Study Design
The translation to Hebrew and the validation process of the translated iHOT12 were conducted between September 2020 to December 2021. The process consisted of two steps: 1) translation and cross-cultural adaptation of the English iHOT12 into Hebrew; 2) evaluation of the psychometric properties of the iHOT12-Hebrew version (iHOT12-H): internal consistency, test-retest reliability, standard error of measurement (SEM), floor and ceiling effects, and construct validity of the iHOT12-H with the Western Ontario and McMaster universities Osteoarthritis index (WOMAC). The study was reviewed and approved by the Medical Ethical Committee of XXX.
Translation of the iHOT12
The translation was performed with the permission of the original author of the iHOT12 [14]. The iHOT12 was translated into Hebrew and culturally adapted according to the Consensus-based Standards for the selection of health measurement instruments (COSMIN) guidelines for best practice in questionnaire translation including five stages [23]. In stage 1 (translation), the English version of the iHOT12 was translated to Hebrew by two Hebrew native speakers (two independent versions) who were also fluent in English; an orthopedic surgeon (with over 20 years of experience) and a physiotherapist with a PHD degree (with more than 15 years of experience). A third translator was a professional translator, meeting the need for a translator who is not a health provider, naïve to the questionnaire's concepts. Backward translation was performed by two bilingual native English speakers, who independently translated the Hebrew version of the iHOT12 back into English. Both were naïve to the questionnaire's concepts. An expert committee consisted of an orthopedic doctor specializing in musculoskeletal conditions (and their measurement) in pain population research (MD, MHA), a physiotherapist and pain researcher experienced with a cross-cultural adaptation of questionnaires (PhD, PT), and a physiotherapist with over 20 years' experience in the public and private sector. Subsequently, the investigator and the same experts team came to an agreement on the pre-final version of the iHOT12-H.
The pre-final version of the iHOT12-H was tested on a group of patients with various hip pathologies (N = 30). As no changes were found necessary, the pre-final version was chosen as the final version of the iHOT12-H (Appendix 1).
Participants
Patients attending hip clinics of the 3rd and 4th authors were asked to participate in the study. Inclusion criteria were: men and women, between 18 and 60 years of age, who suffered from hip pain. Following informed consent, they completed the iHOT12-H and WOMAC questionnaires.
Measurement instruments
The iHOT12-H:
The English iHOT12 is a valid and reliable disease-specific questionnaire that measures physical function and health-related quality of life in a younger patient population with hip pathology [14]. The iHOT12 consists of 12 questions with a 100-mm visual analog scale. Each question has equal weight and is scored between 0 (maximum limitation) and 100 (full function). The final score is calculated as the mean of all questions ranging from 0 to 100. Higher scores reflect better physical functioning and better health-related quality of life [14]. Missing values are ignored, and the score is the mean of the existing values.
The WOMAC:
The WOMAC is a 24-item questionnaire. A valid and reliable Hebrew version is available [24]. Subjects rate their level of suffering using a visual analogue scale (10 cm VAS) where 0 represents no suffering while 10 represents high level of suffering. The results were standardized to a scale of 0 to 100 and the final scores were the mean of the 24 items.
Procedures
Validity
Construct validity is the extent to which the results of the translated questionnaire correlate with results of other questionnaires that measure the same construct [23]. In this study, we evaluated the magnitude of relationships between the iHOT12-H and the WOMAC questionnaires.
Reliability
To describe reliability of the iHOT12-H we assessed internal consistency, measurement error, and test-retest reliability. For test-retest reliability, 51 patients completed the iHOT12-H twice within a 2-week interval. Participants were also asked whether they had improved or worsened over the past two weeks and were included only if symptoms had not changed. This time interval was considered adequate to prevent the patients from remembering their answers ("recall bias"), and short enough to ensure that clinical change had not occurred.
Sample size:
For validity, the input parameters were as follows: assuming a modest effect size of 0.3, α = 0.05 and β = 0.9, considering loss of 10% subjects, the total sample size recommended was at least 126 patients. For test-retest reliability we assumed that the intraclass correlation coefficient (ICC) score will be more than 0.8, with a power of 0.8, the sample size recommended was of 51 patients.
Statistical analysis
Statistical analysis was performed using the IBM SPSS Statistics software, version 28.0 (IBM Corporation, Armonk, NY). Normal distribution of all data was assessed by the Kolmogorov-Smirnov test. Patient characteristics were analyzed by means of descriptive statistics. A P value less than 0.05 (P < 0.05) was used to indicate statistical significance.
Reliability
Reliability is the degree to which the measurement is free from measurement error [23]. To evaluate reliability, internal consistency, test-retest reliability, and measurement error were calculated [25].
Internal consistency
For internal consistency we calculated Cronbach's alpha, with the following ratings: weak correlation of 0.50-0, medium: 0.50–0.75, very good: 0.75–0.90, and excellent: >0.90 [25].
Test-retest reliability
For test-retest reliability we used intraclass correlation coefficient (ICC), implementing the two-way mixed effect test-retest absolute agreement method. The ICC values were as follows: poor: <0.40, fair: 0.40–0.59, good: 0.60–0.74, and excellent: 0.75-1.00 [26]. Interpretability and repeatability refer to the degree to which one can assign qualitative meaning to quantitative scores [23]. It was determined by calculating floor and ceiling effects, which are present if more than 15% of respondents have the lowest or highest possible score [25].
Measurement error
The standard error of measurement (SEM) was calculated using the formula \(\text{S}\text{E}\text{M}=\text{S}\text{D}\times \sqrt{1-\text{I}\text{C}\text{C}}\), where SD = standard deviation [25].
Validity
To validate the Hebrew translation of the iHOT12, it was compared to the WOMAC scores using the Spearman correlation coefficient (not all outcomes were normally distributed). The accepted grading criteria were used: 0 to 0.39 weak correlation, 0.40 to 0.59 medium correlation:, and 0.6 to 1.0 strong correlation [27].