Integrating Multiple Data Sources for Meta-analysis to Improve Patient-Centered Outcomes Research [Methods Study], United States, 2013-2017 (ICPSR 39490)
Version Date: Sep 8, 2025 View help for published
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Kay Dickersin, Johns Hopkins University
https://doi.org/10.3886/ICPSR39490.v1
Version V1
Summary View help for Summary
Meta-analyses combine the results of many studies to find out how well a treatment or other healthcare intervention works. Most meta-analyses use public sources of data, such as published journal articles, as the main sources of information for study results. But journal articles are not the only sources of study results. Some results appear in other places, such as clinical study reports. Clinical study reports are documents that describe what researchers did and found in much more detail than journal articles. However, these reports may not be available to the public. As a result, meta-analyses may not include all available information about a treatment.
The research team wanted to learn whether adding or replacing public and nonpublic data sources changed the results of meta-analyses. To find out, the research team added and replaced data as they conducted two meta-analyses. The first looked at adult use of a nerve-pain medicine. The second meta-analysis looked at adult use of a medicine to treat bipolar depression.
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Study Purpose View help for Study Purpose
To determine whether multiple data sources about RCTs affected systematic reviews and meta-analyses of patient-centered outcomes (PCOs) research (e.g., trial quality assessment, pooled effect estimates) and to produce open access guidance about using multiple data sources, for producers of systematic reviews of PCOs research.
Study Design View help for Study Design
The research team examined the effect of adding and replacing public and nonpublic data sources for each clinical trial included in meta-analyses for two case studies: (1) gabapentin for neuropathic pain and (2) quetiapine for bipolar depression. The research team conducted searches to identify all sources of information about randomized clinical trials for these two interventions and determined whether these trials included patient-centered outcomes. The research team included patient co-investigators and clinical experts.
The research team searched for public sources of clinical trial results, such as study registries, reviews from the U.S. Food and Drug Administration (FDA), conference abstracts, and journal articles. The team also searched for nonpublic sources of study results, such as clinical study reports and individual patient data. The team assessed the completeness and consistency of the methodological information in each data source, including information about interventions, comparators, outcomes, and results. To examine the effect of using multiple data sources for each clinical trial, the research team conducted a series of meta-analyses in which the team added or replaced data from each of the sources for one domain, measure, or time point.
The team included outcomes in the meta-analyses if the outcomes included a point estimate and a measure of precision, such as a standard error or confidence interval.
Data Source View help for Data Source
Public and nonpublic data sources for clinical trials used in meta-analyses
Notes
The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.