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

ABSTRACT: 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.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.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.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.ClinicalTrials.gov: NCT00613366, NCT00886834, NCT01001897, NCT01147497 and NCT01307111.

SUBMITTER: Turok DK

PROVIDER: S-EPMC3103448 | biostudies-literature | 2011 Apr

REPOSITORIES: biostudies-literature

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

Turok David K DK Espey Eve E Edelman Alison B AB Lotke Pamela S PS Lathrop Eva H EH Teal Stephanie B SB Jacobson Janet C JC Simonsen Sara E SE Schulz Kenneth F KF

Trials 20110429

<h4>Background</h4>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 cont ...[more]

PMID: 21527040

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Project description:BACKGROUND:Family planning is an effective tool for preventing death among women who do not want to become pregnant and has been shown to improve newborn health outcomes, advance women's empowerment, and bring socioeconomic benefits through reductions in fertility and population growth. Yet among the populations that would benefit the most from family planning, uptake remains too low. The emergence of digital health tools has created new opportunities to strengthen health systems and promote behavior change. In this study, women with an unmet need for family planning in Western Kenya were randomized to receive an encouragement to try an automated investigational digital health intervention that promoted the uptake of family planning. OBJECTIVE:The objectives of the pilot study were to explore the feasibility of a full-scale trial-in particular, the recruitment, encouragement, and follow-up data collection procedures-and to examine the preliminary effect of the intervention on contraception uptake. METHODS:This pilot study tested the procedures for a randomized encouragement trial. We recruited 112 women with an unmet need for family planning from local markets in Western Kenya, conducted an eligibility screening, and randomized half of the women to receive an encouragement to try the investigational intervention. Four months after encouraging the treatment group, we conducted a follow-up survey with enrolled participants via short message service (SMS) text message. RESULTS:The encouragement sent via SMS text messages to the treatment group led to differential rates of intervention uptake between the treatment and control groups; however, uptake by the treatment group was lower than anticipated (19/56, 33.9% vs 1/56, 1.8%, in the control group). Study attrition was also substantial. We obtained follow-up data from 44.6% (50/112) of enrolled participants. Among those in the treatment group who tried the intervention, the instrumental variables estimate of the local average treatment effect was an increase in the probability of contraceptive uptake of 41.0 percentage points (95% uncertainty interval -0.03 to 0.85). CONCLUSIONS:This randomized encouragement design and study protocol is feasible but requires modifications to the recruitment, encouragement, and follow-up data collection procedures. TRIAL REGISTRATION:ClinicalTrials.gov NCT03224390; https://clinicaltrials.gov/ct2/show/NCT03224390 (Archived by WebCite at http://www.webcitation.org/70yitdJu8).

Project description:CONTEXT:Community education and engagement are important for informing family planning projects. The objective of this study was to update two prior systematic reviews assessing the impact of community education and engagement interventions on family planning outcomes. EVIDENCE ACQUISITION:Sixteen electronic databases were searched for studies relevant to a priori determined inclusion/exclusion criteria in high development settings, published from March 2011 through April 2016, updating two reviews that included studies from 1985 through February 2011. EVIDENCE SYNTHESIS:Nine relevant studies were included in this updated review related to community education, in addition to 17 from the prior review. No new community engagement studies met inclusion criteria, as occurred in the prior review. Of new studies, community education modalities included mass media, print/mail, web-based, text messaging, and interpersonal interventions. One study on mass media intervention demonstrated a positive impact on reducing teen and unintended pregnancies. Three of four studies on interpersonal interventions demonstrated positive impacts on medium-term family planning outcomes, such as contraception and condom use. Three new studies demonstrated mostly positive, but inconsistent, results on short-term family planning outcomes. CONCLUSIONS:Findings from this systematic review update are in line with a previous review showing the positive impact of community education using traditional modalities on short-term family planning outcomes, identifying additional impacts on long-term outcomes, and highlighting new evidence for education using modern modalities, such as text messaging and web-based education. More research is necessary to provide a stronger evidence base for directing community education and engagement efforts in family planning contexts. THEME INFORMATION:This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

