Category: Statistics

JMIR Res Protoc. 2023 Oct 2;12:e45512. doi: 10.2196/45512.

ABSTRACT

BACKGROUND: Over 10 million newborns worldwide undergo resuscitation at birth each year. Pediatricians may use electrocardiogram (ECG), pulse oximetry (PO), and stethoscope in determining heart rate (HR), as HR guides the need for and steps of resuscitation. HR must be obtained quickly and accurately. Unfortunately, the current diagnostic modalities are either too slow, obtaining HR in more than a minute, or inaccurate. With time constraints, a reliable robust heart rate detector (HRD) modality is required. This paper discusses a protocol for conducting a methods-based comparison study to determine the HR accuracy of a novel real-time HRD based on 3D-printed dry-electrode single-lead ECG signals for cost-effective and quick HR determination. The HRD’s HR results are compared to either clinical-grade ECG or PO monitors to ensure robustness and accuracy.

OBJECTIVE: The purpose of this study is to design and examine the feasibility of a proof-of-concept HRD that quickly obtains HR using biocompatible 3D-printed dry electrodes for single-lead neonatal ECG acquisition. This study uses a novel HRD and compares it to the gold-standard 3-lead clinical ECG or PO in a hospital setting.

METHODS: A cross-sectional study is planned to be conducted in the neonatal intensive care unit or postpartum unit of a large community teaching hospital in Toronto, Canada, from June 2023 to June 2024. In total, 50 newborns will be recruited for this study. The HRD and an ECG or PO monitor will be video recorded using a digital camera concurrently for 3 minutes for each newborn. Hardware-based signal processing and patent-pending embedded algorithm-based HR estimation techniques are applied directly to the raw collected single-lead ECG and displayed on the HRD in real time during video recordings. These data will be annotated and compared to the ECG or PO readings at the same points in time. Accuracy, F₁-score, and other statistical metrics will be produced to determine the HRD’s feasibility in providing reliable HR.

RESULTS: The study is ongoing. The projected end date for data collection is around July 2024.

CONCLUSIONS: The study will compare the novel patent-pending 3D-printed dry electrode-based HRD’s real-time HR estimation techniques with the state-of-the-art clinical-grade ECG or PO monitors for HR accuracy and examines how fast the HRD provides reliable HR. The study will further provide recommendations and important improvements that can be made to implement the HRD for clinical applications, especially in neonatal resuscitation efforts. This work can be seen as a stepping stone in the development of robust dry-electrode single-lead ECG devices for HR estimations in the pediatric population.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45512.

PMID:37782528 | DOI:10.2196/45512

J Nerv Ment Dis. 2023 Oct 1;211(10):759-763. doi: 10.1097/NMD.0000000000001694. Epub 2023 Jul 10.

ABSTRACT

Since its introduction, schizoaffective disorder (SAD) has been one of the most controversial diagnoses in psychiatry, both clinically and nosologically. In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), SAD diagnostic criteria were changed, and instead of a cross-sectional diagnosis, a longitudinal approach covering the life course of the illness was adopted. In this study, the meaning of this conceptual shift in the diagnosis of SAD in clinical practice is investigated throughout the course of the illness for patients with SAD. Sixty-two inpatients diagnosed with SAD according to DSM-5 diagnostic criteria are included in this study. The course of the illness from its onset to the present is investigated retrospectively. The disease duration is 18.3 ± 9.1 years. The most common diagnoses in the first hospitalization are bipolar disorder (manic episodes) and psychotic disorder, not otherwise specified. Furthermore, the time that elapsed between the first psychiatric application of the patients and the diagnosis of SAD is 9.5 ± 7.3 years. Further, when the course of the illness is grouped according to the predominance of affective and psychotic disorders, recurrent affective disorders are observed most frequently (29.3%), followed by mixed-episode disorders and a shift from affective disorders to psychotic disorders (22.4%). It is found that SAD has a heterogeneous course, and affective disorder diagnoses are more dominant during the course of the illness. The clinical relevance of the longitudinal emphasis on the total duration of the illness in the DSM-5 is also demonstrated. The affective and psychotic dichotomy, based on Kraepelin, has failed to elucidate the course of the disease in clinical practice. Therefore, clinicians should meticulously evaluate the entire course of the illness for SAD and avoid conclusive judgments over a single episode.

PMID:37782519 | DOI:10.1097/NMD.0000000000001694

JAMA Pediatr. 2023 Oct 2. doi: 10.1001/jamapediatrics.2023.4003. Online ahead of print.

