US Department of Health and Human Services, Food and Drug Administration. (2009) Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims. Available via www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. Accessed 6 June 2019.
Google Scholar
National Quality Forum. (2013) Patient Reported Outcomes (PROs) in performance measurement. Available via www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=72537. Accessed 22 Feb 2020.
Google Scholar
Rothman, M. L., Beltran, P., Cappelleri, J. C., Lipscomb, J., & Teschendorf, B. (2007). Patient-reported outcomes: conceptual issues. Value in Health, 10, S66–S75. https://doi.org/10.1111/j.1524-4733.2007.00269.x.
Article
PubMed
Google Scholar
Blakeley, J. O., Coons, S. J., Corboy, J. R., Leidy, N. K., Mendoza, T. R., & Wefel, J. S. (2016). Clinical outcome assessment in malignant glioma trials: measuring signs, symptoms, and functional limitations. Neuro-oncology, 18(Suppl 2), ii13–ii20. https://doi.org/10.1093/neuonc/nov291.
Article
PubMed
PubMed Central
Google Scholar
Dueck, A. C., Mendoza, T. R., Mitchell, S. A., Reeve, B. B., Castro, K. M., Rogak, L. J., Atkinson, T. M., Bennett, A. V., Denicoff, A. M., O'Mara, A. M., Li, Y., Clauser, S. B., Bryant, D. M., Bearden 3rd, J. D., Gillis, T. A., Harness, J. K., Siegel, R. D., Paul, D. B., Cleeland, C. S., Schrag, D., Sloan, J. A., Abernethy, A. P., Bruner, D. W., Minasian, L. M., Basch, E., & National Cancer Institute PRO-CTCAE Study Group. (2015). Validity and reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncology, 1, 1051–1059. https://doi.org/10.1001/jamaoncol.2015.2639.
Article
PubMed
PubMed Central
Google Scholar
Stephens, R. J., Hopwood, P., Girling, D. J., & Machin, D. (1997). Randomized trials with quality of life endpoints: are doctors’ ratings of patients’ physical symptoms interchangeable with patients’ self-ratings? Quality of Life Research, 6, 225–236.
Article
CAS
Google Scholar
Kotronoulas, G., Kearney, N., Maguire, R., Harrow, A., Di Domenico, D., Croy, S., & MacGillivray, S. (2014). What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. Journal of Clinical Oncology, 32, 1480–1501. https://doi.org/10.1200/JCO.2013.53.5948.
Article
PubMed
Google Scholar
Eiser, C., & Morse, R. (2001). Quality-of-life measures in chronic diseases of childhood. Health Technology Assessment, 5, 1–157.
Article
CAS
Google Scholar
Kobayashi, K., & Kamibeppu, K. (2011). Quality of life reporting by parent-child dyads in Japan, as grouped by depressive status. Nursing & Health Sciences, 13, 170–177. https://doi.org/10.1111/j.1442-2018.2011.00595.x.
Article
Google Scholar
Sato, I., Higuchi, A., Yanagisawa, T., Mukasa, A., Ida, K., Sawamura, Y., Sugiyama, K., Saito, N., Kumabe, T., Terasaki, M., Nishikawa, R., Ishida, Y., & Kamibeppu, K. (2013). Factors influencing self- and parent-reporting health-related quality of life in children with brain tumors. Quality of Life Research, 22, 185–201. https://doi.org/10.1007/s11136-012-0137-3.
Article
PubMed
Google Scholar
Engelen, V., Detmar, S., Koopman, H., Maurice-Stam, H., Caron, H., Hoogerbrugge, P., Egeler, R. M., Kaspers, G., & Grootenhuis, M. (2012). Reporting health-related quality of life scores to physicians during routine follow-up visits of pediatric oncology patients: Is it effective? Pediatric Blood & Cancer, 58, 766–774. https://doi.org/10.1002/pbc.23158.
Article
Google Scholar
Engelen, V., van Zwieten, M., Koopman, H., Detmar, S., Caron, H., Brons, P., Egeler, M., Kaspers, G. J., & Grootenhuis, M. (2012). The influence of patient reported outcomes on the discussion of psychosocial issues in children with cancer. Pediatric Blood & Cancer, 59, 161–166. https://doi.org/10.1002/pbc.24089.
