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ADULT UROLOGY

ASSESSMENT OF HEALTH-RELATED QUALITY OF LIFE IN


RENAL TRANSPLANT AND HEMODIALYSIS PATIENTS USING
THE SF-36 HEALTH SURVEY
MASATO FUJISAWA, YASUJI ICHIKAWA, KUNIHIKO YOSHIYA, SHUJI ISOTANI,
AKIHIRO HIGUCHI, SHUNSUKE NAGANO, SOICHI ARAKAWA, GAKU HAMAMI,
OSAMU MATSUMOTO, AND SADAO KAMIDONO

ABSTRACT
Objectives. To determine whether the health-related quality of life (HQOL) for renal transplant patients
improved using SF-36 survey scores and to examine which clinical measures after renal transplantation are
connected to aspects of their HQOL.
Methods. A total of 117 renal transplant patients and 114 hemodialysis patients, including 49 awaiting
transplantation and 65 not awaiting transplantation, were included in this study. The scale scores of the
SF-36 survey concerning HQOL were compared between the two groups of patients. The relationships of the
clinical episode and complications with the scale scores were examined.
Results. The renal transplant patients had significantly higher scores in the physical functioning, bodily pain,
general health, and social functioning scales than did the hemodialysis patients. The role-physical function-
ing, bodily pain, and social functioning scales of the transplant patients were significantly higher than those
of the hemodialysis patients not awaiting transplantation. In contrast, the scores, except for that of general
health, of the transplant patients were not significantly different from those of the hemodialysis patients
awaiting transplantation. Multiple regression analysis demonstrated that the scale scores of physical func-
tioning, general health, and vitality were significantly dependent on the serum level of creatinine in the renal
transplant patients (P ⬍0.05). The scores of physical functioning and general health of the patients with a
creatinine level ⬎2 mg/dL were significantly lower than those of the patients with 1 mg/dL ⬍ creatinine level
ⱕ1.5 mg/dL or a creatinine level ⱕ1 mg/dL (P ⬍0.05). An episode of hospitalization was not related to the
scale scores, but an instance of rejection had an effect on the scores of social functioning and role-emotional
functioning.
Conclusions. The SF-36 health survey is a short but comprehensive scale for evaluating a patient’s HQOL.
The renal transplant patients’ HQOL improved compared with that of the hemodialysis patients. The most
important factor affecting HQOL was the serum creatinine level at the time of testing with the SF-36
survey. UROLOGY 56: 201–206, 2000. © 2000, Elsevier Science Inc.

G raft survival after renal transplantation has


improved remarkably after the introduction
of cyclosporine and tacrolimus. Although clini-
the efficacy of the transplantation, such measures
do not fully address the patient’s general or dis-
ease-specific health status. It should be realized
cians have relied on the graft survival to determine that renal transplantation is likely to affect not only
patients’ physical well-being but also their social
and psychological well-being. A patient’s health-
From the Department of Urology, Kobe University School of Med- related quality of life (HQOL) has increasingly
icine, Kobe; Department of Urology, Miki Municipal Hospital,
Miki; Department of Urology, Hyogo Prefectural Nishinomiya been recognized as an outcome that can and
Hospital, Nishinomiya; Department of Urology, Hara Genitouri- should be measured in studies of the effects of dis-
nary Hospital, Kobe; and Department of Urology, Hyogo Prefec- ease and treatments on patients. The SF-36 survey
tural Amagasaki Hospital, Amagasaki , Japan (SF-36) has become an extensively used generic
Reprint requests: Masato Fujisawa, M.D., 7-5-2 Kusunoki-cho,
Chuo-ku, Kobe 650-0017, Japan
measure throughout the world.1 It is considered
Submitted: December 20, 1999, accepted (with revisions): valid, reliable, comprehensive, brief, and poten-
March 27, 2000 tially useful for individual patient applications.

