Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials.

Clinical trials for Alzheimer's disease (AD) are slower to enroll study participants, take longer to complete, and are more expensive than trials in most other therapeutic areas. The recruitment and retention of a large number of qualified, diverse volunteers to participate in clinical research studies remain among the key barriers to the successful completion of AD clinical trials. An advisory panel of experts from academia, patient-advocacy organizations, philanthropy, non-profit, government, and industry convened in 2020 to assess the critical challenges facing recruitment in Alzheimer's clinical trials and develop a set of recommendations to overcome them. This paper briefly reviews existing challenges in AD clinical research and discusses the feasibility and implications of the panel's recommendations for actionable and inclusive solutions to accelerate the development of novel therapies for AD.

Severe sepsis 3-hour bundle compliance and mortality.

Severe sepsis is a major cause of mortality among hospitalized patients. We tracked severe sepsis 3-hour bundle compliance and mortality over time. Those patients with severe sepsis who received the entire bundle had improved in-hospital survivability over those patients who did not receive the bundle.

Testing the Assumption of Measurement Invariance in the SAMHSA Mental Health and Alcohol Abuse Stigma Assessment in Older Adults.

This study examined the assumption of measurement invariance of the SAMSHA Mental Health and Alcohol Abuse Stigma Assessment. This is necessary to make valid comparisons across time and groups. The data come from the Primary Care Research in Substance Abuse and Mental Health for Elderly trial, a longitudinal multisite, randomized trial examining two modes of care (Referral and Integrated). A sample of 1,198 adults over the age of 65 who screened positive for depression, anxiety, and/or at-risk drinking was used. Structural equation modeling was used to assess measurement invariance in a two-factor measurement model (Perceived Stigma, Comfort Level). Irrespective of their stigma level, one bias indicated that with time, respondents find it easier to acknowledge that it is difficult to start treatment if others know they are in treatment. Other biases indicated that sex, mental quality of life and the subject of stigma had undue influence on respondents' feeling people would think differently of them if they received treatment and on respondents' comfort in talking to a mental health provider. Still, in the present study, these biases in response behavior had little effect on the evaluation of group differences and changes in stigma. Stigma decreased for patients of both the Referral and Integrated care groups.

Screening and brief intervention for substance misuse among older adults: the Florida BRITE project.

OBJECTIVES: We developed and examined the effectiveness of the Florida Brief Intervention and Treatment for Elders (BRITE) project, a 3-year, state-funded pilot program of screening and brief intervention for older adult substance misusers. METHODS: Agencies in 4 counties conducted screenings among 3497 older adults for alcohol, medications, and illicit substance misuse problems and for depression and suicide risk. Screening occurred in elders' homes, senior centers, or other selected sites. Individuals who screened positive for substance misuse were offered brief intervention with evidence-based practices and rescreened at discharge from the intervention program and at follow-up interviews. RESULTS: Prescription medication misuse was the most prevalent substance use problem, followed by alcohol, over-the-counter medications, and illicit substances. Depression was prevalent among those with alcohol and prescription medication problems. Those who received the brief intervention had improvement in alcohol, medication misuse, and depression measures. CONCLUSIONS: The BRITE program effectively shaped state policy by responding to legislative mandates to address the needs of an increasing, but underserved, elder population. The pilot paved the way for obtaining a federally funded grant to expand BRITE to 27 sites in 17 counties in Florida.

Implications of nested designs in school-based mental health services research.

Evaluating school-based mental health services for children and youth with emotional disturbance (ED) has been a challenge for researchers. One particular challenge is the study design of using the student as the statistical unit of analysis, which in certain cases may lead to a violation of the "independence of error" assumption. However, the alternative to this nested design, including fewer students and more schools, can be costly and administratively complex. This study examines data from two national studies including 314 students with ED and served in special education programs and their caregivers from 24 schools in the US to identify the extent to which nesting or design effects occur in this population. The results show that variables focusing on psychopathology are less affected by nesting but school-related variables such as academic functioning are more affected. Design effects varied by grade level, suggesting that grade should be considered when designing such evaluations.

A scoring system for detection of macrosomia and prediction of shoulder dystocia: a disappointment.

OBJECTIVE: To develop a scoring system for the detection of a macrosomic fetus (birth weight (BW) >or= 4000 g) and predict shoulder dystocia among large for gestational age fetuses. STUDY DESIGN: We retrospectively identified all singletons with accurate gestational age (GA) that were large for GA (abdominal circumference (AC) or estimated fetal weight (EFW) >or= 90% for GA) at >or=37 weeks with delivery within three weeks. The scoring system was: 2 points for biparietal diameter, head circumference, AC, or femur length >or=90% for GA, or if the amniotic fluid index (AFI) was >or=24 cm; for biometric parameters <90% or with AFI <24 cm, 0 points. The predictive values for detection of shoulder dystocia were calculated. RESULTS: Of the 225 cohorts that met the inclusion criteria the rate of macrosomia was 39% and among vaginal deliveries (n = 120) shoulder dystocia occurred in 12% (15/120; 95% confidence interval (CI) 7-20%). The sensitivity of EFW >or=4500 g to identify a newborn with shoulder dystocia was 0% (95% CI 0-21%), positive predictive values 0% (95% CI 0-46%), and likelihood ratio of 0. For a macrosomia score >6, the corresponding values were 20% (4-48%), 25% (5-57%) and 2.3. CONCLUSION: Though the scoring system can identify macrosomia, it offers no advantage over EFW. The scoring system and EFW are poor predictors of shoulder dystocia.