In the last post, we explored the importance of clinical guidelines in preventing human error. We particularly reviewed how the absence or inadequacy or guidelines may impair patient safety. In this post, we will review the stages of developing guidelines, and the factors that make them effective.

The stages in the development of guidelines have been exhaustively reviewed by Wendy Lim and colleagues in their paper titled Evidence-based guidelines – an introduction, and by Paul Shekelle and colleagues in a paper titled Clinical guidelines: developing guidelines. The guideline-development stages they outlined are:

• • Identifying the subject area and the need for the guidelines
  • Establishing the members of the group and their specific roles
  • Defining the clinical question to be addressed by the guideline
  • Defining the eligibility criteria for the studies to be reviewed
  • Conducting a ‘systematic search of the literature’
  • Identifying and evaluating the evidence and the data quality 
  • Specifying the method of translating the different forms of evidence into a recommendation
  • Developing the recommendations
  • Specifying a method of reviewing and updating the guideline

For any guideline to have ‘ultimate validity and usefulness‘, Mark Linskey and Steven Kalkanis, in their paper titled Evidence-linked, clinical practice guidelines-getting serious; getting professional, identified three ‘key factors‘. The first is that the members of the ‘guideline panel’ be carefully selected. As explained by Robbie Foy and colleagues in the book Clinical Risk Management, it is important for the guideline development group to possess the right skills, and not to have any conflicts of interest. The other two key factors in developing effective guidelines which Linskey and Kalkanis discussed were the application of reliable processes for ‘identification and synthesis‘ of the evidence‘, and for ‘guideline construction‘. Foy and colleagues also highlighted the need for ‘intensive review of up to date evidence’, and for ‘validation by external review’, before guidelines are published.

In a similar vein, Patrick O’Connor, writing in a paper titled Adding value to evidence-based clinical guidelines, also discussed several ingredients of effective guidelines. He specifically advised that guidelines should:

• • Cite the ‘number needed to treat to obtain a specified benefit’
  • List the expected benefits of each recommendation
  • Specify the ‘cost of various potential therapies’
  • State the ‘potential economic and personal burden on the patient and caregiver’
  • List the evidence of recommendations for particular patient groups
  • Clarify ‘the influence of patient-specific factors such as age, life expectancy, and comorbidity on anticipated benefits of the recommendations’
  • Enable ‘customization of care in complex clinical scenarios’
  • Respect ‘the individuality of patients and the professional judgment of highly skilled physicians’.

Beyond the established requirements of guideline development, Lim and colleagues urged guideline developers to also consider other factors such as ‘the likely benefits, risks, inconvenience and costs associated with each treatment’. David Scalzitti, in his paper titled Evidence-Based guidelines: application to clinical practice, also added that emerging evidence will necessitate revision of the guideline recommendations.

In the next post, we will look at the clinical benefits of checklists.