Tag: statistics

PLoS One. 2023 Aug 29;18(8):e0290735. doi: 10.1371/journal.pone.0290735. eCollection 2023.

ABSTRACT

Enterobacter cloacae is a Gram-negative rod with multidrug-resistant potential due to chromosomally-induced AmpC β-lactamase. We evaluated characteristics, antibiotic utilization, and outcomes associated with battlefield-related E. cloacae infections (2009-2014). Single initial and serial E. cloacae isolates (≥24 hours from initial isolate from any site) associated with a clinical infection were examined. Susceptibility profiles of initial isolates in the serial isolation group were contrasted against last isolate recovered. Characteristics of 112 patients with E. cloacae infections (63 [56%] with single initial isolation; 49 [44%] with serial isolation) were compared to 509 patients with bacterial infections not attributed to E. cloacae. E. cloacae patients sustained more blast trauma (78%) compared to non-E. cloacae infections patients (75%; p<0.001); however, injury severity scores were comparable (median of 34.5 and 33, respectively; p = 0.334). Patients with E. cloacae infections had greater shock indices (median 1.07 vs 0.92; p = 0.005) and required more initial blood products (15 vs. 14 units; p = 0.032) compared to patients with non-E. cloacae infections. Although E. cloacae patients had less intensive care unit admissions (80% vs. 90% with non-E. cloacae infection patients; p = 0.007), they did have more operating room visits (5 vs. 4; p = 0.001), longer duration of antibiotic therapy (43.5 vs. 34 days; p<0.001), and lengthier hospitalizations (57 vs. 44 days; p<0.001). Patients with serial E. cloacae had isolation of infecting isolates sooner than patients with single initial E. cloacae (median of 5 vs. 8 days post-injury; p = 0.046); however, outcomes were not significantly different between the groups. Statistically significant resistance to individual antibiotics did not develop between initial and last isolates in the serial isolation group. Despite current combat care and surgical prophylaxis guidelines recommending upfront provision of AmpC-inducing antibiotics, clinical outcomes did not differ nor did significant antibiotic resistance develop in patients who experienced serial isolation of E. cloacae versus single initial isolation.

PMID:37643169 | DOI:10.1371/journal.pone.0290735

J Craniofac Surg. 2023 Aug 29. doi: 10.1097/SCS.0000000000009702. Online ahead of print.

ABSTRACT

INTRODUCTION: Dentofacial deformities impose a negative impact on quality of life (QOL). Orthognathic surgery is the main pillar of treatment for these conditions and has proven its impact on the improvement of the functional and psychosocial aspects of QOL. The Orthognathic Quality of Life Questionnaire (OQLQ), developed by Cunningham and colleagues, is a well-established instrument for assessing QOL in patients with dentofacial deformities.

OBJECTIVE: The aim of this study was to perform a translation, transcultural adaptation, and validation of a Hebrew version of the OQLQ.

METHODS: Transcultural adaptation was done following guidelines proposed by Beaton and colleagues resulting in a pilot study conducted on 20 patients undergoing orthognathic surgery. Internal consistency, reliability, and sensitivity were evaluated by means of Cronbach alpha, intraclass correlation coefficient (test-retest), and Wilcoxon test, respectively. Validity was assessed by comparing the OQLQ with the Hebrew version of the Oral Health Impact Scale-14 (Oral Health Impact Profile Scale-14) using the Spearman correlation test.

RESULTS: Internal consistency showed a good correlation between domains and excellent test-retest reliability. Sensitivity to change was statistically significant in all but 3 questions. The Hebrew version of the OQLQ exhibited a strong correlation with Oral Health Impact Profile Scale-14 in total score and moderate to high correlations among domains.

CONCLUSION: The Hebrew version of the OQLQ is a valid and reliable and specific instrument to measure QOL for Hebrew-speaking patients undergoing orthognathic surgery.

PMID:37643130 | DOI:10.1097/SCS.0000000000009702

Environ Sci Technol. 2023 Aug 29. doi: 10.1021/acs.est.3c02216. Online ahead of print.

