What question did this study set out to answer?

To establish and validate meaningful individual-level change thresholds for symptomatic adverse event worsening using the PRO-CTCAE instrument.

November 6, 2024Quality of Life ResearchOpen Access

Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®)

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To establish and validate meaningful individual-level change thresholds for symptomatic adverse event worsening using the PRO-CTCAE instrument.
Evaluated patient-reported toxicity data from clinical trials NCT03249090 (AFT-39) and NCT02158637 (MC1091).
Applied anchor- and distribution-based psychometric methods to determine score changes representing clinically meaningful symptom deterioration.
Identified individual-level worsening thresholds across core PRO-CTCAE items to distinguish clinically meaningful symptom deterioration from random variation.
Provided standardized criteria to detect actionable increases in symptomatic adverse events among patients receiving cancer therapy.

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Implication

Randomized trial analysis identifies meaningful individual worsening thresholds for PRO-CTCAE toxicity scores in cancer patients, highlighting improved tracking of adverse events.

Abstract

gov: NCT03249090 (AFT-39), NCT02158637 (MC1091).

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Cite This Study

Lee et al. (2024) studied this question.

synapsesocial.com/papers/69d88d4c52654bb436d19460 https://doi.org/10.1007/s11136-024-03819-5

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Implication

Randomized trial analysis identifies meaningful individual worsening thresholds for PRO-CTCAE toxicity scores in cancer patients, highlighting improved tracking of adverse events.

Abstract

gov: NCT03249090 (AFT-39), NCT02158637 (MC1091).

Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®)

Key Points

No abstract yet

Implication

Abstract

Discussion

Cite This Study

Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®)

Key Points

No abstract yet

Implication

Abstract

Discussion

Cite This Study

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