Prioritization and Resource Allocation in the Context of the COVID-19 Pandemic: Recommendations for Colorectal and Pancreatic Cancer in Germany.

In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities. The final version of the guideline received consent from the executive boards of nine societies of the Association of Scientific Medical Societies in Germany (AWMF), 20 further professional organizations and 22 other experts from various disciplines as well as patient representatives. The guiding principle for the prioritization of decisions is the minimization of harm. Prioritization decisions to fulfill this overall goal should be guided by (1) the urgency relevant to avoid or reduce harm, (2) the likelihood of success of the diagnostic or therapeutic measure advised, and (3) the availability of alternative treatment options. In the event of a relevant risk of harm as a result of prioritization, these decisions should be made by means of a team approach. Gender, age, disability, ethnicity, origin, and other social characteristics, such as social or insurance status, as well as the vehemence of a patient's treatment request and SARS-CoV-2 vaccination status should not be used as prioritization criteria. The guideline provides concrete recommendations for (1) diagnostic procedures, (2) surgical procedures for cancer, and (3) systemic treatment and radiotherapy in patients with colorectal or pancreatic cancer within the context of the German healthcare system.

Cocreation of Assistive Technologies for Patients With Long COVID: Qualitative Analysis of a Literature Review on the Challenges of Patient Involvement in Health and Nursing Sciences.

BACKGROUND: Digital assistive technologies have the potential to address the pressing need for adequate therapy options for patients with long COVID (also known as post-COVID-19 condition) by enabling the implementation of individual and independent rehabilitation programs. However, the involvement of the target patient group is necessary to develop digital devices that are closely aligned to the needs of this particular patient group. OBJECTIVE: Participatory design approaches, such as cocreation, may be a solution for achieving usability and user acceptance. However, there are currently no set methods for implementing cocreative development processes incorporating patients. This study addresses the following research questions: what are the tasks and challenges associated with the involvement of patient groups? What lessons can be learned regarding the adequate involvement of patients with long COVID? METHODS: First, a literature review based on a 3-stage snowball process was conducted to identify the tasks and challenges emerging in the context of the cocreation of digital assistive devices and services with patient groups. Second, a qualitative analysis was conducted in an attempt to extract relevant findings and criteria from the identified studies. Third, using the method of theory adaptation, this paper presents recommendations for the further development of the existing concepts of cocreation in relation to patients with long COVID. RESULTS: The challenges of an active involvement of patients in cocreative development in health care include hierarchical barriers and differences in the levels of specific knowledge between professionals and patients. In the case of long COVID, patients themselves are still inexperienced in dealing with their symptoms and are hardly organized into established groups. This amplifies general hurdles and leads to questions of group identity, power structure, and knowledge creation, which are not sufficiently addressed by the current methods of cocreation. CONCLUSIONS: The adaptation of transdisciplinary methods to cocreative development approaches focusing on collaborative and inclusive communication can address the recurring challenges of actively integrating patients with long COVID into development processes.

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.

[Quality and ethics in healthcare]. / Qualität und Ethik in der Gesundheitsversorgung.

The term "quality" in healthcare is frequently used but defined in different ways. On the one hand, quality describes the nature or characteristic of things and is descriptive in this respect. In quality management and quality assurance, however, the focus is on the normative dimension of quality, referring to the evaluation of structures, processes, or results of actions in the context of healthcare. There are several links between ethical considerations in healthcare and quality of healthcare. First, the provision and assurance of high quality is an ethical imperative, mandated by the principles of beneficence and nonmaleficence. However, for high ethical quality of care, the ethical principles of respect for patient autonomy and justice must also be considered. Last but not least, the determination and justification of what "good" or "high" quality in healthcare means must be reflected from an ethical perspective. This article analyses these ethical dimensions of quality management and quality assurance. To achieve this goal, it first explains which ethical requirements have to be considered as quality criteria in patient care. Subsequently, ethically relevant challenges in determining quality in healthcare are identified based on criteria of outcome quality, and the teaching of professional competencies in medical education is discussed as a possible contribution to quality and quality assurance in healthcare. The paper concludes with considerations on determining and assuring quality under conditions of limited healthcare resources.

Decisions on the allocation of intensive care resources in the context of the COVID-19 pandemic : Clinical and ethical recommendations of DIVI, DGINA, DGAI, DGIIN, DGNI, DGP, DGP and AEM.

