Minimal Detectable Difference Research Articles

Cross-cultural adaptation, validity and reliability of the Japanese version of ABILHAND-kids for children with cerebral palsy using Rasch measurement model

Purpose The aim of this study was to develop the Japanese version of the ABILHAND-Kids and to examine its psychometric properties for Japanese children with cerebral palsy (CP). Methods The experimental version of 75 items was developed using forward-backward translation method. Parents of 137 children with CP answered it. Their responses were analyzed to successive items, and psychometric properties of the final version were investigated through the Rasch measurement model. Results The Japanese version of the ABILHAND-Kids contained 22 items. It showed valid item-patient targeting, no significant floor and ceiling effects, and no differential item functioning for demographic and clinical subgroups. All items contributed to the definition of one-dimensional measure. For internal consistency, the person separation index was 0.94. For test-retest reliability, the intraclass correlation coefficients were 0.96 (95% CI: 0.92–0.98). The minimal detectable difference was calculated with a logit score of 0.79 and a total raw score of 4.50. The logit score showed a strong correlation with the Manual Ability Classification System level (ρ= −0.70) and the Gross Motor Function Classification System level (ρ= −0.62). Conclusions The Japanese version of the ABILHAND-Kids was found to be valid and reliable. It appears to be a good tool for assessing manual abilities in daily activities in children with CP.

Psychometric properties of the Turkish version of Central Sensitization Inventory-9 in patients with chronic musculoskeletal pain.

The aim of the study was to assess the psychometric properties of the Turkish version of Central Sensitization Inventory-9 (CSI-9) in patients with chronic musculoskeletal pain. The methodological study included 92 patients with chronic musculoskeletal pain. The original version of the CSI-9 was translated and culturally adapted into Turkish. The internal consistency and test-retest reliability were evaluated with Cronbach's α and the intraclass correlation coefficient (ICC), respectively. The assessment of reproducibility was conducted with the standard error of measurement (SEM) and minimal detectable difference (MDD) values. Convergent validity was explored by correlation analysis between the CSI-9 and Central Sensitization Inventory (CSI-25), Brief Pain Inventory (BPI), and European Quality of Life Survey-5 Dimensions (EQ-5D). The structural validity was assessed with factor analysis. Floor and ceiling effects were also analyzed. We found a very good internal consistency (Cronbach's α of 0.83) and excellent test-retest reliability (ICC of 0.96) of the Turkish CSI-9. The SEM demonstrated a range between 0.19 and 1.12, and the MDD was observed to vary from 1.17 to 1.35. The CSI-9 correlated significantly with the CSI-25 ( r = 0.77, P < 0.001), the pain severity subscale of the BPI ( r = 0.41 to 0.53, P < 0.001), the pain interference subscale of the BPI ( r = 0.21 to 0.58, P = 0.02 to P < 0.001), the EQ-5D ( r = 0.24 to 0.48, P < 0.05), and the EQ-5D visual analog scale ( r = -0.41, P < 0.001). One factor was identified within the CSI-9. Our data suggest that the Turkish CSI-9 is reliable and valid outcome measure for assessing CS in patients with chronic musculoskeletal pain.

Long-term night-to-night variability of sleep-disordered breathing using a radar-based home sleep apnea test: a prospective cohort study.

Night-to-night variability of sleep-disordered breathing (SDB) limits the diagnostic accuracy of a single measurement. Multiple recordings using a reliable, affordable method could reduce the uncertainty and avoid misdiagnosis, which could be possible with radar-based home sleep apnea testing (HSAT). We recruited consecutive patients with suspected SDB and performed contactless radar-based HSAT with automated scoring (Sleepiz One) over ten nights. During the first night, patients were simultaneously measured with peripheral-arterial tonometry. Twenty-four of the 28 included patients could achieve a minimum of four measurements. The failure rate was 16% (201 of 238 measurements). The apnea-hypopnea index (AHI) and oxygen desaturation index were consistently lower with radar-based HSAT compared to peripheral arterial tonometry. The variability of the AHI was considerable, with a standard error of measurement of 5.2/h (95%CI 4.6-5.7/h) and a minimal detectable difference of 14.4/h (95%CI 12.7-15.9/h). Alcohol consumption partially accounted for the variability, with an AHI increase of 1.7/h (95%CI 0.6-2.8/h) for each standard drink. Based on a single measurement, 17% of patients were misdiagnosed, and 32% were misclassified for SDB severity. After five measurements, the mean AHI of the measured nights stabilized with no evidence of substantial changes with additional measurements. Night-to-night variability is considerable and stable over ten nights. HSAT using radar-based methods over multiple nights is feasible and well tolerated by patients. It could offer lower costs and allow for multiple-night testing to increase accuracy. However, validation and reducing the failure rate are necessary for implementation in the clinical routine. "Recording of Multiple Nights Using a New Contactless Device (Sleepiz One Connect) in Obstructive Sleep Apnea", ClinicalTrials.gov, NCT05134402.