Article
Google Scholar
Wolfe, J., Orellana, L., Cook, E. F., Ullrich, C., Kang, T., Geyer, J. R., Feudtner, C., Weeks, J. C., & Dussel, V. (2014). Improving the care of children with advanced cancer by using an electronic patient-reported feedback intervention: results from the PediQUEST randomized controlled trial. Journal of Clinical Oncology, 32, 1119–1126. https://doi.org/10.1200/JCO.2013.51.5981.
Article
PubMed
PubMed Central
Google Scholar
Haverman, L., van Rossum, M. A., van Veenendaal, M., van den Berg, J. M., Dolman, K. M., Swart, J., Kuijpers, T. W., & Grootenhuis, M. A. (2013). Effectiveness of a web-based application to monitor health-related quality of life. Pediatrics, 131, e533–e543. https://doi.org/10.1542/peds.2012-0958.
Article
PubMed
Google Scholar
Quinten, C., Maringwa, J., Gotay, C. C., Martinelli, F., Coens, C., Reeve, B. B., Flechtner, H., Greimel, E., King, M., Osoba, D., Cleeland, C., Ringash, J., Schmucker-Von Koch, J., Taphoorn, M. J., Weis, J., & Bottomley, A. (2011). Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. Journal of the National Cancer Institute, 103, 1851–1858. https://doi.org/10.1093/jnci/djr485.
Article
PubMed
PubMed Central
Google Scholar
Mercieca-Bebber, R., Williams, D., Tait, M. A., Roydhouse, J., Busija, L., Sundaram, C. S., Wilson, M., Langford, A., Rutherford, C., Roberts, N., King, M., Vodicka, E., Devine, B., & International Society for Quality of Life Research (ISOQOL). (2018). Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR). Quality of Life Research, 27, 2581–2591.
Article
Google Scholar
Mercieca-Bebber, R., Williams, D., Tait, M. A., Rutherford, C., Busija, L., Roberts, N., Wilson, M., Shunmuga Sundaram, C., Roydhouse, J., & International Society for Quality of Life Research (ISOQOL) Australia and New Zealand Special Interest Group. (2019). Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR). Quality of Life Research, 28, 955–962.
Article
Google Scholar
Johnston, D. L., Nagarajan, R., Caparas, M., Schulte, F., Cullen, P., Aplenc, R., & Sung, L. (2013). Reasons for non-completion of health related quality of life evaluations in pediatric acute myeloid leukemia: a report from the Children’s Oncology Group. PLoS One, 8, e74549. https://doi.org/10.1371/journal.pone.0074549.
Article
CAS
PubMed
PubMed Central
Google Scholar
Schepers, S. A., Engelen, V. E., Haverman, L., Caron, H. N., Hoogerbrugge, P. M., Kaspers, G. J., Egeler, R. M., & Grootenhuis, M. A. (2014). Patient reported outcomes in pediatric oncology practice: suggestions for future usage by parents and pediatric oncologists. Pediatric Blood & Cancer, 61, 1707–1710. https://doi.org/10.1002/pbc.25034.
Article
CAS
Google Scholar
Nelson, E. C., Eftimovska, E., Lind, C., Hager, A., Wasson, J. H., & Lindblad, S. (2015). Patient reported outcome measures in practice. BMJ, 350, g7818. https://doi.org/10.1136/bmj.g7818.
Article
PubMed
Google Scholar
Berry, D. L., Blumenstein, B. A., Halpenny, B., Wolpin, S., Fann, J. R., Austin-Seymour, M., Bush, N., Karras, B. T., Lober, W. B., & McCorkle, R. (2011). Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. Journal of Clinical Oncology, 29, 1029–1035. https://doi.org/10.1200/JCO.2010.30.3909.
