title: Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol.
abstract: 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 Although there are many potential sources of published and unpublished data for systematic reviews, there are no established methods for choosing among multiple reports or data sources about the same trial.
  
  
  
  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by the inclusion of data from multiple published sources (e.g., journal articles and conference abstracts) as well as unpublished aggregate data (e.g., "clinical study reports") and individual participant data (IPD).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.
  
  
  
  CRD42015014037 , CRD42015014038.
authors.affiliation: 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.
authors.forename: Evan
authors.initials: E
authors.lastname: Mayo-Wilson
authors.affiliation: 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.|Department of Gastroenterology and Hepatology, Johns Hopkins School of Medicine, 600 North Wolfe Street, Blalock 449, Baltimore, MD, 21287, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Hutfless
authors.affiliation: 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.
authors.forename: Tianjing
authors.initials: T
authors.lastname: Li
authors.affiliation: 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.
authors.forename: Gillian
authors.initials: G
authors.lastname: Gresham
authors.affiliation: 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.
authors.forename: Nicole
authors.initials: N
authors.lastname: Fusco
authors.affiliation: Department of Neurology, Johns Hopkins School of Medicine, 855 North Wolfe Street, Baltimore, MD, 21205, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Ehmsen
authors.affiliation: 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.
authors.forename: James
authors.initials: J
authors.lastname: Heyward
authors.affiliation: Laboratory for Computational Sensing and Robotics, Johns Hopkins Whiting School of Engineering, 3400 North Charles St., Baltimore, MD, 21218, USA.
authors.forename: Swaroop
authors.initials: S
authors.lastname: Vedula
authors.affiliation: Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
authors.forename: Diana
authors.initials: D
authors.lastname: Lock
authors.affiliation: Behavioral Biology, Center for Mind-Body Research, Johns Hopkins School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, 21224, MD, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Haythornthwaite
authors.affiliation: Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, 500 North Broadway, Suite 305, Baltimore, MD, 21205, USA.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Payne
authors.affiliation: The TMJ Association, Ltd., P.O. Box 26770, Milwaukee, WI, 53226-0770, USA.
authors.forename: Theresa
authors.initials: T
authors.lastname: Cowley
authors.affiliation: Peabody Institute, Johns Hopkins University, 1 East Mount Vernon Place, Baltimore, MD, 21202, USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Tolbert
authors.affiliation: Welch Medical Library, Johns Hopkins School of Medicine, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
authors.forename: Lori
authors.initials: L
authors.lastname: Rosman
authors.affiliation: Welch Medical Library, Johns Hopkins School of Medicine, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
authors.forename: Claire
authors.initials: C
authors.lastname: Twose
authors.affiliation: Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Baltimore, MD, 21205, USA.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Stuart
authors.affiliation: Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 North Broadway, Baltimore, MD, 21205, USA.
authors.forename: Hwanhee
authors.initials: H
authors.lastname: Hong
authors.affiliation: University of Maryland School of Pharmacy, 220 Arch Street, Baltimore, MD, 21201, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Doshi
authors.affiliation: Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, MD, 21205, USA.
authors.forename: Catalina
authors.initials: C
authors.lastname: Suarez-Cuervo
authors.affiliation: Center for Public Health and Human Rights, Johns Hopkins School of Medicine, 615 N Wolfe St, Baltimore, MD, 21205, USA.
authors.forename: Sonal
authors.initials: S
authors.lastname: Singh
authors.affiliation: 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.
authors.forename: Kay
authors.initials: K
authors.lastname: Dickersin
mesh_terms: D000588:Amines / Q000627:therapeutic use; D000700:Analgesics / Q000627:therapeutic use; D014150:Antipsychotic Agents; D001714:Bipolar Disorder / Q000188:drug therapy; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use; D003627:Data Interpretation, Statistical; D000077206:Gabapentin; D006801:Humans; D015201:Meta-Analysis as Topic; D009437:Neuralgia / Q000188:drug therapy; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D018802:Patient-Centered Care / Q000706:statistics & numerical data*; D000069348:Quetiapine Fumarate / Q000627:therapeutic use; D012107:Research Design; D015983:Selection Bias; D000078202:Systematic Reviews as Topic; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use
chemical_list: D000588:Amines; D000700:Analgesics; D014150:Antipsychotic Agents; D003509:Cyclohexanecarboxylic Acids; D000069348:Quetiapine Fumarate; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin