Assessment of the Health-Related Quality of Life Impact of EUFLEXXA (1% Sodium Hyaluronate) Using Short Form 36 (SF-36) Data Collected in aRandomized Clinical Trial Evaluating Treatment of Osteoarthritis Knee Pain
Bibliographic record
Abstract
Background: Outcome measurements of clinical trials such as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) have provided disease specific data on lower extremity osteoarthritis (OA).The impact of the disease, condition, or treatment on the dimensions of functioning and well-being has been supplemented by the use of general health-related quality of life (HRQoL) instruments.Objective: To examine patients' general HRQoL measures using the Short Form 36 (SF-36) from the 26-wk double-blind, randomized, saline (IA-SA)-controlled FLEXX Trial and the 26-wk open-label Extension Study, which evaluated efficacy and safety of intra-articular (IA) injections of a bioengineered hyaluronic acid (HA [BioHA]) for treatment of OA knee pain.Methods: HRQoL of participants treated with IA-BioHA in the FLEXX Trial was compared to patients' baseline HRQoL and to United States population and OA norms using the SF-36v2.This study evaluated the durability of improvement in physical health related domains of the SF-36 observed at week 26 of the FLEXX Trial by assessing the physical functioning scores at week 52 for patients who received a second course of 3 weekly injections of IA-BioHA during the FLEXX Trial Extension Study.Results: Baseline SF-36 scores indicated significant physical limitations in patients enrolled in the FLEXX Trial relative to United States population and OA population norms.Changes between the SF-36 scores for IA-BioHA-treated patients at week 26 continued to improve following a repeat injection series through week 52, with a significantly lower bodily pain domain (P=0.014).Conclusions: Patients treated with IA-BioHA in the FLEXX Trial experienced significantly greater improvement in physical functioning and disability at 26 weeks as measured by the SF-36.A repeat injection series of IA-BioHA resulted in further improvement towards United States population norms in their physical ability with a significant reduction in bodily pain from the end of the FLEXX trial to the end of the Extension Study (week 52).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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 source (direct Gemma or distilled Codex), 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".