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GIN-McMaster Guideline Development Checklist
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This page allows users to read and learn about the topics and items included in the GIN-McMaster Guideline Development Checklist (GDC) as well as to provide feedback and suggestions. The GDC is organized into 18 topics for the guideline development process, with corresponding items to consider for each topic. Users of the checklist should review all topics and items before applying them as they are not necessarily sequential and many are interconnected.
The overall guideline development process is outlined in the diagram below, which portrays the relationships between the various topics in guideline development and the groups involved. Please also see the online glossary for definitions of terms and acronyms appearing throughout the checklist.
Where identified, the checklist includes links to learning tools, articles and guides to learn about the items in the checklist. Also included are resources and tools with suggested methodology for implementing the items that developers may use to in their guideline development. The brief examples that are included in some items are for clarification and elaboration and are not meant to be extensive instructions for how to accomplish the steps.
We would like to obtain feedback so that the checklist may be updated in the future based on the experience of users. Please click the 'feedback' link beside the topic or item, which will open up an email message for users to submit comments and suggestions for existing items, new items or topics, learning tools, and resources for implementation.
Clicking on the links in the list of guideline development topics below will bring you to that specific section in the checklist. Clicking again on the topic title in the checklist will bring you back to the list of topics.
Guideline Development Topics:
1. Organization, Budget, Planning and Training
4. Establishing Guideline Group Processes
5. Identifying Target Audience and Topic Selection
6. Consumer and Stakeholder Involvement
7. Conflict of Interest Considerations
9. Considering Importance of Outcomes and Interventions, Values, Preferences and Utilities
10. Deciding what Evidence to Include and Searching for Evidence
11. Summarizing Evidence and Considering Additional Information
12. Judging Quality, Strength or Certainty of a Body of Evidence
13. Developing Recommendations and Determining their Strength
14. Wording of Recommendations and of Considerations of Implementation, Feasibility and Equity
16. Dissemination and Implementation
Guideline Development Process Diagram:
Checklist:
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Guideline Development Steps |
Source(s) |
Learning Tools, Guides, & Links |
Resources & Tools for Implementing Step |
Feedback (Click to Open) |
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1. Establish the structure of the guideline development group and determine the roles, tasks, and relationships among the various groups to be involved (e.g. oversight committee/body to direct guideline topic selection and group membership, working group consisting of experts and methodologists to synthesize evidence, a secretariat to provide administrative support, guideline panel to develop recommendations, and stakeholders and consumers for consultation). (see Topics 3, 4 & 6) |
PATS: Group Composition and Processes
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2. Perform a thorough assessment of the proposed guideline development project with respect to financial and feasibility issues concerning the guideline development group (e.g. availability of resources to complete the project, expected commitment from guideline panel and staff, etc.). |
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3. Obtain organizational approval to proceed with the guideline project. |
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4. Prepare a budget for the development of the guideline, outlining the estimated costs for each step (e.g. working group and staff remuneration, outsourcing of certain tasks to outside organizations or groups, travel expenses, publication and dissemination expenses, etc.). |
AWMF Rules for Guidelines: Tips for Funding Strategy (in German; see AWMF Manual pg. 15 for English)
Dutch Knowledge Base for Guideline Development: Tool for project management in guideline development |
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5. Determine whether guideline panel members will be provided any payment or reimbursement for their time or will work as volunteers. |
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6. Obtain or secure funding for the development of the guideline, with attention to conflict of interest considerations. (see Topic 7) |
AWMF Rules for Guidelines: Tips for Funding Strategy (in German; see AWMF Manual pg. 15 for English)
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7. Outline and arrange the administrative support that will be required to facilitate the guideline development process (e.g. a secretariat of the working group to organize and obtain declaration of interests, arrange group meetings, etc.). |
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8. Plan and prepare for training and support that will be required for those involved in the guideline development process (e.g. conflict of interest related education or training for guideline panel members, teaching sessions for patients to be involved in the guideline group, etc.). (see Topics 4 & 6) |
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9. Set a timeline for the completion of the guideline and target dates for the completion of milestones in the guideline development process. |
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Dutch Knowledge Base for Guideline Development: Tool for project management in guideline development |
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10. Determine what, if any, legal considerations are relevant for the planned guideline (e.g. reimbursement policies for orphan drugs). |
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11. Prepare a protocol for the entire guideline that can be completed as the project progresses in order to keep the guideline development group on track, including an outline of the overall goals and objectives for the guideline, the timeline, task assignments, steps that will require documentation of decisions, and the proposed methodology for all steps (i.e. those covered in this checklist, for example the methods for forming the guideline group, selection of topics to be covered in guideline, consensus methods, consultation methods, evidence search and selection methods, etc.). |
