Development and validation of a shortversion checklist for patients undergoing hemodialysis based on the International Classification of Functioning, Disability and Health Hideyo Tsutsui, Takayoshi Ohkubo, Yoshinari Tsuruta, Sawako Kato, Yoshinari Yasuda & Yoshiharu Oshida Clinical and Experimental Nephrology Official Publication of the Japanese Society of Nephrology ISSN 1342-1751 Clin Exp Nephrol DOI 10.1007/s10157-014-1075-x
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Author's personal copy Clin Exp Nephrol DOI 10.1007/s10157-014-1075-x
ORIGINAL ARTICLE
Development and validation of a short-version checklist for patients undergoing hemodialysis based on the International Classification of Functioning, Disability and Health Hideyo Tsutsui • Takayoshi Ohkubo • Yoshinari Tsuruta • Sawako Kato • Yoshinari Yasuda • Yoshiharu Oshida
Received: 17 September 2014 / Accepted: 14 December 2014 Ó Japanese Society of Nephrology 2014
Abstract Background In 2009, we developed a ‘‘100-category checklist’’ for patients undergoing hemodialysis (HD) based on the International Classification of Functioning, Disability and Health, and we confirmed its validity. However, we found that for patients’ daily assessment, 100 categories were too many. The purpose of the present study was to develop and validate a short version of the ‘‘100category checklist.’’ Methods A total of 100 outpatients undergoing HD were recruited. They were interviewed using the ‘‘100-category checklist’’ and asked whether they had experienced problems after starting HD. From the ‘‘100-category checklist,’’ we extracted categories that had greater than a 50 % rate of ‘‘yes’’ responses. Content validity was evaluated using the frequency of patients who had a
H. Tsutsui (&) T. Ohkubo Department of Hygiene and Public Health, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan e-mail:
[email protected] H. Tsutsui Y. Oshida Research Center of Health, Physical Fitness, and Sports, Nagoya University, Furo-cho, Chikusa-ku, Nagoya 464-8601, Japan Y. Tsuruta Meiyo Clinic, 64-3 Yatori-cho, Toyohashi 441-8023, Japan S. Kato Department of Nephrology, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya 466-0064, Japan Y. Yasuda Department of Chronic Kidney Disease Initiatives, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya 466-0064, Japan
problem in each category. Criterion validity was evaluated based on the correlation of the score from the ‘‘shortversion checklist’’ categories with that from the Kidney Disease Quality of Life (KDQOLTM) questionnaire. Construct validity was evaluated using Spearman correlation coefficients between the number of problem categories and the presence of HD-related complications. Cronbach’s coefficient alpha was calculated to evaluate internal consistency. Results Twenty-two categories were identified as problem categories. Criterion validity showed that 12 categories were significantly correlated with subscales of the KDQOLTM. Construct validity showed that the presence of complications contributed to an increased number of problems associated with HD. Cronbach’s coefficient alpha of this checklist was 0.79. Conclusion The ‘‘short-version checklist’’ had a certain degree of validity, suggesting its usefulness in a simplified assessment of patients undergoing HD. Keywords Short-version checklist Hemodialysis International Classification of Functioning, Disability and Health Validity evaluation
Introduction Quality of life (QOL) investigations for patients undergoing hemodialysis (HD) have been performed all over the world [1, 2]. Health-related QOL (HRQOL) of patients undergoing HD is determined by the complex interplay of psychosocial factors in addition to disease severity and treatment-related factors [3, 4]. Patients undergoing HD need to be able to self-manage a long-term disease, and frequently have to make decisions about fluid intake,
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nutrition, physical activity, and symptom management [5, 6]. Therefore, it is necessary to ascertain the physical and psychosocial problems these patients experience. In 2009, as an index to evaluate the QOL of patients undergoing HD, we developed a ‘‘100-category checklist’’ for patients undergoing HD, based on the International Classification of Functioning, Disability and Health (ICF) [5]. This checklist assesses physical and psychosocial problems in patients undergoing HD. We then confirmed the validity of this checklist [7]. However, the number of categories in the checklist was too many to be used routinely in the field. The purpose of the present study was to develop a ‘‘short-version checklist’’ from the ‘‘100-category checklist’’ and to evaluate its validity.
