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This is an updated preprint of our Delphi study to develop a person-centered outcome set for routine diabetes care in Europe: Objective: Standardised patient-reported outcomes (PRO) data can contextualise clinical outcomes enabling precision diabetes monitoring and care. Comprehensive outcome sets can guide this process, but their implementation in routine diabetes care has remained challenging and has not been successful at the international level. We aimed to address this with a person-centred outcome set for Type 1 and 2 diabetes that can be feasibly implemented and sustained in international healthcare settings. Methods: A questionnaire-based Delphi study consisting of three consecutive survey rounds and based on previously identified outcomes was undertaken to reach consensus on the outcome set. Participants included patients (N=94), health professionals (N=65), representatives of industry (N=22) and health authorities (N=3). Subsequent consensus meetings were held to finalise the outcome set. Results: The list of preliminary person-centred outcomes presented in the Delphi study included 64outcomes and was shortlisted via the consensus process to 46 outcomes (27 clinical outcomes and 19 PROs). Two main collection times were recommended: 1) linked to a medical visit (e.g., diabetes-specific well-being, symptoms, and psychological health) and 2) annually (e.g., clinical data, general well-being, and diabetes self-management-related outcomes). Conclusions: PROs are often considered in a non-standardised way in routine diabetes care. We propose a person-centred outcome set for diabetes, specifically considering psychosocial and behavioural aspects, which was agreed by four international key stakeholder groups. It guides standardised patient-important outcome collection at scale to support individual and population level healthcare decision-making. It will be implemented and tested in Europe as part of the H2O project. &nbsp

Pre-print of asystematic literature review toidentify candidate patient reported outcomes with potential to inform individual patient care and service development for inclusion in a digital outcome set to be collected in routine diabetes care.

Systematic literature reviewto identify candidate patient reported outcomes with potential to inform individual patient care and service development for inclusion in a digital outcome set to be collected in routine diabetes care. Abstractfor a short oralpresentation given at the58th European Association for the Study of Diabetes (EASD) Annual Meeting (September, 2022). &nbsp

Collecting patient-reported outcomes (PROs) in a standardised way and integrating them with clinical data can empower patients and support diabetes care. We sought to develop a patient-centred core outcome set (COS) to be used in routine diabetes care employing an international multi-stakeholder consensus process focusing on outcome relevance, feasibility and measurement frequency. The three-round Delphi study and subsequent consensus meeting led to a comprehensive outcome set and recommendations for frequency of measurement for each included outcome. The outcome set allows for collecting patient-reported and clinical data in a standardised way to sustainably support diabetes management on the international level and inform research and policy making., {"references":["Walker RJ, Garacci E, Campbell JA, Egede LE. The influence of daily stress on glycemic control and mortality in adults with diabetes. J Behav Med. 2020;43(5):723-31","Hermanns N, Ehrmann D, Shapira A, Kulzer B, Schmitt A, Laffel L. Coordination of glucose monitoring, self-care behaviour and mental health: achieving precision monitoring in diabetes. Diabetologia. 2022","Nano J, Carinci F, Okunade O, Whittaker S, Walbaum M, Barnard-Kelly K, et al. A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach. Diabet Med. 2020;37(12):2009-18","Skovlund SE, Troelsen LH, Klim L, Jakobsen PE, Ejskjaer N. The participatory development of a national core set of person-centred diabetes outcome constructs for use in routine diabetes care across healthcare sectors. Res Involv Engagem. 2021;7(1):62","Terwee CB, Zuidgeest M, Vonkeman HE, Cella D, Haverman L, Roorda LD. Common patient-reported outcomes across ICHOM Standard Sets: the potential contribution of PROMIS®. BMC Med Inform Decis Mak. 2021;21(1):259","Svedbo Engström M, Leksell J, Johansson UB, Borg S, Palaszewski B, Franzén S, et al. New Diabetes Questionnaire to add patients' perspectives to diabetes care for adults with type 1 and type 2 diabetes: nationwide cross-sectional study of construct validity assessing associations with generic health-related quality of life and clinical variables. BMJ Open. 2020;10(11):e038966","Stamm T, Bott N, Thwaites R, Mosor E, Andrews M, Borgdorff J, et al. Building a Value-Based Care Infrastructure in Europe: The Health Outcomes Observatory. NEJM Catalyst. 2021;2"]}

