Guideline Development Group Methodology

Tumour groups were established by the NCCP to develop national clinical practice guidelines for some common cancers. Nominations to the Tumour Groups were received from the relevant postgraduate medical training bodies. Chairpersons were agreed by the tumour groups.  Governance is provided by a multidisciplinary steering group.  Membership of each tumour group includes representatives from all relevant clinical disciplines in addition to a methodologist, project manager and librarian. 

Methodology for Developing Evidence-Based Guidelines

Step 1 - Develop clinical questions

  • This defines the scope of the guideline

Step 2 - Search for and find the evidence

  • Commences with international guidelines
  • Primary literature is searched based on the hierarchy of evidence

Step 3 - Appraise the literature for validity and applicability

  • Guidelines are appraised using the AGREE II instrument
  • Primary papers are appraised using appraisal checklists

Step 4 - Making recommendations

  • The evidence is applied in conjunction with clinical expertise
  • Recommendations are graded to reflect the level of evidence

Step 5 - Draft Guideline

  • Internal peer review – National (NCCP website)
  • External peer review – International Guideline Development Group

Developing Clinical Questions

The first step in guideline development is to identify areas of new and emerging evidence or areas where there is variance in practice.  The question then forms the basis for gathering the evidence, the search strategy, the inclusion and exclusion criteria for evidence to be included and the types of evidence being gathered.

To formulate the clinical question to be answered it is broken down into its component parts using the PI(E)COT framework:

  • Participant/Population
  • Intervention/Exposure
  • Control/Comparison
  • Outcome
  • Time

Search for and find the evidence

The first step in searching for the evidence is the identification of international guidelines.  Searches of the primary literature are only conducted if the answers to the clinical questions are not found in up to date evidence based guidelines.

The clinical question formulated in step one is used to conduct literature searches of the primary literature.  Search terms should be developed using components from all elements of the PICOT.  A protocol has been developed for the guideline development process by the HSE librarians who are members of the tumour groups.  A copy of each search strategy is kept to facilitate updating of the search over time.  The literature is searched based on the hierarchy of evidence.

Appraise the literature for validity and applicability

Critical appraisal is “An explicit and independent process for judging the quality of research evidence””

In essence there are three points to remember when appraising evidence:

Are the results valid?

What are the results?

Are the results applicable/generalisable to the patient/population?

International guidelines are appraised using the international, validated tool the AGREE II instrument.  Primary papers are appraised using validated checklists developed by the Scottish Intercollegiate Guideline Network (SIGN).

Making recommendations

The final recommendations are formulated through a structured formal process.  Each question is discussed in detail and the following items are considered:

  • What evidence is available to answer the question?
  • What is the quality of the evidence?
    • Is the evidence consistent?
    • Is the evidence generalisable to the Irish population?
    • Is the evidence applicable in the Irish context?
    • What will the potential impact be?
  • Benefit versus harm
  • Resources

The final evidence statement and recommendations are written in real time.  The final recommendations are graded to reflect the level of evidence.

National Endorsement

Guidelines will be submitted to the National Clinical Effectiveness Committee (NCEC) in the Department of Health for national endorsement.

Implementation and Audit

The implementation plan is based on the Behaviour Change Wheel (Michie 2011) and the World Health Organisation (WHO 2013) implementation outcome variables – acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, coverage and sustainability.  Audit criteria are based on the recommendations.