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

ABSTRACT: Placebo 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.In 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.Patients 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.Optimizing 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.Ethical 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.

SUBMITTER: Rief W

PROVIDER: S-EPMC5223324 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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

Rief Winfried W Shedden-Mora Meike C MC Laferton Johannes A C JA Auer Charlotte C Petrie Keith J KJ Salzmann Stefan S Schedlowski Manfred M Moosdorf Rainer R

BMC medicine 20170110 1

<h4>Background</h4>Placebo 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.<h4>Metho ...[more]

PMID: 28069021

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Project description:Study Design Systematic review. Objective To examine the relationship between the patient's preoperative expectations and short-term postoperative satisfaction and functional outcome in lumbar spine surgery. Methods The Medline, Embase, and Cochrane databases were queried using a predefined search algorithm to identify all lumbar spine studies analyzing the influence of preoperative expectations on postoperative satisfaction and functional outcome. Two independent reviewers and a third independent mediator reviewed the literature and performed study screening, selection, methodological assessment, and data extraction using an objective protocol. Results Of 444 studies identified, 13 met the inclusion criteria. Methodological quality scores ranged from 59 to 100% with the greatest variability in defining patient characteristics and the methods of assessing patient expectations. Patient expectations were assessed in 22 areas, most frequently back and leg pain expectations and general expectations. Functional outcome was assessed by 13 tools; the most common were the visual analog scale, Oswestry Disability Index (ODI), and Short Form Health Survey (SF-36). Positive expectations for symptomatology, activity, general health, and recovery correlated with satisfaction. General expectations correlated with higher SF-36 Physical Subcomponent scores, better global function, and lower ODI outcome. Conclusions on the influence of the expectations for pain were limited due to the study heterogeneity, but the evidence suggests a positive correlation between the expectation and outcome for back and leg pain. Conclusions Positive expectations correlated significantly with short-term postoperative satisfaction and functional outcome, including higher SF-36 scores, earlier return to work, and decreased ODI scores. Future expectation-based investigations will benefit from implementation of the standardized methods of expectation, satisfaction, and outcome analysis discussed herein.

Project description:IntroductionComplete recovery after surgery depends on psychological factors such as preoperative information, expectations, and surgery-associated anxiety. Prior studies have shown that even a short preoperative psychological intervention aiming at optimized expectations (EXPECT) can improve postoperative outcomes in coronary artery bypass patients. However, this intervention may benefit only a small subgroup of heart surgery patients since implementing preoperative psychological interventions into the daily clinical routine is difficult due to the additional time and appointments. It is unclear whether the EXPECT intervention can be shortened and whether heart valve patients would also benefit from interventions that optimize patients' expectations. The multicenter ValvEx trial aims (i) to adapt an effective preoperative psychological intervention (EXPECT) to make it brief enough to be easily integrated into the preoperative routine of heart valve patients and (ii) to examine if the adapted preoperative psychological intervention improves the subjectively perceived illness-related disability (PDI) up to 3 months after surgery.Materials and analysisIn two German university hospitals, N = 88 heart valve patients who undergo heart surgery are randomized into two groups [standard of care (SOC) vs. standard of care plus interventional expectation manipulation (SOC and EXPECT)] after baseline assessment. Patients in the EXPECT group additionally to standard of care participate in the preoperative psychological intervention (30-40 min), focusing on optimizing expectations and have two booster-telephone calls (4 and 8 weeks after the surgery, approx. 15 min). Both groups have assessments again on the evening before the surgery, 4 to 6 days, and 3 months after the surgery.DiscussionThe trial demonstrates excellent feasibility in the clinical routine and a high interest by the patients.Ethics and disseminationThe Ethics Committees of the Department of Medicine of the Philipps University of Marburg and the Department of Medicine of the University of Giessen approved the study protocol. Study results will be published in peer-reviewed journals and presented at congresses.Clinical trial registrationClinicalTrials.gov, identifier NCT04502121.

