Two-way Random Effects Research Articles

Identifying unstable ramp lesions using ultrasonography.

Patients with suspected ramp lesions on magnetic resonance imaging (MRI) or ultrasonography (US) healed and showed no instability based on intraoperative arthroscopic findings. The purpose of this study was to assess the use of US in evaluating ramp lesions preoperatively and intraoperatively. Eighty-two knees that underwent anterior cruciate ligament (ACL) reconstruction between January 2022 and June 2023 were included to assess the ramp lesion complication rate and instability using arthroscopic findings. The detection rate of ramp lesions using US at the initial visit and preoperatively was also investigated. The test-retest reliability was assessed using the intraclass correlation coefficient and analyzed using two-way random effects and absolute agreement. The patients were divided into two groups based on the presence or absence of ramp lesions, and these data were compared using Student's t-test. Statistical significance was set at p < 0.05. On ultrasound examination, 90.0% of the cases had a ramp lesion at the initial examination, of which 22.2% were poorly delineated on the day of surgery. In the cases where the ramp lesion was unstable at the time of surgery, it could be delineated using US. In the cases where the ramp lesion was stable, it was difficult to delineate the lesion using US. Unstable ramp lesions complicating ACL injuries could be detected using US.

Do Hounsfield Units From Intraoperative CT Scans Correlate With Preoperative Values?

There is increasing interest in forecasting postoperative complications using bone density metrics. Vertebral Hounsfield unit measurements obtained from CT scans performed for surgical planning or other purposes, known as opportunistic CTs, have shown promise for their ease of measurement and the ability to target density measurement to a particular region of interest. Concomitant with the rising interest in prognostic bone density measurement use has been the increasing adoption of intraoperative advanced imaging techniques. Despite the interest in both outcome prognostication and intraoperative advanced imaging, there is little information regarding the use of CT-based intraoperative imaging as a means to measure bone density. (1) Can vertebral Hounsfield units be reliably measured by physician reviewers from CT scans obtained intraoperatively? (2) Do Hounsfield units measured from intraoperative studies correlate with values measured from preoperative CT scans? To be eligible for this retrospective study, patients had to have been treated with the use of an intraoperative CT scan for instrumented spinal fusion for either degenerative conditions or traumatic injuries between January 2015 and December 2022. Importantly, patients without a preoperative CT scan of the fused levels within 180 days before surgery or who were indicated for surgery because of infection, metastatic disease, or who were having revision surgery after prior instrumentation were excluded from the query. Of the 285 patients meeting these inclusion criteria, 53% (151) were initially excluded for the following reasons: 36% (102) had intraoperative CT scans obtained after placement of instrumentation, 16% (47) had undergone intraoperative CT scans but the studies were not accessible for Hounsfield unit measurement, and 0.7% (2) had prior kyphoplasty wherein the cement prevented Hounsfield unit measurement. Finally, an additional 19% (53) of patients were excluded because the preoperative CT and intraoperative CT were obtained at different peak voltages, which can influence Hounsfield unit measurement. This yielded a final population of 81 patients from whom 276 preoperative and 276 intraoperative vertebral Hounsfield unit measurements were taken. Hounsfield unit data were abstracted from the same vertebra(e) from both preoperative and intraoperative studies by two physician reviewers (one PGY3 and one PGY5 orthopaedic surgery resident, both pursuing spine surgery fellowships). For a small, representative subset of patients, measurements were taken by both reviewers. The feasibility and reliability of Hounsfield unit measurement were then assessed with interrater reliability of values measured from the same vertebra by the two different reviewers. To compare Hounsfield unit values from intraoperative CT scans with preoperative CT studies, an intraclass correlation using a two-way random effects, absolute agreement testing technique was employed. Because the data were formatted as multiple measurements from the same vertebra at different times, a repeated measures correlation was used to assess the relationship between preoperative and intraoperative Hounsfield unit values. Finally, a linear mixed model with patients handled as a random effect was used to control for different patient and clinical factors (age, BMI, use of bone density modifying agents, American Society of Anesthesiologists [ASA] classification, smoking status, and total Charlson comorbidity index [CCI] score). We found that Hounsfield units can be reliably measured from intraoperative CT scans by human raters with good concordance. Hounsfield unit measurements of 31 vertebrae from a representative sample of 10 patients, measured by both reviewers, demonstrated a correlation value of 0.82 (95% CI 0.66 to 0.91), indicating good correlation. With regard to the relationship between preoperative and intraoperative measurements of the same vertebra, repeated measures correlation testing demonstrated no correlation between preoperative and intraoperative measurements (r = 0.01 [95% CI -0.13 to 0.15]; p = 0.84). When controlling for patient and clinical factors, we continued to observe no relationship between preoperative and intraoperative Hounsfield unit measurements. As intraoperative CT and measurement of vertebral Hounsfield units both become increasingly popular, it would be a natural extension for spine surgeons to try to extract Hounsfield unit data from intraoperative CTs. However, we found that although it is feasible to measure Hounsfield data from intraoperative CT scans, the obtained values do not have any predictable relationship with values obtained from preoperative studies, and thus, these values should not be used interchangeably. With this knowledge, future studies should explore the prognostic value of intraoperative Hounsfield unit measurements as a distinct entity from preoperative measurements. Level III, diagnostic study.

