The Treatment Expectation Questionnaire (TEX-Q): Validation of a generic multidimensional scale measuring patients' treatment expectations.

BACKGROUND: Patients' expectations, as a central mechanism behind placebo and nocebo effects, are an important predictor of health outcomes. Yet, theoretically based generic assessment tools allowing for an integrated understanding of expectations across conditions and treatments are lacking. Based on the preliminary 35-item version, this study reports the development and validation of the Treatment Expectation Questionnaire (TEX-Q), a generic, multidimensional self-report scale measuring patients' expectations of medical and psychological treatments. METHODS: The TEX-Q was developed in a validation sample of n = 251 patients undergoing different treatments using exploratory factor analyses and item analyses, as well as analysis of convergent and divergent validity. Confirmatory factor analysis was conducted in an independent sample of n = 303 patients undergoing cancer treatment. Two-weeks test-retest reliability was assessed in n = 28 psychosomatic outpatients. RESULTS: Factor analyses revealed six theoretically founded stable subscales. The TEX-Q assesses expectations of treatment benefit, positive impact, adverse events, negative impact, process and behavioural control with a total of 15 items. Results for the subscales and the sum score indicated good internal consistency (α = .71-.92), moderate to high test-retest reliability (r = .39-.76) as well as good convergent validity with regard to other expectation measures (r = .42-.58) and divergent validity with regard to measures of generalized expectations (r < .32) and psychopathology (r < .28). CONCLUSIONS: While further validation is needed, the results suggest that the TEX-Q is a valid and reliable scale for the generic, multidimensional assessment of patients' treatment expectations. The TEX-Q overcomes constraints of ad-hoc and disease-specific scales, while allowing to compare the impact of different expectation constructs across conditions and treatments.

Pre-surgery optimization of patients' expectations to improve outcome in heart surgery: Study protocol of the randomized controlled multi-center PSY-HEART-II trial.

The PSY-HEART-I trial indicated that a brief expectation-focused intervention prior to heart surgery improves disability and quality of life 6 months after coronary artery bypass graft surgery (CABG). However, to investigate the clinical utility of such an intervention, a large multi-center trial is needed to generalize the results and their implications for the health care system. The PSY-HEART-II study aims to examine whether a preoperative psychological intervention targeting patients' expectations (EXPECT) can improve outcomes 6 months after CABG (with or without heart valve replacement). EXPECT will be compared to Standard of Care (SOC) and an intervention providing emotional support without targeting expectations (SUPPORT). In a 3-arm multi-center randomized, controlled, prospective trial (RCT), N = 567 patients scheduled for CABG surgery will be randomized to either SOC alone or SOC and EXPECT or SOC and SUPPORT. Patients will be randomized with a fixed unbalanced ratio of 3:3:1 (EXPECT: SUPPORT: SOC) to compare EXPECT to SOC and EXPECT to SUPPORT. Both psychological interventions consist of 2 in-person sessions (à 50 minute), 2 phone consultations (à 20 minute) during the week prior to surgery, and 1 booster phone consultation post-surgery 6 weeks later. Assessment will occur at baseline approx. 3-10 days before surgery, preoperatively the day before surgery, 4-6 days later, and 6 months after surgery. The study's primary end point will be patients' illness-related disability 6 months after surgery. Secondary outcomes will be patients' expectations, subjective illness beliefs, quality of life, length of hospital stay and blood sample parameters (eg, inflammatory parameters such as IL-6, IL-8, CRP). This large multi-center trial has the potential to corroborate and generalize the promising results of the PSY-HEART-I trial for routine care of cardiac surgery patients, and to stimulate revisions of treatment guidelines in heart surgery.

Baseline depressive symptoms, personal control, and concern moderate the effects of preoperative psychological interventions: the randomized controlled PSY-HEART trial.

This study examined whether baseline (3-14 days pre-surgery) levels of (i) depressive or (ii) anxiety symptoms and (iii) illness beliefs moderate the effects of additional preoperative interventions before coronary artery bypass graft surgery on (i) depressive or (ii) anxiety symptoms and (iii) illness beliefs 1 day before surgery, 1 week and 6 months after surgery. In the PSY-HEART trial, 115 patients were assessed. They were randomized into one of three groups: 1. receiving standard medical care only (SMC), additional psychological interventions: 2. aiming to optimize patients' expectations (EXPECT), or 3. focusing on emotional support. Patients with a higher baseline level of depressive symptoms receiving a preoperative psychological intervention indicated lower depressive symptoms 6 months after surgery compared to SMC. EXPECT increased personal control and concern levels in patients with low baseline personal control/concern 1 day before surgery. Brief preoperative psychological interventions can improve psychological outcomes in heart surgery patients. Baseline status may moderate these effects. The study has been approved by the medical ethics committee of the Philipps University of Marburg and has been pre-registered at www.clinicaltrials.gov (NCT01407055) on August 1, 2011.