WHO Rapid Advice Guidelines on Avian Influenza
Allergic Rhinitis and its Impact on Asthma (ARIA) Guideline Methods
ACCP Antithrombotic Therapy and Prevention of Thrombosis, 9th edition, Guideline Methods, as well as 8th edition Methods and 7th edition Methods |
AWMF Rules for Guidelines: Developing a Project Plan (in German; see AWMF Manual pg. 12 for English)
Dutch Knowledge Base for Guideline Development: Tool for project management in guideline development |
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1. Decide on a process for priority setting of guideline topics needed and who will be responsible for directing the process (e.g. priorities set by oversight committee at headquarters of sponsoring organization, priorities referred by government ministries of health or by professional societies). |
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Institute of Medicine: Setting Priorities for CPGs
SUPPORT Tools for evidence-informed health Policymaking (STP) 3: Setting Priorities
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2. Apply a systematic and transparent process with specific criteria for the proposal of a guideline topic during priority setting (e.g. high prevalence and burden of disease, avoidable mortality and morbidity, high cost, emerging diseases or emerging care options, variation in clinical practice, rapidly changing evidence, etc.). |
SIGN: Topic Selection Criteria and Application Form
AWMF Rules for Guidelines: Selection of the Guideline Topic (in German; see AWMF Manual pg. 7 for English)
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Dutch Knowledge Base for Guideline Development: Tool for the analysis of clinical care gaps |
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3. Involve appropriate stakeholders in the priority setting process and guideline topic selection (e.g. clinicians, professional societies, policymakers, payers, the public). (see Topic 6) |
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4. Consider and decide how different perspectives about the importance and resources required for implementing the guideline recommendations will be considered (e.g. patients, payers, clinicians, public health programs). (see Topic 11) |
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5. Search for any existing up-to-date guidelines covering the proposed topic and assess their credibility (e.g. AGREE II). Determine whether existing guideline(s) can be adapted or if a completely new guideline should be developed. (see also Topic 10) |
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Clinical Practice Guidelines Literature Search Strategy
AWMF Rules for Guidelines: Search and Evaluation of Existing Guidelines (in German; see AWMF Manual pg. 27 for English)
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6. Discuss the need or opportunity to partner with other organizations that develop guidelines to determine whether a collaborative effort will be sought for the development of the guideline, or any part of the guideline. |
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7. Perform a scoping exercise for the proposed guideline topic with respect to implementation issues and barriers to change (e.g. if developed the guideline is likely to improve health outcomes, implementation of healthcare recommendations is feasible, resources are available, etc.). |
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8. Select or provide a consensus method to be used to agree on the priorities set and the guideline topic selected (e.g. voting, Delphi consensus). (see Topic 4) |
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9. Document the priority setting process and guideline topic selected to ensure transparency. |
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1. Seek multidisciplinary representation for the guideline development group, including members from the target audience, patients and carers, frontline clinicians, content experts, methodology experts, and experts in health economics, to fulfill the roles required (e.g. for the working group, guideline panel). (see also Topic 6) |
PATS: Group Composition and Processes
AWMF Rules for Guidelines: Guideline Group Composition (in German; see AWMF Manual pg. 10 for English) |
AWMF Letter Template for Nominating Representatives (AWMF Manual Appendix 1 pg. 63) |
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2. Decide on methods for recruitment and enrollment of members for the guideline development group (e.g. widespread advertising of posts, competitive appointment by interview, etc.). |
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3. Achieve a topic-appropriate balance of expertise and adequate representation for the guideline panel (e.g. experts and primary care physicians who form the target audience, gender and geographical distribution of panel members), which may be iterative if additional members are required as the target audience and topics within the guideline are refined. (see Topic 5) |
Pagliari & Grimshaw 2002: Impact of group structure and process on guideline development |
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4. Consider the optimum group size for the guideline development group, particularly the guideline panel (e.g. too small of a group may lack sufficient experience, content expertise and wide representation, too large of group may lack cohesiveness and effective group interaction). |
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5. Outline roles for the guideline group members and the tasks they will be responsible for (e.g. forming a writing team, group reporter(s) to take meeting minutes and document decisions made, providing methodology consultation, conducting systematic reviews and obtaining other evidence, providing patient perspective, providing specialist clinician perspective, etc.). |
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6. Select group leader(s), or chair(s), experienced in group facilitation, maintaining constructive dynamics, identifying and resolving conflicts, remaining neutral and objective, and having methodological expertise and content expertise. |
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7. Document the guideline group member selection process and roles to ensure transparency. |
ACCP Antithrombotic Therapy and Prevention of Thrombosis, 9th edition, Guideline Methods |
