Hemodialysis International 2014; 18:S32–S38

Home hemodialysis and conventional in-center hemodialysis in Japan: A comparison of health-related quality of life Yusuke WATANABE, Yoichi OHNO, Tsutomu INOUE, Hiroshi TAKANE, Hirokazu OKADA, Hiromichi SUZUKI Department of Nephrology, Saitama Medical University, Saitama, Japan

Abstract Health-related quality of life (HRQOL) is an important measure of how disease affects patients’ daily life. Conventional in-center hemodialysis (CHD) patients have been found to have decreased HRQOL. Recent study reported that at-home hemodialysis (HHD) improved the long-term HRQOL compared with CHD; however, there have been no data from Japanese HHD patients. A sample of 80 Japanese hemodialysis patients (46 HHD and 34 CHD) was matched for age, sex, and cause of end-stage renal disease. Patient HRQOL was measured using two health surveys: Medical Outcomes Study 36 Item Short Form Health Survey—Version 2 and Kidney Disease Quality of Life—Short Form. HHD patients reported better scores on seven out of eight domains (all domains except general heath) of the Medical Outcomes Study 36 Item Short Form Health Survey—Version 2, as well as better Kidney Disease Quality of Life—Short Form scores with respect to symptoms and problems, effect of kidney disease, and work status. No significant differences were observed for burden of kidney disease, cognitive function, quality of social interaction, sexual function, or sleep. More than 65% of HHD patients stated that they were not bothered at all by limitations on food and water intake. Japanese HHD patients demonstrate significantly higher HRQOL scores. However, while their HRQOL and employment rate were high and they were able to enjoy fewer dietary restrictions, kidney disease remained a great burden. Key words: Health-related quality of life (HRQOL), Kidney Disease Quality of Life (KDQOL), Medical Outcomes Study 36 Item Short Form Health Survey—Version 2 (SF-36 v2), home hemodialysis (HHD), end-stage renal disease (ESRD)

INTRODUCTION Recent advances in dialysis therapy have contributed to improved survival of patients with end-stage renal disease Correspondence to: H. Suzuki, MD, PhD, Department of Nephrology, Saitama Medical University, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350–0495, Japan. E-mail: [email protected] Funding disclosure: This study received no funding from any external source.

(ESRD). However, it is well documented that healthrelated quality of life (HRQOL) is impaired in patients treated with conventional thrice-weekly in-center hemodialysis (HD).1–4 In HD patient populations, low HRQOL scores are associated with hospitalization and death.5,6 To improve the survival and HRQOL of patients who require HD, interest in more frequent HD regimens has grown substantially during the past decade. Two methods have been proposed: short daily HD (1.5–2.5 hours per day, 6 days a week) and nocturnal HD (6–8 hours per day, 6 days a week). Recent studies have demonstrated that

© 2014 International Society for Hemodialysis DOI:10.1111/hdi.12221

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these intensive HD modalities improve clinical and biochemical parameters, as well as HRQOL, as compared with conventional HD.7–16 As an intensive HD therapy site, we offer at-home or in-center HD facilities. Home hemodialysis (HHD) is a treatment method that allows patients to receive HD therapy at their own home. Patients can decide on their own HD schedule and can receive HD both more frequently and for a longer duration. Advantages of HHD include flexible scheduling, flexible prescriptions, less travel to HD centers, a more liberal diet, and more privacy;7,17 however, the responsibility and time required for HD preparation and completion is a major burden.7,17 A recent study has demonstrated that patients who received short daily HD at home had better survival rates than those who received in-center HD.18 HRQOL in Japanese HHD patients has not yet been investigated, and it is therefore not known whether there is any advantage to HHD in this population. Therefore, in this study, we compare HRQOL in Japanese HHD and conventional in-center patients.

