Zusammenfassung
Eine intransparente, unvollständige und unpräzise Berichtserstattung von Forschungsergebnissen ist ein beständiges Problem in der Bio-Medizinischen Forschung. Dies führt zu einer eingeschränkten Nachvollziehbarkeit von Forschungsergebnissen und schränkt die Übertragbarkeit der Ergebnisse deutlich ein. Auch bei Studien zu digitalen Interventionen im Bereich Electronic-Health (E-Health) ist die intransparente, unvollständige und unpräzise Berichtserstattung von Forschungsergebnissen zunehmend in der Diskussion. Dieser Beitrag verfolgt drei wesentliche Ziele: Es wird dargestellt, warum ein qualitativ hochwertiges Reporting von Studienergebnissen zu digitalen Interventionen von hoher Relevanz ist. Auf dieser Basis werden ausgewählte Reporting Guidelines und Frameworks beschrieben, die für das Berichten von Studienergebnissen zu digitalen Interventionen entwickelt wurden. Zudem werden weitere Elemente beschrieben, die die Berichterstattung unterstützen können, wie etwa ein Evidenzkonzept und allgemeine Entwicklungsmodelle digitaler Interventionen.
‚Proper words in proper places make the true definition of style.‘ ~ Jonathan Swift (2018 [1720])
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsLiteratur
Adu MD, Malabu UH, Callander EJ, Malau-Aduli AE, Malau-Aduli BS (2018) Considerations for the development of mobile phone apps to support diabetes self-management: systematic review. JMIR Mhealth Uhealth 6(6):e10115. https://doi.org/10.2196/10115
Agarwal S, LeFevre AE, Lee J, L’Engle K, Mehl G, Sinha C et al (2016) Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist. BMJ 352:i1174. https://doi.org/10.1136/bmj.i1174
Agarwal S, Lefevre AE, Labrique AB (2017) A call to digital health practitioners: new guidelines can help improve the quality of digital health evidence. JMIR Mhealth Uhealth 5(10):e136. https://doi.org/10.2196/mhealth.6640
Ahmadiankalati M, Steins-Loeber S, Paslakis G (2020) Review of randomized controlled trials using e-Health interventions for patients with eating disorders. Front Psych 11:568. https://doi.org/10.3389/fpsyt.2020.00568
Albrecht U, Kuhn B, Land J, Amelung VE, von Jan U (2018) Nutzenbewertung von digitalen Gesundheitsprodukten (Digital Health) im gesellschaftlichen Erstattungskontext. Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz 61(3):340–348. https://doi.org/10.1007/s00103-018-2696-0
Amina A, Safae A, Mohammed B (2019) Gastroenterology meets machine learning: status quo and quo vadis. Adv Bioinforma 2019:1870975–1870975. https://doi.org/10.1155/2019/1870975
Ann MS, Thomas NR, Abby CK, Christopher DG, Stephen S (2016) IDEAS (integrate, design, assess, and share): a framework and toolkit of strategies for the development of more effective digital interventions to change health behavior. J Med Internet Res 18(12):e317. https://doi.org/10.2196/jmir.5927
Arsenijevic J, Tummers L, Bosma N (2020) Adherence to electronic health tools among vulnerable groups: systematic literature review and meta-analysis. J Med Internet Res 22(2):e11613. https://doi.org/10.2196/11613
Bashi N, Fatehi F, Fallah M, Walters D, Karunanithi M (2018) Self-management education through mHealth: review of strategies and structures. JMIR Mhealth Uhealth 6(10):e10771. https://doi.org/10.2196/10771
Baumel A, Faber K, Mathur N, John MK, Muench F (2017) Enlight: a comprehensive quality and therapeutic potential evaluation tool for mobile and web-based eHealth interventions. J Med Internet Res 19(3):e82. https://doi.org/10.2196/jmir.7270
Beatty L, Binnion C (2016) A systematic review of predictors of, and reasons for, adherence to online psychological interventions. Int J Behav Med 23(6):776–794. https://doi.org/10.1007/s12529-016-9556-9
Blandford A, Gibbs J, Newhouse N, Perski O, Singh A, Murray E (2018) Seven lessons for interdisciplinary research on interactive digital health interventions. Digit Health 4:205520761877032. https://doi.org/10.1177/2055207618770325
Byambasuren O, Sanders S, Beller E, Glasziou P (2018) Prescribable mHealth apps identified from an overview of systematic reviews. Npj Digit Med 1(1):12. https://doi.org/10.1038/s41746-018-0021-9
Cameron DN, Harvey AS (2006) eHealth literacy: essential skills for consumer health in a networked world. J Med Internet Res 8(2):e9. https://doi.org/10.2196/jmir.8.2.e9
