ORIGINAL ARTICLE Validity and Reliability of the Indonesian Version of Kidney Disease Quality of Life (KDQOL-. Questionnaire in Hemodialysis Patients at Hasan Sadikin Hospital. Bandung. Indonesia Rudi Supriyadi1. Fauliza Rakhima2. Rubin S. Gondodiputro1. Guntur Darmawan2,3 Division of Nephrology and Hypertension. Department of Internal Medicine. Faculty of Medicine Universitas Padjadjaran - Hasan Sadikin Hospital. Bandung. Indonesia. Department of Internal Medicine. Faculty of Medicine Universitas Padjadjaran - Hasan Sadikin Hospital. Bandung. Indonesia. Department of Internal Medicine. Faculty of Medicine. Krida Wacana Christian University. Jakarta. Indonesia. Corresponding Author: Rudi Supriyadi. MD. Division of Nephrology and Hypertension. Department of Internal Medicine. Faculty of Medicine Universitas Padjadjaran - Hasan Sadikin Hospital. Jalan Professor Eyckman No. Bandung. Jawa Barat, 40161. Indonesia. email: rudisdoc@gmail. ABSTRAK Latar belakang: prevalensi penyakit ginjal kronik (PGK) dan pasien dialisis meningkat setiap tahunnya di Indonesia. Pengaruh PGK dan dialisis terhadap kualitas hidup pasien merupakan bagian penting dalam tatalaksana PGK. Kuesioner Kidney Disease Quality of Life (KDQOL-. merupakan instrumen khusus penilaian kualitas hidup pasien PGK dan dialisis yang telah diterjemahkan di berbagai negara, namun belum pernah dilakukan di Indonesia. Penelitian ini bertujuan untuk menentukan validitas dan reliabilitas kuesioner KDQOL-36 versi bahasa Indonesia pada pasien di Indonesia. Metode: penerjemahan kuesioner KDQOL-36 ke bahasa Indonesia dan penerjemahan kembali ke bahasa Inggris dilakukan oleh penerjemah bersertifikat, dilanjutkan dengan penilaian kuesioner lebih lanjut oleh tim ahli. Kuesioner versi akhir diuji pada pasien hemodialisis rutin di Unit Hemodialisis RSUP. Dr. Hasan Sadikin Bandung. Validitas dianalisis dengan uji korelasi Pearson antara skor total skala target penyakit ginjal, kesehatan umum (SF-. dan seluruh skala dalam KDQOL-36. Konsistensi internal diuji dengan koefisien Cronbach Alpha dan reliabilitas dianalisis dengan uji test-retest. Hasil: subjek penelitian berjumlah 103 pasien, sebagian besar laki-laki . ,4%), dengan median usia 51 . tahun dan telah menjalani hemodialisis rata-rata 3,4 (SB 2,. Hasil uji validitas menunjukkan korelasi bermakna . <0,. antara skor total skala target penyakit ginjal. SF-12 dan setiap skor dalam skala tersebut. Seluruh skala dalam KDQL-36 menunjukkan reliabilitas tes-retest yang baik. Nilai reliabilitas konsistensi internal dapat diterima dengan nilai Cronbach Alpha Ou 0,7 untuk seluruh skala. Kesimpulan: kuesioner KDQOL-36 versi bahasa Indonesia memiliki validitas dan reliabilitas yang baik untuk menilai kualitas hidup pasien hemodialisis rutin. Kata kunci: KDQOL-36, validitas, reliabilitas, hemodialisis. ABSTRACT Background: the prevalence of chronic kidney disease (CKD) and dialysis patients is increasing every year in Indonesia. The impact of CKD and dialysis on patient quality of life (QOL) has been recognized as an important outcome measure in the management of CKD. The Kidney Disease Quality of Life (KDQOL-. has been validated and is widely used as a measure of QOL for CKD and dialysis patients in many countries, but not in Indonesia. The Acta Med Indones - Indones J Intern Med A Vol 51 A Number 4 A October 2019 Vol 51 A Number 4 A October 2019 Validity and reliability of the Indonesian version of KDQOL-36 questionnaire aim of this study is to determine the reliabity and validity of the Indonesian version of KDQOL-36 on hemodialysis patients in Indonesia. Methods: the KDQOL-36 was translated into Indonesian language by a certified translator and then it was back-translated into English. The translated questionnaire was further reviewed by an expert The final questionnaire was administered to hemodialysis patients in Hemodialysis Unit at Hasan Sadikin General Hospital. Validity was measured using PearsonAos correlation between the kidney disease-targeted scores, generic dimensions (SF-. scores and each scale score in KDQOL-36. The internal consistensy was assessed using CronbachAos Alpha and reliability was examined using test-retest. Results: out of 103 patients, we found that most subjects were male . 4%) with median age of 51 . The duration of hemodialysis was 3. 