Health economic evaluation of blended collaborative care for older multimorbid heart failure patients: study protocol.

BACKGROUND: Integrated care, in particular the 'Blended Collaborative Care (BCC)' strategy, may have the potential to improve health-related quality of life (HRQoL) in multimorbid patients with heart failure (HF) and psychosocial burden at no or low additional cost. The ESCAPE trial is a randomised controlled trial for the evaluation of a BCC approach in five European countries. For the economic evaluation of alongside this trial, the four main objectives were: (i) to document the costs of delivering the intervention, (ii) to assess the running costs across study sites, (iii) to evaluate short-term cost-effectiveness and cost-utility compared to providers' usual care, and (iv) to examine the budgetary implications. METHODS: The trial-based economic analyses will include cross-country cost-effectiveness and cost-utility assessments from a payer perspective. The cost-utility analysis will calculate quality-adjusted life years (QALYs) using the EQ-5D-5L and national value sets. Cost-effectiveness will include the cost per hospital admission avoided and the cost per depression-free days (DFD). Resource use will be measured from different sources, including electronic medical health records, standardised questionnaires, patient receipts and a care manager survey. Uncertainty will be addressed using bootstrapping. DISCUSSION: The various methods and approaches used for data acquisition should provide insights into the potential benefits and cost-effectiveness of a BCC intervention. Providing the economic evaluation of ESCAPE will contribute to a country-based structural and organisational planning of BCC (e.g., the number of patients that may benefit, how many care managers are needed). Improved care is expected to enhance health-related quality of life at little or no extra cost. TRIAL REGISTRATION: The study follows CHEERS2022 and is registered at the German Clinical Trials Register (DRKS00025120).

Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial.

BACKGROUND: Previous studies have demonstrated the efficacy of rehabilitation after a cardiovascular procedure. Especially older and multimorbid patients benefit from rehabilitation after a cardiac procedure. Prehabilitation prior to cardiac procedures may also have positive effects on patients' pre- and postoperative outcomes. Results of a current meta-analysis show that prehabilitation prior to cardiac procedures can improve perioperative outcomes and alleviate adverse effects. Germany currently lacks a structured cardiac prehabilitation program for older patients, which is coordinated across healthcare sectors. METHODS: In a randomized, controlled, two-arm parallel group, assessor-blinded multicenter intervention trial (PRECOVERY), we will randomize 422 patients aged 75 years or older scheduled for an elective cardiac procedure (e.g., coronary artery bypass graft surgery or transcatheter aortic valve replacement). In PRECOVERY, patients randomized to the intervention group participate in a 2-week multimodal prehabilitation intervention conducted in selected cardiac-specific rehabilitation facilities. The multimodal prehabilitation includes seven modules: exercise therapy, occupational therapy, cognitive training, psychosocial intervention, disease-specific education, education with relatives, and nutritional intervention. Participants in the control group receive standard medical care. The co-primary outcomes are quality of life (QoL) and mortality after 12 months. QoL will be measured by the EuroQol 5-dimensional questionnaire (EQ-5D-5L). A health economic evaluation using health insurance data will measure cost-effectiveness. A mixed-methods process evaluation will accompany the randomized, controlled trial to evaluate dose, reach, fidelity and adaptions of the intervention. DISCUSSION: In this study, we investigate whether a tailored prehabilitation program can improve long-term survival, QoL and functional capacity. Additionally, we will analyze whether the intervention is cost-effective. This is the largest cardiac prehabilitation trial targeting the wide implementation of a new form of care for geriatric cardiac patients. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00030526). Registered on 30 January 2023.

Assessment of health-related quality of life in individuals with depressive symptoms: validity and responsiveness of the EQ-5D-3L and the SF-6D.

