Category: Statistics

JAMA Otolaryngol Head Neck Surg. 2024 Feb 29. doi: 10.1001/jamaoto.2024.0042. Online ahead of print.

ABSTRACT

IMPORTANCE: Despite the aggressive progression of fulminant acute invasive fungal sinusitis (AIFS), data on prognostic factors have been disparate, hindering the development of a staging system. A composite staging system may improve prognostication for patient counseling and conduct of clinical research.

OBJECTIVE: To identify prognostically important factors in AIFS and to incorporate the factors into a comprehensive Functional Severity Staging System and Clinical Severity Staging System.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included adult patients diagnosed with pathology-proven AIFS from June 1, 1992, to December 31, 2022, at Washington University Medical Center and Barnes-Jewish Hospital, a tertiary care center in St Louis, Missouri. Data were analyzed from April to July 2023.

MAIN OUTCOME AND MEASURES: Sequential sequestration and conjunctive consolidation was used to develop a composite staging system to predict 6-month overall survival.

RESULTS: Of 71 patients with pathology-proven AIFS over the 30-year period, the median (range) age of the cohort was 56 (19-63) years, and there were 47 (66%) male patients. The median (range) follow-up time was 2 (0-251) months. There were 28 patients alive within 6 months, for a 39% survival rate. Symptoms, comorbidity burden, and presence and duration of severe neutropenia were associated with 6-month survival and were consolidated into a 3-category Clinical Severity Staging System with 6-month survival of 75% for stage A (n = 16), 41% for stage B (n = 27), and 18% for stage C (n = 28). The discriminative power of the composite staging system was moderate (C statistic, 0.63).

CONCLUSION AND RELEVANCE: This cohort study supports the clinical importance of symptomatology, comorbidity burden, and prolonged severe neutropenia at the time of AIFS presentation. The composite clinical staging system may be useful for clinicians when counseling patients with AIFS and conducting clinical research.

PMID:38421674 | DOI:10.1001/jamaoto.2024.0042

JAMA Oncol. 2024 Feb 29. doi: 10.1001/jamaoncol.2024.0002. Online ahead of print.

NO ABSTRACT

PMID:38421658 | DOI:10.1001/jamaoncol.2024.0002

JAMA Netw Open. 2024 Feb 5;7(2):e240275. doi: 10.1001/jamanetworkopen.2024.0275.

ABSTRACT

IMPORTANCE: Critically ill children presenting to emergency departments (EDs) in non-children’s hospitals are at high risk for experiencing medical errors, including medication errors. Video telemedicine consultations with pediatric specialists have the potential to reduce the risk of medication errors beyond the current standard of care, telephone consultations.

OBJECTIVE: To compare the rates of ED physician-related medication errors among critically ill children randomized to receive either video telemedicine or telephone consultations.

DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized, unbalanced crossover trial was conducted at 15 community EDs in northern California between September 2014 and March 2018. Analyses were conducted from May 2022 to January 2023. Participants included acutely ill children younger than 15 years presenting to a participating ED.

INTERVENTIONS: Participating EDs were randomized to use video telemedicine or telephone for consultations with pediatric critical care physicians according to 1 of 4 unbalanced (3 telemedicine to 1 telephone) crossover treatment assignment sequences.

MAIN OUTCOMES AND MEASURES: Pharmacists reviewed medical records to document physician-related medication errors using a previously validated instrument. Multilevel logistic regression analyses were performed to create models with the medication order as the unit of analysis and adjusting for age, the log-transformed Revised Pediatric Emergency Assessment Tool score, and hospital study period.

