THE ASIAN DIABETES QUALITY OF LIFE QUESTIONNAIRE

JOURNAL OF MEDICAL RESEARCH THE ASIAN DIABETES QUALITY OF LIFE QUESTIONNAIRE: VALIDITY AND RELIABILITY STUDY IN VIETNAMESE TYPE DIABETES MELLITUS PATIENTS, 2017 Thang Nguyen Huu1, Thu Ha Nguyen Thi2, Thanh Pham Hai3, Kaung Wai Linn4 Institute for Preventive Medicine and Public Health, Hanoi Medical University, Hanoi City, Vietnam ²Master student of Hospital Management 25, Hanoi Medical University, Hanoi City, Vietnam, ³Public Health Student, year 2015- 2019, Hanoi Medical University, Hanoi City, Vietnam, ⁴Vejthani Hospital, Bangkok, Thailand The study was implemented to create a Vietnamese version of the Asian Diabetes Quality of Life Questionaire (AsianDQOL questionnaire), which was revised for Vietnamese type diabetes patients This study was methodologically designed to assess the reliability and validity of the AsianDQOL questionnaire The study was carried out in the Thanh Nhan Hospital at Hanoi City, in Vietnam Total 293 type diabetes patients constituted as the samples of the study The cultural adaptation process of the questionnaire was conducted in three phases: language validity, content validity, and pilot application Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were used to test the construct validity of the questionnaire The reliability of the AsianDQOL questionnaire was evaluated with Cronbach’s alpha internal consistency coefficient, item-total correlation, test-retest analysis, and parallel forms reliability The EFA revealed that the AsianDQOL questionnaire consists of 17 items for Vietnamese type diabetes group The CFA supported the five-factor questionnaire yielded by the EFA Good fit index values were obtained Cronbach’s alpha internal consistency coefficient ranged from 0.45 to 0.84 In addition, the item-total correlation, test-retest analysis, and parallel forms reliability of the questionnaire were not highly correlated The Vietnamese AsianDQOL questionnaire is a valid and reliable instrument to evaluate the level of quality of life in Vietnamese type diabetes patients Key words: quality of life; questionaire; type diabetes; Vietnamese, non-communicable disease I INTRODUCTION Diabetes is increasingly becoming the fastest growing non-communicable disease The prevalence of adult diabetes in 2014 doubled compared to 1980, rising from 4.7% to 8.5% [1] In November 2013, there were around 382 million people worldwide with diabetes, with new forms of life-threatening disability [2] In 2015, according to the IDF report, there Corresponding author: Nguyen Huu Thang Hanoi Medical University Email: thangtcyt@gmail.com Received: 05/11/2019 Accepted: 09/12/0219 46 were nearly 415 million people with diabetes worldwide [3] In 2009, the Asian had been bear 60% of the world diabetic population [4] In Viet Nam, there were over 3.5 million cases of diabetes in Vietnam in 2017 [5] Measurement of QOL has many roles in the field provides valuable information to help health workers and patients to work together to make the best possible choices for appropriate interventions Measurement of QOL is among widely used to assess changes the course of treatment, giving a holistic view of the effects of treatment and illness on the patient An increasing number of studies have JMR 124 E5 (8) - 2019 JOURNAL OF MEDICAL RESEARCH found there is impact of illness on the QOL of patients such as cancer, hypertension, chronic renal failure, hip replacement and diabetes For example, the Adam Lloyd’s study at the United Kingdom in 2001 has been carried out that the complications of type diabetes have a significant impact on the QOL [6] What we know about measurement of QOL at Vietnamese type diabetes mellitus (T2DM) group was based on using the 36-Item Short Form Survey (SF-36) questionnaire [7;8] On the questionnaire to a different culture11 The AsianDQOL questionnaire had 21 variables so the minimum of sample size with 10% extra was 231 We also took 30 patients from the pre-test to check the language, which means that our minimum sample size was 261 subjects Measurements This cross-sectional study was carried out in the Endocrinology Clinic, Department of Diabetes, Thanh Nhan Hospital, Hanoi, Viet Nam All participants had been interviewed from September to November, 2017 Introductory Features Form This form consists of questions relating to certain demographic co-morbidities and treatment characteristics of the Vietnamese T2DM patients (such as age, occupation, education level, health insurance or duration of diabetes mellitus) The Asian Diabetes Quality of Life Questionnaire The instrument used was a questionnaire, includes information about the subject, was