Health-Related Quality Of LifeNCT02514395
Translation & Linguistic Validation of Knee and Osteoarthritis Outcome Score (KOOS) Questionnaire in Marathi Language
An observational study of Health-Related Quality Of Life, run by TPCT's Terna College of Physiotherapy.
Trial summary
Background: KOOS is a self -administered instrument which assesses the patient's opinion about the Knee associated problems. For now it is available in English \& various other languages \& is a complete instrument in itself. In India it has been translated in Hindi so far. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health-Related Quality Of Life
- What is being tested?
- disability index administration -self report form
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Nov 2013
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible subjects who the fulfilled the inclusion criteria were register for the study.
Who may be able to join
- Subjects who were diagnosed for osteoarthritis of knee
- who have not undergone any physical therapy treatment previously were considered eligible.
Who cannot join
- 1)subjects who didn't give any informed consent
About this study
Official title: Translation & Linguistic Validation of Knee and Osteoarthritis Outcome Score (KOOS) Questionnaire in Marathi Language: Cross Section Survey
Background:
KOOS is a self -administered instrument which assesses the patient's opinion about the Knee associated problems. For now it is available in English \& various other languages \& is a complete instrument in itself.
Read more
In India it has been translated in Hindi so far. However, each province in this country has a unique language. Maharashtra is the second largest state in India and Marathi is the regional language of the communication. Since KOOS is a self-report measure, its translation in this local language was thought to be necessary. This disease specific measure which is originally designed for English speaking region when employed to non-English population needed to be translated with unique method to achieve a normative equivalence and linguistic validation.
Methods: After taking permission from KOOS web manager T1, T2, T12, B1 \& B2 versions were formatted according to the guidelines laid down by AAOS for cross cultural adaptation of health status measure. T12 version was sent for the field testing. Total 32 subjects who met the eligibility criteria were Included in this study.
Results:
Statistical analysis for reliability with test re-test method suggested Perfect correlation (r =1) between day 1 \& 2. A range of 0.83-0.54 co-relation co-efficient (r) demonstrated the validity of KOOS and its subscales when compared against the 8 different domains of SF-36. All this correlations were statistically highly significant. Sport and recreation subscale had many missing responses since many items in this subscale were not appropriate for the Maharashtrian cultural set-up. Participants additionally provided the information about other functional activities which were difficult to execute due to knee associated pain and disability.
Conclusion: Marathi version of KOOS is proved to be a reliable \& valid measure. Future scope: this study demonstrate a need to undertake the cross cultural adaptation since a constant pattern of impairment revealed in the execution of daily activities such as sitting on the floor and attending certain yoga postures etc.
Key words: linguistic validation, disease specific self-report, KOOS, Marathi translation, quality of life.
Read the detailed description
Disability index is used as the Outcome measures and is a diagnostic tools and prognostic tool. This index allows a healthcare professional to measure impact of psycho-social and physical factors on the functional performance, ability of the patient. The people suffering from osteoarthritis is determined by the interplay of psychosocial, physical and physiological neuromuscular factors such as Quadriceps strength, knee pain, and age . These components have shown to be more important determinants of functional impairment in elderly subjects than the severity of knee osteoarthritis as assessed radiographically.Disability index which are designed to measure the influence of this factors on functional outcome are hence used clinically to justify the treatment and capture the meaningful recovery.
The disease specific measures which are designed to assess the specific diagnostic group or specific population with a goal to detect a clinical change with the intervention of known efficacy should have good reliability, validity, responsiveness, and low burden of administration to be clinically useful. Such measures should be standardized and patient- centered that can be administered at a low cost. Hence a questionnaire was developed to assess short- and long-term patient-relevant outcomes following knee injury in form of Knee Injury and Osteoarthritis Outcome Score (KOOS). This is self-administered and assesses five outcomes: Pain, Symptoms, Activities of Daily Living, Sport and Recreation Function, and Knee-Related Quality Of Life.
