Editorial :: Is The Cochrane Collaboration prepared for the era of patient-centred outcomes research? - The Cochrane Library

Editorial :: open access

..........Given the experience with involvement of consumers and patients in Cochrane Reviews, the Collaboration is well equipped to advance the field of patient-centered outcomes research. It is the largest single producer of systematic reviews worldwide, it is a leader in the field of systematic review methods, and its backbone is individuals driven by the motivation to improve health care. In addition, the Collaboration has an active consumer group. Nevertheless, a bit more attention to the vantage points that patients face when making healthcare decisions and some thinking 'outside the Cochrane box' might be required to face these new challenges.
Specifically, the strong focus on RCTs and readily accessible endpoints restricts many Cochrane Reviews to outcomes that are important to trial designers and sponsors but not necessarily important to patients.
For regulatory purposes clinical trials focus primarily on outcomes that are easy to assess, such as symptom scales. Impairment of health status, however, is often related to severity of symptoms as well as intended and unintended treatment effects. Reviewers need to place more focus on outcome measures that reflect the entire continuum of patients' needs, including the impact of symptoms. In addition, many of the outcomes that patients care about relate to harms, which may not always be reliably assessed with outcomes used in RCTs. A broader focus on non-randomised studies will be necessary to cover the scope of patient-centered outcomes; especially rare but important adverse events are often measured more reliably with observational studies.
Furthermore, patients and consumers need to be engaged early (at the title registration stage) to identify outcomes that matter most to them. This will come with many challenges, the strong involvement of the industry in patient advocacy groups being only one of them. Initiatives such as INVOLVE (www.invo.org.uk) in the United Kingdom or Project CONNECT in the United States (www2.shepscenter.unc.edu/connect) demonstrate that patient engagement in research is achievable and important. There is guidance on how to best engage patients at the outset of a systematic review to identify patient-centered outcomes, but patient involvement at the planning stages of Cochrane Reviews varies and largely depends on the engagement of the Cochrane Review Group............