Ordinal Scale Research Articles

Interpreting Change in Disorders of Consciousness Using the Coma Recovery Scale-Revised.

The purpose of this study was to differentiate clinically meaningful improvement or deterioration from normal fluctuations in patients with disorders of consciousness (DoC) following severe brain injury. We computed indices of responsiveness for the Coma Recovery Scale-Revised (CRS-R) using data from a clinical trial of 180 participants with DoC. We used CRS-R scores from baseline (enrollment in a clinical trial) and a 4-week follow-up assessment period for these calculations. To improve precision, we transformed ordinal CRS-R total scores (0-23 points) to equal-interval measures on a 0-100 unit scale using Rasch Measurement theory. Using the 0-100 unit total Rasch measures, we calculated distribution-based 0.5 standard deviation (SD) minimal clinically important difference, minimal detectable change using 95% confidence intervals, and conditional minimal detectable change using 95% confidence intervals. The distribution-based minimal clinically important difference evaluates group-level changes, whereas the minimal detectable change values evaluate individual-level changes. The minimal clinically important difference and minimal detectable change are derived using the overall variability across total measures at baseline and 4 weeks. The conditional minimal detectable change is generated for each possible pair of CRS-R Rasch person measures and accounts for variation in standard error across the scale. We applied these indices to determine the proportions of participants who made a change beyond measurement error within each of the two subgroups, based on treatment arm (amantadine hydrochloride or placebo) or categorization of baseline Rasch person measure to states of consciousness (i.e., unresponsive wakefulness syndrome and minimally conscious state). We compared the proportion of participants in each treatment arm who made a change according to the minimal detectable change and determined whether they also changed to another state of consciousness. CRS-R indices of responsiveness (using the 0-100 transformed scale) were as follows: 0.5SD minimal clinically important difference = 9 units, minimal detectable change = 11 units, and the conditional minimal detectable change ranged from 11 to 42 units. For the amantadine and placebo groups, 70% and 58% of participants showed change beyond measurement error using the minimal detectable change, respectively. For the unresponsive wakefulness syndrome and minimally conscious state groups, 54% and 69% of participants changed beyond measurement error using the minimal detectable change, respectively. Among 115 participants (64% of the total sample) who made a change beyond measurement error, 29 participants (25%) did not change state of consciousness. CRS-R indices of responsiveness can support clinicians and researchers in discerning when behavioral changes in patients with DoC exceed measurement error. Notably, the minimal detectable change can support the detection of patients who make a "true" change within or across states of consciousness. Our findings highlight that the continued use of ordinal scores may result in incorrect inferences about the degree and relevance of a change score.

Interventions in root‐filled teeth identified in general dental practice: A 6‐year longitudinal observational study

AbstractAimTo investigate what happens to cross‐sectionally identified root‐filled teeth over a 6‐year period, regardless of the time that elapsed since primary root canal treatment, in a cohort of adult patients regularly attending a Public Dental Service. A secondary aim was to investigate how the cumulative events affecting root‐filled teeth over the same time were associated with variables obtained from a baseline examination.MethodologyAdult patients with ≥1 previously root‐filled tooth and regularly attending the Public Dental Service in Örebro County were enrolled for study participation in 2015. General dental practitioners examined all identified root‐filled teeth in this cohort at baseline using a standardized protocol and were also responsible for further decision‐making and treatments. After six years, information on events of the root‐filled teeth was collected from dental records. The highest rating (most invasive treatment) on a 5‐point ordinal scale was used in the analyses. Regression analyses with stepwise selection were performed for associations between patient‐ and tooth‐related factors and events.ResultsA total of 445 patients with 1007 root‐filled teeth were followed the entire observation time. Twenty (2.0%) of the root‐filled teeth had endodontic retreatment and 150 (14.9%) were extracted over six years. Among teeth with periapical radiolucency or pain, the majority did not undergo retreatment or extraction; however, the multivariate analysis demonstrated that retreatment or extraction was associated with baseline recordings of teeth with periapical radiolucency (p < .0001), tenderness to percussion (p < .0001), and poor coronal restoration (p < .0001).ConclusionsThis study corroborates the notion that in general dentistry, root‐filled teeth with radiological signs of apical disease often remain untreated over time. Furthermore, it also reveals that root‐filled teeth presenting with mild pain do not necessarily receive any intervention. However, teeth with baseline signs of apical periodontitis, pain, or inadequate coronal restoration were more likely to have received intervention during the six‐year period.

Analysis and Reporting of Randomized Trials in Cleft Palate Surgery: Learning from the Timing of Primary Surgery (TOPS) Trial.