Abstract PO3-07-11: Concordance between abbreviated and complete magnetic resonance protocols for screening woman at moderate and high risk for breast cancer

Abstract Introduction: Patients at high risk for developing breast cancer are potential beneficiaries of personalized screening strategies. Breast magnetic resonance imaging (MRI) has shown high sensitivity, but its broader use remains constrained by issues such as high cost and long examination time. The abbreviated magnetic resonance protocol is presented as an alternative to overcome these challenges. Our primary outcome was to evaluate the concordance of the final report between full and abbreviated protocols. Secondary outcomes included the acquisition and reading time of images from the abbreviated protocol. Methods: A cross-sectional study was conducted on asymptomatic women at moderate and high risk for breast cancer who underwent the full MRI screening protocol in private health institutions in the city of Belo Horizonte, Brazil. The abbreviated protocol was derived from the full protocol by the computer through selection of specific sequences. Each image was independently blind read, and assigned a category from the Breast Imaging - Reporting and Data System (BI-RADS) by at least two examiners. The results were then compared using the Cohen's kappa and Intraclass Correlation Coefficients. Results: The study included 170 women, and a concordance rate of 96,9% was found for the reported BI-RADS category between protocols in this population. A 21-minute reduction was observed in examination time for the abbreviated protocol. Conclusion: The significant concordance between protocols indicates that despite the reduction in acquisition time, number of acquired images, and method's complexity, the abbreviated MRI protocol meets most screening demands. It is, therefore, a viable alternative for cost reduction and improving patients tolerability for the studied population. Table 1. Clinical characteristics of the study population Absolute and percentage data about age, personal risk for breast cancer, family history, and previous genetic testing in the study population. Table 2. Concordance analysis between abbreviated and complete MRI protocols based on the ACR-BIRADS classification - Coen Kappa and Intraclass Correlation Coefficient The Kappa value of 0.9687 (95% CI 0.9426 - 0.9949, p &amp;lt; 0.01) indicates almost perfect concordance between the two protocols. The intraclass correlation coefficient of 0.982 (95% CI 0.97 - 0.987, p &amp;lt; 0.01), also indicates excellent concordance using the two-way random effect models criteria. Citation Format: Mariana Mitraud Ottoni Guedes, Agnaldo Lopes da Silva Filho, Thais Paiva Moraes, Adriene Moraes Campos, Ivie Braga de Paula, Felipe Marcondes de Oliveira Coelho, Barbara Silveira Santana, Bertha Andrade Coelho, Maria Fernanda Sperotto Valadares Gontijo, Leticia Martins De Araujo Campos Linhares, Anna Dias Salvador, Waldeir José de Almeida Junior, José Tadeu Campos de Avelar. Concordance between abbreviated and complete magnetic resonance protocols for screening woman at moderate and high risk for breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-07-11.

A Pretest Estimator for the Two-Way Error Component Model

For a panel data linear regression model with both individual and time effects, empirical studies select the two-way random-effects (TWRE) estimator if the Hausman test based on the contrast between the two-way fixed-effects (TWFE) estimator and the TWRE estimator is not rejected. Alternatively, they select the TWFE estimator in cases where this Hausman test rejects the null hypothesis. Not all the regressors may be correlated with these individual and time effects. The one-way Hausman-Taylor model has been generalized to the two-way error component model and allow some but not all regressors to be correlated with these individual and time effects. This paper proposes a pretest estimator for this two-way error component panel data regression model based on two Hausman tests. The first Hausman test is based upon the contrast between the TWFE and the TWRE estimators. The second Hausman test is based on the contrast between the two-way Hausman and Taylor (TWHT) estimator and the TWFE estimator. The Monte Carlo results show that this pretest estimator is always second best in MSE performance compared to the efficient estimator, whether the model is random-effects, fixed-effects or Hausman and Taylor. This paper generalizes the one-way pretest estimator to the two-way error component model.

Reliability and validity of a graphical computerized adaptive test Longshi scale for rapid assessment of activities of daily living in stroke survivors

Stroke survivors frequently experience difficulties in daily activities, such as bathing, feeding, and mobility. This study aimed to evaluate the reliability and validity of a computer-adaptive test-Longshi scale (CAT-LS) for assessing activities of daily living (ADL) in stroke survivors. This cross-sectional study collected data using an electronic application. The ADL function of stroke survivors in rehabilitation departments of hospitals was assessed using both the CAT-LS and BI. Correlations between the CAT-LS and Barthel index (BI) and concurrent validity were evaluated using Pearson’s correlation test and multiple linear regression. Interrater reliability was evaluated using the intraclass correlation coefficient based on a two-way random effect. The internal consistency of the CAT-LS was assessed using Cronbach’s coefficient (α) and corrected item-total correlations. Overall, 103 medical institutions in China were used in this study. In total, 7151 patients with stroke were included in this study. The CAT-LS classified patients into three ADL groups (bedridden, domestic, and community) with significantly different BI scores (P < 0.05). The CAT-LS results obtained using the decision-tree scoring model were consistent with the scores for each BI item. A strong correlation was observed between CAT-LS and BI (Pearson’s r: 0.6–0.894, P < 0.001). The CAT-LS demonstrated good internal consistency (Cronbach’s α, 0.803–0.894) and interrater reliability (ICC, 0.928–0.979). CAT-LS is time-efficient and requires < 1 min to administer. The CAT-LS is a reliable and valid tool for assessing ADL function in stroke survivors and can provide rapid and accurate assessments that reduce the burden on healthcare professionals. Further validation of this tool in other populations and settings is necessary.Study registration number: No.: ChiCTR2000034067; http://www.chictr.org.cn/showproj.aspx?proj=54770.

