Study on the consistency of doctor-report outcomes and patient-report outcomes in symptoms of traditional Chinese Medicine: a small sample size trial in diabetics.

Patient-Reported Outcomes (PROs) data are increasingly common and widely accepted in clinical investigations of symptoms. Agreements or differences regarding Doctor-Report Outcomes (DROs) VS PROs data are unclear. In this study, we conducted a clinical trial and investigated the agreement levels of DROs VS 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. Our results show that most of the agreements regarding DROs VS PROs were moderate; few were modest and substantial. However, the DROs data failed to agree with the PROs data well in which symptoms effective evaluation criteria overlapped with the inclusion criteria. We believe this results are caused by distortion of information during the doctor's decision process. We suggest that the effective evaluation criteria should not be overlapped with the inclusion criteria in the DROs design. And if it is unavoidable, PROs design should be worth considering.