The Timing of Primary Surgery (TOPS) trial was published August 2023 in the New England Journal of Medicine and is a milestone achievement for a study focused on cleft palate. Due to the complexity of outcome reporting in cleft and the rarity of such comparative trials, TOPS presents a useful opportunity to critically review the design, analysis and reporting strategies utilised. This perspective article focused on the inclusion of participants, the choice of the primary outcome measure and the analysis of ordinal data within the trial. Considerations for future comparative studies in cleft care are discussed.

The mediating effect of entrepreneurial self-efficacy on business experience and performance of women-owned enterprises

This study aims to investigate the mediating effect of entrepreneurial self-efficacy on the relationship between the business experience and performance of women-owned enterprises in South Africa. A quantitative methodology with random sampling was employed. Qualtrics was used to administer the online questionnaire; a sample size of 258 was attained to test the study hypotheses. This cross-sectional study design followed recommendations from scholars on a minimum of 100 as an adequate sample size for regression analysis. Hierarchical regression and mediation analysis were employed to analyze the primary data collected from women entrepreneurs in South Africa.Using ordinal data, a seven-point Likert scale was adopted to operationalize constructs. Out of all the entrepreneurial self-efficacy antecedents and dimensions that were tested, industry experience emerged as the most influential predictor of business performance (β = 0.496*) when mediated by the innovation dimension of entrepreneurial self-efficacy. Although the management dimension of entrepreneurial self-efficacy showed strong predictive power, it did not exhibit significant mediating effects. Consequently, there was only partial mediation of the innovation dimension of entrepreneurial self-efficacy in the relationship between industry experience and business performance. Industry experience and business performance are antecedents and outcomes of entrepreneurial self-efficacy, respectively; they were partially mediated by the innovation dimension of entrepreneurial self-efficacy.

Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults.

Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults.

Dimensionality assessment in ordinal data: a comparison between parallel analysis and exploratory graph analysis.

In the social sciences, accurately identifying the dimensionality of measurement scales is crucial for understanding latent constructs such as anxiety, happiness, and self-efficacy. This study presents a rigorous comparison between Parallel Analysis (PA) and Exploratory Graph Analysis (EGA) for assessing the dimensionality of scales, particularly focusing on ordinal data. Through an extensive simulation study, we evaluated the effectiveness of these methods under various conditions, including varying sample size, number of factors and their association, patterns of loading magnitudes, and symmetrical or skewed item distributions with assumed underlying normality or non-normality. Results show that the performance of each method varies across different scenarios, depending on the context. EGA consistently outperforms PA in correctly identifying the number of factors, particularly in complex scenarios characterized by more than a single factor, high inter-factor correlations and low to medium primary loadings. However, for datasets with simpler and stronger factor structures, specifically those with a single factor, high primary loadings, low cross-loadings, and low to moderate interfactor correlations, PA is suggested as the method of choice. Skewed item distributions with assumed underlying normality or non-normality were found to noticeably impact the performance of both methods, particularly in complex scenarios. The results provide valuable insights for researchers utilizing these methods in scale development and validation, ensuring that measurement instruments accurately reflect theoretical constructs.

Measurement of Nasal Skin Thickness and Body Mass Index in Preoperative Rhinoplasty Patients Utilizing Computed Tomography Scanning and Ultrasound Techniques: A Prospective Comparative Study.

One of the most important indicators of rhinoplasty success is nasal skin thickness. Nasal thickness can lead to irregularities over the osseocartilaginous framework among patients with thin nasal skin and difficulty making tip work changes in patients with thick nasal skin. This study aimed to compare different objective methods. These include computed tomography (CT) and ultrasound (US) techniques, and report the relationship between nasal skin thickness and body mass index (BMI). A prospective cross-sectional study that included all patients at the rhinoplasty clinic (King Abdul-Aziz University Hospital), Riyadh, Saudi Arabia, between December 2022 and March 2023. Age, sex, and Fitzpatrick skin type were collected from the patients' histories and physical examinations. Body mass index was calculated for the subjects. The study sample included 29 patients. The median age of the patients was 25 years (interquartile range: 20-32 y). Most of the included patients were Saudi (89.7%, n = 26). Females represented 62.1% of the study sample. The average BMI was 25.6 ± 4.95 kg/m 2 . The highest correlation was observed between the US and CT tip ( r = 0.544, P < 0.01) and rhinion ( r = 0.525, P < 0.01) measurements. Body mass index was not associated with any US or CT measurements when BMI was used as a continuous or ordinal variable. The correlation between the US and CT measurements was highest for rhinoin and tip measurements, whereas supratip measurements were not correlated ( r = -0.029, P = 0.88). The correlation between mid-dorsum and nasion measurements was low (~0.3). The correlation between nasal skin thickness using CT and US varies depending on the nasal point and location. Body mass index was not associated with nasal skin thickness.

Factor retention in ordered categorical variables: Benefits and costs of polychoric correlations in eigenvalue-based testing

An essential step in exploratory factor analysis is to determine the optimal number of factors. The Next Eigenvalue Sufficiency Test (NEST; Achim, 2017) is a recent proposal to determine the number of factors based on significance tests of the statistical contributions of candidate factors indicated by eigenvalues of sample correlation matrices. Previous simulation studies have shown NEST to recover the optimal number of factors in simulated datasets with high accuracy. However, these studies have focused on continuous variables. The present work addresses the performance of NEST for ordinal data. It has been debated whether factor models – and thus also the optimal number of factors – for ordinal variables should be computed for Pearson correlation matrices, which are known to underestimate correlations for ordinal datasets, or for polychoric correlation matrices, which are known to be instable. The central research question is to what extent the problems associated with Pearson correlations and polychoric correlations deteriorate NEST for ordinal datasets. Implementations of NEST tailored to ordinal datasets by utilizing polychoric correlations are proposed. In a simulation, the proposed implementations were compared to the original implementation of NEST which computes Pearson correlations even for ordinal datasets. The simulation shows that substituting polychoric correlations for Pearson correlations improves the accuracy of NEST for binary variables and large sample sizes (N = 500). However, the simulation also shows that the original implementation using Pearson correlations was the most accurate implementation for Likert-type variables with four response categories when item difficulties were homogeneous.

Radiotherapy Related Bowel and Bladder Toxicity after Prostate Cancer Irradiation

Background: Pelvic radiotherapy is a primary treatment modality for organ-confined prostate cancer and early-stage endometrial cancer. While effective in improving survival rates and reducing recurrence, it is associated with a range of side effects that can impact patient quality of life. Objective: The study aimed to assess the incidence, management, and resolution of acute and chronic side effects of pelvic radiotherapy in prostate and endometrial cancer patients, focusing on bowel and bladder functions. Methods: This single-center, observational study included 50 patients diagnosed with prostate or endometrial cancer who underwent pelvic radiotherapy with a dose of 66-70 Gy using a four-field technique on a linear accelerator. Patients were assessed for bladder and bowel dysfunction, with follow-up at 6, 12, and 18 months post-treatment. Statistical analysis involved univariate weighted distribution of response frequencies and paired t-tests for ordinal scale scores, using SPSS version 25 for data analysis. Results: Of the participants, 22% experienced dysuria, 64% reported bladder outlet obstruction, and 20% had constipation. Acute bowel symptoms like diarrhea occurred in 32%, and chronic proctitis developed in 22% of patients. Urinary symptoms appeared by the third week and generally resolved within weeks; however, bowel symptoms persisted longer but returned to baseline by 18 months post-treatment. Approximately 70% of patients reported good tolerance to radiotherapy. Conclusion: Pelvic radiotherapy is effective in treating prostate and endometrial cancers but requires management of transient side effects to improve patient outcomes. Advanced radiotherapy techniques such as IMRT and 3D CRT have shown potential in reducing these side effects, emphasizing the need for continuous technological advancements and patient-centered care in radiotherapy.

Robust and efficient estimation in ordinal response models using the density power divergence

In real life, we frequently encounter ordinal variables depending upon independent covariates. The latent linear regression model is useful for modelling such data. One can find the model's parameters' maximum likelihood estimate (MLE). Though noted for its optimum properties, a small proportion of outliers may destabilize the MLE. This paper uses the minimum density power divergence estimate (MDPDE) as a robust alternative. The roles of different link functions are analysed in this context. We discuss their asymptotic properties in this setup. Unlike the MLE, the MDPDEs are robust for– lower values of the gross error sensitivity, and very high breakdown point. Also, the slope’s MDPDEs never implode. In simulation studies for pure data, MDPDEs perform almost as good as the MLE. However, the MDPDEs outperform the MLE in data contamination. Moreover, MDPDEs are very competitive with the other robust alternatives. Finally, this article is wrapped up with a real-data example.

Abstract PO3-05-11: Enhancing the interpretation of real-world quality of life (QoL) in patients (pts) with hormone receptor positive human epidermal growth factor 2 negative (HR+/HER2−) advanced breast cancer (ABC) enrolled in the POLARIS trial

