New research found the risk of serious adverse reaction following prescription of an 

oral or topical carbonic anhydrase inhibitor (CAI)

 was low and similar between agents, in contrast to a known reluctance in CAI prescriptions due to the potential risk of life-threatening complications.

Led by Donald A. Redelmeier, MD, Sunnybrook Health Sciences Centre, the team examined the safety of CAIs in a universal health care system in Canada by comparing adverse event rates of patients prescribed an oral CAI with matched controls in those prescribed a topical CAID.

“In comparison with topical CAIs, there was a modest difference in the risk of a SCAR event and no increased risk of a general adverse drug reaction,” wrote investigators.

A matched longitudinal cohort study identified consecutive patients older than 65 years old who were prescribed an oral or topical CAI in Ontario between January 1995 - January 2020. Exclusions included a lack of valid health care insurance or younger than 66 years.

Oral CAI were defined as either acetazolamide or methazolamide, while a topical CAI was defined as dorzolamide, brinzolamide, or a combination agent. Included baseline demographic data were age, sex, socioeconomic status, and home location, while data on race or ethnicity were not available.

Patients were matched 1:1 based on age, sex, and diabetes status identified, wherein 1 patient was prescribed an oral CAI and 1 patient was prescribed a topical CAI.

The primary endpoint was considered a severe complicated adverse reaction (SCAR), representing a physician diagnosis of at least 1 of 3 idiosyncratic adverse events, including Stevens-Johnson syndrome, toxic epidermal necrolysis, or aplastic anemia.

Investigators defined time zero as the date of the first prescription for an oral or topical CAI. The analysis examined the risk of SCAR events in the 120 days following initial treatment using conditional logistic regression.

A total of 64,477 patients were prescribed an oral CAI and 111,598 were prescribed a topical CAI during the 25-years of the study. After matching, investigators obtained a cohort of 128,942 total patients, which consisted of 64,471 patients prescribed an oral CAI and 64,471 prescribed a topical CAI.

They noted differences between groups because of the proportion of patients with glaucoma, repeated visual field tests, recent eye surgery, and hospital admissions. Data show the mean age of 75 years, 71,958 (55.8%) were women, and 25,058 (19.4%) had a diagnosis of diabetes.

The most common oral agent was acetazolamide (n = 59,554; 92.4%) and the most common topical CAI was dorzolamide or combination agents (n = 45,505; 70.6%).

Data show patients prescribed an oral CAI accounted for 187 SCAR events (absolute risk, 2.90 per 1000 patients), whereas patients prescribed a topical CAI accounted for 134 SCAR events (absolute risk, 2.08 per 1000 patients). Investigators found the difference was equivalent to a risk ratio of 1.40, with a number needed to harm of 1 in 1220 patients (95% CI, 1.12 - 1.74, 

Additionally, the risk of a SCAR event was consistent regardless of age, sex, and socioeconomic status, while living in a rural location and patients diagnosed with diabetes was associated with marginally lower risk in multivariable analysis.

Redelmeier and colleagues noted oral CAIs should not be initiated casually, so informed consent discussions should be held with patients initiating the agents.

“At the same time, this population-level analysis supports reconsidering the reluctance toward prescribing oral CAIs, given the low risk of severe adverse events,” investigators concluded.

Serious Adverse Events of Oral and Topical Carbonic Anhydrase Inhibitors

Articles

Oral CAIS had a slightly higher, but small risk of severe adverse reaction compared to topical CAIS, which may help the reluctance to prescribe. 


Low Adverse Reaction Risk Seen In Oral, Topical Carbonic Anhydrase Inhibitors

Investigators have developed a new machine learning technique to better predict high risk patients for 

 following an emergency department (ED) visit.

A team, led by Matthew K. Nock, PhD, Department of Psychology, Harvard University, identified a way to forecast suicide attempts within 1 and 6 months of presentation at an emergency department for psychiatric issues.

Research shows 50% of individuals who commit suicide make a health care visit within 1 month of death. There are a number of evidence-based interventions to reduce the risk of suicide, but to be expensive they must target high-risk patients.

In the prognostic study, the investigators assessed the 1-month and 6-month risk of suicide for 1818 patients presenting at the emergency department at Massachusetts General Hospital between February 4, 2015 and March 13, 2017. The median age of the study was 33 years.

