Authors’ checklist – clinical trial
Below you will find a checklist to help you prepare your manuscript to meet the guidelines for revision.
Once the checklist is complete, and revisions have been incorporated—please acknowledge in the cover letter that the checklist has been completed, and please clearly indicate (page numbers) where in the manuscript any changes have been made.
Please note, that if the paper is accepted, we cannot proceed to Production until the journal guidelines have been met.
General points
□ Please carefully follow CONSORT guidelines. Please download and complete the CONSORT checklist, and include a participant flow diagram in the article.
□ Please provide trial registration number and name of the trial registry.
□ We encourage you to post the study protocol on a publicly accessible website, with a permanent URL. Please provide the protocol link with your final corrections.
□ Please clearly indicate funding and other non-financial support and the role of funders at end of Discussion section.
□ We cannot allow priority claims, such as “first”, “new”, “novel”. Please rephrase any instances in the text.
□ Define all abbreviations.
□ Please give actual numbers (numerator and denominator) together with percentages.
□ Please do not translate hazard ratios, relative risks, or odds ratios into percentages, since this can be misleading. Please simply indicate these numbers and let the reader interpret the data.
□ All abstracts and references “in press” should be updated with DOIs or page numbers as appropriate. For papers listed in references that are “in press” we need to see a galley proof and/or letter from the publisher stating that it is “in press” as well as (where known) the full expected citation (i.e., publication date/volume/issue etc.). References that are “submitted” should be removed and citations in the text replaced with “(unpublished data; authors)”.
□ Avoid slashes (except ratios).
□ Compound structures for all compounds used in the manuscript must be provided, per journal policy. Please either refer to published chemical structure, or provide complete geometric representation of the molecular structure in the manuscript, if referring to a new compound.
□ Use approved gene names. Italicize (approved gene names only) and format appropriately (e.g., all caps for human genes, first letter cap for mouse genes – see http://www.genenames.org/ or http://www.informatics.jax.org/).
□ Please use American English throughout.
□ Please carefully follow the linked guidelines of reporting standards if your study falls within one the following categories, and fill in and return the checklist(s) where applicable:
Animal preclinical studies / ARRIVEObservational cohort and case-control studies / STROBE
Systematic reviews and meta-analyses / PRISMA and MOOSE
Genetic association studies / STREGA
Genetic risk prediction studies / GRIPS
Diagnostic/prognostic studies / STARD and TRIPOD
Prognostic markers / REMARK
Case reports / CARE
Study protocols / SPIRIT
Heath economic evaluation / CHEERS
Health quality improvement / SQUIRE
Biospecimens / BRISQ
Microarrays / MIAME
For more information on reporting standards, please visit: http://www.equator-network.org/
Article order
1. Title page (article title, full authorship and affiliations, corresponding author contact details)
2. Abstract
3. Keywords (4-6 keywords)
4. Highlights and Research in Context sections
5. Introduction
6. Materials and Methods
7. Results
8. Discussion (please make sure Results and Discussion are separate sections, not combined)
9. Acknowledgements
10. Funding Sources
11. Conflicts of Interest
12. Author Contributions
13. References
14. Figure Legends
Title
□ Please avoid abbreviations in title. Please either define functionally (e.g., “the influenza viral HA protein”) or spell out (“influenza viral hemagglutinin”).
Highlights
□ Please provide 2–3 sentences in bulleted format, summarizing the key findings in your paper.
□ Each sentence (bullet) should be <125 characters including spaces.
Research in context
□ Please provide a short paragraph (100 words max) which will help the non-specialist reader understand the most important message from the findings.
□ In particular, why the findings are relevant to human health (for the more basic research papers), and/or how the findings can help improve our understanding of the disease mechanisms (for the more clinical papers).
□ This should be written not only for scientists and clinicians, but also for curious members of the general public. Therefore, please use clear and simple language, avoiding jargon and abbreviations.