ABSTRACT

To estimate the bioconcentration factor (BCF), the in vitro intrinsic clearance (CL_{IN VITRO,INT}) from rainbow trout liver S9 fractions (RT-S9) can be applied to in vitro-in vivo extrapolation (IVIVE) models, yet uncertainties remain in model parameterization. An alternative model approach is evaluated: a regression model was built in the form log BCF = a × log K_ow + b × log CL_{IN VITRO,INT}. The coefficients a and b were fitted based on a training set of 40 chemicals. A high robustness of the coefficients and good accuracy of BCF prediction were found on independent datasets of neutral organic chemicals (measured log K_ow 3.3-6.2). BCF predictions were similar to or in better agreement with in vivo BCFs compared to IVIVE models (2.4- to 2.9- vs 2.8- to 3.6-fold misprediction) for training and test sets. Species-matched models (trout, carp) did not result in improvements. This study presents the largest dataset on CL_{IN VITRO,INT} and BCFs to assess predictivity of the RT-S9 assay. The robustness of the regression statistics on different datasets and the high statistical weight of the CL_{IN VITRO,INT} term illustrate the predictive power of the RT-S9 assay as an important step toward regulatory acceptance to replace animal experiments.

PMID:37643004 | DOI:10.1021/acs.est.3c02216

JMIR Res Protoc. 2023 Aug 29;12:e48503. doi: 10.2196/48503.

ABSTRACT

BACKGROUND: Executive function, including prospective memory, initiating, planning, and sequencing everyday activities, is frequently affected by acquired brain injury (ABI). Executive dysfunction necessitates the use of compensatory cognitive strategies and, in more severe cases, human support over time. To compensate for the executive dysfunction experienced, growing options for electronic mainstream and assistive technologies may be used by people with ABI and their supporters.

OBJECTIVE: We outline the study protocol for a series of single-case experimental designs (SCEDs) to evaluate the effectiveness of smart home, mobile, and/or wearable technologies in reducing executive function difficulties following ABI.

METHODS: Up to 10 adults with ABI who experience executive dysfunction and have sufficient cognitive capacity to provide informed consent will be recruited across Victoria and New South Wales, Australia. Other key inclusion criteria are that they have substantial support needs for everyday living and reside in community dwellings. On the basis of the participant’s identified goal(s) and target behavior(s), a specific electronic assistive technology will be selected for application. Both identification of the target behavior(s) and selection of the assistive technology will be determined via consultation with each participant (and their key support person, if applicable). The choice of SCED will be individualized for each participant based on the type of technology used in the intervention, the difficulty level of the behavior targeted for change, and the anticipated rate of change. For each SCED, repeated measurements of the target behavior(s) during the baseline condition will provide performance data for comparison with the performance data collected during the intervention condition (with technology introduced). Secondary outcome measures will evaluate the impact of the intervention. The protocol includes 2 customizable Microsoft Excel spreadsheets for electronic record keeping.

RESULTS: Recruitment period is June 2022 through March 2024. Trial results for the individual participants will be graphed and analyzed separately using structured visual analysis supplemented with statistical analysis. Analysis will focus on important features of the data, including both within- and between-phase comparisons for response level, trend, variability, immediacy, consistency, and overlap. An exploratory economic evaluation will determine the impact on formal and informal support usage, together with quality of life, following the implementation of the new technological intervention.

CONCLUSIONS: The study has been designed to test the cause-effect functional relationships between the intervention-in this case, electronic assistive technology-and its effect in changing the target behavior(s). The evaluation evidence gained will offer new insights into the application of various electronic assistive technologies for people who experience executive dysfunction following ABI. Furthermore, the results will help increase the capacity of key stakeholders to harness the potential of technology to build independence and reduce the cost of care for this population.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622000835741, https://www.anzctr.org.au/ACTRN12622000835741.aspx.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48503.

PMID:37642985 | DOI:10.2196/48503

JMIR Public Health Surveill. 2023 Aug 29;9:e47579. doi: 10.2196/47579.

ABSTRACT

BACKGROUND: The incidence of oropharyngeal squamous cell carcinomas (OPSCC) has increased in recent decades, and human papillomavirus (HPV) infection is the main cause of OPSCC. The data regarding causes of death (CODs) are vitally important in informing follow-up strategies and revising treatment strategies to deal with any possible preventable treatment-related COD. However, limited studies have assessed the competing COD by HPV status in patients with OPSCC.

OBJECTIVE: We aimed to analyze the distribution of the competing COD according to HPV status in OPSCC.

METHODS: We retrospectively included stage I-IVB patients with OPSCC from the Surveillance, Epidemiology, and End Results database between 2010 and 2015. The association between HPV status and head and neck cancer-specific mortality (HNCSM), second primary cancer mortality (SPCM), and noncancer-caused mortality (NCCM) were analyzed. The chi-square test, Kaplan-Meier analysis, and Fine and Gray model were used for statistical analysis.

RESULTS: We included 5852 patients in this study and 73.2% (n=4283) of them had HPV-related tumors. A total of 1537 (26.3%) patients died, including 789 (51.3%), 333 (21.7%), and 415 (27%) patients who died from head and neck cancer, second cancer, and noncancer causes, respectively. The 5-year HNCSM, SPCM, NCCM, and overall mortality were 14.7%, 6.5%, 7.7%, and 26.4%, respectively. Those with HPV-positive disease had a lower cumulative incidence of HNCSM (subdistribution hazard ratio [sHR] 0.362, 95% CI 0.315-0.417; P<.001), SPCM (sHR 0.400, 95% CI 0.321-0.496; P<.001), and NCCM (sHR 0.460, 95% CI 0.378-0.560; P<.001) than those with HPV-negative disease. The 5-year risk of HNCSM was 26.9% and 10.7% in those with HPV-negative and HPV-positive disease, respectively (P<.001). The 5-year risk of SPCM was 12.4% and 4.6% in those with HPV-negative and HPV-positive disease, respectively (P<.001). The 5-year risk of NCCM of death was 13.7% and 5.8% in those with HPV-negative and HPV-positive disease, respectively (P<.001). Using the Fine and Gray competing-risks model, our results show that those with HPV-negative tumors had a significantly higher risk of HNCSM (P<.001), SPCM (P<.001), and NCCM (P<.001) than those with HPV-negative tumors.

CONCLUSIONS: HPV-positive OPSCC has a lower NCSM, SPCM, and NCCM as compared to those with HPV-negative OPSCC. HPV positivity is a favorable prognostic factor in the context of overcoming cancer as well as in terms of reducing the risk of other CODs in OPSCC. Our finding supports the need to tailor patient follow-up based on the HPV status of patients with OPSCC.

PMID:37642982 | DOI:10.2196/47579

JAMA Netw Open. 2023 Aug 1;6(8):e2328934. doi: 10.1001/jamanetworkopen.2023.28934.

ABSTRACT

IMPORTANCE: Medical and nonmedical cannabis use and cannabis use disorders (CUD) have increased with increasing cannabis legalization. However, the prevalence of CUD among primary care patients who use cannabis for medical or nonmedical reasons is unknown for patients in states with legal recreational use.

OBJECTIVE: To estimate the prevalence and severity of CUD among patients who report medical use only, nonmedical use only, and both reasons for cannabis use in a state with legal recreational use.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional survey study took place at an integrated health system in Washington State. Among 108 950 adult patients who completed routine cannabis screening from March 2019 to September 2019, 5000 were selected for a confidential cannabis survey using stratified random sampling for frequency of past-year cannabis use and race and ethnicity. Among 1688 respondents, 1463 reporting past 30-day cannabis use were included in the study.

EXPOSURE: Patient survey-reported reason for cannabis use in the past 30 days: medical use only, nonmedical use only, and both reasons.

MAIN OUTCOMES AND MEASURES: Patient responses to the Composite International Diagnostic Interview-Substance Abuse Module for CUD, corresponding to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition CUD severity (0-11 symptoms) were categorized as any CUD (≥2 symptoms) and moderate to severe CUD (≥4 symptoms). Adjusted analyses were weighted for survey stratification and nonresponse for primary care population estimates and compared prevalence of CUD across reasons for cannabis use.

RESULTS: Of 1463 included primary care patients (weighted mean [SD] age, 47.4 [16.8] years; 748 [weighted proportion, 61.9%] female) who used cannabis, 42.4% (95% CI, 31.2%-54.3%) reported medical use only, 25.1% (95% CI, 17.8%-34.2%) nonmedical use only, and 32.5% (95% CI, 25.3%-40.8%) both reasons for use. The prevalence of CUD was 21.3% (95% CI, 15.4%-28.6%) and did not vary across groups. The prevalence of moderate to severe CUD was 6.5% (95% CI, 5.0%-8.6%) and differed across groups: 1.3% (95% CI, 0.0%-2.8%) for medical use, 7.2% (95% CI, 3.9%-10.4%) for nonmedical use, and 7.5% (95% CI, 5.7%-9.4%) for both reasons for use (P = .01).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of primary care patients in a state with legal recreational cannabis use, CUD was common among patients who used cannabis. Moderate to severe CUD was more prevalent among patients who reported any nonmedical use. These results underscore the importance of assessing patient cannabis use and CUD symptoms in medical settings.

PMID:37642968 | DOI:10.1001/jamanetworkopen.2023.28934

JAMA Netw Open. 2023 Aug 1;6(8):e2330763. doi: 10.1001/jamanetworkopen.2023.30763.

ABSTRACT

IMPORTANCE: The impact of group-based prenatal care (GPNC) model in the US on the risk of gestational diabetes (GD) and related adverse obstetric outcomes is unknown.

