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.
Ergina
Patrick L
PL
Department of Surgery, McGill University Health Centre, Montreal, QC, Canada. patrick.ergina@muhc.mcgill.ca
Cook
Jonathan A
JA
Blazeby
Jane M
JM
Boutron
Isabelle
I
Clavien
Pierre-Alain
PA
Reeves
Barnaby C
BC
Seiler
Christoph M
CM
Altman
Douglas G
DG
Aronson
Jeffrey K
JK
Barkun
Jeffrey S
JS
Campbell
W Bruce
WB
Cook
Jonathan A
JA
Feldman
Liane S
LS
Flum
David R
DR
Glasziou
Paul
P
Maddern
Guy J
GJ
Marshall
John C
JC
McCulloch
Peter
P
Nicholl
Jon
J
Strasberg
Steven M
SM
Meakins
Jonathan L
JL
Ashby
Deborah
D
Black
Nick
N
Bunker
John
J
Burton
Martin
M
Campbell
Marion
M
Chalkidou
Kalipso
K
Chalmers
Iain
I
de Leval
Marc
M
Deeks
Jon
J
Grant
Adrian
A
Gray
Muir
M
Greenhalgh
Roger
R
Jenicek
Milos
M
Kehoe
Sean
S
Lilford
Richard
R
Littlejohns
Peter
P
Loke
Yoon
Y
Madhock
Rajan
R
McPherson
Kim
K
Rothwell
Peter
P
Summerskill
Bill
B
Taggart
David
D
Tekkis
Parris
P
Thompson
Matthew
M
Treasure
Tom
T
Trohler
Ulrich
U
Vandenbroucke
Jan
J
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