MATERIALS AND METHODS Subjects HD patients at Saitama Medical University Hospital were enrolled in this study from January to April 2011. All patients were below 75 years of age. All patients provided written informed consent before participating in the study, which was approved by the institutional ethics committee. A total of 80 patients (46 HHD, 34 in-center HD) participated in this study. Only patients who could perform activities of daily living independently and fill out the questionnaire independently were eligible. Patients were excluded from the study if they had started HD therapy or changed HD modality within the previous 3 months. In our hospital, patients who are interested in HHD receive training for at least 3 months, and are only able to begin HHD once they have reached a certain level of technical proficiency. Basically, HD sessions vary in length from 3 to 5 hours, and are performed an average of five to six times per week. The type of dialyzer is polysulfone, the area of dialyzer is 1.3–2.1 m2, the dialysate volume is 500 mL/ min, and blood flow is 200–250 mL/min. HD was performed during the day, and nocturnal HD was not carried out. Basically, preparation, cannulation, starting, and finishing of HD were performed by patients themselves, and supported by the family (caregiver). We recommend that HHD patients achieve an HD product over 70 and that they go fewer than two days

Hemodialysis International 2014; 18:S32–S38

between each dialysis session.19 HHD can be performed using the Nikkiso DBB-27 (Nikkiso Co., Tokyo, Japan) with a water treatment system MH-500CX (Japan Water System Co., Tokyo, Japan). A clinical engineer and a nurse do a home visit every 6 months, and a 24-hour telephone support system has been established. In-center HD patients receive HD three times a week for 3–5 hours per session. These patients’ HD prescription targets a single-pool Kt/V (normalized clearance by time product, a derived quantity related to treatment-related change in urea concentration) of greater than 1.2. Dialysis conditions other than time and frequency were essentially identical between conventional HD and HHD patients. Vascular access for all patients was via arteriovenous fistula.

Measures Quality of life was assessed via the Short Form Health Survey—Version 2 (SF-36 v2) and the Kidney Disease Quality of Life Instrument—Short Form (KDQOL-SFTM).

SF-36 v2 The SF-36 v2 is a validated tool for assessing HRQOL.20 It is made up of eight subscales: physical functioning, physical role (i.e., role limitations caused by physical problems), bodily pain, general health, vitality, social functioning, emotional role (i.e., role limitations caused by emotional problems), and mental health. Quality of life is divided into physical, mental and role-social domains; the eight subscales can be summed into the physical component scale, the mental component scale and the role– social component scale. Physical component scale is mainly associated with the physical functioning and physical role, while mental component scale is found to be associated with the vitality, mental health and social functioning. Role–social component scale is mainly associated with emotional role and role–physical.21 Possible scores for each scale range from 0 to 100, with higher scores indicating better HRQOL or less impairment for that domain. Population norms for these scales have been established. Summary scores for the general population have been normalized with a mean of 50 and an standard devition (SD) of 10.20

KDQOL-SF The KDQOL-SF is an expansion of the SF-36 developed specifically for people with kidney disease on dialysis.22 The KDQOL-SF was validated for Japan by Green et al.23 The expanded version of the instrument contains eight

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dialysis-specific dimensions: burden of kidney disease, cognitive function, symptoms or problems, effects of kidney disease on daily life, quality of social interaction, sexual function, sleep, and work status. Higher scores on the KDQOL-SF suggest better HRQOL. The scale of effects of kidney disease on daily life include questions like: At what extent are patients bothered by fluid and dietary restriction in five steps? We extracted the results for the questions, and compared them between HHD and conventional HD groups.

Data The clinical parameters included in our analysis were hemoglobin, serum albumin, creatinine, blood urea nitrogen, calcium, phosphate, parathyroid hormone, and preand post-HD blood pressure. In conventional HD patients, blood sampling was conducted before the beginning of HD; in HHD patients, blood sampling was normally done on days on which HHD was not conducted.

Comorbid conditions Information about comorbid conditions that could affect HRQOL was obtained. Participants gave information regarding the presence or absence of ischemic heart disease, congestive heart failure, atrial fibrillation, hypertension requiring anti-hypertensive agents, peripheral vascular disease, cerebrovascular disease, and diabetes mellitus.

Statistical analyses We used chi-square or Fisher’s exact probability test to compare categorical variables (sex, causes of ESRD, comorbid illness, and fluid and dietary restrictions). We compared age, biochemical markers, and unadjusted scores for the eight major scales and two summary scores of the SF-36, and the eight scales of the KDQOL, using Student’s t test. All values were expressed as mean ± SD, and a P value of less than 0.05 was considered significant. Statistical analyses were performed using the statistical software Statistical Package for the Social Sciences (ver. 19, IBM, Tokyo, Japan).

RESULTS Table 1 presents patients’ clinical characteristics. No significant differences were observed between the HHD and conventional HD groups for age, sex, duration of HD therapy, and causes of ESRD. However, the conventional HD group had a significantly longer duration of their current HD therapy.

