Report your results

If you have published the results in a peer-reviewed journal, please could you provide a link to the publication on PubMed or its DOI link (starting https://doi.org/)?

If your study is complete but you have not published or are not planning to publish, we would be happy to upload a basic results summary to your record. The basic results should include the following four sections and not contain any interpretation of the results:

• Participant Flow:  A flow diagram showing participants involved at each stage of the study (namely enrolment, intervention allocation, follow-up, and data analysis). Please see an example of a flow diagram.
• Baseline Characteristics: Table(s) showing demographic data and any clinical characteristics for participants at baseline, as well as any measures assessed at baseline that are used in analysing a primary outcome measure. Please see an example of a baseline characteristics table.
• Outcome Measures: Table(s) of the results for the outcome measures listed in the ISRCTN study record. It is essential you should report on the primary outcome measure listed in the ISRCTN study record. Secondary outcome measures can also be reported here. Please see an example of an outcome measures table.
• Adverse Events: Table(s) of all anticipated and unanticipated serious adverse events (life-threatening) and other adverse events (non-life-threatening), which will include a description of the adverse event and the number of participants affected. If there were no adverse events associated with your study, then please include a statement to the effect of “There were no adverse events associated with this study.”

Please note that the ICMJE guidelines state that providing basic results to a registry in the requested tabular format is not considered prior publication and will not stop you from publishing in a peer-reviewed journal.  For example, this example of a study has both basic results and peer-reviewed publications. However, editors of journals that follow the ICMJE recommendations may consider the posting of more detailed descriptions of study results beyond the requested tabular format to be prior publication.

Basic results can be provided for both interventional and observational studies. Existing reporting guidelines - CONSORT for interventional studies and STROBE for observational studies - can be referred to as a starting point as they both specify how to present information in tabular formats (participant flows, baseline characteristics, list of outcomes), but these reporting guidelines are primarily aimed at publications in peer-reviewed journals.

For examples of basic results summaries, please see the following study records: “My Life After Stroke” - a feasibility study and Using vitamin K to improve strength and balance in older people.

Upload your basic results summary:

Upload your statistical analysis plan:

Upload your protocol:

Upload your IPD (individual participant data):

By submitting this form you agree that we can contact you to request clarification of the submitted updates and to confirm that the update has been made. We’ll store the form and any subsequent related email correspondence in our records but won’t share it with third parties and will otherwise use it in line with our privacy policy https://www.isrctn.com/page/privacy.

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