Reporting of Patient-Reported Outcomes in Randomized Trials

Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.

The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the reporting of randomized controlled trials (RCTs); however, it lacks guidance on the reporting of patient-reported outcomes (PROs), which are often inadequately reported in trials, thus limiting the value of these data. In this article, we describe the development of the CONSORT PRO extension based on the meth...

1406padherence to Consort Patient-reported Outcomes Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: a Systematic Review.

Results: PRO was most frequently a measurement of the patients quality of life (n = 88, 71%), a measurement of the patients symptoms (n = 22, 18%) or both (n = 11, 9%). Unfortunately, the majority of trials did not report on PRO at all (201 of 325; 62%). Of the remaining 124 trials, the mean PRORQS score was 5.0 on an 11 points scale. Among the 11 items included in the PRORQS, none was correctl...

Patient-Reported Outcomes In Randomized Controlled Trials of Gynecological Cancers: A Systematic Review

Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

BACKGROUND Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. OBJECT...

Patient-reported outcomes better discriminate active treatment from placebo in randomized controlled trials in rheumatoid arthritis.

BACKGROUND Recent randomized controlled trials (RCTs) in rheumatoid arthritis (RA) have used patient- and physician-reported outcomes, ESR and/or CRP as components of ACR response criteria to assess efficacy. OBJECTIVES Mean changes from baseline in patient- and physician-reported outcome measures, ESR and CRP were compared in two RCTs in patients with active RA. Comparisons between active an...