translated from the Asian DQOL questionnaire10 which had been developed, tested and applied in different languages: English, Malay/Indonesia and Chinese/Mandarin An initial questionnaire in Vietnamese language was drafted based on the English version The Vietnamese version questionnaire was translated by a team member of researcher from English to Vietnamese After that, an independent English translation had translated the Vietnamese version questionnaire back to English version to test the reliable of translation This initial draft comprised of 21 questions and items These items included: Financial, Memory, Energy, Diet and Relationship The choices of answers were in a 5-point rating scale ranging from ‘‘very dissatisfied’’ to ‘‘very satisfied’’ Each answer provided a score Sample size and sampling Data collection The acceptable sample size that should be taken for factor analysis was 10 times as many observations as the number of variables to be analysed in a reliable factor analysis for adapting All the data in our study was input by the Epidata 3.1 software The software application used to analyse the data were SPSS 23.0 for Windows (SPSS Inc., Chicago, IL, USA) and the other hand, in a recent issue of Diabetes Care, Hill-Briggs et al found out that the SF36 did not improve in a population whose outcomes to be measured [9] There is a need a validation and reliability tools for measuring QOL with Vietnamese T2DM patients With this in mind, we tried to test the Asian Diabetes QOL (AsianDQOL) Questionnaire, which was standardized in Malaysia [10], to find a standardized questionnaire that measures QOL in Vietnamese T2DM patients II METHODS Research participants The study population consisted of the patients receiving treatment for T2DM at Thanh Nhan Hospital The inclusion criteria were including the T2DM patients who were volunteer to participate to the study Study settings and study time JMR 124 E5 (8) - 2019 47 JOURNAL OF MEDICAL RESEARCH AMOS 23.0 (Karagöz, 2016) Data analysis and statistical method Adapting in Vietnamese cultural The Vietnamese cultural adaptation process of the questionnaire was organized as following two sections: language validity and content validity During this stage, the AsianDQOL questionnaire was translated from English to Vietnamese by the researchers In order to identify language validity, a pre-test was conducted with the sample size of 30 The Cronbach’s Alpha of the total questionnaire was 0.88, which showed no statement in the questionnaire was misunderstood Testing of the Asian Diabetes Quality of Life Questionnaire Validity Factor analysis was chosen to determine the construct validity of the questionnaire, KaiserMeyer-Olkin (KMO) analysis to determine the sample adequacy, and Bartlett’s test of sphericity to determine the sample test size The theorem asserts that the KMO should be above 0.60 and the result of Bartlett’s test of sphericity should be statistically significant [11] The system comes complete with the principal component analysis with the varimax rotational used to make the factor pattern more invariant [11] It was connected to CFA to support the findings regarding the sub dimensions of the questionnaire On combining this result with others, we concluded that the lower limits of the model’s data fitness index were defined as follows: X2/df ratio from CFA ≤ 5, RMSEA ≤ 0.08, and GFI, CFI, and IFI values > 0.90 [11] Reliability The aim of Cronbach’s alpha internal consistency coefficient is to examine the reliability of Likert-type scales A measuring tool is considered unreliable if the Cronbach’s alpha coefficient is below 0.40, poorly reliable 48 if it ranges from 0.40 to 0.59, highly reliable if it ranges from 0.60 to 0.79, and very reliable if it ranges from 0.80 to 1.00 [12] The itemtotal correlation coefficients are positioned on examine the relationship between the scores from the AsianDQOL questionnaire test items and the total test score A coefficient greater than 0.20 was considered acceptable when selecting the items [12] Cut-off point The cut-off point had been based on the quartile of the validated Vietnamese questionnaire Ethical issues In the process of adapting the AsianDQOL questionnaire to the Vietnamese culture, Professor Khalid Abdul Kadir was first contacted via e-mail, and permission was obtained to use the questionnaire Subsequently, to carry out the study, written permission was acquired from the Thanh Nhan Hospital institution where the study was conducted In addition, the participants were informed about the research and notified that their personal data would be kept confidential Finally, voluntary participants were enrolled in