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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
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Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
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Blinding and Randomization.

Anton Bespalov1,2, Karsten Wicke3, Vincent Castagné4

  • 1Partnership for Assessment and Accreditation of Scientific Practice, Heidelberg, Germany. anton.bespalov@paasp.net.

Handbook of Experimental Pharmacology
|November 8, 2019
PubMed
Summary
This summary is machine-generated.

Blinding and randomization are crucial in research to prevent bias. This guidance clarifies when and how to apply these methods, emphasizing their use when confirmatory research impacts decisions or other bias mitigation isn't possible.

Keywords:
Good Research PracticeResearch rigorRisks of bias

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Area of Science:

  • Research Methodology
  • Scientific Integrity

Background:

  • Good Research Practice guidelines stress blinding and randomization.
  • Limited specific guidance exists on their application.

Purpose of the Study:

  • Disambiguate blinding and randomization: define terms, explain rationale, and detail implementation.
  • Promote understanding of these methods as tools against bias, not mandatory procedures.
  • Provide criteria for when blinding and randomization are most appropriate.

Main Methods:

  • Literature review and conceptual analysis of blinding and randomization techniques.
  • Discussion of risks of bias and mitigation strategies.
  • Framework development for decision-making on applying these methods.

Main Results:

  • Blinding involves concealing treatment allocation from participants and researchers.
  • Randomization ensures unbiased allocation of participants to study groups.
  • These methods are essential for reducing bias in confirmatory research.

Conclusions:

  • Apply blinding and randomization judiciously, especially in high-impact, non-repeatable confirmatory research.
  • Utilize these techniques when they are the most effective means to counteract bias.
  • Prioritize robust research practices to ensure scientific validity and reliable outcomes.