Carbonnel F, Ninot G (2019) Identifying frameworks for validation and monitoring of consensual behavioral intervention technologies: narrative review. J Med Internet Res 21(10):e13606. https://doi.org/10.2196/13606
Cavanagh K (2010) Turn on, tune in and (don’t) drop out: engagement, adherence, attrition, and alliance with internet-based interventions. In: Oxford guide to low intensity CBT interventions. Undefined. Oxford University Press, New York, S 227–233. https://doi.org/10.1093/med:psych/9780199590117.003.0021
Champion KE, Parmenter B, McGowan C, Spring B, Wafford QE, Gardner LA et al (2019) Effectiveness of school-based eHealth interventions to prevent multiple lifestyle risk behaviours among adolescents: a systematic review and meta-analysis. Lancet Digit Health 1(5):e206–e221. https://doi.org/10.1016/s2589-7500(19)30088-3
Collins L (2018) Optimization of behavioral, biobehavioral, and biomedical interventions: the multiphase optimization strategy (MOST). Springer International Publishing, Cham
Coravos A, Khozin S, Mandl KD (2019) Developing and adopting safe and effective digital biomarkers to improve patient outcomes. Npj Digit Med 2(1):14. https://doi.org/10.1038/s41746-019-0090-4
DeSmet A, Thompson D, Baranowski T, Palmeira A, Verloigne M, Bourdeaudhuij ID (2016) Is participatory design associated with the effectiveness of serious digital games for healthy lifestyle promotion? A meta-analysis. J Med Internet Res 18(4):e94. https://doi.org/10.2196/jmir.4444
Donkin L, Christensen H, Naismith SL, Neal B, Hickie IB, Glozier N (2011) A systematic review of the impact of adherence on the effectiveness of e-Therapies. J Med Internet Res 13(3):e52. https://doi.org/10.2196/jmir.1772
Enam A, Torres-Bonilla J, Eriksson H (2018) Evidence-based evaluation of eHealth interventions: systematic literature review. J Med Internet Res 20(11):e10971. https://doi.org/10.2196/10971
Eyles H, Jull A, Dobson R, Firestone R, Whittaker R, Morenga LT et al (2016) Co-design of mHealth delivered interventions: a systematic review to assess key methods and processes. Curr Nutr Rep 5(3):160–167. https://doi.org/10.1007/s13668-016-0165-7
Eysenbach G (2005) The law of attrition. J Med Internet Res 7(1):e11. https://doi.org/10.2196/jmir.7.1.e11
Eysenbach G, Group C-E (2011) CONSORT-EHEALTH: improving and standardizing evaluation reports of web-based and mobile health interventions. J Med Internet Res 13(4):e126. https://doi.org/10.2196/jmir.1923
Faes L, Liu X, Wagner SK, Fu DJ, Balaskas K, Sim DA et al (2020) A clinician’s guide to artificial intelligence: how to critically appraise machine learning studies. Transl Vis Sci Technol 9(2):7. https://doi.org/10.1167/tvst.9.2.7
Fischer F (2020) Digitale Interventionen in Prävention und Gesundheitsförderung: Welche Form der Evidenz haben wir und welche wird benötigt? Bundesgesundheitsbl Gesundheitsforsch Gesundheitsschutz:1–7. https://doi.org/10.1007/s00103-020-03143-6
van Gemert-Pijnen JE, Nijland N, van Limburg M, Ossebaard HC, Kelders SM, Eysenbach G, Seydel ER (2011) A holistic framework to improve the uptake and impact of eHealth technologies. J Med Internet Res 13(4):e111. https://doi.org/10.2196/jmir.1672
Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S et al (2014) Reducing waste from incomplete or unusable reports of biomedical research. Lancet 383(9913):267–276. https://doi.org/10.1016/s0140-6736(13)62228-x
Guo C, Ashrafian H, Ghafur S, Fontana G, Gardner C, Prime M (2020) Challenges for the evaluation of digital health solutions – a call for innovative evidence generation approaches. Npj Digit Med 3(1):110. https://doi.org/10.1038/s41746-020-00314-2
Henderson M, Donnachie C (2019) Improving eHealth intervention development and quality of evaluations. Lancet Digit Health 1(5):e194–e195. https://doi.org/10.1016/s2589-7500(19)30106-2
Hennessy M, Heary C, Laws R, Rhoon L, Toomey E, Wolstenholme H, Byrne M (2019) The effectiveness of health professional-delivered interventions during the first 1000 days to prevent overweight/obesity in children: a systematic review. Obes Rev 20(12):1691–1707. https://doi.org/10.1111/obr.12924
Hill AB (1965) The reasons for writing. BMJ 2(5466):870–872. https://doi.org/10.1136/bmj.2.5466.870
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan A-W, Michie S (2014) Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 348(mar073):g1687–g1687. PMID:24609605
