Effects of an Explicit Value Clarification Method With Computer-Tailored Advice on the Effectiveness of a Web-Based Smoking Cessation Decision Aid: Findings From a Randomized Controlled Trial

Background Smoking continues to be a driver of mortality. Various forms of evidence-based cessation assistance exist; however, their use is limited. The choice between them may also induce decisional conflict. Offering decision aids (DAs) may be beneficial; however, insights into their effective elements are lacking. Objective This study tested the added value of an effective element (ie, an “explicit value clarification method” paired with computer-tailored advice indicating the most fitting cessation assistance) of a web-based smoking cessation DA. Methods A web-based randomized controlled trial was conducted among smokers motivated to stop smoking within 6 months. The intervention group received a DA with the aforementioned elements, and the control group received the same DA without these elements. The primary outcome measure was 7-day point prevalence abstinence 6 months after baseline (time point 3 [t=3]). Secondary outcome measures were 7-day point prevalence of abstinence 1 month after baseline (time point 2 [t=2]), evidence-based cessation assistance use (t=2 and t=3), and decisional conflict (immediately after DA; time point 1). Logistic and linear regression analyses were performed to assess the outcomes. Analyses were conducted following 2 (decisional conflict) and 3 (smoking cessation) outcome scenarios: complete cases, worst-case scenario (assuming that dropouts still smoked), and multiple imputations. A priori sample size calculation indicated that 796 participants were needed. The participants were mainly recruited on the web (eg, social media). All the data were self-reported. Results Overall, 2375 participants were randomized (intervention n=1164, 49.01%), of whom 599 (25.22%; intervention n=275, 45.91%) completed the DAs, and 276 (11.62%; intervention n=143, 51.81%), 97 (4.08%; intervention n=54, 55.67%), and 103 (4.34%; intervention n=56, 54.37%) completed time point 1, t=2, and t=3, respectively. More participants stopped smoking in the intervention group (23/63, 37%) than in the control group (14/52, 27%) after 6 months; however, this was only statistically significant in the worst-case scenario (crude P=.02; adjusted P=.04). Effects on the secondary outcomes were only observed for smoking abstinence after 1 month (15/55, 27%, compared with 7/46, 15%, in the crude and adjusted models, respectively; P=.02) and for cessation assistance uptake after 1 month (26/56, 46% compared with 18/47, 38% only in the crude model; P=.04) and 6 months (38/61, 62% compared with 26/50, 52%; crude P=.01; adjusted P=.02) but only in the worst-case scenario. Nonuse attrition was 34.19% higher in the intervention group than in the control group (P<.001). Conclusions Currently, we cannot confidently recommend the inclusion of explicit value clarification methods and computer-tailored advice. However, they might result in higher nonuse attrition rates, thereby limiting their potential. As a lack of statistical power may have influenced the outcomes, we recommend replicating this study with some adaptations based on the lessons learned. Trial Registration Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270 International Registered Report Identifier (IRRID) RR2-10.2196/21772

The CONSORT-EHEALTH checklist is intended for authors of randomized trials evaluating web-based and Internet-based applications/interventions, including mobile interventions, electronic games (incl multiplayer games), social media, certain telehealth applications, and other interactive and/or networked electronic applications. Some of the items (e.g. all subitems under item 5 -description of the intervention) may also be applicable for other study designs.
The goal of the CONSORT EHEALTH checklist and guideline is to be a) a guide for reporting for authors of RCTs, b) to form a basis for appraisal of an ehealth trial (in terms of validity) CONSORT-EHEALTH items/subitems are MANDATORY reporting items for studies published in the Journal of Medical Internet Research and other journals / scientific societies endorsing the checklist.
As the CONSORT-EHEALTH checklist is still considered in a formative stage, we would ask that you also RATE ON A SCALE OF 1-5 how important/useful you feel each item is FOR THE PURPOSE OF THE CHECKLIST and reporting guideline (optional).
