Conforming to Guidelines
- Submissions to ATVB will be reviewed for conforming to the following guidelines:
- NIH principles and guidelines for reporting preclinical research http://www.nih.gov/about/reporting-preclinical-research.htm
- STROBE (& MOOSE) guidelines for observational studies http://www.strobe-statement.org/
- PRISMA (& MOOSE) guidelines for systematic reviews and meta-analyses http://www.prisma-statement.org/
- STARD guidelines for studies of diagnostic accuracy http://www.stard-statement.org/
- CONSORT guidelines for Randomized Controlled Trials http://www.consort-statement.org/
Complying With the National Institutes of Health Guidelines and Principles for Rigor and Reproducibility
- Complying With the National Institutes of Health Guidelines and Principles for Rigor and Reproducibility http://atvb.ahajournals.org/content/36/7/1303.full
Guidelines for Clinical Trials
- In accordance with the Clinical Trial Registration Statement from the International Committee of Medical Journal Editors (Circulation. 2005;111:1337) and (http://content.nejm.org/cgi/content/full/NEJMe078110), all clinical trials must be registered in a public trials registry at or before the onset of participant enrollment. This requirement applies to all clinical trials that begin enrollment after July 1, 2005.
- Research is considered to be a clinical trial if it involves prospective assignment of human subjects to an intervention or comparison group to study the relation between a health-related intervention and a health outcome. Studies that are designed for other purposes, such as to study pharmacokinetics or major toxicity (e.g., phase 1 trials), are exempt.
- The registry must be accessible to the public at no charge, searchable, open to all prospective registrants, and managed by a not-for-profit organization. The registry must include the following information: a unique identifying number, a statement of the intervention(s), study hypothesis, definition of primary and secondary outcome measurements, eligibility criteria, target number of subjects, funding source, contact information for the principal investigator, and key dates (registration date, start date, and completion date). The registry sponsored by the United States National Library of Medicine (http://www.clinicaltrials.gov) meets these requirements and is recommended by the editors.
- Other registries are acceptable if they meet these requirements. In addition to www.clinicaltrials.gov, the following registries are recommended by the ICMJE:
- In accordance with the ICMJE’s recommendation, we will also accept registration of clinical trials in any of the primary registers that participate in the World Health Organization’s International Clinical Trial Registry Platform. Primary registers are WHO selected registers managed by not-for-profit entities that will accept registrations for any interventional trials, delete duplicate entries from their own register, and provide data directly to the WHO. Please note that registration in any WHO partner registers is insufficient.
- The authors will be requested to provide the exact URL and unique identification number for the trial registration at the time of submission. Since this information will be published in a footnote on the first page of the article, we ask that you include the URL and identification number on the title page of your manuscript.
- Clinical trial reports should also comply with the Consolidated Standards of Reporting Trials (CONSORT) and include a flow diagram presenting the enrollment, intervention allocation, follow-up, and data analysis with number of subjects for each (http://www.consort-statement.org/?o=1011). Please also refer specifically to the CONSORT Checklist of items to include when reporting a randomized clinical trial.
- Results posted in the same clinical trials registry in which the primary registration resides will not be considered prior publication if they are presented in the form of a brief abstract (500 words or less) or a table.
Compliance with NIH and Other Research Funding Agency Accessibility Requirements
- Several research funding agencies now require or request authors to submit the post-print (the article after peer review and acceptance but not the final published article) to a repository that is accessible online by all without charge. Within medical research, 3 funding agencies in particular have announced such policies:
- The US National Institutes of Health (NIH) requires authors to deposit post-prints of articles, which have received NIH funding, in its repository PubMed Central (PMC). This deposit should be done within the 12 months after publication of the final article in the journal.
- The Howard Hughes Medical Institute (HHMI) requires, as a condition of research grants, deposit in PMC, but within 6 months after publication of the final article.
- The Wellcome Trust requires, as a condition of research grants, deposit in UK PMC within 6 months after publication of the final article.