BACKGROUND: The EQ-5D and the SF-6D are examples of commonly used generic preference-based instruments for assessing health-related quality of life (HRQoL). However, their suitability for mental disorders has been repeatedly questioned. OBJECTIVE: To assess the responsiveness and convergent validity of the EQ-5D-3L and SF-6D in patients with depressive symptoms. METHODS: The data analyzed were from cardiac patients with depressive symptoms and were collected as part of the SPIRR-CAD (Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease) trial. The EQ-5D-3L and SF-6D were compared with the HADS (Hospital Anxiety and Depression Scale) and PHQ-9 (Patient Health Questionnaire) as disease-specific instruments. Convergent validity was assessed using Spearman's rank correlation. Effect sizes were calculated and ROC analysis was performed to determine responsiveness. RESULTS: Data from 566 patients were analysed. The SF-6D correlated considerably better with the disease-specific instruments (|rs|= 0.63-0.68) than the EQ-5D-3L (|rs|= 0.51-0.56). The internal responsiveness of the SF-6D was in the upper range of a small effect (ES: - 0.44 and - 0.47), while no effect could be determined for the EQ-5D-3L. Neither the SF-6D nor the EQ-5D-3L showed acceptable external responsiveness for classifying patients' depressive symptoms as improved or not improved. The ability to detect patients whose condition has deteriorated was only acceptable for the EQ-5D-3L. CONCLUSION: Overall, both the convergent validity and responsiveness of the SF-6D are better than those of the EQ-5D-3L in patients with depressive symptoms. The SF-6D appears, therefore, more recommendable for use in studies to evaluate interventions for this population.

Outcome assessment using estimation of left ventricular filling pressure in asymptomatic patients at risk for heart failure with preserved ejection fraction.

AIMS: High prevalence and lack of pharmacological treatment are making heart failure with preserved ejection fraction (HFpEF) a growing public health problem. No algorithm for the screening of asymptomatic patients with risk for HFpEF exists to date. We assessed whether HFA/ESC 2007 diagnostic criteria for HFpEF are helpful to investigate the cardiovascular outcome in asymptomatic patients. METHODS AND RESULTS: We performed an analysis of the Diagnostic Trial on Prevalence and Clinical Course of Diastolic Dysfunction and Heart Failure (DIAST-CHF) that recruited patients with cardiovascular risk factors. All patients underwent a comprehensive diagnostic workup at baseline. Asymptomatic patients with preserved LVEF (>50%) were selected and classified according to HFA/ESC surrogate criteria for left ventricular elevated filling pressure (mean E/e' >15 or E/e' >8 and presence of either NT-proBNP > 220 ng/l, BNP > 200 ng/l or atrial fibrillation) into elevated filling pressure (FPe) or controls. Cardiovascular hospitalizations and all-cause death were assessed for both groups over a 10-year-follow-up.851 asymptomatic patients (age 65.5 ± 7.6 years, 44% female) were included in the analysis. FPe-patients were significantly older (p < 0.001), more often female (p = 0.003) and more often had a history of coronary artery disease, atrial fibrillation and renal dysfunction (p < 0.001, respectively) compared to controls. Incidence of death was significantly higher in the FPe group after a 10-year follow-up (p < 0.001), whereas cardiovascular hospitalization did not differ between groups. CONCLUSION: Asymptomatic patients that fulfill HFA/ESC diagnostic criteria for HFpEF are at higher risk of symptomatic HFpEF and have a worse 10-year-outcome than those who do not fulfill criteria.

National survey of evaluation practices and performance-guided resource allocation at German medical schools.

Background: Little is known about evaluation practices as well as performance-oriented allocation of resources according to teaching quality at German medical schools. For this reason, the Association of the Scientific Medical Societies in Germany and the German Association of Medical Faculties aimed to analyse current practices at German medical schools. Methods: Data were collected by a questionnaire which was sent to all medical schools in Germany. Results: 30 medical schools with 33 undergraduate medical programs participated in the survey (response rate: 83%). The evaluation tools used at these schools mainly assessed structural and procedural aspects of teaching and were designed to obtain overall student ratings of teaching quality. Evaluation tools were quite heterogeneous across the sample, and some uncertainty remained with regard to the psychometric properties of these tools and whether they meet international quality standards. Various algorithms underlying resource allocation for teaching are being used, but most focus on quantity rather than quality of teaching. Conclusion: A nationwide agreement on a generalizable definition of high-quality teaching is desirable. At the same time, reliable and valid tools measuring teaching quality need to be identified and/or created. This could be accomplished through a wider collaboration of medical schools and could represent an advancement for the allocation of resources for high-quality teaching.

Direct assessment of adherence and drug interactions in patients with hypertensive crisis-A cross-sectional study in the Emergency Department.

