Introduction
Methods
Patients
The procedure for data collection
Data collection instruments
Statistical methods
Item generation
Item reduction
Validation
Item level analysis
Internal consistency reliability of Scale scores
Construct validity
Content validity
Reproducibility and sensitivity to change
Results
Item generation phase
Item reduction phase
Item reduction | Validation phase | |
---|---|---|
Socio-demographic data
| ||
Sex, % males | 62.4 | 63.5 |
Age, years, mean ± SD | 50.7 ± 14.6 | 49.4 ± 12.8 |
(range) | (19 – 81) | (20 – 71) |
Living arrangement : | ||
Live alone, % | 18.6 | 20.2 |
Children, % | 65.9 | 75.5 |
Patients conceived child after transplantation, % | 6.5 | 9.7 |
Employment status
| ||
Employed, % | 28.5 | 37.5 |
Unemployed : | ||
Declared in chronic ill heath (health pension), % | 37.4 | 36.4 |
Retired, % | 40.5 | 49.1 |
Others, % | 22.1 | 14.5 |
Return to occupation after transplantation, %
| 37.2 | 51.1 |
Item reduction | Validation phase | |
---|---|---|
Period of transplantation, years | 6.8 ± 3.7 | 5.4 ± 3.14 |
Previous unsuccessful kidney transplants, % | - | 9.6 |
Patient with rejection | 23.2 | 21.4 % |
Cause of ESRD
| ||
Chronic glomerular nephritis, % | 42 | 40.4 |
Diabetic nephropathy, % | 3 | 2.9 |
Vascular nephropathy, % | 4.5 | 3.8 |
Interstitial nephropathy, % | 13.5 | 10.6 |
Hereditary nephropathy,% | 17 | 23.1 |
Unclassified nephropathy,% | 20 | 19.2 |
Different modalities of dialysis
| ||
Hemodialysis | 97.3 | 96.2 |
Peritoneal dialysis | 2.7 | 3.8 |
Duration of dialysis, years, mean ± SD | 2.5 ± 2 | 3.8 ± 4.2 |
Comorbidities
| ||
Hypertension | 78.8 | 88.5 |
Diabetes | 13 | 13.5 |
Hepatitis | 0.6 | 6.7 |
Peripheral vascular disease | 0.6 | 5.8 |
Depression | - | 3.8 |
Smoking status | 36.5 | 31.1 |
BMI, kg/m2, mean ± SD | 25.5 ± 4.7 | 24.5 ± 4.0 |
Comorbidity index, mean ± SD | 1.6 ± 0.9 | 1.5 ± 0.8 |
Treatments
| ||
Calcineurin inhibitors | 94.6 | 96.2 |
Corticosteroids | 89.3 | 97.1 |
Antimetabolites | 75.3 | 77.9 |
Antihypertensive drugs | 87.1 | 90.4 |
Antilipemic agents | 53.2 | 45.2 |
Antidiabetic agents | 9.7 | 15.4 |
Antithrombotics | 28.5 | 29.8 |
Protease Inhibitors | 19.9 | 26.0 |
Erythropoietin therapy | 12.2 | 10.6 |
Hospital admissions
| ||
During the last 12 months | - | 45.2 |
Related to Kidney Transplantation | - | 66.0 |
Validation phase
Item level analysis and internal consistency reliability scores
ReTransQOL Dimensions | Mean ± SD (Min – Max) | Cronbach's α coefficient (range if item was deleted) | IICa (Min – Max) | IIC % > 0.40 | IDVb | IDV % < 0.40 |
---|---|---|---|---|---|---|
Physical Health (PH) | 58.5 ± 19.2 (13.9 – 95.3) | 0.86 (0.84 – 0.86) | 0.48 – 0.73 | 100% | 0.07 – 0.50 | 92.5% |
Mental Health (MH) | 69.3 ± 17.3 (4.9 – 100) | 0.84 (0.80 – 0.85) | 0.38 – 0.71 | 88.9% | 0.04 – 0.48 | 83.3% |
Medical Care (MC) | 64.4 ± 11.0 (37.3 – 84.8) | 0.83 (0.79 – 0.83) | 0.44–0.70 | 100% | 0.01 – 0.44 | 97.7% |
Fear of losing the graft (FG) | 53.8 ± 20.9 (3.6 – 96.4) | 0.79 (0.75 – 0.78) | 0.64 – 0.78 | 100% | 0.07 – 0.53 | 95.8% |
Treatment (TR) | 65.8 ± 15.5 (23.1 – 94.8) | 0.70 (0.66 – 0.71) | 0.37 – 0.66 | 77% | 0.01 – 0.49 | 91.6% |