Hoque MR, Rahman MS, Nipa NJ, Hasan MR (2020) Mobile health interventions in developing countries: a systematic review. Health Informatics J 26(4):2792–2810. https://doi.org/10.1177/1460458220937102
Johansen M, Thomsen SF (2016) Guidelines for reporting medical research: a critical appraisal. Int Sch Res Notices 2016:1346026. https://doi.org/10.1155/2016/1346026
Karnoe A, Furstrand D, Bang CK, Norgaard O, Kayser L (2018) Assessing competencies needed to engage with digital health services: development of the eHealth literacy assessment toolkit. J Med Internet Res 20(5):e178. https://doi.org/10.2196/jmir.8347
Kowatsch T, Otto L, Harperink S, Cotti A, Schlieter H (2020) A design and evaluation framework for digital health interventions. It – Information Technology 61(5–6):253–263. https://doi.org/10.1515/itit-2019-0019
Kushniruk A, Nøhr C (2016) Participatory design, user involvement and health IT evaluation. In: Evidence-based health informatics. IOS Press BV, Amsterdam
Labrique A, Vasudevan L, Weiss W, Wilson K (2018) Establishing standards to evaluate the impact of integrating digital health into health systems. Glob Health Sci Pract 6(Supplement 1):S5–S17. https://doi.org/10.9745/ghsp-d-18-00230
Lalloo C, Shah U, Birnie KA, Davies-Chalmers C, Rivera J, Stinson J, Campbell F (2017) Commercially available smartphone apps to support postoperative pain self-management: scoping review. JMIR Mhealth Uhealth 5(10):e162. https://doi.org/10.2196/mhealth.8230
Li R, Liang N, Bu F, Hesketh T (2020) The effectiveness of self-management of hypertension in adults using mobile health: systematic review and meta-analysis. JMIR Mhealth Uhealth 8(3):e17776. https://doi.org/10.2196/17776
Linardon J, Fuller-Tyszkiewicz M (2019) Attrition and adherence in smartphone-delivered interventions for mental health problems: a systematic and meta-analytic review. J Consult Clin Psychol 88(1):1–13. https://doi.org/10.1037/ccp0000459
Linardon J, Cuijpers P, Carlbring P, Messer M, Fuller-Tyszkiewicz M (2019) The efficacy of app-supported smartphone interventions for mental health problems: a meta-analysis of randomized controlled trials. World Psychiatry 18(3):325–336. https://doi.org/10.1002/wps.20673
Liu X, Rivera SC, Faes L, di Ruffano LF, Yau C, Keane PA et al (2019) Reporting guidelines for clinical trials evaluating artificial intelligence interventions are needed. Nat Med 25(10):1467–1468. https://doi.org/10.1038/s41591-019-0603-3
Mathews SC, McShea MJ, Hanley CL, Ravitz A, Labrique AB, Cohen AB (2019) Digital health: a path to validation. NPJ Digit Med 2(1):38. https://doi.org/10.1038/s41746-019-0111-3
Mattila E, Lappalainen R, Välkkynen P, Sairanen E, Lappalainen P, Karhunen L et al (2016) Usage and dose response of a mobile acceptance and commitment therapy app: secondary analysis of the intervention arm of a randomized controlled trial. JMIR Mhealth Uhealth 4(3):e90. https://doi.org/10.2196/mhealth.5241
Moore G, Wilding H, Gray K, Castle D (2019) Participatory methods to engage health service users in the development of electronic health resources: systematic review. J Particip Med 11(1):e11474. https://doi.org/10.2196/11474
Murray E, Hekler EB, Andersson G, Collins LM, Doherty A, Hollis C et al (2016) Evaluating digital health interventions key questions and approaches. Am J Prev Med 51(5):843–851. https://doi.org/10.1016/j.amepre.2016.06.008
NICE (2021) Evidence standards framework for digital health technologies. National Institute for Health and Care Excellence. https://www.nice.org.uk/corporate/ecd7/resources/evidence-standardsframework-for-digital-health-technologies-pdf-1124017457605. Zugegriffen am 22.06.2021
Page MJ, Moher D (2017) Evaluations of the uptake and impact of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement and extensions: a scoping review. Syst Rev 6(1):263. https://doi.org/10.1186/s13643-017-0663-8
Pawloski PA, Brooks GA, Nielsen ME, Olson-Bullis BA (2019) A systematic review of clinical decision support systems for clinical oncology practice. J Natl Compr Cancer Netw 17(4):331–338. https://doi.org/10.6004/jnccn.2018.7104
Peiris D, Miranda JJ, Mohr DC (2018) Going beyond killer apps: building a better mHealth evidence base. BMJ Glob Health 3(1):e000676. https://doi.org/10.1136/bmjgh-2017-000676
Piontek K, Hannich H-J (2019) Qualitätssicherung wissenschaftlichen Arbeitens. In: Online Lehrbuch der Medizinischen Psychologie und Medizinischen Soziologie.
