Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial

Abstract

BackgroundPlacebo effects contribute substantially to outcome in most fields of medicine. While clinical trials typically try to control or minimize these effects, the potential of placebo mechanisms to improve outcome is rarely used. Patient expectations about treatment efficacy and outcome are major mechanisms that contribute to these placebo effects. We aimed to optimize these expectations to improve outcome in patients undergoing coronary artery bypass graft (CABG) surgery.MethodsIn a prospective three-arm randomized clinical trial with a 6 month follow-up, 124 patients scheduled for CABG surgery were randomized to either a brief psychological pre-surgery intervention to optimize outcome expectations (EXPECT); or a psychological control intervention focusing on emotional support and general advice, but not on expectations (SUPPORT); or to standard medical care (SMC). Interventions were kept brief to be feasible with a heart surgery environment; “dose” of therapy was identical for both pre-surgery interventions. Primary outcome was disability 6 months after surgery. Secondary outcomes comprised further clinical and immunological variables.ResultsPatients in the EXPECT group showed significantly larger improvements in disability (−12.6; −17.6 to −7.5) than the SMC group (−1.9; −6.6 to +2.7); patients in the SUPPORT group (−6.7; −11.8 to 1.7) did not differ from the SMC group. Comparing follow-up scores and controlling for baseline scores of EXPECT versus SUPPORT on the variable disability only revealed a trend in favor of the EXPECT group (P = 0.09). Specific advantages for EXPECT compared to SUPPORT were found for mental quality of life and fitness for work (hours per week). Both psychological pre-surgery interventions induced less pronounced increases in pro-inflammatory cytokine concentrations reflected by decreased interleukin-8 levels post-surgery compared to changes in SMC patients and lower interleukin-6 levels in patients of the EXPECT group at follow-up. Both pre-surgery interventions were characterized by great patient acceptability and no adverse effects were attributed to them. Considering the innovative nature of this approach, replication in larger, multicenter trials is needed.ConclusionsOptimizing patients’ expectations pre-surgery helps to improve outcome 6 months after treatment. This implies that making use of placebo mechanisms has the potential to improve long-term outcome of highly invasive medical interventions. Further studies are warranted to generalize this approach to other fields of medicine.Trial registrationEthical approval for the study was obtained from the IRB of the Medical School, University of Marburg, and the trial was registered at (NCT01407055) on July 25, 2011.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-016-0767-3) contains supplementary material, which is available to authorized users.

Optimizing preoperative expectations leads to a shorter length of hospital stay in CABG patients: Further results of the randomized controlled PSY-HEART trial

“…In our explorative look into moderation mechanisms, emotional impairment plays an important role which further underlines this interpretation. Our recently published data on long-term outcomes show a supremacy of the EXPECT intervention over the SUPPORT and SMC intervention on long-term disability, mental quality of life and fitness for work (35). Taken together, these results give a hint to the importance of expectations on long-term health outcomes whereas emotional support and the therapeutic relationship might be sufficient for an improvement in short-term recovery.…”

“…Notably, those intervention studies addressing preoperative expectations did not measure if the effect of their interventions was due to a change in expectations (33,34). The recently published long-term results of our PSY-HEART trial (35) show that we were able to establish a psychological intervention targeting at optimizing pre-surgical expectations which led to lower disability, a better mental quality of life and more fitness for work 6 months after a CABG. In this article we want to report the results of the PSY-HEART trial on short-term outcomes.…”

Patientenerwartungen optimieren: Beschreibung einer präoperativen Kurzintervention am Beispiel von Patienten vor einer Bypass-Operation

“…Die Relevanz von Patientenerwartungen in der Behandlung sowohl psychischer als auch körperlicher Erkrankungen wird durch Erkenntnisse aus der Placeboforschung immer deutlicher [Rief und Glombiewski, 2016;Rief et al, 2017]. Ansätze zur systematischen Nutzung dieses Wissens sind jedoch noch rar [Enck et al, 2013].…”

Depressive symptoms in patients with an implantable cardioverter defibrillator: Does treatment expectations play a role?

“…To our knowledge, little attention has been paid to the role of treatment expectations in A C C E P T E D M A N U S C R I P T 5 depressive symptoms in patients with an ICD, although patients' expectations towards medical treatment may influence their health outcomes (12,13). For example, in patients undergoing coronary artery bypass surgery (CABG), their illness beliefs prior to surgery predicted disability, quality of life, and depression 3 months post surgery (14).…”