Health Evaluation and Referral Assistant: A Randomized Controlled Trial of a Web-Based Screening, Brief Intervention, and Referral to Treatment System to Reduce Risky Alcohol Use Among Emergency Department Patients

Background Computer technologies hold promise for implementing alcohol screening, brief intervention, and referral to treatment (SBIRT). Questions concerning the most effective and appropriate SBIRT model remain. Objective The aim of this study was to evaluate the impact of a computerized SBIRT system called the Health Evaluation and Referral Assistant (HERA) on risky alcohol use treatment initiation. Methods Alcohol users (N=319) presenting to an emergency department (ED) were considered for enrollment. Those enrolled (n=212) were randomly assigned to the HERA, to complete a patient-administered assessment using a tablet computer, or a minimal-treatment control, and were followed for 3 months. Analyses compared alcohol treatment provider contact, treatment initiation, treatment completion, and alcohol use across condition using univariate comparisons, generalized estimating equations (GEEs), and post hoc chi-square analyses. Results HERA participants (n=212; control=115; intervention=97) did not differ between conditions on initial contact with an alcohol treatment provider, treatment initiation, treatment completion, or change in risky alcohol use behavior. Subanalyses indicated that HERA participants, who accepted a faxed referral, were more likely to initiate contact with a treatment provider and initiate treatment for risky alcohol use, but were not more likely to continue engaging in treatment, or to complete treatment and change risky alcohol use behavior over the 3-month period following the ED visit. Conclusions The HERA promoted initial contact with an alcohol treatment provider and initiation of treatment for those who accepted the faxed referral, but it did not lead to reduced risky alcohol use behavior. Factors which may have limited the HERA’s impact include lack of support for the intervention by clinical staff, the low intensity of the brief and stand-alone design of the intervention, and barriers related to patient follow-through, (eg, a lack of transportation or childcare, fees for services, or schedule conflicts). Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): NCT01153373; https://clinicaltrials.gov/ct2/show/NCT01153373 (Archived by WebCite at http://www.webcitation.org/6pHQEpuIF)

TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") yes Other:

1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   The title does include target group: "Health Evaluation and Referral Assistant: a randomized controlled trial of a web-based screening, brief intervention and referral to treatment system to reduce risky alcohol use among emergency department patients" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Methods: Alcohol users (n=319) presenting to an emergency department were considered for enrollment. Those enrolled (n=212) were randomly assigned to the HERA, to complete a patient-administered assessment using a tablet computer, or a minimal-treatment Control, and were followed for three months. Analyses compared alcohol treatment provider contact, treatment initiation, treatment completion, and alcohol use across condition using univariate comparisons, Generalized Estimating Equations (GEE), and post-hoc chi-square analyses."

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   The HERA is a stand-alone, self-administered, web-based assessment completed by the patients. "Alcohol users (n=319) presenting to an emergency department were considered for enrollment. Those enrolled (n=212) were randomly assigned to the HERA, to complete a patient-administered assessment using a tablet computer, or a minimal-treatment Control, and were followed for three months."

1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT
Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional offline trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Participants were approached and enrolled in person during their emergency department visit, and those who enrolled and randomized to the HERA intervention condition completed the self administered web-based assessment. All received minimal treatment counseling from clinicians as typical treatment in addition to randomization into the HERA intervention.

1b-iv) RESULTS section in abstract must contain use data
Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5

Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "HERA participants (n=212: control=115; intervention=97) did not differ between conditions on initial contact with an alcohol treatment provider, treatment initiation, treatment completion, or change in risky alcohol use behavior. Subanalyses indicated HERA participants who accepted a faxed referral were more likely to initiate contact with a treatment provider and initiate treatment for risky alcohol use, but were not more likely to continue engaging in treatment, or to complete treatment and change risky alcohol use behavior over the 3 month period post visit."

1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials
Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "HERA promoted initial contact with an alcohol treatment provider and initiation of treatment for those who accepted the faxed referral, but it did not lead to reduced risky alcohol "use behavior. Factors which may have limited the HERA's impact include lack of support for the intervention by clinical staff, the low intensity of the brief and stand-alone design of the intervention, and barriers related to patient follow-through, (e.g., a lack of transportation or childcare, fees for services, and/or schedule conflicts)."

