A QUALITY ASSESSMENT OF RANDOMIZED CONTROL TRIALS OF PRIMARY-TREATMENT OF BREAST-CANCER
A QUALITY ASSESSMENT OF RANDOMIZED CONTROL TRIALS OF PRIMARY-TREATMENT OF BREAST-CANCER
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DOI：
10.1200/jco.1986.4.6.942
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发表时间：
1986-06-01
影响因子：
45.3
通讯作者：
CHALMERS, TC
中科院分区：
文献类型：
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作者：
LIBERATI, A;HIMEL, HN;CHALMERS, TC
采用定量方法对早期乳腺癌主要治疗的随机对照试验（RCT）方法进行了综述。根据标准化评分系统，对63项RCT进行了评价，这些RCT比较了对34，000多名患者进行的各种治疗方式，并在119篇论文中进行了报告。制定了一个百分比分数来评估研究的内部有效性（指其设计和执行的质量）和外部有效性（指确定其普遍性所需的信息的呈现）。总分也计算为两者的组合。63项随机对照试验的平均总分为50%（95%置信区间[CI] = 46%-54%），不同类型试验之间的差异较小且无统计学显著性。这些研究中最常见的方法学缺陷与随机化过程有关（63项随机对照试验中只有27项采用了真正的盲法程序），（只有26项随机对照试验将所有患者纳入分析），随访时间表的描述（仅12项RCT充分报告）、副作用报告（33项RCT提供了充分信息）和患者人群描述（29项RCT满意）。通过给主要调查员打电话，在100分制中，质量分数提高了7分，这表明一些缺陷在于报告，而不是业绩。有证据表明，随着时间的推移，质量得到了改善，越来越多的趋势，涉及生物统计学家在研究团队是积极相关的内部效度的提高，但不与外部。
The methodology of randomized control trials (RCTs) of the primary treatment of early breast cancer has been reviewed using a quantitative method. Sixty-three RCTs comparing various treatment modalities tested on over 34,000 patients and reported in 119 papers were evaluated according to a standardized scoring system. A percentage score was developed to assess the internal validity of a study (referring to the quality of its design and execution) and its external validity (referring to presentation of information required to determine its generalizability). An overall score was also calculated as the combination of the two. The mean overall score for the 63 RCTs was 50% (95% confidence interval [CI] = 46% to 54%) with small and nonstatistically significant differences between types of trial. The most common methodologic deficiencies encountered in these studies were related to the randomization process (only 27 of the 63 RCTs adopted a truly blinded procedure), the handling of withdrawals (only 26 RCTs included all patients in the analyses), the description of the follow-up schedule (only 12 RCTs reported adequately), the report of side effects (adequate information given in 33 RCTs), and the description of the patient population (satisfactory in 29 RCTs). Telephone calls to the principal investigators improved the quality scores by seven points on a scale of 100, indicating that some of the deficiencies lay in reporting rather than performance. There was evidence that quality has improved over time and that the increasing tendency of involving a biostatistician in the research team was positively associated with the improvment of the internal validity but not with the external.