ABSTRACT

IMPORTANCE: While the prevalence of autism spectrum disorder (ASD) continues to increase and early diagnosis is emphasized, there is limited information on outcomes for children diagnosed with ASD in early childhood using contemporary diagnostic criteria.

OBJECTIVES: To determine the frequency with which children who are clinically diagnosed with ASD at 12 to 36 months of age continue to meet diagnostic criteria for ASD at 5 to 7 years of age and to evaluate whether baseline child-specific and demographic characteristics and receipt of interventions are associated with ASD persistence.

DESIGN, SETTING, AND PARTICIPANTS: In this natural history cohort study, children who received a clinical ASD diagnosis at 12 to 36 months of age underwent a research diagnostic assessment at 5 to 7 years of age. Research assessments occurred from August 14, 2018, to January 8, 2022.

INTERVENTION: Children received community-based interventions, and parents provided details about interventions received.

MAIN OUTCOMES AND MEASURES: The main outcome was persistence of ASD diagnosis based on current functioning. An experienced research psychologist assigned an ASD diagnosis (present or absent) according to criteria from the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) after the research assessment. The research assessment included administration of the Autism Diagnostic Observation Schedule-2, Autism Diagnostic Interview-Research, and a cognitive measure.

RESULTS: Of the 213 participants diagnosed with ASD at initial clinical assessment (mean [SD] age, 24.6 [3.9] months; 177 boys [83.1%]), 79 (37.1%) did not continue to meet diagnostic criteria for ASD (nonpersistent ASD) at research assessment (mean [SD] age, 74.3 [7.1] months). All children with nonpersistent ASD had IQ of at least 70, while there was a bimodal distribution of IQ for those with persistent ASD (46 with IQ <70 and 88 with IQ ≥70). All children received some interventions, and 201 (94.4%) received ASD-specific intervention, mostly applied behavioral analysis. In a multilevel logistic regression model, the only variables associated with increased odds of being in the nonpersistent ASD group at 6 years of age were higher baseline adaptive skills (b coefficient = -0.287 [SE, 0.108]) and female sex (b = 0.239 [SE, 0.064]).

CONCLUSIONS AND RELEVANCE: The findings of this cohort study suggest that among toddlers diagnosed with ASD, baseline adaptive function and sex may be associated with persistence of ASD.

PMID:37782510 | DOI:10.1001/jamapediatrics.2023.4003

JAMA Netw Open. 2023 Oct 2;6(10):e2336483. doi: 10.1001/jamanetworkopen.2023.36483.

ABSTRACT

IMPORTANCE: Natural language processing tools, such as ChatGPT (generative pretrained transformer, hereafter referred to as chatbot), have the potential to radically enhance the accessibility of medical information for health professionals and patients. Assessing the safety and efficacy of these tools in answering physician-generated questions is critical to determining their suitability in clinical settings, facilitating complex decision-making, and optimizing health care efficiency.

OBJECTIVE: To assess the accuracy and comprehensiveness of chatbot-generated responses to physician-developed medical queries, highlighting the reliability and limitations of artificial intelligence-generated medical information.

DESIGN, SETTING, AND PARTICIPANTS: Thirty-three physicians across 17 specialties generated 284 medical questions that they subjectively classified as easy, medium, or hard with either binary (yes or no) or descriptive answers. The physicians then graded the chatbot-generated answers to these questions for accuracy (6-point Likert scale with 1 being completely incorrect and 6 being completely correct) and completeness (3-point Likert scale, with 1 being incomplete and 3 being complete plus additional context). Scores were summarized with descriptive statistics and compared using the Mann-Whitney U test or the Kruskal-Wallis test. The study (including data analysis) was conducted from January to May 2023.

MAIN OUTCOMES AND MEASURES: Accuracy, completeness, and consistency over time and between 2 different versions (GPT-3.5 and GPT-4) of chatbot-generated medical responses.

