Irritable temperament predicts bipolar disorder risk

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Mon, 10/09/2023 - 09:05

Evaluation of temperament in mental health outpatients showed a significant association between the irritable temperament type and a diagnosis of bipolar I and bipolar II disorders, based on data from more than 1,700 individuals.

When German psychiatrist Emil Kraepelin (1856-1926) studied emotions in patients with affective disorders, he identified four temperaments: the depressive (DT), the hyperthymic (HT), the irritable (IT), and the cyclothymic (CT). Subsequent researchers later identified an anxious temperament (AT).

“The notion that temperaments can be useful in predicting bipolar disorders sparked a plethora of research,” wrote Elie G. Karam, MD, of Saint George Hospital, Beirut, and colleagues. In particular, the cyclothymic (CT) and irritable (IT) temperament types have been targeted in studies of patients with bipolar disorders, but previous studies of temperament and bipolar have been limited by methodological issues, they said.

In a study published in European Psychiatry, the researchers reviewed data from 1,723 consecutive adult outpatients who presented to a university-based mental health clinic with various symptoms between January 2014 and September 2019.

Patients were assessed using the Hypomania Checklist-32 (HCL-32) and the Temperament Evaluation of Memphis, Pisa, Paris, and San Diego-Auto-questionnaire (TEMPS-A), then were diagnosed by psychiatrists using DSM-5 criteria. Patients with any bipolar types as defined by the DSM-5 underwent simple and multiple binary logistic regression analyses. The analysis included continuous scores and categorical normalized z-scores.

A total of 369 patients had confirmed DSM-5 diagnosis of bipolar disorder (52 with type I, 176 with type II, 102 with other specified bipolar and related disorder, and 39 with substance- or medication-induced bipolar disorder. The mean age of the participants was 38 years, and 54% were female.

In a bivariate analysis, all continuous temperament scores were significant predictors of bipolar disorder; all except AT remained significant in multivariate analysis. Increasing scores of IT, CT, and HT were associated with bipolar disorder, but increasing scores of DT were reflective of lower chance of bipolar disorder, the researchers noted.

In multivariate analysis of categorical normalized z-scores, IT and CT were significant predictors of bipolar disorder. At the highest point, CT was the stronger predictor, compared with IT (odds ratio, 3.84 vs. 2.55); having a higher DT score significantly reduced the odds of bipolar disorder (OR, 0.50).

However, “after adjusting for the presence of all temperaments as well as age and gender, only IT remained a significant predictor of patients with bipolar I disorder with adjusted OR of 1.19,” the researchers wrote.

“Correlations among temperaments were solid whether looking at patients with bipolarity or not, further emphasizing the necessity of controlling for them,” the researchers wrote in their discussion.

The findings were limited by several factors including the lack of structured interviews, the use of an outpatient-only sample, and the small number of bipolar I patients, the researchers noted.

However, the result suggest that IT can serve as a predictor of bipolar I and bipolar II disorders they said. Given the underdiagnosis of bipolar disorder in many studies, the incorporation of temperaments into the assessment of patients and research participants alike is likely to help us detect the presence of bipolarity more readily and quite importantly help us in our quest to understand their genesis,” they concluded.

The study was supported in part by anonymous private unrestricted donations to IDRAAC, Lebanon, and by Eli Lilly. The researchers had no financial conflicts to disclose.

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Evaluation of temperament in mental health outpatients showed a significant association between the irritable temperament type and a diagnosis of bipolar I and bipolar II disorders, based on data from more than 1,700 individuals.

When German psychiatrist Emil Kraepelin (1856-1926) studied emotions in patients with affective disorders, he identified four temperaments: the depressive (DT), the hyperthymic (HT), the irritable (IT), and the cyclothymic (CT). Subsequent researchers later identified an anxious temperament (AT).

“The notion that temperaments can be useful in predicting bipolar disorders sparked a plethora of research,” wrote Elie G. Karam, MD, of Saint George Hospital, Beirut, and colleagues. In particular, the cyclothymic (CT) and irritable (IT) temperament types have been targeted in studies of patients with bipolar disorders, but previous studies of temperament and bipolar have been limited by methodological issues, they said.

In a study published in European Psychiatry, the researchers reviewed data from 1,723 consecutive adult outpatients who presented to a university-based mental health clinic with various symptoms between January 2014 and September 2019.

Patients were assessed using the Hypomania Checklist-32 (HCL-32) and the Temperament Evaluation of Memphis, Pisa, Paris, and San Diego-Auto-questionnaire (TEMPS-A), then were diagnosed by psychiatrists using DSM-5 criteria. Patients with any bipolar types as defined by the DSM-5 underwent simple and multiple binary logistic regression analyses. The analysis included continuous scores and categorical normalized z-scores.

A total of 369 patients had confirmed DSM-5 diagnosis of bipolar disorder (52 with type I, 176 with type II, 102 with other specified bipolar and related disorder, and 39 with substance- or medication-induced bipolar disorder. The mean age of the participants was 38 years, and 54% were female.

In a bivariate analysis, all continuous temperament scores were significant predictors of bipolar disorder; all except AT remained significant in multivariate analysis. Increasing scores of IT, CT, and HT were associated with bipolar disorder, but increasing scores of DT were reflective of lower chance of bipolar disorder, the researchers noted.

In multivariate analysis of categorical normalized z-scores, IT and CT were significant predictors of bipolar disorder. At the highest point, CT was the stronger predictor, compared with IT (odds ratio, 3.84 vs. 2.55); having a higher DT score significantly reduced the odds of bipolar disorder (OR, 0.50).

However, “after adjusting for the presence of all temperaments as well as age and gender, only IT remained a significant predictor of patients with bipolar I disorder with adjusted OR of 1.19,” the researchers wrote.

“Correlations among temperaments were solid whether looking at patients with bipolarity or not, further emphasizing the necessity of controlling for them,” the researchers wrote in their discussion.

The findings were limited by several factors including the lack of structured interviews, the use of an outpatient-only sample, and the small number of bipolar I patients, the researchers noted.

However, the result suggest that IT can serve as a predictor of bipolar I and bipolar II disorders they said. Given the underdiagnosis of bipolar disorder in many studies, the incorporation of temperaments into the assessment of patients and research participants alike is likely to help us detect the presence of bipolarity more readily and quite importantly help us in our quest to understand their genesis,” they concluded.

The study was supported in part by anonymous private unrestricted donations to IDRAAC, Lebanon, and by Eli Lilly. The researchers had no financial conflicts to disclose.

Evaluation of temperament in mental health outpatients showed a significant association between the irritable temperament type and a diagnosis of bipolar I and bipolar II disorders, based on data from more than 1,700 individuals.

When German psychiatrist Emil Kraepelin (1856-1926) studied emotions in patients with affective disorders, he identified four temperaments: the depressive (DT), the hyperthymic (HT), the irritable (IT), and the cyclothymic (CT). Subsequent researchers later identified an anxious temperament (AT).

“The notion that temperaments can be useful in predicting bipolar disorders sparked a plethora of research,” wrote Elie G. Karam, MD, of Saint George Hospital, Beirut, and colleagues. In particular, the cyclothymic (CT) and irritable (IT) temperament types have been targeted in studies of patients with bipolar disorders, but previous studies of temperament and bipolar have been limited by methodological issues, they said.

In a study published in European Psychiatry, the researchers reviewed data from 1,723 consecutive adult outpatients who presented to a university-based mental health clinic with various symptoms between January 2014 and September 2019.

Patients were assessed using the Hypomania Checklist-32 (HCL-32) and the Temperament Evaluation of Memphis, Pisa, Paris, and San Diego-Auto-questionnaire (TEMPS-A), then were diagnosed by psychiatrists using DSM-5 criteria. Patients with any bipolar types as defined by the DSM-5 underwent simple and multiple binary logistic regression analyses. The analysis included continuous scores and categorical normalized z-scores.

A total of 369 patients had confirmed DSM-5 diagnosis of bipolar disorder (52 with type I, 176 with type II, 102 with other specified bipolar and related disorder, and 39 with substance- or medication-induced bipolar disorder. The mean age of the participants was 38 years, and 54% were female.

In a bivariate analysis, all continuous temperament scores were significant predictors of bipolar disorder; all except AT remained significant in multivariate analysis. Increasing scores of IT, CT, and HT were associated with bipolar disorder, but increasing scores of DT were reflective of lower chance of bipolar disorder, the researchers noted.

In multivariate analysis of categorical normalized z-scores, IT and CT were significant predictors of bipolar disorder. At the highest point, CT was the stronger predictor, compared with IT (odds ratio, 3.84 vs. 2.55); having a higher DT score significantly reduced the odds of bipolar disorder (OR, 0.50).

However, “after adjusting for the presence of all temperaments as well as age and gender, only IT remained a significant predictor of patients with bipolar I disorder with adjusted OR of 1.19,” the researchers wrote.

“Correlations among temperaments were solid whether looking at patients with bipolarity or not, further emphasizing the necessity of controlling for them,” the researchers wrote in their discussion.

The findings were limited by several factors including the lack of structured interviews, the use of an outpatient-only sample, and the small number of bipolar I patients, the researchers noted.

However, the result suggest that IT can serve as a predictor of bipolar I and bipolar II disorders they said. Given the underdiagnosis of bipolar disorder in many studies, the incorporation of temperaments into the assessment of patients and research participants alike is likely to help us detect the presence of bipolarity more readily and quite importantly help us in our quest to understand their genesis,” they concluded.

The study was supported in part by anonymous private unrestricted donations to IDRAAC, Lebanon, and by Eli Lilly. The researchers had no financial conflicts to disclose.

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Adverse event rates compared for colchicine, NSAIDs when starting allopurinol for gout

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Fri, 10/06/2023 - 15:29

 

TOPLINE:

Matched cohort studies revealed infrequent adverse events (AEs) with either treatment, but the number needed to harm for any AE was more than three times higher with colchicine versus NSAIDs.

METHODOLOGY:

  • The researchers conducted two matched retrospective cohort studies using the U.K. Clinical Practice Research Datalink and the Hospital Episode Statistics primary care datasets to compare AEs in adults initiating allopurinol for gout with and without colchicine or NSAID prophylaxis.
  • For the study, 13,945 patients with gout who received colchicine were matched to 13,945 patients who received no prophylaxis. In addition, 25,980 patients with gout who received NSAIDs were matched to 25,980 who received no prophylaxis.
  • The researchers used proportional hazard models to explore the associations between prophylaxis with either colchicine or NSAIDs and AEs.

TAKEAWAY:

  • The incidence of most AEs was less than 200 per 10,000 patient-years, but the most common AE among patients given colchicine was diarrhea, with an incidence of 784.4 per 10,000 person-years, whereas the most common AE in those given NSAIDs was angina, with an incidence of 466.6 per 10,000 person-years.
  • The number needed to harm in relation to any AE was 14.7 for colchicine, driven mainly by diarrhea, and 48.1 for NSAID.
  • Compared with patients who started allopurinol without prophylaxis, those treated with colchicine were more likely to experience diarrhea, myocardial infarction, neuropathy, myalgia, and bone marrow suppression, whereas those treated with NSAIDs were more likely to experience angina, acute kidney injury, myocardial infarction, and peptic ulcer disease.
  • Diarrhea, the most common AE, occurred in 17.9% of individuals who received colchicine.

IN PRACTICE:

“Our findings will provide much-needed information about the safety of flare prophylaxis that can inform treatment decisions and the choice between colchicine or NSAID for prophylaxis when initiating allopurinol, directly benefiting people with gout and their clinicians,” the authors write.

SOURCE:

First author Edward Roddy, MD, of Keele (England) University, and colleagues published their report online in BMJ’s Annals of the Rheumatic Diseases.