Abstract Background POLARIS is a prospective, observational real-world study of pts with HR+/HER2− ABC receiving palbociclib in routine clinical practice. We have previously shown that palbociclib treatment did not have any significant adverse impact on pt QoL when assessed by the EORTC-QLQ-C30 questionnaire,1 consistent with published clinical trial findings. Now, to enhance interpretation, we sought to characterize EORTC scores (using updated POLARIS data) into terms that are meaningful to pts, physicians, and other stakeholders, using a similar approach to established clinical problem threshold methodology.2 Methods EORTC data were collected at baseline (BL), monthly for the first 3 months, and every 3 months thereafter until palbociclib discontinuation. Response options for each EORTC question (ordinal scale from 1=very poor to 7=excellent) were grouped into “favorable” (taking a conservative approach of using only responses 5, 6 or 7) and “less favorable” (response of ≤4) for the two items on global health status/QoL. The proportion of pts with favorable or less favorable response was compared between subgroups (line of therapy, age, race, bone metastases, visceral metastases, and dose modification) at timepoints BL, month 6, 12, and 18 using Fisher’s exact test. Results Between January 2017 and December 2018, 1285 pts were enrolled, of whom 1250 received at least one dose of palbociclib and subsequently analyzed as part of the final data cut of 09 Jan 2023. EORTC Q29 ‒ Overall Health completion rates were 1167/1250 (93.4%) at baseline, 732/1250 (58.6%) at month 6, 484/1250 (38.7%) at month 12, and 353/1250 (28.2%) at month 18 (Table). The proportion of pts with a favorable response for EORTC Q29 was consistently higher than with a not favorable response (BL, 56.1% vs 43.9%; month 6, 69.3% vs 30.7%; month 12, 68.6% vs 31.4%; and month 18, 70.0% vs 30.0%; Table). When analyzed by subgroup, no significant differences were observed in the proportion of pts with a favorable (to less favorable) response for any subgroup covariate, except for age at BL; however, this significance was not observed at month 6, 12 or 18 (Table). Similar results were observed for EORTC Q30 – Overall QoL (data not shown). Conclusions The proportion of pts indicating a favorable response in the EORTC questionnaire Overall Health and Overall QoL questions increased or were maintained in pts with HR+/HER2− ABC treated with palbociclib from BL through to month 18 across overall and all subgroups. It is important to note that these data are conditional on the pts who responded to the questions, whose numbers diminished over time. XX XX Citation Format: Gabrielle Rocque, Joanne Blum, Yan Ji, Timothy Pluard, John Migas, Shailendra Lakhanpal, Erin Jepsen, Eric Gauthier, Yao Wang, Monica Montelongo, Joseph C. Cappelleri, Connie Chen, Meghan Karuturi, Debu Tripathy. Enhancing the interpretation of real-world quality of life (QoL) in patients (pts) with hormone receptor positive human epidermal growth factor 2 negative (HR+/HER2−) advanced breast cancer (ABC) enrolled in the POLARIS trial [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 PO3-05-11.

Abstract PO4-03-08: Enhanced Assessment of Clinical Behavior of TNBC and TPBC using Quantified Levels of HER2, Estrogen and Progestin Receptor Proteins and Expression of Their Cognate Genes

Abstract Background: Renewed interest in clinical relevance of low-HER2 protein in breast cancer management prompted a retrospective investigation of a unique de-identified Database of quantified biomarkers associated with patient outcomes. Currently, IHC of ER, PR and HER2 proteins provides semi-quantitative results, at times complicated by variation in methods and interpretation (cf. ASCO/CAP Guidelines). Our goal was to ascertain relationships of these clinical analytes to predict cancer relapse when quantified for protein products and cognate gene expression. Methods: Database contained 2756 quantified HER2 results by ELISA (Oncogene Sciences) or by EIA (Triton Diagnostics) of which 198 patients had associated clinical outcomes. No definition of HER2-low has been accepted for IHC, although &amp;gt; 50% of biopsies may be categorized as HER2-low (cf. ASCP CE Programs). Microarray results obtained for ~ 22,000 genes using RNA purified from LCM-procured carcinoma cells of 247 primary breast biopsies were analyzed. ESR1, PGR and ERBB2 gene expression levels in 276 biopsies had been validated by RTqPCR. To assess distribution and dispersion of HER2 protein, cumulative relative frequency distribution analyses were employed, focusing on cut-offs within interquartile range. Permutations and combinations of the 3 biomarkers based on IHC definitions (cf. ASCO/CAP Guidelines) were examined. Tertiles and quartiles of data sets were used to explore association between biomarker levels and clinical outcomes. Box plots depicted protein and gene expression levels, Progression-Free Survival (PFS), or Overall Survival (OS) across ER/PR/HER2 categories and compared differences using a Kruskal-Wallis ANOVA Rank Test. Cox regressions were used to contrast hazard ratios among the ER/PR/HER2 groups. Kaplan-Meier plots visualized survival rates among groups and a log-rank test detected statistical discrepancies. We investigated differences between groups for categorical variables using chi-squared tests (Fisher's exact test for non-normally distributed data), while for ordinal variables, ANOVA tests were used (Kruskal-Wallis for non-normally distributed data). Categorical variables were summarized as count (%), and ordinal variables were summarized as median [IQR]. Analyses were performed using R version 4.2.2 (Innocent and Trusting). Results: Neither quantified ER or PR alone nor ER/PR collectively were related to HER2 oncoprotein levels. Influence of menopausal status on biopsy biomarker profiles was investigated. With a median cutoff for HER2 protein, patients with ER+/PR+/HER2+ (TPBC) exhibited increased OS, whereas those with TNBC had decreased OS, of 8 combinations possible. Using tertiles and quartiles, TPBC was exhibited by 34-37% of specimens compared to TNBC, which represented 9.1-12.7% of biopsies when biomarker proteins were quantified. After qPCR data were stratified by ER/PR/HER2 status with a 50% quantile cut for HER2, 39% were TPBC and 10% were TNBC. Using microarray data with the same cutoffs, only 14% were TPBC and 17% were TNBC. Once TPBC were identified by either microarray or by qPCR, increased ESR1, PGR and ERBB2 expression collectively was associated with increased PFS and OS of patients. In general, biopsies that were TNBC or other combinations of biomarker’s gene expression correlated with poorer prognosis and overall survival. Conclusions: Quantifying levels of ER, PR and HER2 proteins as well as of ESR1, PGR and ERBB2 expression were correlated with prediction of clinical outcomes of TNBC, TPBC and patients with other biomarker subsets. Results support quantitative assessment of these biomarkers in biopsies to assess utility of the HER2-low type in personalizing breast cancer management and prediction of risk of relapse. Citation Format: James Wittliff, Michael Daniels. Enhanced Assessment of Clinical Behavior of TNBC and TPBC using Quantified Levels of HER2, Estrogen and Progestin Receptor Proteins and Expression of Their Cognate Genes [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 PO4-03-08.