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as standalone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Patients were enrolled from four EDs (see Table 1) between 8 AM and 7 PM, with shifts occurring every day of the week. Research assistants (RAs) approached all adult patients at their bedside during their ED visit. Patients 18 years and older with risky alcohol use were considered."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified. An evaluation version of novaPDF was used to create this PDF file. Purchase a license to generate PDF files without this notice.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "The HERA is a self-administered patient assessment completed on a tablet computer during the ED visit. The assessment was designed to require no computer literacy beyond the ability to read at the 8th grade reading level and respond to questions using a numeric keypad or stylus." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Patients were enrolled in person from four EDs (see Table 1) between 8 AM and 7 PM during their ED visit. Research assistants (RAs) approached all adult patients at their bedside during their ED visit. Patients 18 years and older with risky alcohol use were considered. "The HERA is a self-administered patient assessment completed on a tablet computer during the ED visit."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
An evaluation version of novaPDF was used to create this PDF file. Purchase a license to generate PDF files without this notice.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Research assistants (RAs) approached all adult patients at their bedside during their ED visit. Patients 18 years and older with risky alcohol use were considered." "All participants gave their informed consent and signed a written consent form prior to inclusion in the study." 4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Online questionnaires were not used to obtain outcomes.

4b-ii) Report how institutional affiliations are displayed
Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Institutional affiliations were disclosed as part of the informed consent process.
5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Developers are not discussed in this paper, but are discussed in the previously published papers detailing the methods of this study [26,34].
The prototype of the HERA was called the Dynamic Assessment and Referral System for Substance Abuse (DARSSA). The name was changed to reflect our long-term plans to expand the system to provide SBIRT for other non-substance problems, like depression and interpersonal violence.

 
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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Methods process is not discussed in this paper, but is discussed in the cited, previously published papers detailing the methods of this study [26,34].
To arrive at more design principles focus groups were conducted. Interviews were also conducted with 65 healthcare professionals from a variety of medical specialties to represent a range of provider types, as well as 13 tobacco, alcohol, and drug-using medical patients [34].

5-iii) Revisions and updating
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).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   N/A

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   This is not discussed in this paper.

5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used
Ensure replicability by publishing the source code, 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. 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   We did not because the content is proprietary.

5-vi) Digital preservation
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.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   N/A, the software is proprietary

5-vii) Access
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" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Patients 18 years and older with risky alcohol use were considered." "Research assistants (RAs) approached all adult patients at their bedside during their ED visit." "The HERA is a self-administered patient assessment completed on a tablet computer during the ED visit." subitem not at all important essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Participants in the intervention condition (HERA) (1) were offered a dynamic referral, (2) their treating physician received the Healthcare Provider Report, and (3) the patient received the Patient Feedback Report with a tailored referral list. Participants assigned to the minimal intervention control condition (Control) were given a standardized, printed list of local treatment providers instead of dynamic referrals and Healthcare Provider Reports were not made available."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.

Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Participants meeting eligibility criteria and who consented to participate were offered the HERA service once during their ED visit.
"Research assistants (RAs) approached all adult patients at their bedside during their ED visit." "Patients 18 years and older with risky alcohol use were considered. Risky alcohol users were defined as having used

5-x) Clarify the level of human involvement
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". 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 a RCT setting (discuss under item 21generalizability). An evaluation version of novaPDF was used to create this PDF file. Purchase a license to generate PDF files without this notice.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Designed as a stand-alone, automated, SBIRT system, clinician involvement was kept to a minimum. Research assistants introduced the service, obtained informed consent, and were present to troubleshoot any technical or user difficulties with the system. Providers were also encouraged, but not required, to counsel patients in response to their feedback report, for the intervention condition, and provided minimal treatment for the control condition.

