Heidi Splete

Women who were Black, Latina, American Indian, or Alaska Native were significantly less likely than White women to receive guidelines-adherent treatment for endometrial cancer, based on data from more than 80,000 women.

The incidence of uterine cancer has increased across all ethnicities in recent decades, and adherence to the National Comprehensive Cancer Network treatment guidelines has been associated with improved survival, wrote Victoria A. Rodriguez, MSW, MPH, of the University of California, Irvine, and colleagues. “To date, however, there are few studies that have looked at endometrial cancer disparities with adherence to National Comprehensive Cancer Network treatment guidelines.”

In a retrospective study published in Obstetrics & Gynecology, the researchers used data from the SEER (Surveillance, Epidemiology, and End Results) database between Jan. 1, 2006, and Dec. 31, 2015. The study population included 83,883 women aged 18 years and older who were diagnosed with their first or only endometrial carcinoma. The primary dependent variable was adherence to the NCCN guidelines for the initial course of treatment, which included a combination of therapies based on cancer subtype and the extent of the disease, the researchers said.

The researchers combined the guidelines and the corresponding data from the SEER database to create “a binary variable representing adherence to [NCCN] guidelines (1 = adherent treatment, 0 = nonadherent treatment).”

Approximately 60% of the total patient population received guidelines-adherent treatment. In a multivariate analysis, Black women, Latina women, and American Indian or Alaska Native women were significantly less likely than White women to receive such treatment (odds ratios, 0.88, 0.92, and 0.82, respectively), controlling for factors including neighborhood socioeconomic status, age, and stage at diagnosis, year of diagnosis, histology, and disease grade. Asian women and Native Hawaiian/Pacific Islander women were significantly more likely to received guidelines-adherent treatment, compared with White women (OR, 1.14 and 1.19, respectively).

The researchers also found a significant gradient in guidelines-adherent treatment based on neighborhood socioeconomic status. Relative to the highest neighborhood socioeconomic status group, women in the lower groups had significantly lower odds of receiving guidelines-adherent treatment, with ORs of 0.89, 0.84, 0.80, and 0.73, respectively, for the high-middle neighborhood socioeconomic group, the middle group, the low-middle group, and the lowest group (P < .001 for all).

“Our study is novel in that it examines neighborhood socioeconomic disparities in the understudied context of treatment adherence for endometrial cancer,” the researchers noted.

The study findings were limited by several factors in including the retrospective design and potential for unmeasured confounding variables not included in SEER, such as hospital and physician characteristics, the researchers said. Also, the SEER data set was limited to only the first course of treatment, and did not include information on patient comorbidities that might affect treatment.

“Future research should qualitatively explore reasons for nonadherent treatment within endometrial cancer and other cancer sites among various racial-ethnic groups and socioeconomic status groups, with special attention to low-income women of color,” the researchers emphasized. More research on the impact of comorbidities on a patient’s ability to receive guidelines-based care should be used to inform whether comorbidities should be part of the NCCN guidelines.

However, the results were strengthened by the large sample size and diverse population, so the findings are generalizable to the overall U.S. population, the researchers said.

“Interventions are needed to ensure that equitable cancer treatment practices are available for all individuals regardless of their racial-ethnic or socioeconomic backgrounds,” they concluded.
 

Pursue optimal treatment to curb mortality

Even more concerning than the increase in the incidence of endometrial cancer in the United States is the increase in mortality from this disease, said Emma C. Rossi, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Therefore, it is critical that we identify factors which might be contributing to the increasing lethality of this cancer,” she emphasized. “One such potential factor is race, as it has been observed that Black race is associated with an increased risk of death from endometrial cancer. Historically, this was attributed to the more aggressive subtypes of endometrial cancer (such as serous) which have a higher incidence among Black women. However, more recently, population-based studies have identified that this worse prognosis is independent of histologic cell type,” which suggests that something in our health care delivery is contributing to these worse outcomes.

“The present study helps to confirm these concerning associations, shedding some light on contributory factors, in this case, modifiable (adherence to recommended guidelines) and less modifiable (neighborhood socioeconomic environments) [ones],” Dr. Rossi noted. “The guidelines that are established by the NCCN are chosen after they have been shown to be associated with improved outcomes (including either survival or quality of life), and therefore lack of adherence to these outcomes may suggest inferior quality care is being delivered.”

Studies such as this are helpful in exposing the problem of treatment disparity to help identify sources of problems to develop solutions, she added.

The results should inspire clinicians “to feel agency in changing these outcomes, albeit by tackling very difficult social, political, and health system shortfalls,” she said.
 

Identify barriers to care

Barriers to greater adherence to guidelines-based care include varying definitions of such care, Dr. Rossi said.

“This is particularly true for surgical management of endometrial cancer, which remains controversial with respect to lymph node assessment. Lack of surgical staging with lymph node assessment was considered noncompliant care for this study; however, lymphadenectomy has not specifically, in and of itself, been associated with improved outcomes, and therefore some surgeons argue against performing it routinely,” she explained.

“Lack of access to sophisticated surgical tools and advanced surgical techniques may account for nonguidelines-based care in the patients with early-stage endometrial cancer; however, there are likely other differences in the ability to deliver guideline-concordant care (such as chemotherapy and radiation therapy) for advanced-stage cancers,” Dr. Rossi said. “Patient and provider positive attitudes toward adjuvant therapy, access to transportation, supportive home environments, paid sick leave, well-controlled or minimal comorbidities are all factors which promote the administration of complex adjuvant therapies such as chemotherapy and radiation. In low-resource neighborhoods and minority communities, barriers to these factors may be contributing to nonguidelines-concordant care.”

Dr. Rossi emphasized the need to “dive deeper into these data at individual health-system and provider levels.” For example, research is needed to compare the practice patterns and models of high-performing clinical practices with lower-performing practices in terms of factors such as tumor boards, journal review, peer review, dashboards, and metrics. By doing so, “we can ensure that we are understanding where and why variations in care are occurring,” Dr. Rossi said.

The study was supported in part by the Faculty Mentor Program Fellowship from the University of California, Irvine, graduate division. Ms. Rodriguez was supported in part by a grant from the National Cancer Institute. The researchers had no financial conflicts to disclose. Dr. Rossi had no financial conflicts to disclose.

Women who were Black, Latina, American Indian, or Alaska Native were significantly less likely than White women to receive guidelines-adherent treatment for endometrial cancer, based on data from more than 80,000 women.

The incidence of uterine cancer has increased across all ethnicities in recent decades, and adherence to the National Comprehensive Cancer Network treatment guidelines has been associated with improved survival, wrote Victoria A. Rodriguez, MSW, MPH, of the University of California, Irvine, and colleagues. “To date, however, there are few studies that have looked at endometrial cancer disparities with adherence to National Comprehensive Cancer Network treatment guidelines.”

In a retrospective study published in Obstetrics & Gynecology, the researchers used data from the SEER (Surveillance, Epidemiology, and End Results) database between Jan. 1, 2006, and Dec. 31, 2015. The study population included 83,883 women aged 18 years and older who were diagnosed with their first or only endometrial carcinoma. The primary dependent variable was adherence to the NCCN guidelines for the initial course of treatment, which included a combination of therapies based on cancer subtype and the extent of the disease, the researchers said.

The researchers combined the guidelines and the corresponding data from the SEER database to create “a binary variable representing adherence to [NCCN] guidelines (1 = adherent treatment, 0 = nonadherent treatment).”

Approximately 60% of the total patient population received guidelines-adherent treatment. In a multivariate analysis, Black women, Latina women, and American Indian or Alaska Native women were significantly less likely than White women to receive such treatment (odds ratios, 0.88, 0.92, and 0.82, respectively), controlling for factors including neighborhood socioeconomic status, age, and stage at diagnosis, year of diagnosis, histology, and disease grade. Asian women and Native Hawaiian/Pacific Islander women were significantly more likely to received guidelines-adherent treatment, compared with White women (OR, 1.14 and 1.19, respectively).

The researchers also found a significant gradient in guidelines-adherent treatment based on neighborhood socioeconomic status. Relative to the highest neighborhood socioeconomic status group, women in the lower groups had significantly lower odds of receiving guidelines-adherent treatment, with ORs of 0.89, 0.84, 0.80, and 0.73, respectively, for the high-middle neighborhood socioeconomic group, the middle group, the low-middle group, and the lowest group (P < .001 for all).

“Our study is novel in that it examines neighborhood socioeconomic disparities in the understudied context of treatment adherence for endometrial cancer,” the researchers noted.

The study findings were limited by several factors in including the retrospective design and potential for unmeasured confounding variables not included in SEER, such as hospital and physician characteristics, the researchers said. Also, the SEER data set was limited to only the first course of treatment, and did not include information on patient comorbidities that might affect treatment.

“Future research should qualitatively explore reasons for nonadherent treatment within endometrial cancer and other cancer sites among various racial-ethnic groups and socioeconomic status groups, with special attention to low-income women of color,” the researchers emphasized. More research on the impact of comorbidities on a patient’s ability to receive guidelines-based care should be used to inform whether comorbidities should be part of the NCCN guidelines.

However, the results were strengthened by the large sample size and diverse population, so the findings are generalizable to the overall U.S. population, the researchers said.

“Interventions are needed to ensure that equitable cancer treatment practices are available for all individuals regardless of their racial-ethnic or socioeconomic backgrounds,” they concluded.
 

Pursue optimal treatment to curb mortality

Even more concerning than the increase in the incidence of endometrial cancer in the United States is the increase in mortality from this disease, said Emma C. Rossi, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Therefore, it is critical that we identify factors which might be contributing to the increasing lethality of this cancer,” she emphasized. “One such potential factor is race, as it has been observed that Black race is associated with an increased risk of death from endometrial cancer. Historically, this was attributed to the more aggressive subtypes of endometrial cancer (such as serous) which have a higher incidence among Black women. However, more recently, population-based studies have identified that this worse prognosis is independent of histologic cell type,” which suggests that something in our health care delivery is contributing to these worse outcomes.

“The present study helps to confirm these concerning associations, shedding some light on contributory factors, in this case, modifiable (adherence to recommended guidelines) and less modifiable (neighborhood socioeconomic environments) [ones],” Dr. Rossi noted. “The guidelines that are established by the NCCN are chosen after they have been shown to be associated with improved outcomes (including either survival or quality of life), and therefore lack of adherence to these outcomes may suggest inferior quality care is being delivered.”

Studies such as this are helpful in exposing the problem of treatment disparity to help identify sources of problems to develop solutions, she added.

The results should inspire clinicians “to feel agency in changing these outcomes, albeit by tackling very difficult social, political, and health system shortfalls,” she said.
 

Identify barriers to care

Barriers to greater adherence to guidelines-based care include varying definitions of such care, Dr. Rossi said.

“This is particularly true for surgical management of endometrial cancer, which remains controversial with respect to lymph node assessment. Lack of surgical staging with lymph node assessment was considered noncompliant care for this study; however, lymphadenectomy has not specifically, in and of itself, been associated with improved outcomes, and therefore some surgeons argue against performing it routinely,” she explained.

“Lack of access to sophisticated surgical tools and advanced surgical techniques may account for nonguidelines-based care in the patients with early-stage endometrial cancer; however, there are likely other differences in the ability to deliver guideline-concordant care (such as chemotherapy and radiation therapy) for advanced-stage cancers,” Dr. Rossi said. “Patient and provider positive attitudes toward adjuvant therapy, access to transportation, supportive home environments, paid sick leave, well-controlled or minimal comorbidities are all factors which promote the administration of complex adjuvant therapies such as chemotherapy and radiation. In low-resource neighborhoods and minority communities, barriers to these factors may be contributing to nonguidelines-concordant care.”

Dr. Rossi emphasized the need to “dive deeper into these data at individual health-system and provider levels.” For example, research is needed to compare the practice patterns and models of high-performing clinical practices with lower-performing practices in terms of factors such as tumor boards, journal review, peer review, dashboards, and metrics. By doing so, “we can ensure that we are understanding where and why variations in care are occurring,” Dr. Rossi said.

The study was supported in part by the Faculty Mentor Program Fellowship from the University of California, Irvine, graduate division. Ms. Rodriguez was supported in part by a grant from the National Cancer Institute. The researchers had no financial conflicts to disclose. Dr. Rossi had no financial conflicts to disclose.

Women who were Black, Latina, American Indian, or Alaska Native were significantly less likely than White women to receive guidelines-adherent treatment for endometrial cancer, based on data from more than 80,000 women.

The incidence of uterine cancer has increased across all ethnicities in recent decades, and adherence to the National Comprehensive Cancer Network treatment guidelines has been associated with improved survival, wrote Victoria A. Rodriguez, MSW, MPH, of the University of California, Irvine, and colleagues. “To date, however, there are few studies that have looked at endometrial cancer disparities with adherence to National Comprehensive Cancer Network treatment guidelines.”

In a retrospective study published in Obstetrics & Gynecology, the researchers used data from the SEER (Surveillance, Epidemiology, and End Results) database between Jan. 1, 2006, and Dec. 31, 2015. The study population included 83,883 women aged 18 years and older who were diagnosed with their first or only endometrial carcinoma. The primary dependent variable was adherence to the NCCN guidelines for the initial course of treatment, which included a combination of therapies based on cancer subtype and the extent of the disease, the researchers said.

The researchers combined the guidelines and the corresponding data from the SEER database to create “a binary variable representing adherence to [NCCN] guidelines (1 = adherent treatment, 0 = nonadherent treatment).”

Approximately 60% of the total patient population received guidelines-adherent treatment. In a multivariate analysis, Black women, Latina women, and American Indian or Alaska Native women were significantly less likely than White women to receive such treatment (odds ratios, 0.88, 0.92, and 0.82, respectively), controlling for factors including neighborhood socioeconomic status, age, and stage at diagnosis, year of diagnosis, histology, and disease grade. Asian women and Native Hawaiian/Pacific Islander women were significantly more likely to received guidelines-adherent treatment, compared with White women (OR, 1.14 and 1.19, respectively).

The researchers also found a significant gradient in guidelines-adherent treatment based on neighborhood socioeconomic status. Relative to the highest neighborhood socioeconomic status group, women in the lower groups had significantly lower odds of receiving guidelines-adherent treatment, with ORs of 0.89, 0.84, 0.80, and 0.73, respectively, for the high-middle neighborhood socioeconomic group, the middle group, the low-middle group, and the lowest group (P < .001 for all).

“Our study is novel in that it examines neighborhood socioeconomic disparities in the understudied context of treatment adherence for endometrial cancer,” the researchers noted.

The study findings were limited by several factors in including the retrospective design and potential for unmeasured confounding variables not included in SEER, such as hospital and physician characteristics, the researchers said. Also, the SEER data set was limited to only the first course of treatment, and did not include information on patient comorbidities that might affect treatment.

“Future research should qualitatively explore reasons for nonadherent treatment within endometrial cancer and other cancer sites among various racial-ethnic groups and socioeconomic status groups, with special attention to low-income women of color,” the researchers emphasized. More research on the impact of comorbidities on a patient’s ability to receive guidelines-based care should be used to inform whether comorbidities should be part of the NCCN guidelines.

However, the results were strengthened by the large sample size and diverse population, so the findings are generalizable to the overall U.S. population, the researchers said.

“Interventions are needed to ensure that equitable cancer treatment practices are available for all individuals regardless of their racial-ethnic or socioeconomic backgrounds,” they concluded.
 

Pursue optimal treatment to curb mortality

Even more concerning than the increase in the incidence of endometrial cancer in the United States is the increase in mortality from this disease, said Emma C. Rossi, MD, of the University of North Carolina at Chapel Hill, in an interview.

