and move about frequently instead of sitting for long periods. Immunomodulatory medications may be adjusted to reduce the risk of a blot clot forming.

Infusion-related reactions are also a risk of therapy, and symptoms of a reaction need to be managed immediately and appropriately, with antihistamines, corticosteroids, interruption of the infusion, slowing of the infusion rate after symptom resolution, and permanent discontinuation in the case of grade 4 reactions.

The potential for longer survival exists, Colson said, due to appropriate supportive care measures.

Editors’ Note: The intent of this new column is to discuss topics at the intersection of technology and psychiatry – “Techiatry.” We’ve enlisted two leaders in this field to write for the column. Steven R. Daviss, MD, DFAPA (@HITshrink), is the chief medical informatics officer at M3 Information and chairs the American Psychiatric Association’s Committee on Mental Health Information Technology. James (Jay) H. Shore, MD, MPH, chairs the APA Committee on Telepsychiatry, is director of telemedicine at the Helen & Arthur E. Johnson Depression Center, and an associate professor of psychiatry at the University of Colorado at Denver, Aurora. Email them at [email protected].
 

Medicine is late to the game when it comes to technology, specifically information technology. And psychiatry, even more so. Jay will talk in future columns about early use of telepsychiatry in the 1960s and since. But here in 2016, a surprisingly low percentage of us are using it to deliver care, despite the fact that half of the counties in the United States lack psychiatrists – and telemedicine has been shown to improve access to care.

Nonetheless, telemedicine and other uses of technology across all specialties is growing quickly, as usability, mobile technology, economics, and policy-making all converge. The integration of mental health care (including addiction treatment) with primary care is one of the driving forces in expanding access to the expertise that physicians trained in psychiatry possess. The collaborative care model of integrated care has the most evidence, making regular access to psychiatric consultants a weekly event.

Editors’ Note: The intent of this new column is to discuss topics at the intersection of technology and psychiatry – “Techiatry.” We’ve enlisted two leaders in this field to write for the column. Steven R. Daviss, MD, DFAPA (@HITshrink), is the chief medical informatics officer at M3 Information and chairs the American Psychiatric Association’s Committee on Mental Health Information Technology. James (Jay) H. Shore, MD, MPH, chairs the APA Committee on Telepsychiatry, is director of telemedicine at the Helen & Arthur E. Johnson Depression Center, and an associate professor of psychiatry at the University of Colorado at Denver, Aurora. Email them at [email protected].
 

Medicine is late to the game when it comes to technology, specifically information technology. And psychiatry, even more so. Jay will talk in future columns about early use of telepsychiatry in the 1960s and since. But here in 2016, a surprisingly low percentage of us are using it to deliver care, despite the fact that half of the counties in the United States lack psychiatrists – and telemedicine has been shown to improve access to care.

Nonetheless, telemedicine and other uses of technology across all specialties is growing quickly, as usability, mobile technology, economics, and policy-making all converge. The integration of mental health care (including addiction treatment) with primary care is one of the driving forces in expanding access to the expertise that physicians trained in psychiatry possess. The collaborative care model of integrated care has the most evidence, making regular access to psychiatric consultants a weekly event.

Editors’ Note: The intent of this new column is to discuss topics at the intersection of technology and psychiatry – “Techiatry.” We’ve enlisted two leaders in this field to write for the column. Steven R. Daviss, MD, DFAPA (@HITshrink), is the chief medical informatics officer at M3 Information and chairs the American Psychiatric Association’s Committee on Mental Health Information Technology. James (Jay) H. Shore, MD, MPH, chairs the APA Committee on Telepsychiatry, is director of telemedicine at the Helen & Arthur E. Johnson Depression Center, and an associate professor of psychiatry at the University of Colorado at Denver, Aurora. Email them at [email protected].
 

Medicine is late to the game when it comes to technology, specifically information technology. And psychiatry, even more so. Jay will talk in future columns about early use of telepsychiatry in the 1960s and since. But here in 2016, a surprisingly low percentage of us are using it to deliver care, despite the fact that half of the counties in the United States lack psychiatrists – and telemedicine has been shown to improve access to care.

Nonetheless, telemedicine and other uses of technology across all specialties is growing quickly, as usability, mobile technology, economics, and policy-making all converge. The integration of mental health care (including addiction treatment) with primary care is one of the driving forces in expanding access to the expertise that physicians trained in psychiatry possess. The collaborative care model of integrated care has the most evidence, making regular access to psychiatric consultants a weekly event.

COPENHAGEN – Neoadjuvant therapy with the PD-1 checkpoint inhibitor nivolumab is safe, does not delay surgery, and may offer clinical benefit in some patients with early-stage non–small cell lung cancer, preliminary results of a clinical trial show.

Among 17 patients with previously untreated stage I-IIIA non–small cell lung cancer (NSCLC) who had two courses of nivolumab (Opdivo) followed by surgical resection, 12 had pathologic evidence of tumor regression, including 7 who had what investigators termed a “major pathologic response,” defined as less than 10% residual viable tumor, reported Patrick M. Forde, MBBCh, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore.