Abstract PO5-14-05: Circulating tumor DNA fraction correlates with residual cancer burden post-neoadjuvant chemotherapy in triple negative breast cancer patients

Abstract Background: Pathologic response after preoperative/neoadjuvant chemotherapy is a continuum that can range from no residual cancer to extensive disease. Viable cancers can shed tumor DNA into the blood and we hypothesized that plasma ctDNA levels can reflect pathologic response as continuum. Patients and methods: Post-neoadjuvant plasma samples were obtained after completion of chemotherapy but before surgery from patients with stage I to III TNBC who received treatment with durvalumab concurrent with weekly nab-paclitaxel followed by dose dense doxorubicin/cyclophosphamide in a single arm neoadjuvant clinical trial (NCT02489448). Up to 3 mL of blood was collected into EDTA- and heparin- containing vacutainer tubes, and plasma cfDNA was extracted and twice purified in the lab at Predicine Inc. Pathologic response was quantified on a continuous scale using the Residual Cancer Burden (RCB) score, and also categorized as RCB-0 (complete pathologic response, n=21), -I (minimal residual cancer, n=7), -II (moderate residual cancer, n=13), and -III (extensive residual cancer, n=3). Median follow-up was 35 months (range 25-70 months). Tumor whole exome sequencing (WES) data was previously generated using HiSeq 4000 at the Yale Center for Genome Analysis (dbGaP: PRJNA558949). A personalized MRD panel of up to 60 personalized variants per patient was designed based on the tumor WES data, and ultra-deep next-generation sequencing (100,000X) of plasma cfDNA was performed using the PredicineBEACON assay for MRD detection by Predicine. CtDNA positivity (MRD) was defined as a weighted score equivalent to 2 or more tumor variants detected in the plasma. cfDNA tumor fraction was measured based on mutant allele fraction of observed variants. Adjusted tumor fraction could be confidently measured for 37 out of 44 patients that had enough confidently called personalized ctDNA variants. We compared tumor fraction versus RCB score as continuous variables, and also compared tumor fraction between RCB categories as ordinal variables. Invasive disease-free survival was examined by Kaplan-Meier analysis. Bioinformatic data analysis was performed using Graphpad Prism and R. Results: 44 of 48 plasma samples yielded successful cfDNA generation and sequencing. Six patients (13.6%) were MRD positive. Among these 6 cases, 3 had RCB-0 response (14.3% of RCB 0 cases), 1 had RCB II response (7.7% of RCB II cases), and 2 had RCB III response (66.7% of RCB III cases). The median cfDNA tumor fraction of patients with pathological complete response to treatment (pCR) was significantly lower than patients with residual disease (RD) (0.06% vs. 0.3%, p=0.02). There was a positive correlation between RCB scores and tumor fraction (r= 0.45, Spearman). Tumor fraction was more strongly correlated with later recurrence than a binary ctDNA positivity call. Tumor fraction was significantly higher in patients that later experienced local or metastatic recurrence (n=8) compared to those with no evidence of disease (n=29) (Wilcoxon test, p=0.02). Both ctDNA positive RCB III cases had metastatic recurrence while the remaining 4 ctDNA positive cases currently remain recurrence-free. Mutational genomic landscape of both tumor WES and plasma ctDNA samples identified hotspot mutations in 19 cancer-associated genes. Novel hot-spot mutations were observed in the plasma of two patients following treatment. TP53 mutations were highly prevalent in tissue and plasma, however no significant association of mutation of any gene with treatment response was detected. Conclusions: PredicineBeacon MRD assay was successfully performed on 3 mL plasma samples collected using from EDTA and heparin-containing tubes. Tumor fraction correlated with residual disease, RCB score and disease recurrence. Citation Format: Naing Lin Shan, Billie Gould, Kim Blenman, Julia Foldi, Pan Du, Frank Zhang, Myles Walsh, Lajos Pusztai. Circulating tumor DNA fraction correlates with residual cancer burden post-neoadjuvant chemotherapy in triple negative breast cancer patients [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 PO5-14-05.

