Treatment FAQ

in a single-blind study, who is "blind" to the treatment?

by Greta Wisoky Published 2 years ago Updated 1 year ago
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A type of clinical trial in which only the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over.

Who is blind in a single blind study?

A single-blind study occurs when the participants are deliberately kept ignorant of either the group to which they have been assigned or key information about the materials they are assessing, but the experimenter is in possession of this knowledge.

Who should be blinded in a clinical trial?

Differential treatment or assessment of participants potentially resulting in bias may occur at any phase of a trial. If possible, trialists should blind 5 groups of individuals involved in trials: participants, clinicians (surgeons), data collectors, outcome adjudicators and data analysts.

What is a blind study in research?

Listen to pronunciation. (BLINE-ded STUH-dee) A type of study in which the patients (single-blinded) or the patients and their doctors (double-blinded) do not know which drug or treatment is being given. The opposite of a blinded study is an open label study.

What is a blind participant?

Blinding, in research, refers to a practice where study participants are prevented from knowing certain information that may somehow influence them—thereby tainting the results.

Why are patients blinded in clinical trials?

Blinding is used in Clinical Trials to remove any bias that can be caused intentionally or unintentionally if participants or the research team are aware of who is receiving an active or placebo treatment.

Who is blinded in a double-blind study?

A type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over. This makes results of the study less likely to be biased.

What is blinded treatment?

A blinded (or masked) clinical trial is a field study of a drug in which the recipient does not know if he is receiving the actual drug versus a placebo. A double-blind clinical trial is one in which both the recipient and the administrator does not know if the recipient is receiving the actual drug.

What is a blinded?

Usually, it's the participants in the clinical trial that are “blinded”, meaning they don't know whether they are being treated with the drug in development or a placebo. A placebo is an inactive substance given to a control group in order to asses the real drug in testing.

What is a single blind review process?

Single-blind peer review is the traditional method of review. In it, reviewers know the identity of authors, but authors don't know the identity of reviewers. (In double-blind review, neither reviewers nor authors know who the other party is.

What is blinding and unblinding in clinical trials?

A clinical trial is called single blind when only one party is blinded, usually the participants....Types of blinding.TypeDescriptionUnblinded or open labelAll parties are aware of the treatment the participant receivesSingle blind or single-maskedOnly the participant is unaware of the treatment they receive2 more rows

How do you conduct a blind study?

Give one group of people the actual pill and one group a placebo, but don't tell the participants which pill they are receiving. Explanation: In order for a study to be "blind," the participants can't know which group they are sorted into.

What is a blind study in statistics?

In a single-blind study the participants do not know what treatment groups they are in, but the researchers interacting with them do know. In a double-blind study, the participants do not know what treatment groups they are in and neither do the researchers who are interacting with them directly.

What’s the difference between method and methodology?

Methodology refers to the overarching strategy and rationale of your research project . It involves studying the methods used in your field and...

What’s the difference between quantitative and qualitative methods?

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings. Quantitative methods allow yo...

What is sampling?

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in...

What’s the difference between reliability and validity?

Reliability and validity are both about how well a method measures something: Reliability refers to the  consistency of a measure (whether the r...

What is the difference between internal and external validity?

I nternal validity is the degree of confidence that the causal relationship you are testing is not influenced by other factors or variables . Ext...

What is experimental design?

Experimental design means planning a set of procedures to investigate a relationship between variables . To design a controlled experiment, you ne...

What are independent and dependent variables?

You can think of independent and dependent variables in terms of cause and effect: an independent variable is the variable you think is the ca...

What is the difference between quantitative and categorical variables?

Quantitative variables are any variables where the data represent amounts (e.g. height, weight, or age). Categorical variables are any variables...

What is the difference between discrete and continuous variables?

Discrete and continuous variables are two types of quantitative variables : Discrete variables represent counts (e.g. the number of objects in a...

Why do blind people not know if they are taking placebos?

This is done to reduce the risk of errors, since some participants might produce spurious results if they know that they are taking the placebo or medication.

What are the two major models that one can use in clinical trials?

When undertaking a clinical trial, the two major models that one can use are the single blind and double blind trials. Selecting the right trial is important since it can affect the outcome of the trial or introduce errors.

What is the superior model of clinical research?

In a double-blind study, both the participants and the experimenters do not know which group got the placebo and which got the experimental treatment. This is considered to be the superior model of clinical research since it eliminates outcomes that are produced due to placebo effect, as well as observer bias by the experimenter.

How many groups of people are in a clinical trial?

For any clinical trial, there are usually two groups of people who are experimented on. Members of one group are given a placebo, and the members of another group are given the treatment that is being studied.

Why does the experimenter not know which group received the placebo or the experimental drug?

The fact that the experimenter does not know which group received the placebo or the experimental drug means that the risk of conscious and unconscious observer bias is reduced, making the study more accurate.

What is double blind study?

In a double-blind study, both participants and experimenters are blinded. In a triple-blind study, the assignment is hidden not only from participants and experimenters, but also from the researchers analyzing the data.

What is a method in science?

Methods are the specific tools and procedures you use to collect and analyze data (for example, experiments, surveys, and statistical tests ). In shorter scientific papers, where the aim is to report the findings of a specific study, you might simply describe what you did in a methods section.

What is a sample in research?

A sample is a subset of individuals from a larger population. Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

What is methodology in research?

Methodology refers to the overarching strategy and rationale of your research project. It involves studying the methods used in your field and the theories or principles behind them, in order to develop an approach that matches your objectives.

