Evidence map›Paper›PMID 21527040›Full record

SynthesisTrials2011

The methodology for developing a prospective meta-analysis in the family planning community.

David K Turok, Eve Espey, Alison B Edelman, Pamela S Lotke, Eva H Lathrop, Stephanie B Teal, Janet C Jacobson, Sara E Simonsen, Kenneth F Schulz

5 registry-linked trialsOpen access · goldAbstract readMeta-AnalysisMulticenter StudyRandomized Controlled Trial
In one paragraph

Synthesis in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 9 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 4 pooled it
1.0field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00613366 nacompletednot on this map

Effect of Prophylactic Misoprostol Prior to Intrauterine Device Insertion

TypeinterventionalSponsorOregon Health and Science UniversityRan2007 to 2010Enrolled40ConditionsContraceptionArmsMisoprostol, Magnesium Oxide
NCT00886834 nacompletednot on this map

A Randomized Control Trial of Misoprostol vs. Placebo Prior to IUD Insertion in Nulliparous Women

TypeinterventionalSponsorUniversity of UtahRan2009 to 2011Enrolled108ConditionsContraceptionArmsMisoprostol, Placebo
NCT01001897 nacompletednot on this map

A Randomized Control Trial of Misoprostol vs. Placebo for Cervical Preparation in IUD Insertion for Nulliparous Women

TypeinterventionalSponsorUniversity of ArizonaRan2009 to 2011Enrolled61ConditionsContraceptionArmsMisoprostol, Placebo
NCT01147497 nacompletednot on this map

A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in Intrauterine Device Insertion for Nulliparous Women

TypeinterventionalSponsorEmory UniversityRan2010 to 2011Enrolled78ConditionsContraceptionArmsMisoprostol, Placebo
NCT01307111 nacompletednot on this map

A Randomized Control Trial of Misoprostol Versus Placebo for Cervical Priming in IUD Insertion for Nulliparous Women

TypeinterventionalSponsorUniversity of New MexicoRan2011 to 2013Enrolled85ConditionsPainArmsMisoprostol, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 4 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Interventions for pain with intrauterine device insertion.The Cochrane database of systematic reviews · 2015
    Pooled it
  5. Article
  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 1 country.

David K TurokDepartment of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah, USA. david.turok@hsc.utah.edu
Eve Espey
Alison B Edelman
Pamela S Lotke
Eva H Lathrop
Stephanie B Teal
Janet C Jacobson
Sara E Simonsen
Kenneth F Schulz
University of Utah · USEmory University · USFamily Health International 360 · USOregon Health & Science University · USUniversity of Arizona · USUniversity of Colorado Denver · USUniversity of New Mexico · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProspective 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.

methodsAfter 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.

resultsAll 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.

conclusionsPMA 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 registrationClinicalTrials.gov: NCT00613366, NCT00886834, NCT01001897, NCT01147497 and NCT01307111.

Indexed as

Family Planning ServicesIntrauterine DevicesResearch DesignCooperative BehaviorEvidence-Based MedicineFemaleHumansInterinstitutional RelationsMisoprostolOxytocicsParityPregnancyProspective StudiesTreatment OutcomeUnited StatesMisoprostolOxytocics

Identifiers

PMID21527040
PMCPMC3103448
OpenAlexW2122986860

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.