Category: Statistics

JAMA Netw Open. 2024 Jun 3;7(6):e2418120. doi: 10.1001/jamanetworkopen.2024.18120.

ABSTRACT

IMPORTANCE: Varenicline is the most effective sole pharmacotherapy for smoking cessation. If used in combination with nicotine replacement therapy (NRT), cessation rates may be further improved, but the efficacy and safety of the combination need to be evaluated.

OBJECTIVE: To examine whether hospitalized smokers treated with varenicline and NRT lozenges achieve higher prolonged smoking abstinence rates compared with those treated with varenicline alone.

DESIGN, SETTING, AND PARTICIPANTS: A double-blind, placebo-controlled randomized clinical trial was conducted in adult medical or surgical inpatients of 5 Australian public hospitals with a history of smoking 10 cigarettes or more per day, interested in quitting, and available for 12-month follow-up between May 1, 2019, and May 1, 2021 (final 12-month data collection in May 2022). Data analysis was performed from June 1 to August 30, 2023.

INTERVENTIONS: A 12-week varenicline regimen was initiated during hospitalization at standard doses in all participants. Participants were randomized to additionally use NRT (2 mg) or placebo lozenges if there was an urge to smoke. Behavioral support (Quitline) was offered to all participants.

MAIN OUTCOMES AND MEASURES: The primary outcome was biochemically verified sustained abstinence at 6 months. Secondary outcomes included self-reported prolonged abstinence, 7-day point prevalence abstinence (3, 6, and 12 months), and medicine-related adverse events.

RESULTS: A total of 320 participants (mean [SD] age, 52.5 [12.1] years; 183 [57.2%] male) were randomized. The conduct of biochemical verification was affected by COVID-19 restrictions; consequently, the biochemically verified abstinence in the intervention vs control arms (18 [11.4%] vs 16 [10.1%]; odds ratio [OR], 1.14; 95% CI, 0.56-2.33) did not support the combination therapy. The secondary outcomes in the intervention vs control arms of 7-day point prevalence abstinence at 6 months (54 [34.2%] vs 37 [23.4%]; OR, 1.71; 95% CI, 1.04-2.80), prolonged abstinence at 12 months (47 [29.9%] vs 30 [19.1%]; OR, 1.77; 95% CI, 1.05-3.00), and 7-day point prevalence abstinence at 12-months (48 [30.6%] vs 31 [19.7%]; OR, 1.79; 95% CI, 1.07-2.99) significantly improved with the combination therapy. The self-reported 6-month prolonged abstinence (61 [38.6%] vs 47 [29.7%]; OR, 1.49; 95% CI, 0.93-2.39) favored the combination therapy but was not statistically significant. Medicine-related adverse events were similar in the 2 groups (102 [74.5%] in the intervention group vs 86 [68.3%] in the control group).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of the combination of varenicline and NRT lozenges in hospitalized adult daily smokers, the combination treatment improved self-reported abstinence compared with varenicline alone, without compromising safety, but it did not improve biochemically validated abstinence.

TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12618001792213.

PMID:38935378 | DOI:10.1001/jamanetworkopen.2024.18120

JAMA Netw Open. 2024 Jun 3;7(6):e2418887. doi: 10.1001/jamanetworkopen.2024.18887.

ABSTRACT

IMPORTANCE: The US has the highest maternal mortality rate among developed countries. The Centers for Disease Control and Prevention deems nearly all of these deaths preventable, especially those attributable to mental health conditions. Coordination between US health care and social service systems could help further characterize circumstances and risks associated with perinatal suicide mortality.

OBJECTIVE: To examine contextual and individual precipitating circumstances and risks associated with perinatal suicide.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional observational study used a convergent mixed methods design to explore factors contributing to maternal suicides and deaths of undetermined intent (hereinafter, undetermined deaths) identified in National Violent Death Reporting System (NVDRS) data for January 1, 2003, to December 31, 2021. Analyses included decedents who were aged 10 to 50 years and pregnant or post partum at death (collectively, the perinatal group) and demographically matched female decedents who were not pregnant or recently pregnant (nonperinatal group) at death. Analyses were performed between December 2022 and December 2023.

EXPOSURES: Pregnancy status at death (perinatal or nonperinatal).

MAIN OUTCOMES AND MEASURES: The main outcomes included contributing circumstances associated with suicides and undetermined deaths cited in coroner, medical examiner, or law enforcement case narratives. The study examined quantitative differences between groups using a matched analysis and characterized key themes of salient suicide circumstances using qualitative content analysis.

