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Saudi Journal of Kidney Diseases and Transplantation
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RENAL DATA FROM ASIA - AFRICA  
Year : 2015  |  Volume : 26  |  Issue : 6  |  Page : 1246-1252
Cross-cultural adaptation, validation and reliability of the South Indian (Kannada) version of the kidney disease and quality of life (KDQOL-36) instrument


1 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India
2 Department of Nephrology, Kasturba Medical College, Kasturba Hospital, Manipal University, Manipal, Karnataka, India
3 Department of Statistics, Manipal University, Manipal, Karnataka, India
4 Department of Health Management and Policy, Center for Global Health and College of Pharmacy, University of Michigan, MI, USA

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Date of Web Publication30-Oct-2015
 

   Abstract 

Health-related quality of life is an essential aspect concerned with the treatment outcomes. The main objective of the study is to evaluate the validity and reliability of the South Indian (Kannada) version of the Kidney Disease and Quality of Life-36 (KDQOL-36) instrument for hemodialysis (HD) patients. The KDQOL-36 instrument was validated by the committee of experts consisting of healthcare providers such as nephrologists (three), senior HD staff nurse (one) and clinical pharmacist (one). The measurement properties such as variability, reliability and validity were determined by administering the questionnaire to 82 patients on HD who were randomly selected from the HD units of three hospitals. The test and retest methods were used for reliability. Test-re-test reliability was assessed with a subsample of 45 patients by two administrations of the KDQOL-36 seven days apart. Data were collected through a face-to-face interview. It was evaluated computing intraclass correlation coefficients (ICC) and internal consistency estimated by computing Cronbach's-alfa. Reliability of each Kannada version of the KDQOL-36 sub-scale (symptoms/problems, burden of kidney disease, effects of kidney disease, physical component score [PCS] and mental component score [MCS] was good (Cronbach's-alfa >0.7, ranging from 0.72 to 0.77). The ICC ranged from 0.83 to 0.99 and the 95% confidence interval was 0.76-0.99 for test-retest of the KDQOL-36. The reliability measured with Cronbach's alfa, which was more than 0.72 and ICC ranged from 0.83 to 0.99, indicating that the Kannada version of the KDQOL-36 is reliable and valid for evaluating the health-related quality of life in Kannada-speaking HD patients.

How to cite this article:
Mateti UV, Nagappa AN, Attur RP, Nagaraju SP, Mayya SS, Balkrishnan R. Cross-cultural adaptation, validation and reliability of the South Indian (Kannada) version of the kidney disease and quality of life (KDQOL-36) instrument. Saudi J Kidney Dis Transpl 2015;26:1246-52

How to cite this URL:
Mateti UV, Nagappa AN, Attur RP, Nagaraju SP, Mayya SS, Balkrishnan R. Cross-cultural adaptation, validation and reliability of the South Indian (Kannada) version of the kidney disease and quality of life (KDQOL-36) instrument. Saudi J Kidney Dis Transpl [serial online] 2015 [cited 2020 Aug 4];26:1246-52. Available from: http://www.sjkdt.org/text.asp?2015/26/6/1246/168662

   Introduction Top


End-stage renal disease (ESRD) is a major public hazard affecting both developed and developing countries, including India. [1] In ESRD, initiation of renal replacement therapies, such as hemodialysis (HD) or peritoneal dialysis (PD) or transplantation, are usually indicated. [2]

In India, most of the ESRD patients depend upon HD due to the lack of finance support and ignorance. [3],[4] Health-related quality of life (HRQOL) is an important measure in ESRD because long-term HD often compromises the patient's ability to earn, affecting their financial income. As a result, the patients invariably depend on family income, and this has a negative effect on the marital status, family and social activities. The patients need to visit a dialysis center two to three times a week for HD. The patients have to depend on the health care staff and caregivers. [5] The ESRD patients with economic burden, dependency along with the morbidity of the disease are likely to feel negative and depressive. There is a need to take stock of the situation regarding the quality of life (QOL) and the components of social, pathological and ESRD-related morbidities. The outcome of the inventory of above would be able to identify the key factors and plan for diminishing their effects on the QOL of patients. The Kidney Disease Quality of Life (KDQOL) is a multi-dimensional kidney disease-specific HRQOL instrument that usually includes subjective evaluations of both positive and negative aspects of life. [6] The KDQOLShort form v.1.3, which contains the Short form-36 generic items and 43 kidney disease- specific items is developed by Hays et al; at present, the KDQOL-SF v.1.3 is developed to a shorter version known as the KDQOL-36 questionnaire. [7],[8] The KDQOL-36 subscale consists of both disease-specific (24-questions) and generic specific (12-questions) items [symptoms/ problems, burden of kidney disease and effects of kidney disease; physical component score (PCS) and mental component score (MCS)]. [9] The scale of the KDQOL-36 questionnaire is transformed into 0-100 scores, with higher scores reflecting better quality of life. The scale of scores computed with the KDQOL-36TM scoring program is available free for download online ( http://www.rand.org/health/surveys_tools/kdqol.html). The main objective of the study is to evaluate the validity and reliability of the South Indian (Kannada) Version of the KDQOL-36 instrument for HD patients.