Item number | Items label | Response modalities |
---|---|---|
1 | Have you had physical pain? | All most time |
2 | Has your graft bothered you? | Most of time |
3 | Have you felt tired? | A good bit of the time |
4 | Do you engage in physical exercise? | Some of the time |
5 | Do you feel energetic? | A little of the time |
None of time | ||
6 | You are as well as anyone else | Definitely agree |
7 | You have stopped doing certain things. | Mostly agree |
8 | You feel autonomous. | Not agree not disagree |
9 | You can do your housework and errands by yourself. | Mostly disagree |
Definitely disagree | ||
10 | Do you feel physically affected? | |
11 | Are you annoyed by the side effects of treatment? | |
12 | Is your weight a problem for you? | |
13 | Do you feel relieved? | |
14 | Do you feel sick? | No at all |
15 | Have you been able to forget that you received a graft? | A little bit |
16 | Do you often think about your graft? | Moderately |
17 | Are you satisfied with your graft? | Quite a bit |
18 | Does your family offer you moral support? | Extremely |
19 | Has your family accepted your illness? | |
20 | Do you feel misunderstood by the people around you? | |
21 | Do you feel close to your friends? | |
22 | Do you feel sad? | |
23 | Have you enjoyed life as much as possible? | |
24 | Do you feel discouraged? | All most time |
25 | Are you able to put up with daily worries and stress? | Most of time |
26 | Do you feel isolated? | A good bit of the time |
27 | Are you anxious about your state of health? | Some of the time |
28 | Does waiting for the results of medical tests distress you or make you feel scared? | A little of the time |
29 | Do you think about a possible return to dialysis? | None of time |
30 | Do you still sometimes think about dialysis? | |
31 | You would say that you have a normal life. | Definitely agree |
32 | You live with the graft as if you have a second life, a rebirth. | Mostly agree |
33 | Do you think you will have enough income to provide for your needs? | Not agree not disagree |
Mostly disagree | ||
Definitely disagree | ||
34 | Do you have hobbies/leisure activities? | All most time |
Most of time | ||
A good bit of the time | ||
Some of the time | ||
A little of the time | ||
None of time | ||
35 | Is taking medications a constraint for you? | |
36 | Are you scared of the possible side effects of the anti-rejection treatment? | |
37 | Are your doctor's orders restrictive? | |
38 | Do you trust your nephrologist? | |
39 | Do you have trust in the prescribed treatments? | |
40 | Are you satisfied by your nephrologist's ability to listen? | No at all |
41 | Do you feel sufficiently informed by your nephrologist? | A little bit |
42 | Do you feel like you are sufficiently informed about the side effects of your treatments? | Moderately |
43 | Do you feel like you are sufficiently informed about complications of the graft? | Quite a bit |
44 | Do you feel supported by the medical team? | Extremely |
45 | Are you satisfied by your medical follow-up? |
Construct validity
- Factor analysis
