Jeff Craven

Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research in Obstetrics & Gynecology.

“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues wrote.

Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index (BMI) after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecological surgery between March 2016 and August 2019. Patients in the study were aged a median 61 years with a median BMI of 26 kg/m², but 32 patients with a BMI of 40 or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.

In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.

The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%), compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5 to 6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering, compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”

The analysis of patients with a BMI of 40 or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 (range, 17-60) was significantly associated with not developing a wound complication, compared with a BMI of 32 (range, 17-56) (P < .001), and that 41% of patients with a BMI of at least 40 experienced wound complications, compared with 15% of patients with a BMI of less than 40 (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% CI, 1.06-1.14).
 

Applicability of results unclear for patients with higher BMI

Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Dr. Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.

“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, who noted the median BMI of 26 for patients included in the study. A study that included only patients with a BMI of 40 or higher “would have made these results more applicable.”

The low rate of wound complications in the study could potentially be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29, compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67.

“It’s hard to cross-trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical-site infections and wound complications in the heavy patient with comorbidities is still unanswered.”

The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”

This study was funded in part by a support grant from the National Institutes of Health/National Cancer Institute Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speaker’s bureau positions with AstraZeneca, Biom’Up, Bovie Medical, C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical, JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix, UpToDate, and Verthermia. Dr. Temkin reported no relevant financial disclosures.

Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research in Obstetrics & Gynecology.

“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues wrote.

Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index (BMI) after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecological surgery between March 2016 and August 2019. Patients in the study were aged a median 61 years with a median BMI of 26 kg/m², but 32 patients with a BMI of 40 or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.

In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.

The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%), compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5 to 6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering, compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”

The analysis of patients with a BMI of 40 or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 (range, 17-60) was significantly associated with not developing a wound complication, compared with a BMI of 32 (range, 17-56) (P < .001), and that 41% of patients with a BMI of at least 40 experienced wound complications, compared with 15% of patients with a BMI of less than 40 (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% CI, 1.06-1.14).
 

Applicability of results unclear for patients with higher BMI

Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Dr. Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.

“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, who noted the median BMI of 26 for patients included in the study. A study that included only patients with a BMI of 40 or higher “would have made these results more applicable.”

The low rate of wound complications in the study could potentially be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29, compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67.

“It’s hard to cross-trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical-site infections and wound complications in the heavy patient with comorbidities is still unanswered.”

The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”

This study was funded in part by a support grant from the National Institutes of Health/National Cancer Institute Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speaker’s bureau positions with AstraZeneca, Biom’Up, Bovie Medical, C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical, JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix, UpToDate, and Verthermia. Dr. Temkin reported no relevant financial disclosures.

Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research in Obstetrics & Gynecology.

“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues wrote.

Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index (BMI) after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecological surgery between March 2016 and August 2019. Patients in the study were aged a median 61 years with a median BMI of 26 kg/m², but 32 patients with a BMI of 40 or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.

In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.

The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%), compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5 to 6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering, compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”

The analysis of patients with a BMI of 40 or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 (range, 17-60) was significantly associated with not developing a wound complication, compared with a BMI of 32 (range, 17-56) (P < .001), and that 41% of patients with a BMI of at least 40 experienced wound complications, compared with 15% of patients with a BMI of less than 40 (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% CI, 1.06-1.14).
 

Applicability of results unclear for patients with higher BMI

Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Dr. Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.

“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, who noted the median BMI of 26 for patients included in the study. A study that included only patients with a BMI of 40 or higher “would have made these results more applicable.”

The low rate of wound complications in the study could potentially be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29, compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67.

“It’s hard to cross-trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical-site infections and wound complications in the heavy patient with comorbidities is still unanswered.”

The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”

This study was funded in part by a support grant from the National Institutes of Health/National Cancer Institute Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speaker’s bureau positions with AstraZeneca, Biom’Up, Bovie Medical, C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical, JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix, UpToDate, and Verthermia. Dr. Temkin reported no relevant financial disclosures.

Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research published in Obstetrics & Gynecology.

“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” wrote Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues.

Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecologic surgery between March 2016 and August 2019.

The median age of the patients was 61 years and median BMI was 26 kg/m². Thirty-two patients with a BMI of 40 kg/m² or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.

In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.

The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%) compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5-6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”

The analysis of patients with a BMI of 40 kg/m² or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) did so in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 kg/m² (range, 17-60 kg/m²) was significantly associated with not developing a wound complication compared with a BMI of 32 kg/m² (range, 17-56 kg/m²) (P < .001), and that 41% of patients with a BMI of at least 40 kg/m² experienced wound complications compared with 15% of patients with a BMI of less than 40 kg/m² (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% confidence interval, 1.06–1.14).
 

Applicability of results unclear for patients with higher BMI

Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.

“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, noting the median BMI of 26 kg/m² for patients included in the study. A study that included only patients with a BMI of 40 kg/m² or higher “would have made these results more applicable,” she said.

The low rate of wound complications in the study could be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29 kg/m² compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67 kg/m².

“It’s hard to cross trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical site infections and wound complications in the heavy patient with comorbidities is still unanswered.”

The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”

This study was funded in part by a support grant from NIH/NCI Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speakers bureau positions with AstraZeneca, Biom’Up, Bovie Medical Co., C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical Inc., JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix Inc., UpToDate, and Verthermia Inc. Dr. Temkin reported no relevant financial disclosures.

Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research published in Obstetrics & Gynecology.

“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” wrote Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues.

Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecologic surgery between March 2016 and August 2019.

The median age of the patients was 61 years and median BMI was 26 kg/m². Thirty-two patients with a BMI of 40 kg/m² or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.

In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.

The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%) compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5-6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”

The analysis of patients with a BMI of 40 kg/m² or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) did so in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 kg/m² (range, 17-60 kg/m²) was significantly associated with not developing a wound complication compared with a BMI of 32 kg/m² (range, 17-56 kg/m²) (P < .001), and that 41% of patients with a BMI of at least 40 kg/m² experienced wound complications compared with 15% of patients with a BMI of less than 40 kg/m² (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% confidence interval, 1.06–1.14).
 

Applicability of results unclear for patients with higher BMI

Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.

“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, noting the median BMI of 26 kg/m² for patients included in the study. A study that included only patients with a BMI of 40 kg/m² or higher “would have made these results more applicable,” she said.

The low rate of wound complications in the study could be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29 kg/m² compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67 kg/m².

“It’s hard to cross trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical site infections and wound complications in the heavy patient with comorbidities is still unanswered.”

The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”

This study was funded in part by a support grant from NIH/NCI Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speakers bureau positions with AstraZeneca, Biom’Up, Bovie Medical Co., C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical Inc., JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix Inc., UpToDate, and Verthermia Inc. Dr. Temkin reported no relevant financial disclosures.

Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research published in Obstetrics & Gynecology.

“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” wrote Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues.

Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecologic surgery between March 2016 and August 2019.

The median age of the patients was 61 years and median BMI was 26 kg/m². Thirty-two patients with a BMI of 40 kg/m² or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.

In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.

The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%) compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5-6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”

The analysis of patients with a BMI of 40 kg/m² or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) did so in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 kg/m² (range, 17-60 kg/m²) was significantly associated with not developing a wound complication compared with a BMI of 32 kg/m² (range, 17-56 kg/m²) (P < .001), and that 41% of patients with a BMI of at least 40 kg/m² experienced wound complications compared with 15% of patients with a BMI of less than 40 kg/m² (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% confidence interval, 1.06–1.14).
 

Applicability of results unclear for patients with higher BMI

Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.

“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, noting the median BMI of 26 kg/m² for patients included in the study. A study that included only patients with a BMI of 40 kg/m² or higher “would have made these results more applicable,” she said.

The low rate of wound complications in the study could be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29 kg/m² compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67 kg/m².

“It’s hard to cross trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical site infections and wound complications in the heavy patient with comorbidities is still unanswered.”

The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”

This study was funded in part by a support grant from NIH/NCI Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speakers bureau positions with AstraZeneca, Biom’Up, Bovie Medical Co., C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical Inc., JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix Inc., UpToDate, and Verthermia Inc. Dr. Temkin reported no relevant financial disclosures.

Younger adolescents who underwent metabolic and bariatric surgery had outcomes similar to those of older adolescents undergoing the same procedure, according to recent research in Pediatrics.

Five years after metabolic and bariatric surgery (MBS), adolescents between ages 13 and 15 years had similar outcomes with regard to reduction in body mass index percentage, hypertension and dyslipidemia, and improved quality of life, compared with adolescents between ages 16 and 19 years, according to Sarah B. Ogle, DO, MS, of Children’s Hospital Colorado at the University of Colorado at Denver, Aurora, and colleagues.

“These results appear promising for the treatment of severe obesity in young patients,” Dr. Ogle and colleagues wrote, “however, further controlled studies are needed to fully evaluate the timing of surgery and extended long-term durability.”

The researchers analyzed the outcomes of adolescents enrolled in the Teen–Longitudinal Assessment of Bariatric Surgery who were aged 19 years or younger and underwent MBS between March 2007 and December 2011 at five U.S. centers. In the group of younger adolescents (66 participants), the mean age at surgery was 15.1 years, while the group of older adolescents (162 participants) had a mean age of 17.7 years at the time of surgery. Both groups consisted mostly of White (71.6%-72.7%) girls (72.7%-75.9%) who were morbidly obese (mean BMI, 52.4-53.1 kg/m²). With regard to baseline comorbidities, about three-quarters of participants in the younger (72.4%) and older (77.0%) adolescent groups had dyslipidemia. More than one-quarter of younger adolescents had hypertension (27.3%) compared with more than one-third of older adolescents (37.1%). The prevalence of type 2 diabetes was 10.6% in the younger adolescent group and 13.6% among older adolescents.

At 5-year follow-up, there was a similar BMI reduction maintained from baseline in the younger adolescent group (–22.2%; 95% confidence interval, –26.2% to –18.2%) and the older adolescent group (–24.6%; 95% CI, –27.7% to –22.5%; P = .59). There was a similar number of participants who had remission of dyslipidemia at 5 years in the younger adolescent group (61%; 95% CI, 46.3%-81.1%) and older adolescent group (58%; 95% CI, 48.0%-68.9%; P = .74). In participants with hypertension, 77% of younger adolescents (95% CI, 57.1%-100.0%) and 67% of older adolescents (95% CI, 54.5%-81.5%) achieved remission at 5 years after MBS, which showed no significant differences after adjustment (P = .84). For participants with type 2 diabetes at baseline, 83% of younger adolescents (6 participants) and 87% of older adolescents (15 participants) experienced remission by 5 years after surgery. Participants in both younger and older adolescent groups had similar quality of life scores at 5 years after surgery. When analyzing nutritional abnormalities, the researchers found younger adolescents in the group were less at risk for elevated transferrin levels (prevalence ratio, 0.52; P = .048) as well as less likely to have low vitamin D levels (prevalence ratio, 0.8; P = .034).
 

Pediatricians still concerned about safety

In an interview, Kelly A. Curran, MD, MA, assistant professor of pediatrics at University of Oklahoma Children’s Hospital in Oklahoma City, said that the findings by Dr. Ogle and colleagues add to a “growing body of literature about the importance of bariatric surgery for both younger and older adolescents.

“While many often see bariatric surgery as a ‘last resort,’ this study shows good outcomes in resolving obesity-related health conditions in both young and older teens over time – and something that should be considered more frequently than it is currently being used,” she said.

Guidelines from the American Society for Metabolic and Bariatric Surgery removed a restriction for younger age before a patient undergoes MBS, and a policy statement from the American Academy of Pediatrics encouraged increased use and access to MBS for younger adolescents. However, Dr. Curran noted that many pediatricians are still concerned about performing MBS on younger adolescents.

“Despite growing evidence of safety, I think many pediatricians worry about the potential for unintended consequences and potential impact on adolescent development or for lifelong micronutrition deficiencies – especially as there are no longitudinal studies over a lifetime,” she said.

“[W]ith the growing obesity epidemic and the long-term consequences of obesity on health and quality of life – the potential to help impact adolescents’ lives – for now and for the future – is impressive,” Dr. Curran said, acknowledging the ethical challenges involved with performing MBS on a patient who may be too young to understand the full risks and benefits of surgery.

“There are always inherent ethical challenges in providing surgery for patients too young to understand – we are asking parents to act in their child’s best interests, which may be murky to elucidate,” she explained. “While there is [a] growing body of literature around the safety and efficacy in bariatric surgery for children and adolescents, there are still many unanswered questions that remain – especially for parents. Parents can feel trapped in between these two choices – have children undergo surgery or stick with potentially less effective medical management.”

The limitations of the study include its observational nature, small sample size of some comorbidities, and a lack of diversity among participants, most of whom were White and female. In addition, “long-term studies examining the impact of bariatric surgery during adolescence would be important to give more perspective and guidance on the risks and benefits for teens,” Dr. Curran said.

The study was funded by the National Institutes of Health and grants from the National Institute of Diabetes and Digestive and Kidney Diseases as well as grants from Cincinnati Children’s Hospital Medical Center, Nationwide Children’s Hospital, Texas Children’s Hospital and Baylor College of Medicine, University of Pittsburgh, and the University of Alabama at Birmingham. The authors and Dr. Curran reported no conflicts of interest.
 

Younger adolescents who underwent metabolic and bariatric surgery had outcomes similar to those of older adolescents undergoing the same procedure, according to recent research in Pediatrics.

Five years after metabolic and bariatric surgery (MBS), adolescents between ages 13 and 15 years had similar outcomes with regard to reduction in body mass index percentage, hypertension and dyslipidemia, and improved quality of life, compared with adolescents between ages 16 and 19 years, according to Sarah B. Ogle, DO, MS, of Children’s Hospital Colorado at the University of Colorado at Denver, Aurora, and colleagues.

“These results appear promising for the treatment of severe obesity in young patients,” Dr. Ogle and colleagues wrote, “however, further controlled studies are needed to fully evaluate the timing of surgery and extended long-term durability.”

The researchers analyzed the outcomes of adolescents enrolled in the Teen–Longitudinal Assessment of Bariatric Surgery who were aged 19 years or younger and underwent MBS between March 2007 and December 2011 at five U.S. centers. In the group of younger adolescents (66 participants), the mean age at surgery was 15.1 years, while the group of older adolescents (162 participants) had a mean age of 17.7 years at the time of surgery. Both groups consisted mostly of White (71.6%-72.7%) girls (72.7%-75.9%) who were morbidly obese (mean BMI, 52.4-53.1 kg/m²). With regard to baseline comorbidities, about three-quarters of participants in the younger (72.4%) and older (77.0%) adolescent groups had dyslipidemia. More than one-quarter of younger adolescents had hypertension (27.3%) compared with more than one-third of older adolescents (37.1%). The prevalence of type 2 diabetes was 10.6% in the younger adolescent group and 13.6% among older adolescents.

At 5-year follow-up, there was a similar BMI reduction maintained from baseline in the younger adolescent group (–22.2%; 95% confidence interval, –26.2% to –18.2%) and the older adolescent group (–24.6%; 95% CI, –27.7% to –22.5%; P = .59). There was a similar number of participants who had remission of dyslipidemia at 5 years in the younger adolescent group (61%; 95% CI, 46.3%-81.1%) and older adolescent group (58%; 95% CI, 48.0%-68.9%; P = .74). In participants with hypertension, 77% of younger adolescents (95% CI, 57.1%-100.0%) and 67% of older adolescents (95% CI, 54.5%-81.5%) achieved remission at 5 years after MBS, which showed no significant differences after adjustment (P = .84). For participants with type 2 diabetes at baseline, 83% of younger adolescents (6 participants) and 87% of older adolescents (15 participants) experienced remission by 5 years after surgery. Participants in both younger and older adolescent groups had similar quality of life scores at 5 years after surgery. When analyzing nutritional abnormalities, the researchers found younger adolescents in the group were less at risk for elevated transferrin levels (prevalence ratio, 0.52; P = .048) as well as less likely to have low vitamin D levels (prevalence ratio, 0.8; P = .034).
 

Pediatricians still concerned about safety

In an interview, Kelly A. Curran, MD, MA, assistant professor of pediatrics at University of Oklahoma Children’s Hospital in Oklahoma City, said that the findings by Dr. Ogle and colleagues add to a “growing body of literature about the importance of bariatric surgery for both younger and older adolescents.

“While many often see bariatric surgery as a ‘last resort,’ this study shows good outcomes in resolving obesity-related health conditions in both young and older teens over time – and something that should be considered more frequently than it is currently being used,” she said.

Guidelines from the American Society for Metabolic and Bariatric Surgery removed a restriction for younger age before a patient undergoes MBS, and a policy statement from the American Academy of Pediatrics encouraged increased use and access to MBS for younger adolescents. However, Dr. Curran noted that many pediatricians are still concerned about performing MBS on younger adolescents.

“Despite growing evidence of safety, I think many pediatricians worry about the potential for unintended consequences and potential impact on adolescent development or for lifelong micronutrition deficiencies – especially as there are no longitudinal studies over a lifetime,” she said.

