Journal of Advanced Nursing

Cover image for Vol. 72 Issue 9

Edited By: Editor-in-Chief: Roger Watson; Editors: Robyn Gallagher, Mark Hayter, Jane Noyes, Rita Pickler & Brenda Roe

Impact Factor: 1.917

ISI Journal Citation Reports © Ranking: 2015: 8/114 (Nursing (Social Science)); 10/116 (Nursing (Science))

Online ISSN: 1365-2648

Clinical Trial


Last updated: January 2016

Manuscripts submitted to JAN should not exceed 5,000 words for the main text, including quotations but excluding the abstract, summary statement, tables and references.

Authors considering submitting a manuscript under this category are advised to consult and follow the CONSORT guidelines for reporting trials. JAN has signed up to the All Trials Agreement and trials should be registered publicly. The registration number should be provided in your manuscript, after the abstract. Guidance is available from the World Health Organization and the U.S. National Institutes of Health.

Organising your manuscript:

Separate files to be created and uploaded onto ScholarOne Manuscripts:

Title page file:
Your title page should include the following information:
• Full title (maximum 25 words)
• Running head
• Author details: names (please put last names in CAPITALS), job titles and affiliations (maximum of 3 per author), qualifications (maximum of 3 per author, including RN/RM where appropriate)
• Acknowledgements (if applicable)
Conflict of Interest statement
Funding Statement

In general we do not include country names in published articles and therefore encourage you to omit these from your manuscript title.

Impact Statement
We ask all authors to prepare a short statement (approximately 100 words), using bullet points if necessary, on any impact you see your paper having in terms of patients, clinical practice, education, or wider social and economic issues. This will be seen by editors and reviewers and may be used for promotional purposes.

Main file, to include:
Abstract: Use CONSORT for abstracts. 250-300 words. Your abstract should use the following headings: Aims (of the article), Background, Design, Methods, Results, Conclusion. The abstract should not contain abbreviations or detailed statistics. The Aim should simply state: ‘To…”
Trial registration: List the trial registry, along with the unique identifying number.
Summary Statement: Please see the Summary Statement guidelines.
Keywords: A maximum of 10, including nurses/midwives/nursing.
Main Text: To include the headings below.

Tables and Figures should be uploaded as separate files.

The main text of your clinical trial paper should include the following headings and sub-headings:

INTRODUCTION
Clearly identify the rationale, context, international relevance of the topic.

Background
This should be a substantial, critical summary of relevant theoretical and empirical literature Present the theoretical framework of the research, identifying and providing an overview of the conceptual model and/or theory that guided the study.

Should end with conclusions drawn from published literature to establish the rationale for the trial.


THE STUDY

Aim/s
State the aims of the study as a narrative study purpose, for example 'The aim of the study was to…'. State the research questions or hypotheses to be tested.

Design / Methodology
Studies must adhere demonstrably to the CONSORT statement and include a CONSORT style flow diagram and CONSORT checklist, which can be downloaded from www.consort-statement.org.

Sample/s
Include how sample/s recruited and if an RCT how randomization was undertaken, by whom and how bias was addressed. Include power calculation and justify sample size

Data collection
Describe the following (as appropriate):

Validity and reliability/Rigour
Describe trial governance processes.
Ethical considerations
Identify any particular ethical issues that were attached to this research. Provide a statement of ethics committee approval. Do not name the university or other institution from which ethics committee approval was obtained. State only that ethics committee approval was obtained from a university and/or whatever other organisation is relevant.
Data analysis
Include whether intention to treat analysis was performed and how loss to follow up was handled.

RESULTS
Describe the following (as appropriate):

Participant flow

Flow of participants through each stage (a CONSORT flow diagram is mandatory). Specifically, for each group report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from study as planned, together with reasons.

Recruitment:

Dates defining the periods of recruitment and follow-up.

Baseline data:

Baseline demographic and clinical characteristics of each group.

Numbers analysed:

Number of participants (denominator) in each group included in each analysis and whether the analysis was by "intention-to-treat". State the results in absolute numbers when feasible (e.g., 10/20, not 50%).

Outcomes and estimation:

For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., 95% confidence interval).

Ancillary analyses:

Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those pre-specified and those exploratory.

Adverse events:

All important adverse events or side effects in each intervention group.



DISCUSSION
Discussion must be in relation to the literature. Do previous research findings match or differ from yours?

Draw conclusions about what new knowledge has emerged from the study. For example, this new knowledge could contribute to new conceptualisations or question existing ones; it could lead to the development of tentative/substantive theories (or even hypotheses), it could advance/question existing theories or provide methodological insights, or it could provide data that could lead to improvements in practice.

Limitations
End with study limitations including but not confined to sample representativeness and/or sample size, generalisability/external validity of results.

CONCLUSION
Provide real conclusions, not just a summary/repetition of the findings.

Draw conclusions about the adequacy of the theory in relation to the data. Indicate whether the data supported or refuted the theory. Indicate whether the conceptual model was a useful and adequate guide for the study.

Identify recommendations for practice/research/education/management or policy as appropriate, and consistent with the limitations.



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