Introduction
Materials and methods
Data sources
Participants
Measures
Socio-demographic characteristics
Medical characteristics
-
Difficulty to respect the immunosuppressant schedule
-
Modification of immunosuppressive therapy
-
Modification of the dosage of treatments (other than immunosuppressive therapy drugs)
Health-related quality of life
Data collection procedures
Ethical aspects
Statistical analysis
Results
Socio-demographic characteristics
n | % | |
---|---|---|
Male | 656 | 61.8% |
Age, years (mean ± SD) | 55.2 ± 12.4 | |
Level of education
| ||
Primary or less | 260 | 25.8% |
Secondary 1st stage (college & high school) | 483 | 48% |
Higher than secondary, 2nd stage or university | 264 | 26.2% |
Living arrangement
| ||
Live alone | 186 | 19.2% |
Employment status
| ||
Employed | 377 | 35.5% |
Unemployed | 566 | 33.1% |
Retired | 118 | 31.4% |
Medical characteristics
n | % | ||
---|---|---|---|
Medical characteristics
| Cadaveric donor transplantation | 1035 | 97.5% |
Duration of transplantation, years | 8.5 ± 5.8 | ||
Patients with rejection since renal transplant | 222 | 22.9% | |
Major causes of ESRD
| |||
Chronic glomerular nephritis | 380 | 35.8% | |
Interstitial nephropathy | 122 | 11.5% | |
Hereditary nephropathy | 206 | 19.4% | |
Duration of dialysis, months (mean ± SD) | 31.3 ± 37.2 | ||
Intercurrent health events in the last four weeks
|
245
|
23.2%
| |
Hospitalization | 111 | 11.1% | |
Critical illness | 47 | 4.7% | |
Infectious disease | 123 | 13.7% | |
Acute rejection episodes | 42 | 4.0% | |
Graft surgery | 17 | 1.9% | |
Comorbidities
| |||
Hypertension | 844 | 80.9% | |
BMI > 30 (kg/m2) | 140 | 13.4% | |
Diabetes mellitus | 133 | 12.9% | |
Current smokers | 122 | 11.8% | |
Treatments, compliance and side
| Side effects | 838 | 79% |
Mean number of side effects per patient | 5.7 ±3.9 | ||
Range | (1–17) | ||
Mean number of drugs per patient | 5.1 ±3.1 | ||
Immunosuppressive treatment
| |||
Calcineurin inhibitors | 956 | 90.6% | |
Corticosteroids | 593 | 56.2% | |
Antimetabolites | 769 | 72.9% | |
Proliferation inhibitors | 53 | 5.0% | |
Monotherapy | 109 | 10.3% | |
Bitherapy | 564 | 53.5% | |
Tritherapy | 378 | 35.8% | |
Other treatment
| |||
Antihypertensive drugs | 890 | 84.4% | |
Hypolipidemics | 540 | 51.2% | |
Antidiabetic agents | 100 | 9.5% | |
Non-compliant to treatment | 239 | 22.5% | |
Side effects related to:
| |||
General health | 548 | 51.6% | |
Mental health | 467 | 44.0% | |
Body modification | 771 | 72.7% | |
Sexual disorders | 288 | 27.1% | |
Diarrhea | 216 | 20.4% |
Treatment
Health related quality of life
Dimensions | Means ± SD |
---|---|
S F - 3 6
| |
Physical Functioning- PF | 74.8 ± 24.3 |
Social Functioning- SF | 74.9 ± 23.6 |
Role Physical- RP | 64.4 ± 41.3 |
Role Emotional- RE | 68.8 ± 41.3 |
Mental Health | 65.5 ± 18.7 |