Exercise-Induced Functional Changes in People with Parkinson's Disease following External Cueing and Task-Based Intervention.

The purpose of this study was to evaluate change in motor function, gait speed, dynamic balance, balance confidence, and quality of life (QoL) in nine participants with Parkinson's disease (PwPD) completing Lee Silverman Voice Treatment BIG (LSVT-BIG), an external cueing and task-based intervention. Although supported as an efficacious treatment in PwPD, there is limited research examining clinically meaningful change in outcome measures related to external cueing and task-based interventions. This was a case series of nine PwPD (age range 64-76 years, 55% male) who completed the LSVT-BIG protocol. Disease duration ranged from 1 to 17 years and was classified as moderate in all participants (Hoehn and Yahr = 2 or 3). Outcome measures included motor function (MDS-UPDRS Part III Motor), gait speed, dynamic balance (MiniBEST), Activities-specific Balance Confidence (ABC), and Summary Index for PD Quality of Life 39 (PDQ-SI). Assessments were completed at baseline (BASE), end of treatment (EOT), and 4 weeks after EOT (EOT+4). Minimal detectable change (MDC) or minimal clinical important difference (MCID) was observed in one or more outcome measures in 8 of 9 participants at EOT and EOT+4 across domains of motor function (67%, 78%), gait speed (78%, 67%), balance confidence (44%, 33%), quality of life (44%, 78%), and dynamic balance (22%, 22%). Discussion. In this case series, 8 of 9 participants showed MDC or MCID changes across multiple functional domains. Improvements were observed immediately post (EOT) and 4-week post-treatment (EOT+4) suggesting a temporal component of the LSVT-BIG impact on functional change. Future research should include clinical trials to examine additional external cueing and task-based intervention efficacy with consideration of intensity, frequency, and mode of delivery across disease severity.

The effect of manual therapy on ankle dorsiflexion range of motion: A pilot crossover randomized trial

IntroductionRestricted ankle dorsiflexion is common after lower limb injury. The aim of this pilot study was to investigate the effect of passive ankle joint mobilization and calf muscle massage on ankle dorsiflexion range of motion in adults with residual restricted dorsiflexion. The secondary aim was to assess the methodology of the pilot study to inform a larger clinical trial. MethodThe study design was a randomized crossover trial with assessor blinding. Twenty-five healthy participants with a history of lower limb injury were included in the study. Ankle joint mobilization and calf muscle massage were applied for 5 min in a random order, one to two weeks apart. Ankle dorsiflexion was measured by using the weight-bearing lunge pre- and post-intervention (cm). Paired t-tests were used to analyze the effect of the manual therapy interventions on restricted ankles. A minimal detectable difference 95% (MMD95) was calculated. The pilot study was analyzed for suitability of inclusion criteria, blinding of assessors and the manual therapist, and the washout period. ResultsA significant increase in dorsiflexion was demonstrated for ankle joint mobilization (change score = 0.51 ± 0.76, p = 0.003) and calf muscle soft tissue massage (change score = 0.91 ± 1.07, p < 0.001). There was no difference in change scores between manual therapy techniques (mobilization 0.51 ± 0.76, massage 0.91 ± 1.07, p = 0.12). Evaluation of the pilot study revealed limitations to be modified in future studies. ConclusionThese preliminary data indicate ankle joint mobilization and calf muscle soft tissue massage had similar effects on increasing ankle dorsiflexion range of motion in ankles with residual dorsiflexion restriction.

Reliability and Concurrent Validity of Smartphone Clinometer Application for Measuring Scapular Rotations in Subjects With and Without Shoulder Pain.