RESULTS: This study included 1150 perinatal decedents identified in the NVDRS: 456 (39.6%) were pregnant at death, 203 (17.7%) were pregnant within 42 days of death, and 491 (42.7%) were pregnant within 43 to 365 days before death, yielding 694 postpartum decedents. The nonperinatal comparison group included 17 655 female decedents aged 10 to 50 years. The mean (SD) age was 29.1 (7.4) years for perinatal decedents and 35.8 (10.8) years for nonperinatal decedents. Compared with matched nonperinatal decedents, perinatal decedents had higher odds of the following identified contributing circumstances: intimate partner problems (IPPs) (odds ratio [OR], 1.45 [95% CI, 1.23-1.72]), recent argument (OR, 1.33 [95% CI, 1.09-1.61]), depressed mood (OR, 1.39 [95% CI, 1.19-1.63]), substance abuse or other abuse (OR, 1.21 [95% CI, 1.03-1.42]), physical health problems (OR, 1.37 [95% CI, 1.09-1.72]), and death of a family member or friend (OR, 1.47 [95% CI, 1.06-2.02]). The findings of the qualitative analysis emphasized the importance of mental health and identified 128 decedents (12.4%) with postpartum depression.

CONCLUSIONS AND RELEVANCE: This study provides insights into complex factors surrounding maternal suicide, and it highlights opportunities for further research to understand long-term consequences of perinatal mental health. These findings also underscore the need for targeted evidence-based interventions and effective policies targeting mental health, substance use, and IPPs to prevent maternal suicide and enhance maternal health outcomes.

PMID:38935375 | DOI:10.1001/jamanetworkopen.2024.18887

JAMA Netw Open. 2024 Jun 3;7(6):e2418923. doi: 10.1001/jamanetworkopen.2024.18923.

ABSTRACT

IMPORTANCE: Little is known about the degree to which suspected sepsis drives broad-spectrum antibiotic use in hospitals, what proportion of antibiotic courses are unnecessarily broad in retrospect, and whether these patterns are changing over time.

OBJECTIVE: To describe trends in empiric broad-spectrum antibiotic use for suspected community-onset sepsis.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used clinical data from adults admitted to 241 US hospitals in the PINC AI Healthcare Database. Eligible participants were aged 18 years or more and were admitted between 2017 and 2021 with suspected community-onset sepsis, defined by a blood culture draw, lactate measurement, and intravenous antibiotic administration on admission.

EXPOSURES: Empiric anti-methicillin-resistant Staphylococcus aureus (MRSA) and/or antipseudomonal β-lactam agent use.

MAIN OUTCOMES AND MEASURES: Annual rates of empiric anti-MRSA and/or antipseudomonal β-lactam agent use and the proportion that were likely unnecessary in retrospect based on the absence of β-lactam resistant gram-positive or ceftriaxone-resistant gram-negative pathogens from clinical cultures obtained through hospital day 4. Annual trends were calculated using mixed-effects logistic regression models, adjusting for patient and hospital characteristics.

RESULTS: Among 6 272 538 hospitalizations (median [IQR] age, 66 [53-78] years; 443 465 male [49.6%]; 106 095 Black [11.9%], 65 763 Hispanic [7.4%], 653 907 White [73.1%]), 894 724 (14.3%) had suspected community-onset sepsis, of whom 582 585 (65.1%) received either empiric anti-MRSA (379 987 [42.5%]) or antipseudomonal β-lactam therapy (513 811 [57.4%]); 311 213 (34.8%) received both. Patients with suspected community-onset sepsis accounted for 1 573 673 of 3 141 300 (50.1%) of total inpatient anti-MRSA antibiotic days and 2 569 518 of 5 211 745 (49.3%) of total antipseudomonal β-lactam days. Between 2017 and 2021, the proportion of patients with suspected sepsis administered anti-MRSA or antipseudomonal therapy increased from 63.0% (82 731 of 131 275 patients) to 66.7% (101 003 of 151 435 patients) (adjusted OR [aOR] per year, 1.03; 95% CI, 1.03-1.04). However, resistant organisms were isolated in only 65 434 cases (7.3%) (30 617 gram-positive [3.4%], 38 844 gram-negative [4.3%]) and the proportion of patients who had any resistant organism decreased from 9.6% to 7.3% (aOR per year, 0.87; 95% CI, 0.87-0.88). Most patients with suspected sepsis treated with empiric anti-MRSA and/or antipseudomonal therapy had no resistant organisms (527 356 of 582 585 patients [90.5%]); this proportion increased from 88.0% in 2017 to 91.6% in 2021 (aOR per year, 1.12; 95% CI, 1.11-1.13).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of adults admitted to 241 US hospitals, empiric broad-spectrum antibiotic use for suspected community-onset sepsis accounted for half of all anti-MRSA or antipseudomonal therapy; the use of these types of antibiotics increased between 2017 and 2021 despite resistant organisms being isolated in less than 10% of patients treated with broad-spectrum agents.