“Therefore, it is critical that we identify factors which might be contributing to the increasing lethality of this cancer,” she emphasized. “One such potential factor is race, as it has been observed that Black race is associated with an increased risk of death from endometrial cancer. Historically, this was attributed to the more aggressive subtypes of endometrial cancer (such as serous) which have a higher incidence among Black women. However, more recently, population-based studies have identified that this worse prognosis is independent of histologic cell type,” which suggests that something in our health care delivery is contributing to these worse outcomes.

“The present study helps to confirm these concerning associations, shedding some light on contributory factors, in this case, modifiable (adherence to recommended guidelines) and less modifiable (neighborhood socioeconomic environments) [ones],” Dr. Rossi noted. “The guidelines that are established by the NCCN are chosen after they have been shown to be associated with improved outcomes (including either survival or quality of life), and therefore lack of adherence to these outcomes may suggest inferior quality care is being delivered.”

Studies such as this are helpful in exposing the problem of treatment disparity to help identify sources of problems to develop solutions, she added.

The results should inspire clinicians “to feel agency in changing these outcomes, albeit by tackling very difficult social, political, and health system shortfalls,” she said.
 

Identify barriers to care

Barriers to greater adherence to guidelines-based care include varying definitions of such care, Dr. Rossi said.

“This is particularly true for surgical management of endometrial cancer, which remains controversial with respect to lymph node assessment. Lack of surgical staging with lymph node assessment was considered noncompliant care for this study; however, lymphadenectomy has not specifically, in and of itself, been associated with improved outcomes, and therefore some surgeons argue against performing it routinely,” she explained.

“Lack of access to sophisticated surgical tools and advanced surgical techniques may account for nonguidelines-based care in the patients with early-stage endometrial cancer; however, there are likely other differences in the ability to deliver guideline-concordant care (such as chemotherapy and radiation therapy) for advanced-stage cancers,” Dr. Rossi said. “Patient and provider positive attitudes toward adjuvant therapy, access to transportation, supportive home environments, paid sick leave, well-controlled or minimal comorbidities are all factors which promote the administration of complex adjuvant therapies such as chemotherapy and radiation. In low-resource neighborhoods and minority communities, barriers to these factors may be contributing to nonguidelines-concordant care.”

Dr. Rossi emphasized the need to “dive deeper into these data at individual health-system and provider levels.” For example, research is needed to compare the practice patterns and models of high-performing clinical practices with lower-performing practices in terms of factors such as tumor boards, journal review, peer review, dashboards, and metrics. By doing so, “we can ensure that we are understanding where and why variations in care are occurring,” Dr. Rossi said.

The study was supported in part by the Faculty Mentor Program Fellowship from the University of California, Irvine, graduate division. Ms. Rodriguez was supported in part by a grant from the National Cancer Institute. The researchers had no financial conflicts to disclose. Dr. Rossi had no financial conflicts to disclose.

The American College of Gastroenterology has issued new guidelines on management of Clostridioides difficile infection that now include roles for fecal microbial transplant (FMT), combination testing, and bezlotoxumab.

The ACG’s previous guidelines on the diagnosis, management, and treatment of what was then still called Clostridium difficile were published in 2013. Since then, the organism’s name changed to Clostridioides difficile, and that’s just the beginning of the changes reflected in the scientific literature, wrote lead author Colleen R. Kelly, MD, of Brown University, Providence, R.I., and colleagues.

“Other developments include the increased recognition of diagnostic challenges in the era of nucleic acid amplification–based testing, new therapeutic options for treatment and prevention of recurrence, and increasing evidence to support fecal microbiota transplantation (FMT) in recurrent and severe infection,” the authors said.

The guidelines, published in the American Journal of Gastroenterology, include 23 graded recommendations addressing issues of prevention, diagnosis, treatment, prevention of recurrence, and guidance for special populations in the management of C. difficile infection (CDI).
 

New faces among familiar ones

In terms of diagnosis, the new guidelines recommend using both a highly sensitive testing modality and a highly specific one to help distinguish colonization from active infection. Specifically, the authors recommend that stool is first tested using a highly sensitive test, either nucleic acid amplification testing or glutamate dehydrogenase, followed by an enzyme immunoassays for its high specificity.

Changes to treatment recommendations include the initial use of oral vancomycin or oral fidaxomicin for cases of nonsevere CDI. Oral metronidazole may be considered for initial nonsevere CDI in low-risk patients, the authors noted. The evidence is strong for the continued recommendations of vancomycin (125 mg four times daily for 10 days) and fidaxomicin (200 mg twice daily for 10 days) for patients with severe CDI. For patients with fulminant CDI, the recommendations call for medical therapy including volume resuscitation and oral vancomycin, although combination therapy with parenteral metronidazole may be considered despite the very low quality of evidence.

A notable update to the guidelines is the recommendation of fecal microbiota transplant (FMT) for both severe and fulminant CDI cases that are resistant to antibiotics and to prevent recurrence in at-risk patients. Although the quality of evidence is ranked as low, the recommendation is strong, the authors wrote. “Beyond improved cure rates, FMT may result in decreased rates of CDI-related colectomy and sepsis and may offer survival benefit in this critically ill patient population.” However, most patients in studies of FMT required multiple treatments in combination with anti-CDI antibiotics.

Other recommendations to prevent recurrence include oral vancomycin prophylaxis during the subsequent use of systemic antibiotics in patients with a history of CDI. The guidelines also recommend bezlotoxumab for prevention of CDI recurrence in high-risk patients, and advise against discontinuing antisecretory therapy in CDI patients if there is an appropriate indication for use.

Based on the lack of quality evidence, the guidelines recommend against the use of probiotics for preventing CDI in patients being treated with antibiotics and for prevention of recurrent infection.
 

Special populations

For patients with inflammatory bowel disease, the guidelines recommend C. difficile testing when these individuals present with acute flares and diarrhea, and the use of vancomycin for treatment. In addition, the authors strongly recommended FMT for recurrent CDI in these patients. For pregnant, postpartum, and breastfeeding patients with CDI, the guidelines recommend vancomycin, and either vancomycin or fidaxomicin may be used for treating CDI in immunocompromised patients, the authors noted.

The updated guidelines are designed to complement those issued by the Infections Disease Society of America and Society of Healthcare Epidemiologists of America, the researchers noted.
 

Reflecting the research

The previous guidelines for C. difficile were issued in 2013, and much has changed since then in terms of epidemiology, diagnosis, treatment, and infection control, Sahil Khanna, MBBS, MS, of the Mayo Clinic, Rochester, Minn., said in an interview.

Notably, diagnostic testing has “made leaps and bounds” and new treatments have become available that were not included in earlier guidelines, said Dr. Khanna. In particular, the new guidelines are recommending a two-step diagnostic assay; “the diagnostic algorithm has changed, and hopefully that will help us change practice” to identify active infection more quickly and efficiently.

Another important update is the recommendation of fidaxomicin as an option for initial nonfulminant CDI as an alternative to vancomycin, Dr. Khanna said, noting that metronidazole remains an option for low-risk patients. An additional change is the advice to use a different treatment for a second recurrent infection rather than repeating the initial treatment.  

The recommendation of bezlotoxumab for prevention of CDI recurrence in patients who are at high risk of recurrence is the first time this drug has appeared in major guidelines, Dr. Khanna observed.

The recommendation in support of fecal microbiota transplant is a key update to the management of CDI, including the guidance that the procedure can be repeated if necessary, he said.

Looking ahead, “Additional research is needed to fully understand the best testing algorithms for CDI,” Dr. Khanna explained. “More studies also are needed to show how FMT fully fits into the picture, and some current studies are looking at its potential earlier in the course of infection.”

The guidelines were developed in collaboration with the Practice Parameters Committee of the American College of Gastroenterology and received no outside funding. Dr. Kelly disclosed serving as a site investigator of a clinical trial for Finch Therapeutics and is an unpaid clinical advisory board member for OpenBiome. Dr. Khanna has coauthored previous guidelines on C. difficile. He disclosed consulting relationships with Finch, GlaxoSmithKline, Jetson, ProbioTech, and Shire/Takeda, as well as research support from Rebiotix, Seres, and Vedanta.

The American College of Gastroenterology has issued new guidelines on management of Clostridioides difficile infection that now include roles for fecal microbial transplant (FMT), combination testing, and bezlotoxumab.

The ACG’s previous guidelines on the diagnosis, management, and treatment of what was then still called Clostridium difficile were published in 2013. Since then, the organism’s name changed to Clostridioides difficile, and that’s just the beginning of the changes reflected in the scientific literature, wrote lead author Colleen R. Kelly, MD, of Brown University, Providence, R.I., and colleagues.

“Other developments include the increased recognition of diagnostic challenges in the era of nucleic acid amplification–based testing, new therapeutic options for treatment and prevention of recurrence, and increasing evidence to support fecal microbiota transplantation (FMT) in recurrent and severe infection,” the authors said.

The guidelines, published in the American Journal of Gastroenterology, include 23 graded recommendations addressing issues of prevention, diagnosis, treatment, prevention of recurrence, and guidance for special populations in the management of C. difficile infection (CDI).
 

New faces among familiar ones

In terms of diagnosis, the new guidelines recommend using both a highly sensitive testing modality and a highly specific one to help distinguish colonization from active infection. Specifically, the authors recommend that stool is first tested using a highly sensitive test, either nucleic acid amplification testing or glutamate dehydrogenase, followed by an enzyme immunoassays for its high specificity.

Changes to treatment recommendations include the initial use of oral vancomycin or oral fidaxomicin for cases of nonsevere CDI. Oral metronidazole may be considered for initial nonsevere CDI in low-risk patients, the authors noted. The evidence is strong for the continued recommendations of vancomycin (125 mg four times daily for 10 days) and fidaxomicin (200 mg twice daily for 10 days) for patients with severe CDI. For patients with fulminant CDI, the recommendations call for medical therapy including volume resuscitation and oral vancomycin, although combination therapy with parenteral metronidazole may be considered despite the very low quality of evidence.

A notable update to the guidelines is the recommendation of fecal microbiota transplant (FMT) for both severe and fulminant CDI cases that are resistant to antibiotics and to prevent recurrence in at-risk patients. Although the quality of evidence is ranked as low, the recommendation is strong, the authors wrote. “Beyond improved cure rates, FMT may result in decreased rates of CDI-related colectomy and sepsis and may offer survival benefit in this critically ill patient population.” However, most patients in studies of FMT required multiple treatments in combination with anti-CDI antibiotics.

Other recommendations to prevent recurrence include oral vancomycin prophylaxis during the subsequent use of systemic antibiotics in patients with a history of CDI. The guidelines also recommend bezlotoxumab for prevention of CDI recurrence in high-risk patients, and advise against discontinuing antisecretory therapy in CDI patients if there is an appropriate indication for use.

Based on the lack of quality evidence, the guidelines recommend against the use of probiotics for preventing CDI in patients being treated with antibiotics and for prevention of recurrent infection.
 

Special populations

For patients with inflammatory bowel disease, the guidelines recommend C. difficile testing when these individuals present with acute flares and diarrhea, and the use of vancomycin for treatment. In addition, the authors strongly recommended FMT for recurrent CDI in these patients. For pregnant, postpartum, and breastfeeding patients with CDI, the guidelines recommend vancomycin, and either vancomycin or fidaxomicin may be used for treating CDI in immunocompromised patients, the authors noted.

The updated guidelines are designed to complement those issued by the Infections Disease Society of America and Society of Healthcare Epidemiologists of America, the researchers noted.
 

Reflecting the research

The previous guidelines for C. difficile were issued in 2013, and much has changed since then in terms of epidemiology, diagnosis, treatment, and infection control, Sahil Khanna, MBBS, MS, of the Mayo Clinic, Rochester, Minn., said in an interview.

Notably, diagnostic testing has “made leaps and bounds” and new treatments have become available that were not included in earlier guidelines, said Dr. Khanna. In particular, the new guidelines are recommending a two-step diagnostic assay; “the diagnostic algorithm has changed, and hopefully that will help us change practice” to identify active infection more quickly and efficiently.

Another important update is the recommendation of fidaxomicin as an option for initial nonfulminant CDI as an alternative to vancomycin, Dr. Khanna said, noting that metronidazole remains an option for low-risk patients. An additional change is the advice to use a different treatment for a second recurrent infection rather than repeating the initial treatment.  

The recommendation of bezlotoxumab for prevention of CDI recurrence in patients who are at high risk of recurrence is the first time this drug has appeared in major guidelines, Dr. Khanna observed.

The recommendation in support of fecal microbiota transplant is a key update to the management of CDI, including the guidance that the procedure can be repeated if necessary, he said.

Looking ahead, “Additional research is needed to fully understand the best testing algorithms for CDI,” Dr. Khanna explained. “More studies also are needed to show how FMT fully fits into the picture, and some current studies are looking at its potential earlier in the course of infection.”

The guidelines were developed in collaboration with the Practice Parameters Committee of the American College of Gastroenterology and received no outside funding. Dr. Kelly disclosed serving as a site investigator of a clinical trial for Finch Therapeutics and is an unpaid clinical advisory board member for OpenBiome. Dr. Khanna has coauthored previous guidelines on C. difficile. He disclosed consulting relationships with Finch, GlaxoSmithKline, Jetson, ProbioTech, and Shire/Takeda, as well as research support from Rebiotix, Seres, and Vedanta.

The American College of Gastroenterology has issued new guidelines on management of Clostridioides difficile infection that now include roles for fecal microbial transplant (FMT), combination testing, and bezlotoxumab.

The ACG’s previous guidelines on the diagnosis, management, and treatment of what was then still called Clostridium difficile were published in 2013. Since then, the organism’s name changed to Clostridioides difficile, and that’s just the beginning of the changes reflected in the scientific literature, wrote lead author Colleen R. Kelly, MD, of Brown University, Providence, R.I., and colleagues.

“Other developments include the increased recognition of diagnostic challenges in the era of nucleic acid amplification–based testing, new therapeutic options for treatment and prevention of recurrence, and increasing evidence to support fecal microbiota transplantation (FMT) in recurrent and severe infection,” the authors said.

The guidelines, published in the American Journal of Gastroenterology, include 23 graded recommendations addressing issues of prevention, diagnosis, treatment, prevention of recurrence, and guidance for special populations in the management of C. difficile infection (CDI).
 

New faces among familiar ones

In terms of diagnosis, the new guidelines recommend using both a highly sensitive testing modality and a highly specific one to help distinguish colonization from active infection. Specifically, the authors recommend that stool is first tested using a highly sensitive test, either nucleic acid amplification testing or glutamate dehydrogenase, followed by an enzyme immunoassays for its high specificity.

Changes to treatment recommendations include the initial use of oral vancomycin or oral fidaxomicin for cases of nonsevere CDI. Oral metronidazole may be considered for initial nonsevere CDI in low-risk patients, the authors noted. The evidence is strong for the continued recommendations of vancomycin (125 mg four times daily for 10 days) and fidaxomicin (200 mg twice daily for 10 days) for patients with severe CDI. For patients with fulminant CDI, the recommendations call for medical therapy including volume resuscitation and oral vancomycin, although combination therapy with parenteral metronidazole may be considered despite the very low quality of evidence.

A notable update to the guidelines is the recommendation of fecal microbiota transplant (FMT) for both severe and fulminant CDI cases that are resistant to antibiotics and to prevent recurrence in at-risk patients. Although the quality of evidence is ranked as low, the recommendation is strong, the authors wrote. “Beyond improved cure rates, FMT may result in decreased rates of CDI-related colectomy and sepsis and may offer survival benefit in this critically ill patient population.” However, most patients in studies of FMT required multiple treatments in combination with anti-CDI antibiotics.

Other recommendations to prevent recurrence include oral vancomycin prophylaxis during the subsequent use of systemic antibiotics in patients with a history of CDI. The guidelines also recommend bezlotoxumab for prevention of CDI recurrence in high-risk patients, and advise against discontinuing antisecretory therapy in CDI patients if there is an appropriate indication for use.

