Effectiveness of a Conversational Chatbot (Dejal@bot) for the Adult Population to Quit Smoking: Pragmatic, Multicenter, Controlled, Randomized Clinical Trial in Primary Care

Background Tobacco addiction is the leading cause of preventable morbidity and mortality worldwide, but only 1 in 20 cessation attempts is supervised by a health professional. The potential advantages of mobile health (mHealth) can circumvent this problem and facilitate tobacco cessation interventions for public health systems. Given its easy scalability to large populations and great potential, chatbots are a potentially useful complement to usual treatment. Objective This study aims to assess the effectiveness of an evidence-based intervention to quit smoking via a chatbot in smartphones compared with usual clinical practice in primary care. Methods This is a pragmatic, multicenter, controlled, and randomized clinical trial involving 34 primary health care centers within the Madrid Health Service (Spain). Smokers over the age of 18 years who attended on-site consultation and accepted help to quit tobacco were recruited by their doctor or nurse and randomly allocated to receive usual care (control group [CG]) or an evidence-based chatbot intervention (intervention group [IG]). The interventions in both arms were based on the 5A’s (ie, Ask, Advise, Assess, Assist, and Arrange) in the US Clinical Practice Guideline, which combines behavioral and pharmacological treatments and is structured in several follow-up appointments. The primary outcome was continuous abstinence from smoking that was biochemically validated after 6 months by the collaborators. The outcome analysis was blinded to allocation of patients, although participants were unblinded to group assignment. An intention-to-treat analysis, using the baseline-observation-carried-forward approach for missing data, and logistic regression models with robust estimators were employed for assessing the primary outcomes. Results The trial was conducted between October 1, 2018, and March 31, 2019. The sample included 513 patients (242 in the IG and 271 in the CG), with an average age of 49.8 (SD 10.82) years and gender ratio of 59.3% (304/513) women and 40.7% (209/513) men. Of them, 232 patients (45.2%) completed the follow-up, 104/242 (42.9%) in the IG and 128/271 (47.2%) in the CG. In the intention-to-treat analysis, the biochemically validated abstinence rate at 6 months was higher in the IG (63/242, 26%) compared with that in the CG (51/271, 18.8%; odds ratio 1.52, 95% CI 1.00-2.31; P=.05). After adjusting for basal CO-oximetry and bupropion intake, no substantial changes were observed (odds ratio 1.52, 95% CI 0.99-2.33; P=.05; pseudo-R2=0.045). In the IG, 61.2% (148/242) of users accessed the chatbot, average chatbot-patient interaction time was 121 (95% CI 121.1-140.0) minutes, and average number of contacts was 45.56 (SD 36.32). Conclusions A treatment including a chatbot for helping with tobacco cessation was more effective than usual clinical practice in primary care. However, this outcome was at the limit of statistical significance, and therefore these promising results must be interpreted with caution. Trial Registration Clinicaltrials.gov NCT 03445507; https://tinyurl.com/mrnfcmtd International Registered Report Identifier (IRRID) RR2-10.1186/s12911-019-0972-z

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.

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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

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support"). Does your paper address subitem 1a-ii?
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

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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 Smokers over the age of 18 years who attended on-site consultation and accepted help to quit tobacco were recruited by their doctor or nurse and randomly allocated to receive usual care (control group [CG]) or an evidence-based chatbot intervention (intervention group [IG]). The interventions in both arms were based on the 5A's (ie, Ask, Advise, Assess, Assist, and Arrange) in the US Clinical Practice Guideline, which combines behavioral and pharmacological treatments and is structured in several follow-up appointments.
subitem not at all important 1 2 3 4 5 essential 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)
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 Smokers over the age of 18 years who attended on-site consultation and accepted help to quit tobacco were recruited by their doctor or nurse and randomly allocated to receive usual care (control group [CG]) or an evidence-based chatbot intervention (intervention group [IG]). 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)
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

INTRODUCTION
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

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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

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 stand-alone 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)