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1. Establish how and how often communication with guideline panel members and other groups will take place, who will be responsible for making the arrangements, and consider when to deviate from this approach. |
AWMF Rules for Guidelines: Inaugural Meeting (in German; see AWMF Manual pg. 23 for English) |
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2. Set expectations and awareness of the group process through an introduction, training, and support for the guideline development group members (e.g. setting ideal conditions for group discussion and decision-making). |
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3. As part of the training for the guideline development group, ensure that group members understand what the process and proposed methods will be and that they need to be adhered to (e.g. consensus methods that may be used, anonymous or non-anonymous voting, assessment of evidence, group discussion and contributing ideas). |
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4. Aim to set optimal conditions for group members to be provided equal opportunities to contribute and for their ideas and arguments to be given appropriate consideration (e.g. during group discussion, decision-making, and when formulating recommendations). |
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5. Establish methods for dealing with conflict or disputes among group members and dysfunction in the group process. |
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6. Provide opportunities for discussion and feedback about the group process throughout the guideline development project. |
E*, 6 |
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7. Establish a method for structured and timely distribution and archiving of documents used and produced in the guideline development. |
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8. Set a quorum for meetings (e.g. 75% of group must be present to formulate guideline recommendations), but expect that all group members attend all meetings as far as possible. |
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9. Set or plan meeting times and locations (virtual or in-person) in advance and prepare a scope and specific agenda for each meeting. |
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10. Keep a record of all meetings with minutes and determine whether or not to make them publically or internally available (e.g. who attended, what was the agenda, what decisions were made, what next steps will be). |
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1. Identify, define and/or review the primary audience (e.g. primary care physicians, health program managers) and secondary audience(s) (e.g. hospital administrators) for the guideline and determine how many audiences can be addressed with the guideline. |
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2. Consult appropriate stakeholders about the target audience(s) identified to ensure they are applicable for the guideline topic and no relevant audience is missed. (see Topic 6) |
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3. Establish a method and criteria to generate and prioritize a candidate list of topics to be addressed within the guideline (e.g. where evidence is most confusing or controversial, where there is currently uncertainty or inconsistency in practice, questions about screening, diagnosis, and treatment, etc.). |
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4. Consult appropriate stakeholders to ensure all relevant topics for the guideline have been identified and will meet the needs of the target audience(s). (see Topic 6) |
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5. Select or provide a consensus development method to be used by the group in agreeing on the final topics selected to be addressed within the guideline (e.g. Delphi method, nominal group technique). |
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6. Document the processes of identifying the target audience(s) and selection of topics for the guideline to ensure transparency.
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1. Identify the appropriate stakeholders to involve and consult with in the development of the guideline to incorporate views of all those who might be affected by the guideline (e.g. professional groups, health managers, policy makers, industry representatives). |
NICE 2007: An overview for stakeholders, the public and the NHS |
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2. Identify the appropriate consumers to involve and consult with in the development of the guideline (e.g. individual patients, carers who provide non-reimbursed care and support to patients, members of the public as potential patients and as funders of healthcare through taxation, community organizations that represent the interests of patients, and advocates representing the interests of patients and carers). |
NICE 2008: A guide for patients and carers contributing to a NICE guideline
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3. Establish methods for consumer and stakeholder involvement and maintain a registry of stakeholders for the guideline (e.g. enrollment of consumer and stakeholder members to participate directly on the guideline panel, announce call for separate consumer and stakeholder meeting(s) or workshop(s), electronic distribution of documents and feedback, open period for review of documents and feedback). |
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4. Provide information (e.g. training and introduction sessions) for consumers and stakeholders involved directly on the guideline panel to clarify roles and maximize contributions (e.g. evaluating evidence objectively, avoiding recommendations based on self-interests). |
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5. Determine the roles, tasks and timing for consultation with consumers and stakeholders not directly participating on the guideline panel (e.g. at specific milestones during the guideline development process including opportunities to comment on priority setting, topics for the guideline, identifying target audience, identifying patient-important outcomes, identifying additional evidence, point to consequences that the panel has not considered, review the final guideline draft, etc.). |
PATS: Integrating Values and Consumer Involvement
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6. Develop or adopt standard templates for consumer and stakeholder input and comments during consultation, with clear instructions or training modules to ensure effective input. |
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7. Offer adequate time for consumer and stakeholder feedback and consultation. |
