title: 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.
abstract: BACKGROUND
  Post-transplant patient quality of life (QOL) is affected by a number of different factors. A nationwide patient registry has been established to evaluate QOL and determine the effects of transplant and immunosuppressive regimens on patient outcomes.
  
  
  METHODS
  Patients were contacted directly at national meetings, through transplant centers, and patient support groups and invited to participate in the registry. All transplant patients aged 16 and over were eligible to enroll. Patients completed a 100-item self-administered questionnaire consisting of questions about patient demographics, organ functioning, and other post-transplant outcomes. General QOL was measured by the Short form - 12 (SF-12). The Memphis Survey, an instrument developed and psychometrically validated at the University of Tennessee, was administered to patients to evaluate side-effects associated with immunosuppression. Data were analyzed from the first 722 patients who entered the registry. Side-effect profile and QOL outcomes were evaluated by organ type, time since transplant and immunosuppressive regimen. Multiple regression analyses were conducted to determine predictors of post-transplant QOL.
  
  
  RESULTS
  When outcomes were analyzed by organ type, there were no differences in SF-12 or total weighted Memphis scores. Analysis by time since transplant demonstrated that side-effects in the mobility domain increased with patient age and time since transplant. Analysis by immunosuppressive regimen focused on cyclosporine and tacrolimus-based regimens congruent with similar classifications reported in previous studies (Pirsch JD et al. Transplantation 1997: 63: 977, Shield CF III et al. Transplantation 1997: 64: 1738). When analyzed by regimen, there were no differences between the groups in terms of patients reporting good to excellent organ function, treatment for rejection, infection, and over-immunosuppression. Statistically significant differences were observed when side-effect profile was analyzed by immunosuppressive regimen. Patients on cyclosporine-based regimens reported greater overall side-effect severity and more problems with mobility and life roles. Cyclosporine patients also reported more problems in the miscellaneous subscale, including high blood pressure, enlarged gums and hair growth, but less trouble with trembling hands. Multiple stepwise regression models identified several side-effect subscales as having profound effects on mental and physical QOL.
  
  
  CONCLUSIONS
  Transplant recipients report good to excellent levels of QOL, however, side-effects associated with immunosuppressive regimens impair post-transplant QOL. Problems in certain domains, such as mobility, are found to increase with time since transplant. Tacrolimus-based regimens are associated with fewer and less severe side-effects than cyclosporine-based regimens in key domains that affect post-transplant QOL.
authors.affiliation: College of Nursing, University of Tennessee Health Science Center, Memphis, TN 38163, USA. dhathaway@utmem.edu
authors.forename: Donna
authors.initials: D
authors.lastname: Hathaway
authors.forename: Rebecca
authors.initials: R
authors.lastname: Winsett
authors.forename: Mary
authors.initials: M
authors.lastname: Prendergast
authors.forename: Indu
authors.initials: I
authors.lastname: Subaiya
mesh_terms: D000203:Activities of Daily Living; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use; D003625:Data Collection; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016377:Organ Transplantation / Q000523:psychology*; D011788:Quality of Life; D012042:Registries / Q000706:statistics & numerical data*; D012044:Regression Analysis; D011795:Surveys and Questionnaires; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus