In summary, the majority of previous studies assessing the validity and reliability of the KDQOL-36™ have been conducted in the West [
6,
25]. This is the first time that the Cantonese Chinese KDQOL-36™ has been validated on dialysis patients in Hong Kong. Our results suggest that the scale is reliable and has an acceptable level of validity for understanding the health-related QoL of dialysis patients.
Criterion validity of the Cantonese Chinese KDQOL-36
There were high correlations, at
r >0.84, between the physical and mental summary scores of SF-36 and SF-12. SF-12 demonstrated evidence of criterion validity, as the two scales were very similar. Despite the high correlations on the PCS and MCS, our study was unable to draw any conclusions on the equivalence of SF-36 and SF-12 due to the medium effect size of the PCS from the two scales. According to Lam [
26], the generally accepted minimal clinically important difference (MCID) standard is 0.5. For those scores with a difference in effect, <0.5 was considered as having measurement equivalence [
27]. The moderate effect size was related to the number of items selected for PCS in SF-12 might indicate the loss of crucial information in the short version. In 2005, a Chinese Hong Kong (HK) specific SF-12 was developed where six of the items that were selected were different from those of the standard SF-12 [
16]. The scale had a different scoring algorithm and was found to be more sensitive to the Hong Kong Chinese population.
To further investigate the issue of scale equivalence, comparisons were made using the Chinese (HK) specific SF-12 data extracted from the SF-36 data. The results also demonstrated high correlations between SF-36 and the Chinese (HK) specific SF-12 on the PCS and MCS score. Most importantly, the effect size for the PCS was reduced to 0.32, which is within the generally accepted MCID, while the effect size for the MCS was 0.04. Table
7 gives details of the comparisons. The results corroborated Lam’s study that the effect size decreased if the HK specific version was used instead of the standard version for heart disease patients. The difference in effect size could be due to the selected items in the Standard SF-12 versions being not sensitive enough to measure the overall physical health of dialysis patients. For instance, the dialysis patients were encouraged to engage in moderate activities to maintain the body’s functions. Instead of asking whether their health restricted the patients to performing ‘moderate activities’, the HK specific version was changed to ‘vigorous activities’. Because ’to climb several flights of stairs’ might not be applicable to most Hong Kong people, as escalators are available in most apartment buildings, ‘to walk several blocks’ was therefore included in the specific scale. Instead of asking ‘How much does pain interfere with your normal work?’, the selected item was changed to ‘How much pain have you had during the past 4 weeks?’ The revised item selection was able to measure an individual’s physical abilities to perform certain activities in daily life. Moreover, it is easily comprehensible and relevant to the living circumstances in Hong Kong. The items for the PCS in the standard SF-12 may not be an equivalent substitute for the SF-36 for Chinese dialysis patients. The items could be revised using the HK specific version to ensure its equivalence.
Table 7
Comparisons of SF-36 and Chinese (HK) specific SF-12
PCS | Mean ± SD |
SF-36 | 27.44 ± 13.35 |
Chinese (HK) specific SF-12 | 31.69 ± 11.33 |
Difference | -4.25 |
Correlation | 0.876** |
Effect size | 0.32 |
MCS | |
SF-36 | 42.92 ± 13.86 |
Chinese (HK) specific SF-12 | 42.86 ± 12.58 |
Difference | -1.81 |
Correlation | 0.901** |
Effect size | 0.04 |
Our results supported the hypotheses on convergent and discriminant validity. A correlation coefficient of above 0.4 for convergent validity is considered satisfactory [
28]. There were significant negative correlations between the disease-specific domain scores and the depression score, with the MCS having the highest correlation with depression, at
r = -0.516. With regard to symptoms and problems, the effects of kidney disease and the burden of kidney disease, the correlations were moderate. The nature and progression of end stage renal disease causes patients to get used to the idea that they will need lifelong treatment and to accept the disruption in their daily life activities [
29]. As a result, the patients were less depressed compared with the newly diagnosed patients, even though they were bothered by the symptoms and impacts of kidney disease in their daily life. A relatively low correlation was found between the PCS and depression. A possible explanation for this is that the items selected in the Standard SF-12 are not sensitive enough to capture the situation for dialysis patients. On the other hand, the evidence shows that anxiety is common in patients on maintenance dialysis and that this aspect is understudied [
30]. In our study, anxiety levels were less prominent with regard to the question of whether kidney disease is a burden to patients and their families due to the prolonged trajectory of the illness. For discriminant validity, the scale is able to discriminate between the QoL of dialysis and transplant patients, producing significantly different results. The results corroborated those of previous studies confirming that transplant RRT provides a better QOL compared with other replacement methods [
31].
The KDQOL-36™ is considered reliable and to have good reproducibility, as indicated by the high ICC value of >0.98 in all of the subscales. For test-retest reliability, an ICC of 0.70-0.86 demonstrated the stability of the scale over time [
32]. The Kappa Index of 0.68-1 and Weighted Kappa of 0.73-1 indicated a substantial to perfect agreement across various items in test and retest reliability [
33]. The Cronbach’s alpha values suggested that the scale is internally reliable. The internal reliability of all of the subscales exceeded 0.65, with the exception of the PCS and MCS. As mentioned, the item selection for the PCS may need to be revised using the Hong Kong specific version to replace the standard version. The relatively low Cronbach’s alpha for the MCS could have been affected by the fewer items in the scale. Any instrument with more than 14 items may have a higher Cronbach’s alpha value even if the items reflect different underlying constructs [
34].