Last updated: March 15, 2023
6.1 Clinical and Content Experts
6.1.1 Conflict of Interest, Confidentiality and Acknowledgment
6.2.1 Identification of Peer Reviewers
6.2.2 Conflict of Interest, Confidentiality and Acknowledgment
6.3.1 Identification of Stakeholders
6.3.2 Conflict of Interest, Confidentiality and Acknowledgment
Appendix: Identification and Selection of Clinical and Content Experts
The Task Force collaborates with a number of external partners: clinical and content experts, peer reviewers and stakeholders. Clinical and content experts are engaged early in the guideline process to serve as advisors to the working group and provide topic-specific expertise throughout the guideline process. Peer reviewers are invited to review and provide feedback on the Evidence Review and Synthesis Centre’s (ERSC) protocol and evidence review and the Task Force’s guideline. Stakeholders are engaged early and often throughout the guideline process. They participate in numerous activities, such as providing feedback on key documents, endorsing Task Force guidelines and disseminating guideline materials.
The guideline working group aims to engage appropriate clinical or content experts as early as possible in the guideline process. The process for identification and selection of clinical experts is outlined in the Appendix. Experts act as advisors to the working group, providing input to inform development of the protocol, evidence review and guideline. Prior to participation, the Science Team will provide experts with a virtual Task Force and guideline-specific orientation session. Clinical and content experts do not provide input or vote on the direction or strength of recommendations, however, they may provide input on the wording of recommendations, for example, to help improve clarity.
Activities of clinical and content experts include the following:
Each potential clinical or content expert is asked to declare potential conflicts of interest using a Disclosure Form (See the Task Force Policy on disclosures of interests and management of conflicts of interest, Appendix I). The Task Force’s Oversight Committee for Conflict of Interest (COI) will assess declared interests and decide whether or not the individual may participate as a clinical or content expert advisor to the working group. This may require seeking additional information on specific declared interests from the expert. Potential experts with COI may be allowed to participate in certain situations, such as when the COI is deemed manageable and not so extensive as to potentially impair the credibility of their input, if the COI is nonfinancial, and if highly knowledgeable reviewers without such conflicts are unavailable. More information on the management of COI is available in the Task Force COI Policy.
Prior to participating in document review, all clinical or content experts must sign a Confidentiality Agreement (See Chapter 1, Appendix 2).
Clinical and content experts must also sign an Acknowledgement Agreement prior to participation. Clinical and content experts provide the Task Force with consent to publicly acknowledge their participation in the final published guideline and to post disclosures on the Task Force website, independent of their agreement with the final recommendations. To maintain transparency in the guideline process, the conditions of this agreement are irrevocable.
Peer reviewers are qualified individuals, external to the Task Force, with content-specific (scientific or clinical) expertise, who are invited to review and provide feedback on key scientific documents generated by the Task Force and ERSCs. These reviewers are individuals who provide their own feedback and are not already acting as clinical or content experts as described in section 6.1.
For protocols and evidence reviews, the journal manages most of the peer review process, with some administrative support provided by the Task Force Office. For guidelines, the Task Force Chair, Science Team and Task Force Office manage an internal peer reviewer process prior to journal submission.
The KT Team and Science Team use a formal process to identify potential topic-specific peer reviewers early in the guideline development process. For each guideline topic, the list of peer reviewers (and stakeholders) is approved by the working group (by non-objection).
Protocol and Evidence Review
For protocols and evidence reviews, the Task Force Office will send the list of potential reviewers to the journal. The journal will select the top peer reviewer candidates from the list and the Task Force Office will email selected individuals to request their commitment and confirm their availability to review the manuscript. The journal may request the Task Force Office contact additional potential peer reviewers as needed. The journal conducts all subsequent management of peer reviewers, with administrative support from the Task Force Office, as needed.
Guideline
For guidelines, the Task Force Office sends invitations to potential peer reviewers and coordinates necessary forms (see section 6.2.2). The same individuals who reviewed the protocol and evidence review will be invited to participate in review of the guideline, as well as any other potential reviewers identified as candidates. In some cases, invited peer reviewers may not be able to participate in the review of Task Force guidelines (e.g., resource constraints, Task Force Office unable to receive response despite multiple attempts). The working group may elect to modify the list (typically by adding or replacing reviewers) as needed.
Protocol and Evidence Review
For protocols and evidence reviews, the journal manages its own policies related to COI, confidentiality and acknowledgement. Peer reviewers may be asked to agree to the journal’s open peer review policy.
Guideline
For guidelines, each peer reviewer is asked to declare potential conflicts of interest using a Disclosure Form (See the Task Force Policy on disclosures of interests and management of conflicts of interest, Appendix I). The Task Force’s Oversight Committee for COI will assess declared interests and determine next steps. In some cases, the Task Force may not invite an individual with a significant COI to participate as a guideline peer reviewer. Otherwise, declared interests and COI are taken into consideration by the guideline working group and Task Force when interpreting the input peer reviewers provide. More information on the management of COI is available in the Task Force COI Policy.
