Consensus-based recommendations for the development and expansion of palliative day care clinics in Germany: results of a Delphi study.

BACKGROUND: Needs-based, patient-oriented palliative care includes palliative day care clinics as a specialized semi-inpatient care offer. However, the establishment and development of these facilities has been unsystematic. Research is needed to strengthen their transparency and ensure their accessibility, quality, and structural adequacy. A national Delphi study was conducted to generate appropriate recommendations for the establishment and development of palliative day care clinics in Germany. METHODS: Recommendations were formulated from focus group data on the development and expansion of palliative day care clinics in Germany. Experts on in- and outpatient palliative care rated 28 recommendations for relevance and feasibility, respectively, using a 4-point Likert-type scale. Suggestions for improvement were captured via free text comments. Items were considered consented when more than 80% of the experts scored them 4 (strongly agree) or 3 (somewhat agree), regarding both relevance and feasibility. RESULTS: A total of 23 experts (32% response rate) completed three Delphi rounds. Following the first round, 10 of 28 recommendations were revised according to participants' comments; 1 recommendation was rejected. After the second round, 3 of these 10 recommendations were revised, while 3 were rejected. Consensus was achieved after the third round for 22 of the initial recommendations. CONCLUSIONS: The Delphi-consented recommendations provide a basis for the targeted evidence- and needs-based development of palliative day care clinics. The findings show a need for standards setting and the meaningful integration of these clinics into existing structures. TRIAL REGISTRATION: The present study was prospectively registered on April 20, 2020, with the German Clinical Trials Register (DRKS00021446).

Willingness and preparedness to provide care: interviews with individuals of different ages and with different caregiving experiences.

BACKGROUND: At present, the provision of informal care to older relatives is an essential pillar of the long-term care system in Germany. However, the impact of demographic and social changes on informal caregiving remains unclear. METHODS: Thirty-three semi-structured interviews were conducted with care consultants, informal caregivers and people without any caregiving experience to explore if people are willing to provide older adult care and how prepared these are with regard to the possibility of becoming care dependent themselves. RESULTS: In total, three main categories (willingness to provide care, willingness to receive care and information as preparation) with several sub-categories were identified during the content analysis. While almost all interviewees were willing to provide care for close family members, most were hesitant to receive informal care. Other factors such as the available housing space, flexible working hours and the proximity of relatives were essential indicators of a person's preparedness to provide informal care. It is, however, unclear if care preferences change over time and generations. Six out of 12 informal caregivers and nine out of 14 care consultants also reported an information gap. Because they do not possess adequate information, informal caregivers do not seek help until it is too late and they experience high physical and mental strain. Despite the increased efforts of care consultants in recent years, trying to inform caregivers earlier was seen as almost impossible. CONCLUSIONS: The very negative perception of caregiving as a burden was a reoccurring theme throughout all interviews and influenced people's willingness to receive care as well as seeking timely information. Despite recent political efforts to strengthen home-based care in Germany, it remains unclear whether political efforts will be effective in changing individuals' perceptions of informal caregiving and their willingness to be better prepared for the highly likely scenario of having to care for a close relative or becoming care dependent at a later stage in life.

Exploring the status of and demand for palliative day-care clinics and day hospices in Germany: a protocol for a mixed-methods study.

BACKGROUND: To date, the establishment and development of palliative day-care clinics and day hospices in Germany have been completely unsystematic. Research is needed to gain insight into these services and to ensure their accessibility and quality. Accordingly, the ABPATITE research project aims at: (1) identifying the characteristics of palliative day-care clinics and day hospices in Germany, (2) determining demand and preferences for these services, and (3) proposing recommendations (with expert agreement) for the needs-based establishment and development of these services. METHODS: The research is a multi-perspective, prospective, observational study following a mixed-methods approach across three study phases. In phase 1a, qualitative expert interviews will be conducted to capture the facility-related characteristics of palliative day-care clinics and day hospices in Germany; the results will feed into a questionnaire sent to all such institutions identified nationwide. In phase 1b, a questionnaire will be sent to local statutory health insurance providers, to gain insight into their contracts and accounting and remuneration models. In phase 2a, a service preference survey will be conducted with patients and family caregivers. In phase 2b, semi-structured interviews with management staff will explore the factors that promote and hinder the provision of service. In phase 2c, the external perspective will be surveyed via focus groups with local actors involved in hospice and palliative care. In phase 3a, focus groups with representatives from relevant areas will be conducted to develop recommendations. Finally, in phase 3b, recommendations will be agreed upon through a Delphi survey. DISCUSSION: The empirically developed recommendations should enable the establishment and development of day hospices and palliative day-care clinics in Germany to be better managed, more oriented to actual demand, and more effectively integrated into wider health care services. Importantly, the findings are expected to optimize the overall development of hospice and palliative care services. TRIAL REGISTRATION: The study was prospectively registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien) (Registration N° DRKS00021446; date of registration: April 20, 2020). The study is searchable under the International Clinical Trials Registry Platform Search Portal of the World Health Organization, under the German Clinical Trials Register number.

Integrating patient perspectives in medical decision-making: a qualitative interview study examining potentials within the rare disease information exchange process in practice.

BACKGROUND: Many European countries have recently implemented national rare disease plans. Although the network is strengthening, especially on the macro and meso levels, patients still go a long way through healthcare systems, with many health professionals involved and scarce evidence to gather. Specifically, patient involvement in the form of shared decision-making can offer further potential to increase healthcare systems' efficiency on a micro level. Therefore, we examine the implementation of the shared decision-making concept thus far, and explore whether efficiency potentials exist-which are particularly relevant within the rare disease field-and how they can be triggered. METHODS: Our empirical evidence comes from 101 interviews conducted from March to September 2014 in Germany; 55 patients, 13 family members, and 33 health professionals participated in a qualitative interview study. Transcripts were analyzed using a directed qualitative content analysis. RESULTS: The interviews indicate that the decision-making process is increasingly relevant in practice. In comparison, however, the shared decision-making agreement itself was rarely reported. A majority of interactions are dominated by individual, informed decision-making, followed by paternalistic approaches. The patient-physician relationship was characterized by a distorted trust-building process, which is affected by not only dependencies due to the diseases' severity and chronic course, but an often-reported stigmatization of patients as stimulants. Moreover, participation was high due to a pronounced engagement of those affected, diminishing as patients' strength vanish during their odyssey through health care systems. The particular roles of "expert patients" or "lay experts" in the rare disease field were revealed, with further potential in integrating the gathered information. CONCLUSIONS: The study reveals the named efficiency potentials, which are unique for rare diseases and make the further integration of shared decision-making very attractive, facilitating diagnostics and disease management. It is noteworthy that integrating shared decision-making in the rare disease field does not only require strengthening the position of patients but also that of physicians. Efforts can be made to further integrate the concept within political frameworks to trigger the identified potential and assess the health-economic impact.

Treatment-related experiences and preferences of patients with lung cancer: a qualitative analysis.

BACKGROUND: Lung cancer is one of the most common types of cancer worldwide, and it causes significant challenges for patients due to the poor survival rate and treatment-related side-effects. Because of lung cancer's great burden, identification and use of the patients' preferences can help to improve patients' quality of life. OBJECTIVE: Interviews with patients who have lung cancer were used to ascertain a range of experiences and to make recommendations regarding the improvement of treatment based on these patients' preferences. Because chemotherapy is the common treatment option for lung cancer, we focused on this treatment. The interviews were audio-taped, verbally transcribed and evaluated via content analysis. SETTING AND PARTICIPANTS: A total of 18 participants (11 men and 7 women) with small or non-small-cell lung cancer who were receiving chemotherapy in one clinic were interviewed between June and July 2013. RESULTS: Two main aspects with different subthemes were identified during the interviews. One main aspect focused on organizational context, such as the treatment day process, or experiences with different stakeholders, such as with the health insurance company or physicians. The other category referred to experiences that influenced psychosocial factors, including physical and mental experiences. DISCUSSION AND CONCLUSION: Patients reported different experiences concerning physical, psychological and organizational areas during chemotherapy. Nevertheless, some potential areas for improving care, and therefore the quality of life of patients with lung cancer, could be identified. These improvement measures highlighted that with small, non-time-consuming and inexpensive changes, the treatment for patients with lung cancer can be improved.