“[W]ith the growing obesity epidemic and the long-term consequences of obesity on health and quality of life – the potential to help impact adolescents’ lives – for now and for the future – is impressive,” Dr. Curran said, acknowledging the ethical challenges involved with performing MBS on a patient who may be too young to understand the full risks and benefits of surgery.

“There are always inherent ethical challenges in providing surgery for patients too young to understand – we are asking parents to act in their child’s best interests, which may be murky to elucidate,” she explained. “While there is [a] growing body of literature around the safety and efficacy in bariatric surgery for children and adolescents, there are still many unanswered questions that remain – especially for parents. Parents can feel trapped in between these two choices – have children undergo surgery or stick with potentially less effective medical management.”

The limitations of the study include its observational nature, small sample size of some comorbidities, and a lack of diversity among participants, most of whom were White and female. In addition, “long-term studies examining the impact of bariatric surgery during adolescence would be important to give more perspective and guidance on the risks and benefits for teens,” Dr. Curran said.

The study was funded by the National Institutes of Health and grants from the National Institute of Diabetes and Digestive and Kidney Diseases as well as grants from Cincinnati Children’s Hospital Medical Center, Nationwide Children’s Hospital, Texas Children’s Hospital and Baylor College of Medicine, University of Pittsburgh, and the University of Alabama at Birmingham. The authors and Dr. Curran reported no conflicts of interest.
 

Younger adolescents who underwent metabolic and bariatric surgery had outcomes similar to those of older adolescents undergoing the same procedure, according to recent research in Pediatrics.

Five years after metabolic and bariatric surgery (MBS), adolescents between ages 13 and 15 years had similar outcomes with regard to reduction in body mass index percentage, hypertension and dyslipidemia, and improved quality of life, compared with adolescents between ages 16 and 19 years, according to Sarah B. Ogle, DO, MS, of Children’s Hospital Colorado at the University of Colorado at Denver, Aurora, and colleagues.

“These results appear promising for the treatment of severe obesity in young patients,” Dr. Ogle and colleagues wrote, “however, further controlled studies are needed to fully evaluate the timing of surgery and extended long-term durability.”

The researchers analyzed the outcomes of adolescents enrolled in the Teen–Longitudinal Assessment of Bariatric Surgery who were aged 19 years or younger and underwent MBS between March 2007 and December 2011 at five U.S. centers. In the group of younger adolescents (66 participants), the mean age at surgery was 15.1 years, while the group of older adolescents (162 participants) had a mean age of 17.7 years at the time of surgery. Both groups consisted mostly of White (71.6%-72.7%) girls (72.7%-75.9%) who were morbidly obese (mean BMI, 52.4-53.1 kg/m²). With regard to baseline comorbidities, about three-quarters of participants in the younger (72.4%) and older (77.0%) adolescent groups had dyslipidemia. More than one-quarter of younger adolescents had hypertension (27.3%) compared with more than one-third of older adolescents (37.1%). The prevalence of type 2 diabetes was 10.6% in the younger adolescent group and 13.6% among older adolescents.

At 5-year follow-up, there was a similar BMI reduction maintained from baseline in the younger adolescent group (–22.2%; 95% confidence interval, –26.2% to –18.2%) and the older adolescent group (–24.6%; 95% CI, –27.7% to –22.5%; P = .59). There was a similar number of participants who had remission of dyslipidemia at 5 years in the younger adolescent group (61%; 95% CI, 46.3%-81.1%) and older adolescent group (58%; 95% CI, 48.0%-68.9%; P = .74). In participants with hypertension, 77% of younger adolescents (95% CI, 57.1%-100.0%) and 67% of older adolescents (95% CI, 54.5%-81.5%) achieved remission at 5 years after MBS, which showed no significant differences after adjustment (P = .84). For participants with type 2 diabetes at baseline, 83% of younger adolescents (6 participants) and 87% of older adolescents (15 participants) experienced remission by 5 years after surgery. Participants in both younger and older adolescent groups had similar quality of life scores at 5 years after surgery. When analyzing nutritional abnormalities, the researchers found younger adolescents in the group were less at risk for elevated transferrin levels (prevalence ratio, 0.52; P = .048) as well as less likely to have low vitamin D levels (prevalence ratio, 0.8; P = .034).
 

Pediatricians still concerned about safety

In an interview, Kelly A. Curran, MD, MA, assistant professor of pediatrics at University of Oklahoma Children’s Hospital in Oklahoma City, said that the findings by Dr. Ogle and colleagues add to a “growing body of literature about the importance of bariatric surgery for both younger and older adolescents.

“While many often see bariatric surgery as a ‘last resort,’ this study shows good outcomes in resolving obesity-related health conditions in both young and older teens over time – and something that should be considered more frequently than it is currently being used,” she said.

Guidelines from the American Society for Metabolic and Bariatric Surgery removed a restriction for younger age before a patient undergoes MBS, and a policy statement from the American Academy of Pediatrics encouraged increased use and access to MBS for younger adolescents. However, Dr. Curran noted that many pediatricians are still concerned about performing MBS on younger adolescents.

“Despite growing evidence of safety, I think many pediatricians worry about the potential for unintended consequences and potential impact on adolescent development or for lifelong micronutrition deficiencies – especially as there are no longitudinal studies over a lifetime,” she said.

“[W]ith the growing obesity epidemic and the long-term consequences of obesity on health and quality of life – the potential to help impact adolescents’ lives – for now and for the future – is impressive,” Dr. Curran said, acknowledging the ethical challenges involved with performing MBS on a patient who may be too young to understand the full risks and benefits of surgery.

“There are always inherent ethical challenges in providing surgery for patients too young to understand – we are asking parents to act in their child’s best interests, which may be murky to elucidate,” she explained. “While there is [a] growing body of literature around the safety and efficacy in bariatric surgery for children and adolescents, there are still many unanswered questions that remain – especially for parents. Parents can feel trapped in between these two choices – have children undergo surgery or stick with potentially less effective medical management.”

The limitations of the study include its observational nature, small sample size of some comorbidities, and a lack of diversity among participants, most of whom were White and female. In addition, “long-term studies examining the impact of bariatric surgery during adolescence would be important to give more perspective and guidance on the risks and benefits for teens,” Dr. Curran said.

The study was funded by the National Institutes of Health and grants from the National Institute of Diabetes and Digestive and Kidney Diseases as well as grants from Cincinnati Children’s Hospital Medical Center, Nationwide Children’s Hospital, Texas Children’s Hospital and Baylor College of Medicine, University of Pittsburgh, and the University of Alabama at Birmingham. The authors and Dr. Curran reported no conflicts of interest.
 

Areas with active cannabis dispensaries have seen a decrease in opioid-related mortalities, recent research has shown.

“Our findings suggest that higher storefront cannabis dispensary counts are associated with reduced opioid related mortality rates at the county level,” wrote Greta Hsu, PhD, professor of management, University of California, Davis, and Balázs Kovács, PhD, associate professor of organizational behavior, Yale University, New Haven, Conn. “This association holds for both medical and recreational dispensaries, and appears particularly strong for deaths associated with synthetic (nonmethadone) opioids, which include the highly potent synthetic opioid fentanyl and its analogs.”

Results ‘may be even stronger’ than reported

Christopher G. Fichtner, MD, clinical professor of psychiatry and neuroscience at the University of California, Riverside, said in an interview that the evidence for using cannabis as an opioid substitution for pain management has not been balanced, but noted “the bulk of it suggests that there is some harm reduction benefit by having liberalized access to cannabis.”

Courtesy Dr. Christopher Fichtner

One strength of the study by Dr. Hsu and Dr. Kovács was how they were able to examine implementation of legalization of medical or recreational cannabis, rather than simply a change in the law, he said.

“By looking at dispensary count, it’s actually looking at a better measure of on-the-ground implementation than just change in policy,” Dr. Fichtner explained. “You’re looking at what was actually accomplished in terms of making cannabis legally available.”

The choice to evaluate storefront dispensaries only and not include delivery services in their data, “probably makes it a relatively conservative estimate. I think that would be a strength, that their findings may be even stronger than what it is they’re reporting,” Dr. Fichtner said.

“I do think, if anything, the paper is relatively tentative about advancing its conclusions, which I think is a weakness in a lot of these studies,” he added. In 2017, the National Academy of Sciences released a report that found evidence cannabis or cannabinoids can significantly reduce pain symptoms. In that report, “one of their strongest conclusions is that there’s conclusive or substantial evidence that cannabis or cannabinoids are effective management of chronic pain,” Dr. Fichtner said.

He said that digging deeper into what kinds of pain cannabis can treat is one area for future research. “Certainly, it seems that it’s unlikely that cannabis is going to be good for every kind of pain,” he said. “What kinds of pain is it better for than others? Is it some benefit for many kinds of pain, or only a few types of pain?”

The authors reported no relevant financial disclosures. Dr. Fichtner is the author of a book on cannabis policy in the United States, but reported no other financial disclosures.
 

Areas with active cannabis dispensaries have seen a decrease in opioid-related mortalities, recent research has shown.

“Our findings suggest that higher storefront cannabis dispensary counts are associated with reduced opioid related mortality rates at the county level,” wrote Greta Hsu, PhD, professor of management, University of California, Davis, and Balázs Kovács, PhD, associate professor of organizational behavior, Yale University, New Haven, Conn. “This association holds for both medical and recreational dispensaries, and appears particularly strong for deaths associated with synthetic (nonmethadone) opioids, which include the highly potent synthetic opioid fentanyl and its analogs.”

Results ‘may be even stronger’ than reported

Christopher G. Fichtner, MD, clinical professor of psychiatry and neuroscience at the University of California, Riverside, said in an interview that the evidence for using cannabis as an opioid substitution for pain management has not been balanced, but noted “the bulk of it suggests that there is some harm reduction benefit by having liberalized access to cannabis.”

Courtesy Dr. Christopher Fichtner

One strength of the study by Dr. Hsu and Dr. Kovács was how they were able to examine implementation of legalization of medical or recreational cannabis, rather than simply a change in the law, he said.

“By looking at dispensary count, it’s actually looking at a better measure of on-the-ground implementation than just change in policy,” Dr. Fichtner explained. “You’re looking at what was actually accomplished in terms of making cannabis legally available.”

The choice to evaluate storefront dispensaries only and not include delivery services in their data, “probably makes it a relatively conservative estimate. I think that would be a strength, that their findings may be even stronger than what it is they’re reporting,” Dr. Fichtner said.

“I do think, if anything, the paper is relatively tentative about advancing its conclusions, which I think is a weakness in a lot of these studies,” he added. In 2017, the National Academy of Sciences released a report that found evidence cannabis or cannabinoids can significantly reduce pain symptoms. In that report, “one of their strongest conclusions is that there’s conclusive or substantial evidence that cannabis or cannabinoids are effective management of chronic pain,” Dr. Fichtner said.

He said that digging deeper into what kinds of pain cannabis can treat is one area for future research. “Certainly, it seems that it’s unlikely that cannabis is going to be good for every kind of pain,” he said. “What kinds of pain is it better for than others? Is it some benefit for many kinds of pain, or only a few types of pain?”

The authors reported no relevant financial disclosures. Dr. Fichtner is the author of a book on cannabis policy in the United States, but reported no other financial disclosures.
 

Areas with active cannabis dispensaries have seen a decrease in opioid-related mortalities, recent research has shown.

“Our findings suggest that higher storefront cannabis dispensary counts are associated with reduced opioid related mortality rates at the county level,” wrote Greta Hsu, PhD, professor of management, University of California, Davis, and Balázs Kovács, PhD, associate professor of organizational behavior, Yale University, New Haven, Conn. “This association holds for both medical and recreational dispensaries, and appears particularly strong for deaths associated with synthetic (nonmethadone) opioids, which include the highly potent synthetic opioid fentanyl and its analogs.”

Results ‘may be even stronger’ than reported

Christopher G. Fichtner, MD, clinical professor of psychiatry and neuroscience at the University of California, Riverside, said in an interview that the evidence for using cannabis as an opioid substitution for pain management has not been balanced, but noted “the bulk of it suggests that there is some harm reduction benefit by having liberalized access to cannabis.”

Courtesy Dr. Christopher Fichtner

One strength of the study by Dr. Hsu and Dr. Kovács was how they were able to examine implementation of legalization of medical or recreational cannabis, rather than simply a change in the law, he said.

“By looking at dispensary count, it’s actually looking at a better measure of on-the-ground implementation than just change in policy,” Dr. Fichtner explained. “You’re looking at what was actually accomplished in terms of making cannabis legally available.”

The choice to evaluate storefront dispensaries only and not include delivery services in their data, “probably makes it a relatively conservative estimate. I think that would be a strength, that their findings may be even stronger than what it is they’re reporting,” Dr. Fichtner said.

“I do think, if anything, the paper is relatively tentative about advancing its conclusions, which I think is a weakness in a lot of these studies,” he added. In 2017, the National Academy of Sciences released a report that found evidence cannabis or cannabinoids can significantly reduce pain symptoms. In that report, “one of their strongest conclusions is that there’s conclusive or substantial evidence that cannabis or cannabinoids are effective management of chronic pain,” Dr. Fichtner said.

He said that digging deeper into what kinds of pain cannabis can treat is one area for future research. “Certainly, it seems that it’s unlikely that cannabis is going to be good for every kind of pain,” he said. “What kinds of pain is it better for than others? Is it some benefit for many kinds of pain, or only a few types of pain?”

The authors reported no relevant financial disclosures. Dr. Fichtner is the author of a book on cannabis policy in the United States, but reported no other financial disclosures.
 

Is gouty nephropathy real? It’s a question that has been posed often in rheumatology over the last several decades.

HYWARDS/Getty Images

A new study found 36% of patients with untreated gout at a medical center in Vietnam have diffuse hyperechoic renal medulla as seen on ultrasound, which could indicate the presence of microcrystalline nephropathy. However, the results, published in Kidney International, may raise more questions than answers about the existence of gouty nephropathy and its relation to chronic kidney disease (CKD).

In their study, Thomas Bardin, MD, of the department of rheumatology at Lariboisière Hospital in Paris and colleagues evaluated 502 consecutive patients from Vien Gut Medical Center in Ho Chi Minh City, Vietnam, using B-mode renal ultrasound. The patients were mostly men with a median age of 46 years, body mass index of 25 kg/m², estimated disease duration of 4 years, and uricemia of 423.2 micromol/L (7.11 mg/dL). Patients had a median estimated glomerular filtration rate (eGFR) of 78 mL/min per 1.73 m². There was a history of hypertension in 112 patients (22.3%), type 2 diabetes in 58 patients (11.5%), renal lithiasis in 28 patients (5.6%), and coronary heart disease in 5 patients (1%).

While 39% of patients had previously used allopurinol for “a generally short period,” patients were not on urate-lowering therapy at the time of the study. Clinical tophi were present in 279 patients (55.6%), urate arthropathies in 154 patients (30.7%), and 43 patients (10.4%) used steroids daily.

B-mode renal ultrasound showed 181 patients (36%; 95% confidence interval, 32%-40%) had “hyperechoic pattern of Malpighi pyramids compared with the adjacent cortex,” which was “associated with twinkling artifacts” visible on color Doppler ultrasound. There was a significant association between renal medulla hyperechogenicity and patient age, disease duration, use of steroids, clinical tophi, and urate arthropathy (P less than .0001 for all). A significant association was also seen between renal medulla hyperechogenicity and decreased eGFR (P < .0001), proteinuria (P = .0006), leukocyturia (P = .0008), hypertension (P = .0008), hyperuricemia (P = .002), and coronary heart disease (P = .006).

In a multivariate analysis, there was a significant association between renal medulla hyperechogenicity and clinical tophi (odds ratio, 7.27; 95% CI, 3.68–15.19; P < .0001), urate arthropathy (OR, 3.46; 95% CI, 1.99–6.09; P < .0001), estimated gout duration (OR, 2.13; 95% CI, 1.55–2.96; P < .0001), double contour thickness (OR, 1.45; 95% CI, 1.06–1.97; P < .02), and eGFR (OR, 0.30; 95% CI, 0.09–0.89; P < .034).

“The finding was observed mainly in tophaceous gout, which involved a large proportion of our patients who had received very little treatment with urate-lowering drugs and was associated with moderately impaired renal function and urinary features compatible with tubulointerstitial nephritis,” Dr. Bardin and colleagues wrote in the study. The researchers also found “similar features” in 4 of 10 French patients at the Paris Necker Hospital in Paris, and noted that similar findings have been reported in Japan and Korea, which they said may mean hyperechoic medulla “is not unique to Vietnamese patients.”
 

Relation to CKD still unclear

In a related editorial, Federica Piani, MD, and Richard J. Johnson, MD, of the division of renal diseases and hypertension at the University of Colorado at Denver, Aurora, explained that gout was considered by some clinicians to be a cause of CKD in a time before urate-lowering therapies, because as many as 25% of patients with gout went on to experience kidney failure and about half experienced lower kidney function.