In view of the globally evolving coronavirus disease (COVID-19) pandemic, German hospitals rapidly expanded their intensive care capacities. However, it is possible that even with an optimal use of the increased resources, these will not suffice for all patients in need. Therefore, recommendations for the allocation of intensive care resources in the context of the COVID-19 pandemic have been developed by a multidisciplinary group of authors with the support of eight scientific medical societies. The recommendations for procedures and criteria for prioritisations in case of resource scarcity are based on scientific evidence, ethicolegal considerations and practical experience. Medical decisions must always be based on the need and the treatment preferences of the individual patient. In addition to this patient-centred approach, prioritisations in case of resource scarcity require a supraindividual perspective. In such situations, prioritisations should be based on the criterion of clinical prospect of success in order to minimize the number of preventable deaths due to resource scarcity and to avoid discrimination based on age, disabilities or social factors. The assessment of the clinical prospect of success should take into account the severity of the current illness, severe comorbidities and the patient's general health status prior to the current illness.

[Decisions on the allocation of intensive care resources in the context of the COVID-19 pandemic : Clinical and ethical recommendations of DIVI, DGINA, DGAI, DGIIN, DGNI, DGP, DGP and AEM. German version]. / Entscheidungen über die Zuteilung intensivmedizinischer Ressourcen im Kontext der COVID-19-Pandemie : Klinisch-ethische Empfehlungen der DIVI, der DGINA, der DGAI, der DGIIN, der DGNI, der DGP, der DGP und der AEM.

In view of the globally evolving Coronavirus Disease (COVID-19) pandemic, German hospitals rapidly expanded their intensive care capacities. However, it is possible that even with an optimal use of the increased resources, these will not suffice for all patients in need. Therefore, recommendations for the allocation of intensive care resources in the context of the COVID-19 pandemic have been developed by a multidisciplinary authors group with support of eight scientific medical societies. The recommendations for procedures and criteria for prioritisations in case of resource scarcity are based on scientific evidence, ethico-legal considerations and practical experience. Medical decisions must always be based on the need and the treatment preferences of the individual patient. In addition to this patient-centred approach, prioritisations in case of resource scarcity require a supra-individual perspective. In such situations, prioritisations should be based on the criterion of clinical prospect of success in order to minimize the number of preventable deaths due to resource scarcity and to avoid discrimination based on age, disabilities or social factors. Assessment of the clinical prospect of success should take into account the severity of the current illness, severe comorbidities and the patient's general health status prior to the current illness.

Value and Values in Cancer Care. Assessing the Benefit of Treatment in Patients with Advanced Cancer.

In recent years, the term "value-based healthcare" has been increasingly used in debates about costs and outcomes of health interventions in cancer care. This paper distinguishes 2 meanings of the term "value" and explores the relevance of both meanings of the word for assessing the "value" of cancer drugs. At the focus of the analysis are value judgments which form an integral part of the assessment of benefit of cancer drugs. The review concludes with a reflection on individual competences and systemic factors which are relevant to decision making about the value of treatment in situations of non-curative cancer.

Cost-effectiveness of methods in personalized medicine. Results of a decision-analytic model in patients with acute myeloid leukemia with normal karyotype.

BACKGROUND: During the last years, molecular genetic data are increasingly used as prognostic and predictive factors in acute myeloid leukemia (AML). The molecular genetic profile permits a rapid risk categorization and beyond that a prediction of differential treatment efficacy of post-remission chemotherapy versus an allogeneic hematopoietic cell transplantation (HCT) in specific subgroups. METHODS: The aim of this study was to evaluate cost-effectiveness of two different strategies of risk categorization (conventional cytogenetic diagnostics (CCD) versus molecular genetic diagnostics (MGD)) in patients with AML, using a decision-analytic state-transition model. The model is run as (Monte Carlo) microsimulation in which individuals pass through in cycles with a cycle length of one month and a time horizon of ten years. FINDINGS: Results show that on average, individuals within the MGD group generated about US$ 32,000 higher costs but survived about seven months longer than individuals within the CCD group. This leads to an Incremental Cost-Effectiveness Ratio (ICER) of about US$ 4928 per survived month. INTERPRETATION: With a GDP (Gross Domestic Product) of US$ 26,467 (€ 33,630) per capita in Germany in 2012, the base-case ICER of US$ 4928 per survived month projected to US$ 59,136 per survived year is in between the simple GDP and the three times GDP per capita.

The Role of Physicians in Rationing Cancer Care. Attitudes of German Oncologists.

