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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

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"]}

Background Chronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear. Objective The aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone. Methods Smartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week’s average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain–related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used. Results We screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI −0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app. Conclusions The study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques. Trial Registration ClinicalTrials.gov NCT02019134; https://clinicaltrials.gov/ct2/show/NCT02019134 International Registered Report Identifier (IRRID) RR2-10.1186/1745-6215-15-490

Einleitung: Mehr als die H��lfte der Krebspatientinnen und -patienten nutzen komplement��rmedizinische Verfahren w��hrend ihrer Krebstherapie. Trotz des Wunsches nach komplement��rmedizinischen Konsultationen durch onkologisch t��tige ��rztinnen und ��rzte berichten Patientinnen und Patienten in Konsultationen oft nicht ��ber ihre Nutzung. Gr��nde hierf��r scheinen vielf��ltig und umfassen die Bef��rchtung, mit ihrem Wunsch nicht verstanden zu werden. Andererseits w��nschen sich onkologisch t��tige ��rztinnen und ��rzte Fortbildungsm��glichkeiten zur Komplement��rmedizin. Zur Verbesserung der ��rztin/Arzt-Patientinnen/Patienten-Kommunikation ��ber dieses Thema sollen Wege zur Implementierung systematisch entwickelter Konzepte f��r komplement��rmedizinische Konsultationen in der Routineversorgung entwickelt werden. Im Einzelnen folgte diese Arbeit vier Zielen in der Entwicklung und Evaluation: (1) von Outcomes und Outcome-Messungen f��r Kommunikationstrainings in der Onkologie, (2) von Bildungskompetenzen f��r Gesundheitsberufe in der integrativen Onkologie, (3) von Kriterien zur Identifikation seri��ser Anbietender komplement��rmedizinischer Verfahren, (4) eines systematisch entwickelten Frameworks f��r komplement��rmedizinische Konsultationen durch onkologisch t��tige ��rztinnen und ��rzte. Methoden und Material: (1) Empfehlungen f��r Outcomes und Outcome-Messungen wurden in einem drei-stufigen Prozess aus systematischer Literaturrecherche, Expertinnen und Experten-Workshop sowie Konsensusprozess generiert, (2) Bildungskompetenzen wurden anhand einer systematischen Literatur��bersicht und einem internationalen, interprofessionellen Konsensusprozess entwickelt, (3) Kriterien zu seri��sen Anbietenden wurden in einem Delphi-Konsensusprozess entwickelt und durch Stakeholder evaluiert und (4) unter Anwendung von Mixed-Methods-Verfahren wurde ein Framework f��r eine komplement��rmedizinische Konsultation entwickelt und durch onkologisch t��tige ��rztinnen und ��rzte sowie externe Bewertende der Konsultationssituationen evaluiert. Ergebnisse: (1) Empfehlungen zur Evaluation von Kommunikationstrainings in der Onkologie, (2) Konsens ��ber 37 Bildungskompetenzen (11 aus dem Bereich Wissen, 17 aus dem Bereich Fertigkeiten, neun aus dem Bereich F��higkeiten) f��r Gesundheitsberufe in der integrativen Onkologie, (3) Kriterienliste mit acht obligatorischen und drei fakultativen Kriterien zu seri��sen Anbietenden komplement��rmedizinischer Verfahren; (4) KOKON-KTO Framework (Konsultationsmanual; Blended Learning Training) zur F��hrung komplement��rmedizinischer Konsultationen in der Onkologie. Diskussion: Durch Anwendung diverser Implementierungsstrategien und -ans��tze k��nnen die Ergebnisse dieser Arbeit dazu beitragen, die Kommunikation zwischen ��rztinnen/��rzten und Patientinnen/Patienten bez��glich komplement��rmedizinischer Verfahren in der Onkologie zu verbessern. Zuk��nftige Studien sollten neben dem Einbezug interkultureller Kompetenzen, diese Strategien auch auf Gesundheitsberufe wie Pflegende anwenden., More than half of cancer patients use complementary medicine therapies (CM) during their cancer treatment. Despite the desire for CM consultations by oncology physicians, many patients do not disclose their use. Reasons for this seem to be multifactorial and often refer to the fear of not being accepted with their wish for CM. On the other hand, oncology physicians would like to be given the opportunity for further training in CM. In order to improve this situation and the physician-patient communication about this topic, strategies for implementing and evaluating systematically developed concepts for CM consultations for cancer patients in routine care become urgent. In detail, this work followed four objectives for the development and evaluation of: (1) recommendations for outcomes and outcome measures for the evaluation of communication training in oncology, (2) educational competencies for health professionals in integrative oncology, (3) criteria for the identification of reputable CM providers, and (4) a systematically developed communication framework (consultation manual, blended learning training) for CM consultations by the treating oncology physician. Methods and material: (1) Recommendations for outcomes and outcome measures were generated in a three-step developing process consisting of a systematic literature search, expert workshop and a subsequent consensus procedure, (2) educational competencies were developed through a systematic literature search and an international and interprofessional consensus procedure by relevant stakeholder groups, (3) criteria for the identification of reputable CM providers were developed in an interprofessional Delphi-consensus procedure and subsequently evaluated and implemented with the involvement of various stakeholder groups, and (4) using mixed-methods and a leading implementation strategy, a framework for CM consultations was developed and evaluated by oncology physicians and external raters of the consultation situations. Results: (1) Recommendations for the evaluation of communication training in oncology were recorded, (2) 37 core competencies (11 from the field of knowledge, 17 from the field of skills, 9 from the field of abilities) were developed for health professionals in integrative oncology, (3) a list of 8 mandatory and 3 optional criteria for the identification of reputable complementary medicine providers was developed, and (4) KOKON-KTO framework (consultation manual, blended learning training) for advising cancer patients on CM was developed. Discussion: By applying various implementation strategies and approaches, the results of this work can improve the communication between physicians and patients regarding CM in oncology. Future studies should not only include intercultural competencies, but also expand the strategies for health professionals such as nursing care.

