Diabetology International

, Volume 2, Issue 2, pp 55–64 | Cite as

Development of a novel scale to assess the quality of life in type 1 diabetic patients for beta cell replacement therapy

  • Nobuyo Hatanaka
  • Morihito Takita
  • Takuhiro Yamaguchi
  • Masahiro Kami
  • Shinichi Matsumoto
Original article

Abstract

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.

Keywords

Type 1 diabetes Quality of life Familial support Social acceptance Transplantation therapy 

Notes

Acknowledgments

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.

Supplementary material

13340_2011_23_MOESM1_ESM.doc (96 kb)
Supplementary material 1 (DOC 96 kb)

References

  1. 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
  2. 2.
    Tharavanij T, Betancourt A, Messinger S, Cure P, Leitao CB, Baidal DA, Froud T, Ricordi C, Alejandro R. Improved long-term health-related quality of life after islet transplantation. Transplantation. 2008;86(9):1161–7.PubMedCrossRefGoogle Scholar
  3. 3.
    Poggioli R, Faradji RN, Ponte G, Betancourt A, Messinger S, Baidal DA, Froud T, Ricordi C, Alejandro R. Quality of life after islet transplantation. Am J Transplant. 2006;6(2):371–8.PubMedCrossRefGoogle Scholar
  4. 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.
  5. 5.
    Hanberger L, Ludvigsson J, Nordfeldt S. Health-related quality of life in intensively treated young patients with type 1 diabetes. Pediatr Diabetes. 2009;10(6):374–81.PubMedCrossRefGoogle Scholar
  6. 6.
    El Achhab Y, Nejjari C, Chikri M, Lyoussi B. Disease-specific health-related quality of life instruments among adults diabetic: a systematic review. Diabetes Res Clin Pract. 2008;80(2):171–84.PubMedCrossRefGoogle Scholar
  7. 7.
    Garratt AM, Schmidt L, Fitzpatrick R. Patient-assessed health outcome measures for diabetes: a structured review. Diabet Med. 2002;19(1):1–11.PubMedCrossRefGoogle Scholar
  8. 8.
    Anderson RM, Fitzgerald JT, Wisdom K, Davis WK, Hiss RG. A comparison of global versus disease-specific quality-of-life measures in patients with NIDDM. Diabetes Care. 1997;20(3):299–305.PubMedCrossRefGoogle Scholar
  9. 9.
    Jacobson AM. Quality of life in patients with diabetes mellitus. Semin Clin Neuropsychiatry. 1997;2(1):82–93.PubMedGoogle Scholar
  10. 10.
    Shaban C, Fosbury JA, Cavan DA, Kerr D, Skinner TC. The relationship between generic and diabetes specific psychological factors and glycaemic control in adults with type 1 diabetes. Diabetes Res Clin Pract. 2009;85(3):e26–9.PubMedCrossRefGoogle Scholar
  11. 11.
    ter Braak EW, Appelman AM, van de Laak M, Stolk RP, van Haeften TW, Erkelens DW. Clinical characteristics of type 1 diabetic patients with and without severe hypoglycemia. Diabetes Care. 2000;23(10):1467–71.PubMedCrossRefGoogle Scholar
  12. 12.
    Watkins K, Connell CM. Measurement of health-related QOL in diabetes mellitus. Pharmacoeconomics. 2004;22(17):1109–26.PubMedCrossRefGoogle Scholar
  13. 13.
    Barshes NR, Vanatta JM, Mote A, Lee TC, Schock AP, Balkrishnan R, Brunicardi FC, Goss JA. Health-related quality of life after pancreatic islet transplantation: a longitudinal study. Transplantation. 2005;79(12):1727–30.PubMedCrossRefGoogle Scholar
  14. 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
  15. 15.
    Dziuban CD, Shirkey EC. When is a correlation matrix appropriate for factor analysis? Some decision rules. Psychol Bull. 1974;81(6):358–61.CrossRefGoogle Scholar
  16. 16.
    Debono M, Cachia E. The impact of diabetes on psychological well being and quality of life. The role of patient education. Psychol Health Med. 2007;12(5):545–55.PubMedCrossRefGoogle Scholar
  17. 17.
    Peyrot M, Rubin RR, Siminerio LM. Physician and nurse use of psychosocial strategies in diabetes care: results of the cross-national Diabetes Attitudes, Wishes and Needs (DAWN) study. Diabetes Care. 2006;29(6):1256–62.PubMedCrossRefGoogle Scholar
  18. 18.
    Weinger K, Lee J. Psychosocial and psychiatric challenges of diabetes mellitus. Nurs Clin North Am. 2006;41(4):667–80.PubMedCrossRefGoogle Scholar
