Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients

冠状动脉旁路移植术（CABG）是一种极具侵入性的医疗干预。据推测，即使在这些条件下，治疗结果也基本上由非特异性效应决定，例如患者的期望。在早期阶段针对患者的期望可能有可能优化心脏手术后的结果。本研究的目的是通过一个简短的心理教育计划来优化患者在接受心脏手术前的结果预期。采用随机对照设计，将180例计划接受择期CABG的患者随机分配到标准医疗信息组，或在手术前两周内进行额外的期望操纵干预（EMI），或注意力控制组（支持性治疗组）。主要目标是通过EMI增强对有利结果的积极期望（手术非特异性效应），处理不良事件的应对能力，并减少负面期望和误解。在EMI前后、手术后10天和6个月后进行评估;相同的评估点用于2种对照条件。主要结局是残疾，这在以前的研究中已被证明是由患者的期望强烈决定的。此外，治疗成功的心理和生物学的预测和介质进行了分析。这种期望干预的积极结果将对临床实践产生重大影响。为了优化治疗结果，不仅需要改进治疗特异性程序（例如，心脏手术），但也要解决非特异性因素，如病人的期望。

Coronary artery bypass graft surgery (CABG) is an extremely invasive medical intervention. It is postulated that even under these conditions, treatment outcome is substantially determined by non-specific effects, e.g. patient‘s expectation. Targeting patients‘ expectations at an early stage might have potential to optimize outcomes after cardiac surgery. The purpose of this research project is to optimize patients‘ outcome expectations before undergoing cardiac surgery through a brief psycho-educational program. Using a randomized controlled design, 180 patients who are scheduled to undergo elective CABG are randomly assigned either to standard medical information alone, or to an additional expectation manipulation intervention (EMI) during the two weeks before surgery, or to an attention-control group (―supportive therapy‖). The main goal is to enhance positive expectations (surgery ‗non-specific effects‘) about favorable outcome through EMI, about coping abilities to deal with adverse events, and to reduce negative expectations and misconceptions. Assessment takes place before and after EMI, 10 days after surgery and 6 months later; same assessment points are used for the 2 control conditions. Primary outcome is disability, which has been shown to be strongly determined by patient‘s expectation in previous studies. Moreover, psychological and biological predictors and mediators of treatment success are analyzed. A positive result for this expectation intervention would have major implications for clinical practice. In order to optimize treatment outcome, it is not only necessary to improve the treatment-specific procedures (e.g., cardiac surgery) but also to address non-specific factors such as patients‘ expectations.