Changes in attitudes, beliefs, and experiences related to pregnancy during graduate medical education training from 2005 to 2021.

Today, 50% of medical students are women, and residency and fellowship training years overlap with peak times for starting families. The authors describe attitudes toward pregnancy during residency and fellowship and report pregnancy rates and complications for female residents and resident partners across several decades. A web-based survey was emailed to 1,057 residents in 2005 (period 1) and 1,860 residents in 2021 (period 2). Anonymous surveys were sent to all trainees including pregnant trainees, affected co-trainees and trainee partners. Resident attitudes and pregnancy characteristics were compared between groups using the chi-square (χ2) test for categorical variables and the Kruskal-Wallis test for ordinal variables. A total of 442 residents (41.8%) responded to the 2005 survey, and 525 (28.2%) responded to the 2021 survey. Most residents who covered for a pregnant resident had positive feelings about covering for their colleagues during both time periods, although more positive attitudes were present during the period 2. Only about 10% of residents received compensation for their coverage during both time periods. Among residents with a pregnancy during training (i.e., themselves or partners), most characterized having a baby in training as "somewhat difficult" or "very difficult" at both time periods. Pregnancy complication rates were 33% and 44% for training years 2005 and 2021. As medical education evolves, training programs should be proactive in creating structured support systems for pregnant residents and resident partners to minimize adverse maternal and fetal outcomes and to improve training programs. Future studies are needed to elucidate the causality of higher-than-expected pregnancy complication rates.

Clinical validation of automated depth camera-based measurement of the Fugl-Meyer assessment for upper extremity

Objective Depth camera-based measurement has demonstrated efficacy in automated assessment of upper limb Fugl-Meyer Assessment for paralysis rehabilitation. However, there is a lack of adequately sized studies to provide clinical support. Thus, we developed an automated system utilizing depth camera and machine learning, and assessed its feasibility and validity in a clinical setting. Design Validation and feasibility study of a measurement instrument based on single cross-sectional data. Setting Rehabilitation unit in a general hospital Participants Ninety-five patients with hemiparesis admitted for inpatient rehabilitation unit (2021–2023). Main measures Scores for each item, excluding those related to reflexes, were computed utilizing machine learning models trained on participant videos and readouts from force test devices, while the remaining reflex scores were derived through regression algorithms. Concurrent criterion validity was evaluated using sensitivity, specificity, percent agreement and Cohen's Kappa coefficient for ordinal scores of individual items, as well as correlations and intraclass correlation coefficients for total scores. Video-based manual assessment was also conducted and compared to the automated tools. Result The majority of patients completed the assessment without therapist intervention. The automated scoring models demonstrated superior validity compared to video-based manual assessment across most items. The total scores derived from the automated assessment exhibited a high coefficient of 0.960. However, the validity of force test items utilizing force sensing resistors was relatively low. Conclusion The integration of depth camera technology and machine learning models for automated Fugl-Meyer Assessment demonstrated acceptable validity and feasibility, suggesting its potential as a valuable tool in rehabilitation assessment.

Hospitalization Endpoint in Clinical Trials of Outpatient Settings: using Anti-SARS-COV-2 Therapy as an Example.

