Impact of "Spin" on the Interpretation of Results of Randomized Trials in the Field of Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Interpretation of the Beneficial Effect of the Experimental Treatment
研究概览
简要总结
Randomized controlled trials (RCT) are the gold standard for therapeutic evaluation. Rapid dissemination of trial results and their translation into clinical practice is particularly important. Abstracts published or presented in conferences are a large, rapid and free method to disseminate these results. However, this mode of dissemination may have serious consequences for patients if abstracts are not an accurate and unbiased reflection of the trial results. Investigators have great freedom when writing their abstracts and articles: they can choose the data and decide how to present it. Consequently, they have many opportunities to shape readers' impressions of their results, that is, to add "spin" (ie, spin is a specific way of reporting to convince readers that the beneficial effect of the experimental treatment is higher than shown by the results).
Objective: To assess the impact of spin on the interpretation of results in abstracts of randomized controlled trials with non-statistically significant results in the field of cancer.
详细描述
The investigators planned a RCT in which the unit of randomization is the abstract. The planning, implementation, analysis and writing of this study followed the CONSORT Statement12.
Design
The investigators performed a RCT comparing the interpretation of results in abstracts a) with and b) without spin.
- Identification of abstracts of randomized trials with spin. The investigators selected a sample of negative published RCTs (i.e. non statistically significant results) with a spin in abstract conclusion identified in previous works. Inclusion criteria were 1) RCTs with non-statistically significant primary outcome, 2) spin in the abstract conclusion.
- Abstracts' modification Selected abstracts were systematically rewritten to contain no "spin". All abstracts were presented in the same format without the names of authors, references, or the name of the journal in which it was published, and the names of treatments were masked by using generic terms.
- Assessment Abstracts were assessed by corresponding authors of randomized trials, experts of specific grants and investigator of trials registered in http://clinicaltrials.gov. Experts were invited to participate in our study. They were not informed of the objectives of our study. Each clinician was randomized to evaluate 1 abstract with or 1 abstract without spin.
- The primary endpoint was the interpretation of abstract results by participants. All readers participating in the study evaluated the abstract of randomized trial and answered the following question: Based on this abstract, do you think treatment A would be beneficial to patients?
Randomization characteristics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Interpretation of the Beneficial Effect of the Experimental Treatment
时间窗: 1 month
The primary endpoint was the interpretation of abstract results by the participants. All readers participating in the study evaluated the abstracts of randomized trials and answered the following questions: based on this abstract, do you think treatment A would be beneficial to patients? (answer: numerical scale from 0 not at all likely tp 10 very likely)
次要结局
- Importance of the Study(1 month)
- Overall Rigor of the Study Methodology(1 month)
- Interest in Reading Full Text(1 month)
- Need for More Evidence (Run a New Trial)(1 month)