The investigators sought main outcomes of suicide attempts 1 and 6 months following an ED visit, defined by combining data from electronic health records (EHR) with patient 1-month (n = 1102) and 6-month (n = 1220) through follow-up surveys.

The team used an ensemble machine learning technique to develop predictive models and a risk score for suicide.

In the month following the ED visit, 12.9% (n = 137) participants attempted suicide, while 22% (n = 268) attempted suicide within 6 months.

The investigators looked a clinician assessments and found these alone was a little better than chance at predicting suicide attempts, with externally validated area under the receiver operating characteristic curve of 0.67 for the 1-month model and 0.60 for the 6-month model.

However, prediction accuracy was slightly higher in the EHR models (1-month model: AUC, 0.71; 6 month model: AUC, 0.65) and was best using patient self-reports (1-month model: AUC, 0.76; 6-month model: AUC, 0.77). This was particularly true when patient-self-reports were combined with EHR data and/or clinician data (1-month model: AUC, 0.77; and 6 month model: AUC, 0.79).

The team also tested a model using the 20 patient self-report questions and an EHR-based risk score.

This model performed similarly well (1-month model: AUC, 0.77; 6 month model: AUC, 0.78).

However, the best 1-month model had a positive predicted value of 30.7% in patients classified as having the highest risk in the top 25% of the sample for suicide attempts, accounting for 64.8% of all 1-month attempts.

On the other hand, the best 6-month model had a 46% positive predicted value of patients of the highest risk class for suicide attempts, accounting for 50.2% of all 6-month attempts.

“The results of this prognostic study suggest that suicide risk assessments made using EHR-based and self-report–based risk scores may yield relatively accurate and clinically actionable predictions about the risk of suicide attempts by patients after presenting to an ED,” the authors wrote. “These results highlight the need for tests of the implementation of such risk assessment tools to target preventive interventions.”

Prediction of Suicide Attempts Using Clinician Assessment, Patient Self-report, and Electronic Health Records

Approximately 50% of individuals who commit suicide make a health care visit in the proceeding month. 

Machine Learning Better Predicts Suicide Risk After Emergency Department Visits

A recent investigation into children with attention deficit/hyperactivity disorder (ADHD) found significant associations between the condition and common allergic conditions such as food allergy, respiratory allergy, and skin allergy.

Prior studies have predominantly considered the associations of respiratory allergy and skin allergy in patients with ADHD. However, little is known of the association between food allergy and ADHD, and available data on the subject had been inconsistent.

Investigators led by Buyun Liu, MD, PhD, Department of Epidemiology at the University of Iowa, suggested that the inconsistent findings could have been partly due to limited sample sizes and statistical power.

As such, Liu and colleagues analyzed large-sclae and nationally representative data to determine association of food allergy and other allergic conditions with ADHD in children in the United States.

The team utilized data from the National Health Interview Survey (NHIS), a leading health survey that is conducted annually by the National Center for Health Statistics at the Centers for Disease Control and Prevention (CDC).

The survey included detailed health-related information pertaining to physical and mental health, and allergic conditions were defined based on responses to several questions.

The questions, which were addressed to parents and guardians, included the following:

“During the past 12 months, has [your child] had (1) any kind of food or digestive allergy; (2) any kind of respiratory allergy; (3) eczema or any kind of skin allergy?”

ADHD was defined based on an affirmative response to the question: “Has a doctor or health professional ever told you that [your child] had Attention Deficit Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD)?”

Additional demographic data, including age, sex, race/ethnicity, sex, education, family income, and geographic region were collected using standardized questionnaires featured in the interview.

All data analyses were conducted using the survey procedures of SAS 9.4 (SAS Institute Inc., Cary, NC, USA), and 2-sided p < 0.05 was considered statistically significant.

A total of 192,573 children aged 4-17 years old were included in the analysis. Among those children, 8603 had food allergy, 24,218 had respiratory allergy, and 18,703 had skin allergy.

Investigators noted that children with skin allergy were younger, more likely to be black, and they had higher family education levels than children without skin allergy, while children with respiratory allergy, compared with those without respiratory allergy, were older, more likely to be male, white, and they had higher family education levels

A diagnostic history of ADHD was reported in 15,376 children. The data gathered indicated that children with ADHD were older, more likely to be male and white, and they had lower family income levels.

