The CONSORT statement
Open accessAbstract
Randomized control trials (RCT's) are the gold standard in evaluating and efficiently translating research data into clinical practice. The CONSORT statement was conceptualized in order to help ascertain standardization and reproducibility of RCT's. The articles publishing the CONSORT 2010 statement along with their bibliographies were identified and thoroughly reviewed. The CONSORT statement is made up of a 25-item checklist that provides the author with a solid backbone around which to construct and present an RCT. It sets standards on the trial's design, analysis, and interpretation of the results.
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Allocation concealment ensures the unpredictability of treatment allocation by patients and investigators, which is essential for maintaining the integrity of a study.
“Allocation concealment ensures the unpredictability of treatment allocation by patients and investigators, which is essential for maintaining the integrity of a study. The optimal approach to achieving this is through the implementation of an independent and centralized allocation protocol (Cuschieri 2019).”
From Adherence to the CONSORT statement of randomized clinical trials on dentin hypersensitivity treatment using mouthwashes (2025) · cites this paper as Cuschieri 2019
The CONSORT Statement checklist (item 9; page not provided) calls for concealing the allocation sequence until interventions are assigned, supporting the claim that allocation should not be predictable in advance. It does not say that an independent, centralized allocation protocol is the optimal approach, or specifically identify patients and investigators as the people from whom allocation must be concealed. (LLM, conf=0.86)
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Cites
Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gotzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010) · BMJ · doi:10.1136/bmj.c869 · Cited by 8,883 · cited 5× · see citing works
“Furthermore, since not all trial reports are fully freely available for readers, the abstract may be the only source of initial information accessible to readers.[3]”
InfluentialMoher, D., Hopewell, S., Schulz, K. F., Montori, V., Gøtzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2010.03.004 · Cited by 1,858 · see citing works
What is missing from descriptions of treatment in trials and reviews?
Glasziou, P., Meats, E., Heneghan, C., & Shepperd, S. (2008) · BMJ · doi:10.1136/bmj.39590.732037.47 · Cited by 614 · see citing works
Epidemiology and reporting of randomised trials published in PubMed journals
Chan, A.-W., & Altman, D. G. (2005) · The Lancet · doi:10.1016/s0140-6736(05)71879-1 · Cited by 474 · see citing works
Randomized controlled trials – a matter of design
Siepmann, T., Spieth, P. M., Kubasch, A. S., Penzlin, A. I., Illigens, B. M.-W., & Barlinn, K. (2016) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s101938 · Cited by 292 · see citing works
WASP (Write a Scientific Paper): Understanding research metrics
Cuschieri, S. (2018) · Early Human Development · doi:10.1016/j.earlhumdev.2018.01.015 · Cited by 11 · see citing works
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Karimi, L., Mokhtari Seghaleh, M., Khalili, R., & Vahedian-Azimi, A. (2022) · BMC Women s Health · doi:10.1186/s12905-022-01653-w · Cited by 19 · see citing works
Alsadat Hosseini, F., Parvan, K., Jasemi, M., Parizad, N., Esmaili Zabihi, R., & Aazami, S. (2021) · CIN: Computers, Informatics, Nursing · doi:10.1097/cin.0000000000000772 · Cited by 9 · see citing works
De Vleminck, A., Matthys, O., Turola, E., Dierickx, S., Dombrecht, L., Van Goethem, V., Deliens, L., Lapeire, L., Hudson, P., Eecloo, K., et al. (2025) · International Journal of Nursing Studies · doi:10.1016/j.ijnurstu.2025.105192 · Cited by 8 · see citing works
Osumili, B., Fan, L., Paik, J. S., Pantalone, K. M., Ranta, K., Sapin, H., & Tofé, S. (2024) · Diabetes Research and Clinical Practice · doi:10.1016/j.diabres.2024.111717 · Cited by 8 · see citing works
Fütterer, T., Bardach, L., Kuhn, J., Keller, S. D., & Gerjets, P. (2026) · Educational Psychology Review · doi:10.1007/s10648-026-10133-8 · Cited by 17 · see citing works
Neto, L. T., Wambier, L. M., & Chibinski, A. C. R. (2025) · The Saudi Dental Journal · doi:10.1007/s44445-025-00017-y
- Authors
- Cuschieri, S.
- Affiliations
- University of Malta (MT)
- Corresponding author
- Cuschieri, Sarah
- ORCID
- Cuschieri, Sarah
- Venue
- Saudi Journal of Anaesthesia
- Published
- 2019
- Volume
- 13
- Issue
- 5
- Pages
- 27
- ISSN
- 0975-3125 (ISSN-L)
- 1658-354X
- PMC
- PMC6398298
- OpenAlex
- W2915079824
- Cited by
- 476
- References
- 6
- Citations by year
- 2026: 77 · 2025: 153 · 2024: 134 · 2023: 51 · 2022: 42 · 2021: 14 · 2020: 4 · 2019: 1
- FWCI
- 10.19
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- other-oa
- Locations
- Saudi Journal of Anaesthesia (publishedVersion, other-oa)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-sa)
- PubMed Central (publishedVersion, cc-by-nc-sa)
- PubMed (publishedVersion)
- OAR@UM (University of Malta) (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Keywords
- CONSORT statement, randomized controlled trials, reporting guidelines, reproducibility, trial design, trial analysis, trial interpretation
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