Prior to participating in guideline review, all peer reviewers must sign a Confidentiality Agreement (See Chapter 1, Appendix 2).
As per the Task Force’s open review process, guideline peer reviewers must also sign a binding Acknowledgement Agreement prior to participation to maximize transparency. They agree to have their names, affiliations, comments, and disclosed conflict of interests posted on the Task Force website, and for their names and affiliations to be published in the final guideline.
A minimum of three peer reviewers is required for review of each key document in the guideline development process: draft protocol, draft evidence review and draft guideline. At the discretion of the working group, and with approval of the Task Force Chair, certain topics may warrant fewer guideline reviewers due to the availability of qualified reviewers.
Protocol and Evidence Review
After Task Force approval of draft protocols and evidence reviews, the journal coordinates sending materials to peer reviewers for review. The journal conducts all subsequent management of peer reviewers, with administrative support from the Task Force Office, as needed. Peer reviewer reports are typically included on the journal’s website.
Guideline
Following Task Force approval of a draft guideline, the Science Team and Task Force Office coordinate sending the guideline to peer reviewers for review. After all peer reviewer feedback is received, the Science Team will create a disposition table with reviewer comments and proposed responses. The working group will review this disposition tables and, in conjunction with the Science Team, summarize key issues. Comments, responses and a summary of key issues will be shared with the entire Task Force for consideration during review of the final version of the guideline.
This is an open process; names and affiliations of the external reviewers are identified in the disposition tables received by the working group and Task Force. Upon guideline release, reviewer names, affiliations, comments, and disclosed conflict of interests are posted on the Task Force website along with the Task Force’s responses to the comments to maximize transparency. Peer reviewer names and affiliations are also published in the final guideline.
Stakeholders are representatives of organizations who are invited by the Task Force to provide their perspectives. Stakeholder organizations can include health care organizations (e.g., professional societies, associations, etc.), government-related organizations, and, in certain cases, selected groups of practitioners. There are some organizations that are considered to be core stakeholder organizations for all Task Force guidelines (general), and others that are selected based upon the guideline topics (guideline-specific). They are invited to review and provide feedback on key scientific documents (i.e., protocol including analytical framework, evidence review, draft guideline) generated by the Task Force and ERSCs.
Effective engagement of stakeholders is central to the successful management of the dissemination, uptake and impact of guidelines. Therefore, the Task Force strives to foster positive relationships with stakeholders by maintaining open and transparent communication.
The Task Force’s approach to stakeholder engagement is an iterative process involving the following activities:
The KT Team and Science Team use a formal process to identify potential topic-specific stakeholders early in the guideline development process.
For each guideline topic, the stakeholder (and peer reviewer) list is approved by the working group (by non-objection). The Task Force Office sends invitations to potential stakeholder organizations and coordinates necessary forms (see section 6.3.2). A stakeholder organization will identify one or more people to act as a representative. If the organization identifies an individual who is already a peer reviewer, the Task Force will request that another individual be selected to represent the organization. As a general rule, once a list is established, the same individuals will be invited to participate at all stages (protocol, evidence review and guideline). In some cases, invited stakeholders may not be able to participate in the review of Task Force documents (e.g., resource constraints, Task Force Office unable to receive response despite multiple attempts). The working group may elect to modify the list (typically by adding or replacing stakeholders) at any stage during the guideline development process.
Normally, only national organizations are invited to participate as stakeholders, but in some cases non-national groups may be included if their input is felt to be critical. The task of identifying appropriate stakeholders may be outsourced by the Task Force at its discretion.
Stakeholder organizations include but are not limited to the following:
The Task Force recognizes that different stakeholders have a range of capacity to be engaged. Each guideline topic will have its own unique set of stakeholders and a corresponding plan for KT.
Each potential stakeholder is asked to declare potential conflicts of interest using a Disclosure Form (See the Task Force Policy on disclosures of interests and management of conflicts of interest, Appendix I). COI among stakeholders do not exclude them from reviewing Task Force and ERSC products. Interests and COI declared by stakeholders are taken into consideration by the guideline working group, Task Force and ERSCs when interpreting the input they provide. More information on the management of COI is available in the Task Force COI Policy.
Prior to participating in document review, all stakeholders must sign a Confidentiality Agreement (See Chapter 1, Appendix 2).
As per the Task Force’s open review process, stakeholders must also sign a binding Acknowledgement Agreement prior to participation to maximize transparency. They agree to have their names, affiliations, comments, and disclosed conflict of interests posted on the Task Force website, and for their names and affiliations to be published in the final guideline. Stakeholders who review protocols and final evidence reviews agree to have this information published on the journal’s website.