Based on the lack of quality evidence, the guidelines recommend against the use of probiotics for preventing CDI in patients being treated with antibiotics and for prevention of recurrent infection.
 

Special populations

For patients with inflammatory bowel disease, the guidelines recommend C. difficile testing when these individuals present with acute flares and diarrhea, and the use of vancomycin for treatment. In addition, the authors strongly recommended FMT for recurrent CDI in these patients. For pregnant, postpartum, and breastfeeding patients with CDI, the guidelines recommend vancomycin, and either vancomycin or fidaxomicin may be used for treating CDI in immunocompromised patients, the authors noted.

The updated guidelines are designed to complement those issued by the Infections Disease Society of America and Society of Healthcare Epidemiologists of America, the researchers noted.
 

Reflecting the research

The previous guidelines for C. difficile were issued in 2013, and much has changed since then in terms of epidemiology, diagnosis, treatment, and infection control, Sahil Khanna, MBBS, MS, of the Mayo Clinic, Rochester, Minn., said in an interview.

Notably, diagnostic testing has “made leaps and bounds” and new treatments have become available that were not included in earlier guidelines, said Dr. Khanna. In particular, the new guidelines are recommending a two-step diagnostic assay; “the diagnostic algorithm has changed, and hopefully that will help us change practice” to identify active infection more quickly and efficiently.

Another important update is the recommendation of fidaxomicin as an option for initial nonfulminant CDI as an alternative to vancomycin, Dr. Khanna said, noting that metronidazole remains an option for low-risk patients. An additional change is the advice to use a different treatment for a second recurrent infection rather than repeating the initial treatment.  

The recommendation of bezlotoxumab for prevention of CDI recurrence in patients who are at high risk of recurrence is the first time this drug has appeared in major guidelines, Dr. Khanna observed.

The recommendation in support of fecal microbiota transplant is a key update to the management of CDI, including the guidance that the procedure can be repeated if necessary, he said.

Looking ahead, “Additional research is needed to fully understand the best testing algorithms for CDI,” Dr. Khanna explained. “More studies also are needed to show how FMT fully fits into the picture, and some current studies are looking at its potential earlier in the course of infection.”

The guidelines were developed in collaboration with the Practice Parameters Committee of the American College of Gastroenterology and received no outside funding. Dr. Kelly disclosed serving as a site investigator of a clinical trial for Finch Therapeutics and is an unpaid clinical advisory board member for OpenBiome. Dr. Khanna has coauthored previous guidelines on C. difficile. He disclosed consulting relationships with Finch, GlaxoSmithKline, Jetson, ProbioTech, and Shire/Takeda, as well as research support from Rebiotix, Seres, and Vedanta.

Psoriasis patients treated with biological disease-modifying antirheumatic drugs had a significantly lower incidence of psoriatic arthritis (PsA) compared with those treated with phototherapy, in a study of 464 adults.

Epidemiologic data show that PsA may be diagnosed as long as 5-10 years after a diagnosis of plaque psoriasis, but PsA ultimately occurs in up to 25% of cases, wrote the study investigators, Paolo Gisondi, MD, of the section of dermatology and venereology, department of medicine, at Università degli Studi di Verona, Italy, and colleagues.

“The delay between the onset of skin manifestations of psoriasis and joint disease may provide a therapeutic window of clinical opportunity for preventing the progression from psoriasis to PsA,” but the impact of continuous systemic treatment with biological disease-modifying antirheumatic drugs (DMARDs) has not been well studied, the researchers said.

In the retrospective, nonrandomized study published in Annals of the Rheumatic Diseases, the researchers reviewed data from adults with moderate to severe plaque psoriasis who received continuous treatment with biologic DMARDs, compared with those who received narrow-band ultraviolet light B (nb-UVB) phototherapy, between January 2012 and September 2020.

Patients with a past or present PsA diagnosis were excluded from the study. A total of 234 patients were treated with biologic DMARDs for at least 5 years and 230 were treated with at least three courses of nb-UVB phototherapy; all patients were followed for an average of 7 years.

PsA was determined based on the Classification for Psoriatic Arthritis criteria. Incidence was defined in terms of cases per 100 patients per year.

During the follow-up period, 51 patients (11%) developed incident PsA: 19 (8%) in the biologic DMARDs group and 32 (14%) in the nb-UVB phototherapy group. The annual incidence rate of PsA was 1.20 cases per 100 patients per year in the biologic DMARDs group compared with 2.17 cases per 100 patients per year in the phototherapy group (P = .006).

In a multivariate analysis, independent risk factors for PsA were older age (adjusted hazard ratio, 1.04; P < .001), nail psoriasis (aHR 3.15; P = .001), and psoriasis duration greater than 10 years (aHR, 2.02; P = .001). Most other baseline demographics, including smoking status, baseline Psoriasis Area and Severity Index (PASI) scores, and comorbidities, were similar in patients who did and did not develop PsA.

Of the patients taking biologic DMARDs, 39 (17%) were treated with infliximab, 17 (7%) with etanercept, 67 (29%) with adalimumab, 50 (21%) with ustekinumab, and 61 (26%) with secukinumab; 35 of these patients switched biologics during the study period.

The study findings were limited by several factors including the retrospective design and the resulting potential for biases, notably the potential confounding bias by indication because of the lack of randomization, the researchers noted. Another limitation was the inability to perform a subgroup analysis of biologic DMARD classes because of the small sample size, the authors said. However, they added, the findings were strengthened by the complete database and accurate PsA diagnoses supported by an expert rheumatologist.

Larger prospective and intervention studies are needed to validate the results, the researchers emphasized. However, data from the current study suggest that continued treatment with biologic DMARDs “may reduce the risk of incident PsA in patients with moderate to severe chronic plaque psoriasis,” they concluded.

The study was supported by the European Union’s Horizon 2020 Research and Innovation Program. Dr. Gisondi and several coauthors disclosed relationships with Abbvie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi, and UCB. The study was supported by the European Union’s Horizon 2020 Research and Innovation Program.

Psoriasis patients treated with biological disease-modifying antirheumatic drugs had a significantly lower incidence of psoriatic arthritis (PsA) compared with those treated with phototherapy, in a study of 464 adults.

Epidemiologic data show that PsA may be diagnosed as long as 5-10 years after a diagnosis of plaque psoriasis, but PsA ultimately occurs in up to 25% of cases, wrote the study investigators, Paolo Gisondi, MD, of the section of dermatology and venereology, department of medicine, at Università degli Studi di Verona, Italy, and colleagues.

“The delay between the onset of skin manifestations of psoriasis and joint disease may provide a therapeutic window of clinical opportunity for preventing the progression from psoriasis to PsA,” but the impact of continuous systemic treatment with biological disease-modifying antirheumatic drugs (DMARDs) has not been well studied, the researchers said.

In the retrospective, nonrandomized study published in Annals of the Rheumatic Diseases, the researchers reviewed data from adults with moderate to severe plaque psoriasis who received continuous treatment with biologic DMARDs, compared with those who received narrow-band ultraviolet light B (nb-UVB) phototherapy, between January 2012 and September 2020.

Patients with a past or present PsA diagnosis were excluded from the study. A total of 234 patients were treated with biologic DMARDs for at least 5 years and 230 were treated with at least three courses of nb-UVB phototherapy; all patients were followed for an average of 7 years.

PsA was determined based on the Classification for Psoriatic Arthritis criteria. Incidence was defined in terms of cases per 100 patients per year.

During the follow-up period, 51 patients (11%) developed incident PsA: 19 (8%) in the biologic DMARDs group and 32 (14%) in the nb-UVB phototherapy group. The annual incidence rate of PsA was 1.20 cases per 100 patients per year in the biologic DMARDs group compared with 2.17 cases per 100 patients per year in the phototherapy group (P = .006).

In a multivariate analysis, independent risk factors for PsA were older age (adjusted hazard ratio, 1.04; P < .001), nail psoriasis (aHR 3.15; P = .001), and psoriasis duration greater than 10 years (aHR, 2.02; P = .001). Most other baseline demographics, including smoking status, baseline Psoriasis Area and Severity Index (PASI) scores, and comorbidities, were similar in patients who did and did not develop PsA.

Of the patients taking biologic DMARDs, 39 (17%) were treated with infliximab, 17 (7%) with etanercept, 67 (29%) with adalimumab, 50 (21%) with ustekinumab, and 61 (26%) with secukinumab; 35 of these patients switched biologics during the study period.

The study findings were limited by several factors including the retrospective design and the resulting potential for biases, notably the potential confounding bias by indication because of the lack of randomization, the researchers noted. Another limitation was the inability to perform a subgroup analysis of biologic DMARD classes because of the small sample size, the authors said. However, they added, the findings were strengthened by the complete database and accurate PsA diagnoses supported by an expert rheumatologist.

Larger prospective and intervention studies are needed to validate the results, the researchers emphasized. However, data from the current study suggest that continued treatment with biologic DMARDs “may reduce the risk of incident PsA in patients with moderate to severe chronic plaque psoriasis,” they concluded.

The study was supported by the European Union’s Horizon 2020 Research and Innovation Program. Dr. Gisondi and several coauthors disclosed relationships with Abbvie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi, and UCB. The study was supported by the European Union’s Horizon 2020 Research and Innovation Program.

Psoriasis patients treated with biological disease-modifying antirheumatic drugs had a significantly lower incidence of psoriatic arthritis (PsA) compared with those treated with phototherapy, in a study of 464 adults.

Epidemiologic data show that PsA may be diagnosed as long as 5-10 years after a diagnosis of plaque psoriasis, but PsA ultimately occurs in up to 25% of cases, wrote the study investigators, Paolo Gisondi, MD, of the section of dermatology and venereology, department of medicine, at Università degli Studi di Verona, Italy, and colleagues.

“The delay between the onset of skin manifestations of psoriasis and joint disease may provide a therapeutic window of clinical opportunity for preventing the progression from psoriasis to PsA,” but the impact of continuous systemic treatment with biological disease-modifying antirheumatic drugs (DMARDs) has not been well studied, the researchers said.

In the retrospective, nonrandomized study published in Annals of the Rheumatic Diseases, the researchers reviewed data from adults with moderate to severe plaque psoriasis who received continuous treatment with biologic DMARDs, compared with those who received narrow-band ultraviolet light B (nb-UVB) phototherapy, between January 2012 and September 2020.

Patients with a past or present PsA diagnosis were excluded from the study. A total of 234 patients were treated with biologic DMARDs for at least 5 years and 230 were treated with at least three courses of nb-UVB phototherapy; all patients were followed for an average of 7 years.

PsA was determined based on the Classification for Psoriatic Arthritis criteria. Incidence was defined in terms of cases per 100 patients per year.

During the follow-up period, 51 patients (11%) developed incident PsA: 19 (8%) in the biologic DMARDs group and 32 (14%) in the nb-UVB phototherapy group. The annual incidence rate of PsA was 1.20 cases per 100 patients per year in the biologic DMARDs group compared with 2.17 cases per 100 patients per year in the phototherapy group (P = .006).

In a multivariate analysis, independent risk factors for PsA were older age (adjusted hazard ratio, 1.04; P < .001), nail psoriasis (aHR 3.15; P = .001), and psoriasis duration greater than 10 years (aHR, 2.02; P = .001). Most other baseline demographics, including smoking status, baseline Psoriasis Area and Severity Index (PASI) scores, and comorbidities, were similar in patients who did and did not develop PsA.

Of the patients taking biologic DMARDs, 39 (17%) were treated with infliximab, 17 (7%) with etanercept, 67 (29%) with adalimumab, 50 (21%) with ustekinumab, and 61 (26%) with secukinumab; 35 of these patients switched biologics during the study period.

The study findings were limited by several factors including the retrospective design and the resulting potential for biases, notably the potential confounding bias by indication because of the lack of randomization, the researchers noted. Another limitation was the inability to perform a subgroup analysis of biologic DMARD classes because of the small sample size, the authors said. However, they added, the findings were strengthened by the complete database and accurate PsA diagnoses supported by an expert rheumatologist.

Larger prospective and intervention studies are needed to validate the results, the researchers emphasized. However, data from the current study suggest that continued treatment with biologic DMARDs “may reduce the risk of incident PsA in patients with moderate to severe chronic plaque psoriasis,” they concluded.

The study was supported by the European Union’s Horizon 2020 Research and Innovation Program. Dr. Gisondi and several coauthors disclosed relationships with Abbvie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi, and UCB. The study was supported by the European Union’s Horizon 2020 Research and Innovation Program.

Approximately one-third of individuals with autism spectrum disorder (ASD) are prescribed multiple medications to manage comorbidities and symptoms, according to data from a retrospective cohort study of more than 26,000 patients.

“Clinicians caring for patients with ASD are tasked with the challenges of managing the primary disease, as well as co-occurring medical conditions, and coordinating with educational and social service professionals to provide holistic care,” wrote Aliya G. Feroe of Harvard Medical School, Boston, and colleagues.

The medication classes used to treat individuals with ASD include ADHD medications, antipsychotics, antidepressants, mood stabilizers, benzodiazepines, anxiolytics, and hypnotics, but the prescription rates of these medications in ASD patients have not been examined in large studies, the researchers said.

In a study published in JAMA Pediatrics, the researchers identified 26,722 individuals with ASD using a United States health care database from Jan. 1, 2014, to Dec. 31, 2019. Data included records of inpatient and outpatient claims, and records of prescriptions filled through commercial pharmacies. Individuals received at least 1 of 24 of the most common medication groups for ASD or comorbidities. The average age of the study participants was 14 years, and 78% were male. Diagnostic codes for ASD were based on the International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision.

Over the 6-year study period, approximately one-third of the participants were taking three or more medications at once, ranging from 28.6% to 31.5%. In any 1 year, approximately 41% of children were prescribed a single medication, 17% received two prescriptions, 7.9% received four, and 3.4% received five. Medication changes occurred more frequently within classes than between classes, and reasons for these changes may include patient preference, adverse effects, and cost, the researchers noted.

The overall number of children prescribed particular drugs remained consistent, the researchers noted. “For example, the total number of individuals prescribed methylphenidate shifted from 832 in 2014 to 850 in 2015, 899 in 2016, 863 in 2017, and 838 in 2018,” they wrote.

In 15 of the 24 medication groups included in the study, at least 15% of the individuals had unspecified anxiety disorder, anxiety neurosis, or major depressive disorder; in 11 of the medication groups, at least 15% had some form of ADHD. ADHD prevalence in patients taking stimulants varied based on ADHD type, the researchers said.

The most common comorbidities in patients taking antipsychotics were combined type ADHD (11.6%-17.8%) and anxiety disorder (13.1%-30.1%). The study findings suggest that many clinicians are incorporating medications into ASD management, the researchers said.

“Although there is no medical treatment for the core deficits of social communication and repetitive behavioral patterns in ASD, the American Academy of Pediatrics recommends that clinicians consider medications in the management of common comorbid conditions, including seizures, ADHD, anxiety disorders, mood disorders, and disruptive behavior disorders,” they said.

The findings were limited by several factors including the potential for inconsistent reporting of diagnoses and pharmacy claims, the researchers noted. Other limitations included a lack of direct clinical assessment to validate diagnoses and the absence of validated diagnostic instruments to screen for comorbidities, they added.

“Our findings suggest that clinicians may be increasingly using integrated approaches to treating patients with ASD and co-occurring conditions, and further work is necessary to determine the relative effects of pharmacotherapy vs. behavioral interventions on outcomes in patients with ASD,” the researchers concluded.
 

Many reasons for multiple medications

“The researchers put in a lot of effort to provide data on a large scale,” Herschel Lessin, MD, of Children’s Medical Group, Poughkeepsie, N.Y., said in an interview.

“The findings illustrate the reality that autistic children are prescribed a lot of medications for a lot of reasons, some of which are not entirely clear,” Dr. Lessin said. The study also reflects the chronic lack of behavioral health services for children, he noted. Many children with ASD are referred for services they are unable to access, he said. “As a result, they see doctors who can only prescribe medications to try to control behavior or symptoms for which the cause is unclear,” and which could be ASD or other comorbidities, he emphasized.

