Exploring the Acceptability, Feasibility, and Effectiveness of a Digital Parenting Program to Improve Parental Well-being After the Christchurch Earthquakes: Cluster-Randomized Trial

Background Up to 6 years after the 2011 Christchurch earthquakes, approximately one-third of parents in the Christchurch region reported difficulties managing the continuously high levels of distress their children were experiencing. In response, an app named Kākano was co-designed with parents to help them better support their children’s mental health. Objective The objective of this study was to evaluate the acceptability, feasibility, and effectiveness of Kākano, a mobile parenting app to increase parental confidence in supporting children struggling with their mental health. Methods A cluster-randomized delayed access controlled trial was carried out in the Christchurch region between July 2019 and January 2020. Parents were recruited through schools and block randomized to receive immediate or delayed access to Kākano. Participants were given access to the Kākano app for 4 weeks and encouraged to use it weekly. Web-based pre- and postintervention measurements were undertaken. Results A total of 231 participants enrolled in the Kākano trial, with 205 (88.7%) participants completing baseline measures and being randomized (101 in the intervention group and 104 in the delayed access control group). Of these, 41 (20%) provided full outcome data, of which 19 (18.2%) were for delayed access and 21 (20.8%) were for the immediate Kākano intervention. Among those retained in the trial, there was a significant difference in the mean change between groups favoring Kākano in the brief parenting assessment (F1,39=7, P=.012) but not in the Short Warwick-Edinburgh Mental Well-being Scale (F1,39=2.9, P=.099), parenting self-efficacy (F1,39=0.1, P=.805), family cohesion (F1,39=0.4, P=.538), or parenting sense of confidence (F1,40=0.6, P=.457). Waitlisted participants who completed the app after the waitlist period showed similar trends for the outcome measures with significant changes in the brief assessment of parenting and the Short Warwick-Edinburgh Mental Well-being Scale. No relationship between the level of app usage and outcome was found. Although the app was designed with parents, the low rate of completion of the trial was disappointing. Conclusions Kākano is an app co-designed with parents to help manage their children’s mental health. There was a high rate of attrition, as is often seen in digital health interventions. However, for those who did complete the intervention, there was some indication of improved parental well-being and self-assessed parenting. Preliminary indications from this trial show that Kākano has promising acceptability, feasibility, and effectiveness, but further investigation is warranted. Trial Registration Australia New Zealand Clinical Trials Registry ACTRN12619001040156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377824&isReview=true

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: You're editing your response. Sharing this URL allows others to also edit your response. 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 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 Somewhat -there is a secondary paper outlining the key features of Kākano that is referred to in the manuscript to provide this information.

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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 Yes, in the objective section of the abstract it is stated the Kākano is "fully-automated" You're editing your response. Sharing this URL allows others to also edit your response.  t  o  -f  a  c  e  a  s  s  e  s  s  m  e  n  t  s  i  n  t  h  e  M  E  T  H  O  D  S  s  e  c  t  i  o  n  o  f  t  h  e  A  B  S  T  R  A  C  T Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials 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 Web-based pre-intervention and post-intervention testing was undertaken

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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.
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 Yes, as follows: "Kākano, is an app co-designed with parents to help manage their children's big emotions. There was a high rate of attrition as is often seen in digital health interventions but for those who did complete it, there was some indication of improved parental wellbeing and self-assessed parenting." You're editing your response. Sharing this URL allows others to also edit your response. 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, as follows in the introduction "Following the 2011 Christchurch earthquakes, up to a third of parents continued to report elevated distress in their children up to 6 years later [14]. This distress placed increased demand on the resources of a region that were, and still are, struggling to cope with post-earthquake recovery. Although there were some parenting digital interventions available that could provide support, they were not developed for the population of New Zealand. In particular, interventions developed elsewhere did not consider Te Ao Māori (the Māori worldview) and would potentially be seen as less relevant and engaging for Māori, the indigenous population in New Zealand. This is particularly problematic as Māori face many disparities in health and well-being and need more engaging supports."

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You're editing your response. Sharing this URL allows others to also edit your response. 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 Not applicable as no changes were made. You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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We state the following about elligibility "Parents were eligible to participate in the trial if they were caregivers or parents of one or more children aged 5-12 years of age; the children were attending a school participating in the trial; the parents had access to a web-enabled technology compatible with installing and running the Kākano app; the parents reported struggling with parenting or a wanted to learn more skills to aid their parenting, and the parents were aged 18 or over. Parents who were receiving public or private parenting support or training, or had received support or training in the past year; and those that were unable to read, write or speak conversational English were excluded from the trial.
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified. 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

Your answer
You're editing your response. Sharing this URL allows others to also edit your response. 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 "Schools serving families representative of the target population for this app (a high proportion of Māori families or communities particularly affected by the earthquakes) were identified in the Christchurch region. Identified and consenting schools were block randomized to allow parents to receive either immediate access to Kākano or delayed access. "

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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 The manuscripts specifies that this is an online trial, based in New Zealand and the timepoints for data collection. 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 paper implies self-assessment by stating that participants completed the questionnaires themselves You're editing your response. Sharing this URL allows others to also edit your response.  Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This information was displayed on consent forms as seen in the appendices. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is reported in the development paper which is referenced in this manuscript.

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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 briefly explain why the item is not applicable/relevant for your study This will be described in a separate paper.

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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 There was no further development of the app from the development paper. 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 Your answer 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 Your answer 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 A demo site will be developed in the future.

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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 Access to the app is described in the methods section, specifically, access was obtained via a text or email link.

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- Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The instructions provided to participants are outlined in the manuscript. Specifically, they were instructed to use it weekly.

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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).
C l e a r s e l e c t i o n You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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The manuscript indicates that the process is fully automated. 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 Attrition was accounted for and stated in the methods section.
You're editing your response. Sharing this URL allows others to also edit your response. 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 per above. We used block randomized as specified in the manuscript.

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You're editing your response. Sharing this URL allows others to also edit your response. 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 were aware of the intervention and the waitlist as per the information sheet in the appendices.

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You're editing your response. Sharing this URL allows others to also edit your response. 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 Statistical methods are outlined as per "Demographic features were described by randomized group using means and standard deviations or frequencies and percentages. The comparisons of the primary and secondary outcome measures were undertaken using a linear mixed model analysis. These models compared the changes from pre to postintervention between the randomized groups. The analyses of the changes were only undertaken in the completed cohort. Usage measures were summarized for those who completed the study and those who did not using means, medians, standard deviations and ranges. The associations between the usage metrics and the change in outcome measures were tested and analysed using Spearman's rank correlation coefficients. A two-tailed pvalue <0.05 was taken to indicate statistical significance and all analyses were undertaken using SPSS v26 [22]." These were overseen by a statistician.

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You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is specified as per the following "Following reading the participant information sheet, the completion of consent and accepting the terms and conditions of using the app, participants completed baseline questionnaires"

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You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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This was an open access trial and did not recruit participants due to pathology or distress. Contact details for those that were distressed were provided in the participant information sheet and all participants were able to obtain further supports through schools. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is reported in figure 2.
You're editing your response. Sharing this URL allows others to also edit your response.  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

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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is reported in figure 2 of the paper.
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

Your answer
You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is reported in figure 2 of the paper. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study No significant changes or secular events fell during the trial period; "No significant changes or secular events fell during the trial period."

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You're editing your response. Sharing this URL allows others to also edit your response. 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 Trial recruitment changed as outlined in "However, it became obvious early in the recruitment that achieving near simultaneous recruitment of a cluster of schools was not feasible. The first cohort took much longer than anticipated due to difficulties with engaging schools and local communities and getting consent. The design was therefore modified to a pre-post comparison of immediate access and delayed access groups, with the delayed access groups getting the intervention after the delay, primarily to get additional acceptability, feasibility and effectiveness data."

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? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study This is provided in the results section as per tables 1 and 2 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. 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 We did not report any binary outcomes so this is not applicable to this study.
You're editing your response. Sharing this URL allows others to also edit your response. 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 per above, feedback from the participants is reported in the manuscript.

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You're editing your response. Sharing this URL allows others to also edit your response. D  I  S  C  U  S  S  I  O  N   2  2  )  I  n  t  e  r  p  r  e  t  a  t  i  o  n  c  o  n  s  i  s  t  e  n  t  w  i  t  h  r  e  s  u  l  t  s  ,  b  a  l  a  n  c  i  n  g  b  e  n  e  f  i  t  s  a  n  d  h  a  r  m  s  ,  a  n  d  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  Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study

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We are considering further application at present You're editing your response. Sharing this URL allows others to also edit your response.  T  o  g  e  n  e  r  a  t  e  a  r  e  c  o  r  d  t  h  a  t  y  o  u  f  i  l  l  e  d  i  n  t  h  i  s  f  o  r  m  ,  w  e  r  e  c  o  m  m  e  n  d  t  o  g  e  n  e  r  a  t  e  a  P  D  F  o  f  t  h  i  s  p  a  g  e  (  o  n  a  M  a  c  ,  s  i  m  p  l  y  s  e  l  e  c  t  "  p  r  i  n  t  "  a  n  d  t  h  e  n  s  e  l  e  c  t  "  p  r  i  n  t  a  s  P  D  F  "  )  b  e  f  o  r  e  y  o  u  s  u  b  m  i  t  i  t  .   W  h  e  n  y  o  u  s  u  b  m  i  t  y  o  u  r  (  r  e  v  i  s  e  d  )  p  a  p  e  r  t  o  J  M  I  R  ,  p  l  e  a  s  e  u  p  l  o  a  d  t  h  e  P  D  F  a  s  s  u  p  p  l  e  m  e  n  t  a  r  y  f  i  l  e  .   D  o  n  '  t  w  o  r  r  y  i  f  s  o  m  e  t  e  x  t  i  n  t  h  e  t  e  x  t  b  o  x  e  s  i  s  c  u  t  o  f  f  ,  a  s  w  e  s  t  i  l  l  h  a  v  e  t  h  e  c  o  m  p  l  e  t  e  i  n  f  o  r  m  a  t  i  o  n  i  n  o  u  r  d  a

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