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A Randomized Trial of Pessary in Singleton
Pregnancies with a Short Cervix
(TOPS)
IDE# G160176ProtocolEunice Kennedy Shiver
National Institute of Child Health and Human Development (NICHE)
MaternalFetal
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How to fill out a randomized trial of
How to fill out a randomized trial of
01
Determine the research question and hypothesis to be tested in the trial.
02
Define the study population and inclusion/exclusion criteria.
03
Randomly assign participants to either the intervention group or control group.
04
Implement the intervention or treatment according to the study protocol.
05
Collect data on outcomes of interest in a systematic and standardized manner.
06
Analyze the data using appropriate statistical methods.
07
Interpret the results and draw conclusions based on the findings.
Who needs a randomized trial of?
01
Researchers conducting clinical trials to evaluate the efficacy of new treatments or interventions.
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Healthcare providers looking to determine the best course of treatment for their patients.
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Policy makers and regulatory agencies making decisions about healthcare policies and guidelines.
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Pharmaceutical companies seeking to obtain approval for new drugs or therapies.
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What is a randomized trial of?
A randomized trial is a study in which participants are randomly assigned to different treatment groups or control groups.
Who is required to file a randomized trial of?
Researchers conducting clinical trials are required to file a randomized trial.
How to fill out a randomized trial of?
Researchers must follow specific protocols and guidelines for conducting and reporting randomized trials.
What is the purpose of a randomized trial of?
The purpose of a randomized trial is to compare the effectiveness of different treatments or interventions.
What information must be reported on a randomized trial of?
Information such as study design, participants, interventions, outcomes, and results must be reported on a randomized trial.
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