Repeated Automated Mobile Text Messaging Reminders for Follow-Up of Positive Fecal Occult Blood Tests: Randomized Controlled Trial

Background Fecal occult blood tests (FOBTs) are recommended by the US Preventive Services Task Force as a screening method for colorectal cancer (CRC), but they are only effective if positive results are followed by colonoscopy. Surprisingly, a large proportion of patients with a positive result do not follow this recommendation. Objective The objective of this study was to examine the effectiveness of text messaging (short message service, SMS) in increasing adherence to colonoscopy follow-up after a positive FOBT result. Methods This randomized controlled trial was conducted with patients who had positive CRC screening results. Randomization was stratified by residential district and socioeconomic status (SES). Subjects in the control group (n=238) received routine care that included an alert to the physician regarding the positive FOBT result. The intervention group (n=232) received routine care and 3 text messaging SMS reminders to visit their primary care physician. Adherence to colonoscopy was measured 120 days from the positive result. All patient information, including test results and colonoscopy completion, were obtained from their electronic medical records. Physicians of study patients completed an attitude survey regarding FOBT as a screening test for CRC. Intervention and control group variables (dependent and independent) were compared using chi-square test. Logistic regression was used to calculate odds ratios (ORs) and 95% CIs for performing colonoscopy within 120 days for the intervention group compared with the control group while adjusting for potential confounders including age, gender, SES, district, ethnicity, and physicians’ attitude. Results Overall, 163 of the 232 patients in the intervention group and 112 of the 238 patients in the control group underwent colonoscopy within 120 days of the positive FOBT results (70.3% vs 47.1%; OR 2.17, 95% CI 1.49-3.17; P<.001); this association remained significant after adjusting for potential confounders (P=.001). Conclusions A text message (SMS) reminder is an effective, simple, and inexpensive method for improving adherence among patients with positive colorectal screening results. This type of intervention could also be evaluated for other types of screening tests. Trial Registration ClinicalTrials.gov NCT03642652; https://clinicaltrials.gov/ct2/show/NCT03642652 (Archived by WebCite at http://www.webcitation.org/74TlICijl)

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the fourdigit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 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 o ine 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.
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 brie y explain why the item is not applicable/relevant for your study Yes-Repeated automated mobile text reminders for follow-up of positive fecal occult blood tests -a randomised controlled trial 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 brie y explain why the item is not applicable/relevant for your study N/A -there were no interventions other than text messages ‫את‬  subitem not at all important 1 2 3 4 5 essential 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * 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 brie y explain why the item is not applicable/relevant for your study Yes-Repeated automated mobile text reminders for follow-up of positive fecal occult blood tests -a randomised controlled trial 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) 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 brie y explain why the item is not applicable/relevant for your study Yes-"The intervention group (n = 232) received routine care and three short message service reminders to visit their primary care physician" ‫את‬ ‫לערוך‬ ‫לאחרים‬ ‫גם‬ ‫יאפשר‬ ‫הזו‬ ‫האתר‬ ‫כתובת‬ ‫שיתוף‬ ‫שלך.‬ ‫התשובה‬ ‫את‬ ‫לערוך‬ ‫בחרת‬ ‫שלך.‬ ‫התשובה‬ ‫חדשה‬ ‫תשובה‬ ‫הוספת‬ subitem not at all important 1 2 3 4 5 essential 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) 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 brie y explain why the item is not applicable/relevant for your study No human involvement necessary -fully automated 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), 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 o ine 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) 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 brie y explain why the item is not applicable/relevant for your study "This randomized controlled trial was conducted with patients who had positive colorectal cancer screening results.". and "All patient information, including test results and colonoscopy completion, were obtained from their computerised medical records." ‫את‬  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) 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 brie y explain why the item is not applicable/relevant for your study As the intervention was passive (reception of text messages) we addressed this in the methods: "The intervention group (n = 232) received routine care and three short message service reminders to visit their primary care physician"..."Results: Of 232 patients in the intervention group, 163 had a colonoscopy within 120 days from the positive FOBT, and of 238 patients in the control group, 112 of 238 had a colonoscopy within 120 days from the positive FOBT (70% vs. 47%, P<.0001). " 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) 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 brie y explain why the item is not applicable/relevant for your study N/A 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) 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 brie y explain why the item is not applicable/relevant for your study "no studies have yet used SMS technology to increase adherence to recommendations for CRC screening follow-up after a positive FOBT." 2a-ii) Scienti c background, rationale: What is known about the (type of) system Scienti c background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this speci c study, from which stakeholder viewpoint is the study performed, potential impact of ndings [2]. Brie y justify the choice of the comparator. including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address subitem 2a-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 brie y explain why the item is not applicable/relevant for your study "A positive FOBT requires immediate follow-up with colonoscopy and surgery should be performed when CRC is found. .A delay in follow-up signi cantly undermines the bene ts of CRC screening, including incidence, mortality, lifeyears saved, and net costs of screening ", "Several studies have described interventions aimed at increasing follow-up rates and showed mixed results", ""no studies have yet used SMS technology to increase adherence to recommendations for CRC screening follow-up after a positive FOBT."