Comparison of different approaches applied in Analytic Hierarchy Process - an example of information needs of patients with rare diseases.

BACKGROUND: The Analytic Hierarchy Process (AHP) is increasingly used to measure patient priorities. Studies have shown that there are several different approaches to data acquisition and data aggregation. The aim of this study was to measure the information needs of patients having a rare disease and to analyze the effects of these different AHP approaches. The ranking of information needs is then used to display information categories on a web-based information portal about rare diseases according to the patient's priorities. METHODS: The information needs of patients suffering from rare diseases were identified by an Internet research study and a preliminary qualitative study. Hence, we designed a three-level hierarchy containing 13 criteria. For data acquisition, the differences in outcomes were investigated using individual versus group judgements separately. Furthermore, we analyzed the different effects when using the median and arithmetic and geometric means for data aggregation. A consistency ratio ≤0.2 was determined to represent an acceptable consistency level. RESULTS: Forty individual and three group judgements were collected from patients suffering from a rare disease and their close relatives. The consistency ratio of 31 individual and three group judgements was acceptable and thus these judgements were included in the study. To a large extent, the local ranks for individual and group judgements were similar. Interestingly, group judgements were in a significantly smaller range than individual judgements. According to our data, the ranks of the criteria differed slightly according to the data aggregation method used. CONCLUSIONS: It is important to explain and justify the choice of an appropriate method for data acquisition because response behaviors differ according to the method. We conclude that researchers should select a suitable method based on the thematic perspective or investigated topics in the study. Because the arithmetic mean is very vulnerable to outliers, the geometric mean and the median seem to be acceptable alternatives for data aggregation. Overall, using the AHP to identify patient priorities and enhance the user-friendliness of information websites offers an important contribution to medical informatics.

Who prefers the 'cost-effectiveness ratio' prioritization approach in health-care decisions? Results of an empirical analysis.

BACKGROUND: The problem of resource scarcity has led to an on-going debate about priority setting in the health-care system. Prioritization via the economic-based cost-effectiveness ratio (CER), for example, is controversial and has many advocates as well as opponents. Hence, the aim of our research is to analyse the fairness consideration of the CER approach in comparison with other prioritization approaches and to investigate whether these preferences depend on the field of study. METHODS: We developed and tested a unique questionnaire. Between October 2011 and January 2012, freshmen and advanced university students of medicine, law, economics, philosophy and religion in Germany were asked to choose among four prioritization approaches (CER, minimum health, random selection and age) using a dichotomous choice technique. The data were analysed by descriptive and microeconometric regression techniques. RESULTS: Data on 913 students were included in the study. A majority of the students prioritized cost-effectiveness second after minimum health. Advanced economics students preferred the CER approach significantly more than did incoming economics students. The attitudes of the advanced philosophy/religion students towards the CER were significantly more negative compared with the respective freshmen. Further, gender had a strong, significant impact on attitudes: women chose the CER less often than men did (P < 0.01). CONCLUSION: The results of this study indicate that attitudes presented by opinion leaders in the investigated fields of study seem to be in line with the perceptions of the respective fields' advanced students. Because of these differences, the debate on how to deal with scarce resources may remain complicated.

Applying the Analytic Hierarchy Process in healthcare research: A systematic literature review and evaluation of reporting.