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Does your paper address subitem 2a-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 Tobacco addiction is the leading cause of preventable morbidity and mortality in the world. However, only 1 in 20 cessation attempts is supervised by a health professional. The potential advantages of mobile technologies for health (mHealth) can circumvent these problems and facilitate tobacco-cessation interventions for public health systems. Given its easy scalability to large populations, chatbots are a potentially useful complement to usual treatment, with the consequent savings, whether they are integrated into a global plan for aiding smokers to quit or used alone. METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * 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 aim of this study was to assess the effectiveness of a chatbot, with an evidence-based design and including elements of AI and natural language processing, for helping people stop smoking compared with clinical practice in primary care.
Does your paper address CONSORT subitem 3a? * 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 a pragmatic, multicenter, controlled, and randomized clinical trial. The study was conducted in 34 primary health care centers in the Community of Madrid region (Spain) and had a follow-up period of 6 months.
subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 3b? * 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 trial protocol was previously registered [19] and no changes were made to the methods, intervention, or comparator, except for an additional analysis by subgroups, which was not included in the initial study design.

3b-i) Bug fixes, Downtimes, Content Changes
Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].

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Does your paper address subitem 3b-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 trial protocol was previously registered [19] and no changes were made to the methods, intervention, or comparator, except for an additional analysis by subgroups, which was not included in the initial study design.
subitem not at all important 1 2 3 4 5 essential 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 included must have smoked at least one cigarette over the previous month, accept professional help for quitting in the following month, own a smartphone in which a messaging app (Telegram) could be installed, confirm their availability to be reached for 6 months following the intervention, and provide informed written consent.

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.

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Does your paper address subitem 4a-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 Computer or internet illiteracy of patients was not assessed. 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 webbased 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.

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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 included were smokers aged over 18 years who visited their doctor or nurse for consultation for any reason during the inclusion period 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. Does your paper address subitem 4a-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 ..and provide informed written consent. Sent as Multimedia Appendix 3 and 4 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 Family practitioners and nurses from the 262 health care centers in the Madrid Health Service were offered to participate.
4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
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 Family practitioners and nurses from the 262 health care centers in the Madrid Health Service were offered to participate.

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).

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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 JFA-T, EO-E, and CM-L designed the chatbot and own the intellectual property rights. The remaining research team members (authors, developers, and sponsors) were not involved in the development of the intervention.

5-ii) Describe the history/development process
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. 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 A pilot test was conducted prior to the beginning of the clinical trial to assess usability and to train the AI categories. The final version from the pilot study (February 2018) was implemented in the randomized controlled trial and its content was not modified at any stage.
Dejal@bot was developed based on scientific evidence by doctors with expertise in tobacco use and ICTs between 2015 and 2018 (see Multimedia Appendix 5 for screenshots of the app). Its internal structure is a script recreating the interaction between a professional and a patient that takes numerous variants as required by the patient's needs and characteristics. The chatbot is bidirectional and provides multimedia links to cessation advice (by providing access to evidence-based techniques with cognitive-behavioral, motivational, relapseprevention, and problem-solving components); information about the prescribed medication for helping to quit; and advice on how to cope with abstinence-related problems and relaxation exercises in diverse formats, such as video, graphs, games, and web links (of note, all these are similar to the resources health care workers could offer to the patients in the CG). Dejal@bot also incorporates gamification elements (knowledge and skills acquisition) with a system for scoring points and obtaining badges that grant access to specific information depending on the abstinence period and personal needs. This feedback is complemented with messages of encouragement and emphasis on the achieved goals. The intervention was described in detail in the protocol [19] and in the TIDieR (Template for Intervention Description and Replication) checklist (Multimedia Appendix 6).

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 The final version from the pilot study (February 2018) was implemented in the randomized controlled trial and its content was not modified at any stage

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
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 collection was monitored weekly and the collaborators were contacted in case of incongruous or incomplete information. subitem not at all important 1 2 3 4 5 essential 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.