- As a service to authors, the Publisher (Wolters Kluwer Health/Lippincott Williams & Wilkins) of the AHA journals will identify to PMC articles that require depositing. The Copyright Transfer Agreement provides the primary mechanism for identifying such articles. The AHA also requests that, during the submission process in our peer review submission site, funding is indicated in the Author Disclosure area of the submission process.
- WKH/LWW will transmit the post-print of an article, which is based on research funded in whole or in part by 1 or more of these 3 agencies, to PMC.
- On NIH request, it remains the legal responsibility of the author(s) to confirm with the NIH the provenance of their manuscript for purposes of deposit.
- Author(s) will not deposit their articles themselves.
- Author(s) will not alter the post-print already transmitted to NIH.
- Author(s) will not authorize the display of the post-print prior to:
- 12 months after publication of the final article, in the case of NIH
- 6 months after publication of the final article, in the case of HHMI and the Wellcome Trust
- For more information on PubMed Central, please visit http://nihms.nih.gov.
- If you have questions about your manuscripts submission to PMC after acceptance, please contact ATVBJournal@lww.com.
- A Permissions and Rights Question and Answer is also available (http://atvb.ahajournals.org/content/permissions-rights-q-and-a).
Criteria for SNP/Genome-Wide Association Studies
- Phenotypes: There must be a clearly defined phenotype or trait. Cases must be defined using standardized criteria. The criteria for control status must be defined (eg, age and sex individuals with normal invasive or noninvasive investigations, or alternatively, older controls free of symptomatic disease).
- Population: Cases and controls must be of the same ethnic group. Authors should indicate measures taken to test for population stratification.
- Study Population Size: The study population must be large enough to detect effect sizes appropriate for the trait. Power calculation should be provided indicating the sample size required to detect variants of a given minor allele frequency (MAF) and effect size (odds ratio per risk allele). Genome-wide association studies for common complex traits generally require more than 2000 cases and controls for initial genotyping and replication in other cohorts.
- Multiple Testing: Genetic association studies generally involve the testing of multiple genetic variants and various associated phenotypes in a number of subgroups. Statistical analysis of data must provide evidence of correction for multiple testing.
- Replication in independent population(s) is generally required. Exceptions may include very large studies where genome-wide significance (p = 5 X 10-8) is achieved in the initial study or when a nonsynonymous coding variant in a gene of high biological plausibility is tested in a large well-characterized population with a clearly defined phenotype.
- Replication requires testing the same or closely linked variant and phenotype using the same study design in a population of the same ethnic origin as the screening population. Several large genome-wide association studies have made their case/control data publically available to bona fide investigators. Thus, where appropriate, authors are encouraged to use these resources to meta-analyze these datasets with their own. Since individual SNPs vary by the genotyping platform used, imputed data (r2>0.8 based on HapMap data) may be used provided that the authors indicate that a proxy was used and provide its rs number.
- Data Presentation:
- Provide rs number and chromosomal position numbers for all variants reported.
- Provide criteria that have been used in the selection of tag SNPs.
- Describe linkage disequilibrium (LD) relationships between typed and imputed variants.
- Provide details on the measures that have been taken to ensure genotyping accuracy including % successful genotype calls and information on departure from Hardy- Weinberg equilibrium.
- Provide raw genotype frequencies; allele frequencies are not adequate.
- Provide HUGO gene names in the appropriate annotation and use standard format.
- Indicate the boundaries used when studying a gene of interest (eg, exons, intron/exon boundaries, 10 kb 5' and 5 kb 3').
- Positive and Negative Findings: Negative findings can and should be reported if above criteria are followed.
