| Field (based on PRISMA-P) | Content |
|---|---|
| Actual review question | What is the efficacy of single layer closure of the uterus as compared with double layer closure at caesarean birth? |
| Type of review question | Intervention |
| Objective of the review | To ascertain whether there are differences in efficacy between single versus two-layer closure of the uterus. Surgical technique differs between individual surgeons at present, and the existing guideline does not discuss which technique may be most appropriate. |
| Eligibility criteria – population/disease/condition/issue/domain | Women undergoing planned (elective) or unplanned (emergency/intrapartum) caesarean birth
|
| Eligibility criteria – intervention(s)/exposure(s)/prognostic factor(s) | Single layer closure of the uterus |
| Eligibility criteria – comparator(s)/control or reference (gold) standard | Double layer closure |
| Outcomes and prioritisation | Critical outcomes:
|
| Eligibility criteria – study design | Only published full text papers Systematic reviews of RCTs RCTs |
| Other inclusion/exclusion criteria | Exclude classical incision and vertical incision |
| Proposed stratified, sensitivity/sub-group analysis, or meta-regression | If heterogeneity identified: subgroup analysis for different numbers of caesarean birth (CB) (i.e. first CB versus repeat CB, need to include multiple repeat CB) |
| Selection process – duplicate screening/selection/analysis | Duplicate screening/selection/analysis will not be undertaken for this review as this question was not prioritised for it. Included and excluded studies will be cross checked with the committee and with published systematic reviews when available. |
| Data management (software) | If pairwise meta-analyses are undertaken, they will be performed using Cochrane Review Manager (RevMan5). ‘GRADE’ will be used to assess the quality of evidence for each outcome. STAR will be used for bibliographies/citations and study sifting, data extraction and quality assessment/critical appraisal. |
| Information sources – databases and dates | Sources to be searched: Medline, Medline In-Process, CCTR, CDSR and Embase. Limits (e.g. date, study design): All study designs. Standard animal/non-English language filters will be applied. No date limit will be applied and no supplementary search techniques will be used. See appendix B for full strategies. |
| Identify if an update | Yes, this question was included in the 2011 guideline. Studies meeting the current protocol criteria and previously included in the 2011 guideline (CG132) will be included in this update. |
| Author contacts | Developer: National Guideline Alliance |
| Highlight if amendment to previous protocol | For details please see section 4.5 of Developing NICE guidelines: the manual |
| Search strategy – for one database | For details please see appendix B |
| Data collection process – forms/duplicate | A standardised evidence table format will be used, and published as appendix D (clinical evidence tables). |
| Data items – define all variables to be collected | For details please see evidence tables in appendix D (clinical evidence tables). |
| Methods for assessing bias at outcome/study level | Appraisal of methodological quality: The methodological quality of each study will be assessed using an appropriate checklist: ROBIS for systematic reviews Cochrane risk of bias tool for randomised studies For details please see section 6.2 of Developing NICE guidelines: the manual The risk of bias across all available evidence will evaluated for each outcome using an adaptation of the ‘Grading of Recommendations Assessment, Development and Evaluation (GRADE) toolbox’ developed by the international GRADE working group http://www |
| Criteria for quantitative synthesis | For details please see section 6.4 of Developing NICE guidelines: the manual |
| Methods for quantitative analysis – combining studies and exploring (in)consistency | Synthesis of data: Meta-analysis will be conducted where appropriate using Review Manager. For detailed methods for meta-analysis, please see full guideline methods chapter. Minimum important differences Any significant difference will be used as the MID for the following outcomes:
For the remaining outcomes, default values will be used of: 0.8 and 1.25 relative risk for dichotomous outcomes; 0.5 times the control group SD for continuous outcomes, unless more appropriate values are identified by the guideline committee or in the literature. Double sifting, data extraction and methodological quality assessment: Sifting, data extraction, appraisal of methodological quality and GRADE assessment will be performed by the systematic reviewer. Quality control will be performed by the senior systematic reviewer. Dual quality assessment and data extraction will not be performed |
| Meta-bias assessment – publication bias, selective reporting bias | For details please see section 6.2 of Developing NICE guidelines: the manual. |
| Confidence in cumulative evidence | For details please see sections 6.4 and 9.1 of Developing NICE guidelines: the manual |
| Rationale/context – what is known | For details please see the introduction to the evidence review |
| Describe contributions of authors and guarantor | A multidisciplinary committee developed the guideline. The committee was convened by the National Guideline Alliance and chaired by Sarah Fishburn in line with section 3 of Developing NICE guidelines: the manual. Staff from the National Guideline Alliance undertook systematic literature searches, appraised the evidence, conducted meta-analysis and cost-effectiveness analysis where appropriate, and drafted the guideline in collaboration with the committee. For details please see the methods chapter. |
| Sources of funding/support | The National Guideline Alliance is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists |
| Name of sponsor | The National Guideline Alliance is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists |
| Roles of sponsor | NICE funds the National Guideline Alliance to develop guidelines for the NHS in England. |
| PROSPERO registration number | Not registered with PROSPERO |
CDSR: Cochrane Database of Systematic Reviews; CENTRAL: Cochrane Central Register of Controlled Trials; DARE: Database of Abstracts of Reviews of Effects; GRADE: Grading of Recommendations Assessment, Development and Evaluation; HTA: Health Technology Assessment; NGA: National Guideline Alliance; NHS: National health service; NICE: National Institute for Health and Care Excellence; RCT: randomised controlled trial; RoB: risk of bias; SD: standard deviation
From: Techniques to close the uterus at caesarean birth
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