23Na MRI: inter-reader reproducibility of normal fibroglandular sodium concentration measurements at 3 T.

BACKGROUND: To study the reproducibility of 23Na magnetic resonance imaging (MRI) measurements from breast tissue in healthy volunteers. METHODS: Using a dual-tuned bilateral 23Na/1H breast coil at 3-T MRI, high-resolution 23Na MRI three-dimensional cones sequences were used to quantify total sodium concentration (TSC) and fluid-attenuated sodium concentration (FASC). B1-corrected TSC and FASC maps were created. Two readers manually measured mean, minimum and maximum TSC and mean FASC values using two sampling methods: large regions of interest (LROIs) and small regions of interest (SROIs) encompassing fibroglandular tissue (FGT) and the highest signal area at the level of the nipple, respectively. The reproducibility of the measurements and correlations between density, age and FGT apparent diffusion coefficient (ADC) values were evaluatedss. RESULTS: Nine healthy volunteers were included. The inter-reader reproducibility of TSC and FASC using SROIs and LROIs was excellent (intraclass coefficient range 0.945-0.979, p < 0.001), except for the minimum TSC LROI measurements (p = 0.369). The mean/minimum LROI TSC and mean LROI FASC values were lower than the respective SROI values (p < 0.001); the maximum LROI TSC values were higher than the SROI TSC values (p = 0.009). TSC correlated inversely with age but not with FGT ADCs. The mean and maximum FGT TSC and FASC values were higher in dense breasts in comparison to non-dense breasts (p < 0.020). CONCLUSIONS: The chosen sampling method and the selected descriptive value affect the measured TSC and FASC values, although the inter-reader reproducibility of the measurements is in general excellent. RELEVANCE STATEMENT: 23Na MRI at 3 T allows the quantification of TSC and FASC sodium concentrations. The sodium measurements should be obtained consistently in a uniform manner. KEY POINTS: • 23Na MRI allows the quantification of total and fluid-attenuated sodium concentrations (TSC/FASC). • Sampling method (large/small region of interest) affects the TSC and FASC values. • Dense breasts have higher TSC and FASC values than non-dense breasts. • The inter-reader reproducibility of TSC and FASC measurements was, in general, excellent. • The results suggest the importance of stratifying the sodium measurements protocol.

Contributions for the Validation of the European Portuguese Version of the Vascular Quality of Life-6 Questionnaire for Peripheral Artery Disease.

INTRODUCTION: Peripheral arterial disease (PAD) is an occlusive atherosclerotic disease of the arteries of the extremities of the body that affects more than 230 million people worldwide. The most common symptom is intermittent claudication, described as leg pain which occurs mainly while walking. The symptoms impair the ambulation and functional capacity of patients, leading to loss of mobility, disease deterioration, increased risk of other cardiovascular diseases, and lower quality of life (QoL). Therefore, the aim of this study was to perform a cross-cultural adaptation and validation of the VascuQol-6 questionnaire for the Portuguese population to obtain a quick, sensitive, and easy-to-use way to assess the QoL of Portuguese patients diagnosed with PAD. METHODS: The Vascular Quality of Life-6 Questionnaire (VascuQoL-6) was adapted and translated into European Portuguese using standard validation methodology, including 115 patients with a mean age of 64.67 (7.23) years, with PAD with IC stable for more than three months; and ABI < 0.9 at rest. VascuQoL-6, SF-36, International Physical Activity Questionnaire (IPAQ), and the PAD Knowledge Questionnaire (PADKQ) were used. Reliability, construct validity analysis through convergent and discriminant validity, known-group validity, and responsiveness analysis were tested. RESULTS: The Cronbach's alpha was 0.64 and the average inter-item correlation was 0.27, indicating acceptable internal consistency. VascuQoL-6 was positively associated with SF-36 Physical Component Summary and Mental Component Summary scores (r = 0.64, p < 0.01 and r = 0.42, p < 0.01, respectively). In turn, there was no significant correlation between VascuQoL-6 scores and the PADKQ or IPAQ. A statistically significant difference between groups according to IC severity [F(2.47) = 8.35, p < 0.001] was found. A paired samples t-test showed differences between VascuQol-6 scores before a walking program (M = 15.65, SD = 3.09), and after a walking program (M = 17.41, SD = 2.71), t(67) = 3.94, p ≤ 0.001. CONCLUSION: The VascuQoL-6 is a six-item instrument to assess the QoL associated with PAD with good psychometric properties, convergent and discriminant validity with SF-36, PADKQ and IPAQ. The instrument proved to have known group validity and responsiveness.