The large sample size strengthens the study findings, but some of the challenges include the use of claims data, which do not indicate how diagnoses were made, said Dr. Lessin. An additional limitation is the fact that many medications for children with autism are used off label, so the specific reason for their use may be unknown, he said.

The take-home message for clinicians is that children with ASD are getting a lot of medications, and pediatricians are not usually responsible for multiple medications,” Dr. Lessin said. Ultimately, the study is “a plea for more research,” to tease out details of what medications are indicated and helpful, he said.

The study received no outside funding. The researchers and Dr. Lessin had no financial conflicts to disclose. Dr. Lessin serves on the Pediatric News editorial advisory board.

Approximately one-third of individuals with autism spectrum disorder (ASD) are prescribed multiple medications to manage comorbidities and symptoms, according to data from a retrospective cohort study of more than 26,000 patients.

“Clinicians caring for patients with ASD are tasked with the challenges of managing the primary disease, as well as co-occurring medical conditions, and coordinating with educational and social service professionals to provide holistic care,” wrote Aliya G. Feroe of Harvard Medical School, Boston, and colleagues.

The medication classes used to treat individuals with ASD include ADHD medications, antipsychotics, antidepressants, mood stabilizers, benzodiazepines, anxiolytics, and hypnotics, but the prescription rates of these medications in ASD patients have not been examined in large studies, the researchers said.

In a study published in JAMA Pediatrics, the researchers identified 26,722 individuals with ASD using a United States health care database from Jan. 1, 2014, to Dec. 31, 2019. Data included records of inpatient and outpatient claims, and records of prescriptions filled through commercial pharmacies. Individuals received at least 1 of 24 of the most common medication groups for ASD or comorbidities. The average age of the study participants was 14 years, and 78% were male. Diagnostic codes for ASD were based on the International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision.

Over the 6-year study period, approximately one-third of the participants were taking three or more medications at once, ranging from 28.6% to 31.5%. In any 1 year, approximately 41% of children were prescribed a single medication, 17% received two prescriptions, 7.9% received four, and 3.4% received five. Medication changes occurred more frequently within classes than between classes, and reasons for these changes may include patient preference, adverse effects, and cost, the researchers noted.

The overall number of children prescribed particular drugs remained consistent, the researchers noted. “For example, the total number of individuals prescribed methylphenidate shifted from 832 in 2014 to 850 in 2015, 899 in 2016, 863 in 2017, and 838 in 2018,” they wrote.

In 15 of the 24 medication groups included in the study, at least 15% of the individuals had unspecified anxiety disorder, anxiety neurosis, or major depressive disorder; in 11 of the medication groups, at least 15% had some form of ADHD. ADHD prevalence in patients taking stimulants varied based on ADHD type, the researchers said.

The most common comorbidities in patients taking antipsychotics were combined type ADHD (11.6%-17.8%) and anxiety disorder (13.1%-30.1%). The study findings suggest that many clinicians are incorporating medications into ASD management, the researchers said.

“Although there is no medical treatment for the core deficits of social communication and repetitive behavioral patterns in ASD, the American Academy of Pediatrics recommends that clinicians consider medications in the management of common comorbid conditions, including seizures, ADHD, anxiety disorders, mood disorders, and disruptive behavior disorders,” they said.

The findings were limited by several factors including the potential for inconsistent reporting of diagnoses and pharmacy claims, the researchers noted. Other limitations included a lack of direct clinical assessment to validate diagnoses and the absence of validated diagnostic instruments to screen for comorbidities, they added.

“Our findings suggest that clinicians may be increasingly using integrated approaches to treating patients with ASD and co-occurring conditions, and further work is necessary to determine the relative effects of pharmacotherapy vs. behavioral interventions on outcomes in patients with ASD,” the researchers concluded.
 

Many reasons for multiple medications

“The researchers put in a lot of effort to provide data on a large scale,” Herschel Lessin, MD, of Children’s Medical Group, Poughkeepsie, N.Y., said in an interview.

“The findings illustrate the reality that autistic children are prescribed a lot of medications for a lot of reasons, some of which are not entirely clear,” Dr. Lessin said. The study also reflects the chronic lack of behavioral health services for children, he noted. Many children with ASD are referred for services they are unable to access, he said. “As a result, they see doctors who can only prescribe medications to try to control behavior or symptoms for which the cause is unclear,” and which could be ASD or other comorbidities, he emphasized.

The large sample size strengthens the study findings, but some of the challenges include the use of claims data, which do not indicate how diagnoses were made, said Dr. Lessin. An additional limitation is the fact that many medications for children with autism are used off label, so the specific reason for their use may be unknown, he said.

The take-home message for clinicians is that children with ASD are getting a lot of medications, and pediatricians are not usually responsible for multiple medications,” Dr. Lessin said. Ultimately, the study is “a plea for more research,” to tease out details of what medications are indicated and helpful, he said.

The study received no outside funding. The researchers and Dr. Lessin had no financial conflicts to disclose. Dr. Lessin serves on the Pediatric News editorial advisory board.

Approximately one-third of individuals with autism spectrum disorder (ASD) are prescribed multiple medications to manage comorbidities and symptoms, according to data from a retrospective cohort study of more than 26,000 patients.

“Clinicians caring for patients with ASD are tasked with the challenges of managing the primary disease, as well as co-occurring medical conditions, and coordinating with educational and social service professionals to provide holistic care,” wrote Aliya G. Feroe of Harvard Medical School, Boston, and colleagues.

The medication classes used to treat individuals with ASD include ADHD medications, antipsychotics, antidepressants, mood stabilizers, benzodiazepines, anxiolytics, and hypnotics, but the prescription rates of these medications in ASD patients have not been examined in large studies, the researchers said.

In a study published in JAMA Pediatrics, the researchers identified 26,722 individuals with ASD using a United States health care database from Jan. 1, 2014, to Dec. 31, 2019. Data included records of inpatient and outpatient claims, and records of prescriptions filled through commercial pharmacies. Individuals received at least 1 of 24 of the most common medication groups for ASD or comorbidities. The average age of the study participants was 14 years, and 78% were male. Diagnostic codes for ASD were based on the International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision.

Over the 6-year study period, approximately one-third of the participants were taking three or more medications at once, ranging from 28.6% to 31.5%. In any 1 year, approximately 41% of children were prescribed a single medication, 17% received two prescriptions, 7.9% received four, and 3.4% received five. Medication changes occurred more frequently within classes than between classes, and reasons for these changes may include patient preference, adverse effects, and cost, the researchers noted.

The overall number of children prescribed particular drugs remained consistent, the researchers noted. “For example, the total number of individuals prescribed methylphenidate shifted from 832 in 2014 to 850 in 2015, 899 in 2016, 863 in 2017, and 838 in 2018,” they wrote.

In 15 of the 24 medication groups included in the study, at least 15% of the individuals had unspecified anxiety disorder, anxiety neurosis, or major depressive disorder; in 11 of the medication groups, at least 15% had some form of ADHD. ADHD prevalence in patients taking stimulants varied based on ADHD type, the researchers said.

The most common comorbidities in patients taking antipsychotics were combined type ADHD (11.6%-17.8%) and anxiety disorder (13.1%-30.1%). The study findings suggest that many clinicians are incorporating medications into ASD management, the researchers said.

“Although there is no medical treatment for the core deficits of social communication and repetitive behavioral patterns in ASD, the American Academy of Pediatrics recommends that clinicians consider medications in the management of common comorbid conditions, including seizures, ADHD, anxiety disorders, mood disorders, and disruptive behavior disorders,” they said.

The findings were limited by several factors including the potential for inconsistent reporting of diagnoses and pharmacy claims, the researchers noted. Other limitations included a lack of direct clinical assessment to validate diagnoses and the absence of validated diagnostic instruments to screen for comorbidities, they added.

“Our findings suggest that clinicians may be increasingly using integrated approaches to treating patients with ASD and co-occurring conditions, and further work is necessary to determine the relative effects of pharmacotherapy vs. behavioral interventions on outcomes in patients with ASD,” the researchers concluded.
 

Many reasons for multiple medications

“The researchers put in a lot of effort to provide data on a large scale,” Herschel Lessin, MD, of Children’s Medical Group, Poughkeepsie, N.Y., said in an interview.

“The findings illustrate the reality that autistic children are prescribed a lot of medications for a lot of reasons, some of which are not entirely clear,” Dr. Lessin said. The study also reflects the chronic lack of behavioral health services for children, he noted. Many children with ASD are referred for services they are unable to access, he said. “As a result, they see doctors who can only prescribe medications to try to control behavior or symptoms for which the cause is unclear,” and which could be ASD or other comorbidities, he emphasized.

The large sample size strengthens the study findings, but some of the challenges include the use of claims data, which do not indicate how diagnoses were made, said Dr. Lessin. An additional limitation is the fact that many medications for children with autism are used off label, so the specific reason for their use may be unknown, he said.

The take-home message for clinicians is that children with ASD are getting a lot of medications, and pediatricians are not usually responsible for multiple medications,” Dr. Lessin said. Ultimately, the study is “a plea for more research,” to tease out details of what medications are indicated and helpful, he said.

The study received no outside funding. The researchers and Dr. Lessin had no financial conflicts to disclose. Dr. Lessin serves on the Pediatric News editorial advisory board.

Low adenoma detection rates (ADRs) were associated with a greater risk of death in colorectal cancer (CRC) patients, especially among those with high-risk adenomas, based on a review of more than 250,000 colonoscopies.

pixologicstudio/Thinkstock

“Both performance quality of the endoscopist as well as specific characteristics of resected adenomas at colonoscopy are associated with colorectal cancer mortality,” but the impact of these combined factors on colorectal cancer mortality has not been examined on a large scale, according to Elisabeth A. Waldmann, MD, of the Medical University of Vienna and colleagues.

In a study published in Clinical Gastroenterology & Hepatology, the researchers reviewed 259,885 colonoscopies performed by 361 endoscopists. Over an average follow-up period of 59 months, 165 CRC-related deaths occurred.

Across all risk groups, CRC mortality was higher among patients whose colonoscopies yielded an ADR of less than 25%, although this was not statistically significant in all groups.

The researchers then stratified patients into those with a negative colonoscopy, those with low-risk adenomas (one to two adenomas less than 10 mm), and those with high-risk adenomas (advanced adenomas or at least three adenomas), with the negative colonoscopy group used as the reference group for comparisons. The average age of the patients was 61 years, and approximately half were women.

Endoscopists were classified as having an ADR of less than 25% or 25% and higher.

Among individuals with low-risk adenomas, CRC mortality was similar whether the ADR on a negative colonoscopy was less than 25% or 25% or higher (adjusted hazard ratios, 1.25 and 1.22, respectively). CRC mortality also remained unaffected by ADR in patients with negatively colonoscopies (aHR, 1.27).

By contrast, individuals with high-risk adenomas had a significantly increased risk of CRC death if their colonoscopy was performed by an endoscopist with an ADR of less than 25%, compared with those whose endoscopists had ADRs of 25% or higher (aHR, 2.25 and 1.35, respectively).

“Our study demonstrated that adding ADR to the risk stratification model improved risk assessment in all risk groups,” the researchers noted. “Importantly, stratification improved most for individuals with high-risk adenomas, the group demanding most resources in health care systems.”

The study findings were limited by several factors including the focus on only screening and surveillance colonoscopies, not including diagnostic colonoscopies, and the inability to adjust for comorbidities and lifestyle factors that might impact CRC mortality, the researchers noted. The 22.4% average ADR in the current study was low, compared with other studies, and could be a limitation as well, although previous guidelines recommend a target ADR of at least 20%.

“Despite the extensive body of literature supporting the importance of ADR in terms of CRC prevention, its implementation into clinical surveillance is challenging,” as physicians under pressure might try to game their ADRs, the researchers wrote.

The findings support the value of mandatory assessment of performance quality, the researchers added. However, “because of the potential possibility of gaming one’s ADR one conclusion drawn by the study results should be that endoscopists’ quality parameters should be monitored and those not meeting the standards trained to improve rather than requiring minimum ADRs as premise for offering screening colonoscopy.”
 

Improve performance, but don’t discount patient factors

The study is important at this time because colorectal cancer is the third-leading cause of cancer death in the United States, Atsushi Sakuraba, MD, of the University of Chicago said in an interview.

“Screening colonoscopy has been shown to decrease CRC mortality, but factors influencing outcomes after screening colonoscopies remain to be determined,” he said.

“It was expected that high-quality colonoscopy performed by an endoscopist with ADR of 25% or greater was associated with a lower risk for CRC death,” Dr. Sakuraba said. “The strength of the study is that the authors demonstrated that high-quality colonoscopy was more important in individuals with high-risk adenomas, such as advanced adenomas or at least three adenomas.”

The study findings have implications for practice in that they show the importance of monitoring performance quality in screening colonoscopy, Dr. Sakuraba said, “especially when patients have high-risk adenomas.” However, “the authors included only age and sex as variables, but the influence of other factors, such as smoking, [body mass index], and race, need to be studied.”

The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

Low adenoma detection rates (ADRs) were associated with a greater risk of death in colorectal cancer (CRC) patients, especially among those with high-risk adenomas, based on a review of more than 250,000 colonoscopies.

pixologicstudio/Thinkstock

“Both performance quality of the endoscopist as well as specific characteristics of resected adenomas at colonoscopy are associated with colorectal cancer mortality,” but the impact of these combined factors on colorectal cancer mortality has not been examined on a large scale, according to Elisabeth A. Waldmann, MD, of the Medical University of Vienna and colleagues.

In a study published in Clinical Gastroenterology & Hepatology, the researchers reviewed 259,885 colonoscopies performed by 361 endoscopists. Over an average follow-up period of 59 months, 165 CRC-related deaths occurred.

Across all risk groups, CRC mortality was higher among patients whose colonoscopies yielded an ADR of less than 25%, although this was not statistically significant in all groups.

The researchers then stratified patients into those with a negative colonoscopy, those with low-risk adenomas (one to two adenomas less than 10 mm), and those with high-risk adenomas (advanced adenomas or at least three adenomas), with the negative colonoscopy group used as the reference group for comparisons. The average age of the patients was 61 years, and approximately half were women.

Endoscopists were classified as having an ADR of less than 25% or 25% and higher.

Among individuals with low-risk adenomas, CRC mortality was similar whether the ADR on a negative colonoscopy was less than 25% or 25% or higher (adjusted hazard ratios, 1.25 and 1.22, respectively). CRC mortality also remained unaffected by ADR in patients with negatively colonoscopies (aHR, 1.27).

By contrast, individuals with high-risk adenomas had a significantly increased risk of CRC death if their colonoscopy was performed by an endoscopist with an ADR of less than 25%, compared with those whose endoscopists had ADRs of 25% or higher (aHR, 2.25 and 1.35, respectively).

“Our study demonstrated that adding ADR to the risk stratification model improved risk assessment in all risk groups,” the researchers noted. “Importantly, stratification improved most for individuals with high-risk adenomas, the group demanding most resources in health care systems.”

The study findings were limited by several factors including the focus on only screening and surveillance colonoscopies, not including diagnostic colonoscopies, and the inability to adjust for comorbidities and lifestyle factors that might impact CRC mortality, the researchers noted. The 22.4% average ADR in the current study was low, compared with other studies, and could be a limitation as well, although previous guidelines recommend a target ADR of at least 20%.

“Despite the extensive body of literature supporting the importance of ADR in terms of CRC prevention, its implementation into clinical surveillance is challenging,” as physicians under pressure might try to game their ADRs, the researchers wrote.

