Category: Statistics

Br J Psychiatry. 2024 May 6:1-8. doi: 10.1192/bjp.2024.68. Online ahead of print.

ABSTRACT

BACKGROUND: Despite the recognised importance of mental disorders and social disconnectedness for mortality, few studies have examined their co-occurrence.

AIMS: To examine the interaction between mental disorders and three distinct aspects of social disconnectedness on mortality, while taking into account sex, age and characteristics of the mental disorder.

METHOD: This cohort study included participants from the Danish National Health Survey in 2013 and 2017 who were followed until 2021. Survey data on social disconnectedness (loneliness, social isolation and low social support) were linked with register data on hospital-diagnosed mental disorders and mortality. Poisson regression was applied to estimate independent and joint associations with mortality, interaction contrasts and attributable proportions.

RESULTS: A total of 162 497 individuals were followed for 886 614 person-years, and 9047 individuals (5.6%) died during follow-up. Among men, interaction between mental disorders and loneliness, social isolation and low social support, respectively, accounted for 47% (95% CI: 21-74%), 24% (95% CI: -15 to 63%) and 61% (95% CI: 35-86%) of the excess mortality after adjustment for demographics, country of birth, somatic morbidity, educational level, income and wealth. In contrast, among women, no excess mortality could be attributed to interaction. No clear trends were identified according to age or characteristics of the mental disorder.

CONCLUSIONS: Mortality among men, but not women, with a co-occurring mental disorder and social disconnectedness was substantially elevated compared with what was expected. Awareness of elevated mortality rates among socially disconnected men with mental disorders could be of importance to qualify and guide prevention efforts in psychiatric services.

PMID:38708564 | DOI:10.1192/bjp.2024.68

Public Health Nurs. 2024 May 6. doi: 10.1111/phn.13320. Online ahead of print.

ABSTRACT

INTRODUCTION: The aging of the population requires an appropriate knowledge of the type of care that needs to be provided to inform healthcare policies. In Italy, neither home care nursing, nor the patient experiences have ever been described.

OBJECTIVES: To describe the characteristics of nurses and care recipients involved in home care.

METHODS: A descriptive cross-sectional study conducted in 18 Italian Regions. Between April and October 2023, data from nurses and patients involved in home care were collected through two surveys. Psychosocial conditions in workplaces, missed care, and care experiences were assessed using validated tools. Descriptive statistics and Pearson’s correlations were performed.

RESULTS: A total of 46 local healthcare units were included in this study, with a total of 2549 nurses and 4709 care recipients. Nurses (mean age 46.60; 79.48% female; 44.68% regional nursing diploma as the highest qualification) reported good working conditions (42.37; SD = 12.25; range = 0-100) and a high mean number of missed care activities (5.11; SD = 3.19; range 0-9). Most nurses (83.41%) reported high levels of job satisfaction, while 20.28% intended to leave their job. Patients (mean age 75.18; 57.57% female; 36.95% primary school), on the other hand, rated positively the care they had received (8.23; range = 0-10).

CONCLUSIONS: Despite the perception of critical issues at work and some missed care, satisfaction in nurses and patients was high. These data constitute a preliminary snapshot of the studied phenomena, which will be investigated through more in-depth analyses.

PMID:38708563 | DOI:10.1111/phn.13320

J Clin Pharmacol. 2024 May 6. doi: 10.1002/jcph.2449. Online ahead of print.

ABSTRACT

Current recommendations for refractory status epilepticus (SE) unresponsive to benzodiazepines suggest a loading dose of levetiracetam (LEV) of 60 mg/kg to a maximum of 4500 mg. LEV therapeutic drug monitoring can help guide therapy and is garnering increasing attention. The objective of this study is to simulate the probability of target attainment (PTA) of fixed dose and weight-based loading doses of LEV with respect to established therapeutic target concentrations. Meta-regression of the current literature was performed to evaluate the relationship between intravenous LEV loading dose and seizure cessation in refractory SE patients. A previously published pharmacokinetic model was used to simulate the PTA capacity of competing single intravenous dosing schemes (fixed vs weight-based dosing) to achieve maximum (C_peak) and 12-h (C_12h) plasma concentrations that exceed 12 mg/L. The meta-regression indicated that dosage was not a statistically significant modulator of seizure control at dosages between 20 and 60 mg/kg. Stochastic simulations showed all dosing schemes achieved plasma C_peak >12 mg/L, but C_12h levels were <12 mg/L in subjects over 60 kg with a fixed dose ≤2000 mg or in subjects <60 kg with a weight-based dose <30 mg/kg. Dosages of 40 and 60 mg/kg provided ≥90% PTAs across all weights. Using a weight-based loading dose of 40 mg/kg, up to a suggested maximum of 4500 mg, improves the likelihood of achieving a sustained therapeutic drug concentration after the initial LEV dose, whereas fixed <3000 mg may not achieve the desired concentration before maintenance dosing.

