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    sugar, blood lipids, use of tobacco and alcohol, diet,

    medication misuse and obesity. Non-modifiable factors

    include age, gender, race and genetics (Brown et al. 2003,

    de Jong & Brenner 2004). Ageing has been shown to be

    associated with a decline in renal function (Brown et al.

    2003). Obesity [body mass index (BMI) of more than

    30 kg/m2], especially abdominal obesity, is frequently

    accompanied by several factors in addition to hypertension

    that may accelerate the risk for CKD. Abdominal obesity

    refers to subjects with central fat distribution and is a major

    risk factor for renal function abnormalities (Pinto-Sietsma

    et al. 2003, Kramer et al. 2005). Because the number of

    nephrons does not increase after birth, increasing body

    weight must result in an increase in the single nephron

    glomerular filtration rate (GFR) (Kramer et al. 2005).The

    early stage of CKD is often asymptomatic; when symptoms

    do arise with progression towards renal failure, it is often

    too late to change behaviours to preserve renal function.

    Chagnac et al. (2003) showed that therapeutic interventionswere often ineffective at the end stage of CKD. Therefore,

    current standards call for early intervention for patients with

    progressive CKD.

    Many studies have shown that early stage CKD patients

    who received predialysis education had lower hospitalisation

    rates and shorter lengths of stay when hospitalised than those

    who did not receive health education. Researchers have also

    indicated that patients with predialysis care experienced less

    urgent dialysis (Levin et al. 1997) and better biochemical

    parameters at the start of dialysis therapy (Devins et al. 2003,

    Goldstein et al. 2004, Tungsanga et al. 2005). Early

    intervention to retard renal function deterioration was

    recommended when patients serum creatinine (Scr) level

    was 1530 mg/dl, or GFR level is from 30 to 59 ml/minutes

    (Hebert et al. 2001). Such results indicate that predialysis

    education programs could be beneficial for CKD patients. In

    contrast, some results of predialysis care have been inconsis-

    tent; intensive predialysis management showed little effect on

    mortality or kidney function deterioration (Devins et al.

    2003, Goldstein et al. 2004, Tungsanga et al. 2005). Also,

    investigators have concluded that intensive predialysis man-

    agement may not be cost effective (Harris et al. 1998).

    In addition to biological outcomes, researchers havestressed that psychosocial indicators should be considered

    in follow-up research (Devins et al. 2003). The literature

    indicates that quality of life (QOL) is a better measure of

    comprehensive responses to the physical, mental and social

    dimensions often measured separately by psychosocial instru-

    ments. QOL has become an important variable in the

    evaluation of therapeutic interventions (Valderrabano et al.

    2001). Many studies have recognised that the QOL of

    patients with established renal failure is less than that of the

    general population (Valderrabano et al. 2001, Suet-Ching

    2001, Patel et al. 2002). But few studies have measured the

    QOL of patients in the early stage of CKD.

    In Taiwan, alternatives to contemporary medicine are

    readily available and commonplace. Patients with impaired

    renal function often use alternative treatments, especially

    traditional Chinese herbs. A phenomenological study indi-

    cated that, after being diagnosed with established renal

    failure, patients in Taiwan seek further information, includ-

    ing getting a second opinion from a traditional Chinese

    medicine specialist and explore alternative treatment to

    recover renal function (Lin et al. 2005). Many Taiwanese

    believe that traditional herbs are natural and thus harmless.

    Long periods of information seeking, however, can cause

    treatment delays and prevent the patient from receiving

    effective treatment in time (Sesso & Yoshihiro 1997, Lin

    et al. 2005). In addition, the improper use of herbal

    medicine can deteriorate kidney function. Therefore, healtheducation for CKD patients that includes information on the

    use of Chinese herbal medicine could be an appropriate

    method to prevent or retard the development of renal failure

    in Taiwan.

    Patients with CKD have been identified as a patient group

    in need of specific education (Goldstein et al. 2004, Tung-

    sanga et al. 2005). A predialysis educational program may

    produce important benefits by increasing illness-related

    knowledge and promoting QOL (Harris et al. 1998, Klang

    et al. 1999). More research is needed to understand the

    effects of an educational intervention on patients with early

    stage CKD. Thus, a multidisciplinary predialysis care team

    was convened to develop an intervention designed to improve

    renal function protection in persons with early stage CKD.

