The telephone-based application of the modified fatigue impact scale in individuals with multiple sclerosis: An investigation of measurement properties.

BACKGROUND: Fatigue is one of the most common symptoms reported by individuals with multiple sclerosis and it contributes to the reduction of the functionality. Therefore, it is important to assess the impact of fatigue on daily living of individuals with multiple sclerosis. The Modified Fatigue Impact Scale (MFIS) is an instrument to assess the perception of the impact of fatigue. However, there have been no investigations about the measurement properties of this instrument administered over the telephone for individuals with multiple sclerosis. OBJECTIVES: To verify the concurrent validity, the test-retest reliability, the standard error of measurement (SEM) and the minimal detectable change (MDC) of the MFIS applied over the telephone to assess the perception of the impact of fatigue of individuals with multiple sclerosis. METHODS: The MFIS, composed of 21 items covering three domains: physical, cognitive and psychosocial, was applied at three different moments with an interval of 5-7 days. To establish the concurrent criterion validity, the face-to-face application and the first evaluation by telephone were used. The two telephone assessments were used to assess the test-retest reliability The intraclass correlation coefficient (ICC) with 95 % confidence interval (CI) and the Bland-Altman method were used. The standard error of measurement (SEM) and the MDC was calculated according to reliability results. RESULTS: Thirty individuals (40.83 ± 10.61, 60 % female) were included. The median score on the Expanded Disability Status Scale was 2.00 (±4.00). The majority of participants experienced fatigue (n = 17; 56.67 %). A significant and high magnitude correlation (0.70 ≤ ICC ≤ 0.87, p < 0.001) was found in the investigation of concurrent criterion validity. The Bland-Altman method showed a mean difference between 0.70 to 2.17 points between face-to-face and telephone-based application of the MFIS. For test-retest reliability, a significant and very high magnitude correlation (0.91 ≤ ICC ≤ 0.97, p < 0.001) was found. The Bland-Altman method showed a mean difference between -0.03 and -0.77 points between two telephone-based applications. The SEM and the MDC were 0.71 and 1.97 points. CONCLUSION: The telephone-based application of the MFIS to assess the perceived impact of fatigue in individuals with multiple sclerosis demonstrated adequate measurement properties, and may be a valuable tool to assess patients in clinical practice.

Developing an international consensus Reporting guideline for intervention Fidelity in Non-Drug, non-surgical trials: The ReFiND protocol.

BACKGROUND: Inadequate reporting of fidelity to interventions in trials limits the transparency and interpretation of trial findings. Despite this, most trials of non-drug, non-surgical interventions lack comprehensive reporting of fidelity. If fidelity is poorly reported, it is unclear which intervention components were tested or implemented within the trial, which also hinders research reproducibility. This protocol describes the development process of a reporting guideline for fidelity of non-drug, non-surgical interventions (ReFiND) in the context of trials. METHODS: The ReFiND guideline will be developed in six stages. Stage one: a guideline development group has been formed to oversee the guideline methodology. Stage two: a scoping review will be conducted to identify and summarize existing guidance documents on the fidelity of non-drug, non-surgical interventions. Stage three: a Delphi study will be conducted to reach consensus on reporting items. Stage four: a consensus meeting will be held to consolidate the reporting items and discuss the wording and structure of the guideline. Stage five: a guidance statement, an elaboration and explanation document, and a reporting checklist will be developed. Stage six: different strategies will be used to disseminate and implement the ReFiND guideline. DISCUSSION: The ReFiND guideline will provide a set of items developed through international consensus to improve the reporting of intervention fidelity in trials of non-drug, non-surgical interventions. This reporting guideline will enhance transparency and reproducibility in future non-drug, non-surgical intervention research.

Translation and cross-cultural adaptation into Portuguese-Brazil of NuHISS, Enlight, and uMARS.

BACKGROUND: Easy access to the Internet enables the creation of many online applications. In this sense, questionnaires were developed to evaluate the usability of health area online applications: the National Usability-Focused Health Information System Scale (NuHISS), the Enlight, and the User Version of the Mobile Application Rating Scale (uMARS). Those scales do not have a Portuguese (Brazil) version which is adequate to Brazil's culture. As a consequence, they can not be properly used in Brazil. OBJECTIVE: To translate and cross-cultural adapt the NuHISS, Enlight, and uMARS to Portuguese (Brazil). METHODS: A methodological study involving the translation and cross-cultural adaptation of the questionnaires NuHISS, Enlight, and uMARS was conducted following international guidelines recommendations. The questionnaires pass trough an initial translation, translation synthesis, back translation, expert committee, and a pre-final version test. RESULTS: Thirdy-two health professionals analyzed NuHiss, Enlight, and uMARS translated and cross-cultural adapted Portuguese (Brazil) version. There was conceptual equivalence between the translated and original versions, and no significant adaptations were needed during the translation process. 93.8% of professionals assume that the language is cohesive and 96.9% of them consider that the content is cohesive. CONCLUSION: The NuHISS, Enlight, and uMARS were successfully translated and cross-culturally adapted to Portuguese (Brazil) and can be properly applied in Brazil. Brazilian health professionals should use the questionnaires NuHISS, Enlight, and uMARS to evaluate health area applications usability.