Vitality- VT | 53.3 ± 19.3 |
Bodily Pain- BP | 68.3 ± 25.8 |
General Heath- GH | 55.4 ± 21 |
Physical Component Summary- PCS | 45.8 ± 9.7 |
Mental Component Summary- MCS | 46.0 ± 10.5 |
R e T r a n s Q o l
| |
Physical Health - PH | 63.8 ± 17.4 |
Mental Health - MH | 72.6 ± 16.7 |
Medical Care - MC | 75.0 ± 14.9 |
Fear of losing the Graft - FG | 58.4 ± 20.4 |
Treatment - TRT | 70.7 ± 13.9 |
Variables included the final regression model for both HRQOL questionnaires
Dimensions | Variables | β coeff. | 95% CI | P values |
---|---|---|---|---|
PF R2 = 0.31 | Intercept | 95.4 | [91.1; 99.6] | p < .0001 |
Female | -4.7 | [-7.6; -1.7] | p < 0.0018 | |
Age ≥ 75 years | -23.3 | [-30.4; -16.2] | p < .0001 | |
Low educational (primary or less) | -7.5 | [-11.2; -3.8] | p < .0001 | |
Unemployment | -6.3 | [-9.4; -3.2] | p < .0001 | |
BMI > 30 (kg/m2) | -5.8 | [-10; -1.6] | p < 0.0065 | |
Critical illness in the last 4 weeks | -8.0 | [-14.9; -1.1] | p < 0.0237 | |
Diabetes | -5.6 | [-10.1; -1] | p < 0.0163 | |
Side effects related to general health | -17.0 | [-20.9; -13.1] | p < .0001 | |
Side effects related to mental health | -6.8 | [-10.5; -3] | p < 0.0004 | |
Recent surgery | -9.5 | [-24.9; 6] | p < 0.2283 | |
Infectious disease in the last 4 weeks | -4.8 | [-9.1; -0.4] | p < 0.0311 | |
RP R2 = 0.22 | Intercept | 90.5 | [82.8; 98.1] | p < .0001 |
Female | -6.9 | [-12.2; -1.6] | p < 0.0104 | |
Age ≥ 75 years | -20.1 | [-33.1; -7] | p < 0.0026 | |
Low educational (primary or less) | -11.4 | [-18; -4.8] | p < 0.0007 | |
Hospitalization in the last 4 weeks | -17.9 | [-27.1; -8.8] | p < 0.0001 | |
Critical illness in the last 4 weeks | -31.5 | [-44.8; -18.1] | p < .0001 | |
Infectious disease in the last 4 weeks | -10.9 | [-19; -2.9] | p < 0.0080 | |
Side effects related to general health | -21.5 | [-28.7; -14.3] | p < .0001 | |
Side effects related to mental health | -16.0 | [-22.8; -9.1] | p < .0001 | |
BP R2 = 0.23 | Intercept | 85.3 | [80.6; 90] | p < .0001 |
Female | -4.9 | [-8.1; -1.6] | p < 0.0035 | |
Age ≥ 75 years | -8.3 | [-16.1; -0.4] | p < 0.0402 | |
Low educational (primary or less) | -6.5 | [-10.5; -2.5] | p < 0.0016 | |
Infectious disease in the last 4 weeks | -9.1 | [-14; -4.3] | p < 0.0002 | |
Side effects related to general health | -18.7 | [-23.2; -14.2] | p < .0001 | |
Side effects related to mental health | -9.7 | [-14; -5.4] | p < .0001 | |
Side effects related to body modification | -4.2 | [-7.7; -0.7] | p < 0.0193 | |
MH R2 = 0.24 | Intercept | 81.1 | [77.7; 84.6] | p < .0001 |
Female | -5.6 | [-8; -3.3] | p < .0001 | |
Family status (living alone) | -4.6 | [-7.2; -1.9] | p < 0.0007 | |
Duration of dialysis > 3 years | -3.3 | [-5.8; -0.8] | p < 0.0087 | |
Hospitalization in the last 4 weeks | -7.7 | [-11.4; -4] | p < .0001 | |