Clinical assessment of scapular motion is obscured by a lack of clinically accessible and feasible angular measurement tools. This study evaluates the reliability and validity of the smartphone "Clinometer" app in measuring scapular upward rotation (UR) and anteroposterior tilt. Psychometric analysis. We recruited 57 participants-10 with and 47 without shoulder pain. Two physical therapists consecutively measured both scapular movements using the Clinometer app at the arm by the side (rest), 30°, 60°, 90°, and 120° of humeral elevation in the scapular plane; one therapist measured again after 2days. For evaluating concurrent validity, we compared the Clinometer scores with those measured using an electromagnetic motion capture system in 10 healthy participants. Intraclass correlation coefficients (ICC) with standard error of measurement (SEM) and minimal detectable difference at 90% confidence intervals (MDD90) were calculated. Concurrent validity was evaluated using repeated-measures analysis of variance followed by post hoc testing with Tukey-Kramer test (P < .05). We observed good intrarater reliability (ICC: UR = .76-.85, tilt = .69-.9; SEM: 2.2°-3.5°; MDD90: ∼5°-8°) and moderate to good interrater reliability (ICC: UR = .66-.78, tilt = .66-.76; SEM: 3.6°-8°; MDD90: ∼9°-18°) for both rotations. The Clinometer scores for UR were comparable to electromagnetic motion capture system at all angles except 90° (difference ∼8°); for scapular tilt, the scores were comparable only at rest and 30° elevation. The Clinometer app is reliable and valid for measuring scapular UR throughout and for scapular tilt at lower humeral elevation angles. The MDD90 values for scapular rotations computed in this study can be helpful in rehabilitation planning and future research.

Reliability, accuracy, and minimal detectable difference of a mixed concept marker set for finger kinematic evaluation

The study of finger biomechanics requires special tools for accurately recording finger joint data. A marker set to evaluate finger postures during activities of daily living is needed to understand finger biomechanics in order to improve prosthesis design and clinical interventions. The purpose of this study was to evaluate the reliability of a proposed hand marker set (the Warwick marker set) to capture finger kinematics using motion capture. The marker set consisted of the application of two and three marker clusters to the fingers of twelve participants who participated in the tests across two sessions. Calibration markers were applied using a custom palpation technique. Each participant performed a series of range of motion movements and held a set of objects. Intra and inter-session reliability was calculated as well as Standard Error of Measurement (SEM) and Minimal Detectable Difference (MDD).The findings showed varying levels of intra- and inter-session reliability, ranging from poor to excellent. The SEM and MDD values were lower for the intra-session range of motion and grasp evaluation. The reduced reliability can potentially be attributed to skin artifacts, differences in marker placement, and the inherent kinematic variability of finger motion. The proposed marker set shows potential to assess finger postures and analyse activities of daily living, primarily within the context of single session tests.

Intraobserver and interobserver reliability of standardized capillary refill time in dogs is high following observer training.

To assess intraobserver and interobserver reliability of capillary refill time (CRT) measurement in dogs using a standardized technique after training. 20 dogs presented to the emergency room. Dogs presented to the emergency room were prospectively recruited. Using a timing device and standardized technique, CRT was measured at the oral mucosa of the inner lip. Measurements were performed by 2 emergency and critical care residents (observer 1 [Ob1] and observer 2 [Ob2]) and repeated 3 times by each observer for each dog. CRT values and signalment were recorded. Intraobserver and interobserver reliability were analyzed by calculation of the coefficient of variation (CV%), intraclass correlation coefficient (ICC), and minimal detectable difference. Reliability was considered high if CV% was lower than 10% and ICC was between 0.9 and 1. Median CRT for Ob1 was 1.22 seconds and for Ob2 was 1.19 seconds. Intraobserver reliability was high, evidenced by a median CV% of 6.2% (range, 1.0% to 18.6%) and 9.5% (range, 1.3% to 22.6%) and an ICC of 0.97 (95% CI, 0.94 to 0.99) and 0.95 (95% CI, 0.90 to 0.98) for Ob1 and Ob2, respectively. Between observers, the CV% was 4.4% (range, 0.8% to 17.5%) and the ICC was 0.98 (95% CI, 0.94 to 0.99), indicating high interobserver reliability. The minimal detectable differences for intraobserver and interobserver were 0.30 and 0.34 seconds, respectively. The reported high reliability of CRT despite its subjective nature enhances its usefulness in daily practice. However, further research on the validity of CRT is warranted.

