Future policy and research for advance care planning in dementia: consensus recommendations from an international Delphi panel of the European Association for Palliative Care.

Advance care planning (ACP) is increasingly recognised in the global agenda for dementia care. The European Association for Palliative Care (EAPC) Taskforce on ACP in Dementia aimed to provide recommendations for policy initiatives and future research. We conducted a four-round Delphi study with a 33-country panel of 107 experts between September, 2021, and June, 2022, that was approved by the EAPC Board. Consensus was achieved on 11 recommendations concerning the regulation of advance directives, equity of access, and dementia-inclusive approaches and conversations to express patients' values. Identified research gaps included the need for an evidence-based dementia-specific practice model that optimises engagement and communication with people with fluctuating and impaired capacity and their families to support decision making, while also empowering people to adjust their decisions if their goals or preferences change over time. Policy gaps included insufficient health services frameworks for dementia-inclusive practice. The results highlight the need for more evidence and policy development that support inclusive ACP practice models.

[Primary Care Inequalities to the Disadvantage of the Population of Socially Deprived Urban Areas: A Case Study of Essen, Germany]. / Primärärztliche Versorgungsungleichheiten zu Ungunsten der Bevölkerung sozial benachteiligter Stadtgebiete ­ eine Fallanalyse am Beispiel der Stadt Essen.

Background As a large city in the middle of a metropolitan area, the city of Essen is characterized by strong social segregation and a north-south divide in the social status of its population. The conventional demand planning does not take such strong disparities within a planning unit into account. The present study aims to analyze the distribution of primary care structures using the example of two large urban areas within the city of Essen and to identify perspectives for strengthening primary care in disadvantaged urban areas. Methods First, a secondary data analysis was carried out at the district level and the study area Essen North (258,790 residents), consisting of 19 districts, was defined on the basis of two inclusion criteria - 1. location of the district north of the A40 freeway and 2. a mean subsistence rate>17.20 percent (average value of the city of Essen). Subsequently the study area was compared with the rest of the city (332,242 residents) with regard to the indicators a) social status, and b) available general practioners and pediatricians. The data of the selected indicators is based on the social reporting of the city of Essen and the "Online Practice Search" (Online-Praxissuche) of the Association of Statutory Health Insurance Physicians North Rhine. The resulting database (last update: 10/20212) was then evaluated at the district level and the primary care situation of the two urban areas was compared. Results The results revealed a significantly lower primary care coverage in the socially disadvantaged study area Essen North by about 25 percent for general practioners and by almost half for pediatricians. Thus, higher social disadvantage was associated with poorer access to primary care close to home, especially for children and adolescents. Conclusion The distribution of primary care providers in the city of Essen increases the risk of contributing to the manifestation of geographic disparities and health inequalities. The existing planning system in particular is not suitable for addressing the threatening or already existing undersupply of primary health care to the population in disadvantaged urban districts.

Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences: study protocol for a multi-center, cluster-randomized controlled trial focusing on nursing home residents (BEVOR trial).

BACKGROUND: According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents. METHODS: This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications. DISCUSSION: This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.

Financial Toxicity of Cancer Drugs: Possible Remedies from an Ethical Perspective.

Spiraling costs of cancer treatments have become a major concern for the payers in the health care system and for individual patients suffering from the cancer drugs' financial toxicity. This article discusses possible solutions from an ethical perspective. First, it gives some orientation about what constitutes a fair price for innovative anticancer agents. While a definitive answer remains difficult, there are good reasons to enter into price negotiations with the pharmaceutical companies to align the price with the R&D costs and the added value of the product. Information about the drug's cost-effectiveness should be available, a fixed threshold, however, seems ethically problematic. Rather, a 'signal cost-effectiveness threshold' should indicate when the drug price requires special justification. Further strategies include an improved benefit assessment after market authorization by independent publicly financed studies, which will provide a valid basis for price negotiations and clinical decision-making at the micro level. Last but not least, cancer treatments should be tailored not only to the biology of the tumor but also to the preferences of the patient. Primarily mandated by the respect for autonomy, promoting patient-centered care has the potential to improve quality of care and enable a wise use of scarce health care resources.

Does facilitated Advance Care Planning reduce the costs of care near the end of life? Systematic review and ethical considerations.

