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).

[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.

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.

Therapy preferences of patients with lung and colon cancer: a discrete choice experiment.

OBJECTIVES: There is increasing interest in studies that examine patient preferences to measure health-related outcomes. Understanding patients' preferences can improve the treatment process and is particularly relevant for oncology. In this study, we aimed to identify the subgroup-specific treatment preferences of German patients with lung cancer (LC) or colorectal cancer (CRC). METHODS: Six discrete choice experiment (DCE) attributes were established on the basis of a systematic literature review and qualitative interviews. The DCE analyses comprised generalized linear mixed-effects model and latent class mixed logit model. RESULTS: The study cohort comprised 310 patients (194 with LC, 108 with CRC, 8 with both types of cancer) with a median age of 63 (SD =10.66) years. The generalized linear mixed-effects model showed a significant (P<0.05) degree of association for all of the tested attributes. "Strongly increased life expectancy" was the attribute given the greatest weight by all patient groups. Using latent class mixed logit model analysis, we identified three classes of patients. Patients who were better informed tended to prefer a more balanced relationship between length and health-related quality of life (HRQoL) than those who were less informed. Class 2 (LC patients with low HRQoL who had undergone surgery) gave a very strong weighting to increased length of life. We deduced from Class 3 patients that those with a relatively good life expectancy (CRC compared with LC) gave a greater weight to moderate effects on HRQoL than to a longer life. CONCLUSION: Overall survival was the most important attribute of therapy for patients with LC or CRC. Differences in treatment preferences between subgroups should be considered in regard to treatment and development of guidelines. Patients' preferences were not affected by sex or age, but were affected by the cancer type, HRQoL, surgery status, and the main source of information on the disease.

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.

Health-related quality of life questionnaires in lung cancer trials: a systematic literature review.

BACKGROUND: Lung cancer is one of the leading causes of cancer deaths. Treatment goals are the relief of symptoms and the increase of overall survival. With the rising number of treatment alternatives, the need for comparable assessments of health-related quality of life (HRQoL) parameters grows. The aim of this paper was to identify and describe measurement instruments applied in lung cancer patients under drug therapy. METHODS: We conducted a systematic literature review at the beginning of 2011 using the electronic database Pubmed. RESULTS: A total of 43 studies were included in the review. About 17 different measurement instruments were identified, including 5 generic, 5 cancer-specific, 4 lung cancer-specific and 3 symptom-specific questionnaires. In 29 studies at least 2 instruments were used. In most cases these were cancer and lung cancer-specific ones. The most frequently used instruments are the EORTC QLQ-C30 and its lung cancer modules LC13 or LC17. Only 5 studies combined (lung) cancer-specific questionnaires with generic instruments. CONCLUSIONS: The EORTC-C30 and EORTC-LC13 are the most frequently used health-related quality of life measurement instruments in pharmacological lung cancer trials.

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.

Evaluation of medical and health economic effectiveness of non-pharmacological secondary prevention of coronary heart disease.