Project description:BackgroundDespite showing a prognostic value in general surgical patients, preoperative asymptomatic elevated white blood cell (WBC) count is not considered a risk factor for cardiac surgery. Whereas there is sporadic evidence of its value as a preoperative risk marker, it has not been looked at methodically as a specific index of outcome during cardiac surgery. Using a national database we sought to determine the relationship between preoperative WBC count and postoperative outcome in cardiac surgical patients.MethodsCardiac surgeries were extracted from the 2007-2013 American College of Surgeons National Surgical Quality Improvement Program database. Leukocytosis was defined by a preoperative WBC count greater than 11,000 cells/μL. A univariate analysis compared the incidence of adverse outcomes for patients with and without leukocytosis. A multivariate logistic regression model was constructed in order to test whether leukocytosis was an independent predictor of morbidity and mortality.ResultsOut of a total of 10,979 cardiac surgery patients 863 (7.8%) had preoperative leukocytosis. On univariate analysis, patients with leukocytosis experienced greater incidences of 30-day mortality, wound complications, and medical complications. Wound complications included surgical site infection as well as wound dehiscence. The medical complications included all other non-surgical causes of increased morbidity and infection leading to urinary tract infection, pneumonia, ventilator dependence, sepsis and septic shock. After stepwise model adjustment, leukocytosis was a strong predictor of medical complications (OR 1.22, 95% CI: 1.09-1.36, p = 0.002) with c-statistic of 0.667. However, after stepwise model adjustment leukocytosis was not a significant predictor of 30-day mortality and wound complications.ConclusionPreoperative leukocytosis is associated with adverse postoperative outcome after cardiac surgery and is an independent predictor of infection-related postoperative complications.

Project description:AIMS:There are many reasons for the increase in post-operative mortality and morbidity in patients undergoing surgery. In fact, an activated inflammatory state before cardiac surgery, can potentially worsen the patient's prognosis and the effects of this preoperative inflammatory state in the medium-term remains unknown. METHODS:There were 470 consecutive patients who underwent cardiac surgery, and were divided in three groups according to the median values of preoperative C-reactive protein (CRP) and fibrinogen (FBG): The first group was the low inflammatory status group (LIS) with 161 patients (CRP < 0.39 mg/dL and FBG < 366 mg/dL); the second was the medium inflammatory status group (MIS) with 150 patients (CRP < 0.39 mg/dL and FBG ? 366 mg/dL or CRP ? 0.39 mg/dL and FBG < 366 mg/dL,); and the third was the high inflammatory status group (HIS) with 159 patients (CRP ? 0.39 mg/dL and FBG ? 366 mg/dL,). RESULTS:The parameters to be considered for the patients before surgery were similar between the three groups except, however, for age, left ventricular ejection fraction (LVEF) and the presence of arterial hypertension. The operative mortality was not significantly different between the groups (LIS = 2.5%, MIS = 6%, HIS = 6.9%, p = 0.16) while mortality for sepsis was significantly different (LIS = 0%, MIS = 1.3%, HIS = 3.7%, p = 0.03). The infections were more frequent in the HIS group (p = 0.0002). The HIS group resulted in an independent risk factor for infections (relative risk (RR) = 3.1, confidence interval (CI) = 1.2-7.9, p = 0.02). During the 48-months follow-up, survival was lower for the HIS patients. This HIS group (RR = 2.39, CI = 1.03-5.53, p = 0.05) and LVEF (RR = 0.96, CI = 0.92-0.99, p = 0.04) resulted in independent risk factors for mortality during the follow-up. CONCLUSIONS:The patients undergoing cardiac surgery with a preoperative highly activated inflammatory status are at a higher risk of post-operative infections. Furthermore, during the intermediate follow-up, the preoperative highly activated inflammatory status and LVEF resulted in independent risk factors for mortality.

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

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

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