Choosing Important Health Outcomes For Comparative Effectiveness Research: A Systematic Review.

Abstract

A core outcome set (COS) is a standardised set of outcomes which should be measured and reported, as a minimum, in all effectiveness trials for a specific health area. This will allow Results to be compared, contrasted and combined as appropriate, as well as ensuring that all trials contribute usable information. The aim of this review was to identify studies which sought to determine which outcomes or domains to measure in all clinical trials in a specific condition, and to describe the methodological techniques used in these studies. We developed a multi-faceted search strategy for electronic databases (MEDLINE, SCOPUS, and Cochrane Methodology Register). We included studies which sought to determine which outcomes/domains to measure in all clinical trials in a specific condition. 198 studies (250 reports) were included in the review. Studies covered various areas of health, most commonly cancer, rheumatology, neurology, heart and circulation, and dentistry and oral health. A variety of Methods have been used to develop COS, including semi-structured discussion, unstructured group discussion, the Delphi Technique, Consensus Development Conference, surveys and Nominal Group Technique. The most common groups involved were clinical experts and non-clinical research experts. Thirty-one (16%) studies reported that the public had been involved in the process. The geographic locations of participants were predominantly North America (n=164; 83%) and Europe (n=150; 76%). This review has brought together the existing research in a single place. COS will increase the efficiency and value of the research process and make it easier for people to make well-informed decisions about health care. Design of new trials will be simplified, risk of measuring inappropriate outcomes reduced, and selective reporting of outcomes less likely. We have highlighted future areas of research, including the need for methodological guidance for COS development and better reporting of COS studies.