Consolidated Standards of Reporting Trials: Patient-Reported Outcomes - CONSORT PRO Extension
06 Nov 2018
Patient-reported outcome (PRO) data is defined as the “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”, which facilitate the evaluation of disease burden and treatment outcomes from patient perspective. The PROs include subjective measures such as health-related quality of life (HRQL), satisfaction ratings, symptom severity, and adherence to medication from RCTs, and enable clinical decision making, establishment of treatment preferences and to meet patient’s information needs.
The collection of PRO data includes costs associated with questionnaire administration and analysis with patient and investigator time. The RCTs and PROs need to be well designed, analyzed appropriately, and reported in a way that makes the results accessible and useful to end-users. Poor quality reporting can control synthesis of trial results across studies, using meta-analytic or other synthesis approaches and controls the valid application of PRO findings in clinical practice. Improved reporting makes PRO results easy for use in clinical practice and inform evidence synthesis and health policy. Results for PRO including HRQL from clinical trials are widely used for clinical decision making as well as comparative effectiveness, health policy, and reimbursement decision. Clinical trial which use HRQL as an outcome should be well performed. Patients value HRQL data so it can be used to initiate treatment preferences.
Reporting of all RCT outcomes, including PROs, should be complete and transparent. The standard CONSORT (Consolidated Standards of Reporting Trials) guideline was prepared to improve the reporting of randomized clinical trials (RCTs). The ‘Enhancing the Quality and Transparency of Health Research (EQUATOR) Network’ proposed the PRO extension on the methodological framework for guideline development. Initial work for the development and establishment of guidance for RCTs with HRQL as an outcome, was led by the International Society for Quality of Life Research (ISOQOL) Reporting Guidelines Task Force. For the development of an official CONSORT extension, the International Society for Quality of Life Research (ISOQOL) formed a Task force which arrived at consensus regarding recommended standards for reporting PROs in the publications of RCTs. The ISOQOL developed these recommendations with input from the membership and endorsed by the ISOQOL leadership. These recommendations have now been used in conjunction with information from other key stakeholders to inform consensus meeting.
The CONSORT PRO guidance supplements the standard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes, which focuses on parallel-group trials, but a number of extensions for reporting other trial designs (cluster, noninferiority, and equivalence), interventions (nonpharmacologic and herbal therapies), and for specific data, such as harms have been developed. A number of leading international journals and editorial groups follow the original CONSORT statement and its subsequent ‘extensions’.