Preferred Reporting Items for a Systematic Review and Meta-analysis of Individual Participant Data

Abstract

IMPORTANCE Systematic reviews and meta-analyses of individual participant data (IPD) aim to collect, check, and reanalyze individual-level data from all studies addressing a particular research question and are therefore considered a gold standard approach to evidence synthesis. They are likely to be used with increasing frequency as current initiatives to share clinical trial data gain momentum and may be particularly important in reviewing controversial therapeutic areas. OBJECTIVE To develop PRISMA-IPD as a stand-alone extension to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement, tailored to the specific requirements of reporting systematic reviews and meta-analyses of IPD. Although developed primarily for reviews of randomized trials, many items will apply in other contexts, including reviews of diagnosis and prognosis. DESIGN Development of PRISMA-IPD followed the EQUATOR Network framework guidance and used the existing standard PRISMA Statement as a starting point to draft additional relevant material. A web-based survey informed discussion at an international workshop that included researchers, clinicians, methodologists experienced in conducting systematic reviews and meta-analyses of IPD, and journal editors. The statement was drafted and iterative refinements were made by the project, advisory, and development groups. The PRISMA-IPD Development Group reached agreement on the PRISMA-IPD checklist and flow diagram by consensus. FINDINGS Compared with standard PRISMA, the PRISMA-IPD checklist includes 3 new items that address (1) methods of checking the integrity of the IPD (such as pattern of randomization, data consistency, baseline imbalance, and missing data), (2) reporting any important issues that emerge, and (3) exploring variation (such as whether certain types of individual benefit more from the intervention than others). A further additional item was created by reorganization of standard PRISMA items relating to interpreting results. Wording was modified in 23 items to reflect the IPD approach. CONCLUSIONS AND RELEVANCE PRISMA-IPD provides guidelines for reporting systematic reviews and meta-analyses of IPD.

Multiple outcomes and analyses in clinical trials create challenges for interpretation and research synthesis

“…Trialists should register their studies [49e51] and consult the EQUATOR Network [52] for relevant reporting guidelines for protocols [28] and research reports [26]. Systematic reviewers should use reporting guidelines when publishing protocols [53] and final reports using aggregate data [54] or IPD [55]. Our results demonstrate that such efforts could reduce opportunities for cherrypicking.…”

Heart Rate and Rhythm and the Benefit of Beta-Blockers in Patients With Heart Failure

“…This report was prepared according to the Preferred Reporting Items for Systematic reviews and MetaAnalyses (PRISMA) IPD guidance (14) and prospectively registered with Clinicaltrials.gov (NCT0083244) and the PROSPERO database of systematic reviews (CRD42014010012). (15) Detailed rationale and methods have previously been published.…”

Cognitive-behavioral therapy for body dysmorphic disorder: A systematic review and meta-analysis of randomized controlled trials

“…Results on secondary outcomes, namely depressive symptoms and insight/delusionality, should especially be interpreted with caution as they were based on reports in five and four studies, respectively. Given the relatively small sample, future metaanalyses of individual participant data may be helpful to further increase power and better control for potential confounds (Stewart et al, 2015). Finally, several studies failed to report on the ethnic background of their participants; over 80% of patients included in the trials that reported this information were from White backgrounds and, thus, it is unclear whether CBT is equally acceptable and efficacious in patients from ethnic minorities.…”