Guideline ► Methodology
GUIDELINE DEVELOPMENT GROUP (GDG)
The Guideline Development Group (GDG) was formed in 2009 by the CAN-ADAPTT Coordinating Team and the GDG Chair, Dr. Peter Selby. There are seven members of the GDG ranging from family physician to public health researcher to physician specialists (see below for a list of GDG members). Each GDG member was a Section Lead for one of the seven guidelines listed in the introduction. GDG Members were identified by the Chair to include experts in each topic area while ensuring a multi-disciplinary and nationally representative committee. Each GDG member was contracted through CAMH for their participation on the GDG, which included a modest honorarium to support their attendance at meetings and compensation for travel and accommodation for in-person meetings. Each GDG member confirmed that they had not received funds from the Tobacco Industry. No conflicts of interest were identified by members of the GDG that could have compromised the summary statements contained within this document. The GDG recognizes that representation from all potential guideline target end users was not possible. The intent was to leverage the CAN-ADAPTT Network members that represented a greater number of professional groups involved in smoking cessation throughout the guideline development process to provide critical input into the drafting of the guideline.
The Guideline Development Group (GDG) was directly responsible for the review of existing guidelines and evidence and the development of summary statements for the CAN-ADAPTT Clinical Practice Guideline.
Peter Selby, MBBS, CCFP, FCFP, MHSc, Dip ABAM
Principal Investigator, CAN-ADAPTT
Chair, CAN-ADAPTT Guideline Development Group
Section Co-Lead: Mental Health and/or Other Addiction(s)
Clinical Director, Addictions Program
Head, Nicotine Dependence Clinic
Centre for Addiction and Mental Health
Departments of Dalla Lana School of Public Health
Family and Community Medicine, and Psychiatry
University of Toronto
Gerry Brosky, MD, MSc, CCFP
Section Lead: Counselling and Psychosocial Approaches
Associate Professor, Department of Family Medicine
Halifax, Nova Scotia
Sheila Cote-Meek, BScN, MBA, PhD
Section Lead: Aboriginal Peoples
Associate Vice-President, Academic & Indigenous Programs
Professor, School of Native Human Services
Charl Els, MBChB, FCPsych, MMedPsych (cum laude), ABAM, MROCC
Section Co-Lead: Mental Health and/or Other Addiction(s)
Addiction Psychiatrist, Medical Review Officer
Associate Professor (adjunct), School of Public Health
Associate Clinical Professor, Faculty of Medicine and Dentistry
Associate Clinical Professor, John Dossetor Health Ethics Centre
University of Alberta
Jennifer O’Loughlin, PhD, CRC, CAHS fellow
Section Lead: Youth (Children and Adolescents)
Professor, Department of Social and Preventive Medicine
University of Montreal
Alice Ordean MD, CCFP, MHSc
Section Lead: Pregnant and Breastfeeding Women
Family Physician, Urban Family Health Team, St. Joseph's Health Centre
Medical Director, Toronto Centre for Substance Use in Pregnancy, St. Joseph's Health Centre
Assistant Professor, Department of Family and Community Medicine, University of Toronto
Robert D. Reid, PhD, MBA
Section Lead: Hospital-based Populations
Deputy Chief, Division of Prevention and Rehabilitation, University of Ottawa Heart Institute
Professor, Faculty of Medicine, University of Ottawa
CAN-ADAPTT wishes to acknowledge the contribution to the clinical practice guideline from Paul McDonald. Dr. McDonald was involved in the early Guideline Development Group meetings but was not involved in the final review and approval of the clinical practice guideline.
IDENTIFYING AND EVALUATING THE EVIDENCE
IDENTIFYING EXISTING CLINICAL PRACTICE GUIDELINES
Prior to being engaged in the CAN-ADAPTT Project, the Guidelines Advisory Committee had conducted, in November 2006, a full review of CPGs in the area of smoking cessation published in the English language. At that time, nine guidelines met the basic pre-determined quality criteria: they contained recommendations linked to the evidence, and included some indication that a systematic search of the literature had been conducted. [Appendix C - Dowload complete guideline for appendices]
In December 2008, a new systematic search was conducted for the CAN-ADAPTT Project, to identify CPGs published since the previous review. This search used the same terms as November 2006, such as smoking, tobacco, or nicotine. The search was conducted in Ovid MEDLINE, Ovid Embase, guideline repositories such as National Guideline Clearinghouse, renowned developers with a history of developing high quality guidelines, as well as websites of national and international specialty societies. A general internet search was also conducted to ensure that no CPGs were missed. Five guidelines, which met the basic pre-determined quality criteria (as above), were found to be published after the initial search in 2006. [Appendix D- Dowload complete guideline for appendices]
REVIEW AND APPRAISAL OF IDENTIFIED CLINICAL PRACTICE GUIDELINES
The 14 guidelines (combining those from 2006 and 2008) identified in both reviews were evaluated by four independent reviewers using the AGREE Instrument. The reviewers were practicing family physicians in Ontario who had each been formally trained in the application of the AGREE Instrument.
