The DOI matches its Crossref record; 13 of the 13 references it cites were found in a registry or an index.
The challenges faced in the design, conduct and analysis of surgical randomised controlled trials
Open accessAbstract
Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation. Unlike other medical areas, the randomised controlled trial (RCT) design has not become the default study design for the evaluation of surgical interventions. Surgical trials are difficult to successfully undertake and pose particular practical and methodological challenges. However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use. This article will consider the design, conduct and analysis of an RCT of a surgical intervention. The issues will be reviewed under three headings: the timing of the evaluation, defining the research question and trial design issues. Recommendations on the conduct of future surgical RCTs are made. Collaboration between research and surgical communities is needed to address the distinct issues raised by the assessment of surgical interventions and enable the conduct of appropriate and well-designed trials.
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Cites
Evaluating non-randomised intervention studies
Deeks, J., Dinnes, J., D'Amico, R., Sowden, A., Sakarovitch, C., Song, F., Petticrew, M., & Altman, D. (2003) · Health Technology Assessment · doi:10.3310/hta7270 · Cited by 2,907
Improving the reporting of pragmatic trials: An extension of the CONSORT statement
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McDonald, A. M., Knight, R. C., Campbell, M. K., Entwistle, V. A., Grant, A. M., Cook, J. A., Elbourne, D. R., Francis, D., Garcia, J., Roberts, I., et al. (2006) · Trials · doi:10.1186/1745-6215-7-9 · Cited by 946
Self-citationPost-randomisation exclusions: the intention to treat principle and excluding patients from analysis
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“However, exclusions threaten the value of randomisation, and reasons should be specified prior to commencement of randomisation [68].”
BackgroundTreatment allocation by minimisation
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Need for expertise based randomised controlled trials
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Factors that limit the quality, number and progress of randomised controlled trials
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Cited by
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
Chan, A.-W., Tetzlaff, J. M., Gotzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., et al. (2013) · BMJ · doi:10.1136/bmj.e7586 · Cited by 6,251
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Barker, T. H., Migliavaca, C. B., Stein, C., Colpani, V., Falavigna, M., Aromataris, E., & Munn, Z. (2021) · BMC Medical Research Methodology · doi:10.1186/s12874-021-01381-z · Cited by 738
Evaluation and stages of surgical innovations
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Finch, T. L., Rapley, T., Girling, M., Mair, F. S., Murray, E., Treweek, S., McColl, E., Steen, I. N., & May, C. R. (2013) · Implementation Science · doi:10.1186/1748-5908-8-43 · Cited by 177
Metadata
- Authors
- Cook, J. A.
- Venue
- Trials
- Published
- 2009-02-06
- Volume
- 10
- Issue
- 1
- Pages
- 9-9
- ISSN
- 1745-6215 (ISSN-L)
- OpenAlex
- W2158052420
- Cited by
- 351
- References
- 13
- FWCI
- 8.20
- Type
- journal article
- Language
- en
- Open access
- gold
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