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.

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.

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.

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.

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.

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.

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.

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.

[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.

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.

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.

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)

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.

Cultural Translation and Validation of the Bariatric Quality of Life Index to European Portuguese.

INTRODUCTION: Obesity is a chronic noncommunicable disease, defined by a body mass index over 30 kg/m2. Its impact is not restricted to its association with higher risks of mortality and morbidity from other noncommunicable diseases, but also with a decrease in quality of life (QoL). There are several tools to assess QoL, from generic health-related tools to obesity-related specific ones. However, to assess QoL in patients undergoing bariatric surgery, only the Bariatric Analysis and Reporting Outcome System was available, which presented some significant problems. Therefore, the Bariatric Quality of Life (BQL) Index was developed. The aim of this study was the validation and cultural adaptation of the BQL Index for European Portuguese. METHODS: A cross-sectional study was conducted, with the presentation of two questionnaires to the participants: BQL Index and EQ-5D-3L (European Quality of Life 5 Dimensions and 3 Level) Index. Direct translation followed reviewing, back-translation, comparison, and pilot testing were performed. Retest was done six months after the baseline. The following psychometric properties were assessed: convergent validity using the Spearman r correlation coefficient between BQL Index and EQ-5D-3L Index; internal consistency based on Cronbach alpha coefficient; and reproducibility between test and retest through Spearman r correlation coefficient and intraclass correlation coefficient (ICC). RESULTS: A total of 260 participants were included, the mean age was 45 ± 10 years old, the mean body mass index was 44 ± 6.5 kg/m2 and 78% were females. The most frequent obesity-related comorbidities were osteoarticular disease (69%), anxiety/depression (60%), and hypertension (54%). The most common eating patterns were volume eater (67%) and sweet eater (62%). Quality of Life scores were 41.3 ± 9.3 for the BQL Index, 0.35 ± 0.19 for the EQ-5D-3L Index and 55.7 ± 19.8 for the EQ-5D-3L VAS. The translation yielded good convergent validity (r = 0.62), good internal consistency (alpha = 0.94), and good reproducibility (r = 0.62 and ICC = 0.79). CONCLUSION: Our translation exhibited good parametric properties, with validity within the original BQL values, higher internal consistency, and good reproducibility.

Validity and reliability of measurement of peripheral oxygen saturation during the 6-Minute Walk Test in patients with systemic sclerosis.

Peripheral oxygen saturation (SpO2) using the fingers may have important limitations due to Raynaud's phenomenon and sclerodactyly in patients with systemic sclerosis (SSc). Sensors located at more central body positions may be more accurate as these as less prone to Raynaud attacks. To determine the validity and reliability of the SpO2 measured at the finger, forehead, and earlobe during the 6-Minute Walk Test (6MWT). Eighty two patients with SSc had an arterial line placed while performing the 6MWT. Peripheral oxygen saturation was simultaneously measured by finger, forehead, and earlobe sensors and compared to the arterial oxygen saturation (SaO2) measured before and after the 6MWT. 40 patients repeated the 6MWT one week later to determine re-test reliability. We used Bland-Altman plots to display the agreement between SpO2 and SaO2. The intraclass correlation coefficient for repeated measurement of minimum SpO2 was calculated. The mean difference between SpO2 and SaO2 after the 6MWT was - 3% (SD: ± 5), 0% (SD: ± 2), and 1% (SD: ± 2) for the finger, forehead, and earlobe, respectively. The minimum SpO2 measured at the finger demonstrated the poorest re-test reliability: The ICC (95% CI) showed good agreement using the ear and forehead probe (ICCear = 0.89 [95% CI 0.80; 0.94]; ICCforehead = 0.77 [95% CI 0.60; 0.87]), while a modest reliability was found using the finger probe (ICCfinger = 0.65 95% CI [0.43; 0.80]). SpO2 should be measured using either the earlobe or forehead during the 6MWT in patients with SSc. Clinical Trials.Gov (NCT04650659).

Translation, cultural adaptation, and validation of the Standardized Cosmesis and Health Nasal Outcomes Survey in Japanese (J-SCHNOS).

BACKGROUND: Rhinoplasty is one of the most popular plastic surgery techniques. The evaluation of both functional and cosmetic aspects of rhinoplasty is essential for planning and assessing surgery results. The Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) is a validated questionnaire used to assess both functional and aesthetic symptoms in patients with nasal problems, and it has been translated into several languages. The purpose of this study was to translate, culturally adapt, and validate the SCHNOS in Japanese among patients undergoing rhinoplasty. METHODS: This was a prospective validation study of the Japanese version of the SCHNOS (J-SCHNOS). The first phase involved translation and cross-cultural adaptation of the SCHNOS. The second phase included validation of the J-SCHNOS among native Japanese speakers. RESULTS: In total, 357 participants completed the final version of the J-SCHNOS (219 males and 138 females; mean age 43.4 years). The J-SCHNOS showed high internal consistency with excellent Cronbach's alpha values for both obstruction (SCHNOS-O) (0.96) and cosmetic (SCHNOS-C) (0.93) domains. The reproducibility was high, with an excellent intraclass correlation coefficient (ICC) >0.9 for all items. Exploratory factor analysis showed unidimensional structures in both the SCHNOS-O and the SCHNOS-C. CONCLUSION: The J-SCHNOS is a reliable and valid tool to assess the severity of nasal problems in patients undergoing rhinoplasty.

