Eligibility for Substance Use Clinical Trials Among Emergency Psychiatry Patients: The Impact of Exclusion Criteria.

Objective: The first objective was to identify common exclusion criteria used in clinical trials. The second objective was to quantify the degree to which these criteria exclude emergency psychiatry patients. Methods: Qualitative Content Analysis was used for the first objective, identifying common exclusion criteria used in recent high-impact substance use clinical trials. A retrospective record review was used for the second objective, which examined the frequency of these exclusion criteria in a 1-month sample of adults receiving psychiatric evaluation in an emergency department. Results: Most trials had exclusions for co-occurring psychiatric problems (76.6%), medical problems (74.0%), prior or current treatment (72.7%), motivation for change (61.1%), pregnancy or lactation (57.1%), or using other specified substances of abuse (54.6%). In the clinical sample, exclusions for co-occurring psychiatric problems would make 94.7% of patients ineligible. Other exclusions had a combined effect of making 76% of patients ineligible. Conclusions: Clinical trials using typical exclusion criteria exclude nearly all emergency psychiatry patients with substance use problems.

Clinical Trials Studying Suicide Risk Reduction: Who is Excluded From Participation.

OBJECTIVE: The use of exclusion criteria in clinical trials can cause research participants to differ markedly from clinical populations, which negatively impacts generalizability of results. This study identifies and quantifies common and recurring exclusion criteria in clinical trials studying suicide risk reduction, and estimates their impact on eligibility among a clinical sample of adults in an emergency department with high suicide risk. METHOD: Recent trials were identified by searching PubMed (terms suicide, efficacy, effectiveness, limited to clinical trials in prior 5 years). Common exclusion criteria were identified using Qualitative Content Analysis. A retrospective chart review examined a one-month sample of all adults receiving psychiatric evaluation in a large urban academic emergency department. RESULTS: The search yielded 27 unique clinical trials studying suicide risk reduction as a primary or secondary outcome. After research fundamentals (e.g. informed consent, language fluency), the most common exclusion criteria involved psychosis (77.8%), cognitive problems (66.7%), and substance use (63.0%). In the clinical sample of adults with high suicide risk (N = 232), psychosis exclusions would exclude 53.0% of patients and substance use exclusions would exclude 67.2% of patients. Overall, 5.6% of emergency psychiatry patients would be eligible for clinical trials that use common exclusion criteria. CONCLUSIONS: Recent clinical trials studying suicide risk reduction have low generalizability to emergency psychiatry patients with high suicide risk. Trials enrolling persons with psychosis and substance use in particular are needed to improve generalizability to this clinical population.

Exclusion criteria limit who can enroll in trials studying suicide risk reduction.Trials most frequently exclude psychosis, cognitive problems, and substance use.Trials have poor generalizability to emergency psychiatry patients.

Spatiotemporal variation in heatwaves and elderly population exposure across China.

Heatwaves have been intensified worldwide due to climate change, posing great health risks, especially to elderly populations. However, in China, limited studies have employed the heat index to decipher the spatiotemporal trends of heatwaves and their impacts on the elderly population. By comparing the three heatwave definitions, this study aimed to evaluate the long-term spatiotemporal variations in heatwaves from 1964 to 2022 across China using the Excess Heat Factor (EHF). We took advantage of high-resolution reanalysis temperature data on the Google Earth Engine (GEE) platform to efficiently calculate the heatwaves. Our results revealed that the frequency and duration of heatwaves increased significantly in approximately 77 % of China's total area, with South China experiencing the most frequent and prolonged heatwaves. Conversely, in most areas, no significant trend was discerned in the growth of the maximum and average heatwave intensities. The total number of elderly people affected by heatwaves surged from approximately 11.96 million in 2001 to over 30.31 million in 2020, with an estimated additional 1.12 million older adults exposed to heatwaves annually across the nation (R2 = 0.60, p < 0.05). The population factor exhibited largest effect on the exposure of heatwaves, followed by climate effects and combined factors, with the corresponding explanatory power about 42.84 %, 34.85 % and 22.31 %, respectively. These individuals predominantly resided in the Northeast China, Southwest China, and South China. We also found geographical variations in heatwave exposure along elevations and land use types. These insights underscore the pressing necessity for formulating strategic interventions to mitigate the health threats presented by mounting heatwave exposure, especially for susceptible groups like the elderly in China.