title: The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice.
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.
authors.forename: Melanie
authors.initials: M
authors.lastname: Calvert
authors.forename: Michael
authors.initials: M
authors.lastname: Brundage
authors.forename: Paul B
authors.initials: PB
authors.lastname: Jacobsen
authors.forename: Holger J
authors.initials: HJ
authors.lastname: Schünemann
authors.affiliation: Head, Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), GIMEMA Data Center, Via Benevento, 6, 00161 Rome, Italy. f.efficace@gimema.it.
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
mesh_terms: D002986:Clinical Trials as Topic; D019317:Evidence-Based Medicine; D006801:Humans; D007558:Italy; D063868:Patient Outcome Assessment; D017060:Patient Satisfaction; D011050:Policy Making; D011788:Quality of Life; D011795:Surveys and Questionnaires