[email protected]

COPENHAGEN – Neoadjuvant therapy with the PD-1 checkpoint inhibitor nivolumab is safe, does not delay surgery, and may offer clinical benefit in some patients with early-stage non–small cell lung cancer, preliminary results of a clinical trial show.

Among 17 patients with previously untreated stage I-IIIA non–small cell lung cancer (NSCLC) who had two courses of nivolumab (Opdivo) followed by surgical resection, 12 had pathologic evidence of tumor regression, including 7 who had what investigators termed a “major pathologic response,” defined as less than 10% residual viable tumor, reported Patrick M. Forde, MBBCh, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore.

[email protected]

COPENHAGEN – Neoadjuvant therapy with the PD-1 checkpoint inhibitor nivolumab is safe, does not delay surgery, and may offer clinical benefit in some patients with early-stage non–small cell lung cancer, preliminary results of a clinical trial show.

Among 17 patients with previously untreated stage I-IIIA non–small cell lung cancer (NSCLC) who had two courses of nivolumab (Opdivo) followed by surgical resection, 12 had pathologic evidence of tumor regression, including 7 who had what investigators termed a “major pathologic response,” defined as less than 10% residual viable tumor, reported Patrick M. Forde, MBBCh, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University in Baltimore.

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DENVER – Ureteral jets were best visualized during cystoscopy with the help of 10% dextrose or sodium fluorescein, instead of phenazopyridine or normal saline, findings from a multicenter, randomized controlled trial suggested.

User satisfaction also was significantly higher with 10% dextrose and fluorescein, compared with the other interventions, Luis Espaillat-Rijo, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

Average total cystoscopy time, time to first jet visualization, and rates of postoperative urinary tract infections were similar among groups, noted Dr. Espaillat-Rijo, who conducted the research at the Cleveland Clinic Florida in Weston.

Historically, surgeons used intravenous indigo carmine to evaluate ureteral patency during intraoperative cystoscopy, but the Food and Drug Administration announced a shortage in June 2014 that has not resolved.

Hypothesizing that not all alternatives confer equivalent visibility, the researchers randomly assigned 174 female cystoscopy patients aged 18 years or older to one of four interventions: intravenous sodium fluorescein, preoperative oral phenazopyridine (Pyridium), 10% dextrose solution, or normal saline (control).

The researchers excluded patients with kidney disease or a history of surgery for renal or ureteral obstruction. The primary outcome was visibility of the urine jet, which surgeons described as clearly visible, somewhat visible, or not at all visible. Surgeons also were asked how satisfied or confident they were in assessing ureteral patency with the test media, Dr. Espaillat-Rijo said.

The study groups were demographically similar. Fluorescein and 10% dextrose resulted in the highest visibility, with more than 80% of surgeons describing the ureteral jets as “clearly visible” with these modalities, compared with about 60% of cases in which phenazopyridine or saline was used (P = .001, for differences among groups).

Similarly, more than 80% of surgeons reported being very or somewhat satisfied with 10% dextrose and fluorescein, while about 60% of surgeons said they were very or somewhat satisfied with phenazopyridine and saline (P less than .001).

“It was interesting that phenazopyridine was not more visible than control saline,” Dr. Espaillat-Rijo said. “Surgeons also noted that it was harder to evaluate the uroepithelium when it was tinged with Pyridium.”

Use of these interventions did not add time to the procedure, he noted. Total cystoscopy time averaged 4.5 minutes and was similar among groups. Average time to detection of the first jet also was similar among all four interventions, ranging from 1.8 to 2.5 minutes.

None of the patients had allergic reactions or adverse events considered related to an intervention. The rates of urinary tract infection ranged from approximately 22% to 30% and were similar among groups. Three ureteral obstructions were correctly identified and released intraoperatively, and none was identified postoperatively. One patient had an episode of acute urinary retention 4 days after surgery that led to bladder rupture.

“Because we had no postoperative ureteral injuries, we were unable to detect the sensitivity or specificity for each method,” Dr. Espaillat-Rijo said. “Another limitation is that we did not have the power to find a difference in our secondary outcomes, and indigo carmine was not used as a control.”

The Cleveland Clinic Florida sponsored the study. The researchers reported having no relevant financial disclosures.

DENVER – Ureteral jets were best visualized during cystoscopy with the help of 10% dextrose or sodium fluorescein, instead of phenazopyridine or normal saline, findings from a multicenter, randomized controlled trial suggested.

User satisfaction also was significantly higher with 10% dextrose and fluorescein, compared with the other interventions, Luis Espaillat-Rijo, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

Average total cystoscopy time, time to first jet visualization, and rates of postoperative urinary tract infections were similar among groups, noted Dr. Espaillat-Rijo, who conducted the research at the Cleveland Clinic Florida in Weston.

Historically, surgeons used intravenous indigo carmine to evaluate ureteral patency during intraoperative cystoscopy, but the Food and Drug Administration announced a shortage in June 2014 that has not resolved.

