Article from the Journal of Traumatic Stress (2020) by Maya E. O’Neil, Juliette M. Harik, Marian S. McDonagh, Tamara P. Cheney, Frances C. Hsu, David C. Cameron, Kathleen F. Carlson, Sonya B. Norman, and Jessica L. Hamblen.

Abstract: Given the extensive research on posttraumatic stress disorder (PTSD) treatment, a single, updatable repository of data from PTSD treatment studies would be useful for clinical, research, and policy stakeholders. To meet this need, we established a preliminary dataset of abstracted PTSD trial data, which serve as the basis for the PTSD Trials Standardized Data Repository (PTSD-Repository), maintained by the National Center for PTSD (NCPTSD).We followed systematic review methods to identify published randomized controlled trials (RCTs) of PTSD interventions. We consulted with a panel of experts to determine a priori inclusion criteria, ensure that we captured all relevant studies, and identify variables for abstraction. We searched multiple databases for materials published from 1980 to 2018 and reviewed reference lists of relevant systematic reviews and clinical practice guidelines. In total, 318 RCTs of PTSD interventions that enrolled almost 25,000 participants were included. We abstracted 337 variables across all studies, including study, participant, and intervention characteristics as well as results. In the present paper, we describe our methods and define data elements included in the data tables. We explain coding challenges, identify inconsistencies in reporting across study types, and discuss ways stakeholders can use PTSD-Repository data to enhance research, education, and policy. The abstracted data are currently publicly available on the NCPTSD website and can be used for future systematic reviews and identifying research gaps and as an information resource for clinicians, patients, and family members.

Citation: O'Neil, M. E., Harik, J. M., McDonagh, M. S., Cheney, T. P., Hsu, F. C., Cameron, D. C., Carlson, K. F., Norman, S. B., & Hamblen, J. L. (2020). Development of the PTSD-Repository: A publicly available repository of randomized controlled trials for posttraumatic stress disorder. Journal of Traumatic Stress, 33, 410-419. https://doi.org/10.1002/jts22520

The Sample Characteristics dataset includes information on the participants who are included in the studies. This information is provided at the study level—meaning, data are not broken down into the specific treatment arms such as the intervention or control groups. Use this dataset if you want to learn more about the number of participants in the study; inclusion and exclusion criteria related to substance use and suicidality; baseline clinical characteristics such as PTSD severity, trauma type, military status, and comorbidities; and, basic demographic information such as age, gender or race for the sample as a whole (not individual participants). Visualizations made from this dataset will be based on the 496 RCTs included in the PTSD-Repository. Values reported as "NA" or not reported "NR" by the study are null values (empty cells). Data is at the study level.

The purpose of this project was to identify and abstract data from randomized controlled trials (RCTs) of posttraumatic stress disorder (PTSD) interventions to support the development of a publicly accessible data repository by the National Center for Posttraumatic Stress Disorder.

The 2019 Report and Evidence Tables (Appendix E & F) are included in the downloadable .zip file. For more information, visit AHRQ's page, and look under "Previous Versions" tab: https://effectivehealthcare.ahrq.gov/products/ptsd-pharm-treatment/research

This dataset provides within-arm results for dichotomous outcomes: loss of diagnosis and clinically meaningful response. Included is information on how loss of diagnosis and clinically meaningful response were defined as well as the percent of participants who achieved loss of PTSD diagnosis/clinically meaningful response Each treatment arm is presented on its own row. There are also separate rows for studies with more than one measure, time point and analysis type or when there is more than one definition of diagnostic change or clinically meaningful change.

The Other Outcomes dataset includes information on whether the trial includes measures of depression, anxiety, substance use, sleep, anger, quality of life and functioning. Results in this dataset are provided for each treatment arm. The name of the measure is included as well as the between-group effect sizes. Use this dataset to learn how about the effects of PTSD treatments on other outcomes.
Values abstracted as not applicable ("NA") or not reported ("NR") from the study are null values (empty cells).
Study level variables, like military status and percent female, are included for ease of filtering. These columns are not individual arm or arm comparison level data.

Learn about treatment options for people with PTSD who also have substance use problems.

Each study in the PTSD-Repository was coded for risk of bias (ROB) in specific domains as well as an overall risk of bias for the study. Detailed information about the specific coding strategy is available in Comparative Effectiveness Review [CER] No. 207, Psychological and Pharmacological Treatments for Adults with Posttraumatic Stress Disorder. (See our "Risk of Bias" data story.)
Most domains were rated as Yes (i.e., minimal risk of bias), No (i.e., high risk of bias) or Unclear (i.e., bias could not be determined). The overall study rating is based on the domains and is coded as low, medium or high risk of bias. The 4 domains that were included as components of the overall rating include: Selection bias--randomization adequate, allocation concealment adequate, groups similar at baseline and whether they used intention to treat analyses; Performance bias--care providers masked and patients masked; Detection bias--outcome assessors masked; Attrition bias--overall attrition less than or equal to 20% vs over 20%; differential attrition less than or equal to 15% vs over 15%.
Additional items assessed (but not considered as part of the overall rating) include: Reporting bias--all prespecified outcomes reported; Reporting bias--method for handling dropouts; Outcome measures equal valid and reliable; Study reports adequate treatment fidelity based on measurements by independent raters.

This dataset provides within-arm results for continuous measures. Included is information on score means and variance, and pre-post comparisons (pre-post score difference, statistical test p-value, and study-reported effect sizes). Where possible, the within-arm standardized effect size (analog of Cohen’s d) was calculated. For the calculated effect size, negative values indicate a lower score at follow-up compared to baseline, while positive values indicate a higher score at follow-up. Each treatment arm is presented on its own row. There are also separate rows for studies with more than one measure, time point and analysis type.

The PTSD Repository allows researchers to quickly identify relevant PTSD treatment clinical trials and download data in a variety of formats for the purpose of conducting systematic reviews and meta-analyses.

The U.S. Department of Veterans Affairs (VA) has established a long-term partnership to commission AHRQ to utilize its Evidence-based Practice Centers to develop update reviews to inform the VA’s PTSD-Repository – a publicly accessible clinical trials database maintained by the National Center for PTSD (NCPTSD).

The 2023 Report, Executive Summary and Evidence Tables (Appendix E, F, G1, & G2) are included in the downloadable .zip file. For more information, visit AHRQ's page: https://effectivehealthcare.ahrq.gov/products/ptsd-pharm-non-pharm-treatment/research