Abstract
□ The abstract should conform to the CONSORT guidelines for abstracts (CONSORT for Abstracts: Lancet 2008; 371: 281–83), and must include:
a) Background: A sentence indicating the aim of this study. Please be sufficiently clear such that all readers (including non-MDs, and non-specialists) will have a clear sense of the rationale for the study.
b) Methods: A brief summary of the main patient characteristics (i.e., main entry criteria)
c) Methods: Details of the regimens used.
d) Methods: Details of how randomisation was done (e.g., allocation concealment; nature of blinding, if any; how sequence was generated; stratification factors, etc.).
e) Methods: An explicit description of the actual primary endpoint.
f) Methods: The nature by which analyses were done (e.g., intention to treat, per protocol).
g) Methods: The trial registration number.
h) Methods: The status of the trial – is it ongoing/still enrolling/is this an interim analysis, etc.?
i) Findings: Efficacy data for the primary endpoint only.
j) Findings: The most common (grade 3-4) adverse events (including actual numbers of patients affected); any serious adverse events.
k) Interpretation: please do not just restate your findings. What do they mean, clinically? What are their implications? Please be sufficiently clear such that all readers (including non-MDs, and non-specialists) will have a clear sense of the importance of the findings. How does the current study advance translational goals relative to the published literature?
l) A line at the end of the abstract stating who funded the research.
□ Please define all abbreviations.
Introduction
□ Please include a clear explanation for the rationale of the study, and sufficient scientific background information. The general reader (i.e., non-specialist) should have a clear sense for why the study was undertaken, and how the current study advances translational goals relative to the published literature.
□ Define all abbreviations first time even if they have been defined in the Abstract.
Materials and Methods
□ Please carefully follow CONSORT checklist for Methods. Must clearly describe trial design, participant information, interventions, outcomes (with primary and secondary endpoints defined), sample size, randomization, blinding and statistical methods.
□ Please very carefully check that all dosing information is accurate and complete. For example, please confirm that the dose, route, and frequency of administration (and the form, e.g., a particular salt) are correct.
□ All experiments must be clearly described.
□ Provide accession numbers for all materials deposited in a public database, e.g., PDB. Accession numbers should be clearly identified under a separate subheading at the end of the Methods section. Microarray data must be deposited in a MIAME-compliant database.
□ Please clearly state whether the authors have obtained signed informed consent from human subjects, and whether the study protocol has been approved by the relevant ethical committee. The section should also include a statement regarding conformation to standards indicated by the Declaration of Helsinki.
□ Provide accession numbers for all materials deposited in a public database e.g. PDB. Accession numbers should be clearly identified under a separate subheading at the end of the Methods section.
□ Reagent Identification: In an effort to support reproducibility, we request that you please—whenever available—include a Research Resource Identifier (RRID) for any biological reagents used in the study. These include, for example, antibodies, genetically modified organisms and cell lines. To find an RRID, please visit https://scicrunch.org/resources and enter your search term(s) there. For search tips and help, contact . Once you have located an RRID, please insert "RRID:" plus the identifier in the appropriate location in the manuscript. For example:
· Antibodies: "Sections were stained with a rabbit polyclonal antibody against ERK1 (Abgent Cat# AP7251E, RRID: AB_2140114)."
· Genetically modified organisms: "Subjects in this study were Fgf9Eks/Fgf9+ mice (RRID: MGI_3840442)..."
□ Data Deposition, Database Linking, and Materials Sharing:
· It is expected that the authors will be willing to distribute any new reagents described in the Methods section of the manuscript to qualified researchers for their own use upon written request. Data sets must be made freely available to readers from the date of publication and must be provided to editors and peer reviewers at submission for the purposes of evaluating the manuscript. If there are restrictions to the availability of any materials or data, these must be disclosed in the cover letter and in the Methods at the time of submission.
· Elsevier collaborates with a number of repositories to link articles on ScienceDirect with relevant repositories, giving readers one-click access to underlying data that give them a better understanding of the research described. For more information, visit the database linking page. For supported data repositories a repository banner will automatically appear next to your published article on ScienceDirect.
