Skip to main content
SpringerLink
Log in

Measuring Patient-Reported Outcomes in Solid Organ Transplant Recipients

An Overview of Instruments Developed to Date

  • Leading Article
  • Published:
PharmacoEconomics Aims and scope Submit manuscript

Abstract

Improvements in organ preservation methods, immunosuppressive regimens and general post-transplant care have resulted in an increased life expectancy and a continually decreasing morbidity after solid organ transplantation. As attention gradually moves towards improving subjective patient outcomes, the use of patient-reported outcome measures (PROs) thus becomes increasingly important in post-transplant patient management.

This paper provides a brief systematic overview of the transplant-specific PRO measures, and their psychometric properties, developed and used in solid organ transplant recipients to date.

PRO measures may focus on or encompass different aspects of life relevant to organ transplant patients: overall quality of life (QOL), physical, psychological and social functioning, and adherence. Overall QOL can be measured using transplant-specific or generic QOL instruments, or a combination of both.

In general, very little information is available on the psychometric properties of PRO measures, and there is no gold standard for PRO measurement. Transplant-specific and generic PRO instruments are complementary. Generic instruments will continue to be important for economic evaluations, but transplant-specific instruments may be more useful for patient management purposes, as they are generally more sensitive to small but clinically relevant changes in outcomes in transplant populations.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I
Table II
Table III
Table IV
Table V

Similar content being viewed by others

References

  1. Adam R, McMaster P, O’Grady JG, et al. Evolution of liver transplantation in Europe: report of the European Liver Transplant Registry. Liver Transpl 2003; 9 (12): 1231–1243

    Article  PubMed  Google Scholar 

  2. Butler J, Khadim G, Paul KM, et al. Selection of patients for heart transplantation in the current era of heart failure therapy. J Am Coll Cardiol 2004; 43 (5): 787–793

    Article  PubMed  Google Scholar 

  3. Kirklin JK, McGiffin DC, Pinderski LJ, et al. Selection of patients and techniques of heart transplantation. Surg Clin North Am 2004; 84 (1): 257–xii

    Article  PubMed  Google Scholar 

  4. Taylor DO, Edwards LB, Boucek MM, et al. The Registry of the International Society for Heart and Lung Transplantation: twenty-first official adult heart transplant report 2004. J Heart Lung Transplant 2004; 23 (7): 796–803

    Article  PubMed  Google Scholar 

  5. Trulock EP, Edwards LB, Taylor DO, et al. The Registry of the International Society for Heart and Lung Transplantation: twenty-first official adult lung and heart-lung transplant report 2004. J Heart Lung Transplant 2004; 23 (7): 804–815

    Article  PubMed  Google Scholar 

  6. Eurotransplant International Foundation. Eurotransplant International Foundation annual report 2005. Leiden, The Netherlands: Eurotransplant International Foundation, 2005 [online]. Available from URL: http://www.eurotransplant.nl/files/annual_report/AR2005_def.pdf [Accessed 2007 Mar 7]

    Google Scholar 

  7. Chan C, Maurer J, Cardella C, et al. A randomized controlled trial of verapamil on cyclosporine nephrotoxicity in heart and lung transplant recipients. Transplantation 1997; 63 (10): 1435–1440

    Article  PubMed  CAS  Google Scholar 

  8. Eisen HJ, Tuzcu EM, Dorent R, et al. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med 2003; 349 (9): 847–858

    Article  PubMed  CAS  Google Scholar 

  9. Andreassen AK, Hartmann A, Offstad J, et al. Hypertension prophylaxis with omega-3 fatty acids in heart transplant recipients. J Am Coll Cardiol 1997; 29 (6): 1324–1331

    Article  PubMed  CAS  Google Scholar 

  10. Holm T, Andreassen AK, Aukrust P, et al. Omega-3 fatty acids improve blood pressure control and preserve renal function in hypertensive heart transplant recipients. Eur Heart J 2001; 22 (5): 428–436

    Article  PubMed  CAS  Google Scholar 

  11. Pethig K, Heublein B, Wahlers T, et al. Mycophenolate mofetil for secondary prevention of cardiac allograft vasculopathy: influence on inflammation and progression of intimal hyperplasia. J Heart Lung Transplant 2004; 23 (1): 61–66

    Article  PubMed  Google Scholar 

  12. Vivekananthan K, Kalapura T, Mehra M, et al. Usefulness of the combined index of systolic and diastolic myocardial performance to identify cardiac allograft rejection. Am J Cardiol 2002; 90 (5): 517–520

