Snowdon C, Garcia J, Elbourne D
Medical Statistics Unit, London School of Hygiene and Tropical Medicine, University of London, London WC1E 7HT.
BMJ. 1998 Jul 4;317(7150):21-6. doi: 10.1136/bmj.317.7150.21.
To assess views of parents of babies who participated in a neonatal trial, about feedback of trial results.
Qualitative analysis of interviews.
Parents' homes.
Parents of 24 surviving babies enrolled in a UK randomised controlled trial comparing ventilatory support by extracorporeal membrane oxygenation with conventional management.
Views about contents of results, reactions to results, effect of hindsight, and importance of feedback.
Information about mortality was well understood by the parents but morbidity was less clearly reported. Even when the content was emotionally exacting, the information was still wanted as it removed uncertainty; provided an endpoint to difficult events; promoted further discussion within couples; and acknowledged their contribution to answering an important clinical question.
Feedback of trial results to participants should be a consideration of researchers, but a careful approach is required. This study was based on a highly selective group of parents within a particularly sensitive trial. More research is needed to assess the extent to which these results can be generalised to other trials or to groups such as bereaved parents.
评估参与一项新生儿试验的婴儿的父母对试验结果反馈的看法。
访谈的定性分析。
父母家中。
24名存活婴儿的父母，这些婴儿参与了一项英国随机对照试验，该试验比较了体外膜肺氧合通气支持与传统治疗方法。
对结果内容的看法、对结果的反应、事后诸葛亮的影响以及反馈的重要性。
父母对死亡率信息理解良好，但发病率报告不太清晰。即使内容在情感上要求苛刻，信息仍被需要，因为它消除了不确定性；为困难事件提供了一个终点；促进了夫妻间的进一步讨论；并认可了他们对回答一个重要临床问题的贡献。
向参与者反馈试验结果应是研究人员考虑的问题，但需要谨慎对待。本研究基于一项特别敏感试验中的一组高度选择性的父母。需要更多研究来评估这些结果能在多大程度上推广到其他试验或推广到如失去亲人的父母等群体。
