Tag: nevin manimala

Med Care. 2023 Sep 19. doi: 10.1097/MLR.0000000000001915. Online ahead of print.

ABSTRACT

BACKGROUND: The shift from in-person to virtual visits, known as telehealth (TH), during the COVID-19 pandemic was a significant change for North Carolina (NC) Medicaid beneficiaries seeking treatment for musculoskeletal (MSK) conditions, as remote care for these conditions was previously unavailable. We used this policy change to investigate factors associated with TH uptake and whether TH availability mitigated disparities in access to care or affected emergency department (ED) visits among these beneficiaries.

RESEARCH DESIGN: Using 2019-2021 NC Medicaid claims, we identified beneficiaries receiving treatment for MSK conditions before COVID-19 (March 2019-February 2020) and analyzed uptake of newly available TH during COVID-19 (April 2020-March 2021). We used descriptive analysis and Poisson generalized estimating equations to quantify TH uptake, factors associated with TH uptake, and the association with ED visits during COVID-19.

RESULTS: Black and Hispanic beneficiaries were less likely to use TH compared with White and non-Hispanic counterparts (10%, P<0.001 and 20%, P=0.03, respectively). Adults eligible for Tailored Plans, specialized NC Medicaid plans for those with significant behavioral health needs or intellectual/developmental disabilities, were less likely to use TH [adjusted risk ratio (ARR):0.83, 95% CI (0.78, 0.87)]; youth eligible for Tailored Plans were more likely to use TH [ARR:1.28, 95% CI (1.16, 1.42)]. Lower county-level internet access was associated with lower TH use [ARR: 0.85, 95% CI (0.82, 0.99)]. No statistical difference in ED utilization was observed between TH users and non-users.

CONCLUSIONS: TH has the potential to deliver convenient care to beneficiaries with MSK conditions who can access it. Further research and policy changes should explore and address underlying factors driving disparities and improve equitable access to care for this population.

PMID:37733405 | DOI:10.1097/MLR.0000000000001915

Acta Med Litu. 2022;29(2):311-319. doi: 10.15388/Amed.2022.29.2.16. Epub 2022 Jun 29.

ABSTRACT

BACKGROUND: Simulation as a proxy tool for conditional clinical training became a powerful technique for introducing trainees to the ultrasound imaging world, allowing them to become a trained sonographer taking into consideration different rates of progress in completing a specific task against the time and ensuring the long-lasting maintenance of the obtained practical skills. Adding a costly, but effective high-fidelity simulator to the residency program justified the expense, demonstrating efficiency of training for improving the clinical performance and confidence of trainees.

MATERIALS AND METHODS: A pilot study in Riga Maternity Hospital within the framework of the study “Role of metabolome, biomarkers and ultrasound parameters in successful labor induction” (Fundamental and Applied Research Programme lzp-2021/1-0300) was performed between March 1st 2022 and 31st April 2022. A virtual-reality simulator (ScanTrainer, Medaphor^TM, Cardiff, UK) was used with the teaching module for assessment of the uterine cervix. Five trainees in obstetrics and two young specialists included in the study. None of them had Fetal Medicine Foundation certificate of competence in the assessment of the uterine cervical lenght before. The time used on the simulator, the number of simulations and a mean confidence in cervical length assessment before and after simulation were recorded.

RESULTS: The study on assesment of uterine cervical lenght demonstrated statistically significant increase in confidence (p=0.008) and statistically significant decrease in time needed to complete correctly the same tasks for the trainees (p=0.008) that shows a positive learning curve over the time of training on ScanTrainer, Medaphor.

CONCLUSIONS: The simple task allows to become a certified specialist in uterine cervical assessment in the short period of time. That support the productiveness of the simulation-based education. The training program should be updated taking into consideration simulation curriculum.

PMID:37733389 | PMC:PMC9799008 | DOI:10.15388/Amed.2022.29.2.16

JAMA Oncol. 2023 Sep 21. doi: 10.1001/jamaoncol.2023.3482. Online ahead of print.

