Test reliability and comparability of paper and Chinese electronic version of the western Ontario and McMaster University osteoarthritis index: protocol for a randomised controlled clinical trial

Introduction
The Western Ontario and McMaster University osteoarthritis index (WOMAC) is the most commonly used indicator of disease-specific outcome in knee osteoarthritis for its convenience and reliability. It has two formats the paper-based WOMAC (p-WOMAC) and the electronic WOMAC (e-WOMAC). In China, the p-WOMAC has been widely used though e-WOMAC is yet untested. This study aims to test whether e-WOMAC is consistent with the p-WOMAC before and after the intervention.

Methods and analysis
A total of 70 patients from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine will be randomly assigned in two groups, named, group A and group B. This study is divided into three stages. In the first stage, patients in group A will be evaluated first by p-WOMAC and then by e-WOMAC. Patients in group B will be evaluated by e-WOMAC and then by p-WOMAC. In the second stage of the study, drug interventions will be implemented. 200 mg celecoxib will be administered orally once a day starting from the second day of enrolment for a period of 21 days. In the third stage, postintervention evaluation will be conducted after administration. Patients in group A will be evaluated first by e-WOMAC and then by p-WOMAC. Patients in group B will be evaluated first by p-WOMAC and then by e-WOMAC. In order to avoid the possible bias because of patients’ potential memory, e-WOMAC and p-WOMAC will be taken for each patient at 15 min apart. The primary outcome of the study is the mean score difference in WOMAC, and the secondary outcomes are the score differences in WOMAC subscales: pain, stiffness and physical function.

Ethics and dissemination
The protocol has been approved by the Independent Review Board of SGH (approval number: 2020-814-21-01). The results of the trial will be submitted for publication in a peer-reviewed journal.

Trial registration number
ChiCTR2100050914.

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Novembre 2022

Understanding eating behaviours, mental health and weight change in young adults: protocol paper for an international longitudinal study

Introduction
Understanding the complexities of change in eating behaviours, mental health, well-being and weight is crucial to inform healthcare and service provision, particularly in light of the exacerbating effects of the COVID-19 pandemic. This study aims to address the need for more comprehensive cross-sectional and longitudinal evidence, by tracking eating behaviours, mental health, health related behaviours and weight over a 12-month period, in a sample of young adults (18–35 years) in the UK and Australia.

Methods and analysis
Online surveys administered via the Prolific online research platform will be used for data collection at baseline, 6 months and 12 months. The survey (approximately 45 min) measures demographics, the impact of COVID-19, body mass index (BMI), weight management and health service usage, eating behaviours, personality, mental health, and health-related behaviours. An optional substudy component at each time point aims to validate self-reported weight in the main survey through images. Study inclusion criteria are; aged 18–34 years at baseline, BMI ≥20 kg/m2, and residing in the UK or Australia. A target of 500 participants at baseline was set, recruited through Prolific, and with recruitment stratified by BMI, sex and country. The proposed analyses include creating static predictive models using baseline data (eg, using latent class analysis, factor analysis or similar), and mapping changes longitudinally (eg, using multivariate regressions). These analyses will enable changes in the study measures to be identified, as well as predictors and outcomes of change.

Ethics and dissemination
Ethical approval was granted by Leeds Beckett University, UK (reference number 86004) and the University of Newcastle, Australia (reference number H-2022–0110). Study findings will be disseminated through scientific journals, conferences, institute websites and social media, and briefings tailored to policy, practice and the public, with the intention to help inform the future development of health and well-being care and support for young adults across Australia and the UK.

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Settembre 2022