Factors | ||||||
---|---|---|---|---|---|---|
Dimensions Labels
|
1
|
2
|
3
|
4
|
5
|
Item number
|
Eigenvalues | 9.25 | 4.10 | 2.99 | 2.43 | 2.08 | |
% of variance | 20.56 | 9.12 | 6.65 | 5.4 | 4.6 | |
Physical Health- PH
|
.726
| q5 | ||||
.674
| q6 | |||||
.641
| q36 | |||||
.588
| .355 | q7 | ||||
.573
| q8 | |||||
.551
| q4 | |||||
.538
| .313 | q14 | ||||
.536
| q9 | |||||
.508
| q33 | |||||
.305
| q35 | |||||
Medical Care – MC
|
.767
| q43 | ||||
.737
| q42 | |||||
.708
| q40 | |||||
.645
| q41 | |||||
.633
| q49 | |||||
.608
| q45 | |||||
.574
| q44 | |||||
.544
| q46 | |||||
.327 |
.370
| q34 | ||||
.474 |
.330
| q13 | ||||
.387 |
.307
| q17 | ||||
Fear of losing graft – FG
|
.719
| q31 | ||||
.709
| q32 | |||||
.689
| q16 | |||||
.668
| q30 | |||||
.622
| q15 | |||||
.561
| .338 | q29 | ||||
Treatment – TR
| .327 |
.305
| q39 | |||
.389 |
.617
| q1 | ||||
.569
| q11 | |||||
.565
| q12 | |||||
.536 |
.547
| q3 | ||||
.356 |
.546
| q38 | ||||
.524
| q10 | |||||
.394
| q2 | |||||
.304 |
.379
| q37 | ||||
Mental Health – MH
|
.671
| q28 | ||||
.657
| q19 | |||||
.650
| q21 | |||||
.647
| q20 | |||||
.574
| q22 | |||||
.464 | .308 |
.512
| q23 | |||
.500 |
.404
| q26 | ||||
.478 |
.312
| q27 | ||||
.595 |
.432
| q24 |
- Correlation between SF36 and RTQ
ReTransQol | |||||
---|---|---|---|---|---|
SF36
|
Physical Health
|
Mental Health
|
Medical Care
|
Fear of losing the Graft
|
Treatment
|
Physical Function- PF | 0.680** | 0.445** | 0.268** | 0.133 | 0.387** |
Social Function- SF | 0.641** | 0.605** | 0.184 | 0.290** | 0.489** |
Role Function-Physical-RFP | 0.554** | 0.450** | 0.153 | 0.085 | 0.276** |
Role Function-Emotional-RFE | 0.612** | 0.618** | 0.241** | 0.190 | 0.389** |
Emotional Well-being – EW | 0.543** | 0.638** | 0.235** | 0.385** | 0.474** |
Vitality- VT | 0.746** | 0.559** | 0.230* | 0.366** | 0.593** |
Bodily Pain- BP | 0.564** | 0.451** | 0.113 | 0.163 | 0.546** |
General Health Perception-GHP | 0.760** | 0.498** | 0.318** | 0.356** | 0.497** |
Physical Score Composite | 0.635 ** | 0.374** | 0.117 | 0.101 | 0.388** |
Psychological Score Composite | 0.641** | 0.760** | 0.223 | 0.375** | 0.546** |
- Known Group Validity
ReTransQol | SF36 | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
PH
|
MH
|
MC
|
FG
|
TR
|
PH
|
SF
|
RF
|
RE
|
MH
|
V
|
BP
|
GH
| |
Variables associated with a decreased quality of life
| |||||||||||||
Unemployed | + | + | + | + | + | + | + | + | + | ||||
Living alone | + | ||||||||||||
Female | + | ||||||||||||
Age > 55 | + | + | + | + | + | ||||||||
Hospitalizations in previous 12 months | + | + | + | + | + | ||||||||
Hospitalizations in previous 12 months for KT | + | + | |||||||||||
Period of transplantation | + | + | |||||||||||
Comorbidities index | + | + | + | + | |||||||||
Diabetes | + | + | |||||||||||
Depression | + | + | + | ||||||||||
BMI | + | ||||||||||||
Smoking status | + | ||||||||||||
Stressful life events | + | + | + | + | + | ||||||||
Variables associated with increased quality of life
| |||||||||||||
Previous unsuccessful Kidney transplants | + | + | + | + | |||||||||
Antimetabolites | + |