· Newly described data sets must be deposited to a public repository, and accession numbers must be clearly identified under a separate subheading at the end of the Methods section. Please refer to relevant database identifiers using the following format in your article: "Database: xxxx" for single accession numbers and "Database: xxxx, yyyy, zzzz" for multiple accession numbers (e.g., "Genbank: NM_000492"; "GEO: GSE6364"; "PDB: 1TUP, 1KW4, 3H5X"). Examples of appropriate public repositories are:
o DNA and RNA sequences: GenBank, EMBL-EBI, DDBJ
o Protein sequence: EMBL-EBI, Protein Data Bank
o Microarray and deep sequencing data: GEO, ArrayExpress
o SNPs and CNVs: dbSNP, DGVa, dbVAR
o Genotypes and phenotypes: dbGaP
o Proteomics data: PRIDE, PeptideAtlas
o Protein interaction data: IMEx consortium of databases
o Chemical compound: PubChem
o Brain imaging data: OpenfMRI repository, Neurovault repository
· Where there is no public repository and if the data sets are too large to submit to the journal as Supplementary data, authors should either consult the journal editorial office for advice or provide five separate copies of these data to the editors in an appropriate format (for example, CD or DVD) for the purposes of peer review.
Results
□ Please carefully follow CONSORT checklist for what to include in Results section, including participant flow, recruitment information, numbers of subjects, and outcomes.
□ Subheadings should be fewer than 100 characters including spaces.
□ Describe the experiments clearly and what each figure shows.
□ All figures and tables must be called out, and called out in sequential order.
□ Tables should be provided in an editable format (so individual numbers/texts can be copied).
Figures
□ Do not use bold face.
□ Be consistent with the font size throughout.
□ Please use Arial font.
□ Use lowercase font (a, b, c…) to denote individual panels in a composite figure.
□ Do not add box outline to graphs.
□ Do not use titles in the graph or artwork. Titles should appear at the beginning of the figure legend.
□ Nomenclature and abbreviations should be consistent with the text.
□ Check that the figures are in approved format and resolution.
□ All figure panels must be on a single page. (One figure per page, please.)
Figure legends
□ Please provide titles for all figures.
□ Legends should briefly describe the experiment and clearly describe the display item. There should be no discussion or statement (conclusion) about the results.
□ Each part of the display item should be clearly defined and explained, e.g., numbers in the quadrant indicate the percentage of cells.
□ Statistical tests should be clear. Error bars should be defined. The number of independent experiments must be indicated.
Discussion
□ Please follow CONSORT checklist, and include discussion on limitations, generalizability, and interpretation of results.
□ Should be no longer than 5 pages of double-spaced 12 point font on A4 paper.
□ No subheadings.
□ Do not repeat discussion of results.
□ Please conclude with a brief paragraph highlighting main points of study, including a statement regarding the translational value of the work. As with the Introduction and Abstract, please make sure the language is clear to the general audience, including non-specialists.
Conflicts of Interest
□ Please include a conflict of interest statement directly after the Discussion.
Patent Applications
If you intend to file a patent related to the findings presented in this manuscript, please ensure your patent application is submitted before submitting your revised manuscript. Please note that once a paper is accepted by the Editor, the accepted (uncorrected proof) version will appear online fairly quickly—usually within 48 hours of acceptance. This online version is accessible to the public, and may affect patent applications in certain countries.
References
□ All references must be in Harvard style formatting.
Author declaration form
□ We require a completed “Author declaration form” signed by all authors. The form can be downloaded from http://www.ebiomedicine.com/pb/assets/raw/Health%20Advance/journals/ebiom/EBM_AuthorDeclaration.pdf
□ Please ensure all statements in the declaration form exactly match those in your manuscript, including Author contributions, Role of the funding source, Conflicts of interest, Ethical research conduct/Patient consent where applicable.
Supplemental Data
□ All supplementary materials should have appropriate headings and figures should have legends.
□ All supplementary materials should be consistent with the main text, e.g., nomenclature.
□ All supplementary materials should be combined in one single file for uploading.