Minimal important difference and patient acceptable symptom state for common outcome instruments in patients with a closed humeral shaft fracture - analysis of the FISH randomised clinical trial data
Bibliographic record
Abstract
BACKGROUND: Two common ways of assessing the clinical relevance of treatment outcomes are the minimal important difference (MID) and the patient acceptable symptom state (PASS). The former represents the smallest change in the given outcome that makes people feel better, while the latter is the symptom level at which patients feel well. METHODS: We recruited 124 patients with a humeral shaft fracture to a randomised controlled trial comparing surgery to nonsurgical care. Outcome instruments included the Disabilities of Arm, Shoulder, and Hand (DASH) score, the Constant-Murley score, and two numerical rating scales (NRS) for pain (at rest and on activities). A reduction in DASH and pain scores, and increase in the Constant-Murley score represents improvement. We used four methods (receiver operating characteristic [ROC] curve, the mean difference of change, the mean change, and predictive modelling methods) to determine the MID, and two methods (the ROC and 75th percentile) for the PASS. As an anchor for the analyses, we assessed patients' satisfaction regarding the injured arm using a 7-item Likert-scale. RESULTS: The change in the anchor question was strongly correlated with the change in DASH, moderately correlated with the change of the Constant-Murley score and pain on activities, and poorly correlated with the change in pain at rest (Spearman's rho 0.51, -0.40, 0.36, and 0.15, respectively). Depending on the method, the MID estimates for DASH ranged from -6.7 to -11.2, pain on activities from -0.5 to -1.3, and the Constant-Murley score from 6.3 to 13.5. The ROC method provided reliable estimates for DASH (-6.7 points, Area Under Curve [AUC] 0.77), the Constant-Murley Score (7.6 points, AUC 0.71), and pain on activities (-0.5 points, AUC 0.68). The PASS estimates were 14 and 10 for DASH, 2.5 and 2 for pain on activities, and 68 and 74 for the Constant-Murley score with the ROC and 75th percentile methods, respectively. CONCLUSION: Our study provides credible estimates for the MID and PASS values of DASH, pain on activities and the Constant-Murley score, but not for pain at rest. The suggested cut-offs can be used in future studies and for assessing treatment success in patients with humeral shaft fracture. TRIAL REGISTRATION: ClinicalTrials.gov NCT01719887, first registration 01/11/2012.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.012 | 0.020 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".