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The search strategy was developed and undertaken by an experienced search specialist. Fifteen international electronic literature databases were searched to identify research published between inception and January 2012, with Medical Subject Headings descriptors and keywords such as infibulation, applying neither methodology search filters nor language or other search restrictions. The search strategy for MEDLINE (Ovid MEDLINE In-Process & Other Non-Indexed Citations 1946 to 20 January 2012) is shown:
((female$ or wom#n or girl$1) adj3 (mutilation$ or circumcis$ or cutting$)).tw.
((removal$ or alteration$ or excision$) adj6 female genital$).tw.
(clitoridectom$ or clitorectom$).tw.
(infibulat$ or reinfibulat$ or deinfibulat$).tw.
One reviewer (RCB) manually screened the bibliographies of published reviews on FGM/C and all included studies for additional qualifying studies. RCB did additional searches for the relevant grey literature and unpublished studies in OpenGrey, OpenSigle, OAIster, browsed websites of six international organisations that are engaged in projects regarding FGM/C, and communicated with experts in the field.
Selection of studies and extraction of data.
Studies retrieved were eligible for inclusion if they satisfied all our criteria: Be an empirical quantitative study with or without a comparison group published in any language that presented original quantitative data for physical health outcomes in women who had undergone any type of FGM/C as defined by the WHO.1 All physical health outcomes were eligible, including but not limited to death, infections, infertility, fistula, pain, urinary complications, shock (primary outcomes), and bleeding/haemorrhage, menstrual complications, obstetric complications, vaginal calculus formation, cysts, tissue injury, fractured/displaced bones, urethral meatal stenosis/ urethral stricture, abscesses, keloid and other scarring (secondary outcomes). We applied the following exclusion criteria: Qualitative studies, studies without a quantitative measure of a physical consequence of FGM/C, and all genital modifications not captured by the WHO stated FGM/C definition.
Screening, quality appraisal and data extraction were independently undertaken by two investigators (RCB and VU), with discrepancies resolved by consensus. The two investigators confirmed the eligibility of first titles and abstracts and then full texts. Quality assessment of the identified studies was undertaken as recommended in the Cochrane Handbook, using design specific checklists based on the User’s Guide framework.16 This was done at the study level. The investigators extracted study information and data onto a standardised data collection form, which had been piloted. Data extracted included publication details, study design, sample characteristics, FGM/C characteristics, methods of outcome measurement and health consequences. We contacted authors for additional data or clarification where needed.
We grouped the data according to outcomes across the studies, keeping the outcome categories or labels as reported in each individual study. We estimated associations for dichotomous unadjusted variables in terms of relative risks (RR) with 95% CIs. ORs and 95% CIs were used for case–control studies and adjusted analyses. Outcomes that were sufficiently similar across studies, and reasonable resistant to biases and relatively homogeneous in this respect, were aggregated in meta-analyses. When available, we pooled adjusted estimates; otherwise, we pooled the unadjusted estimates based on crude data from the individual studies. ORs and RRs greater than one indicate an increased risk of complications with FGM/C; if less than one, they indicate a decreased risk.
We anticipated heterogeneity between studies due to different study methodologies and geographical and population differences. Heterogeneity was examined using the ? 2 test and I 2 statistic. We used a random-effects model to account for within-study and between-study heterogeneity.
In random-effects meta-analysis, the weight assigned to each included study is adjusted to include a measure of variation (? 2 ) in the effects reported between studies. We used the Mantel-Haenszel method for unadjusted dichotomous data, and for adjusted data we used the generic inverse-variance method, in which weight is given to each study according to the inverse of the variance of the effect, to minimise uncertainty about the pooled effect estimates. Analyses were done with Review Manager (V.5.2.8).
We applied the instrument Grading of Recommendations Assessment, Development and Evaluation (GRADE) to assess the extent to which we have confidence in the effect estimates.17 GRADE is a transparent and systematic approach to grading our confidence in the evidence. For resource reasons, we used GRADE only for outcomes eligible for meta-analysis.
Those of us who did the systematic review were not masked to the authors, institution or journal of publication. The use of non-masked reviewers is accepted practice in meta-analyses and has been shown not to bias results.18 In line with recommendations,14 results from the studies deemed to have the highest internal validity were given preference. In this communication, we present all studies that reported outcomes for differentially FGM/C exposed groups of women, that is, studies with a comparison group.
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