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No significant differences were observed between the HHD and conventional HD groups for the various comorbid illnesses that can affect QOL. A relatively large segment of the HHD group had previously undergone peritoneal dialysis (PD) or PD + HD combined therapy. In these individuals, HD and PD combined therapy was performed with 1 HD day (4–5 hours per session), 5 PD days and 1 rest day per week. We found no significant difference in either hemoglobin or albumin levels between the two groups; however, HD product was significantly higher in the HHD group. A smaller dose of erythropoiesisstimulating agent was able to maintain hemoglobin levels in HHD patients. Table 2 shows unadjusted mean composite and subscale scores for the SF-36 and the KDQOL. For the SF-36, HHD patients had higher unadjusted scores than conventional HD patients in all composite and subscale scores with the exception of general health and mental health composite (recall that higher scores indicate higher function or less disability for a given domain). For the KDQOL, HHD patients had higher scores in symptoms/ problems, effect of kidney disease, and work status (recall that higher scores indicate higher function or less disability for a given domain). Conversely, no significant difference was observed in mean scores for burden of kidney disease, cognitive function, quality of social interaction, sexual function, or sleep between the two groups. Table 3 shows what percentage of patients reported that they were not bothered by fluid and dietary restrictions related to their kidney disease at all, as assessed via the KDQOL. The responses of more than 65% of HHD patients indicated they were not bothered at all by limits of drinking water and food. Thus, in fact most HHD patients had no limitations on food and water.

DISCUSSION This study is the first to examine differences in HRQOL in Japanese HHD and conventional HD patients, using two well-established HRQOL survey instruments. Between HHD and HD patients groups, there is no significant difference in age, sex, cause of ESRD, and duration of HD therapy, but HHD patients reported better scores in on seven out of eight domains of the SF-36 (all except general heath), as well as better KDQOL scores with respect to symptoms and problems, effect of kidney disease, and work status. In the effect of kidney disease on daily life, there was a significant difference in diet between HHD and HD patients. Home HD patients are released from the strict dietary restrictions that apply to conventional HD patients, and are able to consume food and

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QOL in Japanese HHD patients

Table 1 Patient characteristics Characteristic Number Age in years Male gender (%) Time on dialysis in years Time on current therapy in years Causes of ESRD n (%) Diabetic nephropathy Glomerulonephritis Hypertension Other Comorbid illnesses n (%) Ischemic heart disease Congestive heart failure Atrial fibrillation Hypertension Peripheral vascular disease Diabetes mellitus Prior renal replacement therapy n (%) New to dialysis Conventional hemodialysis Kidney transplant Peritoneal dialysis or PD + HD combined therapy Selected laboratory values Hemoglobin (g/dL) Albumin (g/dL) Creatinine (mg/dL) Blood urea nitrogen (mg/dL) Calcium (mg/dL) Phosphate (mg/dL) Intact PTH (pg/mL) Dialysis sessions per week Dialysis hours per session Hemodialysis product ESA dose (IU per month)

Home hemodialysis

Conventional hemodialysis

46 54.0 ± 8.3 40 (87.0) 6.4 ± 5.7 2.7 ± 1.9

34 57.1 ± 7.6 26 (76.4) 7.4 ± 8.3 6.4 ± 7.2

8 (17.4) 20 (43.5) 8 (17.4) 10 (21.7)

7 (20.6) 10 (29.4) 11 (32.4) 6 (17.6)

1 (2.2) 2 (4.3) 2 (4.3) 39 (84.8) 0 (0) 8 (17.4)

3 (8.8) 2 (5.9) 1 (2.9) 25 (73.5) 1 (2.9) 7 (20.6)

14 (30.4) 16 (34.8) 0 (0) 16 (34.8)

29 (85.3)

11.0 ± 1.4 4.0 ± 0.5 7.7 ± 2.4 34.7 ± 12.1 9.5 ± 0.6 4.1 ± 1.1 153.7 ± 108.0 5.6 ± 1.0 3.2 ± 0.7 101.2 ± 35.1 16,714.3 ± 14,120

P value 0.1 0.2 0.6

Home hemodialysis and conventional in-center hemodialysis in Japan: a comparison of health-related quality of life.

Health-related quality of life (HRQOL) is an important measure of how disease affects patients' daily life. Conventional in-center hemodialysis (CHD) ...
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