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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 The Dejal@bot structure is simple: (1) The user writes messages in the Telegram app installed into their smartphone; (2) Telegram anonymizes this message upon receipt by assigning an identification number to the user and forwards the message to the software installed in the research team server; (3) the software processes the message; (4) our reply is sent to Telegram; and (5) Telegram forwards the response to the user.
Screenshots sent in Multimedia Appendix 5

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.
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 https://cuidabot.es/dejalobot

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). 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 The intervention strategy for both arms was based on the 5A's (ie, Ask, Advise, Assess, Assist, and Arrange) in the US Clinical Practice Guideline [2]. During the recruitment phase, all patients who met the inclusion criteria were interviewed in person about their tobacco consumption and received advice to cease smoking from their doctor or nurse, who also inquired about their willingness to quit smoking. Those accepting to attempt cessation in the following month and agreed to participate in the trial were randomly assigned into the IG or the CG. Patients received a personal intervention that combined behavioral and pharmacological treatment and was structured in several follow-up visits, whether online via a chatbot or face-to-face with their assigned health care professional.
Patients in the CG received usual clinical practice that aided in their tobacco cessation process, which is based on scientific recommendations and protocols in the services portfolio of the Madrid Health System Patients in the IG were offered an intervention with contents similar to the CG but delivered via a chatbot.No instructions or recommendations were given to the chatbot users regarding timing, frequency, or intensity of use. No further appointments were set between the professional and the patient other than the follow-up at 6 months (T1), and no additional co-interventions were provided outside the trial setting. The patient could contact the chatbot at any time and place, and decided the duration and frequency of interactions

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?

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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 in the CG received usual clinical practice that aided in their tobacco cessation process, which is based on scientific recommendations and protocols in the services portfolio of the Madrid Health System.
Patients in the IG were offered an intervention with contents similar to the CG but delivered via a chatbot. No instructions or recommendations were given to the chatbot users regarding timing, frequency, or intensity of use. No further appointments were set between the professional and the patient other than the follow-up at 6 months (T1), and no additional co-interventions were provided outside the trial setting.

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 21 -generalizability). Two visits were defined for patient data collection ( Figure 1): baseline (T0) and at 6 months (T1). The health care collaborators collected participants' data in a collection notebook designed ad hoc, which could be accessed from the work computer with a personal password. Additionally, professionals were responsible for the clinical follow-up of patients in the control group (CG) and keeping records of it at each visit.

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). 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

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No instructions or recommendations were given to the chatbot users regarding timing, frequency, or intensity of use. No further appointments were set between the professional and the patient other than the follow-up at 6 months (T1), and no additional co-interventions were provided outside the trial setting.

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.

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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 No further appointments were set between the professional and the patient other than the follow-up at 6 months (T1), and no additional co-interventions were provided outside the trial setting.
6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed subitem not at all important 1 2 3 4 5 essential 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 The primary outcome was continuous abstinence at 6 months, which was biochemically validated by CO-oximetry, involving measurement of exhaled air in parts per million (ppm), following the recommendations in the Russell Standard [20]. Therefore, the patient must declare not having smoked in the previous 6 months and have a negative CO-oximetry result (<10 ppm) to be considered a "nonsmoker." The secondary outcomes were changes in quality of life, number of contacts between the therapist or the chatbot and the patient, and total time of interaction. 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.
Copy and paste relevant sections from manuscript text Information regarding contact time and number of interactions was automatically recorded in the data collection notebook (CG) or by the chatbot (IG).

Copy and paste relevant sections from manuscript text
There was a feedback form to the chatbot users when the trial was ended.
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 No changes to trial outcomes were made after the trial commenced.

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.

