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Table 2 Level of reporting in recently conducted prostate cancer RCTs (65 studies published between 2004 and 2012) according to the new CONOSRT PRO extension

From: The CONSORT Patient-Reported Outcome (PRO) extension: implications for clinical trials and practice

Consort 2010 statement PRO extension Level of reporting, n (%)
Structured summary of trial design, methods, results, and conclusions The PRO should be identified in the abstract as a primary or secondary outcome 59/65 (91%)
Specific objectives or hypotheses The PRO hypothesis should be stated and relevant domains identified, if applicable. 24/65 (37%)
Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed. Evidence of PRO Instrument validity and reliability should be provided or cited if available including the person completing the PRO and methods of data collection (paper telephone electronic other). 43/65 (66%), Yes, for all PRO instruments used in the study.
15/65 (23%), reported “mode of administration”
Statistical Methods used to compare groups for primary and secondary outcomes Statistical approaches for dealing with missing data are explicitly stated. 12/65 (18%)
Trial limitations addressing sources of potential bias, imprecision, and, if relevant multiplicity of analyses PRO-specific limitations and implications for generalizability and clinical practice should be discussed. 23/65 (35%) PRO-specific limitations discussed.
  37/65 (57%) Implications for generalizability
Generalizability (external validity, applicability) of trial findings   
  1. Data extracted from Efficace et al. [20].