RESULTS: A total of 696 patient encounters were included in the trial (mean [SD] age, 4.2 [4.6] years; median [IQR] age, 2.1 [0.5-2.1] years; 304 female [43.7%]), with 537 patient encounters (77.2%) assigned to video telemedicine and 159 patient encounters (22.8%) assigned to telephone. At least 1 physician-related medication error occurred for 87 patients (12.5%), including 20 of 159 patients (12.6%) in the telephone cohort and 67 of 537 patients (12.5%) in the telemedicine cohort. Of the 2414 medication orders, errors occurred in 124 cases (5.1%), including 26 of 513 orders (5.1%) in the telephone cohort and 98 of 1901 orders (5.2%) in the telemedicine cohort. In the multivariable analysis, the adjusted odds ratio of experiencing a medication error among those assigned to telemedicine was 0.86 (95% CI, 0.49-1.52; P = .61).

CONCLUSIONS AND RELEVANCE: This cluster randomized crossover trial found no statistically significant differences in physician-related medication errors between critically ill children assigned to receive telephone consultations vs video telemedicine consultations.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02877810.

PMID:38421649 | DOI:10.1001/jamanetworkopen.2024.0275

JAMA Netw Open. 2024 Feb 5;7(2):e240447. doi: 10.1001/jamanetworkopen.2024.0447.

ABSTRACT

IMPORTANCE: Youth-onset type 2 diabetes (T2D) has a more aggressive phenotype than adult-onset T2D, including rapid loss of glycemic control and increased complication risk.

OBJECTIVE: To identify associations of growth hormone mediators with glycemic failure, beta cell function, and insulin sensitivity in youth-onset T2D.

DESIGN, SETTING, AND PARTICIPANTS: This post hoc secondary analysis of the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) randomized clinical trial, which enrolled participants from July 2004 to February 2009, included 398 participants from 15 university-affiliated medical centers with available plasma samples from baseline and 36 months. Participants were youths aged 10 to 17 years with a duration of T2D of less than 2 years who were randomized to metformin, metformin plus lifestyle intervention, or metformin plus rosiglitazone. Participants were followed up for a mean (SD) of 3.9 (1.5) years during the trial, ending in 2011. Statistical analysis was performed from August 2022 to November 2023.

EXPOSURE: Plasma insulin-like growth factor-1 (IGF-1), growth hormone receptor (GHR), and insulin-like growth factor binding protein 1 (IGFBP-1).

MAIN OUTCOMES AND MEASURES: Main outcomes were (1) loss of glycemic control during the TODAY study, defined as hemoglobin A1c (HbA1c) level of 8% or more for 6 months or inability to wean from insulin therapy, and (2) baseline and 36-month measures of glycemia (fasting glucose, HbA1c), insulin sensitivity (1/fasting C-peptide), high-molecular-weight adiponectin, and beta cell function (C-peptide index, C-peptide oral disposition index).

RESULTS: This analysis included 398 participants (mean [SD] age, 13.9 [2.0] years; 248 girls [62%]; 166 Hispanic participants [42%]; 134 non-Hispanic Black participants [34%], and 84 non-Hispanic White participants [21%]). A greater increase in IGF-1 level between baseline and 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995 [95% CI, 0.991-0.997]; P < .001) and higher C-peptide index per 100-ng/mL increase in IGF-1 (β [SE], 0.015 [0.003]; P < .001). A greater increase in log2 GHR level between baseline and 36 months was associated with higher odds of glycemic failure (OR, 1.75 [95% CI, 1.05-2.99]; P = .04) and lower C-peptide index (β [SE], -0.02 [0.006]; P < .001). A greater increase in log2 IGFBP-1 level between baseline and 36 months was associated with higher odds of glycemic failure (OR, 1.37 [95% CI, 1.09-1.74]; P = .007) and higher high-molecular-weight adiponectin (β [SE], 431 [156]; P = .007).

CONCLUSIONS AND RELEVANCE: This study suggests that changes in plasma growth hormone mediators are associated with loss of glycemic control in youth-onset T2D, with IGF-1 associated with lower risk and GHR and IGFBP-1 associated with increased risk.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00081328.

PMID:38421647 | DOI:10.1001/jamanetworkopen.2024.0447

JAMA Netw Open. 2024 Feb 5;7(2):e240649. doi: 10.1001/jamanetworkopen.2024.0649.