Evaluation of an automated von Willebrand factor glycoprotein IbM activity assay compared with 3 alternative von Willebrand factor activity assays.

Background: To overcome deficiencies of the traditional von Willebrand factor (VWF) ristocetin cofactor activity assay (VWF:RCo), several automated assays for VWF platelet-binding activity have been developed. Information on the performance of these assays and their diagnostic utility remains limited. Objectives: To validate the VWF:glycoprotein IbM assay INNOVANCE VWF Ac and compare it with an automated VWF:RCo assay as well as with an automated assay and a manual VWF:Ab assay and to generate reference ranges and analyze reproducibility of the VWF:glycoprotein IbM assay. Methods: Clinical sites enrolled healthy subjects and patients representing the intended use population; VWF activity assays were performed, and results were analyzed. The performance of the INNOVANCE VWF Ac assay was also compared between the BCS XP System and the CS-2500 and CS-5100 analyzers. Results: The INNOVANCE VWF Ac assay correlated well with the VWF:RCo assay and the automated HemosIL VWF:Ab assay, with Pearson coefficients of >.9 and a predicted bias of ≤5.0 IU/dL at VWF levels of 30 IU/dL and ≤5.8 IU/dL at the levels of 50 IU/dL, but correlation and bias were not as good when compared with the REAADS manual VWF:Ab assay. Reference ranges observed for healthy subjects correlated well with previously published findings. Reproducibility of the INNOVANCE VWF Ac assay on the BCS XP System and the CS analyzers was excellent, as was correlation among devices. Conclusion: The characteristics of the INNOVANCE VWF Ac assay regarding comparability with other VWF activity assays, reference ranges, and precision support the use of this assay for evaluation of patients with concern for von Willebrand disease.

Classification of short and long term mild traumatic brain injury using computerized eye tracking.

Accurate, and objective diagnosis of brain injury remains challenging. This study evaluated useability and reliability of computerized eye-tracker assessments (CEAs) designed to assess oculomotor function, visual attention/processing, and selective attention in recent mild traumatic brain injury (mTBI), persistent post-concussion syndrome (PPCS), and controls. Tests included egocentric localisation, fixation-stability, smooth-pursuit, saccades, Stroop, and the vestibulo-ocular reflex (VOR). Thirty-five healthy adults performed the CEA battery twice to assess useability and test-retest reliability. In separate experiments, CEA data from 55 healthy, 20 mTBI, and 40 PPCS adults were used to train a machine learning model to categorize participants into control, mTBI, or PPCS classes. Intraclass correlation coefficients demonstrated moderate (ICC > .50) to excellent (ICC > .98) reliability (p < .05) and satisfactory CEA compliance. Machine learning modelling categorizing participants into groups of control, mTBI, and PPCS performed reasonably (balanced accuracy control: 0.83, mTBI: 0.66, and PPCS: 0.76, AUC-ROC: 0.82). Key outcomes were the VOR (gaze stability), fixation (vertical error), and pursuit (total error, vertical gain, and number of saccades). The CEA battery was reliable and able to differentiate healthy, mTBI, and PPCS patients reasonably well. While promising, the diagnostic model accuracy should be improved with a larger training dataset before use in clinical environments.