ABSTRACT

IMPORTANCE: Germline gene panel testing is recommended for men with advanced prostate cancer (PCa) or a family history of cancer. While evidence is limited for some genes currently included in panel testing, gene panels are also likely to be incomplete and missing genes that influence PCa risk and aggressive disease.

OBJECTIVE: To identify genes associated with aggressive PCa.

DESIGN, SETTING, AND PARTICIPANTS: A 2-stage exome sequencing case-only genetic association study was conducted including men of European ancestry from 18 international studies. Data analysis was performed from January 2021 to March 2023. Participants were 9185 men with aggressive PCa (including 6033 who died of PCa and 2397 with confirmed metastasis) and 8361 men with nonaggressive PCa.

EXPOSURE: Sequencing data were evaluated exome-wide and in a focused investigation of 29 DNA repair pathway and cancer susceptibility genes, many of which are included on gene panels.

MAIN OUTCOMES AND MEASURES: The primary study outcomes were aggressive (category T4 or both T3 and Gleason score ≥8 tumors, metastatic PCa, or PCa death) vs nonaggressive PCa (category T1 or T2 and Gleason score ≤6 tumors without known recurrence), and metastatic vs nonaggressive PCa.

RESULTS: A total of 17 546 men of European ancestry were included in the analyses; mean (SD) age at diagnosis was 65.1 (9.2) years in patients with aggressive PCa and 63.7 (8.0) years in those with nonaggressive disease. The strongest evidence of association with aggressive or metastatic PCa was noted for rare deleterious variants in known PCa risk genes BRCA2 and ATM (P ≤ 1.9 × 10-6), followed by NBN (P = 1.7 × 10-4). This study found nominal evidence (P < .05) of association with rare deleterious variants in MSH2, XRCC2, and MRE11A. Five other genes had evidence of greater risk (OR≥2) but carrier frequency differences between aggressive and nonaggressive PCa were not statistically significant: TP53, RAD51D, BARD1, GEN1, and SLX4. Deleterious variants in these 11 candidate genes were carried by 2.3% of patients with nonaggressive, 5.6% with aggressive, and 7.0% with metastatic PCa.

CONCLUSIONS AND RELEVANCE: The findings of this study provide further support for DNA repair and cancer susceptibility genes to better inform disease management in men with PCa and for extending testing to men with nonaggressive disease, as men carrying deleterious alleles in these genes are likely to develop more advanced disease.

PMID:37733366 | DOI:10.1001/jamaoncol.2023.3482

JAMA Otolaryngol Head Neck Surg. 2023 Sep 21. doi: 10.1001/jamaoto.2023.2958. Online ahead of print.

ABSTRACT

IMPORTANCE: The COVID-19 pandemic affected millions of people and has become a dominant etiology of olfactory dysfunction (OD). No interventions with definitive clinical utility exist. Gabapentin represents a potential therapy for COVID-19-induced OD.

OBJECTIVE: To evaluate the efficacy of oral gabapentin on olfactory function and olfaction-related quality of life in patients with COVID-19-induced OD.

DESIGN, SETTING, AND PARTICIPANTS: This pilot double-blinded, placebo-controlled randomized clinical trial (RCT) was conducted at Washington University School of Medicine in St Louis from January 7, 2022, to February 3, 2023. Adults with at least 3 months of OD after COVID-19 infection were eligible for inclusion. Participants with a history of other causes of OD or contraindications to gabapentin were excluded.

INTERVENTION: Patients were randomized 1:1 to oral gabapentin or placebo. All patients underwent titration to a maximum tolerable dose, which was maintained during an 8-week fixed-dose (FD) phase then tapered off. Participants were monitored for 4 weeks following cessation of study medication.

MAIN OUTCOMES AND MEASURES: Outcomes were assessed following the 8-week FD phase and 4 weeks after taper completion. The primary outcome measure was the response rate determined by subjective improvement in OD on the Clinical Global Impression of Improvement (CGI-I) after the FD phase. Other subjective and objective measures of olfactory function were also assessed as secondary outcome measures.