BACKGROUND: The Analytic Hierarchy Process (AHP), developed by Saaty in the late 1970s, is one of the methods for multi-criteria decision making. The AHP disaggregates a complex decision problem into different hierarchical levels. The weight for each criterion and alternative are judged in pairwise comparisons and priorities are calculated by the Eigenvector method. The slowly increasing application of the AHP was the motivation for this study to explore the current state of its methodology in the healthcare context. METHODS: A systematic literature review was conducted by searching the Pubmed and Web of Science databases for articles with the following keywords in their titles or abstracts: "Analytic Hierarchy Process," "Analytical Hierarchy Process," "multi-criteria decision analysis," "multiple criteria decision," "stated preference," and "pairwise comparison." In addition, we developed reporting criteria to indicate whether the authors reported important aspects and evaluated the resulting studies' reporting. RESULTS: The systematic review resulted in 121 articles. The number of studies applying AHP has increased since 2005. Most studies were from Asia (almost 30%), followed by the US (25.6%). On average, the studies used 19.64 criteria throughout their hierarchical levels. Furthermore, we restricted a detailed analysis to those articles published within the last 5 years (n = 69). The mean of participants in these studies were 109, whereas we identified major differences in how the surveys were conducted. The evaluation of reporting showed that the mean of reported elements was about 6.75 out of 10. Thus, 12 out of 69 studies reported less than half of the criteria. CONCLUSION: The AHP has been applied inconsistently in healthcare research. A minority of studies described all the relevant aspects. Thus, the statements in this review may be biased, as they are restricted to the information available in the papers. Hence, further research is required to discover who should be interviewed and how, how inconsistent answers should be dealt with, and how the outcome and stability of the results should be presented. In addition, we need new insights to determine which target group can best handle the challenges of the AHP.

Does the perception of fairness and standard of care in the health system depend on the field of study? Results of an empirical analysis.

BACKGROUND: The main challenge in the context of health care reforms and priority setting is the establishment and/or maintenance of fairness and standard of care. For the political process and interdisciplinary discussion, the subjective perception of the health care system might even be as important as potential objective criteria. Of special interest are the perceptions of academic disciplines, whose representatives act as decision makers in the health care sector. The aim of this study is to explore and compare the subjective perception of fairness and standard of care in the German health care system among students of medicine, law, economics, philosophy, and religion. METHODS: Between October 2011 and January 2012, we asked freshmen and advanced students of the fields mentioned above to participate in a paper and pencil survey. Prior to this, we formulated hypotheses. The data were analysed by micro econometric regression techniques. RESULTS: Data from 1,088 students were included in the study. Medical students, freshmen, and advanced students perceive the standard of care significantly as being better than non-medical students. Differences in the perception of fairness are not significant between the freshmen of the academic disciplines; however, they increase with the number of study terms. Besides the field of study, further variables such as gender and health status have a significant impact on perceptions. CONCLUSIONS: Our results show that there are differences in the perception of fairness and standard of care between academic disciplines, which might influence the interdisciplinary discussion on health care reforms and priority setting.

Patients' and Relatives' Preferences for Outpatient and Day Care Services Within End-of-Life Care in Germany - A Discrete Choice Experiment.

Purpose: In Germany, patients with incurable chronic diseases living at home increasingly have the option of using outpatient and day care hospice and specialized palliative care services. The present study examined and compared patients' and their relatives' preferences for end-of-life outpatient and day care services. Patients and Methods: The study used a questionnaire integrating a discrete choice experiment. For six scenarios, participants chose between two hypothetical end-of-life care offers, described by seven attributes. The model compared place of care, frequency and duration of care and support, specialized medical palliative care, accompanied activities, and relieving patient counselling. The model also included optional overnight care and willingness to pay. Patients and the relatives of patients suffering from incurable, chronic diseases who were not yet receiving palliative care were recruited via hospitals and self-help groups (06/2021-07/2022). Results: The results were based on data from 436 questionnaires (patients: n=263, relatives: n=173). All attributes had a statistically significant impact on choice decisions, with place of care showing the greatest importance. All respondents highly preferred care in the patient's home over out-of-home care. Patients stressed the importance of special medical (palliative) care and valued accompanied activities, often facilitated by hospice volunteers. Relatives, but not patients, considered the frequency and duration of care highly relevant. Conclusion: The results suggest a higher demand for care in the patient's home than for out-of-home care. Patients' and relatives' high preference for special medical care and the relief of family caregiver burden should be considered in the design of day care services.