The "One-Step" approach for QT analysis increases the sensitivity of nonclinical QTc analysis.

Whether a compound prolongs cardiac repolarization independent of changes in beat rate is a critical question in drug research and development. Current practice is to resolve this in two steps. First, the QT interval is corrected for the influence of rate and then statistical significance is tested. There is renewed interest in improving the sensitivity of nonclinical corrected QT interval (QTc) assessment with modern studies having greater data density than previously utilized. The current analyses examine the effects of moxifloxacin or vehicle on the QT interval in nonhuman primates (NHPs) using a previously described one-step method. The primary end point is the statistical sensitivity of the assessment. Publications suggest that for a four animalcrossover (4 × 4) in NHPs the minimal detectable difference (MDD) is greater than or equal to 10 ms, whereas in an eight animal crossover the MDD is ~6.5 ms. Using the one-step method, the MDD for the four animal NHP assessments was 3 ms. In addition, the one-step model accounted for day-to-day differences in the heart rate and QT-rate slope as well as drug-induced changes in these parameters. This method provides an increase in the sensitivity and reduces the number of animals necessary for detecting potential QT change and represents "best practice" in nonclinical QTc assessment in safety pharmacology studies.

Test-retest reliability and construct validity of trunk extensor muscle force modulation accuracy.

Low back pain is associated with changes in trunk muscle structure and function and motor control impairments. Voluntary force modulation (FM) of trunk muscles is a unique and under-investigated motor control characteristic. One of the reasons for this paucity of evidence is the lack of exploration and publication on the reliability and validity of trunk FM protocols. The purpose of this study was to determine the within- and between-day test-retest reliability and construct validity for trunk extensor muscle FM. Twenty-nine healthy participants were tested under three FM conditions with different modulation rates. Testing was performed on a custom-built apparatus designed for trunk isometric force testing. FM accuracy relative to a fluctuating target force (20-50%MVF) was quantified using the root mean square error of the participant's generated force relative to the target force. Reliability and precision of measurement were assessed using the Intraclass Correlation Coefficient (ICC), standard error of measurement (SEM), minimal detectable difference (MDD95), and Bland-Altman plots. In a subset of participants, we collected surface electromyography of trunk and hip muscles. We used non-negative matrix factorization (NNMF) to identify the underlying motor control strategies. Within- and between-day test-retest reliability was excellent for FM accuracy across the three conditions (ICC range: 0.865 to 0.979). SEM values ranged 0.9-1.8 Newtons(N) and MDD95 ranged from 2.4-4.9N. Conditions with faster rates of FM had higher ICCs. NNMF analysis revealed two muscle synergies that were consistent across participants and conditions. These synergies demonstrate that the muscles primarily involved in this FM task were indeed the trunk extensor muscles. This protocol can consistently measure FM accuracy within and between testing sessions. Trunk extensor FM, as measured by this protocol, is not specific to any trunk muscle group but is the result of modulation by all the trunk extensor muscles.

Comparing the sensitivity of cross-over and parallel study designs for QTc assessment: An analysis based on a single large study of moxifloxacin in 48 nonhuman primates

The cardiovascular safety pharmacology (SP) study conducted to satisfy ICH S7A and S7B has commonly used a cross-over study design where each animal receives all treatments. In an increasing number of cases, cross-over designs are not possible and parallel studies have to be used. These can seldom be as large as 8 animals/treatment to match an n = 8 cross-over. Animals in parallel designs receive only one treatment. Parallel studies will have a different sensitivity to detect changes. This sensitivity is a critical question in using nonclinical QTc evaluations to support an integrated proarrhythmic risk assessment under the newly released ICH E14/S7B Q&As. The current analysis used a study large enough (n = 48) to be analyzed both as a parallel and as a cross-over design to directly compare the performance of the two experimental designs coupled to different statistical models, while all other study conduct aspects were the same.A total of 48 nonhuman primates (NHP) received 2 different treatments twice: vehicle, moxifloxacin (80 mg/kg), vehicle, moxifloxacin (80 mg/kg). Post-dose QTc interval data were recorded for 48 h for each treatment. Data were analyzed using 12 animals randomly selected for each treatment in a parallel design or as an n = 48 animal cross-over study. Different statistical models were used. The primary endpoint was the residual deviation (sigma) from the models applied to hourly time intervals. The sigma was used to determine the minimal detectable difference (MDD) for the study design-statistical model combination.Two statistical models were applicable to either study design. They gave similar sigma and resulting MDD values. In cross-over designs, the individual animal identification (ID) can be used in the statistical model. This enabled the smallest MDD value. Simple statistical models for analysis were identified: Treatment + Baseline for parallel designs and Treatment + ID for cross-over designs.The statistical sensitivity of NHP parallel study designs is reasonable (MDD for n = 6 of 12.7 ms), and in combination with testing exposures higher than likely to be necessary in man could be used in an integrated risk assessment. Where sensitivity of the NHP in vivo QTc assessment is critical, the cross-over design enabled a higher sensitivity (MDD 12.2 ms for n = 4; 8 ms for n = 8).

