CONSORT-EHEALTH (V 1.6.1) - Submission/Publication Form

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.

Items numbered 1., 2., 3., 4a., 4b etc are original CONSORT or CONSORT-NPT (non-pharmacologic treatment) items.
Items with Roman numerals (i., ii, iii, iv etc.) are CONSORT-EHEALTH extensions/clarifications.

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.

YOUR ANSWERS WILL BE PUBLISHED AS A SUPPLEMENTARY FILE TO YOUR PUBLICATION IN JMIR AND ARE CONSIDERED PART OF YOUR PUBLICATION (IF ACCEPTED).
Please fill in these questions diligently. Information will not be copyedited, so please use proper spelling and grammar, use correct capitalization, and avoid abbreviations.

DO NOT FORGET TO SAVE AS PDF _AND_ CLICK THE SUBMIT BUTTON SO YOUR ANSWERS ARE IN OUR DATABASE !!!

Citation Suggestion (if you append the pdf as Appendix we suggest to cite this paper in the caption):
Eysenbach G, CONSORT-EHEALTH Group
CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions
J Med Internet Res 2011;13(4):e126
URL: http://www.jmir.org/2011/4/e126/
doi: 10.2196/jmir.1923
PMID: 22209829

    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    TITLE AND ABSTRACT

    1a) TITLE: Identification as a randomized trial in the title

    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions

    NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    INTRODUCTION

    2a) In INTRODUCTION: Scientific background and explanation of rationale

    This is a required question
    This is a required question
    This is a required question
    This is a required question

    2b) In INTRODUCTION: Specific objectives or hypotheses

    This is a required question

    METHODS

    3a) Description of trial design (such as parallel, factorial) including allocation ratio

    This is a required question

    3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons

    This is a required question
    This is a required question
    This is a required question

    4a) Eligibility criteria for participants

    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    4b) Settings and locations where the data were collected

    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    6b) Any changes to trial outcomes after the trial commenced, with reasons

    This is a required question

    7a) How sample size was determined

    NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed
    This is a required question
    This is a required question

    7b) When applicable, explanation of any interim analyses and stopping guidelines

    This is a required question

    8a) Method used to generate the random allocation sequence

    NPT: When applicable, how care providers were allocated to each trial group
    This is a required question

    8b) Type of randomisation; details of any restriction (such as blocking and block size)

    This is a required question

    9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

    This is a required question

    10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

    This is a required question

    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
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    11b) If relevant, description of the similarity of interventions

    (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention)
    This is a required question

    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
    This is a required question
    This is a required question
    This is a required question

    12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses

    This is a required question

    X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)

    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    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
    This is a required question

    13b) For each group, losses and exclusions after randomisation, together with reasons

    This is a required question
    This is a required question
    This is a required question

    14a) Dates defining the periods of recruitment and follow-up

    This is a required question
    This is a required question
    This is a required question

    14b) Why the trial ended or was stopped (early)

    This is a required question

    15) A table showing baseline demographic and clinical characteristics for each group

    NPT: When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group
    This is a required question
    This is a required question
    This is a required question

    16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

    This is a required question
    This is a required question
    This is a required question
    This is a required question

    17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

    This is a required question
    This is a required question
    This is a required question

    17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended

    This is a required question

    18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

    This is a required question
    This is a required question
    This is a required question

    19) All important harms or unintended effects in each group

    (for specific guidance see CONSORT for harms)
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    DISCUSSION

    22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence

    NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

    This is a required question
    This is a required question

    21) Generalisability (external validity, applicability) of the trial findings

    NPT: External validity of the trial findings according to the intervention, comparators, patients, and care providers or centers involved in the trial
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    OTHER INFORMATION

    23) Registration number and name of trial registry

    This is a required question

    24) Where the full trial protocol can be accessed, if available

    This is a required question

    25) Sources of funding and other support (such as supply of drugs), role of funders

    This is a required question

    X27) Conflicts of Interest (not a CONSORT item)

    This is a required question
    This is a required question

    About the CONSORT EHEALTH checklist

    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question
    This is a required question

    STOP - Save this form as PDF before you click submit

    To generate a record that you filled 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 file. Don't worry if some text in the textboxes is cut off, as we still have the complete information in our database. Thank you!

    Final step: Click submit !

    Click submit so we have your answers in our database!