© 2000, ELSEVIER SCIENCE INC. 0090-4295/00/$20.00


ALL RIGHTS RESERVED PII S0090-4295(00)00623-3 201
TABLE I. Patient characteristics
Tx (n ⴝ 117) HD Awaiting Tx (n ⴝ 49) HD Not Awaiting Tx (n ⴝ 65)
Duration of dialysis (yr) 3.1 ⫾ 3.8 10.0 ⫾ 6.8 7.7 ⫾ 5.0
Sex (M/F) 50/67 37/12 45/20
Cause of ESRD CGN and some unknown CGN, IgA, NS, DM, DPK, CGN, DM, DPK, RR ⫽ 58, 3, 3, 1
cases Hypo, T, HS ⫽ 36, 4,
2, 2, 2, 1, 1, 1
Age at Tx (yr) 33 ⫾ 9.5 — —
CD 31 — —
LD 86 — —
Prior transplant None — —
Term of transplantation 10.5 ⫾ 6.9 — —
(yr)
Patients with rejection 40 — —
episode (n)
Creatinine (mg/dL) 1.2 ⫾ 0.53 — —
Patients with
complications after Tx
or with HD (n)
Diabetes 5 2 3
Hypertension 35 46 44
Liver dysfunction 19 5 5
Age at SF-36 survey (yr) 43.9 ⫾ 9.1 45.8 ⫾ 11.9 45.7 ⫾ 6.8
KEY: HD ⫽ hemodialysis; ESRD ⫽ end-stage renal disease; Tx ⫽ transplantation; CD ⫽ cadaveric donor; LD ⫽ living-related donor; CGN ⫽ chronic glomerular nephritis;
IgA ⫽ IgA nephropathy; NS ⫽ nephrotic syndrome; DM ⫽ diabetic nephropathy; DPK ⫽ polycystic kidney disease; Hypo ⫽ hypoplastic kidney; T ⫽ toxicemia; HS ⫽
Henöch-Schonlein purpura; RR ⫽ reflux nephropathy.
Values presented as mean ⫾ SD.

Numerous international cross-cultural adaptations (RP), bodily pain (BP), general health (GH), vitality (VT),
of the original instrument, as well as the results of social functioning (SF), role-emotional functioning (RE), and
mental health (MH). The number of questions directed to each
its validation for normal subjects and different health concept range from two (for SF and BP) to 10 (for PF),
chronic conditions, are already available.2– 6 Some and the number of response options per question range from
reports suggest that the SF-36 can be useful in as- two (no, yes) to six (none, very mild, mild, moderate, severe,
sessing the HQOL of renal transplant recipients.2 and very severe).1 Each question is given a score from 0 to 100.
Therefore, we administered the SF-36 to patients A mean score is produced for each health concept, ranging
from 0 to 100, with higher scores indicative of a better out-
who underwent renal transplantation and exam- come. Information on the patient’s age, sex, medical history,
ined which items affected their HQOL after renal duration of the transplantation and hemodialysis before trans-
transplantation. We also compared the HQOL of plantation, instances of rejection, complications such as he-
the renal transplant patients with that of hemodi- patic dysfunction and hypertension, hospitalization during
alysis patients. the past year, interventions occurring after the transplanta-
tion, and the findings from the most recent laboratory data
were abstracted from the patients’ medical records.
MATERIAL AND METHODS All descriptive data are reported as the mean ⫾ SD. Multiple
A total of 126 renal transplant patients who underwent 33 regression analysis was used to quantify and assess the rela-
cadaveric and 93 living-related transplantations were enrolled tionship between the results of the quality-of-life (QOL) in-
in this study. Patients were recruited from the outpatient clin- strument and a number of independent variables such as clin-
ics of the Departments of Urology in Kobe University School of ical conditions. In the multiple regression analysis, each
Medicine and Nishinomiya Hospital and were informed of the parameter of medical history and complications was given a
study during routine follow-up visits to the hospital. The pa- score of 0 or 1. Differences in the mean value between the
tients who answered fewer than one half of the items on at transplant and hemodialysis patients were analyzed by a two-
least one scale were excluded from the psychometric analyses. tailed, unpaired t test. Significance was present at the 5% level.
The remaining 117 renal transplant patients (50 men and 67
women) and 114 hemodialysis patients, including 65 hemo- RESULTS
dialysis patients not awaiting renal transplantation and 49 pa-
tients awaiting transplantation, were analyzed in this study. The scale score of PF, RP, BP, GH, VT, SF, RE,
The patient profiles are presented in Table I. All renal trans- and MH in the renal transplant patients was 86.2,
plant patients received immunosuppressive therapy with aza- 77.6, 80.2, 56.4, 63.3, 82.1, 78.0, and 70.0, respec-
thioprine and a steroid; azathioprine, a steroid, and tacroli- tively. In contrast, the scale score of PF, RP, BP,
mus; or azathioprine, a steroid, and cyclosporine. In some
cases, azathioprine was substituted with mizoribine. The GH, VT, SF, RE, and MH in the hemodialysis pa-
SF-36 contains 36 questions that assess eight aspects of tients was 81.6, 68.0, 70.2, 51.0, 59.2, 74.5, 74.6,
HQOL: physical functioning (PF), role-physical functioning and 68.5, respectively. In the hemodialysis patients

