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Cited by 31Posttraumatic Stress Disorder ResearchMeta-analysis and systematic reviewsMigration, Health and Trauma

Evaluating treatments for posttraumatic stress disorder, alcohol and other drug use disorders using meta-analysis of individual patient data: Design and methodology of a virtual clinical trial

Saavedra, Lissette M., Morgan-López, Antonio A., Hien, Denise A., López-Castro, Teresa, Ruglass, Lesia M., Back, Sudie E., Fitzpatrick, Skye, Norman, Sonya B. +3 more·2021·Contemporary Clinical Trials
DOI 10.1016/j.cct.2021.106479
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Abstract

This paper describes Project Harmony, a Virtual Clinical Trial (VCT) funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) to harmonize and analyze data from over 40 independent psychological, pharmacologic and/or combined pharmacological treatment studies for posttraumatic stress disorder and comorbid alcohol and other drug use disorders (PTSD/AOD). The study attends to three distinct analysis challenges: (1) variation in measurement of PTSD/AOD across studies, time, populations and reporters, (2) cross-study variation in treatment effect sizes and (3) non-randomized, cross-study variation in the classification of treatments (despite within-study randomization of treatment arms). To address these challenges, the study combines meta-analysis of individual patient data (MIPD), integrative data analysis (IDA) and propensity score weighting (PSW) to integrate raw data from these clinical trials. This protocol shows how this VCT analytic framework was used to (1) develop commensurate scale scores of PTSD and AOD severity when measures vary across studies, (2) compare the efficacy of evidence-based treatment models for PTSD/AOD, (3) test for potential mediators of treatment effects on AOD and PTSD across treatment models, and (4) explore individual- and study-level moderators to inform for whom each of the treatment models works best. The advantages of the general VCT approach are juxtaposed against the limitations of single randomized controlled trials and conventional meta-analysis.

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  • Individual patient data meta-analysis with propensity score weighting was used to analyze raw participant-level data from the four studies, using integrative data analysis to address variations in measurement across studies.

    “To address limitations of pooling summaries of treatment effects, we used MIPD with propensity score weighting (PSW) to analyze raw, participant-level data from these four studies, using integrative data analysis (IDA) to address variations in measurement across studies (Morgan-López, Hien et al., 2022; Saavedra et al., 2021).”

    From Cannabis use and trauma-focused treatment for co-occurring posttraumatic stress disorder and substance use disorders: A meta-analysis of individual patient data (2024) · cites this paper as Saavedra et al., 2021

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Authors
Saavedra, L. M., Morgan-López, A. A., Hien, D. A., López-Castro, T., Ruglass, L. M., Back, S. E., Fitzpatrick, S., Norman, S. B., Killeen, T. K., Ebrahimi, C. T., & Hamblen, J.
Affiliations
  • RTI International (US)
  • Rutgers, The State University of New Jersey (US)
  • City College of New York (US)
  • Medical University of South Carolina (US)
  • York University (US)
  • University of California San Diego (US)
  • Dartmouth College (US)
Corresponding author
Saavedra, Lissette M.
ORCID
Venue
Contemporary Clinical Trials
Publisher
Elsevier BV
Published
2021-08
Volume
107
Pages
106479
ISSN
1551-7144 (ISSN-L)
DOI
10.1016/j.cct.2021.106479
OpenAlex
W3173581237
Cited by
31
References
92
Citations by year
2026: 8 · 2025: 7 · 2024: 2 · 2023: 5 · 2022: 9
FWCI
0.54
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • Contemporary Clinical Trials (publishedVersion)
  • PubMed (publishedVersion)
Funders
National Institute on Alcohol Abuse and Alcoholism (R01AA025853)
Topics
  • Social Sciences › Psychology › Clinical Psychology › Posttraumatic Stress Disorder Research
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Social Sciences › Psychology › Clinical Psychology › Migration, Health and Trauma
Keywords
post-traumatic stress disorder, alcoholism, comorbid substance use disorders, virtual clinical trials, integrative data analysis, propensity score weighting, treatment effect heterogeneity, treatment moderators, treatment efficacy comparison
MeSH terms
Combined Modality Therapy, Humans, Stress Disorders, Post-Traumatic, Substance-Related Disorders

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