The State of Patient-Reported Outcome Measures in Rheumatology
Authors' conclusion
One in 9 PROs remained unpublished for ≥ 4 years after initial trial reporting, and compliance with CONSORT-PRO reporting guidelines was poor.
Study context
- Population
- Clinical trials that informed new US Food and Drug Administration (FDA) approvals for the first rheumatological indication between 1995 and 2021
- Participants
- 262 participants110 pivotal trials
- Outcome
- Quality (CONSORT-PRO compliance, MCID/statistical significance) and timeliness of PRO reporting
Methodological detailsmeta-research of pivotal trials informing FDA approvals 1995–2021
- Meta-research of pivotal trials informing FDA approvals 1995–2021
Main finding
As reported in the abstract
CONSORT-PRO reporting standards met (of 90 included studies)
- Met all 5 recommended items
- 1 (1.1%)
- Met 4 items
- 10 (11.1%)
- Met 3 items
- 17 (18.9%)
- Met 2 items
- 21 (23.3%)
- Met 1 item
- 26 (28.9%)
- Met none of the reporting standards
- 15 (16.7%)
- Patient-reported outcome (PROs) not published upfront (subset analysis)
- 70/212; 33%
- PROs unpublished ≥ 4 years after initial trial reporting
- 22/212; 10.4%
Observational data: associations, not effects.
Further findings
PROs meeting minimum clinically important difference (MCID) and statistical significance thresholds
- Met MCID thresholds
- 149/262; 56.9%
- Statistically significant
- 223/262; 85.1%
- Published PROs meeting both MCID and statistical significance
- 94/212; 44.3%
Publication rates by PRO instrument
- Highest: HAQ-DI
- 97.4%
- Lowest: 36-item Short Form Health Survey
- 81.8%
Original publication
The State of Patient-Reported Outcome Measures in Rheumatology. J Rheumatol. Published 1 June 2024. doi:10.
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