Receiving a summary of the results of a trial: qualitative study of participants' views
Receiving a summary of the results of a trial: qualitative study of participants' views
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DOI：
10.1136/bmj.38675.677963.3a
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发表时间：
2006-01-28
影响因子：
105.7
通讯作者：
Kenyon, S
中科院分区：
文献类型：
--
作者：
Dixon-Woods, M;Jackson, C;Kenyon, S
目的 探讨试验参与者对收到妊娠期试验结果摘要的反应。设计采用半结构化访谈的定性研究。参与者 20 名怀孕时曾怀孕的女性参加了抗生素治疗早产和胎膜早破的 ORACLE 试验，并要求获得试验结果副本。结果 参加 ORACLE 试验的妇女中不到五分之一表示希望收到试验结果。尽管一些女性难以理解该传单，但对总结试验结果的传单的反应总体上是积极或中性的，并且有证据表明可能对出现不良结果的女性产生负面影响。女性要求提供结果是因为她们有兴趣能够完成自己的个人叙述。她们希望知道自己被分配到试验的哪个部分以及对自己怀孕的影响，但他们对收到的通用摘要感到失望。妇女的叙述表明对试验结果有些困惑。 结论 提出了定期向研究参与者提供研究结果的建议，但没有通过研究来显示这样做的后果或应如何最好地管理它。需要谨慎行事，更多地评估应如何处理结果反馈以及风险、收益和成本的评估。
Objective To explore trial participants' responses to receiving a summary of the results of a trial in pregnancy.Design Qualitative study with semistructured interviews.Participants 20 women who had when pregnant participated in the ORACLE trial of antibiotics for preterm labour and preterm rupture of the membranes and requested a copy of the trial results.Results Less than a fifth of women who participated in the ORACLE trial indicated that they wished to receive the trial results. Reactions to the leaflet summarising the trial results were generally positive or neutral, although some women had difficulty in understanding the leaflet, and there was evidence of possible negative implications for women who had adverse outcomes. Women requested the results because they were interested in being able to complete their own personal narrative. They wished to know to which arm of the trial they had been allocated and the implications for their own pregnancy, and they were disappointed with receiving a generic summary. Women's accounts indicated some confusion about the trial findings.Conclusions Recommendations that research participants be routinely provided with the results of studies have been made without the benefit of research to show the consequences of doing this or how it should best be managed. Caution is needed, as is more evaluation of how feedback of results should be handled, and assessment of the risks, benefits, and costs.