    Such an educational intervention has not been previously

    developed and evaluated in Taiwan. Therefore, the purpose

    of this study was to investigate physical, knowledge and QOL

    outcomes of an educational intervention for patients with

    CKD.

    Methods

    This study used a one-group repeated-measures design. Aneducational intervention delivered by a multidisciplinary

    predialysis care team and focused on renal function protec-

    tion for people with CKD was held with follow-up data

    collection. Outcomes physical indicators, QOL and knowl-

    edge of renal function protection were measured at

    baseline, six and 12 months. Throughout the 12-month

    period, participants were able to contact the predialysis care

    team with any questions about CKD.

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    Participants and setting

    The study was approved by the institutional review boards of

    participating hospitals. After approval by the Health Depart-

    ment of Tainan City, a health screening data bank ( n = 2071)

    was obtained. The first step was to screen for people with Scr.

    between 15 and 3 mg/dl. A total of 640 potentially eligible

    persons were identified. Each person was contacted bytelephone and invited to participate in the study. Among

    the 640 persons identified in the initial screening process,

    reasons for not participating were inconvenience of trans-

    portation, not interested in the intervention and having an

    alternative treatment plan. Some decided not to participate

    without giving any reason. One hundred and fifty four

    persons agreed to participate. Each of the 154 persons next

    visited a nephrologist at their convenience to determine study

    eligibility. Inclusion criteria included: (1) Scr between 15 and

    3 mg/dl; (2) diagnosed as CKD by their doctors; (3) aged

    18 years or older; and (4) spoke Mandarin or Taiwanese. Of

    the 154 who initially agreed to participate, 66 persons

    fulfilled the selection criteria. All participants gave written

    informed consent prior to data collection.

    Educational intervention

    The educational intervention consisted of one workshop,

    individual consultations every six months and a telephone

    number for participant questions. The predialysis care team

    for the workshop consisted of a nephrologist, nurse, nutri-

    tionist and social worker. The workshop included content on

    renal protection, nutrition, exercise and the use of Chineseherbal medicine. An educational handout describing CKD

    disease-related information was given to each participant.

    The physician focused on the context of renal function,

    pharmacological management and the causes of CKD, as well

    as the use of Chinese herbal medicine. The nurse provided

    information on health promotion for renal function protec-

    tion. The nutritionist covered content on diet for people with

    decreased renal function, including information on foods to

    choose and to avoid. The social worker raised the issue of

    support systems for people with CKD. The workshop lasted

    for 150 minutes with two short breaks. Desserts recom-

    mended by the nutritionist were provided during the breaks

    for educational purposes. Lunch boxes were also designed by

    the nutritionist and given to the participants at the end of the

    workshop. A masters-prepared nurse case manager per-

    formed the individual consultations and answered

    phone calls from the participants. Individual consultations

    and measures of the study indicators at the sixth and

    twelfth month were undertaken at the same time. The

    multidisciplinary team served as a resource for the case

    manager in consultations.

    Instruments

    Study instruments included physical indicators, World Health

    Organisation Quality of Life (WHOQOL) questionnaire,

    renal protection knowledge checklist and demographics. The

    research assistant called the participants prior to their regular

    outpatient clinic check up and reminded them for the follow-

    up data collection every six month. Face-to-face interview for

    individual questions and measuring study outcomes were

    performed at follow-ups.

    Physical indicators

    The renal function assessment consisted of Scr., blood urea

    nitrogen (BUN) and GFR. The GFR was estimated by the

    CockcroftGault prediction formula (K/DOQI Work Group,

    2002):

    GFR 140 age BWkg 085 if female=Scr. 72

    Body composition, including body weight, muscle weight,

    percentage body fat, body fat, waist to hip ratio (WHR) and

    BMI, were measured by INNBODYODY 3.0 Body composition

    analyser (INNBODYODY 3.0 Biospace (Upwards Biosystems Ltd,

    Taipei, Taiwan); Okamoto et al. 2006). Blood pressure was

    taken in a seated position using an automated sphygmo-

    manometer.

    Quality of life: the World Health Organisation qualityof life questionnaire

    Quality of life was evaluated using WHOQOL-BREF-

    Taiwan Version (The WHOQOL Taiwan Group, 2000), a

    28-item instrument. The WHOQOL-BREF Taiwan Version

    encompasses four domains: physical health (seven items),

    psychological health (six items), social relationships (four

    items), environmental domain (nine items) and two global

    items (In general, How would you rate your quality of life?

    and In general, How satisfied are you with your health?).

    This instrument measured patients QOL during the two -

    weeks prior to data collection points with a 5-point Likert

    scale: 1 = not satisfied at all, 2 = somewhat satisfied,

    3 = moderately satisfied, 4 = very satisfied and 5 = extremely

    satisfied. Higher scores indicated a better QOL. The reli-

    ability of the overall questionnaire was 090 (The WHOQOL

    Taiwan Group 2000). Internal consistency for each of

    the four domains ranged from 068077. Content

    validity, convergent validity, criteria-related validity and

    construct validity were examined. The overall QOL internal

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    consistency for this study was 093. Internal consistency for

    each of the four domains ranged from 073083.

    Renal protection knowledge checklist

    A disease-specific knowledge of renal protection checklist

    was developed for this study. Two nephrologists and three

    nurses with at least five years of clinical experience with CKD

    evaluated the content validity prior to the study. The check-

    list consisted of 20 items covering three domains: renal

    function protection (11 items), knowledge of using Chinese

    herbs in related to renal function (five items) and diet with

    CKD (four items). Item responses were dichotomous, i.e.

    true or false. Each correctly answered item was scored

    with five points. Total scores for the checklist ranged from 0

    to 100. Higher scores indicated higher knowledge of renal

    function protection. The reliability of the questionnaire was

    from 043054.

    DemographicsDemographic variables included gender, age, language, to-

    bacco and alcohol use, state of residence, level of education,

    occupation and personal medical history (self-report).

    Data analysis

    Statistical analyses were conducted using SPSSSPSS (version 14.0)

    (SPSS Taiwan Corp., Taipei, Taiwan). All continuous vari-

    ables were examined assuming normal distributions.

    Descriptive statistics (means, standard deviations and fre-

    quencies) were examined for all study variables. Repeated

    measures analysis of variance (ANOVA)(ANOVA) was used for variables

    collected longitudinally at three points (baseline, six and

    12 months) to test the equality of means across times, known

    as the within-subjects effects. Using the repeated measures

    can reduce the error term, thus increase the power of the

    analysis with fewer subjects. Therefore, in this study we

    applied repeated measures ANOVAANOVA to determine whether

    physical indicators (renal function and body composition),

    QOL and knowledge of renal function protection differed

    among baseline, six and 12 month time points. There might

    be correlation between the measures across time for each

    variable because they were from the same people, (Munro

    2005:215) also known as compound symmetry. Mauchlys

    test of Sphericity was non-significant (p > 005) and thus the

    assumption of compound symmetry was met, indicating that

    the correlations across the measurements were the same and

    the variances were equal across measurements. Statistical

    significance was set at p < 005 and all p-values were

    reported two sided.

    Results

    Study sample

    Data from 66 participants were analysed in this study. Fifty-

    three participants were males and 13 (20%) were females.

    The mean age was 674 years (range 3389 SD 1159). The

    average years of education were nine (SD 45). Forty-four

    participants (67%) were married. More than half of

    the participants were Buddhist (n = 36, 55%). Most of the

    participants were retired or unemployed (n = 47, 71%).

    The average range of income was between 015, 000 NT

    dollars (approximately 0470 US dollars) per month. Seven

    (11%) participants smoked and only one participant drank

    alcohol regularly.

    Physical indicators

    Table 1 summarises the physical indicator outcomes. The

    major criterion for selection of participants in this study

    Table 1 Physical indicators at three time

    points (n = 66)Variable

    Baseline

    mean (SD)

    Sixth month

    Mean (SD)

    Twelfth month

    Mean (SD) F Post hoc

    GFR 421 (106) 411 (111) 412 (117) 287

    Scr 21 (05) 22 (07) 21 (07) 150

    BUN 286 (03) 308 (104) 295 (130) 104

    SBP 1415 (16

    0) 141

    0 (15

    7) 141

    9 (15

    9) 2

    87

    DBP 842 (83) 849 (74) 847 (76) 272

    Body weight 682 (87) 678 (86) 684 (81) 278

    Muscle weight 466 (59) 465 (60) 460 (57) 285

    Body fat 225 (46) 223 (46) 228 (44) 287

    WHR 103 (02) 101 (01) 100 (01) 603* 12*

    BMI 254 (33) 251 (34) 250 (33) 437* 12*

    *p < 005. GFR, glomerular filtration rate; Scr, serum creatinine; BUN, blood urea nitrogen;

    SBP, systolic blood pressure; DBP, diastolic blood pressure; WHR, waisthip ratio; BMI, body

    mass index.