The findings support the value of mandatory assessment of performance quality, the researchers added. However, “because of the potential possibility of gaming one’s ADR one conclusion drawn by the study results should be that endoscopists’ quality parameters should be monitored and those not meeting the standards trained to improve rather than requiring minimum ADRs as premise for offering screening colonoscopy.”
 

Improve performance, but don’t discount patient factors

The study is important at this time because colorectal cancer is the third-leading cause of cancer death in the United States, Atsushi Sakuraba, MD, of the University of Chicago said in an interview.

“Screening colonoscopy has been shown to decrease CRC mortality, but factors influencing outcomes after screening colonoscopies remain to be determined,” he said.

“It was expected that high-quality colonoscopy performed by an endoscopist with ADR of 25% or greater was associated with a lower risk for CRC death,” Dr. Sakuraba said. “The strength of the study is that the authors demonstrated that high-quality colonoscopy was more important in individuals with high-risk adenomas, such as advanced adenomas or at least three adenomas.”

The study findings have implications for practice in that they show the importance of monitoring performance quality in screening colonoscopy, Dr. Sakuraba said, “especially when patients have high-risk adenomas.” However, “the authors included only age and sex as variables, but the influence of other factors, such as smoking, [body mass index], and race, need to be studied.”

The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

Low adenoma detection rates (ADRs) were associated with a greater risk of death in colorectal cancer (CRC) patients, especially among those with high-risk adenomas, based on a review of more than 250,000 colonoscopies.

pixologicstudio/Thinkstock

“Both performance quality of the endoscopist as well as specific characteristics of resected adenomas at colonoscopy are associated with colorectal cancer mortality,” but the impact of these combined factors on colorectal cancer mortality has not been examined on a large scale, according to Elisabeth A. Waldmann, MD, of the Medical University of Vienna and colleagues.

In a study published in Clinical Gastroenterology & Hepatology, the researchers reviewed 259,885 colonoscopies performed by 361 endoscopists. Over an average follow-up period of 59 months, 165 CRC-related deaths occurred.

Across all risk groups, CRC mortality was higher among patients whose colonoscopies yielded an ADR of less than 25%, although this was not statistically significant in all groups.

The researchers then stratified patients into those with a negative colonoscopy, those with low-risk adenomas (one to two adenomas less than 10 mm), and those with high-risk adenomas (advanced adenomas or at least three adenomas), with the negative colonoscopy group used as the reference group for comparisons. The average age of the patients was 61 years, and approximately half were women.

Endoscopists were classified as having an ADR of less than 25% or 25% and higher.

Among individuals with low-risk adenomas, CRC mortality was similar whether the ADR on a negative colonoscopy was less than 25% or 25% or higher (adjusted hazard ratios, 1.25 and 1.22, respectively). CRC mortality also remained unaffected by ADR in patients with negatively colonoscopies (aHR, 1.27).

By contrast, individuals with high-risk adenomas had a significantly increased risk of CRC death if their colonoscopy was performed by an endoscopist with an ADR of less than 25%, compared with those whose endoscopists had ADRs of 25% or higher (aHR, 2.25 and 1.35, respectively).

“Our study demonstrated that adding ADR to the risk stratification model improved risk assessment in all risk groups,” the researchers noted. “Importantly, stratification improved most for individuals with high-risk adenomas, the group demanding most resources in health care systems.”

The study findings were limited by several factors including the focus on only screening and surveillance colonoscopies, not including diagnostic colonoscopies, and the inability to adjust for comorbidities and lifestyle factors that might impact CRC mortality, the researchers noted. The 22.4% average ADR in the current study was low, compared with other studies, and could be a limitation as well, although previous guidelines recommend a target ADR of at least 20%.

“Despite the extensive body of literature supporting the importance of ADR in terms of CRC prevention, its implementation into clinical surveillance is challenging,” as physicians under pressure might try to game their ADRs, the researchers wrote.

The findings support the value of mandatory assessment of performance quality, the researchers added. However, “because of the potential possibility of gaming one’s ADR one conclusion drawn by the study results should be that endoscopists’ quality parameters should be monitored and those not meeting the standards trained to improve rather than requiring minimum ADRs as premise for offering screening colonoscopy.”
 

Improve performance, but don’t discount patient factors

The study is important at this time because colorectal cancer is the third-leading cause of cancer death in the United States, Atsushi Sakuraba, MD, of the University of Chicago said in an interview.

“Screening colonoscopy has been shown to decrease CRC mortality, but factors influencing outcomes after screening colonoscopies remain to be determined,” he said.

“It was expected that high-quality colonoscopy performed by an endoscopist with ADR of 25% or greater was associated with a lower risk for CRC death,” Dr. Sakuraba said. “The strength of the study is that the authors demonstrated that high-quality colonoscopy was more important in individuals with high-risk adenomas, such as advanced adenomas or at least three adenomas.”

The study findings have implications for practice in that they show the importance of monitoring performance quality in screening colonoscopy, Dr. Sakuraba said, “especially when patients have high-risk adenomas.” However, “the authors included only age and sex as variables, but the influence of other factors, such as smoking, [body mass index], and race, need to be studied.”

The researchers had no financial conflicts to disclose. Dr. Sakuraba had no financial conflicts to disclose.

Help your patients understand colorectal cancer prevention and screening options by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/CRC.

About one-third of individuals with adult-onset idiopathic dystonia experience major depression or dysthymia, data from a meta-analysis of 54 studies show.

Adult-onset idiopathic dystonia (AOID) is the third-most common movement disorder after essential tremor and Parkinson’s disease, and data show that depression and anxiety are the largest contributors to reduced quality of life in these patients, wrote Alex Medina Escobar, MD, of the University of Calgary (Alta.), and colleagues. However, “the pathogenic mechanisms of depression and anxiety in AOID remain unclear” and might involve a combination of biologic factors, as well as social stigma.

In the meta-analysis, published in Neuroscience and Biobehavioral Reviews, the researchers examined the point prevalence of supraclinical threshold depressive symptoms/depressive disorders in AOID using 54 studies. The resulting study population included 12,635 patients: 6,977 with cervical dystonia, 732 with cranial dystonia, 4,504 with mixed forms, 303 with laryngeal dystonia, and 119 with upper-limb dystonia. The studies were published between 1988 and 2020, and included patients from 21 countries in 52 single-center studies and 2 multicenter studies.

Overall, the pooled prevalence of either supraclinical threshold depressive symptoms or depressive disorders was 31.5% for cervical dystonia, 29.2 % for cranial dystonia, and 33.6 % for clinical samples with mixed forms of AOID.

Among patients with cervical dystonia, major depressive disorder was more prevalent than dysthymia, but among patients with cranial dystonia, dysthymia was more prevalent. Among patients with mixed forms, the prevalence of major depressive disorder was higher than dysthymia. Heterogeneity varied among the studies but was higher in studies that used rating scales.

Treatment of patients with AOID does not take into account the impact of depression on quality of life, Dr. Escobar and colleagues reported.

“The current model of care for AOID remains primarily centered on the treatment of the movement disorder with local injections of botulinum toxin. Such model appears to be inefficient to guarantee resources to address these comorbidities within secondary or tertiary care, or through shared care pathways engaging both primary and hospital-based care.” They also said the use of antidepressants and cognitive-behavioral therapy as a way to target negative body concept or social stigma among these patients are “underexplored and underutilized.”

The study findings were limited by several factors, including the inclusion only of studies published in English. In addition, most of the studies were conducted at movement disorders clinics, which may have yielded a patient population with more severe AOID. Further limitations included the inability to perform subgroup analysis based on demographic and clinical factors, and the insufficient number of studies for meta-analysis of laryngeal and hand dystonia, Dr. Escobar and colleagues added.

However, the results represent the first pooled estimate of depression prevalence in AOID and confirm a high prevalence across different clinical forms, the researchers said. The heterogeneity across studies highlights the need for standardized screening for depression and improved diagnosis of mood disorders in AOID.

“The meta-analytic estimates provided here will be highly useful for the planning of future mechanistic and interventional studies, as well as for the redefinition of current models of care,” they concluded.

The study received no outside funding. Dr. Escobar and colleagues had no disclosures.

About one-third of individuals with adult-onset idiopathic dystonia experience major depression or dysthymia, data from a meta-analysis of 54 studies show.

Adult-onset idiopathic dystonia (AOID) is the third-most common movement disorder after essential tremor and Parkinson’s disease, and data show that depression and anxiety are the largest contributors to reduced quality of life in these patients, wrote Alex Medina Escobar, MD, of the University of Calgary (Alta.), and colleagues. However, “the pathogenic mechanisms of depression and anxiety in AOID remain unclear” and might involve a combination of biologic factors, as well as social stigma.

In the meta-analysis, published in Neuroscience and Biobehavioral Reviews, the researchers examined the point prevalence of supraclinical threshold depressive symptoms/depressive disorders in AOID using 54 studies. The resulting study population included 12,635 patients: 6,977 with cervical dystonia, 732 with cranial dystonia, 4,504 with mixed forms, 303 with laryngeal dystonia, and 119 with upper-limb dystonia. The studies were published between 1988 and 2020, and included patients from 21 countries in 52 single-center studies and 2 multicenter studies.

Overall, the pooled prevalence of either supraclinical threshold depressive symptoms or depressive disorders was 31.5% for cervical dystonia, 29.2 % for cranial dystonia, and 33.6 % for clinical samples with mixed forms of AOID.

Among patients with cervical dystonia, major depressive disorder was more prevalent than dysthymia, but among patients with cranial dystonia, dysthymia was more prevalent. Among patients with mixed forms, the prevalence of major depressive disorder was higher than dysthymia. Heterogeneity varied among the studies but was higher in studies that used rating scales.

Treatment of patients with AOID does not take into account the impact of depression on quality of life, Dr. Escobar and colleagues reported.

“The current model of care for AOID remains primarily centered on the treatment of the movement disorder with local injections of botulinum toxin. Such model appears to be inefficient to guarantee resources to address these comorbidities within secondary or tertiary care, or through shared care pathways engaging both primary and hospital-based care.” They also said the use of antidepressants and cognitive-behavioral therapy as a way to target negative body concept or social stigma among these patients are “underexplored and underutilized.”

The study findings were limited by several factors, including the inclusion only of studies published in English. In addition, most of the studies were conducted at movement disorders clinics, which may have yielded a patient population with more severe AOID. Further limitations included the inability to perform subgroup analysis based on demographic and clinical factors, and the insufficient number of studies for meta-analysis of laryngeal and hand dystonia, Dr. Escobar and colleagues added.

However, the results represent the first pooled estimate of depression prevalence in AOID and confirm a high prevalence across different clinical forms, the researchers said. The heterogeneity across studies highlights the need for standardized screening for depression and improved diagnosis of mood disorders in AOID.

“The meta-analytic estimates provided here will be highly useful for the planning of future mechanistic and interventional studies, as well as for the redefinition of current models of care,” they concluded.

The study received no outside funding. Dr. Escobar and colleagues had no disclosures.

About one-third of individuals with adult-onset idiopathic dystonia experience major depression or dysthymia, data from a meta-analysis of 54 studies show.

Adult-onset idiopathic dystonia (AOID) is the third-most common movement disorder after essential tremor and Parkinson’s disease, and data show that depression and anxiety are the largest contributors to reduced quality of life in these patients, wrote Alex Medina Escobar, MD, of the University of Calgary (Alta.), and colleagues. However, “the pathogenic mechanisms of depression and anxiety in AOID remain unclear” and might involve a combination of biologic factors, as well as social stigma.

In the meta-analysis, published in Neuroscience and Biobehavioral Reviews, the researchers examined the point prevalence of supraclinical threshold depressive symptoms/depressive disorders in AOID using 54 studies. The resulting study population included 12,635 patients: 6,977 with cervical dystonia, 732 with cranial dystonia, 4,504 with mixed forms, 303 with laryngeal dystonia, and 119 with upper-limb dystonia. The studies were published between 1988 and 2020, and included patients from 21 countries in 52 single-center studies and 2 multicenter studies.

Overall, the pooled prevalence of either supraclinical threshold depressive symptoms or depressive disorders was 31.5% for cervical dystonia, 29.2 % for cranial dystonia, and 33.6 % for clinical samples with mixed forms of AOID.

Among patients with cervical dystonia, major depressive disorder was more prevalent than dysthymia, but among patients with cranial dystonia, dysthymia was more prevalent. Among patients with mixed forms, the prevalence of major depressive disorder was higher than dysthymia. Heterogeneity varied among the studies but was higher in studies that used rating scales.

Treatment of patients with AOID does not take into account the impact of depression on quality of life, Dr. Escobar and colleagues reported.

“The current model of care for AOID remains primarily centered on the treatment of the movement disorder with local injections of botulinum toxin. Such model appears to be inefficient to guarantee resources to address these comorbidities within secondary or tertiary care, or through shared care pathways engaging both primary and hospital-based care.” They also said the use of antidepressants and cognitive-behavioral therapy as a way to target negative body concept or social stigma among these patients are “underexplored and underutilized.”

The study findings were limited by several factors, including the inclusion only of studies published in English. In addition, most of the studies were conducted at movement disorders clinics, which may have yielded a patient population with more severe AOID. Further limitations included the inability to perform subgroup analysis based on demographic and clinical factors, and the insufficient number of studies for meta-analysis of laryngeal and hand dystonia, Dr. Escobar and colleagues added.

However, the results represent the first pooled estimate of depression prevalence in AOID and confirm a high prevalence across different clinical forms, the researchers said. The heterogeneity across studies highlights the need for standardized screening for depression and improved diagnosis of mood disorders in AOID.

“The meta-analytic estimates provided here will be highly useful for the planning of future mechanistic and interventional studies, as well as for the redefinition of current models of care,” they concluded.

The study received no outside funding. Dr. Escobar and colleagues had no disclosures.

Schizophrenia patients with parkinsonism show distinctive patterns of cortical surface markers, compared with schizophrenia patients without parkinsonism and healthy controls, results of a multimodal magnetic resonance imaging study suggest.

Sensorimotor abnormalities are common in schizophrenia patients, however, “the neurobiological mechanisms underlying parkinsonism in [schizophrenia], which in treated samples represents the unity of interplay between spontaneous and antipsychotic drug-exacerbated movement disorder, are poorly understood,” wrote Robert Christian Wolf, MD, of Heidelberg (Germany) University, and colleagues.

In a study published in Schizophrenia Research (2021 May;231:54-60), the investigators examined brain imaging findings from 20 healthy controls, 38 schizophrenia patients with parkinsonism (SZ-P), and 35 schizophrenia patients without parkinsonism (SZ-nonP). Dr. Wolf and colleagues examined three cortical surface markers: cortical thickness, complexity of cortical folding, and sulcus depth.

Compared with SZ-nonP patients, the SZ-P patients showed significantly increased complexity of cortical folding in the left supplementary motor cortex (SMC) and significantly decreased left postcentral sulcus (PCS) depth. In addition, left SMC activity was higher in both SZ-P and SZ-nonP patient groups, compared with controls.

In a regression analysis, the researchers examined relationships between parkinsonism severity and brain structure. They found that parkinsonism severity was negatively associated with left middle frontal complexity of cortical folding and left anterior cingulate cortex cortical thickness.

“Overall, the data support the notion that cortical features of distinct neurodevelopmental origin, particularly cortical folding indices such as [complexity of cortical folding] and sulcus depth, contribute to the pathogenesis of parkinsonism in SZ,” the researchers wrote.

The study findings were limited by several factors, including the cross-sectional design, the potential limitations of the Simpson-Angus Scale in characterizing parkinsonism, the inability to record lifetime antibiotics exposure in the patient population, and the inability to identify changes in brain stem nuclei, the researchers noted. However, the results were strengthened by the well-matched study groups and use of multimodal MRI, they said.

Consequently, “these data provide novel insights into different trajectories of cortical development in SZ patients evidencing parkinsonism,” and suggest a link between abnormal neurodevelopmental processes and an increased risk for movement disorders in schizophrenia, they concluded.

