title: The methodology for developing a prospective meta-analysis in the family planning community.
abstract: BACKGROUND
  Prospective meta-analysis (PMA) is a collaborative research design in which individual sites perform randomized controlled trials (RCTs) and pool the data for meta-analysis. Members of the PMA collaboration agree upon specific research interventions and outcome measures, ideally before initiation but at least prior to any individual trial publishing results. This allows for uniform reporting of primary and secondary outcomes. With this approach, heterogeneity among trials contributing data for the final meta-analysis is minimized while each site maintains the freedom to design a specific trial. This paper describes the process of creating a PMA collaboration to evaluate the impact of misoprostol on ease of intrauterine device (IUD) insertion in nulliparous women.
  
  
  METHODS
  After the principal investigator developed a preliminary PMA protocol, he identified potential collaborating investigators at other sites. One site already had a trial underway and another site was in the planning stages of a trial meeting PMA requirements. Investigators at six sites joined the PMA collaborative. Each site committed to enroll subjects to meet a pre-determined total sample size. A final common research plan and site responsibilities were developed and agreed upon through email and face-to-face meetings. Each site committed to contribute individual patient data to the PMA collaboration, and these data will be analyzed and prepared as a multi-site publication. Individual sites retain the ability to analyze and publish their site's independent findings.
  
  
  RESULTS
  All six sites have obtained Institutional Review Board approval and each has obtained individual funding to meet the needs of that site's study. Sites have shared resources including study protocols and consents to decrease costs and improve study flow. This PMA protocol is registered with the Cochrane Collaboration and data will be analyzed according to Cochrane standards for meta-analysis.
  
  
  CONCLUSIONS
  PMA is a novel research method that improves meta-analysis by including several study sites, establishing uniform reporting of specific outcomes, and yet allowing some independence on the part of individual sites with respect to the conduct of research. The inclusion of several sites increases statistical power to address important clinical questions. Compared to multi-center trials, PMA methodology encourages collaboration, aids in the development of new investigators, decreases study costs, and decreases time to publication.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00613366, NCT00886834, NCT01001897, NCT01147497 and NCT01307111.
authors.affiliation: Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah, USA. david.turok@hsc.utah.edu
authors.forename: David K
authors.initials: DK
authors.lastname: Turok
authors.forename: Eve
authors.initials: E
authors.lastname: Espey
authors.forename: Alison B
authors.initials: AB
authors.lastname: Edelman
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Lotke
authors.forename: Eva H
authors.initials: EH
authors.lastname: Lathrop
authors.forename: Stephanie B
authors.initials: SB
authors.lastname: Teal
authors.forename: Janet C
authors.initials: JC
authors.lastname: Jacobson
authors.forename: Sara E
authors.initials: SE
authors.lastname: Simonsen
authors.forename: Kenneth F
authors.initials: KF
authors.lastname: Schulz
mesh_terms: D003299:Cooperative Behavior; D019317:Evidence-Based Medicine; D005193:Family Planning Services; D005260:Female; D006801:Humans; D007373:Interinstitutional Relations; D007434:Intrauterine Devices / Q000009:adverse effects; D016595:Misoprostol / Q000009:adverse effects / Q000627:therapeutic use*; D010120:Oxytocics / Q000009:adverse effects / Q000627:therapeutic use*; D010298:Parity; D011247:Pregnancy; D011446:Prospective Studies; D012107:Research Design; D016896:Treatment Outcome; D014481:United States
chemical_list: D010120:Oxytocics; D016595:Misoprostol