Methods Patients A total of 100 outpatients undergoing regular HD were recruited from Meiyo Clinic in Toyohashi, Japan, between November and December 2011 and July 2013 [7]. Exclusion criteria were: (1) HD duration less than 5 years, (2) dementia, and (3) hearing disorder. Written informed consent was obtained from all patients. This study was approved by the committee of the Research Center of Health, Physical Fitness, and Sports, Nagoya University (Approval Number 23-09).
Procedures Data collection Using the ‘‘100-category checklist’’ for patients undergoing HD based on the ICF [5], the patients were interviewed and asked whether they had experienced any problems in each category of the checklist after starting HD. We defined categories for which more than 50 % of patients had problems as a ‘‘problem category’’ according to previous studies [8, 9]. We developed a ‘‘short-version checklist’’ using the list of a ‘‘problem category’’. The study patients were interviewed using the ‘‘shortversion checklist.’’ They also completed the Kidney Disease Quality of Life Short Form (KDQOL-SF) version 1.3 for Japanese [10]. The KDQOLTM includes kidney-disease-targeted scales and 36-item health survey scales as subscales [11]. The Japanese version was developed by Green et al. [10].
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Statistical analysis The validity of the ‘‘short-version checklist’’ was assessed by evaluating content validity, criterion validity, and construct validity. The reliability evaluation was performed using Cronbach’s coefficient alpha as a measure of internal consistency [12]. Content validity was evaluated using the frequency of patients who reported a problem in each category. Using the method of previous studies for defining problem categories, a category was identified as a ‘‘problem category’’ when 50 % or more of the patients have problems [8, 9]. To evaluate the extent of a patient’s problems in each category, the number of categories extracted as problem categories was counted. Criterion validity was evaluated using Spearman’s correlation coefficients between the categories in the ‘‘shortversion checklist’’ and the KDQOLTM scores. Construct validity was evaluated by examining known group validity. The purpose of evaluating the construct validity was to ascertain whether the QOL based on the presence of complications during HD could be used to discriminate groups in terms of QOL that are known or expected to differ clinically or are expected to differ. We chose carpal tunnel syndrome (CTS) [13–16], anemia [17, 18], and secondary hyperparathyroidism (SHPT) [19–22] as an index of construct validity from among the complications known to reduce the QOL of patients undergoing HD. In addition to these complications, the complications that reduce the QOL of patients undergoing HD include cardiovascular disease (CVD) [23] and cerebrovascular disorders [24, 25]. However, in the present study, those with CVD or cerebrovascular disorders were significantly older than those without the diseases. Accordingly, we could not rule out the possibility that an extracted problem category was affected by old age. Therefore, CVD and cerebrovascular disorders were not chosen for the index of constructive validity. A patient’s QOL was considered to be lower when a patient had a greater number of problem categories. Patients were grouped according to the presence of CTS, anemia, and SHPT for comparison. Spearman correlation coefficients between the number of problem categories in each component and the existence of CTS, anemia, and SHPT were calculated to evaluate the construct validity. To evaluate internal consistency in all the categories, Cronbach’s coefficient alpha was calculated, and reliability assessment was performed. Differences with two-tailed P values of \0.05 were considered statistically significant. Statistical analysis was performed using the SPSS statistical software package (SPSS, version 19.0, SPSS, Tokyo, Japan).
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Results Characteristics of patients The characteristics of the 100 patients in total and by the presence of complications are shown in Table 1. The mean age was 61 years, and the mean duration of
HD was 12.9 years. The most common underlying diseases were chronic glomerulonephritis (CGN) in 38 % and diabetic nephropathy (DMN) in 22 % of the patients [7]. The mean age was higher in the CTS group; the mean duration of HD was longer in the SHPT group. The most common underlying disease was CGN in all groups.
