Physicians' attitudes towards secondary use of clinical data for biomedical research purposes in Germany. Results of a quantitative survey.

BACKGROUND: For biomedical data-driven research purposes, secondary use of clinical data carries great but largely untapped potential. Physicians' attitudes and their needs towards secondary data use are essential to inform its practical and ethically sound implementation but are currently understudied. OBJECTIVE: Therefore, the objectives of the study are to assess physicians' (i) general attitudes and concerns, (ii) willingness to adapt workflows and to make data available for secondary use, (iii) group-specific conditions toward implementation of secondary use and associated concerns of physician-scientists and purely clinical physicians. METHODS: We developed an online survey based on a literature review and an expert interview study. Physicians in private practice and at two large German university hospitals were surveyed from May 2021 until January 2022. RESULTS: In total, 446 physicians participated in the survey. 96% [380/397] of all physicians reported a positive attitude towards secondary use; 87% [31/397] are in-principle willing to support secondary use of clinical data along with a small proportion of physicians with fundamental reservations. Secondly, the most important conditions for adapting workflows were funding of additional time and effort for research-adequate documentation (71% [286/390]) and the most important condition for providing patients' clinical data was reliable protection of patients' privacy (67% [254/382]). Thirdly, physician-scientists were more likely than purely clinical physicians to request additional funding for research-adequate documentation as a precondition for support (83% vs 69%, P = .002) and the privilege to conduct research with their own patients' clinical data before other researchers are allowed to (43% vs 11%, P < .001); while purely clinical physicians more frequently require reliable protection of patient privacy (76% vs 62%, P = .007) and monetary compensation (45% vs 25%, P < .001). CONCLUSION: Since this study presents high in-principle willingness of physicians to support secondary use along with little general concerns, it seems essential to address physicians' group-specific conditions toward secondary use in order to gain their support.

Patients' Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer.

BACKGROUND: Secondary use of clinical data for biomedical research purposes holds great potential for various types of noninterventional, data-driven studies. Patients' willingness to support research with their clinical data is a crucial prerequisite for research progress. OBJECTIVE: The aim of the study was to learn about patients' attitudes and expectations regarding secondary use of their clinical data. In a next step, our results can inform the development of an appropriate governance framework for secondary use of clinical data for research purposes. METHODS: A questionnaire was developed to assess the willingness of patients with cancer to provide their clinical data for biomedical research purposes, considering different conditions of data sharing and consent models. The Cancer Registry of the German federal state of Baden-Württemberg recruited a proportionally stratified random sample of patients with cancer and survivors of cancer based on a full census. RESULTS: In total, 838 participants completed the survey. Approximately all participants (810/838, 96.7%) showed general willingness to make clinical data available for biomedical research purposes; however, they expected certain requirements to be met, such as comparable data protection standards for data use abroad and the possibility to renew consent at regular time intervals. Most participants (620/838, 73.9%) supported data use also by researchers in commercial companies. More than half of the participants (503/838, 60%) were willing to give up control over clinical data in favor of research benefits. Most participants expressed acceptance of the broad consent model (494/838, 58.9%), followed by data use by default (with the option to opt out at any time; 419/838, 50%); specific consent for every study showed the lowest acceptance rate (327/838, 39%). Patients expected physicians to share their data (763/838, 91.1%) and their fellow patients to support secondary use with their clinical data (679/838, 81%). CONCLUSIONS: Although patients' general willingness to make their clinical data available for biomedical research purposes is very high, the willingness of a substantial proportion of patients depends on additional requirements. Taking these perspectives into account is essential for designing trustworthy governance of clinical data reuse and sharing. The willingness to accept the loss of control over clinical data to enhance the benefits of research should be given special consideration.

Patient-Reported Financial Distress in Cancer: A Systematic Review of Risk Factors in Universal Healthcare Systems.