Comparison of the accuracy and reproducibility of AI based echocardiography and CMR analysis for cardiac function assessment in oncology patients at risk of cardiotoxicity

Abstract Funding Acknowledgements Type of funding sources: None. Background Serial screening for cancer therapy related cardiac dysfunction (CTRCD) demands precise measurement of left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS) to detect cardiotoxicity early and avoid inappropriate treatment breaks. Precision can be maximised by better image quality and more accurate analysis(1). Cardiovascular magnetic resonance (CMR) is gold standard for image acquisition(2,3), but the benefit of fully-automated AI-based analysis is unclear(4). Purpose To compare the precision (test-retest reproducibility) of AI-based analysis with human measurement for quantification of LVEF and GLS using echocardiography (TTE) and CMR. Methods Consented adult oncology patients underwent paired same day repeat scans using TTE and CMR (GE Vivid9 machine and Siemens 1.5T Aera) following EACVI protocols. Manual image analysis was performed by 2 blinded experts (ECHO-PAC and CVI42 software). TTE images were analysed by two FDA-approved fully-automated (unsupervised) AI packages (EchoAI1 and EchoAI2), and CMR images by one FDA-approved AI package (CMRAI1) and one validated fully-automated inline deep-learning algorithm (CMRAI2). Precision was calculated between repeat studies for each modality and analysis technique by the mean absolute difference (MAD), co-efficient of variation (CoV), minimal detectable difference (MDD) and Bland-Altman limits of agreement; compared using Levene’s test. Results 48 patients (median age 52 years, 81% female, 60% breast cancer), underwent same day repeat TTE and CMR (4 scans). Manual median LVEF was lower with TTE than CMR 57% (95%CI 56.2–57.8) vs 61.4% (95%CI 61–67.7), p&amp;lt;0.01. Analysis failed in 8%, 12% and 4% TTE scans using EchoAI1, EchoAI2 and manual techniques. There were no significant differences in the MAD, CoV or MDD in measurements for LVEF (p&amp;gt;0.05) between analysis methods, Table 1. Human analysis was superior to EchoAI1 for measurements of GLS; MAD 1.37 vs 2.71 (p&amp;lt;0.01), MDD 2.5 vs 5.7 (p&amp;lt;0.01) and CoV 6.9% vs 10.6%, (p = 0.03). There were zero analysis failures for analysis of CMR data. The CoV (3.6% vs 4.5%, p = 0.03), MAD (1.8 vs 2.9, p = 0.03) and MDD (4.3 vs 4.8, p&amp;gt;0.5) for LVEF metrics was lower with CMRAI2 compared to human analysis. The CoV (6.2% vs 11.7%, P&amp;lt;0.01), MAD (1.23 vs 1.92, p = 0.03) and MDD (2.4 vs 3.6, p&amp;gt;0.05) for repeat GLS measurements was lower with human analysis compared with CMRAI1. There were no other significant differences, Table 1. Conclusions Measurement precision is higher with CMR than TTE, in keeping with prior studies. Fully automated AI algorithms can provide incremental improvements in LVEF measurement precision for analysing CMR images. AI techniques for analysis of echocardiographic images provide similar precision to expert human readers. With continued development, fully-automated analysis algorithms should improve confidence in CTRCD surveillance imaging for cancer patients, with results generalisable to other clinical indications.

Reliability of sonographic measurements of the ulnar collateral ligament: a multi-rater prospective study.