Self-directed Learning Ability and Shadow Education Expenditures: A Comparison of Impact on Student Achievement in Korea During COVID-19

This study examines the impact of students’ self-directed learning (SDL) ability and parental expenditures for shadow education, and other factors, on academic achievement in South Korea during the pandemic. Busan Education Longitudinal Study panel data for 2019 (pre-COVID) and 2020–2021 (COVID) were utilized. National exam scores of middle and high school students in Korean, English, and math subject areas were analyzed using multiple regression, random effects, and two-way random effects models. The analysis revealed that, during the pandemic, parents’ high expenditures to provide shadow education to complement their children’s public education did not significantly influence academic achievement. In contrast, SDL ability was found to have a significant impact on achievement in all three subject areas during the pandemic. The findings underscore the importance of programs, policies, and teaching strategies that develop students’ SDL skills to enable them to learn on their own when a crisis restricts traditional teacher-guided classroom instruction.

Comparison of raw accelerometry data from ActiGraph, Apple Watch, Garmin, and Fitbit using a mechanical shaker table.

The purpose of this study was to evaluate the reliability and validity of the raw accelerometry output from research-grade and consumer wearable devices compared to accelerations produced by a mechanical shaker table. Raw accelerometry data from a total of 40 devices (i.e., n = 10 ActiGraph wGT3X-BT, n = 10 Apple Watch Series 7, n = 10 Garmin Vivoactive 4S, and n = 10 Fitbit Sense) were compared to reference accelerations produced by an orbital shaker table at speeds ranging from 0.6 Hz (4.4 milligravity-mg) to 3.2 Hz (124.7mg). Two-way random effects absolute intraclass correlation coefficients (ICC) tested inter-device reliability. Pearson product moment, Lin's concordance correlation coefficient (CCC), absolute error, mean bias, and equivalence testing were calculated to assess the validity between the raw estimates from the devices and the reference metric. Estimates from Apple, ActiGraph, Garmin, and Fitbit were reliable, with ICCs = 0.99, 0.97, 0.88, and 0.88, respectively. Estimates from ActiGraph, Apple, and Fitbit devices exhibited excellent concordance with the reference CCCs = 0.88, 0.83, and 0.85, respectively, while estimates from Garmin exhibited moderate concordance CCC = 0.59 based on the mean aggregation method. ActiGraph, Apple, and Fitbit produced similar absolute errors = 16.9mg, 21.6mg, and 22.0mg, respectively, while Garmin produced higher absolute error = 32.5mg compared to the reference. ActiGraph produced the lowest mean bias 0.0mg (95%CI = -40.0, 41.0). Equivalence testing revealed raw accelerometry data from all devices were not statistically significantly within the equivalence bounds of the shaker speed. Findings from this study provide evidence that raw accelerometry data from Apple, Garmin, and Fitbit devices can be used to reliably estimate movement; however, no estimates were statistically significantly equivalent to the reference. Future studies could explore device-agnostic and harmonization methods for estimating physical activity using the raw accelerometry signals from the consumer wearables studied herein.

In-person validation of the Ichthyosis Scoring System.

Ichthyoses are a heterogeneous group of skin disorders characterized by scaling and erythema. Recognizing the variability of scale and erythema by region and ichthyosis subtype, we developed the Ichthyosis Scoring System (ISS) to quantify severity. We previously found ISS to have high inter- and intrarater reliability in evaluating photographic images. To confirm ISS clinical utility, we examined its performance at the 2022 Foundation for Ichthyosis and Related Skin Types conference. Sixty-five participants were evaluated by 3 of 9 medical professionals trained to score ichthyosis scale and erythema using ISS. Intrarater and interrater intraclass correlation coefficients (ICC) were analyzed using one-way and two-way random effects models, respectively. Intrarater reliability was excellent (ICC = 0.931, 95% CI, 0.921-0.940) for scale and good (ICC = 0.876, 95% CI, 0.853-0.899) for erythema scoring. Compared to photo validation with excellent intrarater reliability ratings for both scale (ICC = 0.956, 95% CI, 0.925-0.974) and erythema (ICC = 0.913, 95% CI, 0.855-0.949), ISS demonstrated equivalent reliability for live use. Overall interrater reliability for 10 body sites showed excellent (ICC >0.9) and good (ICC >0.75) agreement and consistency for both scale and erythema. Palms were an exception, demonstrating moderate (ICC >0.5) interrater agreement and consistency for erythema evaluation. ISS is a reliable measure of global and regional ichthyosis severity during in-person evaluations. Ease-of-use, accessibility, and content validity in both live and photographic evaluation endorse ISS as a standard for ichthyosis severity analysis.