Interrater reliability of the modified prone instability test for lumbar segmental instability in individuals with mechanical low back pain.

OBJECTIVE: The purpose of this study was to establish the interrater reliability of measures obtained with a novel Modified Prone Instability Test (mPIT), which, like the original Prone Instability Test (PIT), is proposed to identify lumbar segmental instability. The mPIT has clinical feasibility advantages to the PIT, but its psychometric properties are yet to be determined. DESIGN: Repeated measures (test-retest) design, methods study. METHODS: The mPIT was administered by two blinded testers, an orthopedic physical therapy resident with < 1 year experience and board-certified orthopedic specialist physical therapist with >25 years' experience. Procedures were administered at an outpatient physical therapy clinic of a tertiary Medical Center. Participants included 50 adults (≥18 years old) with mechanical low back pain and no radicular (below the knee) symptoms (mean age 50.7 years, 66% female, 76% reported previous episodes of low back pain). Interrater reliability was measured via Fleiss' kappa coefficient. RESULTS: Assessments of the mPIT had moderate interrater agreement (κ = .579 [95% CI = .302 to .856], p < .001.). CONCLUSION: Measures obtained using the mPIT demonstrated moderate interrater reliability between a new graduate and an experienced clinician, which aligns with several studies examining interrater reliability of the original PIT. Further study examining comparative validation of the mPIT with other lumbar instability measures is warranted.

Early Childhood Oral Health Impact Scale: Psychometric Evaluation in Portuguese Preschoolers.

Objective: to contribute to the validation of the Early Childhood Oral Impact Scale (ECOHIS) by studying its psychometric properties when applied to a Portuguese preschool population. Methods: Cross-sectional study conducted with children aged between three and five-years-old. The non-probabilistic sample included two preschools in the municipality of Lisbon. Children who agreed to participate and whose guardians signed the informed consent were included. Data collection included a questionnaire, administered to the parents, and an intraoral examination of the children. The questionnaire included the Portuguese version of ECOHIS. The intraoral examination included the caries diagnosis according to the World Health Organization criteria. Discriminant validity compared the ECOHIS score between children with and without caries experience (Mann-Whitney U-test). Cohen's d was calculated to estimate the magnitude of the difference. Reliability analysis included Cronbach's α and test-retest. Construct validity was analyzed by the correlation between the ECOHIS score and dmft (Spearman's correlation). A significance level of 5% was used. Results: The sample included 104 children (mean age 4.1 years). ECOHIS values were significantly different between children with and without caries (p=0.004). The Cohen's d was 0.84. The Cronbach's was 0.78, with no significant increase in value when eliminating any of the items. The test-retest showed significant correlation (r=0.76; p=0.01). There was a significant correlation between the ECOHIS score and caries experience (r=0.28; p=0.004). Conclusion: The Portuguese version of the ECOHIS showed good psychometric properties, indicating that it is a reliable and valid tool to measure the impact of oral health in preschool children.

Inter-rater agreement between patient- and proxy-reported cognitive functioning in intensive care unit patients: A cohort study.