202 UROLOGY 56 (2), 2000


awaiting transplantation, the scale score of PF, RP, tacrolimus; or azathioprine, a steroid, and cyclo-
BP, GH, VT, SF, RE, and MH was 81.7, 73.5, 74.1, sporine). However, no significant differences were
49.6, 61.2, 74.9, 80.3, and 67.8, respectively. The found among these three groups.
scale score of PF, RP, BP, GH, VT, SF, RE, and MH
in the hemodialysis patients not awaiting trans- COMMENT
plantation was 81.5, 63.8, 67.2, 52.0, 57.6, 74.2,
70.3, and 69.0, respectively. The renal transplant Ideally, a QOL measure should show little
patients gave significantly higher scores in the change in score over time in stable patients, yet be
scale scores of PF, BP, GH, and SF than all patients sensitive to clinically relevant changes in patient
receiving hemodialysis (Table II). The RP, BP, and well-being after the introduction of new therapy.
SF scores of the transplant patients were signifi- Many reports are available concerning the im-
cantly higher than those of the hemodialysis pa- provement of QOL in transplant patients.7–15
tients not awaiting transplantation. In contrast, the Cross-sectional and prospective studies comparing
scores, except GH of the transplant patients, were dialysis and transplantation commonly report sta-
not statistically different from those of hemodialy- tistically significant improvements in the QOL in
sis patients awaiting transplantation. Regarding the transplant recipients. Eighty-six percent of pa-
the sex of the transplant patients, no differences tients have been able to undertake normal or near
were found in any scale score between the men and normal activity for most of the period after trans-
women. With respect to age, the transplant pa- plantation.13
tients were divided into four groups: younger than Several methods for scoring the HQOL have been
30 years, 30 to 39 years, 40 to 49 years, and 50 reported. Russell et al.5 reported that the mean
years old or older. The younger the patients, the time trade-off score rose from 0.41 to 0.74 after
higher the scale scores tended to be. In particular, renal transplantation. The Sickness Impact Profile
the scale of GH was significantly higher in patients was also used to assess actual health status of trans-
who were younger than 30 years old than in the plant patients.6 However, it takes the patients con-
patients who were older than 40 (P ⬍0.05) (Table siderable time to answer the many questions in-
II). volved. In contrast, the SF-36 survey used in the
Using the clinical data and scale scores, multiple present study consists of only 36 questions. There-
regression analysis demonstrated that the scale fore, it is easier for outpatients to respond to the
scores of PF, GH, and VT were significantly depen- questions. The SF-36 has been extensively studied,
dent on the serum level of creatinine in the renal and its reliability and validity have been reported
transplant patients (P ⬍0.05) (Table III). Separat- for normal populations.1– 4 Use of the SF-36 mea-
ing the transplant patients into four groups accord- sure allowed us to assess the extent to which renal
ing to the serum level of creatinine (creatinine ⬎2, transplantation, as assessed clinically, influenced
1.5 ⬍ creatinine ⱕ2, 1 ⬍ creatinine ⱕ1.5, creati- the patients’ physical, social, and psychological
nine ⱕ 1 mg/dL; normal range 0.5 to 1.3 mg/dL), sense of well-being. Painter et al.15 demonstrated
we compared the scale scores of the transplant pa- by means of the SF-36 survey that organ, including
tients. The scale scores of PF and GH of the pa- kidney, transplant recipients have the potential to
tients with a creatinine level ⬎2 mg/dL were sig- achieve levels of HQOL similar to those of the gen-
nificantly lower than those of the patients with 1 ⬍ eral population. Our study found that all scale
creatinine level ⱕ1.5 mg/dL or a level ⱕ1 mg/dL (P scores of transplant patients in Japan seem to be
⬍0.05) (Table II). similar to those reported by Ware16 in the United
Forty (34.2%) of 117 transplant patients had an States. Therefore, we confirmed that, as was re-
occurrence of clinically defined acute rejection af- ported for their American counterparts, most Jap-
ter transplantation. In comparing the patients who anese transplant patients improved their QOL. Do
had an occurrence of rejection with those who did the scale scores in the SF-36-survey we observed
not, we found that the scale scores of SF and RE represent a real benefit for patients? We demon-
were significantly higher in the former group (P strated that the RP, SF, and BP of transplant pa-
⬍0.05). All other scale scores were similar in both tients were significantly higher than those of he-
groups (Table II). When comparing patients who modialysis patients not awaiting transplantation.
had had a period of hospitalization with those who These differences mean that the transplantation re-
had not, no significant difference was observed be- duced the limitations in both physical and social
tween the two groups. The scores of the patients function. In addition, the bodily pain experienced
with cadaveric transplantation were similar to by patients during hemodialysis was also reduced
those who received a living-related transplanta- after transplantation. The score change most prob-
tion. Patients were divided into three groups ac- ably reflects a change in a multitude of factors,
cording to the immunosuppressive agents (aza- including relief from uremia, renewed indepen-
thioprine and a steroid; azathioprine, a steroid, and dence, and freedom from dialysis, that were attrib-

