Regional differences among female patients with heart failure from the Cardiac Insufficiency BIsoprolol Study in ELDerly (CIBIS-ELD)

Background: The aim of our study was to examine regional differences in the demographics, etiology, risk factors, comorbidities and treatment of female patients with heart failure (HF) in the Cardiac Insufficiency BI soprolol Study in ELDerly (CIBIS-ELD) clinical trial.Methods and results: One hundred and fifty-nine female patients from Germany and 169 from Southeastern (SE) Europe (Serbia, Slovenia and Montenegro) were included in this subanalysis of the CIBIS-ELD trial. Women comprised 54% of the study population in Germany and 29% in SE Europe. German patients were significantly older. The leading cause of HF was arterial hypertension in German patients, 71.7% of whom had a preserved ejection fraction. The leading etiology in SE Europe was the coronary artery disease; 67.6% of these patients had a reduced left ventricular ejection fraction (34.64 ± 7.75%). No significant differences were found in the prevalence of traditional cardiovascular risk factors between the two regions (hypertension, diabetes, hypercholesterolemia, smoking and family history of myocardial infarction). Depression, chronic obstructive pulmonary disease and malignancies were the comorbidities that were noted more frequently in the German patients, while the patients from SE Europe had a lower glomerular filtration rate. Compared with the German HF patients, the females in SE Europe received significantly more angiotensin converting enzyme inhibitors, loop diuretics and less frequently angiotensin receptor blockers and mineralocorticoid receptor antagonists.Conclusions: Significant regional differences were noted in the etiology, comorbidities and treatment of female patients with HF despite similar risk factors. Such differences should be considered in the design and implementation of future clinical trials, especially as women remain underrepresented in large trial populations.

Titration to target dose of bisoprolol vs. carvedilol in elderly patients with heart failure: the CIBIS-ELD trial

AIMS: Various beta-blockers with distinct pharmacological profiles are approved in heart failure, yet they remain underused and underdosed. Although potentially of major public health importance, whether one agent is superior in terms of tolerability and optimal dosing has not been investigated. The aim of this study was therefore to compare the tolerability and clinical effects of two proven beta-blockers in elderly patients with heart failure. METHODS AND RESULTS: We performed a double-blind superiority trial of bisoprolol vs. carvedilol in 883 elderly heart failure patients with reduced or preserved left ventricular ejection fraction in 41 European centres. The primary endpoint was tolerability, defined as reaching and maintaining guideline-recommended target doses after 12 weeks treatment. Adverse events and clinical parameters of patient status were secondary endpoints. None of the beta-blockers was superior with regards to tolerability: 24% [95% confidence interval (CI) 20-28] of patients in the bisoprolol arm and 25% (95% CI 21-29) of patients in the carvedilol arm achieved the primary endpoint (P= 0.64). The use of bisoprolol resulted in greater reduction of heart rate (adjusted mean difference 2.1 b.p.m., 95% CI 0.5-3.6, P= 0.008) and more, dose-limiting, bradycardic adverse events (16 vs. 11%; P= 0.02). The use of carvedilol led to a reduction of forced expiratory volume (adjusted mean difference 50 mL, 95% CI 4-95, P= 0.03) and more, non-dose-limiting, pulmonary adverse events (10 vs. 4%; P < 0.001). CONCLUSION: Overall tolerability to target doses was comparable. The pattern of intolerance, however, was different: bradycardia occurred more often in the bisoprolol group, whereas pulmonary adverse events occurred more often in the carvedilol group. This study is registered with controlled-trials.com, number ISRCTN34827306