Side effects related to mental health | -16.5 | [-19.5; -13.5] | p < .0001 | |
Side effects related to body modification | -4.4 | [-6.9; -1.9] | p < 0.0005 | |
RE R2 = 0.18 | Intercept | 94.8 | [86.5; 103] | p < .0001 |
Female | -6.4 | [-12; -0.8] | p < 0.0252 | |
Low educational (primary or less) | -16.8 | [-24; -9.6] | p < .0001 | |
Age ≥ 75 years | -11.1 | [-25.3; 3.2] | p < 0.1285 | |
Family status (living alone) | -9.1 | [-15.3; -2.8] | p < 0.0045 | |
Hospitalization in the last 4 weeks | -17.4 | [-26.7; -8.1] | p < 0.0003 | |
Infectious disease in the last 4 weeks | -19.1 | [-27.6; -10.7] | p < .0001 | |
Side effects related to mental health | -25.0 | [-32; -18.1] | p < .0001 | |
SF R2 = 0.25 | Intercept | 90.8 | [86.8; 94.8] | p < .0001 |
Female | -4.9 | [-7.6; -2.1] | p < 0.0006 | |
Family status (living alone) | -4.6 | [-7.8; -1.5] | p < 0.0036 | |
Hospitalization in the last 4 weeks | -11.8 | [-16.2; -7.3] | p < .0001 | |
Infectious disease in the last 4 weeks | -7.2 | [-11.5; -2.9] | p < 0.0011 | |
Diabetes | -7.5 | [-11.5; -3.5] | p < 0.0002 | |
Side effects related to general health | -11.3 | [-15; -7.6] | p < .0001 | |
Side effects related to mental health | -16.4 | [-20; -12.8] | p < .0001 | |
VT R2 = 0.22 | Intercept | 62.8 | [59.6; 66.1] | p < .0001 |
Female | -2.4 | [-4.6; -0.1] | p < 0.0366 | |
Hospitalization in the last 4 weeks | -8.3 | [-11.8; -4.8] | p < .0001 | |
Side effects related to general health | -12 | [-15; -8.9] | p < .0001 | |
Side effects related to mental health | -11.7 | [-14.8; -8.7] | p < .0001 | |
Side effects related to body modification | -3.9 | [-6.3; -1.4] | p < 0.0020 | |
GH R2 = 0.18 | Intercept | 63.8 | [62.1; 65.5] | p < .0001 |
Hospitalization in the last 4 weeks | -6.1 | [-10.2; -2] | p < 0.0038 | |
Critical illness in the last 4 weeks | -7.1 | [-13.5; -0.7] | p < 0.0305 | |
Diabetes | -5.4 | [-9; -1.7] | p < 0.0038 | |
Side effects related to general health | -11.6 | [-15.1; -8.1] | p < .0001 | |
Side effects related to mental health | -7.7 | [-11.1; -4.2] | p < .0001 | |
Side effects related to body modification | -5.6 | [-8.4; -2.9] | p < .0001 | |
Non-compliant | -6.3 | [-9.2; -3.4] | p < .0001 | |
PCS (R2 = 0.28) | Intercept | 52.7 | [50.9; 54.5] | p < .0001 |
Female | -1.7 | [-3; -0.4] | p < 0.0084 | |
Age ≥ 75 years | -7.7 | [-11; -4.3] | p < .0001 | |
Low educational (primary or less) | -3.3 | [-4.9; -1.7] | p < .0001 | |
Unemployment | -2.5 | [-3.8; -1.1] | p < 0.0003 | |
Critical illness in the last 4 weeks | -5.7 | [-8.8; -2.6] | p < 0.0003 | |
Infectious disease in the last 4 weeks | -3.2 | [-5.1; -1.3] | p < 0.0012 | |
Side effects related to general health | -9.2 | [-10.8; -7.5] | p < .0001 | |
MCS (R2 = 0.22) | Intercept | 52.1 | [50.3; 54] | p < .0001 |
Female | -1.7 | [-3; -0.4] | p < 0.0113 | |
