Respiratory Guidelines—Which Real World?

Abstract

Clinical practice guidelines are usually developed by a group of experts coming together to review the evidence in a field to make evidence-based recommendations on how to integrate new evidence into practice. The development process often draws on strict methodological rules to assess and assign quality grades to the evidence used to underpin the recommendations. Yet the goal of clinical practice guidelines--to help guide clinicians to understand, translate, and apply new evidence into everyday practice--can be thwarted by a lack of diversity and plurality of committee members, by limitations in the published evidence base, and by the design of the randomized controlled trials (RCTs) that largely underpin their pronouncements. Asthma and chronic obstructive pulmonary disease (COPD) RCTs often represent only a minority (5 to 10%) of the routine care population in whom licensed interventions will be applied. Thus, the implications of extrapolating RCT efficacy (based on idealized patients and management settings) to real-life treatment effectiveness (achieved in broad patient populations being managed in routine care) is unclear. Although RCTs can adequately demonstrate efficacy of a specific treatment, pragmatic trials and postmarketing observational studies are usually required to evaluate the long-term safety of therapeutic interventions. The practical usefulness of clinical practice guidelines may be enhanced by ensuring representation of a broad stakeholder group within guideline committees (e.g., patients, primary and secondary care clinicians, policy makers, and health insurers) and by integrating effectiveness as well as efficacy data. Only in this way can clinical practice guidelines achieve their goal of guiding the meaningful implementation of new research into practice, for the benefit of all stakeholders.