The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice
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The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice Melanie Calvert1, Michael Brundage2, Paul B Jacobsen3, Holger J Schünemann4 and Fabio Efficace5*
Abstract To inform clinical guidelines and patient care we need high quality evidence on the relative benefits and harms of intervention. Patient reported outcome (PRO) data from clinical trials can “empower patients to make decisions based on their values” and “level the playing field between physician and patient”. While clinicians have a good understanding of the concept of health-related quality of life and other PROs, evidence suggests that many do not feel comfortable in using the data from trials to inform discussions with patients and clinical practice. This may in part reflect concerns over the integrity of the data and difficulties in interpreting the results arising from poor reporting. The new CONSORT PRO extension aims to improve the reporting of PROs in trials to facilitate the use of results to inform clinical practice and health policy. While the CONSORT PRO extension is an important first step in the process, we need broader engagement with the guidance to facilitate optimal reporting and maximize use of PRO data in a clinical setting. Endorsement by journal editors, authors and peer reviewers are crucial steps. Improved design, implementation and transparent reporting of PROs in clinical trials are necessary to provide high quality evidence to inform evidence synthesis and clinical practice guidelines. Keywords: Quality of life, CONSORT PRO, Reporting, Clinical trials
Background Randomized controlled clinical trials (RCTs) can provide high-quality data regarding the impact of study interventions on patient outcomes, and remain the ‘gold standard’ of evidence regarding both the benefits and harms associated with an intervention. Over the last twenty years, the number of clinical trials that assess patient reported outcomes (PROs) has substantially increased [1]. PROs can be defined as a “measurement of any aspect of a patient’s health status that comes directly from the patient (i.e. without the interpretation of the patient’s responses by a physician or anyone else” [2] and include health-related quality of life (HRQL), symptoms, satisfaction and adherence to medication. These subjective measures of outcome help evaluate the burden of disease * Correspondence: [email protected] 5 Head, Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), GIMEMA Data Center, Via Benevento, 6, 00161 Rome, Italy Full list of author information is available at the end of the article
and treatment from the patients’ perspective. In the conceptual framework developed by Till and colleagues adapted in (Figure 1) [3], PRO data from clinical trials may directly inform patients and practitioners, or may indirectly inform clinical practice through evidence synthesis into clinical practice guidelines. The quality of data, including PROs, from trials may be threatened by the
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