Category: Statistics

JPEN J Parenter Enteral Nutr. 2024 Jul;48(5):562-570. doi: 10.1002/jpen.2647.

ABSTRACT

BACKGROUND: Patients with inflammatory bowel disease (IBD) are at increased risk of thrombosis. They often need parenteral nutrition (PN) requiring intravenous access for prolonged periods. We assessed the risk of deep vein thrombosis (DVT) associated with peripherally inserted central catheters (PICCs) and tunneled catheters for patients with IBD receiving home PN (HPN).

METHODS: Using the Cleveland Clinic HPN Registry, we retrospectively studied a cohort of adults with IBD who received HPN between June 30, 2019 and January 1, 2023. We collected demographics, catheter type, and catheter-associated DVT (CADVT) data. We performed descriptive statistics and Poisson tests to compare CADVT rates among parameters of interest. We generated Kaplan-Meier graphs to illustrate longevity of CADVT-free survival and a Cox proportional hazard model to calculate the hazard ratio associated with CADVT.

RESULTS: We collected data on 407 patients, of which, 276 (68%) received tunneled catheters and 131 (32%) received PICCs as their initial catheter. There were 17 CADVTs with an overall rate of 0.08 per 1000 catheter days, whereas individual rates of DVT for PICCs and tunneled catheters were 0.16 and 0.05 per 1000 catheter days, respectively (P = 0.03). After adjusting for age, sex, and comorbidity, CADVT risk was significantly higher for PICCs compared with tunneled catheters, with an adjusted hazard ratio of 2.962 (95% CI=1.140-7.698; P = 0.025) and adjusted incidence rate ratio of 3.66 (95% CI=2.637-4.696; P = 0.013).

CONCLUSION: Our study shows that CADVT risk is nearly three times higher with PICCs compared with tunneled catheters. We recommend tunneled catheter placement for patients with IBD who require HPN infusion greater than 30 days.

PMID:38949827 | DOI:10.1002/jpen.2647

JAMA Netw Open. 2024 Jul 1;7(7):e2424099. doi: 10.1001/jamanetworkopen.2024.24099.

NO ABSTRACT

PMID:38949815 | DOI:10.1001/jamanetworkopen.2024.24099

JAMA Netw Open. 2024 Jul 1;7(7):e2419258. doi: 10.1001/jamanetworkopen.2024.19258.

ABSTRACT

IMPORTANCE: In the context of emerging SARS-CoV-2 variants or lineages and new vaccines, it is key to accurately monitor COVID-19 vaccine effectiveness (CVE) to inform vaccination campaigns.

OBJECTIVE: To estimate the effectiveness of COVID-19 vaccines administered in autumn and winter 2022 to 2023 against symptomatic SARS-CoV-2 infection (with all circulating viruses and XBB lineage in particular) among people aged 60 years or older in Europe, and to compare different CVE approaches across the exposed and reference groups used.

DESIGN, SETTING, AND PARTICIPANTS: This case-control study obtained data from VEBIS (Vaccine Effectiveness, Burden and Impact Studies), a multicenter study that collects COVID-19 and influenza data from 11 European sites: Croatia; France; Germany; Hungary; Ireland; Portugal; the Netherlands; Romania; Spain, national; Spain, Navarre region; and Sweden. Participants were primary care patients aged 60 years or older with acute respiratory infection symptoms who were recruited at the 11 sites after the start of the COVID-19 vaccination campaign from September 2022 to August 2023. Cases and controls were defined as patients with positive and negative, respectively, reverse transcription-polymerase chain reaction (RT-PCR) test results.

EXPOSURES: The exposure was COVID-19 vaccination. The exposure group consisted of patients who received a COVID-19 vaccine during the autumn and winter 2022 to 2023 vaccination campaign and 14 days or more before symptom onset. Reference group included patients who were not vaccinated during or in the 6 months before the 2022 to 2023 campaign (seasonal CVE), those who were never vaccinated (absolute CVE), and those who were vaccinated with at least the primary series 6 months or more before the campaign (relative CVE). For relative CVE of second boosters, patients receiving their second booster during the campaign were compared with those receiving 1 booster 6 months or more before the campaign.

