Development and Psychometric Properties of the Health Belief Model Scale for Premature Birth Prevention (HBM-PBP) for Women of Childbearing Age.

Purpose: This study aimed to develop the Health Belief Model scale for premature birth prevention (HBM-PBP) and evaluated its psychometric properties in women of childbearing age. Methods: This study employed a cross-sectional design and included 724 women of childbearing age with intentions of future childbirth or in their first trimester of pregnancy. An item pool was formulated from the literature and in-depth interviews based on the health belief model. Content validation was conducted by experts and through cognitive interviews with women of childbearing age. Construct and concurrent validity and reliability were evaluated using factor analysis, Pearson's correlation analysis, and Cronbach's alpha. Results: The HBM-PBP consisted of 96 items, including perceived susceptibility (21 items, 5 subscales), severity (26 items, 5 subscales), benefits (27 items, 5 subscales), and barriers (22 items, 5 subscales). Convergent and discriminant validity were supported. The Cronbach's alpha coefficient of the domains ranged from 0.87 to 0.94. Conclusion: The HBM-PBP is a valid and reliable measurement scale with good psychometric properties. It can be used to measure health beliefs in women, either as a whole or in individual domains. Health professionals can leverage the HBM-PBP to discern women's health beliefs on premature birth, facilitating tailored interventions and educational efforts.

Sample size calculation for data reliability and diagnostic performance: a go-to review.

Sample size, namely the number of subjects that should be included in a study to reach the desired endpoint and statistical power, is a fundamental concept of scientific research. Indeed, sample size must be planned a priori, and tailored to the main endpoint of the study, to avoid including too many subjects, thus possibly exposing them to additional risks while also wasting time and resources, or too few subjects, failing to reach the desired purpose. We offer a simple, go-to review of methods for sample size calculation for studies concerning data reliability (repeatability/reproducibility) and diagnostic performance. For studies concerning data reliability, we considered Cohen's κ or intraclass correlation coefficient (ICC) for hypothesis testing, estimation of Cohen's κ or ICC, and Bland-Altman analyses. With regards to diagnostic performance, we considered accuracy or sensitivity/specificity versus reference standards, the comparison of diagnostic performances, and the comparisons of areas under the receiver operating characteristics curve. Finally, we considered the special cases of dropouts or retrospective case exclusions, multiple endpoints, lack of prior data estimates, and the selection of unusual thresholds for α and ß errors. For the most frequent cases, we provide example of software freely available on the Internet.Relevance statement Sample size calculation is a fundamental factor influencing the quality of studies on repeatability/reproducibility and diagnostic performance in radiology.Key points• Sample size is a concept related to precision and statistical power.• It has ethical implications, especially when patients are exposed to risks.• Sample size should always be calculated before starting a study.• This review offers simple, go-to methods for sample size calculations.

The reliability and validity of the juvenile idiopathic arthritis magnetic resonance scoring system for temporomandibular joints.

In children with juvenile idiopathic arthritis (JIA), the temporomandibular joint (TMJ) can be involved. To prevent TMJ damage due to inflammation, early recognition is important, for which contrast-enhanced magnetic resonance imaging (MRI) is the gold standard. In this study, the interobserver reliability and construct validity of the Juvenile Idiopathic Arthritis Magnetic Resonance Scoring System for Temporomandibular Joints (JAMRIS-TMJ) was assessed. Two radiologists independently examined 38 MRIs using the JAMRIS-TMJ scoring system. Inter-observer reliability was assessed by Cohen's (weighted) kappa (κ), 95% confidence intervals (CIs) and absolute agreement (%). Construct validity was assessed by correlation between the JAMRIS-TMJ items and TMJ involvement, active maximum interincisal mouth opening (AMIO), and anterior maximum voluntary bite force (AMVBF). The interobserver reliability for the JAMRIS-TMJ items varied from poor to good (κ = 0.18-0.61). Joint enhancement had the highest reliability (κ = 0.61). Correlations were found between TMJ involvement, AMIO, and the JAMRIS-TMJ items, although variation between radiologists and TMJ side existed. No correlation was found between AMVBF and the JAMRIS-TMJ items for both radiologists. The strongest correlations were found between most of the JAMRIS-TMJ items and AMIO. Our findings support the utility of AMIO as a clinical measure of TMJ status in children with JIA.

