The Hawthorne Effect: a randomised, controlled trial
The Hawthorne Effect: a randomised, controlled trial
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DOI：
10.1186/1471-2288-7-30
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发表时间：
2007-07-03
影响因子：
4
通讯作者：
Fisher, Peter
中科院分区：
文献类型：
--
作者：
McCarney, Rob;Warner, James;Fisher, Peter
背景资料：“霍桑效应”可能是影响临床研究推广到常规实践的一个重要因素，但研究较少。霍桑效应在以前的痴呆症临床试验中已有报道，但据我们所知，尚未尝试对其进行量化。我们的目的是比较银杏叶治疗轻中度痴呆的安慰剂对照试验中参与者的最小随访和强化随访。方法：痴呆症试验的参与者被随机分配到强化随访（在基线和随机化后2个月、4个月和6个月进行全面评估访视）或最小随访（在基线进行简短评估，在6个月进行全面评估）。我们的主要成果是认知功能（ADAS-Cog）和参与者和护理人员评定的生活质量（QOL-AD）。结果：我们招募了176名参与者，主要是通过一般的做法。主要分析基于意向治疗（ITT），并有可用数据。在以基线评分作为协变量的ANCOVA模型中，随访组对6个月时ADAS-Cog评分的结局有显著影响（n = 140;平均差异= -2.018; 95% CI-3.914，-0.121; p = 0.037，有利于强化随访组）和参与者评定的生活质量评分（n = 142;平均差异= -1.382; 95% CI-2.642，-0.122; p = 0.032有利于最短随访组）。有照顾者的生活quality of life.Conclusion：我们发现，更密集的后续个人在安慰剂对照的临床试验银杏叶治疗轻度-中度痴呆导致更好的结果比最小的后续行动，测量他们的认知功能。
Background: The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow- up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia.Methods: Participants in a dementia trial were randomised to intensive follow- up (with comprehensive assessment visits at baseline and two, four and six months post randomisation) or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months). Our primary outcomes were cognitive functioning (ADAS-Cog) and participant and carer-rated quality of life (QOL-AD).Results: We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT), with available data. In the ANCOVA model with baseline score as a co- variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95% Cl -3.914, -0.121; p = 0.037 favouring the intensive follow-up group), and on participant- rated quality of life score (n = 142; mean difference = -1.382; 95% Cl -2.642, -0.122; p = 0.032 favouring minimal follow-up group). There was no significant difference on carer quality of life.Conclusion: We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning.