Designing clinical studies in orthopedic traumatology

Abstract

The design of clinical studies in orthopedic traumatology is challenging in several respects. In this era of evidence-based medicine, the pressure is high to choose our treatments solely based on randomized controlled studies. This type of study, when well-constructed, makes it possible to discern the best treatment for a specific fracture in a given group of patients and in connection with a specific outcome. Randomized controlled trials require a lot of resources and are not designed to answer all research questions. Observational studies, such as case-control studies, prospective cohort studies, and cross-sectional studies, also have a role to play in improving scientific knowledge in orthopedic trauma. Regardless of the type of study chosen, the researcher must follow a strict methodology that conforms to practice guidelines in order to ensure the study's conclusions are valid. The guidelines for randomized studies can be found at http://www.consort-statement.org and at http://www.strobe-statement.org for cohort studies. It is also very important to register randomized studies before they begin on a website such as http://www.clinicaltrials.gov, since registration is an increasingly common requirement when submitting an article for publication. Although this preparation is relatively cumbersome, it is essential for producing articles that meet modern scientific criteria.

Keywords: Case-control studies; Cross-sectional studies; Orthopedic trauma; Prospective cohort studies; Randomized controlled trials.