Research Article |
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Corresponding author: Mahmood Majid Salman ( mahmoud_majed@uomustansiriyah.edu.iq ) Academic editor: Petya Milushewa
© 2025 Mahmood Majid Salman, Mohammed Mahmood Mohammed.
This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Citation:
Salman MM, Mohammed MM (2025) Cross-cultural adaptation and validation of a modified version of ARB-VFQ-25 in Iraq. Pharmacia 72: 1-7. https://doi.org/10.3897/pharmacia.72.e160039
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This study aimed to validate a modified Arabic version (mARB-VFQ-25) for Iraqi patients with diabetic maculopathies. Although an Arabic mARB-VFQ-25 exists, it has not yet been validated in Iraq. The adaptation process involved two steps: first, modifying the original to reduce length and remove redundancies, with revisions by an ophthalmologist and a clinical pharmacist for cultural relevance; second, assessing its psychometric properties. Participants diagnosed with diabetic maculopathies were interviewed face-to-face. On average, the questionnaire took approximately 9 minutes and 26 seconds to complete. Internal consistency was acceptable, with Cronbach’s alpha coefficients above 0.4 for most subscales, except for “Ocular pain” (0.285) and “Dependency” (-0.100). The adapted tool is easy to administer, reliable, and time-efficient for evaluating vision-related quality of life among Iraqi patients. In conclusion, the mARB-VFQ-25 is a valid, culturally sensitive, and practical instrument for clinical and research use within this population.
quality of life, diabetic retinopathy, validation studies, cross-cultural comparison, Arabic
Assessment of visual function plays a significant role in measuring quality of life (QoL). It is a valuable tool for evaluating patients with ophthalmological conditions and their treatment, alongside other assessments such as visual field and visual acuity (
In 1996, the National Eye Institute developed the NEI-VFQ-51, a 51-item instrument with 13 subscales to assess vision-related QoL, tested on patients with ophthalmic conditions (
No validation studies of the ARB-VFQ-25 have been conducted in Iraq. Many items are outdated and not culturally aligned with Iraqi contexts. Creating an Iraqi Arabic version is challenging due to regional dialect variations, although most Iraqis understand Standard Arabic, which might be more suitable (
This was a cross-sectional study involving 31 DM patients with diabetic maculopathies. Patients were recruited from the Department of Ophthalmology of Ghazi Al-Hariri Surgical Hospital, Baghdad Medical City, between 1 July 2024, and 1 December 2024. Those who presented for visual consultations or follow-up appointments and met the eligibility criteria were included. All investigations adhered to the principles of the Declaration of Helsinki, informed written consent was obtained from all participants, and Institutional Review Board approval was secured for the study. The study was prepared following the STROBE guidelines for reporting observational studies (
Patients included in this study were aged ≥ 40 years with diabetic maculopathies, diagnosed according to fundus ophthalmoscopy and optical coherence tomography (OCT) (
This study was reviewed and approved by the Research Ethical Committee of the College of Pharmacy, Mustansiriyah University (approval number: 73; reference number: 173; date: 5 June 2024).
The ARB-VFQ-25 was modified to create a new version, termed mARB-VFQ-25, as shown in Table
| Item | Suggestions |
|---|---|
| Item 5 | As newspapers are no longer widely used or read, the statement was changed to ask about reading from books, texts on phones, bills, medication boxes, or any legal documents, including identification cards. |
| Item 14 | As it is not familiar to Iraqis to watch movies in cinemas or plays in theaters, the statement was modified to include attending public activities and festivals and adding “football games” to explain sports events. |
| Item A1 | It was removed, as it repeats the intent of “item 1”. |
| Item A2 | It was removed, as it repeats the intent of “item 2”. |
| Item A3 | It was merged into “item 5”. |
| Item A4 | It was merged into “item 5”. |
| Item A7 | It was merged into “item 14”. |
| Item A8 | It was merged into “item 14”. |
| Item A12 | It was merged into “item 3”. |
| Item A13 | It was merged into “item 24”. |
| Subscales | Items | Number of items | Number of optional items and their details # |
|---|---|---|---|
| General health | 1, A1 | 2 | 1 (item A1) |
| General vision | 2, A2 | 2 | 1 (item A2) |
| Well-being/distress (mental health) | 3, 21, 22, 25, A12 | 5 | 1 (item A12) |
| Ocular pain | 4, 19 | 2 | 0 |
| Near vision issues | 5, 6, 7, A3, A4, A5 | 6 | 3 (items A3, A4, and A5) |
| Distance vision issues | 8, 9, 14, A6, A7, A8 | 6 | 3 (items A6, A7, and A8) |
| Peripheral vision | 10 | 1 | 0 |
| Social function | 11, 13, A9 | 3 | 1 (item A9) |
| Color vision | 12 | 1 | 0 |
| Driving | 15 (15a, 15b, 15c), 16 (16a*) | 2 (with sub-questions) | 0 |
| Role limitation | 17, 18, A11a, A11b | 4 | 2 (items A11a and A11b) |
| Dependency | 20, 23, 24, A13 | 4 | 1 (item A13) |
After the revision of ARB-VFQ-25, some questions were merged, others were omitted, and some were rephrased to be more modern and compatible with Iraqi culture. Following these modifications and revisions, a new questionnaire, mARB-VFQ-25, was designed for testing. All optional items were assigned the letter “A” for further distinction.
