Abstract
Objective To refine the process for endorsement of guidelines and establish the expectations of the College of Family Physicians of Canada (CFPC) regarding the quality and relevance of clinical practice guidelines targeting family physicians and their patients.
Composition of the committee Initially, a group of 6 CFPC staff and selected College members reviewed the previous process for endorsement with the aim of providing a new direction, if needed. The work was then assumed by the Guideline and Knowledge Translation Expert Working Group, a purposefully selected group of 9 family physicians from across Canada with expertise in research, evidence, guidelines, knowledge translation, and continuing professional development and education.
Methods The initial task force reviewed the endorsement process and identified areas for improvement. A draft new process and core criteria for high-quality guidelines were developed. This was approved by the CFPC board. A Guideline and Knowledge Translation Expert Working Group was then formed to further refine the process and the criteria. Multiple resources were used to inform the criteria. The Guideline and Knowledge Translation Expert Working Group will manage the endorsement process of external submitted guidelines, as well as provide high-level guidance to the CFPC regarding in-house guidelines and continuing professional development content.
Report This article provides the expectations of the CFPC regarding clinical practice guidelines and describes in detail the process and criteria for endorsement. Key principles include family physician involvement and guideline funding unlikely to introduce bias, with most criteria falling under 4 themed areas: relation to family medicine, CFPC values, patient engagement and decision making, and scientific rigour. The Guideline and Knowledge Translation Expert Working Group will report to the CFPC board at least once a year. It is hoped that this fully transparent process and these criteria will help advance the quality and standards of clinical practice guideline production in Canada.
Conclusion A comprehensive but reasonable list has been provided that reflects the best standards and recommendations and is consistent with the CFPC’s values while recognizing the landscape of guideline development for its national partners and colleagues. As with all processes, careful consideration and evaluation will be essential.
Clinical practice guidelines are generally appreciated and valued by family physicians.1,2 The volume of information relevant to primary care clinicians is overwhelming, and clear summaries of the best evidence with guidance could provide assistance to front-line clinicians.3 Four of the top 10 most read articles in Canadian Family Physician are guidelines.4 However, guidelines targeting family physicians can have many limitations, including industry influence through funding or conflicts of interest (COIs), inadequate inclusion of patient values and preferences, a disease-centred rather than a patient-centred focus, and minimal consideration of comorbidities, resources, and costs. In addition, a relative lack of family physicians on guideline-writing committees might translate into difficulties with implementation in primary care and clinical recommendations that are impractical to apply in a busy primary care practice.3,5-8
The College of Family Physicians of Canada (CFPC) is frequently approached to endorse clinical practice guidelines developed by external organizations and groups. The CFPC recognizes the value of the endorsement, the importance of this responsibility, and the requirement to perform these evaluations as responsibly and objectively as possible. Endorsement was previously administered by the CFPC’s Health Policy and Government Relations department, with a procedure that was diligent but at times too long, with challenges to finding relevant family physician reviewers and featuring high levels of CFPC board participation. To overcome these challenges, CFPC staff created an alternate process with the leadership transferred to the Programs and Practice Support (PPS) department and led by family physicians.
Composition of the committee
In the first stage, a group of 6 CFPC staff and selected members reviewed the previous process of endorsement with the aim of providing a new direction, if needed. The work was then assumed by the Guideline and Knowledge Translation Expert Working Group, a purposefully selected group of 9 family physicians from across Canada with expertise in research, evidence, guidelines, knowledge translation, and continuing professional development and education.
Methods
Development of process and principles for guideline endorsement. The new guideline endorsement process was developed in 2 stages. The first stage involved the creation of the general procedure to evaluate guidelines for potential endorsement and a set of preliminary criteria. These were developed through an iterative process and then drafted for review and approval by the CFPC board. The criteria were derived from familiar resources and guides that inform quality in clinical practice guidelines, including Clinical Practice Guidelines We Can Trust from the Institute of Medicine, the Guideline International Network, AGREE (Appraisal of Guidelines, Research & Evaluation), and others.9-13 The CFPC board approved the preliminary process and supported proceeding to next steps.
