Guideline development process
Guideline development process
Introduction
The need to develop guidelines for detection, assessment and management of Barrett’s oesophagus and oesophageal adenocarcinoma was identified as a priority arising from the strategic research partnership between ProbeNet and Cancer Council NSW. Cancer Council Australia was approached to collaborate in developing and establishing these Clinical Practice Guidelines for the Management of Barrett's Oesophagus and Early Oesophageal Adenocarcinoma for the Australian community and healthcare setting. No external funding has been received to develop these guidelines.
The guidelines were developed by a multidisciplinary working group (see Guideline Working Party members). Topic leaders from the Working Party membership were designated to address topics in their areas of expertise, with other Working Group members contributing as co-authors. The literature assessed for these guidelines focuses on the diagnosis and management of patients with Barrett’s Oesophagus and early oesophageal adenocarcinoma.
The guideline development process, conducting the literature searches, appraising the literature and formulating and grading recommendations, followed the guideline development process outlined below.
Steps in preparing clinical practice guidelines
Clinical practice guidelines are based on a systematic review where possible. The Working Party developed clinical questions which determined the scope for the guidelines. The search strategy and literature search was conducted by the Project Officer, who distributed the search results to the Working Party authors. Topic groups were assigned to review and synthesise the relevant literature and to formulate evidence-based recommendations where possible. Each topic author followed a clear strategy and the appropriate steps in preparing their guideline sections.
The strategic steps followed are outlined below:
- Structure the research questions
- Develop a search strategy
- Search the literature
- Critically appraise the literature
- Formulate and grade recommendations
Structure the research questions
The Working Party discussed the most important aspects for diagnosing and managing Barrett's Oesophagus and Early Oesophageal Adenocarcinoma and developed clinically focused key questions. These clinical questions were developed and approved by Working Party members. The clinical questions asked for the Barrett's Oesophagus and Early Oesophageal Adenocarcinoma Guidelines are as follows:
Barrett's Oesophagus without Dysplasia
Natural History
- What is the prevalence of BO in the Australian population in comparison with other populations?
- Which factors best predict the risk of developing BO?
- What is the incidence of neoplasia in patients with BO?
- What are the risk factors for progression from non-dysplastic BO to high-grade dysplasia or adenocarcinoma?
Referral
Diagnosis/Definition
- What is the endoscopic definition of BO and how is it described?
- What is the optimal tissue sampling at endoscopy for diagnosis of BO?
- What is the histological definition of BO?
Management
- Are there any medical or surgical interventions that cause regression of BO?
- Are there any treatments that prevent progression of BO to cancer?
- What is appropriate medical systemic therapy for symptoms associated with BO?
- Is there a role for ablative therapy to treat BO?
Surveillance and Follow-up
- How frequently should patients with BO undergo endoscopy?
- Are there groups of patients with non-dysplastic BO that require more frequent surveillance?
- Are there groups of patients with BO that can be discharged from surveillance?
- Is surveillance cost-effective for follow-up of patients with BO?
Barrett's Oesophagus with Dysplasia and/or Adenocarcinoma
Definition and Diagnosis
- What are the histological features of early adenocarcinoma of the oesophagus?
- What are the best modalities for accurately staging early oesophageal adenocarcinoma?
Biomarkers
Management
Low grade dysplasia
High grade dysplasia and early cancer
Develop a search strategy
Appropriate search strategies were constructed for each clinical question. MeSH terms were agreed by the Working Party members and were expanded by the Project Officer after conducting pilot searches and searching the MeSH vocabulary. MeSH index terms were translated to Emtree terms for the Embase database to ensure that appropriate index terms unique to each database were used. When there was no appropriate MeSH or Emtree index term available a combination of free text words were used in order to capture the relevant data.
The following exclusion criteria was applied: studies published pre 1980, languages other than English, conference abstracts and the following study designs: non-systematic reviews, case reports, letters, editorials, comments, animal, in vitro and laboratory studies. This exclusion criteria was then refined as per individual clinical question. The search strategy was approved by the members of the Working Party.
Search the literature
A range of medical databases, guideline clearinghouses and clinical trial portals were searched. These included The Cochrane Library, PubMed, Embase, Trip Database, Econlit, NHS Economic Evaluation Database, the National Guideline Clearinghouse, the National Comprehensive Cancer Network and the National Institute for health and clinical excellence, Scottish Intercollegiate Guidelines Network and Canadian Medical Association. Search results were screened for relevance by the Project Officer and relevant literature was collated, the full text articles obtained and sent to Working Party topic authors to critically appraise, synthesise and use as the evidence base for their topic questions. To view the complete search yield and more detailed information about the literature search such as inclusion and exclusion criteria, please go to each clinical question page. The information can be found in the Appendices on each question page.
