Table 2.
Subitems expanding CONSORT item 5 (description of intervention)
| Subitem | Importance | |
| i) | Mention names, credential, affiliations of the developers, sponsors, and owners [15] (if authors/evaluators are owners or developer of the software, this needs to be declared in a “Conflict of interest” section). | Highly Recommended |
| ii) | Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results. | Highly Recommended |
| iii) | Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was “frozen” during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b). | Highly Recommended |
| iv) | Provide information on quality assurance methods to ensure accuracy and quality of information provided [13], if applicable. |
Highly Recommended |
| v) | Ensure replicability by publishing the source code (preferably as open source), and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting. | Highly Recommended |
| vi) | Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years, also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login. | Highly Recommended |
| vii) | Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained “access to the platform and Internet” [13]. To ensure access for editors/reviewers/readers, consider providing a “backdoor” login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi). | Essential |
| viii) | Describe mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework [6] used to design them (instructional strategy [13], behavior change techniques, persuasive features, etc., see e.g., [17, 18] for terminology). This includes an in-depth description of the content (including where it is coming from and who developed it) [13], “whether [and how] it is tailored to individual circumstances and allows users to track their progress and receive feedback” [15]. This also includes a description of communication delivery channels and – if computer-mediated communication is a component – whether communication was synchronous or asynchronous [15]. It also includes information on presentation strategies [13], including page design principles, average amount of text on pages, presence of hyperlinks to other resources etc. [13]. | Essential |
| ix) | Describe use parameters (e.g., intended “doses” and optimal timing for use) [13]. Clarify what instructions or recommendations were given to the user, for example, regarding timing, frequency, heaviness of use [13], if any, or was the intervention used ad libitum. | Highly Recommended |
| x) | Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention. Detail number and expertise of professionals involved, if any, as well as “type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered” [15]. It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of an RCT setting (discuss under item 21 – generalizability). | Highly Recommended |
| xi) | Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency, etc. [13]. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of an RCT setting (discuss under item 21 – generalizability). | Essential |
| xii) | Describe any co-interventions (including training/support): Clearly state any “interventions that are provided in addition to the targeted eHealth intervention” [13], as eHealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [13]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of an RCT setting (discuss under item 21 – generalizability). | Essential |