RESULTS: Across all questions (n = 284) generated by 33 physicians (31 faculty members and 2 recent graduates from residency or fellowship programs) across 17 specialties, the median accuracy score was 5.5 (IQR, 4.0-6.0) (between almost completely and complete correct) with a mean (SD) score of 4.8 (1.6) (between mostly and almost completely correct). The median completeness score was 3.0 (IQR, 2.0-3.0) (complete and comprehensive) with a mean (SD) score of 2.5 (0.7). For questions rated easy, medium, and hard, the median accuracy scores were 6.0 (IQR, 5.0-6.0), 5.5 (IQR, 5.0-6.0), and 5.0 (IQR, 4.0-6.0), respectively (mean [SD] scores were 5.0 [1.5], 4.7 [1.7], and 4.6 [1.6], respectively; P = .05). Accuracy scores for binary and descriptive questions were similar (median score, 6.0 [IQR, 4.0-6.0] vs 5.0 [IQR, 3.4-6.0]; mean [SD] score, 4.9 [1.6] vs 4.7 [1.6]; P = .07). Of 36 questions with scores of 1.0 to 2.0, 34 were requeried or regraded 8 to 17 days later with substantial improvement (median score 2.0 [IQR, 1.0-3.0] vs 4.0 [IQR, 2.0-5.3]; P < .01). A subset of questions, regardless of initial scores (version 3.5), were regenerated and rescored using version 4 with improvement (mean accuracy [SD] score, 5.2 [1.5] vs 5.7 [0.8]; median score, 6.0 [IQR, 5.0-6.0] for original and 6.0 [IQR, 6.0-6.0] for rescored; P = .002).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, chatbot generated largely accurate information to diverse medical queries as judged by academic physician specialists with improvement over time, although it had important limitations. Further research and model development are needed to correct inaccuracies and for validation.

PMID:37782499 | DOI:10.1001/jamanetworkopen.2023.36483

JAMA Netw Open. 2023 Oct 2;6(10):e2336678. doi: 10.1001/jamanetworkopen.2023.36678.

ABSTRACT

IMPORTANCE: Postmarket analysis of individuals who receive nirmatrelvir and ritonavir (Paxlovid [Pfizer]) is essential because they differ substantially from individuals included in published clinical trials.

OBJECTIVE: To examine the association of nirmatrelvir and ritonavir with prevention of death or admission to hospital in individuals with different risks of complications from COVID-19 infection.

DESIGN, SETTING, AND PARTICIPANTS: This is a cohort study of adult patients in British Columbia, Canada, between February 1, 2022, and February 3, 2023. Patients were eligible if they belonged to 1 of 4 higher-risk groups of individuals who received priority for COVID-19 vaccination. Two groups included clinically extremely vulnerable (CEV) people who were severely (CEV1) or moderately immunocompromised (CEV2). CEV3 individuals were not immunocompromised but had medical conditions associated with a high risk for complications from COVID-19. A fourth expanded eligibility (EXEL) group was added to allow wider access to nirmatrelvir and ritonavir for certain other higher-risk individuals who were not in a CEV group, such as those older than 70 years who were unvaccinated.

EXPOSURES: Patients with COVID-19 who received nirmatrelvir and ritonavir were matched to patients in the same vulnerability group; who were of the same sex, age, and propensity score for nirmatrelvir and ritonavir treatment; and who were also infected within 1 month of the individual treated with nirmatrelvir and ritonavir.

MAIN OUTCOMES AND MEASURES: The primary outcome was death from any cause or emergency hospitalization with COVID-19 within 28 days.

RESULTS: There were 6866 individuals included in the study, of whom 3888 (56.6%) were female and whose median (IQR) age was 70 (57-80) years. Compared with unexposed controls, treatment with nirmatrelvir and ritonavir was associated with statistically significant relative reductions in the primary outcome in the CEV1 group (560 patients; risk difference [RD], -2.5%, 95% CI, -4.8% to -0.2%) and the CEV2 group (2628 patients; RD, -1.7%; 95% CI, -2.9% to -0.5%). In the CEV3 group, the RD was -1.3%, but the findings were not statistically significant (2100 patients; 95% CI, -2.8% to 0.1%). In the EXEL group, treatment was associated with higher risk of the outcome (RD, 1.0%), but the findings were not statistically significant (1578 patients; 95% CI, -0.9% to 2.9%).

CONCLUSIONS AND RELEVANCE: In this cohort study of 6866 individuals in British Columbia, nirmatrelvir and ritonavir treatment was associated with reduced risk of COVID-19 hospitalization or death in CEV individuals, with the greatest benefit observed in severely immunocompromised individuals. No reduction in the primary outcome was observed in lower-risk individuals, including those aged 70 years or older without serious comorbidities.

PMID:37782496 | DOI:10.1001/jamanetworkopen.2023.36678

JAMA Pediatr. 2023 Oct 2. doi: 10.1001/jamapediatrics.2023.3957. Online ahead of print.

ABSTRACT

IMPORTANCE: Neonatal hypoglycemia is common, occurring in up to 50% of infants at risk for hypoglycemia (infant of diabetic mother [IDM], small for gestational age [SGA], large for gestational age [LGA], and preterm) and is associated with long-term neurodevelopmental impairment. Guidelines recommend screening infants at risk of hypoglycemia. The proportion of infants who require screening for neonatal hypoglycemia is unknown.

