FURTHER VALIDATION OF THE PATIENT/PARENT-REPORTED OUTCOME MEASURE OF FRACTURE HEALING (PROOF-LE) QUESTIONNAIRE FOR LOWER EXTREMITY FRACTURES IN CHILDREN
Bibliographic record
Abstract
Clinical trials of pediatric fractures seldom show differences based on patient-reported outcome measures (PROMs), possibly because the PROMs do not adequately capture patients’/parents’ perspectives about outcomes that matter. The Patient Reported Outcomes of Fracture Healing (PROOF) questionnaires are a new set of PROMs designed specifically for children's fractures. Derived from parents and patients, the PROOF includes 4 domains (Scores:0-100): “How it Looks’; “How it Feels”; “How it Works”; and “How it Healed”, which captures the overall recovery experience. This project evaluates the reliability, validity and responsiveness of the PROOF-LE for lower extremity fractures in children. Children with lower extremity fractures were prospectively enrolled. Parents and children (> 8yrs) completed the parent & child versions of the PROOF-LE respectively, at 3 time-points from treatment until full recovery. Test-retest reliability (2-weeks apart) was determined at final healing using intraclass correlation coefficient (ICC); and internal consistency using Cronbach's Alpha. Convergent validity was assessed comparing the total and domain scores of the PROOF-LE to realted domains of the PODCI using Pearson correlation. Construct validity was evaluated by comparing fractures with and without complications. Responsiveness (sensitivity to change) was evaluated over 3 time-points using standardized response means (SRM). Finally, parents’ scores were compared with their respective children's scores, using paired t-test and Pearson correlation. 335 children's [197 boys/138 girls; mean age (SD): 9.9yrs (4.4)] fractures of the pelvis/hip (4), femur (99), knee (24), tibia (141), ankle (40) and foot (27) were included. The PROOF-LE demonstrated moderate to excellent test-retest reliability for the Total and domain scores for children (ICC:0.75 - 0.89) and parents (ICC:0.69-0.88); high internal consistency for children (0.72 - 0.9) and parents (0.72 - 0.91). PROOF-LE domain scores correlated positively with like domains of the PODCI. As hypothesized, fractures with complications scored significantly worse than those without. The PROOF-LE was highly responsive with SRMs of 0.99 (parents) and 1.2 (children) for the total scores over three time-points. Parents’ scores correlated strongly with their children (r=0.89; p < 0 .001) with parents’ scores an average of 2.9 points lower than children's. The PROOF-LE is the only PROM designed specifically to measure outcomes of pediatric lower extremity fractures and their treatments. The child and parent versions of the PROOF-LE are reliable, internally consistent, valid and responsive for lower extremity fractures in children. The PROOF-LE reports scores across four different domains and in total, which allows it to better distinguish pros and cons of competing treatments, information about which will inform future decision-making about treatment choices. The PROOF-LE may be considered as the PROM of choice for pediatric lower extremity fractures and their treatments.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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".