In response to the COVID-19 pandemic, the World Health Organization (WHO) developed a set of outcome measures for trials primarily aimed at hospitalised patients. However, a gap exists in defining outcome standards for non-hospitalised patients. Therefore, this study aims to discuss hospitalisation as a primary outcome in outpatient trials and its potential pitfalls, specifically focusing on trials related to anti-SARS-COV-2 therapy. In this narrative review, researchers thoroughly searched MEDLINE and ClinicalTrials.gov from January 2020 to December 2022, targeting Phase III randomized controlled trials involving outpatients with mild-to-moderate COVID-19. The trials were specifically related to anti-SARS-COV-2 monoclonal antibodies or antiviral agents. The study collected essential data, including the type of intervention, comparator, primary objective, primary endpoint, and the use of estimands in the trial. The search identified 12 trials that evaluated the efficacy of anti-SARS COV-2 therapies in a predefined population. Three studies used hospitalisation and death as primary endpoints in high-risk patients receiving monoclonal antibodies. Nine studies assessed the efficacy of several antiviral agents: four trials used hospitalisation and death as the main endpoints, while others used different measures such as virologic measures using the Reverse Transcription-Polymerase Chain Reaction test (RT-PCR), the eight-point WHO ordinal scale, symptom alleviation by Day 7 and time to clinical response. Choosing hospitalization as an endpoint may provide meaningful data such as the cost-effectiveness ratio of a drug. However, different hospital utilisation patterns and investigator decisions could bias clinical outcomes if no specific criteria are considered. Therefore, investigators should have clear criteria for determining variables that influence this measure.

Staged bilateral total shoulder arthroplasty: a single institutional experience with mid-term follow-up

BackgroundThe preferred surgical approach for surgical treatment of advanced glenohumeral arthritis is shoulder arthroplasty (SA). Considering the growing volume and success of SA, patients with bilateral shoulder disease are likely to undergo surgery on both shoulders. There are numerous studies evaluating the outcomes of bilateral hip and knee arthroplasty, but a paucity of information examining bilateral SA. This study intends to evaluate the clinical outcomes of patients undergoing staged bilateral anatomic total shoulder arthroplasty (aTSA) or reverse total shoulder arthroplasty (rTSA). MethodsInstitutional records were queried for patients who underwent staged bilateral aTSA or rTSA from 2009 to 2020. Patient records were retrospectively reviewed to assess preoperative and postoperative range of motion (ROM) and strength measurements, demographic information, and complications. Mean ± standard deviation was reported for all continuous variables. Mean functional measurements were compared using a 2-Sample t-Test, ordinal variables via Wilcoxon-Mann Whitney test, and categorical variables via Chi-squared test. Patients were included in the outcome analysis if they had a bilateral TSA with the same procedure (i.e. aTSA on both sides, or rTSA on both sides). Results43 patients (15 male, 28 female) were included. There was an average time of 1.8 years between surgeries. Of the 43 patients, 26 patients had staged bilateral aTSAs and 14 had staged bilateral rTSAs with three patients who had different surgeries on each shoulder. The three patients with different surgeries on each shoulder were excluded from outcome analysis. Patients who had staged aTSA operations demonstrated significant improvement in external rotation (P = .0191, P < .001), forward elevation (FE) (P = .0004, P < .001), and internal rotation (IR) (P = .0183, P = .0166) after the first and second surgeries. Staged rTSA patients showed significant improvement in FE after the first (P = .0043) and second surgeries (P = .016). Patients demonstrated significant increase in strength of external rotation (P = .0136), FE (P = .0088), and IR (P = .0206) after the first rTSA. There was no corresponding increase in strength testing after the second bilateral rTSA surgery. The average Single Assessment Numeric Evaluation, Contralateral Single Assessment Numeric Evaluation, American Shoulder and Elbow Surgeons, and Simple Shoulder Test scores for all surgeries were 84 ± 10, 83 ± 13, 75 ± 20, and 9 ± 2, respectively for the first surgery and 82 ± 13, 83 ± 13, 71 ± 21, and 8 ± 3 for the second surgery. ConclusionIndividuals that undergo staged aTSA procedures gain a better ROM and IR strength after both operations. However, individuals that undergo staged rTSA procedures have an improved ROM and strength after the first surgery but limited improvement after the second.

Electronic health record data shows immunosuppressive conditions are associated with poor outcomes in patients hospitalized for COVID-19

Abstract We identified 10,713 adults hospitalized for COVID-19 from 03/2020 to 05/2022 in electronic health record data from Northwestern Medicine. Based on extracted diagnosis codes, we identified 214 of these adults with primary immunodeficiency (PI), 669 with history of solid organ transplant, and 183 with HIV. Assessed COVID-19 outcomes included mortality, a seven-point ordinal severity scale (1 = Death) based on maximum oxygen requirements during care, and hospitalization length. Patients with PI had a significantly higher mean hospitalization length of 11.8 days and a significantly lower mean maximum severity of 3.3 compared to 7.8 days and 3.9 in immunocompetent patients when controlling for obesity and T2DM. These effects were not significant when controlling for age. Patients with transplant had a significantly higher mean hospitalization length of 15.8 days when controlling for obesity, T2DM, and age, and a significantly lower mean maximum severity of 3.2 when controlling for obesity. Significantly higher mortalities were observed in PI and transplant (RR = 1.5, 95% CI 1.2 to 2.0; RR = 1.5, 95% CI 1.3 to 1.7), but these effects were not significant when controlling for age. There were no significant differences in any outcomes for patients with HIV. Our results suggest patients with PI or transplant hospitalized for COVID-19 may have worse clinical outcomes compared to immunocompetent patients. Meanwhile, patients with HIV had similar outcomes to immunocompetent patients.