The association between gout and CKD was thought to be attributable to “frequent deposition of urate crystals in the tubular lumens and interstitium in the outer medulla of these patients,” but the concept was later challenged because “the crystals were generally found focally and did not readily explain the kidney damage.”

But even as interest in rheumatology moved away from the concept of gouty nephropathy to how serum uric acid impacts CKD, “the possibility that urate crystal deposition in the kidney could also be contributing to the kidney injury was never ruled out,” according to Dr. Piani and Dr. Johnson.

Kidney biopsies can sometimes miss urate crystals because the crystals dissolve if alcohol fixation is not used and because the biopsy site is often in the renal cortex, the authors noted. Recent research has identified that dual-energy CT scans can distinguish between calcium deposits and urate crystals better than ultrasound, and previous research from Thomas Bardin, MD, and colleagues in two patients noted a correlation between dual-energy CT scan findings of urate crystals and hyperechoic medulla findings on renal ultrasound.

The results by Dr. Bardin and associates, they said, “have reawakened the entity of urate microcrystalline nephropathy as a possible cause of CKD.”

Robert Terkeltaub, MD, professor of medicine at the University of California, San Diego, and section chief of Rheumatology at the San Diego VA Medical Center, said in an interview that he also believes the findings by Dr. Bardin and associates are real. He cited a study by Isabelle Ayoub, MD, and colleagues in Clinical Nephrology from 2016 that evaluated kidney biopsies in Germany and found medullary tophi were more likely to be present in patients with CKD than without.

“Chronic gouty nephropathy did not disappear. It still exists,” said Dr. Terkeltaub, who was not involved in the study by Dr. Bardin and colleagues.

The prospect that, if “you look hard enough, you’re going to see urate crystals and a pattern that’s attributed in the renal medulla” in patients with untreated gout is “very provocative, and interesting, and clinically relevant, and merits more investigation,” noted Dr. Terkeltaub, who is also president of the Gout, Hyperuricemia and Crystal-Associated Disease Network.

If verified, the results have important implications for patients with gout and its relationship to CKD, Dr. Terkeltaub said, but they raise “more questions than answers.

“I think it’s a really good wake-up call to start looking, doing good detective work here, and looking especially in people who have gout as opposed to just people with chronic kidney disease,” he said.

The authors reported no relevant conflicts of interest. Dr. Johnson, who coauthored an accompanying editorial, reported having equity in XORTX Therapeutics, serving as a consultant for Horizon Pharma, and having equity in Colorado Research Partners LLC. Dr. Terkeltaub reported receiving a research grant from AstraZeneca in the field of hyperuricemia and consultancies with AstraZeneca, Horizon, Sobi, Selecta Biosciences.

Is gouty nephropathy real? It’s a question that has been posed often in rheumatology over the last several decades.

HYWARDS/Getty Images

A new study found 36% of patients with untreated gout at a medical center in Vietnam have diffuse hyperechoic renal medulla as seen on ultrasound, which could indicate the presence of microcrystalline nephropathy. However, the results, published in Kidney International, may raise more questions than answers about the existence of gouty nephropathy and its relation to chronic kidney disease (CKD).

In their study, Thomas Bardin, MD, of the department of rheumatology at Lariboisière Hospital in Paris and colleagues evaluated 502 consecutive patients from Vien Gut Medical Center in Ho Chi Minh City, Vietnam, using B-mode renal ultrasound. The patients were mostly men with a median age of 46 years, body mass index of 25 kg/m², estimated disease duration of 4 years, and uricemia of 423.2 micromol/L (7.11 mg/dL). Patients had a median estimated glomerular filtration rate (eGFR) of 78 mL/min per 1.73 m². There was a history of hypertension in 112 patients (22.3%), type 2 diabetes in 58 patients (11.5%), renal lithiasis in 28 patients (5.6%), and coronary heart disease in 5 patients (1%).

While 39% of patients had previously used allopurinol for “a generally short period,” patients were not on urate-lowering therapy at the time of the study. Clinical tophi were present in 279 patients (55.6%), urate arthropathies in 154 patients (30.7%), and 43 patients (10.4%) used steroids daily.

B-mode renal ultrasound showed 181 patients (36%; 95% confidence interval, 32%-40%) had “hyperechoic pattern of Malpighi pyramids compared with the adjacent cortex,” which was “associated with twinkling artifacts” visible on color Doppler ultrasound. There was a significant association between renal medulla hyperechogenicity and patient age, disease duration, use of steroids, clinical tophi, and urate arthropathy (P less than .0001 for all). A significant association was also seen between renal medulla hyperechogenicity and decreased eGFR (P < .0001), proteinuria (P = .0006), leukocyturia (P = .0008), hypertension (P = .0008), hyperuricemia (P = .002), and coronary heart disease (P = .006).

In a multivariate analysis, there was a significant association between renal medulla hyperechogenicity and clinical tophi (odds ratio, 7.27; 95% CI, 3.68–15.19; P < .0001), urate arthropathy (OR, 3.46; 95% CI, 1.99–6.09; P < .0001), estimated gout duration (OR, 2.13; 95% CI, 1.55–2.96; P < .0001), double contour thickness (OR, 1.45; 95% CI, 1.06–1.97; P < .02), and eGFR (OR, 0.30; 95% CI, 0.09–0.89; P < .034).

“The finding was observed mainly in tophaceous gout, which involved a large proportion of our patients who had received very little treatment with urate-lowering drugs and was associated with moderately impaired renal function and urinary features compatible with tubulointerstitial nephritis,” Dr. Bardin and colleagues wrote in the study. The researchers also found “similar features” in 4 of 10 French patients at the Paris Necker Hospital in Paris, and noted that similar findings have been reported in Japan and Korea, which they said may mean hyperechoic medulla “is not unique to Vietnamese patients.”
 

Relation to CKD still unclear

In a related editorial, Federica Piani, MD, and Richard J. Johnson, MD, of the division of renal diseases and hypertension at the University of Colorado at Denver, Aurora, explained that gout was considered by some clinicians to be a cause of CKD in a time before urate-lowering therapies, because as many as 25% of patients with gout went on to experience kidney failure and about half experienced lower kidney function.

The association between gout and CKD was thought to be attributable to “frequent deposition of urate crystals in the tubular lumens and interstitium in the outer medulla of these patients,” but the concept was later challenged because “the crystals were generally found focally and did not readily explain the kidney damage.”

But even as interest in rheumatology moved away from the concept of gouty nephropathy to how serum uric acid impacts CKD, “the possibility that urate crystal deposition in the kidney could also be contributing to the kidney injury was never ruled out,” according to Dr. Piani and Dr. Johnson.

Kidney biopsies can sometimes miss urate crystals because the crystals dissolve if alcohol fixation is not used and because the biopsy site is often in the renal cortex, the authors noted. Recent research has identified that dual-energy CT scans can distinguish between calcium deposits and urate crystals better than ultrasound, and previous research from Thomas Bardin, MD, and colleagues in two patients noted a correlation between dual-energy CT scan findings of urate crystals and hyperechoic medulla findings on renal ultrasound.

The results by Dr. Bardin and associates, they said, “have reawakened the entity of urate microcrystalline nephropathy as a possible cause of CKD.”

Robert Terkeltaub, MD, professor of medicine at the University of California, San Diego, and section chief of Rheumatology at the San Diego VA Medical Center, said in an interview that he also believes the findings by Dr. Bardin and associates are real. He cited a study by Isabelle Ayoub, MD, and colleagues in Clinical Nephrology from 2016 that evaluated kidney biopsies in Germany and found medullary tophi were more likely to be present in patients with CKD than without.

“Chronic gouty nephropathy did not disappear. It still exists,” said Dr. Terkeltaub, who was not involved in the study by Dr. Bardin and colleagues.

The prospect that, if “you look hard enough, you’re going to see urate crystals and a pattern that’s attributed in the renal medulla” in patients with untreated gout is “very provocative, and interesting, and clinically relevant, and merits more investigation,” noted Dr. Terkeltaub, who is also president of the Gout, Hyperuricemia and Crystal-Associated Disease Network.

If verified, the results have important implications for patients with gout and its relationship to CKD, Dr. Terkeltaub said, but they raise “more questions than answers.

“I think it’s a really good wake-up call to start looking, doing good detective work here, and looking especially in people who have gout as opposed to just people with chronic kidney disease,” he said.

The authors reported no relevant conflicts of interest. Dr. Johnson, who coauthored an accompanying editorial, reported having equity in XORTX Therapeutics, serving as a consultant for Horizon Pharma, and having equity in Colorado Research Partners LLC. Dr. Terkeltaub reported receiving a research grant from AstraZeneca in the field of hyperuricemia and consultancies with AstraZeneca, Horizon, Sobi, Selecta Biosciences.

Is gouty nephropathy real? It’s a question that has been posed often in rheumatology over the last several decades.

HYWARDS/Getty Images

A new study found 36% of patients with untreated gout at a medical center in Vietnam have diffuse hyperechoic renal medulla as seen on ultrasound, which could indicate the presence of microcrystalline nephropathy. However, the results, published in Kidney International, may raise more questions than answers about the existence of gouty nephropathy and its relation to chronic kidney disease (CKD).

In their study, Thomas Bardin, MD, of the department of rheumatology at Lariboisière Hospital in Paris and colleagues evaluated 502 consecutive patients from Vien Gut Medical Center in Ho Chi Minh City, Vietnam, using B-mode renal ultrasound. The patients were mostly men with a median age of 46 years, body mass index of 25 kg/m², estimated disease duration of 4 years, and uricemia of 423.2 micromol/L (7.11 mg/dL). Patients had a median estimated glomerular filtration rate (eGFR) of 78 mL/min per 1.73 m². There was a history of hypertension in 112 patients (22.3%), type 2 diabetes in 58 patients (11.5%), renal lithiasis in 28 patients (5.6%), and coronary heart disease in 5 patients (1%).

While 39% of patients had previously used allopurinol for “a generally short period,” patients were not on urate-lowering therapy at the time of the study. Clinical tophi were present in 279 patients (55.6%), urate arthropathies in 154 patients (30.7%), and 43 patients (10.4%) used steroids daily.

B-mode renal ultrasound showed 181 patients (36%; 95% confidence interval, 32%-40%) had “hyperechoic pattern of Malpighi pyramids compared with the adjacent cortex,” which was “associated with twinkling artifacts” visible on color Doppler ultrasound. There was a significant association between renal medulla hyperechogenicity and patient age, disease duration, use of steroids, clinical tophi, and urate arthropathy (P less than .0001 for all). A significant association was also seen between renal medulla hyperechogenicity and decreased eGFR (P < .0001), proteinuria (P = .0006), leukocyturia (P = .0008), hypertension (P = .0008), hyperuricemia (P = .002), and coronary heart disease (P = .006).

In a multivariate analysis, there was a significant association between renal medulla hyperechogenicity and clinical tophi (odds ratio, 7.27; 95% CI, 3.68–15.19; P < .0001), urate arthropathy (OR, 3.46; 95% CI, 1.99–6.09; P < .0001), estimated gout duration (OR, 2.13; 95% CI, 1.55–2.96; P < .0001), double contour thickness (OR, 1.45; 95% CI, 1.06–1.97; P < .02), and eGFR (OR, 0.30; 95% CI, 0.09–0.89; P < .034).

“The finding was observed mainly in tophaceous gout, which involved a large proportion of our patients who had received very little treatment with urate-lowering drugs and was associated with moderately impaired renal function and urinary features compatible with tubulointerstitial nephritis,” Dr. Bardin and colleagues wrote in the study. The researchers also found “similar features” in 4 of 10 French patients at the Paris Necker Hospital in Paris, and noted that similar findings have been reported in Japan and Korea, which they said may mean hyperechoic medulla “is not unique to Vietnamese patients.”
 

Relation to CKD still unclear

In a related editorial, Federica Piani, MD, and Richard J. Johnson, MD, of the division of renal diseases and hypertension at the University of Colorado at Denver, Aurora, explained that gout was considered by some clinicians to be a cause of CKD in a time before urate-lowering therapies, because as many as 25% of patients with gout went on to experience kidney failure and about half experienced lower kidney function.

The association between gout and CKD was thought to be attributable to “frequent deposition of urate crystals in the tubular lumens and interstitium in the outer medulla of these patients,” but the concept was later challenged because “the crystals were generally found focally and did not readily explain the kidney damage.”

But even as interest in rheumatology moved away from the concept of gouty nephropathy to how serum uric acid impacts CKD, “the possibility that urate crystal deposition in the kidney could also be contributing to the kidney injury was never ruled out,” according to Dr. Piani and Dr. Johnson.

Kidney biopsies can sometimes miss urate crystals because the crystals dissolve if alcohol fixation is not used and because the biopsy site is often in the renal cortex, the authors noted. Recent research has identified that dual-energy CT scans can distinguish between calcium deposits and urate crystals better than ultrasound, and previous research from Thomas Bardin, MD, and colleagues in two patients noted a correlation between dual-energy CT scan findings of urate crystals and hyperechoic medulla findings on renal ultrasound.

The results by Dr. Bardin and associates, they said, “have reawakened the entity of urate microcrystalline nephropathy as a possible cause of CKD.”

Robert Terkeltaub, MD, professor of medicine at the University of California, San Diego, and section chief of Rheumatology at the San Diego VA Medical Center, said in an interview that he also believes the findings by Dr. Bardin and associates are real. He cited a study by Isabelle Ayoub, MD, and colleagues in Clinical Nephrology from 2016 that evaluated kidney biopsies in Germany and found medullary tophi were more likely to be present in patients with CKD than without.

“Chronic gouty nephropathy did not disappear. It still exists,” said Dr. Terkeltaub, who was not involved in the study by Dr. Bardin and colleagues.

The prospect that, if “you look hard enough, you’re going to see urate crystals and a pattern that’s attributed in the renal medulla” in patients with untreated gout is “very provocative, and interesting, and clinically relevant, and merits more investigation,” noted Dr. Terkeltaub, who is also president of the Gout, Hyperuricemia and Crystal-Associated Disease Network.

If verified, the results have important implications for patients with gout and its relationship to CKD, Dr. Terkeltaub said, but they raise “more questions than answers.

“I think it’s a really good wake-up call to start looking, doing good detective work here, and looking especially in people who have gout as opposed to just people with chronic kidney disease,” he said.

The authors reported no relevant conflicts of interest. Dr. Johnson, who coauthored an accompanying editorial, reported having equity in XORTX Therapeutics, serving as a consultant for Horizon Pharma, and having equity in Colorado Research Partners LLC. Dr. Terkeltaub reported receiving a research grant from AstraZeneca in the field of hyperuricemia and consultancies with AstraZeneca, Horizon, Sobi, Selecta Biosciences.

The pretreatment gut microbiome can determine response to methotrexate therapy in patients with newly diagnosed rheumatoid arthritis, according to recent research published in Arthritis & Rheumatology.

About half of patients do not respond to methotrexate (MTX), despite it being a first-line therapy for RA, according to Alejandro Artacho of the Centro Superior de Investigación en Salud Pública in Valencia, Spain, and colleagues. In addition, there is currently no way to predict which patients will respond to MTX.

Dr. Veena Taneja, a researcher and associate professor in the Department of Immunology and Division of Rheumatology at the Mayo Clinic in Rochester, Minn.

The role of the microbiome in drug response for patients with RA “has been known since it was discovered in 1972 that sulfasalazine requires gut bacteria for its activity,” Veena Taneja, PhD, a researcher and associate professor of immunology at the Mayo Clinic in Rochester, Minn., said in an interview. The microbiome and how it functions “needs to be explored as biomarkers as well as for treatment options for RA and other diseases,” added Dr. Taneja, who was not involved with the study.

Using 16S rRNA gene and shotgun metagenomic sequencing, the researchers evaluated whether the gut microbiome of a patient newly diagnosed with RA (NORA) influenced their response to MTX. The researchers extracted DNA from fecal samples in 26 patients from New York University Langone Medical Center, Lutheran Hospital, Staten Island, and Mount Sinai School of Medicine rheumatology clinics 48 hours prior to treatment with MTX and determined the bacterial taxa, operational taxonomic units (OTUs), and ribosomal sequence variants in each sample. These patients then received oral MTX with an average dose of 20 mg per week (range, 15-25 mg). The patients were grouped based on whether they responded (39%) or did not respond (61%) to MTX based on improvement of at least 1.8 in their Disease Activity Score in 28 joints (DAS28) after 4 months and no need to add a biologic.

Patients with a statistically significantly lower level of microbial diversity (P < .05) as measured by OTU level tended to respond better to MTX therapy. In patients who did not respond to MTX, there was a significantly higher abundance of Firmicutes, a significantly lower abundance of Bacteroidetes (P < .05), and a higher ratio of Firmicutes to Bacteroidetes.

There was also a consistent difference between abundance of gut microbial genes in patients who did not respond to MTX. “Taken together, these results indicate that the gut microbiome of NORA patients that respond favorably to MTX is distinct from that of MTX-NR, prompting us to hypothesize that the pretreatment microbiome could be used to predict clinical nonresponse,” the researchers said.

