Journal of Advanced Nursing

Cover image for Vol. 71 Issue 9

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

Impact Factor: 1.741

ISI Journal Citation Reports © Ranking: 2014: 8/108 (Nursing (Social Science)); 10/110 (Nursing (Science))

Online ISSN: 1365-2648

Clinical Trial


Last updated: January 2015

Papers submitted to JAN should not exceed 5000 words for the main text, including quotations but excluding the abstract, summary statement, tables and references.

Organising your paper:

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

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: 250 words. Your abstract should use the following headings: Aims (of the paper), 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 topic.

Background
This should be a substantial, critical review 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 the review for the study.


THE STUDY

Aim/s
State the aims of the study as a narrative study purpose or as research questions or hypotheses to be tested. For example 'The aim of the study was to…'
Design / Methodology
For RCT (randomised clinical trial) or other type of trial, describe the following (as appropriate):

Participants:

Eligibility criteria for participants and the settings and locations where the data were collected

Interventions:

Precise details of the interventions intended for each group and how and when they were actually administered.

Sample size:

How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.

Randomisation - Sequence generation:

Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)

Randomisation - Allocation concealment:

Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned.

Randomisation - Implementation:

Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups.

Blinding (masking):

Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated.

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.

Data collection
Describe the following (as appropriate):

Outcomes:

Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors).

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
Describe the following (as appropriate):

Statistical methods:

Statistical methods used to compare groups for primary outcome(s); Methods for additional analyses, such as subgroup analyses and adjusted analyses. Identify software used.



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 as appropriate, and consistent with the limitations.



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