Compliance with saliva sampling protocols: Electronic monitoring reveals invalid cortisol daytime profiles in noncompliant subjects
Compliance with saliva sampling protocols: Electronic monitoring reveals invalid cortisol daytime profiles in noncompliant subjects
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DOI：
10.1097/01.psy.0000058374.50240.bf
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发表时间：
2003-03-01
影响因子：
3.3
通讯作者：
Kirschbaum, C
中科院分区：
文献类型：
--
作者：
Kudielka, BM;Broderick, JE;Kirschbaum, C
目的：用于随后分析游离皮质醇水平的动态唾液采集现在经常用于测量健康受试者和患者群体的肾上腺皮质活动。尽管实验室外唾液采集的准确时间是最重要的，但没有关于研究参与者遵守给定采样方案的数据。这项研究调查了受试者如何准确地遵守指示，在一天内收集了六个唾液样本。方法：受试者在1天内(清醒后即刻、清醒后30分钟、上午11点、下午3点、晚上8点、晚上10点)采集6份唾液样本。客观依从性是使用电子监测设备对受试者进行测量的，这些受试者在知晓设备性质的情况下(N=23)和不知晓设备的情况下(N=24)。主观依从性的数据是通过自我报告获得的。结果：31名受试者(74%)被发现遵守了采样说明，11名(26%)未能在一天中的正确时间获取至少一次唾液样本。11个不符合标准的受试者中有9个(82%)有两个或更多不符合标准的样本。55%(6/11)的不依从性受试者在采样窗口外采集了样本2。顺从性受试者和非顺应性受试者的昼夜皮质醇曲线有显著差异(F=7.98，p=0.007)。顺从的最重要影响体现在觉醒时皮质醇的升高。顺从的受试者表现出强劲的增长，而不顺从的受试者在醒来后30分钟与基线相比只有很小的变化(t=2.89，p.007)。因此，顺从性受试者的昼夜皮质醇下降幅度更大(t=2.10，p=0.043)。此外，知情组比未知情的受试者更严格遵守抽样方案(p=.001)。自我报告的遵从性在研究组之间也有显著差异(p=.03)。在非知情组中，自我报告的抽样准确性显著高于客观测量的遵从性(p=0.03)；在知情组中，这两种测量方法相似(p=NS)。结论：相当数量的受试者没有在非卧床环境中可靠地获取唾液样本。这可以部分地使皮质醇结果无效，并掩盖感兴趣的受试组之间的潜在差异。因此，我们建议使用电子监测设备或其他适当的方法，并在进行动态唾液采集时向研究参与者告知该设备。
Objective: Ambulatory saliva collections for subsequent analysis of free cortisol levels are now frequently applied to measure adrenocortical activity in healthy subjects and patient populations. Despite the prime importance of accurate timing of saliva collection outside the laboratory, no data are available on the compliance of study participants following a given sampling protocol. This study investigated how accurately subjects adhered to the instructions to collect six saliva samples throughout 1 day. Methods: Subjects were instructed to collect six saliva samples throughout 1 day (directly after awakening, 30 minutes after awakening, 11 AM, 3 PM, 8 PM, 10 PM). Objective compliance was measured using an electronic monitoring device given to the subjects either with ("informed" N = 23) or without ("noninformed" N = 24) their knowledge of the nature of the device. Data on subjective compliance were obtained by self-report. Results: Thirty-one subjects (74%) were found to comply with the sampling instructions, and 11 (26%) failed at least once to obtain the saliva sample at the correct time of day. Nine of the 11 noncompliant subjects (82%) had two or more noncompliant samples. Fifty-five percent (6 of 11) of the noncompliant subjects took sample 2 outside the sampling window. The circadian cortisol profile differed significantly between compliant and noncompliant subjects (F = 7.98, p = .007). The most important effect of compliance was seen in the rise of cortisol at awakening. Compliant subjects showed a robust increase, whereas noncompliant individuals had only minimal changes from baseline at 30 minutes after awakening (t = 2.89, p .007). Thus the steepness of the circadian cortisol decline was greater for compliant subjects (t = 2.10, p = .043). Furthermore, the informed group adhered more closely to the sampling protocol than the noninformed subjects (p = .001). Self-reported compliance also differed significantly between study groups (p = .03). In the noninformed group, self-reported sampling accuracy was significantly higher than objectively measured compliance (p = .03); the two measures were similar in the informed group (p = NS). Conclusions: A significant number of subjects did not obtain saliva samples reliably in an ambulatory setting. This can partially invalidate the cortisol results and mask potential differences between subject groups of interest. We therefore recommend the use of electronic monitoring devices or other suitable methods and that study participants be informed about the device when ambulatory saliva collection is performed.