Table 1 Clinical characteristics of patients Characteristics
Complications All (n = 100)
CTS
Anemia
SHPT
Yes (n = 70)
No (n = 30)
P
Yes (n = 52)
No (n = 48)
P
Yes (n = 33)
No (n = 67)
Sex (men/women) (n) Age (years)
50/50 61 ± 13
38/32 61 ± 10
18/12 60 ± 11
0.598 0.580
33/19 60 ± 9
23/25 62 ± 11
0.118 0.294
17/16 58 ± 11
39/28 62 ± 10
0.669 0.064
Age of hemodialysis introduction (years)
48 ± 14
48 ± 14
48 ± 16
0.873
47 ± 12
50 ± 16
0.243
41 ± 13
52 ± 13
\0.001
Duration of hemodialysis (years)
12.9 ± 6.9
13.9 ± 7.3
10.5 ± 5.1
0.023
13.2 ± 6.4
12.6 ± 7.4
0.632
16.5 ± 7.0
11.2 ± 6.2 \0.001
Chronic glomerulonephritis (n)
38
31
39
0.048
20
18
0.921
18
20
0.017
Diabetic nephropathy (n)
22
15
7
0.833
12
10
0.787
7
15
0.894
Nephrosclerosis (n)
13
9
4
1.000
3
10
0.036
1
12
0.055
IgA nephropathy (n)
8
4
4
0.236
7
1
0.061
3
5
1.000
P
Underlying disease
Polycystic kidney (n)
6
3
3
0.361
4
2
0.679
6
6
0.174
Reflux nephropathy (n)
3
3
0
0.552
3
0
0.244
1
2
1.000
Systemic lupus erythematosus (n)
3
2
1
1.000
1
2
0.606
0
3
0.549
Purpura nephritis (n)
2
1
1
0.512
0
2
0.228
2
0
0.107
Gouty kidney (n)
1
1
0
1.000
1
2
0.679
1
0
0.330
Multiple myeloma (n)
1
0
1
0.300
0
1
0.480
0
1
1.000
Kidney stone (n)
1
0
1
0.300
1
0
1.000
0
1
1.000
Nephrophthisis urinary tract tuberculosis (n)
1
1
0
1.000
0
1
0.480
0
1
1.000
Unidentified (n)
1
0
1
0.300
0
1
0.480
0
1
1.000
Serum creatine (mg/dl)
11.7 ± 2.4
11.6 ± 2.1
11.7 ± 2.9
0.817
12.0 ± 2.1
11.3 ± 2.6
0.154
11.8 ± 2.5
11.6 ± 2.3
0.599
Albumin (g/dl)
3.9 ± 0.3
3.9 ± 0.3
3.9 ± 0.4
0.904
3.9 ± 0.3
3.8 ± 0.3
0.264
3.9 ± 0.3
3.9 ± 0.3
0.666
Type of diabetes (T1DM/T2DM) (n)
7/15
6/9
1/6
0.358
3/9
4/6
0.652
2/5
5/10
1.000
HbA1c (%) (NGSP)
7.0 ± 1.6
7.3 ± 1.5
6.4 ± 1.2
0.037
7.1 ± 1.7
6.9 ± 1.1
0.746
7.4 ± 1.9
6.8 ± 1.2
0.335
Insulin use (n)
10
8
2
0.381
3
7
0.084
3
7
1.000
Data on age, age of HD introduction, duration of HD, serum creatine, albumin, and HbA1c are shown as mean ± SD. The Chi square tests were used for comparisons of sex, underlying disease, type of DM, and insulin use. The unpaired t test was used for comparisons of age, age of HD introduction, duration of HD, serum creatine, albumin, and HbA1c. The value of HbA1c was expressed according to the recommendations of the National Glycohemoglobin Standardization Program T1DM type 1 diabetes mellitus, T2DM type 2 diabetes mellitus, NGSP National Glycohemoglobin Standardization Program
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the 36-item health survey scales of the KDQOLTM score (Table 3). In the ‘‘Activities and participation’’ component, 3 of the 7 categories correlated significantly with kidneydisease-targeted scales of the KDQOLTM score, and 3 of the 7 categories correlated significantly with the 36-item health survey scales of the KDQOLTM score (Table 4). In the ‘‘Environmental factors’’ component, neither of the 2 categories correlated significantly with kidney-disease-targeted scales or the 36-item health survey scales of the KDQOLTM score (Table 5).
