Source
Department of Psychopharmacology, National Institute of Mental Health and Neurosciences, Bangalore, India.
Abstract
BACKGROUND:
Postgraduate students, budding authors, clinicians who read journals, and new reviewers need to develop skills in reading, writing, and reviewing papers that describe randomized controlled trials (RCTs).
MATERIALS AND METHODS:
This commentary critically examines a specially-written paper (published in the same issue of this journal) that describes a fictitious, industry-driven, multicentre RCT comparing the fictitious antidepressant placeboxetine with sertraline in Indian patients with major depressive disorder. Readers are invited to independently assess the RCT paper before they continue with this commentary.
RESULTS:
Scientific aspects of the design and execution of the RCT are examined in the context of ethical issues in research. Comments and suggestions are offered on issues such as the statistical handling of data, manuscript content, and manuscript writing style. The reader's attention is drawn to subtle and not-so-subtle errors, as well as to curiosities in the data.
CONCLUSIONS:
It is hoped that this practical commentary on research design, execution, analysis, and reporting, based on specific examples, will benefit researchers, authors, readers, and reviewers more than guidance delivered in the form of general advice.