International Journal of Rheumatic Diseases 2015; 18: 360–365
ORIGINAL ARTICLE
Translation, cultural adaptation and validation of the WHO fracture risk assessment tool (FRAXâ) into Bengali Md. Nazrul ISLAM,1,2 Nira FERDOUS,2 Peter M. TEN KLOOSTER,3 M. Sheikh Giash UDDIN,2 Salma NASRIN,2 Bipasha PAL2 and Johannes J. RASKER3 1
Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), 2Modern One Stop Arthritis Care and Research Centerâ (MOAC&RCâ), Dhaka, Bangladesh, and 3Department of Psychology, Health and Technology, University of Twente, Enschede, the Netherlands
Abstract Aim: To develop a translated and culturally adapted Bengali version of the WHO Fracture Risk Assessment Tool (FRAXâ) and to test its feasibility, content validity and reliability. Method: The English FRAX was translated and culturally adapted for use in Bangladeshi populations following established forward–backward translation methods and being extensively field-tested. The final version was interviewer-administered to 130 consecutive osteoporotic patients between 40 and 90 years of age. For test–retest reliability, the questionnaire was re-administered after 14 days in 60 odd serial-numbered patients. Results: To better match with the Bengali culture, several adaptations were made to the FRAX items, including replacements and additions for tobacco, prednisolone and alcohol use. The response rate of the pre-final Bengali version of FRAX was 100% and all patients could understand the questions. Test–retest reliability (Pearson’s r) in osteoporotic patients was > 0.93 for all items. Conclusion: The culturally adapted Bengali version of the FRAX appears to be an acceptable and reliable instrument. Further studies are needed to confirm the ability of the tool to accurately predict the 10-year probability of hip and major osteoporotic fractures in the Bengali population. Key words: Bangladesh, Bengali, cross-cultural adaptation, FRAX fracture risk assessment tool, osteoporosis.
INTRODUCTION The National Institute of Health (NIH) consensus statement defines osteoporosis as a skeletal disorder characterized by compromised bone strength that results in an increased risk of fracture.1 Worldwide, an osteoporotic fracture (fragility fracture or low trauma fractures) is estimated to occur every 3 s and a vertebral fracture every 22 s.2 One in three women over 50 years of age
Correspondence: Professor Dr Md. Nazrul Islam, Rheumatology Wing, Deptartment of Medicine, Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbagh Rd, Dhaka, Bangladesh. Email: [email protected]
will experience an osteoporotic fracture, as will one in five men.3 Fractures of the hip and spine are associated with an increased mortality rate of 10–20%.4 In Europe, the disability due to osteoporosis is, with the exception of lung cancer, greater than that caused by cancer.5 Bone mineral density (BMD) measurement is currently the method of reference for evaluating fracture risk and opting for treatment.6 However, in many parts of the world there is a lack of availability to check BMD and such an investigation is too expensive to be used as a treatment threshold for osteoporosis. Moreover, BMD diagnosis does not consider clinical risk factors for osteoporosis, such as smoking, alcohol consumption and corticosteroid use. To overcome these limitations, a World Health Organization (WHO) task force introduced a
© 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd
Development of the Bengali FRAX tool
fracture risk assessment tool (FRAXâ) in 2008. FRAX estimates the 10 years probability of fracture and major osteoporotic fracture (hip, spine, proximal humerus, or forearm) for untreated patients between ages 40 and 90 years, using easily obtainable risk factors for fracture as well as femoral neck BMD when available.7–12 The FRAX tool has been validated in many different countries and frequently translated into local languages. In these studies, the items in the FRAX were not adapted due to no or negligible differences in culture. However, in the Bengali culture, most women and some men take tobacco orally instead of smoking it. Moreover, the use of self-medication and selling of corticosteroids over the counter without prescription makes self-reported recall about steroid intake necessary in Bangladesh. Information regarding alcohol intake is another issue, due to social and religious grounds and availability. People with a license can buy regular alcohol beverages legally, but most other users take home-made alcohol called Deshi Mod or Cholai or other beverages. Thus, several questions in the FRAXâ are likely to require rigorous cultural adaptation for use in the Bengali culture. There are now 220 million Bengali-speaking people all around the world, which will increase up to 450 million by 2025 according to a UN census, and Bengali-speaking people are the seventh biggest linguistic community in the world.13 A valid and reproducible Bengali version of the FRAX would enable the comparison of results and experiences of various therapeutic interventions in this large population. Therefore, the aim of this study was to translate and culturally adapt the English FRAX into Bengali and to examine the content validity and reliability of the tool in Bangladeshi osteoporotic patients.
MATERIALS AND METHODS The study was approved by the Ethics Committee of the Bangabandhu Sheikh Mujib Medical University and performed in accordance with the Declaration of Helsinki principles. Informed verbal consent was obtained from all participants before enrolment.
The FRAXâ tool The original WHO FRAX fracture risk assessment tool contains 10 items. The items are age, height, body weight, previous fracture, parent hip fracture, smoking, glucocorticoid therapy, rheumatoid arthritis, secondary osteoporosis and alcohol intake. Response categories are ‘yes’, ‘no’, or ‘don’t know’.14
International Journal of Rheumatic Diseases 2015; 18: 360–365
Translation and cultural adaptation of the FRAX tool We followed the proposed guidelines by Beaton et al.15 for the translation and cultural adaptation of the FRAX. Two independent forward translations of the English FRAX into Bengali were done by two translators (one rheumatologist and another by a naive translator, both with Bengali as their mother tongue). A synthesis version was developed by the translators and other authors. The synthesized version was back-translated into English by a university teacher who worked in the UK for 6 years and is a professional English translator. Both were blind to the original English version and naive to the concept being measured. An expert committee that included health professionals (rheumatologists, methodologists, language professionals) and the translators involved in the process reviewed all translations and verified the semantic, idiomatic, experiential and conceptual equivalence between the source and the Bengali version. Consensus was reached on any discrepancy, and a preliminary Bengali version of the questionnaire was developed for field-testing to check face and content validity. The translation was straightforward for most items and the response choices, except for items 4, 6, 7 and 10, which required content-related changes or additions. In item 4 (previous fracture), ‘not due to trauma or an accident’ was added to the question. In item 7 (glucocorticoid therapy), ‘white tablets like cucumber seeds/cortan/deltasone/delta’ was added and in item 8 (rheumatoid arthritis) was supplemented with ‘arthritis associated with aging’. The English word ‘hip’ in item 5 (parent hip fracture) was kept in brackets after the Bengali word ‘Kuchki’ and different forms of tobacco use were added to question 6 (smoking) along with translations. Finally, for item 10 (alcohol intake), different available alcoholic beverages in Bangladesh were added, including Bangla Mod or Raw Cholai, Fine Brandy by Keru and Co., Sprit, Mixture Cholai, Dochuani, Tari, Chubichi, and Pochani or Chu. Internationally, one unit of alcohol is equivalent to 8–10 g of alcohol, although slight variations exists between countries. Following milliliter to gram conversions for alcohol,16 for one unit of alcohol, the corresponding milliliters were added to each beverage (Bangla Mod or Raw Cholai 67 mL, Fine Brandy by Keru and Co. 25 mL, Sprit 12 mL, Mixture Cholai 172 mL, Dochuani 27 mL, Tari 345 mL, Pochani or Chu 77 mL and Chubichi 230 mL).
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Field-testing of the pre-final version The pre-final Bengali FRAX was pretested in a convenience sample of 60 male and female patients between 40 and 90 years of age attending the outpatient department of medicine of a medical university or an arthritis care and research center. After informed consent, the questionnaire was administered by an interviewer and subjects were probed about their thoughts regarding the meaning of each item and the chosen response in an open-ended manner. The participants were encouraged to describe their way of expressing the items and any suggestions on the items. The final retranslated and adapted questions were incorporated into the final version after discussion with the expert committee.
Table 1 Demographic information and response rates on the pre-final Bengali FRAX (n = 60) Item 1 2 3
Statistical analysis Test–retest repeatability was measured by Pearson correlation coefficients (r). Content validity was assessed by two experts in the field. Each expert rated each item as 1 (agreed), 0 (underdetermined), or 1 (disagreed). The index of content validity (ICV) of each item was calculated using summation of scores from each expert divided by the number of experts.17
RESULTS Survey of the pre-final version The pre-final Bengali version of the FRAX was tested in 60 outpatients. Forty patients (67%) were female. The mean age, weight and height were 52.5 years, 65.3 kg and 157.9 cm, respectively (Table 1). Most questions were well understood by the respondents. Nineteen patients (31.7%) required further explanation of kuchki or hip joint, one patient (1.7%) mentioned that the names of the drugs were uncommon and 50 patients (83.3%) failed to correctly name
362
Age Weight in kg Height in cm
Mean (SD)
Range
52.5 (7.7) 65.3 (12.2) 157.9 (7.5)
40–72 37–91 140.0–172.5
Response 4 5
6
Broken bone in adult life from low-level injury Broken hip of parents in adult life from low-level injury Current tobacco user
7
Ever taken prednisolone (glucocorticoids)
8
Ever been diagnosed with RA Ever had any of the conditions outlined overleaf On average drink three or more units each day
Further testing of the final version Patients and data collection A total of 130 consecutive male and female osteoporotic patients aged 40–90 years were enrolled for further testing of the reproducibility, feasibility and content validity and of the final Bengali FRAX. The amount of time required to fill in the form was recorded. All odd serial-numbered patients (n = 65) were requested to complete the FRAX again 14 days after the first enrolment. BMD measures of femoral neck and lumbar spine were performed and patients were classified into the WHO categories of ‘normal’, ‘osteopenia’ and ‘osteoporosis’ based on their T-scores.