Article
PubMed
PubMed Central
Google Scholar
Coons, S. J., Gwaltney, C. J., Hays, R. D., Lundy, J. J., Sloan, J. A., Revicki, D. A., Lenderking, W. R., Cella, D., Basch, E., & ISPOR ePRO Task Force. (2009). Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO good research practices task force report. Value in Health, 12, 419–429. https://doi.org/10.1111/j.1524-4733.2008.00470.x.
Article
PubMed
Google Scholar
Fayed, N., Schiariti, V., Bostan, C., Cieza, A., & Klassen, A. (2011). Health status and QOL instruments used in childhood cancer research: deciphering conceptual content using World Health Organization definitions. Quality of Life Research, 20, 247–258. https://doi.org/10.1007/s11136-011-9851-5.
Article
Google Scholar
Macartney, G., Harrison, M. B., VanDenKerkhof, E., Stacey, D., & McCarthy, P. (2014). Quality of life and symptoms in pediatric brain tumor survivors: a systematic review. Journal of Pediatric Oncology Nursing, 31, 65–77. https://doi.org/10.1177/1043454213520191.
Article
PubMed
Google Scholar
Janssens, L., Gorter, J. W., Ketelaar, M., Kramer, W. L. M., & Holtslag, H. R. (2008). Health-related quality-of-life measures for long-term follow-up in children after major trauma. Quality of Life Research, 17, 701–713. https://doi.org/10.1007/s11136-008-9339-0.
Article
PubMed
PubMed Central
Google Scholar
Varni, J. W., Seid, M., & Rode, C. A. (1999). The PedsQL: measurement model for the pediatric quality of life inventory. Medical Care, 37, 126–139.
Article
CAS
Google Scholar
Varni, J. W., Seid, M., & Kurtin, P. S. (2001). PedsQL 4.0: reliability and validity of the pediatric quality of life inventory version 4.0 generic core scales in healthy and patient populations. Medical Care, 39, 800–812.
Article
CAS
Google Scholar
Varni, J. W., Limbers, C. A., Burwinkle, T. M., Bryant, W. P., & Wilson, D. P. (2008). The ePedsQL in type 1 and type 2 diabetes: feasibility, reliability, and validity of the pediatric quality of life inventory internet administration. Diabetes Care, 31, 672–677. https://doi.org/10.2337/dc07-2021.
Article
PubMed
Google Scholar
Kruse, S., Schneeberg, A., & Brussoni, M. (2014). Construct validity and impact of mode of administration of the PedsQL™ among a pediatric injury population. Health and Quality of Life Outcomes, 12, 168. https://doi.org/10.1186/s12955-014-0168-2.
Article
PubMed
PubMed Central
Google Scholar
Vinney, L. A., Grade, J. D., & Connor, N. P. (2012). Feasibility of using a handheld electronic device for the collection of patient reported outcomes data from children. Journal of Communication Disorders, 45, 12–19. https://doi.org/10.1016/j.jcomdis.2011.10.001.
Article
PubMed
Google Scholar
Varni JW. The PedsQL Measurement Model for the Pediatric Quality of Life Inventory (1998-2009) Available via http://www.pedsql.org/index.html. Accessed 6 June 2019.
Thorndike, F. P., Carlbring, P., Smyth, F. L., Magee, J. C., Gonder-Frederick, L., Ost, L., & Ritterband, L. M. (2009). Web-based measurement: effect of completing single or multiple items per webpage. Computers in Human Behavior, 25, 393–401. https://doi.org/10.1016/j.chb.2008.05.006.
Article
Google Scholar
Tourangeau, R., Couper, M. P., & Conrad, F. (2004). Spacing, position, and order: interpretive heuristics for visual features of survey questions. Public Opinion Quarterly, 68, 368–393. https://doi.org/10.1093/poq/afh035.
Article
Google Scholar
Liu, M., & Cernat, A. (2018). Item-by-item versus matrix questions: a web survey experiment. Social Science Computer Review, 36, 690–706. https://doi.org/10.1177/0894439316674459.
Article
Google Scholar
Callegaro, M., Shand-Lubbers, J., & Dennis, J. M. (2009). Presentation of a single item versus a grid: effects on the vitality and mental health scales of the SF-36v2 health survey. Psychology Available via http://www.amstat.org/sections/srms/Proceedings/y2009/Files/400045.pdf.