LIMITATIONS:

The study identified gout based on clinical diagnosis in primary care and only considered AEs serious enough to merit consultation or hospitalization; other limitations included the observational design and lack of data on the use of over-the-counter NSAIDs.

DISCLOSURES:

The study was supported by the National Institute for Health and Care Research’s Research for Patient Benefit program. The researchers had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Matched cohort studies revealed infrequent adverse events (AEs) with either treatment, but the number needed to harm for any AE was more than three times higher with colchicine versus NSAIDs.

METHODOLOGY:

  • The researchers conducted two matched retrospective cohort studies using the U.K. Clinical Practice Research Datalink and the Hospital Episode Statistics primary care datasets to compare AEs in adults initiating allopurinol for gout with and without colchicine or NSAID prophylaxis.
  • For the study, 13,945 patients with gout who received colchicine were matched to 13,945 patients who received no prophylaxis. In addition, 25,980 patients with gout who received NSAIDs were matched to 25,980 who received no prophylaxis.
  • The researchers used proportional hazard models to explore the associations between prophylaxis with either colchicine or NSAIDs and AEs.

TAKEAWAY:

  • The incidence of most AEs was less than 200 per 10,000 patient-years, but the most common AE among patients given colchicine was diarrhea, with an incidence of 784.4 per 10,000 person-years, whereas the most common AE in those given NSAIDs was angina, with an incidence of 466.6 per 10,000 person-years.
  • The number needed to harm in relation to any AE was 14.7 for colchicine, driven mainly by diarrhea, and 48.1 for NSAID.
  • Compared with patients who started allopurinol without prophylaxis, those treated with colchicine were more likely to experience diarrhea, myocardial infarction, neuropathy, myalgia, and bone marrow suppression, whereas those treated with NSAIDs were more likely to experience angina, acute kidney injury, myocardial infarction, and peptic ulcer disease.
  • Diarrhea, the most common AE, occurred in 17.9% of individuals who received colchicine.

IN PRACTICE:

“Our findings will provide much-needed information about the safety of flare prophylaxis that can inform treatment decisions and the choice between colchicine or NSAID for prophylaxis when initiating allopurinol, directly benefiting people with gout and their clinicians,” the authors write.

SOURCE:

First author Edward Roddy, MD, of Keele (England) University, and colleagues published their report online in BMJ’s Annals of the Rheumatic Diseases.

LIMITATIONS:

The study identified gout based on clinical diagnosis in primary care and only considered AEs serious enough to merit consultation or hospitalization; other limitations included the observational design and lack of data on the use of over-the-counter NSAIDs.

DISCLOSURES:

The study was supported by the National Institute for Health and Care Research’s Research for Patient Benefit program. The researchers had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Matched cohort studies revealed infrequent adverse events (AEs) with either treatment, but the number needed to harm for any AE was more than three times higher with colchicine versus NSAIDs.

METHODOLOGY:

  • The researchers conducted two matched retrospective cohort studies using the U.K. Clinical Practice Research Datalink and the Hospital Episode Statistics primary care datasets to compare AEs in adults initiating allopurinol for gout with and without colchicine or NSAID prophylaxis.
  • For the study, 13,945 patients with gout who received colchicine were matched to 13,945 patients who received no prophylaxis. In addition, 25,980 patients with gout who received NSAIDs were matched to 25,980 who received no prophylaxis.
  • The researchers used proportional hazard models to explore the associations between prophylaxis with either colchicine or NSAIDs and AEs.

TAKEAWAY:

  • The incidence of most AEs was less than 200 per 10,000 patient-years, but the most common AE among patients given colchicine was diarrhea, with an incidence of 784.4 per 10,000 person-years, whereas the most common AE in those given NSAIDs was angina, with an incidence of 466.6 per 10,000 person-years.
  • The number needed to harm in relation to any AE was 14.7 for colchicine, driven mainly by diarrhea, and 48.1 for NSAID.
  • Compared with patients who started allopurinol without prophylaxis, those treated with colchicine were more likely to experience diarrhea, myocardial infarction, neuropathy, myalgia, and bone marrow suppression, whereas those treated with NSAIDs were more likely to experience angina, acute kidney injury, myocardial infarction, and peptic ulcer disease.
  • Diarrhea, the most common AE, occurred in 17.9% of individuals who received colchicine.

IN PRACTICE:

“Our findings will provide much-needed information about the safety of flare prophylaxis that can inform treatment decisions and the choice between colchicine or NSAID for prophylaxis when initiating allopurinol, directly benefiting people with gout and their clinicians,” the authors write.

SOURCE:

First author Edward Roddy, MD, of Keele (England) University, and colleagues published their report online in BMJ’s Annals of the Rheumatic Diseases.

LIMITATIONS:

The study identified gout based on clinical diagnosis in primary care and only considered AEs serious enough to merit consultation or hospitalization; other limitations included the observational design and lack of data on the use of over-the-counter NSAIDs.

DISCLOSURES:

The study was supported by the National Institute for Health and Care Research’s Research for Patient Benefit program. The researchers had no financial conflicts to disclose.

A version of this article first appeared on Medscape.com.

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CPAP adherence curbs severe cardiovascular disease outcomes

Article Type
Changed
Thu, 10/05/2023 - 09:20

Use of continuous positive-airway pressure devices for at least 4 hours a day was associated with a reduced risk of major adverse cardiac and cerebrovascular events in adults with cardiovascular disease and obstructive sleep apnea, based on data from more than 4,000 individuals.

Obstructive sleep apnea (OSA) is associated with an increased risk of cardiovascular diseases, but the association between management of OSA with a continuous positive-airway pressure device (CPAP) and major adverse cardiac or cerebrovascular events (MACCEs) remains unclear, wrote Manuel Sánchez-de-la-Torre, PhD, of the University of Lleida, Spain, and colleagues.

In a meta-analysis published in JAMA, the researchers reviewed data from 4,186 individuals with a mean age of 61.2 years; 82.1% were men. The study population included 2,097 patients who used CPAP and 2,089 who did not. The mean apnea-hypopnea index (AHI) was 31.2 events per hour, and OSA was defined as an oxygen desaturation index of 12 events or more per hour or an AHI of 15 events or more per hour. The composite primary outcome included the first MACCE, or death from cardiovascular causes, myocardial infarction, stroke, revascularization procedure, hospital admission for heart failure, hospital admission for unstable angina, or hospital admission for transient ischemic attack. Each of these components was a secondary endpoint.

Overall, the primary outcome of MACCE was similar for CPAP and non-CPAP using patients (hazard ratio, 1.01) with a total of 349 MACCE events in the CPAP group and 342 in the non-CPAP group. The mean adherence to CPAP was 3.1 hours per day. A total of 38.5% of patients in the CPAP group met the criteria for good adherence, defined as a mean of 4 or more hours per day.

However, as defined, good adherence to CPAP significantly reduced the risk of MACCE, compared with no CPAP use (HR, 0.69), and a sensitivity analysis showed a significant risk reduction, compared with patients who did not meet the criteria for good adherence (HR, 0.55; P = .005).

“Adherence to treatment is complex to determine and there are other potential factors that could affect patient adherence, such as health education, motivation, attitude, self-efficacy, psychosocial factors, and other health care system–related features,” the researchers wrote in their discussion.

The findings were limited by several factors including the evaluation only of CPAP as a treatment for OSA, and the inability to assess separate components of the composite endpoint, the researchers noted. Other limitations included the relatively small number of female patients, reliance mainly on at-home sleep apnea tests, and the potential for selection bias, they said.

However, the results suggest that CPAP adherence is important to prevention of secondary cardiovascular outcomes in OSA patients, and that implementation of specific and personalized strategies to improve adherence to treatment should be a clinical priority, they concluded.

The study was funded by the Instituto de Salud Carlos III, the European Union and FEDER, IRBLleida–Fundació Dr Pifarré, SEPAR, ResMed Ltd. (Australia), Associació Lleidatana de Respiratori, and CIBERES. Dr Sánchez-de-la-Torre also disclosed financial support from a Ramón y Cajal grant.

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Use of continuous positive-airway pressure devices for at least 4 hours a day was associated with a reduced risk of major adverse cardiac and cerebrovascular events in adults with cardiovascular disease and obstructive sleep apnea, based on data from more than 4,000 individuals.

Obstructive sleep apnea (OSA) is associated with an increased risk of cardiovascular diseases, but the association between management of OSA with a continuous positive-airway pressure device (CPAP) and major adverse cardiac or cerebrovascular events (MACCEs) remains unclear, wrote Manuel Sánchez-de-la-Torre, PhD, of the University of Lleida, Spain, and colleagues.

In a meta-analysis published in JAMA, the researchers reviewed data from 4,186 individuals with a mean age of 61.2 years; 82.1% were men. The study population included 2,097 patients who used CPAP and 2,089 who did not. The mean apnea-hypopnea index (AHI) was 31.2 events per hour, and OSA was defined as an oxygen desaturation index of 12 events or more per hour or an AHI of 15 events or more per hour. The composite primary outcome included the first MACCE, or death from cardiovascular causes, myocardial infarction, stroke, revascularization procedure, hospital admission for heart failure, hospital admission for unstable angina, or hospital admission for transient ischemic attack. Each of these components was a secondary endpoint.

Overall, the primary outcome of MACCE was similar for CPAP and non-CPAP using patients (hazard ratio, 1.01) with a total of 349 MACCE events in the CPAP group and 342 in the non-CPAP group. The mean adherence to CPAP was 3.1 hours per day. A total of 38.5% of patients in the CPAP group met the criteria for good adherence, defined as a mean of 4 or more hours per day.

However, as defined, good adherence to CPAP significantly reduced the risk of MACCE, compared with no CPAP use (HR, 0.69), and a sensitivity analysis showed a significant risk reduction, compared with patients who did not meet the criteria for good adherence (HR, 0.55; P = .005).

“Adherence to treatment is complex to determine and there are other potential factors that could affect patient adherence, such as health education, motivation, attitude, self-efficacy, psychosocial factors, and other health care system–related features,” the researchers wrote in their discussion.

The findings were limited by several factors including the evaluation only of CPAP as a treatment for OSA, and the inability to assess separate components of the composite endpoint, the researchers noted. Other limitations included the relatively small number of female patients, reliance mainly on at-home sleep apnea tests, and the potential for selection bias, they said.

However, the results suggest that CPAP adherence is important to prevention of secondary cardiovascular outcomes in OSA patients, and that implementation of specific and personalized strategies to improve adherence to treatment should be a clinical priority, they concluded.

The study was funded by the Instituto de Salud Carlos III, the European Union and FEDER, IRBLleida–Fundació Dr Pifarré, SEPAR, ResMed Ltd. (Australia), Associació Lleidatana de Respiratori, and CIBERES. Dr Sánchez-de-la-Torre also disclosed financial support from a Ramón y Cajal grant.

Use of continuous positive-airway pressure devices for at least 4 hours a day was associated with a reduced risk of major adverse cardiac and cerebrovascular events in adults with cardiovascular disease and obstructive sleep apnea, based on data from more than 4,000 individuals.

Obstructive sleep apnea (OSA) is associated with an increased risk of cardiovascular diseases, but the association between management of OSA with a continuous positive-airway pressure device (CPAP) and major adverse cardiac or cerebrovascular events (MACCEs) remains unclear, wrote Manuel Sánchez-de-la-Torre, PhD, of the University of Lleida, Spain, and colleagues.