The use of sonography is a cost-effective and reliable method to evaluate upper extremity superficial tissue structural integrity and pathology. Establishing the measurement reliability of widely used diagnostic ultrasound evaluation for musculoskeletal assessment is paramount enhance accurate clinical evaluations. The objective of this study was to establish the inter-rater and intra-rater reliability of select ulnar collateral ligament (UCL) thickness measures at two distinct anatomical locations in intercollegiate baseball athletes using ultrasound imaging (USI). This was a prospective cohort study conducted in a university research laboratory and included a total of 17 NCAA Division I baseball athletes (age 20.4 ± 1.43, height = 183.63 cm ± 6.27 cm, mass = 89.28 kg ± 8.24 kg). Two trained clinicians measured UCL mid-substance and apex thickness in the throwing extremity, prospectively, on 5 occasions at 1-month intervals during rest. Intraclass correlation coefficients (ICCs) (model 3,3), associated standard error of measurement, and 95% minimal detectable change in thickness were derived. Intrarater reliability estimates for operator 1 were 0.90-0.98 (mid-substance) and 0.91-0.99 (apex). Operator 2's values were 0.92-0.97 and 0.93-0.99, respectively. The standard error of measurement (SEM) ranged from 0.045-0.071 cm (mid-substance) and 0.023-0.067 cm (apex). The minimal detectable difference (MDD95) was 0.12-0.20 cm (mid-substance) and 0.07-0.19 cm (apex). Interrater reliability was 0.86-0.96 (mid-substance) and 0.79-0.98 (apex); most ICCs were >0.90. Measurement of UCL thickness at two locations demonstrated very good to excellent reliability with high precision. Using this protocol, two evaluators can obtain consistent UCL measurement at two positions. This finding has significant implications for the clinical evaluation of superficial tissue pathology of the same individual by two experienced practitioners.

Validity, Reproducibility, and Minimal Detectable Difference of the Functional Upper Extremity Function Test - Simplified Version - for Adults With Moderate to Severe Asthma and COPD.

Upper-limbs (ULs) functional tests which are valid and reliable for individuals with chronic respiratory disease (CRD) are scarce. The aim of this study was to investigate the intra-rater reproducibility, validity, minimal detectable difference (MDD), and learning effect of the Upper Extremity Function Test - simplified version (UEFT_S) functional test and to characterize its performance for adults with moderate-severe asthma and COPD. The UEFT_S was performed twice, and the number of elbow flexions in 20 s was the outcome. In addition, spirometry, 6-min walk test (6MWT), handgrip dynamometry (HGD), and usual and maximum timed-up-and-go tests (TUG_usual and TUG_max) were also performed. Eighty-four individuals with moderate-severe CRD and 84 control individuals matched by anthropometric data were analyzed. Individuals with CRD presented better performance in the UEFT_S than controls (P = .023). UEFT_S correlated significantly with HGD, TUG_usual, TUG_max, and 6MWT (P < .047 for all). The test-retest intraclass correlation coefficient was 0.91 [0.86-0.94], and the MDD was 0.4%. The UEFT_S is a valid and reproducible tool to assess the functionality of the ULs in people with moderate-severe asthma and COPD. When applied in the modified form, the test can be considered simple, fast, and inexpensive, with an easy outcome to interpret.

Patch Repair for Intestinal Perforation Closure in an Ex-Vivo Porcine Model with Burst Pressure Characterization

Background: Bowel perforation is the loss of intestinal wall integrity and can occur by several mechanisms including infection, obstruction, inflammation, trauma and iatrogenic causes. Incidences of bowel perforation range from 1-7% in pediatric trauma patients and 0.02-8% in adults. There is no specific classification for gastrointestinal perforations, but several methods have been used to describe perforations based on etiology, including systemic, inflammatory, medication, neoplastic and instrumentation-induced perforations. We assessed the feasibility of closing small intestine perforations with a mesh patch instead of sutures only. Methods and Findings: Nine porcine ex-vivo small intestine specimens were incised 0.5 cm to simulate bowel perforations. Control group perforations were sutured closed without mesh. The two experimental groups were closed by mesh sewn to the outside (first group) or inside (second group) of the bowel wall. Each specimen was submerged in normal saline and insufflated until air bubbles leaked from the perforation. That insufflation pressure was recorded as the burst pressure. The control group burst at 78.0±17.9 mmHg. The “patch outside” group burst at 54.7±9.1 mmHg. The “patch inside” group burst at 32.0 ±4.6 mmHg. Only the “patch inside” group had statistically significant inferiority, but both groups trended towards inferiority. Conclusions: Preliminary research indicates that patch repair of intestinal perforations is likely inferior to sutures alone, although repair with the patch outside the bowel wall cannot be completely excluded because of the high variability of the data. Further research may try alternate patch types or different variations to find a non-inferior closure method. A sample size of n=9 each would give 80% power to detect a minimal detectable difference of 20 mmHg.

