Clinical trial NCT04521257: Development of Urdu Version of Short Form 36 Health Questionnaire
Official title: Development of Urdu Version of Short Form 36 Health Questionnaire; Validation and Reliability Analysis in Healthy Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: Health Related Quality of Life
Public Health
Health Status Indicators
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects aged between 20 to 60 years both male and female subjects will be included.Current health problems such as chronic allergy, back pain, visual impairments, chronic skin problems, chronic lung problems, deafness or hearing problems, functional impairment in leg or arm or other chronic health problems

Brief summary: Quality of life (QOL) is an overarching term for the quality of the various domains in life. It is a standard level that consists of the expectations of an individual or society for a good life. These expectations are guided by the values, goals and socio-cultural context in which an individual lives. It is a subjective, multidimensional concept that defines a standard level for emotional, physical, material and social well-being. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The original SF-36 stemmed from the Medical Outcome Study, MOS, which was conducted by the RAND Corporation. The primary objectives of this research were to translate, validate and generate normative data on the SF-36 health survey for using among Urdu speaking residents of Pakistan.SF-36 health questionnaire is first translated into Urdu and then apply on healthy subjects to check the validity and reliability of this scale . Instrument will be first translated from English to Urdu by two experts. Both these experts were fluent in English and Urdu language. One expert belongs to allied health care profession and other expert will be junior life scientist. The third expert compares the initial to Urdu translation and formulated the first draft of SF-36 Health Questionnaire. Content validity of SF-36 Health Questionnaire was established by committee method. 10 experts from physical therapy field rate the all 36 items of the SF-36 Health Questionnaire on content validity index developed by RAND Corporation. They rate each item of SF-36 Health Questionnaire for its relevance, clarity, simplicity, and ambiguity on four point ordinal likert scale. Data will be analyzed using SPSS v 25. Intra class correlation coefficient, chronbach alpha and factor analysis will be used to analyses the data.

Detailed description: The 36-item Short Form Health Survey is a brief self administered questionnaire that generates scores across eight dimensions of health: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), mental health (MH), and one single item scale on health transition. It has proved useful in monitoring population health, estimating the burden of different diseases, monitoring outcomes in clinical practice, and evaluating treatment effects. The improved longevity suggests that health status can no longer be well assessed by population mortality statistics; there is a consensus to view health in terms of people's subjective assessment of wellbeing and ability to perform social roles the centrality of people's point of view in monitoring health related quality of life has led to the proliferation of instruments and a rapid development of theoretical literature. Interest in measuring the aspects of health most closely related to quality of life usually referred to as health-related. Quality of life (HR-QOL) has increased in recent years in Pakistan as in other countries. Advances have been made in methods for describing patients' subjective health status using standardized measures, and several valid and reliable patient- based measures are available either as generic or disease and treatment targeted questionnaires. However, most of these are in English and are intended for use in English-speaking settings.With few but relevant exceptions that were actually translated or developed as part of Multilanguage and multinational projects. Most of such efforts were produced by isolated groups of researchers who seldom published their findings in peer-reviewed journals. Among the so-called generic measures, the MOS 36- Item Short Form Health Survey (SF-36) is known for its comprehensiveness, brevity, and high standards of reliability and validity. It was first translated by independent Italian teams in 1990. With the launch of the International Quality of Life Assessment (IQOLA) project. The reliability and validity of the SF-36 have been well documented by the developers of the instrument. A comparison of a series of generic health status measures indicated that the SF-36 is not only psychometrically sound but is also more responsive to clinical improvement than the other instruments tested. Moreover, health functioning changed in the hypothesized direction with increased age, socioeconomic status and disease status in a population-based longitudinal study of the SF-36, which suggests that the instrument is sensitive to changes in the health of the general population. The SF-36 has been cross- culturally translated and Adapted to many cultures and languages. To the Author's knowledge, there is no version of SF-36 in Urdu. Lack of Urdu version of the SF-36 impedes comparison of interventions performed in Urdu rehabilitation clinics with those performed elsewhere.

Eligibility criteria: Inclusion Criteria:

Age between 20 to 60 years both male and female subjects

Exclusion Criteria:

Current health problems such as chronic allergy, back pain, visual impairments, chronic skin problems, chronic lung problems, deafness or hearing problems, functional impairment in leg or arm or other chronic health problems

Primary outcomes:
measure: Short Form 36
timeFrame: 2nd Day
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabiliation Clinic
state: Punjab
city: Lahore
country: Pakistan
facility: Riphah International University
Study officials:
affiliation: Riphah International University
name: Danish Hassan, PhD*
role: PRINCIPAL_INVESTIGATOR
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