Family status (living alone) | -2.2 | [-3.7; -0.7] | p < 0.0039 | |
Hospitalization in the last 4 weeks | -5.7 | [-7.8; -3.6] | p < .0001 | |
Side effects related to body modification | -2.5 | [-3.9; -1.1] | p < 0.0005 | |
Side effects related to mental health | -9.3 | [-11; -7.7] | p < .0001 |
Dimensions | Variables | B coeff. | 95% CI | P values |
---|---|---|---|---|
PH R2 = 0.31 | Intercept | 78.2 | [75.2; 81.2] | p < .0001 |
Female | -2.5 | [-4.5; -0.5] | p < 0.0156 | |
Low educational (primary or less) | -7.3 | [-9.6; -5.1] | p < .0001 | |
BMI > 30 (kg/m2) | -4.6 | [-7.4; -1.7] | p < 0.0021 | |
Unemployment | -7.2 | [-9.4; -5.1] | p < .0001 | |
Duration of dialysis > 3 years | -2.5 | [-4.7; -0.4] | p < 0.0226 | |
Hospitalization in the last 4 weeks | -5.2 | [-8.6; -1.8] | p < 0.0029 | |
Critical illness in the last 4 weeks | -6 | [-10.6; -1.4] | p < 0.0110 | |
Side effects related to general health | -9.8 | [-12.5; -7] | p < .0001 | |
Side effects related to mental health | -6 | [-8.7; -3.3] | p < .0001 | |
Side effects related to body modification | -4.4 | [-6.6; -2.2] | p < .0001 | |
MH R2 = 0.27 | Intercept | 87 | [84.1; 89.9] | p < .0001 |
Female | -4.1 | [-6.1; -2.2] | p < .0001 | |
Family status (living alone) | -8.1 | [-10.3; -5.8] | p < .0001 | |
Dismissal | -3.7 | [-6.7; -0.7] | p < 0.0152 | |
Duration of dialysis > 3 years | -3.9 | [-5.9; -1.8] | p < 0.0003 | |
Hospitalization in the last 4 weeks | -5.1 | [-8.3; -2] | p < 0.0014 | |
Recent surgery | -10.3 | [-18.2; -2.4] | p < 0.0107 | |
Side effects related to general health | -6.4 | [-9.1; -3.7] | p < .0001 | |
Side effects related to mental health | -10.2 | [-12.8; -7.5] | p < .0001 | |
Side effects related to body modification | -3.7 | [-5.9; -1.6] | p < 0.0007 | |
MC R2 = 0.1 | Intercept | 79.2 | [78; 80.5] | p < .0001 |
Family status (living alone) | -3.8 | [-5.9; -1.7] | p < 0.0004 | |
Dismissal | -3.1 | [-6; -0.2] | p < 0.0354 | |
Side effects related to general health | -5.9 | [-8.4; -3.3] | p < .0001 | |
Side effects related to mental health | -3.6 | [-6.1; -1] | p < 0.0056 | |
Side effects related to body modification | -2.9 | [-4.9; -0.8] | p < 0.0057 | |
TR R2 = 0.31 | Intercept | 77.4 | [76.4; 78.4] | p < .0001 |
BMI > 30 (kg/m2) | -3.2 | [-5.3; -1.1] | p < 0.0030 | |
Non-compliant | -4.4 | [-6.1; -2.7] | p < .0001 | |
Side effects related to general health | -9.5 | [-11.5; -7.5] | p < .0001 | |
Side effects related to mental health | -6.8 | [-8.8; -4.8] | p < .0001 | |
Side effects related to body modification | -7.5 | [-9.1; -5.9] | p < .0001 | |
FG R2 = 0.1 | Intercept | 66.5 | [62.3; 70.7] | p < .0001 |
Female | -3 | [-5.8; -0.1] | p < 0.0409 | |
Side effects related to mental health | -11.4 | [-15.1; -7.7] | p < .0001 | |
Side effects related to body modification | -4.9 | [-7.9; -1.8] | p < 0.0016 |