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

Bibliographic Details
Title: 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
Authors: Yujie Zhang, Yuxin Zheng, Ye Zhao, Kaoqiang Liu, Yongli Chai, Fen Lin, Hongsheng Zhan, Weian Yuan
Source: BMJ Open, Vol 12, Iss 11 (2022)
Publisher Information: BMJ Publishing Group, 2022.
Publication Year: 2022
Collection: LCC:Medicine
Subject Terms: Medicine
More Details: 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.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2044-6055
Relation: https://bmjopen.bmj.com/content/12/11/e063576.full; https://doaj.org/toc/2044-6055
DOI: 10.1136/bmjopen-2022-063576
Access URL: https://doaj.org/article/31f0f3aeb7604534829f84929425c6b7
Accession Number: edsdoj.31f0f3aeb7604534829f84929425c6b7
Database: Directory of Open Access Journals
More Details
ISSN:20446055
DOI:10.1136/bmjopen-2022-063576
Published in:BMJ Open
Language:English