The CONSORT PRO Extension

Item 1b. CONSORT 2010: structured summary of trial design, methods, results, and conclusions. PRO Extension: The PRO should be identified in the abstract as a primary or secondary outcome. Example. “The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score.” Explanation. If a PRO is prespecified as a primary or important secondary outcome in the trial, it should be explicitly stated in the abstract to facilitate indexing and identification of studies to inform clinical care and evidence synthesis. Table 1. Information for Reporting Randomized Controlled Trials With Patient reported Outcomes (continued) Section/Topic Item CONSORT 2010 Statement Checklist Item PRO-Specific Extensions Are Prefaced by the letter P Results Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory Including PRO analyses, where relevant Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) Discussion Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses P20/21: PRO–specific limitations and implications for generalizability and clinical practice Generalizability 21 Generalizability (external validity, applicability) of the trial findings Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence PRO data should be interpreted in relation to clinical outcomes including survival data, where relevant Other Information Registration 23 Registration number and name of trial registry Protocol 24 Where the full trial protocol can be accessed, if available Funding 25 Sources of funding and other support (such as supply of drugs), role of funders PATIENT-REPORTED OUTCOMES IN RANDOMIZED TRIALS ©2013 American Medical Association. All rights reserved. JAMA, February 27, 2013—Vol 309, No. 8 817 Downloaded From: http://jama.jamanetwork.com/ by a HSE Eastern Library Service User on 10/02/2015 Introduction Item 2a. CONSORT 2010: Scientific background and explanation of rationale. PRO Elaboration: The relevant background and rationale for why PROs were assessed in the RCT should be briefly described. Example. “Migraine causes severe impairment or bed rest in more than half (57%) of affected people, markedly impairs quality of life both during and between attacks, increases absenteeism and reduces productivity at work, and is associated with increased health care costs.” Explanation. Given the increasing literature on PROs, and the increasing number of validated instruments available to assess them, the Background or Methods section should briefly establish the rationale for including PROs and why the specific outcomes were selected, thus providing appropriate context for the PRO–specific objectives and hypotheses (see item 2b below). When a PRO is a primary study outcome, a more detailed summary of the existing literature regarding its assessments relevant to the study purpose and objectives is helpful. Item 2b. CONSORT 2010: Specific objectives or hypotheses. PRO Extension: The PROs hypothesis should be stated and relevant domains identified, if applicable. Example. “Potential survival benefit needs to be weighed against the burden of treatment. For this reason, HRQOL, a multidimensional construct was included as a secondary end point in the EORTC18991study . . . Theprotocolhypothesized that there would be a differenceinglobalHRQOLscalebetweenboth arms,showingworseHRQOLinthePEGIFN-2b arm. The remaining HRQOL variables were then examined on an exploratory basis.” Explanation. Patient-reported outcome measures may be multidimensional or unidimensional assessing either one or several aspects of health (eg, physical and social function, or symptoms such as fatigue). In addition, PRO measures may assess global health or HRQL at several time points during an RCT. Without a prespecified hypothesis there is a risk of multiple statistical testing and selective reporting of PROs based on statistically significant results. It is recommended that authors report the rationale for the selection of specific patient-reported outcomes and the time frames of interest, including biological or psychosocial evidence for the proposed anticipated benefits or harms where relevant.