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8. Set a policy and process for handling consumer and stakeholder feedback and dealing with different perspectives (e.g. ensure that diverse perspectives are taken into account in making decisions, provide transparent rationale for judgements made, provide an appeal process for stakeholders, publish consultation comments and the guideline development panel's responses). |
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9. Document the enrollment and selection of consumers and stakeholders for the guideline panel and the involvement and consultation with all other consumers and stakeholders to ensure explicit and transparent methods. |
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1. Set a policy for declaration of interests (DOI) of individual participants at admission to the project, including potential guideline panel members prior to their involvement (e.g. what interests should be disclosed, financial, intellectual, academic/clinical, competitive interests of the professional society). |
NICE 2008: Code of practice for declaring and dealing with conflicts of interest
NMHRC 2012: Guideline Development and Conflicts of Interest
AWMF Rules for Guidelines: Disclosure of Conflicts of Interest (in German; see AWMF Manual pg. 19 for English)
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NHMRC: Form for Disclosure of Interests
AWMF Disclosure of Conflicts of Interest Sample Form (AWMF Manual Appendix 2 pg. 66) |
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2. Set a policy for determination of conflicts of interest (COI) and an approach for collecting and updating COI declarations (e.g. how and what level of financial interest should be disclosed, how long a period of time should be covered by the disclosure, who will judge what constitutes a conflict). |
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3. Provide clear instructions and training to the potential guideline group members on how to complete the COI disclosure, including a list of the members who must declare COI and the types of interests to declare including examples. |
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4. Set a policy for management of COI (e.g. individuals with COI not categorically excluded from guideline development but excused from voting on specific recommendations related to the area of conflict, chair should have no COI, evidence summaries prepared by un-conflicted methodologists,). |
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5. Set a policy to manage COI with respect to funding of the guideline development activities (e.g. advocate for public funding, no commercial sponsorship, commercial sponsorship from entities unrelated to topic of guideline, commercial support for non-direct activities such as translation, no single-source sponsor). |
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6. Disclose and publish the funding source and describe the role of the sponsors and support provided for the development of the guideline. |
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7. Explicitly disclose, publish and describe conflicts of interest of the guideline group members, particularly where the conflicts bear on specific recommendations. |
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1. Establish methods for generating the questions for the guideline, prioritizing questions, and selecting and ranking outcomes. |
JCE GRADE Guidelines: Framing the Question and Deciding on Important Outcomes
AWMF Rules for Guidelines: Formulating Clinically Relevant Questions (in German; see AWMF Manual pg. 17 for English)
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2. Generate and document the key questions (e.g. clinical, health, policy, cost-effectiveness) to be answered in the guideline using a standard format (e.g. PICO) and determine the criteria by which the questions generated will be prioritized if it is not feasible to answer all questions (e.g. survey guideline panel members, survey stakeholders). |
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PICO Framework (Population, Intervention, Comparator, Outcome)
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3. Explicitly describe the population to whom the guideline is meant to apply. Take into consideration specific characteristics of the population, such as prevalence of multiple comorbidities in the population, geographical setting, and equity issues (e.g. plausible reasons for anticipating differential relative effects across disadvantaged and advantaged populations). |
PATS: How to Integrate Multiple Comorbidities in Guideline Development |
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4. Determine if regulatory approval is a requirement or not for considering interventions (e.g. for international guidelines this may be not relevant as regulatory approval may not be present for all target countries). |
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5. Explicitly describe the intervention(s) and comparator(s) to be considered in the guideline and develop an analytic framework depicting the relationships among interventions and outcomes. Identify whether or not multiple (treatment) comparisons should be included. |
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6. Identify the important outcomes (e.g. outcomes along the clinical pathway; morbidity, quality of life, mortality), including both desirable (e.g. benefits, less burden, savings) and undesirable effects (e.g. harm, burden, costs, and decrease in patient autonomy). Do not ignore important outcomes for which evidence may be lacking. |
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7. Determine the setting (e.g. countries, hospitals) or include it in the considerations about the population (i.e. population cared for in tertiary care hospitals). |
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8. Mandate a preference for patient-important outcomes over surrogate, indirect outcomes. Consider appropriateness of surrogate outcomes along the causal pathway when data for a patient-important outcome is lacking. |
JCE GRADE Guidelines: Framing the Question and Deciding on Important Outcomes |
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9. Rank the relative importance of the outcomes, taking into consideration the values and preferences of the target population. |
JCE GRADE Guidelines: Framing the Question and Deciding on Important Outcomes |
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10. Determine or develop a process for determining a priori the magnitude of effect for the individual outcomes that is judged as important to the target population. |
