Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02514395 |
| Other study ID # |
2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2012 |
| Est. completion date |
November 2013 |
Study information
| Verified date |
November 2023 |
| Source |
TPCT's Terna College of Physiotherapy |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