Exploratory factor and confirmatory analyses of the polycystic ovary syndrome health-related quality of life questionnaire (PCOSQ-50).

BACKGROUND: A condition-specific instrument is necessary to measure the health-related quality of life among those with polycystic ovary syndrome (PCOS), the most common chronic endocrinopathy among women. The first instrument was developed in 1988, followed by several revisions. However, further recommendations from all versions include additional application and measurement among different cultural populations of women with PCOS and psychometric testing based on use among larger samples of women with PCOS. Thus, the purpose of this study was to explore the factor structure of the Polycystic Ovary Syndrome Questionnaire (PCOSQ-50) using an international cross-sectional survey data from women with PCOS aged 18-42 years. METHODS: Using data from the largest known international cross-sectional study of women with PCOS aged 18-42 years (n = 935) to date, exploratory factor and confirmatory analyses were conducted for the PCOSQ-50, followed by factor labeling using a thematic analysis approach. RESULTS: Respondents were 31.0 ± 5.8 years of age, mostly White (72%), well-educated (56% had a college degree), married (69%), and employed full-time (65%). Three-quarters (74%) of the sample had one or more chronic conditions in addition to PCOS. Approximately 20% of the respondents originated from countries such as the United Kingdom, Australia, South Africa, etc. The PCOSQ-50 demonstrated good reliability but may be best described using a 7-factor model. The 7-factor model revealed goodness-of-fit. Thematic analysis suggested the following labels of those seven factors: hirsutism, fertility, isolation/trepidation, sexual function, self-esteem, emotional, and obesity. CONCLUSION: More research is needed to adapt the current PCOSQ-50, as well as to create an age-appropriate PCOS-specific HRQoL instrument for peri-postmenopausal women with PCOS.

Postreperfusion Renal Allograft Biopsy Predicts Outcome of Single-Kidney Transplantation: A 10-Year Observational Study in China.

Introduction: Biopsy findings often lead to the discard of many donor kidneys although their clinical value is not fully understood. We investigated the predictive value of postreperfusion biopsy on long-term allograft outcome after single-kidney transplantation. Methods: We retrospectively evaluated the significance of histologic findings, read by experienced renal pathologists, in 461 postreperfusion biopsy specimens collected from 2010 to 2017 after deceased donor renal transplant; and performed time-to-event analyses to determine the association between histology and hazard of death-censored graft failure. Recipients were followed-up with over a median time of 6.8 (range, 0.2-11.9) years. We assessed specimens using the Remuzzi score (scale of 0-12) and categorized them into low-score (≤3) and high-score (>3) groups. Kappa coefficients were calculated to assess agreement in procurement versus reperfusion biopsies. Results: High Remuzzi score kidneys came from older donors with a higher incidence of hypertension, higher final creatinine, death from cerebrovascular disease, expanded criteria donor, and a higher kidney donor risk index (KDRI) (all P < 0.001). In adjusted analyses, Remuzzi score was independently associated with death-censored graft failure (hazard ratio [HR] 1.389 for each 1 score rise in Remuzzi score, 95% confidence interval 1.181-1.633, P < 0.001). Overall histologic agreement (procurement biopsy versus reperfusion biopsy) was kappa = 0.137. Conclusion: Our findings suggest that postreperfusion biopsy is associated with long-time graft outcomes after transplant from a deceased donor. Agreement between procurement and reperfusion biopsy was found to be low. Prospective trials are necessary to optimize procurement biopsy practices.

Review of sample size determination methods for the intraclass correlation coefficient in the one-way analysis of variance model.

Reliability of measurement instruments providing quantitative outcomes is usually assessed by an intraclass correlation coefficient. When participants are repeatedly measured by a single rater or device, or, are each rated by a different group of raters, the intraclass correlation coefficient is based on a one-way analysis of variance model. When planning a reliability study, it is essential to determine the number of participants and measurements per participant (i.e. number of raters or number of repeated measurements). Three different sample size determination approaches under the one-way analysis of variance model were identified in the literature, all based on a confidence interval for the intraclass correlation coefficient. Although eight different confidence interval methods can be identified, Wald confidence interval with Fisher's large sample variance approximation remains most commonly used despite its well-known poor statistical properties. Therefore, a first objective of this work is comparing the statistical properties of all identified confidence interval methods-including those overlooked in previous studies. A second objective is developing a general procedure to determine the sample size using all approaches since a closed-form formula is not always available. This procedure is implemented in an R Shiny app. Finally, we provide advice for choosing an appropriate sample size determination method when planning a reliability study.