Need for expertise based randomised controlled trials
Open accessAbstract
Although conventional randomised controlled trials are widely recognised as the most reliable method to evaluate pharmacological interventions,1 2 scepticism about their role in nonpharmacological interventions (such as surgery) remains.3-6 Conventional randomised controlled trials typically randomise participants to one of two intervenions (A or B) and individual clinicians give intervention A to some participants and B to others. An alternative trial design, the expertise based randomised controlled trial, randomises participants to clinicians with expertise in intervention A or clinicians with expertise in intervention B, and the clinicians perform only the procedure they are expert in. We present evidence to support our argument that increased use of the expertise based design will enhance the validity, applicability, feasibility, and ethical integrity of randomised controlled trials in surgery, as well as in other areas. We focus on established surgical interventions rather than new surgical procedures in which clinicians have not established expertise.
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Different levels of expertise of care providers in each trial group can bias treatment effect estimates.
“Different levels of expertise of care providers in each trial group can bias treatment effect estimates.224”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [224]
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Cites
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Altman, D. G., Schulz, K. F., Moher, D., Egger, M., Davidoff, F., Elbourne, D., Gøtzsche, P. C., Lang, T., & for the CONSORT Group (2001) · Annals of Internal Medicine · doi:10.7326/0003-4819-134-8-200104170-00012 · Cited by 3,835 · see citing works
Why we need observational studies to evaluate the effectiveness of health care
Black, N. (1996) · BMJ · doi:10.1136/bmj.312.7040.1215 · Cited by 1,598 · see citing works
Comparison of coronary bypass surgery with angioplasty in patients with multivessel disease.
Bourassa, M., Frye, R., King, S., Detre, K., Alderman, E., Andrews, K., & Sopko, G. (1996) · New England Journal of Medicine · doi:10.1056/nejm199607253350401 · Cited by 1,489 · see citing works
Appointment of New Associate Editor for Circulation
Willerson, J. (1996) · Circulation · doi:10.1161/01.cir.94.6.1193 · Cited by 918 · see citing works
participants, R. T. (1993) · The Lancet · doi:10.1016/0140-6736(93)90348-k · Cited by 600 · see citing works
First-year results of CABRI (Coronary Angioplasty versus Bypass Revascularisation Investigation)
Participants, C. T. (1995) · The Lancet · doi:10.1016/s0140-6736(95)92896-0 · Cited by 471 · see citing works
Inpatient general medicine is evidence based
Sackett, D. L., Ellis, J., Mulligan, I., & Rowe, J. B. (1995) · The Lancet · doi:10.1016/s0140-6736(95)92781-6 · Cited by 433 · see citing works
Self-citationA prospective, randomized study of the management of severe ankle fractures.
Phillips, W. A., Schwartz, H. S., Keller, C. S., et al. (1985) · Journal of Bone and Joint Surgery · doi:10.2106/00004623-198567010-00010 · Cited by 387 · see citing works
Operative Treatment of Fractures of the Tibial Plafond. A Randomized, Prospective Study*
Wyrsch, B., McFerran, M. A., McAndrew, M. P., Limbird, T. J., Harper, M. C., Johnson, K. D., & Schwartz, H. S. (1996) · Journal of Bone and Joint Surgery · doi:10.2106/00004623-199611000-00003 · Cited by 372 · see citing works
Finkemeier, C. G., Schmidt, A. H., Kyle, R. F., et al. (2000) · Journal of Orthopaedic Trauma · doi:10.1097/00005131-200003000-00007 · Cited by 324 · see citing works
Hampton, J. R., Henderson, R., Julian, D. G., et al. (1993) · PubMed · Cited by 273 · see citing works
Bhandari, M., Richards, R. R., Sprague, S., & Schemitsch, E. H. (2002) · Journal of Bone and Joint Surgery · doi:10.2106/00004623-200203000-00009 · Cited by 242 · see citing works
Self-citationPrystowsky, J. B., Bordage, G., & Feinglass, J. M. (2002) · Surgery · doi:10.1067/msy.2002.127550 · Cited by 239 · see citing works
Angiogenesis and breast cancer metastasis
Ellis, L. M., & Fidler, I. (1995) · The Lancet · doi:10.1016/s0140-6736(95)92774-3 · Cited by 232 · see citing works
Surgical practice is evidence based
Howes, N., Chagla, L. S., Thorpe, M., & McCulloch, P. G. (1997) · British journal of surgery · doi:10.1046/j.1365-2168.1997.00513.x · Cited by 207 · see citing works
Minimally invasive versus conventional aortic valve operations: a prospective study in 120 patients
Mächler, H., Bergmann, P. G., Anelli-Monti, M., Dacar, D., Rehak, P., Knez, I., Salaymeh, L., Mahla, E., & RIGLER, B. (1999) · The Annals of Thoracic Surgery · doi:10.1016/s0003-4975(99)00072-7 · Cited by 169 · see citing works
Pitfalls in randomized surgical trials.
LINDEN, W. V. D. (1980) · PubMed · Cited by 157 · see citing works
Clinical studies in surgical journals—have we improved?
