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 |