  19. 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. 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. 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. 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
  23. 23.
    Mulvaney S. Improving patient problem solving to reduce barriers to diabetes self-management. Clin Diabetes. 2009;27(3):99–104.CrossRefGoogle Scholar
  24. 24.
    Hatanaka N, Takita M, Yamaguchi T, Kami M, Matsumoto S. Interests in beta-cell replacement therapies among Japanese patients with type 1 diabetes. Diabetes Res Clin Pract. 2010;89(1):e5–8.PubMedCrossRefGoogle Scholar
  25. 25.
    Lissitz RW, Green SB. Effect of the number of scale points on reliability: a Monte Carlo approach. J App Psychol. 1975;60(1):10–3.CrossRefGoogle Scholar
  26. 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
  27. 27.
    Janssen MF, Birnie E, Haagsma JA, Bonsel GJ. Comparing the standard EQ-5D three-level system with a five-level version. Value Health. 2008;11(2):275–84.PubMedCrossRefGoogle Scholar
  28. 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
  29. 29.
    Dorn SD, Hernandez L, Minaya MT, Morris CB, Hu Y, Leserman J, Lewis S, Lee A, Bangdiwala SI, Green PH, Drossman DA. The development and validation of a new coeliac disease quality of life survey (CD-QOL). Aliment Pharmacol Ther. 2010;31(6):666–75.PubMedCrossRefGoogle Scholar
  30. 30.
    Brod M, Skovlund SE, Wittrup-Jensen KU. Measuring the impact of diabetes through patient report of treatment satisfaction, productivity and symptom experience. Qual Life Res. 2006;15(3):481–91.PubMedCrossRefGoogle Scholar
  31. 31.
    Abraham L, Hareendran A, Mills IW, Martin ML, Abrams P, Drake MJ, MacDonagh RP, Noble JG. Development and validation of a quality-of-life measure for men with nocturia. Urology. 2004;63(3):481–6.PubMedCrossRefGoogle Scholar
  32. 32.
    Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999;79(4):371–83.PubMedGoogle Scholar
  33. 33.
    Hatt SR, Leske DA, Bradley EA, Cole SR, Holmes JM. Development of a quality-of-life questionnaire for adults with strabismus. Ophthalmology. 2009;116(1):139–44.PubMedCrossRefGoogle Scholar
  34. 34.
    Lee H, Nicholson LL, Adams RD, Maher CG, Halaki M, Bae SS. Development and psychometric testing of Korean language versions of 4 neck pain and disability questionnaires. Spine (Phila Pa 1976). 2006;31(16):1841–5.CrossRefGoogle Scholar
  35. 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
  36. 36.
    Lohr KN. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res. 2002;11(3):193–205.CrossRefGoogle Scholar
  37. 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
  38. 38.
    Nickerson CA. Assessing convergent validity of health-state utilities obtained using different scaling methods. Med Decis Making. 1999;19(4):487–98.PubMedCrossRefGoogle Scholar
  39. 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
  40. 40.
    Gorsuch RL. Exploratory factor analysis: its role in item analysis. J Pers Assess. 1997;68(3):532–60.PubMedCrossRefGoogle Scholar
  41. 41.
    Watson R. Publishing the results of factor analysis: interpretation and presentation. J Adv Nurs. 1998;28(6):1361–3.PubMedCrossRefGoogle Scholar
  42. 42.
    Arai K, Yokoyama H, Okuguchi F, Yamazaki K, Takagi H, Hirao K. Association between body mass index and core components of metabolic syndrome in 1486 patients with type 1 diabetes mellitus in Japan (JDDM 13). Endocr J. 2008;55(6):1025–32.PubMedCrossRefGoogle Scholar
  43. 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

Copyright information

© The Japan Diabetes Society 2011

Authors and Affiliations

  • Nobuyo Hatanaka
    • 1
  • Morihito Takita
    • 1
    • 2
  • Takuhiro Yamaguchi
    • 3
  • Masahiro Kami
    • 1
  • Shinichi Matsumoto
    • 1
    • 2
  1. 1.Division of Social Communication System for Advanced Clinical Research, The Institute of Medical ScienceThe University of TokyoTokyoJapan
  2. 2.Islet Cell LaboratoryBaylor Research Institute Fort Worth CampusFort WorthUSA
  3. 3.BiostatisticsTohoku University Graduate School of MedicineSendaiJapan

Personalised recommendations