MAIN OUTCOMES AND MEASURES: The outcome was RT-PCR-confirmed, medically attended, symptomatic SARS-CoV-2 infection. Four CVE estimates were generated: seasonal, absolute, relative, and relative of second boosters. CVE was estimated using logistic regression, adjusting for study site, symptom onset date, age, chronic condition, and sex.

RESULTS: A total of 9308 primary care patients were included, with 1687 cases (1035 females; median [IQR] age, 71 [65-79] years) and 7621 controls (4619 females [61%]; median [IQR] age, 71 [65-78] years). Within 14 to 89 days after vaccination, seasonal CVE was 29% (95% CI, 14%-42%), absolute CVE was 39% (95% CI, 6%-60%), relative CVE was 31% (95% CI, 15% to 44%), and relative CVE of second boosters was 34% (95% CI, 18%-47%) against all SARS-CoV-2 variants. In the same interval, seasonal CVE was 44% (95% CI, -10% to 75%), absolute CVE was 52% (95% CI, -23% to 82%), relative CVE was 47% (95% CI, -8% to 77%), and relative CVE of second boosters was 46% (95% CI, -13% to 77%) during a period of high XBB circulation. Estimates decreased with time since vaccination, with no protection from 180 days after vaccination.

CONCLUSIONS AND RELEVANCE: In this case-control study among older Europeans, all CVE approaches suggested that COVID-19 vaccines administered in autumn and winter 2022 to 2023 offered at least 3 months of protection against symptomatic, medically attended, laboratory-confirmed SARS-CoV-2 infection. The effectiveness of new COVID-19 vaccines against emerging SARS-CoV-2 variants should be continually monitored using CVE seasonal approaches.

PMID:38949812 | DOI:10.1001/jamanetworkopen.2024.19258

JAMA Netw Open. 2024 Jul 1;7(7):e2419373. doi: 10.1001/jamanetworkopen.2024.19373.

ABSTRACT

IMPORTANCE: Discrimination, bullying, and harassment in medicine have been reported internationally, but exposures for Indigenous medical students and physicians, and for racism specifically, remain less examined.

OBJECTIVE: To examine the prevalence of racism, discrimination, bullying, and harassment for Māori medical students and physicians in New Zealand and associations with demographic and clinical characteristics.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used data from an anonymous national survey of Māori medical students and physicians in New Zealand in late 2021 and early 2022. Data were analyzed from March 2022 to April 2024.

EXPOSURES: Age, gender, marginalized status (ie, in addition to being Māori, belonging to other groups traditionally marginalized or underrepresented in medicine), year of medical school, year of graduation, and main work role.

MAIN OUTCOMES AND MEASURES: Direct and witnessed racism, discrimination, bullying, and harassment were measured as any experience in the last year and ever. Any exposure to negative comments about social groups and witnessing discriminatory treatment toward Māori patients or whānau (extended family). Considering leaving medicine, including because of mistreatment, was measured.

RESULTS: Overall, 205 Māori medical students (median [IQR] age, 23.1 [21.6-24.3] years; 137 [67.2%] women) and 200 physicians (median [IQR] age, 36.6 [30.1-45.3] years; 123 [62.8%] women) responded. Direct and witnessed exposure to racism (184 students [91.5%]; 176 physicians [90.7%]) and discrimination (176 students [85.9%]; 179 physicians [89.5%]) ever in medical education, training, or work environments was common. Ever exposure to witnessed and direct bullying (123 students [66.5%]; 150 physicians [89.3%]) and harassment (73 students [39.5%]; 112 physicians [66.7%]) was also common. Most respondents reported witnessing Māori patients or their whānau being treated badly in clinical settings, in direct interactions (67 students [57.8%]; 112 physicians [58.9%]) or behind their backs (87 students [75.0%]; 138 physicians [72.6%]). One-quarter of Māori medical students (45 students), and 37.0% of physicians (61 physicians) had considered leaving or taken a break from medicine because of these experiences. Additional marginalized statuses were significantly associated with any direct experience of mistreatment in the last year for students and physicians. Exposure to some forms of mistreatment were also significantly associated with higher likelihood of thinking about leaving or taking a break from medicine for physicians.