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11. Involve all guideline group members and consult consumers and stakeholders to ensure broad representation from the target population in generating the questions and selecting and rating the important outcomes. |
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12. Document the methods of question generation and prioritization, selection and ranking of outcomes, and stakeholder and consumer consultation to ensure they are explicit transparent. |
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13. Ensure the guideline protocol outlines the target population, target condition, outcomes, and key questions considered to help direct the evidence review. |
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9. Considering Importance of Outcomes and Interventions, Values, Preferences and Utilities |
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1. Decide whether the relative importance of outcomes and interventions, values, preferences or utilities of consumers and stakeholders (e.g. patients and target audience) to inform decisions and deliberations during the guideline development will be elicited indirectly or directly (e.g. review of the published literature vs. consultation with consumers). |
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2. Establish methods for consultation with consumers and stakeholders to obtain information about the relative importance of outcomes and interventions, values, preferences or utilities (e.g. involvement of consumers on guideline panel, surveys or focus groups with broader representation of consumers). |
PATS: Integrating Values and Consumer Involvement
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3. Determine if a structured approach for assessing the confidence in the obtained importance ratings, values, preferences and utilities (i.e. quality of the evidence in them) will be used. |
E, 49 |
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4. Determine if modelling will be used to integrate the relative importance of outcomes and interventions, values, preferences or utilities and how modelling will be done. |
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5. Determine whose perspective(s) will be considered when obtaining information about the relative importance of outcomes and interventions, values, preferences or utilities and when making decisions or formulating recommendations (e.g. patients, public, society, clinicians). |
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6. Consider and document approaches for dealing with conflicting relative importance ratings for outcomes and interventions, values, preferences or utilities (e.g. patient vs. carer, patient vs. public). |
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7. Document the methods of obtaining information about the relative importance of outcomes and interventions, values, preferences or utilities to ensure they are explicit and transparent. |
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8. Document if ethical considerations, such as whether recommendations should give special consideration to certain patient groups or conditions (e.g. elderly, rare disease, those affected by health inequalities). |
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9. Decide how to consider ethical or moral values in making healthcare recommendations (e.g. by considering religious, social, or cultural convictions). |
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10. Deciding what Evidence to Include and Searching for Evidence |
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1. Follow systematic review methods (either full systematic reviews or rapid systematic reviews depending on the topic and organization's framework) or provide a rationale for why this is not done. |
Cochrane Handbook for Systematic Reviews of Interventions 2011
Cochrane Handbook for Diagnostic Test Accuracy Systematic Reviews 2011 |
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2. Develop a protocol for locating, selecting, and synthesizing the evidence (e.g. conduct a search for existing systematic reviews, new systematic review and grey literature search) and determine the types of evidence to include (e.g. databases searched, types of studies, inclusion and exclusion criteria, searching for specific studies on adverse effects or deciding to abstract information on adverse effects from studies on benefit). |
AWMF Rules for Guidelines: Searching the Literature (in German; see AWMF Manual pg. 31 for English) |
AWMF Manual for Systematic Searching of the Literature in the Context of Guideline Development (in German)
AMSTAR: Checklist for Assessing the methodological quality of systematic reviews
SIGN 50 Annex 3: Critical Appraisal Checklists
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3. Decide who will develop the search strategies and perform searching and selection of evidence (e.g. working group of guideline development group, outsource to external agency, form a relationship between guideline development group and external agency to collaborate on development of the guideline). |
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4. Critically appraise existing systematic review(s) selected to be included using a validated tool (e.g. AMSTAR) to ensure it is of adequate quality and appropriate for use in the guideline. |
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5. If an existing systematic review is updated or requires updating, determine how new evidence will be included and how those who conducted the review will be contacted and possibly involved in the update. |
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6. If a new systematic review is required, conduct an assessment to determine if adequate resources (e.g. time and funding) are available to conduct a full systematic review. |
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7. If resources are limited, consider applying a rapid assessment methodology and explicitly describe the methodology, noting important limitations, uncertainties, and the need and urgency to undertake a full systematic review. |
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8. Establish methods for identifying additional evidence and unpublished data (e.g. suggestions from guideline panel members, consulting with stakeholders). |
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9. Set a policy for handling expert input (i.e. expert opinion is not evidence per se and should not be used as evidence; rather, experience or observations that support expert opinions should be described, identified and, if possible, appraised in a systematic and transparent way, e.g. in the conceptual framework). |