Though drug adherence is supposed to be low in hypertensive crisis (HTN-C), there are no data available from direct adherence assessments. The aim of the present study was to evaluate adherence to prescribed antihypertensives and potential interactions of concomitant drugs and foods with prescribed antihypertensives in patients with HTN-C by a direct evaluation via biochemical urine analysis. In the present cross-sectional study, 100 patients with HTN-C, admitted to the emergency department (ED), were included. A biochemical urine analysis using gas chromatography-tandem mass spectrometry was performed. Out of 100 patients, 86 received antihypertensives. Urine analyses could be evaluated unambiguously in 62 patients. In 15 of these 62 patients (24%), a nonadherence could be demonstrated, and in 21 patients (34%), a partial nonadherence could be demonstrated. Patients with nonadherence or partial nonadherence showed a longer hypertension history (15[5-22] vs 10[3-15] years, P = 0.04) were prescribed more general medication (number 7.1 ± 3.4 vs 3.4 ± 1.8; P < 0.01) as well as antihypertensive drugs (number 2.8 ± 1.1 vs 1.5 ± 0.7, P < 0.01). A potential BP-raising trigger by medications or food interaction was frequently detectable, predominantly with nonsteroidal anti-inflammatory drugs (NSAIDs; n = 38), glucocorticoids (n = 8), antidepressants (n = 10), and licorice (n = 10). Nonadherence and partial nonadherence to prescribed antihypertensives might play a crucial role for the occurrence of HTN-C. However, further case-controlled studies are needed to confirm the present findings. Ingestion of concurrent over-the-counter drugs such as NSAIDs but also prescribed drugs as well as aliments may lead to critical BP elevation. In order to prevent HTN-C, the present findings emphasize the importance for clinicians to pay attention to the issue of adherence and co-medication.

Socioeconomic factors in coronary artery disease - Results from the SPIRR-CAD study.

Low socio-economic status (SES) has been associated with an increased coronary risk in Western countries. All stress experiences are more pronounced in low SES patients with stress emanating from problems with family, job, or money. The SPIRR-CAD study offered an excellent opportunity to examine these risk factors in German speaking mildly and medium depressed patients. In the SPIRR CAD study, a German multi centre randomized clinical trial of 450 male and 120 female coronary patients, we examined the standard and psychosocial risk factor profiles in relation to SES, as assessed by educational level. All differences in risk factors between low and high SES were in the inverse direction. Of standard risk factors, only smoking was socially graded and more common in low SES. Of psychosocial factors and emotions, exhaustion showed the strongest and most consistent inverse social gradient, but also anger, anxiety and depression were socially graded. The findings suggest that in German patients, as in other national groups, social gradients in CHD risk are considerable. They can be ascribed to both psychosocial and to standard risk factors. In the present two years follow-up, the prospective significance of psychological and social risk factors was analyzed showing that emotional factors played an important role, in that low and high SES patients differed in the expected direction. However, the differences were not statistically significant and therefore firm conclusions from follow up were not possible. TRIAL REGISTRATION: ISRCTN 76240576; NCT00705965.

The American Psychosomatic Society - integrating mind, brain, body and social context in medicine since 1942.

BACKGROUND: The American Psychosomatic Society is one of the oldest and probably the most influential scientific society in psychosomatic/biopsychosocial research worldwide. The current article delineates the historical development and current strategic orientation of the society. METHOD: Review of published literature, archived materials and current documents of the society. RESULTS: The American Psychosomatic Society (APS) was founded in 1942, originally named the "American Society for Research in Psychosomatic Problems ". It originated from the editorial board of the Journal Psychosomatic Medicine, which had already been founded in 1939 and has become one of the major journals in the field. As an organization, APS has developed into a premier international scientific society, providing an interdisciplinary home for researchers from medicine, psychology and related areas, gathering under the mission "to advance and integrate the scientific study of biological, psychological, behavioral and social factors in health and disease" and dedicated to the goals of Scientific Excellence, Clinical Relevance, and Vibrant and Diverse Membership. Besides editing Psychosomatic Medicine, the APS organizes Annual Meetings and specialized events, issues several scientific awards and scholarships and is engaged in collaborative efforts to improve the research and funding landscape for biobehavioral research in the US and translate psychosomatic research findings into medical education and clinical practice. CONCLUSION: In its 75th anniversary year, the American Psychosomatic Society has developed into the scientific landscape of the 21st century, and its current updated strategy addresses contemporary demands in advancing science and improving holistic patient care.

Evaluation of medical research performance--position paper of the Association of the Scientific Medical Societies in Germany (AWMF).

