methods chapter 2 gillian booth, alice yy cheng canadian diabetes association 2013 clinical practice...

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


International Recognition of 2008 CDA CPGs


• 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)


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


The Process (continued)

6. External Review (national, international)

7. Independent Methods Review

8. Final approval of Steering Committee

9. Publication

10.Dissemination and Implementation


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


Rating the Evidence

Highest available level of evidence

Relevant studies

Formally assign each a level of evidence


• 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)


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


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


Grading Recommendations (continued)

Grade Level of confidence A Higher

B

C

D Lower


Scope and PurposeStakeholder

involvementRigour of developmentApplicabilityEditorial independence

AGREE II


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 √


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)


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 √



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 √



APPLICABILITY

Potential organizational barriers discussed √Potential cost implications considered (√)

CPGs offer review criteria for purpose of monitoring and audit √



EDITORIAL INDEPENDENCE

CPGs are editorially independent of funding body √Conflicts of interest of guideline development members recorded

√



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


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


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


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


http://www.icmje.org/ethical_4conflicts.html




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


CDA Clinical Practice Guidelines

http://guidelines.diabetes.ca – for professionals

1-800-BANTING (226-8464)

http://diabetes.ca – for patients

http://guidelines.diabetes.ca/

http://diabetes.ca/

methods chapter 2 gillian booth, alice yy cheng canadian diabetes association 2013 clinical practice...

Documents

highest level of evidence

implementation slide

international guidelines

review of literature

clinical practice guidelines

cda cpgs

prognosis rating

clinical questions