    Article  PubMed  Google Scholar 

  13. Institute of Medicine, Committee on Health and Behavior: Research, Practice and Policy, Board on Neuroscience and Behavioral Health. Health and behavior: the interplay of biological, behavioral and societal influences. Washington, DC, National Academy Press, 2001 [online]. Available from URL: http://books.nap.edu/openbook.php?record_id=9838&page=r1 [Accessed 2007 Mar 7]

    Google Scholar 

  14. Frasure-Smith N, Lesperance F, Talajic M. Depression following myocardial infarction: impact on 6-month survival. JAMA 1993; 270 (15): 1819–1825

    Article  PubMed  CAS  Google Scholar 

  15. World Health Organization. Innovative care for chronic conditions: building blocks for action. Geneva: World Health Organization, 2002

    Google Scholar 

  16. Yusuf S, Hawken S, Ounpuu S, et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet 2004; 364 (9438): 937–952

    Article  PubMed  Google Scholar 

  17. Scientific Advisory Committee of the Medical Outcomes Trust. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res 2002; 11 (3): 193–205

    Article  Google Scholar 

  18. Joseph JT, Baines LS, Morris MC, et al. Quality of life after kidney and pancreas transplantation: a review. Am J Kidney Dis 2003; 42 (3): 431–445

    Article  PubMed  Google Scholar 

  19. Rodes J, Navasa M. Liver transplantation and quality of life. Can J Gastroenterol 2000; 14 (8): 693–699

    PubMed  CAS  Google Scholar 

  20. De Geest S, Dobbels F, Fluri C, et al. Adherence to the therapeutic regimen in heart, lung, and heart-lung transplant recipients. J Cardiovasc Nurs 2005; 20 (5 Suppl.): S88–S98

    PubMed  Google Scholar 

  21. Cupples SA, Stilley CS. Cognitive function in adult cardiothoracic transplant candidates and recipients. J Cardiovasc Nurs 2005; 20 (5 Suppl.): S74–S87

    PubMed  Google Scholar 

  22. Acquadro C, Berzon R, Dubois D, et al. Incorporating the patient’s perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health 2003; 6 (5): 522–531

    Article  PubMed  Google Scholar 

  23. Szende A, Leidy NK, Revicki D. Health-related quality of life and other patient-reported outcomes in the European centralized drug regulatory process: a review of guidance documents and performed authorizations of medicinal products 1995 to 2003. Value Health 2005; 8 (5): 534–548

    Article  PubMed  Google Scholar 

  24. Cupples S, Dew MA, Grady KL, et al. Report of the Psychosocial Outcomes Workgroup of the Nursing and Social Sciences Council of the International Society for Heart and Lung Transplantation: present status of research on psychosocial outcomes in cardiothoracic transplantation. Review and recommendations for the field. J Heart Lung Transplant 2006; 25 (6): 716–725

    Article  PubMed  Google Scholar 

  25. Grady KL, Lanuza DM. Physical functional outcomes after cardiothoracic transplantation. J Cardiovasc Nurs 2005; 20 (5 Suppl.): S43–S50

    PubMed  Google Scholar 

  26. Hathaway D, Winsett R, Prendergast M, et al. The first report from the patient outcomes registry for transplant effects on life (PORTEL): differences in side-effects and quality of life by organ type, time since transplant and immunosuppressive regimens. Clin Transplant 2003; 17 (3): 183–194

    Article  PubMed  Google Scholar 

  27. Hricik DE, Halbert RJ, Barr ML, et al. Life satisfaction in renal transplant recipients: preliminary results from the transplant learning center. Am J Kidney Dis 2001; 38 (3): 580–587

    Article  PubMed  CAS  Google Scholar 

  28. Matas AJ, Halbert RJ, Barr ML, et al. Life satisfaction and adverse effects in renal transplant recipients: a longitudinal analysis. Clin Transplant 2002; 16 (2): 113–121

    Article  PubMed  Google Scholar 

  29. Siegal B, Halbert RJ, McGuire MJ. Life satisfaction among kidney transplant recipients: demographic and biological factors. Prog Transplant 2002; 12 (4): 293–298

    PubMed  Google Scholar 

  30. Napolitano MA. Development of a pulmonary-specific quality of life scale (PQLS). Ann Behav Med 1999; 21: S168

    Google Scholar 

  31. Napolitano MA, Babyak MA, Palmer S, et al. Effects of a telephone-based psychosocial intervention for patients awaiting lung transplantation. Chest 2002; 122 (4): 1176–1184