Mandatory reporting items are marked with a red *. In the textboxes, either copy & paste the relevant sections from your manuscript into this form -please include any quotes from your manuscript in QUOTATION MARKS, or answer directly by providing additional information not in the manuscript, or elaborating on why the item was not relevant for this study. yes: all primary outcomes were significantly better in intervention group vs control partly: SOME primary outcomes were significantly better in intervention group vs control no statistically significant difference between control and intervention potentially harmful: control was significantly better than intervention in one or more outcomes inconclusive: more research is needed Other: not submitted yet -in early draft status not submitted yet -in late draft status, just before submission submitted to a journal but not reviewed yet submitted to a journal and after receiving initial reviewer comments submitted to a journal and accepted, but not published yet  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 four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR)

JMIR 34246
Your response is too large. Try shortening some answers. 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. 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 16/03/2022, 15:29 CONSORT-EHEALTH (V 1.6.1) -  T  R  A  C  T  :  S  t  r  u  c  t  u  r  e  d  s  u  m  m  a  r  y  o  f  t  r  i  a  l  d  e  s  i  g  n  ,  m  e  t  h  o  d  s  ,  r  e  s  u  l  t  s  ,  a  n  d  c  o  n  c  l  u  s  i  o  n  s   N  P  T  e  x  t  e  n  s  i  o  n  :  D  e  s  c  r  i  p  t  i  o  n  o  f  e  x  p  e  r  i  m  e  n  t  a  l  t  r  e  a  t  m  e  n  t  ,  c  o  m  p  a  r  a  t  o  r  ,  c  a  r  e  p  r  o  v  i  d  e  r  s  ,  c  e  n  t  e  r  s  ,  a  n  d  b  l  i  n  d  i  n  g  s  t  a  t  u  s  . subitem not at all important 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 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). 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 "To test the added value of an effective element (ie, an 'explicit value clarification method' [VCM] paired with computer-tailored advice indicating the most fitting cessation assistance) of a web-based smoking cessation DA.", ie, computer-tailored and web-based to indicate the online set-up of the intervention Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were mainly recruited online (eg, social media). All data was self-reported." Also we clearly state throughout the abstract that the whole RCT and intervention was webbased. 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 "2375 participants were randomized (n = 1164 intervention, 49.01%), of which 599 completed the DAs (n = 275 intervention, 45.91%), and 276 (n = 143 intervention, 51.81%), 97 (n = 54 intervention, 55.67%), and 103 (n = 56 intervention, 54.37%) completed t=1, t=2 and t=3, respectively. " "Non-usage attrition was 34.19% higher in the intervention group than in the control group (P < .001)." 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.  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 "We cannot currently confidently recommend the inclusion of explicit VCMs and computertailored advice. In fact, they might result in higher non-usage attrition rates, thereby limiting their potential. Because a lack of statistical power may have influenced the outcomes, we recommend replicating this study with some adaptations based on lessons learned." 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 " [...] information about the effective elements of smoking cessation DAs is currently lacking and the only smoking cessation DA that has been studied in a Dutch context before [17] has shown a number of limitations: It (1) was largely paper-based, thereby limiting widespread dissemination; (2) lacked an interactive design, even though interactivity has been shown to positively influence factors such as information comprehensibility and attitudinal beliefs [18,19] and; (3) did not explicitly include methods to help end users to become aware of what is important to them personally (in the DA-literature this is often referred to as value clarification [20]), even though this is regarded as an active DA-element [21,22]. Moreover, interestingly, this DA had a positive effect on smoking cessation success, but not on the uptake of cessation assistance [17]. Improving cessation assistance uptake might further increase the effectiveness of smoking cessation DAs [...]." "VISOR was a stand-alone, one-time intervention meant to support adult smokers in the general population in their decision to use smoking cessation assistance and did not have to be used together with a healthcare professional." 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 "Previous studies showed that explicit VCMs seem to be more effective than implicit VCMs in terms of decision-making processes [23], especially in the long run [24] and when people are supported in understanding the implications of their clarified values [25,26]. One approach to facilitate understanding of the implication of clarified values is to show participants which options fit their clarified values best [25], eg, by providing computertailored advice based on answers provided in the explicit VCM. However, so far it has not been studied if the addition of explicit VCMs paired with such advice will also positively impact on smoking cessation outcomes. To advance our understanding of the effectiveness of smoking cessation DAs and to support more people in the Netherlands to quit smoking successfully, we have developed a web-based smoking cessation DA (called VISOR) that includes interactivity and an explicit VCM paired with computer-tailored advice and studied its effects in a randomized controlled trial (RCT 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 "Neither the DA received by the intervention group, nor the DA received by the control group changed throughout the trial." "[...] due to a technical mistake, some participants who completed VISOR, but had not completed t=1 (directly after the decision aid), did not receive an automatic invite for the other follow-ups. When this mistake was discovered, some participants were already lost to follow-up. We dealt with this in 2 different ways: (1) People who had already missed t=2 but completed the DA in the 3 months prior to the discovery of the mistake received the invite to participate in t=2 regardless (n = 38 received this invitation, n = 3 made use of this); (2) people who already missed t=3 were still invited to participate in t=3 but not t=2 (n = 130 received the invitation, n = 5 made use of this Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants could be included if they were (1) currently smoking, (2) motivated to stop smoking within 6 months, (3) between 18-100 years old, (4) able to understand Dutch, and (5) had access to the internet and the necessary internet literacy (skills) to use the DA. The last 2 inclusion criteria were not actively screened for but were deemed inherent to participation. Participants were excluded if they did not meet these inclusion criteria and/or if they exclusively used e-cigarettes." Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
C l e a r s e l e c t i o n Your response is too large. Try shortening some answers. 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 the necessary internet literacy (skills) to use the DA. The last 2 inclusion criteria were not actively screened for but were deemed inherent to participation." a c e a s s e s s m e n t s : 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. 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 "As described in the study protocol [28] participants were mainly recruited online to reflect the online nature of VISOR and the entire trial was web-based (ie, there were no offline contacts)." "30 accounts showed duplicate e-mail addresses; of those, only 8 were linked to accounts in both trial arms (ie, multiple accounts using the same e-mail address in each of the trial arms) and finished baseline with more than 1 account; of those only 2 participants filled in the follow-ups in such a way that they could have a distorting effect on the results (ie, they were first randomized into the intervention group, then in the control group and filled in the follow-ups as participants belonging to the control group even though they received the additional intervention elements) those were therefore adjusted, ie, the 'randomization variable' was changed to 1 = Intervention." Your response is too large. Try shortening some answers.