Iglesias, C. P., Birks, Y. F., & Torgerson, D. J. (2001). Improving the measurement of quality of life in older people: the York SF-12. QJM, 94, 695–698. https://doi.org/10.1093/qjmed/94.12.695.
Article
CAS
PubMed
Google Scholar
Ministry of Health, Labour and Welfare in Japan (2019) National livelihood survey 2018. Available at www.mhlw.go.jp/toukei/saikin/hw/k-tyosa/k-tyosa18/dl/02.pdf [in Japanese]. Accessed 22 Feb 2020.
Google Scholar
Varni, J. W., Limbers, C. A., Neighbors, K., Schulz, K., Lieu, J. E., Heffer, R. W., Tuzinkiewicz, K., Mangione-Smith, R., Zimmerman, J. J., & Alonso, E. M. (2011). The PedsQL™ infant scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Quality of Life Research, 20, 45–55. https://doi.org/10.1007/s11136-010-9730-5.
Article
PubMed
Google Scholar
Kobayashi, K., & Kamibeppu, K. (2010). Measuring quality of life in Japanese children: development of the Japanese version of PedsQL. Pediatrics International, 52, 80–88. https://doi.org/10.1111/j.1442-200X.2009.02889.x.
Article
PubMed
Google Scholar
Sato, I., Higuchi, A., Yanagisawa, T., Murayama, S., Kumabe, T., Sugiyama, K., Mukasa, A., Saito, N., Sawamura, Y., Terasaki, M., Shibui, S., Takahashi, J., Nishikawa, R., Ishida, Y., & Kamibeppu, K. (2014). Impact of late effects on health-related quality of life in survivors of pediatric brain tumors: motility disturbance of limb(s), seizure, ocular/visual impairment, endocrine abnormality, and higher brain dysfunction. Cancer Nursing, 37, E1–E14. https://doi.org/10.1097/NCC.0000000000000110.
Article
PubMed
Google Scholar
Takahashi, M., Adachi, M., Nishimura, T., Hirota, T., Yasuda, S., Kuribayashi, M., & Nakamura, K. (2018). Prevalence of pathological and maladaptive internet use and the association with depression and health-related quality of life in Japanese elementary and junior high school-aged children. Social Psychiatry and Psychiatric Epidemiology, 53, 1349–1359. https://doi.org/10.1007/s00127-018-1605-z.
Article
PubMed
Google Scholar
R Core Team. (2018). R: A language and environment for statistical computing. Vienna: R Foundation for Statistical Computing Available via https://www.R-project.org/. Accessed 15 Jan 2019.
Google Scholar
Sato, I., Higuchi, A., Yanagisawa, T., Mukasa, A., Ida, K., Sawamura, Y., Sugiyama, K., Saito, N., Kumabe, T., Terasaki, M., Nishikawa, R., Ishida, Y., & Kamibeppu, K. (2010). Development of the Japanese version of the pediatric quality of life inventory brain tumor module. Health and Quality of Life Outcomes, 8, 38. https://doi.org/10.1186/1477-7525-8-38.
Article
PubMed
PubMed Central
Google Scholar
Kikuchi, R., Mizuta, K., Urahashi, T., Sanada, Y., Yamada, N., Onuma, E., Ono, M., Endo, M., Sato, I., & Kamibeppu, K. (2017). Development of the Japanese version of the pediatric quality of life inventory™ transplant module. Pediatrics International, 59, 80–88. https://doi.org/10.1111/ped.13051.
Article
PubMed
Google Scholar
Kaneko, M., Sato, I., Soejima, T., & Kamibeppu, K. (2014). Health-related quality of life in young adults in education, employment, or training: development of the Japanese version of pediatric quality of life inventory (PedsQL) generic core scales young adult version. Quality of Life Research, 23, 2121–2131. https://doi.org/10.1007/s11136-014-0644-5.