The Response of Fig to Foliar Application of GA Combination (GA4+GA7) and Nutrition Liquid PRO-SOL on Some of the Growth Parameters

For the growing season (25 February – 30 October 2021), the College of Agriculture at Tikrit University conducted an experiment to convert the wooden canopy to a lath house. Spraying fig seedlings with a Gibberellin acid mixture and Pro-sol nutritional solution allowed researchers to examine the effects on the seedlings’ vegetative development characteristics and chemical content at 0, 25, and 50 mg.L-1. Plants were exposed to three different PRO-SOL nutritional solution concentrations ( 0, 75 and 150 mg.L-1.) There were three separate dates for the addition and distribution: the first on 15 March 2021, the second 15 days later, and so on for the third. A completely randomized block design was used for this study (RCBD). S.A.S., a pre-made statistical program, was used to evaluate the components and their interactions, and the findings were examined using an analysis of variance table. At the 0.05 probability level, the L.S.D. was determined to be the minimal detectable difference. Here is a quick rundown of the study’s findings: The growth rate of the plant, the number of leaves, the diameter of the stem, the number of new branches, the Chlorophyll, Carbohydrate, Nitrogen, and the ratio of Carbohydrates to Nitrogen, Protein, Potassium, and Phosphorous content of the leaves, all reached 46.89 cm, 13.44 sheets after being sprayed with a Gibberellin mixture, especially at the level of 50 mg.L-1 (GA2). One seedling, 16.00 mm in height, with 3.89 limbs. Seedling-1 had a SPAD value of 24.38, and its corresponding percentages were 2.69, 1.26, 2.36, 0.16, and 1.38. PRO-SOL 150mg, which is the maximum recommended dosage. The rate at which the plants in the study increased in height, number of leaves, stem diameter, number of new branches, chlorophyll content, carbohydrates, nitrogen, and the ratio of carbohydrates to nitrogen, protein, and potassium all increased significantly in response to L-1 (Pr2). 50.33 inches, or 14.44 sheets, of phosphorus. One seedling, 17.3mm in diameter, with 4.67 branches. Seedling-1 had the lowest average for the aforementioned characteristics in the comparative treatment (25.38 SPAD units, 3.26 percent, 1.39 percent, 2.10 percent, 0.20 percent, and 1.58 percent). The binary interaction between the Gibberellin mixture and nutrient solution Pro-sol showed significant differences, especially the GA2 Pr2 treatment, which gave the highest rates for all studied traits.

Does the Retül System provide reliable kinematics information for cycling analysis?

The Retül Vantage system is a popular tool to assess dynamic positioning of cyclists. Despite of using a low sampling rate (18 Hz) to record position data, Retül measures shows a moderate to very high correlation with data from gold-standard tridimensional camera systems reaching higher sampling rates, but its reliability has not been tested. Here we assess the reliability of the Retül Vantage system for kinematic assessment of cyclists. This cross-sectional study had two phases. Phase 1 included a survey with certified Retül bike fitters to select the most common variables used in cycling kinematics assessment. Phase 2 involved assessment of the selected cycling kinematics variables to check for intra-examiner reliability. Ten bike fitters answered the online survey (response rate of 47.6%) and 7 variables were identified as the most common to conduct during bike fitting analysis. Then, ten cyclists were submitted to kinematic assessments and Vantage system variables were checked for inter-examiner reliability and standard error of the variables. Good to excellent inter-tester reliability levels were found for all the 7 kinematics variables tested. Standard error of angular variables was lower than 3º for all as well as lower than 5 mm for the linear variable tested. The minimal detectable difference values ranged from 2.15 to 6.55º for angular variables and of 15.51 mm for linear variables. A high and very high degree of intra-rater reliability can be achieved using Retül Vantage system for kinematics assessment of the most common variables included in bike fitting.

Reliability and minimal detectable difference of pressure pain thresholds in a pain-free population.