    Article  PubMed  Google Scholar 

  32. Jones PW, Quirk FH, Baveystock CM. The St George’s Respiratory Questionnaire. Respir Med 1991; 85 Suppl. B: 25–31

    Article  PubMed  Google Scholar 

  33. Younossi ZM, McCormick M, Price LL, et al. Impact of liver transplantation on health-related quality of life. Liver Transpl 2000; 6 (6): 779–783

    Article  PubMed  CAS  Google Scholar 

  34. Belle SH, Porayko MK, Hoofnagle JH, et al. Changes in quality of life after liver transplantation among adults. Liver Transpl Surg 1997; 3 (2): 93–104

    Article  PubMed  CAS  Google Scholar 

  35. Barotfi S, Molnar MZ, Almasi C, et al. Validation of the Kidney Disease Quality of Life-Short Form questionnaire in kidney transplant patients. J Psychosom Res 2006; 60 (5): 495–504

    Article  PubMed  Google Scholar 

  36. Kim WR, Lindor KD, Malinchoc M, et al. Reliability and validity of the NIDDK-QA instrument in the assessment of quality of life in ambulatory patients with cholestatic liver disease. Hepatology 2000; 32 (5): 924–929

    Article  PubMed  CAS  Google Scholar 

  37. Laupacis A, Pus N, Muirhead N, et al. Disease-specific questionnaire for patients with a renal transplant. Nephron 1993; 64 (2): 226–231

    Article  PubMed  CAS  Google Scholar 

  38. Park H, Bang WR, Kim SJ, et al. Quality of life of ESRD patients: development of a tool and comparison between transplant and dialysis patients. Transplant Proc 1992; 24 (4): 1435–1437

    PubMed  CAS  Google Scholar 

  39. Younossi ZM, Guyatt G, Kiwi M, et al. Development of a disease specific questionnaire to measure health related quality of life in patients with chronic liver disease. Gut 1999; 45 (2): 295–300

    Article  PubMed  CAS  Google Scholar 

  40. Ferrer M, Cordoba J, Garin O, et al. Validity of the Spanish version of the Chronic Liver Disease Questionnaire (CLDQ) as a standard outcome for quality of life assessment. Liver Transpl 2006; 12 (1): 95–104

    Article  PubMed  Google Scholar 

  41. Hays RD, Kallich JD, Mapes DL, et al. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res 1994; 3 (5): 329–338

    Article  PubMed  CAS  Google Scholar 

  42. Karam V, Castaing D, Danet C, et al. Longitudinal prospective evaluation of quality of life in adult patients before and one year after liver transplantation. Liver Transpl 2003; 9 (7): 703–711

    Article  PubMed  Google Scholar 

  43. Karam VH, Gasquet I, Delvart V, et al. Quality of life in adult survivors beyond 10 years after liver, kidney, and heart transplantation. Transplantation 2003; 76 (12): 1699–1704

    Article  PubMed  Google Scholar 

  44. Jacobs RJ, Pescovitz MD, Brook B, et al. A self-administered quality of life questionnaire for renal transplant recipients. Nephron 1998; 79 (1): 123–124

    Article  PubMed  CAS  Google Scholar 

  45. Rebollo P, Ortega F, Ortega T, et al. Spanish validation of the “kidney transplant questionnaire”: a useful instrument for assessing health related quality of life in kidney transplant patients. Health Qual Life Outcomes 2003; 1 (1): 56

    Article  PubMed  Google Scholar 

  46. MacNaughton KL, Rodrigue JR, Cicale M, et al. Health-related quality of life and symptom frequency before and after lung transplantation. Clin Transplant 1998; 12 (4): 320–323

    PubMed  CAS  Google Scholar 

  47. Moons P, De Geest S, Versteven K, et al. Psychometric properties of the “Modified Transplant Symptom Occurrence and Symptom Distress Scale”. J Nurs Meas 2001; 9 (2): 115–134

    PubMed  CAS  Google Scholar 

  48. Moons P, Vanrenterghem Y, Van Hooff JP, et al. Health-related quality of life and symptom experience in tacrolimus-based regimens after renal transplantation: a multicentre study. Transpl Int 2003; 16 (9): 653–664

    Article  PubMed  Google Scholar 

  49. Winsett RP, Arheart K, Stratta RJ, et al. Evaluation of an immunosuppressant side effect instrument. Prog Transplant 2004; 14 (3): 210–216, 40

    PubMed  Google Scholar 

  50. Matthees BJ, Anantachoti P, Kreitzer MJ, et al. Use of complementary therapies, adherence, and quality of life in lung transplant recipients. Heart Lung 2001; 30 (4): 258–268

