Tan Teng Hwee, Chen Desiree, Soon Yu Yang, Tey Jeremy Chee Seong
Department of Radiation Oncology, National University Cancer Institute, Singapore, National University Hospital, National University Health System, Singapore.
National University of Singapore, Singapore.
J Med Imaging Radiat Oncol. 2016 Dec;60(6):764-771. doi: 10.1111/1754-9485.12494. Epub 2016 Jul 11.
To determine the prevalence and predictors of bias in reporting of primary efficacy and toxicity endpoints in randomized trials (RCTs) of radiation oncology.
We searched MEDLINE for eligible RCTs published from January 1994 to October 2014. Bias in reporting of primary efficacy endpoint was defined as reporting that treatment was beneficial based on secondary endpoints despite a statistically non-significant difference in primary endpoint. Bias in reporting of toxicity endpoint was defined as not reporting toxicity findings in the abstract, discussion or results table. Logistic regression multivariate models were used to determine predictors of biased reporting.
We found that 13% of 323 RCTs have bias in the reporting of primary efficacy endpoint with non-cooperative group trials as a significant predictor of bias (odds ratio (OR) 2.04, 95% confidence interval (CI) 1.03-4.00, P = 0.04). Thirty-five per cent of 279 RCTs were judged to have bias in the reporting of toxicity endpoint with trials not listed in Clinicaltrials.gov as a significant predictor of bias (OR 3.23, 95% CI 1.43-7.14, P = 0.004).
The prevalence of bias in reporting of primary efficacy and toxicity endpoint for radiotherapy RCTs was 13% and 35% respectively. Non-cooperative group trials were more likely to have bias in the reporting of primary efficacy endpoint. Trials not listed in Clinicaltrials.gov were more likely to have bias in the reporting of toxicity endpoint.
确定放射肿瘤学随机试验（RCT）中主要疗效和毒性终点报告偏差的发生率及预测因素。
我们在MEDLINE中检索了1994年1月至2014年10月发表的符合条件的RCT。主要疗效终点报告偏差定义为尽管主要终点在统计学上无显著差异，但基于次要终点报告治疗有益。毒性终点报告偏差定义为在摘要、讨论或结果表中未报告毒性结果。使用逻辑回归多变量模型确定偏差报告的预测因素。
我们发现，323项RCT中有13%在主要疗效终点报告上存在偏差，非合作组试验是偏差的显著预测因素（优势比（OR）2.04，95%置信区间（CI）1.03 - 4.00，P = 0.04）。279项RCT中有35%被判定在毒性终点报告上存在偏差，未在Clinicaltrials.gov上列出的试验是偏差的显著预测因素（OR 3.23，95% CI 1.43 - 7.14，P = 0.004）。
放射治疗RCT中主要疗效和毒性终点报告偏差的发生率分别为13%和35%。非合作组试验在主要疗效终点报告上更可能存在偏差。未在Clinicaltrials.gov上列出的试验在毒性终点报告上更可能存在偏差。