The weighted prevalence of ADHD was higher among children with allergic conditions.

Among children with food allergy, ADHD prevalence was 12.66% (95% CI 11.57–13.75) compared to those without ADHD (7.99&, 95% CI 7.82–8.15) (p < 0.001)

Likewise, ADHA prevelance was 12.16% (95% CI 11.60–12.72) vs. 7.63% (95% CI 7.46–7.80) among children with and without respiratory allergy (p < 0.001), and 11.46% (95% CI 10.90–12.01) vs. 7.83% (95% CI 7.66–8.01) among children with and without skin allergy (p < 0.001).

Liu and colleagues added that their study extended findings on allergic conditions and ADHD, with insights on food allergy.

“Although the detailed mechanisms linking food allergy and other allergic conditions to ADHD remain to be understood, physicians should be aware of the increased risk of ADHD as a comorbidity of children with allergic conditions,” the team wrote.

The study, "Association of Food Allergy, Respiratory Allergy, and Skin Allergy with Attention Deficit/Hyperactivity Disorder among Children," was published online in 

Prior studies have predominantly considered the associations of respiratory allergy and skin allergy in patients with ADHD, with inconsistent data on food allergy.

ADHD Associated with Food, Skin and Respiratory Allergy

A recent investigation into cystic fibrosis in children and young adults suggested that antimicrobial stewardship initiatives could be beneficial in standardizing care and fostering positive working relationships between cystic fibrosis pulmonologists, ID physicians, and pharmacists.

Cystic fibrosis has affected more than 30,000 individuals in the United States,with a major cause of morbidity and mortality being pulmonary disease and pulmonary exacerbations (PEx), the latter of which if often treated with antibiotics.

Despite the prevalence of PEx in patients with cystic fibrosis, there is no standardized definition to diagnose these events in affected patients, although most include an increase in respiratory symptoms and/or acute decrease in lung function.

Using the framework of antimicrobial stewardship, Geovanny F. Perez MD, MS, Division of Pulmonary Medicine, Oishei Children's Hospital, and fellow investigators aimed to develop an empiric antibiotic algorithm as a quality improvement initiative to initiative to develop consistency among providers in prescribing empiric intravenous (IV) antibiotic therapy for PEx events.

The quality improvement project was conducted at the Children’s National Hospital, a tertiary-care hospital with an accredited CF center.

Pediatric patients and young adults up to 26 years were admitted to the free-standing children’s hospital, and IRB approval for routine collection of demographic and clinical data around the time of PEx in persons with cystic fibrosis was obtained.

Participants 18 years and older provided written consent for the study, while written parental consent was obtained for patients under 18 years old, and assent was obtained from children between the ages of 11 and 17 years.

From there, the data acquired from each participant was used to assess baseline antibiotic use and the impact of the quality improvement initiative on IV antibiotics used for PEx treatment between January 1, 2017 and March 31, 2020.

Soon after, a multidisciplinary team of pulmonologists, infectious disease physisicans, and pharmacists with expertise in cystic fibrosis at Children’s National Hospital was assembled to develop the empiric antibiotic algorithm beginning in July 2017.

The quality improvement project assessed the antibiotic treatment courses of a total of 56 people with cystic fibrosis, with a total of 226 PEx episodes occurring during the study period.

Of those treatment courses, 25 were prescribed in the outpatient setting only (10 in the baseline period and 15 during the intervention), and the remaining courses were all initially prescribed in the inpatient setting.

Investigators observed that the mean age at the first PEx was 12 years old (SD 6.7). Regarding demographics, 55% of all participants who experienced PEx were female, 80% were white, and 71% were non-Hispanic.

After the initiation of the algorithm, the investigators noted that the proportion of PEx with antibiotic use consistent with the algorithm increased from 46.2% to 79.5%, and documentation of justification for broad-spectrum antibiotics increased from 56% to 85%.

Additionally, the use of infectious disease consults increased from 17% to 54%.

The team added that as young patients at their institution are introduced to effective CFTR modulators, the development of an algorithm for outpatient treatment could become an unmet need.

“We would encourage other cystic fibrosis centers to explore their own trends in practice to determine whether a similar intervention may be both feasible and beneficial in the treatment of PEx in perosns with cystic fibrosis,” the team wrote.