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    was Stage 3 of CKD, GFR range from 30 to 59 ml/

    minutes/173m2. Data from the baseline, sixth and twelfth

    month follow-ups showed that the indicators of renal

    function (Scr., BUN and GFR) were not significantly

    different over time (F = 104287; p > 005). Body com-

    position (body weight, muscle weight, body fat percentage

    and total body fat) was also not significantly different at

    the three time points. However, both WHR and BMI were

    significantly different at the three time points (F = 603 and

    F = 437; p < 005). Other physical indicators, including

    systolic blood pressure and diastolic blood pressure, were

    not significantly different within the 12-month follow-up

    period.

    Knowledge checklist

    The 20-item knowledge checklist contained three domains:

    renal function protection, knowledge of using Chinese herbs

    related to renal function and diet with CKD. The overallknowledge scores, covering all three domains, increased at

    the sixth month and decreased at the twelfth month

    (p < 005; Table 2). Similarly, scores from two domains,

    knowledge of using Chinese herbs and diet with CKD,

    increased at six months and decreased 12 months

    (p < 005). However, the renal function protection domain

    showed no significant change over time.

    Quality of life

    The brief version of the WHOQOL contains four domains

    with 26 items. Thirty eight participants completed the QOL

    questionnaire in this study (the remainder left 20% or more

    items blank and thus could not be included in analysis). The

    mean age of those who did not complete the QOL question-

    naires was younger than the 38 participants who did

    (p < 005). Other demographic variables (gender, education

    level, religion and marital and job status) were similar for

    these two groups (p > 005). Table 3 depicts the QOL

    results. There were no significant differences at baseline, sixth

    and twelfth month follow-ups in the physical, psychological,

    social relationship and environmental domains. Two single

    items were asked to evaluate global QOL and health status:

    How would you rate your quality of life? and How satisfied

    are you with your health? The scores for satisfaction with

    personal health increased significantly (F = 964; p < 005).

    However, the global QOL item score increased at the sixthmonth and decreased at the twelfth month (F = 995;

    p < 005).

    Discussion

    These results show that renal function was stable in this

    sample over the 12 months of the study. The physical

    Table 2 Renal function protection

    knowledge at three time points (n = 66)Variable

    Baseline

    mean (SD)

    Sixth month

    Mean (SD)

    Twelfth month

    Mean (SD) F Post hoc

    Overall protection renal

    function knowledge

    856 (60) 920 (50) 842 (60) 1039* 12*

    23*

    Subscales

    Renal function protection 468 (57) 485 (62) 484 (51) 24

    Use of Chinese herbs 224 (38) 227 (35) 193 (51) 139* 12*

    23*

    Diet with CKD 178 (34) 189 (27) 175 (34) 348* 12*

    23*

    *p < 005. CKD, chronic kidney disease.

    Table 3 Quality of life at three time

    points (n = 38)Variable

    Baseline

    mean (SD)

    Sixth month

    Mean (SD)

    Twelfth month

    Mean (SD) F Post hoc

    Global QOL (single item) 31 (06) 32 (08) 26 (08) 964* 23*

    Global health status

    (single item)

    27 (08) 32 (09) 33 (10) 995* 12*

    Physical domain 138 (18) 139 (19) 138 (20) 007

    Psychological domain 125 (16) 128 (17) 129 (13) 111

    Social-related domain 134 (19) 136 (15) 137 (22) 042

    Environment domain 146 (22) 151 (15) 145 (22) 186

    *p < 005; Thirty-eight participants completed the QOL questionnaire. QOL, quality of life.

