Table 1:

Clinical practice guideline methodology: AGREE II checklist21,23,24

AGREE II checklist itemReporting criteriaPlanned guideline protocol
Domain 1: Scope and purpose
1. Guideline objectivesHealth intent, expected benefit, targets
  • To provide information and recommendations for women and their physicians when making decisions about diagnosis, prevention and risk reduction, management and outcomes related to BCRL

2. QuestionsTarget 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

3. PopulationTarget 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

Domain 2: Stakeholder involvement
4. Group membershipParticipants 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

5. Target population preferences and viewsPatients’ 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

6. Target usersIntended audience Use of guideline
  • Physicians as well as women with and at risk of BCRL

  • Inform clinical decisions and standards of care

Domain 3: Rigour of development
7. Search methodsElectronic 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

8. Evidence selection criteriaTarget 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

9. Strengths and limitations of evidenceStudy 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

10. Formulation of recommendationsRecommendation 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

11. Consideration of health benefits, side effects and risksData supporting benefits, harms and side effects, and balance of benefits and harms
  • Tables will be developed to outline the benefits and risks

  • Recommendations will consider the balance between benefits and risks as appropriate

12. Link between recommendations and evidenceLink 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

13. External reviewParticipants, purpose and intent of external review
  • Feedback from external experts and stakeholder groups will be solicited to improve the CPG quality and to obtain feedback on the draft recommendations

14. Updating procedureStatement on when the guideline will be updated
  • The steering committee will determine the timeline and outline criteria for future updates

Domain 4: Clarity of presentation
15. Specific and unambiguous recommendationsRecommendations 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

16. Management optionsPossible management options are clearly described
  • Management options will be articulated given the Canadian health care context, and the focus on self-management of lymphedema

17. Identifiable key recommendationsKey recommendations are easily identifiable
  • Key recommendations will be highlighted in an executive summary

  • Algorithms and flow charts will be created to highlight findings

Domain 5: Applicability
18. Facilitators and barriers to applicationFacilitators 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

19. Implementation advice and toolsTools 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

20. Resource implicationsPotential resource implications of recommendations
  • Where possible, costs related to diagnosis and management will be collected

  • Costs will be considered within the Canadian context

21. Monitoring and auditing criteriaProvide auditing criteria
  • Operational definitions will be determined to inform auditing and measurement of impact

Domain 6: Editorial independence
22. Funding bodyInfluence of funding body on guideline recommendations
  • Initial funding for the stakeholders meeting was received from the Oncology Division of the Canadian Physiotherapy Association

  • The CPG will be completed without influence from any funding body

23. Competing interestsAll 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

  • Note: AGREE II = Appraisal of Guidelines for Research and Evaluation II, AMSTAR = A Measurement Tool to Assess Systematic Reviews, AXIS = Appraisal Tool for Cross-Sectional Studies, BCRL = breast cancer–related lymphedema, CPG = clinical practice guideline, GRADE = Grading of Recommendations Assessment, Development and Evaluation, RCT = randomized controlled trial.

  • * Physicians are the target users in this domain.