Research by Klein and associates provides useful information on the relation between
episiotomy and outcomes such as perineal trauma, but the methodologic implications of …

Randomized controlled trials are increasingly accepted in principle but not always in
practice, particularly for surgical therapies. Successful surgical randomized controlled trials …

Background: Episiotomies are the most frequently performed surgical procedure among
United States women, but there are no published epidemiological studies of the extent of …

All research has flaws. Some flaws are so trivial that the research can still stand as the
definitive study. Other flaws prevent a study from being definitive, but the study still provides …

Objective: The aim is to discuss the various forms of bias in surgical research, including how
it impacts validity and how to recognize and avoid it. Methods: The various factors affecting …

Controlled non-randomized trials (NRS), or cohort studies, are often used to evaluate the
effectiveness of surgical treatments. NRS have limitations which must be considered …

Randomised trials top the hierarchy of evidence. To provide the best evidence to guide
surgical practice, randomised trials must answer clinically important questions, have …

There are clear implications for the informed consent process. There should be a forthright
disclosure of the perils of withholding active therapy. To the extent that important" …

Randomized, controlled clinical trials with negative results are viewed with more skepticism
than trials with positive results. A widely held assumption is that negative results are not …

I am pleased to see ethicists addressing clinical trial design. Clinical trials represent a
fundamental ethical conflict between clinical research and practice. I am less pleased with …