The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. KOOS has been used as a reliable and valid measure when used to evaluate the effectiveness of an intervention in knee osteoarthritis, total knee replacement anterior cruciate ligament and cartilage injury. It has been converted in various regional languages. KOOS has been translated in national language of India ie. Hindi. However, in many provinces of India the primary language of communication varies. In this multi-linguistic country the language shift happens in every province concordant with diversified culture. Maharashtra is second largest state in India with estimated population is over 117 million appx. the primary language of communication is Marathi and over 70 % of population communicate in this regional language. A need for the translational and cross cultural adaptation has been emphasized for the effective and reasonable measurement of responses to any self-report measure whenever and wherever applicable. This is true especially if the self-report measure which was originally designed for English speaking region is being employed to non-English population. It is difficult to achieve normative equivalence which is dependent on openness with strangers, political opinions, tendency to conform or assert oneself , since cultures differ on how willing they are to share personal information. On the other hand information relevant to semantic and conceptual equivalence of demographic questions across languages, can be extracted with less difficulty since the words and ideas are more general and commonly used. This emphasizes a need to translate a health status self-administered measure for use in a new country. It is now recognized that a unique method should be used to achieve a linguistic validation to reach equivalence between the original source and target language of the measure or instrument. A published report by ISPOR suggests the consensus on following Principles of Good Practice in translation and cultural adaptation of any self-report questionnaire. A guidelines has been evolved for the adaptation process and is available in form of a template. Adaptation process is designed to attain semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires Since KOOS is the self-administered instrument, its translation in this local language was thought to be necessary as the majority of population attending physiotherapy clinics communicates in Marathi. Unavailability of the Marathi versions of KOOS hence, poses a difficulty in functional evaluation in this population on day to day basis before and after the treatment. Hence, there exists a need to provide valid and reliable Marathi version of KOOS, so as to facilitate the better understanding of functional evaluation findings in population suffering from knee osteoarthritis. This study aims to translate and check the psychometric properties of the translated version of the KOOS as per the guidelines laid down by AAOS. Objective of this study is to provide a valid and reliable instrument in the regional language which intends to evaluate disease specific functional problems in Marathi speaking population.
Methods:
Study design: cross section survey design- a validation study. Permission was obtained from Institutional local ethic committee. This study was carried out in 2 phases.
Phase I consisted of translation of the English version of KOOS into the Marathi version. Second phase consisted of the field testing of the translated version to check test-retest reliability and validity.
- Conditions
- Health-Related Quality Of Life
- Being tested
- disability index administration -self report form
- Keywords
- linguistic validation, KOOS, Marathi translation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disability index administration -self report formOther
Final T12 version of KOOS was given to the participants by an assistant who was not involved with any prior procedure. At the same time SF- 36 v2[32] generic health measure was also handed over. Filled forms were collected by the same assistant. Next day participants were given another blank copy of Marathi KOOS T12 versions. Hence each participant filled three forms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
It is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee osteoarthritis or mechanical knee somatic dysfunction.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startSep 2012
- Primary completionJul 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-Related Quality Of LifeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- TPCT's Terna College of Physiotherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR. SWATI MESHRAM, TPCT's Terna College of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514395
- Sponsor's protocol ID
- 2
- Status last verified
- Nov 2023
- First submitted
- 6 Jul 2015
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation & Linguistic Validation of Knee and Osteoarthritis Outcome Score (KOOS) Questionnaire in Marathi Language: Cross Section Survey
- ClinicalTrials.gov ID
- NCT02514395
- Acronym / sponsor ID
- 2
- Conditions
- Health-Related Quality Of Life
- Keywords
- linguistic validation, KOOS, Marathi translation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TPCT's Terna College of PhysiotherapyUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Aug 2015 (estimated)
- 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.
Background:
KOOS is a self -administered instrument which assesses the patient's opinion about the Knee associated problems. For now it is available in English \& various other languages \& is a complete instrument in itself.
In India it has been translated in Hindi so far. However, each province in this country has a unique language. Maharashtra is the second largest state in India and Marathi is the regional language of the communication. Since KOOS is a self-report measure, its translation in this local language was thought to be necessary. This disease specific measure which is originally designed for English speaking region when employed to non-English population needed to be translated with unique method to achieve a normative equivalence and linguistic validation.
Methods: After taking permission from KOOS web manager T1, T2, T12, B1 \& B2 versions were formatted according to the guidelines laid down by AAOS for cross cultural adaptation of health status measure. T12 version was sent for the field testing. Total 32 subjects who met the eligibility criteria were Included in this study.
Results:
Statistical analysis for reliability with test re-test method suggested Perfect correlation (r =1) between day 1 \& 2. A range of 0.83-0.54 co-relation co-efficient (r) demonstrated the validity of KOOS and its subscales when compared against the 8 different domains of SF-36. All this correlations were statistically highly significant. Sport and recreation subscale had many missing responses since many items in this subscale were not appropriate for the Maharashtrian cultural set-up. Participants additionally provided the information about other functional activities which were difficult to execute due to knee associated pain and disability.
Conclusion: Marathi version of KOOS is proved to be a reliable \& valid measure. Future scope: this study demonstrate a need to undertake the cross cultural adaptation since a constant pattern of impairment revealed in the execution of daily activities such as sitting on the floor and attending certain yoga postures etc.