"Measuring the Impact of an Empiric Antibiotic Algorithm for Pulmonary Exacerbation in Children and Young Adults with Cystic Fibrosis,"

 was published online in Pediatric Pulmonology.

Despite the prevalence of pulmonary exacerbations in patients with cystic fibrosis, there is no standardized definition to diagnose these events in affected patients.

Algorithm for Outpatient Treatment of Cystic Fibrosis in Young Patients Developed

 can be damaging for women as it increases the likelihood of developing metabolic diseases like diabetes and hypertension, according to new research.

A team, led by Lili Huang, School of Public Health, Shanghai Jiao Tong University School of Medicine, identified the association between short and long sleep duration and the risk of metabolic diseases.

Recent research shows sleep duration could be a factor in metabolic regulation, particularly metabolic rhythm and glucose metabolism. However, the findings at best have been inconsistent and limited because the majority of studies have mainly focused on obstructive sleep apnea (OSA).

“Sleep duration is the core parameter of sleep, while it is easily disturbed by various factors, including physical and psychosocial factors,” the authors wrote.

In the study, the investigators examined 4922 asymptomatic adults who were part of a national survey in China in 2009. They evaluated the early stage of metabolic disease using 3 proxies—triglyceride to high-density lipoprotein cholesterol ration (TG/HDL-C), the product of triglyceride and fasting glucose (TyG), and lipid accumulation product (LAP).

Each participant responded to a questionnaire on their sleep habits and submitted blood samples for analysis. In addition, height, weight, waist circumference, and blood pressure were measured.

The team implemented multivariable linear and logistic regression models to identify the associations of sleep duration with the 3 proxies.

These models show among female participants with less than 7 hours of sleep per day had an increased value of LAP and TyG by 25.232% (95% CI, 10.738-41.623%) and 0.104 (95%CI, 0.024-0.185), respectively, in the crude model compared to females who sleep between 7-9 hours per day.

The effects were lessened, but still significant for LAP (11.405%; 95% CI, 1.613-22.262%).

The results of the logistic regression models were similar to the results of the linear regression models.

Here the investigators found less than 7 hours of sleep per day could increase the risk of elevated LAP (OR, 1.725; 95% CI, 1.042-2.856) after adjusting for multiple covariates.

However, in either model, the investigators did not find any associations among males.

“The relationship between short sleep duration and LAP was still significant among females, even adjustment for multiple covariates,” the authors wrote. “The findings extended the attention to the relationship between sleep duration and early stage of metabolic disease, highlighting the potentiality of sleep intervention in preventing and controlling metabolic disease.”

However, the fact that the associations are more severe for females should warrant future studies on the sex differences.

Abnormal sleep duration is a public health concern as epidemiological data shows associations of sleep duration with clinical metabolic diseases like diabetes, hypertension and cardiovascular diseases.

However, this may also be a consequence of other comorbidities, including depression, which could confound the relationship between sleep duration and outcomes.

Sex-specific association of sleep duration with subclinical indicators of metabolic diseases among asymptomatic adults

There was not an association between sleep duration and metabolic diseases found in men.

Sleep Duration Linked to Increase Risk of Metabolic Disease for Women

It's not uncommon for patients undergoing maintenance hemodialysis (MHD) to experience 

. The impact it has on their quality of life (QOL) is substantial.

Qian Rao, School of Nursing, Chengdu Medical College, and investigators sought to evaluate the prevalence of chronic pain in this population and examine the factors associated with quality of life. 

The team found that chronic pain is prevalent and undermanaged in this patient population, leading to a decrease in quality of life. Based on these findings, healthcare providers should improve pain management and pay attention to the impact of psychological factors on patient quality of life. 

The number of individuals with chronic kidney disease has been increasing in China, and the disease is recognized as a public health issue worldwide. 

Renal replacement therapy is necessary for patients with stage 5 chronic kidney disease. Hemodialysis is the most utilized therapy as it can prolong the life of the patient.

However, hemodialysis is also accompanied by multiple symptoms, most commonly chronic pain presents in up to 82% of patients on maintenance hemodialysis. 

Previous studies have indicated a relationship of poor quality of life among patients undergoing maintenance hemodialysis, and an even stronger connection with patients experienceing chronic pain. 