RESULTS: Sixty-eight participants were enrolled (34 randomized to each arm), a total of 44 participants completed the FD period and 20 (45.4%) reported response to treatment with at least slight improvement in olfaction from baseline. Of those randomized, 51 (75%) were women and 56 were White (82%) with a mean (SD) age of 43 (13.5) years. Baseline demographic features including age, sex, and race and ethnicity were not significantly different between the groups. Of the 18 participants in the gabapentin group, 8 (44%) were responders and of the 26 participants in the placebo group, 12 (46%) reported response to treatment (percent difference, 1.7%; 95% CI, -31.6% to 28.2%). Mixed-model analysis of all secondary outcome measures demonstrated no clinically meaningful or statistically significant difference between the gabapentin and placebo groups throughout the trial. There were no serious adverse events.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, gabapentin was not associated with statistically significant or clinically meaningful benefit over placebo and likely is not an efficacious therapy for COVID-19-induced OD.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05184192.

PMID:37733356 | DOI:10.1001/jamaoto.2023.2958

JAMA Netw Open. 2023 Sep 5;6(9):e2330847. doi: 10.1001/jamanetworkopen.2023.30847.

ABSTRACT

IMPORTANCE: Previous studies have demonstrated sex-specific disparities in performance assessments among emergency medicine (EM) residents. However, less work has focused on intersectional disparities by ethnoracial identity and sex in resident performance assessments.

OBJECTIVE: To estimate intersectional sex-specific ethnoracial disparities in standardized EM resident assessments.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used data from the Association of American Medical Colleges and the Accreditation Council for Graduate Medical Education Milestones (Milestones) assessments to evaluate ratings for EM residents at 128 EM training programs in the US. Statistical analyses were conducted in June 2020 to January 2023.

EXPOSURE: Training and assessment environments in EM residency programs across comparison groups defined by ethnoracial identity (Asian, White, or groups underrepresented in medicine [URM], ie, African American/Black, American Indian/Alaska Native, Hispanic/Latine, and Native Hawaiian/Other Pacific Islander) and sex (female/male).

MAIN OUTCOMES AND MEASURES: Mean Milestone scores (scale, 0-9) across 6 core competency domains: interpersonal and communications skills, medical knowledge, patient care, practice-based learning and improvement, professionalism, and system-based practice. Overall assessment scores were calculated as the mean of the 6 competency scores.

RESULTS: The study sample comprised 128 ACGME-accredited programs and 16 634 assessments for 2708 EM residents of which 1913 (70.6%) were in 3-year and 795 (29.4%) in 4-year programs. Most of the residents were White (n = 2012; 74.3%), followed by Asian (n = 477; 17.6%), Hispanic or Latine (n = 213; 7.9%), African American or Black (n = 160; 5.9%), American Indian or Alaska Native (n = 24; 0.9%), and Native Hawaiian or Other Pacific Islander (n = 4; 0.1%). Approximately 14.3% (n = 386) and 34.6% (n = 936) were of URM groups and female, respectively. Compared with White male residents, URM female residents in 3-year programs were rated increasingly lower in the medical knowledge (URM female score, -0.47; 95% CI, -0.77 to -0.17), patient care (-0.18; 95% CI, -0.35 to -0.01), and practice-based learning and improvement (-0.37; 95% CI, -0.65 to -0.09) domains by postgraduate year 3 year-end assessment; URM female residents in 4-year programs were also rated lower in all 6 competencies over the assessment period.

CONCLUSIONS AND RELEVANCE: This retrospective cohort study found that URM female residents were consistently rated lower than White male residents on Milestone assessments, findings that may reflect intersectional discrimination in physician competency evaluation. Eliminating sex-specific ethnoracial disparities in resident assessments may contribute to equitable health care by removing barriers to retention and promotion of underrepresented and minoritized trainees and facilitating diversity and representation among the emergency physician workforce.

PMID:37733347 | DOI:10.1001/jamanetworkopen.2023.30847

JAMA Netw Open. 2023 Sep 5;6(9):e2334889. doi: 10.1001/jamanetworkopen.2023.34889.

ABSTRACT

IMPORTANCE: Preterm infants with varying degrees of anemia have different tissue oxygen saturation responses to red blood cell (RBC) transfusion, and low cerebral saturation may be associated with adverse outcomes.

