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首页> 外文期刊>Psychosomatic Medicine: Journal of the American Psychosomatic Society >Can attention control conditions have detrimental effects on behavioral medicine randomized trials?
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Can attention control conditions have detrimental effects on behavioral medicine randomized trials?

机译：注意控制条件会对行为医学随机试验产生不利影响吗？

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OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00217919.
机译：目的：在行为干预的随机试验中，注意控制（AC）条件用于平衡非特异性注意。文献中几乎没有关于哪些行为干预和结果值得AC的指导。本研究的主要目的是证明一种情况，其中在行为随机试验中使用AC是不必要的，并且可能有害。方法：在一项随机对照试验中进行了探索性分析，该试验测试了以患者为中心的咨询干预是否能降低355名外周动脉疾病参与者与AC和常规护理（UC）病情相比的低密度脂蛋白胆固醇水平。以患者为中心的咨询干预措施旨在激活参与者，要求其医师降低脂质和/或增加剂量强度，增加药物依从性并减少脂肪摄入。 AC条件涉及与注意力匹配的电话进行的健康教育，而UC条件则包括一份教育小册子。结果：在12个月的随访中，UC和AC条件下平均低密度脂蛋白胆固醇变化分别为-11.1和-6.8 mg / dL（p = .17）。在AC中，增加药物使用或剂量强度的参与者比例显着低于UC：17.5％对30.5％（p = .03）。 AC和UC之间未观察到其他结局的显着差异。结论：AC具有明显较差的药物治疗效果，并且没有迹象表明对其他终点有治疗作用。讨论了在行为随机试验中使用AC的含义。试验注册：clinicaltrials.gov标识符：NCT00217919。

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