[Empirically derived recommendations for the development and expansion of day hospices in Germany - Results of a Delphi expert panel]. / Empirisch abgeleitete Empfehlungen für den Auf- und Ausbau von Tageshospizen in Deutschland ­ Ergebnisse einer Delphi-Befragung mit Expert:innen.

INTRODUCTION: A needs-based and patient-oriented hospice and palliative care also includes day hospices as a specialised semi-inpatient care offer. The establishment and development of these facilities in Germany has been rather unsystematic. In order to ensure quality and adequacy of these structures, research is needed. METHODS: A Delphi consensus study was conducted online from November 2022 to February 2023 aiming at generating recommendations for the development and expansion of day hospices in Germany. For each recommendation, the participants indicated on a four-point verbal rating scale how much they agreed upon a) the relevance and b) the feasibility of the recommendation. Items were considered consented when 80% of the participants (strongly) agreed with the recommendation regarding both criteria. If no consensus was reached, the recommendations were revised according to the participants' free text comments and presented in the next Delphi round. Descriptive analyses were applied. RESULTS: A total of 64 experts participated in the first Delphi round and 44 in the second. In round 1, 34 recommendations and in round 2 six recommendations were consented. The final set contains a total of 40 recommendations: 18 on the tasks of day hospices, 13 on cooperation, 7 on funding, and 2 on public relations. DISCUSSION: Recommendations for the development and expansion of day hospices in Germany were developed. Due to their highly rated feasibility, the recommendations should be directly transferable into care practice. It remains to be seen to what extent they will be taken into account in the renegotiation of the framework agreement for day hospices. CONCLUSION: The Delphi-consented recommendations provide a basis to guide action in the currently very dynamic development of hospice work and palliative care in Germany.

The impact of different care dependencies on people's willingness to provide informal care: a discrete choice experiment in Germany.

BACKGROUND: Informal care provided by family members, friends, or neighbors is a major pillar in the German long-term care system. As the number of care-dependent older adults grow, ensuring their future care still relies on the willingness of family members, friends, or neighbors to assume the role of an informal caregiver. This study aimed to investigate the impact on people's willingness to provide informal care to a close relative with predominately cognitive compared to physical impairments. METHODS: An online survey was distributed to the general population in Germany, which resulted in 260 participants. A discrete choice experiment was created to elicit and quantify people's preferences. A conditional logit model was used to investigate preferences and marginal willingness-to-accept values were estimated for one hour of informal caregiving. RESULTS: Increased care time per day (hours) and expected duration of caregiving were negatively valued by the participants and reduced willingness to care. Descriptions of the two care dependencies had a significant impact on participants' decisions. Having to provide care to a close relative with cognitive impairments was slightly preferred over caring for a relative with physical impairments. CONCLUSIONS: Our study results show the impact of different factors on the willingness to provide informal care to a close relative. How far the preference weights as well as the high willingness-to-accept values for an hour of caregiving can be explained by the sociodemographic structure of our cohort needs to be investigated by further research. Participants slightly preferred caring for a close relative with cognitive impairments, which might be explained by fear or discomfort with providing personal care to a relative with physical impairments or feelings of sympathy and pity towards people with dementia. Future qualitative research designs can help understand these motivations.

Willingness to provide informal care to older adults in Germany: a discrete choice experiment.