Patientenbezogene Endpunkte bei Herzinsuffizienz

Background Heart failure is a global health care challenge that is associated with high morbidity and mortality, as well as reduced self-rated health and quality of life. In a holistic approach to patient care, assessment of the patient’s perspective on their wellbeing, treatment, and participation in care can be captured by patient-reported outcomes. Utilisation of patient-reported outcomes in heart failure in clinical practice and research remains limited. Aims The aim of this work was the integration of patient-reported outcomes in heart failure research to improve our understanding of their potential benefit in patient care and risk prediction. Specifically, the aim of this work was to answer the following questions: \- What is the relationship between self-rated health and occurrence of adverse events during up-titration of beta-blocker therapy in patients with heart failure? \- How, and to what extent, are changes in quality of life influenced by clinical and psychological factors during up-titration of beta-blockers in patients with heart failure? \- How well do patients with heart failure perform specific self-care behaviours across the world and what are the differences and/or similarities between countries? \- What is the predictive value of two consecutive self-rated health assessments with regard to mortality in patients with heart failure? Methods Self-rated health, quality of life and depression were assessed in the investigator-initiated, multicentre, double blind cardiac insufficiency bisoprolol study in elderly (CIBIS-ELD). Heart failure self-care and mortality were assessed in an observational long-term follow-up survey after 2-4 years. Statistical analyses included descriptive methods, Student’s t-tests and chi- squared tests, Kendall’s correlation coefficient analysis, Cox proportional hazard regressions, logistic regressions, multiple linear regressions, and Kaplan-Meier analysis, as appropriate. For all tests, a p-value of ≤0.05 was considered statistically significant. Results Patients’ self-rated health independently predicted adverse events and titration failure during up- titration of beta-blockers. Further, when assessed consecutively, poor self- rated health predicted long-term mortality in elderly patients with chronic heart failure. Changes in health-related quality of life over the course of medication up-titration were determined more strongly by changes in depression than changes in cardiac severity markers. From a global perspective, heart failure self-care skills vary significantly in different countries and need to be improved worldwide. Conclusions This work makes a significant contribution to our understanding of patient-reported outcomes in chronic heart failure. Clinicians are recommended to include the assessment of self-rated health, quality of life, depression and self-care behaviour in their interactions with patients with heart failure. The inclusion of patient-reported assessments is encouraged in the patient centred, shared decision-making process about further support, treatment, and follow-up.Einleitung Herzinsuffizienz ist eine globale Herausforderung an die Gesundheitssysteme und geht einher mit hoher Mortalität, Morbidität und reduzierter selbst-eingeschätzter Gesundheit sowie Lebensqualität. In einem ganzheitlichen Versorgungskonzept der Patienten spielen die vom Patienten berichteten Eindrücke und Bewertungen über sein Wohlbefinden, seine Therapie und seine Teilnahme an der Versorgung eine wesentliche Rolle. Diese „Patient- reported Outcomes“ wurden bislang aber bei der Herzinsuffizienz wenig eingesetzt und sind nicht ausreichend untersucht. Ziele Ziel dieser Arbeit war es, Patient-reported Outcomes bei Patienten mit Herzinsuffizienz in Hinsicht auf potenzielle Verbesserungen bei der Versorgung und für die Risikoprädiktion zu untersuchen. Hierfür sollten die folgenden Fragen beantwortet werden: \- Wie ist der Zusammenhang von der durch den Patienten selbst-eingeschätzten Gesundheit und dem Auftreten von unerwünschten Ereignissen während einer Einstellung auf Betablocker bei herzinsuffizienten Patienten? \- Wie und in welchem Umfang wird die Lebensqualität durch klinische und psychologische Faktoren während der Betablocker Behandlung beeinflusst? \- Wie gut wenden herzinsuffiziente Patienten in verschiedenen Ländern spezielle Selbstpflege- Maßnahmen an, und was sind nationale Unterschiede? \- Welchen Vorhersagewert haben zwei aufeinander folgende Messungen der selbst-eingeschätzten Gesundheit hinsichtlich des Sterberisikos bei herzinsuffizienten Patienten? Methoden Selbst-eingeschätzte Gesundheit, Lebensqualität und Depression wurden in der Investigator-initiierten, multizentrischen, doppelblinden Studie „Cardiac insufficiency bisoprolol study in elderly“ (CIBIS-ELD) untersucht. Herzinsuffizienz Selbstpflege-Verhalten und Sterblichkeit wurden in einer Langzeitnachbeobachtung nach 2-4 Jahren untersucht. Statistische Methoden bestanden aus beschreibender Statistik, Student T-Test, Chi-Quadrat Test, Kendalls Korrelationsanalyse, Cox-Regression, logistischer Regression, multipler lineare Regression und Kaplan-Meier Analyse. Ein p-Wert ≤0.05 wurde als statistisch signifikant erachtet. Ergebnisse Die vom Patienten selbst- eingeschätzte Gesundheit sagte unabhängig unerwünschte Ereignisse und Verzögerungen bei der Einstellung auf Betablocker voraus. Außerdem war eine mehrfach als „schlecht“ selbst-eingeschätzte Gesundheit mit schlechter Prognose bei herzinsuffizienten Patienten in der Langzeitbeobachtung assoziiert. Veränderungen der Lebensqualität während der Medikamenteneinstellung hingen mehr vom Vorhandensein und der Ausprägung einer Depression ab, als von Veränderungen des klinischen Schweregrades der Herzinsuffizienz. Aus globaler Perspektive variierte das Selbstpflege- Verhalten erheblich zwischen den untersuchten Ländern und sollte weltweit verbessert werden. Schlussfolgerungen Diese Arbeit trägt zum Verständnis von Patient-reported Outcomes bei herzinsuffizienten Patienten bei. Pflegende und Ärzte sollten beim Umgang mit herzinsuffizienten Patienten die selbst- eingeschätzte Gesundheit, die Lebensqualität, Depression und das Selbstpflege- Verhalten erheben und beurteilen. Patient-reported Outcomes sind unabdingbar bei der patientenzentrierten Behandlung, die Wert legt auf Mitbestimmung bei der Behandlung und der weiteren Versorgung