The Guideline and Knowledge Translation Expert Working Group was formed, primarily to oversee the process of external guideline endorsement and, to a lesser extent, the CFPC’s own guideline development, knowledge translation, and professional development offerings. This group includes family physician leaders in the areas of guidelines, research, knowledge translation, professional development, and practice support from across Canada. The expert working group reviewed the process and criteria developed in the first stage, then made recommendations to enhance efficiency and rigour, and to capture issues relevant to comprehensive family practice.
Report
Endorsement process. The expert working group created a series of steps to evaluate guidelines submitted for endorsement by the CFPC.
Guideline authors will be asked to complete the “CFPC Endorsement Criteria: Applicant Form” (available from CFPlus*).
The Director of PPS will assign 1 member of the expert working group to be lead reviewer. That person will function similarly to a journal editor in stewarding the guideline through the endorsement process.
The lead reviewer and the Director of PPS will review the application form. At this stage, they might decline to proceed to a full review for guidelines with serious limitations (see criteria below).
Those guidelines proceeding to a full review will be sent to 3 external peer reviewers, with a balance of comprehensive family physicians and family physicians with special interests or a focused practice relevant to the guideline. Reviewers will be given the guideline, the completed “CFPC Endorsement Criteria: Applicant Form,” and a blank “CFPC Endorsement Criteria: Reviewer Form” to complete (available from CFPlus*).
The lead reviewer, with help from CFPC staff, will compile the 3 external reviews. Adding in their own assessment, and in conversation with the Director of PPS, the lead reviewer will make a recommendation to the expert working group for endorsement. Guidelines will be recommended for endorsement if two-thirds of the committee vote in favour, with the Chair (Director of PPS) breaking ties, if necessary.
The final recommendation is prepared by the Director of PPS and forwarded to the Executive Director of Professional Development and Practice Support for approval. If the decision is complex or uncertain, the Executive Director will consult the Chief Executive Officer or the CFPC board.
The lead reviewer will provide feedback to the external peer reviewers, and reviewers will be issued certified Mainpro+ credits for the learning inherent in their review.
The Director of PPS will communicate with the guideline group seeking endorsement.
One appeal per guideline can be submitted formally to the CFPC and will be evaluated by the expert working group, with escalation to the Chief Executive Officer or board as needed.
Endorsement criteria. The criteria listed below serve as a guide to principles of high-quality guidelines and to the values of the CFPC.9-13 To receive endorsement from the CFPC, guidelines must be relevant to family medicine and have included family physician representation on the guideline committee, but otherwise, none of the criteria are absolute requirements. Funding and financial COIs would not wholly prevent endorsement but these features are weighted heavily in consideration and should be formally mitigated or ideally avoided at all stages of guideline production.
Initial criteria are considered fundamental to evaluation of guidelines for endorsement by the CFPC.
Sources of guideline funding, particularly the involvement of the health care or pharmaceutical industry and clarity of that information, are considered essential information.
There must be involvement of family physicians on the primary guideline committee.
At least summaries and decision aids must be available in both official languages.
Other endorsements of the guideline and how this guideline relates to or conflicts with other similar guidelines are also considered.
Full endorsement criteria are broken into sections.
Relation to family medicine.
- Topic relevant to primary care family physicians: Topic and questions should be highly relevant to family physicians, particularly those practising comprehensive care.
- Guideline committee members with CCFP (Certification in Family Medicine) designation: Ideally, more than 30% of committee members should have a CCFP designation, but less than 15% is considered poor representation.
- Guideline committee members who are primarily comprehensive primary care family physicians: Ideally, more than 25% of committee members should be comprehensive primary care family physicians, but less than 10% is considered poor representation.
- Practical application in primary care (time and opportunity cost considered): The guideline recommendations should be easily implemented in a comprehensive primary care practice. If guideline recommendations are not easy to implement, the likely benefit must be substantial and explained in the guideline.
- Guideline document size and primary care summary: Large and complex guideline documents without summaries or key recommendations are considered too cumbersome. Preferred guidelines are short (approximately 10 pages) and provide 1- to 2-page summaries of key points.
- Recommendation language: Where possible, favoured language of recommendations is adaptable and flexible, recognizing the individual patient and practice characteristics, rather than prescriptive and dogmatic. Examples of preferred language include “we recommend” or “we suggest.”14
Values of the CFPC.
