TY - JOUR
T1 - ConSORT-eHealth
T2 - improving and standardizing evaluation reports of web-based and mobile health interventions
AU - Eysenbach, Gunther
AU - CONSORT-EHEALTH Group
AU - Stoner, Susan
AU - Drozd, Filip
AU - Blankers, Matthijs
AU - Crutzen, Rik
AU - Tait, Robert
AU - Mohr, David
AU - Evans, Doug
AU - Kok, Robin
AU - Chumnanvej, Sorayouth
AU - Kooprasertying, Pongsak
AU - Anthony, Stephen
AU - Kivuti, Lucy Wanjuki
AU - Hambly, Karen
AU - Aarts, J. W. M.
AU - Prins, Judith
AU - de la Torre, Isabel
AU - Cook, Royer
AU - Jung, Betty C.
AU - Burkhard, Richard
AU - Ruiz-Baques, Armando
AU - Gabarron, Elia
AU - Ahmadvand, Alireza
AU - Gentles, Stephen
AU - Kauer, Sylvia
AU - Kristjánsdóttir, Ólöf Birna
AU - Choubisa, Rajneesh
AU - Achampong, Emmanuel Kusi
AU - Arvidsson, Daniel
AU - Gagnon, Marie Pierre
AU - Gurgan, Mahmut
AU - Daviss, Steven
AU - Mathieu, Erin
AU - Labrecque, Michel
AU - Anders, Hansen Gottlieb
AU - Lehto, Tuomas
AU - Kaldoudi, Eleni
AU - Klovning, Atle
AU - Chih, Ming Yuan
AU - Antypas, Konstantinos
AU - Eide, Hilde
AU - Lewin, Terry
AU - Leung, Fung Lin Elean
AU - Ancker, Jessica
AU - Fernando, Juanita
AU - Archambault, Patrick M.
AU - Dias, Rodrigo
AU - Lau, Annie
AU - Beck, Peter
AU - Mayo-Wilson, Evan
AU - Bewick, Brigitte
N1 - Copyright the Author(s) 2011. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.
PY - 2011/10
Y1 - 2011/10
N2 - Background: Web-based and mobile health interventions (also called "Internet interventions" or "eHealth/mHealth interventions") are tools or treatments, typically behaviorally based, that are operationalized and transformed for delivery via the Internet or mobile platforms. These include electronic tools for patients, informal caregivers, healthy consumers, and health care providers. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported, RCTs of web-based interventions pose very specific issues and challenges, in particular related to reporting sufficient details of the intervention to allow replication and theory-building. Objective: To develop a checklist, dubbed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth), as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions. Methods: A literature review was conducted, followed by a survey among eHealth experts and a workshop. Results: A checklist instrument was constructed as an extension of the CONSORT statement. The instrument has been adopted by the Journal of Medical Internet Research (JMIR) and authors of eHealth RCTs are required to submit an electronic checklist explaining how they addressed each subitem. Conclusions: CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials. Subitems describing how the intervention should be reported can also be used for non-RCT evaluation reports. As part of the development process, an evaluation component is essential; therefore, feedback from authors will be solicited, and a before-after study will evaluate whether reporting has been improved.
AB - Background: Web-based and mobile health interventions (also called "Internet interventions" or "eHealth/mHealth interventions") are tools or treatments, typically behaviorally based, that are operationalized and transformed for delivery via the Internet or mobile platforms. These include electronic tools for patients, informal caregivers, healthy consumers, and health care providers. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported, RCTs of web-based interventions pose very specific issues and challenges, in particular related to reporting sufficient details of the intervention to allow replication and theory-building. Objective: To develop a checklist, dubbed CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth), as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions. Methods: A literature review was conducted, followed by a survey among eHealth experts and a workshop. Results: A checklist instrument was constructed as an extension of the CONSORT statement. The instrument has been adopted by the Journal of Medical Internet Research (JMIR) and authors of eHealth RCTs are required to submit an electronic checklist explaining how they addressed each subitem. Conclusions: CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials. Subitems describing how the intervention should be reported can also be used for non-RCT evaluation reports. As part of the development process, an evaluation component is essential; therefore, feedback from authors will be solicited, and a before-after study will evaluate whether reporting has been improved.
KW - Evaluation
KW - Guidelines
KW - Internet
KW - Medical informatics
KW - Mobile health
KW - Publishing standards
KW - Quality control
KW - Randomized controlled trials as topic
KW - Reporting standards
UR - http://www.scopus.com/inward/record.url?scp=84856256514&partnerID=8YFLogxK
U2 - 10.2196/jmir.1923
DO - 10.2196/jmir.1923
M3 - Article
C2 - 22209829
AN - SCOPUS:84856256514
SN - 1438-8871
VL - 13
SP - 1
EP - 10
JO - Journal of Medical Internet Research
JF - Journal of Medical Internet Research
IS - 4
M1 - e126
ER -