4 (SD The validity test showed a significant correlation . <0. on kidney disease-targeted total score. SF12 and each score of the scale within it. All of the KDQOL-36 scales showed good test-retest reliability. Internal consistency reliability values were acceptable, with CronbachAos Alpha >0,7 for all scales. Conclusion: the Indonesian version of the KDQOL-36 questionnaire is valid and reliable for evaluating QOL in reguler hemodialysis patients. Keywords: KDQOL-36, validity, reliability, hemodialysis. INTRODUCTION Chronic kidney disease (CKD) is a worldwide health problem, including Indonesia. 1,2 Chronic kidney disease and dialysis affects the patientAos quality of life in terms of physical, psychological, social, and environmental aspects. 3 Quality of life assessment is an important part in CKD 4,5 An evaluation instrument or questionnaire can provide accurate information on patientAos quality of life in order to select type of dialysis and to evaluate treatment 6,7 KDQOL-36 questionnaire is a special instrument to assess quality of life of CKD and dialysis patients. It has been used and translated into many languages with good validity and 8-11 To date, no questionnaire has been available in Indonesian language to assess patientAos condition and treatment. Therefore, it is important to have the Indonesian version of KDQOL-36 questionnaire. Moreover, considering cultural differences, we also need to make translation, cultural adaptation, validity, and reliability test. Our study aimed to analyze validity and reliability of the Indonesian version of KDQOL-36 in hemodialysis patients at Dr. Hasan Sadikin General Hospital. Bandung. METHODS The study was an analytic cross-sectional study, which was conducted at the Hemodialysis Unit of Dr. Hasan Sadikin General Hospital. Bandung between May and July 2016. This study has been approved by the Ethical Committee of Hasan Sadikin Hospital, reference number LB. 01/A05/EC/128/IV/2016. Subjects were patients who had regular or routine hemodialysis for more than 3 months. They were 18 years old or older, able to read and write in Indonesian language, and willing to participate in the Subjects with decreased consciousness and unable to have oral communication were Minimum sample size in this study was calculated using the Correlation Coefficient Hence, minimum sample size in this study was 102 subjects. The study consisted of 2 steps, the first step was translation and adaptation of KDOQL-36 questionnaire into Indonesian language and the second step was validity and reliability The first step was performed according to RAND corporate standard. 13 We had acquired the copyright to translate KDQOL-36 questionnaire from RAND corporate. The questionnaire was translated into Indonesian language by a certified translator and then it was translated back into English. An expert team consisted of 2 nephrologists and 1 certified translator then developed an adaptation of the translated We performed a normality test using Kolmogorov-Smirnov test. To analyze the construct validity, we used PearsonAos correlation test on total score of kidney disease-targeted score, generic score and each of the subscales Each scale in KDQOL-36 was considered Rudi Supriyadi Acta Med Indones-Indones J Intern Med valid when it showed statistically significant . <0. results with low . =0. 200 Ae 0. =0. 400 Ae 0. , high . =0. Ae 0. , or very high . : 0. 800 Ae 1. A reliability test was done using test-retest evaluation and internal consistency was estimated using CronbachAos alpha for each subscale of the KDQOL-36. The test- retest evaluation was performed in the form of 2 questionnaire interviews with 7 to 10 days Scale in KDQOL-36 was considered reliable when there was no significant difference found between the first and second measurement . > 0. Internal consistency was considered reliable when the reliability coefficient Cronbach Alpha was Ou 0. decrease in consciousness . , and hospitalized . Hence, a total of 103 subjects was included to data analyze (Figure . Baseline characteristics of these subjects were displayed in Table 1. RESULTS Occupation, n (%) The study was performed within 3 months, started from April 2016 until June 2016. Initially, there were 107 subjects. We performed first interview then repeated interview within 7-10 days later. Four subjects could not attend the second interview due to dyspnea . Chronic hemodialyzed 136 patients Characteristics Value Age (Yea. Median . Ae . Hemodialysis duration . Mean (SD) 4 . Sex - Male, n (%) 54 . Education, n (%) -- Elementary school 24 . -- Junior high school 16 . -- Senior high school/ vocational 32 . -- University 31 . -- Employed 25 . -- Unemployed 78 . Race, n (%) -- Sundanese 90 . -- Javanese 9 . -- Bataknese 2 . -- Minangnese 1 . -- Others 