BACKGROUND: Health status, including cognitive functioning before critical illness, is associated with long-term outcomes in intensive care unit survivors. Premorbid data are therefore of importance in longitudinal studies. Few patients can self-report at intensive care admission. Consequently, proxy assessments of patients' health status are used. However, it remains unclear how accurately proxies can report on an intensive care patient's cognitive status. OBJECTIVES: The aim of this study was to examine the agreement between patient- and proxy-reporting of the Cognitive Failures Questionnaire and to compare the agreement between proxy reports using the latter questionnaire and the Informant Questionnaire of Cognitive Decline in the Elderly as a reference. METHODS: The present cohort study is part of a longitudinal multicentre study collecting both patient and proxy data using questionnaires and clinical data from medical records during intensive care unit stays. Agreement on patient and proxy pairs was examined using intraclass correlation coefficient (ICC), Spearman's correlation, percentage agreement, and Gwet's AC1 statistics. Agreement between the proxy-reported questionnaires was examined using percentage agreement and Gwet's AC1 statistics. RESULTS: In total, we collected 99 pairs of patient-proxy assessments and 158 proxy-proxy assessments. The ICC for the sum scores revealed moderate agreement (n = 99; ICC = 0.59; 99% confidence interval [CI]: [0.30-0.76]) between patient and proxy. Agreement on items was poor (AC1 = 0.13; 99% CI: [0.01-0.24]) to moderate (AC1 = 0.55; 99% CI: [0.43-0.68]). Agreement using cut-off scores (>43) to indicate cognitive impairment was very good (89.9%, AC1 = 0.87; 99% CI: [0.79-0.95]). Agreement between the proxy-reported Cognitive Failures Questionnaire (>43) and the reference questionnaire (≥3.5) was also very good (n = 158; 85%, AC1 = 0.82; 99% CI: [0.74-0.90]). CONCLUSIONS: Proxy assessments of the Cognitive Failures Questionnaire (>43) may be used to indicate cognitive impairment if patients are unable to self-report. Agreement was high between the two questionnaires determined by proxies, showing that these can be used interchangeably to assess cognitive functioning if proxy reporting is needed.

Inter-reader Agreement for CT/MRI LI-RADS Category M Imaging Features: A Systematic Review and Meta-analysis.

Backgrounds/Aims: To systematically evaluate inter-reader agreement in the assessment of individual Liver Imaging Reporting and Data System (LI-RADS) category M (LR-M) imaging features in computed tomography/magnetic resonance imaging (CT/MRI) LI-RADS v2018, and to explore the causes of poor agreement in LR-M assignment. Methods: Original studies reporting inter-reader agreement for LR-M features on multiphasic CT or MRI were identified using the MEDLINE, EMBASE, and Cochrane databases. The pooled kappa coefficient (κ) was calculated using the DerSimonian-Laird random-effects model. Heterogeneity was assessed using Cochran's Q test and I2 statistics. Subgroup meta-regression analyses were conducted to explore the study heterogeneity. Results: In total, 24 eligible studies with 5,163 hepatic observations were included. The pooled κ values were 0.72 (95% confidence interval, 0.65-0.78) for rim arterial phase hyperenhancement, 0.52 (0.39-0.65) for peripheral washout, 0.60 (0.50-0.70) for delayed central enhancement, 0.68 (0.57-0.78) for targetoid restriction, 0.74 (0.65-0.83) for targetoid transitional phase/hepatobiliary phase appearance, 0.64 (0.49-0.78) for infiltrative appearance, 0.49 (0.30-0.68) for marked diffusion restriction, and 0.61 (0.48-0.73) for necrosis or severe ischemia. Substantial study heterogeneity was observed for all LR-M features (Cochran's Q test: p < 0.01; I2 ≥ 89.2%). Studies with a mean observation size of <3 cm, those performed using 1.5-T MRI, and those with multiple image readers, were significantly associated with poor agreement of LR-M features. Conclusions: The agreement for peripheral washout and marked diffusion restriction was limited. The LI-RADS should focus on improving the agreement of LR-M features.

Assessment of management reasoning: Design considerations drawn from analysis of simulated outpatient encounters.

PURPOSE: Management reasoning is a distinct subset of clinical reasoning. We sought to explore features to be considered when designing assessments of management reasoning. METHODS: This is a hybrid empirical research study, narrative review, and expert perspective. In 2021, we reviewed and discussed 10 videos of simulated (staged) physician-patient encounters, actively seeking actions that offered insights into assessment of management reasoning. We analyzed our own observations in conjunction with literature on clinical reasoning assessment, using a constant comparative qualitative approach. RESULTS: Distinguishing features of management reasoning that will influence its assessment include management scripts, shared decision-making, process knowledge, illness-specific knowledge, and tailoring of the encounter and management plan. Performance domains that merit special consideration include communication, integration of patient preferences, adherence to the management script, and prognostication. Additional facets of encounter variation include the clinical problem, clinical and nonclinical patient characteristics (including preferences, values, and resources), team/system characteristics, and encounter features. We cataloged several relevant assessment approaches including written/computer-based, simulation-based, and workplace-based modalities, and a variety of novel response formats. CONCLUSIONS: Assessment of management reasoning could be improved with attention to the performance domains, facets of variation, and variety of approaches herein identified.

Psychometric properties of the Disability of Arm Shoulder and Hand (DASH) in subjects with frozen shoulder: a reliability and validity study.