In a meta-analysis published in JAMA, the researchers reviewed data from 4,186 individuals with a mean age of 61.2 years; 82.1% were men. The study population included 2,097 patients who used CPAP and 2,089 who did not. The mean apnea-hypopnea index (AHI) was 31.2 events per hour, and OSA was defined as an oxygen desaturation index of 12 events or more per hour or an AHI of 15 events or more per hour. The composite primary outcome included the first MACCE, or death from cardiovascular causes, myocardial infarction, stroke, revascularization procedure, hospital admission for heart failure, hospital admission for unstable angina, or hospital admission for transient ischemic attack. Each of these components was a secondary endpoint.

Overall, the primary outcome of MACCE was similar for CPAP and non-CPAP using patients (hazard ratio, 1.01) with a total of 349 MACCE events in the CPAP group and 342 in the non-CPAP group. The mean adherence to CPAP was 3.1 hours per day. A total of 38.5% of patients in the CPAP group met the criteria for good adherence, defined as a mean of 4 or more hours per day.

However, as defined, good adherence to CPAP significantly reduced the risk of MACCE, compared with no CPAP use (HR, 0.69), and a sensitivity analysis showed a significant risk reduction, compared with patients who did not meet the criteria for good adherence (HR, 0.55; P = .005).

“Adherence to treatment is complex to determine and there are other potential factors that could affect patient adherence, such as health education, motivation, attitude, self-efficacy, psychosocial factors, and other health care system–related features,” the researchers wrote in their discussion.

The findings were limited by several factors including the evaluation only of CPAP as a treatment for OSA, and the inability to assess separate components of the composite endpoint, the researchers noted. Other limitations included the relatively small number of female patients, reliance mainly on at-home sleep apnea tests, and the potential for selection bias, they said.

However, the results suggest that CPAP adherence is important to prevention of secondary cardiovascular outcomes in OSA patients, and that implementation of specific and personalized strategies to improve adherence to treatment should be a clinical priority, they concluded.

The study was funded by the Instituto de Salud Carlos III, the European Union and FEDER, IRBLleida–Fundació Dr Pifarré, SEPAR, ResMed Ltd. (Australia), Associació Lleidatana de Respiratori, and CIBERES. Dr Sánchez-de-la-Torre also disclosed financial support from a Ramón y Cajal grant.

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Severity score predicts mortality in pulmonary tuberculosis

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Changed
Wed, 10/04/2023 - 10:34

A simple and objective severity score based on activities of daily living, hypoxemia, and lymphocytes was an effective predictor of mortality in adults with pulmonary tuberculosis, based on data from approximately 400 individuals.

Although a mortality risk-prediction score could improve treatment for pulmonary tuberculosis patients, such a score has not been previously reported, wrote Takeshi Osawa, MD, of Fukujuji Hospital, Tokyo, and colleagues.

In a study published in the journal CHEST, the researchers used 252 patients from a previous perspective study of newly diagnosed pulmonary tuberculosis as the development cohort, and recruited 165 additional patients between March 2021 and September 2022.

The primary endpoint was all-cause in-hospital mortality. Based on data from the development group, the researchers found that age 65 years and older and age 80 years and older, hypoxemia, activities of daily living, bilateral pulmonary lesions, lymphocyte count of less than 720 microliters, serum albumin less than 2.86 mg/dL, C-reactive protein (CRP) 3.97 mg/dL or higher, and procalcitonin (PCT) 0.130 ng/mL or higher were predictors of all-cause in hospital mortality.

The researchers used this information to create the disease severity score, known as the AHL score. The AHL included three clinical parameters: activity in daily living (semi-dependent, 1 point; totally dependent, 2 points); hypoxemia (1 point) and lymphocytes (< 720 /mcL, 1 point).

The scoring systems for the three parameters were, respectively, 1 point for semi-dependent and 2 points totally dependent (for activity in daily living), 1 point for presence of hypoxemia, and 1 point for lymphocytes less than 720 per microliter. The researchers stratified the scores into levels of low, intermediate, and high risk, with scores of 0, 1-2, and 3-4, respectively.

All-cause in hospital mortality occurred in 39 (15.5%) and 17 (10.3%) of patients in the developmental and validation cohorts, respectively.

The AHL score effectively predicted mortality, dividing patients into three groups of 1.3% low-risk, 8.9% intermediate risk, and 39.3% high-risk in the validation cohort, with a Harrell’s c-statistic of 0.842.

The corresponding numbers for the development cohort were 0, 13.5%, and 55.8%, with a c-statistic of 0.902.

The findings were limited by several factors, including the lack of data from “smear-negative” patients who were treated as outpatients, and more research is needed to determine the applicability of the AHL score in an outpatient population, the researchers noted. Other limitations included the lack of data on long-term mortality in surviving patients who were discharged, and the reliance on assessments that can be performed only in clinical settings in developed countries, they said.

However, the results support the feasibility of the AHL score in clinical settings to accurately predict mortality in patients with pulmonary TB, and may help optimize treatments for this population, they concluded.

The study received no outside funding. All authors disclosed nonfinancial support in the form of measuring reagents from Fujifilm Wako Pure Chemical Corporation during the study but had no relevant financial conflicts to disclose.

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A simple and objective severity score based on activities of daily living, hypoxemia, and lymphocytes was an effective predictor of mortality in adults with pulmonary tuberculosis, based on data from approximately 400 individuals.

Although a mortality risk-prediction score could improve treatment for pulmonary tuberculosis patients, such a score has not been previously reported, wrote Takeshi Osawa, MD, of Fukujuji Hospital, Tokyo, and colleagues.

In a study published in the journal CHEST, the researchers used 252 patients from a previous perspective study of newly diagnosed pulmonary tuberculosis as the development cohort, and recruited 165 additional patients between March 2021 and September 2022.

The primary endpoint was all-cause in-hospital mortality. Based on data from the development group, the researchers found that age 65 years and older and age 80 years and older, hypoxemia, activities of daily living, bilateral pulmonary lesions, lymphocyte count of less than 720 microliters, serum albumin less than 2.86 mg/dL, C-reactive protein (CRP) 3.97 mg/dL or higher, and procalcitonin (PCT) 0.130 ng/mL or higher were predictors of all-cause in hospital mortality.

The researchers used this information to create the disease severity score, known as the AHL score. The AHL included three clinical parameters: activity in daily living (semi-dependent, 1 point; totally dependent, 2 points); hypoxemia (1 point) and lymphocytes (< 720 /mcL, 1 point).

The scoring systems for the three parameters were, respectively, 1 point for semi-dependent and 2 points totally dependent (for activity in daily living), 1 point for presence of hypoxemia, and 1 point for lymphocytes less than 720 per microliter. The researchers stratified the scores into levels of low, intermediate, and high risk, with scores of 0, 1-2, and 3-4, respectively.

All-cause in hospital mortality occurred in 39 (15.5%) and 17 (10.3%) of patients in the developmental and validation cohorts, respectively.

The AHL score effectively predicted mortality, dividing patients into three groups of 1.3% low-risk, 8.9% intermediate risk, and 39.3% high-risk in the validation cohort, with a Harrell’s c-statistic of 0.842.

The corresponding numbers for the development cohort were 0, 13.5%, and 55.8%, with a c-statistic of 0.902.

The findings were limited by several factors, including the lack of data from “smear-negative” patients who were treated as outpatients, and more research is needed to determine the applicability of the AHL score in an outpatient population, the researchers noted. Other limitations included the lack of data on long-term mortality in surviving patients who were discharged, and the reliance on assessments that can be performed only in clinical settings in developed countries, they said.

However, the results support the feasibility of the AHL score in clinical settings to accurately predict mortality in patients with pulmonary TB, and may help optimize treatments for this population, they concluded.

The study received no outside funding. All authors disclosed nonfinancial support in the form of measuring reagents from Fujifilm Wako Pure Chemical Corporation during the study but had no relevant financial conflicts to disclose.

A simple and objective severity score based on activities of daily living, hypoxemia, and lymphocytes was an effective predictor of mortality in adults with pulmonary tuberculosis, based on data from approximately 400 individuals.

Although a mortality risk-prediction score could improve treatment for pulmonary tuberculosis patients, such a score has not been previously reported, wrote Takeshi Osawa, MD, of Fukujuji Hospital, Tokyo, and colleagues.

In a study published in the journal CHEST, the researchers used 252 patients from a previous perspective study of newly diagnosed pulmonary tuberculosis as the development cohort, and recruited 165 additional patients between March 2021 and September 2022.

The primary endpoint was all-cause in-hospital mortality. Based on data from the development group, the researchers found that age 65 years and older and age 80 years and older, hypoxemia, activities of daily living, bilateral pulmonary lesions, lymphocyte count of less than 720 microliters, serum albumin less than 2.86 mg/dL, C-reactive protein (CRP) 3.97 mg/dL or higher, and procalcitonin (PCT) 0.130 ng/mL or higher were predictors of all-cause in hospital mortality.

The researchers used this information to create the disease severity score, known as the AHL score. The AHL included three clinical parameters: activity in daily living (semi-dependent, 1 point; totally dependent, 2 points); hypoxemia (1 point) and lymphocytes (< 720 /mcL, 1 point).

The scoring systems for the three parameters were, respectively, 1 point for semi-dependent and 2 points totally dependent (for activity in daily living), 1 point for presence of hypoxemia, and 1 point for lymphocytes less than 720 per microliter. The researchers stratified the scores into levels of low, intermediate, and high risk, with scores of 0, 1-2, and 3-4, respectively.

All-cause in hospital mortality occurred in 39 (15.5%) and 17 (10.3%) of patients in the developmental and validation cohorts, respectively.

The AHL score effectively predicted mortality, dividing patients into three groups of 1.3% low-risk, 8.9% intermediate risk, and 39.3% high-risk in the validation cohort, with a Harrell’s c-statistic of 0.842.

The corresponding numbers for the development cohort were 0, 13.5%, and 55.8%, with a c-statistic of 0.902.

The findings were limited by several factors, including the lack of data from “smear-negative” patients who were treated as outpatients, and more research is needed to determine the applicability of the AHL score in an outpatient population, the researchers noted. Other limitations included the lack of data on long-term mortality in surviving patients who were discharged, and the reliance on assessments that can be performed only in clinical settings in developed countries, they said.

However, the results support the feasibility of the AHL score in clinical settings to accurately predict mortality in patients with pulmonary TB, and may help optimize treatments for this population, they concluded.

The study received no outside funding. All authors disclosed nonfinancial support in the form of measuring reagents from Fujifilm Wako Pure Chemical Corporation during the study but had no relevant financial conflicts to disclose.

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Pulmonary aspergillosis predicts poor outcomes in critically ill flu patients

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Tue, 10/03/2023 - 15:39

Critically ill influenza patients with associated pulmonary aspergillosis were more than twice as likely to die in intensive care than those without the added infection, based on data from a meta-analysis of more than 1,700 individuals.

Reports of influenza-associated pulmonary aspergillosis (IAPA) are rising in critically ill patients, but data on risk factors, clinical features, and outcomes are limited, Lawrence Y. Lu, MD, of The Prince Charles Hospital, Brisbane, Australia, and colleagues wrote. In addition, diagnosis of IAPA can be challenging, and many clinicians report low awareness of the condition.

In a study published in the journal Chest, the researchers reviewed data from 10 observational studies including 1,720 critically ill influenza patients aged 16 years and older; of these, 331 had IAPA, for a prevalence of 19.2%. The primary outcomes were all-cause mortality in the hospital and in the ICU. Secondary outcomes included ICU length of stay, hospital length of stay, and the need for supportive care (invasive and noninvasive mechanical ventilation, renal replacement therapy, pressor support, and extracorporeal membranous oxygenation).

Overall, mortality among flu patients in the ICU was significantly higher for those with IAPA than those without IAPA (45.0% vs. 23.8%, respectively), as was all-cause mortality (46.4% vs. 26.2%, respectively; odds ratio, 2.6 and P < .001 for both ICU and all-cause mortality).

