IntroductionThe 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 analysisA 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 disseminationThe 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 numberChiCTR2100050914.
Background: The Western Ontario and McMaster University osteoarthritis index (WOMAC) is the most commonly used indicator of disease-specific outcome in knee osteoarthritis (KOA) 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: A total of 240 patients from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (SHUTCM) will be randomly assigned in two groups which are named as 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. 200mg celecoxib will be administered orally once a day starting from the second day of enrollment for a period of 21 days. The third stage is the consistency evaluation stage after intervention. The post-intervention 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 minutes apart in the first and third stages. The comparison will include the overall score of the WOMAC, the score of each subscale and the score of individual items. Comparing the e-WOMAC with the p-WOMAC, the primary outcome of the study is the mean score difference in WOMAC, and the secondary outcomes are the score differences in three WOMAC subscales: pain, stiffness, and physical function. Discussion : This study will test reliability and comparability between e-WOMAC and p-WOMAC. Meanwhile, we will also collect and provide participants’ feedback after comparing two formats of the WOMAC. If the results are favorable, our findings will serve to demonstrate the equivalence of each version of the WOMAC so that it can be implemented in specialized medical activities. Likewise, our results will further demonstrate the feasibility of e-health for the personalize KOA treatment. Trial registration: ChiCTR, ChiCTR2100050914. Registered on 8 Sep 2021, https://www.chictr.org.cn/showproj.aspx?proj=133521 Keywords: Chinese electronic version of WOMAC, Verification, Protocol
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