Financial toxicity is a side effect of cancer that results from the perceived financial distress an individual may experience in the course of the disease. The purpose of this paper is to analyse underlying factors related to subjective financial distress in high-income countries with universal healthcare coverage. A systematic literature review was conducted to identify qualitative and quantitative studies of cancer patient-reported subjective financial distress by performing a search in the databases of PubMed, PsycINFO and CINAHL up to December 2020. A qualitative synthesis was performed linking the time-dependent occurrence of risk factors to derived categories of risk factors. Out of 4321 identified records, 30 quantitative and 16 qualitative studies were eligible. Classification of risk factors resulted in eight categories with a total of 34 subcategories. Subjective financial distress is primarily determined by pre-diagnosis sociodemographic- factors as well as financial and work factors that might change during the course of the disease. The design of healthcare and social security systems shapes the country-specific degree of subjective financial distress. Further research should focus on evolving multidisciplinary intervention schemes and multidimensional instruments for subjective financial distress to account for identified risk factors in universal healthcare systems more precisely.

Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment.

BACKGROUND: The secondary use of clinical data in data-gathering, non-interventional research or learning activities (SeConts) has great potential for scientific progress and health care improvement. At the same time, it poses relevant risks for the privacy and informational self-determination of patients whose data are used. OBJECTIVE: Since the current literature lacks a tailored framework for risk assessment in SeConts as well as a clarification of the concept and practical scope of SeConts, we aim to fill this gap. METHODS: In this study, we analyze each element of the concept of SeConts to provide a synthetic definition, investigate the practical relevance and scope of SeConts through a literature review, and operationalize the widespread definition of risk (as a harmful event of a certain magnitude that occurs with a certain probability) to conduct a tailored analysis of privacy risk factors typically implied in SeConts. RESULTS: We offer a conceptual clarification and definition of SeConts and provide a list of types of research and learning activities that can be subsumed under the definition of SeConts. We also offer a proposal for the classification of SeConts types into the categories non-interventional (observational) clinical research, quality control and improvement, or public health research. In addition, we provide a list of risk factors that determine the probability or magnitude of harm implied in SeConts. The risk factors provide a framework for assessing the privacy-related risks for patients implied in SeConts. We illustrate the use of risk assessment by applying it to a concrete example. CONCLUSIONS: In the future, research ethics committees and data use and access committees will be able to rely on and apply the framework offered here when reviewing projects of secondary use of clinical data for learning and research purposes.

[Individual financial burden following a cancer diagnosis from the perspective of social services in Germany]. / Individuelle finanzielle Belastungen infolge einer Krebserkrankung aus der Perspektive von Sozialdiensten in Deutschland.

BACKGROUND: In addition to physical, psychological and social effects, economic effects and the associated financial burden of a cancer diagnosis may also gain in importance during prolonged disease progression. Counselling by social services is an important factor in coping with this burden. METHODS: People employed in social work in oncology were invited to participate in a survey. The survey comprises 16 items on the perception of financial burdens, changes in the relevance of the topic, risk factors and current counselling practice. RESULTS: 81% of the respondents reported that the financial burden arising from a cancer diagnosis is a relevant topic of consultation for at least half of the patients. For 55%, this topic has become more important in recent years, which is due to higher survival rates, an increased number of younger patients, and poorer social security and working conditions. DISCUSSION AND CONCLUSION: Despite comprehensive insurance coverage, the financial burden of cancer patients has also gained in importance in Germany and must be increasingly taken into account in everyday social service counselling. Due to numerous risk factors and complex reasons, further measures are required to enable the early identification of risk constellations and to improve the situation of those affected.

The COVID-19 Pandemic and Cancer Patients in Germany: Impact on Treatment, Follow-Up Care and Psychological Burden.