ABSTRACT

IMPORTANCE: Systematic reviews of medical imaging diagnostic test accuracy (DTA) studies are affected by between-study heterogeneity due to a range of factors. Failure to appropriately assess the extent and causes of heterogeneity compromises the interpretability of systematic review findings.

OBJECTIVE: To assess how heterogeneity has been examined in medical imaging DTA studies.

EVIDENCE REVIEW: The PubMed database was searched for systematic reviews of medical imaging DTA studies that performed a meta-analysis. The search was limited to the 40 journals with highest impact factor in the radiology, nuclear medicine, and medical imaging category in the InCites Journal Citation Reports of 2021 to reach a sample size of 200 to 300 included studies. Descriptive analysis was performed to characterize the imaging modality, target condition, type of meta-analysis model used, strategies for evaluating heterogeneity, and sources of heterogeneity identified. Multivariable logistic regression was performed to assess whether any factors were associated with at least 1 source of heterogeneity being identified in the included meta-analyses. Methodological quality evaluation was not performed. Data analysis occurred from October to December 2022.

FINDINGS: A total of 242 meta-analyses involving a median (range) of 987 (119-441 510) patients across a diverse range of disease categories and imaging modalities were included. The extent of heterogeneity was adequately described (ie, whether it was absent, low, moderate, or high) in 220 studies (91%) and was most commonly assessed using the I2 statistic (185 studies [76%]) and forest plots (181 studies [75%]). Heterogeneity was rated as moderate to high in 191 studies (79%). Of all included meta-analyses, 122 (50%) performed subgroup analysis and 87 (36%) performed meta-regression. Of the 242 studies assessed, 189 (78%) included 10 or more primary studies. Of these 189 studies, 60 (32%) did not perform meta-regression or subgroup analysis. Reasons for being unable to investigate sources of heterogeneity included inadequate reporting of primary study characteristics and a low number of included primary studies. Use of meta-regression was associated with identification of at least 1 source of variability (odds ratio, 1.90; 95% CI, 1.11-3.23; P = .02).

CONCLUSIONS AND RELEVANCE: In this systematic review of assessment of heterogeneity in medical imaging DTA meta-analyses, most meta-analyses were impacted by a moderate to high level of heterogeneity, presenting interpretive challenges. These findings suggest that, despite the development and availability of more rigorous statistical models, heterogeneity appeared to be incomplete, inconsistently evaluated, or methodologically questionable in many cases, which lessened the interpretability of the analyses performed; comprehensive heterogeneity assessment should be addressed at the author level by improving personal familiarity with appropriate statistical methodology for assessing heterogeneity and involving biostatisticians and epidemiologists in study design, as well as at the editorial level, by mandating adherence to methodologic standards in primary DTA studies and DTA meta-analyses.

PMID:38421646 | DOI:10.1001/jamanetworkopen.2024.0649

J Water Health. 2024 Feb;22(2):414-435. doi: 10.2166/wh.2024.324.

ABSTRACT

Access to safe drinking water, sanitation, and hygiene in Chad’s cities, especially N’Djamena, is a persistent and significant challenge. This study aimed to assess current practices in water, sanitation, and hygiene in N’Djamena’s third and ninth districts. We surveyed 395 households, conducted water source identification, and analyzed seven water samples at the National Water Laboratory. Temperature, ammonium, total coliforms, and aerobic flora values exceeded World Health Organization (WHO) guidelines. Ammonium and temperature averaged 0.7 mg/L and 30.1-31.93 °C, respectively. Bacterial contamination (>100 MPN/100 mL) exceeded the WHO’s 0 MPN/100 mL guidelines, rendering the water unfit for consumption. Survey results indicate that 78.7% use hand pumps, 21.1% have tap water access, and 0.2% rely on rivers for water. Regarding toilets, 92.8% have traditional models, 2.9% have modern facilities, and 4.3% practice open defecation. 95% dispose of untreated wastewater into nature, with only 5% using septic tanks. For solid waste, 72% use illegal dumpsites, 18% rely on public services, and 10% burn waste. Finally, 95.5% of households wash their hands with clean water and soap after using the toilet. It is crucial to treat drinking water and implement proper hygiene and sanitation measures to safeguard the population’s health in the studied area.