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    indicators (Scr, BUN and GFR) were not significantly

    changed across time (p = 005). Two outcome physical

    indicators in this study, the WHR and BMI significantly

    decreased over the 12-month follow-up period. Knowledge

    scores (using Chinese herbs and diet with CKD) increased at

    6 months and decreased at 12 months. There was no

    significant difference among scores for four domains of

    QOL. However, the two global items, overall QOL and

    general health, showed change over time (p < 005). Overall

    QOL was increased at six months and decreased at

    12 months, while general health (as measured by the satis-

    faction with personal health item) increased over time.

    Changes in renal function

    The level of GFR is widely accepted as the best indicator of

    overall kidney function and the definition and staging of

    CKD depends on the assessment of GFR (Levey et al. 1999,

    K/DOQI Work Group 2002). GFR levels were not signifi-cantly changed during baseline, six and 12 month follow-ups

    in this study. The results were consistent with the findings

    from a randomised, controlled trial predialysis education

    study (Klang et al. 1999, Devins et al. 2003). Another

    longitudinal study in Thailand reported similar findings: GFR

    seemed to be stable over a four-year follow-up after imple-

    menting a multidisciplinary educational intervention

    (Tungsanga et al. 2005). Retarding or preventing deteriora-

    tion of renal function as measured by GFR levels is a key task

    of early stage CKD educational intervention.

    The GFR level was stable among participants in this study,

    even though the mean age, 674-year old, was older than

    reported in other studies (Levin et al. 1997, Devins et al.

    2003), indicating that the educational intervention may have

    been successful in retarding deterioration of renal function in

    spite of age, a major risk factor for declining renal function

    (Brown et al. 2003).

    Changes in body composition

    Obesity is believed to be associated with renal damage (Iseki

    et al. 2004). A body of research demonstrates that central fat

    distribution may be more salient to the problem of renaldamage than general obesity. One study revealed that GFR

    decreases linearly with the increase of the WHR ratio after

    adjusting for confounding factors (Pinto-Sietsma et al. 2003).

    In Okinawa, Japan, a study on a group of over 100,000

    individuals identified that obesity was a major risk factor for

    the development of CKD and the degree of obesity also

    predicted the progression to end-stage renal disease (ESRD)

    (Iseki et al. 2004). Similarly, a cohort study with follow-ups

    over 14 years found that higher BMI was a risk for

    hypertension and diabetes, both of which increased the risk

    of ESRD (Gelber et al. 2005).

    Two outcome indicators in this study, WHR and BMI,

    significantly decreased over the 12-month follow-up period.

    This finding may help explain why the renal function

    indicator, GFR, remained stable. Because the nephron num-

    ber does not increase as adults gain weight, increased body

    weight and body size merely enhance single-nephron loading,

    which may lead to a loss of GFR over time (Kramer et al.

    2005). Furthermore, this outcome provides supporting evi-

    dence for early educational intervention in CKD to retard

    renal function deterioration. In other words, an educational

    intervention should include a focus on reducing central body

    fat distribution and BMI to stabilise renal function. Although

    BMI showed a statistically significant decrease at the sixth

    and twelfth month, the average of BMI was still greater than

    25 at the end of the follow-up period.

    Changes in renal function protection knowledge

    A fundamental consideration for delaying the progress of

    CKD is patient education at the early stage (Devins et al.

    2005). Overall knowledge scores increased slightly at the

    sixth month and decreased at the twelfth month in this study.

    This indicates that to maintain patients knowledge of renal

    function protection, use of Chinese herbs and diet, work-

    shops may need to be conducted at least every six months.

    An important issue with this Taiwanese sample was the use

    of Chinese herbs. The intervention developed and delivered in

    this study included content on the use of Chinese herbs,

    which has seldom been the focus of interventions for people

    with early stage CKD. It has been shown that many CKD

    patients in Taiwan use Chinese herbs in the belief that herbs

    will preserve kidney function (Lin et al. 2005). Two retro-

    spective studies revealed that patients with ESRD had

    previously used one or more forms of complementary therapy

    before they received haemodialysis treatment in Taiwan.