The study was funded by the German Research Foundation and the German Federal Ministry of Education and Research. Dr. Wolf and colleagues disclosed no conflicts.

Schizophrenia patients with parkinsonism show distinctive patterns of cortical surface markers, compared with schizophrenia patients without parkinsonism and healthy controls, results of a multimodal magnetic resonance imaging study suggest.

Sensorimotor abnormalities are common in schizophrenia patients, however, “the neurobiological mechanisms underlying parkinsonism in [schizophrenia], which in treated samples represents the unity of interplay between spontaneous and antipsychotic drug-exacerbated movement disorder, are poorly understood,” wrote Robert Christian Wolf, MD, of Heidelberg (Germany) University, and colleagues.

In a study published in Schizophrenia Research (2021 May;231:54-60), the investigators examined brain imaging findings from 20 healthy controls, 38 schizophrenia patients with parkinsonism (SZ-P), and 35 schizophrenia patients without parkinsonism (SZ-nonP). Dr. Wolf and colleagues examined three cortical surface markers: cortical thickness, complexity of cortical folding, and sulcus depth.

Compared with SZ-nonP patients, the SZ-P patients showed significantly increased complexity of cortical folding in the left supplementary motor cortex (SMC) and significantly decreased left postcentral sulcus (PCS) depth. In addition, left SMC activity was higher in both SZ-P and SZ-nonP patient groups, compared with controls.

In a regression analysis, the researchers examined relationships between parkinsonism severity and brain structure. They found that parkinsonism severity was negatively associated with left middle frontal complexity of cortical folding and left anterior cingulate cortex cortical thickness.

“Overall, the data support the notion that cortical features of distinct neurodevelopmental origin, particularly cortical folding indices such as [complexity of cortical folding] and sulcus depth, contribute to the pathogenesis of parkinsonism in SZ,” the researchers wrote.

The study findings were limited by several factors, including the cross-sectional design, the potential limitations of the Simpson-Angus Scale in characterizing parkinsonism, the inability to record lifetime antibiotics exposure in the patient population, and the inability to identify changes in brain stem nuclei, the researchers noted. However, the results were strengthened by the well-matched study groups and use of multimodal MRI, they said.

Consequently, “these data provide novel insights into different trajectories of cortical development in SZ patients evidencing parkinsonism,” and suggest a link between abnormal neurodevelopmental processes and an increased risk for movement disorders in schizophrenia, they concluded.

The study was funded by the German Research Foundation and the German Federal Ministry of Education and Research. Dr. Wolf and colleagues disclosed no conflicts.

Schizophrenia patients with parkinsonism show distinctive patterns of cortical surface markers, compared with schizophrenia patients without parkinsonism and healthy controls, results of a multimodal magnetic resonance imaging study suggest.

Sensorimotor abnormalities are common in schizophrenia patients, however, “the neurobiological mechanisms underlying parkinsonism in [schizophrenia], which in treated samples represents the unity of interplay between spontaneous and antipsychotic drug-exacerbated movement disorder, are poorly understood,” wrote Robert Christian Wolf, MD, of Heidelberg (Germany) University, and colleagues.

In a study published in Schizophrenia Research (2021 May;231:54-60), the investigators examined brain imaging findings from 20 healthy controls, 38 schizophrenia patients with parkinsonism (SZ-P), and 35 schizophrenia patients without parkinsonism (SZ-nonP). Dr. Wolf and colleagues examined three cortical surface markers: cortical thickness, complexity of cortical folding, and sulcus depth.

Compared with SZ-nonP patients, the SZ-P patients showed significantly increased complexity of cortical folding in the left supplementary motor cortex (SMC) and significantly decreased left postcentral sulcus (PCS) depth. In addition, left SMC activity was higher in both SZ-P and SZ-nonP patient groups, compared with controls.

In a regression analysis, the researchers examined relationships between parkinsonism severity and brain structure. They found that parkinsonism severity was negatively associated with left middle frontal complexity of cortical folding and left anterior cingulate cortex cortical thickness.

“Overall, the data support the notion that cortical features of distinct neurodevelopmental origin, particularly cortical folding indices such as [complexity of cortical folding] and sulcus depth, contribute to the pathogenesis of parkinsonism in SZ,” the researchers wrote.

The study findings were limited by several factors, including the cross-sectional design, the potential limitations of the Simpson-Angus Scale in characterizing parkinsonism, the inability to record lifetime antibiotics exposure in the patient population, and the inability to identify changes in brain stem nuclei, the researchers noted. However, the results were strengthened by the well-matched study groups and use of multimodal MRI, they said.

Consequently, “these data provide novel insights into different trajectories of cortical development in SZ patients evidencing parkinsonism,” and suggest a link between abnormal neurodevelopmental processes and an increased risk for movement disorders in schizophrenia, they concluded.

The study was funded by the German Research Foundation and the German Federal Ministry of Education and Research. Dr. Wolf and colleagues disclosed no conflicts.

Severe complications at 5 years were no different for patients with perforated purulent diverticulitis who underwent laparoscopic peritoneal lavage or colon resection, according to data from 199 individuals treated at 21 hospitals in Norway and Sweden. But it may yet prove appropriate in the right patient.

Acute perforated diverticulitis with peritonitis remains a challenging complication with high morbidity and mortality among patients with diverticular disease, and bowel resection remains the standard of treatment, Najia Azhar, MD, of Skåne University Hospital, Malmö, Sweden, and colleagues wrote.

Short-term data suggest that laparoscopic lavage with drainage and antibiotics might be a viable alternative, but long-term data are lacking, they said.

In the Scandinavian Diverticulitis (SCANDIV) trial, published in JAMA Surgery, researchers randomized 101 patients to laparoscopic peritoneal lavage and 98 to colon resection. With 3 patients lost to follow-up, the final analysis included 73 patients who underwent laparoscopic lavage and 69 who underwent resection. The mean age of the lavage patients was 66.4 years, and 39 were men. The mean age of the resection patients was 63.5 years, and 36 were men. The primary outcome was severe complications – excluding stoma reversals and elective sigmoid resections because of recurrence – at an average of 5 years’ follow-up. Secondary outcomes included stoma prevalence, diverticulitis recurrence, and secondary sigmoid resection.

Severe complications were similar for the lavage and resection groups (36% and 35%, respectively), as were the overall mortality rates (32% and 25%, respectively).

The prevalence of stoma was significantly lower in the lavage group, compared with the resection group (8% vs. 33%, P = .002). However, secondary operations (including reversal of stoma) were similar between the lavage and resection groups, performed in 26 lavage patients (36%) versus 24 resection patients (35%).

Diverticulitis recurrence was significantly more common in the lavage, compared with the resection group (21% vs. 4%, P = .004), the researchers noted.

In the laparoscopic lavage group, 30% (n = 21) underwent a sigmoid resection; all but one of these occurred within a year of the index procedure, the researchers wrote. In addition, overall length of hospital stay was similar for both groups.

No significant differences in quality of life were noted between the groups, based on the EuroQoL-5D questionnaire or Cleveland Global Quality of Life scores.
 

Balance secondary pros and cons

Laparoscopic lavage is not common practice today in the United States, the researchers noted. In clinical practice guidelines issued in 2020, the American Society of Colon and Rectal Surgeons strongly recommend colectomy over laparoscopic lavage for the treatment of left-sided colonic diverticulitis. However, the European Society of Coloproctology’s guidelines state that laparoscopic lavage is feasible for patients with peritonitis at Hinchey stage III.

The findings of the current study were limited primarily by the exclusion of 50% of eligible patients because of challenges associated with conducting randomized trials in emergency settings, the researchers noted. However, the number of excluded patients and their baseline characteristics after exclusion were very similar in the two groups, and the study represents the largest randomized trial to date to examine long-term outcomes in patients with perforated diverticulitis.

“Laparoscopic lavage is faster and cost-effective but leads to a higher reoperation rate and recurrence rate, often requiring secondary sigmoid resection,” the researchers emphasized. Consequently, patients undergoing lavage should have consented for resection surgery.

The similar rates of severe complications and quality of life scores support laparoscopic lavage as an option for perforated purulent diverticulitis, but shared decision-making will be essential for better optimal patient management, the researchers concluded.
 

Similar outcomes, but unanswered questions

Even though the primary outcome of disease-related morbidity was similar for both groups, “the issue still remains regarding when and how, if ever, this therapeutic approach should be considered for purulent peritonitis,” Kellie E. Cunningham, MD, and Brian S. Zuckerbraun, MD, both of the University of Pittsburgh, wrote in an accompanying editorial.

Although laparoscopic lavage has the obvious advantages of avoiding a laparotomy and stoma, previous studies have shown a higher rate of early reoperations and recurrent diverticulitis, despite lower stoma prevalence and equal mortality rates, they said. In addition, “patients who are immunosuppressed or would be expected to have a higher mortality rate with failure to achieve definitive source control should likely not be offered this therapy.”

A “philosophical” argument could be made in favor of laparoscopic lavage based on the potential consequences of early treatment failure, they wrote.

“Although one may consider the need for early reoperation a complication, some would argue it affects the minority of patients, thus avoiding the more morbid procedure with creation of a stoma at the index operation in the majority of patients,” they noted. “Additionally, patients who underwent lavage that subsequently proceed to colectomy would have otherwise been offered this therapy initially at the time of the index operation.”

More research is needed to answer questions such as which, if any, operative findings are associated with failure. In addition, an analysis of long-term cost benefits between the two options should be explored, the authors wrote.

Based on current evidence, shared decision-making is necessary, with individualized care and short and long-term trade-offs taken into account, they wrote.
 

Gastroenterologist perspective: Study fills gap in follow-up data

In an interview, David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said the study is important because data have been lacking on outcomes of a laparoscopic lavage without a resection.

The findings represent “a major shift” in the growing consensus among surgeons that laparoscopic lavage is a viable option in appropriate patients, he said.

A key issue is the high rate of morbidity in patients who undergo traditional diverticulitis surgery. Complications can include wound infection and poor quality of life associated with stoma, Dr. Johnson said. Consequently, “a nonoperative approach from a patient perspective is certainly refreshing.”

Dr. Johnson said he was surprised by how well the patients fared after lavage given the severity of the diverticulitis in the patient population. However, this may be in part because of the relatively small numbers of patients at highest risk for complications, such as those with diabetes or immunocompromising conditions.

Dr. Johnson also said he was struck by the fact that the adenocarcinomas in the lavage group were diagnosed within the first year after the procedure. “The cancer diagnosis shouldn’t reflect on the lavage group,” but emphasizes the importance of having an earlier colonoscopy, he noted.

Next steps for research might include identifying a standardized endpoint for lavage, and determining how expanded use of the procedure might impact community practice, Dr. Johnson said. In addition, more research is needed to more clearly define patients most likely to benefit from laparoscopic lavage.

The study was supported in part by the department of surgery at Skåne University Hospital, Akershus University Hospital, and a fellowship to one of the study coauthors from the Southeastern Norway Regional Health Authority. Lead author Dr. Azhar disclosed grants from the department of surgery of Skåne University Hospital. Dr. Cunningham and Dr. Zuckerbraun had no financial conflicts to disclose. Dr. Johnson had no relevant financial disclosures.

Severe complications at 5 years were no different for patients with perforated purulent diverticulitis who underwent laparoscopic peritoneal lavage or colon resection, according to data from 199 individuals treated at 21 hospitals in Norway and Sweden. But it may yet prove appropriate in the right patient.

Acute perforated diverticulitis with peritonitis remains a challenging complication with high morbidity and mortality among patients with diverticular disease, and bowel resection remains the standard of treatment, Najia Azhar, MD, of Skåne University Hospital, Malmö, Sweden, and colleagues wrote.

Short-term data suggest that laparoscopic lavage with drainage and antibiotics might be a viable alternative, but long-term data are lacking, they said.

In the Scandinavian Diverticulitis (SCANDIV) trial, published in JAMA Surgery, researchers randomized 101 patients to laparoscopic peritoneal lavage and 98 to colon resection. With 3 patients lost to follow-up, the final analysis included 73 patients who underwent laparoscopic lavage and 69 who underwent resection. The mean age of the lavage patients was 66.4 years, and 39 were men. The mean age of the resection patients was 63.5 years, and 36 were men. The primary outcome was severe complications – excluding stoma reversals and elective sigmoid resections because of recurrence – at an average of 5 years’ follow-up. Secondary outcomes included stoma prevalence, diverticulitis recurrence, and secondary sigmoid resection.

Severe complications were similar for the lavage and resection groups (36% and 35%, respectively), as were the overall mortality rates (32% and 25%, respectively).

The prevalence of stoma was significantly lower in the lavage group, compared with the resection group (8% vs. 33%, P = .002). However, secondary operations (including reversal of stoma) were similar between the lavage and resection groups, performed in 26 lavage patients (36%) versus 24 resection patients (35%).

Diverticulitis recurrence was significantly more common in the lavage, compared with the resection group (21% vs. 4%, P = .004), the researchers noted.

In the laparoscopic lavage group, 30% (n = 21) underwent a sigmoid resection; all but one of these occurred within a year of the index procedure, the researchers wrote. In addition, overall length of hospital stay was similar for both groups.

No significant differences in quality of life were noted between the groups, based on the EuroQoL-5D questionnaire or Cleveland Global Quality of Life scores.
 

Balance secondary pros and cons

Laparoscopic lavage is not common practice today in the United States, the researchers noted. In clinical practice guidelines issued in 2020, the American Society of Colon and Rectal Surgeons strongly recommend colectomy over laparoscopic lavage for the treatment of left-sided colonic diverticulitis. However, the European Society of Coloproctology’s guidelines state that laparoscopic lavage is feasible for patients with peritonitis at Hinchey stage III.

The findings of the current study were limited primarily by the exclusion of 50% of eligible patients because of challenges associated with conducting randomized trials in emergency settings, the researchers noted. However, the number of excluded patients and their baseline characteristics after exclusion were very similar in the two groups, and the study represents the largest randomized trial to date to examine long-term outcomes in patients with perforated diverticulitis.

“Laparoscopic lavage is faster and cost-effective but leads to a higher reoperation rate and recurrence rate, often requiring secondary sigmoid resection,” the researchers emphasized. Consequently, patients undergoing lavage should have consented for resection surgery.

The similar rates of severe complications and quality of life scores support laparoscopic lavage as an option for perforated purulent diverticulitis, but shared decision-making will be essential for better optimal patient management, the researchers concluded.
 

Similar outcomes, but unanswered questions

Even though the primary outcome of disease-related morbidity was similar for both groups, “the issue still remains regarding when and how, if ever, this therapeutic approach should be considered for purulent peritonitis,” Kellie E. Cunningham, MD, and Brian S. Zuckerbraun, MD, both of the University of Pittsburgh, wrote in an accompanying editorial.

Although laparoscopic lavage has the obvious advantages of avoiding a laparotomy and stoma, previous studies have shown a higher rate of early reoperations and recurrent diverticulitis, despite lower stoma prevalence and equal mortality rates, they said. In addition, “patients who are immunosuppressed or would be expected to have a higher mortality rate with failure to achieve definitive source control should likely not be offered this therapy.”

A “philosophical” argument could be made in favor of laparoscopic lavage based on the potential consequences of early treatment failure, they wrote.

“Although one may consider the need for early reoperation a complication, some would argue it affects the minority of patients, thus avoiding the more morbid procedure with creation of a stoma at the index operation in the majority of patients,” they noted. “Additionally, patients who underwent lavage that subsequently proceed to colectomy would have otherwise been offered this therapy initially at the time of the index operation.”

More research is needed to answer questions such as which, if any, operative findings are associated with failure. In addition, an analysis of long-term cost benefits between the two options should be explored, the authors wrote.

Based on current evidence, shared decision-making is necessary, with individualized care and short and long-term trade-offs taken into account, they wrote.
 