OBJECTIVE: To determine the proportion of infants eligible for neonatal hypoglycemia screening using criteria from the highest-scoring critically appraised clinical guideline.

DESIGN, SETTING, AND PARTICIPANTS: This systematic review of the literature was conducted to identify clinical practice guidelines for neonatal hypoglycemia and took place at a tertiary maternity hospital in Auckland, New Zealand. Eligible guidelines were critically appraised using the Appraisal of Guidelines for Research and Evaluation II tool. Using screening criteria extracted from the highest-scoring guideline, the proportion of infants eligible for neonatal hypoglycemia screening was determined in a retrospective observational cohort study of infants born January 1, 2004, to December 31, 2018. Data were analyzed by logistic regression. Infant participants were included if gestational age was 35 weeks or more, birth weight was 2000 g or more, and they were not admitted to a neonatal intensive care unit less than 1 hour after birth. The data were analyzed from November 2022 through February 2023. A total of 101 372 infants met the inclusion criteria.

EXPOSURE: Risk factors for neonatal hypoglycemia.

MAIN OUTCOME: Proportion of infants eligible for neonatal hypoglycemia screening.

RESULTS: The study team screened 2366 abstracts and 18 guidelines met inclusion criteria for appraisal. There was variability in the assessed quality of guidelines and a lack of consensus between screening criteria. The highest-scoring guideline defined screening criteria as: IDM, preterm (less than 37 weeks’ gestation), SGA (less than 10th percentile), birth weight of less than 2500 g or more than 4500 g, LGA (more than 90th percentile), or gestational age more than 42 weeks. A total of 101 372 infants met criteria for inclusion in the cohort study; median (IQR) gestational age was 39 (38-40) weeks and 51% were male. The overall proportion of infants eligible for screening was 26.3%. There was an increase in the proportion of eligible infants from 25.6% to 28.5% over 15 years, which was not statistically significant after adjustment for maternal age, body mass index, ethnicity, and multiple pregnancy (odds ratio, 0.99; 95% CI, 0.93-1.03; change in proportion per year).

CONCLUSION: A systematic review found that practice guidelines providing recommendations for clinical care of neonatal hypoglycemia were of variable quality with is a lack of consensus regarding definitions for infants at risk for hypoglycemia. In the cohort study, one-quarter of infants were eligible for hypoglycemia screening. Further research is required to identify which infants may benefit from neonatal hypoglycemia screening.

PMID:37782488 | DOI:10.1001/jamapediatrics.2023.3957

IUCrJ. 2023 Nov 1. doi: 10.1107/S2052252523008242. Online ahead of print.

ABSTRACT

Many coherent imaging applications that utilize ultrafast X-ray free-electron laser (XFEL) radiation pulses are highly sensitive to fluctuations in the shot-to-shot statistical properties of the source. Understanding and modelling these fluctuations are key to successful experiment planning and necessary to maximize the potential of XFEL facilities. Current models of XFEL radiation and their shot-to-shot statistics are based on theoretical descriptions of the source and are limited in their ability to capture the shot-to-shot intensity fluctuations observed experimentally. The lack of accurate temporal statistics in simulations that utilize these models is a significant barrier to optimizing and interpreting data from XFEL coherent diffraction experiments. Presented here is a phenomenological model of XFEL radiation that is capable of capturing the shot-to-shot statistics observed experimentally using a simple time-dependent approximation of the pulse wavefront. The model is applied to reproduce non-stationary shot-to-shot intensity fluctuations observed at the European XFEL, whilst accurately representing the single-shot properties predicted by FEL theory. Compared with previous models, this approach provides a simple, robust and computationally inexpensive method of generating statistical representations of XFEL radiation.

PMID:37782462 | DOI:10.1107/S2052252523008242

Med Care. 2023 Oct 2. doi: 10.1097/MLR.0000000000001928. Online ahead of print.

ABSTRACT

BACKGROUND: Although the myriad of provisions under the Affordable Care Act (ACA) have generally increased coverage and financial access to the health systems, language barriers represent a serious challenge to access to care among Limited English Proficiency (LEP) populations.

OBJECTIVE: The aim of this study was to examine the effect of Medicaid expansions under the ACA on the availability of language services and Medicaid acceptance in substance abuse treatment (SAT) facilities.

RESEARCH DESIGN: A quasi-experimental difference-in-differences design with multiple time periods was used to compare changes in the availability of language services and Medicaid as a payment source between Medicaid expansion and nonexpansion states. Facility-level observational data in the National Survey of Substance Abuse Treatment Services 2010-2019 was included.

MEASURES: Availability of LEP services and Medicaid acceptance in the SAT facilities.