BACKGROUND: Frozen Shoulder (FS) is a painful condition characterized by severe pain and progressive restriction of shoulder movement, leading to functional impairment and reduced quality of life. While different Patient Reported Outcome Measurements (PROMs) tools exist for assessing shoulder diseases, few specific PROMs are validated for FS patients. PURPOSE: This study aims to assess the psychometric properties of the Disability of Arm, Shoulder, and Hand (DASH) questionnaire in FS patients. METHODS: One hundred and twenty-four subjects (mean ± SD age = 55.4 ± 7.9 years; 55.6% female) diagnosed with FS were included and completed the DASH questionnaire, the Numerical Pain Rating Scale (NPRS), the Shoulder Pain and Disability Index (SPADI), and the Short-Form Health Survey 36 (SF-36). Floor or ceiling effects were investigated. Structural validity was analysed through a unidimensional Confirmatory Factor Analysis (CFA), internal consistency through Cronbach's alpha, test-retest reliability through the Intraclass Correlation coefficient (ICC), measurement error through the Standard Error of Measurement (SEM), and the Minimum Detectable Change (MDC), and construct validity through the hypothesis testing with the correlation with the other outcome measures used. RESULTS: No floor or ceiling effects were observed. CFA confirmed a one-factor structure after addressing local item dependency (Root Mean Square Error of Approximation = 0.055; Standardized Root Mean Square Residual = 0.077; Comparative Fit Index = 0.970; Tucker-Lewis Index = 0.968). Cronbach's alpha was high (= 0.951), and test-retest reliability was excellent (ICC = 0.999; 95% CI: 0.998-1.000). SEM was equal to 0.5 points, and MDC to 1.5 points. Construct validity was considered satisfactory as 80% of the a-priori hypotheses were met. CONCLUSION: The DASH questionnaire demonstrated good psychometric properties in FS patients, supporting its use as a valuable tool for assessing the impact of FS in clinical and research settings.

Reliability and Validity of Maximal Respiratory Pressures.

BACKGROUND: Maximal respiratory pressure is used to assess the inspiratory and expiratory muscles strength by using maximal inspiratory pressure (PImax ) and maximal expiratory pressure (PEmax). This study aimed to summarize and evaluate the reliability and validity of maximal respiratory pressure measurements. METHODS: This systematic review followed the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) recommendations and was reported by using the PRISMA checklist. Studies published before March 2023 were searched in PubMed and EMBASE databases. RESULTS: A total of 642 studies were identified by using the online search strategy and manual search (602 and 40, respectively). Twenty-three studies were included. The level of evidence for test-retest reliability was moderate for PImax and PEmax (intraclass correlation coefficient > 0.70 for both), inter-rater reliability was low for PImax and very low for PEmax (intraclass correlation coefficient > 0.70 for both), and the measurement error was very low for PImax and PEmax. In addition, concurrent validity presented a high level of evidence for PImax and PEmax (r > 0.80). CONCLUSIONS: Only concurrent validity of maximal respiratory pressure measured with the manometers evaluated in this review presented a high level of evidence. The quality of clinical studies by using maximal respiratory pressure would be improved if more high-quality studies on measurement properties, by following well established guidelines and the COSMIN initiative, were available.

Validation of the Bipolar Recovery Questionnaire for the Portuguese Population: Recovery and Predictors in People with Bipolar Disorder.

INTRODUCTION: The paradigm in mental health care is progressively moving towards a recovery-focused perspective. Thus, there is a need for validated instruments to measure recovery in bipolar disorder (BD). The Bipolar Recovery Questionnaire (BRQ) is the most used instrument to assess it. The aim of this study was to translate and perform a cross-cultural adaptation of the BRQ to European Portuguese (PT-PT) and to explore further associations of recovery with sociodemographic and emotional regulation, as well as recovery predictors to inform future research and clinical practice. METHODS: The BRQ was forward-translated and back-translated until a consensus version was found, and a test-retest design was used to assess temporal stability. Participants were recruited in public hospitals and organizations supporting people with BD, either referred by their psychiatrists or psychologists or through self-referral. Eighty-eight individuals diagnosed with BD were recruited to complete a battery of Portuguese-validated self-report questionnaires to assess recovery (BRQ), clinical mood symptoms (Hospital Anxiety and Depression Scale), affect (Positive and Negative Affect Scale), well-being (brief Quality of Life for Bipolar Disorder; Satisfaction with Life Scale) and emotion regulation (Difficulties in Emotion Regulation Scale). RESULTS: The BRQ showed excellent internal consistency with a Cronbach alpha of 0.92, and test-retest exhibited good reliability (r = 0.88). Construct validity was confirmed through/by positive and moderate correlations with quality of life (QoL; r = 0.58) and positive affect (r = 0.52), and negative moderate correlations with depression (r = -0.64), and negative affect (r = -0.55). Both satisfaction with life (ß = 0.38, p = 0.010) and recovery (ß = 0.34, p = 0.022) impacted quality of life, supporting the BRQ's incremental validity. Depressive symptoms and emotion dysregulation accounted for 51% of its variance. CONCLUSION: The BRQ is a valid and reliable instrument to measure recovery in people with BD in the Portuguese population and is suitable for both clinical and research contexts.