‫את‬
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 brie y explain why the item is not applicable/relevant for your study "the present study examined the effectiveness of sending mobile text messages via SMS to patients as an automated tool to increase adherence to colonoscopy follow-up" 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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study Methods did not change 3b-i) Bug xes, Downtimes, Content Changes Bug xes, 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 xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. [2].
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 brie y explain why the item is not applicable/relevant for your study This is a simple technology and no bugs or downtimes occurred 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 brie y explain why the item is not applicable/relevant for your study "The inclusion criteria were 50-75 years-of-age and agreeing to receive SMS texts from Meuhedet. By Israeli law, health messages via SMS may only be sent to members who actively agree to receive them." 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed. 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 brie y explain why the item is not applicable/relevant for your study "The inclusion criteria were 50-75 years-of-age and agreeing to receive SMS texts from Meuhedet. By Israeli law, health messages via SMS may only be sent to members who actively agree to receive them." 4a-ii) Open vs. closed, web-based vs. face-to-face assessments:

‫את‬
Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), 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 con rmation, phone calls) were used to detect/prevent these.
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 brie y explain why the item is not applicable/relevant for your study All patients were recruited from our patient database and all patient information was obtained from the same database 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. 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 brie y explain why the item is not applicable/relevant for your study All patients were recruited from our patient database and all patient information was obtained from the same database 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 brie y explain why the item is not applicable/relevant for your study All patients were recruited from our patient database and all patient information was obtained from the same database 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.

‫את‬
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 brie y explain why the item is not applicable/relevant for your study All patients were recruited from our patient database and all patient information, including outcome, was obtained from the same database 4b-ii) Report how institutional a liations are displayed Report how institutional a liations are displayed to potential participants [on ehealth media], as a liations 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) The interventions for each group with su cient details to (5 allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 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 brie y explain why the item is not applicable/relevant for your study All patients were recruited from our patient database and all patient information was obtained from the same database 5-i) Mention names, credential, a liations of the developers, sponsors, and owners Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict 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 brie y explain why the item is not applicable/relevant for your study Only text messages were used.

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. 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 brie y explain why the item is not applicable/relevant for your study Only text messages were used

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 brie y explain why the item is not applicable/relevant for your study No revisions or updating 5-iv) Quality assurance methods Provide information on quality assurance methods to ensure accuracy and quality of information 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 brie y explain why the item is not applicable/relevant for your study "Each patient in the intervention group also received an automated text message up to a week after the positive FOBT result. The text read: "Hello. There is a lab test result ready for you. Contact your physician for an explanation of the ndings." Two additional automated text message reminders were sent to the patient at 2 weeks and 1 month reading, "Hello, This is a reminder. It is essential that you contact your physician if you have not already done so." As the SMS messages were sent automatically to a randomly selected population, the patients in the control group were not aware of the intervention. Physicians were blinded regarding which of their patients were in either group." 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
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 brie y explain why the item is not applicable/relevant for your study N/A

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 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 brie y explain why the item is not applicable/relevant for your study N/A