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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 The sample size was calculated based on the outcomes of the FTFT-AP trial [22], a recent clinical trial that assessed the effectiveness of usual clinical practice in our health care system and reported a continuous abstinence rate of 9.6% in the CG at 6 months. Considering a 2-fold success rate compared with the later study [14], an α error of 5%, and a power of 80%, the calculated sample size was 418 patients. With an estimated dropout rate of 10%, the final size was 460 smokers (230 in each arm).
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 Tu respuesta 13/6/22, 22:31 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Página 38 de 64 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full#gid=0 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 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 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 After providing informed consent and following the collection of baseline information, participants were randomly allocated to the intervention group (IG, chatbot) or CG (usual care) at the baseline visit (T0) via simple randomization software and without further restrictions.
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 No other method was used to implement the random allocation sequence 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 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 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 After providing informed consent and following the collection of baseline information, participants were randomly allocated to the intervention group (IG, chatbot) or CG (usual care) at the baseline visit (T0) via simple randomization software and without further restrictions. No other method was used to implement the random allocation sequence.
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

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).

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Does your paper address subitem 11a-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 Given the nature of the intervention, patients and professionals were aware of their treatment allocation. All analyses were performed by trial statisticians and methodologists in the Madrid Primary Care Research Unit who were blinded to the group assignment.
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".

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) 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 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 Given the nature of the intervention, patients and professionals were aware of their treatment allocation.

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 The intervention strategy for both arms was based on the 5A's (ie, Ask, Advise, Assess, Assist, and Arrange) in the US Clinical Practice Guideline. Patients received a personal intervention that combined behavioral and pharmacological treatment and was structured in several follow-up visits, whether online via a chatbot or face-to-face with their assigned health care professional.

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
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 Intention-to-treat analyses were performed by coding all losses to follow-up as smokers, as specified in the previously published protocol 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]).

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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 Intention-to-treat analyses were performed by coding all losses to follow-up as smokers, as specified in the previously published protocol. Missing data were analyzed using the baseline-observation-carried-forward (BOCF) approach.

X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential 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 An analysis by subgroups was also conducted to account for the intensity of use with the chatbot or the contact intensity between patients and professionals.

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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
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 After checking compliance with the inclusion criteria, the patients were informed about the characteristics of the trial, and invited to participate and read an informative document (Multimedia Appendix 3). Patients who accepted to participate provided informed consent (Multimedia Appendix 4).

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) 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 13b) For each group, losses and exclusions after randomisation, together with reasons 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 No safety and security procedures were taken 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 Of the 572 potentially eligible patients who had been invited to participate, 513 accepted, provided informed consent, and were thus enrolled in the trial. Measurements were obtained at the follow-up visit (T1) for 232 (45.2%) patients, 42.9% (104/242) and 47.2% (128/271) in the IG and CG, respectively, without significant intergroup differences (Figure 1). 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * 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 Losses and exclusion after randomization are in Fig 1 (CONSORT flow diagram)

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.

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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 Measurements were obtained at the follow-up visit (T1) for 232 (45.2%) patients, 42.9% (104/242) and 47.2% (128/271) in the IG and CG, respectively, without significant intergroup differences (Figure 1). The analysis of dropouts also did not show significant intergroup differences (Table 2).
subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early) 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 Each collaborator had the objective of recruiting a minimum of 3 patients by offering participation to all smokers attending their consultation for any reason, in consecutive order, between October 1, 2018, and March 31, 2019. Two visits were defined for patient data collection (Figure 1): baseline (T0) and at 6 months (T1). The health care collaborators collected participants' data in a collection notebook designed ad hoc, which could be accessed from the work computer with a personal password. Additionally, professionals were responsible for the clinical follow-up of patients in the control group (CG) and keeping records of it at each visit.

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"

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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 No critical "secular events" fell into the study period.

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group subitem not at all important 1 2 3 4 5 essential 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 The trial ended as planned in the protocol.

Does your paper address CONSORT subitem 15? *
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 Tu respuesta

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
subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 15-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 No significant differences were found between the IG and CG at baseline in terms of sociodemographic variables or those related to their tobacco consumption (Table 1).

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.

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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 Table 2 presents detailed intervention outcomes, from both the intention-to-treat (n=513) and per-protocol (n=232) analyses.
subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

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).
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 Table 2 presents detailed intervention outcomes, from both the intention-to-treat (n=513) and per-protocol (n=232) analyses.
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 In the intention-to-treat analysis using the BOCF at T1, an intergroup difference in the primary outcome was found, with a biochemically validated abstinence rate of 26.0%

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).

