Systematic review

A literature search of MEDLINE (Ovid, supplemented by a recent PubMed search), Embase (Ovid) and the Cochrane Library (Cochrane Database of Systematic Reviews and Cochrane Controlled Register of Trials) will be conducted to identify relevant randomised controlled trials (RCTs), observational studies with control groups and systematic reviews examining treatment outcomes of first-line (e.g. diet and lifestyle changes, bulking agents, pelvic floor exercises), second-line (e.g. transanal irrigation) and/or surgical procedures (e.g. sacral neuromodulation, sphincter repair) in adult patients with FI. The search terms which will be used include ‘faecal incontinence’, any ‘treatment’ terms (e.g. therapy, surgery) and any ‘outcome’ terms (e.g. outcome, effectiveness) as well as any synonyms and spelling variations of these terms. The search will be limited to RCTs, observational studies with control groups and systematic reviews conducted in human adults, published from 2000 onward, with no language restrictions. The search strategy will be reviewed by an information specialist, prior to carrying out the full search.

Any RCTs, observational studies with control groups and systematic reviews performed in humans can be included in the review. Furthermore, included systematic reviews will be scanned for relevant individual studies to be included in this review. Titles and abstracts of potentially relevant articles will be screened, followed by full text screening to assess study eligibility. Both abstract and title screening as well as full text screening will be performed independently by two reviewers using predetermined in- and exclusion criteria. Any disagreement on study eligibility will be resolved through discussion by the two reviewers with referral to a third senior author if necessary.

For each study, a predefined data extraction form will be filled out which includes author name, publication date, characteristics of the study, primary and secondary outcomes and outcome definitions, instruments used to measure outcomes and timing of assessment. Two reviewers will independently extract all data verbatim from the source manuscript and discuss results to ensure that the data forms are complete. No risk of bias assessment will be performed as the aim of the systematic review is only to explore which outcomes are reported on in FI intervention studies.