Effectiveness and cost-effectiveness of a combined lifestyle intervention compared with usual care for patients with early-stage knee osteoarthritis who are overweight (LITE): protocol for a randomised controlled trial
Bibliographic record
Abstract
INTRODUCTION: Obesity is the most important modifiable risk factor for knee osteoarthritis (KOA). Especially in an early stage of the disease, weight loss is important to prevent further clinical and structural progression. Since 2019, general practitioners (GPs) in the Netherlands can refer eligible patients to a combined lifestyle intervention (GLI) to promote physical activity, healthy nutrition and behavioural change. However, GPs scarcely refer patients with KOA to the GLI potentially due to a lack of evidence about the (cost-)effectiveness. The aim of this study is to determine the (cost-)effectiveness of the GLI for patients with early-stage KOA in primary care. METHODS AND ANALYSIS: will be recruited using a range of online and offline strategies and from general practices in the Netherlands. Participants will receive nine 3-monthly questionnaires. In addition, participants will be invited for a physical examination, MRI assessment and blood collection at baseline and at 24-month follow-up. After the baseline assessment, participants are randomised to receive either the 24-month GLI programme in addition to usual care or usual care only. Primary outcomes are self-reported knee pain over 24 months, structural progression on MRI at 24 months, weight loss at 24 months, as well as societal costs and Quality-Adjusted Life-Years over 24-month follow-up. Analyses will be performed following the intention-to-treat principle using linear mixed-effects regression models. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Medical Ethical Committee of the Erasmus MC University Medical Center Rotterdam, The Netherlands (MEC-2020-0943). All participants will provide written informed consent. The results will be disseminated through publications in peer-reviewed journals, presentations at international conferences and among study participants and healthcare professionals. TRIAL REGISTRATION NUMBER: Netherlands Trial Registry (NL9355).
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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 | 0.031 | 0.033 |
| Meta-epidemiology (narrow) | 0.009 | 0.003 |
| Meta-epidemiology (broad) | 0.018 | 0.011 |
| Bibliometrics | 0.004 | 0.004 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.006 | 0.005 |
| Open science | 0.005 | 0.003 |
| Research integrity | 0.009 | 0.009 |
| Insufficient payload (model declined to judge) | 0.074 | 0.011 |
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".