What does this research mean for the field?

Successfully evaluating patient-reported outcomes (PROs) in clinical trials to support labeling claims requires explicit measurement strategies, validated psychometric instruments, prespecified domains, and rigorous statistical planning. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

February 9, 2004Fundamental and Clinical Pharmacology

Assessment of patient‐reported outcomes in clinical trials: the example of health‐related quality of life

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IWIngela WiklundLinköping University

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Implication

Requires prespecified PRO domains, validation, and missing-data plans in trials; leaves open optimal cardiovascular implementation strategies.

Key Points

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Ingela Wiklund (2004) studied this question.

synapsesocial.com/papers/6a06cd82d9167a9c2a582ddd https://doi.org/10.1111/j.1472-8206.2004.00234.x

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Implication

Requires prespecified PRO domains, validation, and missing-data plans in trials; leaves open optimal cardiovascular implementation strategies.

Assessment of patient‐reported outcomes in clinical trials: the example of health‐related quality of life

Discussion

Member takes

Implication

Key Points

Cite This Study

Assessment of patient‐reported outcomes in clinical trials: the example of health‐related quality of life

Discussion

Member takes

Implication

Key Points

Cite This Study

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