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  1. Paul G Shekelle, senior research associate, Health Services Research and Development Service (shekelle@rand.org)a,
  2. Steven H Woolf, professor of family medicineb,
  3. Martin Eccles, professor of clinical effectivenessc,
  4. Jeremy Grimshaw, professor of public healthd
  1. aWest Los Angeles Veterans Affairs Medical Center (111G), 11301 Wilshire Blvd, Los Angeles, CA 90073, USA
  2. bDepartment of Family Practice, Virginia Commonwealth University, Fairfax, Virginia 22033, USA
  3. cCentre For Health Services Research, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA
  4. dHealth Services Research Unit, University of Aberdeen, Aberdeen AB9 2ZD
  1. Correspondence to: Dr Shekelle

    This is the second in a series of four articles on issues in the development and use of clinical guidelines

    The methods of guideline development should ensure that treating patients according to the guidelines will achieve the outcomes that are desired. This article presents a combination of the literature about guideline development and the results of our combined experience in guideline development in North America and Britain. It considers the five steps in the initial development of an evidence based guideline. The dissemination, implementation, and evaluation of practice guidelines will be discussed in the final article in this series.1

    Summary points

    • Identifying and refining the subject area is the first step in developing a guideline

    • Convening and running guideline development groups is the next step

    • On the basis of systematic reviews, the group assesses the evidence about the clinical question or condition

    • This evidence is then translated into a recommendation within a clinical practice guideline

    • The last step in guideline development is external review of the guideline

    Identifying and refining the subject area of a guideline

    Prioritising topics

    Guidelines can be developed for a wide range of subjects. Clinical areas can be concerned with conditions (abnormal uterine bleeding, coronary artery disease) or procedures (hysterectomy, coronary artery bypass surgery). Given the large number of potential areas, some priority setting is needed to select an area for guideline development. Potential areas can emerge from an assessment of the major causes of morbidity and mortality for a given population, uncertainty about the appropriateness of healthcare processes or evidence that they are effective in improving patient outcomes, or the need to conserve resources in providing care.

    Refining the subject area

    The topic for guideline development will usually need to be refined before the evidence can be assessed in order to answer exact questions. The usual way of refining the topic is by a dialogue among clinicians, patients, and the potential …

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