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 briefly explain why the item is not applicable/relevant for your study "Participants received no information regarding the differences between the intervention group and the control group as to not bias the results of the trial." "Participants registered for the study via an online form, which included their provision of informed consent and the creation of an account." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

Yes, see answers for 4b-i and 4b-ii
Your response is too large. Try shortening some answers. 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 "All data were self-assessed." 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 "All recruitment materials (eg, the project website) included a display of the project team's institutional affiliations in some form." Your response is too large. Try shortening some answers. "The developers of the intervention (ie, TG, ES, CD, and CH) were also involved in this evaluation." 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.
C l e a r s e l e c t i o n Your response is too large. Try shortening some answers. 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 accordance with the IPDAS guidelines for DA development [27,28], VISOR was developed by a steering team (TG, ES, CD, and CH) that lead a development process involving both professional experts and potential end users, eg, by assessing their needs and opinions before the initial development [29], and by conducting usability tests-this development process is described in detail elsewhere [28]." The development has already been described in JMIR Research Protocols: https://doi.org/10.2196/21772 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 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 "Neither the DA received by the intervention group, nor the DA received by the control group changed throughout the trial." Your response is too large. Try shortening some answers. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study We provide screenshots of different parts of the intervention, see answers earlier 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 We provide screenshots of different parts of the intervention, see answers earlier 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 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 "VISOR was a stand-alone, one-time intervention [...]" "Throughout the entire study, participants also received information on the duration of VISOR and the questionnaires." 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). 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 "VISOR was a stand-alone, one-time intervention meant to support adult smokers in the general population in their decision to use smoking cessation assistance and did not have to be used together with a healthcare professional. That being said, VISOR could be used to prepare patients/clients for a healthcare consultation about smoking (cessation) and certain cessation assistance options (eg, prescription medication) did require a healthcare provider to prescribe said options. Therefore, if VISOR users chose to use a cessation assistance option that required prescription by a healthcare provider, they were advised to contact their healthcare provider to gain access to this specific option." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants were asked to fill in each follow-up questionnaire if they made use of the entire DA, even when they did not fill in one of the other follow-up questionnaires. To avoid high attrition rates, participants received either 1 automatic reminder after a week (if they had not filled in a follow-up questionnaire at all) or 2 after 2 days and a week (if they already started filling in at least part of a follow-up questionnaire). Participants that started using VISOR or started filling in the baseline questionnaire (t=0) without finishing it also received 2 automatic reminders (after 2 days and a week)." Your response is too large. Try shortening some answers. 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 1 and 6 month(s), participants were queried regarding the choice made (ie, the implemented decision; secondary outcome) and if they were able to abstain from smoking in the previous 7 days (ie, 7-day point prevalence abstinence; secondary and primary outcome)." "After the DA, we measured decisional conflict (secondary outcome) using the decisional conflict scale [9] which was also verified to be unidimensional in our sample (Ω = .98, more information can be found on the OSF [35]). We employed all 16 items using the original statement format with 5 response categories (0 = strongly agree, 1 = agree, 2 = neither agree or disagree, 3 = disagree, 4 = strongly disagree) and created a composite score as 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 original study protocol, and as such described in the Netherlands Trial Register, it was planned to contact participants 4 times after having used VISOR (ie, directly after the DA, after 1 month, 6 months, and 12 months). Unfortunately, we had to extend our recruitment period due to the Coronavirus disease 2019 (COVID-19) pandemic and consequently, the recruitment period lasted for approximately 12 months, ie, 6 months longer than initially planned. Consequently, given the maximum project duration funded by the Dutch Cancer Society, we had to drop the 12-month follow-up measurement. Therefore, the original primary outcome (ie, 7-day point prevalence after 12 months) had to be adjusted and, ultimately, 7-day point prevalence after 6 months was used as the primary outcome." 