Mapping of the PROMIS global health measure to the PROPr in the United States

BackgroundThe Patient-Reported Outcomes Measurement and Information System (PROMIS®) global health items (global-10) yield physical and mental health scale scores and the PROMIS-Preference (PROPr) scoring system estimated from PROMIS domain scores (e.g., PROMIS-29 + 2) produces a single score anchored by 0 (dead or as bad as being dead) to 1 (full health). A link between the PROMIS global-10 and the PROPr is needed.MethodsThe PROMIS-29 + 2 and the PROMIS global-10 were administered to 4102 adults in the Ipsos KnowledgePanel in 2022. The median age was 52 (range 18–94), 50% were female, 70% were non-Hispanic White, and 64% were married or living with a partner. The highest level of education completed for 26% of the sample was a high school degree or general education diploma and 44% worked full-time. We estimated correlations of the PROPr with the PROMIS global health items and the global physical and mental health scales. We examined the adjusted R2 and estimated correlations between predicted and observed PROPr scores.ResultsProduct-moment correlations between the PROMIS global health items and the PROPr ranged from 0.50 to 0.63. The PROMIS global physical health and mental health scale scores correlated 0.74 and 0.60, respectively, with the PROPr. The adjusted R2 in the regression of the PROPr on the PROMIS global health items was 64%. The equated PROPr preference scores correlated (product-moment) 0.80 (n = 4043; p < 0.0001) with the observed PROPr preference scores, and the intra-class correlation (two-way random effects model) was 0.80. The normalized mean absolute error (NMAE) was 0.45 (SD = 0.43). The adjusted R2 in the OLS regression of the PROPr on the PROMIS global health scales was 59%. The equated PROPr preference scores correlated (product-moment) was 0.77 (n = 4046; p < 0.0001) with the observed PROPr preference scores, and the intra-class correlation was 0.77. The NMAE was 0.49 (SD = 0.45).ConclusionsRegression equations provide a reasonably accurate estimate of the PROPr preference-based score from the PROMIS global health items or scales for group-level comparisons. These estimates facilitate cost-effectiveness research and meta-analyses. The estimated PROPr scores are not accurate enough for individual-level applications. Future evaluations of the prediction equations are needed.

The inter- and intra-rater reliability of the manual diaphragm assessment scale in healthy participants

ObjectiveThe main aim of this study was to test the inter and intra-rater reliability of the Manual Diaphragm Assessment (MED) scale and compared with chest expansion (CE) in healthy participants. MethodsA reliability study, with a sample of 45 healthy participants, composed of 30 women and 15 men. Participants were evaluated by two raters. The MED assesses seven different points on the diaphragm and rates its degree of restriction on a scale of 1–5. Upper and lower CE were measured in centimeters with a measuring tape, which is a valid and reliable method. The intraclass coefficients (ICC) for inter and intra-rater reliability for CE and MED were calculated for mean measurement consistency using a two-way random effects model. ResultsThe intra- and inter-rater reliability of MEDs ranged from low to moderate. The majority of the ICC values in intra-rater reliability were greater than in inter-rater reliability, and the majority of the ICC values in both were higher at the left assessment point. CE inter- and intra-reliability ICC varied from moderate to good. For the upper and lower CE, the inter-rater reliability ICC values were greater than 0.74, and the intra-rater reliability was greater than 0.71. ConclusionThe manual evaluation diaphragm scale had poor to moderate intra and inter-reliability. The chest expansion's intra and inter-reliability ranged from moderate to good, which was consistent with previous studies. Measuring chest expansion with a tape is a reliable method of evaluating the diaphragm in a clinical setting.

Agreement, repeatability, and reproducibility of quantitative retinal layer assessment using swept-source and spectral-domain optical coherence tomography in eyes with retinal diseases.

To evaluate the agreement and precision of retinal thickness measurements obtained using swept-source optical coherence tomography (SS-OCT) and spectral-domain OCT (SD-OCT) in healthy eyes and eyes with retinopathy. This cross-sectional prospective study involved three DRI-OCT Triton (SS-OCT) and three 3D-OCT-1 Maestro (SD-OCT) devices. One of each device (Maestro and Triton) was paired with a single operator. Healthy subjects and patients with retinal diseases were recruited, with study eye and testing order randomized. At least 3 scans per eye were captured for wide scan (12 mm × 9 mm-Triton and Maestro) and macular cube scan (7 mm × 7 mm-Triton, 6 mm × 6 mm-Maestro). Thickness of the full retina, ganglion cell layer + inner plexiform layer (GCL+), and ganglion cell complex (GCL++) were obtained from wide scan and cube scans. Agreement of the measurements between the Triton and Maestro was evaluated by Bland-Altman analysis and Deming regression for each group. Repeatability and reproducibility were assessed using a two-way random effect analysis of variance (ANOVA) model for each parameter by group. Twenty-five healthy subjects (25 eyes) and 26 patients with retinal diseases (26 eyes), including, but not limited to, age-related macular degeneration, macular hole, and diabetic retinopathy were recruited. Overall, the measurement differences between Triton and Maestro were <6 μm (mean differences of full retina, GCL++, and GCL+ thickness were ≤5.5 μm, 1.3 μm, and 2.8 μm, respectively) and not statistically significant across the parameters. The repeatability and reproducibility estimates indicate high precision in both devices and groups. Across all the parameters, the repeatability limit was ≤7.6 μm for Triton and ≤12.7 μm for Maestro; reproducibility limit was ≤9.2 μm for Triton and ≤14.4 μm for Maestro. In eyes with retinal pathology, the repeatability coefficient of variation (CV)% was ≤2.6% for Triton and ≤3.4% for Maestro; reproducibility CV% was ≤3.3% for Triton and ≤3.5% for Maestro. Both Triton SS-OCT and Maestro SD-OCT provide reliable measurements of retinal thickness in healthy eyes and eyes with retinal diseases. Excellent agreement between the two devices indicates interoperability when testing healthy eyes or eyes with retinal pathology. These findings support the use of thickness measurements from Triton SS-OCT and Maestro SD-OCT in clinical practice.