Short-version checklist The ‘‘short-version checklist’’ included the following categories from ICF: 17 categories from the ‘‘Body functions’’ component; 5 categories from the ‘‘Body structures’’ component; 7 categories from the ‘‘Activities and participation’’ component; and 2 categories from the ‘‘Environmental factors’’ component. Content validity Of the 31 categories, 22 were identified as problem categories by more than 50 % of patients.
Construct validity Table 6 shows the Spearman correlation coefficients between the number of problem categories in each component and the presence of CTS, anemia, and SHPT. Regarding the ‘‘Body functions’’ and ‘‘Body structures’’ components and the total of the four components, the number of problem categories was significantly correlated with the presence of CTS (P = 0.026, P \ 0.001, and P = 0.002, respectively). Regarding ‘‘Body functions,’’ ‘‘Body structures,’’ ‘‘Activities and participation’’ and ‘‘Environmental factors’’ components and the total of the four components, the number of problem categories was significantly correlated with the presence of anemia (P = 0.001, P = 0.045, P = 0.007,
Criterion validity Tables 2, 3, 4, and 5 showed the results of criterion validity. In the ‘‘Body functions’’ component, 8 of the 17 categories correlated significantly with kidney-disease-targeted scales of the KDQOLTM score, and 8 of the 17 categories correlated significantly with the 36-item health survey scales of the KDQOLTM score (Table 2). In the ‘‘Body structures’’ component, 1 of the 5 categories correlated significantly with kidney-disease-targeted scales of the KDQOLTM score, and 1 of the 5 categories correlated significantly with
Table 2 Proportion of problem category and Spearman correlation coefficients between the checklist of short-version for patients undergoing hemodialysis and the KDQOL (body function component) Category
%a
Kidney-disease-targeted scales
36-item health survey scales 0.239*
b134
Sleep functions
57
0.261*
b210
Seeing functions
61
0.227*
0.279*
b240
Sensations associated with hearing and vestibular function
68
0.188
0.197
b280
Sensation of pain
57
0.404**
0.446**
b420
Blood pressure functions
91
0.050
0.084
b430
Hematological system functions
52
0.144
0.082
b4550
General physical endurance
70
0.280*
0.278*
b4551
Aerobic capacity
56
0.316**
0.396**
b4552
Fatigability
70
0.427**
0.484**
b525
Defecation functions
64
0.044
0.108
b610
Urinary excretory functions
95
0.040
0.068
b620
Urination functions
70
0.007
0.051
b710
Mobility of joint functions
60
0.339**
0.372**
b780
Sensations related to muscles and movement functions
80
0.042
0.018
b810
Protective functions of the skin
71
0.229*
0.239*
b840
Sensation related to the skin
60
0.175
0.208
b850
Functions of hair
62
0.044
0.044
KDQOL Kidney Disease Quality of Life * P \ 0.05, ** P \ 0.01 a
Percentage (%) of the patients who reported it as problem category
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Category
54
Kidney-disease-targeted scales
36-item health survey scales
-0.004
-0.007
s220
Structure of eyeball
s610
Structure of urinary system
100
–
–
s6100
Kidneys
100
–
–
s730
Structure of upper extremity
70
0.284*
0.297**
s830
Structure of nails
56
0.039
-0.015
KDQOL Kidney Disease Quality of Life, – analysis not performed * P \ 0.05, ** P \ 0.01 a
Percentage (%) of the patient who reported it as problem category
Table 4 Proportion of problem category and Spearman correlation coefficients between the checklist of 31 for patients undergoing hemodialysis and the KDQOL (activities and participation component) %a
Category
Kidney-disease-targeted scales
36-item health survey scales
d430
Lifting and carrying objects
48
0.115
0.131
d475
Driving
33
0.087
0.161
d570
Looking after one’s health
37
0.287**
0.251*
d845
Acquiring, keeping and terminating a job
36
0.194
0.171
d850
Remunerative employment
36
0.194
0.171
d9204 d9205
Hobbies Socializing
34 48
0.239* 0.300**
0.269* 0.357**
KDQOL Kidney Disease Quality of Life * P \ 0.05; ** P \ 0.01 a
Percentage (%) of the patient who reported it as problem category
Table 5 Proportion of problem category and Spearman correlation coefficients between the checklist of 31 for patients undergoing hemodialysis and the KDQOL (environmental factors component) Category
%a
Kidney-disease-targeted scales
36-item health survey scales
e110
Products or substances for personal consumption
41
0.023
0.026
e590
Labor and employment services, systems, and policies
43
0.209
0.198
KDQOL Kidney Disease Quality of Life a
Percentage (%) of the patient who reported it as problem category
P = 0.001, and P \ 0.001, respectively). Regarding the ‘‘Environmental factors’’ component, the number of problem categories was significantly correlated with the presence of SHPT (P = 0.026).