Using machine learning, Mr. Artacho and colleagues developed a predictive model based on the initial training cohort of 26 patients to assess MTX response. When the researchers tested the model in a validation cohort of 21 patients, they found it correctly predicted 78% of MTX responders and 83.3% of patients who did not respond to MTX, with the percentage of correct predictions increasing “when considering only those patients with the highest probability score of belonging to either group.”

In a separate set of 20 patients with RA who were prescribed either different conventional synthetic disease-modifying antirheumatic drugs or biologics or had not started any medications, the researchers’ model could not predict clinical response, “suggesting that the potential clinical utility of the model is restricted to RA patients that are both drug naive and exposed directly to MTX, but not to other drugs.”

“Our results open the possibility to rationally design microbiome-modulating strategies to improve oral absorption of MTX and its downstream immune effects, inform clinical decision-making or both,” they said.

Clinical application

Dr. Taneja said the findings of the study are novel and intriguing. “The observations suggest a strong influence of [the] host’s microbiome in response to MTX and in future may inform best treatment options for patients. The study speculates that certain microbial clades or microbes can be used to derive a favorable response in patients. This could explain why “one drug fits all” does not apply in treatment for RA,” she said.

The study is also a “step forward” in using the microbiome in regular clinical practice, she noted. “Since MTX is used as a first line of treatment and is one of the most affordable treatments for RA, the observations are definitely exciting.”

In an interview, Martin Kriegel, MD, PhD, of the department of immunobiology at Yale University, New Haven, Conn., and chair of rheumatology and clinical immunology at the University of Münster (Germany), explained that the prediction model has the potential to one day be a tool for clinicians to predict MTX response in patients with RA. However, he noted the researchers did not test a functional link between MTX and gut microbes in vivo.

“It would be useful to test mechanistic effects of MTX on gut microbial communities in vitro and in vivo,” he said. “In addition, it would be informative to apply the prediction model in other cohorts of RA with a different geographic background, possibly also a different duration of disease. If confirmed in a more heterogeneous group of patients, the tool could potentially be used in the clinic to tell some patients that they might not respond to MTX and therefore start therapy with another agent.”

This study was funded by the National Institutes of Health, the Rheumatology Research Foundation, the Searle Scholars Program, various funds from the Spanish government, the UCSF Breakthrough Program for Rheumatoid Arthritis-related Research, and the Arthritis Foundation Center for Excellence. Four authors report consultancies and memberships on scientific advisory boards with pharmaceutical and biotechnology companies that do not overlap with the current study.

Dr. Taneja reported that her institution holds a patent for developing Prevotella histicola as an anti-inflammatory treatment, of which she is a coinventor. Evelo Biosciences is a licensee for the patent, and Dr. Taneja reported receiving research support from the company. Dr. Kriegel reported receiving salary, consulting fees, honoraria, or research funds from AbbVie, Bristol-Myers Squibb, Cell Applications, Eligo Bioscience, and Roche. He also holds a patent on the use of antibiotics and commensal vaccination to treat autoimmunity.

SOURCE: Artacho A et al. Arthritis Rheumatol. 2020 Dec 13. doi: 10.1002/art.41622.

The pretreatment gut microbiome can determine response to methotrexate therapy in patients with newly diagnosed rheumatoid arthritis, according to recent research published in Arthritis & Rheumatology.

About half of patients do not respond to methotrexate (MTX), despite it being a first-line therapy for RA, according to Alejandro Artacho of the Centro Superior de Investigación en Salud Pública in Valencia, Spain, and colleagues. In addition, there is currently no way to predict which patients will respond to MTX.

Dr. Veena Taneja, a researcher and associate professor in the Department of Immunology and Division of Rheumatology at the Mayo Clinic in Rochester, Minn.

The role of the microbiome in drug response for patients with RA “has been known since it was discovered in 1972 that sulfasalazine requires gut bacteria for its activity,” Veena Taneja, PhD, a researcher and associate professor of immunology at the Mayo Clinic in Rochester, Minn., said in an interview. The microbiome and how it functions “needs to be explored as biomarkers as well as for treatment options for RA and other diseases,” added Dr. Taneja, who was not involved with the study.

Using 16S rRNA gene and shotgun metagenomic sequencing, the researchers evaluated whether the gut microbiome of a patient newly diagnosed with RA (NORA) influenced their response to MTX. The researchers extracted DNA from fecal samples in 26 patients from New York University Langone Medical Center, Lutheran Hospital, Staten Island, and Mount Sinai School of Medicine rheumatology clinics 48 hours prior to treatment with MTX and determined the bacterial taxa, operational taxonomic units (OTUs), and ribosomal sequence variants in each sample. These patients then received oral MTX with an average dose of 20 mg per week (range, 15-25 mg). The patients were grouped based on whether they responded (39%) or did not respond (61%) to MTX based on improvement of at least 1.8 in their Disease Activity Score in 28 joints (DAS28) after 4 months and no need to add a biologic.

Patients with a statistically significantly lower level of microbial diversity (P < .05) as measured by OTU level tended to respond better to MTX therapy. In patients who did not respond to MTX, there was a significantly higher abundance of Firmicutes, a significantly lower abundance of Bacteroidetes (P < .05), and a higher ratio of Firmicutes to Bacteroidetes.

There was also a consistent difference between abundance of gut microbial genes in patients who did not respond to MTX. “Taken together, these results indicate that the gut microbiome of NORA patients that respond favorably to MTX is distinct from that of MTX-NR, prompting us to hypothesize that the pretreatment microbiome could be used to predict clinical nonresponse,” the researchers said.

Using machine learning, Mr. Artacho and colleagues developed a predictive model based on the initial training cohort of 26 patients to assess MTX response. When the researchers tested the model in a validation cohort of 21 patients, they found it correctly predicted 78% of MTX responders and 83.3% of patients who did not respond to MTX, with the percentage of correct predictions increasing “when considering only those patients with the highest probability score of belonging to either group.”

In a separate set of 20 patients with RA who were prescribed either different conventional synthetic disease-modifying antirheumatic drugs or biologics or had not started any medications, the researchers’ model could not predict clinical response, “suggesting that the potential clinical utility of the model is restricted to RA patients that are both drug naive and exposed directly to MTX, but not to other drugs.”

“Our results open the possibility to rationally design microbiome-modulating strategies to improve oral absorption of MTX and its downstream immune effects, inform clinical decision-making or both,” they said.

Clinical application

Dr. Taneja said the findings of the study are novel and intriguing. “The observations suggest a strong influence of [the] host’s microbiome in response to MTX and in future may inform best treatment options for patients. The study speculates that certain microbial clades or microbes can be used to derive a favorable response in patients. This could explain why “one drug fits all” does not apply in treatment for RA,” she said.

The study is also a “step forward” in using the microbiome in regular clinical practice, she noted. “Since MTX is used as a first line of treatment and is one of the most affordable treatments for RA, the observations are definitely exciting.”

In an interview, Martin Kriegel, MD, PhD, of the department of immunobiology at Yale University, New Haven, Conn., and chair of rheumatology and clinical immunology at the University of Münster (Germany), explained that the prediction model has the potential to one day be a tool for clinicians to predict MTX response in patients with RA. However, he noted the researchers did not test a functional link between MTX and gut microbes in vivo.

“It would be useful to test mechanistic effects of MTX on gut microbial communities in vitro and in vivo,” he said. “In addition, it would be informative to apply the prediction model in other cohorts of RA with a different geographic background, possibly also a different duration of disease. If confirmed in a more heterogeneous group of patients, the tool could potentially be used in the clinic to tell some patients that they might not respond to MTX and therefore start therapy with another agent.”

This study was funded by the National Institutes of Health, the Rheumatology Research Foundation, the Searle Scholars Program, various funds from the Spanish government, the UCSF Breakthrough Program for Rheumatoid Arthritis-related Research, and the Arthritis Foundation Center for Excellence. Four authors report consultancies and memberships on scientific advisory boards with pharmaceutical and biotechnology companies that do not overlap with the current study.

Dr. Taneja reported that her institution holds a patent for developing Prevotella histicola as an anti-inflammatory treatment, of which she is a coinventor. Evelo Biosciences is a licensee for the patent, and Dr. Taneja reported receiving research support from the company. Dr. Kriegel reported receiving salary, consulting fees, honoraria, or research funds from AbbVie, Bristol-Myers Squibb, Cell Applications, Eligo Bioscience, and Roche. He also holds a patent on the use of antibiotics and commensal vaccination to treat autoimmunity.

SOURCE: Artacho A et al. Arthritis Rheumatol. 2020 Dec 13. doi: 10.1002/art.41622.

The pretreatment gut microbiome can determine response to methotrexate therapy in patients with newly diagnosed rheumatoid arthritis, according to recent research published in Arthritis & Rheumatology.

About half of patients do not respond to methotrexate (MTX), despite it being a first-line therapy for RA, according to Alejandro Artacho of the Centro Superior de Investigación en Salud Pública in Valencia, Spain, and colleagues. In addition, there is currently no way to predict which patients will respond to MTX.

Dr. Veena Taneja, a researcher and associate professor in the Department of Immunology and Division of Rheumatology at the Mayo Clinic in Rochester, Minn.

The role of the microbiome in drug response for patients with RA “has been known since it was discovered in 1972 that sulfasalazine requires gut bacteria for its activity,” Veena Taneja, PhD, a researcher and associate professor of immunology at the Mayo Clinic in Rochester, Minn., said in an interview. The microbiome and how it functions “needs to be explored as biomarkers as well as for treatment options for RA and other diseases,” added Dr. Taneja, who was not involved with the study.

Using 16S rRNA gene and shotgun metagenomic sequencing, the researchers evaluated whether the gut microbiome of a patient newly diagnosed with RA (NORA) influenced their response to MTX. The researchers extracted DNA from fecal samples in 26 patients from New York University Langone Medical Center, Lutheran Hospital, Staten Island, and Mount Sinai School of Medicine rheumatology clinics 48 hours prior to treatment with MTX and determined the bacterial taxa, operational taxonomic units (OTUs), and ribosomal sequence variants in each sample. These patients then received oral MTX with an average dose of 20 mg per week (range, 15-25 mg). The patients were grouped based on whether they responded (39%) or did not respond (61%) to MTX based on improvement of at least 1.8 in their Disease Activity Score in 28 joints (DAS28) after 4 months and no need to add a biologic.

Patients with a statistically significantly lower level of microbial diversity (P < .05) as measured by OTU level tended to respond better to MTX therapy. In patients who did not respond to MTX, there was a significantly higher abundance of Firmicutes, a significantly lower abundance of Bacteroidetes (P < .05), and a higher ratio of Firmicutes to Bacteroidetes.

There was also a consistent difference between abundance of gut microbial genes in patients who did not respond to MTX. “Taken together, these results indicate that the gut microbiome of NORA patients that respond favorably to MTX is distinct from that of MTX-NR, prompting us to hypothesize that the pretreatment microbiome could be used to predict clinical nonresponse,” the researchers said.

Using machine learning, Mr. Artacho and colleagues developed a predictive model based on the initial training cohort of 26 patients to assess MTX response. When the researchers tested the model in a validation cohort of 21 patients, they found it correctly predicted 78% of MTX responders and 83.3% of patients who did not respond to MTX, with the percentage of correct predictions increasing “when considering only those patients with the highest probability score of belonging to either group.”

In a separate set of 20 patients with RA who were prescribed either different conventional synthetic disease-modifying antirheumatic drugs or biologics or had not started any medications, the researchers’ model could not predict clinical response, “suggesting that the potential clinical utility of the model is restricted to RA patients that are both drug naive and exposed directly to MTX, but not to other drugs.”

“Our results open the possibility to rationally design microbiome-modulating strategies to improve oral absorption of MTX and its downstream immune effects, inform clinical decision-making or both,” they said.

Clinical application

Dr. Taneja said the findings of the study are novel and intriguing. “The observations suggest a strong influence of [the] host’s microbiome in response to MTX and in future may inform best treatment options for patients. The study speculates that certain microbial clades or microbes can be used to derive a favorable response in patients. This could explain why “one drug fits all” does not apply in treatment for RA,” she said.

The study is also a “step forward” in using the microbiome in regular clinical practice, she noted. “Since MTX is used as a first line of treatment and is one of the most affordable treatments for RA, the observations are definitely exciting.”

In an interview, Martin Kriegel, MD, PhD, of the department of immunobiology at Yale University, New Haven, Conn., and chair of rheumatology and clinical immunology at the University of Münster (Germany), explained that the prediction model has the potential to one day be a tool for clinicians to predict MTX response in patients with RA. However, he noted the researchers did not test a functional link between MTX and gut microbes in vivo.

“It would be useful to test mechanistic effects of MTX on gut microbial communities in vitro and in vivo,” he said. “In addition, it would be informative to apply the prediction model in other cohorts of RA with a different geographic background, possibly also a different duration of disease. If confirmed in a more heterogeneous group of patients, the tool could potentially be used in the clinic to tell some patients that they might not respond to MTX and therefore start therapy with another agent.”

This study was funded by the National Institutes of Health, the Rheumatology Research Foundation, the Searle Scholars Program, various funds from the Spanish government, the UCSF Breakthrough Program for Rheumatoid Arthritis-related Research, and the Arthritis Foundation Center for Excellence. Four authors report consultancies and memberships on scientific advisory boards with pharmaceutical and biotechnology companies that do not overlap with the current study.

Dr. Taneja reported that her institution holds a patent for developing Prevotella histicola as an anti-inflammatory treatment, of which she is a coinventor. Evelo Biosciences is a licensee for the patent, and Dr. Taneja reported receiving research support from the company. Dr. Kriegel reported receiving salary, consulting fees, honoraria, or research funds from AbbVie, Bristol-Myers Squibb, Cell Applications, Eligo Bioscience, and Roche. He also holds a patent on the use of antibiotics and commensal vaccination to treat autoimmunity.

SOURCE: Artacho A et al. Arthritis Rheumatol. 2020 Dec 13. doi: 10.1002/art.41622.

Science should be the cornerstone for health policy, and decisions on medical care of transgender and gender-diverse (TGD) individuals should be between a patient and their doctor.

That’s according to a joint policy statement from the Endocrine Society and Pediatric Endocrine Society published in the Journal of Clinical Endocrinology & Metabolism expressing concern about recent proposed legislation that would limit access to medical care for TGD individuals.

“The main emphasis is that we are simply medical people trying to be conservative and science driven in the care of our patients,” Joshua D. Safer, MD, coauthor and executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Why the health care for a particular group of people should be considered political is a mystery to me.”

TGD individuals have seen a recent uptick in efforts to limit or restrict their access to medical care at the federal and state levels. In June 2020, the Department of Health & Human Services finalized a revision to Section 1557 of the Affordable Care Act, rolling back a 2016 rule that determined the phrase “on the basis of sex” included nondiscrimination based on a person’s sex and gender identity. The Endocrine Society opposed this rule revision, arguing that it would allow “providers to deny care to TGD persons as well as discourage patients from seeking routine and gender-affirming care or reporting discrimination.”

Over a dozen U.S. states have introduced proposed legislation concerning medical care of TGD individuals that contain erroneous and misleading information. Proposed laws in Alabama, Missouri, and Texas, for example, would prohibit any use of medical treatments for minors for the purpose of gender-affirming medical care, including “gonadotropin-releasing hormone agonist therapy for pubertal suppression and gender-affirming hormonal therapy,” the authors of the joint statement wrote. In some cases, medical professionals who provide medical care for TGD patients could face criminal charges.

Outside the United States, three High Court judges in the United Kingdom recently ruled that minors aged under 16 years could not legally consent to pubertal suppression. “The recent U.K. court decision could be very disruptive because it would raise a barrier to transgender children receiving puberty blockers at exactly the ages that puberty blockers would be typically used,” Dr. Safer said.

Misleading characterizations of gender-affirming medical care for TGD individuals have also been spread to the general public. A recent Republican primary ballot proposition in Texas asked whether the state should ban “chemical castration, puberty blockers, cross-sex hormones, and genital mutilation surgery on all minor children for transition purposes,” falsely asserting that “Texas children as young as 3 are being transitioned from their biological sex to the opposite sex,” referencing a high-profile custody battle of a transgender child in Texas.

There are several tiers of misinformation that exist within these statements, Dr. Safer noted. “Some statements have suggested that gender-affirming treatment for young children can include hormone therapy or even surgery. Of course, there are no medical treatments for transgender and gender-diverse children prior to puberty.”

For adolescents aged under 18 years, Endocrine Society guidelines released in 2017 state that pubertal suppression is fully reversible and “offered to adolescents who meet diagnostic and treatment criteria, and are requesting care, for gender dysphoria/gender incongruence after they exhibit physical changes of puberty,” Dr. Safer and coauthors wrote in the joint policy statement. Other, more permanent – but still partially reversible – treatments such as hormone therapy are available as options for adolescents with confirmed and persistent gender dysphoria/gender incongruence, after meeting with a team of medical and mental health professionals and giving informed consent, according to the guidelines.

Dr. Safer expressed surprise at the opposition to puberty blockers in proposed state legislation. “Puberty blockers are the conservative option so that we can avoid permanent changes while thoughtful decisions are being made by our adolescent patients with their families and health care providers,” he said.