In addition to the AGREE Instrument, 8 additional questions were included as part of the appraisal. This step, called AGREE Plus was encouraged by the GAC in order to better understand the applicability of the guidelines to the Canadian context. It has been the experience of the GAC that the applicability section of the AGREE often misses important considerations for the guidelines’ use once the guideline is put into practice. The following additional questions were provided by the CAN-ADAPTT Coordinating Team. Each reviewer responded to the questions/statements below using a 4-point Likert scale and/or comments, where appropriate.
1. The recommendations made in the guideline are appropriate for the intended users (i.e., you and your colleagues) to perform.
2. The recommendations made in the guideline are practical for the intended users (i.e., you and your colleagues) to perform.
3. The recommendations made in the guideline are consistent with patient treatment expectations.
4. The recommendations are compatible with existing attitudes and beliefs of the guideline’s intended users (i.e., you and your colleagues).
5. The recommendations can be performed by the guideline’s intended users (i.e., you and your colleagues) without the acquisition of new competencies (knowledge, skills, etc.).
6. What new competencies, if any, would be required?
7. Criteria can be extracted from the guideline that would permit the measurement of specific outcomes related to the recommendations.
8. Criteria can be extracted from the guideline that would permit the measurement of adherence to the recommendations.
CAN-ADAPTT considered only those guidelines that scored highly in multiple AGREE domains, particularly in the areas of Rigour of Development and Editorial Independence, as well as guidelines that were ‘strongly recommended’ by reviewers as being applicable to the Canadian context. The domains of Rigour of Development and Editorial Independence address the majority of the methodological questions that help to determine quality of the guideline development process. The GAC advised that guidelines which do not adequately address these items should not be considered to be a high quality clinical practice guideline and should not be included in the development of CAN-ADAPTT’s guideline.
Six guidelines met our criteria and were selected for use in developing the dynamic CAN-ADAPTT CPG. [Appendix E - Dowload complete guideline for appendices] This process has been developed and was recommended by the Guidelines Advisory Committee (GAC).
CAN-ADAPTT extracted key recommendations from the highest scoring guidelines, and used these as the formal evidence base to inform the development of its guideline.
NOTE: CAN-ADAPTT did not review the primary literature to inform the development of its Summary Statements unless emerging evidence was identified by the Guideline Development Group.
SUMMARY STATEMENTS AND CLINICAL CONSIDERATIONS DEVELOPMENT AND APPROVAL:
A Practice-Informed Approach
The CAN-ADAPTT process of guideline development was informed by the ADAPTE process8. This methodology was unique in that evidence was extracted from existing high quality guidelines to develop summary statements. Evidence tables were created for each of the guideline sections. The existing CPGs identified for inclusion were reviewed and relevant recommendations extracted for each section along with the level of evidence/grade of recommendation attributed to it by the original guideline developer. The CAN-ADAPTT Coordinating Team developed draft summary statements from the existing recommendations for each theme and included it in the evidence tables. The Chair of the GDG reviewed the evidence tables and approved for distribution to the GDG.
The entire GDG reviewed the evidence tables and suggested revisions independently. The CAN-ADAPTT Coordinating Team collated the revisions into one document and re-circulated revisions to each section to the respective GDG lead for review. The updated evidence tables were then prepared for the Annual General Meeting (AGM) of the CAN-ADAPTT Network held in Ottawa 2009. At the AGM, the GDG Section Leads were responsible for leading small group breakout sessions with Network members to review the evidence tables and invite input on the Summary Statements and Clinical Considerations for the CAN-ADAPTT guideline. The feedback was captured by designated recorders in each group as well as in participant workbooks that were collected at the end of the day. Following the AGM, all of the feedback was collated by the CAN-ADAPTT Coordinating Team and re-circulated to the GDG Section Lead for review and presentation to the other GDG members at the next GDG meeting.
During this GDG meeting, each GDG Section Lead was charged with facilitating discussion and eliciting feedback from the other GDG members for their respective section including revision to the Summary Statements, identification of relevant evidence to include in the background section, articulation of key clinical considerations and in assigning a level of evidence/grade of recommendation to each Summary Statement. The GDG Section Leads were supported by the CAN-ADAPTT Coordinating Team who assisted in drafting the content for review and confirmation by the GDG Section Leads. Final revision and approval of all Summary Statements and the level of evidence/ grade of recommendation was accomplished at an in-person GDG meeting where members were required to discuss and vote on final summary statements. Overall, there were seven GDG Meetings from 2009 to 2010.
