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The following is a summary of “State of patient reported outcome measures in rheumatology,” published in the June 2024 issue of Rheumatology by Manswell et al.
Researchers conducted a retrospective study examining the quality and promptness of reporting patient-reported outcome (PRO) measures in rheumatology.
They identified clinical trials that informed new FDA approvals for the first rheumatological indications (1995 and 2021). The documentation of the collected PROs was published, achieved minimal clinically important difference (MCID), was statistically significant (P<0.05), and followed CONSORT-PRO reporting guidelines. The time from FDA approval to PRO publication was assessed using HR and the Kaplan-Meier estimate.
The result showed that 31 FDA approvals were associated with 110 pivotal trials, which reported 262 PRO measures. Among the studies analyzed (n=90), 1 study (1.1%) fulfilled all five recommended criteria. In contrast, 10 studies (11.1%) met four criteria, 17 studies (18.9%) met three criteria, 21 studies (23.3%) met two criteria, 26 studies (28.9%) met one criterion, and 15 studies (16.7%) did not meet any of the reporting standards. Most PROs achieved MCID thresholds (149 out of 262, 56.9%) and demonstrated statistical significance (223 out of 262, 85.1%). The analysis revealed that one-third (70/212, 33.0%) of PROs were published later, with one in nine (22/212, 10.4%) remaining unpublished after four years. The HAQ-DI had the highest publication rate at 97.4%, while SF-36 had the lowest at 81.8%. Publication rates varied among different measures, and less than half (94/212, 44.3%) of the published PROs met the MCID and statistical significance threshold.
Investigators concluded that delayed publication (>4 years for 1/9 of PROs) and poor CONSORT-PRO adherence highlighted the need for improved PRO reporting standards and timely publication efforts.
Source: jrheum.org/content/early/2024/05/26/jrheum.2023-1073