Solomon, M. J., & McLeod, R. S. (1993) · Diseases of the Colon & Rectum · doi:10.1007/bf02050300 · Cited by 141 · see citing works
The randomized clinical trial in orthopaedics
Rudicel, S. A., & Esdaile, J. M. (1985) · Journal of Bone and Joint Surgery · doi:10.2106/00004623-198567080-00026 · Cited by 132 · see citing works
Unbiased, relevant, and reliable assessments in health care
Chalmers, I. (1998) · BMJ · doi:10.1136/bmj.317.7167.1167 · Cited by 98 · see citing works
Bridgewater, B. J. M., Grayson, A. D., Au, J., et al. (2004) · BMJ · doi:10.1136/bmj.38173.577697.55 · Cited by 73 · see citing works
Evidence‐based Surgery: A Passing Fad?
Black, N. A. (1999) · World Journal of Surgery · doi:10.1007/s002689900581 · Cited by 67 · see citing works
Lobato, A. C., Rodriguez‐Lopez, J. A., & Diethrich, E. B. (2002) · Journal of Endovascular Therapy · doi:10.1177/152660280200900302 · Cited by 64 · see citing works
Laparoscopic Herniorrhaphy: Beyond The Learning Curve
DeTurris, S., Cacchione, R. N., Mungara, A., et al. (2002) · Journal of the American College of Surgeons · doi:10.1016/s1072-7515(01)01114-0 · Cited by 59 · see citing works
Surgical evaluation at the crossroads
Pollock, A. V. (1993) · British journal of surgery · doi:10.1002/bjs.1800800807 · Cited by 47 · see citing works
Laparoscopic fundoplication: learning curve and patient satisfaction
Menon, V. S., Manson, J., & BAXTER, J. N. (2003) · Annals of The Royal College of Surgeons of England · doi:10.1308/003588403321001345 · Cited by 29 · see citing works
"Double blind, you are the weakest link -- goodbye!"
Devereaux, P. J. (2002) · BMJ Evidence-Based Medicine · doi:10.1136/ebm.7.1.4 · Cited by 29 · see citing works
Self-citationFixation of femoral neck fractures: A four-flanged nail versus threaded pins in 200 cases
Wihlborg, O. (1990) · Acta Orthopaedica Scandinavica · doi:10.3109/17453679008993552 · Cited by 21 · see citing works
The prospective, randomized, double-blind clinical trial in orthopaedic surgery.
Wehbé, M. A. (1998) · PubMed · Cited by 4 · see citing works
Rc, R. (1996) · PubMed · Cited by 1 · see citing works
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- [12]Devereaux PJ, Bhandari M, Walter S, Sprague S, Guyatt G. Participating surgeons' experience with and beliefs in the procedures evaluated in a randomized controlled trial. Clin Trials 2004;1: 225. [Google Scholar]
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Sorted by citations
Boutron, I., Moher, D., Altman, D. G., Schulz, K. F., Ravaud, P., & for the CONSORT Group* (2008) · Annals of Internal Medicine · doi:10.7326/0003-4819-148-4-200802190-00008 · Cited by 2,292 · see citing works
Boutron, I., Altman, D. G., Moher, D., Schulz, K. F., Ravaud, P., & for the CONSORT NPT Group* (2017) · Annals of Internal Medicine · doi:10.7326/m17-0046 · Cited by 1,538 · see citing works
Reporting methods of blinding in randomized trials assessing nonpharmacological treatments
Boutron, I., Guittet, L., Estellat, C., Moher, D., Hróbjartsson, A., & Ravaud, P. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040061 · Cited by 389 · see citing works
SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
Walwyn, R., & Roberts, C. (2010) · Statistical Methods in Medical Research · doi:10.1177/0962280209105017 · Cited by 93 · see citing works
A Guide to Planning and Executing a Surgical Randomized Controlled Trial
Chung, K. C., & Burns, P. B. (2008) · The Journal of Hand Surgery · doi:10.1016/j.jhsa.2007.11.027 · Cited by 16 · see citing works
- Authors
- Devereaux, P. J., Bhandari, M., Clarke, M., Montori, V. M., Cook, D. J., Yusuf, S., Sackett, D. L., Cinà, C. S., Walter, S. D., Haynes, B., Schünemann, H. J., Norman, G. R., & Guyatt, G. H.
- Affiliations
- McMaster University (CA)
- Cochrane (GB)
- Population Health Research Institute (CA)
- University at Buffalo, State University of New York (US)
- Corresponding author
- Devereaux, P J
- ORCID
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2005-01-06
- Volume
- 330
- Issue
- 7482
- Pages
- 88
- ISSN
- 1756-1833 (ISSN-L)
- 0959-8138
- PMC
- PMC543877
- OpenAlex
- W2096968635
- Cited by
- 427
- References
- 32
- Citations by year
- 2026: 5 · 2025: 11 · 2024: 5 · 2023: 14 · 2022: 7 · 2021: 15 · 2020: 19 · 2019: 18 · 2018: 21 · 2017: 15 · 2016: 20 · 2015: 17 · 2014: 25 · 2013: 24 · 2012: 23
- FWCI
- 38.74
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- BMJ (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Oxford University Research Archive (ORA) (University of Oxford) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- surgical treatment, trial design, clinician expertise, trial validity, applicability, feasibility, ethical integrity, non-pharmacological treatment
- MeSH terms
- Attitude of Health Personnel, Clinical Competence, Ethics, Medical, Feasibility Studies, Humans, Specialization, General Surgery, Reproducibility of Results, Randomized Controlled Trials as Topic
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