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 speci c 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-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 brie y explain why the item is not applicable/relevant for your study "Each patient in the intervention group also received an automated text message up to a week after the positive FOBT result. The text read: "Hello. There is a lab test result ready for you. Contact your physician for an explanation of the ndings." Two additional automated text message reminders were sent to the patient at 2 weeks and 1 month reading, "Hello, This is a reminder. It is essential that you contact your physician if you have not already done so." As the SMS messages were sent automatically to a randomly selected population, the patients in the control group were not aware of the intervention. Physicians were blinded regarding which of their patients were in either group." 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 brie y explain why the item is not applicable/relevant for your study N/A

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 brie y explain why the item is not applicable/relevant for your study "Each patient in the intervention group also received an automated text message up to a week after the positive FOBT result. The text read: "Hello. There is a lab test result ready for you. Contact your physician for an explanation of the ndings." Two additional automated text message reminders were sent to the patient at 2 weeks and 1 month reading, "Hello, This is a reminder. It is essential that you contact your physician if you have not already done so." ." 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).
Does your paper address subitem 5-x?
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 brie y explain why the item is not applicable/relevant for your study Fully automated 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 brie y explain why the item is not applicable/relevant for your study "Each patient in the intervention group also received an automated text message up to a week after the positive FOBT result. The text read: "Hello. There is a lab test result ready for you. Contact your physician for an explanation of the ndings." Two additional automated text message reminders were sent to the patient at 2 weeks and 1 month reading, "Hello, This is a reminder. It is essential that you contact your physician if you have not already done so." ." 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. 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 brie y explain why the item is not applicable/relevant for your study None 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 brie y explain why the item is not applicable/relevant for your study "The dependent variable was adherence to colonoscopy within 120 days after a positive FOBT. This was obtained from the patient's EMR." 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 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le 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 "Each patient in the intervention group also received an automated text message up to a week after the positive FOBT result. The text read: "Hello. There is a lab test result ready for you. Contact your physician for an explanation of the ndings." Two additional automated text message reminders were sent to the patient at 2 weeks and 1 month reading, "Hello, This is a reminder. It is essential that you contact your physician if you have not already done so."." 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).
Does your paper address subitem 6a-iii? 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 brie y explain why the item is not applicable/relevant for your study "To have an 80% chance of detecting a 20% effect of the intervention as signi cant (1-sided, 5% level), a sample of 77 is required in each group. Our group was larger than this.. Our study sample of 232 in each group has a 95% ability to detect a 20% increase in adherence to colonoscopy within 120 days." ‫את‬ ‫לערוך‬ ‫לאחרים‬ ‫גם‬ ‫יאפשר‬ ‫הזו‬ ‫האתר‬ ‫כתובת‬ ‫שיתוף‬ ‫שלך.‬ ‫התשובה‬ ‫את‬ ‫לערוך‬ ‫בחרת‬ ‫שלך.‬ ‫התשובה‬ ‫חדשה‬ ‫תשובה‬ ‫הוספת‬ 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 Mechanism used to implement the random allocation (9 sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 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 brie y explain why the item is not applicable/relevant for your study N/A 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 brie y explain why the item is not applicable/relevant for your study Patients were randomised electronically as all information is on a database, including intervention.
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 brie y explain why the item is not applicable/relevant for your study Patients were randomised electronically as all information is on a database, including intervention.
‫את‬ ‫לערוך‬ ‫לאחרים‬ ‫גם‬ ‫יאפשר‬ ‫הזו‬ ‫האתר‬ ‫כתובת‬ ‫שיתוף‬ ‫שלך.‬ ‫התשובה‬ ‫את‬ ‫לערוך‬ ‫בחרת‬ ‫שלך.‬ ‫התשובה‬ ‫חדשה‬ ‫תשובה‬ ‫הוספת‬ Who generated the random allocation sequence, who (10 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 subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study Patients were randomised electronically as all information is on a database, including intervention.
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 brie y explain why the item is not applicable/relevant for your study Patients were randomised electronically as all information is on a database, including intervention. 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).
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 brie y explain why the item is not applicable/relevant for your study No blinding was done. (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 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".
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 brie y explain why the item is not applicable/relevant for your study "As the SMS messages were sent automatically to a randomly selected population, the patients in the control group were not aware of the 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 brie y explain why the item is not applicable/relevant for your study 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 brie y explain why the item is not applicable/relevant for your study "We compared demographic variables between the intervention and control groups using chi-squared for discrete variables. Logistic regression was used to calculate odds ratios (ORs) and 95% con dence intervals (CIs) for the rate of colonoscopy within 120 days of receiving a positive FOBT result, adjusting for main potential and variables found to be signi cantly related to adherence in univariate analysis." 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]).
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 brie y explain why the item is not applicable/relevant for your study As text messages were "pushed" we had no attrition 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 brie y explain why the item is not applicable/relevant for your study "We compared demographic variables between the intervention and control groups using chi-squared for discrete variables. Logistic regression was used to calculate odds ratios (ORs) and 95% con dence intervals (CIs) for the rate of colonoscopy within 120 days of receiving a positive FOBT result, adjusting for main potential and variables found to be signi cantly related to adherence in univariate analysis."

