ArticleJB & JS open access
The Fallacy of Patient-Reported Outcome Measures: Why They Often Fail to Detect Clinically Important Differences.
Article in JB & JS open access. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Linking FAAM and PROMIS Physical Function Scores: A Crosswalk Study.Foot & ankle orthopaedics · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Patient-reported outcome measures are increasingly common in orthopaedic research yet routinely fail to detect clinically meaningful differences in clinical trials. We assessed if orthopaedic studies are more likely to detect clinically important differences with a binary outcome, such as nonunion surgery, or a continuous patient-reported outcome sensitive to important clinical differences. Methods: We constructed a hypothetical clinical trial comparing 2 treatments for tibial shaft fractures. We assumed the true nonunion rate was 10% in the treatment group and 20% in the control group. Based on recent publications, we assumed nonunion patients had a mean Patient-Reported Outcomes Measurement Information System (PROMIS) physical function score of 40 (standard deviation [SD], 10) and united patients had a mean score of 50 (SD, 10), a difference that is double the minimum clinically important difference. Based on these expected distributions, we simulated 10,000 trials with a sample size of 400 patients to assess the probability of detecting a significant difference between treatment groups at p < 0.05. The trial results were analyzed using the binary outcome of nonunion surgery and PROMIS physical function. Results: Of the 10,000 simulated trials with a 400-patient sample, the observed difference in nonunion surgery between the treatment groups was statistically significant 80.9% (95% confidence interval [CI], 79.2%- 82.6%) of the time. By contrast, the 400-patient sample detected a statistically significant difference between groups in PROMIS physical function only 4.2% (95% CI, 3.8%-4.6%) of the time (difference, 76.7%; 95% CI, 75.8%-77.6%; p < 0.001). Conclusion: Even if patient-reported outcome measures are sensitive to important clinical events, most studies will fail to detect statistically significant differences between the treatment groups when the important clinical outcome occurs in a minority of the overall sample. Orthopaedic surgeons and scientists should be aware of this limitation when designing and appraising studies that compare treatments with patient-reported outcomes. Level of Evidence: Not applicable.
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Registered trials
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