@article{5234867345114412a28bf040e6088abb,
title = "Design and conduct issues in surgical clinical trials",
abstract = "The design and conduct of surgical clinical trials present unique challenges to the investigator that are not encountered in drug studies. Using the Veterans Affairs Cooperative Studies Program Hernia Trial as a case study, this article explores the potential problems and solutions.",
author = "Leigh Neumayer",
note = "Funding Information: In 1995, the American College of Surgeons (ACS) identified the opportunity to study a new technique{\textquoteright}s application to a well-established procedure (laparoscopic inguinal herniorrhaphy). A new collaborative effort among the ACS, Northwestern University, agencies within the National Institutes of Health (NIH), and the Veterans Affairs Cooperative Studies Program resulted in funding for 2 studies. The first study compared open mesh and laparoscopic herniorrhaphy and was funded by the Veterans Affairs Cooperative Studies program in 1998 [1] ; the second study, compared “watchful waiting” with open mesh repair and was funded by the Agency for Healthcare Research and Quality (AHRQ) in 1999 [2] . Analysis of the design and conduct of the open versus laparoscopic hernia trial provides important information on issues, such as site selection, standardization of operative procedures, patient selection and enrollment, reporting of adverse events, and patient retention. ",
year = "2004",
month = dec,
doi = "10.1016/j.amjsurg.2004.09.005",
language = "English (US)",
volume = "188",
pages = "17--21",
journal = "American journal of surgery",
issn = "0002-9610",
publisher = "Elsevier Inc.",
number = "6 SUPPL. 1",
}