    Article  PubMed  CAS  Google Scholar 

  51. De Vito DA, Hoffman LA, Dauber JH, et al. Evaluating the reliability and validity of the Questionnaire for Lung Transplant Patients. Prog Transplant 2002; 12 (3): 191–198

    Google Scholar 

  52. De Vito DA, Kim Y, Vensak J, et al. Validation and refinement of the Questionnaire for Lung Transplant Patients. Prog Transplant 2004; 14 (4): 338–345

    Google Scholar 

  53. Unal G, de Boer JB, Borsboom GJ, et al. A psychometric comparison of health-related quality of life measures in chronic liver disease. J Clin Epidemiol 2001; 54 (6): 587–596

    Article  PubMed  CAS  Google Scholar 

  54. Franke GH, Reimer J, Kohnle M, et al. Quality of life in end-stage renal disease patients after successful kidney transplantation: development of the ESRD symptom checklist. Transplantation module. Nephron 1999; 83 (1): 31–39

    Article  PubMed  CAS  Google Scholar 

  55. Grady KL, Jalowiec A, Grusk BB, et al. Symptom distress in cardiac transplant candidates. Heart Lung 1992; 21 (5): 434–439

    PubMed  CAS  Google Scholar 

  56. Leventhal H, Johnson JE. Laboratory and field experimentation: development of a theory of self-regulation. In: Wooldridge PJ, Schmitt MH, Skipper JK, editors. Behavioral science and nursing theory. St. Louis (MO): CV Mosby, 1983: 189–262

    Google Scholar 

  57. Rhodes VA, Watson PM. Symptom distress: the concept. Past and present. Semin Oncol Nurs 1987; 3 (4): 242–247

    Article  PubMed  CAS  Google Scholar 

  58. De Geest S, Moons P. The patient’s appraisal of side-effects: the blind spot in quality-of-life assessments in transplant recipients. Nephrol Dial Transplant 2000; 15 (4): 457–459

    Article  PubMed  Google Scholar 

  59. Jalowiec A, Grady KL, White-Williams C, et al. Symptom distress three months after heart transplantation. J Heart Lung Transplant 1997; 16 (6): 604–614

    PubMed  CAS  Google Scholar 

  60. Grady KL, Jalowiec A, White-Williams C. Patient compliance at one year and two years after heart transplantation. J Heart Lung Transplant 1998; 17 (4): 383–394

    PubMed  CAS  Google Scholar 

  61. Ziegelmann JP, Griva K, Hankins M, et al. The Transplant Effects Questionnaire (TxEQ): the development of a questionnaire for assessing the multidimensional outcome of organ transplantation. Example of end stage renal disease (ESRD). Br J Health Psychol 2002; 7 (Pt 4): 393–408

    Article  PubMed  Google Scholar 

  62. Griva K, Ziegelmann JP, Thompson D, et al. Quality of life and emotional responses in cadaver and living related renal transplant recipients. Nephrol Dial Transplant 2002; 17 (12): 2204–2211

    Article  PubMed  Google Scholar 

  63. Jalowiec A, Grady KL, White-Williams C. Stressors in patients awaiting a heart transplant. Behav Med 1994; 19 (4): 145–154

    Article  PubMed  CAS  Google Scholar 

  64. Kong IL, Molassiotis A. Quality of life, coping and concerns in Chinese patients after renal transplantation. Int J Nurs Stud 1999; 36 (4): 313–322

    Article  PubMed  CAS  Google Scholar 

  65. Weinert C, Tilden VP. Measures of social support: assessment of validity. Nurs Res 1990; 39 (4): 212–216

    Article  PubMed  CAS  Google Scholar 

  66. Weinert C. A social support measure: PRQ85. Nurs Res 1987; 36 (5): 273–277

    Article  PubMed  CAS  Google Scholar 

  67. Brandt PA, Weinert C. The PRQ: a social support measure. Nurs Res 1981; 30 (5): 277–280

    Article  PubMed  CAS  Google Scholar 

  68. Greenstein S, Siegal B. Compliance and noncompliance in patients with a functioning renal transplant: a multicenter study. Transplantation 1998; 66 (12): 1718–1726

    Article  PubMed  CAS  Google Scholar 

  69. Chisholm MA, Lance CE, Williamson GM, et al. Development and validation of the immunosuppressant therapy adherence instrument (ITAS). Patient Educ Couns 2005; 59 (1): 13–20

    Article  PubMed  Google Scholar 

  70. Glass TR, De Geest S, Weber R, et al. Correlates of self-reported nonadherence to antiretroviral therapy in HIV-infected patients: the Swiss HIV Cohort Study. J Acquir Immune Defic Syndr 2006 Mar; 41 (3): 385–392