Sauerland S (2019) Digitale Gesundheitsinterventionen – Wann braucht es welche Evidenz? KVH J 4/2019:22
Schulz K, Altman DG, Moher D, Group C (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol 63(8):834–840. https://doi.org/10.1016/j.jclinepi.2010.02.005
Schulz K, Antes G, Moher D (2011) CONSORT 2010: Aktualisierte Leitlinie für Berichte randomisierter Studien im Parallelgruppen-Design. DMW – Deutsche Medizinische Wochenschrift 136(08):e20–e23. https://doi.org/10.1055/s-0031-1272980
Short CE, DeSmet A, Woods C, Williams SL, Maher C, Middelweerd A et al (2018) Measuring engagement in eHealth and mHealth behavior change interventions: viewpoint of methodologies. J Med Internet Res 20(11):e292. https://doi.org/10.2196/jmir.9397
Sieverink F, Kelders SM, van Gemert-Pijnen JE (2017) Clarifying the concept of adherence to eHealth technology: systematic review on when usage becomes adherence. J Med Internet Res 19(12):e402. https://doi.org/10.2196/jmir.8578
Swift J (2018 [1720]) Letter to a young gentleman lately entered into holy orders (9 January 1720). In: Radcliffe S (Hrsg) Oxford essential quotes, 6. Aufl. Oxford University Press. https://www.oxfordreference.com/view/10.1093/acref/9780191866692.001.0001/q-oro-ed6-00010553. Zugegriffen am 30.07.2021
Timpel P, Oswald S, Schwarz PEH, Harst L (2020) Mapping the evidence on the effectiveness of telemedicine interventions in diabetes, dyslipidemia, and hypertension: an umbrella review of systematic reviews and meta-analyses. J Med Internet Res 22(3):e16791. https://doi.org/10.2196/16791
Torous J, Firth J, Mueller N, Onnela JP, Baker JT (2017) Methodology and reporting of mobile health and smartphone application studies for Schizophrenia. Harv Rev Psychiatry 25(3):146–154. https://doi.org/10.1097/hrp.0000000000000133
Vandekerckhove P, de Mul M, Bramer WM, de Bont AA (2020) Generative participatory design methodology to develop electronic health interventions: systematic literature review. J Med Internet Res 22(4):e13780. https://doi.org/10.2196/13780
Vilardaga R, Casellas-Pujol E, McClernon JF, Garrison KA (2019) Mobile applications for the treatment of tobacco use and dependence. Curr Addict Rep 6(2):86–97. https://doi.org/10.1007/s40429-019-00248-0
Vogel JP, Dowswell T, Lewin S, Bonet M, Hampson L, Kellie F et al (2019) Developing and applying a „living guidelines“ approach to WHO recommendations on maternal and perinatal health. BMJ Glob Health 4(4):e001683. https://doi.org/10.1136/bmjgh-2019-001683
Wang Y, Min J, Khuri J, Xue H, Xie B, Kaminsky LA, Cheskin LJ (2020) Effectiveness of mobile health interventions on diabetes and obesity treatment and management: systematic review of systematic reviews. JMIR Mhealth Uhealth 8(4):e15400. https://doi.org/10.2196/15400
Warner MM, Kelly JT, Reidlinger DP, Hoffmann TC, Campbell KL (2017) Reporting of Telehealth-Delivered Dietary Intervention Trials in Chronic Disease: Systematic Review. J Med Internet Res 19(12):e410. PMID:29229588
WHO (2018) Classification of digital health interventions v1.0 A shared language to describe the uses of digital technology for health
Zhang R, Nicholas J, Knapp AA, Graham AK, Gray E, Kwasny MJ et al (2019) Clinically meaningful use of mental health apps and its effects on depression: mixed methods study. J Med Internet Res 21(12):e15644. https://doi.org/10.2196/15644
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2022 Der/die Autor(en), exklusiv lizenziert an Springer Fachmedien Wiesbaden GmbH, ein Teil von Springer Nature
About this chapter
Cite this chapter
Kernebeck, S., Busse, T.S., Vollmar, H.C. (2022). Reporting von Studien zu digitalen Interventionen im Gesundheitswesen. In: Lux, T., Köberlein-Neu, J., Müller-Mielitz, S. (eds) E-Health-Ökonomie II. Springer Gabler, Wiesbaden. https://doi.org/10.1007/978-3-658-35691-0_4
Download citation
DOI: https://doi.org/10.1007/978-3-658-35691-0_4
Published:
Publisher Name: Springer Gabler, Wiesbaden
Print ISBN: 978-3-658-35690-3
Online ISBN: 978-3-658-35691-0
eBook Packages: Business and Economics (German Language)