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BCGuidelines.ca - By BC Physicians, for BC Physicians

Guideline Development

Accuracy and readability are the keys to a successful guideline. Specialists and general practitioners on working groups must ensure the guideline is not only based on medical evidence, but provides clear and practical advice for clinical situations they commonly experience.

To this end, guidelines are to be brief and concise (typically, no more than 5 - 6 pages in length, excluding appendices). Plain language is to be used whenever possible, so the guideline does not overwhelm the reader with the magnitude or complexity of the information provided. GPAC guidelines are not intended to be academic textbooks.

Once a topic has been approved for development by GPAC, a working group is formed and, with the support of research officers from the Medical Services Branch, develops a draft.

All working group members are expected to shoulder a share of the work and need to make a determined effort to attend committee meetings. Frequency of meetings and scheduling will be discussed at the first meeting. In addition to contributing to the development of guidelines, working group members are encouraged to comment on implementation strategies and evaluation methods.

GPAC has also established a process for the joint development of guidelines with partner organizations, such as the Heart and Stroke Foundation, and the Family Practice Oncology Network. Partner organizations use these templates and follow the guideline development process contained in this Handbook.

Guidelines are subject to review three to five years after the original Effective Date. Earlier review may be prompted by new evidence. The guideline Effective Date is typically six to eight weeks from the date the guideline was approved by the Commission.

Existing guidelines that undergo a substantive change to the content will be reissued with a new Effective Date; current guidelines that are subject to simple editorial changes or where only minor updates to the content are made, will have a Revised Date added at the end of the guideline but will retain the original Effective Date.

Quality of Evidence

The evidence review process used in the development of GPAC guidelines is conducted with reference to the Oxford Centre for Evidence-Based Medicine Levels of Evidence (May 2001). The CEBM Levels of Evidence document sets out one approach to systematizing the process for different clinical question types.

While levels of evidence are not explicitly stated within the GPAC guidelines, the research approach is standardized.  After the scope of the guideline has been determined and the main clinical questions are formulated, the process of reviewing evidence is as follows, with specific focus on high-quality systematic reviews. Other evidence types (depending on question) are ordered from most desirable to least desirable.

Working groups review available systematic reviews and base recommendations on these.  In cases where systematic reviews are not available, recommendations are based on primary evidence searches including individual randomized controlled trials reviewed by the working group. A full systematic review may not be conducted. For example, for a Therapy/Prevention/Aetiology/Harm question, “systematic reviews (with homogeneity) of randomized controlled trials” are the most desirable product.

The evidence review process is robust, and includes searching various sources, including a minimum of two of the following resources:

  • Medline
  • CADTH
  • CINAHL
  • Therapeutics Initiative
  • Cochrane reviews
  • BMJ Clinical Evidence
  • e-Therapeutics (CPS)
  • Embase
  • AHRQ
  • FDA.gov

A search history is recorded in a search sheet equivalent to that produced by The Cochrane Collaboration.

Oxford Centre for Evidence-based Medicine Levels of Evidence (May 2001)

Therapy / Prevention / Aetiology / Harm

Prognosis

Diagnosis

Differential diagnosis / symptom prevalence study

Economic and decision analyses

Systematic Review (with homogeneity) of Randomized Control Trials

Systematic Review (with homogeneity) of inception cohort studies; Clinical Decision Rule validated in different populations

Systematic Review (with homogeneity) of Level 1 diagnostic studies; Clinical Decision Rule with 1b studies from different clinical centres

Systematic Review (with homogeneity) of prospective cohort studies

Systematic Review (with homogeneity) of Level 1 economic studies

Individual Randomized Control Trial (with narrow Confidence Interval)

Individual inception cohort study with > 80% follow-up; Clinical Decision Rule validated in a single population

Validating cohort study with good reference standards; or Clinical Decision Rule tested within one clinical centre

Prospective cohort study with good follow-up

Analysis based on clinically sensible costs or alternatives; systematic review(s) of the evidence; and including multi-way sensitivity analyses

All or none

All or none case-series

Absolute SpPins and SnNouts

All or none case-series

Absolute better-value or worse-value analyses

Systematic Review (with homogeneity) of cohort studies

Systematic Review (with homogeneity) of either retrospective cohort studies or untreated control groups in Randomized Control Trials

Systematic Review (with homogeneity) of Level >2 diagnostic studies

Systematic Review (with homogeneity) of 2b and better studies

Systematic Review (with homogeneity) of Level >2 economic studies

Individual cohort study (including low quality Randomized Control Trial; e.g., <80% follow-up)

Retrospective cohort study or follow-up of untreated control patients in an Randomized Control Trial; Derivation of Clinical Decision Rule or validated on split-sample only

Exploratory cohort study with good reference standards; Clinical Decision Rule after derivation, or validated only on split-sample or databases

Retrospective cohort study, or poor follow-up

Analysis based on clinically sensible costs or alternatives; limited review(s) of the evidence, or single studies; and including multi-way sensitivity analyses

"Outcomes" Research; Ecological studies

"Outcomes" Research

 

Ecological studies

Audit or outcomes research

Systematic Review (with homogeneity) of case-control studies

 

Systematic Review (with homogeneity) of 3b and better studies

Systematic Review (with homogeneity) of 3b and better studies

Systematic Review (with homogeneity) of 3b and better studies

Individual Case-Control Study

 

Non-consecutive study; or without consistently applied reference standards

Non-consecutive cohort study, or very limited population

Analysis based on limited alternatives or costs, poor quality estimates of data, but including sensitivity analyses incorporating clinically sensible variations.