The perception that puberty blockers will lead to hormone therapy is another misunderstanding and source of misinformation, Dr. Safer explained.

“The fear is that these data suggest that puberty blockers are a ‘gateway drug’ of some sort. But that is false. The reason that most adolescents who take puberty blockers go on to hormone therapy is because most of the adolescents who are identified in our conservative systems are actually transgender and interested in more gender-affirming care as they age,” he said.
 

Effects of discrimination on TGD persons

Many of these proposed state bills have not advanced through state legislatures, but a few – such as the proposed laws in Alabama, Missouri, and Texas – are still currently under consideration.

“In the United States, most recent efforts to single out transgender and gender-diverse people for discrimination in health care have failed. However, the demonization of trans people and attempts to disrupt care have been the source of much stress among our patients,” Dr. Safer said.

Restricting access to health care has “multiple implications” for TGD patients. “In the era when we did not provide care to transgender youth, we had a situation where approximately 40% of transgender people had considered suicide in their lives,” Dr. Safer said. In contrast, having access to these treatments has been shown to improve mental health outcomes in these patients, according to an Endocrine Society position statement.

The purpose of earlier interventions such as puberty blockers is to allow an adolescent to “explore options and live in the experienced gender before making a decision to proceed with gender-affirming hormone therapy,” the authors of the Endocrine Society and Pediatric Endocrine Society joint statement said.

Blocking access to puberty blockers, on the other hand, forces transgender youth to experience a puberty that doesn’t match their gender identity, Dr. Safer noted. “The puberty will include permanent changes which will then have to be reversed with surgery. Why would we intentionally allow that to happen?”

Dr. Safer reported that his spouse is an employee of Parexel. Dr. Tangpricha is the current president of the World Association for Transgender Health and a board member of the American Association of Clinical Endocrinology. The other authors reported no relevant conflicts of interests.

SOURCE: Safer JD et al. J Clin Endocrinol Metab. 2020. doi: 10.1210/clinem/dgaa816.

Science should be the cornerstone for health policy, and decisions on medical care of transgender and gender-diverse (TGD) individuals should be between a patient and their doctor.

That’s according to a joint policy statement from the Endocrine Society and Pediatric Endocrine Society published in the Journal of Clinical Endocrinology & Metabolism expressing concern about recent proposed legislation that would limit access to medical care for TGD individuals.

“The main emphasis is that we are simply medical people trying to be conservative and science driven in the care of our patients,” Joshua D. Safer, MD, coauthor and executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Why the health care for a particular group of people should be considered political is a mystery to me.”

TGD individuals have seen a recent uptick in efforts to limit or restrict their access to medical care at the federal and state levels. In June 2020, the Department of Health & Human Services finalized a revision to Section 1557 of the Affordable Care Act, rolling back a 2016 rule that determined the phrase “on the basis of sex” included nondiscrimination based on a person’s sex and gender identity. The Endocrine Society opposed this rule revision, arguing that it would allow “providers to deny care to TGD persons as well as discourage patients from seeking routine and gender-affirming care or reporting discrimination.”

Over a dozen U.S. states have introduced proposed legislation concerning medical care of TGD individuals that contain erroneous and misleading information. Proposed laws in Alabama, Missouri, and Texas, for example, would prohibit any use of medical treatments for minors for the purpose of gender-affirming medical care, including “gonadotropin-releasing hormone agonist therapy for pubertal suppression and gender-affirming hormonal therapy,” the authors of the joint statement wrote. In some cases, medical professionals who provide medical care for TGD patients could face criminal charges.

Outside the United States, three High Court judges in the United Kingdom recently ruled that minors aged under 16 years could not legally consent to pubertal suppression. “The recent U.K. court decision could be very disruptive because it would raise a barrier to transgender children receiving puberty blockers at exactly the ages that puberty blockers would be typically used,” Dr. Safer said.

Misleading characterizations of gender-affirming medical care for TGD individuals have also been spread to the general public. A recent Republican primary ballot proposition in Texas asked whether the state should ban “chemical castration, puberty blockers, cross-sex hormones, and genital mutilation surgery on all minor children for transition purposes,” falsely asserting that “Texas children as young as 3 are being transitioned from their biological sex to the opposite sex,” referencing a high-profile custody battle of a transgender child in Texas.

There are several tiers of misinformation that exist within these statements, Dr. Safer noted. “Some statements have suggested that gender-affirming treatment for young children can include hormone therapy or even surgery. Of course, there are no medical treatments for transgender and gender-diverse children prior to puberty.”

For adolescents aged under 18 years, Endocrine Society guidelines released in 2017 state that pubertal suppression is fully reversible and “offered to adolescents who meet diagnostic and treatment criteria, and are requesting care, for gender dysphoria/gender incongruence after they exhibit physical changes of puberty,” Dr. Safer and coauthors wrote in the joint policy statement. Other, more permanent – but still partially reversible – treatments such as hormone therapy are available as options for adolescents with confirmed and persistent gender dysphoria/gender incongruence, after meeting with a team of medical and mental health professionals and giving informed consent, according to the guidelines.

Dr. Safer expressed surprise at the opposition to puberty blockers in proposed state legislation. “Puberty blockers are the conservative option so that we can avoid permanent changes while thoughtful decisions are being made by our adolescent patients with their families and health care providers,” he said.

The perception that puberty blockers will lead to hormone therapy is another misunderstanding and source of misinformation, Dr. Safer explained.

“The fear is that these data suggest that puberty blockers are a ‘gateway drug’ of some sort. But that is false. The reason that most adolescents who take puberty blockers go on to hormone therapy is because most of the adolescents who are identified in our conservative systems are actually transgender and interested in more gender-affirming care as they age,” he said.
 

Effects of discrimination on TGD persons

Many of these proposed state bills have not advanced through state legislatures, but a few – such as the proposed laws in Alabama, Missouri, and Texas – are still currently under consideration.

“In the United States, most recent efforts to single out transgender and gender-diverse people for discrimination in health care have failed. However, the demonization of trans people and attempts to disrupt care have been the source of much stress among our patients,” Dr. Safer said.

Restricting access to health care has “multiple implications” for TGD patients. “In the era when we did not provide care to transgender youth, we had a situation where approximately 40% of transgender people had considered suicide in their lives,” Dr. Safer said. In contrast, having access to these treatments has been shown to improve mental health outcomes in these patients, according to an Endocrine Society position statement.

The purpose of earlier interventions such as puberty blockers is to allow an adolescent to “explore options and live in the experienced gender before making a decision to proceed with gender-affirming hormone therapy,” the authors of the Endocrine Society and Pediatric Endocrine Society joint statement said.

Blocking access to puberty blockers, on the other hand, forces transgender youth to experience a puberty that doesn’t match their gender identity, Dr. Safer noted. “The puberty will include permanent changes which will then have to be reversed with surgery. Why would we intentionally allow that to happen?”

Dr. Safer reported that his spouse is an employee of Parexel. Dr. Tangpricha is the current president of the World Association for Transgender Health and a board member of the American Association of Clinical Endocrinology. The other authors reported no relevant conflicts of interests.

SOURCE: Safer JD et al. J Clin Endocrinol Metab. 2020. doi: 10.1210/clinem/dgaa816.

Science should be the cornerstone for health policy, and decisions on medical care of transgender and gender-diverse (TGD) individuals should be between a patient and their doctor.

That’s according to a joint policy statement from the Endocrine Society and Pediatric Endocrine Society published in the Journal of Clinical Endocrinology & Metabolism expressing concern about recent proposed legislation that would limit access to medical care for TGD individuals.

“The main emphasis is that we are simply medical people trying to be conservative and science driven in the care of our patients,” Joshua D. Safer, MD, coauthor and executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System, and professor of medicine at Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Why the health care for a particular group of people should be considered political is a mystery to me.”

TGD individuals have seen a recent uptick in efforts to limit or restrict their access to medical care at the federal and state levels. In June 2020, the Department of Health & Human Services finalized a revision to Section 1557 of the Affordable Care Act, rolling back a 2016 rule that determined the phrase “on the basis of sex” included nondiscrimination based on a person’s sex and gender identity. The Endocrine Society opposed this rule revision, arguing that it would allow “providers to deny care to TGD persons as well as discourage patients from seeking routine and gender-affirming care or reporting discrimination.”

Over a dozen U.S. states have introduced proposed legislation concerning medical care of TGD individuals that contain erroneous and misleading information. Proposed laws in Alabama, Missouri, and Texas, for example, would prohibit any use of medical treatments for minors for the purpose of gender-affirming medical care, including “gonadotropin-releasing hormone agonist therapy for pubertal suppression and gender-affirming hormonal therapy,” the authors of the joint statement wrote. In some cases, medical professionals who provide medical care for TGD patients could face criminal charges.

Outside the United States, three High Court judges in the United Kingdom recently ruled that minors aged under 16 years could not legally consent to pubertal suppression. “The recent U.K. court decision could be very disruptive because it would raise a barrier to transgender children receiving puberty blockers at exactly the ages that puberty blockers would be typically used,” Dr. Safer said.

Misleading characterizations of gender-affirming medical care for TGD individuals have also been spread to the general public. A recent Republican primary ballot proposition in Texas asked whether the state should ban “chemical castration, puberty blockers, cross-sex hormones, and genital mutilation surgery on all minor children for transition purposes,” falsely asserting that “Texas children as young as 3 are being transitioned from their biological sex to the opposite sex,” referencing a high-profile custody battle of a transgender child in Texas.

There are several tiers of misinformation that exist within these statements, Dr. Safer noted. “Some statements have suggested that gender-affirming treatment for young children can include hormone therapy or even surgery. Of course, there are no medical treatments for transgender and gender-diverse children prior to puberty.”

For adolescents aged under 18 years, Endocrine Society guidelines released in 2017 state that pubertal suppression is fully reversible and “offered to adolescents who meet diagnostic and treatment criteria, and are requesting care, for gender dysphoria/gender incongruence after they exhibit physical changes of puberty,” Dr. Safer and coauthors wrote in the joint policy statement. Other, more permanent – but still partially reversible – treatments such as hormone therapy are available as options for adolescents with confirmed and persistent gender dysphoria/gender incongruence, after meeting with a team of medical and mental health professionals and giving informed consent, according to the guidelines.

Dr. Safer expressed surprise at the opposition to puberty blockers in proposed state legislation. “Puberty blockers are the conservative option so that we can avoid permanent changes while thoughtful decisions are being made by our adolescent patients with their families and health care providers,” he said.

The perception that puberty blockers will lead to hormone therapy is another misunderstanding and source of misinformation, Dr. Safer explained.

“The fear is that these data suggest that puberty blockers are a ‘gateway drug’ of some sort. But that is false. The reason that most adolescents who take puberty blockers go on to hormone therapy is because most of the adolescents who are identified in our conservative systems are actually transgender and interested in more gender-affirming care as they age,” he said.
 

Effects of discrimination on TGD persons

Many of these proposed state bills have not advanced through state legislatures, but a few – such as the proposed laws in Alabama, Missouri, and Texas – are still currently under consideration.

“In the United States, most recent efforts to single out transgender and gender-diverse people for discrimination in health care have failed. However, the demonization of trans people and attempts to disrupt care have been the source of much stress among our patients,” Dr. Safer said.

Restricting access to health care has “multiple implications” for TGD patients. “In the era when we did not provide care to transgender youth, we had a situation where approximately 40% of transgender people had considered suicide in their lives,” Dr. Safer said. In contrast, having access to these treatments has been shown to improve mental health outcomes in these patients, according to an Endocrine Society position statement.

The purpose of earlier interventions such as puberty blockers is to allow an adolescent to “explore options and live in the experienced gender before making a decision to proceed with gender-affirming hormone therapy,” the authors of the Endocrine Society and Pediatric Endocrine Society joint statement said.

Blocking access to puberty blockers, on the other hand, forces transgender youth to experience a puberty that doesn’t match their gender identity, Dr. Safer noted. “The puberty will include permanent changes which will then have to be reversed with surgery. Why would we intentionally allow that to happen?”

Dr. Safer reported that his spouse is an employee of Parexel. Dr. Tangpricha is the current president of the World Association for Transgender Health and a board member of the American Association of Clinical Endocrinology. The other authors reported no relevant conflicts of interests.

SOURCE: Safer JD et al. J Clin Endocrinol Metab. 2020. doi: 10.1210/clinem/dgaa816.

A family medicine trained doctor, fresh out of residency, visits a career website to scout out prospective hospitalist jobs in their region. As they scroll through the job listings, they come across one opportunity at a nearby hospital system that seems like a good fit. The listing offers a competitive salary and comprehensive benefits for the position, and mentions hospitalists in the department will have the opportunity to teach medical students.

The only problem? The position is for internal medicine trained doctors only. After searching through several more listings with the same internal medicine requirement, the pool of jobs available to the family medicine doctor seems much smaller.
When Robert M. Wachter, MD, MHM, and Lee Goldman, MD coined the term “hospitalist” in a 1996 New England Journal of Medicine article, hospitalists were primarily clinicians with an internal medicine background, filling the gap created by family medicine doctors who increasingly devoted their time to patients in their practice and spent less time rounding in the hospital.
As family medicine doctors have returned to hospital medicine, it has become difficult to find positions as hospitalists due to a preference by some recruiters and employers that favors internal medicine physicians over those who are trained in family medicine. The preference for internal medicine physicians is sometimes overt, such as a requirement on a job application. But the preference can also surface after a physician has already applied for a position, and they will then discover a recruiter is actually looking for someone with a background in internal medicine. In other cases, family medicine physicians find out after applying that applicants with a background in family medicine are considered, but they’re expected to have additional training or certification not listed on the job application. 
The situation can even be as stark as a hospital system hiring an internal medicine doctor just out of residency over a family medicine doctor with years of experience as a board-certified physician. Hiring practices in large systems across multiple states sometimes don’t just favor internal medicine, they are entirely focused on internal medicine hospitalists, said experts who spoke with The Hospitalist.

Outdated perceptions of family medicine

Victoria McCurry, MD, current chair of the Society of Hospital Medicine’s family medicine Special Interest Group (SIG) Executive Committee and Faculty Director of Inpatient Services at UPMC McKeesport (Pa.) Family Medicine Residency, said hearsay inside the family medicine community influenced her first job search looking for hospitalist positions as a family medicine physician.

Experience, education closes some gaps

Over the years, the American Board of Family Medicine (ABFM) and SHM have offered several opportunities for family medicine doctors to demonstrate their experience and training in hospital medicine. In 2010, ABFM began offering the Focused Recognition of Hospital Medicine board examination, together with the American Board of Internal Medicine. SHM also offers hospitalist fellowships and a designation of Fellow in Hospital Medicine (FHM) for health care professionals. In 2015, ABFM and SHM released a joint statement encouraging the growth of hospitalists trained in family medicine (HTFM) and outlining these opportunities.
These measures help fill a gap in both IM and FM training, but also appear to have some effect in convincing recruiters and employers to consider family medicine doctors for hospitalist positions. An abstract published at Hospital Medicine 2014 reviewed 252 hospitalist positions listed in journals and search engines attempted to document the disparities in job listings, the perceptions of physician recruiters, and how factors like experience, training, and certification impacted a family medicine physician’s likelihood to be considered for a position. HTFMs were explicitly mentioned as being eligible in 119 of 252 positions (47%). The investigators then sent surveys out to physician recruiters of the remaining 133 positions asking whether HTFMs were being considered for the position. The results of the survey showed 66% of the recruiters were open to HTFMs, while 34% of recruiters said they did not have a willingness to hire HTFMs. 
That willingness to hire changed based on the level of experience, training, and certification. More than one-fourth (29%) of physician recruiters said institutional bylaws prevented hiring of HTFMs. If respondents earned a Recognition of Focused Practice in Hospital Medicine (RFPHM) board examination, 78% of physician recruiters would reconsider hiring the candidate. If the HTFM applicant had prior experience in hospital medicine, 87% of physician recruiters said they would consider the candidate. HTFMs who earned a Designation of Fellow in Hospital Medicine (FHM) from SHM would be reconsidered by 93% of physician recruiters who initially refused the HTFM candidate. All physician recruiters said they would reconsider if the candidate had a fellowship in hospital medicine.
However, to date, there is no official American College of Graduate Medical Education (ACGME)-recognized hospitalist board certification or designated specialty credentialing. This can lead to situations where family medicine trained physicians are applying for jobs without the necessary requirements for the position, because those requirements may not be immediately obvious when first applying to a position. “There’s often no specification until you apply and then are informed that you don’t qualify – ‘Oh, no, you  haven’t completed a fellowship,’ or the added qualification in hospital medicine,” Dr. McCurry said.
The 2015 joint statement from AAFP and SHM asserts that “more than two-thirds of HTFMs are also involved in the training of residents and medical students, enhancing the skills of our future physicians.” But when HTFMs do find positions, they may be limited in other ways, such as being prohibited from serving on the faculty of internal medicine residency programs and teaching internal medicine residents. When Dr. Odeti was medical director for Johnston Memorial Hospital in Abingdon, Va., he said he encountered this issue.
“If you are a hospitalist who is internal medicine trained, then you can teach FM or IM, whereas if you’re family medicine trained, you cannot teach internal medicine residents,” he said. “What happened with me, I had to prioritize recruiting internal medicine residents over FM residents to be able to staff IM teaching faculty.”
A rule change has been lobbied by SHM, under the direction of SHM family medicine SIG former chair David Goldstein, MD, to address this issue that would allow HTFMs with a FPHM designation to teach IM residents. The change was quietly made by the ACGME Review Committee for Internal Medicine in 2017, Dr. McCurry said, but implementation of the change has been slow.
“Essentially, the change was made in 2017 to allow for family medicine trainied physicians who have the FPHM designation to teach IM residents, but this knowledge has not been widely dispersed or policies updated to clearly reflect this change,” Dr. McCurry said. “It is a significant change, however, because prior to that, there were explicit policies preventing a family medicine hospitalist from teaching internal medicine residents even if they were experienced.”

