canadian association of gastroenterology policy on the application for , and implementation of , clinical practice guidelines

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association's governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research; Improving patient care provided by members by providing focus on quality and evidence; Creating legislative environments that favour effective clinical practice; Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; and Identifying areas that require further information or research to improve clinical care. The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement.


THE PROCESS FOR CLINICAL PRACTICE GUIDELINE DEVELOPMENT
Clinical practice guidelines (CPGs) are defined as systematically developed recommendations with associated background summary of potential benefits and harms and quality of evidence to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.CPGs should offer recommendations about the usefulness of screening strategies, specific diagnostic tests and/or treatments for a given disorder.The goal of the CPG is to optimize clinical practice, and includes avoiding unnecessary or inaccurate diagnostic tests as well as ineffective or harmful treatments.Therefore, CPGs should be particularly considered for areas with existing wide variations in clinical practice.The steps involved in the development and dissemination of CPGs, endorsed or developed by the Canadian Association of Gastroenterology (CAG), are discussed in the following sections.
1. Selecting a topic a.The need for a particular CPGs will be determined by one, or more, of the following criteria: i. needs assessments from survey of the membership; ii.proposals brought forward by one or more active CAG members; and iii.topics identified as priorities by the CAG Board and Clinical Affairs, particularly in topics for which new, important evidence has emerged.b.CPGs will be considered if there is literature to support an evidence-based approach and if there is a clear clinical need.c.Proposals will be made in writing to the VP-Clinical Affairs (see the Checklist for CPG Proposals; Appendix I).Proposals will be reviewed semiannually by Clinical Affairs.Final approval of a CPG proposal will be made by the CAG Board.A scoping review special article

Identifying key questions and scope of the CPG recommendations
a. Key questions should focus on critical outcomes (benefits and harms) important to patients and could reflect areas of controversy or uncertainty that will benefit from a systematic evidence-based review.b.CPG Panel members are urged to limit the scope of the initiative to issues that can be resolved with available clinical literature, questions that are relevant to practitioners of gastrointestinal medicine, and topics that can be addressed within the time and energy constraints of the CPG process.Authors should also note that long CPG documents, and those with excessive numbers of recommendations, can be difficult to publish in peer-reviewed journals and may have limited impact.c.The CPG Panel should also focus on, and define, the following factors to produce a focused, coherent and readable document: i. which patient or practice settings will be examined?(eg, inclusion and exclusion criteria); ii. which aspects of care will be addressed?(eg, screening, therapy, diagnosis, prognosis); iii.what outcomes will be influenced by the CPG? (eg, morbidity, mortality, quality of life, organizational outcomes, economics); and iv.who are the target users of the CPG? Steering Committee members should, in their planning, follow one of the proposed methodologies outlined in the CMA Handbook on Clinical Practice Guidelines (1) , Canadian Task Force on Preventive Health Care Methods for CPG development and GRADE assessment (2), and/or "Guidelines 2.0: Systematic development of a comprehensive checklist for a successful guideline enterprise" (3).

Systematic literature review
a.The purpose of the systematic review of the literature is to determine whether: i. CPG(s) on a particular topic already exist; and ii.medical evidence exists that will impact on the formulation of the CPG.When possible, it may be preferable to adapt an existing CPG on a particular topic rather than to develop one de novo.Retrieved guidelines should be assessed for their quality using a recognized guideline appraisal system such as the AGREE (www.agreetrust.org)instrument.Guidelines of sufficient quality can then be assessed for their acceptability and applicability to the topic at hand.Some, or all, of the specific recommendations in a particular guideline could be adapted by the working group.The ADAPTE (www.g-i-n.net/document-store/working-groups-documents/adaptation/adapte-resource-toolkit-guideline-adaptation-2-0.pdf/view?searchterm=adapte)Collaboration provides a useful and validated framework to guide this process.b.If a decision is made to proceed with a systematic review, it is recommended that the systematic review be carried out with the aid of a medical information specialist.1.
All CPG Panel members are expected to be familiar with the basic concepts of GRADE methodology as described in recent publications from the GRADE working group (eg, the 2008 BMJ series [4][5][6][7][8][9]) and the GRADE website http://www.gradeworkinggroup.org/index.htm).
Note that CPGs that include recommendations on diagnostic tests or diagnostic strategies should also follow the GRADE methodology, but present unique challenges (6).A summary description of GRADE for diagnostic tests/ strategies is shown in Table 2.