Mapping of Neck Disability Index domains linked to the international classification of functioning and disability / Mapeamento dos domínios do neck disability index vinculados à classificação internacional de funcionalidade e incapacidade

Objective: This study aims to link NDI items to CIF using specific and up-to-date linking rules. Methods: It is a measurement properties analysis study in which two evaluators performed the link between NDI and CIF, both with experience in CIF taxonomy and NDI application. Thus, ten binding rules developed and updated specifically for binding the ICF to other instruments were applied. Results: The Kappa coefficient determined the level of agreement between the evaluators with a confidence interval of 95%. All NDI items were linked to ICF codes; there was no need to use the term "non-definable." The degree of agreement between the evaluators about the domains and the categories of the ICF's first, second, and third levels was almost perfect. Conclusion: Therefore, the NDI is well linked to the codes related to the ICF domains' Activity, Participation, Functions, and Structure. However, no concepts related to contextual factors were identified.

Objetivo: Este estudo visa vincular itens da NDI ao CIF usando regras de vinculação específicas e atualizadas. Métodos: É um estudo de análise de propriedades de medição no qual dois avaliadores realizaram a ligação entre NDI e CIF, ambos com experiência em taxonomia CIF e aplicação de NDI. Assim, foram aplicadas dez regras de vinculação desenvolvidas e atualizadas especificamente para vincular a ICF a outros instrumentos. Resultados: O coeficiente Kappa determinou o nível de concordância entre os avaliadores com um intervalo de confiança de 95%. Todos os itens do NDI estavam vinculados a códigos ICF; não havia necessidade de utilizar o termo "não definível". O grau de concordância entre os avaliadores em relação aos domínios e às categorias do primeiro, segundo e terceiro níveis da ICF foi caracterizado como quase perfeito. Conclusão: Portanto, o NDI está bem ligado aos códigos relacionados à Atividade, Participação, Funções e Estrutura dos domínios da ICF. Entretanto, não foram identificados conceitos relacionados a fatores contextuais.

Reference values and reliability of occlusal force distribution and occlusal time measured by the T-Scan system in adults with healthy dentition.

PURPOSE: Reference values of occlusal characteristics are needed to interpret the data obtained using the T-Scan System. This study aimed to establish reference values for and to assess the reliability of, occlusal force distribution in the maximal intercuspal position and the occlusion time in young adults with healthy dentition. MATERIALS AND METHODS: In total 178 adults with natural dentition participated in this retrospective cross-sectional study, of whom 76 performed a retest session. Several occlusal recordings were obtained from each participant using the T-Scan system while asking them to bite two or three consecutive times (multi-bite) or only once (single-bite) at the maximal intercuspal position. The lateral and anteroposterior occlusal force distribution were determined as percentages in the right and posterior teeth . Occlusion time was measured in seconds. After the occlusal force distribution and occlusion time percentiles were calculated, reliability was assessed by the intraclass correlation coefficient. RESULTS: The 5th-95th percentiles for occlusal force distribution were 34%-67% on the right teeth and 55%-94% on the posterior teeth. The 90th percentile for multi-bite occlusion time was 0.17 s and for single-bite occlusion time was 0.27 s. The intraclass correlation coefficients for lateral occlusal force distribution, anteroposterior occlusal force distribution, multi-bite occlusion time, and single-bite occlusion time were 0.70, 0.68, 0.58, and 0.67, respectively. CONCLUSIONS: This study generated reference values for key occlusal characteristics (occlusal force distribution and occlusion time) when using the T-Scan system. These values showed moderate reliability.