Factors significantly associated with an increased risk for IAPA included organ transplant (OR, 4.8), hematogenous malignancy (OR, 2.5), being immunocompromised in some way (OR, 2.2), and prolonged corticosteroid use prior to hospital admission (OR, 2.4).

IAPA also was associated with more severe disease, a higher rate of complications, longer ICU stays, and a greater need for organ supports, the researchers noted. Clinical features not significantly more common in patients with IAPA included fever, hemoptysis, and acute respiratory distress syndrome.

The findings were limited by several factors including the retrospective design of the included studies and inability to control for all potential confounders, the researchers noted. Other limitations included the variations in study design, variability of practice patterns across locations, and inclusion of data mainly from countries of high socioeconomic status.

“Given the apparent waning of the COVID-19 pandemic and re-emergence of influenza, our analysis also revealed other gaps in the current literature, including the need to validate newer diagnostic methods and to develop a system to measure severity of IAPA,” the researchers added.

However, the current study results reflect IAPA prevalence from previous studies, and support the need to have a lower threshold for IAPA testing and initiation of antifungal treatment, even with limited data for clinical guidance, they concluded.

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

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Critically ill influenza patients with associated pulmonary aspergillosis were more than twice as likely to die in intensive care than those without the added infection, based on data from a meta-analysis of more than 1,700 individuals.

Reports of influenza-associated pulmonary aspergillosis (IAPA) are rising in critically ill patients, but data on risk factors, clinical features, and outcomes are limited, Lawrence Y. Lu, MD, of The Prince Charles Hospital, Brisbane, Australia, and colleagues wrote. In addition, diagnosis of IAPA can be challenging, and many clinicians report low awareness of the condition.

In a study published in the journal Chest, the researchers reviewed data from 10 observational studies including 1,720 critically ill influenza patients aged 16 years and older; of these, 331 had IAPA, for a prevalence of 19.2%. The primary outcomes were all-cause mortality in the hospital and in the ICU. Secondary outcomes included ICU length of stay, hospital length of stay, and the need for supportive care (invasive and noninvasive mechanical ventilation, renal replacement therapy, pressor support, and extracorporeal membranous oxygenation).

Overall, mortality among flu patients in the ICU was significantly higher for those with IAPA than those without IAPA (45.0% vs. 23.8%, respectively), as was all-cause mortality (46.4% vs. 26.2%, respectively; odds ratio, 2.6 and P < .001 for both ICU and all-cause mortality).

Factors significantly associated with an increased risk for IAPA included organ transplant (OR, 4.8), hematogenous malignancy (OR, 2.5), being immunocompromised in some way (OR, 2.2), and prolonged corticosteroid use prior to hospital admission (OR, 2.4).

IAPA also was associated with more severe disease, a higher rate of complications, longer ICU stays, and a greater need for organ supports, the researchers noted. Clinical features not significantly more common in patients with IAPA included fever, hemoptysis, and acute respiratory distress syndrome.

The findings were limited by several factors including the retrospective design of the included studies and inability to control for all potential confounders, the researchers noted. Other limitations included the variations in study design, variability of practice patterns across locations, and inclusion of data mainly from countries of high socioeconomic status.

“Given the apparent waning of the COVID-19 pandemic and re-emergence of influenza, our analysis also revealed other gaps in the current literature, including the need to validate newer diagnostic methods and to develop a system to measure severity of IAPA,” the researchers added.

However, the current study results reflect IAPA prevalence from previous studies, and support the need to have a lower threshold for IAPA testing and initiation of antifungal treatment, even with limited data for clinical guidance, they concluded.

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

Critically ill influenza patients with associated pulmonary aspergillosis were more than twice as likely to die in intensive care than those without the added infection, based on data from a meta-analysis of more than 1,700 individuals.

Reports of influenza-associated pulmonary aspergillosis (IAPA) are rising in critically ill patients, but data on risk factors, clinical features, and outcomes are limited, Lawrence Y. Lu, MD, of The Prince Charles Hospital, Brisbane, Australia, and colleagues wrote. In addition, diagnosis of IAPA can be challenging, and many clinicians report low awareness of the condition.

In a study published in the journal Chest, the researchers reviewed data from 10 observational studies including 1,720 critically ill influenza patients aged 16 years and older; of these, 331 had IAPA, for a prevalence of 19.2%. The primary outcomes were all-cause mortality in the hospital and in the ICU. Secondary outcomes included ICU length of stay, hospital length of stay, and the need for supportive care (invasive and noninvasive mechanical ventilation, renal replacement therapy, pressor support, and extracorporeal membranous oxygenation).

Overall, mortality among flu patients in the ICU was significantly higher for those with IAPA than those without IAPA (45.0% vs. 23.8%, respectively), as was all-cause mortality (46.4% vs. 26.2%, respectively; odds ratio, 2.6 and P < .001 for both ICU and all-cause mortality).

Factors significantly associated with an increased risk for IAPA included organ transplant (OR, 4.8), hematogenous malignancy (OR, 2.5), being immunocompromised in some way (OR, 2.2), and prolonged corticosteroid use prior to hospital admission (OR, 2.4).

IAPA also was associated with more severe disease, a higher rate of complications, longer ICU stays, and a greater need for organ supports, the researchers noted. Clinical features not significantly more common in patients with IAPA included fever, hemoptysis, and acute respiratory distress syndrome.

The findings were limited by several factors including the retrospective design of the included studies and inability to control for all potential confounders, the researchers noted. Other limitations included the variations in study design, variability of practice patterns across locations, and inclusion of data mainly from countries of high socioeconomic status.

“Given the apparent waning of the COVID-19 pandemic and re-emergence of influenza, our analysis also revealed other gaps in the current literature, including the need to validate newer diagnostic methods and to develop a system to measure severity of IAPA,” the researchers added.

However, the current study results reflect IAPA prevalence from previous studies, and support the need to have a lower threshold for IAPA testing and initiation of antifungal treatment, even with limited data for clinical guidance, they concluded.

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

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Sentinel central events prevalent during DISE for obstructive sleep apnea

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Changed
Tue, 10/03/2023 - 10:06

Nearly half of patients undergoing drug-induced sleep endoscopy (DISE) experienced a sentinel central event after an average of 6 minutes in a study of 103 individuals with obstructive sleep apnea (OSA).

DISE has become the top choice for surgical selection in patients with OSA, but it has a variable effect on surgical outcomes, Julianna G. Rodin, MD, of the University of Pennsylvania, Philadelphia, and colleagues explained.

The University of Pennsylvania sleep surgery team developed a comprehensive DISE platform that includes simultaneous collection of respiratory airflow and effort measurements, airway collapsibility, and videoendoscopy.

“This home sleep study-style setup has allowed us to better characterize the upper airway during DISE, and even helped our team diagnose a patient with Cheyne-Stokes breathing/central sleep apnea,” Dr. Rodin said in an interview.

“With it, we also began to notice relatively frequent central and/or mixed sleep disordered breathing events during DISE after propofol dosing initiation,” she said.

In a study presented at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery, Dr. Rodin and colleagues measured both the frequency and timing of sentinel central and/or mixed events (SCent) in adults undergoing DISE to assess the prevalence and impact on DISE.

The researchers also assessed differences in VOTE classification (velum, oropharynx, tongue base, and epiglottis) in sentinel central events, compared with obstructive events. VOTE scores were calculated using a grade of 0 for no obstruction, 1 for partial obstruction, and 2 for total obstruction.

The study population included 103 adults with OSA who underwent DISE with propofol sedation at a single tertiary academic medical center between June 2020 and November 2022. The mean age of the participants was 53.5 years, the mean body mass index (BMI) was 29.7 kg/m2, and 67% were male. The average apnea-hypopnea index (AHI) was 30.7 events per hour. The researchers used a polysomnography platform to capture data on nasal airflow, thoraco-abdominal effort belt signals, and videoendoscopy.

A total of 47 patients (46%) had at least one SCent. The average time to the first SCent was just under 6 minutes, and average transition to obstructive pathology in these patients occurred between 7 and 8 minutes. Using the one-sided prediction interval, at least 95% of patients were expected to transition to obstructive pathology within 12-13 minutes, Dr. Rodin said.

In addition, 29 of the 46 patients with SCent (63%) showed significant variability between central/mixed VOTE scores and obstructive VOTE scores.

No statistically significant differences were noted between patients with and without SCent in terms of demographics or AHI.
 

Surprising prevalence of SCents

“We anecdotally noted that SCents seemed to be somewhat common during the initial period of DISE, but were surprised that we saw at least one SCent in almost 50% of our DISE population,” Dr. Rodin said. “We also saw that the majority of these SCents eventually transitioned to obstructive events after approximately 12 minutes, which is often past the average duration of normal DISE exams.”

The high frequency of differing VOTE scores between SCents and obstructive events also was unexpected, she added. Within the changes in VOTE scores as defined in the study, “there was a higher tendency for SCents to have more complete tongue base collapse compared to no or partial collapse in obstructive events, and to transition from anterior-posterior velum to concentric velum collapse during the obstructive event.”

This outcome could potentially affect a patient’s candidacy for hypoglossal nerve stimulator therapy, she explained.

The takeaway from the current study is an increased awareness of the prevalence and timing of SCents in OSA patients, said Dr. Rodin. Clinicians who offer DISE and PAP alternatives also should be mindful of clinical signs of effort, by monitoring the chest and abdomen during DISE in the absence of respiratory effort belts.

The study findings also suggest that clinicians consider extending the minimum DISE duration to 10 minutes to ensure that the majority of SCents have passed, and delay VOTE scoring until patients transition to obstructive events, she added.

As for additional research, Dr. Rodin said: “If we could repeat the study with a standardized protocol of target-controlled infusion (TCI) of propofol, that would further bolster the data.” However, TCI is not approved in the United States.

“Our propofol dosing technique was not standardized across all patients, which in theory could account for more SCents if patients were more sedated,” Dr. Rodin noted. “However, we did not see a difference in average bispectral index levels across all patients.”

Other limitations of the current study included an inability to visualize the entire upper airway to achieve a complete VOTE score for every patient, which could have led to underestimation of the VOTE difference frequency, she added.
 

 

 

Data inform team approaches to DISE

As DISE procedures become more widespread, “it is paramount that we understand the risks associated with these procedures to increase safety, improve shared decision-making, and encourage a team-based approach in the operating room with our anesthesia colleagues,” said Daniel M. Zeitler, MD, from the University of Washington and Virgina Mason Medical Center, both in Seattle, who served as a moderator for the session in which the study was presented.

“I was surprised by these data for two reasons,” Dr. Zeitler said in an interview. “We typically don’t wait more than a few minutes between induction of anesthesia and the initiation of the airway procedure. This study calls that practice into question, and the duration of time before the onset of a sentinel event was much longer than I would have expected,” he said.

Second, “I was quite surprised that there were no differences in the demographics or AHI between the two groups; this reminds us that AHI and BMI alone may not be themselves predictive of risk and all patients should be assessed similarly.”

“Otolaryngologists performing DISE need to be aware of these data, communicate them to the involved teams, including anesthesia, nursing, and postanesthesia care units, and remember to delay the manipulation of the airway long enough to minimize the risk of a sentinel event,” Dr. Zeitler said. “Perhaps this also means we need improved intraoperative monitoring for these patients, including respiratory airflow and effort monitoring.”

For further research, “we need to increase the number of patients, perform a multicenter study, and expand the study to a wider range of ages, BMI, and AHI,” he added. A recommended algorithm for these cases in order to standardize the practice would be useful.

The study received no outside funding. Dr. Rodin and Dr. Zeitler reported no relevant financial relationships. Several coauthors disclosed funding and relationships with multiple companies unrelated to the current study.