As a multidimensional concept, many factors play a role in a patient's quality of life. Personal, environmental and socio-demographic aspects of a patient's life, along with clinical characteristics like primary disease and comorbidities, influence quality of life. 

Investigators noted the importance of the psychosocial factors associated with quality of life, such as social support, self-efficacy, and depression. Few studies have explored the role of these factors, so this study aimed to identify the predictors of quality of life in this population and examine relationships among pain, self-efficacy, social support, and quality of life. 

The multicenter, cross-sectional study took place from October 2020-April 2021. Maintenance hemodialysis patients who experienced chronic pain while undergoing treatment across 9 hospitals in Chengdu, China, were included in the research.

Patients came from various districts throughout Chengdu, which offered a wide geographic range represented in the investigation. 

The diagnostic criteria for chronic pain according to the Internation Association for the Study of Pain (IASP) was used to determine patient eligibilty. 

The critieria stated that pain had to occur daily or almost daily and had to last longer than 3 months. Also, the patient-reported score had to be equal to or great than 3 on a visual analog scale. 

The Brief Pain inventory (BPI) was used to assess pain interference and severity, as well as pain location, treatments or medications received, and the degree of pain relief 24 hours post-treatment or medication. 

Quality of life was assessed with the Medical Outcomes Study 36-item Short Form Health Survey (SF-36), which has been deployed worldwide to examine quality of life in various population types. 

Additionally, the Pain Self-Efficacy Questionnaire and the Social Support Rating Scale were completed by participating patients for a comprehensive profile. 

Of the 1204 patients who were participating in treatment at any of the 9 study sites, a total of 296 patients were eligible and willing to be included in the research. 

The study consisted mostly of patients who were 60 years of age or older (60.8%) with an age range of 27–93 years. Many were married (83.1%), had completed a junior high School education or below (74.3%), were not currently employed (97%), and reported financial strain (84.5%). 

The SF-36, used to assess quality of life, is made of two subscales: the Mental Component Summary (MCS) and the Physical Component Summary (PCS).

"We found that age, employment status, financial strain, and number of comorbidities were significantly associated with MCS, PCS, and pain self-efficacy scores (p < 0.05)," investigators wrote. 

Predictors of quality of life were identified using stepwise multiple linear regression, as measured in terms of MCS and PCS scores. 

"The independent predictors of MCS score were age (p = 0.004), financial strain (p = 0.001), pain interference (p < 0.001), social support (p = 0.023), and pain self-efficacy (p < 0.001). These variables accounted for 57.3% of the variance in MCS scores (adjusted 

Only 26.7% (322) of the total 1204 patients on maintenance hemodialysis in this study reported chronic pain. The pain severity score was 3.6 (IQR 3-4.6) and the pain interference score was 4 (IQR 3-5), with the duration of chronic pain being reported as 5 years (IQR 1-7 years).

"Based on the results of this study, we put forward the following suggestions," investigators wrote. 

"First, medical staff should pay more attention to the assessment and management of chronic pain among MHD patients. Appropriate pain management strategies are essential to meet the needs of this patient population."

"Second, the influence of psychosocial factors on MHD patients should be researched in detail. Social support and pain self-efficacy play important roles in improving the QOL of MHD patients with chronic pain."

"Psychological therapies such as health education, cognitive behavioral therapy, supportive psychotherapy and mindfulness therapy may be useful for improving pain self-efficacy and social support," investigators concluded.

Chronic Pain and Quality of Life in Maintenance Hemodialysis Patients in China: A Multicenter, Cross-Sectional Study

A new study evaluated factors associated with quality of life by observing levels of chronic pain in Chinese patients who were receiving maintenance hemodialysis.

Chronic Pain is Prevalent Among Patients Receiving Maintenance Hemodialysis

 pandemic, the subject of physician burnout was likely not considered by large swaths of the American public. Despite this, burnout has been an issue that has plagued physicians for decades prior to the pandemic, and the consequences of it are wide-reaching and at times lethal.

In an interview for the latest installment of 

, Lakshmana Swamy, MD, MBA, Cambridge Health Alliance, detailed the history and complications of burnout and how the mental, physical, and emotional effects associated with it worsened with the COVID-19 pandemic.