Case-series (and poor quality cohort and case-control studies)

Case-series (and poor quality prognostic cohort studies)

Case-control study, poor or non-independent reference standard

Case-series or superseded reference standards

Analysis with no sensitivity analysis

Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles"

Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles"

Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles"

Expert opinion without explicit critical appraisal, or based on physiology, bench research or "first principles"

Expert opinion without explicit critical appraisal, or based on economic theory or "first principles"

Produced by Bob Phillips, Chris Ball, Dave Sackett, Doug Badenoch, Sharon Straus, Brian Haynes, Martin Dawes since November 1998. For full definitions and explanations go to http://www.cebm.net/index.aspx?o=1025

Off Label Policy

A number of GPAC guidelines contain recommendations involving medications that have not been approved for sale by Health Canada for that specific indication or patient group (“off label”). GPAC working groups are expected to identify references supporting the efficacy of medications they are recommending – whether or not a given drug or class of drugs has been approved for marketing with respect to that particular indication.

Off label drug therapy recommendations are to be supported with appropriate references and include evidence as to the numbers needed to treat (NNT) and numbers needed to harm (NNH) whenever possible.

External Review

New guidelines, and existing guidelines that have undergone substantive changes, will be subject to peer review to ensure guidelines are clearly written, practical, and free from serious oversights or errors. This is referred to as external review. During this process, a GPAC approved draft is mailed to a random sample of general practitioners, relevant specialties, and stakeholders (typically numbering between 400 and 800 individuals). Appropriate reviewers for specific guidelines are chosen in consultation with MOH medical consultants and research officers.

After the external review process is completed (1-2 months), MSB compiles results and lists comments, word for word, for the working group’s consideration. External review results are reconciled and reported to GPAC when a guideline is under consideration for final approval.

Final Approval

Relevant comments received from the external review process are incorporated into the draft guideline which is again presented to GPAC for final approval. Presentation is typically conducted by the working group chair or an alternate.

If approved, the full guideline is provided to the BCMA for distribution to the respective Section Presidents and members of the Board of Directors for comment. There is a ten day period during which concerns may be raised. The guideline is then presented to the MSC for final approval and adoption for use in British Columbia.

MSC Approval

All new guidelines and all existing guidelines that have undergone substantial revision are presented to the MSC for adoption in BC following consideration by the BCMA Board of Directors.

Minor revisions to existing guidelines may be approved by GPAC and an advisory sent to the MSC. The MSC has granted GPAC the approval to routinely update its guidelines when there are PharmaCare coverage changes, providing the revisions do not involve a change in practice.

Formatting of the guideline into a print-ready format follows this final approval step.

Approval of the full guideline by the BCMA and the MSC is not to be delayed awaiting development of other guideline-related products (e.g., summary, smartphone).

Guideline Distribution

A great guideline, poorly distributed, is not an effective guideline. Proper distribution allows the guideline to reach the target audience expeditiously, and adequately conveys the credibility of the document.

A number of methods are currently used to support guideline uptake, as well as implementation of the recommendations contained within the guidelines, including:

  • Development one to two page guideline summaries;
  • Publishing of all guidelines and supporting documentation online through the www.BCGuidelines.ca web site in multiple formats;
  • Condensing guidelines into Smartphone (iPhone) format for use at the point of care;
  • Provision of each new and revised guideline to guideline related websites (e.g., CMA, National Guidelines Clearing House); and
  • E-mail notification to BCGuidelines.ca mailing list subscribers.

Evaluation and Renewal

The MSC has determined that GPAC needs to develop measures appropriate for evaluating both the usage and efficacy of the guidelines and protocols. There are three general areas used for evaluation:

  • Physician/Public Usage: Website analysis is used to determine usage of www.BCGuidelines.ca, which captures trends in response to the introduction of a new/revised guideline.
  • Practice Change: Specific MSP fee items for either investigations or treatment which are potentially modified by a given GPAC guideline provide process markers for physician practice, as does the ordering of specific prescription medications covered by the recommendations. If the use of any investigations or treatments (i.e. tests and prescriptions) is used for more than one condition, a registry of patients who have been diagnosed with the disease/condition will be created in order to narrow the scope of the search.
  • Patient Outcomes: Data from BC hospitals provide codes for discharge diagnoses and procedures. Vital Statistics provides cause of death and contributory conditions. Both sources can be used to measure trends possibly associated with GPAC clinical guidelines.

GPAC clinical practice guidelines are only one source of information which may influence physicians, so it will be difficult to assert that changes in physician practice or patient outcomes are solely a direct result of new or revised clinical guidelines (unless the GPAC guideline is truly unique in some measurable way).

Every 3-5 years guidelines are formally evaluated using the above data to determine the need for an updated version, or to proceed with retirement of the guideline and reallocation of GPAC resources to a more impactful topic.

Disclaimer The Clinical Practice Guidelines (the "Guidelines") have been developed by the Guidelines and Protocols Advisory Committee on behalf of the Medical Services Commission. The Guidelines are intended to give an understanding of a clinical problem and outline one or more preferred approaches to the investigation and management of the problem. The Guidelines are not intended as a substitute for the advice or professional judgment of a health care professional, nor are they intended to be the only approach to the management of clinical problems.  We cannot respond to patients or patient advocates requesting advice on issues related to medical conditions. If you need medical advice, please contact a health care professional.