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Development, validation and application of the dried blood spot analysis method for the determination of Ustekinumab in patients with Inflammatory bowel disease
Panagiotis-Dimitrios Mingas, Jurij Zdovc, Iztok Grabnar, David Drobne, Tomaž Vovk, 2025, original scientific article

Abstract: Background: Ustekinumab (UST) is a monoclonal antibody (mAb) used in the treatment of inflammatory bowel disease (IBD). Elevated serum concentrations are typically associated with improved therapeutic outcomes, and therapeutic drug monitoring (TDM) is a useful tool for guiding mAbs treatment. This study aimed to develop a dried blood spot (DBS) method for TDM of UST in patients with IBD. Methods: The commercial enzyme-linked immunosorbent assay for plasma samples was optimized for DBS samples and subsequently validated according to international guidelines for classical and DBS-specific validation parameters. It was then applied to analyze serum and DBS samples obtained from venous and capillary blood of IBD patients undergoing UST therapy. Results: The method was linear (3–12 mg/L) with acceptable inter-day accuracy (90.1–106%) and precision (<12%). We confirmed that there was no hematocrit effect and that DBS samples were stable for one month under room conditions. A linear model was developed between venous DBS and serum UST concentrations, which showed no systemic bias, and 71% of the samples were within ±20% of the mean. In addition, a linear correlation between venous DBS and capillary DBS samples was established, showing no significant bias, with 84% of samples within ±20% of the mean. Finally, a novel strategy was developed to overcome the limitations of poor-quality samples (irregular shapes) based on area image analysis. Conclusions: The newly developed DBS method is the first to enable reliable measurement of UST in capillary blood, appropriate clinical interpretation of the measured concentrations, and remote monitoring of patients in the early phase of therapy.
Keywords: ustekinumab, dried blood spots, venous blood, capillary blood, validation, inflammatory bowel disease, ELISA
Published in DiRROS: 17.04.2026; Views: 164; Downloads: 129
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Assessing life balance of European people with multiple sclerosis : a multicenter clinimetric study within the RIMS network
Daphne Kos, Sofie Ferdinand, Marijke Duportail, Isaline Eijssen, Sofie Schouteden, Lore Kerkhofs, Jelka Janša, Núria Filló, Kathleen M. Matuska, Heleen Beckerman, 2020, original scientific article

Abstract: Background Life balance is defined as “a satisfying pattern of daily activity that is healthful, meaningful, and sustainable to an individual within the context of his or her current life circumstances”. To assess life balance, the self-report instrument Life Balance Inventory (LBI) has been developed in the US. The aim of this study was to evaluate cross-cultural, construct validity and test-retest reliability of translated versions of the LBI in people with multiple sclerosis (MS) within different European cultures (Dutch, Flemish, Slovenian, and Spanish). Method The LBI was translated according to the principles of forward/backward translation and the cultural adaption process of patient-reported outcomes and evaluated in people with MS in each country/language area. LBI (score range 1–3; higher scores refer to better balance) was registered twice with an interval of 7 days to evaluate test-retest reliability using Intraclass Correlation Coefficients (ICCs) and Bland Altman analyses. To evaluate construct validity, Pearson correlations of the LBI with quality of life, fatigue, depression and self-efficacy were explored. Results The total sample (n = 313, 50 ± 11 years of age, MS duration 13 ± 8 years) consisted of five subsamples: Dutch (n = 81, 74% women, 54 ± 9.6 years of age), Flemish 1 (n = 42, 57% women, 49 ± 12 years), Flemish 2 (n = 105, 63% women, 50 ± 10.6 years), Slovenian (n = 48, 79% women, 44 ± 11.2 years) and Spanish (n = 37, 62% women, 47 ± 9.0 years). Baseline total LBI scores differed between subsamples (F(4, 312)=7.19, p < 0.001). ICC [95% CI] of total LBI was 0.88 [0.83–0.92] (Flemish 2), 0.65 [0.39–0.82] (Flemish 1), 0.55 [0.37–0.69] (Dutch), 0.45 [0.15–0.67] (Spanish) and 0.35 [0.07–0.59] (Slovenian). Systematic error was present in one sample; no proportional bias occurred. Correlations ranged from 0.05 to 0.55 for quality of life and self-efficacy, from −0.50 to 0.05 for fatigue and from −0.44 to −0.28 for depression, not fully supporting the hypotheses. Conclusion The study results provide limited support for test-retest reliability, cross-cultural and construct validity of the LBI in different European subsamples. Although LBI may serve as a supportive tool in goalsetting in rehabilitation, the current version of LBI is not recommended for (international) research purposes.
Keywords: cross-cultural validation, meaningful activities, patient reported outcome measure (prom), quality of life, rehabilitation
Published in DiRROS: 10.03.2026; Views: 334; Downloads: 151
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Monitoring the dynamic sensitivity of the Solkan footbridge to user-induced excitation
Mirko Kosič, Doron Hekič, Izabela Joanna Drygala, 2025, published scientific conference contribution