Determinants of pain intensity and magnitude of incapability more than two years after arthroscopic Bankart repair for anterior shoulder instability

PurposeIndividuals treated with arthroscopic Bankart repair after anterior shoulder dislocations experience varied discomfort and incapability. The aim of this study was to determine the relative association of mental health and physical health factors with 1) magnitude of capability and 2) pain intensity 2 or more years after surgery. MethodsThis cross-sectional study evaluated 80 military patients that experienced one or more traumatic anterior shoulder dislocations a minimum of 2 years after arthroscopic Bankart repair without remplissage. We measured capability (Oxford Shoulder Instability Score), pain intensity using an 11-point ordinal scale, symptoms of anxiety (GAD-2), symptoms of depression (PHQ-2), catastrophic thinking (PCS-4), and kinesiophobia (Tampa scale for kinesiophobia-4). We also identified preoperative presence of a Hill-Sachs lesion on radiographs and postoperative occurrence of subluxation or a dislocation episode. A negative binominal regression analysis sought factors associated with magnitude of incapability and pain intensity. ResultsGreater incapability was strongly associated with both greater kinesiophobia (Regression Coefficient [RC] = -0.50; 95% Confidence Interval [CI] = -0.73 to -0.26; P = <0.01) and repeat surgery (RC = -0.27; 95% CI = -0.41 to -0.13; P = <0.01). Greater pain intensity was only strongly associated with greater kinesiophobia (RC = 0.25; 95% CI = 0.039 to 0.46; P = 0.021). ConclusionsThe observation that greater unhelpful thinking is associated with greater pain intensity and greater magnitude of incapability after a Bankart repair for anterior shoulder instability, whereas pathophysiological factors such as glenoid bone loss were not, emphasizes the degree to which mindset is associated with musculoskeletal health.

FEASIBILITY, ACCEPTABILITY, AND EFFICACY OF A PILOT EXERCISE PHYSIOLOGY GROUP SERVICE FOR OLDER ADULTS WITH TYPE 2 DIABETES

INTRODUCTION &amp; AIMS Type 2 diabetes prevalence increases with ageing, affecting over half a million older Australians. Medicare type 2 diabetes group interventions can support older adults’ diabetes management. However, Accredited Exercise Physiologist (AEP) delivered service feasibility and acceptability is yet to be assessed. This study aimed to assess feasibility, acceptability and preliminary efficacy of a Medicare type 2 diabetes group exercise and education intervention for older adults. METHODS This study was a single arm feasibility, acceptability, and preliminary efficacy trial of an AEP delivered type 2 diabetes group service for older adults. Participants attended the Diabetes Clinic once per week for 8 weeks, for a group exercise and education session. Attendance, participation, enjoyment, suitability, usefulness, and pre-post clinical health outcomes were assessed. RESULTS The intervention was feasible and acceptable, with 40 participants (71.8±4.5 years old, range 65-81 years, 45% female) attending 87% of sessions, with high treatment compliance within sessions (aerobic training: 86%; resistance training: 86%; education: 87%). Almost all participants (97%) strongly agreed that the program was enjoyable. Significant post intervention improvements (mean difference [95% CI]) were observed for right arm systolic blood pressure (SBP) (-7mmHg [-12, -2], p=0.007), left arm diastolic blood pressure (DBP) (-3mmHg [-5, -0], p=0.021), body weight (-0.7kg [-1.3, -0.0], p=0.039), waist circumference (-1.3cm [-2.2, -0.4], p=0.006), 6-minute walk test (22.8m, [9.1. 36.5], p=0.002), 5 times sit to stand (-0.8sec [-1.2, -0.5], p&amp;lt;0.001), short physical performance battery ordinal scale (0.3 [0.1, 0.5], p=0.009), and whole-body muscle strength (32.2kg [22.3, 42.1], p&amp;lt;0.001). CONCLUSION Older adults attended and enjoyed the AEP led Diabetes Clinic program, while also improving fitness and cardiometabolic health outcomes. Ways to enhance referrals and engage older adults in the programs warrant further investigation. The potential for additional sessions to achieve greater physical activity engagement and diabetes self-management should be further investigated.