 |
Periodicals Home | Search |
User Pref |
Help |
| JPedSurg Home |
Table of Contents |
All Issues | Order |
About this Journal |
<< Issue |
>> Issue |
Vaccination News Home Page subscribe Vaccination NewsLetter
|
|
Periodicals Home | Search |
User Pref |
Help |
| JPedSurg Home |
Table of Contents |
All Issues | Order |
About this Journal |
<< Issue |
>> Issue |
 |
April 2003 • Volume 38 • Number 4
Randomized controlled trials in pediatric surgery: Could we do better?
|
|
| Abstract | TOP |
Background/Purpose: Randomized controlled trials (RCTs) are accepted
as the gold standard for assessing the effectiveness of clinical interventions
but are rarely reported in pediatric surgery. Have RCTs submitted to the British
Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5
years been adequately designed and large enough to produce a valid result?
Methods: Abstracts accepted by the Annual BAPS Congress meetings between
1996 and 2000 were examined in collaboration with a senior health services
researcher. The quality of the design, methodology, statistical analysis and
conclusions, and the adequacy of the sample size were assessed for all
identifiable clinical RCTs.
Results: From 760 accepted abstracts, there were only 9 RCTs (1%) of
clinical interventions. In only 4 trials was the relevant primary end-point
specified at the outset of the study, and none documented the method of
randomization. Only one abstract mentioned blinding with respect to the
intervention or outcome measure. Sample sizes were inadequate to detect even
large clinical differences. To date, only one of these RCTs has been published
in an English-language, peer-reviewed journal.
Conclusions: Clear guidelines exist for the conduct of RCTs, yet
compliance with these standards was rarely documented in abstracts of pediatric
surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric
surgery are difficult to perform, but the specialty would benefit from
well-designed, carefully conducted, multicentre, clinical RCTs to advance
evidence-based practice. J Pediatr Surg 38:556-559. Copyright 2003, Elsevier
Science (USA). All rights reserved.
| Publishing and Reprint Information | TOP |
ALL INFORMATION, DATA, AND
MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION
PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS
OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR
LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND
COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH
YOUR HEALTH CARE PROVIDER.