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dc.contributor.authorTurok, David
dc.contributor.authorEspey, Eve
dc.contributor.authorEdelman, Alison
dc.contributor.authorLotke, Pamela
dc.contributor.authorLathrop, Eva
dc.contributor.authorTeal, Stephanie
dc.contributor.authorJacobson, Janet
dc.contributor.authorSimonsen, Sara
dc.contributor.authorSchulz, Kenneth
dc.date.accessioned2016-05-20T09:02:24Z
dc.date.available2016-05-20T09:02:24Z
dc.date.issued2011en
dc.identifier.citationTurok et al. Trials 2011, 12:104 http://www.trialsjournal.com/content/12/1/104en
dc.identifier.doi10.1186/1745-6215-12-104en
dc.identifier.urihttp://hdl.handle.net/10150/610257
dc.description.abstractBACKGROUND: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.TRIAL REGISTRATION:ClinicalTrials.gov: NCT00613366, NCT00886834, NCT01001897, NCT01147497 and NCT01307111
dc.language.isoenen
dc.publisherBioMed Centralen
dc.relation.urlhttp://www.trialsjournal.com/content/12/1/104en
dc.rights© 2011 Turok et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0)en
dc.titleThe methodology for developing a prospective meta-analysis in the family planning communityen
dc.typeArticleen
dc.identifier.eissn1745-6215en
dc.contributor.departmentDepartment of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah, USAen
dc.contributor.departmentDepartment of Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico, USAen
dc.contributor.departmentDepartment of Obstetrics and Gynecology, Oregon Health & Science University, Portland, Oregon, USAen
dc.contributor.departmentDepartment of Obstetrics and Gynecology, University of Arizona, Tucson, Arizona, USAen
dc.contributor.departmentDepartment of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, Georgia, USAen
dc.contributor.departmentDepartment of Obstetrics and Gynecology, University of Colorado, Denver, Colorado, USAen
dc.contributor.departmentDepartment of Family and Preventive Medicine, Division of Public Health, University of Utah, Salt Lake City, Utah, USAen
dc.contributor.departmentQuantitative Sciences, Family Health International, Research Triangle Park, North Carolina, USAen
dc.identifier.journalTrialsen
dc.description.collectioninformationThis item is part of the UA Faculty Publications collection. For more information this item or other items in the UA Campus Repository, contact the University of Arizona Libraries at repository@u.library.arizona.edu.en
dc.eprint.versionFinal published versionen
refterms.dateFOA2018-08-13T20:19:46Z
html.description.abstractBACKGROUND: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.TRIAL REGISTRATION:ClinicalTrials.gov: NCT00613366, NCT00886834, NCT01001897, NCT01147497 and NCT01307111


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