OBJECTIVE: The evaluation of medical research performance is a key prerequisite for the systematic advancement of medical faculties, research foci, academic departments, and individual scientists' careers. However, it is often based on vaguely defined aims and questionable methods and can thereby lead to unwanted regulatory effects. The current paper aims at defining the position of German academic medicine toward the aims, methods, and consequences of its evaluation. METHODS: During the Berlin Forum of the Association of the Scientific Medical Societies in Germany (AWMF) held on 18 October 2013, international experts presented data on methods for evaluating medical research performance. Subsequent discussions among representatives of relevant scientific organizations and within three ad-hoc writing groups led to a first draft of this article. Further discussions within the AWMF Committee for Evaluation of Performance in Research and Teaching and the AWMF Executive Board resulted in the final consented version presented here. RESULTS: The AWMF recommends modifications to the current system of evaluating medical research performance. Evaluations should follow clearly defined and communicated aims and consist of both summative and formative components. Informed peer reviews are valuable but feasible in longer time intervals only. They can be complemented by objective indicators. However, the Journal Impact Factor is not an appropriate measure for evaluating individual publications or their authors. The scientific "impact" rather requires multidimensional evaluation. Indicators of potential relevance in this context may include, e.g., normalized citation rates of scientific publications, other forms of reception by the scientific community and the public, and activities in scientific organizations, research synthesis and science communication. In addition, differentiated recommendations are made for evaluating the acquisition of third-party funds and the promotion of junior scientists. CONCLUSIONS: With the explicit recommendations presented in the current position paper, the AWMF suggests enhancements to the practice of evaluating medical research performance by faculties, ministries and research funding organizations.

Position paper on the importance of psychosocial factors in cardiology: Update 2013.

BACKGROUND: The rapid progress of psychosomatic research in cardiology and also the increasing impact of psychosocial issues in the clinical daily routine have prompted the Clinical Commission of the German Heart Society (DGK) to agree to an update of the first state of the art paper on this issue which was originally released in 2008. METHODS: The circle of experts was increased, general aspects were implemented and the state of the art was updated. Particular emphasis was dedicated to coronary heart diseases (CHD), heart rhythm diseases and heart failure because to date the evidence-based clinical knowledge is most advanced in these particular areas. Differences between men and women and over the life span were considered in the recommendations as were influences of cognitive capability and the interactive and synergistic impact of classical somatic risk factors on the affective comorbidity in heart disease patients. RESULTS: A IA recommendation (recommendation grade I and evidence grade A) was given for the need to consider psychosocial risk factors in the estimation of coronary risks as etiological and prognostic risk factors. Furthermore, for the recommendation to routinely integrate psychosocial patient management into the care of heart surgery patients because in these patients, comorbid affective disorders (e.g. depression, anxiety and post-traumatic stress disorder) are highly prevalent and often have a malignant prognosis. A IB recommendation was given for the treatment of psychosocial risk factors aiming to prevent the onset of CHD, particularly if the psychosocial risk factor is harmful in itself (e.g. depression) or constrains the treatment of the somatic risk factors. Patients with acute and chronic CHD should be offered anti-depressive medication if these patients suffer from medium to severe states of depression and in this case medication with selective reuptake inhibitors should be given. In the long-term course of treatment with implanted cardioverter defibrillators (ICDs) a subjective health technology assessment is warranted. In particular, the likelihood of affective comorbidities and the onset of psychological crises should be carefully considered. CONCLUSIONS: The present state of the art paper presents an update of current empirical evidence in psychocardiology. The paper provides evidence-based recommendations for the integration of psychosocial factors into cardiological practice and highlights areas of high priority. The evidence for estimating the efficiency for psychotherapeutic and psychopharmacological interventions has increased substantially since the first release of the policy document but is, however, still weak. There remains an urgent need to establish curricula for physician competence in psychodiagnosis, communication and referral to ensure that current psychocardiac knowledge is translated into the daily routine.

Self-rated health predicts adverse events during ß-blocker treatment: the CIBIS-ELD randomised trial analysis.

