In a
randomized experiment
In science, randomized experiments are the experiments that allow the greatest reliability and validity of statistical estimates of treatment effects. Randomization-based inference is especially important in experimental design and in survey sampl ...
, allocation concealment hides the sorting of trial participants into treatment groups so that this knowledge cannot be exploited. Adequate allocation concealment serves to prevent study participants from influencing treatment allocations for subjects. Studies with poor allocation concealment (or none at all) are prone to
selection bias
Selection bias is the bias introduced by the selection of individuals, groups, or data for analysis in such a way that proper randomization is not achieved, thereby failing to ensure that the sample obtained is representative of the population int ...
.
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization.
CONSORT __NOTOC__
Consort may refer to:
Music
* "The Consort" (Rufus Wainwright song), from the 2000 album ''Poses''
* Consort of instruments, term for instrumental ensembles
* Consort song (musical), a characteristic English song form, late 16th–earl ...
guidelines recommend that allocation concealment methods be included in a study's
protocol
Protocol may refer to:
Sociology and politics
* Protocol (politics), a formal agreement between nation states
* Protocol (diplomacy), the etiquette of diplomacy and affairs of state
* Etiquette, a code of personal behavior
Science and technology
...
, and that the allocation concealment methods be reported in detail in their publication; however, a 2005 study determined that most clinical trials have unclear allocation concealment in their protocols, in their publications, or both.
A 2008 study of 146
meta-analyses
A meta-analysis is a statistical analysis that combines the results of multiple scientific studies. Meta-analyses can be performed when there are multiple scientific studies addressing the same question, with each individual study reporting me ...
concluded that the results of
randomized controlled trials
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical te ...
with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the trials' outcomes were
subjective as opposed to
objective
Objective may refer to:
* Objective (optics), an element in a camera or microscope
* ''The Objective'', a 2008 science fiction horror film
* Objective pronoun, a personal pronoun that is used as a grammatical object
* Objective Productions, a Brit ...
.
Allocation concealment is different from
blinding. An allocation concealment method prevents influence on the randomization process, while blinding conceals the outcome of the randomization.
However, allocation concealment may also be called "randomization blinding".
Impact
Without the use of allocation concealment, researchers may (consciously or unconsciously) place subjects expected to have good outcomes in the treatment group, and those expected to have poor outcomes in the control group. This introduces considerable bias in favor of treatment.
Naming
Allocation concealment has also been called randomization blinding, blinded randomization, and bias-reducing allocation among other names. The term 'allocation concealment' was first introduced by Shultz et al. The authors justified the introduction of the term:
Subversion and fraud
Traditionally, each patient's treatment allocation data was stored in a sealed envelopes, which was to be opened to determine treatment allocation. However, this system is prone to abuse. Reports of researchers opening envelopes prematurely or holding the envelopes up to lights to determine their contents has led some researchers to say that the use of sealed envelopes is no longer acceptable. , sealed envelopes were still in use in some clinical trials.
Modern clinical trials often use centralized allocation concealment. Although considered more secure, central allocations are not completely immune from subversion. Typical and sometimes successful strategies include keeping a list of previous allocations (up to 15% of study personnel report keeping lists).
See also
*
Blinded experiment
In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expec ...
*
Design of experiments
The design of experiments (DOE, DOX, or experimental design) is the design of any task that aims to describe and explain the variation of information under conditions that are hypothesized to reflect the variation. The term is generally associ ...
*
Randomized experiment
In science, randomized experiments are the experiments that allow the greatest reliability and validity of statistical estimates of treatment effects. Randomization-based inference is especially important in experimental design and in survey sampl ...
*
Metascience
Metascience (also known as meta-research) is the use of scientific methodology to study science itself. Metascience seeks to increase the quality of scientific research while reducing inefficiency. It is also known as "''research on research''" ...
*
Sealedenvelope.com—a provider of allocation concealment services
References
{{reflist
Design of experiments
Research
Scientific misconduct
Scientific method