Developing quality indicators for cross-sectoral psycho-oncology in Germany: combining the RAND/UCLA appropriateness method with a Delphi technique.

BACKGROUND: Internationally, the need for appropriately structured, high-quality care in psycho-oncology is more and more recognized and quality-oriented care is to be established. Quality indicators are becoming increasingly important for a systematic development and improvement of the quality of care. The aim of this study was to develop a set of quality indicators for a new form of care, a cross-sectoral psycho-oncological care program in the German health care system. METHODS: The widely established RAND/UCLA Appropriateness Method was combined with a modified Delphi technique. A systematic literature review was conducted to identify existing indicators. All identified indicators were evaluated and rated in a two-round Delphi process. Expert panels embedded in the Delphi process assessed the indicators in terms of relevance, data availability and feasibility. An indicator was accepted by consensus if at least 75% of the ratings corresponded to category 4 or 5 on a five-point Likert scale. RESULTS: Of the 88 potential indicators derived from a systematic literature review and other sources, 29 were deemed relevant in the first Delphi round. After the first expert panel, 28 of the dissented indicators were re-rated and added. Of these 57 indicators, 45 were found to be feasible in terms of data availability by the second round of expert panel. In total, 22 indicators were transferred into a quality report, implemented and tested within the care networks for participatory quality improvement. In the second Delphi round, the embedded indicators were tested for their practicability. The final set includes 16 indicators that were operationalized in care practice and rated by the expert panel as relevant, comprehensible, and suitable for care practice. CONCLUSION: The developed set of quality indicators has proven in practical testing to be a valid quality assurance tool for internal and external quality management. The study findings could contribute to traceable high quality in cross-sectoral psycho-oncology by providing a valid and comprehensive set of quality indicators. TRIAL REGISTRATION: "Entwicklung eines Qualitätsmanagementsystems in der integrierten, sektorenübergreifenden Psychoonkologie-AP "Qualitätsmanagement und Versorgungsmanagement" zur Studie "integrierte, sektorenübergreifende Psychoonkologie (isPO)" a sub-project of the "integrierte, sektorenübergreifende Psychoonkologie (isPO)", was registered in the German Clinical Trials Register (DRKS) (DRKS-ID: DRKS00021515) on 3rd September 2020. The main project was registered on 30th October 2018 (DRKS-ID: DRKS00015326).

Integrated, cross-sectoral psycho-oncology (isPO): a new form of care for newly diagnosed cancer patients in Germany.