RESULTS: The proportion of SAT facilities that provide LEP services increased from 40% in 2013 to 53% in 2019. The proportions by state are heterogeneous, ranging from approximately 20% to 70%. The ACA Medicaid expansions are not associated with changes in the availability of LEP services in the facilities. Moreover, Medicaid acceptance in the expansion states increased gradually following the expansion; however, the estimates are not statistically significant.

CONCLUSION: The ACA Medicaid expansion had no impact on the availability of LEP services and the acceptance of Medicaid as a payment source in the SAT facilities.

PMID:37782461 | DOI:10.1097/MLR.0000000000001928

J Fluoresc. 2023 Oct 2. doi: 10.1007/s10895-023-03441-7. Online ahead of print.

ABSTRACT

The serum biomarker copeptin, an innovative and stable substitute biomarker of vasopressin, is associated with stroke. Therefore, establishing a highly sensitive time-resolved fluorescence immunoassay for copeptin (copeptin-TRFIA) is helpful to measure stroke and evaluate its value in clinical applications. Double antibody sandwich was used to establish copeptin-TRFIA. The established method was then assessed. Two coated and Eu³⁺-labeled copeptin monoclonal specific antibodies targeting different antigen epitopes were employed. The serum fluorescence counts of patients with stroke and healthy volunteers were detected by using the well-established copeptin-TRFIA. Serum copeptin levels were measured and analyzed statistically. The actual measurement linearity range of the proposed method was 0.13-44.66 ng/mL. Copeptin-TRFIA had the inter-assay coefficient of variation (CV) of 6.49%-9.08% and the intra-assay CV of 4.75%-7.77%. Patients with cerebral infarction (CI) and intracerebral hemorrhage (ICH) had significantly higher serum copeptin levels than healthy subjects. Copeptin concentrations in the serum of patients with stroke were significantly correlated with the scores of the National Institute for Healthy Stroke Scale (NIHSS) and modified Rankin Scale (mRS). A highly sensitive copeptin-TRFIA was successfully established. Serum copeptin has a certain value in the clinical diagnosis and prognosis of stroke.

PMID:37782447 | DOI:10.1007/s10895-023-03441-7

Arch Orthop Trauma Surg. 2023 Oct 2. doi: 10.1007/s00402-023-05056-w. Online ahead of print.

ABSTRACT

INTRODUCTION: In this study, we evaluate how race corresponds to specific complications and costs following total knee arthroplasty (TKA). Our hypothesis was that minority patients, comprising Black, Asian, and Hispanic patients, would have higher complication and revision rates and costs than White patients.

METHODS: Data from 2014 to 2016 were collected from a large commercial insurance database. TKA patients were assigned under Current Procedural Terminology (CPT-27447) and International Statistical Classification of Diseases (ICD-9-P-8154) codes. Minority patients were compared to White patients before and after matching for age, gender, and tobacco use, diabetes, and obesity comorbidities. Standardized complications, revisions, and total costs at 30 days, 90 days, and 1 year were compared between the groups using unequal variance t tests.

RESULTS: Overall, 140,601 White (92%), 10,247 Black (6.7%), 1072 Asian (0.67%), and 1725 Hispanic (1.1%) TKA patients were included. At baseline, minority patients had 7-10% longer lengths of stay (p = 0.0001) and Black and Hispanic patients had higher Charlson and Elixhauser comorbidity indices (p = 0.0001), while Asian patients had a lower Elixhauser comorbidity index (p < 0.0001). Black patients had significantly higher complication rates and higher rates of revision (p = 0.03). Minority patients were charged 10-32% more (p < 0.0001). Following matching, all minority patients had lengths of stay 8-10% longer (p = 0.001) and Black patients had higher Charlson and Elixhauser comorbidity indices (p < 0.0001) while Asian patients had a lower Elixhauser comorbidity index (p = 0.0008). Black patients had more equal complication rates and there was no significant difference in revisions in any minority cohort. All minority cohorts had significantly higher total costs at all time points, ranging from 9 to 31% (p < 0.0001).

CONCLUSION: Compared to White patients, Black patients had significantly increased rates of complications, along with greater total costs, but not revisions. Asian and Hispanic patients, however, did not have significant differences in complications or revisions yet still had higher costs. As a result, this study corroborates our hypothesis that Black patients have higher rates of complications and costs than White patients following total knee arthroplasty and recommends efforts be taken to tackle health inequities to create more fairness in healthcare. This same hypothesis, however, was not supported when evaluating Asian and Hispanic patients, probably because of the few patients included in the database and deserves further investigation.

PMID:37782427 | DOI:10.1007/s00402-023-05056-w