In response to the ongoing coronavirus disease 2019 (COVID-19) pandemic, governments imposed various measures to decrease the rate of disease spread, and health care policy makers prioritized resource allocation to accommodate COVID-19 patients. We conducted a cross-sectional online survey in Germany (July 2020-June 2021) to assess the frequency of changes to cancer care among cancer patients and to explore the psychological impact of the pandemic writ large. Cancer patients who contacted the Cancer Information Service (Krebsinformationsdienst, KID) of the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) via email were invited to complete an online questionnaire, capturing demographics, cancer specifics (e.g., type, disease phase, primary place of treatment, etc.), and any changes to their medical, follow-up, psycho-oncological or nursing care. General level of psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS) along with face-validated items regarding worries and social isolation specific to the pandemic. In total, 13% of 621 patients reported a change to their treatment or care plan. Of those patients with changes, the majority of changes were made to follow-up care after treatment (56%), to monitoring during treatment (29%) and to psychological counseling (20%). Of the overall sample, more than half of patients (55%) reported symptoms of anxiety and 39% reported symptoms of depression. Patients with a change in cancer care were more likely to report symptoms of depression than those with no change (AOR: 2.18; 95% CI: 1.26-3.76). Concern about the pandemic affecting the quality of health care was a predictor of both anxiety (AOR: 2.76; 95% CI: 1.75-4.35) and depression (AOR: 2.15; 95% CI: 1.43-3.23). Results showed that the majority of cancer patients in our study did not experience a change in their cancer care. However, the level of anxiety and psycho-social burden of cancer patients during the pandemic was high throughout the study period. Our findings underscore the need for health care services and policy makers to assess and to attend cancer patients' medical needs, with added emphasis on patients' psychological and social well-being. This applies particularly in situations where the healthcare system is strained and prioritization is necessary.

Late decisions about treatment limitation in patients with cancer: empirical analysis of end-of-life practices in a haematology and oncology unit at a German university hospital.

BACKGROUND: Decisions to limit treatment (DLTs) are important to protect patients from overtreatment but constitute one of the most ethically challenging situations in oncology practice. In the Ethics Policy for Advance Care Planning and Limiting Treatment study (EPAL), we examined how often DLT preceded a patient's death and how early they were determined before (T1) and after (T2) the implementation of an intrainstitutional ethics policy on DLT. METHODS: This prospective quantitative study recruited 1.134 patients with haematological/oncological neoplasia in a period of 2×6 months at the University Hospital of Munich, Germany. Information on admissions, discharges, diagnosis, age, DLT, date and place of death, and time span between the initial determination of a DLT and the death of a patient was recorded using a standardised form. RESULTS: Overall, for 21% (n=236) of the 1.134 patients, a DLT was made. After implementation of the policy, the proportion decreased (26% T1/16% T2). However, the decisions were more comprehensive, including more often the combination of 'Do not resuscitate' and 'no intense care unit' (44% T1/64% T2). The median time between the determination of a DLT and the patient's death was similarly short with 6 days at a regular ward (each T1/T2) and 10.5/9 (T1/T2) days at a palliative care unit. For patients with solid tumours, the DLTs were made earlier at both regular and palliative care units than for the deceased with haematological neoplasia. CONCLUSION: Our results show that an ethics policy on DLT could sensitise for treatment limitations in terms of frequency and extension but had no significant impact on timing of DLT. Since patients with haematological malignancies tend to undergo intensive therapy more often during their last days than patients with solid tumours, special attention needs to be paid to this group. To support timely discussions, we recommend the concept of advance care planning.

The patient-level effect of the cost of Cancer care - financial burden in German Cancer patients.