    Article  PubMed  Google Scholar 

  71. Chisholm MA, Lance CE, Williamson GM, et al. Development and validation of an immunosuppressant therapy adherence barrier instrument. Nephrol Dial Transplant 2005; 20 (1): 1818

    Article  Google Scholar 

  72. De Geest S, Abraham I, Moons P, et al. Late acute rejection and subclinical noncompliance with cyclosporine therapy in heart transplant recipients. J Heart Lung Transplant 1998; 17 (9): 854–863

    PubMed  Google Scholar 

  73. Schafer-keller P, Steiger J, Denhaerynck K, et al. Using electronic monitoring as reference standard: how well do state of measurement methods measure medication adherence in kidney transplant recipients? American Transplant Congress. Am J Transplant 2005; 5: s331

    Google Scholar 

  74. Walsh JC, Mandalia S, Gazzard BG. Responses to a 1 month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. AIDS 2002; 16 (2): 269–277

    Article  PubMed  Google Scholar 

  75. Feurer ID, Moore DE, Speroff T, et al. Refining a health-related quality of life assessment strategy for solid organ transplant patients. Clin Transplant 2004; 18 Suppl. 12: 39–45

    Article  PubMed  Google Scholar 

  76. Grady KL, Jalowiec A, White-Williams C, et al. Heart transplant candidates’ perception of helpfulness of health care provider interventions. Cardiovasc Nurs 1993; 29 (5): 33–37

    PubMed  CAS  Google Scholar 

  77. US Food and Drug Administration, Department of Health and Human Services. Guidance for industry: patient-reported outcome measures. Use in medical product development to support labeling claims: draft guidance [online]. Available from URL: http://www.fda.gov/cder/guidance/5460dft.pdf [Accessed 2007 Mar 7]

  78. Tell GS, Mittelmark MB, Hylander B, et al. Social support and health-related quality of life in black and white dialysis patients. ANNA J 1995; 22 (3): 301–308; discussion 9–10

    PubMed  CAS  Google Scholar 

  79. Shidler NR, Peterson RA, Kimmel PL. Quality of life and psychosocial relationships in patients with chronic renal insufficiency. Am J Kidney Dis 1998; 32 (4): 557–566

    Article  PubMed  CAS  Google Scholar 

  80. Payne JL, Feurer ID, Pinson CW. Quality of life as part of outcomes analysis in solid organ transplantation. Inside Case Management 2001; 8 (5): 9–11

    Google Scholar 

  81. Cowling T, Jennings LW, Goldstein RM, et al. Liver transplantation and health-related quality of life: scoring differences between men and women. Liver Transpl 2004; 10 (1): 88–96

    Article  PubMed  Google Scholar 

  82. Cowling T, Jennings LW, Jung GS, et al. Comparing quality of life following liver transplantation for Laennec’s versus non-Laennec’s patients. Clin Transplant 2000; 14 (2): 115–120

    Article  PubMed  CAS  Google Scholar 

  83. Whiting JF. Standards for economic and quality of life studies in transplantation. Transplantation 2000; 70 (7): 1115–1121

    Article  PubMed  CAS  Google Scholar 

  84. Younossi ZM, Guyatt G. Quality-of-life assessments and chronic liver disease. Am J Gastroenterol 1998; 93 (7): 1037–1041

    Article  PubMed  CAS  Google Scholar 

  85. Greenstein SM, Siegal B. Postrenal transplant health beliefs and ethnicity: the Compliance Study Group. Transplant Proc 1997; 29 (8): 3741–3742

    Article  PubMed  CAS  Google Scholar 

  86. Bandura A. The explanatory and predictive scope of self-efficacy theory. J Clinical Soc Psychol 1986; 4: 359–373

    Article  Google Scholar 

Download references

Acknowledgements

The authors received no funding for the preparation of this article and have no conflicts of interest to declare that are relevant to this article.

Author information

Authors and Affiliations

  1. Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium

    Irina Cleemput

  2. Centre for Health Services and Nursing Research (CZV), Katholieke Universiteit Leuven, Leuven, Belgium

    Fabienne Dobbels

Authors
  1. Irina Cleemput
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Fabienne Dobbels
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Irina Cleemput.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Cleemput, I., Dobbels, F. Measuring Patient-Reported Outcomes in Solid Organ Transplant Recipients. Pharmacoeconomics 25, 269–286 (2007). https://doi.org/10.2165/00019053-200725040-00002

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00019053-200725040-00002

Keywords

Search

Navigation