Article
PubMed
Google Scholar
Tsuji, N., Kakee, N., Ishida, Y., Asami, K., Tabuchi, K., Nakadate, H., Iwai, T., Maeda, M., Okamura, J., Kazama, T., Terao, Y., Ohyama, W., Yuza, Y., Kaneko, T., Manabe, A., Kobayashi, K., Kamibeppu, K., & Matsushima, E. (2011). Validation of the Japanese version of the pediatric quality of life inventory (PedsQL) cancer module. Health and Quality of Life Outcomes, 9, 22. https://doi.org/10.1186/1477-7525-9-22.
Article
PubMed
PubMed Central
Google Scholar
Steenkamp, J. E. M., & Baumgartner, H. (1998). Assessing measurement invariance in cross-national consumer research. Journal of Consumer Research, 25, 78–90. https://doi.org/10.1086/209528.
Article
Google Scholar
Cheung, G. W., & Rensvold, R. B. (2002). Evaluating goodness-of-fit indexes for testing measurement invariance. Structural Equation Modeling: A Multidisciplinary Journal, 9, 233–255. https://doi.org/10.1207/S15328007SEM0902_5.
Article
Google Scholar
Limbers, C. A., Newman, D. A., & Varni, J. W. (2008). Factorial invariance of child self-report across socioeconomic status groups: a multigroup confirmatory factor analysis utilizing the PedsQL 4.0 generic core scales. Journal of Behavioral Medicine, 31, 401–411. https://doi.org/10.1007/s10865-008-9166-3.
Article
PubMed
Google Scholar
Limbers, C. A., Newman, D. A., & Varni, J. W. (2008). Factorial invariance of child self-report across age subgroups: a confirmatory factor analysis of ages 5 to 16 years utilizing the PedsQL 4.0 generic core scales. Value in Health, 11, 659–668. https://doi.org/10.1111/j.1524-4733.2007.00289.x.
Article
PubMed
Google Scholar
Limbers, C. A., Newman, D. A., & Varni, J. W. (2008). Factorial invariance of child self-report across healthy and chronic health condition groups: a confirmatory factor analysis utilizing the PedsQLTM 4.0 generic core scales. Journal of Pediatric Psychology, 33, 630–639. https://doi.org/10.1093/jpepsy/jsm131.
Article
PubMed
Google Scholar
Schermelleh-Engel, K., Moosbrugger, H., & Müller, H. (2003). Evaluating the fit of structural equation models: tests of significance and descriptive goodness-of-fit measures. Mathematics, 8, 23–74.
Google Scholar
Browne, M. W., & Cudeck, R. (1992). Alternative ways of assessing model fit. Sociological Methods & Research, 21, 230–258.
Article
Google Scholar
Hu, L., & Bentler, P. M. (1999). Cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives. Structural Equation Modeling: A Multidisciplinary Journal, 6, 1–55.
Article
Google Scholar
Meade, A. W., Johnson, E. C., & Braddy, P. W. (2008). Power and sensitivity of alternative fit indices in tests of measurement invariance. The Journal of Applied Psychology, 93, 568–592. https://doi.org/10.1037/0021-9010.93.3.568.
Article
PubMed
Google Scholar
Thomas, R. G., & Conlon, M. (1992). Sample size determination based on fisher’s exact test for use in 2 × 2 comparative trials with low event rates. Controlled Clinical Trials, 13, 134–147. https://doi.org/10.1016/0197-2456(92)90019-V.
Article
CAS
PubMed
Google Scholar
Ministry of Health, Labour and Welfare in Japan (2017) National livelihood survey 2016. Available at www.mhlw.go.jp/toukei/saikin/hw/k-tyosa/k-tyosa16/index.html [in Japanese]. Accessed 22 Feb 2020.
Google Scholar
Ministry of Internal Affairs and Communications in Japan (2017) National population census 2015. Retrieved from: www.stat.go.jp/data/kokusei/2015/kekka/kihon2/pdf/gaiyou.pdf [in Japanese]. Accessed 22 Feb 2020.
Google Scholar
Miwa, K., & Dijkstra, T. (2017). Lexical processes in the recognition of Japanese horizontal and vertical compounds. Reading and Writing, 30, 791–812. https://doi.org/10.1007/s11145-016-9700-6.
Article
Google Scholar