Can you use more than one measure of health?

Yes, but including more than one of either type requires multiple research questions. For example, if you are interested in the effect of a diet on health, you can use multiple measures of health: blood sugar, blood pressure, weight, pulse, and many more.

When was the first study to have a blind researcher?

The first study recorded to have a blinded researcher was conducted in 1907 by W. H. R. Rivers and H. N. Webber to investigate the effects of caffeine. The need to blind researchers became widely recognized in the mid-20th century.

Who advocated blinding researchers?

One early essay advocating the blinding of researchers came from Claude Bernard in the latter half of the 19th century. Bernard recommended that the observer of an experiment should not have knowledge of the hypothesis being tested.

What is unblinding in pharmacology?

Unblinding is common in blinded experiments , particularly in pharmacological trials. In particular, trials on pain medication and antidepressants are poorly blinded. Unblinding that occurs before the conclusion of a study is a source of experimental error, as the bias that was eliminated by blinding is re-introduced.

Why is unblinding a common cause?

A common cause for unblinding is the presence of side effects (or effects) in the treatment group. In pharmacological trials, premature unblinding can be reduced with the use of an active placebo, which conceals treatment allocation by ensuring the presence of side effects in both groups.

When does unblinding occur?

Unblinding occurs in a blinded experiment when information becomes available to one from whom it has been masked. In clinical studies, unblinding may occur unintentionally when a patient deduces their treatment group. Unblinding that occurs before the conclusion of an experiment is a source of bias.

Why is blinding important?

In some fields, such as medicine, it is considered essential. In clinical research, a trial that is not a blinded trial is called an open trial .

What is observer bias?

Likewise, failure to blind researchers results in observer bias. Unblinded data analysts may favor an analysis that supports their existing beliefs ( confirmation bias ). These biases are typically the result of subconscious influences, and are present even when study participants believe they are not influenced by them.

When patients or clinicians cannot be blinded, should trialists ensure that the 2 (or more) allocation

When patients or clinicians cannot be blinded, trialists should ensure that the 2 (or more) allocation groups are, apart from the intervention, treated as equally as possible. This may involve standardizing the care of participants such as cointerventions, frequency of follow-up and management of complications.

What is blinding in clinical research?

Blinding refers to the concealment of group allocation from one or more individuals involved in a clinical research study, most commonly a randomized controlled trial (RCT). Although randomization minimizes differences between treatment groups at the outset of the trial, it does nothing to prevent differential treatment ...

Why is blinding important in RCTs?

Blinding is an important methodologic feature of RCTs to minimize bias and maximize the validity of the results. Researchers should strive to blind participants, surgeons, other practitioners, data collectors, outcome adjudicators, data analysts and any other individuals involved in the trial.

When data collectors or outcome adjudicators cannot be blinded, should they be?

When data collectors or outcome adjudicators cannot be blinded, researchers should ensure that the outcomes being measured are as objective as possible. Furthermore, the outcomes should be reliable (although reliable outcomes are preferable whether or not the assessors are blinded).

Is blinding more difficult to do in surgical trials?

Blinding is unequivocally more difficult to incorporate in trials of surgical interventions than in trials of medical therapie s.10–12Whereas medical trials usually incorporate placebo medications to achieve blinding, surgical treatments often result in incisions and scars that may differ between groups.

Is it harder to blind a surgical intervention?

Randomized controlled trials of surgical interventions are frequently more difficult to blind than RCTs of medications, which typically achieve blinding with placebos. However, imaginative techniques may make blinding more feasible in surgical trials than is commonly believed by many researchers.

Should researchers consider blinding each individual involved in a trial separately?

Researchers should consider methods to blind each individual involved in a trial separately and search for the simplest, least invasive technique of achieving blinding. Determining the feasibility of blinding patients is usually simple.

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Overview

Background

A number of biases are present when a study is insufficiently blinded. Patient-reported outcomes can be different if the patient is not blinded to their treatment. Likewise, failure to blind researchers results in observer bias. Unblinded data analysts may favor an analysis that supports their existing beliefs (confirmation bias). These biases are typically the result of subconscious influences, and are present even when study participants believe they are not influenced by them.

History

The first blind experiment was conducted by the French Royal Commission on Animal Magnetism in 1784 to investigate the claims of mesmerism as proposed by Charles d'Eslon, a former associate of Franz Mesmer. In the investigations, the researchers (physically) blindfolded mesmerists and asked them to identify objects that the experimenters had previously filled with "vital fluid". The subjects were unable to do so.

Unblinding

Unblinding occurs in a blinded experiment when information becomes available to one from whom it has been masked. In clinical studies, unblinding may occur unintentionally when a patient deduces their treatment group. Unblinding that occurs before the conclusion of an experiment is a source of bias. Some degree of premature unblinding is common in blinded experiments. When a blind is imperfect, its success is judged on a spectrum with no blind (or complete failure of blindin…

Applications

Blinding is considered essential in medicine, but is often difficult to achieve. For example, it is difficult to compare surgical and non-surgical interventions in blind trials. In some cases, sham surgery may be necessary for the blinding process. A good clinical protocol ensures that blinding is as effective as possible within ethical and practical constrains.
Studies of blinded pharmacological trials across widely varying domains find evidence of high le…

See also

• Allocation concealment
• Black boxing
• Jadad scale
• Metascience
• Royal Commission on Animal Magnetism

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