Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01760, USA.
Psychosom Med. 2013 Feb;75(2):137-43. doi: 10.1097/PSY.0b013e3182765dd2. Epub 2012 Nov 28.
Attention control (AC) conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance about which behavioral interventions and outcomes merit AC is available in the literature. The primary aim of the present study is to demonstrate a scenario in which use of AC in a behavioral randomized trial was unnecessary and possibly detrimental.
Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered counseling intervention reduced low-density lipoprotein cholesterol levels in 355 participants with peripheral arterial disease, compared with AC and usual care (UC) conditions. The patient-centered counseling intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched telephone-delivered health education, and the UC condition consisted of an educational pamphlet.
At 12-month follow-up, the mean low-density lipoprotein cholesterol changes were -11.1 and -6.8 mg/dL in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased the use or dose intensity of medication was significantly lower in AC than in UC: 17.5% versus 30.5% (p=.03). No significant difference in other outcomes was observed between AC and UC.
AC has significantly worse medication outcomes, and there is no indication of a therapeutic effect on other end points. Implications for the use of AC in behavioral randomized trials are discussed.
clinicaltrials.gov Identifier: NCT00217919.
注意力控制（AC）条件被用于平衡行为干预随机试验中的非特异性注意力。关于哪些行为干预和结果需要 AC 的指导，文献中提供的很少。本研究的主要目的是展示一种情况，即在行为随机试验中使用 AC 是不必要的，甚至可能有害。
在一项随机对照试验中进行了探索性分析，该试验测试了一种以患者为中心的咨询干预是否能降低 355 名外周动脉疾病患者的低密度脂蛋白胆固醇水平，与 AC 和常规护理（UC）条件相比。以患者为中心的咨询干预旨在促使参与者向医生询问降脂药物和/或增加剂量强度、提高药物依从性和减少脂肪摄入。AC 条件涉及注意力匹配的电话提供健康教育，UC 条件包括教育小册子。
在 12 个月的随访中，UC 和 AC 条件下的平均低密度脂蛋白胆固醇变化分别为-11.1 和-6.8mg/dL（p=.17）。在 AC 组中，增加药物使用或剂量强度的参与者比例明显低于 UC 组：17.5%比 30.5%（p=.03）。在其他结局方面，AC 和 UC 之间没有观察到显著差异。
AC 对药物治疗有明显更差的结果，而且没有迹象表明对其他终点有治疗效果。讨论了在行为随机试验中使用 AC 的意义。
clinicaltrials.gov 标识符：NCT00217919。