Hypothesizing that not all alternatives confer equivalent visibility, the researchers randomly assigned 174 female cystoscopy patients aged 18 years or older to one of four interventions: intravenous sodium fluorescein, preoperative oral phenazopyridine (Pyridium), 10% dextrose solution, or normal saline (control).

The researchers excluded patients with kidney disease or a history of surgery for renal or ureteral obstruction. The primary outcome was visibility of the urine jet, which surgeons described as clearly visible, somewhat visible, or not at all visible. Surgeons also were asked how satisfied or confident they were in assessing ureteral patency with the test media, Dr. Espaillat-Rijo said.

The study groups were demographically similar. Fluorescein and 10% dextrose resulted in the highest visibility, with more than 80% of surgeons describing the ureteral jets as “clearly visible” with these modalities, compared with about 60% of cases in which phenazopyridine or saline was used (P = .001, for differences among groups).

Similarly, more than 80% of surgeons reported being very or somewhat satisfied with 10% dextrose and fluorescein, while about 60% of surgeons said they were very or somewhat satisfied with phenazopyridine and saline (P less than .001).

“It was interesting that phenazopyridine was not more visible than control saline,” Dr. Espaillat-Rijo said. “Surgeons also noted that it was harder to evaluate the uroepithelium when it was tinged with Pyridium.”

Use of these interventions did not add time to the procedure, he noted. Total cystoscopy time averaged 4.5 minutes and was similar among groups. Average time to detection of the first jet also was similar among all four interventions, ranging from 1.8 to 2.5 minutes.

None of the patients had allergic reactions or adverse events considered related to an intervention. The rates of urinary tract infection ranged from approximately 22% to 30% and were similar among groups. Three ureteral obstructions were correctly identified and released intraoperatively, and none was identified postoperatively. One patient had an episode of acute urinary retention 4 days after surgery that led to bladder rupture.

“Because we had no postoperative ureteral injuries, we were unable to detect the sensitivity or specificity for each method,” Dr. Espaillat-Rijo said. “Another limitation is that we did not have the power to find a difference in our secondary outcomes, and indigo carmine was not used as a control.”

The Cleveland Clinic Florida sponsored the study. The researchers reported having no relevant financial disclosures.

DENVER – Ureteral jets were best visualized during cystoscopy with the help of 10% dextrose or sodium fluorescein, instead of phenazopyridine or normal saline, findings from a multicenter, randomized controlled trial suggested.

User satisfaction also was significantly higher with 10% dextrose and fluorescein, compared with the other interventions, Luis Espaillat-Rijo, MD, reported at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.

Average total cystoscopy time, time to first jet visualization, and rates of postoperative urinary tract infections were similar among groups, noted Dr. Espaillat-Rijo, who conducted the research at the Cleveland Clinic Florida in Weston.

Historically, surgeons used intravenous indigo carmine to evaluate ureteral patency during intraoperative cystoscopy, but the Food and Drug Administration announced a shortage in June 2014 that has not resolved.

Hypothesizing that not all alternatives confer equivalent visibility, the researchers randomly assigned 174 female cystoscopy patients aged 18 years or older to one of four interventions: intravenous sodium fluorescein, preoperative oral phenazopyridine (Pyridium), 10% dextrose solution, or normal saline (control).

The researchers excluded patients with kidney disease or a history of surgery for renal or ureteral obstruction. The primary outcome was visibility of the urine jet, which surgeons described as clearly visible, somewhat visible, or not at all visible. Surgeons also were asked how satisfied or confident they were in assessing ureteral patency with the test media, Dr. Espaillat-Rijo said.

The study groups were demographically similar. Fluorescein and 10% dextrose resulted in the highest visibility, with more than 80% of surgeons describing the ureteral jets as “clearly visible” with these modalities, compared with about 60% of cases in which phenazopyridine or saline was used (P = .001, for differences among groups).

Similarly, more than 80% of surgeons reported being very or somewhat satisfied with 10% dextrose and fluorescein, while about 60% of surgeons said they were very or somewhat satisfied with phenazopyridine and saline (P less than .001).

“It was interesting that phenazopyridine was not more visible than control saline,” Dr. Espaillat-Rijo said. “Surgeons also noted that it was harder to evaluate the uroepithelium when it was tinged with Pyridium.”

Use of these interventions did not add time to the procedure, he noted. Total cystoscopy time averaged 4.5 minutes and was similar among groups. Average time to detection of the first jet also was similar among all four interventions, ranging from 1.8 to 2.5 minutes.

None of the patients had allergic reactions or adverse events considered related to an intervention. The rates of urinary tract infection ranged from approximately 22% to 30% and were similar among groups. Three ureteral obstructions were correctly identified and released intraoperatively, and none was identified postoperatively. One patient had an episode of acute urinary retention 4 days after surgery that led to bladder rupture.

“Because we had no postoperative ureteral injuries, we were unable to detect the sensitivity or specificity for each method,” Dr. Espaillat-Rijo said. “Another limitation is that we did not have the power to find a difference in our secondary outcomes, and indigo carmine was not used as a control.”

The Cleveland Clinic Florida sponsored the study. The researchers reported having no relevant financial disclosures.