Critically appraise the literature
Relevant articles selected from the literature search were reviewed by the clinical question authors and each article was critically appraised with respect to level of evidence, quality of the evidence, size of the effect and clinical importance and relevance. Level of evidence was assigned according to the following criteria from the NHMRC Evidence Hierarchy:
| Level | Intervention | Diagnosis | Prognosis | Aetiology | Screening |
|---|---|---|---|---|---|
| I | A systematic review of level II studies | A systematic review of level II studies | A systematic review of level II studies | A systematic review of level II studies | A systematic review of level II studies |
| II | A randomised controlled trial | A study of test accuracy with: an independent, blinded comparison with a valid reference standard, among consecutive patients with a defined clinical presentation | A prospective cohort study | A prospective cohort study | A randomised controlled trial |
| III-1 | A pseudo-randomised controlled trial (i.e. alternate allocation or some other method) | A study of test accuracy with: an independent, blinded comparison with a valid reference standard, among non-consecutive patients with a defined clinical presentation | All or none | All or none | A pseudo-randomised controlled trial (i.e. alternate allocation or some other method) |
| III-2 | A comparative study with concurrent controls:
|
A comparison with reference standard that does not meet the criteria required for Level II and III-1 evidence | Analysis of prognostic factors amongst untreated control patients in a randomised controlled trial | A retrospective cohort study | A comparative study with concurrent controls:
|
| III-3 | A comparative study without concurrent controls:
|
Diagnostic case-control study | A retrospective cohort study | A case-control study | A comparative study without concurrent controls:
|
| IV | Case series with either post-test or pre-test/post-test outcomes | Study of diagnostic yield (no reference standard) | Case series, or cohort study of patients at different stages of disease | A cross-sectional study | Case series |
Source: National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRC; 2009.[1] (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)
Formulate and grade recommendations
The body of literature was assessed by each topic author and recommendation grades were assigned using the following criteria adapted from the NHMRC body of evidence matrix:
| Component of Recommendation | ||||
|---|---|---|---|---|
| Volume of evidence 1** | one or more level I studies with a low risk of bias or several level II studies with a low risk of bias | one or two level II studies with a low risk of bias or a systematic review/several level III studies with a low risk of bias | one or two level III studies with a low risk of bias, or level I or II studies with a moderate risk of bias | level IV studies, or level I to III studies/systematic reviews with a high risk of bias |
| Consistency 2** | all studies consistent | most studies consistent and inconsistency may be explained | some inconsistency reflecting genuine uncertainty around clinical question | evidence is inconsistent |
| Clinical impact | very large | substantial | moderate | slight or restricted |
| Generalisability | population/s studied in body of evidence are the same as the target population for the guideline | population/s studied in the body of evidence are similar to the target population for the guideline | population/s studied in body of evidence differ to target population for guideline but it is clinically sensible to apply this evidence to target population3 | population/s studied in body of evidence different to target population and hard to judge whether it is sensible to generalise to target population |
| Applicability | directly applicable to Australian healthcare context | applicable to Australian healthcare context with few caveats | probably applicable to Australian healthcare context with some caveats | not applicable to Australian healthcare context |
- 1 Level of evidence determined from level of evidence criteria
- 2 If there is only one study, rank this component as ‘not applicable’
- 3 For example results in adults that are clinically sensible to apply children OR psychosocial outcomes for one cancer that may be applicable to patients with another cancer.
- ** For a recommendation to be graded A or B, the volume and consistency of evidence must also be graded either A or B!
Source: National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRC; 2009.[1] (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)
Recommendation grades are indicated below:
| Description | |
|---|---|
| Body of evidence can be trusted to guide practice | |
| Body of evidence can be trusted to guide practice in most situations | |
| Body of evidence provides some support for recommendation(s) but care should be taken in its application | |
| Body of evidence is weak and recommendation must be applied with caution | |
| Where no good-quality evidence is available but there is consensus among Guideline committee members, consensus-based guidance points are given, these are called "Practice points" |
Adapted from: National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRC; 2009.[1] (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)
Write the topic
Topic authors were asked to write the content for their guideline question topic using the following format:
- background
- review of the evidence
- evidence summary with levels of evidence and numbered references
- recommendation(s) and corresponding grade(s)
- references
Review of the question topics
The body of evidence and recommendations for each question topic were reviewed by the Guidelines Working Party and final recommendations agreed to, based on the evidence.
Public consultation
The draft guidelines were released for public consultation to all interested parties in Australia for the period from 11 June to 11 July 2014. The consultation process involved soliciting public review of the draft guidelines through posting onto the Cancer Council Australia Cancer Guidelines Wiki and alerting professional societies and other interest groups via link to the site. All feedback on the draft received during the consultation period in Australia was reviewed by the topic authors and Guidelines Working Party. Subsequent changes to the draft was agreed by consensus of the Guideline Working Party, based on consideration of the evidence.
References
<references>
- ↑ 1.0 1.1 1.2 National Health and Medical Research Council. NHMRC Australian Guidelines to reduce health risks from drinking alcohol. Commonwealth of Australia: National Health and Medical Research Council; 2009 Jan 1 Available from: http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/ds10-alcohol.pdf.