Validez y fiabilidad del cuestionario ARMS-e en pacientes con Diabetes mellitus tipo 2 / Validity and reliability of the ARMS-e questionnaire in patients with type 2 Diabetes mellitus

Introducción: El cuestionario “Adherence to Refills and Medications Scale” (ARMS) se diseñó para medir adherencia al tratamiento. Fue traducido y adaptado al español, pero no se han evaluado sus propiedades psicométricas. El objetivo fue evaluar dichas propiedades en una población con diabetes mellitus tipo 2. Método: El estudio se llevó a cabo en farmacias comunitarias de Granada (España) mediante entrevista. Se realizó un análisis factorial de componentes principales (AFCP) con rotación Varimax (validez de constructo), un análisis de concordancia (validez de criterio concurrente y fiabilidad por estabilidad temporal) y alfa de Cronbach y correlación ítem-total (fiabilidad por homogeneidad). Resultados: 107 pacientes entraron en el estudio. El 54,2 % (58) fueron hombres y la edad media fue 70,5 años (D.E.: 9,7). El AFCP extrajo 4 factores que explicaron el 57,49 % de la varianza total. El alfa de Cronbach= 0,428 y el test-retest κ= 0,627 (p > 0,001). Conclusiones: El ARMS-e no puede ser considerado una herramienta útil para medir la adherencia al tratamiento antidiabético oral en esta muestra. (AU)

Introduction: The Adherence to Refills and Medications Scale questionnaire (ARMS) was designed to measure ad-herence to treatment. It was translated and adapted into Spanish, but its psychometric properties have not been evaluated. The aim was to evaluate these properties in a population with type 2 diabetes mellitus. Method: The study was carried out in community pharmacies in Granada (Spain) by interview. A principal compo-nent factor analysis (PCA) with Varimax rotation (construct validity), a concordance analysis (concurrent criterion validity and reliability by temporal stability) and Cronbach’s alpha and item-total correlation (reliability by homo-geneity) were performed. Results: 107 patients entered the study. 54.2 % (58) were male and the mean age was 70.5 (SD: 9.7). The PCA extract-ed 4 factors that explained 57.49 % of the total variance. Cronbach’s alpha= 0.428, and in the test-retest κ= 0.627 (p > 0.001). Conclusions: The ARMS-e cannot be considered a useful tool to measure adherence to oral antidiabetic treatment in this sample. (AU)

Quantitative MRI assessment of joint effusion using T2-relaxometry at 3 Tesla: a feasibility and reproducibility study.

OBJECTIVE: T2-relaxometry could differentiate between physiological and haemorrhagic joint effusion (≥ 5% blood) in vitro. Are quantitative T2-relaxation time measurements of synovial fluid feasible and reproducible in vivo in clinically bleed-free joints of men with haemophilia? MATERIALS AND METHODS: In this cross-sectional study, we measured T2-relaxation times of synovial fluid in clinically bleed-free ankles, knees or elbows of men with severe haemophilia A using a T2-mapping sequence (duration ≤ 7 min) at 3 Tesla MRI. Manual and circular regions of interest (ROI) were drawn in the synovial fluid of each joint by two independent observers to measure T2-relaxation times. Measurement feasibility was expressed as the success rate of the measurements by both observers. The interobserver and intraobserver reproducibility of the measurements were evaluated by the intraclass correlation coefficient of absolute agreement (ICC) and the limits of agreement (LoA) from Bland Altman analysis. RESULTS: We evaluated 39 clinically bleed-free joints (11 ankles, 12 knees, 16 elbows) of 39 men (median age, 24 years; range 17-33) with severe haemophilia A. The success rate of the T2-measurements was ≥ 90%. Interobserver reliability was good to excellent (manual ROI: ICC = 0.92, 95% CI 0.76-0.97; circular ROI: ICC = 0.82, 95% CI 0.66-0.91) and interobserver agreement was adequate (manual ROI: LoA = 71 ms; circular ROI: LoA = 146 ms). Intraobserver reliability was good to excellent (manual ROI: ICC = 0.78, 95% CI - 0.06-0.94; circular RO: ICC = 0.99, 95% CI 0.98-0.99) and intraobserver agreement was good (manual ROI: LoA = 63 ms; circular ROI: LoA = 41 ms). CONCLUSION: T2-relaxometry of synovial fluid in haemophilia patients is feasible with good interobserver and intraobserver reproducibility.

Test-retest reliability and concurrent validity assessment of a novel high-frequency sensor device for anterior tibial translation measurement in loaded and unloaded condition: an exploratory cross-sectional study.

