On the measurement of blinding in randomized, controlled trials.

Williamson, Forrest C., 1989-

On the measurement of blinding in randomized, controlled trials.

dc.contributor.advisor	Stamey, James D.
dc.contributor.advisor	Harvill, Jane L.
dc.creator	Williamson, Forrest C., 1989-
dc.date.accessioned	2015-03-18T18:04:48Z
dc.date.available	2015-03-18T18:04:48Z
dc.date.created	2014-12
dc.date.issued	2014-11-20
dc.date.submitted	December 2014
dc.date.updated	2015-03-18T18:04:48Z
dc.description.abstract	A key feature to many randomized, controlled trials is that they implement a blind; that is, subjects, experimenters, or both are unaware as to which treatment arm an individual has been assigned. The purpose of the blind is to reduce bias and improve retention. The importance of blinding has been emphasized by groups such as the FDA and CONSORT, but the reporting of blinding is not standard and the quantification of blinding success is rare. Two blinding indexes have been proposed to measure the success of blinding in randomized, controlled trials. The James index relies heavily on respondents saying that they do not know which treatment group an individual is assigned to. The Bang index looks more at the proportion of guesses and whether or not they suggest random or informed guessing. The theory behind the Bang index does not allow respondents to guess among more than two groups, including the control group. We have generalized the Bang index to allow for any number of arms. We find that our index, FBI, is powerful to detect events that cannot be measured using the James index. Also, implementing a Bayesian approach using a flat conjugate prior structure yields similar results to the frequentist approach James and Bang take. A guidance is given to aid in educating regulatory officials and trial investigators on the importance reporting blinding results and providing at least one quantitative measure of blinding success. We suggest that investigators report indexes from both paradigms (James and Bang) to measure blinding efficacy for all blinded trials.
dc.format.mimetype	application/pdf
dc.identifier.uri	http://hdl.handle.net/2104/9255
dc.language.iso	en
dc.rights.accessrights	Worldwide access.	en_US
dc.rights.accessrights	Access changed 5/21/20.
dc.subject	Blinding assessment. Blinding index. Masking. Clinical trial. Placebo.
dc.title	On the measurement of blinding in randomized, controlled trials.
dc.type	Thesis
dc.type.material	text
local.embargo.lift	2019-12-01
local.embargo.terms	2019-12-01
thesis.degree.department	Baylor University. Dept. of Statistical Sciences.
thesis.degree.grantor	Baylor University
thesis.degree.level	Doctoral
thesis.degree.name	Ph.D.