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. 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 a RCT setting (discuss under item 21 -generalizability).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   For those who accepted a faxed referral to treatment, the treatment provider called the patient to initiate treatment within 48 hours of receiving the faxed referral. Follow-up calls were also performed by trained research assistants.
"If accepted by the patient, the dynamic referral was faxed by the HERA to a matched treatment facility, along with a brief assessment summary and the patient's contact information. The participating services had agreed to contact the patient within 48

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. 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 a RCT setting (discuss under item 21 -generalizability.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "...the HERA is designed to offer brief intervention and referral to treatment as a stand-alone service." "Intervention and control conditions were treated the same in all aspects of the study procedures; however the groups differed on the type of referral and availability of reports. Participants in the intervention condition (HERA) (1) were offered a dynamic referral, (2) received the Patient Feedback Report with a tailored referral list, and (3) their treating physician received the Healthcare 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Post-visit interview. Immediately after patients were discharged/transferred from the ED, the enrolling RA completed a brief interview to establish whether the treating clinicians provided alcohol treatment counseling, education materials, or referrals for alcohol use treatment. Chart review was not used because of unreliability associated with documentation.
Follow-up assessment. All participants were phoned by an RA and asked if they had initiated contact with an alcohol treatment 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].

Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text   Online questionnaires were not used to obtain outcomes.

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text   Intensity of use was not measured, it is a one time interaction.

6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained
Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

2 3 4 5
subitem not at all important essential

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text   Qualitative feedback was welcome from participants in the form of questions, comments, and suggestions for improvement. Research assistants also observed participants and noted barriers to using the system. This is discussed in the cited, previously published papers detailing the methods of this study [26,34].

Boudreaux ED, Abar B, Baumann BM, Grissom G. A
6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   There were no such changes.
7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   We powered for an attrition rate of 20%

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   N/A 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   N/A 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Participants were randomized to either the intervention or control condition by a random number generator from the Java programming language standard library embedded within the HERA." 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Software used a random number generator that was embedded, and occurred after the patient consented and completed the assessment.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   A random number generator was used to randomize. Research assistants enrolled the patients, but the assignment was done by the random number generator programmed into the HERA.
11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any). An evaluation version of novaPDF was used to create this PDF file. Purchase a license to generate PDF files without this notice.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   This is discussed briefly in the paper and more in depth in the cited, previously published papers detailing the methods of this study [26,34].
"The RA who performed the outcome assessments was partially blinded. Because the HERA is heavily focused on the referral process, and not all patients received the same type of referrals, to avoid confusion, the follow-up questions were tailored to the referral type received at baseline (printed list vs. dynamic 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator". 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   This is discussed in the cited, previously published papers detailing the methods of this study [26,34].
Patients were partially blinded to group assignment in order to minimize bias 26. Boudreaux ED, Abar B, Baumann BM, Grissom G. A randomized clinical trial of the health evaluation and referral assistant (HERA): research methods. Contemp Clin Trials. 2013 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Study Conditions Intervention and control conditions were treated the same in all aspects of the study procedures; however the groups differed on the type of referral and availability of reports. Participants in the intervention condition (HERA) (1) were offered a dynamic referral, (2) received the Patient Feedback Report with a tailored referral list, and (3) their treating physician received the Healthcare Provider Report. Participants assigned to the minimal intervention control condition (Control) were given a standardized, printed list 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Data Analyses Baseline characteristics (e.g., demographics, alcohol use) were compared across intervention conditions using χ² tests of independence and independent samples t-tests to confirm randomization success, and the potential for differential retention rates across conditions was examined using χ² tests of independence. Our primary outcomes (i.e., alcohol treatment provider contact, treatment initiation, alcohol use) were then compared across conditions at one and three months using

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Missing data/attrition at follow-up was addressed using standard intention-to-treat principles whereby the least favorable outcome (e.g., no provider contact, no treatment completion) was assigned to missing data points. Given the use of these principles, the frequencies presented in each table represent observed data while the percentages represent intention-to-treat estimates." 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "We then performed a series of analyses comparing participants in three distinct groups: the control condition, the intervention condition that declined a dynamic referral to providers (Tailored List Only), and the intervention condition that accepted a dynamic referral (Dynamic Referral). Because this categorization allows for preexisting differences across groups (particularly between the Tailored List and Dynamic Referral groups), these models included theoretically relevant covariates that might impact the outcomes of interest (baseline AUDIT scores and readiness to X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)

X26-i) Comment on ethics committee approval
1 2 3 4 5 subitem not at all important essential

Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "This study was approved by the Institutional Review Boards for all data collection sites, in accordance with the ethical standards of the Helsinki Declaration of 1975. All participants gave their informed consent and signed a written consent form prior to inclusion in the study."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   This is discussed in the cited, previously published papers detailing the methods of this study [26,34].
Verbal consent was first obtained to complete the rapid screener for eligibility. If the individual tested positive for at least one substance examined by the study, and was eligible by all other criteria, willing to participate in the clinical trial as explained, written consent was then obtained [26].