BACKGROUND: Financial toxicity of cancer has so far been discussed primarily in the US health care system and is associated with higher morbidity and mortality. In European health care systems, the socio-economic impact of cancer is poorly understood. This study investigates the financial burden and patient-reported outcomes of neuroendocrine (NET) or colorectal (CRC) cancer patients at a German Comprehensive Cancer Center. METHODS: This prospective cross-sectional study surveyed 247 advanced stage patients (n = 122 NET/n = 125 CRC) at the National Center for Tumor Diseases, in Germany about cancer-related out-of-pocket costs, income loss, distress, and quality of life. Multiple linear regression analysis was performed to demonstrate the effects of economic deterioration on patients' quality of life and distress. RESULTS: 81% (n = 199) of the patients reported out-of-pocket costs, and 37% (n = 92) income loss as a consequence of their disease. While monthly out-of-pocket costs did not exceed 200€ in 77% of affected patients, 24% of those with income losses reported losing more than 1.200€ per month. High financial loss relative to income was significantly associated with patients' reporting a worse quality of life (p < .05) and more distress (p < .05). CONCLUSIONS: Financial toxicity in third-party payer health care systems like Germany is caused rather by income loss than by co-payments. Distress and reduced quality of life due to financial problems seem to amplify the burden that already results from a cancer diagnosis and treatment. If confirmed at a broader scale, there is a need for targeted support measures at the individual and system level.

High prevalence of moral distress reported by oncologists and oncology nurses in end-of-life decision making.

OBJECTIVE: Decisions to limit life-prolonging treatment (DLT) are often accompanied by psychological and ethical difficulties. The aim of the study is to investigate prevalence and intensity of moral distress (MD) as well as potential causes experienced by oncology physicians and nurses in DLT situations. METHODS: This prospective study at a German university hospital included n = 100 advanced cancer inpatients with DLT. We surveyed their respective physicians and nurses to assess MD in DLT using an adapted distress thermometer and an open-ended question to specify reasons of MD. We also collected data on the decision-making process from the perspective of the clinicians. RESULTS: Physicians report MD in 67% (n = 51) and nurses in 74% (n = 67) of the cases. The MD level in nurses (mean 2.3; SD 2.3) is significantly higher (P = .005) than in physicians (mean 1.5; SD 1.4). Uncertainties concerning ethical aspects in DLT in a patient case are associated with MD in both physicians (P = .024) and nurses (P = .004). Involvement of nurses in DLT is the strongest predictor (P = .000) for MD as indicated by physicians. Nurses experience MD especially, if the patient has a low quality of life (P = .001). CONCLUSIONS: Moral distress is experienced by both oncologists and nurses in DLT. Nurses report higher MD intensity compared with physicians although the ultimate responsibility for DLT lies with the physicians. Support for the challenging decisions may be provided through the implementation of an ethical guideline and enhanced interprofessional communication.

Trust and responsibility in molecular tumour boards.

Molecular tumour boards (MTBs) offer recommendations for potentially effective, but potentially burdensome, molecularly targeted treatments to a patient's treating physician. In this paper, we discuss the question of who is responsible for ensuring that there is an adequate evidence base for any treatments recommended to a patient. We argue that, given that treating oncologists cannot usually offer a robust evaluation of the evidence underlying an MTB's recommendation, members of the MTB are responsible for ensuring that the evidence level is adequate. We explore two models for how to share responsibility between MTB members. According to the first model, each MTB member, as well as the treating physician, should be held maximally and equally responsible for the recommendations. We argue that this insufficiently accounts for differences in roles and expertise of MTB members. We propose instead that responsibility is delegated via relationships of trust. We argue if these relationships of trust are to be instances of reasonable trust, (a) MTBs should offer a clinical representative to whom a treating physician may delegate the responsibility of ensuring there is sufficient evidence for treatment recommendations, (b) the relationships of trust between the representative and the other MTB members should be clearly defined, and (c) MTB members should be carefully selected. Treating oncologists retain a responsibility to consider general limitations of the evidence for targeted treatments in assessing whether the treatment recommendation offered by an MTB's representative is adequate for a given clinical situation.

Development and Evaluation of an Ethical Guideline for Decisions to Limit Life-Prolonging Treatment in Advanced Cancer: Protocol for a Monocentric Mixed-Method Interventional Study.

