Guideline development process
Author(s):
Guidelines commissioned by
Last modified:
27 June 2014 01:01:02
Guideline development process
Introduction
Cancer Council Australia (CCA) was commissioned by Cancer Australia (CA) to revise the treatment section of the Clinical Practice Guidelines for the Diagnosis and Management of Lung Cancer 2004 (Chapters 5 – Management of non-small cell lung cancer and 6 – Management of small cell lung cancer).
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 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
A clear strategy was developed and each topic author followed the appropriate steps in preparing their guideline sections. The Working Party developed clinical questions and topic groups were assigned to review and synthesise the relevant literature and to formulate evidence-based recommendations. The search strategy and literature search was conducted by the Project Officer, who distributed the search results to the Working Party authors.
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 of treatment for non-small cell lung cancer and small cell lung cancer and developed clinically focussed key questions. These questions were developed and approved by Working Party members.
The clinical questions asked for non-small cell lung cancer and small cell lung cancer, are as follows:
Non small-cell lung cancer
Stage I operable
Surgery
- Does complete mediastinal lymph node dissection improve overall survival compared to mediastinal lymph node staging in stage I NSCLC?
- Is minimally invasive lobectomy as effective as open lobectomy for treatment of operable stage I NSCLC?
Radiotherapy
- What is the role of radiotherapy in the treatment of operable stage I NSCLC?
- What is the role of radiotherapy after surgery in the treatment of operable stage I NSCLC?
Chemotherapy
- What is the role of chemotherapy before surgery in the treatment of operable stage I NSCLC?
- What is the role of chemotherapy after surgery in the treatment of operable stage I NSCLC?
Stage I inoperable
Radiotherapy
Surgery
Chemotherapy
Stage II operable
Surgery
Radiotherapy
Chemotherapy
- What is the role of chemotherapy before surgery in the treatment of operable stage II NSCLC?
- What is the role of chemotherapy after surgery in the treatment of operable stage II NSCLC?
Stage II inoperable
Radiotherapy
Chemotherapy
Stage III operable
Radiotherapy
Surgery
- What is the clinical benefit of mediastinal lymph node dissection in stage IIIA operable NSCLC?
- What is the clinical benefit of the addition of surgery to definitive chemoradiotherapy in stage IIIA (N2) NSCLC?
Chemotherapy
- What is the clinical benefit of adjuvant chemotherapy for patients with stage III operable NSCLC?
- What is the clinical benefit of neoadjuvant chemotherapy for patients with stage III operable NSCLC?
- What is the clinical benefit of the addition of neoadjuvant radiotherapy to neoadjuvant chemotherapy in stage IIIA (N2) disease?
Stage III inoperable
Radiotherapy
- What is the recommended treatment approach for the definitive management of patients with good performance status and inoperable stage III disease?
- What is the optimal radiation dose and fractionation schedule for good performance status patients with inoperable stage III NSCLC undergoing curative therapy?
- What are the principles of radiation therapy in the definitive management of stage III inoperable NSCLC?
- What is the optimal treatment approach for patients with stage III inoperable NSCLC who, because of patient or tumour factors, are not suitable for curative treatment with concurrent chemo-radiotherapy?
- What is the role of prophylactic cranial irradiation (PCI) in patients with stage III NSCLC?
- What is the optimal management of Pancoast tumours?
Stage IV operable
Radiotherapy
Surgery
- What is the clinical benefit of resection of brain metastasis?
- What is the clinical benefit of resection of primary disease after complete resection of metastatic disease?
Stage IV inoperable
Radiotherapy
- What is the clinical benefit of radiotherapy to the lung primary in stage IV NSCLC?
- What is the clinical benefit of radiotherapy to the brain for patients with inoperable brain metastases from NSCLC?
- What is the role of stereotactic radiosurgery in the treatment of brain metastases?
- What is the clinical benefit of radiotherapy to the bone for metastatic disease from NSCLC?
- What is the clinical benefit of radiotherapy in metastatic spinal cord compression?
Chemotherapy
- What is the optimal first-line chemotherapy regimen in patients with stage IV inoperable NSCLC?