CONCLUSIONS AND RELEVANCE: In this study, Māori medical students and physicians reported high exposure to multiple forms of racism, discrimination, bullying, and harassment in medical education, training, and work environments, requiring an urgent response from medical institutions.

PMID:38949810 | DOI:10.1001/jamanetworkopen.2024.19373

JAMA Netw Open. 2024 Jul 1;7(7):e2419624. doi: 10.1001/jamanetworkopen.2024.19624.

ABSTRACT

IMPORTANCE: Addressing poor uptake of low-dose computed tomography lung cancer screening (LCS) is critical, especially for those having the most to gain-high-benefit persons with high lung cancer risk and life expectancy more than 10 years.

OBJECTIVE: To assess the association between LCS uptake and implementing a prediction-augmented shared decision-making (SDM) tool, which enables clinicians to identify persons predicted to be at high benefit and encourage LCS more strongly for these persons.

DESIGN, SETTING, AND PARTICIPANTS: Quality improvement interrupted time series study at 6 Veterans Affairs sites that used a standard set of clinical reminders to prompt primary care clinicians and screening coordinators to engage in SDM for LCS-eligible persons. Participants were persons without a history of LCS who met LCS eligibility criteria at the time (aged 55-80 years, smoked ≥30 pack-years, and current smoking or quit <15 years ago) and were not documented to be an inappropriate candidate for LCS by a clinician during October 2017 through September 2019. Data were analyzed from September to November 2023.

EXPOSURE: Decision support tool augmented by a prediction model that helps clinicians personalize SDM for LCS, tailoring the strength of screening encouragement according to predicted benefit.

MAIN OUTCOME AND MEASURE: LCS uptake.

RESULTS: In a cohort of 9904 individuals, the median (IQR) age was 64 (57-69) years; 9277 (94%) were male, 1537 (16%) were Black, 8159 (82%) were White, 5153 (52%) were predicted to be at intermediate (preference-sensitive) benefit and 4751 (48%) at high benefit, and 1084 (11%) received screening during the study period. Following implementation of the tool, higher rates of LCS uptake were observed overall along with an increase in benefit-based LCS uptake (higher screening uptake among persons anticipated to be at high benefit compared with those at intermediate benefit; primary analysis). Mean (SD) predicted probability of getting screened for a high-benefit person was 24.8% (15.5%) vs 15.8% (11.8%) for a person at intermediate benefit (mean absolute difference 9.0 percentage points; 95% CI, 1.6%-16.5%).

CONCLUSIONS AND RELEVANCE: Implementing a robust approach to personalized LCS, which integrates SDM, and a decision support tool augmented by a prediction model, are associated with improved uptake of LCS and may be particularly important for those most likely to benefit. These findings are timely given the ongoing poor rates of LCS uptake.

PMID:38949809 | DOI:10.1001/jamanetworkopen.2024.19624

Dig Dis Sci. 2024 Jun 29. doi: 10.1007/s10620-024-08518-2. Online ahead of print.

ABSTRACT

BACKGROUND: There are scanty population-based studies investigating the incidence and prevalence rates of inflammatory bowel disease (IBD) in Taiwan.

AIMS: This study aimed to estimate the nationwide prevalence and incidence of IBD and identify its noticeable trends in Taiwan between 2016 and 2020.

METHODS: A retrospective study by analyzing the data from the National Health Insurance Research Database of Taiwan.