FRAX question
9
10
n (%)
Yes No Yes No
4 (6.7) 56 (93.3) 4 (6.7) 56 (93.3)
Yes No Yes No Don’t know Yes No Yes No
21(35) 39 (65) 12 (20) 47 (78.3) 1 (1.7) 30 (50) 30 (50) 21 (35) 39 (65)
Yes No
0 (0) 60 (100)
their disease and were not aware of the names of other diseases. Medical record checks were required in all patients to complete the questionnaire. The mean time required to complete the FRAX questionnaire was 8 (SD = 2) min.
Survey of the final version Out of 130 osteoporotic patients, 125 (96.2%) were female and five (3.8%) male. The mean age, weight and height of the patients were 63.9 years, 52.3 kg and 148.6 cm, respectively (Table 2). According to neck BMD, 80 patients (61.5%; 73.8% by spine) were classified as having osteoporosis, 47 patients (36.2%; 19.8% by spine) as having osteopenia and three patients (2.3%; 6.3 by spine) were normal. Most prevalent comorbid diseases are listed in Table 3. According to the FRAX, 50 patients (38.5%) had a 10-year hip fracture probability ≥ 3%, while 22 patients (16.9%) had a 10year major osteoporosis-related fracture risk ≥ 20% (Table 4). Reliability From the 65 patients selected for the test–retest study, five were unable to complete the FRAX questionnaire again after 14 days due to family (n = 3) or distance
International Journal of Rheumatic Diseases 2015; 18: 360–365
Development of the Bengali FRAX tool
Table 2 Demographic information and response rates on the final Bengali FRAX (n = 130) Item 1 2 3
FRAX question
Mean (SD)
Range
Age Weight in kg Height in cm
63.9 (8.6) 52.3 (9.0) 148.6 (5.5)
44–90 33–90 132.2–166.0
Response 4 5
6 7 8 9
10
Broken bone in adult life from low-level injury Broken hip of parents in adult life from low-level injury Current tobacco user Ever taken prednisolone (glucocorticoids) Ever been diagnosed with RA Ever had any of the conditions outlined overleaf On average drink three or more units each day
n (%)
Yes No Yes No
15 (11.5) 115 (88.5) 8 (6.2) 122 (93.8)
Yes No Yes No Yes No Yes No
25 (19.2) 105 (80.8) 37 (28.5) 93 (71.5) 62 (47.7) 68 (52.3) 42 (32.3) 88 (67.7)
Yes No
0 (0) 130 (100)
Table 3 Disease profile of the patients (n = 130) Disease Rheumatoid arthritis Hypertension Knee osteoarthritis Type 2 diabetes mellitus Lumbar spondylosis Ischemic heart disease Type 1 diabetes mellitus Ankylosing spondylosis Cervical spondylosis Bronchial asthma Cushing’s disease Other†
n (%) 62 (47.7) 27 (20.8) 24 (18.5) 11 (8.5) 10 (7.7) 9 (6.9) 8 (6.2) 7 (5.4) 7 (5.4) 5 (3.8) 5 (3.8) 42 (32.3)
†Stroke, prolapsed lumbar intervertebral disc, spondyloarthritis, chronic kidney disease, hypothyroid, parkinsonism, vasculitis, dyslipidaemia, rotator cuff disease, diffuse parenchymal lung disease, Sj€ ogren’s syndrome, peripheral neuropathy, ulcerative colitis, spondylolisthesis.
(n = 2) problems. Patient characteristics and the results of the test–retest study are shown in (Table 5). Test–retest repeatability (Pearson’s r) was 0.98 and 0.99 for weight and height, respectively. For all other items, reliabilities were perfect except for RA diagnosis (r = 0.93).
International Journal of Rheumatic Diseases 2015; 18: 360–365
Table 4 Distribution of patients (n = 130) according to their 10-year major osteoporosis-related and hip fracture probability Major osteoporosis fracture ≤ 10% 11–20% ≥ 20% Total
Hip fracture (%)
Total (%)
< 3%
≥ 3%
67 (51.5) 13 (10.0) 0 80 (61.5)
1 (0.8) 27 (20.8) 22 (16.9) 50 (38.5)
68 (52.3) 40 (30.8) 22 (16.9) 130 (100)
Table 5 Test-retest reliability of the final Bengali FRAX (n = 60) Item 2 3
4 5
6 7 8 9
10
FRAX question
Test Mean (SD)
Retest Mean (SD)
r
Weight in kg Height in cm
52.3 (9.4) 148.5 (5.7)
52.3 (9.5) 148.5 (5.7)
0.98 0.99
Broken bone in adult life from low-level injury Broken hip of parents in adult life from low-level injury Current tobacco user Ever had prednisolone (glucocorticoids) Ever been diagnosed with RA Ever had any of the conditions outlined overleaf On average drink three or more units each day
N (%)
N (%)
8 (13.3)
8 (13.3)
1.00
5 (8.3)
5 (8.3)
1.00
10 (16.7) 14 (23.3)
10 (16.7) 14 (23.3)
1.00 1.00
24 (40.0)
26 (43.3)
0.93
17 (28.3)
17 (28.3)
1.00
0 (0)
0 (0)
–
ICV The ICV of all items was 1 (agreed) as evaluated by the two experts.