Tables
| Subscales | Items | Number of items | Number of optional items and their details # |
|---|---|---|---|
| General health | 1 | 1 | 0 |
| General vision | 2 | 1 | 0 |
| Well-being/distress (mental health) | 3, 21, 22, 25 | 4 | 0 |
| Ocular pain | 4, 19 | 2 | 0 |
| Near vision issues | 5, 6, 7, A5 | 4 | 1 (item A5) |
| Distance vision issues | 8, 9, 14, A6 | 4 | 1 (item A6) |
| Peripheral vision | 10 | 1 | 0 |
| Social function | 11, 13, A9 | 3 | 1 (item A9) |
| Color vision | 12 | 1 | 0 |
| Driving | 15 (15a, 15b, 15c), 16 (16a*) | 2 (with sub-questions) | 0 |
| Role limitation | 17, 18, A11a, A11b | 4 | 2 (items A11a and A11b) |
| Dependency | 20, 23, 24 | 3 | 0 |
To assess the feasibility, reliability, and validity of the mARB-VFQ-25, the researchers administered it face-to-face to 31 patients with diabetic maculopathies who were eligible for the study. The administration time was recorded to evaluate feasibility. Items were analyzed to determine the percentage of missing responses and to assess whether the questionnaire was suitable and easy to apply to the target population.
Reliability was evaluated using internal consistency (IC) correlations for each subscale. The acceptable range for Cronbach’s alpha is 0.70 to 0.90. Additionally, the item–scale correlation coefficient was calculated to assess scale homogeneity, with coefficients above 0.40 considered acceptable.
The G-power program version 3.1 was used to calculate the sample size (post hoc power analysis), with 80% power, a 0.05 alpha level, an effect size of 0.27, a linear regression model with 25 predictors, and a total sample size of 31 (
Descriptive statistics included the mean (standard deviation) for continuous variables and frequency (percentage) for categorical variables. IC was tested using Cronbach’s alpha coefficient, which ranges between 0 and 1. The closer its value is to 1, the more homogeneous all the elements are. The Cronbach’s alpha coefficient is considered good above 0.7 (
The study included 31 DM patients. The mean age was 62.3 ± 12.0 years; 21 were male (67.74%) and 10 were female (32.26%). Twenty-six patients had hypertension (83.87%), while six patients had a history of stroke, myocardial infarction, or other thrombotic conditions (19.35%).
Regarding feasibility, the analysis of mARB-VFQ-25 items showed no missing answers, except for item 5 (41.9%) and the driving subscale items 15 and 16 (64.5%), as shown in Table
Descriptive data of respondents’ scores according to their answers to mARB-VFQ-25.
| Subscale | Value |
|---|---|
| General health # | 25.00 (0.0–50.0) |
| General Vision $ | 49.03 ± 19.21 |
| Peripheral vision $ | 82.26 ± 27.53 |
| Color vision $ | 92.74 ± 17.31 |
| Near vision $ | 70.23 ± 22.09 |
| Distance vision $ | 79.23 ± 23.96 |
| Social function $ | 88.17 ± 17.45 |
| driving, median # | 66.67 (0–100) |
| role limitation # | 50.00 (25.00–68.75) |
| Ocular pain $ | 64.92 ± 19.48 |
| Dependency $ | 66.67 (50.0–75.0) |
| Well-being/distress # | 31.25 (12.50–68.75) |
| Composite score $ | 63.84 ± 18.39 |
The item–scale correlation coefficients were generally above 0.4 (
| Subscale | Item–scale correlation # |
|---|---|
| General health | 0.695 |
| General vision | 0.515 |
| Peripheral vision | 0.572 |
| Color vision | 0.785 |
| Near vision | 0.842 |
| Distance vision | 0.787 |
| Social function | 0.794 |
| Driving | 0.472 |
| Role limitation | 0.608 |
| Ocular pain | 0.285 |
| Dependency | -0.100 |
| Well-being/distress | 0.497 |
| Composite score | 0.978 |
As shown in Table
Internal reliability (convergent validity) of ARB-VFQ (25- and 30-question versions).
