Quality of life assessment and reporting in randomized controlled trials: a study of literature published from Japan

Health and Quality of Life Outcomes
Mariko NaitoShunichi Fukuhara

Abstract

Standardization of quality of life (QOL) assessment and reporting in clinical trials is an imperative issue. While English-speaking countries have led this movement in standardization, there persists to be a limited amount of information from non-English-speaking including Japan. In this study, we bibliographically analyze the reporting of randomized controlled trials (RCT) conducted in Japan that used a QOL instrument. A PubMed search of reports published between 1970-2003 followed by an examination of QOL reporting and its frequency of use in RCTs published from Japan. Percentages of QOL reporting in RCTs have increased between 1970-2003 both worldwide (0% for 1970-1974 to 4.4% for 2000-2003) and in Japan (0% to 1.8% for the identical periods). We found and evaluated 46 RCT reports published from Japan (32 in English, 14 in Japanese). The most commonly studied clinical condition was cancer (26, 56.5%) and the most common intervention was drug therapy (29, 63.0%). QOL was used as the primary endpoint in 10 studies (21.7%). Authors used established QOL instruments in 12 studies (26.1%), developed original instruments in 8 studies (17.5%) and assessed the symptoms or performance status in 10 studies (21.7%). Authors conceptually...Continue Reading

References

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Citations

Aug 11, 2006·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·W Chr KleijnA A Kaptein
Apr 18, 2006·Journal of Oral Science·Mariko NaitoNobuhiro Hanada
Oct 6, 2007·Nihon Hoshasen Gijutsu Gakkai zasshi·Katsuhiko Ogasawara
Mar 12, 2009·Contemporary Clinical Trials·John F Scoggins, Donald L Patrick
Oct 30, 2013·Journal of Orthopaedic Trauma·Daniel S HorwitzMichael Suk
Oct 14, 2014·Journal of Veterinary Internal Medicine·M A Giuffrida, S M Kerrigan
Oct 20, 2020·Journal of Medical Economics·Shinya OhnoKatsura Tsukamoto

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