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10. Document and publish the search and selection of evidence, judging eligibility, range of evidence included, and search strategies used to ensure the methods are explicit and transparent. |
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11. Summarizing Evidence and Considering Additional Information |
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1. Summarize the evidence using a concise summary (e.g. evidence table, evidence profile or summary of findings table) of the best available evidence for each important outcome, including diagnostic test accuracy, anticipated benefits, harms, resources (costs), the quality of evidence rating, and a summary of the relative and absolute results/estimate of effect for each outcome. |
JCE GRADE Guidelines: GRADE Evidence Profiles and Summary of Findings Tables |
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2. Provide a summary of the additional information needed to inform recommendations (e.g. qualitative narrative summary, evidence table), including values and preferences, factors that might modify the expected effects, need (prevalence, baseline risk, or status), effects on equity, feasibility, and the availability of resources. |
SUPPORT Tools for evidence-informed health Policymaking (STP) 10: Taking equity into consideration
HRPS: Incorporating Considerations of Equity
NICE 2012: Positively Equal: A guide to addressing equality issues in developing clinical guidelines |
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3. Establish methods for obtaining information about resource use and cost (e.g. searching for existing economic evaluations, developing economic model, performing cost-effectiveness analysis). |
HRPS: Improving the use of research evidence in guideline development |
Dutch Knowledge Base for Guideline Development: Tool for cost-effectiveness in guidelines |
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4. Identify the costs, resource use, and, if applicable, cost-effectiveness and describe the nature of the costs (patient, community, society) (e.g. affordability considerations, estimates of resource use and acquisition costs weighed directly against evidence of benefits and harms of an intervention). |
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5. Document the methods in which the additional information is to be incorporated with the synthesized evidence to ensure transparency (e.g. formal consensus on patient values, consensus on equity issues, formal economic analysis, consideration of disaggregated resource use data in a qualitative manner,). |
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6. Provide training about the use of the evidence tables and opportunities for discussion to ensure all members of the guideline panel are familiar with the tables and use them in the appropriate manner. |
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7. In addition to the evidence summary, make available the full systematic review(s) and the original studies and other sources of evidence for the guideline panel to inform deliberations (e.g. set up a collaborative website and/or make available at meetings and via electronic communication). |
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12. Judging Quality, Strength or Certainty of a Body of Evidence |
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1. Select a framework outlining the criteria to be considered in rating the quality of evidence (e.g. GRADE, USPSTF). Avoid modifying grading tools. |
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2. Decide who will be responsible for appraising the quality of evidence (e.g. un-conflicted methodologists participating in the working group). |
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3. Assess the quality of evidence for each important outcome. |
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4. Assess the overall quality of evidence (e.g. lowest quality of evidence from outcomes rated as most important or critical, or highest quality of evidence when all outcomes point in the same direction). |
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5. Report the quality of evidence assessed for the outcomes and the body of evidence. |
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6. Document the judgements made in appraising the quality of evidence to ensure they are transparent and explicit. |
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13. Developing Recommendations and Determining their Strength |
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1. Apply a framework outlining the factors to be considered to arrive at a recommendation. |
JCE GRADE Guidelines: Going from Evidence to Recommendations
PATS: Moving from Evidence to Developing Recommendations in Guidelines |
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2. Plan and share the logistical details of the consensus meeting(s) during which recommendations will be formulated with the participants, including distribution of documents required for the meeting (e.g. evidence summaries, evidence-to-recommendation tables), setting an agenda for the meeting(s) and selecting a consensus development method to be used by the group in agreeing on judgements (e.g. Delphi method, nominal group technique). |
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3. Review the factors of the framework that influence the recommendation, including the direction and strength (e.g. the types of evidence and information relevant to the analysis focusing on the balance between desirable and undesirable consequences informed by the quality of evidence, magnitude of the difference between the benefits and harms, the certainty about or variability in values and preferences, resource use, equity and other factors). |
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4. If applicable, make provisions for formulating recommendations in situations where there is insufficient evidence or very low quality evidence (e.g. conditional recommendation with judgements laid out transparently, no recommendation if the guideline panel feels there is substantial risk that their decision may be wrong, recommend that the intervention be used in the context of research complemented by guidance for what are the best management options until further research becomes available). |