As the German population is continually aging and the majority of older adults still wish to 'age in place', the need for informal care provided by family and friends will correspondingly continue to increase. In addition, while the need for formal (professional) care services is also likely to increase, the supply already does not meet the demand in Germany today. The aim of our study is the elicitation of people's willingness to provide informal care by means of a discrete choice experiment. The self-complete postal survey was disseminated to a random sample of the German general population in Lower Saxony. Data cleansing resulted in a final sample size of 280 participants. A conditional logit and a latent class model were estimated. All attributes were judged as highly relevant by the respondents. The results revealed that an increase in the care hours per day had the greatest negative impact overall on the willingness to provide informal care in our sample. The marginal willingness-to-accept for 1 h of informal care was €14.54 when having to provide informal care for 8 h in reference to 2 h per day. This value is considerably higher than the national minimum wage of €9.82. A three-class latent class model revealed preference heterogeneity. While a monetary compensation is often discussed to increase the willingness and availability of informal care in a country, our results show that this statement could not be generalized within our entire sample.

[Informal care and occupation: Factors influencing the willingness to provide care]. / Informelle Pflege und Berufstätigkeit: Einflussfaktoren auf die Bereitschaft.

INTRODUCTION: The proportion of people in need of care will continue to rise in Germany. In 2019, the majority of people in need of care was cared for at home. Reconciling caregiving and work poses a heavy burden for many caregivers. Therefore, a monetary compensation for care is being discussed politically in order to facilitate the reconciliation of work and care. The aim of this study was to investigate whether and under which circumstances a sample of the German population is willing to care for a close relative. A particular focus was placed on the willingness to reduce working hours, the importance of the expected period of caregiving, and monetary compensation. METHODS: A primary data collection was conducted in two modes using a questionnaire. A self-completion postal survey was sent out via the AOK Lower Saxony and complemented with an online survey. Data was analysed descriptively and using logistic regression. RESULTS: 543 participants were included. 90% of the sample surveyed was willing to provide care for a close relative, with the majority stating that their willingness depended on various factors: both the health status and the person of the family member needing care had the greatest influence. 34% of the employed respondents were not willing to reduce their working hours, mostly for financial reasons. DISCUSSION AND CONCLUSION: Many older adults want to stay in their homes for as long as possible. Thus, the willingness to provide and take over the role of informal caregiver is and will remain a central pillar of the German care system. Negotiating between informal caregiving and professional activities often creates a substantial burden. For people from lower income households monetary compensation might enhance their willingness to provide informal care. However, in order to increase the willingness to engage in informal care of people from different backgrounds and life stages, flexible approaches are needed that go beyond monetary compensation.

A systematic review to identify the use of stated preference research in the field of older adult care.

In the design of long-term care systems, preferences can serve as an essential indication to better tailor services to the needs, wishes and expectations of its consumers. The aim of this systematic review was to summarize and synthesize available evidence on long-term care preferences that have been elicited by quantitative stated-preference methods. The databases PubMed and Web of Science were searched for the period 2000 to 2020 with an extensive set of search terms. Two independent researchers judged the eligibility of studies. The final number of included studies was 66, conducted in 19 different countries. Studies were systematized according to their content focus as well as the survey method used. Irrespective of the heterogeneity of studies with respect to research focus, study population, sample size and study design, some consistent findings emerged. When presented with a set of long-term care options, the majority of study participants preferred to "age in place" and make use of informal or home-based care. With increasing severity of physical and cognitive impairments, preferences shifted toward the exclusive use of formal care. Next to the severity of care needs, the influence on preferences of a range of other independent variables such as income, family status and education were tested; however, none showed consistent effects across all studies. The inclusion of choice-based elicitation techniques provides an impression of how studies operationalized long-term care and measured preferences. Future research should investigate how preferences might change over time and generations as well as people's willingness and realistic capabilities of providing care.

Preferences of patients with asthma or COPD for treatments in pulmonary rehabilitation.

