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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. 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. 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. 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%). 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.

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.

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. 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. 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. 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). 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.

IntroductionThe question of how financial considerations influence medical decision-making is coming to a head in cancer medicine, as cancer medicine is getting more expensive and extensive. As the debate continues, empirical data on specific decision-making situations that are influenced by financial consideration and on the characterisation of financial influence in cancer medicine remain scarce.MethodsWe conducted a qualitative semistructured interview study with physicians who had experience in controlling and budgeting in different settings of cancer care in Germany. Qualitative content analysis was performed to identify specific decision-making situations in cancer medicine influenced by financial considerations and to characterise the financial influence.Resultsn=16 interviews were conducted. We identified 21 medical decision-making situations influenced by financial considerations specific to cancer medicine, which were characterised into four subcategories of financial influence derived from the data: (1) no reimbursement, (2) reimbursement that does not completely cover costs, (3) reimbursement that exceeds the costs and (4) costs covered for treatments with questionable cost-effectiveness. These results imply that medical decisions in cancer medicine could be influenced by financial considerations.ConclusionsThe findings support the hypothesis that medical decision-making in cancer medicine can be influenced by financial considerations. They provide specific examples and a characterisation of the influence as starting points for further quantitative studies on the extent of the financial influence and on the possible effect on high-risk patient groups. Further, they underline the need for ethical analysis regarding the implications for quality of care.

Background Little is known about how financial influences affect medical decision-making and may challenge the primacy principle of patient welfare. First qualitative results in cancer medicine identified specific decision-making situations that can be influenced by financial considerations and characterized by the type of their financial influence. These qualitative findings provide evidence that these influences are largely shaped by reimbursement strategies. Nevertheless, questions on how reimbursement strategies affect medical decision-making, and what their normative dimension is regarding the primacy principle, remain unclear. Methods To address the research questions, we conducted an empirical qualitative content analysis according to Kuckartz and an ethical analysis using Ives’ framework of reflexive balancing following the “standards of practice in empirical bioethics research” and the “framework for empirical bioethics research projects”. Results The empirical analysis identified six financially incentivized actions: to refrain, to reduce, to deflect, to privilege, to prioritize, and to withhold. These were linked to pre-existing definitions from the normative context: rationing, prioritization, deprioritization, and selection. The ethical analysis showed that a lack of transparency about whether reimbursement strategies implement normative priorities or merely regulate costs makes it difficult to assess their compatibility with the primacy of patient welfare. Conclusions The empirical and ethical analyses demonstrate that financial influences, as embedded in reimbursement strategies, can challenge the primacy principle by shaping which options appear feasible or appropriate in practice. Greater transparency and clearer justification of the goals embedded in reimbursement systems are required to determine when such influences are ethically acceptable and how they should be governed. Trial registration Not applicable, as the empirical part of this study is based on qualitative interview data and does not constitute as a clinical trial.

ObjectivesPatient-reported financial effects of a tumour disease in a universal healthcare setting are a multidimensional phenomenon. Actual and anticipated objective financial burden caused by direct medical and non-medical costs as well as indirect costs such as loss of income can lead to subjective financial distress. To better understand subjective financial distress, the presented study explores self-reported determinants for subjective financial distress in German patients with cancer, aiming to inform a new German-language patient-reported outcome measure for determining the financial effects of a tumour disease.DesignSemistructured interviews with n=18 patients with cancer were conducted between May 2021 and December 2021. Patients were recruited based on a purposive sampling strategy in outpatient and inpatient settings. The interviews were audiorecorded, transcribed verbatim and analysed using qualitative content analysis.SettingParticipants were recruited from two German academic cancer centres, that is, the National Center for Tumor Diseases Heidelberg and Jena University Hospital.Participants18 patients who had undergone cancer-related therapy for at least 2 months were interviewed (10 females).ResultsBased on the results of the qualitative content analysis, we developed a multicomponent construct of determinants that could influence subjective financial distress. The self-reported determinants can be classified into material (savings, good salary, shared rent through shared living, employed partner, paid-off house, potential financial support from family and friends, work-related specifics, consumer restrictions, out-of-pocket-costs and anticipated financial changes), social (social support from friends and family), systemic (administrative hurdlers and insurance cover) and inner personal determinants (coping strategies, change of attitude, character traits).ConclusionSubjective financial distress depends not only on material but also on social, systemic and inner personal determinants. Knowledge of these determinants can inform a new comprehensive German-language instrument for measuring self-reported financial effects of a tumour disease.Trial registration numberNCT05319925.

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.BACKGROUNDThe 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.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.OBJECTIVESince 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.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.METHODSIn 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.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.RESULTSWe 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.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.CONCLUSIONSIn 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.

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.

Abstract Background The incidence of colorectal carcinoma (CRC) in patients ≤50 (early-onset-CRC, EOCRC) years is increasing. Given their different phase of life, younger individuals may face specific challenges in terms of body image, professional life, and psychosocial support. However, tailored programs for EOCRC patients are lacking in Germany. JUMP-START, a prospective study at the National Center for Tumor Diseases (NCT) Heidelberg in collaboration with the AIO (Arbeitsgemeinschaft internistische Onkologie) and the foundation for young adults with cancer in Germany aims to identify the specific needs of EOCRC patients and improve multiprofessional care. Materials and Methods Semi-structured interviews were conducted until content saturation, based on an interview guide focused on challenges related to diagnosis, utilization of support programs, and unmet needs. The interview guide was developed in an expert and patient panelist discussion. Qualitative analysis was performed with MAXQDA, using a content structuring qualitative content analysis according to Kuckartz. Results Forty-three EOCRC patients were screened, and 14 participants were interviewed at NCT Heidelberg between October 2023 and January 2024. Three main themes emerged: (1) The impact of CRC diagnosis at an early age on psychological and physical health, daily routine, and future perspectives, (2) Experiences with care service access and utility, and (3) Expectations for a multiprofessional care at a dedicated EOCRC center. Conclusions EOCRC patients highlighted various age-group-specific challenges related to diagnosis and treatment. Tailored multiprofessional programs may optimize care for EOCRC patients. Graphical Abstract Graphical Abstract