The DOI matches its Crossref record; 9 of the 9 references it cites were found in a registry or an index.
Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol
Abstract
There is strong consensus in the clinical trial community that blinding is an important issue in randomized controlled trials. At present grossly incomplete reporting of procedures and the use of any assessment for blinding still prevails. The term ‘double-blind’ has almost become a convention without any checks or balances. Also there is a lack of consensus on quantitative procedures for evaluating the success of blinding in the literature. This article reviews statistical methods of blinding assessment along with software options, and discusses some of the most pressing issues surrounding the acquisition, interpretation, and reporting of blinding data. Finally, it proposes a sample blinding assessment protocol to address some of these issues.
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Cites
Moher, D., Schulz, K. F., & Altman, D. G. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04337-3 · Cited by 5,373
Improving the Quality of Reporting of Randomized Controlled Trials: The CONSORT Statement
Begg, C. (1996) · JAMA · doi:10.1001/jama.1996.03540080059030 · Cited by 3,127
Moher, D., Schulz, K. F., & Altman, D. G. (2001) · BMC Medical Research Methodology · doi:10.1186/1471-2288-1-2 · Cited by 2,755
Moher, D. (2001) · JAMA · doi:10.1001/jama.285.15.1987 · Cited by 2,545
Wood, L., Egger, M., Gluud, L. L., Schulz, K. F., Jüni, P., Altman, D. G., Gluud, C., Martin, R. M., Wood, A. J. G., & Sterne, J. A. C. (2008) · BMJ · doi:10.1136/bmj.39465.451748.ad · Cited by 2,538 · cited 1×
“Empirical evidence demonstrates that inadequate and unclear allocation concealment or blinding is associated with biased estimates of treatment effects (38, 40), whereas some meta-analyses reported that blinding was not associated with a treatment effect on hard endpoints (41, 42).”
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
Balk, E. M. (2002) · JAMA · doi:10.1001/jama.287.22.2973 · Cited by 478
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
How “blind” are double-blind studies?
Margraf, J., Ehlers, A., Roth, W. T., Clark, D. B., Sheikh, J., Agras, W. S., & Taylor, C. B. (1991) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.59.1.184 · Cited by 135
Cited by
A billion-dollar donation: estimating the cost of researchers’ time spent on peer review
Aczel, B., Szaszi, B., & Holcombe, A. O. (2021) · Research Integrity and Peer Review · doi:10.1186/s41073-021-00118-2 · Cited by 306
Metadata
- Authors
- Bang, H., Flaherty, S. P., Kolahi, J., & Park, J.
- Venue
- Clinical Research and Regulatory Affairs
- Publisher
- Informa UK Limited
- Published
- 2010-04-30
- Volume
- 27
- Issue
- 2
- Pages
- 42-51
- ISSN
- 1060-1333 (ISSN-L)
- 1532-2521
- OpenAlex
- W2078668847
- Cited by
- 164
- References
- 9
- FWCI
- 2.69
- Type
- journal article
- Language
- en
- Open access
- closed
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- Bang, H., Flaherty, S. P., Kolahi, J., & Park, J. (2010). Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol. Clinical Research and Regulatory Affairs. https://doi.org/10.3109/10601331003777444
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
