Designing, conducting and reporting clinical research. A step by step approach.
There are five major steps that one must navigate successfully to take a study idea and turn it into a publication that may have an impact on clinical practice. These steps include developing the study question(s), developing the study plan, implementing the study plan, reporting the results and submitting the manuscript(s) for publication. This review takes each of these steps and expands on its important components. More detail is given for steps one, two and five. Furthermore, the review is augmented with tables and checklists that may serve as tools in the planning and execution of a clinical study. Though it does not address every detail for each of the steps discussed, readers of all experience levels should find it a useful tool in the planning, execution and reporting of their next clinical study.
Hanson
Beate P
BP
AO Clinical Investigation and Documentation (AOCID), Clavadelerstrasse, CH-7270 Davos Platz, Switzerland. beate.hanson@aofoundation.org
D035843:Biomedical Research / Q000379:methods*; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods; D011379:Prognosis; D011643:Publishing; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design