| Subscale | Cronbach alpha | |
|---|---|---|
| Without optional items | With optional items | |
| General Health | NA | NA |
| General vision | NA | NA |
| Ocular pain | 0.744 | 0.744 |
| Near vision | 0.655 | 0.680 |
| Distance activities | 0.919 | 0.910 |
| Social functioning | 0.864 | 0.860 |
| Mental health | 0.928 | 0.928 |
| Role difficulties | 0.988 | 0.842 |
| Dependency | 0.835 | 0.835 |
| Driving | 0.522 | 0.522 |
| Color vision | NA | NA |
| Peripheral vision | NA | NA |
As shown in Fig.
This study presents mARB-VFQ-25, which is adapted to the Iraqi context and has satisfactory psychometric properties in terms of internal consistency and feasibility. Some modifications were made to items 5 and 14 to match the Iraqi cultural context and recent cultural changes.
Since newspapers are no longer widely used, item 5 was changed to include reading from books, texts on phones, bills, medication boxes, legal documents, and ID cards. Items A3 and A4 were merged into this item for comprehensiveness. Regarding item 14, as Iraqis rarely watch movies in cinemas or attend plays, the statement was modified to include attending public activities and festivals, with “football games” added for sports events. Other minor modifications were also made. According to guidelines, these changes are minor and maintain the questionnaire’s comparability across cultures and nationalities (Beaton 2000).
The face-to-face administration of the questionnaire took an average of 9 minutes and 26 seconds (± 3 minutes 11 seconds), which was shorter than the original Arabic version (ARB-VFQ-25), the English version, and many other foreign editions (
It is worth noting that the low item–scale correlation with the “Ocular pain” subscale may be due to the nature of the condition studied, as pain is not a main symptom. With the exception of the “Dependency” subscale, all other subscales showed acceptable to optimal Cronbach alpha results. In addition, all subscales demonstrated an acceptable correlation with the composite score, indicating that the items are reliable.
The Dependency subscale showed a negative Cronbach alpha (–0.100), indicating serious reliability problems, unlike the other subscales, which performed well. Scoring errors were ruled out, suggesting the issue stems from conceptual inconsistency among items—possibly measuring divergent aspects of dependency or even opposing traits. The negative value implies that the dependency items were not functioning together as intended, likely due to a problematic item or construct definition. The small number of items in the subscale may have amplified instability, but the negative inter-item covariance points to a deeper lack of coherence. This undermines construct validity, making any results based on the subscale unreliable and preliminary. As
Regarding the study’s limitations, all participants had diabetic maculopathies and were recruited from the Department of Ophthalmology in a single hospital. Although the hospital is a referral center for ophthalmology, including a larger number of patients and recruiting individuals with other ophthalmologic conditions would provide broader representation and may help account for age and other characteristics that could affect responses.
Our results suggest that mARB-VFQ-25 is a valid and reliable tool for assessing vision-related QoL. It is important to establish such a valuable instrument for evaluating vision-related QoL among Iraqi adult patients. Accordingly, further studies on Iraqi and other Arabic patients with miscellaneous eye conditions are required to investigate the influence of vision quality on patients’ well-being and social functioning.
Conflict of interest
The authors have declared that no competing interests exist.
Ethical statements
The authors declared that no clinical trials were used in the present study.
The authors declared that experiments on humans or human tissues were performed for the present study.
Informed consent from the humans, donors or donors’ representatives: This research study has been reviewed and approved by the Research Ethical Committee of the College of Pharmacy, Mustansiriyah University (Approval number: 73, reference number: 173, date: 5 June 2024).
The authors declared that no experiments on animals were performed for the present study.
The authors declared that no commercially available immortalised human and animal cell lines were used in the present study.
Use of AI
No use of AI was reported.
Funding
No funding was reported.
Author contributions
All authors have contributed equally.
Author ORCIDs
Mahmood Majid Salman https://orcid.org/0000-0002-0634-0853
Mohammed Mahmood Mohammed https://orcid.org/0000-0002-1205-4829
Data availability
All of the data that support the findings of this study are available in the main text or Supplementary Information.
Final version of ARB-VFQ-25
Data type: pdf