Discussion
Reliability
Content validity
Cronbach’s coefficient alphas of ‘‘Body functions,’’ ‘‘Body structures,’’ ‘‘Activities and participation,’’ ‘‘Environmental factors’’ and all categories were 0.74, 0.20, 0.62, 0.30, and 0.79, respectively. Cronbach’s coefficient alpha, which added ‘‘Body structures’’ and ‘‘Body functions,’’ was 0.74.
Of the 31 categories, 22 were identified as problem categories by more than 50 % of patients. However, these 22 extracted categories were only for physical problems. For psychosocial problems, there was no category that was identified by more than 50 % of patients as a problem
We developed and validated a ‘‘short-version checklist’’ of the ‘‘100-category checklist’’ for patients undergoing HD.
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Author's personal copy Clin Exp Nephrol Table 6 Spearman correlation coefficients between the number of the problem category in each component and the presence of the CTS, anemia, and SHPT Component
CTS
Anemia
SHPT
Body functions
-0.223*
-0.337**
-0.910
Body structures
-0.601**
-0.201*
-0.045
Activities and participation Environmental factors
-0.134 -0.063
-0.269** -0.340**
-0.110 -0.223*
Total
-0.305**
-0.407**
-0.132
Spearman correlation coefficients were calculated in existence of the CTS, anemia, and SHPT * P \ 0.05; ** P \ 0.01
category. Therefore, it may be inappropriate to use the checklist to assess psychosocial problems. Nevertheless, more than 40 % of patients identified 4 out of 9 categories of psychosocial problems as ‘‘problem categories,’’ and more than 35 % of patients identified 3 categories as ‘‘problem categories’’ (Tables 2, 3, 4, 5). The categories identified by more than 40% of patients as ‘‘problem categories’’ were regarding ‘‘carrying baggage’’ and ‘‘work’’ (Tables 2, 3, 4, 5). Patients undergoing HD often have difficulty carrying items, such as bags, due to CTS and trigger finger disorder [5, 7]. Therefore, it is supposed that the categories of the ‘‘short-version checklist’’ could appropriately assess the problems of Japanese patients undergoing HD. Criterion validity Twelve of the 31 categories showed a significant correlation with subscales of the KDQOLTM. Although 39 % of categories showed significant correlation with KDQOLTM, the correlation was weak in terms of the magnitude of the coefficients. These results were similar to those of the criterion validity of the ‘‘100-category checklist’’ [7]. Construct validity Construct validity showed that CTS, anemia, and SHPT contributed to an increased number of problems associated with HD. Regarding the ‘‘Body functions’’ and ‘‘Body structures’’ components and total categories, the number of problem categories was significantly correlated with the presence of CTS, indicating that there were more complications in the CTS group compared to the non-CTS group. Patients with CTS are reported to have many HD-associated complications other than CTS [13–16]. CTS is often related to vascular access [13], duration of HD [14], accumulation of b-2 microglobulin amyloid fibrils [15], and arterial calcifications [16].