Project description:INTRODUCTION:Use of family planning (FP) is powerfully shaped by social and gender norms, including the perceived acceptability of FP and gender roles that limit women's autonomy and restrict communication and decision-making between men and women. This study evaluated an intervention that catalyzed ongoing community dialogues about gender and FP in Siaya county, Nyanza Province, Kenya. Specifically, we explored the changes in perceived acceptability of FP, gender norms and use of FP. METHODS:We used a mixed-method approach. Information on married men and women's socio-demographic characteristics, pregnancy intentions, gender-related beliefs, FP knowledge, attitudes, and use were collected during county-representative, cross-sectional household surveys at baseline (2009; n11 = 650 women; n12 = 305 men) and endline (2012; n21 = 617 women; n22 = 317 men); exposure to the intervention was measured at endline. We assessed changes in FP use at endline vs. baseline, and fitted multivariate logistic regression models for FP use to examine its association with intervention exposure and explore other predictors of use at endline. In-depth, qualitative interviews with 10 couples at endline further explored enablers and barriers to FP use. RESULTS:At baseline, 34.0% of women and 27.9% of men used a modern FP method compared to 51.2% and 52.2%, respectively, at endline (p<0.05). Exposure to FP dialogues was associated with 1.78 (95% CI: 1.20-2.63) times higher odds of using a modern FP method at endline for women, but this association was not significant for men. Women's use of modern FP was significantly associated with higher spousal communication, control over own cash earnings, and FP self-efficacy. Men who reported high approval of FP were significantly more likely to use modern FP if reporting high approval of FP and more equitable gender beliefs. FP dialogues addressed persistent myths and misconceptions, normalized FP discussions, and increased its acceptability. Public examples of couples making joint FP decisions legitimized communication and decision-making with spouses about FP especially for men; women described partner support as key enabler of FP use. CONCLUSIONS:Our evaluation demonstrates that an intervention that catalyzes open dialogue about gender and FP can shift social norms, enable more equitable couple communication and decision-making and, ultimately, increase use of FP.

Project description:Background:unmet need for family planning is a common cause of uninteded pregnancy which mostly end up with abortion. Many studies were conducted on predictors of unmet need of family planning in Ethiopia. But, up until now, single evidence has not been synthesized and various point prevalence estimates of unmet need for family planning have been reported. Therefore, this sytematic review and meta analysis was established to identify the predictors of unmet need for family planning in Ethiopia. Methods:search engines including PubMed, Embase, CINAHL, Google Scholar, HINARI portal, and Cochrane Library were used to retrieve included articles and reported using the preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA) checklist guidelines. Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) was applied for critical appraisal. All observational studies done on reproductive age women and reported on unmet need for family planning were included. Unmet need for family planning is the percentage of women of reproductive age, either married or in a union, who have an unmet need for family planning to stop or delay childbearing. Random effect model was done to estimate the pooled prevalence of unmet need for family planning. Odds ratio with 95% confidence interval was considered to determine the association of identified variables with unmet need of family planning. Cochran's Q statistic, Egger's and Begg's test were carried out to assess heterogeneity and publication bias. Results:Fifteen articles and 17, 585 reproductive aged women were included to estimate the pooled prevalence of unmet need for family planning and its predictors in Ethiopia. The prevalence of unmet need for family planning in Ethiopia ranges from 26.52 to 36.39%. Age at first marriage <?18?yrs. with OR?=?2.3 (95% CI: 1.08, 4.87), women with no formal education with OR?=?1.9 (95%CI: 1.19, 3.04), partner with no formal education with OR?=?1.78 (95%CI: 1.18, 2.68) and absence of discussion with their partner about family planning with OR?=?3.52 (95%CI, 2.56, 4.87) were predictors of unmet need of family planning in Ethiopia. Conclusion:This meta analysis revealed that, the prevalence of unmet need for family planning in Ethiopia was high as compared with the United Nations sphere standard of unmet need for planning, considered to be high if it is greater than 25%. Early marriage, no formal eduaction and lack of discussion with partner on family planning were predictors of unmet need for family planning. Therefore, efforts are needed to empower women through eduaction, avoiding early marriage and facilitating dicussion of partners about family planning in order to improve family planning usage.

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

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

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