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Standard procedures surrounding data confidentiality and safety were used, such as storage on secure servers, and all research staff were trained and certified on human subjects protections procedures.

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other figures or tables demonstrating usage/dose/engagement. 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the figure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

 
No. This is a one-time use, stand-alone intervention administered in the emergency department during an emergent visit. The program is not repeatedly used by patients over time.
14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Recruitment period was from 5/17/2010-5/27/2011 and follow up period was 8/23/2010-09/16/2011.

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   None noted.
14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study  

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known. 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Of 319 alcohol users who met eligibility criteria and did not report any drug use, 212 individuals were enrolled (see Figure 1).

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).

Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Yes, this was done.
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   This was reported.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   N/A 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Done 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Of the analyzed participants, 196 out of 212 (92.5%) completed the post-visit interview, 157 out of 212 (74.1%) completed the onemonth follow-up, and 157 out of 212 (74.1%) completed the threemonth follow-up (see Figure 1). There were no differences between retained individuals and those lost to follow-up on age (P = .99; .17 respectively), baseline AUDIT scores (P = .62; .34), mental health diagnoses (P = .27-.81; .09-.74), or readiness to change (P = .58; .21). However, at the three-month follow-up, there were more control individuals retained (95/115; 83%) than

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii). 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Yes, this was done.

19) All important harms or unintended effects in each group
(for specific guidance see CONSORT for harms) Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   None noted.

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   None noted.

19-ii) Include qualitative feedback from participants or observations from staff/researchers
Include qualitative feedback from participants or observations from staff/researchers, if available, on strengths and shortcomings of the application, especially if they point to unintended/unexpected effects or uses. This includes (if available) reasons for why people did or did not use the application as intended by the developers.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   No, we did not collect it.

22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group

22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use)
Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

 
The HERA aims to satisfy clinical practice mandates for screening, brief intervention, and referral to treatment for risky alcohol users in the ED setting. For those who accepted the dynamic referral, the HERA was effective at promoting contact with an alcohol treatment provider and initiating risky alcohol use treatment. Unfortunately, when employed as a stand-alone intervention, the HERA did not lead to sustained treatment engagement or changes in alcohol use during the three months following the initial ED visit. These results raise two questions: (1)

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.

Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Future research should examine the efficacy of automated referral systems for alcohol treatment among all alcohol users." "Barriers to patient follow-through in systems like the HERA should be explored in future studies." "Future technology-facilitated interventions may need to integrate motivational tools for behavior change, such as interactive multimedia content and/or longitudinal interaction beyond the ED visit.

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "Limitations Firstly, because a minimal treatment control group was used, rather than true treatment as usual, the assessment and resource list provided to the minimal treatment control group may have had an intervention effect and artificially inflated treatment contact and behavior change in the control group. Secondly, the use of a modified AUDIT allowed for time-sensitive brief assessment of alcohol use, but assessed use over a shorter time period than other methods, such as the Timeline Follow Back, and may not 21) Generalisability (external validity, applicability) of the trial findings NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "By focusing solely on alcohol users who used alcohol above the AUDIT quantity/frequency guidelines and who had not used illicit drug in the past 12 months, the generalizability of the results is limited. Future research should examine the efficacy of automated referral systems for alcohol treatment among all alcohol users."

21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting
Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.

Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "The HERA was designed as a one-time, brief interaction due to the fast-paced ED environment filled with competing demands for time and resources. Minimizing the intervention for this purpose could have adversely affected the HERA's potential for clinical impact. The brief encounter with the HERA, while efficient and time-saving for clinicians, may not be powerful enough to support long-term changes in alcohol use behavior. Future technologyfacilitated interventions may need to integrate motivational tools for behavior change, such as interactive multi-media content

23) Registration number and name of trial registry
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   ClinicalTrials.gov number NCT01153373 24) Where the full trial protocol can be accessed, if available Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   Visit the website clinicaltrials.gov 25) Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study   "This study was funded by a Small Business Technology Transfer grant from the National Institutes of Health (R42DA021455) to Polaris Health Directions, Inc."