methods chapter 2 gillian booth, alice yy cheng canadian diabetes association 2013 clinical practice...
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Methods
Chapter 2
Gillian Booth, Alice YY Cheng
Canadian Diabetes Association 2013 Clinical Practice Guidelines
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Methods – Guiding Principles
• Building on 2008 CPGs
• Rigorous, evidence-based
• Transparency – process, evidence that guidelines are based on and how we evaluated that evidence
• Fulfill criteria outlined in AGREE II instrument
• Harmonization with other guidelines
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
International Recognition of 2008 CDA CPGs
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
• Systematic review of 11 international guidelines on
oral medication for T2DM
• Assessed for consistency with the evidence
• Assessed for quality
– Rigor of development
– Editorial independence
• Conducted by the Johns Hopkins University
Evidence-Based Practice Center
International Recognition of 2008 CDA CPGs (continued)
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
The Process
1. Develop clinical questions
2. Centralized literature search (X3)
3. Review of literature search
4. Write preamble and recommendations
5. Every recommendation reviewed and approved
by 100% consensus of Steering Committee
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
The Process (continued)
6. External Review (national, international)
7. Independent Methods Review
8. Final approval of Steering Committee
9. Publication
10.Dissemination and Implementation
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Identifying Articles
• Identifying clinically important questions– Treatment or prevention– Diagnosis– Prognosis
• Centralized literature search– Systematically conducted lit searches– Known articles– Manual search of listed citations from articles
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Rating the Evidence
Highest available level of evidence
Relevant studies
Formally assign each a level of evidence
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
• Same standardized approach as in 2008
• Set of ‘rules’ to rate studies of a certain type (prevention/treatment, diagnosis, prognosis)
• Rating depends on study design plus strengths and weaknesses of the study
Rating the Evidence (continued)
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Formulating a Recommendation
1) Recommendation What the evidence says
2) Grade What the highest level of evidence is
3) Reference(s) Study which provides the
highest level of evidence
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Grading Recommendations
Grade Best Evidence
A Level 1
B Level 2
C Level 3
D Level 4
High level RCT(s) or systematic review / meta-analysis of RCTs
RCT(s) or systematic review/meta-analysis
Cohort studies
Case control studies, case series
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Grading Recommendations (continued)
Grade Level of confidence A Higher
B
C
D Lower
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Scope and PurposeStakeholder
involvementRigour of developmentApplicabilityEditorial independence
AGREE II
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
AGREE II Criteria
SCOPE AND PURPOSE
Objectives and purpose of CPGs specifically described √Clinical questions covered by CPGs specifically described √Patients to whom CPGs apply are specifically described √
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
STAKEHOLDER INVOLVEMENT
All relevant professional groups involved in process √Patient’s views and preferences sought √Target users of CPGs clearly stated √Guideline has been pilot tested among target users before publication √
AGREE II Criteria (continued)
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
RIGOUR OF DEVELOPMENT
Systematic methods used to search for evidence √Criteria for selecting evidence are clearly described √Methods used to formulate recommendations √Health benefits, side effects and risks considered √Explicit link between supporting evidence and recommendations √
External review prior to publication √Procedure for updating guideline in place √
AGREE II Criteria (continued)
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
RIGOUR OF DEVELOPMENT (cont’d)
Recommendations are specific and unambiguous √Different options for management are presented √Key recommendations are easily identifiable √CPGs are supported with tools for application √
AGREE II Criteria (continued)
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
APPLICABILITY
Potential organizational barriers discussed √Potential cost implications considered (√)
CPGs offer review criteria for purpose of monitoring and audit √
AGREE II Criteria (continued)
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
EDITORIAL INDEPENDENCE
CPGs are editorially independent of funding body √Conflicts of interest of guideline development members recorded
√
AGREE II Criteria (continued)
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Independent Methods Review Process
More than 200 articles
85 recommendations
27 chapters
17 hours of meeting time
10 hour face to face meeting
2 - 3 hour teleconferences x 3
2013
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Gillian Booth (Chair)University of Toronto
Doreen RabiUniversity of Calgary
Dereck HuntMcMaster University
Charlotte McDonaldUniversity of Western Ontario
Valerie PaldaUniversity of Toronto
Sonia ButaliaUniversity of Calgary
2013Independent Methods Review Committee
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Changes to Methods in 2013
• Multiple literature searches throughout period
• Evidence resource persons as chapter authors
• Publishing evidence-based worksheets
• Committee struck to consider how to incorporate cost and/or cost-effectiveness into CPGs
2013
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Duality of Interest
• No employees of a pharmaceutical or device
company
• No board membership of a pharmaceutical or
device company
• Disclosure of duality of interest at the beginning of
each steering committee meeting
• Duality of interest details publicly available
2013
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
http://www.icmje.org/ethical_4conflicts.html
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
Funding Sources
• Canadian Diabetes Association (general funds)
• Unrestricted educational grants– Merck Canada Inc, Novo Nordisk Canada Inc, Eli Lilly
Canada Inc, Bristol-Myers Squibb / AstraZeneca
collaboration, Novartis Pharmaceuticals Canada Inc.
• Companies were not involved in any aspect of
guideline development and did not have access to
guideline meetings, guideline drafts or committee
deliberations
2013
guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association
CDA Clinical Practice Guidelines
http://guidelines.diabetes.ca – for professionals
1-800-BANTING (226-8464)
http://diabetes.ca – for patients
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