Background/Purpose: The current medical environment demands the provision o
f quality healthcare at an affordable cost. Both payers and regulators are
committed to lowering cost through initiation of best practice strategies t
hat include practice guidelines, clinical pathways, and standards of care.
The on ly practical way to join this debate is th rough the use of objectiv
e, unbiased clinical data. This study was undertaken to review the current
slate of the pediatric surgery literature and its value in determining best
clinical practice.
Methods: The National Library of Medicine Medline database was accessed usi
ng the Ovid Internet client software. All references, abstracts, and keywor
d indexes from the core pediatric surgery literature, the Journal of Pediat
ric Surgery, the European Journal of Pediatric Surgery, Pediatric Surgery i
nternational, Zeitschrift fur Kinderchirurgie, and Seminars in Pediatric Su
rgery were downloaded and reviewed. Search criteria were defined to identif
y prospective, randomized, controlled studies. References were then categor
ized as case reports; retrospective case series; prospective case series; r
andomized, controlled studies; laboratory studies; review articles; or misc
ellaneous studies.
Results: As of March 1, 1998, there are 9,373 references, excluding citatio
ns of letters or comments, contained in the core pediatric surgery literatu
re, as provided through Medline. Of these, 485 were identified as studies f
or review, possible prospective case series or prospective, randomized, con
trolled studies. After review, 34 studies (0.3%) were classified as prospec
tive, randomized, controlled studies, whereas 139 (1.48%) were classified a
s prospective studies. There were 3,241 (34.6%) case reports, 5,619 (59.9%)
retrospective case series, 1,109 (11.8%) laboratory studies, 195 (2.1%) re
view articles, and 36 (0.3%) miscellaneous studies that did not fit into ot
her categories. When analyzed by decade of publication, prospective studies
and prospective, randomized, controlled studies (n = 173) numbered 103 in
the 1990s, 63 in the 1980s, and seven in the 1970s.
Conclusions: There is a paucity of scientifically rigorous data on which to
base clinical practice in pediatric surgery. The increasing numbers of pro
spective, case-controlled studies or the more sou nd prospective, randomize
d, controlled trials in the 1990s suggests that pediatric surgeons are awar
e of the need to generate unbiased data to support current clinical practic
e and the development of practice guidelines. Limitations exist in conducti
ng prospective, randomized, controlled trials because of the rare nature of
many pediatric surgical conditions and the lack of clinical "equipoise" ov
er available treatment options. The authors encourage the use of multiinsti
tutional trials and the prospective, randomized, controlled study methodolo
gy to develop data that can be used to guide clinical practice in our evolv
ing healthcare environment. Copyright (C) 1999 by W.B. Saunders Company.