Test-retest reliability and minimal detectable change of four functional tests in community-dwelling older adults with high risk of falls.

Objectives: This study aimed to quantify test-retest reliability and minimal detectable change (MDC) of the four commonly used functional tests in older adults with a high risk of falling. Patients and methods: The cross-sectional study was conducted with 30 community-dwelling older adults (26 females, 4 males; mean age: 73.7±6.0 years; range, 65 to 88 years) with a high fall risk identified by the Thai falls risk assessment test between November 2018 and May 2019. Data from the 10-m walk test at a comfortable gait speed (CGS) and fast gait speed (FGS), timed up and go (TUG) test, five times sit to stand test (FTSST), and 6-min walk test (6MWT) were collected twice for each participant. The interval between test sessions was one week. Test-retest reliability was analyzed by the intraclass correlation coefficient (ICC). Standard error of measurement (SEM) and MDC at the 95% confidence interval (MDC95) were also calculated. Results: The four functional tests had ICC in the range of 0.92 to 0.97. The SEM values of the CGS, FGS, TUG, FTSST, and 6MWT were 0.06 m/sec, 0.04 m/sec, 1.10 sec, 1.30 sec, and 20.60 m, respectively. The MDC95 values of the CGS, FGS, TUG, FTSST, and 6MWT were 0.16 m/sec, 0.12 m/sec, 3.00 sec, 3.50 sec, and 57.20 m, respectively. Conclusion: All functional tests demonstrated excellent test-retest reliability. The SEM and MDC95 of all functional tests were established. These findings can help clinicians interpret the effectiveness of interventions and determine changes in functional ability over time in older adults at high risk of falls.

Repeatability and intra and interrater reproducibility of the DIPA-S eHealth© capture and analysis system for clinical assessment of scoliosis.

PURPOSE: To assess the repeatability, intra and interrater reproducibility of the DIPA-S eHealth© system for capturing and measuring clinical variables of scoliosis, including frontal trunk imbalance (FTI), sagittal trunk imbalance (STI), and angle of trunk rotation (ATR). METHODS: Patients were photographed using the DIPA-S eHealth Capture© mobile application by family members, physiotherapists, or surgeons. Three photos were taken in each position: standing in the frontal and sagittal planes and in the axial plane in forward bending position of the trunk. The photos were analyzed by three independent evaluators using the DIPA-S eHealth Analysis© software. For repeatability, each photo was analyzed twice consecutively by the three evaluators. For intrarater reproducibility, only one evaluator reanalyzed the first photo from each plane with a 5-day interval. For interrater reproducibility, the three evaluators analyzed the first photo from each plane. The intraclass correlation coefficient (ICC), standard error of measurement (SEM), and minimal detectable change (MDC) were used (p < 0.05). RESULTS: The sample comprised 262 images (n = 30). Repeatability was excellent for all three evaluators in all three planes (ICC 0.94 to 1.00). Intrarater reproducibility was excellent in all three planes (ICC 0.88 to 0.99). Interrater analysis was excellent for the frontal and axial planes (ICC 0.98 and 0.93), respectively. However, it was weak in the sagittal plane ICC 0.32. The SEM ranged from 0.02 to 17.6 and MDC from 0.03 to 34.6. CONCLUSION: The DIPA-S eHealth© Capture and Analysis system demonstrates reproducibility for use in the clinical assessment of scoliosis through teleconsultations.

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.

Corrigendum: The effect of low-abundance OTU filtering methods on the reliability and variability of microbial composition assessed by 16S rRNA amplicon sequencing.

[This corrects the article DOI: 10.3389/fcimb.2023.1165295.].

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.

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.

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.

Framework for personalized prediction of treatment response in relapsing-remitting multiple sclerosis: a replication study in independent data.