BACKGROUND: The annual incidence of new cancer cases has been increasing worldwide for many years, and is likely to continue to rise. In Germany, the number of new cancer cases is expected to increase by 20% until 2030. Half of all cancer patients experience significant emotional and psychosocial distress along the continuum of their disease, treatment, and aftercare, and also as long-term survivors. Consequently, in many countries, psycho-oncological programs have been developed to address this added burden at both the individual and population level. These programs promote the active engagement of patients in their cancer therapy, aftercare and survivorship planning and aim to improve the patients' quality of life. In Germany, the "new form of care isPO" ("nFC-isPO"; integrated, cross-sectoral psycho-oncology/integrierte, sektorenübergreifende Psycho-Onkologie) is currently being developed, implemented and evaluated. This approach strives to accomplish the goals devised in the National Cancer Plan by providing psycho-oncological care to all cancer patients according to their individual healthcare needs. The term "new form of care" is defined by the Innovation Fund (IF) of Germany's Federal Joint Committee as "a structured and legally binding cooperation between different professional groups and/or institutions in medical and non-medical care". The nFC-isPO is part of the isPO project funded by the IF. It is implemented in four local cancer centres and is currently undergoing a continuous quality improvement process. As part of the isPO project the nFC-isPO is being evaluated by an independent institution: the Institute for Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), University of Cologne, Germany. The four-year isPO project was selected by the IF to be eligible for funding because it meets the requirements of the federal government's National Cancer Plan (NCP), in particular, the "further development of the oncological care structures and quality assurance" in the psycho-oncological domain. An independent evaluation is required by the IF to verify if the new form of care leads to an improvement in cross-sectoral care and to explore its potential for permanent integration into the German health care system. METHODS: The nFC-isPO consists of six components: a concept of care (C1), care pathways (C2), a psycho-oncological care network (C3), a care process organization plan (C4), an IT-supported documentation and assistance system (C5) and a quality management system (C6). The two components concept of care (C1) and care pathways (C2) represent the isPO clinical care program, according to which the individual cancer patients are offered psycho-oncological services within a period of 12 months after program enrolment following the diagnosis of cancer. The remaining components (C3-C6) represent the formal-administrative aspects of the nFC-isPO that are intended to meet the legally binding requirements of patient care in the German health care system. With the aim of systematic development of the nFC-isPO while at the same time enabling the external evaluators to examine its quality, effectiveness and efficiency under conditions of routine care, the project partners took into consideration approaches from translational psycho-oncology, practice-based health care research and program theory. In order to develop a structured, population-based isPO care program, reference was made to a specific program theory, to the stepped-care approach, and also to evidence-based guideline recommendations. RESULTS: The basic version, nFC-isPO, was created over the first year after the start of the isPO project in October 2017, and has since been subject to a continuous quality improvement process. In 2019, the nFC-isPO was implemented at four local psycho-oncological care networks in the federal state North Rhine-Westphalia, in Germany. The legal basis of the implementation is a contract for "special care" with the German statutory health insurance funds according to state law (§ 140a SCB V; Social Code Book V for the statutory health insurance funds). Besides the accompanying external evaluation by the IMVR, the nFC-isPO is subjected to quarterly internal and cross-network quality assurance and improvement measures (internal evaluation) in order to ensure continuous quality improvement process. These quality management measures are developed and tested in the isPO project and are to be retained in order to ensure the sustainability of the quality of nFC-isPO for later dissemination into the German health care system. DISCUSSION: Demands on quality, effectiveness and cost-effectiveness of in the German health care system are increasing, whereas financial resources are declining, especially for psychosocial services. At the same time, knowledge about evidence-based screening, assessment and intervention in cancer patients and about the provision of psychosocial oncological services is growing continuously. Due to the legal framework of the statutory health insurance in Germany, it has taken years to put sound psycho-oncological findings from research into practice. Ensuring the adequate and sustainable financing of a needs-oriented, psycho-oncological care approach for all newly diagnosed cancer patients, as required by the NCP, may still require many additional years. The aim of the isPO project is to develop a new form of psycho-oncological care for the individual and the population suffering from cancer, and to provide those responsible for German health policy with a sound basis for decision-making on the timely dissemination of psycho-oncological services in the German health care system. TRIAL REGISTRATION: The study was pre-registered at the German Clinical Trials Register (https://www.drks.de/DRKS00015326) under the following trial registration number: DRKS00015326 ; Date of registration: October 30, 2018.

Medical knowledge and information needs among women with pathogenic variants in moderate-risk genes for hereditary breast cancer attending genetic counseling at an academic hospital in Germany-A qualitative approach.

With 69,000 newly diagnosed cases every year, breast cancer (BC) is the most frequent cancer disease among women in Germany. Familial clustering is seen in about 30% of newly diagnosed cases. Besides the high-risk genes BRCA1/2, there are also moderate-risk BC genes (MBCG) that are associated with a 20%-50% risk of BC, such as CHEK2, ATM, and PALB2. In Germany, carriers of pathogenic variants in MBCG receive specific information on their test results, individual risks, and preventive options during genetic counseling for the disclosure of the results in a specialized center. Little is known about the medical knowledge that women have after attending counseling. This study aims to identify the medical knowledge, further information needs, and the possible impact of a lack of information on dealing with everyday life for women with pathogenic variants in MBCG who have attended genetic counseling at an academic hospital in Germany. Problem-centered, guided, individual interviews were conducted with twelve women carrying pathogenic variants in MBCG. The interview guide was developed based on the methods of the problem-centered interview according to Witzel. The interview analysis was based on Mayring's qualitative content analysis. The women were between 29 and 59 years old and carried pathogenic variants in the risk genes CHEK2 (n = 8), ATM (n = 1), or PALB2 (n = 3). Several medical uncertainties and information needs emerged from the data, concerning (a) medical terms, (b) risk perception, (c) BC therapy for hereditary BC, (d) lifestyle advice and risk factors, and (e) family planning and risk-reducing mastectomy. Women with pathogenic variants in MBCG might develop their own conceptions regarding the onset of disease and inheritance. In order to meet the need for information and address the uncertainties that may still exist after genetic counseling, structured, evidence-based and comprehensible written information in German should be developed for this group.