1 . Religion (%) -- Islam Exclusion criteria : Unable to be interviewed due to dyspnea, neurological problems, hearing loss, illiterate Included to the study: 107 patients First interview of Indonesian KDQOL 36 Second interview of Indonesian KDQOL 36: 103 patients Data analysis Figure 1. Indonesian KDQOL Study Algorithm Table 1. Baseline subject characteristics . -- Christian 1 . -- Catholic 2 . A very strong correlation was found between symptoms/problems and total score of kidney disease-targeted scale . = 0. A strong correlation was shown regarding the effect of kidney disease, burden of kidney disease scales and total scores of kidney disease-targeted scale, physical component summary, mental component summary and generic core . = 0. p < 0. Such results demonstrated that the KDQOL-36 questionnaire scales had a good (Table . A comparative test using paired t-test was used, which showed results presented in the form of mean score for each scale of KDQOL-36 The results were not statistically significant in the first and second measurement. The correlation test on the mean score of each scale of kidney disease- targeted scales and Vol 51 A Number 4 A October 2019 Validity and reliability of the Indonesian version of KDQOL-36 questionnaire Table 2. Validity test result of KDQOL-36 questionnaire Total score Scales Number of questions Correlation coefficient . * P value* -- Symptoms/problems <0. -- Effect of kidney disease <0. -- Burden of kidney disease <0. -- Physical Component Summary (PCS) <0. -- Mental Component Summary (MCS) <0. P value Correlation coefficient . ** Kidney disease target Generic core (SF-. *PearsonAos correlation test Table 3. Reliability test-retest result of KDQOL-36 questionnaire Mean (SD) Mean (SD) 09 . -- Effect of kidney disease 11 . -- Burden of kidney disease 69 . -- Physical Component Summary (PCS) 07 . -- Mental Component Summary (MCS) 99 . Scales Kidney disease target -- Symptoms/problems Generic core (SF-. SD=Standard deviation, *paired t-test, **PearsonAos correlation test mental function test between the first and second measurement demonstrated moderate to strong results . = 0. 635 Ae 0. The correlation test on the mean score of physical function between the first and second measurement showed moderately positive result . = 0. Such results indicated that all scales in the KDQOL-36 were reliable. The internal consistency test of all the subscales in the KDQOL-36 was very good with CronbachAos alpha values ranging from 0. 706 to 886 (Table . Table 4. Internal consistency test of the KDQOL-36 Number of CronbachAos -- Symptoms/problems -- Effect of kidney -- Burden of kidney -- Physical Component Summary (PCS) -- Mental Component Summary (MCS) Scales Kidney disease target Generic core (SF-. DISCUSSION Our study was the first study that provides formal translation of KDQOL-36 questionnaire into Indonesian language and it is also the first study analyzing its validity and reliability. Quality of life in patients with hemodialysis is worse throughout the time, which is affected by some factors. This questionnaire is important in measuring dialysis adequacy. The Indonesian version of KDQOL-36 is very useful for all Indonesian healthcare workers who are involved in hemodialysis care since some of the workers . urses, nutritionist, or student. are not fluent in English. We did some adaptation within translation of the questionnaire. The item of Aumoderate activities such as moving a table, pushing a Rudi Supriyadi vacuum cleaner, bowling, or playing golfAy was adapted to Aukegiatan sedang seperti memindahkan meja, menyapu atau mengepel, bersepeda, atau joging . oderate activities such as moving a table, sweeping or mopping, riding a bicycle, or joggin. Ay. Pushing a vacuum cleaner, bowling, or playing golf were considered uncommon activities in Indonesian community, therefore adaptation was made. We chose the substituting activities based on metabolic equivalent (MET) for moderate activities . -6 MET. 14-15 We adapted the item of Auclimbing several flights of stairsAy to Aumenaiki tangga beberapa lantai atau jalan menanjak . limbing several floors or uphill pathwa. Ay. The team agreed to make a slight change in adaptation due to accuracy in Indonesian language and various socio economic conditions in Indonesian communities as some of them do not have stairs in their house. Such adaptation in the questionnaire items has also been done by several countries such as Korea. Philippines. Egypt, and China during their adaptation of the KDQOL-36 and KDQOLSF. 