DISCUSSION To be used across cultures, measures must not only be translated well linguistically, but also have to be adapted to the specific culture to maintain content validity at a conceptual level.15 This may involve changing or replacing items that are not experienced in the target culture.15,18 This study developed a translated and culturally adapted version of the FRAX that can be used in Bengali-speaking populations.
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The most important changes to the FRAX were made for the items about smoking and alcohol consumption. Although cigarette smoking is a well-established risk factor for osteoporosis, smokeless tobacco use also accelerates the age-related loss of BMD.19 Use of tobacco in Bangladesh is very diverse. Men generally prefer smoking, sometimes in addition to chewing with betel nut, gul and khoinee. On the other hand, most women prefer using tobacco as zorda or tamak pata (Sada pata) with betel nut or use gul or Khoinee. Also, more women than men use tobacco.20,21 Consequently, different forms of tobacco use needed to be added along with adequate translation. Additionally, the local names of different alcoholic beverages available in different parts of Bangladesh were added to the item about alcohol consumption. The wide variation in the strength of ethanol observed in the studied samples may be problematic due to the lack of definite guidelines, regulation and monitoring of production procedures or for dilution in Bangladesh. Assessing standard drinks or units of alcohol is difficult as the strength of ethanol is not labeled on the beverages and drink-related hazards cannot properly be addressed. So, we recommend the concerned agencies to come forward with more data to address these issues properly. The study had some weaknesses. There were more women than men in the series of 130 patients. Additionally, the FRAX was interviewer-administered, not only due to the low average level of education of participants, but also due to the poor understandability of medical terminology by more educated persons. In conclusion, the Bengali version of the interviewer-administered FRAX appears to be a feasible, reliable and valid instrument that supports a shift from current BMD-based strategies to the identification of patients at increased fracture risk. The new tool is recommended for use in both clinical decision-making and trials with Bengali-speaking patients to assess the risk of fragility fracture in 40- to 90year-old patients with osteoporosis. More and large epidemiological studies are needed to assess the true ability of the tool to predict the 10-year probability of hip and major osteoporotic fractures in the Bengali population. Until it is calibrated to the local epidemiology of fracture and mortality within this population, we recommend using established FRAX calculators8 of similar-cultured countries, such as India or Sri-Lanka.
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ACKNOWLEDGEMENTS The authors convey their regards and gratefulness to the honorable Professor Dr John A. Kanis, Professor Emeritus, University of Sheffield, and International Osteoporosis Foundation for kind permissions, active inspiration and valuable suggestions. We are thankful to Dr Mizan, Honorary Medical Officer, Bangabandhu Sheikh Mujib Medical University, for his cordial help. The authors remain ever grateful to all the patients for participating in this research. The project was funded by the Science and Technology Division of the Ministry of Science and Information and Communication Technology of the Government of the People’s Republic of Bangladesh.
CONFLICT OF INTEREST None of the authors responsible for this article have conflicts of interest of any kind.
REFERENCES 1 Osteoporosis prevention, diagnosis, and therapy. NIH Consensus Statement 2000, 17, 1–45. 2 Johnell O, Kanis JA (2006) An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporosis Int 17, 1726–33. 3 Kanis JA, Johnell O, Oden A et al. (2000) Long-term risk of osteoporotic fracture in Malm€ o. Osteoporosis Int 11, 669–74. 4 Ioannidis G, Papaioannou A, Hopman WM et al. (2009) Relation between fractures and mortality: results from the Canadian Multicentre Osteoporosis Study. CMAJ 181, 265–71. 5 Roux C, Fechtenbaum J, Kolta S et al. (2007) Mild prevalent and incident vertebral fractures are risk factors for new fractures. Osteoporosis Int 18, 1617–24. 6 Poole KE, Compston JE (2006) Osteoporosis and its management. BMJ 16, 1251–6. 7 Kanis JA, Johnell O, Oden A et al. (2008) FRAX and the assessment of fracture probability in men and women from the UK. Osteoporosis Int 19, 385–97. 8 FRAXâ WHO fracture risk assessment tool. Available from URL: http://www.shef.ac.uk/FRAX/index.aspx (Accessed 4 May 2014.) 9 Guyatt GH, Feeny DH, Patrick DL (1993) Measuring health-related quality of life. Ann Intern Med 118, 622–9. 10 Kanis JA, Borgstrom F, De Laet C et al. (2005) Assessment of fracture risk. Osteoporosis Int 16, 581–9. 11 Kanis JA, Oden A, Johnell O et al. (2001) The burden of osteoporotic fractures: a method for setting intervention thresholds. Osteoporosis Int 12, 417–27.
