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Ineligibility for and Refusal to Participate in Randomized Controlled Trials That Have Studied Impact on Suicide-Related Outcomes in the United States: A Meta-Analysis Publisher Pubmed



Susukida R1 ; Aminesmaeil M1, 2 ; Ryan TC1, 3 ; Kharrazi H4, 5 ; Wilson RF4 ; Musci RJ1 ; Zhang A4 ; Wissow L6, 7 ; Robinson KA8 ; Wilcox HC1, 4, 9, 10
Authors
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Authors Affiliations
  1. 1. Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States
  2. 2. Iranian National Center for Addiction Studies (INCAS), Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Forefront Suicide Prevention, Seattle, WA, United States
  4. 4. Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States
  5. 5. Division of Health Sciences Informatics, Johns Hopkins School of Medicine, Baltimore, MD, United States
  6. 6. Division of Child and Adolescent Psychiatry, University of Washington, Seattle, WA, United States
  7. 7. Department of Health, Behavior, and Society, Johns Hopkins School of Public Health, Baltimore, MD, United States
  8. 8. JHU Evidence-based Practice Center, Johns Hopkins University, Baltimore, MD, United States
  9. 9. Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States
  10. 10. Johns Hopkins University School of Education, Baltimore, MD, United States

Source: Journal of Clinical Psychiatry Published:2022


Abstract

Objective: Ineligibility for and refusal to participate in randomized controlled trials (RCTs) can potentially lead to unrepresentative study samples and limited generalizability of findings. We examined the rates of exclusion and refusal in RCTs that have studied impact on suicide-related outcomes in the US. Data Sources: PubMed, the Cochrane Library, the Campbell Collaboration Library of Systematic Reviews, CINAHL, PsycINFO, and Education Resources Information Center were searched from January 1990 to May 2020 using the terms (suicide prevention) AND (clinical trial). Study Selection: Of 8,403 studies retrieved, 36 RCTs assessing effectiveness on suicide-related outcomes in youth (≤25 years old) conducted in the US were included. Data Extraction: Study-level data were extracted by 2 independent investigators for a random-effects meta-analysis and meta-regression. Results: The study participants (N=13,264) had a mean (SD) age of 14.87 (1.58) years and were 50% male, 23% African American, and 24% Hispanic. The exclusion rate was 36.4%, while the refusal rate was 25.5%. The exclusion rate was significantly higher in the studies excluding individuals not exceeding specified cutoff points of suicide screening tools (51.2%; adjusted linear coefficient [β]=1.30, standard error [SE]=0.15; P=.041) and individuals not meeting the age or school grade criterion (45.9%; β=1.37, SE=0.13; P=.005). Conclusions: The rates of exclusion and refusal in youth prevention interventions studying impact on suicide-related outcomes were not as high compared to the rates found in other mental and behavioral interventions. While there was strong racial/ethnic group representation in RCTs examining youth suicide-related outcomes, suicide severity and age limited eligibility. © Copyright 2022 Physicians Postgraduate Press, Inc.
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