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5. Make provisions for formulating research recommendations and decide where to report them (e.g. in the guideline appendix, suggesting the specific research questions, specific patient-important outcomes to measure and other relevant aspects of what research is needed to reduce the uncertainty about the benefits and/or undesirable downsides of the intervention). |
PATS: Moving from Evidence to Developing Recommendations in Guidelines |
Dutch Knowledge Base for Guideline Development: Tool for knowledge gaps in guidelines |
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6. Formulate the recommendations and summarize the rationale for each recommendation (e.g. narratively or in a table), including details about the judgements made by the group and the explicit link between the recommendation and evidence supporting the recommendation. |
JCE GRADE Guidelines: Going from Evidence to Recommendations
PATS: Moving from Evidence to Developing Recommendations in Guidelines |
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7. Select a method for rating the strength of the formulated recommendations to inform the audience of the guideline about the degree of the guideline group's confidence about following that recommendation. |
AWMF Rules for Guidelines: Grading of Recommendations (in German; see AWMF Manual pg. 42 for English) |
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8. Select a consensus development method to be used by the group in rating the strength of recommendations (e.g. Delphi method, nominal group technique, voting). |
AWMF Summary of Formal Consensus Development Techniques (AWMF Manual Appendix 8 pg. 78) |
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9. Provide suggestions about whether the recommendations are appropriate to serve as performance measures/quality criteria (e.g. management options associated with strong recommendations based on high- or moderate-quality evidence are particularly good candidates for quality criteria, when a recommendation is weak, discussing with patients the relative merits of the alternative management strategies and appropriate documentation of this interaction may become a quality criterion). |
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10. Document the judgements made in formulating the recommendations and determining their strength to ensure they are transparent and explicit. |
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14. Wording of Recommendations and of Considerations of Implementation, Feasibility and Equity |
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1. Decide on standardized wording to use for recommendation statements to ensure clarity and to maintain consistency throughout the guideline, avoiding wording that may be vague and nonspecific. |
Shiffman, Shekelle, et al. 2003. Standardized reporting of clinical practice guidelines
PATS: Moving from Evidence to Developing Recommendations in Guidelines
AWMF Rules for Guidelines: Clarity and Presentation (in German; see AWMF Manual pg. 45 for English) |
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2. Write the recommendations in a way that is actionable with sufficient information so that it is not necessary for guideline users to refer to other material in order to understand the recommendation. |
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3. Provide clear direction or an interpretation aid to describe the implication of the strength of recommendation for clinicians, patients, policy makers, and any other target audience groups. |
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4. Indicate in the recommendation statements the population for which the recommendation is intended, the intervention being recommended, and the alternative approach(es) or intervention(s). |
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5. Include remarks that describe the context, feasibility and applicability of the recommendation and highlight key considerations such as equity issues and specific conditions that might apply to the recommendation (e.g. whether the conditions outlined apply to a specific subpopulation, specific types of the intervention, for certain values and preferences, when certain resources are available, etc.). |
HRPS: Incorporating Considerations of Equity
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6. Report the quality of evidence and the strength of recommendation in proximity to the recommendation statement. |
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7. Establish methods to be used by the group in agreeing on the final wording of recommendation statements (e.g. review and approval, formal consensus). |
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8. Report the recommendations in a way that is comprehensible and visible (e.g. do not embed recommendations within long paragraphs, group recommendations together in a summary section). |
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1. Develop or adopt a standardized format for reporting the guideline, with specific structure, headings, and content. |
Shiffman, Shekelle, et al. 2003. Standardized reporting of clinical practice guidelines
AWMF Guide to Writing the Guideline Report (AWMF Manual Appendix 9 pg. 81) |
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2. Decide on the format(s) to be prepared for the guideline product(s) (e.g. full guideline, full guideline with technical report/systematic reviews, brief guideline for clinicians or policymakers, consumer version for patients) that will correspond to the dissemination plan. (see Topic 16) |
AWMF Rules for Guidelines: Versions (in German; see AWMF Manual pg. 50 for English) |
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3. Decide who will be responsible for writing the guideline product(s) (e.g. sub-committee of the guideline working group) and decide on authorship (e.g. individual authors, organization as author, working group as author). (see Topic 1) |
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4. Conduct a review of the final draft of the guideline report(s) by all members of the guideline development group, allowing sufficient opportunity for feedback, editing and revisions. |
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5. Seek approval from all members of the guideline development group for the final document(s). |
AWMF Rules for Guidelines: Approval (in German; see AWMF Manual pg. 49 for English) |
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6. Initiate organizational (i.e. internal) peer review. |