Process evaluation of a multi-disciplinary complex intervention to improve care for older patients with chronic conditions in rural areas (the HandinHand Study): study protocol

Abstract Background To improve health care in rural areas, especially for increasing numbers of people with chronic diseases, academically qualified nurses could take over expanded roles to meet the challenges of an ageing society and a decreasing number of General Practitioners (GPs). In the project “HandinHand” (HiH), qualified nurses (Expert nurses, ENs) will carry out home visits to older people with chronic diseases over a period of six months. ENs will prepare a care plan in cooperation with GPs to stabilise the care situation and avoid unplanned hospital admissions and GP visits. The process evaluation aims to provide an in-depth analysis of the implementation process and gather important information on barriers and facilitators to the implementation of ENs as a complementary health care structure in primary care, taking into account several context factors. Methods Based on the Medical Research Council (MRC) Framework for complex interventions, a logic model was developed and applied as the basis for data collection. Qualitative and quantitative data will be collected during the study. A mixed methods approach should allow to gain important insights from participants (e.g. ENs, GPs, patients) involved in the study as well as relevant stakeholders. Semi-structured interviews and surveys will be conducted. Data analysis will be based on the logical model, combining qualitative and quantitative data. Qualitative data will be analysed inductively-deductively using qualitative thematic framework analysis. Discussion The process evaluation will provide guidance and conclusions on further development and transferability. Of particular interest is the expanded role of ENs in primary care, which has barely been implemented in Germany and can be seen as a precursor to the development of an Advanced Practice Nursing (APN) role in primary care. </jats:sec

Process evaluation of a multi-disciplinary complex intervention to improve care for older patients with chronic conditions in rural areas (the HandinHand Study): study protocol

Background To improve health care in rural areas, especially for increasing numbers of people with chronic diseases, academically qualified nurses could take over expanded roles to meet the challenges of an ageing society and a decreasing number of General Practitioners (GPs). In the project HandinHand (HiH), qualified nurses (Expert nurses, ENs) will carry out home visits to older people with chronic diseases over a period of six months. ENs will prepare a care plan in cooperation with GPs to stabilise the care situation and avoid unplanned hospital admissions and GP visits. The process evaluation aims to provide an in-depth analysis of the implementation process and gather important information on barriers and facilitators to the implementation of ENs as a complementary health care structure in primary care, taking into account several context factors. Methods Based on the Medical Research Council (MRC) Framework for complex interventions, a logic model was developed and applied as the basis for data collection. Qualitative and quantitative data will be collected during the study. A mixed methods approach should allow to gain important insights from participants (e.g. ENs, GPs, patients) involved in the study as well as relevant stakeholders. Semi-structured interviews and surveys will be conducted. Data analysis will be based on the logical model, combining qualitative and quantitative data. Qualitative data will be analysed inductively-deductively using qualitative thematic framework analysis. Discussion The process evaluation will provide guidance and conclusions on further development and transferability. Of particular interest is the expanded role of ENs in primary care, which has barely been implemented in Germany and can be seen as a precursor to the development of an Advanced Practice Nursing (APN) role in primary care