RESULTS: A total of 2595 patients with catastrophic IBD illness were registered from 2016 to 2020 in Taiwan (CD, 880; UC, 1715). The male-to-female ratio in the study sample was 1.83:1 for CD and 1.69:1 for UC. The median age of those registered with CD and UC was 37 and 47 years, respectively. The incidence rate of CD was 0.65 per 100,000 persons in 2016 and it was increased to 0.81 per 100,000 persons in 2020. The incidence rate of UC was 1.16 per 100,000 persons in 2016 and it was increased to 1.53 in 2020. Overall, the incidence of IBD was increase from 1.81 per 100,000 persons to 2.34 per 100,000 persons between 2016 and 2020. Overall, the prevalence rates of IBD was increase from 14.95 per 100,000 persons to 20.02 per 100,000 persons between 2016 and 2020.

CONCLUSION: The epidemiological stages of IBD in Taiwan was considered in the acceleration in incidence stage, during which incidence rises and prevalence is relatively low. Understanding these geographical differences is important for the rising global burden of IBD.

PMID:38949750 | DOI:10.1007/s10620-024-08518-2

Pharmacoecon Open. 2024 Jul 1. doi: 10.1007/s41669-024-00501-x. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Understanding the socioeconomic burden of multiple sclerosis (MS) is essential to inform policymakers and payers. Real-world studies have associated increasing costs and worsening quality of life (QoL) with disability progression. This study aims to further evaluate the impact of cognition, fatigue, upper and lower limb function (ULF, LLF) impairments, and disease progression per Expanded Disability Status Scale (EDSS) level, on costs and QoL.

METHODS: This was a cross-sectional cohort study including 20,988 patients from the German NeuroTransData MS registry from 2009 to 2019. QoL analyses were based on EQ-5D-5L. Cost analyses included indirect/direct medical and non-medical costs. Eight subgroups, ranging from 439 to 1812 patients were created based on presence of measures for disease progression (EDSS), cognition (Symbol Digit Modalities Test [SDMT]), fatigue (Modified Fatigue Impact 5-Item Scale [MFIS-5]), ULF (Nine-Hole Peg Test [9HPT]), and LLF (Timed 25-Foot Walk [T25FW]). Multivariable linear regression assessed the independent effect of each test’s score on QoL and costs, while adjusting for EDSS and 12 other confounders.

RESULTS: Lower QoL was associated with decreasing cognition (p < 0.001), worsening ULF (p = 0.025), and increasing fatigue (p < 0.0001); however, the negative impact of LLF worsening on QoL was not statistically significant (p = 0.54). Higher costs were associated with decreasing cognition (p < 0.001), worsening of ULF (p = 0.0058) and LLF (p = 0.049), and increasing fatigue (p < 0.0001). Each 1-scale-step worsening function of SDMT, MFIS-5, 9HPT, and T25FW scores resulted in €170, €790, €330, and €520 higher costs, respectively. Modeling disability progression based on SDMT, MFIS-5, 9HPT, and T25FW scores as an interaction with EDSS strata found associations with lower QoL and higher costs at variable EDSS ranges.

CONCLUSIONS: Disease progression in MS measured by 9HPT, SDMT, and MFIS-5 had a significant negative impact on QoL and broad socioeconomic costs independent of EDSS. T25FW had a significant negative association with costs. Cognition, fatigue, ULF, and LLF have stronger impact on costs and QoL in patients with higher EDSS scores. Additional determinants of MS disability status, including SDMT, MFIS-5, 9HPT, and T25FW, should be considered for assessing cost effectiveness of novel therapeutics for MS.

PMID:38949748 | DOI:10.1007/s41669-024-00501-x

Environ Sci Pollut Res Int. 2024 Jun 29. doi: 10.1007/s11356-024-34115-x. Online ahead of print.