   Materials and Methods Top


A cross-sectional study was conducted for a period of 12 months between April 2013 and March 2014 and three different outpatient HD units of teaching, government and corporate hospitals were considered in this study. Ethical approval (IEC-165/2013) was obtained from the Institutional Ethics Committee, Kasturba Hospital, Manipal, before the initiation of the study.

Cross-cultural adaptation and translation of KDQOL-36

The authorization to translate the KDQOL-36 questionnaire into the local language, Kannada, was obtained from its working group Research and Development (RAND) and authors. [7],[8] The questionnaire was modified to necessitate cultural appropriateness. For example, the modifications of the original KDQOL-36 for question number 2, pushing a vacuum cleaner, bowling or playing golf, was adapted to cooking, bathing, dressing, cleaning and walking. The original question 28a read as problems with your access site, which was modified to problems with fistula site to avoid confusion among patients. Question 28b, (meant for PD patients only) problems with your access site, was excluded for obvious reasons as the questionnaire was restricted to HD patients only. Validation of a KDQOL-36 questionnaire consists of three steps: Forward translation, backward translation and pilot testing.

Step 1: Forward translation

In this step, the KDQOL-36 questionnaire (English version) was administered for translation to Kannada by two independent professional translators. The translated Kannada version of the KDQOL-36 was referred back for review to the committee of experts related to healthcare of kidney conditions, for example nephrologists (three), senior HD staff nurse (one) and clinical pharmacist (one). Based on the suggestion of the expert committee, a "reconciliation" version of the KDQOL-36 was prepared.

Step 2: Backward translation

The aim of the backward translation is to cross-check any deviations/discrepancies existing in the translated version from the original questionnaire. The first version of the translated questionnaire of Kannada was subjected to back-translation into English. The translated version was compared with the original KDQOL-36 for any deviations in meaning of the contents. Both the versions matched perfectly and it was accepted. In case of deviations, the translation exercises were repeated till the matching version of the questionnaire was framed. The reconciled back-translation was then compared with the original English version.

Step 3: Pilot-testing

The pilot study was conducted for 12 ESRD patients on HD to determine the translated version in terms of cultural suitability and acceptability (instructions, items and response choices). Further observations on questionnaire were recorded regarding simplicity, ease of reading language and ability to understand.

Sampling and psychometric evaluation of KDQOL-36

The field test of the Kannada version of the KDQOL-36 was conducted on 82 patients of maintenance HD. Patients were selected randomly from the out-patient HD units from all the three centers. The inclusion criterion for choosing the patients was based on HD continuously for the preceding three months in the age group of 18-75 years, with written informed consent.

Ceiling and floor effects

The KDQOL-36 Kannada version was assigned 100% for ceiling and 0% for floor effects. In order to capture the full range of potential responses within the population, both the ceiling and floor effects should be <20%, and the change over time could be detected. [10]

Statistical analysis for reliability and validity of the KDQOL-36

Reliability was evaluated using an internal consistency and test-retest methods. Test-retest reliability was estimated with a subsample of 45 HD patients by two interviews seven days apart. For assessment of internal consistency reliability, the Cronbach's-alfa coefficient was computed. The Cronbach's-alfa value used as a measure of satisfactory internal consistency reliability was 0.70 or higher. [11] In order to assess the test-retest reliability, the intraclass correlation coefficient (ICC) was computed. Construct validity was evaluated by comparing the correlation coefficients between the kidney disease targeted dimensions among sub-scales with the European Quality of Life Visual Analog Scale (EQ-VAS). Pearson's correlation was applied to the normally distributed data variables and Spearman's rho when a criterion of normality was violated. Statistical Package for Social Sciences for windows (version 18) was used for the data analysis. The Pearson's two-tailed tests with P <0.05 were considered as statistically significant.


   Results Top


The HD patients were recruited randomly from teaching (n = 51), corporate (n = 20) and government (n = 11) hospital sectors, amounting to a total of 82 patients. The demographic distribution of the patients was mean ± SD age, 50.69 ± 12.32 years; gender-wise distribution, 71.91% men; duration of HD, 38.10 ± 25.31 months.

