Translation, Cultural Adaptation, and Validation
of the 10-year Fracture Risk Assessment
Tool (FRAX) into Filipino
Pauline Melesse S del Rosario1*, Misael Jonathan A Ticman1 and Leo Daniel D Caro1,2
1Department of Orthopaedics, East Avenue Medical Center, Quezon City, Philippines
2Department of Orthopaedics, University of the Philippines, Philippine General Hospital, Philippines
Submission: December 15, 2019;Published: January 17, 2020
*Corresponding author: P M del Rosario, East Avenue Medical Center, Quezon City, Philippines
How to cite this article: Pauline Melesse S del Rosario, Misael Jonathan A Ticman, Leo Daniel D Caro.Translation, Cultural
Adaptation, and Validation of the 10-year Fracture Risk Assessment Tool (FRAX) into Filipino. Ortho & Rheum Open Access J.
2020; 15(5): 555921. DOI:10.19080/OROAJ.2020.15.555921
Introduction: Screening tools for osteoporosis are relatively expensive and inaccessible to the general Filipino population. This study aims to develop a Filipino version of a validated measure, the Fracture Risk Assessment Tool, in order to facilitate improvement of fracture prevention care in the country.
Methods: The FRAX was translated and culturally adapted into a Filipino version using established forward and backward translation methods and was succeedingly tested for equivalence to the original. The final version was administered to 120 out-patients and was tested for reliability using BMD measurements of the distal radius.
Results: To be better understood and reliably answered by the Filipino population, several qualifiers were added to items such as previous fracture and rheumatoid arthritis. This was to account for the high incidence of high-energy trauma in the country, and the use of the same Filipino term for RA as with other arthritides, respectively.
Conclusion: The Filipino version of the FRAX appears to be an acceptable and reliable instrument, serving as a low-cost alternative to BMD and DXA scans which are generally inaccessible and unaffordable by majority of the population
Osteoporosis remains a major global health problem, causing approximately 8.9 million fractures each year, 25-43% of which are fractures at the hip [1-4]. The combined lifetime risk of fractures of the hip, forearm and vertebrae secondary to osteoporosis is around 40%, roughly the equivalent of the lifetime risk of cardiovascular disease . There is also an increase in the 5-year mortality rate of those with hip and vertebral fractures, which signal or begin a progressive decline in health . Although surveillance, diagnosis and treatment protocols for osteoporosis have been developed and refined, the incidence of hip fractures continue to rise each year, which is unacceptable for a preventable morbidity . According to the Center for Disease Control and Prevention, ethnicity plays a significant role in the prevalence of fragility fractures [7,8]. In the Philippines, although classified as a country with low population risk for hip fractures, these still rank 4th in PhilHealth insurance claims, placing the annual economic burden of fractures higher than colon, prostate, or ovarian carcinoma [9,10].
This is in addition to the loss of productivity of at least one other family member who acts as the primary caregiver of the patient. Screening tools for osteoporosis such as dual energy x-ray absorptiometry is relatively expensive and not widely accessible to the general public, with only 21 machines available in the Philippines. Consequently, many patients who sustain a fragility fracture are not identified as high risk, and subsequently do not receive the appropriate treatment to prevent the said fracture [11,12]. More cost-effective alternatives are available scoring systems that determine the fracture risk of a patient, namely the Fracture Risk Assessment Tool (FRAX) [12-16].
This has been validated, and sometimes reconstructed, in several countries such as Japan and Tunisia, among others [17,18]. There are few local studies describing the prevalence of fractures and osteoporosis among individuals aged 50 and above in the Philippines, however , no national research studies to establish baseline risk for fracture in elderly Filipinos are available [9,19]. Once there is a cost-effective method of identifying and stratifying at-risk individuals, treatment may then be initiated in
accordance with guidelines, improving fracture prevention care
The fracture risk assessment tool contains 10 items
measuring the patient’s age, height, weight and clinical risk
factors such as previous fracture, parental hip fracture, smoking
history, glucocorticoid therapy, rheumatoid arthritis, alcohol
consumption, and secondary osteoporosis. The guidelines for
translation by Beaton, et al.  were followed in the construction
and cultural adaptation of the Filipino FRAX. Two independent
forward translations of the English FRAX into Filipino were done
by a physician and a naïve translator, both of whose mother tongue
is Filipino. Any discrepancies between the two translations were
discussed and resolved by the group. The synthesized Filipino
version was subsequently converted back to English by two other
translators who use English as their first language, both of whom
were blinded to the original FRAX and naïve to the concepts
being measured. A committee that included a general physician,
an orthopedic surgeon and a linguist was then formed. Along
with the translators and authors, they reviewed and verified
all translations made in terms of semantics and conceptual
equivalence to the English version. A consensus was reached on
any discrepancies and a pre-final version was developed for field
testing. The translation was straightforward for most items and
response choices, except for items 4, 7 and 8, which required additions to ensure identification of target
risk factors. In item 4 (previous fracture), “not due to high-energy
trauma” was added to the question. In items 7 and 8 (glucocorticoid
use and rheumatoid arthritis), qualifiers such as disease process,
medications taken and diagnostic examinations were included, as
some glucocorticoids are available as over-the-counter drugs in
the Philippines. Also, the Filipino word for rheumatoid arthritis,
‘rayuma,’ is also often loosely used for other forms of arthritis.