PMID:38708556 | DOI:10.1002/jcph.2449

Clin Pharmacol Drug Dev. 2024 May 6. doi: 10.1002/cpdd.1406. Online ahead of print.

ABSTRACT

The effect of food composition, tablet crushing, and antacid coadministration on maribavir pharmacokinetics was assessed in 2 Phase 1 studies in healthy adults. In the first, a single maribavir 400-mg dose was administered under fasting conditions, with a low-fat/low-calorie or a high-fat/high-calorie meal. In the second, a single maribavir 100-mg dose was administered under fasting conditions, as a crushed tablet, or as a whole tablet alone or with an antacid. The 90% confidence intervals of the geometric mean ratios were within 80%-125% for area under the concentration-time curve (AUC), but not for maximum plasma concentration (C_max) for low-fat/low-calorie and high-fat/high-calorie meals versus fasting or for whole tablet with antacid versus whole tablet alone. The 90% confidence intervals of the geometric mean ratios for AUC and C_max were within 80%-125% for crushed versus whole tablet. Maribavir median time to C_max value in plasma under fed conditions was delayed versus fasting conditions, but there was no statistical difference for crushed versus whole tablet or with versus without antacid. As the antiviral efficacy of maribavir is driven by AUC but not C_max, findings suggest that maribavir can be administered with food or antacids or as a crushed tablet.

PMID:38708555 | DOI:10.1002/cpdd.1406

Hosp Pediatr. 2024 May 6:e2023007454. doi: 10.1542/hpeds.2023-007454. Online ahead of print.

ABSTRACT

OBJECTIVES: Urinary tract infections (UTIs) are the most common bacterial infections in young infants and are traditionally treated with longer intravenous (IV) antibiotic courses. A growing body of evidence supports shorter IV antibiotic courses for young infants. Our primary aim was to decrease the IV antibiotic treatment to 3 days over 2 years for neonates aged 0 to 28 days who have been hospitalized with UTIs.

METHODS: Using quality improvement methods, our primary intervention was to implement a revised clinical pathway recommending 3 (previously 7) days of IV antibiotics. Our primary outcome measure was IV antibiotic duration, and the secondary outcomes were length of stay (LOS) and costs. The balancing measure was readmission within 30 days of discharge. Neonates were identified by using International Classification of Diseases diagnosis codes and excluded if they were admitted to the ICU or had a LOS >30 days. We used statistical process control to analyze outcome measures for 4 years before (baseline) and 2 years after the pathway revision (intervention) in February 2020.

RESULTS: A total of 93 neonates were hospitalized with UTIs in the baseline period and 41 were hospitalized in the intervention period. We found special cause variation, with a significant decrease in mean IV antibiotic duration from 4.7 (baseline) to 3.1 days (intervention) and a decrease in mean LOS from 5.4 to 3.6 days. Costs did not differ between the baseline and intervention periods. There were 7 readmissions during the baseline period, and 0 during the intervention period.

CONCLUSIONS: The implementation of a revised clinical pathway significantly reduced IV antibiotic treatment duration and hospital LOS for neonatal UTIs without an increase in hospital readmissions.

PMID:38708550 | DOI:10.1542/hpeds.2023-007454

Recenti Prog Med. 2024 May;115(5):232-237. doi: 10.1701/4262.42402.

ABSTRACT

BACKGROUND: Ministerial Decrete 77 (DM 77) promotes dehospitalization for chronic patients and defines out-of-hospital health facilities at this purpose. It has never been investigated how much patients with cancer know and judge this decree law.

MATERIAL AND METHODS: The Collegio italiano dei primari oncologi medici ospedalieri (Cipomo) carried out a survey with a dedicated questionnaire on oncological patients attending public hospital to investigate the liking of DM 77.