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 "Considering 50% attrition over the study period, we had aimed to include 1592 smokers at baseline." Your response is too large. Try shortening some answers. 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 "Before the account creation participants were automatically randomized into either the intervention or the control group by the online platform on which questionaries and VISOR were hosted, allocating approximately 50% of the respondents to either group." Your response is too large. Try shortening some answers. 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 "Before the account creation participants were automatically randomized into either the intervention or the control group by the online platform on which questionaries and VISOR were hosted, allocating approximately 50% of the respondents to either group." ? * 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 "Before the account creation participants were automatically randomized into either the intervention or the control group by the online platform on which questionaries and VISOR were hosted, allocating approximately 50% of the respondents to either group.", ie, this was done automatically Your response is too large. Try shortening some answers. 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". Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants received no information regarding the differences between the intervention group and the control group as to not bias the results of the trial." Your response is too large. Try shortening some answers. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants in the intervention group received the DA as described in the introduction (see 1.1 The Smoking Cessation DA VISOR), whereas participants in the control group received the same DA excluding the explicit VCM and computer-tailored advice, ie, for them steps 6 and 7 described in Textbox 1 were skipped. The only other (small) difference was that participants in the intervention group were immediately directed towards the end after they had chosen to use no evidence-based cessation assistance (ie, step 8-access informationwas skipped), which was not the case for the control group. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants registered for the study via an online form, which included their provision of informed consent and the creation of an account." Your response is too large. Try shortening some answers. 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 total sample consisted out of 2375 participants that were randomized of which 1164 participants completed the baseline questionnaire. Subsequently, 599 participants completed the DA(s), 276 participants then filled in t=1 completely, 97 participants filled in t=2 completely and 103 participants filled in t=3 completely. The entire trial flow can be seen in Figure 3. The characteristics of participants that finished the baseline questionnaire can be seen in Table 1."; n included for analyses are described in the respective tables Your response is too large. Try shortening some answers.  D  o  e  s  y  o  u  r  p  a  p  e  r  a  d  d  r  e  s  s  C  O  N  S  O  R  T  s  u  b  i  t  e  m  1  3  b  ?  (  N  O  T  E  :  P  r  e  f  e  r  a  b  l  y  ,  t  h  i  s  i  s  s  h  o  w 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 Shown in Figure 3, which was based on the CONSORT flow 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. 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 Shown in Figure 3, which was based on the CONSORT flow diagram Your response is too large. Try shortening some answers. 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 original study protocol, and as such described in the Netherlands Trial Register, it was planned to contact participants 4 times after having used VISOR (ie, directly after the DA, after 1 month, 6 months, and 12 months). Unfortunately, we had to extend our recruitment period due to the Coronavirus disease 2019 (COVID-19) pandemic and consequently, the recruitment period lasted for approximately 12 months, ie, 6 months longer than initially planned. Consequently, given the maximum project duration funded by the Dutch Cancer Society, we had to drop the 12-month follow-up measurement. Therefore, the original primary outcome (ie, 7-day point prevalence after 12 months) had to be adjusted and, ultimately, 7-day point prevalence after 6 months was used as the primary outcome." "In total, the study consisted out of 4 fully automated and web-based contact moments: t=0 the baseline questionnaire and VISOR, t=1 directly after participants had used VISOR, t=2 after 1 month, and t=3 after 6 months." 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 See answer above, ie, 14a Your response is too large. Try shortening some answers. 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 original study protocol, and as such described in the Netherlands Trial Register, it was planned to contact participants 4 times after having used VISOR (ie, directly after the DA, after 1 month, 6 months, and 12 months). Unfortunately, we had to extend our recruitment period due to the Coronavirus disease 2019 (COVID-19) pandemic and consequently, the recruitment period lasted for approximately 12 months, ie, 6 months longer than initially planned. Consequently, given the maximum project duration funded by the Dutch Cancer Society, we had to drop the 12-month follow-up measurement. Therefore, the original primary outcome (ie, 7-day point prevalence after 12 months) had to be adjusted and, ultimately, 7-day point prevalence after 6 months was used as the primary outcome." 