FM physicians uniquely suited for HM

Requirements aside, it is “arguably not the case” that family medicine physicians need these extra certifications and fellowships to serve as hospitalists, Dr. McCurry said. It is difficult to quantify IM and FM hospitalist quality outcomes due to challenges with attribution, Dr. Odeti noted. One 2007 study published in the New England Journal of Medicine looked at patient quality and cost of care across the hospitalist model, and family medicine practitioners providing inpatients care. The investigators found similar outcomes in the internist model and with family practitioners providing inpatient care. Dr. Odeti said this research supports “the fact that family medicine physicians are equally competent as internists in providing inpatient care.”

HTFMs are growing within SHM

HTFMs are “all over,” being represented in smaller hospitals, larger hospitals, and university hospitals in every state. “But to reach those positions, they probably have to go over more hurdles and have fewer opportunities,” Dr. Chaudhry said.
There isn’t a completely accurate count of family medicine hospitalists in the United States. Out of an estimated 50,000 hospitalists in the U. S., about 16,000 hospitalists are members of SHM. A number of family medicine hospitalists may also take AAFP membership instead of SHM, Dr. Odeti explained.
However, there are a growing number of hospitalists within SHM with a family medicine background. In the 2007-2008 Society of Hospital Medicine Annual Survey, 3.7% of U.S. hospitalists claimed family medicine training. That number increased to 6.9% of physicians who answered the SHM membership data report in 2010.
A Medscape Hospitalist Lifestyle, Happiness & Burnout Report from 2019 estimates 17% of hospitalists are trained in family medicine. In the latest State of Hospital Medicine Report published in 2020, 38.6% of hospital medicine groups containing family medicine trained physicians were part of a university, medical school, or faculty practice; 79.6% did not have academic status; 83.8% were at a non-teaching hospital; 60.7% were in a group in a non-teaching service at a teaching hospital; and 52.8% were in a group at a combination teaching/non-teaching service at a teaching hospital.
Although the Report did not specify whether family medicine hospitalists were mainly in rural or urban areas, “some of us do practice in underserved area hospitals where you have the smaller ICU model, critical access hospitals, potentially dealing with a whole gamut of inpatient medicine from ER, to the hospital inpatient adult cases, to critical care level,” Dr. McCurry said. 
“But then, there are a large number of us who practice in private groups or at large hospitals, academic centers around the country,” she added. “There’s a range of family medicine trained hospitalist practice areas.”

Equal recognition for HTFM in HM

The SHM family medicine SIG has been working to highlight the issue of hiring practices for HTFMs, and is taking a number of actions to bring greater awareness and recognition to family medicine hospitalists.
The family medicine SIG is looking at steps for requesting a new joint statement from ABFM and SHM focused on hiring practices for family medicine physicians as hospitalists. “I think it’s worth considering now that we’re at a point where we comprise about one-fifth of hospitalists as family medicine docs,” Dr. McCurry said. “Is it time to take that joint statement to the next step, and seek a review of how we can improve the balance of hiring in terms of favoring more balanced consideration now that there are a lot more family medicine trained hospitalists than historically?
“I think the call is really to help us all move to that next step in terms of identifying any of the lingering vestiges of expectation that are really no longer applicable to the hiring practices, or shouldn’t be,” she said. 
The next step will be to ask hospitals with internal medicine only requirements for hospitalists to update their bylaws to include family medicine physicians when considering candidates for hospitalist positions. If SHM does not make a distinction to grant Fellow in Hospital Medicine status between internal medicine and family medicine trained hospitalists, “then there should not be any distinction, or there should not be any hindrance by the recruiters, by the bigger systems, as well as by the employers” in hiring a family medicine trained physician for a hospitalist position, Dr. Chaudhry said.
Dr. Odeti, who serves in several leadership roles within Ballad Health, describes the system as being friendly to HTFMs. About one-fourth of the hospitalists in Ballad Health are trained in family medicine. But when Dr. Odeti started his hospitalist practice, he was only one of a handful of HTFMs. He sees a future where the accomplishments and contributions of HTFMs will pave the way for future hospitalists. “Access into the urban hospitals is key, and I hope that SHM and the HTFM SIG will act as a catalyst for this change,” he said.
Colleagues of family medicine hospitalists, especially those in leadership positions at hospitals, can help by raising awareness, as can “those of our colleagues who sit on medical executive committees within their hospitals to review their bylaws, to see what the policies are, and encourage more competitiveness,” Dr. McCurry said. “Truly, the best candidate for the position, regardless of background and training, is what you want. You want the best colleagues for your fellow hospitalists. You want the best physician for your patients in the hospital.”
If training and all other things are equal, family medicine physicians should be evaluated on a case-by-case basis, she said. “I think that that puts the burden back on any good medical committee, and a good medical committee member who is an SHM member as well, to say, ‘If we are committed to quality patient care, we want to encourage the recruitment of all physicians that are truly the best physicians to reduce that distinction between FM and IM in order to allow those best candidates to present, whether they are FM or IM.’ That’s all that we’re asking.”
Dr. Chaudhry emphasized that the preference for internal medicine trained physicians isn’t intentional. “It’s not as if the systems are trying to do it,” he said. “I think it is more like everybody needs to be educated. And through the platform of the Society of Hospital Medicine, I think we can make a difference. It will be a slow change, but we’ll have to keep on working on it.”

Dr. Odeti, Dr. McCurry, and Dr. Chaudhry have no relevant financial disclosures.
 

A family medicine trained doctor, fresh out of residency, visits a career website to scout out prospective hospitalist jobs in their region. As they scroll through the job listings, they come across one opportunity at a nearby hospital system that seems like a good fit. The listing offers a competitive salary and comprehensive benefits for the position, and mentions hospitalists in the department will have the opportunity to teach medical students.

The only problem? The position is for internal medicine trained doctors only. After searching through several more listings with the same internal medicine requirement, the pool of jobs available to the family medicine doctor seems much smaller.
When Robert M. Wachter, MD, MHM, and Lee Goldman, MD coined the term “hospitalist” in a 1996 New England Journal of Medicine article, hospitalists were primarily clinicians with an internal medicine background, filling the gap created by family medicine doctors who increasingly devoted their time to patients in their practice and spent less time rounding in the hospital.
As family medicine doctors have returned to hospital medicine, it has become difficult to find positions as hospitalists due to a preference by some recruiters and employers that favors internal medicine physicians over those who are trained in family medicine. The preference for internal medicine physicians is sometimes overt, such as a requirement on a job application. But the preference can also surface after a physician has already applied for a position, and they will then discover a recruiter is actually looking for someone with a background in internal medicine. In other cases, family medicine physicians find out after applying that applicants with a background in family medicine are considered, but they’re expected to have additional training or certification not listed on the job application. 
The situation can even be as stark as a hospital system hiring an internal medicine doctor just out of residency over a family medicine doctor with years of experience as a board-certified physician. Hiring practices in large systems across multiple states sometimes don’t just favor internal medicine, they are entirely focused on internal medicine hospitalists, said experts who spoke with The Hospitalist.

Outdated perceptions of family medicine

Victoria McCurry, MD, current chair of the Society of Hospital Medicine’s family medicine Special Interest Group (SIG) Executive Committee and Faculty Director of Inpatient Services at UPMC McKeesport (Pa.) Family Medicine Residency, said hearsay inside the family medicine community influenced her first job search looking for hospitalist positions as a family medicine physician.

Experience, education closes some gaps

Over the years, the American Board of Family Medicine (ABFM) and SHM have offered several opportunities for family medicine doctors to demonstrate their experience and training in hospital medicine. In 2010, ABFM began offering the Focused Recognition of Hospital Medicine board examination, together with the American Board of Internal Medicine. SHM also offers hospitalist fellowships and a designation of Fellow in Hospital Medicine (FHM) for health care professionals. In 2015, ABFM and SHM released a joint statement encouraging the growth of hospitalists trained in family medicine (HTFM) and outlining these opportunities.
These measures help fill a gap in both IM and FM training, but also appear to have some effect in convincing recruiters and employers to consider family medicine doctors for hospitalist positions. An abstract published at Hospital Medicine 2014 reviewed 252 hospitalist positions listed in journals and search engines attempted to document the disparities in job listings, the perceptions of physician recruiters, and how factors like experience, training, and certification impacted a family medicine physician’s likelihood to be considered for a position. HTFMs were explicitly mentioned as being eligible in 119 of 252 positions (47%). The investigators then sent surveys out to physician recruiters of the remaining 133 positions asking whether HTFMs were being considered for the position. The results of the survey showed 66% of the recruiters were open to HTFMs, while 34% of recruiters said they did not have a willingness to hire HTFMs. 
That willingness to hire changed based on the level of experience, training, and certification. More than one-fourth (29%) of physician recruiters said institutional bylaws prevented hiring of HTFMs. If respondents earned a Recognition of Focused Practice in Hospital Medicine (RFPHM) board examination, 78% of physician recruiters would reconsider hiring the candidate. If the HTFM applicant had prior experience in hospital medicine, 87% of physician recruiters said they would consider the candidate. HTFMs who earned a Designation of Fellow in Hospital Medicine (FHM) from SHM would be reconsidered by 93% of physician recruiters who initially refused the HTFM candidate. All physician recruiters said they would reconsider if the candidate had a fellowship in hospital medicine.
However, to date, there is no official American College of Graduate Medical Education (ACGME)-recognized hospitalist board certification or designated specialty credentialing. This can lead to situations where family medicine trained physicians are applying for jobs without the necessary requirements for the position, because those requirements may not be immediately obvious when first applying to a position. “There’s often no specification until you apply and then are informed that you don’t qualify – ‘Oh, no, you  haven’t completed a fellowship,’ or the added qualification in hospital medicine,” Dr. McCurry said.
The 2015 joint statement from AAFP and SHM asserts that “more than two-thirds of HTFMs are also involved in the training of residents and medical students, enhancing the skills of our future physicians.” But when HTFMs do find positions, they may be limited in other ways, such as being prohibited from serving on the faculty of internal medicine residency programs and teaching internal medicine residents. When Dr. Odeti was medical director for Johnston Memorial Hospital in Abingdon, Va., he said he encountered this issue.
“If you are a hospitalist who is internal medicine trained, then you can teach FM or IM, whereas if you’re family medicine trained, you cannot teach internal medicine residents,” he said. “What happened with me, I had to prioritize recruiting internal medicine residents over FM residents to be able to staff IM teaching faculty.”
A rule change has been lobbied by SHM, under the direction of SHM family medicine SIG former chair David Goldstein, MD, to address this issue that would allow HTFMs with a FPHM designation to teach IM residents. The change was quietly made by the ACGME Review Committee for Internal Medicine in 2017, Dr. McCurry said, but implementation of the change has been slow.
“Essentially, the change was made in 2017 to allow for family medicine trainied physicians who have the FPHM designation to teach IM residents, but this knowledge has not been widely dispersed or policies updated to clearly reflect this change,” Dr. McCurry said. “It is a significant change, however, because prior to that, there were explicit policies preventing a family medicine hospitalist from teaching internal medicine residents even if they were experienced.”

FM physicians uniquely suited for HM

Requirements aside, it is “arguably not the case” that family medicine physicians need these extra certifications and fellowships to serve as hospitalists, Dr. McCurry said. It is difficult to quantify IM and FM hospitalist quality outcomes due to challenges with attribution, Dr. Odeti noted. One 2007 study published in the New England Journal of Medicine looked at patient quality and cost of care across the hospitalist model, and family medicine practitioners providing inpatients care. The investigators found similar outcomes in the internist model and with family practitioners providing inpatient care. Dr. Odeti said this research supports “the fact that family medicine physicians are equally competent as internists in providing inpatient care.”

HTFMs are growing within SHM

HTFMs are “all over,” being represented in smaller hospitals, larger hospitals, and university hospitals in every state. “But to reach those positions, they probably have to go over more hurdles and have fewer opportunities,” Dr. Chaudhry said.
There isn’t a completely accurate count of family medicine hospitalists in the United States. Out of an estimated 50,000 hospitalists in the U. S., about 16,000 hospitalists are members of SHM. A number of family medicine hospitalists may also take AAFP membership instead of SHM, Dr. Odeti explained.
However, there are a growing number of hospitalists within SHM with a family medicine background. In the 2007-2008 Society of Hospital Medicine Annual Survey, 3.7% of U.S. hospitalists claimed family medicine training. That number increased to 6.9% of physicians who answered the SHM membership data report in 2010.
A Medscape Hospitalist Lifestyle, Happiness & Burnout Report from 2019 estimates 17% of hospitalists are trained in family medicine. In the latest State of Hospital Medicine Report published in 2020, 38.6% of hospital medicine groups containing family medicine trained physicians were part of a university, medical school, or faculty practice; 79.6% did not have academic status; 83.8% were at a non-teaching hospital; 60.7% were in a group in a non-teaching service at a teaching hospital; and 52.8% were in a group at a combination teaching/non-teaching service at a teaching hospital.
Although the Report did not specify whether family medicine hospitalists were mainly in rural or urban areas, “some of us do practice in underserved area hospitals where you have the smaller ICU model, critical access hospitals, potentially dealing with a whole gamut of inpatient medicine from ER, to the hospital inpatient adult cases, to critical care level,” Dr. McCurry said. 
“But then, there are a large number of us who practice in private groups or at large hospitals, academic centers around the country,” she added. “There’s a range of family medicine trained hospitalist practice areas.”

Equal recognition for HTFM in HM

The SHM family medicine SIG has been working to highlight the issue of hiring practices for HTFMs, and is taking a number of actions to bring greater awareness and recognition to family medicine hospitalists.
The family medicine SIG is looking at steps for requesting a new joint statement from ABFM and SHM focused on hiring practices for family medicine physicians as hospitalists. “I think it’s worth considering now that we’re at a point where we comprise about one-fifth of hospitalists as family medicine docs,” Dr. McCurry said. “Is it time to take that joint statement to the next step, and seek a review of how we can improve the balance of hiring in terms of favoring more balanced consideration now that there are a lot more family medicine trained hospitalists than historically?
“I think the call is really to help us all move to that next step in terms of identifying any of the lingering vestiges of expectation that are really no longer applicable to the hiring practices, or shouldn’t be,” she said. 
The next step will be to ask hospitals with internal medicine only requirements for hospitalists to update their bylaws to include family medicine physicians when considering candidates for hospitalist positions. If SHM does not make a distinction to grant Fellow in Hospital Medicine status between internal medicine and family medicine trained hospitalists, “then there should not be any distinction, or there should not be any hindrance by the recruiters, by the bigger systems, as well as by the employers” in hiring a family medicine trained physician for a hospitalist position, Dr. Chaudhry said.
Dr. Odeti, who serves in several leadership roles within Ballad Health, describes the system as being friendly to HTFMs. About one-fourth of the hospitalists in Ballad Health are trained in family medicine. But when Dr. Odeti started his hospitalist practice, he was only one of a handful of HTFMs. He sees a future where the accomplishments and contributions of HTFMs will pave the way for future hospitalists. “Access into the urban hospitals is key, and I hope that SHM and the HTFM SIG will act as a catalyst for this change,” he said.
Colleagues of family medicine hospitalists, especially those in leadership positions at hospitals, can help by raising awareness, as can “those of our colleagues who sit on medical executive committees within their hospitals to review their bylaws, to see what the policies are, and encourage more competitiveness,” Dr. McCurry said. “Truly, the best candidate for the position, regardless of background and training, is what you want. You want the best colleagues for your fellow hospitalists. You want the best physician for your patients in the hospital.”
If training and all other things are equal, family medicine physicians should be evaluated on a case-by-case basis, she said. “I think that that puts the burden back on any good medical committee, and a good medical committee member who is an SHM member as well, to say, ‘If we are committed to quality patient care, we want to encourage the recruitment of all physicians that are truly the best physicians to reduce that distinction between FM and IM in order to allow those best candidates to present, whether they are FM or IM.’ That’s all that we’re asking.”
Dr. Chaudhry emphasized that the preference for internal medicine trained physicians isn’t intentional. “It’s not as if the systems are trying to do it,” he said. “I think it is more like everybody needs to be educated. And through the platform of the Society of Hospital Medicine, I think we can make a difference. It will be a slow change, but we’ll have to keep on working on it.”

