1.Mongolian translation and reliability assessment of the PedsQL™ gastrointestinal symptoms module standard form in pediatric patients with gastrointestinal disorders
Bulgantsetseg G ; Namuun G ; Enkhtuvshin N ; Enkhzul N ; Davaajav O ; Tserendavga D
Mongolian Journal of Health Sciences 2026;95(5):217-222
Background:
The Pediatric Quality of Life Inventory™ (PedsQL™) is a modular, multidimensional instrument designed to assess health-related quality of life (HRQoL) in children and adolescents aged 2 to 18 years. It encompasses both child self-report and parent proxy-report formats and includes generic as well as disease-specific modules, enabling comprehensive HRQoL assessment across healthy and clinical pediatric populations. In Mongolia, gastrointestinal (GI) disorders represent the second leading cause of morbidity among children aged 10 to 14 years. The assessment of HRQoL in children with GI disorders — particularly those with chronic conditions — is of considerable importance for clinicians and researchers in conducting epidemiological surveillance, monitoring treatment outcomes, and evaluating findings from clinical trials.
Aim:
To translate the Pediatric Quality of Life Inventory–Gastrointestinal Symptoms Module Standard Form (PedsQL™-GI version standard form) into Mongolian and to evaluate its internal consistency reliability.
Materials and Methods:
The PedsQL™-GI version standard form was selected for translation following written authorization from the original developers. The bilingual forward translation was conducted by a team comprising a professional linguist and a pediatrician with 15 years of clinical experience and academic proficiency in English, adhering to the developer-provided translation protocol. The preliminary Mongolian version was subsequently reviewed by a senior pediatrician with 25 years of professional experience and academic English, with particular attention to medical terminology accuracy and linguistic equivalence. A separate bilingual team — consisting of a second linguist and a pediatrician — then performed the backward translation into English. A small-group expert panel comprising the back-translation team and the research investigators convened to review discrepancies and finalize the English reconciled version, which was submitted to the original developers for approval before the official release of the Mongolian version. To evaluate the internal consistency reliability of the Mongolian version, the instrument was administered to 25 children aged 8–12 years and 25 adolescents aged 13 years and above, along with their respective caregivers. Data were analyzed using SPSS version 25.0, employing the Intraclass Correlation Coefficient (ICC) and Cronbach’s alpha coefficient.
Results:
The Cronbach’s alpha coefficient for the total instrument was α=0.96, indicating excellent internal consistency reliability. Test-retest reliability, assessed using the Intraclass Correlation Coefficient, yielded ICC=0.79, demonstrating satisfactory measurement stability over repeated administrations.
Conclusions
1. The overall semantic equivalence of the Mongolian version was 97.8%, and 96% of cognitive interview participants rated the questionnaire as “understandable” indicating that the clinical content and conceptual integrity of the original instrument were fully preserved throughout the translation process. 2. A total of 37 adaptation instances were identified during the translation process, encompassing six categories of linguistic and cross-cultural localization: age-appropriate modification, conversion of medical terminology into everyday language, linguistic and cultural adaptation, synonymous substitution, elaboration, and condensation. These adaptations collectively enhanced the content validity of the instrument. 3. The Mongolian version demonstrated excellent internal consistency reliability (Cronbach’s alpha α=0.96) and satisfactory test-retest reliability (Intraclass Correlation Coefficient ICC=0.79), both fully meeting international psychometric standards. These findings confirm that the instrument constitutes a reliable tool for assessing health-related quality of life in Mongolian children with chronic gastrointestinal disorders.
2.Efficacy of tenofovir alafenamide in the treatment of chronic hepatitis B infection
Tuvshinbayar N ; Amaraa R ; Burmaajav B ; Gegeebadrakh B ; Dulguun B ; Enkhtuvshin D
Mongolian Medical Sciences 2019;188(2):17-23
Introduction:
Worldwide, an estimated two billion people have evidence of HBV infection, and approximately 240 million have CHB. In this study, a representative group of Mongolian adults was tested for hepatitis B virus (HBV) in 2017. The prevalence estimates of HBV the general Mongolian adult population were found to be 11.1%, respectively.
In April 2017, EASL added a drug newly approved for treatment of CHB, tenofovir alafenamide (TAF) to
their list of recommended first-line therapies. The requirement for long-term therapy in chronic HBV highlights the importance of these efficacy and safety trends, however their true clinical relevance is yet to be established and further studies with long-term follow up and real-world clinical data are needed.
Goal:
Evaluate for result of tenofovir alafenamide in the treatment of chronic hepatitis B infection.
Materials and Methods:
The clinical trials have evaluated TAF in HBeAg-positive and HBeAg-negative chronic HBV
patients. The trials have similar designs and are randomized, double blind, non-inferiority studies.
The primary efficacy endpoint was the proportion of patients with HBV DNA<29 IU/ml at week
24 and 48. Other prespecified efficacy endpoints were the proportion of patients with HBsAg
seroncoversion to anti-HBs at week 24 and 48. Key secondary safety end- points at week 24 and 48
included the percentage change in T-score, and Z-score bone mineral density (BMD), percentage
change in BMD and change from baseline serum creatinine.
Results:
The primary efficacy endpoint, an HBV DNA level <29 IU/ml at week 24, was achieved by 120
(59.1%) of 203 patients receiving TAF, which was non-inferior to the 63 (55.2%) of 114 patients
receiving TDF who had an HBV DNA<29 IU/ml. After 24 weeks of treatment, patients receiving
TAF had significantly smaller reductions in bone mineral density (BMD) compared with patients
receiving TDF.
Conclusion
The development of TAF, specifically designed to deliver potent antiviral activity but with an
improved safety profile compared with TDF, is therefore timely.
Result Analysis
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