When speaking of burnout, Swamy described the phenomenon as chronic work-related stress brought on by 3 key dimensions including emotional exhaustion, a lack of personal accomplishment, and depersonalization.

“In the years leading up to the pandemic, it was more and more of something people were talking about and I think in clinical circles, certainly, it was sort of a hot topic and it was because we were feeling it,” Swamy said. “We already knew from most of the burnout research (was) from pre-pandemic, and the work we did showed that somewhere between 30% and 50% of ICU nurses were already burned out, and I think the numbers probably similar for physicians and kind of across the board.”

Swamy noted that additional research on burnout has estimated the prevalence to be above 70%, which could be attributed to much more than the distress detailed earlier.

“You're seeing the effects of racism on people, you're seeing poverty, you're seeing people unable to get their medications, substance abuse, that's coming to you in and leading to many of the medical problems you're taking care of in the ICU,” Swamy said. “So, already that is kind of leading to all of that stuff together, combined with the moral distress about being in the ICU and seeing a lot of people not make it out and suffering. All that is contributing. (to burnout). That was what it was like before COVID-19.”

During the first wave of the virus, Swamy and other physicians immediately immersed themselves in research pertaining to the COVID-19 virus. When not in the hospital, Swamy was reviewing literature regarding the manifestations and intricacies of the disease.

“I think it was a bizarre time because it was both terrifying, and yet, it was like a clarion call,” Swamy said. “This was sounding to us specifically; it was unbelievable how much we heard and felt that this is an ICU problem on a mass scale.”

Despite this, an already overwhelmed medical system became increasingly exhausted during the pandemic, with some physicians having to fend off criticisms and confrontation from the patients they were actively trying to save.

“It went from people really celebrating us, which although it was nice, it also felt hollow a lot of the time because we weren't seeing it echoed in leadership, but then it went to people not believing us, people protesting us outside our hospitals, people not getting vaccinated,” Swamy said. “Once the vaccines came out, we thought ‘we did our part, we got us through to the end game’, and then obviously it's not that simple.”

The issue of burnout was further complicated by discordant voices within the healthcare system challenging the idea of vaccines and the healthcare system. Despite this, Swamy believed that most physicians were unified in their opinion on the efficacy of the vaccines and the strength of working physicians nationwide.

“I think that's challenging, because it would be great to have a unified voice and I think we largely do,” Swamy said. “It's always exciting for media to pick up on discordant voices, and amplify those, (but) I think that the vast majority of healthcare workers really are extremely tightly aligned on all of this.”

Podcasts

Dr. Swamy speaks of the history of burnout that preceded the pandemic, and how physicians are struggling with emotional, mental, and physical trauma from COVID-19.

Physician Burnout Reaching Critical Levels During COVID-19 with Lakshmana Swamy, MD, MBA

A recent cross-sectional study concluded that disaggregated comparisons among Asian Americans demonstrated differences in skin cancer risk factors that could be used to identify high-risk subgroups and inform culturally aware counseling.

Despite being the fastest growing racial group in the United States, Asian Americans have remained underrepresented in health disparities research.

However, previous data observed lower rates of sunscreen use among Asian Americans in general compared with non-Hispanic White individuals.

Suephy C. Chen, MD, MS, Department of Dermatology, Duke University School of Medicine, Durnham, North Carolina, and fellow investigators aimed to examine the prevalence of sunburns, indoor tanning, sun-protective behaviors, and total body skin examinations (TBSEs) among Asian Americans compared with non-Hispanic White individuals in addition to examining potential differences among subgroups of Asian Americans.

Chen and colleagues utilized an annual cross-sectional survey of health conditions, behaviors, access, and utilization called the National Health Interview Survey to collect data on respondents 18 years and older who were pooled in 2000, 2005, 2010, and 2015.

Self-reported Asian Indian, Chinese, Filipino, and Other Asian participants were included in the study, while non-Hispanic White participants were included as a reference group. The most populous subgroup, Chinese Americans, was used as the reference for subgroup comparisons.

Outcomes for participants included any sunburn during the last 12 months, sun-protective behaviors performed always or most of the time, any indoor tanning in the last 12 months, and any TBSE during a participant’s lifetime.

