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.
Subject(s)
Randomized Controlled Trials as Topic , Registries , Stress Disorders, Post-Traumatic/therapy , Adult , Humans , ResearchABSTRACT
INTRODUCTION: Overactive bladder (OAB) is a common condition, increasing with age and affecting quality of life. While numerous OAB drugs are available, persistence is low. We evaluated evidence published since 2012 to determine if newer drugs provided better efficacy and harm profiles. METHODS: We searched MEDLINE and the Cochrane Library from 2012 to September 2018 using terms for included drugs and requested information from manufacturers of included drugs. We performed dual review of all systematic review processes, evaluated study quality, and conducted meta-analyses using random effects models. RESULTS: In addition to 31 older studies, we included 20 trials published since 2012 (N = 16,478; 4 good, 11 fair, and 5 poor quality). Where statistical differences were found, they were clinically small (reductions of < 0.5 episodes/day). Solifenacin plus mirabegron improved efficacy outcomes over monotherapy with either drug, but significantly increased constipation compared with solifenacin and dry mouth compared with mirabegron. Solifenacin reduced incontinence over mirabegron and tolterodine and urgency episodes over tolterodine. Mirabegron did not differ from tolterodine in efficacy but had significantly lower incidence of dry mouth than solifenacin or tolterodine. Fesoterodine showed significant improvements but also anticholinergic effects vs. tolterodine. Oxybutynin, solifenacin, and tolterodine had similar efficacy, but dry mouth led to greater discontinuation with oxybutynin. Blurred vision, cardiac arrhythmia, and dizziness were uncommon. CONCLUSION: New evidence confirms small, but clinically uncertain, differences among monotherapies and also between combination and monotherapy, regardless of statistical significance. While drugs mainly differed in incidence of dry mouth or constipation, none provided improved efficacy without increased harms.