Floor and ceiling effects of the KDQOL-36

In the SF-12 scale, emotional well-being and role physical had the highest proportion of floor effects (47% and 42.2%, respectively). Roleemotional and role physical had the highest proportion of ceiling effects (60.2% and 41%, respectively). [Table 1] shows the distribution of central tendency and floor and ceiling effects of the Kannada version of the KDQOL-36.
Table 1: Mean scores and variability (standard deviation, floor and ceiling effects) of the Kannada version of the KDQOL-36 questionnaire among hemodialysis patients (N = 82).

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Reliability of the KDQOL-36

Reliability of the Kannada version of the KDQOL-36 subscale (burden of kidney disease, symptoms/problems, effects of kidney disease, PCS and MCS) was good (Cronbach's alfa >0.7, ranging from 0.72 to 0.77). The detailed description of reliability of corrected item-total correlation and Cronbach's alfa if item deleted in the Kannada version of the KDQOL-36 was as summarized in [Table 2]. Intraclass correlation coefficients ranged from 0.83 to 0.97 and the 95% confidence interval was 0.83-0.99 for test-retest of the Kannada version of the KDQOL-36 [Table 3].
Table 2: The Cronbach's alfa values of Kannada version of the KDQOL-36 questionnaire among hemodialysis patients (N = 82).

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Table 3. Test–retest values of the Kannada version of the KDQOL-36 questionnaire among hemodialysis patients (N = 45).

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Construct validity of the KDQOL-36

The EQ-VAS in kidney disease targeted subscales were correlated with symptoms/problems, effects of kidney disease (P <0.0001) and burden of kidney disease (P <0.05). In the SF12, scales were correlated with pain, roleemotional, social functioning (P <0.05) and role-physical (P <0.0001) [Table 4].
Table 4. Correlation between the domains of the Kannada version of the KDQOL-36 and the VAS scale (N = 82).

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   Discussion Top


This study reported the variability, reliability and validity of the Kannada version of the KDQOL-36 among Kannada-speaking HD patients. Differences between regions and populations require cross-cultural adaptation, validity and reliability assessment of measurement instruments. [12] In India, this is the first validation and reliability study of the KDQOL-36 Kannada version instrument, where, in the field test, for the distribution of responses to specific items domain by the floor and ceiling effects were documented. The emotional well-being was reported to be the highest proportion of floor effect in our study, in contrary to the observations reported in other studies. [7],[13],[14],[15] However, the role-emotional was reported to be the highest proportion of ceiling effect in our study. These findings were similar to those demonstrated by Park et al and El Hafeez et al. [14],[15]

In our study, the internal consistency for the reliability was acceptable for the entire Kannada version of the KDQOL-36 domain items (Cronbach's alfa >0.729). These findings were comparable to the study conducted on validity and reliability of the KDQOL-36 in Thai HD patients. [15] The Kannada KDQOL-36 domain items met the minimal recommended ICC 0.7 requirements in terms of the test-retest reliability evaluation. The findings were comparable to the results reported by Park et al, [14] ElHafeez et al, [15] Thaweethamcharoen et al, [16] Klersy et al [17] and Bataclan et al [18] For the construct validity, all the items of the ESRD targeted sub-scales were confirmed by the positive correlations of the EQ-VAS with kidney disease-targeted scales. These results were consistent with studies conducted by Thaweethamcharoen et al [16] and Joshi et al [19] However, the EQ-VAS was not correlated with physical functioning, general health, emotional wellbeing and energy/fatigue.


   Conclusion Top


In summary, the reliability measured with Cronbach's alfa, which was more than 0.72, and ICC ranged from 0.83 to 0.99, indicating that the Kannada version of the KDQOL-36 is reliable and valid for evaluating the HRQOL in Kannada-speaking HD patients.


   Acknowledgments Top


The authors would like to thank all the patients who actively participated in the present study. Their deepest thanks are due to Dr. Manohar Bairy, Department of Nephrology, Kasturba Medical College, Manipal for his valuable suggestions. The authors would also like to place on record their gratitude to the Hospitals of Hemodialysis Centres for giving permission to conduct this study. Finally, special thanks are due to the Manipal College of Pharmaceutical Sciences, Manipal University for providing the research facilities.

Conflict of interest: None

 
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Bataclan RP, Dial MA. Cultural adaptation and validation of the Filipino version of kidney disease quality of life - Short form (KDQOL-SF version 1.3). Nephrology (Carlton) 2009;14:663-8.  Back to cited text no. 18
    
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Correspondence Address:
Anantha Naik Nagappa
Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka - 576 104
India
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DOI: 10.4103/1319-2442.168662

PMID: 26586066

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