Patient result monitoring of HbA1c shows small seasonal variations and steady decrease over more than 10 years.

OBJECTIVES: Internal and external quality assurance materials often use highly processed matrixes. This can render the materials non-commutable. Monitoring laboratory methods with patient medians helps in identifying and correcting systematic errors that may affect diagnostic accuracy. The aim of the present study was to use HbA1c patient results for monitoring of method performance over time. METHODS: Test HbA1c results from 2010 to 2022 was analyzed (n=722,553) regarding changes over time and seasonal variation. The HbA1c testing was initially performed on a Cobas 501 instrument using immunological detection but in May 2017 the method was replaced by capillary electrophoresis on Capillarys 3 Tera. RESULTS: There was a steady decrease in HbA1c values. From 2011 to 2021 the decrease was for 0.10 percentile 6.6 %, lower quartile 7.9 %, median 10.2 %, mean values 9 %, upper quartile 11.2 %, and 0.90 percentile 9.3 %. No clear shift in HbA1c levels was observed due to the shift in methods. The median HbA1c values per month was approximately 44 mmol/mol (6.2 %, DCCT/NGSP). The only month with a median HbA1c that differed by more than 1 mmol/mol was July with a median value of 42 mmol/mol (6.0 %). CONCLUSIONS: The patient data showed a similar decrease as in the National Diabetes Register which indicates that the method is stable over time without any sudden changes and that the seasonal variation is low. The continuous decrease in HbA1c values over time is most likely to a shift towards earlier detection of patient with diabetes and improved treatment.

Translation and Evaluation of Psychometric Properties of the Persian 8-Item Internalized Transphobia (IT) Scale in Iranian Transgenders.

Objective: Internalized transphobia (IT) is influenced by societal norms and expectations, and it can have significant negative effects on the well-being and mental health of transgender individuals. The aim of this study was to translate and evaluate the psychometric properties of the Persian 8-item IT scale among Iranian transgender individuals in order to enhance the quality and quantity of research in this field. Materials and methods: This cross-sectional and methodological study utilized convenience sampling to recruit 119 transgender individuals in Mashhad, the second most populous city in Iran, in 2021. The Persian translation of the IT scale was developed using the backward-forward translation method. Subsequently, various types of validity and reliability were assessed, including content validity using the content validity index (CVI) and content validity ratio (CVR), face validity based on the impact score, construct validity through confirmatory factor analysis (CFA), internal consistency measured by Cronbach's alpha, and test-retest stability analyzed using the intraclass correlation coefficient (ICC). Results: The CVR ranged from 0.600 to 1, the CVI ranged from 0.800 to 1, and the impact score exceeded 1.5, indicating the appropriate content and face validity of the 8-item IT scale. The construct validity analysis revealed that the questionnaire is one-dimensional. The internal consistency, as measured by Cronbach's alpha, was 0.917, and the ICC for test-retest stability was 0.871. Conclusion: The Persian version of the IT scale demonstrated high and acceptable psychometric properties. The brevity of this scale facilitates its dissemination and utilization in clinical settings.

Reliability and validity of new isokinetic strength assessment for rotator cuff muscles in a muscle architecture-based position.