BACKGROUND: While there is increasing evidence that Advance Care Planning has the potential to strengthen patient autonomy and improve quality of care near the end of life, it remains unclear whether it could also reduce net costs of care. AIM: This study aims to describe the cost implications of Advance Care Planning programmes and discusses ethical conflicts arising in this context. DESIGN: We conducted a systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. DATA SOURCES: We systematically searched the databases PubMed, NHS EED, EURONHEED, Cochrane Library and EconLit. We included empirical studies (no limitation to study type) that investigated the cost implications of Advance Care Planning programmes involving professionally facilitated end-of-life discussions. RESULTS AND DISCUSSION: Seven studies met our inclusion criteria. Four of them used a randomised controlled design, one used a before-after design and two were observational studies. Six studies found reductions in costs of care ranging from USD1041 to USD64,827 per patient, depending on the study period and the cost measurement. One study detected no differences in costs. Studies varied considerably regarding the Advance Care Planning intervention, patient selection and costs measured which may explain some of the variations in findings. NORMATIVE APPRAISAL: Looking at the impact of Advance Care Planning on costs raises delicate ethical issues. Given the increasing pressure to reduce expenditures, there may be concerns that cost considerations could unduly influence the sensitive communication process, thus jeopardising patient autonomy. Safeguards are proposed to reduce these risks. CONCLUSION: The limited data indicate net cost savings may be realised with Advance Care Planning. Methodologically robust trials with clearly defined Advance Care Planning interventions are needed to make the costs and returns of Advance Care Planning transparent.

From hypertension control to global cardiovascular risk management: an educational intervention in a cluster-randomised controlled trial.

BACKGROUND: Guidelines on hypertension management recommend adjusting therapeutic efforts in accordance with global cardiovascular risk (CVR) rather than by blood pressure levels alone. However, this paradigm change has not yet arrived in German General Practice. We have evaluated the effect of an educational outreach visit with general practitioners (GPs), encouraging them to consider CVR in treatment decisions for patients with hypertension. METHODS: Prospective cluster-randomised trial comprising 3443 patients with known hypertension treated by 87 GPs. Practices were randomly assigned to complex (A) or simple (B) intervention. Both groups received a guideline by mail; group A also received complex peer intervention promoting the concept of global CVR. Clinical data were collected at baseline and 6-9 months after intervention. Main outcome was improvement of calculated CVR in the predefined subpopulation of patients with a high CVR (10-year mortality ≥5%), but no manifest cardiovascular disease. RESULTS: Adjusted for baseline the follow-up CVR were 13.1% (95% CI 12.6%-13.6%) (A) and 12.6% (95% CI 12.2%-13.1%) (B) with a group difference (A vs. B) of 0.5% (-0.2%-1.1%), p = 0.179. The group difference was -0.05% in patients of GPs familiar with global CVR and 1.1% in patients of GPs not familiar with with global CVR. However, this effect modification was not significant (p = 0.165). Pooled over groups, the absolute CVR reduction from baseline was 1.0%, p < 0.001. The ICC was 0.026 (p = 0.002). Hypertension control (BP <140/90 mmHg) improved in the same subpopulation from 38.1 to 45.9% in the complex intervention group, and from 35.6 to 46.5% in the simple intervention group, with adjusted follow-up control rates of 46.7% (95% CI 40.4%-53.1%) (A) and 46.9% (95% CI 40.3%-53.5% (B) and an adjusted odds ratio (A vs B) of 0.99 (95% CI 0.68-1.45), p = 0.966. CONCLUSIONS: Our complex educational intervention, including a clinical outreach visit, had no significant effect on CVR of patients with known hypertension at high risk compared to a simple postal intervention. TRIAL REGISTRATION: ISRCTN44478543 .

Willingness to participate in mammography screening: a randomized controlled questionnaire study of responses to two patient information leaflets with different factual content.

BACKGROUND: From 2010 onward, a new leaflet about mammography screening for breast cancer, more informative than the preceding version, has been sent to women in Germany aged 50 to 69 with the invitation to undergo screening. The purpose of this study was to determine the effect of different informational content on the decision whether or not to be screened. METHODS: In a randomized and blinded design, 792 women aged 48 to 49 were sent either the old or the new leaflet. Questionnaires were sent together with the leaflets in order to assess the following: willingness to undergo mammography screening, knowledge, decisional confidence, personal experiences of breast cancer, and demographic data. RESULTS: 370 (46.7%) of the questionnaires were returned, and 353 were evaluable. The two groups did not differ significantly in their willingness to be screened: 81.5% (95% confidence interval [CI] 75.8%-87.2%) versus 88.6% (95% CI 83.9%-91.3%, p = 0.060). A post-hoc analysis showed that women who reported having had personal experience of breast cancer (18.7%) were more willing to be screened if they were given the new leaflet, rather than the old one (interaction p = 0.014). The two groups did not differ in their knowledge about screening (p = 0.260). Women who received the old leaflet reported a higher decisional confidence (p = 0.017). The most commonly mentioned factors affecting the decision were experience of breast cancer in relatives and close acquaintances (26.5% of mentions) and a doctor's recommendation (48.2%). Leaflets (3.6%) and all other factors played only a secondary role. CONCLUSION: The greater or lesser informativeness of the leaflet affected neither the participants' knowledge of mammography screening nor their willingness to undergo it. The leaflet was not seen as an aid to decision-making. The best way to assure an informed decision about screening may be for the patient to discuss the matter personally with a qualified professional.