The effects of patients' expectations on surgery outcome in total hip and knee arthroplasty: a prognostic factor meta-analysis.

Patients' expectations are among the most frequently studied psychological prognostic factors in total knee and hip arthroplasty (TKA/THA). So far, however, evidence on the effect of patients' preoperative expectations on surgery outcome is inconclusive. Heterogeneity of expectation constructs and the use of psychometrically not evaluated measurement instruments have constituted major obstacles for the integration of the current literature. Using a theory-based model of expectation constructs , this meta-analysis set out to disentangle the conflicting results in the current literature. Systematic literature searches yielded k = 46 studies (N = 10,465) that reported associations of preoperative expectations with postoperative pain, functioning and disability, and satisfaction. Random effects meta-analysis revealed a robust small association (r = .16; 95% CI .13, .19) between patients' positive preoperative expectations and better postoperative outcomes. This effect did not differ between THA and TKA, different outcome categories and different follow-up periods. Studies using psychometrically evaluated expectation measures reported significantly higher effects (r = .19; 95% CI .16, .22). Whether this effect varies among different expectation constructs remains unclear. High-quality studies using validated, multidimensional expectation measures are needed to further understand the role of different expectation constructs in THA and TKA surgery.

IL-8 and CRP moderate the effects of preoperative psychological interventions on postoperative long-term outcomes 6 months after CABG surgery - The randomized controlled PSY-HEART trial.

INTRODUCTION: Inflammation has been related to several somatic and psychological disorders and may moderate effects of psychological interventions. In the PSY-HEART trial patients benefitted from preoperative psychological interventions before undergoing coronary artery bypass graft surgery (CABG) and, if necessary, concomitant valvular surgery, compared to standard medical care. In this study we examined whether patients' baseline inflammatory status moderated the intervention effects. MATERIAL AND METHODS: In a prospective three-arm randomized clinical trial with 6-months follow-up, 124 patients scheduled for CABG surgery alone or concomitant with valvular surgery were randomized to (i) standard medical care only (SMC) or two preoperative psychological interventions: (ii) CBT-based optimizing expectations (EXPECT) and an (iii) an active control group focusing on emotional support (SUPPORT). Available baseline CRP- (n = 79), IL-6- (n = 78), IL-8- (n = 78) and TNF-alpha-(n = 80) parameters were considered as potential moderators (CRP as a categorical and continuous moderator). Linear mixed model analyses were calculated to test whether baseline inflammatory levels moderated intervention effects on disability, mental and physical quality of life at 6 months after surgery. RESULTS: IL-8 moderated intervention effects on patients' disability and categorical CRP moderated intervention effects on mental quality of life. Follow-up tests indicated that EXPECT (and in part SUPPORT) led to lower postoperative disability and higher mental quality of life compared to SMC in patients with low baseline inflammatory markers. EXPECT indicated higher mental quality of life compared to SUPPORT in the high CRP subgroup. Patients in the SMC group had higher mental quality of life in the high CRP subgroup compared to the low CRP subgroup. CONCLUSION: Especially for patients with a lower inflammatory baseline status preoperative psychological interventions might be helpful to optimize long-term CABG surgery outcomes.

Effects of Preoperative Psychological Interventions on Catecholamine and Cortisol Levels After Surgery in Coronary Artery Bypass Graft Patients: The Randomized Controlled PSY-HEART Trial.