INTRODUCTION: Pulmonary rehabilitation (PR) aims to improve disease control in patients with chronic obstructive pulmonary disease (COPD) and asthma. However, the success of PR-programs depends on the patients' participation and willingness to cooperate. Taking the patients' preferences into consideration might improve both of these factors. Accordingly, our study aims to analyze patients' preferences regarding current rehabilitation approaches in order to deduce and discuss possibilities to further optimize pulmonary rehabilitation. METHODS AND ANALYSIS: At the end of a 3 weeks in-house PR, patients' preferences concerning the proposed therapies were assessed during two different time slots (summer 2015 and winter 2015/2016) in three clinics using a choice-based conjoint analysis (CA). Relevant therapy attributes and their levels were identified through literature search and expert interviews. Inclusion criteria were as follows: PR-inpatient with asthma and/or COPD, confirmed diagnosis, age over 18 years, capability to write and read German, written informed consent obtained. The CA analyses comprised a generalized linear mixed-effects model and a latent class mixed logit model. RESULTS: A total of 542 persons participated in the survey. The most important attribute was sport and exercise therapy. Rehabilitation preferences hardly differed between asthma and COPD patients. Health-related quality of life (HRQoL) as well as time since diagnosis were found to have a significant influence on patients' rehabilitation preferences. CONCLUSIONS: Patients in pulmonary rehabilitation have preferences regarding specific program components. To increase the adherence to, and thus, the effectiveness of rehabilitation programs, these results must be considered when developing or optimizing PR-programs.

Effectiveness of nonpharmacological secondary prevention of coronary heart disease.

AIM: To summarize the current evidence with regard to the effectiveness of nonpharmacological secondary prevention strategies of coronary heart disease (CHD) and to investigate the comparative effectiveness of interventions of different categories, specific intervention components and the effectiveness in patient subgroups. METHODS: A structured search of databases and manual search were conducted. Clinical trials and meta-analyses published between January 2003 and September 2008 were included if they targeted adults with CHD, had a follow-up of at least 12 months, and reported mortality, cardiac events or quality of life. Two researchers assessed eligibility and methodological quality, in which appropriate, pooled effect estimates were calculated and tested in sensitivity analyses. RESULTS: Of 4798 publications 43 met the inclusion criteria. Overall study quality was satisfactory, but only about half of the studies reported mortality. Follow-up duration varied between 12 and 120 months. Despite substantial heterogeneity, there was strong evidence of intervention effectiveness overall. The evidence for exercise and multimodal interventions was more conclusive for reducing mortality, whereas psychosocial interventions seemed to be more effective in improving the quality of life. Rigorous studies investigating dietary and smoking cessation interventions, specific intervention components and important patient subgroups, were scarce. CONCLUSION: Nonpharmacological secondary prevention is safe and effective, with exercise and multimodal interventions reducing mortality most substantially. There is a lack of studies concerning dietary and smoking cessation interventions. In addition, intervention effectiveness in patient subgroups and of intervention components could not be evaluated conclusively. Future research should investigate these issues in rigorous studies with appropriate follow-up duration to improve the current poor risk factor control of CHD patients.

["But you often come unstuck on particularities" - Care consultants on legislation amendments and the challenges of their job: A qualitative investigation]. / "Aber vielfach scheitert man dann an Besonderheiten" ­ Pflegeberater über Gesetzesänderungen und die Herausforderungen ihrer Arbeit: Eine qualitative Untersuchung.

INTRODUCTION: Since the implementation of long-term care insurance in 1995, various reforms have contributed to the development of the German nursing care system in order to meet the structural and financial needs of the growing number of people in need of care. The aim of this paper is to present an assessment of care consultants on past legislation, challenges encountered during their work and suggestions to improve the current care system. METHODS: 14 semi-structured, face-to-face interviews were conducted with care consultants. All interviews were transcribed verbatim and a qualitative content analysis was performed. RESULTS: Care consultants perceived tangible improvements with regard to the scope of benefits as a direct result of recent legislation changes. The use of these benefits, however, is limited due to an insufficient growth of care infrastructure. Particularly frequent legislation changes, unclear responsibilities and dissimilar regulations between federal states were seen as challenges. DISCUSSION AND CONCLUSION: Complex dependencies within the German nursing care system were identified and the necessity for a public discourse on themes such as self-responsibility, equity and a comprehensive (nationwide) care supply was underlined. A central information platform was proposed in order to concretely improve information about services available locally.