Assessing lower limb angles from sagittal plane images captured with a smartphone for post-stroke gait

BACKGROUND: Clinical gait analysis of sagittal plane lower-limb kinematics using video images is a quantitative tool for clinicians. However, the reliability and validity of limb kinematics after stroke using video images has not been fully investigated. OBJECTIVE: This study aimed to examine the within-session inter-rater reliability and criterion-related validity of lower limb angles measured in sagittal plane images captured using a smartphone for assessing post-stroke gait and to determine which asymmetric parameters are associated with faster gait velocity. METHODS: Thirty-two patients with stroke were included; video images were recorded as they walked at their preferred pace for 1–3 cycles. Lower limb angles (contact, push-off, and excursion angles) and degree of asymmetry were determined based on video images using markers of acromion, greater trochanter, and fifth metatarsal head. Measurement reliability was calculated using the two-way random effects model of intraclass correlation coefficients and minimal detectable change. The criterion validity investigated Pearson’s correlation between lower limb angles and their asymmetry and gait velocity. RESULTS: The lower value of the 95% confidence interval of intraclass correlation coefficients (2.3) of the lower limb was 0.891, and the maximum minimal detectable change was 9.6 degrees. Push-off angle showed a moderate-to-strong correlation with gait velocity, whereas the asymmetry of the push-off angle showed a weak correlation with gait velocity. CONCLUSIONS: Assessing post-stroke gait utilizing video images using a smartphone is feasible. The push-off angle, in particular, may provide insight into the clinical assessment of post-stroke gait.

Development and Validation of a Formative Assessment Tool for Nephrology Fellows' Clinical Reasoning.

Diagnostic errors are commonly driven by failures in clinical reasoning. Deficits in clinical reasoning are common among graduate medical learners, including nephrology fellows. We created and validated an instrument to assess clinical reasoning in a national cohort of nephrology fellows and established performance thresholds for remedial coaching. Experts in nephrology education and clinical reasoning remediation designed an instrument to measure clinical reasoning through a written patient encounter note from a web-based, simulated AKI consult. The instrument measured clinical reasoning in three domains: problem representation, differential diagnosis with justification, and diagnostic plan with justification. Inter-rater reliability was established in a pilot cohort ( n =7 raters) of first-year nephrology fellows using a two-way random effects agreement intraclass correlation coefficient model. The instrument was then administered to a larger cohort of first-year fellows to establish performance standards for coaching using the Hofstee method ( n =6 raters). In the pilot cohort, there were 15 fellows from four training program, and in the study cohort, there were 61 fellows from 20 training programs. The intraclass correlation coefficients for problem representation, differential diagnosis, and diagnostic plan were 0.90, 0.70, and 0.50, respectively. Passing thresholds (% total points) in problem representation, differential diagnosis, and diagnostic plan were 59%, 57%, and 62%, respectively. Fifty-nine percent ( n =36) met the threshold for remedial coaching in at least one domain. We provide validity evidence for a simulated AKI consult for formative assessment of clinical reasoning in nephrology fellows. Most fellows met criteria for coaching in at least one of three reasoning domains, demonstrating a need for learner assessment and instruction in clinical reasoning.

Influence of Joint Line Level on Clinical Outcomes and Range of Motion in Total Ankle Arthroplasty

Category: Ankle Arthritis; Ankle Introduction/Purpose: Restoring the native joint line correlates with better clinical outcomes in total knee arthroplasty. Yet, the effect of joint line elevation on clinical outcomes after total ankle arthroplasty (TAA) remains unclear. A previous study reported that pre- and post-TAA joint line heights, as measured by the joint line height ratio (JLHR), were elevated compared to non- arthritic ankles. However, the clinical impact of this has yet to be determined. Therefore, this study assessed the relationship between the TAA joint line level with post-TAA range of motion (ROM) and PROMIS scores. We hypothesized that an elevated joint line would be associated with restricted post-TAA dorsiflexion and worse postoperative PROMIS scores. Methods: This is a single-center review of 150 patients who underwent primary TAA. Patients with (1)fibular or medial malleolar osteotomy, (2) component subsidence, and (3) incomplete radiographs or outcome scores were excluded. Demographic data, surgical protocol, pre- and postoperative radiographs, and 1-year postoperative PROMIS scores were reviewed. Radiographic measurements included JLHR, pre- and post-TAA tibiotalar dorsiflexion and plantarflexion, and tibial component sagittal alignment. Two graders measured post-TAA JLHRs, and the average of the two graders was used for the analysis. Rater agreement was assessed using intraclass correlation coefficients (two-way random effects model). Relationships between JLHR, post-TAA tibiotalar ROM, and PROMIS scores were investigated using Pearson correlation. Multiple linear regression models were used to investigate the association of JLHR with post-TAA tibiotalar total ROM, dorsiflexion, and plantarflexion, after adjusting for pre- TAA ROM, tibial component sagittal alignment, gastrocnemius release (GR), Tendo-Achilles lengthening (TAL), and polyethylene size. Results: The interobserver reliability of the JLHR was excellent (r=0.98). Mean JLHR decreased from 1.66 pre-TAA to 1.55 post- TAA (P &lt; 0.001), indicating the joint line was significantly lowered postoperatively. Greater elevation of the post-TAA JLHR was associated with significantly decreased post-TAA dorsiflexion (r=-0.26, P&lt; 0.001) and worse 1-year PROMIS physical function (r=- 0.22, P=0.046), pain intensity (r=0.22,P=0.042), and pain interference scores (r=0.29,P=0.007). There was no correlation between JLHR and post-TAA plantarflexion (P=0.76). Regression analysis identified a 5º reduction in post-TAA dorsiflexion with each 1.0 unit increase in JLHR (Coef=-5.13, P=0.005). Post-TAA total ROM (Coef=-3.6,P=0.21) and plantarflexion (Coef=0.91, P=0.67) were not associated with JLHR. Additionally, there was no association between post-TAA total ROM and tibial component sagittal alignment, GR, TAL, or polyethylene size. Conclusion: In this study, the joint line of the ankle was lowered after TAA, and the JLHR was a reliable and clinically applicable method for assessing it. An elevated joint line significantly correlated with restricted post-TAA dorsiflexion, but this may only be clinically relevant for patients with significant (&gt;1.0 unit) changes in the joint line level. In addition, a higher joint line was correlated with worse 1-year PROMIS scores. These results suggest that surgeons should consider the joint line level during TAA preoperative planning to obtain improved clinical outcomes and ankle dorsiflexion.