Dr. Odeti, Dr. McCurry, and Dr. Chaudhry have no relevant financial disclosures.
 

A family medicine trained doctor, fresh out of residency, visits a career website to scout out prospective hospitalist jobs in their region. As they scroll through the job listings, they come across one opportunity at a nearby hospital system that seems like a good fit. The listing offers a competitive salary and comprehensive benefits for the position, and mentions hospitalists in the department will have the opportunity to teach medical students.

The only problem? The position is for internal medicine trained doctors only. After searching through several more listings with the same internal medicine requirement, the pool of jobs available to the family medicine doctor seems much smaller.
When Robert M. Wachter, MD, MHM, and Lee Goldman, MD coined the term “hospitalist” in a 1996 New England Journal of Medicine article, hospitalists were primarily clinicians with an internal medicine background, filling the gap created by family medicine doctors who increasingly devoted their time to patients in their practice and spent less time rounding in the hospital.
As family medicine doctors have returned to hospital medicine, it has become difficult to find positions as hospitalists due to a preference by some recruiters and employers that favors internal medicine physicians over those who are trained in family medicine. The preference for internal medicine physicians is sometimes overt, such as a requirement on a job application. But the preference can also surface after a physician has already applied for a position, and they will then discover a recruiter is actually looking for someone with a background in internal medicine. In other cases, family medicine physicians find out after applying that applicants with a background in family medicine are considered, but they’re expected to have additional training or certification not listed on the job application. 
The situation can even be as stark as a hospital system hiring an internal medicine doctor just out of residency over a family medicine doctor with years of experience as a board-certified physician. Hiring practices in large systems across multiple states sometimes don’t just favor internal medicine, they are entirely focused on internal medicine hospitalists, said experts who spoke with The Hospitalist.

Outdated perceptions of family medicine

Victoria McCurry, MD, current chair of the Society of Hospital Medicine’s family medicine Special Interest Group (SIG) Executive Committee and Faculty Director of Inpatient Services at UPMC McKeesport (Pa.) Family Medicine Residency, said hearsay inside the family medicine community influenced her first job search looking for hospitalist positions as a family medicine physician.

Experience, education closes some gaps

Over the years, the American Board of Family Medicine (ABFM) and SHM have offered several opportunities for family medicine doctors to demonstrate their experience and training in hospital medicine. In 2010, ABFM began offering the Focused Recognition of Hospital Medicine board examination, together with the American Board of Internal Medicine. SHM also offers hospitalist fellowships and a designation of Fellow in Hospital Medicine (FHM) for health care professionals. In 2015, ABFM and SHM released a joint statement encouraging the growth of hospitalists trained in family medicine (HTFM) and outlining these opportunities.
These measures help fill a gap in both IM and FM training, but also appear to have some effect in convincing recruiters and employers to consider family medicine doctors for hospitalist positions. An abstract published at Hospital Medicine 2014 reviewed 252 hospitalist positions listed in journals and search engines attempted to document the disparities in job listings, the perceptions of physician recruiters, and how factors like experience, training, and certification impacted a family medicine physician’s likelihood to be considered for a position. HTFMs were explicitly mentioned as being eligible in 119 of 252 positions (47%). The investigators then sent surveys out to physician recruiters of the remaining 133 positions asking whether HTFMs were being considered for the position. The results of the survey showed 66% of the recruiters were open to HTFMs, while 34% of recruiters said they did not have a willingness to hire HTFMs. 
That willingness to hire changed based on the level of experience, training, and certification. More than one-fourth (29%) of physician recruiters said institutional bylaws prevented hiring of HTFMs. If respondents earned a Recognition of Focused Practice in Hospital Medicine (RFPHM) board examination, 78% of physician recruiters would reconsider hiring the candidate. If the HTFM applicant had prior experience in hospital medicine, 87% of physician recruiters said they would consider the candidate. HTFMs who earned a Designation of Fellow in Hospital Medicine (FHM) from SHM would be reconsidered by 93% of physician recruiters who initially refused the HTFM candidate. All physician recruiters said they would reconsider if the candidate had a fellowship in hospital medicine.
However, to date, there is no official American College of Graduate Medical Education (ACGME)-recognized hospitalist board certification or designated specialty credentialing. This can lead to situations where family medicine trained physicians are applying for jobs without the necessary requirements for the position, because those requirements may not be immediately obvious when first applying to a position. “There’s often no specification until you apply and then are informed that you don’t qualify – ‘Oh, no, you  haven’t completed a fellowship,’ or the added qualification in hospital medicine,” Dr. McCurry said.
The 2015 joint statement from AAFP and SHM asserts that “more than two-thirds of HTFMs are also involved in the training of residents and medical students, enhancing the skills of our future physicians.” But when HTFMs do find positions, they may be limited in other ways, such as being prohibited from serving on the faculty of internal medicine residency programs and teaching internal medicine residents. When Dr. Odeti was medical director for Johnston Memorial Hospital in Abingdon, Va., he said he encountered this issue.
“If you are a hospitalist who is internal medicine trained, then you can teach FM or IM, whereas if you’re family medicine trained, you cannot teach internal medicine residents,” he said. “What happened with me, I had to prioritize recruiting internal medicine residents over FM residents to be able to staff IM teaching faculty.”
A rule change has been lobbied by SHM, under the direction of SHM family medicine SIG former chair David Goldstein, MD, to address this issue that would allow HTFMs with a FPHM designation to teach IM residents. The change was quietly made by the ACGME Review Committee for Internal Medicine in 2017, Dr. McCurry said, but implementation of the change has been slow.
“Essentially, the change was made in 2017 to allow for family medicine trainied physicians who have the FPHM designation to teach IM residents, but this knowledge has not been widely dispersed or policies updated to clearly reflect this change,” Dr. McCurry said. “It is a significant change, however, because prior to that, there were explicit policies preventing a family medicine hospitalist from teaching internal medicine residents even if they were experienced.”

FM physicians uniquely suited for HM

Requirements aside, it is “arguably not the case” that family medicine physicians need these extra certifications and fellowships to serve as hospitalists, Dr. McCurry said. It is difficult to quantify IM and FM hospitalist quality outcomes due to challenges with attribution, Dr. Odeti noted. One 2007 study published in the New England Journal of Medicine looked at patient quality and cost of care across the hospitalist model, and family medicine practitioners providing inpatients care. The investigators found similar outcomes in the internist model and with family practitioners providing inpatient care. Dr. Odeti said this research supports “the fact that family medicine physicians are equally competent as internists in providing inpatient care.”

HTFMs are growing within SHM

HTFMs are “all over,” being represented in smaller hospitals, larger hospitals, and university hospitals in every state. “But to reach those positions, they probably have to go over more hurdles and have fewer opportunities,” Dr. Chaudhry said.
There isn’t a completely accurate count of family medicine hospitalists in the United States. Out of an estimated 50,000 hospitalists in the U. S., about 16,000 hospitalists are members of SHM. A number of family medicine hospitalists may also take AAFP membership instead of SHM, Dr. Odeti explained.
However, there are a growing number of hospitalists within SHM with a family medicine background. In the 2007-2008 Society of Hospital Medicine Annual Survey, 3.7% of U.S. hospitalists claimed family medicine training. That number increased to 6.9% of physicians who answered the SHM membership data report in 2010.
A Medscape Hospitalist Lifestyle, Happiness & Burnout Report from 2019 estimates 17% of hospitalists are trained in family medicine. In the latest State of Hospital Medicine Report published in 2020, 38.6% of hospital medicine groups containing family medicine trained physicians were part of a university, medical school, or faculty practice; 79.6% did not have academic status; 83.8% were at a non-teaching hospital; 60.7% were in a group in a non-teaching service at a teaching hospital; and 52.8% were in a group at a combination teaching/non-teaching service at a teaching hospital.
Although the Report did not specify whether family medicine hospitalists were mainly in rural or urban areas, “some of us do practice in underserved area hospitals where you have the smaller ICU model, critical access hospitals, potentially dealing with a whole gamut of inpatient medicine from ER, to the hospital inpatient adult cases, to critical care level,” Dr. McCurry said. 
“But then, there are a large number of us who practice in private groups or at large hospitals, academic centers around the country,” she added. “There’s a range of family medicine trained hospitalist practice areas.”

Equal recognition for HTFM in HM

The SHM family medicine SIG has been working to highlight the issue of hiring practices for HTFMs, and is taking a number of actions to bring greater awareness and recognition to family medicine hospitalists.
The family medicine SIG is looking at steps for requesting a new joint statement from ABFM and SHM focused on hiring practices for family medicine physicians as hospitalists. “I think it’s worth considering now that we’re at a point where we comprise about one-fifth of hospitalists as family medicine docs,” Dr. McCurry said. “Is it time to take that joint statement to the next step, and seek a review of how we can improve the balance of hiring in terms of favoring more balanced consideration now that there are a lot more family medicine trained hospitalists than historically?
“I think the call is really to help us all move to that next step in terms of identifying any of the lingering vestiges of expectation that are really no longer applicable to the hiring practices, or shouldn’t be,” she said. 
The next step will be to ask hospitals with internal medicine only requirements for hospitalists to update their bylaws to include family medicine physicians when considering candidates for hospitalist positions. If SHM does not make a distinction to grant Fellow in Hospital Medicine status between internal medicine and family medicine trained hospitalists, “then there should not be any distinction, or there should not be any hindrance by the recruiters, by the bigger systems, as well as by the employers” in hiring a family medicine trained physician for a hospitalist position, Dr. Chaudhry said.
Dr. Odeti, who serves in several leadership roles within Ballad Health, describes the system as being friendly to HTFMs. About one-fourth of the hospitalists in Ballad Health are trained in family medicine. But when Dr. Odeti started his hospitalist practice, he was only one of a handful of HTFMs. He sees a future where the accomplishments and contributions of HTFMs will pave the way for future hospitalists. “Access into the urban hospitals is key, and I hope that SHM and the HTFM SIG will act as a catalyst for this change,” he said.
Colleagues of family medicine hospitalists, especially those in leadership positions at hospitals, can help by raising awareness, as can “those of our colleagues who sit on medical executive committees within their hospitals to review their bylaws, to see what the policies are, and encourage more competitiveness,” Dr. McCurry said. “Truly, the best candidate for the position, regardless of background and training, is what you want. You want the best colleagues for your fellow hospitalists. You want the best physician for your patients in the hospital.”
If training and all other things are equal, family medicine physicians should be evaluated on a case-by-case basis, she said. “I think that that puts the burden back on any good medical committee, and a good medical committee member who is an SHM member as well, to say, ‘If we are committed to quality patient care, we want to encourage the recruitment of all physicians that are truly the best physicians to reduce that distinction between FM and IM in order to allow those best candidates to present, whether they are FM or IM.’ That’s all that we’re asking.”
Dr. Chaudhry emphasized that the preference for internal medicine trained physicians isn’t intentional. “It’s not as if the systems are trying to do it,” he said. “I think it is more like everybody needs to be educated. And through the platform of the Society of Hospital Medicine, I think we can make a difference. It will be a slow change, but we’ll have to keep on working on it.”

Dr. Odeti, Dr. McCurry, and Dr. Chaudhry have no relevant financial disclosures.
 

The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.

The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.

The National Board of Physicians and Surgeons (NBPAS) has announced that they are recertifying United Council of Neurologic Subspecialties (UCNS) diplomates as of Nov. 1, 2020. Recertification will include physicians who were initially board certified with UCNS in the subspecialties of autonomic disorders, behavioral neurology and neuropsychiatry, clinical neuromuscular pathology, geriatric neurology, headache medicine, neurocritical care, neuroimaging, and neuro-oncology.

In 2020, UCNS transitioned to a new continuous-certification (C-cert) model that requires its diplomates to pay an annual fee of $175 and complete a 25-question online quiz based on preselected journal articles with an 80% passing grade. In a press release outlining the details of the new C-cert program, UCNS said that diplomates began the transition last year by “attesting they have participated in subspecialty-specific continuing medical education (CME) requirements from the time their most recent certificate was issued through 2019.” Diplomates have a 2-year window, which began in 2019, to meet these transitional CME requirements and complete an attestation statement before their certification lapses. “Diplomates with a status of ‘meeting requirements’ will be issued a replacement certificate that shows their original certification date and will reflect there is no expiration date after they pay the first annual C-cert fee in 2020,” UCNS said in the press release.

“It is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,” Paul G. Mathew, MD, assistant professor of neurology at Harvard Medical School in Boston and Director of Legislative Affairs at NBPAS, said in an interview. “A one-size-fits-all approach for learning with preselected articles is not ideal, and physicians should be able to choose CME and other learning activities that best suit their individual interests and practice.”

The added requirements and fees have caused some UCNS diplomates to consider letting their certification lapse, Dr. Mathew said, but the NBPAS decision offers them a new path to recertification. “Many physicians who would have otherwise let their certification lapse and would no longer be considered board certified in headache medicine and other UCNS subspecialties will now have the option to recertify with NBPAS,” he said.

NBPAS was formed in 2014 in response to controversial American Board of Medical Specialties Maintenance of Certification (MOC) programs. NBPAS recertifies diplomates of all specialties and subspecialties offered by the ABMS and its member boards, including board certification in neurology and neurologic subspecialties offered by the American Board of Psychiatry and Neurology.

Board recertification with NBPAS requires an unrestricted license to practice medicine in the United States, an initial certification with ABPN, the American Osteopathic Association, and/or UCNS, a medical staff appointment/membership in good standing, active hospital privileges based on specialty, and 50 hours of relevant CME credits every 2 years.

“Although MOC compliance is not required for licensure, the vast majority of insurance carriers in the United States require to some extent that their physicians be MOC compliant. As such, the ABMS has a monopoly in that a physician cannot practice medicine without complying with MOC,” Dr. Mathew said. “That’s very gradually changing.”

So far, 13 states have passed legislation limiting ABMS MOC compliance as a requirement for credentialing or licensure, and 136 healthcare institutions have recognized NBPAS as a pathway for physician credentialing, according to an NBPAS press release.
 

Changing the rules

Alan Rapoport, MD, was asked to comment on the recertification situtaion. Dr. Rapoport is clinical professor of neurology at UCLA and the Editor in Chief of Neurology Reviews. “As Dr. Mathew aptly states, it is unfortunate that despite requests from diplomates and other stakeholders, UCNS has decided to impose new requirements and additional fees on diplomates who have unexpired certificates based on passing an examination that granted a 10-year certification,”

For context, Dr. Rapoport explained what has happened to him and about 200 neurologists and a few other specialists who took the first UCNS certifying exam in Headache Medicine. “I sat for the first exam in a testing center in 2006, after paying a large fee. I passed and was granted a certificate for a 10-year certification in Headache Medicine. Prior to the expiration of that certificate, I was told I had to pay about $1,800 and take a similar examination to certify for another 10 years. I was not sure I needed to do that, but I did so anyway and passed and was granted a new, dated certificate for another 10 years of certification in Headache Medicine. Shortly after that I began to get notices from UCNS saying that they were changing their certification process and I would soon have to read their designated articles, take an examination on that literature, pay $175 for this privilege of C-Cert yearly, all in spite of the fact that I had a valid certificate for 10 years of certification.”

After complaints from Dr. Rapoport and many others, “UCNS said we would only have to do this when we had 5 years left on our certification. When they advertised this new C-Cert plan on the AAN Headache Listserv, even though advertising was against the rules of the Listserv, I complained about it saying we had paid for a 10-year certification. Their response was to abruptly take me off the Listserv. Then they temporarily shut it down when others agreed with what I had written.”

Dr. Rapoport has the certificate that proves that he has 6 years left on his certification, but UCNS will not recognize this, he said. “I believe that to be unfair, unethical, and probably illegal, as do many senior Headache specialists in the country who have the same issue. The attorney for the UCNS, who is also the attorney for the AAN, has disregarded our objections to this move.”

Now the NBPAS will be recertifying Headache Medicine doctors and those of other specialties who are in a similar situation and do not want to pay for the privilege of taking exams yearly when they have already been certified. “I expect many specialists will switch to this new way of certifying,” Dr. Rapoport said.

“I believe the UCNS has cheapened the value of their certifications by not honoring them,” Dr. Rapoort said.

Dr. Mathew reports that he collects no salary for his role with NBPAS, but receives reimbursement for travel expenses, and occasionally receives honoraria for speaking on behalf of NBPAS.

Don’t wait to give patients with first-episode psychosis long-acting injectable formulations of second-generation antipsychotics, according to Henry A. Nasrallah, MD.

Many clinicians wait to use long-acting injectables (LAIs) until the patient has experienced multiple relapses, but using them after the first discharge may help prevent future relapse, Dr. Nasrallah, professor of psychiatry, neurology, and neuroscience at the University of Cincinnati, said at the virtual Psychopharmacology Update presented by Current Psychiatry and Global Academy for Medical Education.