BACKGROUND: Coronary heart disease (CHD) is a common and potentially fatal malady with a life time prevalence of over 20%. For Germany, the mortality attributable to chronic ischemic heart disease or acute myocardial infarction is estimated at 140,000 deaths per year. An association between prognosis of CHD and lifestyle risk factors has been consistently shown. To positively influence lifestyle risk factors in patients with CHD, non-pharmaceutical secondary prevention strategies are frequently recommended and implemented. OBJECTIVES: The aim of this HTA (HTA = Health Technology Assessment) is to summarise the current literature on strategies for non-pharmaceutical secondary prevention in patients with CHD and to evaluate their medical effectiveness/efficacy and cost-effectiveness as well as the ethical, social and legal implications. In addition, this report aims to compare the effectiveness and efficacy of different intervention components and to evaluate the generalisability with regard to the German context. METHODS: Relevant publications were identified by means of a structured search of databases accessed through the German Institute of Medical Documentation and Information (DIMDI). In addition, a manual search of identified reference lists was conducted. The present report includes German and English literature published between January 2003 and September 2008 targeting adults with CHD. The methodological quality of included studies was assessed according to pre-defined quality criteria, based on the criteria of evidence based medicine. RESULTS: Among 9,074 publications 43 medical publications met the inclusion criteria. Overall study quality is satisfactory, but only half the studies report overall mortality or cardiac mortality as an outcome, while the remaining studies report less reliable outcome parameters. The follow-up duration varies between twelve and 120 months. Although overall effectiveness of non-pharmaceutical secondary prevention programs shows considerable heterogeneity, there is evidence for the long-term effectiveness concerning mortality, recurrent cardiac events and quality of life. Interventions based on exercise and also multicomponent interventions report more conclusive evidence for reducing mortality, while interventions focusing on psychosocial risk factors seem to be more effective in improving quality of life. Only two studies from Germany fulfill the methodological criteria and are included in this report. Additionally, 25 economic publications met the inclusion criteria. Both, quantity and quality of publications dealing with combined interventions are higher compared with those investigating single component interventions. However, there are difficulties in transferring the international results into the German health care system, because of its specific structure of the rehabilitation system. While international literature mostly shows a positive cost-effectiveness ratio of combined programs, almost without exception, studies investigate out-of hospital or home-based programs. The examination of publications evaluating the cost-effectiveness of single interventions merely shows a positive trend of exercise-based and smoking cessation programs. Due to a lack of appropriate studies, no conclusive evidence regarding psychosocial and dietary interventions is available. Altogether eleven publications concerned with ethical or social issues of non-pharmacological secondary prevention strategies are included. These studies are relatively confirm the assumption that patients with a lower socioeconomic background reflect a population at increased risk and therefore have specific needs to participate in rehabilitation programs. However, there currently remains uncertainty, whether these patients participate in rehabilitation more or less often. As barriers, which deter patients from attending, aspects like a lack of motivation, family commitments or the distance between home and rehabilitation centres are identified. Psychological factors like anxiety, depression and uncertainty as well as physical constraints are also pointed out. DISCUSSION: Non-pharmacological secondary preventive strategies are safe and effective in improving mortality, morbidity and quality of life in patients with CHD. Because of the small number of reliable studies with long term follow up over 60 months, sustainability of observed intervention effects has to be regarded with caution. Due to a lack of suitable studies, it was not possible to determine the effectiveness of interventions in important patient subgroups as well as the comparative effectiveness of different intervention strategies, conclusively. Future research should, amongst others, attempt to investigate these questions in methodologically rigorous studies. With regard to the cost-effectiveness of non-pharmacological interventions, overall, international studies show positive results. However, there are considerable limitations due to the qualitative and quantitative deficiencies of identified studies. The special characteristics of the German rehabilitation system with its primarily inpatient offers result in further difficulties, when trying to transfer international study results to the German health care system. Both, studies demonstrating the cost-effectiveness of inpatient programs and those investigating the cost-effectiveness of single interventions are currently not available. To examine the German rehabilitation programs concerning their efficiency and their potential for optimisation, there is a need for further research. Concerning social and ethical issues, a lack of studies addressing the structure of rehabilitation participants in Germany is striking. The same applies to studies examining the reasons for none participation in non-pharmacological secondary prevention programs. Evidence regarding these questions would provide an informative basis for optimising rehabilitation programs in Germany. CONCLUSION: Non-pharmacological secondary prevention interventions are safe and able to reduce mortality from CHD and cardiac events, as well as to imporve patient's quality of life. Nevertheless, there is considerable need for research; especially the effectiveness of interventions for important subgroups of CHD patients has to be evaluated. In addition to intervention effectiveness, there is also some evidence that interventions generate an appropriate cost-effectiveness ratio. However, future research should investigate this further. The same applies to the sustainability of secondary prevention programs and patient's reasons for not attending them.