The Cochrane Pregnancy and Childbirth Group Data Extraction Form Review title: Review ID: Study ID: Reference ID: Person extracting data (data should be extracted independently by at least 2 people): Date of date extraction: Year of study publication: Title: Author: Reference: Other publications from same study (additional reports of the same study should be grouped under the same study identifier see “Organising studies and references”, p 35 RevMan User Guide): Study eligibility Study Eligibility criteria Characteristics (Insert inclusion criteria for each characteristic as defined in the Protocol) Type of study Randomised Controlled Trial Eligibility criteria met? Yes No Location in text or source (pg & ¶/fig/table/other Unclear ) Quasi-randomised Controlled Trial Participants Types of intervention Types of comparison Types of outcome measures INCLUDE EXCLUDE Reason for exclusion Notes: DO NOT PROCEED IF STUDY EXCLUDED FROM REVIEW 1 Study design Type of study design (e.g. parallel; cluster; cross-over trial) Participants and setting Describe setting: Inclusion criteria: Exclusion criteria: Intervention Experimental intervention: Total number randomised: n= Comparison Control/Comparison intervention: Total number randomised: n= Outcomes: Outcomes: 2 Risk of Bias assessment See Chapter 8 of the Cochrane Handbook. Additional domains may be added for nonrandomised studies. Domain Random sequence generation (selection bias) Allocation concealment (selection bias) Blinding of participants and personnel (performance bias) (if separate judgement by outcome(s) required) Blinding of outcome assessment (detection bias) (if separate judgement by outcome(s) required) Incomplete outcome data (attrition bias) (if separate judgement by outcome(s) required) Selective outcome reporting? (reporting bias) Other bias Notes: Risk of bias Support for judgement (include direct quotes where available Low High Unclear with explanatory comments) Location in text or source (pg & ¶/fig/table/other) Outcome group: All/ Outcome group: Outcome group: All/ Outcome group: Outcome group: All/ Outcome group: 3 Additional information requested Information requested: From: Date: Response: Response forwarded to TSC (Lynn Hampson – lynn@liverpool.ac.uk) to store with original report: Outcomes for main analysis Total number of participants in study = Outcome Measures (Dichotomous) Intervention group Total no. in group = events total Control group Total no. in group = events total Primary 1 2 3 Secondary 4 5 6 7 Total number of participants in study = Outcome Measures (Continuous) Intervention group Total no. in group = mean SD total Control group Total no. in group = mean SD total Primary 1 2 3 4 Secondary 4 5 6 7 Outcomes for sub-group analyses Total number of participants in study = Outcome Measures (Dichotomous) Intervention group Total no. in group = events total Control group Total no. in group = events total Primary 1 2 3 Total number of participants in study = Outcome Measures (Continuous) Intervention group Total no. in study = mean SD total Control group Total no. in study = mean SD total Primary 1 2 3 General conclusions Very brief summary of study authors main findings/conclusions: 5 Notes Exclusion after data extraction Reasons for exclusion: (study design? participants? interventions/ outcomes? attrition? bias?) Dates: Date entered into RevMan and by whom? Date checked and by whom? This form was adapted from “Good practice templates” developed by the Cochrane Editorial Resources Committee http://training.cochrane.org/authors/presentations/collecting-data 6