PMID:38935374 | DOI:10.1001/jamanetworkopen.2024.18923

JAMA Oncol. 2024 Jun 27. doi: 10.1001/jamaoncol.2024.1841. Online ahead of print.

ABSTRACT

IMPORTANCE: The optimal radiotherapy technique for unresectable locally advanced non-small cell lung cancer (NSCLC) is controversial, so evaluating long-term prospective outcomes of intensity-modulated radiotherapy (IMRT) is important.

OBJECTIVE: To compare long-term prospective outcomes of patients receiving IMRT and 3-dimensional conformal radiotherapy (3D-CRT) with concurrent carboplatin/paclitaxel for locally advanced NSCLC.

DESIGN, SETTING, AND PARTICIPANTS: A secondary analysis of a prospective phase 3 randomized clinical trial NRG Oncology-RTOG 0617 assessed 483 patients receiving chemoradiotherapy (3D-CRT vs IMRT) for locally advanced NSCLC based on stratification.

MAIN OUTCOMES AND MEASURES: Long-term outcomes were analyzed, including overall survival (OS), progression-free survival (PFS), time to local failure, development of second cancers, and severe grade 3 or higher adverse events (AEs) per Common Terminology Criteria for Adverse Events, version 3. The percentage of an organ volume (V) receiving a specified amount of radiation in units of Gy is reported as V(radiation dose).

RESULTS: Of 483 patients (median [IQR] age, 64 [57-70] years; 194 [40.2%] female), 228 (47.2%) received IMRT, and 255 (52.8%) received 3D-CRT (median [IQR] follow-up, 5.2 [4.8-6.0] years). IMRT was associated with a 2-fold reduction in grade 3 or higher pneumonitis AEs compared with 3D-CRT (8 [3.5%] vs 21 [8.2%]; P = .03). On univariate analysis, heart V20, V40, and V60 were associated with worse OS (hazard ratios, 1.06 [95% CI, 1.04-1.09]; 1.09 [95% CI, 1.05-1.13]; 1.16 [95% CI, 1.09-1.24], respectively; all P < .001). IMRT significantly reduced heart V40 compared to 3D-CRT (16.5% vs 20.5%; P < .001). Heart V40 (<20%) had better OS than V40 (≥20%) (median [IQR], 2.5 [2.1-3.1] years vs 1.7 [1.5-2.0] years; P < .001). On multivariable analysis, heart V40 (≥20%), was associated with worse OS (hazard ratio, 1.34 [95% CI, 1.06-1.70]; P = .01), whereas lung V5 and age had no association with OS. Patients receiving IMRT and 3D-CRT had similar rates of developing secondary cancers (15 [6.6%] vs 14 [5.5%]) with long-term follow-up.

CONCLUSIONS AND RELEVANCE: These findings support the standard use of IMRT for locally advanced NSCLC. IMRT should aim to minimize lung V20 and heart V20 to V60, rather than constraining low-dose radiation bath. Lung V5 and age were not associated with survival and should not be considered a contraindication for chemoradiotherapy.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00533949.

PMID:38935373 | DOI:10.1001/jamaoncol.2024.1841

J Occup Environ Med. 2024 Jun 27. doi: 10.1097/JOM.0000000000003171. Online ahead of print.

ABSTRACT

OBJECTIVES: To investigate the mediating role of the activation degree of arginine-proline metabolism in the association of coal dust and decreased lung function.

METHODS: CDE represented coal dust exposure, while the Hyp/Arg in BALF gauged arginine-proline metabolism activation. Pulmonary function indicators, including FVC%pred, FEV1/FVC%, and FEV1%pred, DLCO%pred, P(A-a) O2 and 6MWT, were assessed.