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Development of the Bengali FRAX tool
12 Kanis JA, Oden A, Johnell O et al. (2007) The use of clinical risk factors enhances the performance of BMD in the prediction of hip and osteoporotic fractures in men and women. Osteoporosis Int 18, 1033–46. 13 Bengali language. Available from URL: http://en.wikipedia.org/wiki/Bengali_language (Accessed 4 May 2014.) 14 Kanis JA, McCloskey EV, Johansson H et al. (2010) Development and use of FRAX in osteoporosis. Osteoporosis Int 21, S407–13. 15 Beaton DE, Bombardier C, Guillemin F et al. (2000) Guidelines for the process of cross-cultural adaptation of self-report measures. Spine 25, 3186–91. 16 What is a unit? Available from URL: https://www. drinkaware.co.uk/check-the-facts/what-is-alcohol/frequentlyasked-questions#what (Accessed 4 May 2014.) 17 Kuptniratsaikul V, Rattanachaiyanont M (2007) Validation of a modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis. Clin Rheumatol 26, 1641–5.
International Journal of Rheumatic Diseases 2015; 18: 360–365
18 Wagner AK, Gandek B, Aaronson NK et al. (1998) Crosscultural comparisons of the content of SF-36 translations across 10 countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol 51, 925–32. 19 Quandt SA, Spangler JG, Case LD et al. (2005) Smokeless tobacco use accelerates age-related loss of bone mineral density among older women in a multi-ethnic rural community. J Cross Cult Gerontol 20, 109–25. 20 World Health Organization (2008) WHO Report on the Global Tobacco Epidemic, 2008: The MPOWER Package. World Health Organization, Geneva. 21 Global Youth Tobacco Survey (2008) Bangladesh (Ages 13–15) Global Youth Tobacco Survey (GYTS) Fact Sheet. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta, GA.
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ORIGINAL ARTICLE
Translation, cultural adaptation and validation of the WHO fracture risk assessment tool (FRAXâ) into Bengali Md. Nazrul ISLAM,1,2 Nira FERDOUS,2 Peter M. TEN KLOOSTER,3 M. Sheikh Giash UDDIN,2 Salma NASRIN,2 Bipasha PAL2 and Johannes J. RASKER3 1
Department of Rheumatology, Bangabandhu Sheikh Mujib Medical University (BSMMU), 2Modern One Stop Arthritis Care and Research Centerâ (MOAC&RCâ), Dhaka, Bangladesh, and 3Department of Psychology, Health and Technology, University of Twente, Enschede, the Netherlands
Abstract Aim: To develop a translated and culturally adapted Bengali version of the WHO Fracture Risk Assessment Tool (FRAXâ) and to test its feasibility, content validity and reliability. Method: The English FRAX was translated and culturally adapted for use in Bangladeshi populations following established forward–backward translation methods and being extensively field-tested. The final version was interviewer-administered to 130 consecutive osteoporotic patients between 40 and 90 years of age. For test–retest reliability, the questionnaire was re-administered after 14 days in 60 odd serial-numbered patients. Results: To better match with the Bengali culture, several adaptations were made to the FRAX items, including replacements and additions for tobacco, prednisolone and alcohol use. The response rate of the pre-final Bengali version of FRAX was 100% and all patients could understand the questions. Test–retest reliability (Pearson’s r) in osteoporotic patients was > 0.93 for all items. Conclusion: The culturally adapted Bengali version of the FRAX appears to be an acceptable and reliable instrument. Further studies are needed to confirm the ability of the tool to accurately predict the 10-year probability of hip and major osteoporotic fractures in the Bengali population. Key words: Bangladesh, Bengali, cross-cultural adaptation, FRAX fracture risk assessment tool, osteoporosis.
INTRODUCTION The National Institute of Health (NIH) consensus statement defines osteoporosis as a skeletal disorder characterized by compromised bone strength that results in an increased risk of fracture.1 Worldwide, an osteoporotic fracture (fragility fracture or low trauma fractures) is estimated to occur every 3 s and a vertebral fracture every 22 s.2 One in three women over 50 years of age
Correspondence: Professor Dr Md. Nazrul Islam, Rheumatology Wing, Deptartment of Medicine, Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbagh Rd, Dhaka, Bangladesh. Email: [email protected]
will experience an osteoporotic fracture, as will one in five men.3 Fractures of the hip and spine are associated with an increased mortality rate of 10–20%.4 In Europe, the disability due to osteoporosis is, with the exception of lung cancer, greater than that caused by cancer.5 Bone mineral density (BMD) measurement is currently the method of reference for evaluating fracture risk and opting for treatment.6 However, in many parts of the world there is a lack of availability to check BMD and such an investigation is too expensive to be used as a treatment threshold for osteoporosis. Moreover, BMD diagnosis does not consider clinical risk factors for osteoporosis, such as smoking, alcohol consumption and corticosteroid use. To overcome these limitations, a World Health Organization (WHO) task force introduced a
© 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd
Development of the Bengali FRAX tool
fracture risk assessment tool (FRAXâ) in 2008. FRAX estimates the 10 years probability of fracture and major osteoporotic fracture (hip, spine, proximal humerus, or forearm) for untreated patients between ages 40 and 90 years, using easily obtainable risk factors for fracture as well as femoral neck BMD when available.7–12 The FRAX tool has been validated in many different countries and frequently translated into local languages. In these studies, the items in the FRAX were not adapted due to no or negligible differences in culture. However, in the Bengali culture, most women and some men take tobacco orally instead of smoking it. Moreover, the use of self-medication and selling of corticosteroids over the counter without prescription makes self-reported recall about steroid intake necessary in Bangladesh. Information regarding alcohol intake is another issue, due to social and religious grounds and availability. People with a license can buy regular alcohol beverages legally, but most other users take home-made alcohol called Deshi Mod or Cholai or other beverages. Thus, several questions in the FRAXâ are likely to require rigorous cultural adaptation for use in the Bengali culture. There are now 220 million Bengali-speaking people all around the world, which will increase up to 450 million by 2025 according to a UN census, and Bengali-speaking people are the seventh biggest linguistic community in the world.13 A valid and reproducible Bengali version of the FRAX would enable the comparison of results and experiences of various therapeutic interventions in this large population. Therefore, the aim of this study was to translate and culturally adapt the English FRAX into Bengali and to examine the content validity and reliability of the tool in Bangladeshi osteoporotic patients.