A version of this article appeared on Medscape.com.

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Nearly half of patients undergoing drug-induced sleep endoscopy (DISE) experienced a sentinel central event after an average of 6 minutes in a study of 103 individuals with obstructive sleep apnea (OSA).

DISE has become the top choice for surgical selection in patients with OSA, but it has a variable effect on surgical outcomes, Julianna G. Rodin, MD, of the University of Pennsylvania, Philadelphia, and colleagues explained.

The University of Pennsylvania sleep surgery team developed a comprehensive DISE platform that includes simultaneous collection of respiratory airflow and effort measurements, airway collapsibility, and videoendoscopy.

“This home sleep study-style setup has allowed us to better characterize the upper airway during DISE, and even helped our team diagnose a patient with Cheyne-Stokes breathing/central sleep apnea,” Dr. Rodin said in an interview.

“With it, we also began to notice relatively frequent central and/or mixed sleep disordered breathing events during DISE after propofol dosing initiation,” she said.

In a study presented at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery, Dr. Rodin and colleagues measured both the frequency and timing of sentinel central and/or mixed events (SCent) in adults undergoing DISE to assess the prevalence and impact on DISE.

The researchers also assessed differences in VOTE classification (velum, oropharynx, tongue base, and epiglottis) in sentinel central events, compared with obstructive events. VOTE scores were calculated using a grade of 0 for no obstruction, 1 for partial obstruction, and 2 for total obstruction.

The study population included 103 adults with OSA who underwent DISE with propofol sedation at a single tertiary academic medical center between June 2020 and November 2022. The mean age of the participants was 53.5 years, the mean body mass index (BMI) was 29.7 kg/m2, and 67% were male. The average apnea-hypopnea index (AHI) was 30.7 events per hour. The researchers used a polysomnography platform to capture data on nasal airflow, thoraco-abdominal effort belt signals, and videoendoscopy.

A total of 47 patients (46%) had at least one SCent. The average time to the first SCent was just under 6 minutes, and average transition to obstructive pathology in these patients occurred between 7 and 8 minutes. Using the one-sided prediction interval, at least 95% of patients were expected to transition to obstructive pathology within 12-13 minutes, Dr. Rodin said.

In addition, 29 of the 46 patients with SCent (63%) showed significant variability between central/mixed VOTE scores and obstructive VOTE scores.

No statistically significant differences were noted between patients with and without SCent in terms of demographics or AHI.
 

Surprising prevalence of SCents

“We anecdotally noted that SCents seemed to be somewhat common during the initial period of DISE, but were surprised that we saw at least one SCent in almost 50% of our DISE population,” Dr. Rodin said. “We also saw that the majority of these SCents eventually transitioned to obstructive events after approximately 12 minutes, which is often past the average duration of normal DISE exams.”

The high frequency of differing VOTE scores between SCents and obstructive events also was unexpected, she added. Within the changes in VOTE scores as defined in the study, “there was a higher tendency for SCents to have more complete tongue base collapse compared to no or partial collapse in obstructive events, and to transition from anterior-posterior velum to concentric velum collapse during the obstructive event.”

This outcome could potentially affect a patient’s candidacy for hypoglossal nerve stimulator therapy, she explained.

The takeaway from the current study is an increased awareness of the prevalence and timing of SCents in OSA patients, said Dr. Rodin. Clinicians who offer DISE and PAP alternatives also should be mindful of clinical signs of effort, by monitoring the chest and abdomen during DISE in the absence of respiratory effort belts.

The study findings also suggest that clinicians consider extending the minimum DISE duration to 10 minutes to ensure that the majority of SCents have passed, and delay VOTE scoring until patients transition to obstructive events, she added.

As for additional research, Dr. Rodin said: “If we could repeat the study with a standardized protocol of target-controlled infusion (TCI) of propofol, that would further bolster the data.” However, TCI is not approved in the United States.

“Our propofol dosing technique was not standardized across all patients, which in theory could account for more SCents if patients were more sedated,” Dr. Rodin noted. “However, we did not see a difference in average bispectral index levels across all patients.”

Other limitations of the current study included an inability to visualize the entire upper airway to achieve a complete VOTE score for every patient, which could have led to underestimation of the VOTE difference frequency, she added.
 

 

 

Data inform team approaches to DISE

As DISE procedures become more widespread, “it is paramount that we understand the risks associated with these procedures to increase safety, improve shared decision-making, and encourage a team-based approach in the operating room with our anesthesia colleagues,” said Daniel M. Zeitler, MD, from the University of Washington and Virgina Mason Medical Center, both in Seattle, who served as a moderator for the session in which the study was presented.

“I was surprised by these data for two reasons,” Dr. Zeitler said in an interview. “We typically don’t wait more than a few minutes between induction of anesthesia and the initiation of the airway procedure. This study calls that practice into question, and the duration of time before the onset of a sentinel event was much longer than I would have expected,” he said.

Second, “I was quite surprised that there were no differences in the demographics or AHI between the two groups; this reminds us that AHI and BMI alone may not be themselves predictive of risk and all patients should be assessed similarly.”

“Otolaryngologists performing DISE need to be aware of these data, communicate them to the involved teams, including anesthesia, nursing, and postanesthesia care units, and remember to delay the manipulation of the airway long enough to minimize the risk of a sentinel event,” Dr. Zeitler said. “Perhaps this also means we need improved intraoperative monitoring for these patients, including respiratory airflow and effort monitoring.”

For further research, “we need to increase the number of patients, perform a multicenter study, and expand the study to a wider range of ages, BMI, and AHI,” he added. A recommended algorithm for these cases in order to standardize the practice would be useful.

The study received no outside funding. Dr. Rodin and Dr. Zeitler reported no relevant financial relationships. Several coauthors disclosed funding and relationships with multiple companies unrelated to the current study.

A version of this article appeared on Medscape.com.

Nearly half of patients undergoing drug-induced sleep endoscopy (DISE) experienced a sentinel central event after an average of 6 minutes in a study of 103 individuals with obstructive sleep apnea (OSA).

DISE has become the top choice for surgical selection in patients with OSA, but it has a variable effect on surgical outcomes, Julianna G. Rodin, MD, of the University of Pennsylvania, Philadelphia, and colleagues explained.

The University of Pennsylvania sleep surgery team developed a comprehensive DISE platform that includes simultaneous collection of respiratory airflow and effort measurements, airway collapsibility, and videoendoscopy.

“This home sleep study-style setup has allowed us to better characterize the upper airway during DISE, and even helped our team diagnose a patient with Cheyne-Stokes breathing/central sleep apnea,” Dr. Rodin said in an interview.

“With it, we also began to notice relatively frequent central and/or mixed sleep disordered breathing events during DISE after propofol dosing initiation,” she said.

In a study presented at the annual meeting of the American Academy of Otolaryngology–Head and Neck Surgery, Dr. Rodin and colleagues measured both the frequency and timing of sentinel central and/or mixed events (SCent) in adults undergoing DISE to assess the prevalence and impact on DISE.

The researchers also assessed differences in VOTE classification (velum, oropharynx, tongue base, and epiglottis) in sentinel central events, compared with obstructive events. VOTE scores were calculated using a grade of 0 for no obstruction, 1 for partial obstruction, and 2 for total obstruction.

The study population included 103 adults with OSA who underwent DISE with propofol sedation at a single tertiary academic medical center between June 2020 and November 2022. The mean age of the participants was 53.5 years, the mean body mass index (BMI) was 29.7 kg/m2, and 67% were male. The average apnea-hypopnea index (AHI) was 30.7 events per hour. The researchers used a polysomnography platform to capture data on nasal airflow, thoraco-abdominal effort belt signals, and videoendoscopy.

A total of 47 patients (46%) had at least one SCent. The average time to the first SCent was just under 6 minutes, and average transition to obstructive pathology in these patients occurred between 7 and 8 minutes. Using the one-sided prediction interval, at least 95% of patients were expected to transition to obstructive pathology within 12-13 minutes, Dr. Rodin said.

In addition, 29 of the 46 patients with SCent (63%) showed significant variability between central/mixed VOTE scores and obstructive VOTE scores.

No statistically significant differences were noted between patients with and without SCent in terms of demographics or AHI.
 

Surprising prevalence of SCents

“We anecdotally noted that SCents seemed to be somewhat common during the initial period of DISE, but were surprised that we saw at least one SCent in almost 50% of our DISE population,” Dr. Rodin said. “We also saw that the majority of these SCents eventually transitioned to obstructive events after approximately 12 minutes, which is often past the average duration of normal DISE exams.”

The high frequency of differing VOTE scores between SCents and obstructive events also was unexpected, she added. Within the changes in VOTE scores as defined in the study, “there was a higher tendency for SCents to have more complete tongue base collapse compared to no or partial collapse in obstructive events, and to transition from anterior-posterior velum to concentric velum collapse during the obstructive event.”

This outcome could potentially affect a patient’s candidacy for hypoglossal nerve stimulator therapy, she explained.

The takeaway from the current study is an increased awareness of the prevalence and timing of SCents in OSA patients, said Dr. Rodin. Clinicians who offer DISE and PAP alternatives also should be mindful of clinical signs of effort, by monitoring the chest and abdomen during DISE in the absence of respiratory effort belts.

The study findings also suggest that clinicians consider extending the minimum DISE duration to 10 minutes to ensure that the majority of SCents have passed, and delay VOTE scoring until patients transition to obstructive events, she added.

As for additional research, Dr. Rodin said: “If we could repeat the study with a standardized protocol of target-controlled infusion (TCI) of propofol, that would further bolster the data.” However, TCI is not approved in the United States.

“Our propofol dosing technique was not standardized across all patients, which in theory could account for more SCents if patients were more sedated,” Dr. Rodin noted. “However, we did not see a difference in average bispectral index levels across all patients.”

Other limitations of the current study included an inability to visualize the entire upper airway to achieve a complete VOTE score for every patient, which could have led to underestimation of the VOTE difference frequency, she added.
 

 

 

Data inform team approaches to DISE

As DISE procedures become more widespread, “it is paramount that we understand the risks associated with these procedures to increase safety, improve shared decision-making, and encourage a team-based approach in the operating room with our anesthesia colleagues,” said Daniel M. Zeitler, MD, from the University of Washington and Virgina Mason Medical Center, both in Seattle, who served as a moderator for the session in which the study was presented.

“I was surprised by these data for two reasons,” Dr. Zeitler said in an interview. “We typically don’t wait more than a few minutes between induction of anesthesia and the initiation of the airway procedure. This study calls that practice into question, and the duration of time before the onset of a sentinel event was much longer than I would have expected,” he said.

Second, “I was quite surprised that there were no differences in the demographics or AHI between the two groups; this reminds us that AHI and BMI alone may not be themselves predictive of risk and all patients should be assessed similarly.”

“Otolaryngologists performing DISE need to be aware of these data, communicate them to the involved teams, including anesthesia, nursing, and postanesthesia care units, and remember to delay the manipulation of the airway long enough to minimize the risk of a sentinel event,” Dr. Zeitler said. “Perhaps this also means we need improved intraoperative monitoring for these patients, including respiratory airflow and effort monitoring.”

For further research, “we need to increase the number of patients, perform a multicenter study, and expand the study to a wider range of ages, BMI, and AHI,” he added. A recommended algorithm for these cases in order to standardize the practice would be useful.

The study received no outside funding. Dr. Rodin and Dr. Zeitler reported no relevant financial relationships. Several coauthors disclosed funding and relationships with multiple companies unrelated to the current study.

A version of this article appeared on Medscape.com.