Gastroenterologist perspective: Study fills gap in follow-up data

In an interview, David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said the study is important because data have been lacking on outcomes of a laparoscopic lavage without a resection.

The findings represent “a major shift” in the growing consensus among surgeons that laparoscopic lavage is a viable option in appropriate patients, he said.

A key issue is the high rate of morbidity in patients who undergo traditional diverticulitis surgery. Complications can include wound infection and poor quality of life associated with stoma, Dr. Johnson said. Consequently, “a nonoperative approach from a patient perspective is certainly refreshing.”

Dr. Johnson said he was surprised by how well the patients fared after lavage given the severity of the diverticulitis in the patient population. However, this may be in part because of the relatively small numbers of patients at highest risk for complications, such as those with diabetes or immunocompromising conditions.

Dr. Johnson also said he was struck by the fact that the adenocarcinomas in the lavage group were diagnosed within the first year after the procedure. “The cancer diagnosis shouldn’t reflect on the lavage group,” but emphasizes the importance of having an earlier colonoscopy, he noted.

Next steps for research might include identifying a standardized endpoint for lavage, and determining how expanded use of the procedure might impact community practice, Dr. Johnson said. In addition, more research is needed to more clearly define patients most likely to benefit from laparoscopic lavage.

The study was supported in part by the department of surgery at Skåne University Hospital, Akershus University Hospital, and a fellowship to one of the study coauthors from the Southeastern Norway Regional Health Authority. Lead author Dr. Azhar disclosed grants from the department of surgery of Skåne University Hospital. Dr. Cunningham and Dr. Zuckerbraun had no financial conflicts to disclose. Dr. Johnson had no relevant financial disclosures.

Severe complications at 5 years were no different for patients with perforated purulent diverticulitis who underwent laparoscopic peritoneal lavage or colon resection, according to data from 199 individuals treated at 21 hospitals in Norway and Sweden. But it may yet prove appropriate in the right patient.

Acute perforated diverticulitis with peritonitis remains a challenging complication with high morbidity and mortality among patients with diverticular disease, and bowel resection remains the standard of treatment, Najia Azhar, MD, of Skåne University Hospital, Malmö, Sweden, and colleagues wrote.

Short-term data suggest that laparoscopic lavage with drainage and antibiotics might be a viable alternative, but long-term data are lacking, they said.

In the Scandinavian Diverticulitis (SCANDIV) trial, published in JAMA Surgery, researchers randomized 101 patients to laparoscopic peritoneal lavage and 98 to colon resection. With 3 patients lost to follow-up, the final analysis included 73 patients who underwent laparoscopic lavage and 69 who underwent resection. The mean age of the lavage patients was 66.4 years, and 39 were men. The mean age of the resection patients was 63.5 years, and 36 were men. The primary outcome was severe complications – excluding stoma reversals and elective sigmoid resections because of recurrence – at an average of 5 years’ follow-up. Secondary outcomes included stoma prevalence, diverticulitis recurrence, and secondary sigmoid resection.

Severe complications were similar for the lavage and resection groups (36% and 35%, respectively), as were the overall mortality rates (32% and 25%, respectively).

The prevalence of stoma was significantly lower in the lavage group, compared with the resection group (8% vs. 33%, P = .002). However, secondary operations (including reversal of stoma) were similar between the lavage and resection groups, performed in 26 lavage patients (36%) versus 24 resection patients (35%).

Diverticulitis recurrence was significantly more common in the lavage, compared with the resection group (21% vs. 4%, P = .004), the researchers noted.

In the laparoscopic lavage group, 30% (n = 21) underwent a sigmoid resection; all but one of these occurred within a year of the index procedure, the researchers wrote. In addition, overall length of hospital stay was similar for both groups.

No significant differences in quality of life were noted between the groups, based on the EuroQoL-5D questionnaire or Cleveland Global Quality of Life scores.
 

Balance secondary pros and cons

Laparoscopic lavage is not common practice today in the United States, the researchers noted. In clinical practice guidelines issued in 2020, the American Society of Colon and Rectal Surgeons strongly recommend colectomy over laparoscopic lavage for the treatment of left-sided colonic diverticulitis. However, the European Society of Coloproctology’s guidelines state that laparoscopic lavage is feasible for patients with peritonitis at Hinchey stage III.

The findings of the current study were limited primarily by the exclusion of 50% of eligible patients because of challenges associated with conducting randomized trials in emergency settings, the researchers noted. However, the number of excluded patients and their baseline characteristics after exclusion were very similar in the two groups, and the study represents the largest randomized trial to date to examine long-term outcomes in patients with perforated diverticulitis.

“Laparoscopic lavage is faster and cost-effective but leads to a higher reoperation rate and recurrence rate, often requiring secondary sigmoid resection,” the researchers emphasized. Consequently, patients undergoing lavage should have consented for resection surgery.

The similar rates of severe complications and quality of life scores support laparoscopic lavage as an option for perforated purulent diverticulitis, but shared decision-making will be essential for better optimal patient management, the researchers concluded.
 

Similar outcomes, but unanswered questions

Even though the primary outcome of disease-related morbidity was similar for both groups, “the issue still remains regarding when and how, if ever, this therapeutic approach should be considered for purulent peritonitis,” Kellie E. Cunningham, MD, and Brian S. Zuckerbraun, MD, both of the University of Pittsburgh, wrote in an accompanying editorial.

Although laparoscopic lavage has the obvious advantages of avoiding a laparotomy and stoma, previous studies have shown a higher rate of early reoperations and recurrent diverticulitis, despite lower stoma prevalence and equal mortality rates, they said. In addition, “patients who are immunosuppressed or would be expected to have a higher mortality rate with failure to achieve definitive source control should likely not be offered this therapy.”

A “philosophical” argument could be made in favor of laparoscopic lavage based on the potential consequences of early treatment failure, they wrote.

“Although one may consider the need for early reoperation a complication, some would argue it affects the minority of patients, thus avoiding the more morbid procedure with creation of a stoma at the index operation in the majority of patients,” they noted. “Additionally, patients who underwent lavage that subsequently proceed to colectomy would have otherwise been offered this therapy initially at the time of the index operation.”

More research is needed to answer questions such as which, if any, operative findings are associated with failure. In addition, an analysis of long-term cost benefits between the two options should be explored, the authors wrote.

Based on current evidence, shared decision-making is necessary, with individualized care and short and long-term trade-offs taken into account, they wrote.
 

Gastroenterologist perspective: Study fills gap in follow-up data

In an interview, David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia School of Medicine, Norfolk, said the study is important because data have been lacking on outcomes of a laparoscopic lavage without a resection.

The findings represent “a major shift” in the growing consensus among surgeons that laparoscopic lavage is a viable option in appropriate patients, he said.

A key issue is the high rate of morbidity in patients who undergo traditional diverticulitis surgery. Complications can include wound infection and poor quality of life associated with stoma, Dr. Johnson said. Consequently, “a nonoperative approach from a patient perspective is certainly refreshing.”

Dr. Johnson said he was surprised by how well the patients fared after lavage given the severity of the diverticulitis in the patient population. However, this may be in part because of the relatively small numbers of patients at highest risk for complications, such as those with diabetes or immunocompromising conditions.

Dr. Johnson also said he was struck by the fact that the adenocarcinomas in the lavage group were diagnosed within the first year after the procedure. “The cancer diagnosis shouldn’t reflect on the lavage group,” but emphasizes the importance of having an earlier colonoscopy, he noted.

Next steps for research might include identifying a standardized endpoint for lavage, and determining how expanded use of the procedure might impact community practice, Dr. Johnson said. In addition, more research is needed to more clearly define patients most likely to benefit from laparoscopic lavage.

The study was supported in part by the department of surgery at Skåne University Hospital, Akershus University Hospital, and a fellowship to one of the study coauthors from the Southeastern Norway Regional Health Authority. Lead author Dr. Azhar disclosed grants from the department of surgery of Skåne University Hospital. Dr. Cunningham and Dr. Zuckerbraun had no financial conflicts to disclose. Dr. Johnson had no relevant financial disclosures.

Managing depression and anxiety in Parkinson’s disease should start with a review of medications and involve multidisciplinary care, according to a recent summary of evidence.

“Depression and anxiety have a complex relationship with the disease and while the exact mechanism for this association is unknown, both disturbances occur with increased prevalence across the disease course and when present earlier in life, increase the risk of PD by about twofold,” wrote Gregory M. Pontone, MD, of Johns Hopkins University, Baltimore, and colleagues.

Randomized trials to guide treatment of anxiety and depression in patients with Parkinson’s disease (PD) are limited, the researchers noted. However, data from a longitudinal study showed that PD patients whose depression remitted spontaneously or responded to treatment were able to attain a level of function similar to that of never-depressed PD patients, Dr. Pontone and colleagues said.

The researchers offered a pair of treatment algorithms to help guide clinicians in managing depression and anxiety in PD. However, a caveat to keep in mind is that “the benefit of antidepressant medications, used for depression or anxiety, can be confounded when motor symptoms are not optimally treated,” the researchers emphasized.

For depression, the researchers advised starting with some lab work; “at a minimum we suggest checking a complete blood count, metabolic panel, TSH, B12, and folate,” they noted. They recommended an antidepressant, cognitive-behavioral therapy, or both, as a first-line treatment, such as monotherapy with selective norepinephrine reuptake inhibitors or selective serotonin reuptake inhibitors. They advised titrating the chosen monotherapy to a minimum effective dose over a 2- to 3-week period to assess response.

“We recommend continuing antidepressant therapy for at least 1 year based on literature in non-PD populations and anecdotal clinical experience. At 1 year, if not in remission, consider continuing treatment or augmenting to improve response,” the researchers said.

Based on the current DSM-5 criteria, up to one-third of PD patients have an unspecified anxiety disorder, the researchers said, and they recommended using anxiety rating scales to diagnose anxiety in PD. “Given the high prevalence of atypical anxiety syndromes in PD and their potential association with both motor and nonmotor symptoms of the disease, working with the neurologist to achieve optimal control of PD is an essential first step to alleviating anxiety,” they emphasized.

The researchers also advised addressing comorbidities, including cardiovascular disease, chronic pain, diabetes, gastrointestinal issues, hyperthyroidism, and lung disease, all of which can be associated with anxiety. Once comorbidities are addressed, they advised caution given the lack of evidence for efficacy of both pharmacologic and nonpharmacologic anxiety treatments for PD patients. However, first-tier treatment for anxiety could include monotherapy with serotonin-norepinephrine reuptake inhibitors or selective serotonin reuptake inhibitors, they said.

PD patients with depression and anxiety also may benefit from nonpharmacologic interventions, including exercise, mindfulness, relaxation therapy, and cognitive behavioral therapy the researchers said.

Although the algorithm may not differ significantly from current treatment protocols, it highlights aspects unique to PD patients, the researchers said. In particular, the algorithm shows “that interventions used for motor symptoms, for example, dopamine agonists, may be especially potent for mood in the PD population and that augmentation strategies, such as antipsychotics and lithium, may not be well tolerated given their outsized risk of adverse events in PD,” they said.

“While an article of this kind cannot hope to address the gap in knowledge on comparative efficacy between interventions, it can guide readers on the best strategies for implementation and risk mitigation in PD – essentially focusing more on effectiveness,” they concluded.

The study received no outside funding. Dr. Pontone disclosed serving as a consultant for Acadia Pharmaceuticals and Concert Pharmaceuticals.

Managing depression and anxiety in Parkinson’s disease should start with a review of medications and involve multidisciplinary care, according to a recent summary of evidence.

“Depression and anxiety have a complex relationship with the disease and while the exact mechanism for this association is unknown, both disturbances occur with increased prevalence across the disease course and when present earlier in life, increase the risk of PD by about twofold,” wrote Gregory M. Pontone, MD, of Johns Hopkins University, Baltimore, and colleagues.

Randomized trials to guide treatment of anxiety and depression in patients with Parkinson’s disease (PD) are limited, the researchers noted. However, data from a longitudinal study showed that PD patients whose depression remitted spontaneously or responded to treatment were able to attain a level of function similar to that of never-depressed PD patients, Dr. Pontone and colleagues said.

The researchers offered a pair of treatment algorithms to help guide clinicians in managing depression and anxiety in PD. However, a caveat to keep in mind is that “the benefit of antidepressant medications, used for depression or anxiety, can be confounded when motor symptoms are not optimally treated,” the researchers emphasized.

For depression, the researchers advised starting with some lab work; “at a minimum we suggest checking a complete blood count, metabolic panel, TSH, B12, and folate,” they noted. They recommended an antidepressant, cognitive-behavioral therapy, or both, as a first-line treatment, such as monotherapy with selective norepinephrine reuptake inhibitors or selective serotonin reuptake inhibitors. They advised titrating the chosen monotherapy to a minimum effective dose over a 2- to 3-week period to assess response.

“We recommend continuing antidepressant therapy for at least 1 year based on literature in non-PD populations and anecdotal clinical experience. At 1 year, if not in remission, consider continuing treatment or augmenting to improve response,” the researchers said.

Based on the current DSM-5 criteria, up to one-third of PD patients have an unspecified anxiety disorder, the researchers said, and they recommended using anxiety rating scales to diagnose anxiety in PD. “Given the high prevalence of atypical anxiety syndromes in PD and their potential association with both motor and nonmotor symptoms of the disease, working with the neurologist to achieve optimal control of PD is an essential first step to alleviating anxiety,” they emphasized.

The researchers also advised addressing comorbidities, including cardiovascular disease, chronic pain, diabetes, gastrointestinal issues, hyperthyroidism, and lung disease, all of which can be associated with anxiety. Once comorbidities are addressed, they advised caution given the lack of evidence for efficacy of both pharmacologic and nonpharmacologic anxiety treatments for PD patients. However, first-tier treatment for anxiety could include monotherapy with serotonin-norepinephrine reuptake inhibitors or selective serotonin reuptake inhibitors, they said.

PD patients with depression and anxiety also may benefit from nonpharmacologic interventions, including exercise, mindfulness, relaxation therapy, and cognitive behavioral therapy the researchers said.

Although the algorithm may not differ significantly from current treatment protocols, it highlights aspects unique to PD patients, the researchers said. In particular, the algorithm shows “that interventions used for motor symptoms, for example, dopamine agonists, may be especially potent for mood in the PD population and that augmentation strategies, such as antipsychotics and lithium, may not be well tolerated given their outsized risk of adverse events in PD,” they said.

“While an article of this kind cannot hope to address the gap in knowledge on comparative efficacy between interventions, it can guide readers on the best strategies for implementation and risk mitigation in PD – essentially focusing more on effectiveness,” they concluded.

The study received no outside funding. Dr. Pontone disclosed serving as a consultant for Acadia Pharmaceuticals and Concert Pharmaceuticals.

Managing depression and anxiety in Parkinson’s disease should start with a review of medications and involve multidisciplinary care, according to a recent summary of evidence.

“Depression and anxiety have a complex relationship with the disease and while the exact mechanism for this association is unknown, both disturbances occur with increased prevalence across the disease course and when present earlier in life, increase the risk of PD by about twofold,” wrote Gregory M. Pontone, MD, of Johns Hopkins University, Baltimore, and colleagues.

Randomized trials to guide treatment of anxiety and depression in patients with Parkinson’s disease (PD) are limited, the researchers noted. However, data from a longitudinal study showed that PD patients whose depression remitted spontaneously or responded to treatment were able to attain a level of function similar to that of never-depressed PD patients, Dr. Pontone and colleagues said.

The researchers offered a pair of treatment algorithms to help guide clinicians in managing depression and anxiety in PD. However, a caveat to keep in mind is that “the benefit of antidepressant medications, used for depression or anxiety, can be confounded when motor symptoms are not optimally treated,” the researchers emphasized.