RESULTS: Findings revealed a significant association between elevated CDE and increased Hyp/Arg, increased P(A-a) O2, decreased 6MWT, DLCO%pred, and decreased FVC%pred. However, no statistically significant association was found between CDE and FEV1%pred or FEV1/FVC%. The mediating effect of Hyp/Arg was significant for CDE’s impact on P(A-a) O2 and DLCO%pred but not on 6MWT and FVC%pred.

CONCLUSIONS: These results highlight the role of Hyp/Arg in mediating the association between CDE and lung function parameters, shedding light on potential therapeutic avenues for mitigating coal dust-induced lung function impairment.

PMID:38935365 | DOI:10.1097/JOM.0000000000003171

Otol Neurotol. 2024 Jun 26. doi: 10.1097/MAO.0000000000004244. Online ahead of print.

ABSTRACT

OBJECTIVES: To describe the new semisynthetic total ossicular replacement prosthesis (New-SSTORP) and to evaluate the New-SSTORP ossiculoplasty results both with the presence and absence of the stapes superstructure.

STUDY DESIGN: Prospective study.

SETTING: Tertiary referral center.

METHODS: From April 2023 to May 2023, 18 New-SSTORP ossiculoplasties were performed by the first author. In all patients, the New-SSTORP was interposed between the footplate and the eardrum. The study group was divided into two groups (group A and group B). Group A included 13 patients with the absence of stapes superstructure. Group B included five patients with the presence of stapes superstructure. A successful reconstruction was defined as a postoperative air-bone gap ABG ≤20 dB. For all patients of groups A and B, the last audiometric control considered was performed in January 2024. The mean follow-up was 8½ months. The χ2 test was used to compare results. p < 0.05 was considered significant.

MAIN OUTCOME MEASURES: Mean postoperative ABG ≤20 dB.

RESULTS: At the end of follow-up, the overall success rate (ABG ≤20 dB) of New-SSTORP ossiculoplasty was obtained in 88.8% (n = 16 of 18) of cases. In group A, the success rate of New-SSTORP ossiculoplasty occurred in 84.6% (n = 11 of 13) of cases, and in group B, the success rate of New-SSTORP ossiculoplasty occurred in 100% (n = 5 of 5) of cases. There was no audiological statistically significant difference between groups A and B (Fisher value is 1; p < 0.05). In all cases, the time for positioning of New-SSTORP was about 5 minutes.

CONCLUSION: The New-SSTORP has a minimal technical challenge for building and placement. The New-SSTORP ossiculoplasty results are very good both with the presence and absence of SS.

PMID:38935354 | DOI:10.1097/MAO.0000000000004244

AIDS Patient Care STDS. 2024 Jun;38(6):252-258. doi: 10.1089/apc.2024.0060.

ABSTRACT

Adolescents and young adults (AYAs) living with HIV have high rates of co-sexually transmitted infections (STIs). During the coronavirus disease (COVID) pandemic, STI prevention strategies, including access to testing/treatment facilities, availability of health care workers, and condom availability, may have decreased. This study aimed to determine if differences in STI incidence for first infection and reinfection existed between the pre-COVID and COVID eras in a cohort of AYAs living with HIV in Atlanta, GA. Retrospective chart review was conducted for all patients between ages 13 and 24 at the Grady Ponce Clinic. Two eras were identified: a pre-COVID era (January 1, 2009-December31, 2019) and a COVID era (January 1, 2020-June 30, 2021). STIs recorded included gonorrhea, chlamydia, human papillomavirus, syphilis, trichomonas, herpes simplex virus, lymphogranuloma venereum, hepatitis C, bacterial vaginosis, and chancroid. First and recurrent incidence rates for any STIs were reported. Our sample included 766 sexually active AYAs with HIV. A total of 721 patients were included in the pre-COVID era and 583 (80.9%) had at least one STI. A total of 337 patients were included in the COVID era, and 158 had at least one STI (46.9%). The overall first STI incidence rate increased from 42.47 to 58.67 per 100 person-years (PY) and the recurrent STI incidence rate increased from 121.50 to 169.85 per 100 PY from the pre-COVID to the COVID era (p < 0.001). Our study demonstrated significantly higher incidence rates of first and recurrent STIs in AYAs living with HIV in the COVID era. We urge continuation of existing STI prevention programs to avoid secondary clinical and economic adverse effects of increased infections.

PMID:38935346 | DOI:10.1089/apc.2024.0060

Int Urol Nephrol. 2024 Jun 27. doi: 10.1007/s11255-024-04128-z. Online ahead of print.

