Challenges in evaluating surgical innovation.
Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.
Department of Surgery, McGill University Health Centre, Montreal, QC, Canada. patrick.ergina@muhc.mcgill.ca
Patrick L
PL
Ergina
Jonathan A
JA
Cook
Jane M
JM
Blazeby
Isabelle
I
Boutron
Pierre-Alain
PA
Clavien
Barnaby C
BC
Reeves
Christoph M
CM
Seiler
Douglas G
DG
Altman
Jeffrey K
JK
Aronson
Jeffrey S
JS
Barkun
W Bruce
WB
Campbell
Jonathan A
JA
Cook
Liane S
LS
Feldman
David R
DR
Flum
Paul
P
Glasziou
Guy J
GJ
Maddern
John C
JC
Marshall
Peter
P
McCulloch
Jon
J
Nicholl
Steven M
SM
Strasberg
Jonathan L
JL
Meakins
Deborah
D
Ashby
Nick
N
Black
John
J
Bunker
Martin
M
Burton
Marion
M
Campbell
Kalipso
K
Chalkidou
Iain
I
Chalmers
Marc
M
de Leval
Jon
J
Deeks
Adrian
A
Grant
Muir
M
Gray
Roger
R
Greenhalgh
Milos
M
Jenicek
Sean
S
Kehoe
Richard
R
Lilford
Peter
P
Littlejohns
Yoon
Y
Loke
Rajan
R
Madhock
Kim
K
McPherson
Peter
P
Rothwell
Bill
B
Summerskill
David
D
Taggart
Parris
P
Tekkis
Matthew
M
Thompson
Tom
T
Treasure
Ulrich
U
Trohler
Jan
J
Vandenbroucke
D001291:Attitude of Health Personnel; D015982:Bias; D035843:Biomedical Research; D002983:Clinical Competence; D002986:Clinical Trials as Topic; D005069:Evaluation Studies as Topic; D013502:General Surgery; D006801:Humans; D019370:Observation; D011183:Postoperative Complications; D016032:Randomized Controlled Trials as Topic; D013514:Surgical Procedures, Operative / Q000145:classification / Q000193:education; D013673:Technology Assessment, Biomedical