No surgical innovation without evaluation: the IDEAL recommendations.
Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.
Nuffield Department of Surgery, University of Oxford, Oxford, UK. peter.mcculloch@nds.ox.ac.uk
Peter
P
McCulloch
Douglas G
DG
Altman
W Bruce
WB
Campbell
David R
DR
Flum
Paul
P
Glasziou
John C
JC
Marshall
Jon
J
Nicholl
Jeffrey K
JK
Aronson
Jeffrey S
JS
Barkun
Jane M
JM
Blazeby
Isabell C
IC
Boutron
W Bruce
WB
Campbell
Pierre-Alain
PA
Clavien
Jonathan A
JA
Cook
Patrick L
PL
Ergina
Liane S
LS
Feldman
David R
DR
Flum
Guy J
GJ
Maddern
Jon
J
Nicholl
Bournaby C
BC
Reeves
Christoph M
CM
Seiler
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
Patrick L
PL
Ergina
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
Jonathan
J
Meakins
Peter
P
Rothwell
Bill
B
Summerskill
David
D
Taggart
Parris
P
Tekkis
Matthew
M
Thompson
Tom
T
Treasure
Ulrich
U
Trohler
Jan
J
Vandenbroucke
D035843:Biomedical Research; D002986:Clinical Trials as Topic; D035081:Editorial Policies; D005069:Evaluation Studies as Topic; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012109:Research Support as Topic; D013514:Surgical Procedures, Operative / Q000592:standards; D016896:Treatment Outcome