CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions

Gunther Eysenbach, CONSORT-EHEALTH Group, David Moher, Lee Ritterband, Helen Christensen, Susan Stoner, Filip Drozd, Matthijs Blankers, Rik Crutzen, Robert Tait, David Mohr, Doug Evans, Robin Kok, Sorayouth Chumnanvej, Pongsak Kooprasertying, Stephen Anthony, Lucy Wanjuki Kivuti, Karen Hambly, J W M Aarts, Judith Prins, Isabel De la Torre, Royer Cook, Betty C Jung, Richard Burkhard, Armando Ruiz-Baques, Elia Gabarron, Alireza Ahmadvand, Stephen Gentles, Sylvia Kauer, Ólöf Birna Kristjánsdóttir, Rajneesh Choubisa, Emmanuel Kusi Achampong, Daniel Arvidsson, Marie-Pierre Gagnon, Mahmut Gurgan, Steven Daviss, Erin Mathieu, Michel Labrecque, Hansen Gottlieb Anders, Tuomas Lehto, Eleni Kaldoudi, Atle Klovning, Ming-Yuan Chih, Konstantinos Antypas, Hilde Eide, Terry Lewin, Fung Lin Elean Leung, Jessica Ancker, Juanita Fernando, Patrick M Archambault, Rodrigo Dias, Annie Lau, Peter Beck, Evan Mayo-Wilson, Brigitte Bewick, Gunther Eysenbach, CONSORT-EHEALTH Group, David Moher, Lee Ritterband, Helen Christensen, Susan Stoner, Filip Drozd, Matthijs Blankers, Rik Crutzen, Robert Tait, David Mohr, Doug Evans, Robin Kok, Sorayouth Chumnanvej, Pongsak Kooprasertying, Stephen Anthony, Lucy Wanjuki Kivuti, Karen Hambly, J W M Aarts, Judith Prins, Isabel De la Torre, Royer Cook, Betty C Jung, Richard Burkhard, Armando Ruiz-Baques, Elia Gabarron, Alireza Ahmadvand, Stephen Gentles, Sylvia Kauer, Ólöf Birna Kristjánsdóttir, Rajneesh Choubisa, Emmanuel Kusi Achampong, Daniel Arvidsson, Marie-Pierre Gagnon, Mahmut Gurgan, Steven Daviss, Erin Mathieu, Michel Labrecque, Hansen Gottlieb Anders, Tuomas Lehto, Eleni Kaldoudi, Atle Klovning, Ming-Yuan Chih, Konstantinos Antypas, Hilde Eide, Terry Lewin, Fung Lin Elean Leung, Jessica Ancker, Juanita Fernando, Patrick M Archambault, Rodrigo Dias, Annie Lau, Peter Beck, Evan Mayo-Wilson, Brigitte Bewick

Abstract

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) was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). While broadly the CONSORT statement can be applied to provide 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: An instrument and checklist 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.

Conflict of interest statement

The author is editor and publisher of JMIR.

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Source: PubMed

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