[Digital Transformation of Healthcare: A Delphi Study of the Working Groups Digital Health and Validation and Linkage of Secondary Data of the German Network for Health Services Research (DNVF)]. / Digitale Transformation des Gesundheitswesens ­ eine Delphi-Studie der Arbeitsgruppen Digital Health und Validierung und Linkage von Sekundärdaten des Deutschen Netzwerk Versorgungsforschung (DNVF).

AIM OF THE STUDY: The digital transformation in healthcare is also of fundamental importance for healthcare research. For this reason, experts should agree on, prioritize and identify key topics for a medium-term strategy of the German Network for Health Services Research and classify the general development of digital health in the context of health services research. METHODS: Between April and September 2018, the working groups "Digital Health" and "Validation and Linkage of Secondary Data" of the German Network for Health Services Research were asked to submit their expertise online using the methodological approach of a Delphi study. For this purpose, a multi-stage modified Delphi method with quantitative and qualitative approaches was chosen. Initially, a list of theses was drawn from the network's published position papers on digital health applications and medical apps. A total of 131 statements were formulated. The final survey instrument included questions on the biographical background of the participants, 42 developed items (33 statements and 8 open-ended questions), and one free-text field to add further aspects. Items were evaluated with a five-point Likert scale. A statement was accepted if the agreement rate was 75% or higher. RESULTS: Of the 110 potential participants, 50 (46%) took part in the first round and 39 (36%) in the second round of the Delphi survey. In the first round, there was a clear result for 24 of 33 statements. There were 20 statements "agreed with" and four "disagreed with." Nine statements were between 60 and 75% and were presented to the participants again for evaluation in the second round. In round two, of these nine statements, four statements were "agreed with" and five statements were "disagreed with." Digital Health Literacy" emerged as a particular focus in this Delphi study. CONCLUSION: In this Delphi study, experts were involved in selecting and prioritizing possible topics for the Digital Health working group and assessing future developments in digital health in the context of health services research. The results reflect both the expectations and interests of the members and are largely consistent with the recommendations of the report "Digitalization for Health" made by the expert council for assessing developments in the health sector.

"You Always Have It in the Back of Your Mind"-Feelings, Coping, and Support Needs of Women with Pathogenic Variants in Moderate-Risk Genes for Hereditary Breast Cancer Attending Genetic Counseling in Germany: A Qualitative Interview Study.

Hereditary breast cancer accounts for approximately 30% of newly diagnosed breast cancer (BC) cases. Pathogenic variants in moderate-risk BC genes (MBCG) differ from those in high-risk genes in terms of associated cancer risks, affected organs, and available preventive options. Little is known about how MBCG pathogenic variant carriers who have attended post-test genetic counseling perceive their situation, how they cope with their situation, and which support needs they might have. Problem-centered, guided, individual interviews were conducted with twelve women carrying pathogenic variants in MBCG. The interview analysis was based on Mayring's qualitative content analysis. The women were between 29 and 59 years old and carried pathogenic variants in the risk genes CHEK2 (n = 8), ATM (n = 1), or PALB2 (n = 3). Women reported a wide range of feelings, both positive (relief, calmness) and negative (overwhelm, fear, grief, guilt). All women applied strategies of emotion-focused coping to deal with this lifelong situation. Appraisal and evaluation of the affected mother's coping might influence the patient's own behavior and coping style. These results could be used during and after post-test genetic counseling to provide more needs-oriented counseling, and to help women in adjusting to and coping with being a pathogenic variant carrier.

A Vision of Future Healthcare: Potential Opportunities and Risks of Systems Medicine from a Citizen and Patient Perspective-Results of a Qualitative Study.

Advances in (bio)medicine and technological innovations make it possible to combine high-dimensional, heterogeneous health data to better understand causes of diseases and make them usable for predictive, preventive, and precision medicine. This study aimed to determine views on and expectations of "systems medicine" from the perspective of citizens and patients in six focus group interviews, all transcribed verbatim and content analyzed. A future vision of the use of systems medicine in healthcare served as a stimulus for the discussion. The results show that although certain aspects of systems medicine were seen positive (e.g., use of smart technology, digitalization, and networking in healthcare), the perceived risks dominated. The high degree of technification was perceived as emotionally burdensome (e.g., reduction of people to their data, loss of control, dehumanization). The risk-benefit balance for the use of risk-prediction models for disease events and trajectories was rated as rather negative. There were normative and ethical concerns about unwanted data use, discrimination, and restriction of fundamental rights. These concerns and needs of citizens and patients must be addressed in policy frameworks and health policy implementation strategies to reduce negative emotions and attitudes toward systems medicine and to take advantage of its opportunities.

