The Development And Application Of The Scale For Assessing The Report Quality Of Clinical Trials

Background: Randomized Control Clinical Trials (RCTs) have been regarded as the gold standard to testify the safety and efficacy of medication and therapy. The report quality of clinical trials has been attached importance. Some scientists have attempted to assess the quality of report of RCT using various methods since 1980. Objective: In this study the instrument to evaluate the report quality of clinical trials and its detailed explanation has been developed adopting the Delphi method in combination with panel discussion, its validity and reliability has been attempted to be assessed, and the definition of quality also has been discussed at the same time. Method: For the development of the instrument, the Delphi method in combination with panel discussion has been applied in this study, some teachers and postgraduates in the department of epidemiology constituted the program group, and the related specialists, including pharmacologists, clinical doctors, epidemiologists, statisticians and editors of journal, have been selected as the consultative members. The instrument for assessing the report quality of clinical trials and its elaboration and explanation were formed through three phases of consultation, and how to define the quality has been discussed. The evaluation of the clinical trials' reports for the therapy of hypertension, randomly selected from the reports published in 2000, has been...