Development of recommendations
a.The CPG Panel typically will generate a set of recommendations.
It is anticipated that the wording of each recommendation will require multiple iterative revisions until consensus among the panel is achieved, following a modified Delphi process, similar to that used in previous CAG CPGs (10)(11)(12).If a formal consensus conference is planned, it is suggested that the proposed recommendations be circulated to the entire CPG Panel for at least two rounds of iterative revisions before the consensus conference.b.Recommendations should be worded to provide clear and unambiguous guidance to the practitioner.This can be achieved by specifying the patients to whom the recommendation applies, the intervention, and the outcome expected to change.Active verbs such as "do", "offer", "give" and "counsel to" provide clearer guidance than passive verbs such as "should be considered".If there is uncertainty regarding the robustness of the statement, it should be reflected in the strength of the recommendation grading.Authors should avoid using obtuse and/or evasive language in an attempt to improve apparent statement grading at the cost of making the recommendations less guiding.c.Where evidence exists, recommendations should include reference to the pediatric population.d.Each individual recommendation will be accompanied by a grading matrix that will include: i. grading of the quality of medical evidence; and ii.grading of the strength of the recommendation.e. Face-to-face meetings are preferred when feasible.However, communication by e-mail, teleconference and videoconference may also be appropriate leading to a final consensus conference.f.In most cases, it is advisable that a formal consensus process (such as a modified Delphi technique) be adopted by the CPG Panel.g.Where consensus has been obtained, those members rejecting the statement or accepting with major reservations, should be allowed to voice their dissenting position and have it recorded in the meeting minutes for insertion in the final manuscript.h.Voting should be reported in an anonymous aggregate fashion using technology such as electronic touch pads or online voting.i.Where possible, an impartial facilitator should be used to guide the discussion at a consensus conference (if required).The facilitator and Chair/Co-chairs should be nonvoting positions.j.Each initiative should include a discussion about how the CPG will be updated in the future to maintain its clinical relevance.

Reporting
a. A final draft of the CPG must be prepared in a timely fashion following the conclusion of the consensus process.Ideally, this should be accomplished within six months.b.The Steering Committee is responsible for the content of the final draft.All CPG Panel members should be given ample opportunity for input into the final wording of the report.c.The final draft of the report will be posted on a members only section of the CAG website for a period of two weeks for

High
Further research is very unlikely to change confidence in the estimate of effect Moderate Further research is likely to have an important impact on the confidence in the estimate of effect and may change the estimate Low Further research is very likely to have an important impact on the confidence in the estimate of effect and is likely to change the estimate Very low Any estimate of effect is very uncertain

Strength of recommendations ‡
Strong Desirable effects of an intervention outweigh its undesirable effects (strong recommendation for an intervention) or the undesirable effects of an intervention outweigh its desirable effects (strong recommendation against an intervention).A strong recommendation implies that most people will be best served by the recommended course of action.Adherence to such recommendations can be readily used as a performance indicator to judge the quality of the clinical care Weak Weak recommendations are those for which the desirable effects probably outweigh the undesirable effects (weak recommendation for an intervention) or undesirable effects probably outweigh the desirable effects (weak recommendation against an intervention) but appreciable uncertainty exists.A weak recommendation implies that the guideline developers believe most individuals would be best served by the recommended course of action, but some would not be.For clinicians, the implication is that they must recognize that different choices are appropriate and they must help each person arrive at a management decision consistent with their own values and preferences, ie, shared decision making is important.
Policy-making will require substantial debate and involvement of various stakeholders.Weak recommendations result when the balance between desirable and undesirable effects is small, the quality of evidence is lower, and there is more variability in the values and preferences of patients.
*Modified from references 3 to 7, and http://canadiantaskforce.ca/methods/methods-manual/; † GRADE considers several factors in the determination of the quality of the evidence.As a starting point, evidence from randomized controlled studies begins as high quality, while evidence from observational studies begins as low quality evidence.Evidence can then be downgraded depending on several factors: evidence is downgraded based on consideration of risk of bias, inconsistency, indirectness, imprecision and publication bias.Evidence is upgraded based on large effect, dose response, and if all possible confounding and biases would have reduced the demonstrated effect; ‡ For determining the strength of recommendations, the quality of evidence, the balance between the benefits and harms, the values and preferences of patients, and the resource implications of an intervention should be considered.The quality of evidence and the balance between the benefits and harms are the most important considerations.Strong recommendations are made when there is a large difference between the benefits and harms and certainty around that difference, greater certainty or similarity in patient values and preferences and the quality of the evidence is higher.Weak recommendations are made when there is some uncertainty membership review and input (note: only feedback that identifies grave errors, or is factual and supported by published evidence will be considered by the Steering Committee).d.In generating the CPG report, the developers should consider developing tools that will enhance the use of the report (eg, decision aids, algorithms, patient and physician educational material and practice tools).e.It is suggested that the report writers adhere to the check-list developed by the Conference on Guideline Standardization (http://gem.med.yale.edu/cogs/)or incorporated in the AGREE tool.The purpose of this statement is to define a standard for guideline reporting that will promote guideline quality and facilitate implementation.f.Developers should consider publication of CAG-supported CPGs in the Canadian Journal of Gastroenterology and Hepatology.

