METHODS: REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18-80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.
BACKGROUND: The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.
方法:REKOVER是第四阶段,多国,多中心,prospective,真实世界的观察研究。共有750名术后和非手术患者(男性和女性,18-80岁)将从新加坡的13家三级医院(15家医院)招募,泰国,菲律宾和马来西亚。所有接受TRAM/DKPFDC处方并愿意参与研究的患者将被招募。每个网站的招聘时间为6个月。在第1天至第5天的治疗期间,将使用数字疼痛评定量表收集疼痛的严重程度,同时在治疗结束时使用患者总体评估量表评估对治疗的满意度。在研究期间报告的任何不良事件将被记录用于安全性分析(直到第6天)。研究数据将输入ClaimIt门户和移动应用程序(app)(ObvioHealth,美国)。所有的住院病人数据将被输入到门户网站的研究网站和门诊病人将通过应用程序完成。
背景:该研究已获得新加坡各研究中心当地伦理委员会的批准,泰国,菲律宾和马来西亚。调查结果将通过地方和全球会议介绍传播,同行评审科学期刊和继续医学教育的出版物。