Observational or experimental?
Findings from confirmatory randomized trials are generally considered to represent a higher level of evidence than findings from observational studies. Manuscripts presenting randomized trials usually get more favourable evaluations and have lower chances of being rejected. Many authors of observational studies have recognized this phenomenon and try to use the knowledge in order to improve the chances of getting their manuscripts accepted for publication. This approach is then used. First, the observational study is described as a trial and registered in clinicaltrials.gov or some other public trial register. The registration is presented in the manuscript. If it has not been done earlier, an ethics application is also made, and the approval is presented in the manuscript together with a statement about compliance with the Helsinki Declaration.
Then the manuscript is written using the statistical terminology that has been developed for randomised trials, e.g. primary och secondary endpoints, adverse events, efficacy, multiplicity, etc. A post hoc sample size calculation can be included, and the absence of randomisation can be discussed as a “limitation”. Finally, a completed CONSORT Statement checklist is included with the manuscript. Many reviewers are likely to believe that the manuscript actually describes the outcome of an experiment.
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