OBJECTIVE: The aim of the study was to examine whether preoperative psychological interventions targeting patients' expectations are capable of influencing the biological stress response after coronary artery bypass graft (CABG) surgery and could thus improve recovery after heart surgery. METHODS: Randomized controlled trial with assessments 10 days before surgery, after psychological intervention (day of hospital admission, but before surgery), postoperative (6-8 days later), and at follow-up (6 months after surgery). Eligible patients (N = 124) scheduled for elective on-pump CABG or CABG with valve replacement surgery were approached before hospital admission. Standard medical care (SMC) was compared with two additional preoperative psychological interventions: (a) an expectation manipulation intervention to optimize patients' expectations about course and outcomes or (b) supportive therapy, containing the same amount of therapeutic attention, but without specifically focusing on expectations. Postoperative plasma adrenaline, noradrenaline, and cortisol levels were a secondary outcome of our study (primary outcome patients' disability 6 months after surgery and other secondary patient-reported or clinical outcomes were reported elsewhere). RESULTS: Expectation manipulation intervention (3.68 ln pg/mL, 95% confidence interval = 3.38-3.98, p = .015) and supportive therapy (3.70 ln pg/mL, 95% confidence interval = 3.38-4.01, p = .026) led to significantly lower postoperative adrenaline levels compared with SMC (4.26 ln pg/mL, 95% confidence interval = 3.99-4.53) only. There were no treatment effects of the preoperative intervention for noradrenaline (p = .90) or cortisol (p = .30). Higher postoperative adrenaline levels predicted disability 6 months after surgery (r = .258, p = .018). CONCLUSIONS: In addition to SMC, preoperative psychological interventions seem to buffer psychobiological stress responses and could thus facilitate recovery from CABG surgery. Patients' postoperative stress responses could be an important factor for explaining trajectories of long-term outcomes. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov(NCT01407055).

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

OBJECTIVE: To examine the effect of a preoperative expectation-optimizing psychological intervention on length of stay in the hospital and time spent in the Intensive Care Unit (ICU) in patients undergoing elective cardiac surgery. METHODS: In a randomized controlled trial, 124 patients prior to undergoing coronary artery bypass grafting (CABG) or CABG combined with heart valve surgery were randomized to either a) standard medical care alone (SMC) or an additional preoperative intervention, b) an additional expectation manipulation intervention (EXPECT) to optimize patients' expectations, or c) an additional supportive therapy (SUPPORT), containing the same amount of therapeutic attention but without a specific focus. Participants were followed-up post-operatively to assess their length of hospital stay and the time spent in the ICU. RESULTS: Patients in both psychological intervention groups spent significantly less days in the hospital then patients in the SMC group (M(EXPECT)=12.62, M(SUPPORT)=14.13, M(SMC)=17.27, p=0.028). There was a significant linear trend (F(1112)=7.68, p=0.009) showing that the more specific the intervention patients received the shorter they stayed in the hospital. The effect of the intervention on time spent in the ICU was only marginally significant (M(EXPECT)=103.76, M(SUPPORT)=103.10, M(SMC)=158.45, p=0.066). CONCLUSION: Changing patients' preoperative expectations via a psychological intervention leads to less days spent in the hospital. The psychological interventions are associated with positive cost-benefit ratios. Specific psychological mechanisms underlying the effect of our intervention remain unclear and need to be investigated further. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01407055).

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: 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.

Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

BACKGROUND: Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. METHODS: In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. RESULTS: Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. CONCLUSION: Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients.

Patients' Expectations Predict Surgery Outcomes: A Meta-Analysis.

BACKGROUND: Several studies indicate that patients' presurgical expectations can influence postsurgical health outcome. PURPOSE: To estimate the potential for clinical exploitation of this association, a meta-analysis of prospective studies which assess the association between patients' presurgical expectations and postsurgical quality of life is applied to accumulate the overall effect. METHODS: We searched the databases MEDLINE, CENTRAL, and PsychINFO for English- and German-language articles published from 1980 until December 2013. Additionally, manual searches of bibliographies of retrieved articles and relevant reviews were conducted. Prospective studies measuring presurgical expectations and postsurgical quality of life in patients aging 18-65 were selected. Correlations between presurgical expectations and postsurgical quality of life were extracted or provided by the authors. RESULTS: The search yielded 21 prospective studies (including 2611 patients undergoing surgery) with a follow-up period ranging from 1 week to 13 years. The pooled correlations were 0.369 (95% confidence interval (CI), 0.264 to 0.466; P for heterogeneity <0.001; random-effects model) for overall quality of life (11 studies), 0.126 (95% CI, 0.079 to 0.172; P for heterogeneity = 0.63; random-effects model) for physical quality of life (12 studies), and 0.208 (95% CI, 0.113 to 0.299; P for heterogeneity <0.001; random-effects model) for mental quality of life (12 studies), indicating low to moderate associations between presurgery patients' expectations and postsurgery quality of life. CONCLUSIONS: These results confirm the importance of patients' expectations in the prediction of postsurgical outcomes and underline the necessity to optimize these expectations in order to improve postoperative quality of life.