Prevalence estimates incorporated survey weights to produce nationally representative estimates, and all met a reliability threshold with coefficients of variation at less than 30%. Outcomes were compared by race using Rao-Scott χ2 tests. Multivariable logistic regression models additionally adjusted for survey year, sociodemographic variables, cancer-related health behaviors, skin phototype, and personal history of skin cancer.

From 2000 to 2016, investigators pooled a total of 124,631 respondents, 5694 of whom (weighted prevalence, 4.7%) identified as Asian American and 78 336 (weighted prevalence, 69.6%) who identified as non- Hispanic White.

Of the 5694 Asian American individuals, 1073 (21.0%) identified as Asian Indian, 1165 (19.4%) as Chinese, 1312 (23.5%) as Filipino, and 2144 (36.1%) as Other Asian. Lifetime prevalence of skin cancer was 3.7% among non-Hispanic White individuals compared with 0% among Asian Indian, 0.1% among Chinese, 0.8% among Filipino, and 0.1% among Other Asian individuals.

Sunburn prevalence in the past year was 12.4% among Asian Indian, 20.2% among Chinese, 24.2% among Filipino, and 19.0% among Other Asian individuals, while frequent use of at least 1 sun-protective behavior was 62.9% among Asian Indian, 65.7% among Chinese, 70.7% among Filipino, and 66.1% among Other Asian individuals.

Investigators also noted that 1.8% of Asian Indian, 3.1% of Chinese, 3.5% of Filipino, and 3.4% of Other Asian individuals tanned indoors, and that lifetime prevalence of TBSE was 6.5% for Asian Indian, 8.9% for Chinese, 11.5% for Filipino, and 7.4% for Other Asian individuals.

In multivariable models adjusting for sociodemographic variables, health behaviors, photosensitivity, and skin cancer history, all Asian American subgroups were less likely than non-Hispanic White individuals to sunburn, apply sunscreen, tan indoors, and receive TBS.

“Oversampling of Asian American subgroups in future dermatologic studies may facilitate further disaggregated analyses to evaluate for potential masked health disparities,” the team wrote.

Skin Cancer Risk Factors Identified in Asian Americans

Randomized controlled trials (RCT) may not truly be representative of the patient population of individuals with 

A team, led by Heidi Taipale, PhD, quantified the proportion of real-world individuals with schizophrenia spectrum disorders who would be ineligible to participate in randomized controlled trial and identified whether clinical outcomes differ between eligible and ineligible participants.

The majority of research on antipsychotics for patients with schizophrenia spectrum disorders generally rely on randomized clinical trials. However, this type of study design represents only a portion of the population and could result in an efficacy-effectiveness gap.

“RCT outcomes (efficacy) may differ from the utility of interventions in routine clinical practice (effectiveness), in what has been termed the efficacy-effectiveness gap,” the authors wrote. “Efficacy-effectiveness gaps have been identified in several health care areas, including pneumology, oncology, infectology, and internal medicine; nonpharmacological interventions in psychology; and antidepressants.”

To better understand how patient eligibility impacts results, the investigators applied eligibility criteria that is typically used in trials for relapse prevention in patients with schizophrenia to real-world populations.

They identified patients with schizophrenia recorded in national patient registries in Finland and Sweden and selected patients who used antipsychotics continuously for 12 weeks in outpatient care.

Each participant was followed for up to 1 year while receiving maintenance therapy with any second-generation antipsychotic other than clozapine.

The investigators also censored follow-up at treatment discontinuation, initiation of add-on antipsychotics, death, and end of database linkage.

The team sought main outcomes of the proportion of randomized controlled trial ineligible individuals with schizophrenia owing to any and specific trial exclusion criteria. They also compared the risk of hospitalization because of psychosis within 1-year of follow-up in both cohorts of patients.

Overall, the mean age in the Finnish sample (n = 17,801) was 47.5 years and the mean age in the Swedish cohort (n = 7458) was 44.8 years.

The investigators found 79% ( n = 20,060) of potential participants with schizophrenia were deemed ineligible for randomized controlled trials. This included 14,221 individuals in the Finnish cohort and 5839 individuals in the Swedish cohort.

The most common explanation for exclusion was a serious somatic comorbidities and concomitant antidepressant/mood stabilizer use.

However, there was a higher risk of hospitalization because of psychosis among ineligible compared to eligible individuals (Finnish cohort: 18.4% vs 17.2%; HR, 1.14; 95% CI, 1.04-1.24; Swedish cohort: 20.1% vs 14.8%; HR, 1.47; 95% CI, 1.28-1.92).