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Measures of PTH predict postthyroidectomy hypocalcemia

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Mon, 10/02/2023 - 13:05

Postoperative parathyroid hormone (PTH) showed 100% sensitivity in predicting postthyroidectomy hypocalcemia, according to the results of a prospective study of 60 patients.

Postthyroidectomy hypocalcemia remains a major complication in patients who have undergone total thyroidectomy, and early identification can reduce disease burden and improve outcomes, according to Ahmed Sobhy Youssef, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, and colleagues.

In a presentation at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Dr. Youssef presented results of the study, which looked at early postoperative parathyroid hormone as a predictor of postthyroidectomy hypocalcemia.

During his fellowship in Oklahoma in the wake of the COVID-19 pandemic, Dr. Youssef observed a wide variation in follow-up for calcium levels after thyroidectomy. “Some surgeons will order PTH and ionized calcium 4 hours after surgery, others would order later, at 6-8 hours,” he said in an interview. However, “all patients would be admitted for 1-2 nights [before being] discharged home, which meant more restrictions on the number of beds allowed for our head and neck cancer service.”

Discussion with his department chair led to a literature review seeking strategies to discharge patients earlier, and Dr. Youssef developed the idea for early PTH testing.

The study population included 60 adults who underwent thyroidectomy for benign or malignant disease at a single center between January 2022 and January 2023. The researchers measured PTH at 1 hour after surgery and compared it to results of a standard postoperative measure at 4 hours after surgery.

The researchers found a significant positive correlation between PTH measured 1 hour after surgery and ionized calcium (Ca) at 4 hours. The sensitivity of the early PTH assay, defined as “measured below 14 pg/ml,” was 100% to detect hypocalcemia, with an area under the curve of 0.797.

“The results were amazing,” said Dr. Youssef. “We found that when we measure PTH as early as 1 hour after total thyroidectomy, while patients are still in recovery, PTH was very sensitive to predict hypocalcemia.” The correlation was strong with measures at 4 hours.

“Our takeaway message is the 1-hour level PTH is very reliable in predicting hypocalcemia,” he added. This measure can serve as a guide for discharging patients the same day, with instructions to return if they develop any symptoms of hypocalcemia.

The use of early PTH also helped to reduce hospital admissions and identified patients who were eligible for same-day discharge with no need for additional replacement medications, Dr. Youssef said.

So far, “we have had no readmissions for thyroidectomy patients since we started to follow this protocol at our institution,” he noted.

The findings were limited by the relatively small sample size, and more research is needed. However, the results suggest that early measurement of PTH at 1 hour after surgery is an accurate predictor of hypocalcemia in total thyroidectomy patients.

“I strongly recommend high thyroidectomy volume institutions apply the same protocol and publish their data about that so we can come up with a consensus/guideline for management of calcium following thyroidectomy,” Dr. Youssef said.
 

 

 

More proof of PTH’s predictive power

“The utility of postoperative PTH for predicting symptomatic hypocalcemia is beneficial for guiding postoperative management of patients following total thyroidectomy,” said Larissa Sweeny, MD, of the University of Miami, who served as a moderator for the session in which the study was presented.

“Proper identification of patients that require supplemental medications following surgery reduces administration of medications to patients that do not require supplemental medications,” Dr. Sweeny said in an interview.

In addition, better identification not only ensures that the patients who do require supplemental medications receive them but also reduces postoperative complications and readmissions, she said.

For clinical practice, the current study “reinforces the utility of postoperative PTH lab values for guiding medication administration following total thyroidectomy,” said Dr. Sweeny. “I have been using postoperative PTH lab values following total thyroidectomy to guide my postoperative management of these patients for over 6 years.” 

However, looking ahead to additional research, “Correlation with dosage of supplemental calcium and duration to return of normal PTH would be helpful information,” Dr. Sweeny said.

The study received no outside funding. The researchers and Dr. Sweeny report no relevant financial relationships. 

A version of this article appeared on Medscape.com.

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Postoperative parathyroid hormone (PTH) showed 100% sensitivity in predicting postthyroidectomy hypocalcemia, according to the results of a prospective study of 60 patients.

Postthyroidectomy hypocalcemia remains a major complication in patients who have undergone total thyroidectomy, and early identification can reduce disease burden and improve outcomes, according to Ahmed Sobhy Youssef, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, and colleagues.

In a presentation at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Dr. Youssef presented results of the study, which looked at early postoperative parathyroid hormone as a predictor of postthyroidectomy hypocalcemia.

During his fellowship in Oklahoma in the wake of the COVID-19 pandemic, Dr. Youssef observed a wide variation in follow-up for calcium levels after thyroidectomy. “Some surgeons will order PTH and ionized calcium 4 hours after surgery, others would order later, at 6-8 hours,” he said in an interview. However, “all patients would be admitted for 1-2 nights [before being] discharged home, which meant more restrictions on the number of beds allowed for our head and neck cancer service.”

Discussion with his department chair led to a literature review seeking strategies to discharge patients earlier, and Dr. Youssef developed the idea for early PTH testing.

The study population included 60 adults who underwent thyroidectomy for benign or malignant disease at a single center between January 2022 and January 2023. The researchers measured PTH at 1 hour after surgery and compared it to results of a standard postoperative measure at 4 hours after surgery.

The researchers found a significant positive correlation between PTH measured 1 hour after surgery and ionized calcium (Ca) at 4 hours. The sensitivity of the early PTH assay, defined as “measured below 14 pg/ml,” was 100% to detect hypocalcemia, with an area under the curve of 0.797.

“The results were amazing,” said Dr. Youssef. “We found that when we measure PTH as early as 1 hour after total thyroidectomy, while patients are still in recovery, PTH was very sensitive to predict hypocalcemia.” The correlation was strong with measures at 4 hours.

“Our takeaway message is the 1-hour level PTH is very reliable in predicting hypocalcemia,” he added. This measure can serve as a guide for discharging patients the same day, with instructions to return if they develop any symptoms of hypocalcemia.

The use of early PTH also helped to reduce hospital admissions and identified patients who were eligible for same-day discharge with no need for additional replacement medications, Dr. Youssef said.

So far, “we have had no readmissions for thyroidectomy patients since we started to follow this protocol at our institution,” he noted.

The findings were limited by the relatively small sample size, and more research is needed. However, the results suggest that early measurement of PTH at 1 hour after surgery is an accurate predictor of hypocalcemia in total thyroidectomy patients.

“I strongly recommend high thyroidectomy volume institutions apply the same protocol and publish their data about that so we can come up with a consensus/guideline for management of calcium following thyroidectomy,” Dr. Youssef said.
 

 

 

More proof of PTH’s predictive power

“The utility of postoperative PTH for predicting symptomatic hypocalcemia is beneficial for guiding postoperative management of patients following total thyroidectomy,” said Larissa Sweeny, MD, of the University of Miami, who served as a moderator for the session in which the study was presented.

“Proper identification of patients that require supplemental medications following surgery reduces administration of medications to patients that do not require supplemental medications,” Dr. Sweeny said in an interview.

In addition, better identification not only ensures that the patients who do require supplemental medications receive them but also reduces postoperative complications and readmissions, she said.

For clinical practice, the current study “reinforces the utility of postoperative PTH lab values for guiding medication administration following total thyroidectomy,” said Dr. Sweeny. “I have been using postoperative PTH lab values following total thyroidectomy to guide my postoperative management of these patients for over 6 years.” 

However, looking ahead to additional research, “Correlation with dosage of supplemental calcium and duration to return of normal PTH would be helpful information,” Dr. Sweeny said.

The study received no outside funding. The researchers and Dr. Sweeny report no relevant financial relationships. 

A version of this article appeared on Medscape.com.

Postoperative parathyroid hormone (PTH) showed 100% sensitivity in predicting postthyroidectomy hypocalcemia, according to the results of a prospective study of 60 patients.

Postthyroidectomy hypocalcemia remains a major complication in patients who have undergone total thyroidectomy, and early identification can reduce disease burden and improve outcomes, according to Ahmed Sobhy Youssef, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, and colleagues.

In a presentation at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery, Dr. Youssef presented results of the study, which looked at early postoperative parathyroid hormone as a predictor of postthyroidectomy hypocalcemia.

During his fellowship in Oklahoma in the wake of the COVID-19 pandemic, Dr. Youssef observed a wide variation in follow-up for calcium levels after thyroidectomy. “Some surgeons will order PTH and ionized calcium 4 hours after surgery, others would order later, at 6-8 hours,” he said in an interview. However, “all patients would be admitted for 1-2 nights [before being] discharged home, which meant more restrictions on the number of beds allowed for our head and neck cancer service.”

Discussion with his department chair led to a literature review seeking strategies to discharge patients earlier, and Dr. Youssef developed the idea for early PTH testing.

The study population included 60 adults who underwent thyroidectomy for benign or malignant disease at a single center between January 2022 and January 2023. The researchers measured PTH at 1 hour after surgery and compared it to results of a standard postoperative measure at 4 hours after surgery.

The researchers found a significant positive correlation between PTH measured 1 hour after surgery and ionized calcium (Ca) at 4 hours. The sensitivity of the early PTH assay, defined as “measured below 14 pg/ml,” was 100% to detect hypocalcemia, with an area under the curve of 0.797.

“The results were amazing,” said Dr. Youssef. “We found that when we measure PTH as early as 1 hour after total thyroidectomy, while patients are still in recovery, PTH was very sensitive to predict hypocalcemia.” The correlation was strong with measures at 4 hours.

“Our takeaway message is the 1-hour level PTH is very reliable in predicting hypocalcemia,” he added. This measure can serve as a guide for discharging patients the same day, with instructions to return if they develop any symptoms of hypocalcemia.

The use of early PTH also helped to reduce hospital admissions and identified patients who were eligible for same-day discharge with no need for additional replacement medications, Dr. Youssef said.

So far, “we have had no readmissions for thyroidectomy patients since we started to follow this protocol at our institution,” he noted.

The findings were limited by the relatively small sample size, and more research is needed. However, the results suggest that early measurement of PTH at 1 hour after surgery is an accurate predictor of hypocalcemia in total thyroidectomy patients.

“I strongly recommend high thyroidectomy volume institutions apply the same protocol and publish their data about that so we can come up with a consensus/guideline for management of calcium following thyroidectomy,” Dr. Youssef said.
 

 

 

More proof of PTH’s predictive power

“The utility of postoperative PTH for predicting symptomatic hypocalcemia is beneficial for guiding postoperative management of patients following total thyroidectomy,” said Larissa Sweeny, MD, of the University of Miami, who served as a moderator for the session in which the study was presented.

“Proper identification of patients that require supplemental medications following surgery reduces administration of medications to patients that do not require supplemental medications,” Dr. Sweeny said in an interview.

In addition, better identification not only ensures that the patients who do require supplemental medications receive them but also reduces postoperative complications and readmissions, she said.

For clinical practice, the current study “reinforces the utility of postoperative PTH lab values for guiding medication administration following total thyroidectomy,” said Dr. Sweeny. “I have been using postoperative PTH lab values following total thyroidectomy to guide my postoperative management of these patients for over 6 years.” 

However, looking ahead to additional research, “Correlation with dosage of supplemental calcium and duration to return of normal PTH would be helpful information,” Dr. Sweeny said.

The study received no outside funding. The researchers and Dr. Sweeny report no relevant financial relationships. 

A version of this article appeared on Medscape.com.

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Hidradenitis suppurativa experts reach consensus on treatment outcome measures

Article Type
Changed
Thu, 09/28/2023 - 11:25

TOPLINE:

Hidradenitis suppurativa (HS) experts collaborated to reach consensus on a core set of outcome measures, with the intent of improving the management of HS in clinical practice.