Optimizing preoperative expectations in cardiac surgery patients is moderated by level of disability: the successful development of a brief psychological intervention.

Patients' expectations have shown to be a major psychological predictor of health outcome in cardiac surgery patients. However, it is unclear whether patients' expectations can be optimized prior to surgery. This study evaluates the development of a brief psychological intervention focusing on the optimization of expectations and its effect on change in patients' expectations prior to cardiac surgery. Ninety patients scheduled for coronary artery bypass graft were randomly assigned to (1) standard medical care, (2) additional expectation manipulation intervention (EMI), and (3) additional attention control group. Therapists' fidelity to intervention manuals and patients satisfaction with the intervention were assessed for both active intervention conditions. Patients' expectations about post-surgical disability, treatment control, personal control, and disease duration were assessed before and after the psychological intervention. Demographical, medical, and psychosocial characteristics and disability were assessed at baseline. Treatment fidelity and patient satisfaction was very high in both intervention conditions. Only patients receiving EMI developed higher personal control expectations and longer (more realistic) expectations of disease duration. The effect of intervention group on patients' disability expectations and patients' personal control expectations was moderated by patient's level of disability. EMI patients with low to moderate disability developed positive expectations whereas patients with high disability did not. This study shows the successful development of a short psychological intervention that was able to modify patients' expectations, especially in those with low to moderate disability. Given the robust association of expectations and surgery outcome, such an intervention might offer the opportunity to enhance patients' health following cardiac surgery.

Factors associated with disability expectations in patients undergoing heart surgery.

BACKGROUND: Heart surgery patients' expectations have been shown to be related to surgery outcome, independent of medical status. However, it is unclear which factors determine patients' expectations about disability following heart surgery. PURPOSE: Investigating the associations of patients' disability expectations with demographic, medical, and psychosocial factors as well as other aspects of patients' expectations might help to tailor psychological interventions more specifically to optimize patient's expectations. METHODS: Eighty-three patients were invited to a psycho-educational intervention to optimize expectations prior to elective coronary artery bypass graft (CABG). Before the psychological intervention and before surgery, disability expectations, demographical, medical, psychosocial variables as well as patient and treatment related expectations were collected via questionnaires and patients' files. Associations with disability expectations were assessed using hierarchical linear multiple regression analysis. RESULTS: Patients self-rated disability (ß = 0.50; p < 0.001) and beliefs about treatment efficacy (ß = -0.42; p < 0.001) was independently associated with disability expectations. Expectations about the efficacy of patients' own health behavior as well as demographical variables, psychological distress, perceived social support, and measures of medical morbidity did not explain any additional variance in patients' disability expectations. CONCLUSION: CABG patients seem to form their disability expectations upon their perceptions about their current disability and their expectations about the efficacy of treatment. Patients' disability expectations appear to be independent from scientifically established risk factors and other psychosocial patient characteristics in heart surgery. Future research is necessary to further determine what factors psychological interventions should focus on to modify patients' disability expectations.

Enhancing the efficacy of heart surgery by optimizing patients' preoperative expectations: study protocol of a randomized controlled trial.

In coronary heart disease (CHD) and heart surgery, there is sound evidence for the relationship between patients' expectations and treatment outcome, especially for outcome variables such as disability and quality of life. In addition, patients' expectations have been shown to be modifiable through psychological interventions. Therefore, targeting patients' expectations might offer a promising opportunity to enhance heart surgery outcome. However, few studies have tried to actively change patients' expectations before surgery. The purpose of this clinical trial is to optimize patients' outcome expectations before undergoing coronary artery bypass graft surgery (CABG) through a brief psychoeducational program. The present article describes the study protocol and reports preliminary data on feasibility. Using a randomized controlled design, 180 patients who are scheduled to undergo elective CABG are randomly assigned to either (1) standard medical care (SMC) alone, (2) to an additional expectation manipulation intervention during the 2 weeks before surgery, and (3) to an additional attention-control group ("supportive therapy"). The main goal is to test (a) whether expectation manipulation intervention can optimize patients' expectations and (b) whether optimized expectations lead to enhanced surgery efficacy. The primary outcome variable is illness-related disability 6 months after surgery, whereas secondary outcome variables will be quality of life, return to work, physical activity, and medical outcome variables. First, feasibility data of 36 patients show that the patients appreciated the additional psychological intervention before CABG. Satisfaction of those who received psychological interventions was very high.