- Is carboplatin based chemotherapy as effective as cisplatin based chemotherapy for treatment of stage IV inoperable NSCLC?
- Which new agent or platinum combination regimen is best for treatment of stage IV inoperable NSCLC?
- Is monotherapy with new third generation (3G) agents as effective as platinum combination therapy for treatment of stage IV inoperable NSCLC?
- Are three chemotherapy agents better than two chemotherapy agents for treatment of stage IV inoperable NSCLC?
- Are non-platinum doublet chemotherapy regimens as effective as platinum doublet regimens for treatment of stage IV inoperable NSCLC?
- What is the optimal duration of first-line chemotherapy for treatment of stage IV inoperable NSCLC?
- Is chemotherapy with a biologic or targeted therapy superior to chemotherapy alone in unselected patients for treatment of stage IV inoperable NSCLC?
- What is the optimal chemotherapy regimen for overall quality of life for patients in the treatment of stage IV inoperable NSCLC?
- What is the optimal first-line maintenance therapy for treatment of stage IV inoperable NSCLC?
- What is the optimal second-line therapy in patients with stage IV inoperable NSCLC?
- What is the optimal third-line therapy in unselected patients with stage IV inoperable NSCLC?
- What is the optimal systemic therapy regimen for patients with poor performance status for treatment of stage IV inoperable NSCLC?
- What is the optimal systemic therapy regimen for elderly patients for treatment of stage IV inoperable NSCLC?
- What is the optimal systemic therapy regimen in selected patients for treatment of stage IV inoperable NSCLC?
Small cell lung cancer
Limited stage
Chemotherapy
- What is the optimal systemic therapy and duration to be used for the treatment of limited stage small cell lung cancer?
- What is the optimal concurrent chemotherapy to be used for the treatment of limited stage small cell lung cancer with radiotherapy?
Radiotherapy
- Which patients with SCLC benefit from prophylactic cranial irradiation?
- What is the optimal dose and fractionation schedule of prophylactic cranial irradiation in patients with limited stage SCLC?
- What is the optimal timing of thoracic radiotherapy in patients receiving chemotherapy for limited stage SCLC?
- What is the optimal dose and fractionation schedule of thoracic radiotherapy in patients with limited stage SCLC?
- What is the optimal treatment volume in patients with limited stage SCLC receiving thoracic radiotherapy?
Extensive stage
Chemotherapy
- What is the optimal chemotherapy regimen and duration of therapy in extensive stage small cell lung cancer in the first-line setting?
- What is the optimal second-line therapy in patients with extensive stage small cell lung cancer?
Radiotherapy
- What is the optimal dose and fractionation schedule of prophylactic cranial irradiation in patients with extensive stage SCLC?
- Is there a role for thoracic radiotherapy in patients with extensive stage SCLC?
Palliative care
- What is the role of palliative care in symptom management for patients with lung cancer?
- What is the role of advance care planning and timing of referral for patients with lung cancer?
- What is the role of psychological support and interventions in the treatment of lung cancer?
Supportive care
- What is the optimal management of malignant pleural effusions?
- What is the role of case management in the treatment of patients with lung cancer?
- What is the role of topical creams, skin moisturisers and maintenance antibiotics in the treatment of rash from anti-EGFR therapy in patients with lung cancer?
Develop a search strategy
Appropriate search strategies were constructed for each clinical question. MeSH terms were agreed by the Working Party members and where 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 2002 (with the exception of some stage III and IV questions and the relevant articles carried on from the 2004 guidelines), languages other than English, and the following study designs: non-systematic reviews, case reports, letters, editorials, comments, animal, in vitro and laboratory studies. The search strategy was approved by the Chair 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, the National Guideline Clearinghouse, the National Comprehensive Cancer Network, Canadian Medical Association Clinical Practice Guidelines, the Scottish Intercollegiate Guidelines Network and the National Institute for health and clinical excellence. 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 guidelines was released for public consultation to all interested parties in Australia for the period from 1 May to 31 May 2012. 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 groups and sponsors via link to the site. All feedback on the draft received during the consultation period in Australia was reviewed by the Guidelines Working Party topic authors. Subsequent changes to the draft were agreed by consensus, 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.