Systems medicine 2030: A Delphi study on implementation in the German healthcare system.

INTRODUCTION: Systems medicine is based on approaches taken from systems biology, omics research, bio-informatics and network theory. It promises to facilitate a better understanding of the causes of diseases, detection at an earlier stage, and the use of tailor-made approaches to prevention and therapy. This study provides information on how systems medicine could be incorporated into the German healthcare system. METHODS: In a Policy Delphi, consensus and divergence was elicited on whether experts believed systems medicine could be incorporated into the German healthcare system by 2030. Additionally, factors that could influence the implementation process were analysed. 11 theses on potential systems medicine developments and 193 arguments on influencing factors were evaluated. Experts from health and health-related fields were selected using "purposive sampling". RESULTS: The experts interviewed expressed their trust in the provision of a legal-political framework, though they remained uncertain as to whether the necessary social discourse on the ethical and cultural questions surrounding systems medicine would occur. They do not (currently) expect systems medicine to be implemented by 2030. CONCLUSION: Systems medicine is currently regarded as a visionary concept. As such, it would be premature to attempt to judge the success of the translation process at this stage. The results can help with the identification of the challenges involved in implementation, and the action required to achieve this aim.

Expectations for the Development of Health Technology Assessment in Brazil.

The implementation of health technology assessment (HTA) in emerging countries depends on the characteristics of the health care system and the needs of public health care. The objective of this survey was to investigate experts' expectations for the development of HTA in Brazil and to derive measures to strengthen the impact of HTA in Brazil on health care decisions. Based on a scoping literature review, a questionnaire was developed proposing eight theses for seven domains of HTA: (i) capacity building, (ii) public involvement, (iii) role of cost-effectiveness analysis (CEA), (iv) institutional framework, (v) scope of HTA studies, (vi) methodology of HTA, and (vii) HTA as the basis for jurisdiction. Thirty experts responded in full to the survey and agreed to five of the eight theses proposed. Experts suggested several measures to promote HTA within the scope of each domain, thus addressing capacity building related to HTA, availability, and reliability of population data, and legal endowment of the HTA system. Finally, HTA processes in Brazil should also address public health issues (e.g., appraisal of interventions directed at chronic diseases).

Evaluation of a complex integrated, cross-sectoral psycho-oncological care program (isPO): a mixed-methods study protocol.

INTRODUCTION: International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme 'isPO' is aiming to ensure a provision of care in inpatient and outpatient settings according to a stepped-care approach. Up to now, psycho-oncological care is missing regulated and standardised processes to demonstrate the effectiveness. This study protocol describes the process and outcome evaluation that is conducted, along with the isPO study. The programme evaluation is aiming to proof effectiveness, explain potential discrepancies between expected and observed outcomes. Additionally, provide insight into the implementation process, as well as contextual factors that might promote or inhibit the dissemination and implementation of the stepped care programme will be gained. In addition to these measures, a cost-consequence analysis will provide further evidence aimed at integrating psycho-oncological care into primary healthcare. METHODS AND ANALYSIS: The evaluation concept is based on a tripartite strategy consisting of a prospective, formative and summative evaluation. To capture all determinants, a concurrent mixed-method design is applied comprising qualitative (interviews and focus groups) and quantitative (standardised questionnaires) surveys of patients and healthcare providers. In addition, analysis of the psycho-oncological care data (isPO care data) and statutory health insurance claims data will be conducted. Primary and secondary data will complement one another (data linkage) to obtain a more comprehensive picture of the effectiveness and implementation of the complex intervention within the isPO study. ETHICS AND DISSEMINATION: The study has been approved by the ethics committee of the Medical Faculty of the University of Cologne. For all collected data, the relevant national and European data protection regulations will be considered. All personal identifiers (eg, name, date of birth) will be pseudonymised. Dissemination strategies include annual reports as well as quality workshops for the organisations, the presentation of results in publications and on conferences, and public relations. TRIAL REGISTRATION NUMBER: DRKS00015326; Pre-results.