Medical DevicesMinimal Important Differences In Melanoma-Related Quality Of Life
Quantitative assessments of patient quality of life are becoming increasingly important in the context of clinical trials. In addition to establishing benchmark score differences that are useful when interpreting study results, Minimal Important Differences (MIDs) inform discussions of clinically meaningful change in patient status.
In a recent study by researchers at the University of Texas M. D. Anderson Cancer Center, various techniques to quantify MIDs were applied to data from the Functional Assessment of Cancer Therapy - Melanoma (FACT-M). These included analyses linked to patient performance status indicators over time such as the Karnofsky Performance Status Scale and the Eastern Cooperative Oncology Group Performance Status Scale.
Askew and colleagues reported that different performance indicators serving as clinical "anchors" yielded varying MID estimates.
The goals of the current study will contribute to and hopefully expand the on-going discussion of how investigators define clinically meaningful change in patient quality of life.
Dr. Janice Cormier, Associate Professor of Surgery and Biostatistics, who along with colleagues, developed and validated the FACT-Melanoma questionnaire noted that, "With the increased interest expressed by the U.S. Food and Drug Administration in patient reported outcomes for clinical trial research, the need for evidence-based standards for interpreting differences in patient status has become increasingly important."
This will be discussed in Value in Health, the official journal of the International Society for Pharmacoeconomics and outcomes Research.
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research and help health care leaders to make decisions that are solidly evidence-based. The journal is published bi-monthly and has a regular readership of over 4,000 clinicians, decision-makers, and researchers worldwide.
ISPOR is a nonprofit, international organization that strives to translate pharmacoeconomics and outcomes research into practice to ensure that society allocates scarce health care res wisely, fairly, and efficiently.
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