OBJECTIVE: To determine the effects of the GPNC model on risk of GD, its progression, and related adverse obstetric outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This is a single-site, parallel-group, randomized clinical trial conducted between February 2016 and March 2020 at a large health care system in Greenville, South Carolina. Participants were individuals aged 14 to 45 years with pregnancies earlier than 21 weeks’ gestational age; follow-up continued to 8 weeks post partum. This study used an intention-to-treat analysis, and data were analyzed from March 2021 to July 2022.

INTERVENTIONS: Eligible participants were randomized to receive either CenteringPregnancy, a widely used GPNC model, with 10 group-based sessions or traditional individual prenatal care (IPNC).

MAIN OUTCOMES AND MEASURES: The primary outcome was the incidence of GD diagnosed between 24 and 30 weeks of gestation. The secondary outcomes included progression to A2 GD (ie, GD treated with medications) and GD-related adverse obstetric outcomes (ie, preeclampsia, cesarean delivery, and large for gestational age). Log binomial models were performed to estimate risk differences (RDs), 95% CIs, and P values between GPNC and IPNC groups, adjusting for all baseline covariates.

RESULTS: Of all 2348 participants (mean [SD] age, 25.1 [5.4] years; 952 Black participants [40.5%]; 502 Hispanic participants [21.4%]; 863 White participants [36.8%]), 1176 participants were randomized to the GPNC group and 1174 were randomized to the IPNC group. Among all participants, 2144 (91.3%) completed a GD screening (1072 participants [91.3%] in GPNC vs 1071 [91.2%] in IPNC). Overall, 157 participants (6.7%) developed GD, and there was no difference in GD incidence between the GPNC (83 participants [7.1%]) and IPNC (74 participants [6.3%]) groups, with an adjusted RD of 0.7% (95% CI, -1.2% to 2.7%). Among participants with GD, GPNC did not reduce the risk of progression to A2 GD (adjusted RD, -6.1%; 95% CI, -21.3% to 9.1%), preeclampsia (adjusted RD, -7.9%; 95% CI, -17.8% to 1.9%), cesarean delivery (adjusted RD, -8.2%; 95% CI, -12.2% to 13.9%), and large for gestational age (adjusted RD, -1.2%; 95% CI, -6.1% to 3.8%) compared with IPNC.

CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial among medically low-risk pregnant individuals, the risk of GD was similar between participants who received GPNC intervention and traditional IPNC, indicating that GPNC may be a feasible treatment option for some patients.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02640638.

PMID:37642966 | DOI:10.1001/jamanetworkopen.2023.30763

JAMA Netw Open. 2023 Aug 1;6(8):e2331168. doi: 10.1001/jamanetworkopen.2023.31168.

ABSTRACT

IMPORTANCE: Despite the large health burden, reliable data on sepsis epidemiology are lacking; studies using International Statistical Classification of Diseases and Related Health Problems (ICD)-coded hospital discharge diagnosis for sepsis identification suffer from limited sensitivity. Also, ICD data do not allow investigation of underlying pathogens and antimicrobial resistance.

OBJECTIVES: To generate reliable epidemiological estimates by linking data from a population-based database to a reference standard of clinical medical record review.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective, observational cohort study using a population-based administrative database including all acute care hospitals of the Scania region in Sweden in 2019 and 2020 to identify hospital-treated sepsis cases by ICD codes. From this database, clinical medical records were also selected for review within 6 strata defined by ICD discharge diagnosis (both with and without sepsis diagnosis). Data were analyzed from April to October 2022.

MAIN OUTCOMES AND MEASURES: Hospital and population incidences of sepsis, case fatality, antimicrobial resistance, and temporal dynamics due to COVID-19 were assessed, as well as validity of ICD-10 case identification methods compared with the reference standard of clinical medical record review.

RESULTS: Out of 295 531 hospitalizations in 2019 in the Scania region of Sweden, 997 patient medical records were reviewed, among which 457 had sepsis according to clinical criteria. Of the patients with clinical sepsis, 232 (51%) were female, and 357 (78%) had at least 1 comorbidity. The median (IQR) age of the cohort was 76 (67-85) years. The incidence of sepsis in hospitalized patients according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria in 2019 was 4.1% (95% CI, 3.6-4.5) by medical record review. This corresponds to an annual incidence rate of 747 (95% CI, 663-832) patients with sepsis per 100 000 population. No significant increase in sepsis during the COVID-19 pandemic nor a decrease in sepsis incidence when excluding COVID-19 sepsis was observed. Few sepsis cases caused by pathogens with antimicrobial resistance were found. The validity of ICD-10-based case identification in administrative data was low.