GRADES OF RECOMMENDATION AND LEVELS OF EVIDENCE
Summary Statements were assigned Grades of Recommendation (GR) and Levels of Evidence (LoE) using a modified GRADE approach9. Given that this process built from existing clinical practice guidelines, traditional GRADE evidence tables were not used. The GDG utilized the Grading guide table, compiled by UptoDate10 to help consider the level of evidence and grade of recommendation for its Summary Statements. The Guideline Development Group Members reviewed each Summary Statement and weighed the clarity of risk and benefit, quality of the supporting evidence, and implications of the Summary Statement and assigned a GR and LoE for each. Members of the Guideline Development Group voted on the wording of the Summary Statement and each GR and LoE.
CAN-ADAPTT NETWORK PARTICIPATION
Composition of Network
The example of the AGM, as described above, demonstrates how the CAN-ADAPTT methodology also included engagement of the target end users; researchers, health care providers and manager/ decision makers in its process of guideline development. The feedback approach was iterative allowing for ongoing participation and reflection from the target end users. The impact or effectiveness of Clinical Practice Guidelines is often limited by the lack of consideration given to implementation or the applicability of the CPGs to local context and provider needs11. It was the aim of CAN-ADAPTT to explore the value and contribute to emerging guideline methods integrating implementation considerations into guideline development12.
CAN-ADAPTT targeted a variety of groups and key stakeholders for membership in the Network and participation in the guideline development process though a number of strategies. These included connecting with professional associations/ organizations representing various related disciplines and practices, presenting and displaying at conferences, sending out email blasts, conducting workshops, and publishing articles in professional journals and newsletters, as well as other promotional materials. Recruiting health providers committed to smoking cessation was considered particularly important, as they are in a unique position to engage in the delivery of smoking cessation interventions and thus are likely to use a revised, up-to-date, evidence-based guideline on smoking cessation practices. Network members were recruited from across Canada, and almost all Canadian provinces and territories had participants. Between 2008 and March 2011, more than 800 individuals have joined CAN-ADAPTT’s Network, and were invited to participate in the development of these guidelines.
Methods of Participation
CAN-ADAPTT members were invited to contribute to the guideline development and implementation process in a number of ways, including:
·Providing direct feedback to CAN-ADAPTT team
·Participating in CAN-ADAPTT workshops
·Participating in Annual General Meeting(s)
·Providing feedback via the Guideline Discussion Board
·Applying for CAN-ADAPTT seed grants
·Contributing a tool or resource
Practitioner, stakeholder and researcher input was collected via:
·Annual General Meetings (2 meetings held in November 1, 2009 and October 1, 2010 with 50-60 participants at each)
·Stakeholder meetings (n=118)
·Online discussion board (posts, n=221)
The most significant and successful forum for soliciting members’ comments, suggestions and recommendations regarding the guideline was at the Annual General Meetings.
An update of this guideline was not scheduled or required by our funder, Health Canada. Funding support of CAN-ADAPTT continues until March 2012. Dr. Peter Selby will seek funding opportunities to continue the work of CAN-ADAPTT including an update to the guideline.
DISSEMINATION AND IMPLEMENTATION
Four regional coordinators representing Western Canada, Ontario, Quebec and Atlantic Canada provided information on the CAN-ADAPTT initiative, and collaborated with regional providers, researchers, policy makers and other stakeholders on guideline dissemination strategies. The guideline was disseminated to regional provider networks, at conferences and workshops, integrated into existing educational efforts, and summary articles were published in newsletters and journals.
CAN-ADAPTT members were encouraged to disseminate the guideline by e-mail, and to discuss the guideline with colleagues. Members have also been incorporating the guideline into training or educational sessions.
National and professional organizations have been promoting the guideline primarily through passive dissemination such as publishing articles in newsletters, and providing links to the CAN-ADAPTT guideline on their websites.
The CAN-ADAPTT website provides a virtual networking space where CAN-ADAPTT members are invited to comment on the guideline, suggest smoking cessation tools and resources and identify additional research gaps. Any member can post to an existing subject thread or create a new discussion topic.
8. Harrison MB, Légaré F, Graham ID, Fervers B. Adapting clinical practice guidelines to local context and assessing barriers to their use. CMAJ. 2010 Feb 9;182(2):E78-84.
10. UpToDate. Grading guide. No date. Available from: http://www.uptodate.com/home/about/policies/grade.html; and Guyatt G, Gutterman D, Baumann MH, Addrizzo‐Harris D, Hylek EM, Phillips B, Raskob G, Lewis SZ, Schünemann H. Grading strength of recommendations and quality of evidence in clinical guidelines: Report from an American College of Chest Physicians task force. Chest. 2006 Jan;129(1):174-81, originally adapted from the GRADE Working Group.
11. Grimshaw J, Eccles M, Tetroe J. Implementing clinical guidelines: current evidence and future implications. J Contin Educ Health Prof. 2004 Fall;24 Suppl 1:S31-7. Review.
12. Graham ID, Beardall S, Carter AO, Tetroe J, Davies B. The state of the science and art of practice guidelines development, dissemination and evaluation in Canada. J Eval Clin Pract. 2003 May;9(2):195-202.
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