Statistical Considerations in Heart Failure Research
Dec 22, 2022
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Statistical experts Janet Wittes, Eric Leifer, Bill Abraham, and Mitchell Psotka discuss the complexities of Statistical Analytical Plans (S-TEMANs) in heart failure research, emphasizing the importance of clear definitions for accurate estimations. They highlight the need to go beyond P values, focusing on patient reported outcomes and confidence intervals to analyze clinical trial data and make informed decisions.
S-TEMAN aligns trial calculations with intended estimates, enhancing result interpretation.
P-values need backing from estimated values and confidence intervals for comprehensive understanding.
Deep dives
Understanding S-TEMAN in Clinical Trials
S-TEMAN is a concept that ensures trials calculate numbers that represent a clear understanding of what they aim to estimate. In clinical trials focused on continuous outcomes like symptoms, the intended estimate and the calculated number can differ significantly. S-TEMAN serves as a disciplined approach to align study calculations with the actual targeted value in the population, offering a roadmap for precise interpretation of trial results.
Importance of Clarity with S-TEMAN in Trial Design
In designing studies, including the S-TEMAN specifically in protocols helps clarify the questions trials seek to answer and guides handling patient-related complexities. By stating the research's core question and understanding patient behaviors during the trial, the S-TEMAN framework enhances trial design, ensuring a clear comparison and precise measurement of intended outcomes.
Evaluating Clinical Significance Beyond P-Values
P-values, seen as a level of certainty in findings, should be supplemented by estimated values and confidence intervals to provide a comprehensive understanding of treatment effects. Interpreting clinical trials should extend beyond statistical significance to include clinical meaningfulness. By defining thresholds for significance, trials can navigate the balance between statistical certainty and actual clinical impact, crucial for patient-oriented outcomes.
Janet Wittes, Eric Leifer, Bill Abraham, and Mitchell Psotka join the podcast to discuss all-things statistics. What is an estimand? How should we treat p-values?
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