Quality of LifeNCT04521257
Development of Urdu Version of Short Form 36 Health Questionnaire
An observational study of Quality of Life, run by Riphah International University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Quality of Life
- How many people
- 80 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jul 2020to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- Age between 20 to 60 years both male and female subjects
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Riphah Rehabiliation Clinic
Lahore, Punjab Province, 54770
Riphah International University
Lahore, 54000
About this study
Official title: Development of Urdu Version of Short Form 36 Health Questionnaire; Validation and Reliability Analysis in Healthy Population
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.
Read the 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.
- Conditions
- Quality of Life
- Keywords
- Health Related Quality of Life, Public Health, Health Status Indicators
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form 36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.
Measured: 2nd Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Jul 2020
- Primary completion1 May 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danish Hassan, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521257
- Sponsor's protocol ID
- REC/20/2027 Shaheer Haider
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016 Oct 4;4:2050312116671725. doi: 10.1177/2050312116671725. eCollection 2016.
PubMed 27757230Kolotkin RL, Andersen JR. A systematic review of reviews: exploring the relationship between obesity, weight loss and health-related quality of life. Clin Obes. 2017 Oct;7(5):273-289. doi: 10.1111/cob.12203. Epub 2017 Jul 10.
PubMed 28695722Puciato D, Rozpara M, Borysiuk Z. Physical Activity as a Determinant of Quality of Life in Working-Age People in Wroclaw, Poland. Int J Environ Res Public Health. 2018 Mar 29;15(4):623. doi: 10.3390/ijerph15040623.
PubMed 29596312Hasanvand S, Rassouli M, Mandegari Z, Salmani N, Moghimkhan F. A Critical Review of Instruments Measuring the Quality of Life of Cancer Patients in Iranian Studies and Their Psychometrics Properties. Asian Pac J Cancer Prev. 2019 Feb 26;20(2):333-343. doi: 10.31557/APJCP.2019.20.2.333.
PubMed 30803191Lu WC, Tzeng NS, Kao YC, Yeh CB, Kuo TB, Chang CC, Chang HA. Correlation between health-related quality of life in the physical domain and heart rate variability in asymptomatic adults. Health Qual Life Outcomes. 2016 Oct 21;14(1):149. doi: 10.1186/s12955-016-0555-y.
PubMed 27765048
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Urdu Version of Short Form 36 Health Questionnaire; Validation and Reliability Analysis in Healthy Population
- ClinicalTrials.gov ID
- NCT04521257
- Acronym / sponsor ID
- REC/20/2027 Shaheer Haider
- Conditions
- Quality of Life
- Keywords
- Health Related Quality of Life, Public Health, Health Status Indicators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Age between 20 to 60 years both male and female subjects
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short Form 36
Time frame: 2nd Day
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Background: PubMed 27757230Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016 Oct 4;4:2050312116671725. doi: 10.1177/2050312116671725. eCollection 2016.
- Background: PubMed 28695722Kolotkin RL, Andersen JR. A systematic review of reviews: exploring the relationship between obesity, weight loss and health-related quality of life. Clin Obes. 2017 Oct;7(5):273-289. doi: 10.1111/cob.12203. Epub 2017 Jul 10.
- Background: PubMed 29596312Puciato D, Rozpara M, Borysiuk Z. Physical Activity as a Determinant of Quality of Life in Working-Age People in Wroclaw, Poland. Int J Environ Res Public Health. 2018 Mar 29;15(4):623. doi: 10.3390/ijerph15040623.
- Background: PubMed 30803191Hasanvand S, Rassouli M, Mandegari Z, Salmani N, Moghimkhan F. A Critical Review of Instruments Measuring the Quality of Life of Cancer Patients in Iranian Studies and Their Psychometrics Properties. Asian Pac J Cancer Prev. 2019 Feb 26;20(2):333-343. doi: 10.31557/APJCP.2019.20.2.333.
- Background: PubMed 27765048Lu WC, Tzeng NS, Kao YC, Yeh CB, Kuo TB, Chang CC, Chang HA. Correlation between health-related quality of life in the physical domain and heart rate variability in asymptomatic adults. Health Qual Life Outcomes. 2016 Oct 21;14(1):149. doi: 10.1186/s12955-016-0555-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danish Hassan, PhD* principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form 36 (time frame: 2nd Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04521257, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.