Dissemination:
a.The CPG report must be submitted to a peer-review process with the intent of publication.b.Request for dissemination will not be entertained from parties who are not sponsors of the CPG initiative.c.The CAG will simultaneously contact all sponsors of a CPG initiative to advise on publication and to gauge interest in further dissemination initiatives.The CAG must be involved in any dissemination projects of the CPG (beyond original publication), in whole or in part, which include any reference to the CAG.d.Interested parties should contact the CAG directly with a proposal, inclusive of project details, time lines and budget.e.Other potential tools for dissemination include: i. posting on the CAG website and e-Portal; ii.making the CPG available to the National Guideline Clearinghouse; iii.presentation at Canadian Digestive Diseases Week and regional meetings; and iv.other initiatives such as collaboration with other specialty societies, presentations at national/international meetings and research trials should also be considered.

Funding
The CAG is not in a financial position to continuously fund the development and update of multiple CPGs on its own.If industry support is required, multisponsorship is advantageous and will be sought out, ideally in a "blind trust" fashion.Only in extraordinary circumstances will single-industry sponsorship be allowed with prior approval from the CAG board.Funding sources for any CPG will be disclosed during the process and in any publication arising as a result of process.Funding sources will not influence the CPG process in any way.All funding obtained for a particular CPG will be handled as a "grant-inkind" through the CAG office.In situations where there is an excess of funds, these will be either applied to the publication costs and dissemination of the CPG or toward the development of other CPGs identified as a priority.CPG organizers are strongly encouraged to seek funding from federal and provincial granting bodies that offer programs to support consensus endeavors (eg, CIHR, CPAC).Funding of CPG Panel members will be in keeping with CAG guidelines for visiting speakers (economy airfare, modest setting and hotels).

Framework for the management of conflict of interest
Preamble: Collaboration among physicians, medical researchers and pharmaceutical/biotechnology companies can enhance patient care by promoting the discovery and development of new treatments.However, relationships between individual physicians and the industry may create conflicts of interest, potentially resulting in undue influence on professional judgment, particularly in the CPG development process (13,14).
Because CPG reports are intended to guide current standards of care, it is essential that potential conflicts of interest (COI) be handled in a consistent fashion.The purpose of this framework is to outline steps required to identify and manage potential COIs.

Ethics and conference funding
To minimize the risk of COI, bias or undue influence, funding for any CAG-sponsored CPG will adhere to the following principles: a. no direct industry funding of participants; b. underwriting of the CPG through unrestricted, pooled industry funds from multiple sponsors where possible; and c. financial transparency (see section 8).

C. Framework for managing declared COI
Management of declared COIs must balance the need for unbiased opinion and discussion with the potential loss of valuable or critical information through the exclusion of content experts who have disclosed an actual or potential COI.As such, a COI should not necessarily preclude participation in a CPG provided that the COI framework is adhered to. 1.The Chair of COI subcommittee or CAG Ethics Committee Lead may consider excluding from the CPG Panel any member who is believed to have a real COI that may seriously impact the actual or perceived integrity and validity of the consensus process.This will be assessed on a case-by-case basis, and justified in writing to the CPG Steering Committee and VP-Clinical Affairs.2. The group consultation process of the CPG will be considered to be in camera.Industry partners will not be present at the consensus conference or in any part of the process.3. The options for management of a declared COI are: a.A priori stratification of each participant according to their declared significant COI and its relevance to a particular issue b.If a member of the panel is believed to have a significant COI that could impact the actual or perceived integrity and validity of the consensus process, this COI will be reported by the CAG Ethics Committee Lead or COI Subcommittee Chair, as applicable.The member will be contacted by the chair of COI subcommittee to review the possibility of their stepping down from the discussion and voting process.c.Otherwise, for any participant who would present minimal or moderate COI, a reporting approach by which all participants are permitted to discuss and vote but the degree of conflict for each voter is reported in the manuscript will be followed.

