Domain 1: Scope and purpose |
1. Guideline objectives | Health intent, expected benefit, targets |
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2. Questions | Target population Interventions or exposures Outcomes Context |
Women with breast cancer with or at risk of developing lymphedema Diagnosis, risk reduction, management and outcomes Improve the care of women with BCRL; focus on self-management Canadian health care system
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3. Population | Target population Clinical condition Severity of disease |
Adult women with breast cancer* Breast cancer — from diagnosis to palliative stages Lymphedema — all stages and severity of the condition
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Domain 2: Stakeholder involvement |
4. Group membership | Participants Membership expertise Institutions and organizations Geographic location Members’ roles |
Steering committee, management team and working groups: researchers, clinicians, specialist and patient representatives from across Canada Partners: Canadian Physiotherapy Association Oncology Division, CancerControl Alberta’s Guideline Resource Unit and the Canadian Lymphedema Framework Member roles will be defined and shared
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5. Target population preferences and views | Patients’ views and preferences |
Patient representatives will be involved at all stages of guideline development Literature review of patients’ values and preferences Survey, focus groups and consultation with patient groups
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6. Target users | Intended audience Use of guideline |
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Domain 3: Rigour of development |
7. Search methods | Electronic databases Time periods of searches Search strategy |
MEDLINE, Embase, Scopus, CINAHL, Proquest Dissertations and Theses Global, PEDro, Cochrane Library, Trip Pro, Agency for Healthcare Research and Quality’s National Guideline Clearinghouse Guidelines and systematic reviews: Mar. 1, 2014, to Oct. 31, 2021; RCTs: Mar. 1, 2014, to Oct. 31, 2021 Further details on the search terms and strategy are provided in Appendix 1 (available at www.cmajopen.ca/content/10/2/E338/suppl/DC1)
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8. Evidence selection criteria | Target population Study design Outcomes Languages |
Women with BCRL CPGs; systematic reviews; cross-sectional studies (diagnosis); cohort studies (prognosis); RCTs (treatment and management) Diagnosis and assessment; risk reduction and prevention; management and treatment; outcomes and surveillance No language restrictions
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9. Strengths and limitations of evidence | Study methodology to evaluate quality |
CPGs: AGREE II appraisal; systematic reviews: AMSTAR; cross-sectional studies: AXIS; cohort studies: Newcastle–Ottawa Scale; RCTs: Cochrane risk-of-bias tool Rating of evidence: tables reflecting GRADE and detailing the level of evidence, consistency of results, direction of results, magnitude of benefit (versus harm) and applicability to practice context in Canada will be developed
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10. Formulation of recommendations | Recommendation development process |
ADAPTE will be used to incorporate recommendations from existing guidelines Noncontentious findings: steering committee will vote in situations where the level of evidence and the balance between benefits and harms is established, findings are consistent across studies and the recommendation is applicable to the Canadian context Contentious findings or in cases in which there is no evidence: stakeholder consensus on recommendation (best practice statement) or explanation of reasons if consensus cannot be reached
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11. Consideration of health benefits, side effects and risks | Data supporting benefits, harms and side effects, and balance of benefits and harms |
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12. Link between recommendations and evidence | Link between evidence and recommendations is explicit |
The recommendations will be supported by the level of evidence, the extent of the evidence (total number of studies and total number of subjects), the direction of effect and the magnitude of effect and, where possible, consideration will be given to the stage and severity of lymphedema
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13. External review | Participants, purpose and intent of external review |
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14. Updating procedure | Statement on when the guideline will be updated |
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Domain 4: Clarity of presentation |
15. Specific and unambiguous recommendations | Recommendations are specific with circumstances and relevant populations identified |
Recommendations will be presented with a clear purpose and in an actionable statement format Areas of uncertainty and those requiring further research will be identified A lay summary of the findings will be shared with stakeholder groups
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16. Management options | Possible management options are clearly described |
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17. Identifiable key recommendations | Key recommendations are easily identifiable |
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Domain 5: Applicability |
18. Facilitators and barriers to application | Facilitators and barriers to the guideline’s application are described |
Information on barriers and facilitators to the CPG will be sought at the draft CPG stage The CPG will be evaluated in Alberta, Canada, before national implementation
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19. Implementation advice and tools | Tools to support application of the guideline |
Materials will be created to support CPG implementation Short videos will be created for health care professionals and patients; videos will be housed on the Oncology Division of the Canadian Physiotherapy Association and Canadian Lymphedema Framework websites
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20. Resource implications | Potential resource implications of recommendations |
Where possible, costs related to diagnosis and management will be collected Costs will be considered within the Canadian context
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21. Monitoring and auditing criteria | Provide auditing criteria |
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Domain 6: Editorial independence |
22. Funding body | Influence of funding body on guideline recommendations |
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23. Competing interests | All group members must declare competing interests |
All CPG steering committee, management team and working group members will be required to provide written documentation declaring any competing interests People associated with industry or private businesses or who declare other competing interests that could influence the guideline process or development will not be eligible to participate
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