UROLOGY 56 (2), 2000 203


TABLE II. SF-36 scale scores in transplant and hemodialysis patients
PF RP BP GH VT SF RE MH
Patients
Transplant patients (n ⫽ 117) 86.2 ⫾ 14.8* 77.6 ⫾ 35.0* 80.2 ⫾ 21.6† 56.4 ⫾ 19.0* 63.3 ⫾ 20.3 82.1 ⫾ 19.7* 78.0 ⫾ 37.2 70.0 ⫾ 19.7
Hemodialysis patients (n ⫽ 114) 81.6 ⫾ 17.0* 68.0 ⫾ 39.1 70.2 ⫾ 23.6† 51.0 ⫾ 19.2* 59.2 ⫾ 21.4 74.5 ⫾ 26.0* 74.6 ⫾ 38.5 68.5 ⫾ 22.4
Hemodialysis patients awaiting 81.7 ⫾ 16.0 73.5 ⫾ 35.5 74.1 ⫾ 21.9 49.6 ⫾ 18.1* 61.2 ⫾ 19.6 74.9 ⫾ 24.5 80.3 ⫾ 34.6 67.8 ⫾ 22.4
Tx (n ⫽ 49)
Hemodialysis patients not 81.5 ⫾ 17.8 63.8 ⫾ 41.5* 67.2 ⫾ 24.5† 52.0 ⫾ 20.0 57.6 ⫾ 22.7 74.2 ⫾ 27.3* 70.3 ⫾ 40.9 69.0 ⫾ 22.5
awaiting Tx (n ⫽ 65)
Serum creatinine (mg/dL)
Creatinine ⱕ1 (n ⫽ 43) 87.4 ⫾ 1.9* 77.3 ⫾ 5.5 81.5 ⫾ 3.3 59.4 ⫾ 2.8† 63.5 ⫾ 3.3 83.6 ⫾ 2.9 78.3 ⫾ 6.0 71.2 ⫾ 3.0
1 ⬍ creatinine ⱕ1.5 (n ⫽ 50) 87.4 ⫾ 1.8* 82.0 ⫾ 4.2 80.9 ⫾ 2.8 59.5 ⫾ 2.5† 63.8 ⫾ 2.8 81.9 ⫾ 2.7 81.3 ⫾ 4.5 69.1 ⫾ 2.8
1.5 ⬍ creatinine ⱕ2 (n ⫽ 14) 85.4 ⫾ 4.5 67.9 ⫾ 12.1 82.1 ⫾ 5.6 50.2 ⫾ 4.8 62.9 ⫾ 4.1 79.6 ⫾ 4.8 69.1 ⫾ 12.3 73.4 ⫾ 3.7
Creatinine ⬎2 (n ⫽ 10) 76.5 ⫾ 8.2* 70.0 ⫾ 12.8 68.4 ⫾ 8.9 37.0 ⫾ 6.2† 61.0 ⫾ 8.1 80.2 ⫾ 9.3 73.3 ⫾ 13.9 64.4 ⫾ 8.7
Age at survey (yr)
Age ⬍30 (n ⫽ 8) 91.9 ⫾ 7.5 68.8 ⫾ 34.7 81.3 ⫾ 13.5 69.3 ⫾ 20.4* 68.1 ⫾ 12.5 79.8 ⫾ 21.1 79.3 ⫾ 24.8 71.5 ⫾ 8.4
30 ⱕ age ⬍40 (n ⫽ 32) 87.7 ⫾ 13.9 80.5 ⫾ 30.0 77.7 ⫾ 21.5 59.4 ⫾ 16.1 58.4 ⫾ 19.8 82.2 ⫾ 19.3 76.0 ⫾ 39.0 64.9 ⫾ 21.7*
40 ⱕ age ⬍50 (n ⫽ 49) 84.8 ⫾ 18.0 82.7 ⫾ 31.1 83.7 ⫾ 22.6 54.4 ⫾ 17.6* 63.7 ⫾ 19.7 82.1 ⫾ 20.7 83.6 ⫾ 33.5 70.2 ⫾ 20.1
Age ⱖ50 (n ⫽ 28) 85.5 ⫾ 10.9 67.9 ⫾ 41.3 76.6 ⫾ 21.9 53.0 ⫾ 22.6* 67.0 ⫾ 23.2 82.8 ⫾ 19.3 70.3 ⫾ 43.8 75.0 ⫾ 18.5*
Episode of acute rejection
Yes (n ⫽ 40) 88.5 ⫾ 2.0 84.4 ⫾ 4.2 84.8 ⫾ 2.8 59.0 ⫾ 2.5 67.5 ⫾ 2.8 88.9 ⫾ 2.3† 87.4 ⫾ 4.3* 74.3 ⫾ 2.7
No (n ⫽ 77) 85.1 ⫾ 1.8 74.1 ⫾ 4.4 77.8 ⫾ 2.6 55.1 ⫾ 2.3 61.4 ⫾ 2.4 78.6 ⫾ 2.4† 73.2 ⫾ 4.7* 67.7 ⫾ 2.4
KEY: PF ⫽ physical functioning; RP ⫽ role-physical functioning; BP ⫽ bodily pain; GH ⫽ general health; VT ⫽ vitality; SF ⫽ social functioning; RE ⫽ role-emotional functioning; MH ⫽ mental health; Tx ⫽ transplantation.
Values presented as the mean ⫾ SD.
Transplant patients were classified according to serum creatinine level, age at survey, or an episode of acute rejection.
* P ⬍0.05.