et al. Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines. Can J Gastroenterol Hepatol 2014;28(9):473-480.
An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association's governance policies, is to optimize the care of patients with digestive disorders.Clinical practice guidelines are one means of achieving this goal.
©2014 Pulsus Group Inc.All rights reserved H Singh, GI Leontiadis, L Hookey, Key Words: Clinical Practice Guidelines, Methodology, GRADE

canadian association of gastroenterology policy on the application for, and implementation of, clinical practice guidelines of
Déterminer les secteurs où il faut obtenir plus d'information ou effectuer plus de recherches pour améliorer les soins cliniques.Le présent document fournit les assises nécessaires pour s'assurer que les directives cliniques produites par l'ACG soient utiles, pertinentes, crédibles et applicables.Il faut adhérer le plus étroitement possible aux recommandations pour obtenir l'aval de l'ACG.the literature may be required before submission of a CPG proposal to determine whether the evidentiary base is sufficient to support the development of a CPG.If a CPG already exists in a given area, justification for an update initiative must be included in the proposal (particularly if the existing CPG is a CAGsponsored initiative).d.All aspects of CAG-approved CPG initiative must be administered via the CAG National Office, including funding.

Selecting the CAG Steering Committee and the CPG Panel
Eighty percent or more of the CPG Panel members should agree with the grading of the evidence and recommendations.A summary description of GRADE for therapeutic interventions is shown in Table sections/heds/sys_rev; http://www.york.ac.uk/inst/crd/index.htm;and http://www.cochrane.org.Guidelines, like primary studies, may be retrieved using systematic search techniques, but because some (eg, NICE guidelines) are only published by organizations and not in journals, other search strategies may be required.The National Guidelines Clearinghouse (www.guidelines.gov) is considered to be the most comprehensive website on which to find guidelines on a given topic.c.It is critical that the GRADE methodology is followed to develop the CPGs and rate the: i. quality of the evidence; and ii.strength of the recommendation(s).

TAble 2 Grading of Recommendations Assessment, Development and evaluation (GRADe) for diagnostic tests/strategies; differences from GRADe for therapeutic interventions* Factors that can influence and decrease quality of evidence Differences from quality of evidence for therapeutic interventions
When randomized controlled trials or observational studies have compared two or more diagnostic tests or strategies and have reported their effect on patient-important clinical outcomes (such as mortality, morbidity, or quality of life), then the GRADE approach is similar to the classic approach for therapeutic interventions.However, such studies are yet uncommon.•Todate, most of the diagnostic studies compare two or more diagnostic test/ strategies and only report diagnostic accuracy outcomes (such as sensitivity and specificity).Such outcomes are surrogates for patient-important clinical outcomes; the CPG Panel has to make inferences about the likely impact of the use of a diagnostic test/strategy on patient-important clinical outcomes.Evidence from cross sectional or cohort studies that report diagnostic accuracy starts as high quality evidence.However, such studies are very vulnerable to high risk of bias and indirectness of outcomes, and typically end providing low quality evidence.Modified from reference 6. Note, for determining the strength of recommendations for diagnostic tests/strategies, the CPG panel should consider the same criteria as for the recommendations for therapeutic interventions; that is, the quality of evidence, the balance between the benefits (reported patient-important clinical outcomes or presumed patient-important clinical outcomes resulting from the accuracy of the test) and harms (complications of the test), the values and preferences of patients, and the resource implications of an intervention Each proposed member of the CPG Panel must provide full disclosure of all potential sources of COI by completing and submitting a declaration of COI form for the 24-month period before the start date of the consensus process (Appendix IV).Review of the disclosure statements will be carried out by one of the processes outlined above, before the finalization of the CPG Panel members.a.Each member's COI declaration statement will be classified as: i. minimal COI (advisory board participation, speakers honoraria, member of public advocacy group or foundation); ii.moderate COI (consultant, speaker's bureau); or iii.significant COI (research funding, stockholder, employee of pharmaceutical firm, holder of intellectual property, government or governmental agency employee or contractor).3. Members of the CPG Panel may report concerns regarding potential COI of another member in writing to the CAG Ethics Committee Lead for reassessment.4. Disclosure information for each member, and the process of assessment and management of actual or potential COI, must be part of the final CPG report and related publications. *