MATERIALS AND METHODS The study was approved by the Ethics Committee of the Bangabandhu Sheikh Mujib Medical University and performed in accordance with the Declaration of Helsinki principles. Informed verbal consent was obtained from all participants before enrolment.
The FRAXâ tool The original WHO FRAX fracture risk assessment tool contains 10 items. The items are age, height, body weight, previous fracture, parent hip fracture, smoking, glucocorticoid therapy, rheumatoid arthritis, secondary osteoporosis and alcohol intake. Response categories are ‘yes’, ‘no’, or ‘don’t know’.14
International Journal of Rheumatic Diseases 2015; 18: 360–365
Translation and cultural adaptation of the FRAX tool We followed the proposed guidelines by Beaton et al.15 for the translation and cultural adaptation of the FRAX. Two independent forward translations of the English FRAX into Bengali were done by two translators (one rheumatologist and another by a naive translator, both with Bengali as their mother tongue). A synthesis version was developed by the translators and other authors. The synthesized version was back-translated into English by a university teacher who worked in the UK for 6 years and is a professional English translator. Both were blind to the original English version and naive to the concept being measured. An expert committee that included health professionals (rheumatologists, methodologists, language professionals) and the translators involved in the process reviewed all translations and verified the semantic, idiomatic, experiential and conceptual equivalence between the source and the Bengali version. Consensus was reached on any discrepancy, and a preliminary Bengali version of the questionnaire was developed for field-testing to check face and content validity. The translation was straightforward for most items and the response choices, except for items 4, 6, 7 and 10, which required content-related changes or additions. In item 4 (previous fracture), ‘not due to trauma or an accident’ was added to the question. In item 7 (glucocorticoid therapy), ‘white tablets like cucumber seeds/cortan/deltasone/delta’ was added and in item 8 (rheumatoid arthritis) was supplemented with ‘arthritis associated with aging’. The English word ‘hip’ in item 5 (parent hip fracture) was kept in brackets after the Bengali word ‘Kuchki’ and different forms of tobacco use were added to question 6 (smoking) along with translations. Finally, for item 10 (alcohol intake), different available alcoholic beverages in Bangladesh were added, including Bangla Mod or Raw Cholai, Fine Brandy by Keru and Co., Sprit, Mixture Cholai, Dochuani, Tari, Chubichi, and Pochani or Chu. Internationally, one unit of alcohol is equivalent to 8–10 g of alcohol, although slight variations exists between countries. Following milliliter to gram conversions for alcohol,16 for one unit of alcohol, the corresponding milliliters were added to each beverage (Bangla Mod or Raw Cholai 67 mL, Fine Brandy by Keru and Co. 25 mL, Sprit 12 mL, Mixture Cholai 172 mL, Dochuani 27 mL, Tari 345 mL, Pochani or Chu 77 mL and Chubichi 230 mL).
361
Md. N. Islam et al.
Field-testing of the pre-final version The pre-final Bengali FRAX was pretested in a convenience sample of 60 male and female patients between 40 and 90 years of age attending the outpatient department of medicine of a medical university or an arthritis care and research center. After informed consent, the questionnaire was administered by an interviewer and subjects were probed about their thoughts regarding the meaning of each item and the chosen response in an open-ended manner. The participants were encouraged to describe their way of expressing the items and any suggestions on the items. The final retranslated and adapted questions were incorporated into the final version after discussion with the expert committee.