Background/aim: Isokinetic strength assessment of the rotator cuff muscle is frequently applied in a variety of shoulder postures, but none of these consider muscular architecture, which is one of the most important aspects of improving strength development. This study aimed to examine the test and retest reliability and validity of the muscle architecture-based position (MABP), which is 25° abduction and 20° external rotation, in healthy subjects to be able to select a better isokinetic assessment position for shoulder rotator cuff muscles. Materials and methods: A total of 54 healthy males with a mean age of 21.0 ± 1.2 years and mean body mass index of 22.8 ± 1.7 kg/m2 completed an isokinetic measurement session. All of the tests were performed on an IsoMed 2000 isokinetic dynamometer concentrically and eccentrically for both upper limbs at 60°/s angular velocity. All of the participants completed 3 measurement sessions: the first represented the isokinetic testing and was performed in the scapular neutral position (SNP) (45° shoulder flexion and abduction), the second represented the MABP (25° abduction and 20° ER) for shoulder rotator cuff muscles, and the third represented the test and retest of the MABP. Results: The correlations between the 2 techniques for assessing concurrent validity ranged from 0.908 to 0.994. The values obtained from the MABP were higher than those obtained in the SNP. There was no systematic bias for any measurements between the MABP and the retest of the MABP (p > 0.05). The intraclass correlation coefficients representing the test and retest reliability results for each variable measured with the MABP was higher than 0.98 and this value was considered as excellent reliability. Conclusion: In conclusion, the MABP can be used to assess the isokinetic strength of the rotator cuff muscles safely and confidently, with increased quantities of force being released and measurement at optimal muscle tension.

Reliability of a Smartphone App to Objectively Monitor Performance Outcomes in Degenerative Cervical Myelopathy: Observational Study.

BACKGROUND: Developing new clinical measures for degenerative cervical myelopathy (DCM) is an AO Spine RECODE-DCM Research, an international and multi-stakeholder partnership, priority. Difficulties in detecting DCM and its changes cause diagnostic and treatment delays in clinical settings and heightened costs in clinical trials due to elevated recruitment targets. Digital outcome measures can tackle these challenges due to their ability to measure disease remotely, repeatedly, and more economically. OBJECTIVE: The aim of this study is to assess the reliability of the MoveMed battery of performance outcome measures. METHODS: A prospective observational study in decentralized secondary care was performed in England, United Kingdom. The primary outcome was to determine the test-retest reliability of the MoveMed performance outcomes using the intraclass correlation (ICC) of agreement . The secondary outcome was to determine the measurement error of the MoveMed performance outcomes using both the SE of the mean (SEM) of agreement and the smallest detectable change (SDC) of agreement . Criteria from the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) manual were used to determine adequate reliability (ie, ICC of agreement ≥0.7) and risk of bias. Disease stability was controlled using 2 minimum clinically important difference (MCID) thresholds obtained from the literature on the patient-derived modified Japanese Orthopaedic Association (p-mJOA) score, namely, MCID ≤1 point and MCID ≤2 points. RESULTS: In total, 7 adults aged 59.5 (SD 12.4) years who live with DCM and possess an approved smartphone participated in the study. All tests demonstrated moderate to excellent test-retest coefficients and low measurement errors. In the MCID ≤1 group, ICC of agreement values were 0.84-0.94 in the fast tap test, 0.89-0.95 in the hold test, 0.95 in the typing test, and 0.98 in the stand and walk test. SEM of agreement values were ±1 tap, ±1%-3% stability score points, ±0.06 keys per second, and ±10 steps per minute, respectively. SDC of agreement values were ±3 taps, ±4%-7% stability score points, ±0.2 keys per second, and ±27 steps per minute, respectively. In the MCID ≤2 group, ICC of agreement values were 0.61-0.91, 0.75-0.77, 0.98, and 0.62, respectively; SEM of agreement values were ±1 tap, ±2%-4% stability score points, ±0.06 keys per second, and ±10 steps per minute, respectively; and SDC of agreement values were ±3-7 taps, ±7%-10% stability score points, ±0.2 keys per second, and ±27 steps per minute, respectively. Furthermore, the fast tap, hold, and typing tests obtained sufficient ratings (ICC of agreement ≥0.7) in both MCID ≤1 and MCID ≤2 groups. No risk of bias factors from the COSMIN Risk of Bias checklist were recorded. CONCLUSIONS: The criteria from COSMIN provide "very good" quality evidence of the reliability of the MoveMed tests in an adult population living with DCM.

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.

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.

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.

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.

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.

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.

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.

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.

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.