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Related Concept Videos

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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Censoring Survival Data01:09

Censoring Survival Data

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Survival analysis is a statistical method used to analyze time-to-event data, often employed in fields such as medicine, engineering, and social sciences. One of the key challenges in survival analysis is dealing with incomplete data, a phenomenon known as "censoring." Censoring occurs when the event of interest (such as death, relapse, or system failure) has not occurred for some individuals by the end of the study period or is otherwise unobservable, and it might have many different...
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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.
To choose a cluster sample, divide the population into clusters (groups) and then randomly select some of the clusters. All the members from these clusters are in the cluster sample. For example, if you randomly sample four departments from your...
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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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Random Error01:04

Random Error

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Random or indeterminate errors originate from various uncontrollable variables, such as variations in environmental conditions, instrument imperfections, or the inherent variability of the phenomena being measured. Usually, these errors cannot be predicted, estimated, or characterized because their direction and magnitude often vary in magnitude and direction even during consecutive measurements. As a result, they are difficult to eliminate. However, the aggregate effect of these errors can be...
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Group Design02:01

Group Design

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The most basic experimental design involves two groups: the experimental group and the control group. The two groups are designed to be the same except for one difference— experimental manipulation. The experimental group gets the experimental manipulation—that is, the treatment or variable being tested—and the control group does not. Since experimental manipulation is the only difference between the experimental and control groups, we can be sure that any differences between...
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Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
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Are missing data adequately handled in cluster randomised trials? A systematic review and guidelines.

Karla Díaz-Ordaz1, Michael G Kenward2, Abie Cohen3

  • 1Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK karla.diaz-ordaz@lshtm.ac.uk.

Clinical Trials (London, England)
|June 7, 2014
PubMed
Summary

Missing data are common in cluster randomized trials but poorly handled, often with methods assuming strong conditions. Improved reporting and accessible methods are needed for valid trial inferences.

Keywords:
Cluster randomised trialsmissing datamultiple imputation

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Area of Science:

  • Biostatistics
  • Clinical Trials Methodology
  • Epidemiology

Background:

  • Missing data can introduce bias and affect variance estimation in statistical analyses.
  • Handling missing data is particularly complex in cluster randomized trials.
  • A review of current practices for managing missing data in these trials was lacking.

Purpose of the Study:

  • To systematically review the reporting and handling of missing data in published cluster randomized trials.
  • To identify common statistical methods used to address missing data in this trial design.

Main Methods:

  • Systematic identification of cluster randomized trials published in English in 2011 via MEDLINE/PubMed.
  • Exclusion of non-randomized, pilot/feasibility, secondary/interim analyses, economic evaluations, and trials without individual-level data.
  • Extraction of information on missing data and statistical handling methods from a random sample of included trials.

Main Results:

  • Missing data were present in 72% of the 132 included trials.
  • Only 32 trials reported methods for handling missing data.
  • Common methods included single imputation (22 trials) and multiple imputation without accounting for clustering (8 trials).

Conclusions:

  • Missing data are prevalent in cluster randomized trials but inadequately reported.
  • Current methods often rely on strong, unstated assumptions, potentially compromising inference validity.
  • More accessible methods valid under general Missing-at-Random assumptions should be promoted.