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2008 Clinical Practice Guidelines - Canadian Diabetes Association

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Methods<br />

<strong>Canadian</strong> <strong>Diabetes</strong> <strong>Association</strong> <strong>Clinical</strong> <strong>Practice</strong> <strong>Guidelines</strong> Expert Committee<br />

The initial draft of this chapter was prepared by Gillian Booth MD MSc FRCPC,<br />

Sarah Capes MD MSc FRCPC and Vincent Woo MD FRCPC<br />

PROCESS<br />

Following the process used to develop previous <strong>Canadian</strong><br />

<strong>Diabetes</strong> <strong>Association</strong> clinical practice guidelines (1,2), an<br />

Executive Committee, Steering Committee and Expert<br />

Committee with broad expertise and geographic representation<br />

were assembled. In total, 99 volunteer physicians and<br />

allied health professionals (including endocrinologists, family<br />

doctors, pediatricians, nephrologists, cardiologists, ophthalmologists,<br />

neurologists, urologists, diabetes nurse<br />

educators, dietitians, pharmacists, podiatrists, psychologists<br />

and other professionals, as well as researchers in a variety<br />

of disciplines) participated in the guideline development<br />

process.<br />

The following basic principles were adopted to ensure<br />

that the values and empirical basis underlying each recommendation<br />

were explicitly identified, and to facilitate the<br />

critical scrutiny and analysis of each recommendation by<br />

other organizations and individuals.<br />

• Each recommendation had to address a clinically important<br />

question related to 1 or more of the following:<br />

detection, prognosis, prevention or management of diabetes<br />

and its sequelae. Health benefits, risks and side<br />

effects of interventions were considered in formulating<br />

the recommendations.<br />

•Whenever possible, each recommendation had to be<br />

justified by the strongest clinically relevant, empirical<br />

evidence that could be identified; the citation(s) reporting<br />

this evidence had to be noted adjacent to the relevant<br />

guideline.<br />

• The strength of this evidence, based on prespecified criteria<br />

from the epidemiologic literature and other guidelines<br />

processes, had to be noted (3-8).<br />

• This evidence had to be incorporated into a recommendation<br />

that was assigned a grade based on the available<br />

evidence, its methodological strength and its applicability<br />

to the <strong>Canadian</strong> population.<br />

• Each recommendation had to be approved by the<br />

Steering Committee and Executive Committee, with<br />

100% consensus.<br />

• <strong>Guidelines</strong> based on biological or mechanistic reasoning,<br />

expert opinion or consensus had to be explicitly<br />

identified and graded as such.<br />

IDENTIFYING AND APPRAISING<br />

THE EVIDENCE<br />

At the outset of the process, and in order to ensure a consistent<br />

approach to the development of recommendations, committee<br />

members from each section of the guidelines attended<br />

a workshop on evidence-based methodology. Committee<br />

members identified clinically important questions related to<br />

diagnosis, prognosis, prevention and treatment of diabetes<br />

and its complications.<br />

Authors were to explicitly define a) the population to<br />

which a guideline would apply; b) the test, risk factor or intervention<br />

being addressed; c) the “gold standard” test or relevant<br />

intervention to which the test or intervention in question<br />

was compared; and d) clinically relevant outcomes being targeted.This<br />

information was used to develop specific, clinically<br />

relevant questions that were the focus of literature<br />

searching. For each question, individual strategies were developed<br />

combining diabetes terms with methodological terms.A<br />

librarian with expertise in literature reviews performed a<br />

comprehensive search of the relevant English-language, published,<br />

peer-reviewed literature using validated search strategies<br />

(http://hiru.mcmaster.ca/hedges/indexHIRU.htm) of<br />

electronic databases (MEDLINE, EMBASE, CINAHL, the<br />

Cochrane Central Register of Trials and PsycINFO [where<br />

appropriate]).This was complemented by authors’ own manual<br />

and electronic searches. For topics that were covered in<br />

the 2003 guidelines, the literature searches focused on new<br />

evidence published since those guidelines. For new topics, the<br />

search time frame included the literature published since<br />

1990, or earlier where relevant.<br />

Key citations retrieved from the literature searches were<br />

then reviewed. Each citation that was used to formulate or<br />

revise a recommendation was assigned a level of evidence<br />

according to the prespecified criteria in Table 1, reflecting the<br />

methodological quality of the paper.When evaluating papers,<br />

authors were required to use standardized checklists that<br />

highlighted the most important elements of a well-conducted<br />

study.The level of evidence was then determined by the cited<br />

paper’s objectives, methodological rigour, susceptibility to bias<br />

and generalizability (Table 1). Because they could not be critically<br />

appraised, meeting abstracts, narrative review articles,<br />

news reports and other sources could not be used to support<br />

recommendations. Papers evaluating the cost-effectiveness of<br />

therapies or diagnostic tests were not included.<br />

S5<br />

METHODS

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