Abstract
Existing literature reveals shortcomings in reporting on digital health interventions (DHIs) development and evaluation, resulting in limited traceability and hampered knowledge growth. Despite existing health research reporting guidelines, a specific guideline for the participatory development and evaluation of DHIs is lacking. This study aimed to develop a consensus-based reporting guideline to increase the transparency and comparability of both the participatory development and evaluation of DHIs. Following the methodology recommended by the EQUATOR Network and Mohers et al., a web-based Delphi Study comprising three rounds (two surveys; one workshop) was conducted. An international panel of 66 experts from 23 countries agreed on 68 items for the final reporting guideline, derived from existing reporting guidelines and refined through expert consultation. The final consensus-based reporting guideline ParDE-DHI addresses a significant gap in the systematic reporting of participatory development and evaluation of DHIs. Tailored to the unique challenges of participatory design and research, it enhances the credibility and comparability of study designs and results. This is a crucial step towards promoting best practices and advancing methodological rigor in the field. International and interdisciplinary panel input ensures adaptability and relevance across digital health contexts, ultimately fostering improved participation and knowledge sharing within the research community.
Similar content being viewed by others
Data availability
The datasets generated from this review are available from the corresponding author upon request.
References
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).
Dieudonné, J. et al. Was wird unter einer Public-Health-Intervention verstanden? Ergebnisse eines Delphi-Prozesses im deutschsprachigen Raum. Z. Evidenz. Fortbild.Qualitat. Gesundheitswesen 182-183, 89–97, https://doi.org/10.1016/j.zefq.2023.05.022 (2023).
Acknowledgements
We wish to express our sincere gratitude to all experts who participated in the Delphi study and significantly contributed to the creation of a reporting guideline for the participatory development and evaluation of digital health interventions. This study received no funding.
Funding
Open Access funding enabled and organized by Projekt DEAL.
Author information
Authors and Affiliations
Contributions
V.W. developed and designed the methodology. V.W. also conceptualized and designed the initial draft of the reporting guideline, prepared the two online surveys, and organized the workshop. A.M., J.N., and T.S.B. provided holistic support throughout all phases. After the workshops, V.W. finalized the reporting guideline and obtained further feedback from A.M., J.N., and T.S.B. regarding the wording and form. V.W. wrote the initial draft of the published work, which was then critically reviewed by A.M., J.N., T.S.B., and S.M. The same procedure was followed for the visualizations. All authors constantly accessed and verified the underlying reported data.SM supervised the entire methodological and analytical process.
Corresponding author
Ethics declarations
Competing interests
The authors declare no competing interests.
Additional information
Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary information
Rights and permissions
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
About this article
Cite this article
Weirauch, V., Mainz, A., Nitsche, J. et al. Consensus-based reporting guideline for participatory development and evaluation of digital health interventions. npj Digit. Med. (2026). https://doi.org/10.1038/s41746-026-02355-5
Received:
Accepted:
Published:
DOI: https://doi.org/10.1038/s41746-026-02355-5
