Results from RCTs and systematic reviews: to whom do they apply?

Article type
Authors
O'Connell D, Henry D, Glasziou P, Sarunac J, Hill S, Lowe J, Sackett D
Abstract
Introduction: Evidence-based medicine involves the application of findings from randomised controlled trials (RCTs) and systematic reviews to clinical practice. However the identification of individual patients in whom the benefits of a particular treatment will outweigh the risks is problematic.

Objective: (1) To undertake a systematic review of the literature on the applicability (or generalisability) of results from RCTs or systematic reviews.

(2) To produce a pragmatic guide on how to assess applicability and how to use the findings of RCTs to identify subgroups in the community who are likely to benefit from a particular treatment.

Methods: A literature search is in progress using Medline, hand searching of key journals and checking references from identified papers. The papers are being reviewed by study members, grouped into subject areas and annotated bibliographies will be produced. From these, a synthesis of the literature will be compiled describing the methods currently used to assess applicability, the assumptions required and areas for further research.

Results: So far we have identified 378 articles to be reviewed. Initial impressions suggest that there are very few papers addressing general methods for assessing applicability. The majority tend to focus on a particular aspect such as subgroup analysis, patient selection or heterogeneity of treatment effect. A summary of the literature and preliminary conclusions will be presented at the meeting.

Discussion: This project should contribute to better policy and clinical decisions regarding the implementation and funding of new technologies based on an accurate appraisal of the applicability of the findings from RCTs and systematic reviews to particular groups of patients in hospital, general practice and community settings.