| Field (based on PRISMA-P) | Content |
|---|---|
| Review question | What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction? |
| Type of review question | Intervention |
| Objective of the review | To determine the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction. |
| Eligibility criteria – population/disease/condition/issue/domain |
Adults with acute large bowel obstruction caused by colorectal cancer or suspected colorectal cancer Subgroups:
|
| Eligibility criteria – intervention(s) |
|
| Eligibility criteria – comparator(s) |
|
| Outcomes and prioritisation | Critical outcomes:
|
| Eligibility criteria – study design |
|
| Other inclusion exclusion criteria | Inclusion:
|
| Proposed sensitivity/sub-group analysis, or meta-regression | For observational studies, multivariate analysis should adjust for the following characteristics:
|
| Selection process – duplicate screening/selection/analysis | Sifting, data extraction, appraisal of methodological quality and GRADE assessment will be performed by the systematic reviewer. Resolution of any disputes will be with the senior systematic reviewer and the Topic Advisor. Quality control will be performed by the senior systematic reviewer. |
| Data management (software) |
Pairwise meta-analyses will be performed using Cochrane Review Manager (RevMan5). ‘GRADEpro’ will be used to assess the quality of evidence for each outcome. NGA STAR software will be used for study sifting, data extraction, recording quality assessment using checklists and generating bibliographies/citations. |
| Information sources – databases and dates |
Potential sources to be searched (to be confirmed by Information Scientist): Medline, Medline In-Process, CCTR, CDSR, DARE, HTA, Embase Limits (e.g. date, study design): Apply standard animal/non-English language exclusion Limit to RCTs and systematic reviews in first instance, but download all results Dates: post-2000 |
| Identify if an update | Not an update |
| Author contacts |
https://www Developer: NGA |
| 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) or H (economic evidence tables). |
| Data items – define all variables to be collected | For details please see evidence tables in appendix D (clinical evidence tables) or H (economic evidence tables). |
| Methods for assessing bias at outcome/study level |
Standard study checklists were used to critically appraise individual studies. For details please see section 6.2 of Developing NICE guidelines: the manual Appraisal of methodological quality: The methodological quality of each study will be assessed using an appropriate checklist:
The risk of bias across all available evidence was 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 (where suitable) | For details please see section 6.4 of Developing NICE guidelines: the manual |
| Methods for analysis – combining studies and exploring (in)consistency |
Synthesis of data: Pairwise meta-analysis of randomised trials will be conducted where appropriate. When meta-analysing continuous data, final and change scores will be pooled if baselines are comparable. If any studies report both, the method used in the majority of studies will be analysed. Minimally important differences: The guideline committee identified statistically significant differences as appropriate indicators for clinical significance for all outcomes except for quality of life for which published MIDs from literature will be used (see outcomes section for more information). |
| Meta-bias assessment – publication bias, selective reporting bias |
For details please see section 6.2 of Developing NICE guidelines: the manual. If sufficient relevant RCT evidence is available, publication bias will be explored using RevMan software to examine funnel plots. |
| Assessment of confidence in cumulative evidence | For details please see sections 6.4 and 9.1 of Developing NICE guidelines: the manual |
| Rationale/context – Current management | 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 Peter Hoskin 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 Supplement 1: methods. |
| 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 those working in the NHS, public health, and social care in England |
| PROSPERO registration number | Not registered |
CCTR: Cochrane Central Register of Controlled Trials; CDSR: Cochrane Database of Systematic Reviews; DARE: Database of Abstracts of Reviews of Effects; EQ-5D: EuroQol five dimensions questionnaire; EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Items; EORTC QLQ-CR29: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire colorectal cancer module (29 items); EORTC QLQ-CR38: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire colorectal cancer module (38 items); FACT-C: Functional Assessment of Cancer Therapy questionnaire (colorectal cancer); FACT-G: Functional Assessment of Cancer Therapy questionnaire (general); GRADE: Grading of Recommendations Assessment, Development and Evaluation; HTA: Health Technology Assessment; MID: minimal important difference; MRI: magnetic resonance imaging; NGA: National Guideline Alliance; NHS: National health service; NICE: National Institute for Health and Care Excellence; PRISMA-P: Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols; PROSPERO: International Prospective Register for Systematic Reviews; RCT: randomised controlled trial; RCT: randomised controlled trial; ROBINS-I: Risk of Bias in Non-randomised Studies – of Interventions; ROBIS: risk of bias in systematic reviews; SD: standard deviation
From: Effectiveness of stenting for acute large bowel obstruction
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