Disappointment and drop-out rate after being allocated to control group in a smoking cessation trial
Disappointment and drop-out rate after being allocated to control group in a smoking cessation trial
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DOI：
10.1016/j.cct.2009.09.003
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发表时间：
2010-01-01
影响因子：
2.2
通讯作者：
Tonnesen, H.
中科院分区：
文献类型：
--
作者：
Lindstrom, D.;Sundberg-Petersson, I.;Tonnesen, H.
背景：如果患者同意参加随机试验，则可以合理地推测患者更愿意接受干预。本研究的目的是调查患者被随机分配到对照组后的反应。方法：两项随机试验中的嵌套研究。通过结构化调查问卷进行电话访谈。参与者在两项戒烟试验中被随机分为对照组后受到邀请。主要结果指标是对对照组分配的反应和退出率。结果：30 次可能的访谈中有 27 次成功完成。十四人表示对被分配到对照组感到失望。五人表示不理解同意信息，其中三人非常失望。令人惊讶的是，这三个人表示他们没想到会进行随机分组。一位女士表示，她“感觉自己被骗了”。对照组共有 9/117（7.7%）例失访，干预组有 4/105（3.8%）例失访（P=0.26）。对照组主动撤回同意的比例略高，对照组中有5人（4.3%），干预组没有主动撤回同意（P=0.06）。结论：分配到对照组后失望情绪很常见。这是对照组较高辍学率的可能解释。同意信息至关重要，因为那些非常失望的人声称他们没有收到可以理解的信息。 (C) 2009 Elsevier Inc. 保留所有权利。
Background: If a patient agrees to take part in a randomised trial it is reasonable to presume that the patient would prefer to be allocated into the intervention. This study's aim was to investigate how patients react after they have been randomised into control group.Methods: Nested study within two randomised trials. Telephone interviews with a structured questionnaire. The participants were invited after they had been randomised into the control group in two smoking cessation trials. The main outcome measures were reaction to control group allocation and drop-out rates.Results: Twenty-seven out of 30 possible interviews were successfully completed. Fourteen persons expressed that they were disappointed of being allocated to the control group. Five persons said that they had not understood the consent information and three of these were very disappointed. Surprisingly these three persons said that they had not expected a randomization. A woman expressed that she "felt as if I was being swindled". There were in total 9/117 (7.7%) lost to follow-up in the control group and there were 4/105 (3.8%) losses to follow-up in the intervention group (P=0.26). Active withdrawal of consent was slightly higher among the control group, five in the control group (4.3%) and no active withdrawals in the intervention group (P=0.06).Conclusions: Disappointment was common after allocation to the control group. This is a probable explanation of the higher drop-out rate in the control group. The consent information is of highest importance since those who were very disappointed claimed they did not receive understandable information. (C) 2009 Elsevier Inc. All rights reserved.