    Complementary therapies used, included traditional Chinese

    herbs, which were not always reported to health care

    providers (Chiou 1999, Lin et al. 2005). In Taiwan, many

    people believe Herbs cannot harm, only cure. Herbs arepanacea. Natural things are better than synthetic ones

    Chinese herb medicines do not give side effects (Dahi 2001,

    Isnard et al. 2005). However, the effects of herbal medicine

    are controversial; their use may harm the kidney itself.

    Study participants expressed that all Chinese herbs were

    safe, warm, nourishing. Thus, people may not use them

    carefully with physicians prescriptions. Our findings

    highlight that although herb medicine may have many

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    advantages, health professionals have to be very careful in

    evaluating the patients reliance and use of it. The misuse of

    herbs may lead to a decreased of GFR or even directly to a

    nephrotoxic state (Dahi 2001). In Taiwanese culture, many

    people use Chinese herbs for restorative preparations and to

    build up physical strength (Teng et al. 1995). Furthermore,

    because Chinese herbs are perceived as natural foods for daily

    use, patients with CKD may not recognise Chinese herbs as

    medicines and thus not report their use during a medication

    history. The use of Chinese herbs and culturally appropriate

    lifestyle interventions need attention in future research.

    Changes in quality of life

    Health status may influence ones perception of QOL (Suet-

    Ching 2001). In this study, participants in the early stage of

    CKD may not yet experience or be aware of CKD symptoms.

    Perceived overall health in our study was high compared with

    haemodialysis patients (Sesso & Yoshihiro 1997). Althoughwe found that overall satisfaction with health status reported

    by CKD patients did improve over time, we suspect that the

    improvement might not reflect the true improvement of

    health status but rather could be an intervention effect.

    Research indicates that when GFR is below 30 ml/minutes/

    173m2, symptoms associated with uraemia, such as lack of

    energy or fatigue, may appear (Patel et al. 2002). These

    symptoms may affect peoples QOL (Sesso & Yoshihiro

    1997). The average GFR for the studied participants was

    41 ml/minutes/173m2. QOL measured overall and through

    four subdimensions, was significantly higher in this study

    than other ones where patients kidney function was lower

    (Jang et al. 2004, Perlman et al. 2005, Yang et al. 2005).

    However, the scores for overall QOL in this study decreased

    at the twelfth month follow-up although GFR levels

    remained stable. It is possible that post intervention lifestyle

    adjustments, such as changes in diet, may have affected

    perceptions of QOL.

    Limitations

    This study must be interpreted with limitations in mind.

    Generalisability of the study findings may be restricted due tothe small sample size and selection bias. It is possible that

    participants might have better health and higher motivation

    to learn health promotion activities than those who did not

    participate. The one-group design also limits drawing

    conclusions about the effects of the educational intervention.

    However, current recommendations emphasise early

    intervention. This study used a one-group design with

    repeated measurements over 12 months; for ethical reasons,

    we wanted all participants to receive an educational

    intervention.

    Conclusion

    Early predialysis educational interventions are recommended

    to slow the progression of CKD. Although the participants in

    this study were older than those in previous studies average

    renal function remained stable during the one-year follow-up

    period, indicating that the educational intervention may have

    had some success in retarding deterioration of renal function.

    The intervention may also improve knowledge related to

    renal function protection and perceptions of general physical

    health. This study reports that overall knowledge scores

    (renal function protection, Chinese herbs and diet) showed

    significant differences between the baseline, sixth and twelfth

    month follow-up. Knowledge of use of Chinese herbs and

    diet domains increased at the sixth month then decreased at

    the twelfth month, while the renal function protectiondomain showed no change over time. This study provides

    evidence that Taiwanese CKD patients routinely use Chinese

    herbs and may not report their use to health care providers or

    understand possible adverse effects on renal function. Edu-

    cation for early-stage CKD patients should incorporate more

    traditional, culturally specific diet information and emphasise

    content on traditional Chinese herbs for patients likely to use

    alternative therapies. Finally, overall QOL scores in this

    study decreased at the twelfth month follow-up, despite

    stable renal function.

    Acknowledgements

    This study was funded by National Science Council, Taiwan

    (NSC92-2314-B-006-097). We would like to thank the

    patients with CKD who participated in this study and Blair

    G. Darney for editorial assistance.

    Contributions

    Study design: MY, J-JH; data collection and analysis: MY,

    J-JH, H-LT and manuscript preparation: MY, J-JH, H-LT.

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