- Broad representation on guideline committee: For most guidelines, we would prefer broad representation on the committee, including family physicians, other generalized specialists (such as general internists), other specialists, pharmacists, nurse practitioners or nurses, allied providers, methodologists, and most important, patients.
- Social justice lens: Guidelines should not negatively affect social justice such as the social determinants of health or diversity.
- Financial COIs: Financial COIs should be minimized, clearly described if present, and, where present, managed with clear description of how they are managed (eg, exclusion from voting).
- Presence of health care pharmaceutical industry employees on the guideline committee or membership: Ideally, there are no employees of the health care pharmaceutical industry on guideline committees. If present, this needs to be clearly described and management of this COI explained.
- Reputational risk to CFPC: Potential reputational risks should be considered, particularly for controversial topics, areas with polarized views, and other potentially challenging areas.
Patient engagement and decision making.
- Presentation of information: Guidelines that provide benefits and harms of interventions in absolute values for patient-oriented outcomes and avoid the use of surrogate markers are preferred.
- Shared informed decision-making content: To support informed patient choice, guidelines should provide decision-making content and resources that include a description of risks.
- Consideration of financial costs to the system: Increasing health care costs are a concern and guidelines should address how these issues were considered.
- Consideration of costs to the patient: In this case, costs means both financial costs and inconvenience to the patient (increasing testing, more interventions, more health care visits, etc), reflecting principles of minimally disruptive medicine.15 The authors should consider, if costs (in all forms) to patients are increasing, how other benefits have warranted the increased costs.
Scientific rigour.
- Development of clinical questions: Ideally, questions are developed in an iterative blinded fashion with contribution from the entire guideline committee.
- Evidence assessment: Guidelines should be informed by independent systematic reviews that are published or available with the guideline.
- Strength of the evidence and recommendations: The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach or something similar should be used in the guideline to evaluate the strength of the evidence and the recommendations.
- External peer review: All guidelines should have external peer review that includes a broad array of users and stakeholders (including patients), and that is responsive and transparent regarding feedback.
Issues not noted above.
- Issues not noted above: Anything the reviewers or the expert working group members might believe is relevant but that is not included in the criteria above.
Transparency. We have provided all relevant documents in the CFPlus* supplements, including the “CFPC Endorsement Criteria: Applicant Form” with a description of each criterion, the similar “CFPC Endorsement Criteria: Reviewer Form,” and the “CFPC Endorsement Process” document.
Conclusion
The CFPC takes its role regarding endorsement of guidelines relevant to family physicians seriously. We have provided a comprehensive but reasonable list that reflects the best standards and recommendations and is consistent with the CFPC’s values while recognizing the landscape of guideline development for our national partners and colleagues. As with all processes, careful consideration and evaluation will be essential. The Guideline and Knowledge Translation Expert Working Group will review their process and outcomes every 6 to 12 months, report to the CFPC board, and adjust as needed.
If you would like to be a guideline reviewer for the CFPC, we would appreciate hearing from you (mallan{at}cfpc.ca).
Notes
Editor’s key points
▸ Primary care practitioners appreciate the guidance clinical practice guidelines offer, but guidelines are often developed without meaningful input from those who will be implementing them. This can translate into difficulties with putting guidelines intended for primary care into practice and can lead to clinical recommendations that are impractical to apply in a busy primary care setting.
▸ The College of Family Physicians of Canada aimed to establish criteria, set out here, for the endorsement of clinical practice guidelines in order to provide a clear and transparent process and ensure that endorsed guidelines are of high quality and relevant for family physicians and their patients.
Footnotes
Contributors
All authors contributed to the criteria and to preparing the manuscript for submission.
Competing interests
None declared
This article is eligible for Mainpro+ certified Self-Learning credits. To earn credits, go to www.cfp.ca and click on the Mainpro+ link.
La traduction en français de cet article se trouve à www.cfp.ca dans la table des matières du numéro de juillet 2021 à la page e169.
↵* The “CFPC Endorsement Criteria: Applicant Form,” the “CFPC Endorsement Criteria: Reviewer Form,” and the “CFPC Endorsement Process” documents are available at www.cfp.ca. Go to the full text of the article online and click on the CFPlus tab.
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