Development of a novel scale to assess the quality of life in type 1 diabetic patients for beta cell replacement therapy
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The main purpose of beta cell replacement therapy for type 1 diabetic patients is to improve their health-related quality of life (HR-QoL). Previous HR-QoL surveys for beta cell replacement therapy on the point of familial support and public understanding have not been studied adequately. We hypothesize that familial support and public understanding have a significant impact on HR-QoL of type 1 diabetic patients, and low HR-QoL assessed with a new scale is associated with seeking a new therapy. The initial questionnaire with 26 items was created after content validation based on 778 inquiries from patients or associates. One hundred five type 1 diabetic patients answered the questionnaire as well as separate questions about their opinions on beta cell replacement therapy. Finally, the new scale, named the Japanese Insulin-Dependent Diabetic Patient QoL (JAPID-QoL) scale, consisted of 19 items with the following three subscales: diabetes status, familial support and social acceptance. Cronbach’s α for overall scale was 0.878, and those for three subscales were over 0.70. All items were satisfied with convergent validity. Lower scores on the JAPID-QoL scale were associated with higher interest in and acceptance of beta cell replacement therapy (Spearman’s coefficients; r = −0.25, p < 0.001 and r = −0.33, p < 0.001, respectively) and also correlated with the necessity of psychosomatic care (r = −0.49, p < 0.001). Our newly proposed JAPID-QoL scale showed enough reliability and validity to assess HR-QoL of type 1 diabetic patients. The patients who had a low HR-QoL on the JAPID-QoL scale desired to receive beta cell replacement therapy and psychosomatic care.
KeywordsType 1 diabetes Quality of life Familial support Social acceptance Transplantation therapy
This study was supported in part by the Health Labour Sciences Research Grant for Research on Basic Researches from the Japanese Ministry of Health, Labour and Welfare (H19-Trans-General-004) and All Saints Health Foundation (Fort Worth, TX). The authors thank the non-profit organization, Japan IDDM network, for its cooperation. The authors wish to thank Mr. Jeffrey A. SoRelle for editing this manuscript.
- 1.Benhamou PY, Milliat-Guittard L, Wojtusciszyn A, Kessler L, Toso C, Baertschiger R, Debaty I, Badet L, Penfornis A, Thivolet C, Renard E, Bayle F, Morel P, Morelon E, Colin C, Berney T, GRAGIL group. Quality of life after islet transplantation: data from the GRAGIL 1 and 2 trials. Diabet Med. 2009;26(6):617–21.PubMedCrossRefGoogle Scholar
- 4.U.S. Food and Drug Administration. Guidance for Industry: considerations for allogeneic pancreatic islet cell products. 2009. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM182441.pdf. Accessed 8 Feb 2010.
- 14.Cure P, Pileggi A, Froud T, Messinger S, Faradji RN, Baidal DA, Cardani R, Curry A, Poggioli R, Pugliese A, Betancourt A, Esquenazi V, Ciancio G, Selvaggi G, Burke GW 3rd, Ricordi C, Alejandro R. Improved metabolic control and quality of life in seven patients with type 1 diabetes following islet after kidney transplantation. Transplantation. 2008;85(6):801–12.PubMedCrossRefGoogle Scholar
- 19.Matsumoto S, Noguchi H, Shimoda M, Ikemoto T, Naziruddin B, Jackson A, Tamura Y, Olson G, Fujita Y, Chujo D, Takita M, Kobayashi N, Onaca N, Levy M. Seven consecutive successful clinical islet isolations with pancreatic ductal injection. Cell Transplant. 2009;19(3):291–7.PubMedCrossRefGoogle Scholar
- 20.Matsumoto S, Okitsu T, Iwanaga Y, Noguchi H, Nagata H, Yonekawa Y, Yamada Y, Fukuda K, Tsukiyama K, Suzuki H, Kawasaki Y, Shimodaira M, Matsuoka K, Shibata T, Kasai Y, Maekawa T, Shapiro J, Tanaka K. Insulin independence after living-donor distal pancreatectomy and islet allotransplantation. Lancet. 2005;365(9471):1642–4.PubMedCrossRefGoogle Scholar
- 21.Matsumoto S, Okitsu T, Iwanaga Y, Noguchi H, Nagata H, Yonekawa Y, Yamada Y, Fukuda K, Shibata T, Kasai Y, Maekawa T, Wada H, Nakamura T, Tanaka K. Successful islet transplantation from nonheartbeating donor pancreata using modified Ricordi islet isolation method. Transplantation. 2006;82(4):460–5.PubMedCrossRefGoogle Scholar
- 22.Garfield SA, Malozowski S, Chin MH, Narayan KM, Glasgow RE, Green LW, Hiss RG, Krumholz HM, Diabetes Mellitus Interagency Coordinating Committee (DIMCC) Translation Conference Working Group. Considerations for diabetes translational research in real-world settings. Diabetes Care. 2003;26(9):2670–4.PubMedCrossRefGoogle Scholar
- 26.Nishisato S, Torii Y. Effects of categorizing continuous normal variables on the product-moment correlation. Jpn Psychol Res. 1970;13:45–9.Google Scholar
- 28.Fayers RM, Machin D. Questionnaire development and scoring. In: Fayers RM, Machin D, editors. Quality of life: assessment, analysis and interpretation. West Sussex: John Wiley; 2000. p. 135–53.Google Scholar
- 35.Everitt BS. Latent variables, factor analysis, and causal modeling. In: Bellack AS, Hersen M, editors. Comprehensive clinical psychology. Oxford: Elsevier Science; 1998. p. 287–311.Google Scholar
- 37.Fayers RM, Machin D. Multi-item scales. In: Fayers RM, Machin D, editors. Quality of life: assessment, analysis and interpretation. West Sussex: John Wiley; 2000. p. 72–90.Google Scholar
- 39.Streiner DL, Norman GR. Validity. In: Streiner DL, Norman GR, editors. Health measurement scales: a practical guide to their development and use. 3rd ed. New York: Oxford University Press; 1995. p. 172–93.Google Scholar
- 43.Katayama S, Kikkawa R, Isogai S, Sasaki N, Matsuura N, Tajima N, Urakami T, Uchigata Y, Ohashi Y. Effect of captopril or imidapril on the progression of diabetic nephropathy in Japanese with type 1 diabetes mellitus: a randomized controlled study (JAPAN-IDDM). Diabetes Res Clin Pract. 2002;55(2):113–21.PubMedCrossRefGoogle Scholar