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 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. 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 total sample consisted out of 2375 participants that were randomized of which 1164 participants completed the baseline questionnaire. Subsequently, 599 participants completed the DA(s), 276 participants then filled in t=1 completely, 97 participants filled in t=2 completely and 103 participants filled in t=3 completely. The entire trial flow can be seen in Figure 3. The characteristics of participants that finished the baseline questionnaire can be seen in Table 1."; n included for analyses are described in the respective tables "30 accounts showed duplicate e-mail addresses; of those, only 8 were linked to accounts in both trial arms (ie, multiple accounts using the same e-mail address in each of the trial arms) and finished baseline with more than 1 account; of those only 2 participants filled in the follow-ups in such a way that they could have a distorting effect on the results (ie, they were first randomized into the intervention group, then in the control group and filled in the follow-ups as participants belonging to the control group even though they received the additional intervention elements) those were therefore adjusted, ie, the 'randomization variable' was changed to 1 = Intervention." 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 "However, we deviated from the checklist in one respect: Participants were only invited for the follow-up measurements if they completed the DA(s), that is, if they completed the intervention until the end. This was done as we wanted to ensure that the participants, that we included for the analysis, received the additional intervention elements-as those were the focus of our RCT." Your response is too large. Try shortening some answers. 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 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 Next to attrition analyses (see 3.2. Attrition), we also describe insights regarding usage time; eg, "[...] available data provided by the intervention host indicates that the differences in usage times between the 2 groups were significantly different. The median usage time of the intervention group was approximately 9 minutes, while in the control group it was approximately 6 minutes (see the OSF for more information [35])." Your response is too large. Try shortening some answers. 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 "Furthermore, due to a technical mistake, some participants who completed VISOR, but had not completed t=1 (directly after the decision aid), did not receive an automatic invite for the other follow-ups. When this mistake was discovered, some participants were already lost to follow-up. We dealt with this in 2 different ways: (1) People who had already missed t=2 but completed the DA in the 3 months prior to the discovery of the mistake received the invite to participate in t=2 regardless (n = 38 received this invitation, n = 3 made use of this); (2) people who already missed t=3 were still invited to participate in t=3 but not t=2 (n = 130 received the invitation, n = 5 made use of this  c  o  n  s  i  d  e  r  i  n  g  o  t  h  e  r  r  e  l  e  v  a  n  t  e  v  i  d  e  n  c  e   N  P  T  :  I  n  a  d  d  i  t  i  o  n  ,  t  a  k  e  i  n  t  o  a  c  c  o  u  n  t  t  h  e  c  h  o  i  c  e  o  f  t  h  e  c  o  m  p  a  r  a  t  o  r  ,  l  a  c  k  o  f  o  r  p  a  r  t  i  a  l  b  l  i  n  d  i  n  g  ,  a  n  d  u  n  e  q  u  a  l  e  x  p  e  r  t  i  s  e  o  f  c  a  r  e  p  r  o  v  i  d  e  r  s  o  r  c  e  n  t  e  r  s  i  n  e  a  c  h  g  r  o  u  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 article was to report on the effects of adding an explicit VCM with computer-tailored advice to a smoking cessation DA (called VISOR) on both smoking cessation outcomes and decisional conflict. Contrary to our expectations, we did not find any effect on decisional conflict. Also, while the worst-case scenarios might suggest an effect on smoking cessation rates and cessation assistance uptake, this finding was not replicated in the either the complete case analyses or the MI-analyses. Moreover, given the fact that Blankers et al. [55] have shown that analyses based on penalized imputation can be biased when missingness is unbalanced between trial arms (as in our case), we cannot confidently speak of effects on smoking cessation success and cessation assistance uptake, despite the suggestion of effects in the worst-case scenarios. That said, all the significant and non-significant effects found were in the expected direction, ie, participants in the intervention group showed more smoking cessation, more evidence-based cessation assistance uptake, and less decisional conflict." Your response is too large. Try shortening some answers.  T  :  E  x  t  e  r  n  a  l  v  a  l  i  d  i  t  y  o  f  t  h  e  t  r  i  a  l  f  i  n  d  i  n  g  s  a  c  c  o  r  d  i  n  g  t  o  t  h  e  i  n  t  e  r  v  e  n  t  i  o  n  ,  c  o  m  p  a  r  a  t  o  r  s  ,  p  a  t  i  e  n  t  s  ,  a  n  d  c  a  r  e  p  r  o  v  i  d  e  r  s  o  r  c  e  n  t  e  r  s  i  n  v  o  l  v  e  d  i  n  t  h  e  t  r  i  a  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 developers of the intervention (ie, TG, ES, CD, and CH) were also involved in this evaluation." Your response is too large. Try shortening some answers.

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