PMID:38421634 | DOI:10.2166/wh.2024.324

J Water Health. 2024 Feb;22(2):350-366. doi: 10.2166/wh.2024.291.

ABSTRACT

The present study explores the suitability of groundwater for drinking purpose and evaluates non-carcinogenic health risks for children, women, and men. For this purpose, 47 groundwater samples were collected and analyzed for physicochemical parameters, including nitrate concentration. The results revealed that nitrate concentration varied from 15 to 85 mg/L and that 48.93% of the groundwater samples exceeded the Bureau of Indian Standards’ limits of 45 mg/L. The spatial map of the pollution index of groundwater specifies that most of the study area lies in moderate to high pollution zones. Principal component analysis was also applied, and five principal components achieving eigenvalues more than 1 with a cumulative variance of 77.36% were found to be sufficient. The findings of non-carcinogenic risk rates range from 0.628 to 3.559 (average of 2.069) for children, 0.427 to 2.421 (average of 1.408) for women, and 0.362 to 2.049 (average of 1.191) for men, and approximately 80% of the population in the study region is exposed to high health risks. The health risk assessment specified that children in the study area are more susceptible than women and men. The findings of this study suggest that groundwater quality in the region has deteriorated, emphasizing the need for treatment before drinking.

PMID:38421629 | DOI:10.2166/wh.2024.291

Eur J Prev Cardiol. 2024 Feb 29:zwae088. doi: 10.1093/eurjpc/zwae088. Online ahead of print.

ABSTRACT

AIMS: Since lifetime accumulation of cardiovascular risk factors is getting important, early identification and management of risk factors are emphasised. The global prevalence of metabolic syndrome (MetS), a constellation of these risk factors, is increasing, particularly among young adults. We aimed to investigate the association between cumulative exposure to metabolic risk and cardiovascular disease (CVD) in young adults.

METHODS: In this nationwide population-based cohort, we analysed 3,688,787 young adults (<40 years) with two biennial National Health Screening examinations from 2009 to 2012. Participants were categorised into MetS-free, MetS-developed, MetS-recovered, or MetS-persistent group, based on MetS presence at each examination. The endpoint was new CVD development, including myocardial infarction (MI), and ischaemic stroke.

RESULTS: During follow-up (median, 7.7 years), CVD occurred in 19,219 individuals (0.5%). CVD incidence rates were 0.58, 1.17, 1.20, and 1.83 (1,000 person-year) in the MetS-free, MetS-developed, MetS-recovered, and MetS-persistent groups, respectively. CVD risk was proportionally associated with cumulative metabolic risk exposure, with a maximum 2-fold increase in the MetS-persistent group (aHR 1.94, 95% CI 1.84-2.04), and followed by the MetS-recovered and MetS-developed groups with similar risks. Among the MetS components, persistent exposure to elevated blood pressure (BP) had the greatest association with CVD risk (aHR 1.69, 95% CI 1.63-1.76). This tendency was consistent in the analyses of the risk of MI and ischaemic stroke.

CONCLUSIONS: CVD risk increased in an exposure-dependent manner among young adults. Efforts to optimise cardiometabolic profile, particularly BP, even after the establishment of MetS, might help promote long-term cardiovascular prognosis.

PMID:38421612 | DOI:10.1093/eurjpc/zwae088

Probiotics Antimicrob Proteins. 2024 Feb 29. doi: 10.1007/s12602-024-10216-4. Online ahead of print.