OBJECTIVE: To determine whether RBC transfusion in preterm infants is associated with increases in cerebral and mesenteric tissue saturation (Csat and Msat, respectively) or decreases in cerebral and mesenteric fractional tissue oxygen extraction (cFTOE and mFTOE, respectively) and whether associations vary based on degree of anemia, and to investigate the association of Csat with death or neurodevelopmental impairment (NDI) at 22 to 26 months corrected age.

DESIGN, SETTING, AND PARTICIPANTS: This was a prospective observational secondary study conducted among a subset of infants between August 2015 and April 2017 in the Transfusion of Prematures (TOP) multicenter randomized clinical trial at 16 neonatal intensive care units of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Preterm neonates with gestational age 22 to 28 weeks and birth weight 1000 g or less were randomized to higher or lower hemoglobin thresholds for transfusion. Data were analyzed between October 2020 and May 2022.

INTERVENTIONS: Near-infrared spectroscopy monitoring of Csat and Msat.

MAIN OUTCOMES AND MEASURES: Primary outcomes were changes in Csat, Msat, cFTOE, and mFTOE after transfusion between hemoglobin threshold groups, adjusting for age at transfusion, gestational age, birth weight stratum, and center. Secondary outcome at 22 to 26 months was death or NDI defined as cognitive delay (Bayley Scales of Infant and Toddler Development-III score <85), cerebral palsy with Gross Motor Function Classification System level II or greater, or severe vision or hearing impairment.

RESULTS: A total of 179 infants (45 [44.6%] male) with mean (SD) gestational age 25.9 (1.5) weeks were enrolled, and valid data were captured from 101 infants during 237 transfusion events. Transfusion was associated with a significant increase in mean Csat of 4.8% (95% CI, 2.7%-6.9%) in the lower-hemoglobin threshold group compared to 2.7% (95% CI, 1.2%-4.2%) in the higher-hemoglobin threshold group, while mean Msat increased 6.7% (95% CI, 2.4%-11.0%) vs 5.6% (95% CI, 2.7%-8.5%). Mean cFTOE and mFTOE decreased in both groups to a similar extent. There was no significant change in peripheral oxygen saturation (SpO2) in either group (0.2% vs -0.2%). NDI or death occurred in 36 infants (37%). Number of transfusions with mean pretransfusion Csat less than 50% was associated with NDI or death (odds ratio, 2.41; 95% CI, 1.08-5.41; P = .03).

CONCLUSIONS AND RELEVANCE: In this secondary study of the TOP randomized clinical trial, Csat and Msat were increased after transfusion despite no change in SpO2. Lower pretransfusion Csat may be associated with adverse outcomes, supporting further investigation of targeted tissue saturation monitoring in preterm infants with anemia.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01702805.

PMID:37733345 | DOI:10.1001/jamanetworkopen.2023.34889

Eur J Phys Rehabil Med. 2023 Sep 21. doi: 10.23736/S1973-9087.23.07987-X. Online ahead of print.

ABSTRACT

BACKGROUND: The nutritional status of individuals with cancer is a crucial determinant of their health and well-being, and addressing nutrition-related functioning conditions is essential for maintaining physical activity levels and participating in daily activities.

AIM: This study aims to identify an evidence-based International Classification of Functioning, Disability and Health (ICF) scale using item response theory for nutrition conditions in patients with cancer, which can differentiate and assess nutrition-related functioning conditions of cancer survivors.

DESIGN: Cross-sectional study.

SETTING: Sir Run Run Hospital, Nanjing Medical University.

POPULATION: One hundred cancer patients were enrolled.

METHODS: Via convenience sampling, the study administered a questionnaire consisting of 89 ICF items to participants. The original five-point rating system was binarized (1 = no problem, 0 = problem). Through data shaping, non-parametric IRT analysis and parametric IRT analysis, psychometric properties of nutritional ICF scale were calculated using R software.