The objective of this work was to evaluate the inter-rater and intra-rater reliability and minimal detectable difference (MDD) of pressure pain thresholds (PPTs) in pain-free participants with two examiners over two consecutive days in a cross-sectional study design. Examiners used a standardized method to measure and locate a specific testing site over tibialis anterior for PPT testing with a hand-held algometer. The mean of each examiner's three PPT measurements was used to calculate the intraclass correlation coefficient, inter-rater reliability, and intra-rater reliability. The minimal detectable difference (MDD) was calculated. Eighteen participants were recruited (11 female). The inter-rater reliability was 0.94 and 0.96 on day 1 and day 2, respectively. Intra-rater reliability for the examiners was 0.96 and 0.92 on day 1 and day 2, respectively. The MDD on day 1 was 1.24kg/cm2 (CI: 0.76-2.03) and the MDD on day 2 was 0.88kg/cm2 (CI: 0.54-1.43). This study demonstrates high inter- and intra-rater reliability and the MDD values for this method of pressure algometry.

Reliability of the Heartbeat Tracking Task to Assess Interoception.

Interoception refers to the competence in perceiving and interpreting internal sensations emerging from the body. The most common approach to assess interoception is through cardiac interoceptive tests like the heartbeat tracking task (HTT), which measures the accuracy on perceive and counting heartbeats during a period. However, the literature is scarce in providing adequate reliability evidence for this measure so that the interoception assessment may be threaten. In addition to HTT accuracy, it is possible to determine sensibility (self-reported confidence) and interoceptive awareness (correspondence between accuracy and sensibility). Thus, we measured the test-retest reliability of HTT and also investigated the behavior of HTT outcomes along the task. Therefore, 31 healthy adults (16 males) with 27.8 (9.4) years old performed two consecutive HTT interspersed by one day. Intraclass correlation coefficient (ICC), standard error of measurement (SEM) and minimal detectable difference (MD) analyzes showed 'Good' relative reliability for interoceptive accuracy (ICC = 0.880; SEM = 0.263; MD = 0.728; p < 0.001) and 'Moderate' for sensibility (ICC = 0.617; SEM = 0.648; MD = 1.797; p < 0.001) and awareness (ICC = 0.593; SEM = 0.227; MD = 0.628; p < 0.001). The absolute reliability shows low threshold values for observing true effects in HTT outcomes. The results also showed that reducing the number of HTT blocks did not impact the outcomes. The HTT showed to be reliable in determine the interoceptive competences in healthy adults.

Interactions in the 2×2×2 factorial randomised clinical STEPCARE trial and the potential effects on conclusions: a protocol for a simulation study

BackgroundRandomised clinical trials with a factorial design may assess the effects of multiple interventions in the same population. Factorial trials are carried out under the assumption that the trial interventions have no interactions on outcomes. Here, we present a protocol for a simulation study investigating the consequences of different levels of interactions between the trial interventions on outcomes for the future 2×2×2 factorial designed randomised clinical Sedation, TEmperature, and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial in comatose patients after out-of-hospital cardiac arrest.MethodsBy simulating a multisite trial with 50 sites and 3278 participants, and a presumed six-month all-cause mortality of 60% in the control population, we will investigate the validity of the trial results with different levels of interaction effects on the outcome. The primary simulation outcome of the study is the risks of type-1 and type-2 errors in the simulated scenarios, i.e. at what level of interaction is the desired alpha and beta level exceeded. When keeping the overall risk of type-1 errors ≤ 5% and the risk of type-2 errors ≤ 10%, we will quantify the maximum interaction effect we can accept if the planned sample size is increased by 5% to take into account possible interaction between the trial interventions. Secondly, we will assess how interaction effects influence the minimal detectable difference we may confirm or reject to take into account 5% (small interaction effect), 10% (moderate), or 15% (large) positive interactions in simulations with no ‘true’ intervention effect (type-1 errors) and small (5%), moderate (10%), or large negative interactions (15%) in simulations with ‘true’ intervention effects (type-2 errors). Moreover, we will investigate how much the sample size must be increased to account for a small, moderate, or large interaction effects.DiscussionThis protocol for a simulation study will inform the design of a 2×2×2 factorial randomised clinical trial of how potential interactions between the assessed interventions might affect conclusions. Protocolising this simulation study is important to ensure valid and unbiased results.Trial registrationNot relevant