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Syst Rev. 2015 Nov 2;4:143. doi: 10.1186/s13643-015-0134-z.

Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol.

Author information

1
Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA. evan.mayo-wilson@jhu.edu.
2
Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
3
Department of Gastroenterology and Hepatology, Johns Hopkins School of Medicine, 600 North Wolfe Street, Blalock 449, Baltimore, MD, 21287, USA.
4
Department of Neurology, Johns Hopkins School of Medicine, 855 North Wolfe Street, Baltimore, MD, 21205, USA.
5
Laboratory for Computational Sensing and Robotics, Johns Hopkins Whiting School of Engineering, 3400 North Charles St., Baltimore, MD, 21218, USA.
6
Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
7
Behavioral Biology, Center for Mind-Body Research, Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, 21224, MD, USA.
8
Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 500 North Broadway, Suite 305, Baltimore, MD, 21205, USA.
9
The TMJ Association, Ltd., P.O. Box 26770, Milwaukee, WI, 53226-0770, USA.
10
Peabody Institute, Johns Hopkins University, 1 East Mount Vernon Place, Baltimore, MD, 21202, USA.
11
Welch Medical Library, Johns Hopkins School of Medicine, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
12
Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Baltimore, MD, 21205, USA.
13
University of Maryland School of Pharmacy, 220 Arch Street, Baltimore, MD, 21201, USA.
14
Center for Public Health and Human Rights, Johns Hopkins School of Medicine, 615 N Wolfe St, Baltimore, MD, 21205, USA.

Abstract

BACKGROUND:

Systematic reviews should provide trustworthy guidance to decision-makers, but their credibility is challenged by the selective reporting of trial results and outcomes. Some trials are not published, and even among clinical trials that are published partially (e.g., as conference abstracts), many are never published in full. Although there are many potential sources of published and unpublished data for systematic reviews, there are no established methods for choosing among multiple reports or data sources about the same trial.

METHODS:

We will conduct systematic reviews of the effectiveness and safety of two interventions following the Institute of Medicine (IOM) guidelines: (1) gabapentin for neuropathic pain and (2) quetiapine for bipolar depression. For the review of gabapentin, we will include adult participants with neuropathic pain who do not require ventilator support. For the review of quetiapine, we will include adult participants with acute bipolar depression (excluding mixed or rapid cycling episodes). We will compare these drugs (used alone or in combination with other interventions) with placebo or with the same intervention alone; direct comparisons with other medications will be excluded. For each review, we will conduct highly sensitive electronic searches, and the results of the searches will be assessed by two independent reviewers. Outcomes, study characteristics, and risk of bias ratings will be extracted from multiple reports by two individuals working independently, stored in a publicly available database (Systematic Review Data Repository) and analyzed using commonly available statistical software. In each review, we will conduct a series of meta-analyses using data from different sources to determine how the results are affected by the inclusion of data from multiple published sources (e.g., journal articles and conference abstracts) as well as unpublished aggregate data (e.g., "clinical study reports") and individual participant data (IPD). We will identify patient-centered outcomes in each report and identify differences in the reporting of these outcomes across sources.

SYSTEMATIC REVIEW REGISTRATION:

CRD42015014037 , CRD42015014038.

PMID:
26525044
PMCID:
PMC4630908
DOI:
10.1186/s13643-015-0134-z
[Indexed for MEDLINE]
Free PMC Article

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