ACCEPTED WITH REVISIONS REGISTRATION
All clinical trials must be registered at an appropriate online public registry (see Trial Registration requirements). All manuscripts reporting clinical trials, including those limited to secondary exploratory or post hoc analysis of trial outcomes, must include a copy of the trial protocol including the complete statistical analysis plan (see Protocols), a CONSORT flow diagram ( Figure), and a completed CONSORT checklist. Interventions include but are not limited to drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, process-of-care changes, and the like. The ICMJE defines a clinical trial as any research project that prospectively assigns human participants to intervention or comparison groups to study the cause-and-effect relationship between an intervention and a health outcome. Maximum length: 3000 words of text (not including abstract, tables, figures, acknowledgments, references, and online-only material) with no more than a total of 5 tables and/or figures. A list of 3 Key Points is required (see guidance on preparing Key Points). Follow EQUATOR Reporting Guidelines.Ī structured abstract is required for more information, see instructions for preparing Abstracts for Reports of Original Data. Data included in research reports must be original and should be as timely and current as possible (see Timeliness of Data). Each manuscript should clearly state an objective or hypothesis the design and methods (including the study setting and dates, patients or participants with inclusion and exclusion criteria and/or participation or response rates, or data sources, and how these were selected for the study) the essential features of any interventions the main outcome measures the main results of the study a discussion section placing the results in context with the published literature and addressing study limitations and the conclusions and relevant implications for clinical practice or health policy. These reports typically include randomized trials (see Clinical Trial), intervention studies, cohort studies, case-control studies, epidemiologic assessments, other observational studies, surveys with high response rates (see Reports of Survey Research), cost-effectiveness analyses and decision analyses (see Reports of Cost-effectiveness Analyses and Decision Analyses), and studies of screening and diagnostic tests (see also Reports of Diagnostic Tests).
Decisions and Management of Editorial Conflicts of Interest.Personal Communications and Unpublished Data.Ethical Approval of Studies and Informed Consent.Reporting Demographic Information for Study Participants.Reports of Cost-effectiveness Analyses and Decision Analyses.Data Access, Responsibility, and Analysis.Funding/Support and Role of Funder/Sponsor.Conflicts of Interest and Financial Disclosures.Depositing Research Articles in Approved Public Repositories.Previous or Planned Meeting Presentation or Release of Information.Previous Publication, Related Manuscripts and Reports, and Preprints.About Previous Release of Information, Embargo, and Access.Authorship Form and Publishing Agreement.Copies of Previous Editorial and Reviewer Comments.Statistical Methods and Data Presentation.Gene Names, Symbols, and Accession Numbers.Names of Drugs, Devices, and Other Products.Manuscript Preparation and Submission Requirements.Systematic Review (without meta-analysis).
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