New Reporting Guideline for Digital Health Interventions

World Health Organization (WHO). Classification of Digital Interventions, Services and Applications in Health: a Shared Language to Describe the Uses of Digital Technology for Health, 2nd ed. (WHO, 2023). Haig, M., Main, C., Chávez, D. & Kanavos, P. A value framework to assess patient-facing digital health technologies that aim to improve chronic disease management: a Delphi approach. Value Health J. Int. Soc. Pharmacoecon. Outcomes Res. 26, 1474–1484, https://doi.org/10.1016/j.jval.2023.06.008 (2023). Kilfoy, A. et al. An umbrella review on how digital health intervention co-design is conducted and described. npj Digit. Med. 7, 374, https://doi.org/10.1038/s41746-024-01385-1 (2024). Agarwal, S. et al. Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist (2016). Perrin Franck, C. et al. iCHECK-DH: guidelines and checklist for the reporting on digital health implementations. J. Med. Internet Res. 25, e46694, https://doi.org/10.2196/46694 (2023). Eysenbach, G. CONSORT-EHEALTH: improving and standardizing evaluation reports of web-based and mobile health interventions. J. Med. Internet Res. 13, e126, https://doi.org/10.2196/jmir.1923 (2011). Fischer, F. Digitale Interventionen in Prävention und Gesundheitsförderung: Welche Form der Evidenz haben wir und welche wird benötigt?. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 63, 674–680, https://doi.org/10.1007/s00103-020-03143-6 (2020). Murray, E. et al. Evaluating digital health interventions: key questions and approaches. Am. J. Prev. Med. 51, 843–851, https://doi.org/10.1016/j.amepre.2016.06.008 (2016). Sieverink, F., Kelders, S. M. & van Gemert-Pijnen, J. E. Clarifying the concept of adherence to ehealth technology: systematic review on when usage becomes adherence. J. Med. Internet Res. 19, e402, https://doi.org/10.2196/jmir.8578 (2017). Harst, L., Wollschlaeger, B., Birnstein, J., Fuchs, T. & Timpel, P. Evaluation is key: providing appropriate evaluation measures for participatory and user-centred design processes of healthcare IT. Int. J. Integr. Care 21, 24, https://doi.org/10.5334/ijic.5529 (2021). Staniszewska, S. et al. GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. BMJ (Clin. Res. ed.) 358, j3453, https://doi.org/10.1136/bmj.j3453 (2017). Kernebeck, S. & Fischer, F. Theoretische, methodische und organisatorische Fragestellungen. In Partizipative Technikentwicklung im Sozial- und Gesundheitswesen, edited by S. Kernebeck & F. Fischer 25–36 (Hogrefe AG, Bern, 2024). International Collaboration for Participatory Health Research (ICPHR). Position Paper 1: What is Participatory Health Research? Available at https://www.icphr.org/position-papers--discussion-papers/position-paper-no-1 (2013). Bødker, S., Dindler, C., Iversen, O. S. & Smith, R. C. What Is Participatory Design? In Participatory Design Synthesis Lectures on Human-Centered Informatics (2022), pp. 5–13. Vargas, C., Whelan, J., Brimblecombe, J. & Allender, S. Co-creation, co-design, co-production for public health - a perspective on definition and distinctions. Public Health Res. Pract. 32; https://doi.org/10.17061/phrp3222211 (2022). Vandekerckhove, P., de Mul, M., Bramer, W. M. & de Bont, A. A. Generative participatory design methodology to develop electronic health interventions: systematic literature review. J. Med. Internet Res. 22, e13780. https://doi.org/10.2196/13780 (2020). Vaughn, L. M. & Jacquez, F. Participatory research methods – choice points in the research process. J. Particip. Res. Methods 1; https://doi.org/10.35844/001c.13244 (2020). Nguyen, Q. Evaluation in participatory design – the whys and the nots, 161–166; https://doi.org/10.1145/3537797.3537828 (2022). Messina, A. et al. Participatory methods in designing digital health interventions for informal caregivers of people with dementia. A systematic review. Internet Interv. 39, 100799. https://doi.org/10.1016/j.invent.2024.100799 (2025). Busse, T. S. et al. Involving health care professionals in the development of electronic health records: scoping review. JMIR Hum. factors 10, e45598, https://doi.org/10.2196/45598 (2023). Weirauch, V., Soehnchen, C., Burmann, A. & Meister, S. Methods, indicators, and end-user involvement in the evaluation of digital health interventions for the public: scoping review. J. Med. Internet Res. 26, e55714, https://doi.org/10.2196/55714 (2024). Kernebeck, S. et al. Digitale Gesundheitsinterventionen entwickeln, evaluieren und implementieren Teil II – Diskussionspapier der Arbeitsgruppe Digital Health des Deutschen Netzwerk Versorgungsforschung (DNVF). Gesundheitswesen (Bundesverb. Arzte Offentlichen Gesundheitsdienstes) 85, 65–70, https://doi.org/10.1055/a-1915-4371 (2023). Merkel, S. & Kucharski, A. Participatory design in gerontechnology: a systematic literature review. Gerontologist 59, e16–e25, https://doi.org/10.1093/geront/gny034 (2019). Duncan, E. et al. Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study. BMJ Open 10, e033516, https://doi.org/10.1136/bmjopen-2019-033516 (2020). Hoffmann, T. C. et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ (Clin. Res. ed.) 348, g1687, https://doi.org/10.1136/bmj.g1687 (2014). Niederberger, M. et al. Delphi studies in social and health sciences-recommendations for an interdisciplinary standardized reporting (DELPHISTAR). Results of a Delphi study. PloS One 19, e0304651, https://doi.org/10.1371/journal.pone.0304651 (2024). Moher, D., Schulz, K. F., Simera, I. & Altman, D. G. Guidance for developers of health research reporting guidelines. PLOS Med. 7, e1000217, https://doi.org/10.1371/journal.pmed.1000217 (2010). Weirauch, V., Mainz, A., Busse, T. S., Nitsche, J. & Meister, S. Development and consensus of a reporting guideline for the participatory evaluation of Digital Health Interventions: Delphi Study Protocol. Delphi Study Protocol; https://doi.org/10.17605/OSF.IO/8SWEK (2024). EQUATOR Network. The EQUATOR Network register of reporting guidelines under development. Reporting guidelines under development for other study designs. Available at: https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-other-study-designs/#DigHealthInt (2025). Husereau, D. et al. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. BMJ (Clin. Res. ed.) 376, e067975, https://doi.org/10.1136/bmj-2021-067975 (2022). Tong, A., Sainsbury, P. & Craig, J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups (2007). Elm et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J. Clin. Epidemiol. 61, 344–349, https://doi.org/10.1016/j.jclinepi.2007.11.008 (2008). Gattrell, W. T. et al. ACCORD (ACcurate COnsensus Reporting Document): a reporting guideline for consensus methods in biomedicine developed via a modified Delphi. PLOS Med. 21, e1004326, https://doi.org/10.1371/journal.pmed.1004326 (2024). Niederberger, M. & Deckert, S. Das Delphi-Verfahren: Methodik, Varianten und Anwendungsbeispiele. Z. Evidenz Fortbild. Qualitat Gesundheitswesen 174, 11–19, https://doi.org/10.1016/j.zefq.2022.08.007 (2022). Jacob, C. et al. A sociotechnical framework to assess patient-facing eHealth tools: results of a modified Delphi process. npj Digit. Med. 6, 232, https://doi.org/10.1038/s41746-023-00982-w (2023).