Abstract: This paper presents a comprehensive monitoring study of the dynamic sensitivity of the Solkan footbridge in Slovenia, with a focus on its response to user-induced actions. An extensive ambient vibration measurement campaign was carried out, during which 26 triaxial accelerometers were strategically deployed along the bridge to capture its modal characteristics in all three spatial directions. The structure’s dynamic response was monitored under both regular pedestrian traffic and elevated loading conditions during a local marathon event, allowing for the assessment of its behaviour across a broad spectrum of realworld scenarios. Preliminary measurements revealed reduced pedestrian comfort, primarily due to resonance effects resulting from bridge–user interaction. The study highlights the importance of field-based dynamic assessments in diagnosing performance issues and informing mitigation strategies. The findings contribute to the advancement of resilient and dynamically efficient design and maintenance practices for pedestrian bridges.
Keywords: modal model validation, footbridges, ambient vibrations, dynamic sensitivity, user-induced excitation
Published in DiRROS: 22.01.2026; Views: 301; Downloads: 112
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Evaluation of cut slope stability in the Lesser Himalaya of Nepal
Krishna Kumar Shrestha, Kabi Raj Paudyal, Dinesh Pathak, Alessandro Franci, Prem Bahadur Thapa, 2025, original scientific article

Abstract: A spatial inventory of cut slopes in the central and western Lesser Himalaya of Nepal was prepared and characterised to evaluate their stability. The stability of these cut slopes is governed by the geotechnical properties of rock/soil together with slope geometry, groundwater conditions and human interventions. Numerous cut slope failures were observed in areas where slope geometry is modified for engineering developments such as roads, dams, powerhouses, industrial development, etc. Two modelling sites were evaluated using the Limit Equilibrium Method (LEM), Finite Element Method (FEM), and Particle Finite Element Method (PFEM). Pre-failure analyses using LEM and FEM under dry and saturated conditions revealed that the stability of the Lesser Himalayan hillslopes with considerable soil thickness is predominantly controlled by the depth of groundwater level (GWL). Slopes remain stable with a factor of safety (FoS)>1.3 when the GWL lies below 7 m from the surface and gradually become unstable as it approaches the surface. This trend for both slopes confirms that elevated groundwater during the rainy season is the major cause of frequent cut slope failures in the Himalayan regions. The comparison of FoS from LEM and Strength Reduction Factor (SRF) from FEM showed a strong cross-correlation (90–99 %), revealing minimal variation which affirmed the validity of the adopted modelling techniques used in this study. Post-failure simulations of these sites were further analysed using an innovative approach, the robust PFEM modelling technique, to compute the dynamic failure mechanism. Sensitivity analysis of both modelled sites showed that friction angle and cohesion are the most significant parameters for slope stability evaluation. Moreover, forward and back analyses indicated that computed results are in good agreement, thus depicting reliability and performances along with the model validation.
Keywords: cut slope, slope stability, numerical modelling, evaluation and validation, Lesser Himalaya, Nepal
Published in DiRROS: 23.12.2025; Views: 948; Downloads: 190
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Psychometric properties of the Slovenian adaptation of Zuckerman-Kuhlman Cross-Cultural 50 item personality questionnaire (ZKPQ-50-CC) in a sample of emerging adults
Timotej Glavač, Žan Lep, Maja Zupančič, 2023, original scientific article