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7. Decide on the method(s) of external peer review, to review the final document(s) for accuracy, practicality, clarity, organization, and usefulness of the recommendations, as well as to ensure input from broader and important perspectives that the guideline group did not encompass (e.g. invited peer review, public consultation period with incorporation of feedback and responses from the guideline development group, submitting to peer-reviewed publication). |
AWMF Rules for Guidelines: External Assessment (in German; see AWMF Manual pg. 48 for English) |
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8. Document the internal and external peer review process and, if applicable, publish consultation comments and the guideline development group's responses. |
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1. Prepare an active dissemination plan with various approaches to enhance the adoption of the guideline, taking into consideration utilization and copyrights (e.g. make guideline available online, develop formal relationships with those in health care systems responsible for guideline dissemination and implementation to support guideline uptake, press conference, social media strategy, dissemination at professional society meetings, publish guideline in a journal that is accessed by the target audience). |
AWMF Rules for Guidelines: Preparation of Implementation (in German; see AWMF Manual pg. 52 for English)
HRPS: Disseminating and Implementing Guidelines
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Dutch Knowledge Base for Guideline Development: Tool for implementation of guidelines
Dutch Knowledge Base for Guideline Development: Tool for electronic disclosure of guidelines |
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2. Develop or adapt tools, support, and derivative products to provide guidance on how the recommendations can be implemented into practice (e.g. mobile applications, integration with clinical decision support systems, make guideline adaptable as an educational resource for target audience for education outreach). |
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3. Make considerations for adaptation of the guideline and provide specific instructions for how target end users who would like to adapt the guidelines to other contexts can do so in a systematic and transparent way (e.g. modifying a recommendation based on local resources and baseline risk, implications that deviate from the judgements made by the guideline panel). |
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4. Set rules and regulations for translation of the guideline into other languages (e.g. allow translation by third party organizations following approval by the guideline group, include staff responsible for translation in guideline working group). |
European Society of Cardiology: Rules for Translation of Guidelines and Their Derivative Products |
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1. Conduct an internal evaluation (i.e. self-assessment) of the guideline development process, including the guideline panel meeting(s) held to formulate recommendations, by asking guideline group members for feedback. |
E, 66 |
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2. Consider pilot testing the guideline with the target end users (e.g. with members of target audience and stakeholders who participated in the guideline development group). |
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3. Provide criteria and tools for target end users to monitor and audit the implementation and use of the guideline recommendations (e.g. identify outcomes that should change with implementation and suggest methods for measuring the outcomes). |
AWMF Rules for Guidelines: Preparing the Evaluation (in German; see AWMF Manual pg. 55 for English) |
Dutch Knowledge Base for Guideline Development: Tool for monitoring guidelines |
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4. Provide support and tools for prospective evaluation of the guideline to determine its effectiveness after implementation (e.g. using randomized evaluations where possible, using before-after evaluations cautiously due to uncertainties regarding the effects of implementation). |
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5. Consider the potential involvement of the guideline development group in prospective evaluation(s) of the guideline (e.g. partnering with organizations that implement the guideline to plan evaluation studies). |
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6. Plan to collect feedback and evaluations from users to identify how to improve the intrinsic implementability of the recommendations in subsequent versions of the guideline. |
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1. Set a policy, procedure and timeline for routinely monitoring and reviewing whether the guideline needs to be updated (e.g. update systematic review every 3 years to determine if there is any new evidence available). |
AWMF Rules for Guidelines: Updating (in German; see AWMF Manual pg. 57 for English) |
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2. Decide who will be responsible for routinely monitoring the literature and assessing whether new significant evidence is available (e.g. consider involvement of experts not previously involved in the guideline development group to periodically review the guideline). |
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3. Set the conditions that will determine when a partial or a full update of the guideline is required (e.g. if only certain recommendation statements need to be updated, or whether many recommendations are out of date making the entire guideline invalid, or when recommendations are necessary for newly available treatments). |
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4. Make arrangements for guideline group membership and participation after completion of the guideline (e.g. rotating membership every 1-2 years, selection of a new group at time of updating, continuing participation by guideline panel chair). |
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5. Plan the funding and logistics for updating the guideline in the future (e.g. securing ongoing funding, standing oversight committee to oversee the updating process). |
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6. Document the plan and proposed methods for updating the guideline to ensure they are followed. |
Cancer Care Ontario Program in Evidence-Based Care: Document Assessment and Review |
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*E - Item informed by expert consultation
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