Hawthorne effect with transient behavioral and biochemical changes in a randomized controlled sleep extension trial of chronically short-sleeping obese adults: implications for the design and interpretation of clinical studies.
Hawthorne effect with transient behavioral and biochemical changes in a randomized controlled sleep extension trial of chronically short-sleeping obese adults: implications for the design and interpretation of clinical studies.
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DOI：
10.1371/journal.pone.0104176
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Sleep Extension Study Group
中科院分区：
文献类型：
--
作者：
Cizza G;Piaggi P;Rother KI;Csako G;Sleep Extension Study Group
评估在睡眠延长试验开始时参与研究本身在筛选、随机化和磨合访问之间的影响。对受试者进行筛选，81天后（中位数）返回进行随机化（对照与干预），121天后参加磨合访视。门诊。肥胖（N = 125；男/女，30/95；黑人/白人/其他，N = 73/44/8），平均体重107.6±19.7 kg，睡眠时间<6.5 h /夜。非药物延长睡眠。睡眠时间（日记和活动记录仪）、睡眠质量（匹兹堡睡眠质量指数）、每日嗜睡（爱普沃斯嗜睡量表）、空腹血糖、胰岛素和血脂。在任何干预之前，筛选和随机分组之间出现了明显的改善。睡眠持续时间增加（日记：357.4±51.2比388.1±48.6分钟/晚；平均值±SD； P<0.001筛选vs随机化；活动记录仪：344.3±41.9比358.6±48.2分钟/晚；P<0.001）睡眠质量改善（PSQI评分9.1±3.2比8.2±3.0，P<0.001），嗜睡倾向改善（ESS评分8.9±4.6比8.3±4.5,P = 0.06），胰岛素抵抗下降（0.327±0.038比0.351±0.045；Quicki指数，P<0.001），血脂改善（HDL-C除外）。空腹血糖异常（25% vs. 11%; P = 0.007）和代谢综合征（42% vs. 29%; P = 0.007）均下降。在没有干预的情况下，早期的代谢改善在磨合期就消失了。样本量相对较小。筛选和随机化之间生化和行为参数的改善改变了“真实”研究基线，从而可能影响结果。虽然考虑了均值回归和安慰剂效应，但这些发现与“霍桑效应”最为一致，根据“霍桑效应”，在实验研究中测量的行为会随着研究人员的关注而变化。这是第一次关于霍桑效应的生物化学变化被记录下来。这些发现对临床研究的设计和实施具有启示意义。ClinicalTrials.gov NCT00261898。
To evaluate the effects of study participation per se at the beginning of a sleep extension trial between screening, randomization, and the run-in visit. Subjects were screened, returned for randomization (Comparison vs. Intervention) after 81 days (median), and attended run-in visit 121 days later. Outpatient. Obese (N = 125; M/F, 30/95; Blacks/Whites/Other, N = 73/44/8), mean weight 107.6±19.7 kg, <6.5 h sleep/night. Non-pharmacological sleep extension. Sleep duration (diaries and actigraphy watch), sleep quality (Pittsburgh Sleep Quality Index), daily sleepiness (Epworth Sleepiness Scale), fasting glucose, insulin and lipids. Prior to any intervention, marked improvements occurred between screening and randomization. Sleep duration increased (diaries: 357.4 ±51.2 vs. 388.1±48.6 min/night; mean±SD; P<0.001 screening vs. randomization; actigraphy: 344.3 ±41.9 vs. 358.6±48.2 min/night; P<0.001) sleep quality improved (9.1±3.2 vs. 8.2±3.0 PSQI score; P<0.001), sleepiness tended to improve (8.9±4.6 vs. 8.3±4.5 ESS score; P = 0.06), insulin resistance decreased (0.327±0.038 vs. 0.351±0.045; Quicki index; P<0.001), and lipids improved, except for HDL-C. Abnormal fasting glucose (25% vs. 11%; P = 0.007), and metabolic syndrome (42% vs. 29%; P = 0.007) both decreased. In absence of intervention, the earlier metabolic improvements disappeared at the run-in visit. Relatively small sample size. Improvements in biochemical and behavioral parameters between screening and randomization changed the “true” study baseline, thereby potentially affecting outcome. While regression to the mean and placebo effect were considered, these findings are most consistent with the “Hawthorne effect”, according to which behavior measured in the setting of an experimental study changes in response to the attention received from study investigators. This is the first time that biochemical changes were documented with respect to the Hawthorne effect. The findings have implications for the design and conduct of clinical research. ClinicalTrials.gov NCT00261898.
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