the study II RESULTS Demographic of the Vietnamese type diabetes mellitus group Of the study population, 293 subjects completed and returned the questionnaire 159 subjects were men (54.3%) and 134 (45.7%) women The mean age was 62.8 (±9.52) There was 63.8% of participation of subjects of 60 years old and above The majority of those who responded has less than a high school education Just a small number of those interviewed reported that did not use health insurance (0.3%) Over half of those questioned reported that they had the duration JMR 124 E5 (8) - 2019 JOURNAL OF MEDICAL RESEARCH of diabetes mellitus (DM) for less than years The most co-morbidities were vision problem (11.6%) and hypertension (10.6%) Over 50% of the reporters did not use insulin for treatment of DM2 Validity The KMO analysis revealed a KMO coefficient of 0.849 in Vietnamese patients, while Bartlett’s test of sphericity revealed a X2 value of 2310.6 The test results were significant at p = 0.000 This indicates that the sample size was adequate and appropriate for factor analysis in Vietnamese T2DM patients’ groups The EFA to determine the validity of the 21-item AsianDQOL questionnaire used for Vietnamese T2DM patients resulted in factor loading of all items were greater than 0.5 (Table 2) Hence, a five-dimensional, 17-item AsianDQOL questionnaire was obtained for Vietnamese T2DM patients For the 17-item AsianDQOL questionnaire used for Vietnamese T2DM patients, the following fit index values were found after the CFA In the assessment, no good fit was found for the first model At this phase of the analysis, recommendations for modification were reviewed, and high covariances were found between items and (Future medical expenses and Financial burned family) Error covariances for these items were associated, and a second CFA model was applied After the modification, the following CFA fit index values were found in the second model showed an acceptable fit (Table 1) Figure 1: Confirmatory factor analysis for Vietnamese language questionnaire JMR 124 E5 (8) - 2019 49 JOURNAL OF MEDICAL RESEARCH Table CFA fit indices for Vietnamese type diabetes patients   X2 Df X2 /df CFI IFI GFI RMSEA Model 292.365 109 2.682 0.918 0.919 0.893 0.076 Model 255.270 108 2.364 0.934 0.935 0.905 0.068 Reliability The Cronbach’s alpha reliability analysis of the the 17-item AsianDQOL questionnaire used for Vietnamese T2DM patients resulted in the following internal consistency coefficients: 0.91 for the sub-dimension “financial”, 0.84 for the sub-dimension “memory”, 0.76 for the sub-dimension “energy”, 0.65 for the sub-dimension “diet”,0.45 for the sub-dimension “relationship” and 0.88 for the entire questionnaire (Table 2) The Asian DQOL questionnaire and its sub-dimensions were found to be highly reliable (p < 0.05) The item-total correlation coefficients of the Asian DQOL questionnaire were also examined The item-total correlation coefficients ranged from 0.09 to 0.70 in the Vietnamese T2DM patients There were items which were unacceptable levels: sexual desire, sexual problem and enjoy diet The correlation between each item and the total score was statistically significant (p < 0.05) Cut-off point The overall of total score to this Vietnamese version questionnaire was unexpected The median score was 44, the 25th centile score was 38 and 75th centile score was 48 Generally, we found values for score of 38 points and below was considered poor, 39 – 44 scores were moderate, 45 – 48 points were good and above 48 points was excellent QOL   Table Factor loadings and item-total correlations of the Vietnamese type diabetes patients Corrected Item-Total Factor loading Mean Financial burden family 0.87 2.87 1.17 0.65 Medical expenses difficulties 0.86 2.71 1.21 0.7 Future medical expenses 0.85 3.02 1.11 0.67 Financial burden 0.82 2.84 1.13 0.7 Medical cost 0.64 2.81 1.07 0.54 Scale items SD Correlation % Variance Explained Cronbach’s Alpha 72.91 0.91 Financial 50 JMR 124 E5 (8) - 2019 JOURNAL OF MEDICAL RESEARCH Factor loading Mean SD Corrected Item-Total Correlation Recent recall 0.81 2.25 0.9 0.55 Old recall 0.79 2.27 0.91 0.57 Recognition 0.77 2.19 0.92 0.49 Memory 0.7 2.23 0.91 0.54 Quality of work 0.87 2.61 0.99 0.51 Activities 0.83 2.63 1.03 0.52 Weak tired 0.6 2.54 0.96 0.46 Enjoy diet 0.77 2.6 0.92 0.17* Left out 0.72 2.18 0.91 0.42 Sad about diet 0.52 2.31 0.97 0.56 Sexual desire 0.84 2.93 0.28 0.09* Sexual problem 0.71 2.94 0.25 0.11* Scale items % Variance Explained Cronbach’s Alpha 66.99 0.84 68.14 0.76 58.92 0.65 64.46 0.45 Memory Energy Diet Relationship IV DISCUSSION The present study described the new QOL assessment tool in Vietnamese language version based on Viet Nam population The Vietnamese version questionnaire had been different in number of questions with the original questionnaire (17 questions compared with 21 questions) But versions of questionnaire had the same number of components (5 groups in both questionnaires) The most striking result to emerge from the data is that the relationship component had the Cronbach’s Alpha was < 0.5 As JMR 124 E5 (8) - 2019 expected, our experiments show that marital sexual activity declines with age and at older ages, substantial proportions of Vietnamese are sexually inactive The values are hardly distinguishable from Nicolosi A.