会议专题

The agreement of Doctor-Report Outcomes and Patient-Report Outcomes in a symptom study: a small sample size trial in diabetics

  Background: Patient-Reported Outcomes (PROs) data are increasingly common and widely accepted in clinical investigations of symptoms.Agreements or differences regarding Doctor-Report Outcomes (DROs) and PROs data are unclear.Methods: In this study, we conducted a clinical trial and investigated the levels of agreement on DROs and PROs in symptoms of diabetics.This study had a parallel self-controlled and double blind design.In total, 90 diabetics who presented with the required symptoms were enrolled in this study, and 83 patients completed the study.The severity (none, mild, moderate, and severe) of each symptom was consistently compared with the Visual Analogue Scale (VAS) for the PROs measure and the numerical rating scales (NRS) for the DROs measure.The Kappa index was used to test the agreement in the variables.Results: Our results show that most of the agreement strength regarding DROs and PROs was moderate;some agreement strength results were modest, and some were substantial.However, the DROs data failed to agree with the PROs data in the symptoms-related effective evaluation criteria overlapping the inclusion criteria, which is caused by distortions of information regarding the doctor” s decision process.Conclusions: We suggested that effective evaluation criteria should not be overlapped with the inclusion criteria in the DROs design research or otherwise be evaluated on the basis of the PROs data.

Agreement Symptom Trial Patient-Report Outcomes Kappa index

Jun SUN Weian YUAN Hao LU Zhen LI Jian JIANG

Department of Pharmacy,General Hospital of Jinan Military Command,Jinan,Shandong Province,China;Post Department of Clinical Pharmacology,Shuguang Hospital,Shanghai University of Traditional Chinese Med Department of Endocrinology,Shuguang Hospital,Shanghai University of Traditional Chinese Medicine,Sh

国内会议

首届两岸四地中医药循证高峰论坛

北京

英文

386-392

2015-06-05(万方平台首次上网日期,不代表论文的发表时间)