Table 1 Demographic information and response rates on the pre-final Bengali FRAX (n = 60) Item 1 2 3
Statistical analysis Test–retest repeatability was measured by Pearson correlation coefficients (r). Content validity was assessed by two experts in the field. Each expert rated each item as 1 (agreed), 0 (underdetermined), or 1 (disagreed). The index of content validity (ICV) of each item was calculated using summation of scores from each expert divided by the number of experts.17
RESULTS Survey of the pre-final version The pre-final Bengali version of the FRAX was tested in 60 outpatients. Forty patients (67%) were female. The mean age, weight and height were 52.5 years, 65.3 kg and 157.9 cm, respectively (Table 1). Most questions were well understood by the respondents. Nineteen patients (31.7%) required further explanation of kuchki or hip joint, one patient (1.7%) mentioned that the names of the drugs were uncommon and 50 patients (83.3%) failed to correctly name
362
Age Weight in kg Height in cm
Mean (SD)
Range
52.5 (7.7) 65.3 (12.2) 157.9 (7.5)
40–72 37–91 140.0–172.5
Response 4 5
6
Broken bone in adult life from low-level injury Broken hip of parents in adult life from low-level injury Current tobacco user
7
Ever taken prednisolone (glucocorticoids)
8
Ever been diagnosed with RA Ever had any of the conditions outlined overleaf On average drink three or more units each day
Further testing of the final version Patients and data collection A total of 130 consecutive male and female osteoporotic patients aged 40–90 years were enrolled for further testing of the reproducibility, feasibility and content validity and of the final Bengali FRAX. The amount of time required to fill in the form was recorded. All odd serial-numbered patients (n = 65) were requested to complete the FRAX again 14 days after the first enrolment. BMD measures of femoral neck and lumbar spine were performed and patients were classified into the WHO categories of ‘normal’, ‘osteopenia’ and ‘osteoporosis’ based on their T-scores.
FRAX question
9
10
n (%)
Yes No Yes No
4 (6.7) 56 (93.3) 4 (6.7) 56 (93.3)
Yes No Yes No Don’t know Yes No Yes No
21(35) 39 (65) 12 (20) 47 (78.3) 1 (1.7) 30 (50) 30 (50) 21 (35) 39 (65)
Yes No
0 (0) 60 (100)
their disease and were not aware of the names of other diseases. Medical record checks were required in all patients to complete the questionnaire. The mean time required to complete the FRAX questionnaire was 8 (SD = 2) min.
Survey of the final version Out of 130 osteoporotic patients, 125 (96.2%) were female and five (3.8%) male. The mean age, weight and height of the patients were 63.9 years, 52.3 kg and 148.6 cm, respectively (Table 2). According to neck BMD, 80 patients (61.5%; 73.8% by spine) were classified as having osteoporosis, 47 patients (36.2%; 19.8% by spine) as having osteopenia and three patients (2.3%; 6.3 by spine) were normal. Most prevalent comorbid diseases are listed in Table 3. According to the FRAX, 50 patients (38.5%) had a 10-year hip fracture probability ≥ 3%, while 22 patients (16.9%) had a 10year major osteoporosis-related fracture risk ≥ 20% (Table 4). Reliability From the 65 patients selected for the test–retest study, five were unable to complete the FRAX questionnaire again after 14 days due to family (n = 3) or distance
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Development of the Bengali FRAX tool
Table 2 Demographic information and response rates on the final Bengali FRAX (n = 130) Item 1 2 3
FRAX question
Mean (SD)
Range
Age Weight in kg Height in cm
63.9 (8.6) 52.3 (9.0) 148.6 (5.5)
44–90 33–90 132.2–166.0
Response 4 5
6 7 8 9
10
Broken bone in adult life from low-level injury Broken hip of parents in adult life from low-level injury Current tobacco user Ever taken prednisolone (glucocorticoids) Ever been diagnosed with RA Ever had any of the conditions outlined overleaf On average drink three or more units each day
n (%)
Yes No Yes No
15 (11.5) 115 (88.5) 8 (6.2) 122 (93.8)
Yes No Yes No Yes No Yes No
25 (19.2) 105 (80.8) 37 (28.5) 93 (71.5) 62 (47.7) 68 (52.3) 42 (32.3) 88 (67.7)
Yes No
0 (0) 130 (100)
Table 3 Disease profile of the patients (n = 130) Disease Rheumatoid arthritis Hypertension Knee osteoarthritis Type 2 diabetes mellitus Lumbar spondylosis Ischemic heart disease Type 1 diabetes mellitus Ankylosing spondylosis Cervical spondylosis Bronchial asthma Cushing’s disease Other†
n (%) 62 (47.7) 27 (20.8) 24 (18.5) 11 (8.5) 10 (7.7) 9 (6.9) 8 (6.2) 7 (5.4) 7 (5.4) 5 (3.8) 5 (3.8) 42 (32.3)
†Stroke, prolapsed lumbar intervertebral disc, spondyloarthritis, chronic kidney disease, hypothyroid, parkinsonism, vasculitis, dyslipidaemia, rotator cuff disease, diffuse parenchymal lung disease, Sj€ ogren’s syndrome, peripheral neuropathy, ulcerative colitis, spondylolisthesis.
(n = 2) problems. Patient characteristics and the results of the test–retest study are shown in (Table 5). Test–retest repeatability (Pearson’s r) was 0.98 and 0.99 for weight and height, respectively. For all other items, reliabilities were perfect except for RA diagnosis (r = 0.93).