Translation and psychometric evaluation of the German version of the thirst distress scale for patients with heart failure

Background In patients with chronic heart failure, thirst can be perceived as an intensive and burdensome symptom, which may have a negative impact on patients quality of life. To initiate thirst-relieving interventions, assessment of thirst and its related distress is essential. At the time of this study, no instrument was available to evaluate thirst distress in patients with heart failure in Germany. Objective The aims of this study were to translate the "Thirst Distress Scale for patients with Heart Failure" (TDS-HF) from English into German and to test validity and reliability of the scale. Methods The English version of the TDS-HF was translated into German. A linguistically and culturally sensitive forward-and-backward translation was performed. Psychometric evaluation included confirmatory factor analysis, reliability in terms of internal consistency, and concurrent validity. Results Eighty-four hospitalized patients (mean age, 72 +/- 10 years; 29% female; mean left ventricular ejection fraction, 36% +/- 12%; 62% New York Heart Association functional classes III-IV, 45% on fluid restriction) from an acute care hospital were involved in the study. The item-total correlation ranged from 0.58 to 0.78. Interitem correlations varied between 0.37 and 0.79. Internal consistency was high, with a Cronbach alpha of 0.89. There was a high correlation between the total score of the TDS-HF and the visual analog scale to assess thirst intensity (r = 0.72, P &amp;lt;= .001), and a low correlation with fluid restriction (r = 0.35, P = .002). Conclusions The evaluation of the German TDS-HF showed satisfactory psychometric properties in this sample. The instrument is usable for further research and additional psychometric testing.</p

Rollenverständnis von Pflegeexpert_innen in der Primär- und Akutversorgung in Deutschland

Zusammenfassung. Hintergrund: Die Zunahme komplexer Versorgungssituationen aufgrund einer steigenden Anzahl älterer Menschen mit chronischen Erkrankungen bei gleichzeitigem Mangel an pflegerischem und medizinischem Fachpersonal erfordert innovative Versorgungskonzepte. Im Rahmen der Implementierung und Entwicklung neuer, innovativer pflegerischer Rollen gilt ein unklares Rollenverständnis als Barriere. Fragestellung/Ziel: Beschreibung des Rollenverständnisses von Pflegeexpert_innen (PE) in der Primär- und Akutversorgung in Deutschland. Methode: Mittels Fragebögen werden PE zur Rollenklarheit, -kompetenz und -ausübung sowie zur wahrgenommenen Handlungsautonomie und interprofessionellen Zusammenarbeit im Querschnitt befragt. Die Auswertung erfolgt deskriptiv. Ergebnisse: Es haben acht bzw. 14 PE (Primär- bzw. Akutversorgung) an der Befragung teilgenommen. PE üben mehrheitlich oft/sehr oft sowohl die klinische Rolle (77,5% bzw. 85,7%) als auch die von Expert_innen (75% bzw. 78,6%) aus. Die Mehrheit gibt an, ihre Rolle gegenüber Patient_innen (75% bzw. 92,9%) und Ärzt_innen (87,5% bzw. 90,9%) erklären zu können. Ein hohes Maß an Handlungsautonomie wird eher von PE aus der Akutversorgung wahrgenommen. Schlussfolgerungen: Trotz Gemeinsamkeiten hinsichtlich des Rollenverständnisses können PE der Akutversorgung offenbar von bereits etablierten Strukturen profitieren, was sich u.a. in der wahrgenommenen Handlungsautonomie widerspiegelt. </jats:p