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Related Concept Videos

Crossover Experiments01:16

Crossover Experiments

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Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
Crossover designs are performed even with smaller sample sizes since the samples can act as their controls. These are better than simple randomized trials since patients are exposed to all the treatments.
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Randomized Experiments01:13

Randomized Experiments

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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.
Simple randomization
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Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

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Body:Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
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Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs01:20

Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs

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Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
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Cluster Sampling Method01:20

Cluster Sampling Method

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Appropriate sampling methods ensure that samples are drawn without bias and accurately represent the population. Because measuring the entire population in a study is not practical, researchers use samples to represent the population of interest.
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Blinding01:11

Blinding

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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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Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials.

Sheila Sprague1,2, Taryn Scott3, Shannon Dodds3

  • 1Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada. sprags@mcmaster.ca.

Trials
|August 14, 2020
PubMed
Summary

This study details the selection of orthopedic practices for novel cluster randomized crossover trials comparing antiseptic solutions for fracture care. The PREP-IT program successfully identified and characterized participating sites for these orthopedic fracture trials.

Keywords:
ClusterCluster characteristicsOrthopedicPragmaticRandomized crossoverSurgical site infection

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Area of Science:

  • Orthopedics
  • Clinical Trials Methodology
  • Infectious Disease Prevention

Background:

  • Cluster randomized crossover (CRXO) trials are efficient but underutilized in orthopedic fracture research.
  • The PREP-IT program initiated two CRXO trials (Aqueous-PREP and PREPARE) to address this gap.
  • Disseminating knowledge on CRXO trial implementation in orthopedics is crucial.

Purpose of the Study:

  • To describe the process of identifying and selecting orthopedic practices for the PREP-IT CRXO trials.
  • To characterize the selected orthopedic practices (clusters) participating in the trials.
  • To provide a methodological example for future orthopedic CRXO studies.

Main Methods:

  • Two pragmatic cluster randomized crossover trials (Aqueous-PREP and PREPARE) were conducted.
  • Orthopedic practices were identified and screened for eligibility.
  • Selected practices were randomized to intervention sequences comparing iodophor and chlorhexidine solutions.

Main Results:

  • 30 orthopedic practices were selected from 58 identified potential sites.
  • Most practices were Level I trauma centers (100% Aqueous-PREP, 87% PREPARE).
  • Detailed patient volumes, surgeon numbers, and infection preventionist access were recorded for participating practices.

Conclusions:

  • The PREP-IT trials exemplify adherence to reporting standards for CRXO trials.
  • Clear definition of cluster units and detailed selection processes were maintained.
  • Comprehensive descriptions of key cluster characteristics were provided for transparency and reproducibility.