RESULTS: Anonymous responses were obtained from 1.443 patients. Median age 64ys, 42% males, 21% live alone, 70% have a companion. 19% thinks that oral chemotherapy could be managed outside the hospital, 26.68% carried out follow-up (FU),19.15% parenteral therapy, 32.16% basic examinations. Home is preferred by 21.8%, a health facility close to home by 36.3%, hospital by 37.54%. 59.67% would like FU in hospital by their personal oncologist, 5.47% by GP, 35.41% by both together and 9.45% by oncologist outside the hospital. Asked what they might feel about being followed out of the hospital, 29.94% say of not being treated at its best, 12.68% of not being able to be visited in hospital anymore, 5.27% of being abandoned, 30.7% of being freer and 10.88% of feeling less sick. Regarding the use of new technical tools to favor dehospitalisation, 44.15% answered yes, 15.88% no and 30.07% did not know. About the distance or traveling time from home to the therapy administration side, 20.26% answered this should be no more than 15 km or 30 mins, 9.91% no more than 30 km or 45 mins, 5.47% no more than 50 km or 60 mins but 39.5% say that the distance does not matter to them but only the continuity of care. The question related to the inconveniences with going to hospital for therapy: 40.81% waiting time, 20.47% lack of parking, 17.02% rotation of doctors,12.76% travel time and 5.62% bureaucracy.

CONCLUSIONS: The patients’ answers suggest that dehospitalization could improve their quality of life, but at the condition of being able to maintain a close relationship with the personal oncologist.

PMID:38708534 | DOI:10.1701/4262.42402

Nan Fang Yi Ke Da Xue Xue Bao. 2024 Apr 20;44(4):689-696. doi: 10.12122/j.issn.1673-4254.2024.04.10.

ABSTRACT

OBJECTIVE: To construct a nonparametric proportional hazards (PH) model for mixed informative interval-censored failure time data for predicting the risks in heart transplantation surgeries.

METHODS: Based on the complexity of mixed informative interval-censored failure time data, we considered the interdependent relationship between failure time process and observation time process, constructed a nonparametric proportional hazards (PH) model to describe the nonlinear relationship between the risk factors and heart transplant surgery risks and proposed a two-step sieve estimation maximum likelihood algorithm. An estimation equation was established to estimate frailty variables using the observation process model. Ⅰ-spline and B-spline were used to approximate the unknown baseline hazard function and nonparametric function, respectively, to obtain the working likelihood function in the sieve space. The partial derivative of the model parameters was used to obtain the scoring equation. The maximum likelihood estimation of the parameters was obtained by solving the scoring equation, and a function curve of the impact of risk factors on the risk of heart transplantation surgery was drawn.

RESULTS: Simulation experiment suggested that the estimated values obtained by the proposed method were consistent and asymptotically effective under various settings with good fitting effects. Analysis of heart transplant surgery data showed that the donor’s age had a positive linear relationship with the surgical risk. The impact of the recipient’s age at disease onset increased at first and then stabilized, but increased against at an older age. The donor-recipient age difference had a positive linear relationship with the surgical risk of heart transplantation.

CONCLUSION: The nonparametric PH model established in this study can be used for predicting the risks in heart transplantation surgery and exploring the functional relationship between the surgery risks and the risk factors.

PMID:38708502 | DOI:10.12122/j.issn.1673-4254.2024.04.10

J Clin Lab Anal. 2024 May 6:e25040. doi: 10.1002/jcla.25040. Online ahead of print.

ABSTRACT

BACKGROUND: Despite advancements in antibiotic therapy and resuscitation protocols, sepsis and septic shock remain major contributors to morbidity and mortality in children. We aimed to investigate the utility of soluble urokinase plasminogen activator receptor (suPAR) for the early detection of septic shock and to evaluate its accuracy in predicting mortality.

METHODS: A prospective study was conducted in a tertiary pediatric emergency department (ED), enrolling patients diagnosed with the sepsis, severe sepsis, or septic shock. In addition to assessing infection biomarkers such as C-reactive protein and procalcitonin, suPAR levels were quantified upon admission using enzyme-linked immunosorbent assay. The primary outcome measure was 30-day mortality.