Background: Clinical research on mobile health (mHealth) interventions is too slow in comparison to the rapid speed of technological advances, thereby impeding sustainable research and evidence-based implementation of mHealth interventions. Objective: We aimed to establish practical lessons from the experience of our working group, which might accelerate the development of future mHealth interventions and their evaluation by randomized controlled trials (RCTs). Methods: This paper is based on group and expert discussions, and focuses on the researchers’ perspectives after four RCTson mHealth interventions for chronic pain. Results: The following five lessons are presented, which are based on practical application, increase of speed, and sustainability: (1) explore stakeholder opinions, (2) develop the mHealth app and trial simultaneously, (3) minimize complexity, (4) manage necessary resources, and (5) apply behavior change techniques. Conclusions: The five lessons developed may lead toward an agile research environment. Agility might be the key factor in the development and research process of a potentially sustainable and evidence-based mHealth intervention.

Alizé A Rogge,1 Isabel Baur,2 Gabriele Blettner,3 Ulrike Holtkamp,4 Markus Horneber,5 Patrick Jahn,6 Stefanie Joos,7 Silva Keberle,8 Anita Kettelgerdes,9 David Klemperer,10 Alfred Längler,11 Petra Voiß,12,13 Joachim Weis,14 Claudia M Witt1,15,16 1Institute for Social Medicine, Epidemiology, and Health Economics, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany; 2Legal Institute, Competence Center Medicine - Ethics - Law Helvetiae, University of Zurich, Zurich, Switzerland; 3Deutsche Krebshilfe, INFONETZ KREBS, Bonn, Germany; 4German Leukemia & Lymphoma Patients‘ Association, Bonn, Germany; 5Department of Internal Medicine, Division of Oncology and Hematology, Paracelsus Medical University, Klinikum Nuremberg, Nuremberg, Germany; 6Department for Nursing Science, Institute for Health Science, Medical Faculty, Eberhard Karls University Tübingen, Tübingen, Germany; 7Institute for General Practice and Interprofessional Health Care, University Clinic Tübingen, Tübingen 72076, Germany; 8Eskamed AG, Basel, Switzerland; 9TK – Techniker Krankenkasse, Hamburg, Germany; 10Faculty of Social and Health Sciences, Ostbayerische Technische Hochschule Regensburg, Regensburg., Germany; 11Gemeinschaftskrankenhaus Herdecke, Institute of Integrative Medicine, Witten/Herdecke University, Herdecke, Germany; 12Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany; 13Gynaecological Clinic, Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe, Germany; 14Department of Self-Help Research, Comprehensive Cancer Center University Clinic Freiburg, Freiburg i.Br., Germany; 15Institute for Complementary and Integrative Medicine, University of Zurich and University Hospital Zurich, Zurich, Switzerland; 16Center for Integrative Medicine, University of Maryland School of Medicine Baltimore, Baltimore, MarylandCorrespondence: Claudia M WittInstitute for Complementary and Integrative Medicine, University Hospital Zurich and University Zurich, Sonneggstrasse 6, Zurich 8091, SwitzerlandEmail claudia.witt@uzh.chPurpose: Even in cases of positive evidence for complementary medicine (CM) therapies, it is still difficult for cancer patients to identify reputable providers. The aim of this study was to develop and evaluate a criteria list to provide guidance to cancer patients seeking a reputable CM provider.Methods: The design combined a literature review, an expert consensus procedure (n=15) and an assessment from three stakeholder perspectives (patients (n=18), CM providers (n=26) and oncology physicians (n=20)).Results: A total of 30 existing CM criteria were extracted from the literature, and 12 more were added by the experts. The main challenge was to define criteria that could easily be applied by the patients. A final comprehensive list of 8 criteria guiding cancer patients to find a reputable CM provider was developed.Conclusion: Health professionals and cancer information services might find the criteria list helpful when aiming to strengthen patients’ awareness of quality-related factors associated with CM providers. The criteria developed might be helpful when standards are established for quality assurance in CM in oncology.Keywords: neoplasms, complementary medicine, patient-centered care, standards, healthcare quality assurance

