Interventions in randomised controlled trials in surgery: issues to consider during trial design.
Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.
Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. natalie.blencowe@bristol.ac.uk.|Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK. natalie.blencowe@bristol.ac.uk.
Natalie S
NS
Blencowe
Leeds Institute for Clinical Trials Research, University of Leeds, Clarendon Road, Leeds, UK. j.m.b.brown@leeds.ac.uk.
Julia M
JM
Brown
Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. jonathan.cook@ndorms.ox.ac.uk.
Jonathan A
JA
Cook
Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. chris.metcalfe@bristol.ac.uk.
Chris
C
Metcalfe
Academic Department of Surgery, School of Cancer Sciences, Queen Elizabeth Hospital University of Birmingham, Edgbaston, Birmingham, UK. dion.morton@uhb.nhs.uk.
Dion G
DG
Morton
School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, UK. j.nicholl@sheffield.ac.uk.
Jon
J
Nicholl
Leeds Institute for Clinical Trials Research, University of Leeds, Clarendon Road, Leeds, UK. l.sharples@leeds.ac.uk.
Linda D
LD
Sharples
Health Services Research Unit, University of Aberdeen, 3rd Floor, Health Sciences Building, Foresterhill, Aberdeen, UK. streweek@mac.com.
Shaun
S
Treweek
Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Clifton, Bristol, BS8 2PS, UK. j.m.blazeby@bristol.ac.uk.|Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK. j.m.blazeby@bristol.ac.uk.
Jane M
JM
Blazeby
D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D012107:Research Design / Q000592:standards; D013514:Surgical Procedures, Operative / Q000009:adverse effects / Q000592:standards; D016896:Treatment Outcome