BACKGROUND: Magnetic resonance imaging (MRI) and manual tests remain the standard for diagnosing anterior cruciate ligament (ACL) rupture. Furthermore, the passive knee displacement, also described as anterior tibial translation (ATT), is used in order to make decisions about surgery or to assess rehabilitation outcomes. Unfortunately, these manual tests are limited to passive situations, and their application to assess knee stability in loaded, weight-bearing positions are missing. Therefore, a new device with high-performance sensors and a new sensor setting was developed. The aim of this exploratory cross-sectional study was to assess the test-retest reliability of this new device in a first step and the concurrent validity in a second step. METHODS: A total of 20 healthy volunteers were measured. Measurement consistency of the new device was assessed on the basis of reliability during Lachman test setting and in loaded position by artificial knee perturbation in a test-retest procedure. In a second step, the concurrent validity was evaluated with the Lachmeter® as a reference instrument. Intraclass correlation coefficient (ICC), standard error of measurement (SEM), the minimal detectable change (MDC) and Bland-Altman analysis were evaluated to assess the quality criteria. RESULTS: The measurements with the new device during the Lachman test provided a mean ATT of 5.46±2.22mm. The SEM ranged from 0.60 to 0.69mm resulting in an MDC between 1.67 and 1.93mm for the new device. In the loaded test situation, the mean ATT was 2.11±1.20mm, with test-retest reliability also showing good correlation (r>0.83). The comparison of the two measurement methods with an ICC of (r>0.89) showed good correlation, which also underlines the reasonable agreement of the Bland-Altman analysis. CONCLUSIONS: The evaluation of the test-retest reliability of the new device during the knee stability testing in passive situation as well as in a functional, loaded situation presented good reliability. In addition, the new device demonstrated good agreement with the reference device and therefore good validity. Furthermore, the quality criteria demonstrated the ability of the new device to detect the cut-off value (3-5mm) described in the literature for the diagnosis of ACL-deficient knees, which underlines the clinical relevance of this new device as a reliable and valid tool.

Study protocol of translation into Spanish and cross-cultural adaptation and validation of the problem areas in diabetes-Pediatric version (PAID-Peds) survey.

AIM: The metabolic and psychological management of paediatric type 1 diabetes mellitus (T1DM) can be challenging over time given that T1DM may cause a negative emotional burden and, consequently, result in poor metabolic control of the disease. The objectives of this study are to translate the Problem Area in Diabetes Survey-Pediatric version (PAID-Peds) into Spanish, adapt it culturally and validate it. DESIGN: Multicenter cross sectional study. METHODS: 636 patients aged 8-17 years, diagnosed with T1DM, under treatment with insulin and follow-up at the Miguel Servet University Hospital in Zaragoza (Aragón, Spain), the Ramón y Cajal University Clinical Hospital in Madrid (Spain) and at the Sant Joan de Déu Hospital in Barcelona (Catalonia, Spain) between 1 January 2023 and 31 December 2024 will be included. This study will consist of two phases: (1) Translation and cultural adaptation of the original PAID-Peds® survey into Spanish following eight steps; (2) Validation of the Spanish version of the PAIS-Peds® survey. The statistical analysis will be performed using Jamovi® 2.1.23. The reliability or internal consistency will be calculated using Cronbach's alpha index (considering an index higher than 0.8 to be good) and the test-retest will be evaluated using the intraclass correlation coefficient. For validity, confirmatory factor analysis will be calculated. This study has been approved by the ethics and research committees at each centre. RESULTS: The translation and validation into Spanish language of the Problem Area in Diabetes Survey-Pediatric version will be feasible, valid and reliable to detecting the youth-perceived burden of T1DM. Therapeutic education in diabetes-recommended by the WHO and the Diabetes Education Study Group-has shown encouraging results in glycaemia and psychosocial and behavioural factors in T1DM.

[Adaptation and Validation for European Portuguese of the Auditory Performance Categories-II and Infant-Toddler Meaningful Auditory Integration Scale for Children with Cochlear Implant]. / Adaptação e Validação para Português Europeu das Escalas Categories Auditory Performance-II e Infant-Toddler Meaningful Auditory Integration Scale em Crianças com Implante Coclear.

INTRODUCTION: The Categories of Auditory Performance II (CAP-II) scale and the Infant-Toddler Meaningful Audit Integration Scale (IT-MAIS) are simple and quick questionnaires that allow assessment of the auditory performance of children with cochlear implant (CI). The aim of this study was to translate, adapt and validate the European Portuguese version of the CAP-II and IT-MAIS scales. METHODS: A total of 85 participants completed the European Portuguese version of the CAP-II and IT-MAIS questionnaires, of which 45 were parents of children with pediatric cochlear implants (9.84 ± 4.22 years) and another 40 were parents of children with normal hearing (8.35 ± 3.56 years). Inter-rater reproducibility, test-retest reproducibility, comparison of study group versus control group results, internal consistency and correlation of the new scales were evaluated. RESULTS: The CAP-II and IT-MAIS scales showed high reliability and reproducibility, respectively, with an intraclass correlation coefficient (ICC) of 0.979 (p < 0.001) and a Spearman's correlation of 0.924 for the CAP-II scale, and an ICC of 0.932 (p < 0.001) and Spearman's correlation coefficient of 0.732 for the IT-MAIS scale. The IT-MAIS and CAP-II versions showed strong internal consistency (Cronbach's α coefficient value of 0.887 for the CAP-II scale and Spearman's positive correlation of 0.677 for the IT-MAIS scale, respectively) and allowed for the differentiation between children with normal hearing and post-implantation children (p = 0.001 and p < 0.001 respectively for each of the scales). There was no association between parental education and the results on the scales (p > 0.05). CONCLUSION: The findings demonstrated that the European Portuguese version of these scales is a valid and reliable tool for assessing auditory performance in European Portuguese-speaking children with hearing loss.