Agreement and precision of wide and cube scan measurements between swept-source and spectral-domain OCT in normal and glaucoma eyes

This study aimed to evaluate agreement of Wide scan measurements from swept-source optical coherence tomography (SS-OCT) Triton and spectral-domain OCT (SD-OCT) Maestro in normal/glaucoma eyes, and to assess the precision of measurements from Wide and Cube scans of both devices. Three Triton and three Maestro operator/device configurations were created by pairing three operators, with study eye and testing order randomized. Three scans were captured for Wide (12 mm × 9 mm), Macular Cube (7 mm × 7 mm–Triton; 6 mm × 6 mm-Maestro), and Optic Disc Cube (6 mm × 6 mm) scans for 25 normal eyes and 25 glaucoma eyes. Parameter measurements included circumpapillary retinal nerve fiber layer(cpRNFL), ganglion cell layer + inner plexiform layer (GCL+), and ganglion cell complex (GCL++). A two-way random effect analysis of variance model was used to estimate the repeatability and reproducibility; agreement was evaluated by Bland–Altman analysis and Deming regression. The precision estimates were low, indicating high precision, for all thickness measurements with the majority of the limits < 5 µm for the macula and < 10 µm for the optic disc. Precision of the Wide and Cube scans were comparable. Excellent agreement between the two devices was found for Wide scans, with the mean difference < 3 µm across all measurements (cpRNFL < 3 µm, GCL+ < 2 µm, GCL ++ < 1 µm), indicating interoperability. A single Wide scan covering the peripapillary and macular regions may be useful for glaucoma diagnosis and management.

Determining State Expenditures in India: Relative Role of Own Revenues, Central Transfers and Fiscal Deficit

This article analyses the relative role of state’s own revenues, tax and non-tax, central transfers, and borrowing in determining state expenditures. We have examined the prevailing hypotheses regarding explaining determinants of government expenditures such as the Wagner, Wiseman-Peacock and Clark’s Critical Limit hypotheses in the context of state governments in India. We have also looked at Revenue and Spend, Tax and Spend, and the Fiscal Synchronization hypotheses. We have quantified the relative magnitudes of the differential effects of these sources of financing state-level primary expenditures for two groups of states namely, medium and large states (ML) and small and hilly states (SH) in a panel data framework. In addition to the variables reflecting financing sources, this study also examines other prevailing hypotheses affecting state expenditures such as those relating to cyclical increases emanating from election years and years of economic slowdown. Based on results of the Hausman test, we have estimated a two-way random effects model. Our findings indicate that with respect to own tax revenues, the magnitude of responsiveness of primary expenditure is 0.22 for the ML group and 0.10 for the SH group of states. For fiscal transfers, these magnitudes are 0.29 for ML states and 0.20 for SH states. For borrowing, the relevant coefficients are 0.33 for ML states and 0.13 for SH states. Thus, for the ML group, the maximum responsiveness is with respect to borrowing, followed by fiscal transfers and own tax revenues. In the case of the SH group, central transfers explain the largest variation in state-level primary expenditure, followed by borrowing and own tax revenues. We also find that for two out of three general elections in the sample period namely, 2009 and 2014, there was a positive and significant response of primary expenditures. Further, in years of economic slowdown, there is a positive response except in one case where the income effect was dominant and primary expenditure also fell along with the slowdown.