BACKGROUND: Against the background of limited resources, the rise in the cost of therapy as well as in the number of cancer patients fuels the discussion about the necessity to ration, i.e., setting limits to beneficial treatment for cost reasons. Recently, we presented the self-reported prevalence of bedside rationing among German oncologists. Here, we describe oncologists' views on cost containment strategies and their role therein. METHODS: We performed an online survey including structured questions and free field sections with the members of the German Society of Hematology and Oncology. RESULTS: In the perception of oncologists, cost considerations and negotiations are gaining in importance and consume considerable working time. This negatively affects job satisfaction in 72% of the 345 respondents. Oncologists are concerned that the quality of care will suffer from rationalization and implicit rationing. They are ambivalent as to who is best suited to decide about resource rationing: 66% support the view that limits for costly procedures should be set by a form of commission; nevertheless, 48% consider physicians as the best decision makers in these situations. CONCLUSION: We suggest a broad public discussion and an interdisciplinary debate among the oncology community to define and legitimize decisions on rationing by setting explicit criteria.

Swiss University Students' Attitudes toward Pharmacological Cognitive Enhancement.

Pharmacological cognitive enhancement (PCE) refers to the nonmedical use of prescription or recreational drugs to enhance cognitive performance. Several concerns about PCE have been raised in the public. The aim of the present study was to investigate students' attitudes toward PCE. Students at three Swiss universities were invited by e-mail to participate in a web-based survey. Of the 29,282 students who were contacted, 3,056 participated. Of these students, 22% indicated that they had used prescription drugs (12%) or recreational substances including alcohol (14%) at least once for PCE. The use of prescription drugs or recreational substances including alcohol prior to the last exam was reported by 16%. Users of pharmacological cognitive enhancers were more likely to consider PCE fair (24%) compared with nonusers (11%). Only a minority of the participants agreed with the nonmedical use of prescription drugs by fellow students when assuming weak (7%) or hypothetically strong efficacy and availability to everyone (14%). Two-thirds (68%) considered performance that is obtained with PCE less worthy of recognition. Additionally, 80% disagreed that PCE is acceptable in a competitive environment. More than half (64%) agreed that PCE in academia is similar to doping in sports. Nearly half (48%) claimed that unregulated access to pharmacological cognitive enhancers increases the pressure to engage in PCE and educational inequality (55%). In conclusion, Swiss students' main concerns regarding PCE were related to coercion and fairness. As expected, these concerns were more prevalent among nonusers than among users of pharmacological cognitive enhancers. More balanced information on PCE should be shared with students, and future monitoring of PCE is recommended.

Medication and monitoring in palliative sedation therapy: a systematic review and quality assessment of published guidelines.

CONTEXT: Palliative sedation therapy (PST) is increasingly used in patients at the end of life. However, consensus about medications and monitoring is lacking. OBJECTIVES: To assess published PST guidelines with regard to quality and recommendations on drugs and monitoring. METHODS: We searched CINAHL, the Cochrane Library, Embase, PsycINFO, PubMed, and references of included articles until July 2014. Search terms included "palliative sedation" or "sedation" and "guideline" or "policy" or "framework." Guideline selection was based on English or German publications that included a PST guideline. Two investigators independently assessed the quality of the guidelines according to the Appraisal of Guidelines for Research and Evaluation II instrument (AGREE II) and extracted information on drug selection and monitoring. RESULTS: Nine guidelines were eligible. Eight guidelines received high quality scores for the domain "scope and purpose" (median 69%, range 28-83%), whereas in the other domains the guidelines' quality differed considerably. The majority of guidelines suggest midazolam as drug of first choice. Recommendations on dosage and alternatives vary. The guidelines' recommendations regarding monitoring of PST show wide variation in the number and details of outcome parameters and methods of assessment. CONCLUSION: The published guidelines on PST vary considerably regarding their quality and content on drugs and monitoring. Given the need for clear guidance regarding PST in patients at the end of life, this comparative analysis may serve as a starting point for further improvement.

Rationing cancer care: a survey among the members of the german society of hematology and oncology.

Rising costs of cancer care and the growing burden of cancer in a world of finite resources seem to make rationing in oncology inevitable. Information is currently lacking about oncologists' strategies in responding to resource constraints and the prevalence of withholding costly treatments. An online survey was offered via e-mail to physician members of the German Society of Hematology and Oncology. Those actively practicing were asked to complete an online questionnaire asking how limited resources were currently affecting their clinical practice. Two-thirds of 345 participating oncologists reported withholding costly treatments in at least some instances. Regarding their rationale, 70% stated that evidence for costly intervention was not convincing enough, and 59% said that they rationed approved treatments because of an unfavorable cost/benefit calculation. Only 29% reported being explicit about their rationing decision if the patient did not know or inquire about the respective intervention. Withholding expensive procedures from individual patients was widespread among the respondents. Oncologists withheld treatments not only if they perceived the scientific evidence to be questionable but also if they perceived reimbursement prospects or the cost/benefit ratio to be unfavorable, a behavior that could be called rationing. Currently this mostly refers to costly procedures with limited additional benefits. Although this result may be interpreted as indicating that oncologists assume responsibility for spending the resources in a justified way, more transparency and an open discussion on cost-effectiveness and the just allocation of costly treatments is needed.