- Functional Studies: All genetic studies will be greatly enhanced by the provision of functional data where possible. The effects of nonsynonymous coding SNPs in genes of biological significance are often readily addressed using cell based assays and genetically modified animal models. However many significant and replicated SNPs will lie in intergenic regions and may or may not be causally linked to the disease phenotype. Fine mapping and attention to recombination hotspots may define an interval within which the causative variant is likely to reside. Biology of noncoding variants can be furthered explored using routine molecular biology techniques including luciferase assays, effects on transcription factor binding sites and gene expression data including pathway analysis. Finally, deep resequencing of the region of interest may identify novel coding variants associated with the disease phenotype.
- Data must be made publicly available (eg, http://view.ncbi.nlm.nih.gov/dbgap).
- For further reading on these guidelines, please see: http://atvb.ahajournals.org/content/22/7/1058.
Criteria for Epidemiology and Biomarker Studies
- ATVB welcomes original research in the epidemiology of atherosclerosis and vascular disease and biomarker discovery.
- Priority will be given to studies that describe novel findings that add significantly to previously published information and facilitate the translation of molecular mechanisms into clinical applications.
- Authors are encouraged to integrate their findings with previous information on the biology of systems and pathways relevant to arteriosclerosis, thrombosis, and vascular biology.
- The correct use of statistical methods is essential for proper interrogation and interpretation of study data.
Criteria for Microarray Studies
- The journal welcomes manuscripts utilizing mRNA microarray analyses of vascular tissue or cells native or targeted to the vessel wall in pathological states.
- Authors should follow MIAME standards (see Nature Genetics 2001 Dec;29(4):365-70) and provide evidence that data are submitted to the NCBI's Gene Expression Omnibus (GEO) repository.
- Standard annotation of data sets should be included (eg, DAVID, http://david.abcc.ncifcrf.gov/).
- In addition, the journal requires that key target genes be validated at the mRNA level and protein level (when reliable antibodies are available).
- The journal will give higher priority to manuscripts that define new, unanticipated target genes involved in vascular pathobiology or follow up with a testable hypothesis that yields new mechanistic insight into a specific pathway or process.
Data and Reagent availability
- Guidelines for Deposition of Protein and Nucleic Acid Data
- Preparation of Data: Submitted data should follow the MIAME checklist (for more information, see http://www.mged.org/Workgroups/MIAME/miame.html).
- Accessibility of Data: Authors of papers that include genomic, proteomic, or other high-throughput data are required to make their data easily accessible for the reviewers and the editors during the review process. You may submit your data to the NCBI gene expression and hybridization array data repository (GEO, http://www.ncbi.nlm.nih.gov/geo) and provide the GEO accession number; or, you may provide a link to a secure or publicly accessible website which hosts the data. Prior to publication, the data must be submitted and an accession number obtained. Access to the information in the database must be available at the time of publication. GEO has a web-based submission route, suitable for a small number of samples, or a batch submission tool (called SOFT). GEO is accessible from http://ncbi.nlm.nih.gov.geo.
- Newly reported nucleotide or protein sequences must be deposited in GenBank (http://www.ncbi.nlm.nih.gov/Genbank/index.html), EMBL (http://www.ebi.ac.uk), or DNA Data Bank of Japan (http://www.ddbj.nig.ac.jp) databases, and an accession number must be obtained. Access to the information in the database must be available at the time of publication. Authors are responsible for arranging release of data at the time of publication. The authors must also provide a statement in the manuscript that this sequence has been scanned against the database and all sequences with significant relatedness to the new sequence identified (and their accession numbers included in the text of the manuscript).
- Please provide sex-specific and/or racial/ethnic-specific data, when appropriate, in describing outcomes of epidemiologic analyses or clinical trials; or specifically state that no sex-based or racial/ethnic-based differences were present. See the Uniform Requirements for more details.
- To allow others to replicate and build on work published in ATVB, the journal expects that authors make materials, data, and associated protocols available to readers. There is also an expectation for materials used in the manuscript (e.g. cloned DNAs; antibodies; cell lines, animals, computer programs) be available promptly on request by qualified researchers for their own use. It is reasonable for authors to charge an appropriate amount to cover costs associated with shipping the requested materials.
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