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.
McCulloch
Peter
P
Nuffield Department of Surgery, University of Oxford, Oxford, UK. peter.mcculloch@nds.ox.ac.uk
Altman
Douglas G
DG
Campbell
W Bruce
WB
Flum
David R
DR
Glasziou
Paul
P
Marshall
John C
JC
Nicholl
Jon
J
Aronson
Jeffrey K
JK
Barkun
Jeffrey S
JS
Blazeby
Jane M
JM
Boutron
Isabell C
IC
Campbell
W Bruce
WB
Clavien
Pierre-Alain
PA
Cook
Jonathan A
JA
Ergina
Patrick L
PL
Feldman
Liane S
LS
Flum
David R
DR
Maddern
Guy J
GJ
Nicholl
Jon
J
Reeves
Bournaby C
BC
Seiler
Christoph M
CM
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
Ergina
Patrick L
PL
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
Meakins
Jonathan
J
Rothwell
Peter
P
Summerskill
Bill
B
Taggart
David
D
Tekkis
Parris
P
Thompson
Matthew
M
Treasure
Tom
T
Trohler
Ulrich
U
Vandenbroucke
Jan
J
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