- Title
- Primary subject area
- Research question
- Abstract
- Ethics
Objectives - a clear statement of the main aim of the study and the major hypothesis tested or research question posed
Design - including factors such as prospective, randomisation, blinding, placebo control, case control, crossover, criterion standards for diagnostic tests, etc.
Setting - include the level of care, eg primary, secondary; number of participating centres. Be general rather than give the name of the specific centre, but give the geographical location if this is important
Participants (instead of patients or subjects) - numbers entering and completing the study, sex, and ethnic group if appropriate. Give clear definitions of how selected, entry and exclusion criteria.
Interventions - what, how, when and for how long. This heading can be deleted if there were no interventions but should normally be included for randomised controlled trials, crossover trials, and before and after studies.
Main outcome measures - those planned in the protocol, those finally measured (if different, explain why).
• Results - main results with (for quantitative studies) 95% confidence intervals and, where appropriate, the exact level of statistical significance and the number need to treat/harm. Whenever possible, state absolute rather than relative risks.
Conclusions - primary conclusions and their implications, suggesting areas for further research if appropriate.
do not go beyond the data from the study. Conclusions are important because this is often the only part that readers look at.
Trial registration - registry and number (for clinical trials and, if available, for observational studies and systematic reviews).