The Quality of Life Questionnaire Core 30 (QLQ-C30) and Functional Assessment of Cancer-General (FACT-G) differ in responsiveness, relative efficiency, and therefore required sample size

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• 作者：Madeleine T. King ; Melanie L. Bell ; Daniel Costa ; Phyllis Butow ; Byeongsang Oh
• 关键词：Quality of life ; Health status ; Reliability ; Validity ; Sample size ; Statistical data analysis
• 刊名：Journal of Clinical Epidemiology
• 出版年：January, 2014
• 年：2014
• 卷：67
• 期：1
• 页码：100-107
• 全文大小：205 K

文摘

Objectives

Quality of Life Questionnaire Core 30 (QLQ-C30) and Functional Assessment of Cancer Therapy-General (FACT-G) are widely used cancer-specific health-related quality of life (HRQOL) questionnaires. We aimed to compare their responsiveness with clinically important effects and statistical efficiency to detect such effects.

Study Design and Setting

Secondary analysis of QLQ-C30 and FACT-G data from a randomized controlled trial of Medical Qigong (n聽=聽162 heterogeneous cancer patients). Difference in responsiveness (DR) and relative efficiency (RE) were calculated for five domains.

Results

FACT-G total score was more efficient than QLQ-C30 global scale for detecting change within the intervention arm [RE聽=聽0.31 (0.083, 0.69)] and comparing change between trial arms [RE聽=聽0.17 (0.009, 0.58)]. In the social domain, the QLQ-C30 scale was more responsive [DR聽=聽0.28 (0.024, 0.54)] and more efficient within arm only [RE聽=聽5.25 (1.21, 232.26)]. In the physical, functional/role, and emotional domains, neither questionnaire was more responsive or efficient.

Conclusion

FACT-G would require about one-third the sample of QLQ-C30 to detect a given change in overall HRQOL, whereas in the social domain, it would require five times the sample size. FACT-G won advantage in overall HRQOL by reduced 鈥渘oise鈥?(smaller standard deviation achieved by summing across 27 items), whereas QLQ-C30 won advantage in the social domain via a larger 鈥渟ignal鈥?(achieved through well-targeted item content).