Introdução: As escalas Categories of Auditory Performance II (CAP-II) e Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) são questionários simples e de rápida aplicação que permitem avaliar o desempenho auditivo de crianças com implante coclear (IC). O objetivo deste estudo foi a tradução, adaptação e validação da versão em português europeu das escalas CAP-II e IT-MAIS. Métodos: Um total de 85 participantes completaram a versão em português europeu dos questionários CAP-II e IT-MAIS, dos quais 45 eram pais de crianças com IC pediátrico (9,84 ± 4,22 anos) e outros 40 eram pais de crianças com audição normal (8,35 ± 3,56 anos). Foi avaliada a reprodutibilidade entre avaliadores, a reprodutibilidade teste-reteste, a comparação dos resultados do grupo de estudo versus grupo de controlo, a consistência interna e a correlação das novas escalas. Resultados: As escalas CAP-II e IT-MAIS apresentaram uma elevada confiabilidade e reprodutibilidade, respetivamente com coeficiente de correlação intraclasse (ICC) de 0,979 (p < 0,001) e correlação de Spearman de 0,924 para a escala CAP-II, e ICC de 0,932 (p < 0,001) e coeficiente de correlação de Spearman de 0,732 para a escala IT-MAIS. As versões do IT-MAIS e do CAP-II apresentaram uma forte consistência interna (valor do coeficiente α de Cronbach de 0,887 para a escala CAP-II e correlação positiva de Spearman de 0,677 para a escala IT-MAIS, respetivamente) e permitem diferenciar entre crianças com audição normal e crianças pós-implantação (p = 0,001 e p < 0,001 respetivamente para cada uma das escalas). Não se verificou existir associação estatisticamente significativa entre a escolaridade e o resultado nas escalas (p > 0,05). Conclusão: A versão em português europeu destas escalas demonstrou ser uma ferramenta válida e confiável na avaliação do desempenho auditivo em crianças falantes de português europeu com deficiência auditiva.

Interoperator reproducibility of quantitative ultrasound analysis of hepatic steatosis in participants with suspected MASLD: A prospective study.

OBJECTIVES: To evaluate the reproducibility of tissue attenuation imaging (TAI) and tissue scatter distribution imaging (TSI) measurements in adults with suspected metabolic dysfunction-associated steatotic liver disease (MASLD) between radiologists with varying experience. MATERIALS AND METHODS: Participants with suspected MASLD were prospectively recruited. TAI and TSI were performed for each participant by two radiologists with different levels of experience. Interoperability reliability was assessed on the basis of Bland-Altman analysis and intraclass correlation coefficients (ICCs). The study determined and compared the diagnostic performance of TAI and TSI with clinical prediction models using proton magnetic resonance spectroscopy (1H-MRS) as a reference. RESULTS: A total of 180 participants (women, n = 56; men, n = 124, mean age, 46.98 ± 14.92 years; mean BMI, 25.81 ± 4.47) were enrolled from August 2022 to September 2022. Bland-Altman plots showed only slight deviation in the TAI and TSI results of the two radiologists; there was good interoperator reproducibility for TAI (ICC = 0.92) and TSI (ICC = 0.86). Senior and junior radiologists performed examinations labeled as TAI-1 and TSI-1, and TAI-2 and TSI-2, respectively. The areas under the curves (AUCs) of TAI-1, TAI-2, TSI-1, and TAI-2 for the detection of ≥5 % hepatic steatosis were 0.90, 0.96, 0.91 and 0.96, respectively. According to ROC analysis, the diagnostic performance of both radiologists for TAI and TSI was statistically similar and superior to that of the clinical prediction model. CONCLUSIONS: TAI and TSI have good reproducibility between radiologists with different levels of experience. Meanwhile, both TAI and TSI demonstrated good diagnostic performance for hepatic steatosis (≥5%), surpassing that of clinical prediction models.