Affective responses to stretching exercises: Exploring the timing of assessments

Affective responses during exercise have been identified as a predictor of exercise adherence. However, research has been mostly limited to aerobic and resistance exercise. Considering that stretching activities are also an important component of physical fitness, this quasi-experimental study was designed to: 1) compare affective responses during and immediately after stretching exercises in apparently healthy adults, and 2) assess the consistency and repeatability of affect ratings obtained one week apart. For this purpose, we analyzed the Feeling Scale (FS) and Felt Arousal Scale (FAS) ratings using Time (during and after stretching) x Intensity (light, moderate, vigorous) x Stretched Muscle Group (quadriceps, hamstrings, glutes, latissimus dorsi, triceps) with repeated measures analysis of variance (ANCOVA) in 34 participants (21 males; aged 32.8 ± 8.6 years). The repeatability of FS and FAS ratings was assessed using two-way random-effects models, Intraclass Correlation Coefficients (ICC), and Bland-Altman plots. FS scores were higher following the stretching exercises, whereas FAS scores were lower, particularly in the vigorous intensity. In general, the inter-day repeatability for FS and FAS measurements was good across muscle groups. ICC tended to be higher at vigorous intensities. Ratings of core affect can be collected during static passive stretches using the FAS and FAS in ecologically valid settings. These results suggest that an adequate assessment of core affective responses to stretching activities should be performed during the exercises.

Evaluation of inter-rater and test-retest reliability for near-infrared spectroscopy reactive hyperemia measures.

Near-infrared spectroscopy (NIRS) is a non-invasive tool used to measure blood flow in peripheral tissues. More information on inter-rater agreement and test-retest reliability of NIRS-based reperfusion assessments is needed. To assess inter-rater agreement for NIRS based data analysis, and evaluate the measurement's reliability across days. On three separate days (average days between visits 1 and 3: 19.4±6.9days), participants' (N=15 males, 22±2yr.) post-occlusion reactive hyperemia (PORH) was measured in the left gastrocnemius muscle using Continuous-Wave NIRS (CW-NIRS). A blood pressure cuff was placed proximal to the knee and inflated to occlude lower leg blood flow for 5min. The following CW-NIRS parameters were selected: (1) percent saturation in HbO2 (StO2%) at baseline; (2) the O2Hb range used to normalize the NIRS signal; (3) the time for the O2Hb signal to reach 50% peak post-occlusion hyperemia (T1/2), and (4) the post peak hyperemic O2Hb recovery slope (O2REC-SLP). Absolute agreement between the two analysts was calculated using two-way random effects Intraclass Correlation Coefficients (ICC2,1). Consistency between analysts and across days was calculated using two-way mixed models (ICC3,1). Mean and 95% confidence intervals (CI) of ICCs are reported. Coefficient of variation (CV) and standard error of the measurement (SEM) are reported. The ICC2,1 data indicated "adequate" to "excellent" absolute agreement between the two NIRS analysts. ICC2,3 data indicated "adequate" to "good" reliability across visits. The CV and SEM for rater 1 and rater 2 across visit were StO2 (CV: 3.79%±2.71% and 4.50%±2.37%; SEM: 3.42 and 3.82), O2Hb range (CV: 10.50±5.93 and 12.79±12.41; SEM: 3.26 and 4.71), T1/2 (CV: 11.15%±5.52% and 10.96%±4.50; SEM: 1.22 and 1.11), and O2REC-SLP (CV: 19.49%±9.99% and 18.45%±9.48%; SEM: 0.04 and 0.04). It is concluded that NIRS parameters assessed show adequate reliability between analysts and across three visits. It is recommended, when feasible and because of the absence of 100% reliability, that investigators employ more than one rater for scoring at least a portion of the data across each trial in a study's control condition in order to have the ability to estimate the magnitude of error attributable to imperfect reliability.

Poster 303: Radiographs Demonstrate Poor Interrater Reliability and Accuracy for Evaluation of Postoperative Healing for Osteochondral Allograft Transplants of the Knee

Objectives: To evaluate the reliability of radiographs to evaluate healing of osteochondral allografts in the knee compared to CT scans as gold standard imaging. Methods: A retrospective review of prospectively enrolled patients who underwent osteochondral allograft transplantation for focal chondral defects of the knee was performed. At 6 months, all patients prospectively underwent CT scan of the knee. A retrospective review was performed to assess knee radiographs obtained in clinic at 3 and 6 months postoperatively. Three board-eligible orthopaedic sports fellows independently graded available radiographs while remaining blinded to the CT scan results. Separately, two board-eligible orthopaedic sports fellows graded CT scans utilizing the ACTOCA system, and their consensus measurements served as the gold standard for this study. Intraclass correlation (ICC) with a two-way random effects model and kappa coefficients were calculated for grades between the three raters. Results: Among the 44 grafts prospectively imaged, 13 (29.5%) grafts had radiographs at 3 months and 28 (63.6%) grafts had radiographs available for evaluation at 6 months. Among three graders, assessment of integration demonstrated low to moderate reliability (ICC: 0.25-0.41). Contrary to this, assessment of qualities such as graft sclerosis and cyst formation on radiographs demonstrated poor interrater reliability with inability to reject the null hypothesis that all grades were assigned randomly (p&gt;0.05) (Table 1). At 6 months, in patients with large cysts (&gt; 3 mm) on CT, only 2/18 (11%) were accurately detected on radiographs and 5/18 (27.8%) were underestimated as small cysts. In patients with small cysts (&lt; 3 mm) on CT, only 4/42 grafts (9.5%) were accurately graded, and 3/42 (7.1%) evaluated grafts were overestimated to have large cysts (Figure 1). Among patients who had small or large cysts at 6 months, only 1/21 (4.8%) and 1/3 (33.3%) radiographic assessments detected this cystic change at 3 months, respectively. Patients with crossing trabeculae on CT were associated with a mean radiographic integration score of 81.0 ± 15.7, which was significantly greater than those with a discernible cleft &lt; 3 mm (mean 68.7 ± 19.3, p=0.01). However, these groups were not significantly different than radiographic scores for grafts that had discernible clefts &gt; 3 mm (80.0 ± 19.7, p&gt;0.05). Among the 23 patients with a 6-month radiograph available, 4 required subsequent surgery for symptomatic failure. Three (75%) of these patients demonstrated large cyst formation on CT scan at 6 months. Conclusions: Evaluation of osteochondral allograft healing by radiographs alone may be inaccurate and associated with missed abnormalities such as cyst formation. [Table: see text]