X26-i) Comment on ethics committee approval
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 brie y explain why the item is not applicable/relevant for your study "The study was approved by the Meuhedet Institutional Review Board (trial reference number: 01-023-03-16)."

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 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 brie y explain why the item is not applicable/relevant for your study "The study was exempt from informed consent, and only agreement to receive text messages was required. "

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) 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 brie y explain why the item is not applicable/relevant for your study N/A 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 brie y explain why the item is not applicable/relevant for your study "A total of 470 eligible patients were randomized 232 (49.36%) in the intervention group and 238 (50.64%) in the control group. " ‫את‬ ‫לערוך‬ ‫לאחרים‬ ‫גם‬ ‫יאפשר‬ ‫הזו‬ ‫האתר‬ ‫כתובת‬ ‫שיתוף‬ ‫שלך.‬ ‫התשובה‬ ‫את‬ ‫לערוך‬ ‫בחרת‬ ‫שלך.‬ ‫התשובה‬ ‫חדשה‬ ‫תשובה‬ ‫הוספת‬ 13b) For each group, losses and exclusions after randomisation, together with reasons subitem not at all important 1 2 3 4 5 essential 14a) Dates de ning the periods of recruitment and follow-up Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow 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 brie y explain why the item is not applicable/relevant for your study "Fifty-two (18%) patients were excluded from the control group, 20 because of family history of CRC, 2 died during the study, 16 had an oncology diagnosis and 14 had a colonoscopy prior to the positive FOBT. Eighty-seven (27.2%) patients were excluded from the intervention group, 26 because of family history of CRC, 6 had an oncology diagnosis, 12 had a colonoscopy prior to the positive FOBT, and 43 refused to receive an SMS after the initial approval or they were unable to receive SMS although they agreed to receive it." and Figure 1 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 gures or tables demonstrating usage/dose/engagement. Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure 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 brie y explain why the item is not applicable/relevant for your study "43 refused to receive an SMS after the initial approval or they were unable to receive SMS although they agreed to receive it." 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 brie y explain why the item is not applicable/relevant for your study "In 2016 3,397 patients aged 50-75 had a positive FOBT result. Of these, A total of 609 patients from Meuhedet who had a positive FOBT in 2016 were randomly selected and allocated were randomized to intervention and control groups;" 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 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 brie y explain why the item is not applicable/relevant for your study N/A 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 brie y explain why the item is not applicable/relevant for your study For each group, number of participants (denominator) (16 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 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 brie y explain why the item is not applicable/relevant for your study Table 1 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.
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 brie y explain why the item is not applicable/relevant for your study "We also examined potential confounders such as gender, age, SES, ethnicity, and district " 16-i) Report multiple "denominators" and provide de nitions Report multiple "denominators" and provide de nitions: 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 speci c prede ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
‫את‬ ‫לערוך‬ ‫לאחרים‬ ‫גם‬ ‫יאפשר‬ ‫הזו‬ ‫האתר‬ ‫כתובת‬ ‫שיתוף‬ ‫שלך.‬ ‫התשובה‬ ‫את‬ ‫לערוך‬ ‫בחרת‬ ‫שלך.‬ ‫התשובה‬ ‫חדשה‬ ‫תשובה‬ ‫הוספת‬ 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% con dence interval 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 brie y explain why the item is not applicable/relevant for your study "Of 232 patients in the intervention group (who received a text reminder), 163 had a colonoscopy within 120 days of a positive fecal occult blood test, and 112 of 238 had one in the control group (70% vs. 47%, P<.0001). "