BACKGROUND: Many patients with advanced cancer receive chemotherapy close to death and are referred too late to palliative or hospice care, and therefore die under therapy or in intensive care units. Oncologists still have difficulties in involving patients appropriately in decisions about limiting tumor-specific or life-prolonging treatment. OBJECTIVE: The aim of this Ethics Policy for Advanced Care Planning and Limiting Treatment Study is to develop an ethical guideline for end-of-life decisions and to evaluate the impact of this guideline on clinical practice regarding the following target goals: reduction of decisional conflicts, improvement of documentation transparency and traceability, reduction of distress of the caregiver team, and better knowledge and consideration of patients' preferences. METHODS: This is a protocol for a pre-post interventional study that analyzes the clinical practice on treatment limitation before and after the guideline implementation. An embedded researcher design with a mixed-method approach encompassing both qualitative and quantitative methods is used. The study consists of three stages: (1) the preinterventional phase, (2) the intervention (development and implementation of the guideline), and 3) the postinterventional phase (evaluation of the guideline's impact on clinical practice). We evaluate the process of decision-making related to limiting treatment from different perspectives of oncologists, nurses, and patients; comparing them to each other will allow us to develop the guideline based on the interests of all parties. RESULTS: The first preintervention data of the project have already been published, which detailed a qualitative study with oncologists and oncology nurses (n=29), where different approaches to initiation of end-of-life discussions were ethically weighted. A framework for oncologists was elaborated, and the study favored an anticipatory approach of preparing patients for forgoing therapy throughout the course of disease. Another preimplementational study of current decision-making practice (n=567 patients documented) demonstrated that decisions to limit treatment preceded the death of many cancer patients (62/76, 82% of deceased patients). However, such decisions were usually made in the last week of life, which was relatively late. CONCLUSIONS: The intervention will be evaluated with respect to the following endpoints: better knowledge and consideration of patients' treatment wishes; reduction of decisional conflicts; improvement of documentation transparency and traceability; and reduction of the psychological and moral distress of a caregiver team. REGISTERED REPORT IDENTIFIER: RR1-10.2196/9698.

[Frequency and Timing of Decisions to Limit Intensive Medical Care and Tumor-Specific Therapy in University Hematology and Oncology]. / Häufigkeit und Zeitpunkt von Entscheidungen gegen intensivmedizinische Maßnahmen und tumorspezifische Therapien in einer universitären Hämatologie und Onkologie.

Background Decisions to limit treatment (DLT) are important in order to prevent overtreatment at the end of life. However, they are not always discussed with the patient in advance or sufficiently documented. In a study to improve DLT in patients with an advanced hematological/ oncological disease we examined how often DLT precede deaths and how early they are determined. Methods In a period of 6 months, 567 patients with advanced hematological/ oncological neoplasias had been recruited for the cross-sectional study at the University hospital in Munich. Using a standardized registration form an embedded researcher documented which DLT were determined for the patients and which of them were implemented until death. Results For 26 % (n = 147) of the 567 patients a DLT was determined. These DLT were mostly documented in writing from the beginning on (90 %; n = 132), 20 % (n = 30) were modified. The proportion of deceased patients with DLT was 82 % (n = 62 of 76 deceased). The median time between the initial determination of a DLT and the patient's death was 6 days at normal ward and 10.5 days at palliative ward. Compared to hematological patients, DLT were more frequently diagnosed in patients with an oncological disease (64 vs. 36 %) and the decisions were made slightly earlier (7 vs. 5 days before death). Conclusion Our results show that DLT precede the death of many patients with a hematological/ oncological disease, but usually are made in the last week of life. This leads to the risk that the remaining few days to death are not sufficient for discussions with all parties involved and the planning of the end of life. These findings resulted in the development of an ethics policy for treatment limitation in cancer patients, which should support the concept of advance care planning. The project is funded by the German Cancer Aid.

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.