More than just a manuscript
Research in clinical practice is a heavy investment of time and resources, and the processes involved are often underestimated. Getting published in a peer-reviewed journal can be a taxing endeavour, and there are many questions worth considering regarding the planning, execution and management of a clinical study.
What study design can be used to answer the study question? And for internal considerations, is the proposed design viable from an ethical, methodological, resource and financial perspective?
What is the rationale for the study? Is there a gap in the literature the study can address?
What are the ethical and governance considerations for the study?
Has the protocol been developed with the appropriate framework?
What is the most appropriate journal for publication?
Have the formatting requirements been met?
How will the order of authorship be determined?
Who will manage the submission to the ethics review committee and corresponding feedback?
Who will manage the submission to the journal and corresponding feedback?
Who will deal with general correspondence pertaining to the article?
Have the data collection forms and a study mastersheet been established?
Will staff training and pilot runs be required?
How will the patients be recruited?
What are the key data sources and how will the data be obtained from them?
How will the study progress and data quality be monitored?
Is the statistical plan appropriate for the study?
Have appropriate parameters been used for the analysis?
Are the analysis methods robust and reproducible?
What is the best way to interpret and present the results?
What are the limitations that need to be considered?