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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 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 An additional exploratory analysis by subgroups, which the protocol did not contemplate, was performed to assess the intensive use of the chatbot, defined as more than 4 contacts with the chatbot and over 30 minutes of total interaction time throughout the 6 months. The biochemically validated abstinence rate in the IG at T1 was significantly higher for patients who contacted the chatbot intensively versus those who did not (68.6% versus 40.9%, respectively; P=.02), which was in contrast to that observed in the CG (47.6% for patients having intensive contact with the health care worker versus 35.4% who were not; P=.30), for which also intensive contact was defined as more than 4 contacts and over 30 minutes of total interaction time throughout the 6 months.

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).
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 An additional exploratory analysis by subgroups, which the protocol did not contemplate, was performed to assess the intensive use of the chatbot, defined as more than 4 contacts with the chatbot and over 30 minutes of total interaction time throughout the 6 months. The biochemically validated abstinence rate in the IG at T1 was significantly higher for patients who contacted the chatbot intensively versus those who did not (68.6% versus 40.9%, respectively; P=.02), which was in contrast to that observed in the CG (47.6% for patients having intensive contact with the health care worker versus 35.4% who were not; P=.30), for which also intensive contact was defined as more than 4 contacts and over 30 minutes of total interaction time throughout the 6 months.
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 No harms or unintended effects were detected 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 was a feedback form to the chatbot users when the trial was ended.
No technical support service was available during the trial, which the authors believed would improve the chatbot accessibility and the retention rate.
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). The aim of this study was to assess the effectiveness of a chatbot, with an evidence-based design and including elements of AI and natural language processing, for helping people stop smoking compared with clinical practice in primary care. Although no significant difference in smoking cessation rates was obtained, our results suggest an effect that is certainly promising (OR 1.5), with a difference in effect ranging from no effect (OR 1) or a 1% decrease (OR 0.99) in the raw result up to over 2-fold increase (OR 2.33). However, all values within the interval limits are reasonably compatible with the data, given the statistical assumptions made to calculate the interval. Therefore, these results must be interpreted with caution. 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 Further evidence is still required to assess the effectiveness of mHealth in smoking cessation. Although there are trials assessing the use of SMS text messages and apps for quitting, interventions using chatbots need to be evaluated, and qualitative studies about cost-effectiveness, usability, and satisfaction must be conducted. Additionally, determining the components that mainly affect effectiveness will be of interest to achieve behavioral changes and increased participation of users, because a strong association appears to exist between the time of use or accomplishment of tasks and dropout rates. From the ethics perspective, the importance of high-quality studies evaluating these treatments must be highlighted, which will prevent the patient from being disfavored by incomplete, biased, or nonevidence-based interventions, and will also avoid decreased accessibility of certain population segments to quality therapies.

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.

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 subitem not at all important 1 2 3 4 5 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 The main limitation of this trial was the dropout rate of 54.8% (281/513). Given the pragmatic design of the trial, no further midterm reinforcements or visits could be scheduled. Additionally, 38.8% (94/242) of the IG users never entered the chatbot. Losses to follow-up were homogeneous in both study arms, both quantitatively and in terms of participants' characteristics after the intervention.

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

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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 The results are applicable to the smoking population over 18 years of age who goes to their family doctor or primary care nurse in a public health service 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 Our trial has a pragmatic design, with real-life conditions of clinical practice in terms of recruitment (inclusion criteria for patients and professionals), prescribed medication (patients were treated by their assigned practitioners at their usual consultations, without further restrictions), and minimum number of mandatory visits (baseline and at 6 months).

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (financial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

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Does your paper address subitem X27-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 JFA-T, EO-E, and CM-L designed the chatbot and own the intellectual property rights. The remaining research team members (authors, developers, and sponsors) were not involved in the development of the intervention.
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