Poster 136: Augmented Meniscus Radial Tear Healing via Local Transforming Growth Factor-beta 1 (TGF- β1) Gene Therapy in a Rat Model

Objectives: Meniscus tears cause significant musculoskeletal impairment and are among the most common knee injuries. Tears in the inner third of the meniscus have intrinsically poor healing capacity due to insufficient blood supply. In an effort to improve healing, use of biologic augments is a promising area of investigation. Tissue engineering strategies, such as growth factor gene therapy, have emerged as encouraging approaches to improving meniscal healing. Transforming Growth Factor-Beta 1 (TGF-β1) gene therapy has shown promise in vitro and ex vivo as a therapeutic strategy, but its effects on meniscus healing in vivo remain unknown. This study aimed to determine whether local delivery of viral vectors carrying the TGF-β1 gene could improve the healing of a meniscus tear involving the avascular zone in vivo in a rat model. Methods: Recombinant adenoviruses were generated using the AdEasy system. Briefly, the coding regions of mouse TGFβ1 were PCR amplified and cloned into an adenoviral shuttle vector and subsequently used to generate recombinant adenoviruses in HEK293 cells. The resulting adenoviruses were designated as Adv-TGF-β1. An analogous adenovirus expressing only GFP (Adv-GFP) was used as mock virus controls. To achieve local delivery of viral vectors to the injury site, we utilized a thermoresponsive biodegradable polydiolcitrate-gelatin delivery scaffold (PPCNg). A full-thickness radial tear was made in the medial meniscus of the left hind leg of twelve Wistar rats. Rats were divided into two groups: one receiving a mixture of PPCNg+TGF-β1 (n = 3) and the other receiving PPCNg+GFP (n = 3). A 4ºC pre-chilled solution of PPCNg seeded with Adv-TGF-β1 or Adv-GFP at 1011 infectious viral particles/injection was administered at the site of the induced meniscus tear. After 3 weeks, rats were euthanized, and the menisci were histologically evaluated by hematoxylin and eosin (H&amp;E) staining. The histologic assessment and scoring of meniscus tissue wound healing were done by one blinded and one unblinded observer, each using selected wound healing parameters as described in Table 1, and the results were averaged. The intra-class correlation coefficient (ICC) was computed based on a mean rating (k=2), absolute agreement, and two-way random effects model to assess the agreement between the wound healing score rating of the two observers. Statistical significance between groups was determined using the Mann-Whitney Wilcoxon rank sum test. A value of p &lt; 0.05 was considered statistically significant. All animal procedures were performed according to an Institutional Animal Care and Use Committee protocol at the home institution. Results: Immediately after and 3 weeks post-surgery, there was no evidence of infection, dehiscence, or functional deficit. Histologic evaluation of the sections (n = 8/group) of harvested rat menisci (n = 2/group) revealed improved healing of tears in the PPCNg+TGF-β1 group compared to the control group (5.7 ± 0.48 vs. 5.0 ± 0.89, p = 0.011) (Figure 1B). The lesion area demonstrated significantly greater neovascularization (2.75 ± 0.45 vs. 2.06 ± 0.68, p = 0.004), better collagen organization (1.94 ± 0.25 vs. 1.62 ± 0.50, p = 0.038), and increased hypercellularity (1.0 ± 0.00 vs. 1.3 ± 0.48, p = 0.018) in the PPCNg+TGF-β1 group compared to the controls (Figure 1C). Moderate absolute agreement between the two raters was observed in their wound healing score ratings (ICC = 0.615). Conclusions: Our results indicate that PPCNg-mediated delivery of Adv-TGF-β1 enhanced the early (3 weeks) healing of the meniscus lesion in rats compared with control (Adv-GFP) gene therapy. Further, localized administration of Adv-TGF-β1 induced greater neovascularization, better organization of collagen fibers, and increased hypercellularity at the injury site in the Adv-TGFβ-1 rat group compared with controls at 3 weeks post-injury. These results together suggest that TGF-β1 gene therapy may enhance meniscus healing by inducing more cellular proliferation and infiltration and greater neovascularization at the injury site to serve as nourishment for the establishment of new wound matrix, leading to more significant deposition and remodeling of mature collagen matrix. Further study that includes larger sample sizes, confirmation of successful gene transfer to meniscal cells around the tear site, and investigations of both later time points of wound healing and the mechanisms by which local TGF-β1 gene therapy may modulate augmented meniscus healing in this rat model of meniscal defect is necessary to better determine the potential future clinical utility of local TGF-β1 gene therapy to treat of meniscus tears with poor healing capacity. [Table: see text]