[Benefit-risk evaluation of new drugs as a basis for decisions on prioritization in hematology/oncology: methodical challenges and problem-solving strategies]. / Nutzen-Risiko-Bewertung neuer Wirkstoffe als Grundlage für Priorisierungsentscheidungen in der Hämatologie/Onkologie: Methodische Herausforderungen und Lösungsansätze.

Innovations in the drug treatment of cancer patients pose several medical and ethical challenges. The increasing incidence and prevalence of cancer, in combination with the availability of new and usually highly expensive anticancer drugs, are associated with a significant increase in the general costs for the treatment of cancer patients. Therefore, the development of scientific strategies for judgments on benefits is indispensable. In this paper, the authors analyze the benefit assessment and the benefit-risk assessment as a foundation for decisions on prioritization in hematology and oncology. In a first step, regulatory aspects and shortcomings regarding the design of clinical trials in oncology before and after approval of anticancer drugs are identified as factors that contribute to difficulties in establishing the effectiveness of new drugs entering the health care market. The authors will conclude with suggestions for the improvement of benefit-risk analyses and the generation of scientific data necessary for such analyses.

[Economical aspects in clinical practice: results from an explorative interview study on the perspectives of oncologists in Germany and England]. / Ökonomische Aspekte in der klinischen Praxis aus der Perspektive onkologisch tätiger Ärzte in Deutschland und England: Ergebnisse einer explorativen Interviewstudie.

BACKGROUND: Costs for medical care and strategies to handle limited resources in health care are discussed in many European countries. Few empirical studies explore the oncologists' perceptions and views regarding economical aspects in clinical practice. RESEARCH PARTICIPANTS AND METHODS: Semi-structured interviews with physicians working in oncology in Germany and England. For this paper, parts of the transcripts in which interviewees discuss economical aspects of clinical practice were analysed exploratively and according to principles of content analysis. RESULTS: 17 (Germany) and 12 (England) research interviews were analysed. German physicians described different forms of implicit rationing. The effects of economic considerations are judged as predominantly negative. Physicians working in England named concrete situations in which interventions are not performed because of cost considerations. The rationing of medical care was viewed as necessary in light of limited resources. The assignment of allocation decisions on the macro-level was favoured because of the resulting relief for the physician-patient relationship. CONCLUSIONS: The narratives of interviewees in both countries differ regarding the perceptions and views on economical aspects in clinical practice. The specific approaches of each health care system towards the allocation of limited resources offer one basis for explanations of these differences.

[The "bad news consultation assessment scale" (Aufklärungsgesprächbewertungsskala, AGBS): a tool for assessing communication competencies when breaking bad news to cancer patients]. / Die Aufklärungsgesprächbewertungsskala (AGBS): Ein Instrument zur Bewertung kommunikativer Kompetenzen bei der Aufklärung von Patienten uber Tumorerkrankungen.

INTRODUCTION: In German-speaking countries "breaking bad news" courses are increasingly included in the medical undergraduate curriculum. In this paper we present an instrument (Aufklärungsgesprächbewertungsskala, AGBS) for the evaluation of communication competencies in the context of disclosing the diagnosis of cancer to patients as well as the results of the reliability analysis for this instrument. METHODS: Following a systematic literature review we selected the "breaking bad news assessment schedule" (BAS) as a model for developing the AGBS. The checklist was translated into German and modified. Following the use of the instrument in a teaching module for 4th year medical students Cronbach's alpha was calculated for the estimation of internal consistency, the intraclass coefficient (ICC) was used for the estimation of interrater reliability. RESULTS: 58 videotaped interactions between students and simulated patients were used for reliability analysis. The AGBS shows good values with respect to internal consistency (Cronbach's alpha 0.88) and overall interrater reliability (ICC 0.86). Further analysis indicates that the values for interrater reliability differ depending on the communication competencies evaluated when using the AGBS. CONCLUSION: The AGBS is a reliable instrument which may be used in medical undergraduate courses to evaluate student-simulated patient interaction during the disclosure of cancer diagnosis. The varying values for the interrater reliability in the different parts of the AGBS may serve as a basis for the further development of instruments for the evaluation of communication skills.