BACKGROUND: Individualizing and optimizing treatment of relapsing-remitting multiple sclerosis patients is a challenging problem, which would benefit from a clinically valid decision support. Stühler et al. presented black box models for this aim which were developed and internally evaluated in a German registry but lacked external validation. METHODS: In patients from the French OFSEP registry, we independently built and validated models predicting being free of relapse and free of confirmed disability progression (CDP), following the methodological roadmap and predictors reported by Stühler. Hierarchical Bayesian models were fit to predict the outcomes under 6 disease-modifying treatments given the individual disease course up to the moment of treatment change. Data was temporally split on 2017, and models were developed in patients treated earlier (n = 5517). Calibration curves, discrimination, mean squared error (MSE) and relative percentage of root MSE (RMSE%) were assessed by external validation of models in more-recent patients (n = 3768). Non-Bayesian fixed-effects GLMs were also applied and their outcomes were compared to these of the Bayesian ones. For both, we modelled the number of on-therapy relapses with a negative binomial distribution, and CDP occurrence with a binomial distribution. RESULTS: The performance of our temporally-validated relapse model (MSE: 0.326, C-Index: 0.639) is potentially superior to that of Stühler's (MSE: 0.784, C-index: 0.608). Calibration plots revealed miscalibration. Our CDP model (MSE: 0.072, C-Index: 0.777) was also better than its counterpart (MSE: 0.131, C-index: 0.554). Results from non-Bayesian fixed-effects GLM models were similar to the Bayesian ones. CONCLUSIONS: The relapse and CDP models rebuilt and externally validated in independent data could compare and strengthen the credibility of the Stühler models. Their model-building strategy was replicable.

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.

Clinically relevant estimation of minimal number of trials for the uncontrolled manifold analysis.

Movement biomarkers are crucial for assessing sensorimotor impairments and tracking the effects of interventions over time. The Uncontrolled Manifold (UCM) analysis has been proposed as a novel biomarker for evaluating movement stability and coordination in various motor tasks across neurological and musculoskeletal disorders. Through inter-trial analysis, the UCM partitions the variance of elemental variables (e.g., finger forces) into components that affect (VORT) and do not affect (VUCM) a performance variable (e.g., total force). A third index, ΔV, is computed as the normalized difference between VORT and VUCM. However, the minimum number of trials required to achieve stable UCM estimates, considering its clinimetric properties, is unknown. This study aimed to determine the minimal number (N) of trials for UCM estimates by computing bootstrap estimates of standard errors (SE) at different N trials using thresholds based on the minimal detectable change (MDC, i.e., the minimum change in an outcome measure beyond measurement error). Thirteen adults (24.6 ± 1.1 years old) performed a finger-pressing coordination task. We computed the 95 % confidence intervals (CI) of bootstrap SE distributions for each UCM estimate and detected the lowest number of trials with the 95 % CI of SE below each MDC threshold. We found the minimal N of trials required was VUCM = 14, VORT = 4 and ΔV = 18. Our findings highlight that a relatively low number of trials (i.e., N = 18) are sufficient to compute all UCM estimates beyond the MDC, supporting the use of the UCM framework in clinical settings where many repetitions of a motor task are not practical.

BD SurePath Direct to Slide (DTS) cervical cytology: Migrating the benefits of liquid-based cytology to low-resource settings.

OBJECTIVES: The benefits of liquid-based cytology (LBC) in routine cervical cancer screening are often associated with the availability of instrumented platforms and economic considerations. A low-cost alternative to LBC in low-volume settings remains an unmet need. METHODS: A multisite evaluation of the BD SurePath (SurePath) LBC Direct to Slide (DTS) method was conducted. The DTS preparations were evaluated across 3 sites. Cytology features for DTS preparation included predetermined thresholds for total cellularity, cell distribution, cellular preservation, and stain quality. Rare event detection was evaluated using SiHa cells spiked into pools from negative cytology specimens. Concordance between Bethesda classification results was evaluated for SurePath LBC and DTS methods using routinely collected SurePath specimens in a split-sample study design. RESULTS: The DTS specimens met criteria for total cellularity, cell distribution, cellular preservation, and stain quality in more than 98% of all cases. Rare event detection was observed with an average detection of 5 SiHa cells per 2 mL of specimen. Concordant cervical cytology classifications were observed between SurePath LBC and DTS methods. CONCLUSIONS: The results demonstrate that the DTS process is suitable for routine cervical cytology evaluation. The procedure is reproducible and detected abnormal cervical cells in concordance with standard SurePath LBC preparation.

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.

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.

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.