Open AccessA simplified guide to randomized controlled trials
Author(s) -
Bhide Amar,
Shah Prakesh S.,
Acharya Ganesh
Publication year - 2018
Publication title -
acta obstetricia et gynecologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.401
H-Index - 102
eISSN - 1600-0412
pISSN - 0001-6349
DOI - 10.1111/aogs.13309
Subject(s) - randomized controlled trial , medicine , psychological intervention , clinical trial , intervention (counseling) , research design , medical physics , physical therapy , surgery , nursing , statistics , pathology , mathematics
A randomized controlled trial is a prospective, comparative, quantitative study/experiment performed under controlled conditions with random allocation of interventions to comparison groups. The randomized controlled trial is the most rigorous and robust research method of determining whether a cause–effect relation exists between an intervention and an outcome. High‐quality evidence can be generated by performing an randomized controlled trial when evaluating the effectiveness and safety of an intervention. Furthermore, randomized controlled trials yield themselves well to systematic review and meta‐analysis providing a solid base for synthesizing evidence generated by such studies. Evidence‐based clinical practice improves patient outcomes and safety, and is generally cost‐effective. Therefore, randomized controlled trials are becoming increasingly popular in all areas of clinical medicine including perinatology. However, designing and conducting an randomized controlled trial, analyzing data, interpreting findings and disseminating results can be challenging as there are several practicalities to be considered. In this review, we provide simple descriptive guidance on planning, conducting, analyzing and reporting randomized controlled trials.