ABSTRACT

The presence of phenazopyridine in water is an environmental problem that can cause damage to human health and the environment. However, few studies have reported the adsorption of this emerging contaminant from aqueous matrices. Furthermore, existing research explored only conventional modeling to describe the adsorption phenomenon without understanding the behavior at the molecular level. Herein, the statistical physical modeling of phenazopyridine adsorption into graphene oxide is reported. Steric, energetic, and thermodynamic interpretations were used to describe the phenomenon that controls drug adsorption. The equilibrium data were fitted by mono, double, and multi-layer models, considering factors such as the numbers of phenazopyridine molecules by adsorption sites, density of receptor sites, and half saturation concentration. Furthermore, the statistical physical approach also calculated the thermodynamic parameters (free enthalpy, internal energy, Gibbs free energy, and entropy). The maximum adsorption capacity at the equilibrium was reached at 298 K (510.94 mg g^-1). The results showed the physical meaning of adsorption, indicating that the adsorption occurs in multiple layers. The temperature affected the density of receptor sites and half saturation concentration. At the same time, the adsorbed species assumes different positions on the adsorbent surface as a function of the increase in the temperature. Meanwhile, the thermodynamic functions revealed increased entropy with the temperature and the equilibrium concentration.

PMID:38949732 | DOI:10.1007/s11356-024-34115-x

Drug Saf. 2024 Jun 29. doi: 10.1007/s40264-024-01456-y. Online ahead of print.

ABSTRACT

BACKGROUND: Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health Organization recommendations and require continuous safety monitoring.

OBJECTIVE: We assessed the frequency and severity of adverse events within 7 days of administering GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4) in Belgium, Germany, and Spain during the 2022/2023 influenza season.

METHODS: In this enhanced safety surveillance study, adults who received GSK’s IIV4 and parents/guardians/legally acceptable representatives of vaccinated children (aged 6 months-17 years) were invited to complete adverse drug reaction cards reporting adverse events within 7 days post-vaccination.

RESULTS: In total, 1332 participants (53.6% female) received at least one dose of GSK’s IIV4, including 43 children who received two doses. Overall, 97.8% of adverse drug reaction cards were completed and returned in the study. All participants in Belgium were adults, while 54.7% and 7.4% in Spain and Germany, respectively, were pediatric participants aged 6 months-17 years. After Dose 1, across all age groups, 49.8% of participants reported at least one adverse event. The most common adverse events (cumulative frequency >5%) following Dose 1 were injection-site pain (37.6%), fatigue (15.0%), headache (13.2%), injection-site swelling (9.3%), myalgia (7.6%), and injection-site erythema (7.4%). Across all countries, adverse events were most common in adults aged 18-65 years (59.7%), followed by those aged 3-17 years (47.0%), >65 years (35.7%), and 6-35 months (23.5%). After Dose 2, 18.6% of participants reported at least one adverse event, with general disorders and administration site conditions again being the most frequent.

CONCLUSIONS: Across all age and risk groups for serious disease, no serious adverse events related to GSK’s IIV4 were reported within 7 days post-vaccination. This study supports and confirms the acceptable safety profile of GSK’s IIV4 across all recommended age groups.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number: not applicable.

PMID:38949714 | DOI:10.1007/s40264-024-01456-y

Methods Mol Biol. 2024;2833:65-77. doi: 10.1007/978-1-0716-3981-8_8.

ABSTRACT

Pyrazinamide (PZA) is a key component of chemotherapy for the treatment of drug-susceptible tuberculosis (TB) and is likely to continue to be included in new drug combinations. Potentiation of PZA could be used to reduce the emergence of resistance, shorten treatment times, and lead to a reduction in the quantity of PZA consumed by patients, thereby reducing the toxic effects. Acidified medium is required for the activity of PZA against Mycobacterium tuberculosis. In vitro assessments of pyrazinamide activity are often avoided because of the lack of standardization, which has led to a lack of effective in vitro tools for assessing and/or enhancing PZA activity.We have developed and optimized a novel, robust, and reproducible, microtiter plate assay, that centers around acidity levels that are low enough for PZA activity. The assay can be applied to the evaluation of novel compounds for the identification of potentiators that enhance PZA activity. In this assay, potentiation of PZA is demonstrated to be statistically significant with the addition of rifampicin (RIF), which can, therefore, be used as a positive control. Conversely, norfloxacin demonstrates no potentiating activity with PZA and can be used as a negative control. The method, and the associated considerations, described here, can be adapted in the search for potentiators of other antimicrobials.

PMID:38949702 | DOI:10.1007/978-1-0716-3981-8_8