Patients’ expectations in the context of medical treatment represent a growing area of research, with accumulating evidence suggesting their influence on health outcomes across a variety of medical conditions. However, the aggregation of evidence is complicated due to an inconsistent and disintegrated application of expectation constructs and the heterogeneity of assessment strategies. Therefore, based on current expectation concepts, this critical review provides an integrated model of patients’ expectations in medical treatment. Moreover, we review existing assessment tools in the context of the integrative model of expectations and provide recommendations for improving future assessment. The integrative model includes expectations regarding treatment and patients’ treatment-related behavior. Treatment and behavior outcome expectations can relate to aspects regarding benefits and side effects and can refer to internal (e.g., symptoms) and external outcomes (e.g., reactions of others). Furthermore, timeline, structural and process expectations are important aspects with respect to medical treatment. Additionally, generalized expectations such as generalized self-efficacy or optimism have to be considered. Several instruments assessing different aspects of expectations in medical treatment can be found in the literature. However, many were developed without conceptual standardization and psychometric evaluation. Moreover, they merely assess single aspects of expectations, thus impeding the integration of evidence regarding the differential aspects of expectations. As many instruments assess treatment-specific expectations, they are not comparable between different conditions. To generate a more comprehensive understanding of expectation effects in medical treatments, we recommend that future research should apply standardized, psychometrically evaluated measures, assessing multidimensional aspects of patients’ expectations that are applicable across various medical treatments. In the future, more research is needed on the interrelation of different expectation concepts as well as on factors influencing patients’ expectations of illness and treatment. Considering the importance of patients’ expectations for health outcomes across many medical conditions, an integrated understanding and assessment of such expectations might facilitate interventions aiming to optimize patients’ expectations in order to improve health outcomes.

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.

ObjectiveThe Generalized Anxiety Disorder scale (GAD-7) is one of the most frequently used diagnostic self-report scales for screening, diagnosis and severity assessment of anxiety disorder. Its psychometric properties from the view of the Item Response Theory paradigm have rarely been investigated. We aimed to close this gap by analyzing the GAD-7 within a large sample of primary care patients with respect to its psychometric properties and its implications for scoring using Item Response Theory.MethodsRobust, nonparametric statistics were used to check unidimensionality of the GAD-7. A graded response model was fitted using a Bayesian approach. The model fit was evaluated using posterior predictive p-values, item information functions were derived and optimal predictions of anxiety were calculated.ResultsThe sample included N = 3404 primary care patients (60% female; mean age, 52,2; standard deviation 19.2) The analysis indicated no deviations of the GAD-7 scale from unidimensionality and a decent fit of a graded response model. The commonly suggested ultra-brief measure consisting of the first two items, the GAD-2, was supported by item information analysis. The first four items discriminated better than the last three items with respect to latent anxiety.ConclusionThe information provided by the first four items should be weighted more heavily. Moreover, estimates corresponding to low to moderate levels of anxiety show greater variability. The psychometric validity of the GAD-2 was supported by our analysis.

Objective The harmonization of core outcome domains in clinical trials facilitates comparison and pooling of data, and simplifies the preparation and review of research projects and comparison of risks and benefits of treatments. Therefore, we provide recommendations for the core outcome domains that should be considered in clinical trials on the efficacy and effectiveness of interventions for somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. Methods The European Network on Somatic Symptom Disorders group of more than 20 experts in the field met twice in Hamburg to discuss issues of assessment and intervention research in somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. The consensus meetings identified core outcome domains that should be considered in clinical trials evaluating treatments for somatic symptom disorder and associated functional somatic syndromes. Results The following core domains should be considered when defining ascertainment methods in clinical trials: a) classification of somatic symptom disorder/bodily distress disorder, associated functional somatic syndromes, and comorbid mental disorders (using structured clinical interviews), duration of symptoms, medical morbidity, and prior treatments; b) location, intensity, and interference of somatic symptoms; c) associated psychobehavioral features and biological markers; d) illness consequences (quality of life, disability, health care utilization, health care costs; e) global improvement and treatment satisfaction; and f) unwanted negative effects. Conclusions The proposed criteria are intended to improve synergies of clinical trials and to facilitate decision making when comparing different treatment approaches. These recommendations should not result in inflexible guidelines, but increase consistency across investigations in this field.

This comprehensive review provides an overview about placebo and nocebo phenomena in antidepressant trials. Improvements in the placebo groups may partly be explained through methodological issues such as natural course of depression and regression to the mean, but also fundamentally reflect investigators' and participants' expectations. A meta-analysis by our group of 96 randomized placebo-controlled trials showed large placebo responses to antidepressant medication. Moderator analyses revealed substantially larger placebo responses in observer ratings compared with self-report. Effect sizes in observer ratings showed strong increase with publication year while this effect was not found for patients' self-ratings. This reflects the strong influence of investigators' expectations. The analysis of 'nocebo effects', e.g. adverse effects in placebo groups of antidepressant trials also confirms the impact of expectations: nocebo symptoms reflected the typical side-effect patterns expected in the drug group, with higher symptoms rates in the placebo groups of tricyclic antidepressant trials compared with placebo groups of trials testing selective serotonin reuptake inhibitors. While the placebo response seems to be similar for women and men, gender differences were found for nocebo rates. In the conclusion, we discuss potential implications for clinical trial designs and argue for interventions aimed at optimizing positive expectations of treatment benefit while minimizing the impact of adverse effects.

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Patients, especially older ones, can benefit from enhanced treatment information given additionally to routine care. Enhanced information about mode of action and potential side effects of endocrine therapy when included into clinical routine might foster patient autonomy and prevent early disruptions in adherence.

IntroductionPersistent somatic symptoms (PSS) are highly prevalent in all areas of medicine; they are disabling for patients and costly for society. The subjective symptom burden often correlates poorly with the underlying disease severity, and patients’ needs for effective treatment are far from being met. Initial evidence indicates that, in addition to disease-specific pathophysiological processes, psychological factors such as expectations, somatosensory amplification and prior illness experiences contribute to symptom persistence in functional as well as in somatic diseases. However, prospective studies investigating the transition from acute to chronic somatic symptoms, integrating pathophysiological, psychological and social factors, are scarce. A better understanding of the multifactorial mechanisms of symptom persistence is crucial for developing targeted mechanism-based interventions for effective prevention and treatment of PSS. Thus, the overall aim of the interdisciplinary SOMACROSS research unit is to identify generic and disease-specific risk factors and aetiological mechanisms of symptom persistence across a range of diseases.Methods and analysisSeven projects will investigate risk factors and mechanisms of symptom persistence in a total of 3916 patients across 10 medical conditions. All study designs are prospective and share common assessment points, core instruments and outcome variables to allow comparison and validation of results across projects and conditions. Research will focus on the identification of generic and disease-specific mechanisms associated with unfavourable symptom course. The development of a multivariate prediction model will facilitate the understanding of the course of PSS across diseases.Ethics and disseminationAll individual SOMACROSS studies were approved by the ethics committees of the Medical Chambers Hamburg and Münster, Germany. Findings will be disseminated through peer-reviewed publications, scientific conferences and the involvement of relevant stakeholders, patients and the lay public. This interdisciplinary research unit will fundamentally contribute to earlier recognition of patients at risk, and to the development of prevention and tailored treatment concepts for PSS.