METHODOLOGY:

  • Participants in the study were 55 HS experts from the HiSTORIC group (dermatologists, internists, surgeons, and nurses) and 24 patient research partners.
  • The group identified clinician- and patient-reported HS outcome measures in the literature, then participated in an online item reduction survey, followed by an electronic Delphi survey to reach consensus on which measures should be used in clinical practice. Consensus was defined as at least 67% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing about the use of a measure in clinical practice.
  • The initial literature search yielded 11 HS studies with clinician-reported outcome measures and 12 with patient-reported outcomes; of these, eight and five, respectively, were included in the final reduction survey.

TAKEAWAY:

  • The group reached consensus on two HS outcome measures for use in clinical practice: the HS Investigator Global Assessment (HS-IGA) score, a clinician-reported outcome measure selected by the HS experts, and the HS Quality of Life (HiSQOL) score, a patient-reported outcome measure selected by the patient research partners.
  • The HS-IGA score uses a number between 0 and 5 based on the sum of abscesses, inflammatory and noninflammatory nodules, and tunnels in regions of the upper or lower body.
  • The HiSQOL, a disease-specific quality-of-life measure for adults with HS, is designed to capture unique features of HS, including symptoms (such as pain, itch, odor, and drainage) and psychosocial outcomes and activities that may be affected by the disease.

IN PRACTICE:

“The intent of these recommendations is to provide an objective framework with both clinician and patient input that can facilitate bidirectional discussion, trust building, and decision making on the current treatment strategy and the need to adjust or escalate treatment in an appropriate time frame,” the authors wrote.

SOURCE:

The study was published online in JAMA Dermatology. The lead author was Nicole Mastacouris, MS, and the corresponding author was Amit Garg, MD, both of Northwell Health, New Hyde Park, N.Y.

LIMITATIONS:

The consensus results may have been affected by variations in HS management by region. Neither measure has been studied in clinical practice, and practice variability may limit their implementation.

DISCLOSURES:

The study was supported by grants from UCB and AbbVie. Ms. Mastacouris had no financial disclosures. Dr. Garg disclosed grant support from AbbVie and UCB during the conduct of the study, as well as personal fees from AbbVie, UCB, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences during the conduct of the study; Dr. Garg also holds patents for HS-IGA and HiSQOL. Many other coauthors disclosed relationships with multiple companies, including AbbVie and UCB, and some also disclosed patents, including patents for HiSQOL and HS Area and Severity Index.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Hidradenitis suppurativa (HS) experts collaborated to reach consensus on a core set of outcome measures, with the intent of improving the management of HS in clinical practice.

METHODOLOGY:

  • Participants in the study were 55 HS experts from the HiSTORIC group (dermatologists, internists, surgeons, and nurses) and 24 patient research partners.
  • The group identified clinician- and patient-reported HS outcome measures in the literature, then participated in an online item reduction survey, followed by an electronic Delphi survey to reach consensus on which measures should be used in clinical practice. Consensus was defined as at least 67% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing about the use of a measure in clinical practice.
  • The initial literature search yielded 11 HS studies with clinician-reported outcome measures and 12 with patient-reported outcomes; of these, eight and five, respectively, were included in the final reduction survey.

TAKEAWAY:

  • The group reached consensus on two HS outcome measures for use in clinical practice: the HS Investigator Global Assessment (HS-IGA) score, a clinician-reported outcome measure selected by the HS experts, and the HS Quality of Life (HiSQOL) score, a patient-reported outcome measure selected by the patient research partners.
  • The HS-IGA score uses a number between 0 and 5 based on the sum of abscesses, inflammatory and noninflammatory nodules, and tunnels in regions of the upper or lower body.
  • The HiSQOL, a disease-specific quality-of-life measure for adults with HS, is designed to capture unique features of HS, including symptoms (such as pain, itch, odor, and drainage) and psychosocial outcomes and activities that may be affected by the disease.

IN PRACTICE:

“The intent of these recommendations is to provide an objective framework with both clinician and patient input that can facilitate bidirectional discussion, trust building, and decision making on the current treatment strategy and the need to adjust or escalate treatment in an appropriate time frame,” the authors wrote.

SOURCE:

The study was published online in JAMA Dermatology. The lead author was Nicole Mastacouris, MS, and the corresponding author was Amit Garg, MD, both of Northwell Health, New Hyde Park, N.Y.

LIMITATIONS:

The consensus results may have been affected by variations in HS management by region. Neither measure has been studied in clinical practice, and practice variability may limit their implementation.

DISCLOSURES:

The study was supported by grants from UCB and AbbVie. Ms. Mastacouris had no financial disclosures. Dr. Garg disclosed grant support from AbbVie and UCB during the conduct of the study, as well as personal fees from AbbVie, UCB, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences during the conduct of the study; Dr. Garg also holds patents for HS-IGA and HiSQOL. Many other coauthors disclosed relationships with multiple companies, including AbbVie and UCB, and some also disclosed patents, including patents for HiSQOL and HS Area and Severity Index.

A version of this article first appeared on Medscape.com.

TOPLINE:

Hidradenitis suppurativa (HS) experts collaborated to reach consensus on a core set of outcome measures, with the intent of improving the management of HS in clinical practice.

METHODOLOGY:

  • Participants in the study were 55 HS experts from the HiSTORIC group (dermatologists, internists, surgeons, and nurses) and 24 patient research partners.
  • The group identified clinician- and patient-reported HS outcome measures in the literature, then participated in an online item reduction survey, followed by an electronic Delphi survey to reach consensus on which measures should be used in clinical practice. Consensus was defined as at least 67% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing about the use of a measure in clinical practice.
  • The initial literature search yielded 11 HS studies with clinician-reported outcome measures and 12 with patient-reported outcomes; of these, eight and five, respectively, were included in the final reduction survey.

TAKEAWAY:

  • The group reached consensus on two HS outcome measures for use in clinical practice: the HS Investigator Global Assessment (HS-IGA) score, a clinician-reported outcome measure selected by the HS experts, and the HS Quality of Life (HiSQOL) score, a patient-reported outcome measure selected by the patient research partners.
  • The HS-IGA score uses a number between 0 and 5 based on the sum of abscesses, inflammatory and noninflammatory nodules, and tunnels in regions of the upper or lower body.
  • The HiSQOL, a disease-specific quality-of-life measure for adults with HS, is designed to capture unique features of HS, including symptoms (such as pain, itch, odor, and drainage) and psychosocial outcomes and activities that may be affected by the disease.

IN PRACTICE:

“The intent of these recommendations is to provide an objective framework with both clinician and patient input that can facilitate bidirectional discussion, trust building, and decision making on the current treatment strategy and the need to adjust or escalate treatment in an appropriate time frame,” the authors wrote.

SOURCE:

The study was published online in JAMA Dermatology. The lead author was Nicole Mastacouris, MS, and the corresponding author was Amit Garg, MD, both of Northwell Health, New Hyde Park, N.Y.

LIMITATIONS:

The consensus results may have been affected by variations in HS management by region. Neither measure has been studied in clinical practice, and practice variability may limit their implementation.

DISCLOSURES:

The study was supported by grants from UCB and AbbVie. Ms. Mastacouris had no financial disclosures. Dr. Garg disclosed grant support from AbbVie and UCB during the conduct of the study, as well as personal fees from AbbVie, UCB, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences during the conduct of the study; Dr. Garg also holds patents for HS-IGA and HiSQOL. Many other coauthors disclosed relationships with multiple companies, including AbbVie and UCB, and some also disclosed patents, including patents for HiSQOL and HS Area and Severity Index.

A version of this article first appeared on Medscape.com.

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Hidradenitis suppurativa experts reach consensus on treatment outcome measures

Article Type
Changed
Thu, 09/28/2023 - 11:17

 

TOPLINE:

Hidradenitis suppurativa (HS) experts collaborated to reach consensus on a core set of outcome measures, with the intent of improving the management of HS in clinical practice.

METHODOLOGY:

  • Participants in the study were 55 HS experts from the HiSTORIC group (dermatologists, internists, surgeons, and nurses) and 24 patient research partners.
  • The group identified clinician- and patient-reported HS outcome measures in the literature, then participated in an online item reduction survey, followed by an electronic Delphi survey to reach consensus on which measures should be used in clinical practice. Consensus was defined as at least 67% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing about the use of a measure in clinical practice.
  • The initial literature search yielded 11 HS studies with clinician-reported outcome measures and 12 with patient-reported outcomes; of these, eight and five, respectively, were included in the final reduction survey.

TAKEAWAY:

  • The group reached consensus on two HS outcome measures for use in clinical practice: the HS Investigator Global Assessment (HS-IGA) score, a clinician-reported outcome measure selected by the HS experts, and the HS Quality of Life (HiSQOL) score, a patient-reported outcome measure selected by the patient research partners.
  • The HS-IGA score uses a number between 0 and 5 based on the sum of abscesses, inflammatory and noninflammatory nodules, and tunnels in regions of the upper or lower body.
  • The HiSQOL, a disease-specific quality-of-life measure for adults with HS, is designed to capture unique features of HS, including symptoms (such as pain, itch, odor, and drainage) and psychosocial outcomes and activities that may be affected by the disease.

IN PRACTICE:

“The intent of these recommendations is to provide an objective framework with both clinician and patient input that can facilitate bidirectional discussion, trust building, and decision making on the current treatment strategy and the need to adjust or escalate treatment in an appropriate time frame,” the authors wrote.

SOURCE:

The study was published online in JAMA Dermatology. The lead author was Nicole Mastacouris, MS, and the corresponding author was Amit Garg, MD, both of Northwell Health, New Hyde Park, N.Y.

LIMITATIONS:

The consensus results may have been affected by variations in HS management by region. Neither measure has been studied in clinical practice, and practice variability may limit their implementation.

DISCLOSURES:

The study was supported by grants from UCB and AbbVie. Ms. Mastacouris had no financial disclosures. Dr. Garg disclosed grant support from AbbVie and UCB during the conduct of the study, as well as personal fees from AbbVie, UCB, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences during the conduct of the study; Dr. Garg also holds patents for HS-IGA and HiSQOL. Many other coauthors disclosed relationships with multiple companies, including AbbVie and UCB, and some also disclosed patents, including patents for HiSQOL and HS Area and Severity Index.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Hidradenitis suppurativa (HS) experts collaborated to reach consensus on a core set of outcome measures, with the intent of improving the management of HS in clinical practice.

METHODOLOGY:

  • Participants in the study were 55 HS experts from the HiSTORIC group (dermatologists, internists, surgeons, and nurses) and 24 patient research partners.
  • The group identified clinician- and patient-reported HS outcome measures in the literature, then participated in an online item reduction survey, followed by an electronic Delphi survey to reach consensus on which measures should be used in clinical practice. Consensus was defined as at least 67% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing about the use of a measure in clinical practice.
  • The initial literature search yielded 11 HS studies with clinician-reported outcome measures and 12 with patient-reported outcomes; of these, eight and five, respectively, were included in the final reduction survey.

TAKEAWAY:

  • The group reached consensus on two HS outcome measures for use in clinical practice: the HS Investigator Global Assessment (HS-IGA) score, a clinician-reported outcome measure selected by the HS experts, and the HS Quality of Life (HiSQOL) score, a patient-reported outcome measure selected by the patient research partners.
  • The HS-IGA score uses a number between 0 and 5 based on the sum of abscesses, inflammatory and noninflammatory nodules, and tunnels in regions of the upper or lower body.
  • The HiSQOL, a disease-specific quality-of-life measure for adults with HS, is designed to capture unique features of HS, including symptoms (such as pain, itch, odor, and drainage) and psychosocial outcomes and activities that may be affected by the disease.