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 brie y explain why the item is not applicable/relevant for your study "We conducted the analysis including the 43 patients who did not receive the SMS, and found that adherence rates remained signi cantly higher both in the Results of any other analyses performed, including (18 subgroup analyses and adjusted analyses, distinguishing prespeci ed from exploratory 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 de nitions 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 de ned (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 brie y explain why the item is not applicable/relevant for your study The intervention was not user-dependent: "Each patient in the intervention group also received an automated text message up to a week after the positive FOBT result. The text read: "Hello. There is a lab test result ready for you. Contact your physician for an explanation of the ndings." Two additional automated text message reminders were sent to the patient at 2 weeks and 1 month reading, "Hello, This is a reminder. It is essential that you contact your physician if you have not already done so."." 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 brie y 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 brie y explain why the item is not applicable/relevant for your study "Of 232 patients in the intervention group (who received a text reminder), 163 had a colonoscopy within 120 days of a positive fecal occult blood test, and 112 of 238 had one in the control group (70% vs. 47%, P<.0001). " and "The adjusted likelihood of adherence to colonoscopy was 2.5 higher in the intervention group after adjusting for confounding factorsOR for the intervention group vs. the control group was 2.9 (95%CI: 1.92-4.48; p=0.001)."

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 brie y explain why the item is not applicable/relevant for your study As the only difference (Table 2) beween the intervention and control groups was the intervention and the outcome, we did not present this analysis 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 brie y explain why the item is not applicable/relevant for your study The intervention is sending three text messages to paatients who agreed to receive text messages to their personal mobile phone. We did not perceive there to be a risk. This was supported by the IRB.

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 nonuse of the intervention/usability issues, biases through informed consent procedures, unexpected events.
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 brie y explain why the item is not applicable/relevant for your study "A limitation of this study is that only patients who agreed to receive text messages were included in the study, which created a biased population in terms of age, cultural beliefs, and SES. "

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 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 brie y explain why the item is not applicable/relevant for your study "This study was conducted in one of four healthcare provider organisations in Israel. Selection of providers is voluntary, and our member distribution in terms of age, gender and SES are similar to the Israeli population. In addition, the Israeli population is very ethnically diverse, and includes immigrants from many countries. Our ndings are therefore generalisable to other populations." 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 brie y explain why the item is not applicable/relevant for your study Our intervention is feasible in routine applications, inexpensive, and does not depend on any other factors.
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 brie y explain why the item is not applicable/relevant for your study Where the full trial protocol can be accessed, if available (24 Sources of funding and other support (such as supply of (25 drugs), role of funders (X27) Con icts of Interest (not a CONSORT item subitem not at all important 1 2 3 4 5 essential 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 brie y explain why the item is not applicable/relevant for your study https://clinicaltrials.gov/ct2/home 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 brie y explain why the item is not applicable/relevant for your study No funding or support was received. X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial 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.
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 brie y explain why the item is not applicable/relevant for your study This study was part of our role in the organisation, and aimed at improving adherence, part of the organizational agenda.
‫את‬ ‫לערוך‬ ‫לאחרים‬ ‫גם‬ ‫יאפשר‬ ‫הזו‬ ‫האתר‬ ‫כתובת‬ ‫שיתוף‬ ‫שלך.‬ ‫התשובה‬ ‫את‬ ‫לערוך‬ ‫בחרת‬ ‫שלך.‬ ‫התשובה‬ ‫חדשה‬ ‫תשובה‬ ‫הוספת‬ STOP -Save this form as PDF before you click submit To generate a record that you lled in this form, we recommend to generate a PDF of this .page (on a Mac, simply select "print" and then select "print as PDF") before you submit it .When you submit your (revised) paper to JMIR, please upload the PDF as supplementary le Don't worry if some text in the textboxes is cut off, as we still have the complete information !in our database.