ABSTRACT

PURPOSE: Following transurethral resection of the prostate (TURP), there is no clear recommendation for the catheter duration, and objective criteria are needed to determine appropriate time for trial off catheter. Current study is aimed to identify the high-risk patients for failed trial off catheter and the association with preoperative voiding efficiency with postoperative failed trial without catheter.

METHODOLOGY: This is cross-sectional single institutional study. All eligible patients who underwent TURP were followed preoperatively for symptoms and workup, including voiding efficiency based on ultrasound findings, intraoperatively for resection parameters, and postoperatively for a trial off a catheter. All the findings were documented, and the data were analyzed on SPSS(TM) 22. Demographic variables were calculated in the form of frequency and percentages. The association of voiding efficiency with failed trials off catheters was checked through Chi-square and binary logistic regression analysis.

RESULTS: 132 patients were included in the study. The mean voiding efficiency was 57.5%. Based on voiding efficiency cut off, of 50%, patients were divided into two groups. The association between voiding efficiency and failed trials off catheters was not found to be statistically significant, with a p value of 0.79. Only prevoid volume, postvoid volume, duration of symptoms, and upper tract damage were found to be statistically significant predictors of failed trial off catheter, with a p value of < 0.05.

PMID:38935322 | DOI:10.1007/s11255-024-04128-z

Int Ophthalmol. 2024 Jun 27;44(1):285. doi: 10.1007/s10792-024-03210-w.

ABSTRACT

BACKGROUND: To evaluate the agreement between the Goldman applanation tonometer (GAT), Tono-Pen, and noncontact tonometer (NCT) in the measurement of intraocular pressure (IOP) in pseudophakic children.

METHODS: The medical records of nonglaucomatous pseudophakic children between 2009 and 2019 were retrospectively analyzed. A total of 46 eyes of 23 patients operated for bilateral pediatric cataract were included in the study. The patients’ mean age was 13.4 ± 4.1 years. Central corneal thickness (CCT) and IOP values measured with the GAT, Tono-Pen, and NCT were recorded. Agreement between the tonometers was evaluated by intraclass correlation coefficients (ICC) and the Bland-Altman method.

RESULTS: The mean IOP of the 46 eyes included in the study was measured as 13.7 ± 2.3 mm Hg with the GAT, 16.0 ± 2.3 mm Hg with NCT, and 16.5 ± 2.3 mm Hg with the Tono-Pen (p < 0.001). There is no statistical difference between NCT and Tono-Pen measurements, while GAT measurements were significantly lower than those of the NCT and Tono-pen. ICC values showed fair agreement between NCT and Tono-Pen (ICC = 0.720), whereas there was poor agreement between GAT and NCT (ICC = 0.501) and Tono-pen (ICC = 0.314).

CONCLUSIONS: With all devices included in the study, thicker corneas were associated with higher IOP measurements. Although there was moderate agreement between the NCT and Tono-Pen, there was a statistically significant difference in the IOP values provided by the three devices. Our results suggest these devices should not be used interchangeably.

PMID:38935310 | DOI:10.1007/s10792-024-03210-w

Environ Sci Pollut Res Int. 2024 Jun 27. doi: 10.1007/s11356-024-34034-x. Online ahead of print.

ABSTRACT

In light of China’s objectives for carbon peak and carbon neutrality, there is an opportunity for fintech to leverage its technological advantages and enhance its integration with green finance (GF). This can bring about enhanced coverage and precision of financial services for green industries, facilitating the transformation towards a sustainable, greener, and low-carbon real economy. We investigate how fintech development influences the carbon emission reduction effects of GF utilizing a two-way fixed effects model with a panel dataset covering 30 provinces in China from 2011 to 2020. Our findings indicate that the negative impact of GF on carbon emissions (CE) is heightened in areas with high levels of fintech development. Furthermore, we notice regional disparities in how fintech development impacts the effectiveness of GF in reducing CE. Specifically, fintech has a statistically significant impact in the central and western regions, whereas its significance is absent in the eastern region. Lastly, our mechanism analysis reveals that fintech plays a vital role in enhancing GF’s capacity to mitigate CE, which is achieved through channels of promoting green technology innovation (GTI), alleviating corporate financing constraints (FC), and optimizing energy structure (ES). These findings provide compelling evidence for the positive effect of fintech on the environment and offer justification for promoting the development of fintech and GF.

PMID:38935283 | DOI:10.1007/s11356-024-34034-x