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Guidelines for Reporting Outcomes in Trial Protocols : vimarsana.com
Guidelines for Reporting Outcomes in Trial Protocols
This report, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)–Outcomes 2022 extension, is a consensus statement on the standards
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Primary Outcome
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Analysis Metric
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Minimal Important Change
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Outcome Data Collected Are Continuous
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Will Be Analyzed
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Cutoff Values
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Outcome Assessments Will Be Performed
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Several Time Points After Randomization
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Time Points That Will Be Used
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Composite Outcome Is Used
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Define All Individual Components
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Composite Outcome
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Target Difference Between Treatment Groups
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Minimal Important Difference
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Difference Elicitation
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Data Collection
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What Is Known About
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Study Instruments
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Population Similar
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Study Sample
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Who Will Assess
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Any Planned Methods
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Secondary Outcomes
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Coprimary Outcomes
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Same Outcome Assessed
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Multiple Time Points
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Subgroup Analyses
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