RESULTS: Overall 72 patients and 80 healthy children included. Plasma suPAR levels demonstrated a statistically significant elevation in the sepsis, severe sepsis, and septic shock groups compared with the control group (p < 0.001 for all). The septic shock group exhibited the highest suPAR levels upon admission, surpassing both the sepsis and severe sepsis groups (p = 0.009 and 0.042). ROC analysis underscored the promising potential of suPAR with an AUC of 0.832 for septic shock. Analysis of mortality prediction revealed significantly higher suPAR levels in nonsurvivors than survivors (9.7 ng/mL vs. 4.2 ng/mL; p < 0.001). Employing plasma suPAR levels to discriminate between mortality and survival, a threshold of ≥7.0 ng/mL demonstrated a sensitivity of 90.9% and specificity of 71.0%.

CONCLUSION: Plasma suPAR levels have the potential as a biomarker for predicting mortality in children with septic shock. In pediatric septic shock, the presence of plasma suPAR ≥7 ng/mL along with an underlying disease significantly increases the risk of mortality.

PMID:38708489 | DOI:10.1002/jcla.25040

Eur Rev Med Pharmacol Sci. 2024 Apr;28(8):3263-3267. doi: 10.26355/eurrev_202404_36054.

ABSTRACT

OBJECTIVE: To determine whether there is a relationship between carotid artery stenosis percentage and complications.

PATIENTS AND METHODS: The study included 109 patients treated with carotid artery stenting in our center. The indication for stenting was accepted as carotid artery stenosis above 50% in symptomatic patients and over 70% in asymptomatic patients. Complications were compared between groups with <90% and ≥90% stenosis.

RESULTS: There was no procedure-related mortality in any of the patients. Minor complications developed in 22 patients (20.2%). Prolonged hypotension/bradycardia occurred in 17 patients (77.3%), and a transient ischemic attack in five (22.7%). Inguinal access complications were detected in three patients (2.7%). Major complications developed in 11 patients (10%), of whom five (45.4%) had hyperperfusion syndrome, five (45.4%) had microinfarcts, and one (9%) had acute stent thrombosis. No significant difference was observed in age, gender, major and minor complications, or inguinal access site complications between the patients with <90% and ≥90% stenosis. There was also no statistically significant difference in complications according to the open or closed cell morphology of the selected stent.

CONCLUSIONS: The most important result of our study is that there was no significant difference in complications between the patients who underwent carotid stenting due to <90% and ≥90% stenosis.

PMID:38708484 | DOI:10.26355/eurrev_202404_36054

Eur Rev Med Pharmacol Sci. 2024 Apr;28(8):3227-3240. doi: 10.26355/eurrev_202404_36051.

ABSTRACT

OBJECTIVE: This study aimed to evaluate pain control, functioning, and quality of life (QoL) recovery in patients with chronic low back pain (cLBP) or post-traumatic osteoarthritis (OA) pain in the ankle/foot area, treated with tapentadol prolonged release and unresponsive to other treatments.

PATIENTS AND METHODS: Two observational retrospective studies were conducted using clinical practice datasets of patients with chronic pain in cLBP and OA foot/ankle at different time points (total follow-up=60-90 days). The studies assessed pain intensity by the Numerical Rating Scale (NRS) pain scale (patients were classified as responder in case of ≥30% pain reduction), QoL by the 5-level EQ-5D (EQ-5D-5L) questionnaire, patient satisfaction by the 7-point Patients’ Global Impression of Change (PGIC) scale; cLBP health status by the Roland Morris Disability Questionnaire (RMDQ); foot and ankle functional status by European Foot and Ankle Society (EFAS) score; and treatment-related AEs.

RESULTS: For the cLBP setting, 37 patients were enrolled, of which 86.50% were classified as responders (n=32; CI: 75.5% ÷ 97.5%). For the foot/ankle OA pain setting, 21 patients were enrolled. Pain assessment at final follow-up was available only for 11 patients, of which 72.73% (n=8; CI: 39.0% ÷ 94.0%) were classified as responders. Statistically significant improvements were seen in the RMDQ, EQ-5D-5L, and PGIC scores in cLBP. Improvements in the EFAS, EQ-5D-5L, and PGIC scores were seen in OA as well. The incidence of treatment-related adverse reactions was low in both studies.

CONCLUSIONS: In the study population, tapentadol prolonged release was effective and well tolerated in treating cLBP and post-traumatic foot/ankle OA chronic pain when used in a multimodal manner. The reduction in pain was accompanied by clinically relevant improvements in patients’ functionality and QoL.

PMID:38708481 | DOI:10.26355/eurrev_202404_36051