Patient-reported data informing early benefit assessment of rare diseases in Germany: A systematic review.

BACKGROUND: Since the implementation of the Regulation on Patient Integration (2003), the Act on the Reorganization of the Pharmaceutical Market (2011), and the Patient Rights Law (2013), the inclusion of patient perspectives has been further anchored in the German early benefit assessment process. During the assessment of rare disease interventions, patient perspectives are particularly important, as clinical studies are often designed acknowledging small samples and patients suffering from severe symptoms and the chronic course of the disease. Therefore, our research question is whether patient perspectives are considered as part of early benefit assessments for rare diseases. We also strive to examine how patient perspectives are methodologically elicited and presented. METHODS: Our empirical evidence comes from a systematic review of orphan drug value dossiers submitted to the German Federal Joint Committee as well as the corresponding evaluations conducted between January 1, 2011 and March 1, 2019 (n = 81). Data on patient perspective integration were extracted using the following patient-reported outcome subcategories: clinical patient-reported outcomes, health-related quality of life, patient preferences, and patient satisfaction. RESULTS: The analysis demonstrates the specific relevance of patient-reported outcomes raised as part of the medical data set and presented during the early benefit assessment process. They are predominantly presented in the form of health-related quality of life data (n = 75%) and clinical outcomes (n = 49%). Preferences (n = 2%) and satisfaction (n = 1%) are still rarely presented, although the heated methodological discussion in Germany would suggest otherwise. While various methodologies for the integration of clinical outcomes and quality of life data were found, presenting data on satisfaction and preferences still lacks methodological rigor. The German Federal Joint Committee has not yet integrated these data in their decision text. Clinical outcomes and quality of life have been included in 46% and 73% of the cases, respectively. CONCLUSIONS: The underlying analysis demonstrates that there is still a relative high potential for the regular and systematic inclusion of patient perspectives within the early benefit assessment process for rare diseases. In particular, patient preferences and patient satisfaction are still rarely included suggesting the need for a clear-cut methodological foundation and incentives.

Informal and formal care preferences and expected willingness of providing elderly care in Germany: protocol for a mixed-methods study.

INTRODUCTION: In Germany, the number of elderly people in need of care is expected to increase from 2.4 million in 2015 to 3.2 million in 2030. The subsequent rise in demand for long-term care facilities is unlikely to be met by the current care structures and available staff. Additionally, many Germans still prefer to be cared for at home for as long as possible. In light of recent changes, such as increasing employment rates of women and growing geographical distances of family members, informal caregiving becomes more challenging in the future. The aim of this study is to explore preferences for informal and formal care services in the German general population, as well as the expected willingness of providing elderly care. METHODS AND ANALYSIS: A mixed-methods approach will be used to explore care preferences and expected willingness of providing elderly care in the German general population. A systematic literature review will be performed to provide an overview of the current academic literature on the topic. Qualitative interviews will be conducted with informal caregivers, care consultants and people with no prior caregiving experiences. A labelled discrete choice experiment will be designed and conducted to quantitatively measure the preferences for informal and formal care in the German general population. People between 18 and 65 years of age will be recruited in cooperation with a (regional) statutory health insurance (AOK Lower Saxony). A mixed multinomial logit regression model and a latent class finite mixture model will be used to analyse the data and test for subgroup differences in care preferences. ETHICS AND DISSEMINATION: The study has been approved by the Committee for Clinical Ethics of the Medical School in Hannover. Data will be treated confidential to ensure the participants' anonymity. The results will be discussed and disseminated to relevant stakeholders in the field. TRIAL REGISTRATION NUMBER: DRKS00012266.