Key words: linguistic validation, disease specific self-report, KOOS, Marathi translation, quality of life.
Detailed description
Disability index is used as the Outcome measures and is a diagnostic tools and prognostic tool. This index allows a healthcare professional to measure impact of psycho-social and physical factors on the functional performance, ability of the patient. The people suffering from osteoarthritis is determined by the interplay of psychosocial, physical and physiological neuromuscular factors such as Quadriceps strength, knee pain, and age . These components have shown to be more important determinants of functional impairment in elderly subjects than the severity of knee osteoarthritis as assessed radiographically.Disability index which are designed to measure the influence of this factors on functional outcome are hence used clinically to justify the treatment and capture the meaningful recovery.
The disease specific measures which are designed to assess the specific diagnostic group or specific population with a goal to detect a clinical change with the intervention of known efficacy should have good reliability, validity, responsiveness, and low burden of administration to be clinically useful. Such measures should be standardized and patient- centered that can be administered at a low cost. Hence a questionnaire was developed to assess short- and long-term patient-relevant outcomes following knee injury in form of Knee Injury and Osteoarthritis Outcome Score (KOOS). This is self-administered and assesses five outcomes: Pain, Symptoms, Activities of Daily Living, Sport and Recreation Function, and Knee-Related Quality Of Life.
The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. KOOS has been used as a reliable and valid measure when used to evaluate the effectiveness of an intervention in knee osteoarthritis, total knee replacement anterior cruciate ligament and cartilage injury. It has been converted in various regional languages. KOOS has been translated in national language of India ie. Hindi. However, in many provinces of India the primary language of communication varies. In this multi-linguistic country the language shift happens in every province concordant with diversified culture. Maharashtra is second largest state in India with estimated population is over 117 million appx. the primary language of communication is Marathi and over 70 % of population communicate in this regional language. A need for the translational and cross cultural adaptation has been emphasized for the effective and reasonable measurement of responses to any self-report measure whenever and wherever applicable. This is true especially if the self-report measure which was originally designed for English speaking region is being employed to non-English population. It is difficult to achieve normative equivalence which is dependent on openness with strangers, political opinions, tendency to conform or assert oneself , since cultures differ on how willing they are to share personal information. On the other hand information relevant to semantic and conceptual equivalence of demographic questions across languages, can be extracted with less difficulty since the words and ideas are more general and commonly used. This emphasizes a need to translate a health status self-administered measure for use in a new country. It is now recognized that a unique method should be used to achieve a linguistic validation to reach equivalence between the original source and target language of the measure or instrument. A published report by ISPOR suggests the consensus on following Principles of Good Practice in translation and cultural adaptation of any self-report questionnaire. A guidelines has been evolved for the adaptation process and is available in form of a template. Adaptation process is designed to attain semantic, idiomatic, experiential, and conceptual equivalence between the source and target questionnaires Since KOOS is the self-administered instrument, its translation in this local language was thought to be necessary as the majority of population attending physiotherapy clinics communicates in Marathi. Unavailability of the Marathi versions of KOOS hence, poses a difficulty in functional evaluation in this population on day to day basis before and after the treatment. Hence, there exists a need to provide valid and reliable Marathi version of KOOS, so as to facilitate the better understanding of functional evaluation findings in population suffering from knee osteoarthritis. This study aims to translate and check the psychometric properties of the translated version of the KOOS as per the guidelines laid down by AAOS. Objective of this study is to provide a valid and reliable instrument in the regional language which intends to evaluate disease specific functional problems in Marathi speaking population.
Methods:
Study design: cross section survey design- a validation study. Permission was obtained from Institutional local ethic committee. This study was carried out in 2 phases.
Phase I consisted of translation of the English version of KOOS into the Marathi version. Second phase consisted of the field testing of the translated version to check test-retest reliability and validity.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects who the fulfilled the inclusion criteria were register for the study.
Key inclusion criteria (2 listed)
- Subjects who were diagnosed for osteoarthritis of knee
- who have not undergone any physical therapy treatment previously were considered eligible.
Key exclusion criteria (1 listed)
- 1)subjects who didn't give any informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disability index administration -self report formFinal T12 version of KOOS was given to the participants by an assistant who was not involved with any prior procedure. At the same time SF- 36 v2[32] generic health measure was also handed over. Filled forms were collected by the same assistant. Next day participants were given another blank copy of Marathi KOOS T12 versions. Hence each participant filled three forms. | Other | – |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 2 days
It is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee osteoarthritis or mechanical knee somatic dysfunction.
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 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Health-Related Quality Of Life, run by TPCT's Terna College of Physiotherapy.
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 2 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 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2023.