Abstract: The aim of the present study was to validate the Slovenian version of the ZKPQ-50-CC (Aluja et al., 2006). The ZKPQ-50- CC is a shortened, cross-culturally validated version of the Zuckerman Kuhlman Personality Questionnaire (ZKPQ; Zuckerman et al., 1988), based on an alternative five-factor model of personality. Our sample included 2138 emerging adults (1534 females; Mage = 21.28 years; SD = 3.62) who filled in both the ZKPQ-50-CC and the Big Five Inventory (BFI; John et al., 1991). The results of a confirmatory factor analysis showed similarities to those of the original validation study across four European countries (Aluja et al., 2006). To improve upon the psychometric properties of the ZKPQ-50-CC scales, however, we removed six items with low factor loadings (below .30), resulting in the ZKPQ-44-CC. The five factors (Impulsive Sensation Seeking, Neuroticism-Anxiety, Aggression-Hostility, Activity, and Sociability) of the adjusted instrument suggested acceptable internal reliability, as well as satisfactory convergent and divergent validity against the BFI factors. We also determined relatively high levels of temporal stability (measurements two years apart) of the alternative five factors in a smaller follow-up sample (n = 168). Despite several drawbacks, we consider the ZKPQ-44-CC appropriate for psychological research in Slovenia.
Keywords: Zuckerman’s alternative five-factor personality model, the ZKPQ-50-CC, Slovenian validation, validity, internal reliability, temporal stability, Zuckerman-Kuhlman Cross-Cultural 50 item personality questionnaire ZKPQ-50-CC, test validity, psychometrics, test reliability
Published in DiRROS: 08.07.2025; Views: 563; Downloads: 398
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An international comparability study on quantification of mRNA gene expression ratios: CCQM-P103.1
Alison S. Devonshire, Tina Demšar, Jana Žel, Andrej Blejec, Mojca Milavec, 2016, original scientific article

Abstract: Measurement of RNA can be used to study and monitor a range of infectious and non-communicable diseases, with profiling of multiple gene expression mRNA transcripts being increasingly applied to cancer stratification and prognosis. An international comparison study (Consultative Committee for Amount of Substance (CCQM)-P103.1) was performed in order to evaluate the comparability of measurements of RNA copy number ratio for multiple gene targets between two samples. Six exogenous synthetic targets comprising of External RNA Control Consortium (ERCC) standards were measured alongside transcripts for three endogenous gene targets present in the background of human cell line RNA. The study was carried out under the auspices of the Nucleic Acids (formerly Bioanalysis) Working Group of the CCQM. It was coordinated by LGC (United Kingdom) with the support of National Institute of Standards and Technology (USA) and results were submitted from thirteen National Metrology Institutes and Designated Institutes. The majority of laboratories performed RNA measurements using RT-qPCR, with datasets also being submitted by two laboratories based on reverse transcription digital polymerase chain reaction and one laboratory using a next-generation sequencing method. In RT-qPCR analysis, the RNA copy number ratios between the two samples were quantified using either a standard curve or a relative quantification approach. In general, good agreement was observed between the reported results of ERCC RNA copy number ratio measurements. Measurements of the RNA copy number ratios for endogenous genes between the two samples were also consistent between the majority of laboratories. Some differences in the reported values and confidence intervals (‘measurement uncertainties’) were noted which may be attributable to choice of measurement method or quantification approach. This highlights the need for standardised practices for the calculation of fold change ratios and uncertainties in the area of gene expression profiling.
Keywords: RNA copy number ratio, RT-qPCR, gene expression, normalisation, standardisation, molecular diagnostic, transcriptomics, cancer, diagnostics, biomarker identification and validation
Published in DiRROS: 04.03.2025; Views: 988; Downloads: 542
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