ABSTRACT

Functionalizing foods involve discovering and integrating new candidate health-promoting bacteria into the food matrix. This study aimed (i) to reveal the probiotic potential of autochthonous Lacticaseibacillus paracasei AD22 by a series of in vitro tests and molecular characterization and (ii) to evaluate its application to the matrix of brined white cheese, which is the most common cheese in Türkiye, in terms of survival and stress response. To evaluate in vitro probiotic characteristics, L. paracasei AD22 was exposed to functional, technological, and safety tests. Pilot scale production was conducted to integrate L. paracasei AD22 into the brined white cheese matrix. The expression levels of stress-related genes (dnaK, groES, ftsH, argH, and hsp20) were detected by reverse-transcriptase polymerase chain reaction to determine the transcriptional stress response during ripening. The presence of genes encoding stress-related proteins was determined by whole-genome sequence analysis using a subsystem approach; the presence of antibiotic resistance and virulence genes was determined by ResFinder4.1 and VirulenceFinder 2.0 databases. The BAGEL4 database determined the presence of bacteriocin clusters. L. paracasei AD22 was found to survive in pH 2 and medium with 12% NaCl and did not cause hemolysis. Adhesion of the strain to Caco2 cells was 76.26 ± 4.81% and it had coaggregation/autoaggregation properties. It was determined that L. paracasei AD22 exceeded 7 log cfu/g in the cheese matrix at the end of the ripening period. Total mesophilic aerobes decreased in the cheese inoculated with L. paracasei AD22 after the 45th day of ripening. While hsp20 and groES genes were downregulated during ripening, argH was upregulated. Both downregulation and upregulation were observed in dnaK and ftsH. Fold changes indicating the expression levels of dnaK, groES, ftsH, argH, and hsp20 genes were not statistically significant during ripening (p > 0.05). Whole-genome sequence profiles revealed that the strain did not contain antibiotic and virulence genes but bacteriocin clusters encoding Enterolysin A (Class III bacteriocin), Carnosine CP52 (class II bacteriocin), Enterocin X beta chain (Class IIc bacteriocin), and the LanT region. Subsystems approach manifested that the most functional part of the genomic distribution belonged to metabolism, protein processing, and stress response functions. The study findings highlight that L. paracasei AD22 will provide biotechnological innovation as a probiotic adjunct because it contains tolerance factors and probiotic characteristics to produce new functional foods.

PMID:38421575 | DOI:10.1007/s12602-024-10216-4

Clin Transl Oncol. 2024 Feb 29. doi: 10.1007/s12094-024-03393-9. Online ahead of print.

ABSTRACT

PURPOSE: To describe the incidences of hypogonadism, hypertension, and dyslipidaemia in patients with stage 1 seminoma (S1S) testicular cancer (TC) treated with a risk-adapted strategy.

METHODS: A retrospective analysis from 2000 to 2020 was conducted. Active surveillance (AS), carboplatin one cycle, and carboplatin two cycles were offered according to risk factors. Cumulative incidences and relapse-free survival (RFS) were estimated.

RESULTS: Of the 145 patients, 8 (5.4%) were excluded due to bilateral TC or hypogonadism at diagnosis. Median follow-up time was 8.2 years. Eighty-four, 30, and 33 patients were treated with AS, carboplatin one cycle, and carboplatin two cycles, respectively. In the overall population, the 5-year and 10-year cumulative incidences were 1.6% and 5.3% for hypogonadism; 2.0% and 8.6% for hypertension; and 12.4% and 25.1% for dyslipidaemia. No statistically significant differences were found in the incidences among the three adjuvant strategies. Five-year and 10-year RFS were 85.9% and 83.3% for AS; 92.4% and 84.0% for carboplatin one cycle; and 96.7% at both times for carboplatin two cycles.

CONCLUSION: There were no statistically differences in cumulative incidences of hypogonadism, hypertension, and dyslipidaemia in S1S patients treated with a risk-adapted strategy.

PMID:38421563 | DOI:10.1007/s12094-024-03393-9