8-10,16 Tao, et. did a change from Aubowling and playing golfAy to Auwalking and Tai ChiAy during the translation and validation of the KDQOL-36 into Chinese language. 16 Abd Elhafeez et al. 12 omitted Aubowling and playing golfAy during translation of the KDQOL-36 into Arabic language in Egypt. 8 AuSeveral flights of stairsAy was translated to Au 1 or more floorsAy in Egypt and to Au3 or 4 floorsAy in Korea. 8,10 Adaptation has been done due to different social and cultures in each country and intended to acquire equal understanding with the original Another change in our translated KDQOL-36 was Auaccomplished less than you would likeAy to Aumenyelesaikan pekerjaan kurang sesuai dengan yang diharapkan . ccomplished less equal than you would lik. Ay in order to ease understanding. Answer choice for questions in subgroup Auhow do you feel and how things have been with you during the past 4 weeksAy was changed from Auenough timeAy to Ausering . Ay, and answer choice for questions in subgroup Auhow true or false is each of the following statements for youAy was changed from Aumostly trueAy to Ausangat benar Acta Med Indones-Indones J Intern Med . ery tru. Ay and Aumostly falseAy to Ausangat salah . ery wron. Ay. Correlation test of the KDQOL-36 for kidney disease-targeted and generic score showed strong correlation . > 0. and the result was statistically significant . < 0. Hence, the Indonesian version of KDOQL-36 had good validity for all subscales. Our result was in accordance with results of studies in other countries. Thaweethamcharoen, et al. 17 in Thailand demonstrated a significant correlation between kidney disease target, physical component summary, and mental component summary . = 0. p < 0. 11 Similar findings were also demonstrated by Chen, et. with moderate correlation . = 0. within the scales. Our Indonesian questionnaire reliability test demonstrated a non-significant mean score of all scales between the first and second measurement . > 0. meanwhile internal consistency showed the CronbachAos alpha of Ou 0. 706 Ae . for all scales. The present study showed that the Indonesian version of the KDQOL-36 is Similar studies in other countries have also demonstrated good reliability and internal consistency with CronbachAos alpha of Ou 0. study in Thailand has shown a non-significant difference of test-retest result between the first and second measurement . > 0. with CronbachAos alpha of Ou 0. for all 11 Furthermore, studies in China and India have also demonstrated similar results. 17,18 Regarding the mean score for kidney disease target, our study demonstrated that the lowest score was found on the burden of kidney disease . and the highest score on the symptoms/problems . The result was similar to the study conducted in Thailand and Hong Kong. 11,16,19 Such result might be due to similarity of the subjectAos baseline characteristics including mean age, occupation, and duration of undergoing hemodialysis. Mean age of subjects 49 SD 15. in Thailand and 47. 6 (SD in Hong Kong with most subjects were unemployed and had undergone hemodialysis 8 (SD 3. 11,16 However, a study of Spanish version of the KDQOL-36 by Ricardo, et al. 20, which studied Vol 51 A Number 4 A October 2019 Validity and reliability of the Indonesian version of KDQOL-36 questionnaire Hispanic population in the United States of America showed that the highest mean score was in the effects of kidney disease. Higher level of education . 3% of subjectsAo education level were universit. and social cultural aspects might influence the result. Higher score in effects of kidney disease scale than other scales also showed that chronic kidney disease did not affect hemodialysis patientAos quality of life in the United States of America. There were some limitations in our study. First, it was conducted only in a single unit of medical center and further studies in several centers are still required to reduce bias in social and cultural aspects. Second, data collection was performed through one person interview since the subjects were not able to fill the questionnaire during hemodialysis treatment. Further studies should be carried out to evaluate interviewer factor and difference in data collection methods, which may affect subjectAos interpretation to the questions in the questionnaire. CONCLUSION Our study shows that the Indonesian version of the KDQOL-36 questionnaire has a good validity and reliability for evaluating QoL in routine hemodialysis patients at Dr. Hasan Sadikin General Hospital. Bandung. REFERENCES