RESULTS: The study extracted a unidimensional scale with 32 items and constructed 2-parameter logistic model with good fitness, whose root mean square error approximation (RMSEA) = 0.0759, Tucker-Lewis Index (TLI) = 0.9655, and Comparative Fit Index (CFI) = 0.9677. The model demonstrated high reliability, as indicated by a Cronbach’s α of 0.95, Guttman λ<inf>2</inf> of 0.95, Molenaar Sijtsma statistic of 0.96 and a latent class reliability coefficient (LCRC) of 0.98. Besides, there was a strong correlation between the total score of 32 ICF items and the score of Patient-Generated Subjective Global Assessment (PG-SGA, P<0.001, r=-0.77) and Mini Nutritional Assessment (MNA, P<0.001, r=0.76), suggesting the 32-item scale had high validity.

CONCLUSIONS: The study constructed an evidence-based ICF scale for nutrition conditions in patients with cancer with 32-item and 2PLM for evaluating nutrition-associated health level in persons with cancer, including high validity and reliability.

CLINICAL REHABILITATION IMPACT: The IRT model based on ICF provided a promising assessment tool to discriminate nutrition-associated health level of persons with cancer, and offered an auxiliary method for selecting rehabilitation intervention targets. This has the potential to lead to improved outcomes in cancer treatment and increased quality of life for cancer survivors.

PMID:37733333 | DOI:10.23736/S1973-9087.23.07987-X

J Am Acad Orthop Surg. 2023 Oct 1;31(19):e845-e858. doi: 10.5435/JAAOS-D-23-00063. Epub 2023 Aug 21.

ABSTRACT

INTRODUCTION: Acute blood loss anemia requiring allogeneic blood transfusion is still a postoperative complication of total knee arthroplasty (TKA). This study aimed to use machine learning models for the prediction of blood transfusion after primary TKA and to identify contributing factors.

METHODS: A total of 2,093 patients who underwent primary TKA at our institution were evaluated using data extracted from the hospital quality improvement database to identify patient demographics and surgical variables that may be associated with blood transfusion. A multilayer perceptron neural network (MPNN) machine learning algorithm was used to predict risk factors for blood transfusion and factors associated with increased length of stay. Statistical analyses including bivariate correlate analysis, Chi-Square test, and Student t-test were performed for demographic analysis and to determine the correlation between blood transfusion and other variables.

RESULTS: The results demonstrated important factors associated with transfusion rates, including preoperative hemoglobin level, preoperative creatinine level, length of surgery, simultaneous bilateral surgeries, tranexamic acid usage, American Society of Anesthesiologists Physical Status score, preoperative albumin level, ethanol usage, preoperative anticoagulation medications, age, and TKA type (conventional versus robotic-assisted). Patients who underwent a blood transfusion had a markedly greater length of stay than those who did not. The MPNN machine learning model achieved excellent performance across discrimination (AUC = 0.894).

DISCUSSION: The MPNN machine learning model showed its power as a statistical analysis tool to predict the ranking of factors for blood transfusion. Traditional statistics are unable to differentiate importance or predict in the same manner as a machine learning model.

CONCLUSION: This study demonstrated that MPNN for the prediction of patient-specific blood transfusion rates after TKA represented a novel application of machine learning with the potential to improve preoperative planning for treatment outcomes.

PMID:37733328 | DOI:10.5435/JAAOS-D-23-00063

J Trauma Acute Care Surg. 2023 Sep 21. doi: 10.1097/TA.0000000000004142. Online ahead of print.

ABSTRACT

BACKGROUND: Activated Protein C (aPC) plays dual roles after injury, driving both trauma-induced coagulopathy (TIC) by cleaving, and thus inactivating, factors Va and VIIIa and depressing fibrinolysis while also mediating an inflammomodulatory milieu via protease activated receptor-1 (PAR-1) cytoprotective signaling. Because of this dual role, it represents and ideal target for study and therapeutics after trauma. A known aPC variant, 3K3A-aPC, has been engineered to preserve cytoprotective activity while retaining minimal anticoagulant activity rendering it potentially ideal as a cytoprotective therapeutic after trauma. We hypothesized that 3K3A-aPC would mitigate the endotheliopathy of trauma by protecting against endothelial permeability.