The largest risks of hospitalization because of psychosis were found in ineligible individuals owing to treatment resistance, tardive dyskinesia, and history of suicide attempts.

The investigators also said with more ineligibility criteria met, larger risks of hospitalization due to psychosis were identified in both Sweden and Finland.

“RCTs may represent only about a fifth of real-world individuals with schizophrenia spectrum disorders,” the authors wrote. “Underrepresented (ineligible) patients with schizophrenia spectrum disorders have moderately higher risks of admission due to psychosis while receiving maintenance treatment than RCT-eligible patients.”

The investigators said the results should yield future studies targeting real-world populations currently not represented by randomized controlled trials.

Representation and Outcomes of Individuals With Schizophrenia Seen in Everyday Practice Who Are Ineligible for Randomized Clinical Trials

Ineligible patients with schizophrenia have a higher risk of hospitalization for a number of reasons, including suicide attempts.

Making Sense of Trial Eligibility for Schizophrenia Studies

A new investigation observed several courses of insomnia in adults who had experienced traumatic brain injury (TBI), with moderate and severe cases of insomnia being particularly prevalent.

Roughly 2.5 million adults seek medical care for traumatic brain injuries in the United States every year, with insomnia considered to be one of the most common complaints among patients.

Over the years, studies of insomnia in TBR have often been hampered by heterogeneous TBI samples, inconsistent operational definitions of insomnia, and highly variable follow-up durations.

Investigators led by Emerson M. Wickwire, PhD, University of Maryland School of Medicine, used advanced, data-driven analytic approaches to identify unique trajectories of insomnia 12 months after TBI based on a serial assessment using standardized measures.

Participants for the study were identified through the Federal Interagency Traumatic Brain Injury Repository (FITBIR). Participants were only identified by a global unique identifier, and common data elements were collected from February 26, 2014 to August 8, 2018.

The study included participants aged 17 years or older from TRACK-TBI, a longitudinal, multi-site observational study. Participants were enrolled at 1 of 18 participating level I trauma centers and enrolled within 24 hours of TBI injury.

Race and ethnicity data, which have been associated with TBI outcomes, were obtained via self-report during clinical interviews, and participants completed serial assessments at 2, 3, and 6 weeks, and 12 months thereafter. The assessments captured clinical, neuroimaging, and blood biomarkers to improve TBI classification and outcome assessments.

The data were analyzed from July 1, 2020 to November 15, 2021.

The final sample included a total of 2022 participants (1377 [68.1%] men; mean [SD] age, 40.1 [17.2] years) from the FITBIR database and the TRACK-TBI study.

The data were best fit by a 5-class latent class mixed model (LCMM).

Of the total number of participants, investigators observed that 1245 (61.6%) reported persistent mild insomnia symptoms (class 1) while 627 (31.0%) initially reported mild insomnia symptoms that resolved over time (class 2) and 91 (4.5%) reported persistent severe insomnia symptoms (class 3).

Additionally, 44 (2.2%) initially reported severe insomnia symptoms that resolved by 12 months (class 4) and 15 (0.7%) had initially reported no insomnia symptoms, though they did experience severe symptoms by 12 months (class 5).

In a multinomial logistic regression model, investigators identified several factors significantly associated with insomnia trajectory class membership. These factors included female sex (odds ratio [OR], 1.65 [95% CI, 1.02-2.66]), Black race (OR, 2.36 [95% CI, 1.39-4.01]), history of psychiatric illness (OR, 2.21 [95% CI, 1.35-3.60]), and findings consistent with intracranial injury on computed tomography (OR, 0.36 [95% CI, 0.20-0.65]) when comparing class 3 with class 1. 

To the team’s knowledge, the cohort study represented the largest analysis of insomnia after TBI to date. Though they collected significant data on the associations of insomnia regarding Black race, female sex, pre-TBI psychiatric history, and prior TBI, additional research was warranted.

“However, more work is needed to identify mechanisms underlying these associations, to understand the impact of insomnia trajectory group status on TBI outcomes, and to identify optimal subgroup-specific treatment approaches,” the team wrote.

Significant associations between insomnia and race, sex, and psychiatric history were also observed.

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