Schlaganfälle gelten als häufigste Ursache für Behinderungen im Erwachsenenalter in Deutschland und Österreich. 75% der Schlaganfallpatient_innen leiden als Folge der Erkrankungen unter Beeinträchtigungen der oberen Extremität. Die Spiegeltherapie (ST) bietet Möglichkeiten diese motorischen und sensorischen Beeinträchtigungen zu reduzieren. Nichtsdestotrotz ist der Erfolg der ST u.a. abhängig von den Aufmerksamkeitsleistungen der Patient_innen. Motivation, Zielsetzung und Selbstwirksamkeitserwartungen können in Aufmerksamkeitsprozesse eingreifen und diese top-down beeinflussen. Aus diesem Grund scheint es sinnvoll Leistungsrückmeldungen, sogenanntes Feedback, in die virtuelle ST (VST) zu implementieren. VST stellt eine computergestützte Form der ST dar, in der Patient_innen Bewegungsanweisungen im virtuellen Raum durchführen. Um den Einfluss von Motivation und Selbstwirksamkeit auf die Aufmerksamkeit während der VST zu untersuchen, wurden in einer randomisiert kontrollierten Studie 20 Proband_innen (erstmaliger ischämischer Schlaganfall) einer Interventions- oder einer Kontrollgruppe zugeteilt. Die Interventionsgruppe wurde aktiv in die Planung von Therapiezielen miteinbezogen, die es innerhalb von drei Therapieeinheiten zu erreichen galt. Des Weiteren erhielt sie Feedback über ihre Aufmerksamkeitsleistungen während der Therapie (u.a. Token-System). Die Kontrollgruppe hingegen erhielt die herkömmliche VRT. Die Outcome-Variablen (Aufmerksamkeit, Motivation, Zeit), sowie (neuro-) psychologische und motorische Variablen wurden zu mehreren Zeitpunkten während der Studie gemessen. Es konnten keine signifikanten Ergebnisse für den Einfluss von Motivation und Selbstwirksamkeit auf die Aufmerksamkeit festgestellt werden. Dennoch zeigte die Interventionsgruppe höhere Werte in Motivation und Aufmerksamkeit als die Kontrollgruppe. Des Weiteren konnten die Proband_innen höhere Ergebnisse der motorischen Verbesserung aufweisen als Proband_innen der Kontrollgruppe. Es bleibt zu untersuchen, ob die Ergebnisse keine Signifikanz aufweisen konnten aufgrund der geringen Stichprobengröße oder aufgrund fehlender Effekte. Jedoch zeigen die Ergebnisse erstmalig den Einfluss von Feedbackgaben in der standardisierten VST, sodass Erkenntnisse aus dieser Studie zur Weiterentwicklung von VST-Systemen verwendet werden können.