The Task Force engages stakeholders at various points throughout the guideline development and launch process.
As mentioned in Chapter 2, the Task Force may solicit topic suggestions from stakeholders by inviting them to complete the Topic Submission Form on the Task Force website.
A minimum of ten stakeholders is required for review of each document in the guideline development process: draft protocol, draft evidence review and draft guideline. At the discretion of the working group, and with approval of the Task Force Chair, certain topics may warrant fewer reviewers due to the availability of qualified reviewers.
Protocol and Evidence Review
After Task Force approval of draft protocols and evidence reviews, the Science Team and Task Force Office coordinate sending materials to stakeholders for review. In addition to the draft documents, stakeholders receive a review checklist which asks for specific feedback (e.g., feedback on eligibility criteria for protocols, clarity of results and conclusions in evidence review).
Once external review for a protocol or evidence review draft is complete, the ERSC will create a disposition table with compiled reviewer comments and proposed responses. The working group will review this disposition table and, in conjunction with the ERSC and Science Team, summarize key issues. Comments, responses and a summary of key issues will be shared with the entire Task Force for consideration during review of the final version of the protocol and evidence review. Stakeholder information and comments are typically published with the protocol and evidence review as an additional file.
Guideline
Following Task Force approval of a draft guideline, the Science Team and Task Force Office coordinate sending the guideline to stakeholders for review. A review checklist asking for specific feedback (e.g., clarity of guideline objective, whether or not patient groups are clearly described) is included with the draft guideline materials.
After all stakeholder feedback is received, the Science Team will create a disposition table with reviewer comments and proposed responses. The working group will review this disposition table and, in conjunction with the Science Team, summarize key issues. Comments, responses and a summary of key issues will be shared with the entire Task Force for consideration during review of the final version of guideline.
This is an open process; names and affiliations of the external reviewers are identified in the disposition tables received by the working group and Task Force. Upon guideline release, reviewer names, affiliations, comments, and disclosed conflict of interests are posted on the Task Force website along with the Task Force’s responses to the comments to maximize transparency. Stakeholder names and affiliations are also published in the final guideline.
Stakeholders are engaged before the launch of a new guideline to give them lead time to prepare for the release. For example, they may need time to prepare for media interactions and/or to make changes to policies or programs.
Pre-launch engagement may take the form of letters announcing upcoming guidelines, technical briefings, webinars, and the early release of guidelines and KT tools. For example, for each guideline, certain stakeholders are invited to attend a briefing before the release. This session gives stakeholders the opportunity to ask questions regarding the development and roll-out of the guideline. Each organization that attends a briefing and/or receives advance materials is required to sign and return the Confidentiality Agreement (see Chapter 1, Appendix 2). Depending upon their particular requirements and their respective relationships with the Task Force, some organizations are given embargoed copies of the guideline and KT tools before the guideline release.
Prior to a guideline’s release, the Task Force will seek formal endorsement from organizations that guide primary care practice in Canada, including the CFPC and NPAC. These organizations were selected as the primary endorsement organizations because of their unique historical relationship with the Task Force and primary care providers in Canada. Depending upon the topic of the guideline, pre-launch endorsement may also be sought from other organizations (e.g., disease-specific organizations). If an organization chooses to endorse the guideline, the KT team will coordinate a formal endorsement statement and official letter of endorsement. Prior to sharing the draft guideline, the KT Team and Task Force Office collect signed confidentially agreements from all reviewers at the organization and any individuals involved in administration of the review.
The Task Force will also seek statements of support from organizations whose mandate is relevant to primary care (e.g., Canadian Cancer Society, Canadian Partnership Against Cancer). The KT Team coordinates this process, including collection of confidentiality agreements. If an organization chooses to support the guideline, they will provide the KT Team with the statement they wish to use.
Outreach and education through various KT initiatives is an integral component of the Task Force stakeholder engagement process. These initiatives may be simple (distributing resources or KT tools or providing links to the website) or more involved (establishing partnerships to develop KT tools for a specific audience).
Other initiatives include publications in major peer-reviewed journals, presentations and distribution of KT materials at major conferences, presentations to key organizations, and distribution of the guideline and KT tools to stakeholders upon guideline release.
Stakeholders may also be enlisted to assist with dissemination of Task Force materials following the launch (e.g., by posting a link to the Task Force guideline on their respective websites, sharing links to Task Force guidelines and KT tools on their social media accounts, or distributing KT tools at annual meetings).
Qualitative and quantitative data on all stakeholder engagement activities are collected on an ongoing basis for the Task Force’s annual evaluation of its dissemination activities and uptake of guidelines by stakeholders (see Chapter 7). The following are some indicators of engagement:
Appendix: Identification and Selection of Clinical and Content Experts