P ⬍0.01.
TABLE III. Multiple regression study concerning each scale score
PF RP BP GH VT SF RE MH
Age at transplantation 0.22 0.903 0.723 0.879 0.888 0.199 0.454 0.454
Term of hemodialysis 0.005 0.877 0.322 0.253 0.342 0.328 0.453 0.527
Sex 0.215 0.011 0.083 0.747 0.577 0.251 0.049 0.448
Serum creatinine 0.04 0.189 0.46 0.002 0.022 0.885 0.895 0.428
Hypertension 0.845 0.468 0.998 0.994 0.633 0.4 0.199 0.82
Hepatic dysfunction 0.358 0.978 0.444 0.082 0.23 0.113 0.426 0.182
Acute rejection 0.765 0.365 0.359 0.486 0.291 0.019 0.57 0.24
KEY: Abbreviations as in Table II.

uted to the successful renal transplantation. In a previous experience such as rejection and hospi-
contrast, the scale scores, except for GH, of the talization.
patients awaiting transplantation were not signifi- In conclusion, SF-36 is a short but comprehen-
cantly different from those of transplant patients, sive scale for evaluating HQOL. The transplant pa-
although no apparent differences in patient char- tients’ subjective QOL improved noticeably com-
acteristics were observed between the hemodialy- pared with the hemodialysis patients. The most
sis patients awaiting and not awaiting transplanta- important factor affecting HQOL was the present
tion. These results suggested that the desire to serum creatinine level.
undergo the transplantation may improve the
scores of HQOL compared with those of hemodi-
alysis patients not awaiting transplantation. The ACKNOWLEDGMENT. To Dr. Shunichi Fukuhara, a Japanese
scale scores of MH in the transplant patients were member of IQOLA, Kyoto University, for supporting this
the same as those of the hemodialysis patients. study and to the Urology Nursing Team at Kobe University
Hospital, the Transplant Nursing Team at Hyogo Prefectural
Therefore, mental health care support should be a Nisinomiya Hospital (E. Hirose, T. Kageyama, and Y. Miy-
consideration, even in the event of a successful amoto), and the Dialysis Nursing Team at Hara Genitourinary
transplantation. Hospital for their help with this study at the outpatient clinics.
We analyzed which factors have the most effect
on the scale scores of the SF-36. The multiple re-
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