Development and Evaluation of the Scale for Assessing the Report Quality of Clinical Trials / 药物流行病学杂志

ABSTRACT

Objective:To develop the instrument for the evaluation of the report quality of clinical trials with the modified Delphi method in combination with panel discussions, and assess its validity and reliability. Method: For the development of the instrument, the modified Delphi method in combination with a panel discussion was applied. The consulting panel included pharmacologists, clinical doctors, epidemiologists, statisticians and editors of journal. 30 reports for the therapy of hypertension published in 2000 were selected for the estimation of the instrument of the validity and reliability. The interclass correlation coefficient (ICC) was used to test the reliability. The CONSORT statement was used as a control, and a Kendall correlation was worked out to estimate the validity. Result:A total of 10 specialists took part in the consultation. During the first round of consultation, the expert harmonious coefficient (W) reached to 0. 505 and 19 items were identified. A total of 100 scores were distributed to the 19 items in the second round, and finally the scale was completed. After scoring the 30 reports on hypertension therapy by two readers independently, the interclass correlation coefficients (ICC) of the total score were 0.921,and 0.987 in the introduction part, 0.875 in materials and methods, 0.902 in results, and 0.966 in the discussion and others, P