LAIs and clozapine are “vastly underutilized” after the first discharge, he noted. “I really encourage everybody to use them without hesitation as early as possible.”

In patients with first-episode psychosis, “the most important thing, in my opinion, is to start establishing a therapeutic alliance with the patient from day one,” Dr. Nasrallah said. “It’s always important in psychiatry, but it’s particularly important for first-episode psychosis.”

These patients respond to low doses of antipsychotics and should not be given first-generation antipsychotics because of a risk for acute extrapyramidal symptoms, tardive dyskinesia, and neurotoxicity.

“I usually select an antipsychotic that is extended release and also available as a long-acting injectable formulation,” Dr. Nasrallah said, noting that it helps when he gives a patient a long-acting injectable right after discharge. During hospitalization, Dr. Nasrallah said, he educates the patient and their family about psychosis, treatment, how psychosis affects the brain, and adherence to treatment.

“The primary goal, of course, is to achieve remission and very importantly, to prevent a second episode,” he said. “This is the golden opportunity for us psychiatrists to prevent the patient from relapsing again and again. That is the reason for disability and for brain damage, because every psychotic episode destroys brain tissue. That is why I am very eager to not only achieve a remission in the first episode but also to position the patient to be protected after discharge by giving them long-acting injectable.”

After a clinician performs a full workup to rule out substance use or a general medical condition inducing first-episode psychosis, Dr. Nasrallah recommends paliperidone extended-release (ER), given to patients in the morning because of its tolerability and the availability of an LAI version of the drug. “I start with 3 mg a day; that’s the lowest dose,” he said. “If the patient is very sick and agitated, I might go to 6 mg a day, which is actually a very good dose for first-episode patients, and it’s still quite well tolerated.”

Oral or injectable lorazepam taken as needed may be given to a patient with first-episode psychosis with agitation. For patients who manifest akathisia, twice or thrice daily propranolol at dose of 10-20 mg can be used off label, he said. Dr. Nasrallah also recommended twice-daily omega 3 at a dose of 1,000 mg or N-acetylcysteine at a dose of 600 mg per day as supplements.

“They’re not approved by the [Food and Drug Administration] for first-episode psychosis, but there are numerous publications in the literature by academic psychiatrists showing that they are quite beneficial, and they reduce the two destructive processes during psychosis, which are neuroinflammation and oxidative stress, or free radicals,” he said. “Those two supplements can help in the acute phase of the illness.”

Another option for clinicians is to begin a patient with first-episode psychosis on oral aripiprazole at a dose of 5 mg per day for 2 days, increasing the dose to 7.5 mg per day for 2 days, then increasing to 10 mg per day. “It is not extended-release, so you have to start with low doses to protect the patient from side effects,” Dr. Nasrallah explained. “Some patients may need 15 or 20 [mg], but most first-episode patients may do well on 10 [mg] without risking side effects.”
 

Planning for discharge

Patients who tolerate aripiprazole can start the long-acting aripiprazole lauroxil at discharge, and clinicians have two options to choose from. One formulation “requires 2 weeks of oral supplementation, which you can do in the hospital if you start the patient on oral aripiprazole, and then you can give that injection prior to discharge.” Another option involves giving the patient “any antipsychotic you like and then switch[ing] the patient to aripiprazole lauroxil. The full dose can be given without oral supplementation on the day of discharge.”

Dr. Nasrallah emphasized the use of LAIs in patients discharged for first-episode psychosis. In a study published in JAMA Psychiatry, researchers found use of LAI risperidone in patients with first-episode psychosis significantly reduced the risk of psychotic exacerbation and relapse compared with patients who were given oral risperidone (JAMA Psychiatry. 2015;72:822-9).

“This kind of well-done study shows you that you can do a great job protecting your patient from the very beginning by giving long-acting injectables,” Dr. Nasrallah explained. “That’s why you have to develop rapport with the patient. That’s why you have to convince the patient to take the injectable, and that’s why you have to educate the patient about the hazards of psychosis to the brain, and the fact that it’s very hard to remember to take the pills, because the illness itself can interfere with that due to cognitive impairment [and] negative symptoms.” Another reason for nonadherence is that the patients might not believe they are sick, he added.

After 2 or 3 weeks, if a patient with first-episode psychosis has a minimal response or does not response at all to an LAI, clozapine is an “aggressive” option that may help nonresponders. For patients with schizophrenia, “about 65%-70% would respond to a dopamine antagonist and the remaining 30% are going to need clozapine sooner or later,” Dr. Nasrallah said. “For clozapine after one or two failures [on LAIs] with an adequate dose and adequate duration, don’t wait. Give the patient clozapine, give them an opportunity to regain their life. I’ve seen some very gratifying results with clozapine in those who respond to it.

“The outcome of schizophrenia may be far less malignant than the perception out there if we actually ensure adherence very early and manage the first-episode aggressively, like cardiologists manage the first heart attack,” he said. “[Cardiologists] do everything in their power to protect the patient from a second heart attack, and I regard psychosis as a ‘brain attack.’ ”

Global Academy and this news organization are owned by the same parent company. Dr. Nasrallah reported that he has received research grants from Acadia; served as a consultant for Acadia, Alkermes, Allergan, Janssen, Otsuka, Indivior, Intracellular, Neurocrine, Sunovion, Teva, and Boehringer-Ingelheim; and is on the speakers bureau for Acadia, Alkermes, Allergan, Janssen, Otsuka, Indivior, Intracellular, Neurocrine, Noven, Sunovion, and Teva.

Don’t wait to give patients with first-episode psychosis long-acting injectable formulations of second-generation antipsychotics, according to Henry A. Nasrallah, MD.

Many clinicians wait to use long-acting injectables (LAIs) until the patient has experienced multiple relapses, but using them after the first discharge may help prevent future relapse, Dr. Nasrallah, professor of psychiatry, neurology, and neuroscience at the University of Cincinnati, said at the virtual Psychopharmacology Update presented by Current Psychiatry and Global Academy for Medical Education.

LAIs and clozapine are “vastly underutilized” after the first discharge, he noted. “I really encourage everybody to use them without hesitation as early as possible.”

In patients with first-episode psychosis, “the most important thing, in my opinion, is to start establishing a therapeutic alliance with the patient from day one,” Dr. Nasrallah said. “It’s always important in psychiatry, but it’s particularly important for first-episode psychosis.”

These patients respond to low doses of antipsychotics and should not be given first-generation antipsychotics because of a risk for acute extrapyramidal symptoms, tardive dyskinesia, and neurotoxicity.

“I usually select an antipsychotic that is extended release and also available as a long-acting injectable formulation,” Dr. Nasrallah said, noting that it helps when he gives a patient a long-acting injectable right after discharge. During hospitalization, Dr. Nasrallah said, he educates the patient and their family about psychosis, treatment, how psychosis affects the brain, and adherence to treatment.

“The primary goal, of course, is to achieve remission and very importantly, to prevent a second episode,” he said. “This is the golden opportunity for us psychiatrists to prevent the patient from relapsing again and again. That is the reason for disability and for brain damage, because every psychotic episode destroys brain tissue. That is why I am very eager to not only achieve a remission in the first episode but also to position the patient to be protected after discharge by giving them long-acting injectable.”

After a clinician performs a full workup to rule out substance use or a general medical condition inducing first-episode psychosis, Dr. Nasrallah recommends paliperidone extended-release (ER), given to patients in the morning because of its tolerability and the availability of an LAI version of the drug. “I start with 3 mg a day; that’s the lowest dose,” he said. “If the patient is very sick and agitated, I might go to 6 mg a day, which is actually a very good dose for first-episode patients, and it’s still quite well tolerated.”

Oral or injectable lorazepam taken as needed may be given to a patient with first-episode psychosis with agitation. For patients who manifest akathisia, twice or thrice daily propranolol at dose of 10-20 mg can be used off label, he said. Dr. Nasrallah also recommended twice-daily omega 3 at a dose of 1,000 mg or N-acetylcysteine at a dose of 600 mg per day as supplements.

“They’re not approved by the [Food and Drug Administration] for first-episode psychosis, but there are numerous publications in the literature by academic psychiatrists showing that they are quite beneficial, and they reduce the two destructive processes during psychosis, which are neuroinflammation and oxidative stress, or free radicals,” he said. “Those two supplements can help in the acute phase of the illness.”

Another option for clinicians is to begin a patient with first-episode psychosis on oral aripiprazole at a dose of 5 mg per day for 2 days, increasing the dose to 7.5 mg per day for 2 days, then increasing to 10 mg per day. “It is not extended-release, so you have to start with low doses to protect the patient from side effects,” Dr. Nasrallah explained. “Some patients may need 15 or 20 [mg], but most first-episode patients may do well on 10 [mg] without risking side effects.”
 

Planning for discharge

Patients who tolerate aripiprazole can start the long-acting aripiprazole lauroxil at discharge, and clinicians have two options to choose from. One formulation “requires 2 weeks of oral supplementation, which you can do in the hospital if you start the patient on oral aripiprazole, and then you can give that injection prior to discharge.” Another option involves giving the patient “any antipsychotic you like and then switch[ing] the patient to aripiprazole lauroxil. The full dose can be given without oral supplementation on the day of discharge.”

Dr. Nasrallah emphasized the use of LAIs in patients discharged for first-episode psychosis. In a study published in JAMA Psychiatry, researchers found use of LAI risperidone in patients with first-episode psychosis significantly reduced the risk of psychotic exacerbation and relapse compared with patients who were given oral risperidone (JAMA Psychiatry. 2015;72:822-9).

“This kind of well-done study shows you that you can do a great job protecting your patient from the very beginning by giving long-acting injectables,” Dr. Nasrallah explained. “That’s why you have to develop rapport with the patient. That’s why you have to convince the patient to take the injectable, and that’s why you have to educate the patient about the hazards of psychosis to the brain, and the fact that it’s very hard to remember to take the pills, because the illness itself can interfere with that due to cognitive impairment [and] negative symptoms.” Another reason for nonadherence is that the patients might not believe they are sick, he added.

After 2 or 3 weeks, if a patient with first-episode psychosis has a minimal response or does not response at all to an LAI, clozapine is an “aggressive” option that may help nonresponders. For patients with schizophrenia, “about 65%-70% would respond to a dopamine antagonist and the remaining 30% are going to need clozapine sooner or later,” Dr. Nasrallah said. “For clozapine after one or two failures [on LAIs] with an adequate dose and adequate duration, don’t wait. Give the patient clozapine, give them an opportunity to regain their life. I’ve seen some very gratifying results with clozapine in those who respond to it.

“The outcome of schizophrenia may be far less malignant than the perception out there if we actually ensure adherence very early and manage the first-episode aggressively, like cardiologists manage the first heart attack,” he said. “[Cardiologists] do everything in their power to protect the patient from a second heart attack, and I regard psychosis as a ‘brain attack.’ ”

Global Academy and this news organization are owned by the same parent company. Dr. Nasrallah reported that he has received research grants from Acadia; served as a consultant for Acadia, Alkermes, Allergan, Janssen, Otsuka, Indivior, Intracellular, Neurocrine, Sunovion, Teva, and Boehringer-Ingelheim; and is on the speakers bureau for Acadia, Alkermes, Allergan, Janssen, Otsuka, Indivior, Intracellular, Neurocrine, Noven, Sunovion, and Teva.

Don’t wait to give patients with first-episode psychosis long-acting injectable formulations of second-generation antipsychotics, according to Henry A. Nasrallah, MD.

Many clinicians wait to use long-acting injectables (LAIs) until the patient has experienced multiple relapses, but using them after the first discharge may help prevent future relapse, Dr. Nasrallah, professor of psychiatry, neurology, and neuroscience at the University of Cincinnati, said at the virtual Psychopharmacology Update presented by Current Psychiatry and Global Academy for Medical Education.

LAIs and clozapine are “vastly underutilized” after the first discharge, he noted. “I really encourage everybody to use them without hesitation as early as possible.”

In patients with first-episode psychosis, “the most important thing, in my opinion, is to start establishing a therapeutic alliance with the patient from day one,” Dr. Nasrallah said. “It’s always important in psychiatry, but it’s particularly important for first-episode psychosis.”

These patients respond to low doses of antipsychotics and should not be given first-generation antipsychotics because of a risk for acute extrapyramidal symptoms, tardive dyskinesia, and neurotoxicity.

“I usually select an antipsychotic that is extended release and also available as a long-acting injectable formulation,” Dr. Nasrallah said, noting that it helps when he gives a patient a long-acting injectable right after discharge. During hospitalization, Dr. Nasrallah said, he educates the patient and their family about psychosis, treatment, how psychosis affects the brain, and adherence to treatment.

“The primary goal, of course, is to achieve remission and very importantly, to prevent a second episode,” he said. “This is the golden opportunity for us psychiatrists to prevent the patient from relapsing again and again. That is the reason for disability and for brain damage, because every psychotic episode destroys brain tissue. That is why I am very eager to not only achieve a remission in the first episode but also to position the patient to be protected after discharge by giving them long-acting injectable.”

After a clinician performs a full workup to rule out substance use or a general medical condition inducing first-episode psychosis, Dr. Nasrallah recommends paliperidone extended-release (ER), given to patients in the morning because of its tolerability and the availability of an LAI version of the drug. “I start with 3 mg a day; that’s the lowest dose,” he said. “If the patient is very sick and agitated, I might go to 6 mg a day, which is actually a very good dose for first-episode patients, and it’s still quite well tolerated.”

Oral or injectable lorazepam taken as needed may be given to a patient with first-episode psychosis with agitation. For patients who manifest akathisia, twice or thrice daily propranolol at dose of 10-20 mg can be used off label, he said. Dr. Nasrallah also recommended twice-daily omega 3 at a dose of 1,000 mg or N-acetylcysteine at a dose of 600 mg per day as supplements.

“They’re not approved by the [Food and Drug Administration] for first-episode psychosis, but there are numerous publications in the literature by academic psychiatrists showing that they are quite beneficial, and they reduce the two destructive processes during psychosis, which are neuroinflammation and oxidative stress, or free radicals,” he said. “Those two supplements can help in the acute phase of the illness.”

Another option for clinicians is to begin a patient with first-episode psychosis on oral aripiprazole at a dose of 5 mg per day for 2 days, increasing the dose to 7.5 mg per day for 2 days, then increasing to 10 mg per day. “It is not extended-release, so you have to start with low doses to protect the patient from side effects,” Dr. Nasrallah explained. “Some patients may need 15 or 20 [mg], but most first-episode patients may do well on 10 [mg] without risking side effects.”
 

Planning for discharge

Patients who tolerate aripiprazole can start the long-acting aripiprazole lauroxil at discharge, and clinicians have two options to choose from. One formulation “requires 2 weeks of oral supplementation, which you can do in the hospital if you start the patient on oral aripiprazole, and then you can give that injection prior to discharge.” Another option involves giving the patient “any antipsychotic you like and then switch[ing] the patient to aripiprazole lauroxil. The full dose can be given without oral supplementation on the day of discharge.”

Dr. Nasrallah emphasized the use of LAIs in patients discharged for first-episode psychosis. In a study published in JAMA Psychiatry, researchers found use of LAI risperidone in patients with first-episode psychosis significantly reduced the risk of psychotic exacerbation and relapse compared with patients who were given oral risperidone (JAMA Psychiatry. 2015;72:822-9).

“This kind of well-done study shows you that you can do a great job protecting your patient from the very beginning by giving long-acting injectables,” Dr. Nasrallah explained. “That’s why you have to develop rapport with the patient. That’s why you have to convince the patient to take the injectable, and that’s why you have to educate the patient about the hazards of psychosis to the brain, and the fact that it’s very hard to remember to take the pills, because the illness itself can interfere with that due to cognitive impairment [and] negative symptoms.” Another reason for nonadherence is that the patients might not believe they are sick, he added.

After 2 or 3 weeks, if a patient with first-episode psychosis has a minimal response or does not response at all to an LAI, clozapine is an “aggressive” option that may help nonresponders. For patients with schizophrenia, “about 65%-70% would respond to a dopamine antagonist and the remaining 30% are going to need clozapine sooner or later,” Dr. Nasrallah said. “For clozapine after one or two failures [on LAIs] with an adequate dose and adequate duration, don’t wait. Give the patient clozapine, give them an opportunity to regain their life. I’ve seen some very gratifying results with clozapine in those who respond to it.

“The outcome of schizophrenia may be far less malignant than the perception out there if we actually ensure adherence very early and manage the first-episode aggressively, like cardiologists manage the first heart attack,” he said. “[Cardiologists] do everything in their power to protect the patient from a second heart attack, and I regard psychosis as a ‘brain attack.’ ”

Global Academy and this news organization are owned by the same parent company. Dr. Nasrallah reported that he has received research grants from Acadia; served as a consultant for Acadia, Alkermes, Allergan, Janssen, Otsuka, Indivior, Intracellular, Neurocrine, Sunovion, Teva, and Boehringer-Ingelheim; and is on the speakers bureau for Acadia, Alkermes, Allergan, Janssen, Otsuka, Indivior, Intracellular, Neurocrine, Noven, Sunovion, and Teva.