IN PRACTICE:

“The intent of these recommendations is to provide an objective framework with both clinician and patient input that can facilitate bidirectional discussion, trust building, and decision making on the current treatment strategy and the need to adjust or escalate treatment in an appropriate time frame,” the authors wrote.

SOURCE:

The study was published online in JAMA Dermatology. The lead author was Nicole Mastacouris, MS, and the corresponding author was Amit Garg, MD, both of Northwell Health, New Hyde Park, N.Y.

LIMITATIONS:

The consensus results may have been affected by variations in HS management by region. Neither measure has been studied in clinical practice, and practice variability may limit their implementation.

DISCLOSURES:

The study was supported by grants from UCB and AbbVie. Ms. Mastacouris had no financial disclosures. Dr. Garg disclosed grant support from AbbVie and UCB during the conduct of the study, as well as personal fees from AbbVie, UCB, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences during the conduct of the study; Dr. Garg also holds patents for HS-IGA and HiSQOL. Many other coauthors disclosed relationships with multiple companies, including AbbVie and UCB, and some also disclosed patents, including patents for HiSQOL and HS Area and Severity Index.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Hidradenitis suppurativa (HS) experts collaborated to reach consensus on a core set of outcome measures, with the intent of improving the management of HS in clinical practice.

METHODOLOGY:

  • Participants in the study were 55 HS experts from the HiSTORIC group (dermatologists, internists, surgeons, and nurses) and 24 patient research partners.
  • The group identified clinician- and patient-reported HS outcome measures in the literature, then participated in an online item reduction survey, followed by an electronic Delphi survey to reach consensus on which measures should be used in clinical practice. Consensus was defined as at least 67% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing about the use of a measure in clinical practice.
  • The initial literature search yielded 11 HS studies with clinician-reported outcome measures and 12 with patient-reported outcomes; of these, eight and five, respectively, were included in the final reduction survey.

TAKEAWAY:

  • The group reached consensus on two HS outcome measures for use in clinical practice: the HS Investigator Global Assessment (HS-IGA) score, a clinician-reported outcome measure selected by the HS experts, and the HS Quality of Life (HiSQOL) score, a patient-reported outcome measure selected by the patient research partners.
  • The HS-IGA score uses a number between 0 and 5 based on the sum of abscesses, inflammatory and noninflammatory nodules, and tunnels in regions of the upper or lower body.
  • The HiSQOL, a disease-specific quality-of-life measure for adults with HS, is designed to capture unique features of HS, including symptoms (such as pain, itch, odor, and drainage) and psychosocial outcomes and activities that may be affected by the disease.

IN PRACTICE:

“The intent of these recommendations is to provide an objective framework with both clinician and patient input that can facilitate bidirectional discussion, trust building, and decision making on the current treatment strategy and the need to adjust or escalate treatment in an appropriate time frame,” the authors wrote.

SOURCE:

The study was published online in JAMA Dermatology. The lead author was Nicole Mastacouris, MS, and the corresponding author was Amit Garg, MD, both of Northwell Health, New Hyde Park, N.Y.

LIMITATIONS:

The consensus results may have been affected by variations in HS management by region. Neither measure has been studied in clinical practice, and practice variability may limit their implementation.

DISCLOSURES:

The study was supported by grants from UCB and AbbVie. Ms. Mastacouris had no financial disclosures. Dr. Garg disclosed grant support from AbbVie and UCB during the conduct of the study, as well as personal fees from AbbVie, UCB, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences during the conduct of the study; Dr. Garg also holds patents for HS-IGA and HiSQOL. Many other coauthors disclosed relationships with multiple companies, including AbbVie and UCB, and some also disclosed patents, including patents for HiSQOL and HS Area and Severity Index.

A version of this article first appeared on Medscape.com.

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Hidradenitis suppurativa experts reach consensus on treatment outcome measures

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Thu, 09/28/2023 - 13:28

 

TOPLINE:

Hidradenitis suppurativa (HS) experts collaborated to reach consensus on a core set of outcome measures, with the intent of improving the management of HS in clinical practice.

METHODOLOGY:

  • Participants in the study were 55 HS experts from the HiSTORIC group (dermatologists, internists, surgeons, and nurses) and 24 patient research partners.
  • The group identified clinician- and patient-reported HS outcome measures in the literature, then participated in an online item reduction survey, followed by an electronic Delphi survey to reach consensus on which measures should be used in clinical practice. Consensus was defined as at least 67% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing about the use of a measure in clinical practice.
  • The initial literature search yielded 11 HS studies with clinician-reported outcome measures and 12 with patient-reported outcomes; of these, eight and five, respectively, were included in the final reduction survey.

TAKEAWAY:

  • The group reached consensus on two HS outcome measures for use in clinical practice: the HS Investigator Global Assessment (HS-IGA) score, a clinician-reported outcome measure selected by the HS experts, and the HS Quality of Life (HiSQOL) score, a patient-reported outcome measure selected by the patient research partners.
  • The HS-IGA score uses a number between 0 and 5 based on the sum of abscesses, inflammatory and noninflammatory nodules, and tunnels in regions of the upper or lower body.
  • The HiSQOL, a disease-specific quality-of-life measure for adults with HS, is designed to capture unique features of HS, including symptoms (such as pain, itch, odor, and drainage) and psychosocial outcomes and activities that may be affected by the disease.

IN PRACTICE:

“The intent of these recommendations is to provide an objective framework with both clinician and patient input that can facilitate bidirectional discussion, trust building, and decision making on the current treatment strategy and the need to adjust or escalate treatment in an appropriate time frame,” the authors wrote.

SOURCE:

The study was published online in JAMA Dermatology. The lead author was Nicole Mastacouris, MS, and the corresponding author was Amit Garg, MD, both of Northwell Health, New Hyde Park, N.Y.

LIMITATIONS:

The consensus results may have been affected by variations in HS management by region. Neither measure has been studied in clinical practice, and practice variability may limit their implementation.

DISCLOSURES:

The study was supported by grants from UCB and AbbVie. Ms. Mastacouris had no financial disclosures. Dr. Garg disclosed grant support from AbbVie and UCB during the conduct of the study, as well as personal fees from AbbVie, UCB, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences during the conduct of the study; Dr. Garg also holds patents for HS-IGA and HiSQOL. Many other coauthors disclosed relationships with multiple companies, including AbbVie and UCB, and some also disclosed patents, including patents for HiSQOL and HS Area and Severity Index.

 

 

A version of this article first appeared on Medscape.com.

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TOPLINE:

Hidradenitis suppurativa (HS) experts collaborated to reach consensus on a core set of outcome measures, with the intent of improving the management of HS in clinical practice.

METHODOLOGY:

  • Participants in the study were 55 HS experts from the HiSTORIC group (dermatologists, internists, surgeons, and nurses) and 24 patient research partners.
  • The group identified clinician- and patient-reported HS outcome measures in the literature, then participated in an online item reduction survey, followed by an electronic Delphi survey to reach consensus on which measures should be used in clinical practice. Consensus was defined as at least 67% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing about the use of a measure in clinical practice.
  • The initial literature search yielded 11 HS studies with clinician-reported outcome measures and 12 with patient-reported outcomes; of these, eight and five, respectively, were included in the final reduction survey.

TAKEAWAY:

  • The group reached consensus on two HS outcome measures for use in clinical practice: the HS Investigator Global Assessment (HS-IGA) score, a clinician-reported outcome measure selected by the HS experts, and the HS Quality of Life (HiSQOL) score, a patient-reported outcome measure selected by the patient research partners.
  • The HS-IGA score uses a number between 0 and 5 based on the sum of abscesses, inflammatory and noninflammatory nodules, and tunnels in regions of the upper or lower body.
  • The HiSQOL, a disease-specific quality-of-life measure for adults with HS, is designed to capture unique features of HS, including symptoms (such as pain, itch, odor, and drainage) and psychosocial outcomes and activities that may be affected by the disease.

IN PRACTICE:

“The intent of these recommendations is to provide an objective framework with both clinician and patient input that can facilitate bidirectional discussion, trust building, and decision making on the current treatment strategy and the need to adjust or escalate treatment in an appropriate time frame,” the authors wrote.

SOURCE:

The study was published online in JAMA Dermatology. The lead author was Nicole Mastacouris, MS, and the corresponding author was Amit Garg, MD, both of Northwell Health, New Hyde Park, N.Y.

LIMITATIONS:

The consensus results may have been affected by variations in HS management by region. Neither measure has been studied in clinical practice, and practice variability may limit their implementation.

DISCLOSURES:

The study was supported by grants from UCB and AbbVie. Ms. Mastacouris had no financial disclosures. Dr. Garg disclosed grant support from AbbVie and UCB during the conduct of the study, as well as personal fees from AbbVie, UCB, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences during the conduct of the study; Dr. Garg also holds patents for HS-IGA and HiSQOL. Many other coauthors disclosed relationships with multiple companies, including AbbVie and UCB, and some also disclosed patents, including patents for HiSQOL and HS Area and Severity Index.

 

 

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Hidradenitis suppurativa (HS) experts collaborated to reach consensus on a core set of outcome measures, with the intent of improving the management of HS in clinical practice.

METHODOLOGY:

  • Participants in the study were 55 HS experts from the HiSTORIC group (dermatologists, internists, surgeons, and nurses) and 24 patient research partners.
  • The group identified clinician- and patient-reported HS outcome measures in the literature, then participated in an online item reduction survey, followed by an electronic Delphi survey to reach consensus on which measures should be used in clinical practice. Consensus was defined as at least 67% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing about the use of a measure in clinical practice.
  • The initial literature search yielded 11 HS studies with clinician-reported outcome measures and 12 with patient-reported outcomes; of these, eight and five, respectively, were included in the final reduction survey.

TAKEAWAY:

  • The group reached consensus on two HS outcome measures for use in clinical practice: the HS Investigator Global Assessment (HS-IGA) score, a clinician-reported outcome measure selected by the HS experts, and the HS Quality of Life (HiSQOL) score, a patient-reported outcome measure selected by the patient research partners.
  • The HS-IGA score uses a number between 0 and 5 based on the sum of abscesses, inflammatory and noninflammatory nodules, and tunnels in regions of the upper or lower body.
  • The HiSQOL, a disease-specific quality-of-life measure for adults with HS, is designed to capture unique features of HS, including symptoms (such as pain, itch, odor, and drainage) and psychosocial outcomes and activities that may be affected by the disease.

IN PRACTICE:

“The intent of these recommendations is to provide an objective framework with both clinician and patient input that can facilitate bidirectional discussion, trust building, and decision making on the current treatment strategy and the need to adjust or escalate treatment in an appropriate time frame,” the authors wrote.

SOURCE:

The study was published online in JAMA Dermatology. The lead author was Nicole Mastacouris, MS, and the corresponding author was Amit Garg, MD, both of Northwell Health, New Hyde Park, N.Y.

LIMITATIONS:

The consensus results may have been affected by variations in HS management by region. Neither measure has been studied in clinical practice, and practice variability may limit their implementation.

DISCLOSURES:

The study was supported by grants from UCB and AbbVie. Ms. Mastacouris had no financial disclosures. Dr. Garg disclosed grant support from AbbVie and UCB during the conduct of the study, as well as personal fees from AbbVie, UCB, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Incyte, Insmed, Janssen, Novartis, Pfizer, Sonoma Biotherapeutics, Union Therapeutics, Ventyx Biosciences, and Viela Biosciences during the conduct of the study; Dr. Garg also holds patents for HS-IGA and HiSQOL. Many other coauthors disclosed relationships with multiple companies, including AbbVie and UCB, and some also disclosed patents, including patents for HiSQOL and HS Area and Severity Index.

 

 

A version of this article first appeared on Medscape.com.

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FROM JAMA DERMATOLOGY

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