(2005) who studied sexual activity, the prevalence of sexual dysfunction and related help-seeking behaviour among 6700 middle-aged and elderly people in Asia [13] The result could capture such this delicate information if the patients selfreported questionnaire [13; 14] We aware that our research may have 51 JOURNAL OF MEDICAL RESEARCH limitations The first is all the the participants were elderly The second is our sample size only focused in a province in Vietnam These limitations highlight evidence of the difficulty of collecting data and study place, all the subjects were outpatients and lack of valid instrument to refer V CONCLUSION To sum up, our findings pointed that the Vietnamese AsianDQOL questionnaire was valid and reliable with Vietnamese T2DM patients Further research planned is to test in younger Vietnamese T2DM patients with a new questionnaire develop from the AsianDQOL Further researches needed to establish whether the AsianDQOL questionnaire is suitable for all age Asian T2DM patients Acknowledgments We gratefully acknowledge the assistance provided by Thanh Nhan Hospital in support of our research REFERENCES Global Report on Diabetes (2016), Geneva, Switzerland: World Health Organization, Binh Van Ta (2007), The Fundamentals of Diabetes Mellitus Increase Blood Glucose Hanoi Medical Publishing Company IDF IDF Diabetes Atlas (2015) 7th edition Chan JCN, Malik V, Jia W, et al (2009) Diabetes in Asia: Epidemiology, Risk Factors, and Pathophysiology JAMA, 301(20), 21292140 doi:10.1001/jama.2009.726 International Diabetes Federation (IDF) (2017) IDF Western Pacific members https:// www.idf.org/our-network/regions-members/ western-pacific/members/119-vietnam.html Published 2017 Accessed June 19, 2018 52 Lloyd A, Sawyer W, Hopkinson P (2001) Impact of Long-Term Complications on Quality of Life in Patients with Type Diabetes not Using Insulin Value Health, 4(5), 392 - 400 doi:10.1046/j.1524-4733.2001 45029.x Tuan Nguyen Dinh (2013), Quality of life of patients with type diabetes treatment outpatient at Le Loi hospital, Vung Tau city 2013 Xuan Nguyen Thi (2015), Quality of life of type diabetic patients in outpatient clinic at Me Linh district general hospital and some related factors in 2015 Hill-Briggs F, Gary TL, BaptisteRoberts K, Brancati FL (2005), Thirty-Six – Item Short-Form Outcomes Following a Randomized Controlled Trial in Type Diabetes Diabetes Care, 28(2), 443 - 444 doi:10.2337/ diacare.28.2.443 10 Goh SGK, Rusli BN, Khalid B a K Development and validation of the Asian Diabetes Quality of Life (AsianDQOL) Questionnaire Diabetes Res Clin Pract 108(3), 489 - 498 11 Hair JF, Black WC, Babin BJ, Anderson RE (2009), Multivariate Data Analysis (7th Edition) Prentice Hall, 100, 109 - 116 12 Bowling A, Ebrahim S (2005), Handbook of Health Research Methods: Investigation, Measurement and Analysis Open University Press, 397 13 Nicolosi A, Glasser DB, Kim SC, Marumo K, Laumann EO (2005), GSSAB Investigators’ Group Sexual behaviour and dysfunction and help-seeking patterns in adults aged 40 - 80 years in the urban population of Asian countries BJU Int, 95(4), 609 - 614 doi:10.1111/j.1464-410X.2005 05348.x 14 Hisasue S, Kumamoto Y, Sato Y, et al (2005), Prevalence of female sexual dysfunction symptoms and its relationship to quality of life: a Japanese female cohort study Urology, 65(1), 143-148 doi: 10.1016/j.urology.2004.08.003 JMR 124 E5 (8) - 2019 ... statement in the questionnaire was misunderstood Testing of the Asian Diabetes Quality of Life Questionnaire Validity Factor analysis was chosen to determine the construct validity of the questionnaire, ... selecting the items [12] Cut-off point The cut-off point had been based on the quartile of the validated Vietnamese questionnaire Ethical issues In the process of adapting the AsianDQOL questionnaire. .. characteristics of the Vietnamese T2DM patients (such as age, occupation, education level, health insurance or duration of diabetes mellitus) The Asian Diabetes Quality of Life Questionnaire The instrument