CONCLUSIONS AND RELEVANCE: In this cohort study of sepsis epidemiology, sepsis was a considerable burden to public health in Sweden. Supplying administrative data with information from clinical medical records can help to generate reliable data on sepsis epidemiology.

PMID:37642964 | DOI:10.1001/jamanetworkopen.2023.31168

JAMA Netw Open. 2023 Aug 1;6(8):e2331264. doi: 10.1001/jamanetworkopen.2023.31264.

ABSTRACT

IMPORTANCE: Synthetic opioids, such as the fentanyl analogue and nitazene drug class, are among the fastest growing types of opioids being detected in patients in the emergency department (ED) with illicit opioid overdose (OD). However, clinical outcomes from OD of novel potent opioids (NPOs), specifically nitazenes, are unknown aside from small case series.

OBJECTIVE: To determine naloxone administration and clinical sequelae of patients who were in the ED with NPO overdose compared with fentanyl OD.

DESIGN, SETTING, AND PARTICIPANTS: This is a cohort study subgroup analysis of adults admitted to the ED and tested positive for NPOs among in the ongoing nationwide ToxIC Fentalog cohort study from 2020 to 2022. Patients who were in the ED with a presumed acute opioid OD and residual blood samples were included, and those testing positive for NPOs were analyzed. Patients were included in this analysis if their confirmatory testing was positive for an NPO analyte, such as brorphine, isotonitazene, metonitazene, and/or N-piperidinyl etonitazene. A comparison group included patients that were positive for fentanyl and devoid of any other analytes on toxicologic analysis.

EXPOSURES: Patients were exposed to NPOs, including brorphine, isotonitazene, metonitazene and/or N-piperidinyl etonitazene.

MAIN OUTCOMES AND MEASURES: The primary outcome was the total number of naloxone doses and total cumulative naloxone dose administered as part of routine clinical care following the OD. Naloxone requirements and clinical sequelae of NPO-positive patients were compared with those testing positive for fentanyl only.

RESULTS: During the study period, 2298 patients were screened, of whom 717 met inclusion criteria, 537 had complete laboratory testing data, with 11 (2.0%) positive for only fentanyl and 9 (1.7%) positive for NPOs (brorphine, isotonitazene, metonitazene, or N-piperidinyl etonitazene). The age range of patients was aged 20 to 57 years (4 males [44.4%] and 5 females [55.6%]). The NPO group received a statistically significantly higher mean (SD) number of naloxone boluses in-hospital (1.33 [1.50]) compared with the fentanyl group (0.36 [0.92]) (P = .02), which corresponded to a moderately large effect size (Cohen d = 0.78). Metonitazene overdose was associated with cardiac arrest and more naloxone doses overall. Metonitazene cases had a mean (SD) number of 3.0 (0) naloxone doses, and 2 of 2 patients (100%) with metonitazene overdoses were administered cardiopulmonary resuscitation.

CONCLUSIONS AND RELEVANCE: In this cohort study of patients admitted to the ED with confirmed opioid overdose testing positive for NPOs, in-hospital naloxone dosing was high compared with patients who tested positive for fentanyl alone. Further study is warranted to confirm these preliminary associations.

PMID:37642962 | DOI:10.1001/jamanetworkopen.2023.31264

Environ Sci Pollut Res Int. 2023 Aug 29. doi: 10.1007/s11356-023-29367-y. Online ahead of print.

ABSTRACT

The benthic foraminiferal community is an excellent bio-indicator of pollution in coastal and marginal marine settings. Their abundance, diversity and its relationship with environmental parameters, viz. grain size, organic carbon (C_org) and trace metals concentration, from the surface sediment layer of the southwestern shelf of the Bay of Bengal, have been used to understand the marine pollution in this study. A total of 32 surface sediment samples were collected at various water depths.The samples were analysed for grain size distribution, organic matter (OM), foraminiferal and trace metals studies. Statistical analyses such as correlation matrix, PCA (Principal Component Analysis) and cluster analysis show that the foraminiferal species composition is significantly influenced by the organic carbon (C_org), Co, Pb, Zn, Cr, and Ni concentrations. The dominance of stress-tolerant species, viz. Ammonia beccarii, Ammonia tepida, Nonion faba, Bulimina marginata, Bolivina robusta, Elphidium craticulatum and Elphidium advenum, as well as less species diversity, demonstrates the elevated C_org and trace metal pollution in the marine environment.

PMID:37642911 | DOI:10.1007/s11356-023-29367-y