The pre-final Filipino FRAX was tested on a convenience
sample of 58 men and women aged 50-90 years old admitted by the
orthopedic surgery department of a tertiary government hospital.
Informed consent was obtained from all individual participants
included in the study. The questionnaire was administered, and
participants were probed about clarifications needed on any of
the items. All odd numbered patients were requested to answer
the Filipino FRAX again 10 days after admission, and test-retest
reliability was tested. The final version was field tested on
120 male and female subjects aged 50-90 years old, and BMD
measurements of the distal radius were simultaneously measured
and recorded. Clinical risk factors and BMI were then used to
determine 10-year fracture risk using charts provided by the
FRAX. These were then correlated to BMD T-scores to test for
validity of the final version.
The pre-final version was field tested on 58 in-patients,
31 (53.4%) of which were female and 27 (46.5%) were male,
with a mean age of 68.06. Most questions were understood by
the respondents. Nine patients required further explanation
of galanggalangan or wrist, while three others inquired about
other glucocorticoids which were not given as an example on the
questionnaire. Odd serial numbered patients were requested to
answer the questionnaire on the 10th day of admission. Test retest
reliability (Pearson r) was 0.98 and 0.99 for weight and height,
respectively. Repeatability was perfect for all items except for
diagnosis of rheumatoid arthritis (r = 0.91). Patient demographics
and responses on the pre-final FRAX is summarized in Table 1.
The final version of the Filipino FRAX was administered to
120 outpatients, 78 (65%) of which were female and 42 (35%)
were male, aged 50-90 (55.5 ± 6.34). There was a total of 9
dropouts due to questionnaires being deemed invalid for being
incompletely answered. Pearson r for 10-year 3 fracture risk and
BMD t-scores was -0.650 (p < 0.01) (Table 2).
Measures have been translated, as well as culturally adapted,
across countries in order to maintain validity and equivalence
between the original and translated version at a conceptual
level. This is especially true if the questionnaire is to be used
in a different country and language, as is in our case . This
study developed a translated and culturally adapted version of
the FRAX that can be used in Filipino-speaking populations. The
most significant changes to the FRAX were additions of qualifiers
to items such as previous fracture and rheumatoid arthritis, to
ensure that they measure the target risk factors. This is due to the
high prevalence of high energy trauma and the use of the Filipino
word rayuma to pertain to other forms of arthritis. This study,
however, has some limitations, including a sample gathered by
convenience at a tertiary public hospital.
Patients who do not have the means to seek consult at a tertiary
centre may also have less familiarity with medical terms used in
the questionnaire. Also, for some patients, the questionnaire was
interviewer-administered, due to the inability to read and write
and low educational status of several subjects. Given that the
Filipino FRAX has significant reliability in comparison to standards
of measurement (e.g. BMD) in screening for osteoporosis and
fracture risk, the authors recommend that this tool be used by
general practitioners as well as specialists in their daily patient
care to allow early intervention in the prevention of fractures. It
appears to be an acceptable and reliable instrument which may
be used as a low-cost alternative to standards of measurement in
areas where the former is inaccessible and unaffordable by the
general population. This study is the first translation of the FRAX in
Filipino. Further studies are encouraged to validate its results and
to determine its ability to prognosticate fractures and to quantify
fracture risk. Furthermore, the tool may be translated to other
Philippine dialects to benefit a larger population with different
ethnicities. Larger, epidemiological studies are recommended to
obtain data on fracture risk in the Filipino population.
Diagnosis and treatment of osteoporosis prior to a fracture
is currently of low priority, despite a wide range of therapeutic
options that are available. This risk assessment tool serves to
identify individuals at high risk for eventually developing a
fragility fracture, and in turn influence clinical decision-making,
especially in regions of the country wherein bone densitometry is
not available. Fracture prevention intervention should be deemed
as necessary as fracture management, in order to lower fragility
fracture incidence and cost in the country.
Pauline Melisse del Rosario and Misael Jonathan Ticman
declare that they have no conflict of interest. Leo Daniel Caro
discloses that he is a speaker for Unilab’s product Alendra
(Alendronic Acid). However, no grants or research support was
received from the company, and no commercial benefits will be
conferred upon the authors.
International Osteoporosis Foundation, International Society for Clinical Densitometry. International Osteoporosis Foundation, International Society for Clinical Densitometry (ISCD) official positions on FRAX.