METHODS: We used electric cell-substrate impedance sensing (ECIS) to measure permeability changes in real time in primary endothelial cells. These were cultured, grown to confluence, and treated with a 2 μg/mL solution of 3K3A-aPC at 180, 120, 60, 30 minutes prior to stimulation with ex vivo plasma taken from severely injured trauma patients (ISS > 15 and BD < -6) (TP). Cells treated with thrombin and untreated cells were included in this study as control groups. Permeability changes were recorded in real time via ECIS for 30 minutes after treatment with TP. We quantified permeability changes in the control and treatment groups as area under the curve (AUC). Rac1/RhoA activity was also compared between these groups. Statistical significance was determined by one-way ANOVA followed by a post hoc analysis using Tukey’s multiple comparison’s test.

RESULTS: Treatment with aPC mitigated endothelial permeability induced by ex vivo trauma plasma at all pre-treatment time points. The AUC of the 30-minute 3K3A-aPC pre-treatment group was higher than TP alone (mean diff. 22.12 95% CI [13.75, 30.49], p < 0.0001) (Figure). Moreover, the AUC of the 60, 120, and 180-minute pre-treatment groups was also higher than TP alone (mean diff. 16.30 95% CI [7.93, 24.67], 19.43 95% CI [11.06, 27.80], and 18.65 95% CI [10.28, 27.02], all p < .0001 respectively. Rac1/RhoA activity was higher in the aPC pre-treatment group when compared to all other groups (p < 0.01).

CONCLUSIONS: Pre-treatment with 3K3A-aPC, which retains its cytoprotective function but has only ~5% of its anti-coagulant function, abrogates the effects of trauma-induced endotheliopathy. This represents a potential therapeutic treatment for dysregulated thrombo-inflammation for injured patients by minimizing aPC’s role in trauma-induced coagulopathy while concurrently amplifying its essential cytoprotective function.

LEVEL OF EVIDENCE: Level III, Prognostic/Epidemiological.

PMID:37733304 | DOI:10.1097/TA.0000000000004142

J Integr Complement Med. 2023 Sep 21. doi: 10.1089/jicm.2022.0809. Online ahead of print.

ABSTRACT

Background: To evaluate the efficacy and safety of Keluoxin (KLX) capsules and provide validated evidence for the application of KLX in the treatment of diabetic kidney disease (DKD). Methods: A multicenter, randomized, double-blind, placebo-controlled trial design was used to screen 129 patients with DKD (urinary albumin-to-creatinine ratio [UACR]: male, 2.5-30 mg/mmol; female, 3.5-30 mg/mmol) and with Qi and Yin deficiency and blood stasis symptoms. Written informed consent was obtained from all patients. The patients were randomly divided into KLX and control groups. The KLX group was orally administered KLX (6 g/day) and irbesartan tablets (150 mg/day), whereas the control group was administered KLX placebo (6 g/day) and irbesartan tablets (150 mg/day). Patients were observed for 24 weeks to evaluate the natural logarithm of the UACR (log-UACR), the odds ratio (OR) for a sustained increase in the UACR of at least 30% and 40%, estimated glomerular filtration rate (eGFR), changes in symptoms and quality-of-life scores, and adverse events. Results: The changes of the natural log-UACR during the 24 weeks compared with baseline in the KLX group were better than those in the control group (LS mean ± standard error, -0.26 ± 0.10 vs. 0.01 ± 0.09, p = 0.0292). The incidence of a sustained increase in the UACR of at least 30% and 40% was found to be significantly lower in the KLX group (OR, 0.26; 95% confidence interval [CI], 0.09-0.75; OR, 0.29; 95% CI, 0.10-0.82). Changes in symptoms and quality-of-life scores in the KLX group were better than those in the control group. There was no statistically significant difference in eGFR or the incidence of adverse events between the groups. Conclusions: Overall, these results suggest that KLX capsules combined with irbesartan can reduce microalbuminuria, relieve the symptoms, and improve the quality of life for patients with type 2 early DKD compared with the use of irbesartan alone. Trial registration: Chinese Clinical Trial Registry, registration number: ChiCTR2100052764.

PMID:37733303 | DOI:10.1089/jicm.2022.0809