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Table 4 Distribution of patients (n = 130) according to their 10-year major osteoporosis-related and hip fracture probability Major osteoporosis fracture ≤ 10% 11–20% ≥ 20% Total
Hip fracture (%)
Total (%)
< 3%
≥ 3%
67 (51.5) 13 (10.0) 0 80 (61.5)
1 (0.8) 27 (20.8) 22 (16.9) 50 (38.5)
68 (52.3) 40 (30.8) 22 (16.9) 130 (100)
Table 5 Test-retest reliability of the final Bengali FRAX (n = 60) Item 2 3
4 5
6 7 8 9
10
FRAX question
Test Mean (SD)
Retest Mean (SD)
r
Weight in kg Height in cm
52.3 (9.4) 148.5 (5.7)
52.3 (9.5) 148.5 (5.7)
0.98 0.99
Broken bone in adult life from low-level injury Broken hip of parents in adult life from low-level injury Current tobacco user Ever had prednisolone (glucocorticoids) Ever been diagnosed with RA Ever had any of the conditions outlined overleaf On average drink three or more units each day
N (%)
N (%)
8 (13.3)
8 (13.3)
1.00
5 (8.3)
5 (8.3)
1.00
10 (16.7) 14 (23.3)
10 (16.7) 14 (23.3)
1.00 1.00
24 (40.0)
26 (43.3)
0.93
17 (28.3)
17 (28.3)
1.00
0 (0)
0 (0)
–
ICV The ICV of all items was 1 (agreed) as evaluated by the two experts.
DISCUSSION To be used across cultures, measures must not only be translated well linguistically, but also have to be adapted to the specific culture to maintain content validity at a conceptual level.15 This may involve changing or replacing items that are not experienced in the target culture.15,18 This study developed a translated and culturally adapted version of the FRAX that can be used in Bengali-speaking populations.
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The most important changes to the FRAX were made for the items about smoking and alcohol consumption. Although cigarette smoking is a well-established risk factor for osteoporosis, smokeless tobacco use also accelerates the age-related loss of BMD.19 Use of tobacco in Bangladesh is very diverse. Men generally prefer smoking, sometimes in addition to chewing with betel nut, gul and khoinee. On the other hand, most women prefer using tobacco as zorda or tamak pata (Sada pata) with betel nut or use gul or Khoinee. Also, more women than men use tobacco.20,21 Consequently, different forms of tobacco use needed to be added along with adequate translation. Additionally, the local names of different alcoholic beverages available in different parts of Bangladesh were added to the item about alcohol consumption. The wide variation in the strength of ethanol observed in the studied samples may be problematic due to the lack of definite guidelines, regulation and monitoring of production procedures or for dilution in Bangladesh. Assessing standard drinks or units of alcohol is difficult as the strength of ethanol is not labeled on the beverages and drink-related hazards cannot properly be addressed. So, we recommend the concerned agencies to come forward with more data to address these issues properly. The study had some weaknesses. There were more women than men in the series of 130 patients. Additionally, the FRAX was interviewer-administered, not only due to the low average level of education of participants, but also due to the poor understandability of medical terminology by more educated persons. In conclusion, the Bengali version of the interviewer-administered FRAX appears to be a feasible, reliable and valid instrument that supports a shift from current BMD-based strategies to the identification of patients at increased fracture risk. The new tool is recommended for use in both clinical decision-making and trials with Bengali-speaking patients to assess the risk of fragility fracture in 40- to 90year-old patients with osteoporosis. More and large epidemiological studies are needed to assess the true ability of the tool to predict the 10-year probability of hip and major osteoporotic fractures in the Bengali population. Until it is calibrated to the local epidemiology of fracture and mortality within this population, we recommend using established FRAX calculators8 of similar-cultured countries, such as India or Sri-Lanka.
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ACKNOWLEDGEMENTS The authors convey their regards and gratefulness to the honorable Professor Dr John A. Kanis, Professor Emeritus, University of Sheffield, and International Osteoporosis Foundation for kind permissions, active inspiration and valuable suggestions. We are thankful to Dr Mizan, Honorary Medical Officer, Bangabandhu Sheikh Mujib Medical University, for his cordial help. The authors remain ever grateful to all the patients for participating in this research. The project was funded by the Science and Technology Division of the Ministry of Science and Information and Communication Technology of the Government of the People’s Republic of Bangladesh.
CONFLICT OF INTEREST None of the authors responsible for this article have conflicts of interest of any kind.
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18 Wagner AK, Gandek B, Aaronson NK et al. (1998) Crosscultural comparisons of the content of SF-36 translations across 10 countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol 51, 925–32. 19 Quandt SA, Spangler JG, Case LD et al. (2005) Smokeless tobacco use accelerates age-related loss of bone mineral density among older women in a multi-ethnic rural community. J Cross Cult Gerontol 20, 109–25. 20 World Health Organization (2008) WHO Report on the Global Tobacco Epidemic, 2008: The MPOWER Package. World Health Organization, Geneva. 21 Global Youth Tobacco Survey (2008) Bangladesh (Ages 13–15) Global Youth Tobacco Survey (GYTS) Fact Sheet. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, Atlanta, GA.
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