The people who are involved in designing, executing, analysis of the experiment, including the patients or subjects undergoing treatment, are referred to as participants, and anyone in this list or all of them can be imposed to blindness about the experiment. Therefore, the protocols and treatments are not revealed to any of the members participating in the research until the experiment is complete.
The poor-blinded studies pose a high risk of false-positive results by favoring the experimental group, and therefore, blinding gives confidence about the significance and authenticity of the data in the study. Blinding plays an important role in randomized controlled trials, where trials are conducted randomly across the subjects.
Blinding has wide applications in various fields and includes the following:
In the medical and pharmaceutical field where antidepressants are considered as placebos by many studies, where they are believed to be used just due to systematic errors in blinded studies.
In physics, it is mandatory and a standard procedure to blind the data analysis, after which one of them is allowed to unblind the data. This practice is followed to prevent publication bias regardless of results obtained.
Social sciences are another common field that is highly prone to observer bias; therefore, blinding studies are strongly encouraged.
In forensic studies, blinding helps in preventing subconscious behavior by the police officer toward the suspect before any judgment based on the available witnesses. Therefore, the movement of applying blinded procedure in the crimes by not letting the police officers know about the witness is increasing.
In music orchestras, the performance usually takes place behind the curtains so that the judges cannot know who the performer is. This helps in giving unbiased judgments. Blind tests are also performed to test the quality of the instruments.
Causes of Bias and Types of Blinded Experiments
Different types of biases are observed due to various reasons in a clinical blinded trial and are as follows:
If the information is not masked efficiently
Biases still exist in all the participants even when they feel that the information known cannot influence their decisions.
The patient can report different outcomes with their half-knowledge if they are not blinded properly.
If the protocol is not masked effectively, the observer may have a biased opinion.
Similarly, data analysts may favor the data that supports the existing leaked information.
The blindness can be introduced among different groups among the participants, and accordingly, the experiment is known as follows:
Single-blinded experiment: Here, only one party is blinded, and mostly a patient who does not know their treatment plan.
Double-blinded experiment: In this case, both patients and researchers do not know the treatment plan.
Triple blinded experiment: Here, in addition to patient and researcher, a third party that usually includes a monitoring committee, also does not know the treatment plan.
As per the CONSORT (consolidated standards of reporting trials) protocol, the names of the blinding experiment are misleading, as the details are not sufficient to justify the category of people who are blinded and therefore, their guidelines recommend describing trial details of blinding with details such as who has been blinded and to what information, and how successful the blinding was.
Unblinded Experiments
Unblinding occurs unintentionally, and the efficiency and success of blinding are tested by surveying among the patients by asking questions about their treatment if they have received a placebo or the drug. The success of blinding can be known only from the patient’s response that indicates the degree of unblinding. If the experiment is unblinded to some extent, it is called a poorly blinded experiment and is ranked above unblinded and below the blinded studies.
Once the study is completed, data can be unblinded or revealed to patients about their treatment regimen and is called post-study unblinding.
If unblinding occurs just before the conclusion is revealed, it is still considered an experimental failure as the bias that was eliminated by blinding was re-introduced into the trial. In a case where one of the participants becomes aware of the information that has been masked to them, they become unblinded. This is called premature unblinding, and this can intentionally occur in cases of emergencies as per code-break protocols. Unblinding against code-break protocols are strictly forbidden and documented. Unblinding is very common in pharmacological clinical trials involving anti-depressants and pain medications, as one can rightly guess the ingredient of the treatment due to their effects and side effects. To reduce this issue, an active placebo is given to both the control and treated groups to induce similar side effects.
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