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Regarding the ‘‘Body functions,’’ ‘‘Body structures,’’ ‘‘Activities and participation’’ and ‘‘Environmental factors’’ components and total categories, the number of problem categories was significantly correlated with the presence of anemia, indicating that the influence of physical and mental symptoms on everyday life was greater in the anemia than in the non-anemia group. Anemia in patients undergoing dialysis was reported to be associated with significantly worse QOL compared to patients without anemia [17]. Akizawa et al. reported that mental and physical component summary scores for QOL (MCS, PCS), calculated from a standardized health-related SF-36 questionnaire score were nearly 1.6 points lower in patients with hemoglobin (Hb)\8 g/dl than those with Hb 11–12 g/ dl. These results were consistent with the present results since severe anemia was reported to be associated with decreased physical functioning of Japanese patients undergoing HD [18]. Regarding the ‘‘Environmental factors’’ component, the number of problem categories was significantly correlated with the presence of SHPT, suggesting that physical symptoms exerted a greater influence on daily life and social relationships in the SHPT than in the non-SHPT group. Patients with chronic kidney disease are known to develop hypocalcemia, hyperphosphatemia, and low vitamin D3 levels [19]. These changes stimulate the parathyroid glands and lead to hypersecretion of parathyroid hormone, causing SHPT [20]. SHPT is also associated with poor self-reported HRQOL in patients undergoing HD [21]. Patients with SHPT experience a variety of clinical symptoms that may adversely affect physical and mental function [22]. Internal consistency We found that overall Cronbach’s coefficient alpha, which was assessed to evaluate the internal consistency of the ‘‘short-version checklist’’ as a whole, was 0.79. Since appropriate scale of Cronbach’s coefficient alpha should be 0.8 or over, the magnitude of the coefficient in the present study might not be large enough. The Cronbach’s coefficient alpha of the ‘‘100-category checklist’’ was 0.86 [7], indicating that internal consistency of the ‘‘short-version checklist’’ was lower than the ‘‘100-category checklist.’’ In particular, the values of the components of ‘‘Body structures’’ and ‘‘Environmental factors’’ were low (0.20 and 0.30, respectively). However, ‘‘Body structures’’ was assessed with ‘‘Body functions’’. Cronbach’s coefficient alpha which added ‘‘Body structures’’ and ‘‘Body functions’’ showed a high value of 0.74, indicating that low alpha of ‘‘Body structures’’ alone would not be a large problem if the two components were assessed simultaneously.
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‘‘Environmental factors’’ of the ‘‘100-category checklist’’ consists of 21 categories. The Cronbach’s coefficient alpha of ‘‘Environmental Factors’’ in the ‘‘100-category checklist’’ was 0.51, which was not very high [7], suggesting that categories for ‘‘Environmental Factors’’ in ICF categories might not be suitable for Japanese patients undergoing HD. However, two categories of ‘‘Environmental Factors’’ in this ‘‘short-version checklist’’ were about food, medicine, and labor. They were important problems in daily medical treatment of patients undergoing HD. Therefore, although the Cronbach’s coefficient alpha was low, these categories would be reasonable to assess the problems of patients undergoing HD. However, in this study, Cronbach’s coefficient alpha was the only measure used to assess reliability. To more precisely evaluate reproducibility, further confirmation by the test–retest method would be needed.
Generalizability The mean age of Japanese patients undergoing dialysis is 67 years, and the most common underlying diseases were DMN in 37.1 % and CGN in 33.6 % of Japanese patients undergoing dialysis [26]. Moreover, the patients undergoing dialysis comprised 24,689 men (67.5%) and 11,901 women (32.5 %) [26]. The mean age of the patients in this study was 61 years, and the most common underlying diseases were CGN in 38 % and DMN in 22 % of the patients. The patients undergoing HD comprised 50 men (50.0 %) and 50 women (50.0 %). These differences in age and sex might be attributable to the difference between the underlying diseases of the Japanese patients undergoing HD and the underlying disease of this study. Therefore, it may not be a representative sample of Japanese patients undergoing dialysis. With respect to the generalizability of the results of this study, further verification is necessary. In conclusion, we developed and validated a ‘‘shortversion checklist’’ of the ‘‘100-category checklist’’ for patients undergoing HD. Because this checklist comprises 31 categories, it is expected that medical staff could assess physical and psychosocial problems of patients undergoing HD in a shorter time period when compared with the ‘‘100category checklist’’. Acknowledgments This study was supported by a Grant from the Kidney Foundation, Japan (JKF10-5) and by a Grant from the Kidney Foundation, Aichi, Japan. The authors would like to thank M. Ogi, Y. Nagata, K. Kita, M. Natsume, F. Ito, and S. Ozaki; head nurse at Meiyo Clinic, for their support with respect to the interviews. Conflict of interest The authors declare no conflicts of interest with regard to this manuscript.
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