BACKGROUND: Self-rated health (SRH) predicts outcome in patients with heart failure. Beta-blockers are known to improve health-related quality of life and reduce mortality in such patients. We aimed to evaluate the relation between SRH and adverse events during titration of beta-blockers in elderly patients with heart failure. METHODS: The cardiac insufficiency bisoprolol study in the elderly (CIBIS-ELD) is a multicentre, double-blind trial, in which 883 patients aged ≥ 65 years with chronic heart failure (73 ± 6 years, 38% women, left ventricular ejection fraction [LVEF] 42% ± 14%) were randomised to bisoprolol or carvedilol. SRH was assessed at baseline and after 12 weeks, using a 5-grade descriptive scale: excellent, very good, good, fair, and poor. RESULTS: Median SRH at baseline and follow-up was good, but more patients reported fair/poor SRH at baseline (36% vs. 30%, p = 0.012). Women, beta-blocker-naïve patients, patients in NYHA class III/IV and those with PHQ-9 score ≥ 12 were more likely to report fair/poor baseline SRH (p < 0.001 for all). During follow-up, SRH improved in 34% of patients and worsened in 8% (p < 0.001). Adverse events were experienced by 64% patients and 38% experienced > 1 adverse event or serious adverse event, with higher prevalence in lower SRH categories. In a multivariate logistic regression model, SRH, age, distance achieved on the 6-min walk test and LVEF >45% predicted adverse events (p < 0.05 for all). CONCLUSIONS: SRH is an independent predictor of adverse events during titration of beta-blockers and correlates with the proportion and number of adverse events per patient.

[Psychosocial co-symptoms in primary care patients with heart failure]. / Psychische Kosymptomatik von hausärztlichen Patienten mit Herzinsuffizienz.

BACKGROUND AND PURPOSE: Psychosocial distress is a common phenomenon in patients with heart failure (HF). The aim of this study was to analyze psychosocial co-symptoms and their relationship with clinical and sociodemographic factors. METHODS: In 363 primary care patients with HF, anxiety, depression and negative affectivity (HADS, DS-14), disease coping (FKV) and social support (F-SozU) were measured by validated questionnaires. Severity of HF (according to NYHA classification and Goldman's Specific Activity Scale) and sociodemographic characteristics were documented by self-report instruments. RESULTS: Increased anxiety and/or depression was found in 29.2% of patients. Anxiety and depression scores were significantly higher than in the German general population (p < 0.005). They were furthermore associated with NYHA and Goldman class (anxiety: p = 0.001; depression: p = 0.001). One third of the sample showed the type D personality pattern, which has been associated with increased mortality in cardiac patients. While HF severity correlated positively with psychological distress, patients living together with other persons had lower HF class than those living alone. Using regression analysis, sociodemographic and psychological variables predicted perceived severity of HF in 20.3% if measured by Goldman's scale (significant for sex, age, depressive symptoms and disease coping), and in 18.6% if measured by NYHA (significant for anxiety). DISCUSSION: Severity of HF symptoms and psychosocial factors are interrelated. Self-reported severity of HF is substantially influenced by demographic and psychological variables. In this, it is not relevant if severity is measured by a nonvalidated (NYHA) or a validated instrument (Goldman). CONCLUSION: In primary care patients with HF, psychosocial co-symptoms are frequent and interfere with perceived severity of disease. Psychological distress should be considered important in diagnostics and treatment, especially in patients living alone.

[Evaluation of the German Type D Scale (DS14) and prevalence of the Type D personality pattern in cardiological and psychosomatic patients and healthy subjects]. / Evaluation der deutschen Typ-D-Skala (DS14) und Prävalenz der Typ-D-Persönlichkeit bei kardiologischen und psychosomatischen Patienten sowie Gesunden.

The Type D personality pattern, consisting of negative affectivity and social inhibition, has been shown by Denollet et al. to predict adverse prognosis in patients with coronary heart disease. For measuring the Type D characteristics, Denollet has devised the 14 item Type D scale (DS14). In the present study, this instrument was translated into German. The validity, reliability and adequacy of the German DS14 were then tested in 2421 persons, including cardiological and psychosomatic patients as well as healthy factory workers. The results document sound psychometric properties of the scale. Cronbach's alpha was 0.87 for the negative affectivity subscale and 0.86 for social inhibition. The two-factor structure of the original instrument could be clearly replicated. The prevalence rates of the Type D pattern were lowest in cardiological patients (25 %) and highest in psychosomatic patients (62 %). The prevalence in this German sample of cardiology patients was also lower than the one observed in healthy factory workers (32.5 %) and in CHD samples reported in the literature. These group differences could not be accounted for by differences in age and sex distribution. In conclusion, the DS14 is a valid and reliable instrument that can be used for an economic evaluation of the Type D characteristics in patients and healthy persons. The possible meaningfulness of the low Type D prevalence in cardiac patients and the prognostic relevance of this pattern require further study.