For depression, the researchers advised starting with some lab work; “at a minimum we suggest checking a complete blood count, metabolic panel, TSH, B12, and folate,” they noted. They recommended an antidepressant, cognitive-behavioral therapy, or both, as a first-line treatment, such as monotherapy with selective norepinephrine reuptake inhibitors or selective serotonin reuptake inhibitors. They advised titrating the chosen monotherapy to a minimum effective dose over a 2- to 3-week period to assess response.

“We recommend continuing antidepressant therapy for at least 1 year based on literature in non-PD populations and anecdotal clinical experience. At 1 year, if not in remission, consider continuing treatment or augmenting to improve response,” the researchers said.

Based on the current DSM-5 criteria, up to one-third of PD patients have an unspecified anxiety disorder, the researchers said, and they recommended using anxiety rating scales to diagnose anxiety in PD. “Given the high prevalence of atypical anxiety syndromes in PD and their potential association with both motor and nonmotor symptoms of the disease, working with the neurologist to achieve optimal control of PD is an essential first step to alleviating anxiety,” they emphasized.

The researchers also advised addressing comorbidities, including cardiovascular disease, chronic pain, diabetes, gastrointestinal issues, hyperthyroidism, and lung disease, all of which can be associated with anxiety. Once comorbidities are addressed, they advised caution given the lack of evidence for efficacy of both pharmacologic and nonpharmacologic anxiety treatments for PD patients. However, first-tier treatment for anxiety could include monotherapy with serotonin-norepinephrine reuptake inhibitors or selective serotonin reuptake inhibitors, they said.

PD patients with depression and anxiety also may benefit from nonpharmacologic interventions, including exercise, mindfulness, relaxation therapy, and cognitive behavioral therapy the researchers said.

Although the algorithm may not differ significantly from current treatment protocols, it highlights aspects unique to PD patients, the researchers said. In particular, the algorithm shows “that interventions used for motor symptoms, for example, dopamine agonists, may be especially potent for mood in the PD population and that augmentation strategies, such as antipsychotics and lithium, may not be well tolerated given their outsized risk of adverse events in PD,” they said.

“While an article of this kind cannot hope to address the gap in knowledge on comparative efficacy between interventions, it can guide readers on the best strategies for implementation and risk mitigation in PD – essentially focusing more on effectiveness,” they concluded.

The study received no outside funding. Dr. Pontone disclosed serving as a consultant for Acadia Pharmaceuticals and Concert Pharmaceuticals.

Patients with cirrhosis treated at hospitals with the highest safety-net burden, defined by their proportion of Medicaid or uninsured patients, had a 5% higher mortality rate than patients who were treated at hospitals with the lowest burden, according to a study of over 300,000 patients.

The study, which was published in the Journal of Clinical Gastroenterology, analyzed inpatient data from the National Inpatient Sample (NIS) database focusing on a 4-year time span between 2012 and 2016. The hospitals were categorized by safety-net burden, which was defined as having either a high, medium, or low number of uninsured patients or patients with Medicaid.

This is the first-known study to evaluate the impact of a hospital’s safety-net burden on hospitalization outcomes in cirrhosis patients, wrote authors Robert J. Wong, MD, MS, of Stanford (Calif.) University and Grishma Hirode, MAS, of the University of Toronto. Previous studies have shown that safety-net hospitals, especially those with a high safety-net burden, have poorer patient outcomes. These hospitals also serve a patient population that is at high risk for chronic liver disease and cirrhosis.

The new analysis included 322,944 individual hospitalizations of patients with cirrhosis. Of these, 57.8% were male, 63.7% were White, 9.9% were Black, and 15.6% were Hispanic. In terms of safety-net burden, 107,446 hospitalizations were at high-burden hospitals, 103,508 were at medium-burden hospitals, and 111,990 hospitalizations were at low-burden hospitals.

Overall, cirrhosis-related hospitalizations in hospitals with the highest burden were found to have significantly greater odds of in-hospital mortality than the lowest tertile hospitals (odds ratio, 1.05, P = .044). The patients were also younger (mean age, 56.7 years vs. 59.8 years in low-burden hospitals). They also had a higher proportion of male patients, minority patients, Hispanic patients, and patients with Medicaid or no insurance.

The odds of hospitalization in the highest tertile hospitals were found to be significantly higher, compared with the middle and lowest tertiles for Blacks and Hispanics, compared with Whites (OR 1.26 and OR 1.63, respectively). Black patients (OR, 1.26; 95%CI, 1.17-1.35; P < .001) and Hispanic patients (OR, 1.63; 95% CI, 1.50-1.78; P< .001) were more likely to be admitted for care at high-burden hospitals (26% to 54%). In-hospital mortality rates among all hospitalizations were 5.95% and the rate did not significantly differ by hospital burden status.

“Despite adjusting for safety-net burden, our study continued to demonstrate ethnic disparities in in-hospital mortality among cirrhosis-related hospitalizations,” the researchers wrote. Overall, the odds of in-hospital mortality were 27% higher in Black patients as compared with White patients.

However, significantly lower mortality was observed in Hispanic patients as compared with White patients (4.9% vs. 6.0%, P < .001), but why this occurred was not entirely clear. “Hispanic patients may be more likely to have NASH [nonalcoholic steatohepatitis]-related cirrhosis, which generally has a slower disease progression, compared with [hepatitis C virus] or alcoholic cirrhosis. As such, it is likely that NASH-cirrhosis Hispanic patients had less severe disease at presentation,” the researchers wrote.
 

Study design has limitations, but shows concerning trends

The study findings were limited by several factors including the inability to show causality based on the observational study design and cross-sectional nature of the database, the researchers said. The NIS database records individual hospitalizations, not individual patient data which means that it may include repeat hospitalizations from the same patient. In addition, the study was limited by a lack of data on outpatient cirrhosis outcomes and non–liver-related comorbidities.

However, the finding that ethnic minorities with cirrhosis were significantly more likely to be hospitalized in high safety-net hospitals than White patients is concerning, and more research is needed, they said.

“These observations highlight that, while disparities in resources and health care delivery inherent to safety-net health systems may partly explain and provide opportunities to improve cirrhosis hospitalization care, they alone do not explain all of the ethnic disparities in cirrhosis outcomes observed,” they concluded.

The current study was important to conduct at this time because rates of cirrhosis are on the rise, Michael Volk, MD, of Loma Linda (Calif.) University Health, said in an interview. “Millions of patients receive care in safety-net hospitals across the country.”

Dr. Volk said that he was not surprised by the overall outcomes. “Unfortunately, I expected that patient outcomes would be worse at safety-net hospitals than wealthier hospitals. However, I was surprised that Blacks had higher in-hospital mortality than Whites, even after adjusting for the hospital.”

Dr. Volk echoed the study’s stated limitation of the lack of data to address disparities.

“Additional research is needed to determine whether the higher in-hospital mortality among Blacks is related to biological differences such as differential rates of disease progression, or social differences such as access to outpatient care,” he said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Volk had no relevant financial conflicts to disclose.

Patients with cirrhosis treated at hospitals with the highest safety-net burden, defined by their proportion of Medicaid or uninsured patients, had a 5% higher mortality rate than patients who were treated at hospitals with the lowest burden, according to a study of over 300,000 patients.

The study, which was published in the Journal of Clinical Gastroenterology, analyzed inpatient data from the National Inpatient Sample (NIS) database focusing on a 4-year time span between 2012 and 2016. The hospitals were categorized by safety-net burden, which was defined as having either a high, medium, or low number of uninsured patients or patients with Medicaid.

This is the first-known study to evaluate the impact of a hospital’s safety-net burden on hospitalization outcomes in cirrhosis patients, wrote authors Robert J. Wong, MD, MS, of Stanford (Calif.) University and Grishma Hirode, MAS, of the University of Toronto. Previous studies have shown that safety-net hospitals, especially those with a high safety-net burden, have poorer patient outcomes. These hospitals also serve a patient population that is at high risk for chronic liver disease and cirrhosis.

The new analysis included 322,944 individual hospitalizations of patients with cirrhosis. Of these, 57.8% were male, 63.7% were White, 9.9% were Black, and 15.6% were Hispanic. In terms of safety-net burden, 107,446 hospitalizations were at high-burden hospitals, 103,508 were at medium-burden hospitals, and 111,990 hospitalizations were at low-burden hospitals.

Overall, cirrhosis-related hospitalizations in hospitals with the highest burden were found to have significantly greater odds of in-hospital mortality than the lowest tertile hospitals (odds ratio, 1.05, P = .044). The patients were also younger (mean age, 56.7 years vs. 59.8 years in low-burden hospitals). They also had a higher proportion of male patients, minority patients, Hispanic patients, and patients with Medicaid or no insurance.

The odds of hospitalization in the highest tertile hospitals were found to be significantly higher, compared with the middle and lowest tertiles for Blacks and Hispanics, compared with Whites (OR 1.26 and OR 1.63, respectively). Black patients (OR, 1.26; 95%CI, 1.17-1.35; P < .001) and Hispanic patients (OR, 1.63; 95% CI, 1.50-1.78; P< .001) were more likely to be admitted for care at high-burden hospitals (26% to 54%). In-hospital mortality rates among all hospitalizations were 5.95% and the rate did not significantly differ by hospital burden status.

“Despite adjusting for safety-net burden, our study continued to demonstrate ethnic disparities in in-hospital mortality among cirrhosis-related hospitalizations,” the researchers wrote. Overall, the odds of in-hospital mortality were 27% higher in Black patients as compared with White patients.

However, significantly lower mortality was observed in Hispanic patients as compared with White patients (4.9% vs. 6.0%, P < .001), but why this occurred was not entirely clear. “Hispanic patients may be more likely to have NASH [nonalcoholic steatohepatitis]-related cirrhosis, which generally has a slower disease progression, compared with [hepatitis C virus] or alcoholic cirrhosis. As such, it is likely that NASH-cirrhosis Hispanic patients had less severe disease at presentation,” the researchers wrote.
 

Study design has limitations, but shows concerning trends

The study findings were limited by several factors including the inability to show causality based on the observational study design and cross-sectional nature of the database, the researchers said. The NIS database records individual hospitalizations, not individual patient data which means that it may include repeat hospitalizations from the same patient. In addition, the study was limited by a lack of data on outpatient cirrhosis outcomes and non–liver-related comorbidities.

However, the finding that ethnic minorities with cirrhosis were significantly more likely to be hospitalized in high safety-net hospitals than White patients is concerning, and more research is needed, they said.

“These observations highlight that, while disparities in resources and health care delivery inherent to safety-net health systems may partly explain and provide opportunities to improve cirrhosis hospitalization care, they alone do not explain all of the ethnic disparities in cirrhosis outcomes observed,” they concluded.

The current study was important to conduct at this time because rates of cirrhosis are on the rise, Michael Volk, MD, of Loma Linda (Calif.) University Health, said in an interview. “Millions of patients receive care in safety-net hospitals across the country.”

Dr. Volk said that he was not surprised by the overall outcomes. “Unfortunately, I expected that patient outcomes would be worse at safety-net hospitals than wealthier hospitals. However, I was surprised that Blacks had higher in-hospital mortality than Whites, even after adjusting for the hospital.”

Dr. Volk echoed the study’s stated limitation of the lack of data to address disparities.

“Additional research is needed to determine whether the higher in-hospital mortality among Blacks is related to biological differences such as differential rates of disease progression, or social differences such as access to outpatient care,” he said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Volk had no relevant financial conflicts to disclose.

Patients with cirrhosis treated at hospitals with the highest safety-net burden, defined by their proportion of Medicaid or uninsured patients, had a 5% higher mortality rate than patients who were treated at hospitals with the lowest burden, according to a study of over 300,000 patients.

The study, which was published in the Journal of Clinical Gastroenterology, analyzed inpatient data from the National Inpatient Sample (NIS) database focusing on a 4-year time span between 2012 and 2016. The hospitals were categorized by safety-net burden, which was defined as having either a high, medium, or low number of uninsured patients or patients with Medicaid.

This is the first-known study to evaluate the impact of a hospital’s safety-net burden on hospitalization outcomes in cirrhosis patients, wrote authors Robert J. Wong, MD, MS, of Stanford (Calif.) University and Grishma Hirode, MAS, of the University of Toronto. Previous studies have shown that safety-net hospitals, especially those with a high safety-net burden, have poorer patient outcomes. These hospitals also serve a patient population that is at high risk for chronic liver disease and cirrhosis.

The new analysis included 322,944 individual hospitalizations of patients with cirrhosis. Of these, 57.8% were male, 63.7% were White, 9.9% were Black, and 15.6% were Hispanic. In terms of safety-net burden, 107,446 hospitalizations were at high-burden hospitals, 103,508 were at medium-burden hospitals, and 111,990 hospitalizations were at low-burden hospitals.

Overall, cirrhosis-related hospitalizations in hospitals with the highest burden were found to have significantly greater odds of in-hospital mortality than the lowest tertile hospitals (odds ratio, 1.05, P = .044). The patients were also younger (mean age, 56.7 years vs. 59.8 years in low-burden hospitals). They also had a higher proportion of male patients, minority patients, Hispanic patients, and patients with Medicaid or no insurance.

The odds of hospitalization in the highest tertile hospitals were found to be significantly higher, compared with the middle and lowest tertiles for Blacks and Hispanics, compared with Whites (OR 1.26 and OR 1.63, respectively). Black patients (OR, 1.26; 95%CI, 1.17-1.35; P < .001) and Hispanic patients (OR, 1.63; 95% CI, 1.50-1.78; P< .001) were more likely to be admitted for care at high-burden hospitals (26% to 54%). In-hospital mortality rates among all hospitalizations were 5.95% and the rate did not significantly differ by hospital burden status.

“Despite adjusting for safety-net burden, our study continued to demonstrate ethnic disparities in in-hospital mortality among cirrhosis-related hospitalizations,” the researchers wrote. Overall, the odds of in-hospital mortality were 27% higher in Black patients as compared with White patients.

However, significantly lower mortality was observed in Hispanic patients as compared with White patients (4.9% vs. 6.0%, P < .001), but why this occurred was not entirely clear. “Hispanic patients may be more likely to have NASH [nonalcoholic steatohepatitis]-related cirrhosis, which generally has a slower disease progression, compared with [hepatitis C virus] or alcoholic cirrhosis. As such, it is likely that NASH-cirrhosis Hispanic patients had less severe disease at presentation,” the researchers wrote.
 

Study design has limitations, but shows concerning trends

The study findings were limited by several factors including the inability to show causality based on the observational study design and cross-sectional nature of the database, the researchers said. The NIS database records individual hospitalizations, not individual patient data which means that it may include repeat hospitalizations from the same patient. In addition, the study was limited by a lack of data on outpatient cirrhosis outcomes and non–liver-related comorbidities.

However, the finding that ethnic minorities with cirrhosis were significantly more likely to be hospitalized in high safety-net hospitals than White patients is concerning, and more research is needed, they said.

“These observations highlight that, while disparities in resources and health care delivery inherent to safety-net health systems may partly explain and provide opportunities to improve cirrhosis hospitalization care, they alone do not explain all of the ethnic disparities in cirrhosis outcomes observed,” they concluded.

The current study was important to conduct at this time because rates of cirrhosis are on the rise, Michael Volk, MD, of Loma Linda (Calif.) University Health, said in an interview. “Millions of patients receive care in safety-net hospitals across the country.”

Dr. Volk said that he was not surprised by the overall outcomes. “Unfortunately, I expected that patient outcomes would be worse at safety-net hospitals than wealthier hospitals. However, I was surprised that Blacks had higher in-hospital mortality than Whites, even after adjusting for the hospital.”

Dr. Volk echoed the study’s stated limitation of the lack of data to address disparities.

“Additional research is needed to determine whether the higher in-hospital mortality among Blacks is related to biological differences such as differential rates of disease progression, or social differences such as access to outpatient care,” he said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Volk had no relevant financial conflicts to disclose.