Study protocols

We welcome submissions of Study Protocol articles for proposed or ongoing prospective clinical research.These should provide a detailed account of the hypothesis, rationale and methodology of the study, andpreference will be given to submissions describing long term studies and those likely to generate a considerable amount of outcome data. Study Protocols for pilot or feasibility studies are not usually considered. We encourage authors to submit the results of the pilot as a research article and the study protocol for the definitive study. Study Protocols are generally not considered if the authors have other articles relating to the protocol published or under consideration.

Articles concerning proposed research which has received ethics approval, undergone peer review and been awarded a grant from a major funding body will be considered for publication without peer review.We will require proof of ethics approval and funding, see Preparing your manuscript guidelines.Study Protocols without major external funding, or where the Editor considers it necessary, will be peer reviewed. Study Protocols without ethics approval will generally not be considered.

Study Protocols should be reported according to SPIRIT guidelines.

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Title page

The title page should:

Should be concise and informative and less than 100 characters. Please also provide a short title of 50 characters.

Abstract

The Abstract should not exceed 350 words. Please minimize the use of abbreviations and do not cite references in the abstract. Reports of randomized controlled trials should follow the CONSORT extension for abstracts. The abstract must include the following separate sections:

• Background: the context and purpose of the study
• Methods: how the study was performed and statistical tests used
• Results: the main findings
• Conclusions: brief summary and potential implications
• Trial registration: If your article reports the results of a health care intervention on human participants, it must preferably be registered in an appropriate registry and the registration number and date of registration should be in stated in this section.

Keywords

Provide three to ten keywords representing the main content of wededomino the article, listed in alphabetical order.

Text

Max. 5000 words not including abstract, figure legends and references (please supply a word count).

Up to 50 references in the Journal's style.

Up to 6 figures and/or tables (total).

If you wish to exceed any of the above, please state in the cover letter the reasons for an increase in length, number of figures or tables, or number of references.

Background

The Background section should explain the background to the study, its aims, a summary of the existing literature and why this study was necessary or its contribution to the field.

Methods

The methods section should include:

• the aim, design and setting of the study
• the characteristics of participants or description of materials
• a clear description of all processes, interventions and comparisons. Generic drug names should generally be used. When proprietary brands are used in research, include the brand names in parentheses
• the type of statistical analysis used, including a power calculation if appropriate

Results

Present the findings of the study including, if appropriate, results of statistical analysis which must be included either in the text or as tables and figures.

Discussion

Discuss any practical or operational issues involved in performing the study and any issues not covered in other sections.

List of abbreviations

If abbreviations are used in the text they should be defined in the text at first use, and a list of abbreviations should be provided.