Sex and gender can affect diabetes outcomes. Evidence suggests this is mediated by various biological and sociocultural factors, including hormones and behaviour. We set out to find out about gender-related differences in health (outcome) priorities. In an exploratory analysis the voting results of a previously conducted Delphi study, undertaken to reach consensus on a person-centred diabetes outcome set, were stratified according to the indicated gender of participating patients. Our results provide initial evidence that men and women prioritise self-reported diabetes outcomes differently: e.g., we saw that feeling in control was a major concern for men, while women felt it was important to be mindful of side effects. Clinicians may want to consider this to measure outcomes in a personalised, gender-conscious way and provide gender-specific diabetes care that supports the achievement of personal treatment goals., Gender, Gender medicine, Diabetes, Diabetes outcomes, Health outcomes, Patient-reported outcomes, Person-centred care, {"references":["Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. (2009). https://www.fda.gov/media/77832/download","Himmelstein, M. S., & Puhl, R. M. (2021). At multiple fronts: Diabetes stigma and weight stigma in adults with type 2 diabetes. Diabet Med, 38(1), e14387. https://doi.org/10.1111/dme.14387","Kautzky-Willer, A., Harreiter, J., & Pacini, G. (2016). Sex and Gender Differences in Risk, Pathophysiology and Complications of Type 2 Diabetes Mellitus. Endocr Rev, 37(3), 278-316. https://doi.org/10.1210/er.2015-1137","Markey, C. N., Markey, P. M., Schneider, C., & Brownlee, S. (2005). Marital Status and Health Beliefs: Different Relations for Men and Women. Sex Roles, 53(5), 443-451. https://doi.org/10.1007/s11199-005-6767- y","Mauvais-Jarvis, F., Berthold, H. K., Campesi, I., Carrero, J. J., Dakal, S., Franconi, F., Gouni-Berthold, I., Heiman, M. L., Kautzky-Willer, A., Klein, S. L., Murphy, A., Regitz-Zagrosek, V., Reue, K., & Rubin, J. B. (2021). Sex- and Gender-Based Pharmacological Response to Drugs. Pharmacol Rev, 73(2), 730-762. https://doi.org/10.1124/pharmrev.120.000206","Samulowitz, A., Gremyr, I., Eriksson, E., & Hensing, G. (2018). \"Brave Men\" and \"Emotional Women\": A Theory- Guided Literature Review on Gender Bias in Health Care and Gendered Norms towards Patients with Chronic Pain. Pain Res Manag, 2018, 6358624. https://doi.org/10.1155/2018/6358624","Stamm, T., Bott, N., Thwaites, R., Mosor, E., Andrews, M., Borgdorff, J., Cossio-Gil, Y., Portu, S., Ferrante, M., Fischer, F., Hameed, F., Hazelzet, J., Hopkins, D., Kalra, D., Metcalfe, T., Molero, E., Newson, R., Patalano, F., Prasser, F., & Styliadou, M. (2021). Building a Value-Based Care Infrastructure in Europe: The Health Outcomes Observatory. NEJM Catalyst, 2. https://doi.org/10.1056/CAT.21.0146"]}

In dieser Arbeit werden die Effekte einer in vivo Applikation von Röntgen-Mikrostrahlen auf FaDu-Tumoren untersucht. Die prä-klinische Therapieform zeichnet sich durch eine räumliche Fraktionierung und sehr hohe Dosis der Strahlung sowie einen hohen therapeutischen Index aus. Evaluiert wurden, sowohl im Vergleich zu einer homogenen Bestrahlung als auch zu unbehandelten Tumoren, die Tumorwachstumsverzögerung, Strahlensensibilität und Chromosomenaberrationen. Die Ergebnisse dieser Arbeit stellen einen wichtigen Schritt für die MRT-Forschung dar. Sie können als Ausgangspunkt für zukünftige Studien und impulsgebend für die Optimierung der Bestrahlungsparameter angesehen werden. In this work, the effects of an in vivo application of X-ray microbeams on FaDu tumors are investigated. This preclinical form of therapy is characterized by a spatial fractionation of the very high radiation dose as well as a high therapeutic index. In comparison to homogeneous irradiation as well as to untreated tumors, tumor growth retardation as well as radiation sensitivity and chromosomal aberrations were evaluated. The results of this work represent an important step for MRT research. They can be considered as a basis for future studies providing an impuls for the optimization of irradiation parameters.