Category: Statistics

J Emerg Nurs. 2024 Apr 6:S0099-1767(24)00077-1. doi: 10.1016/j.jen.2024.03.001. Online ahead of print.

ABSTRACT

INTRODUCTION: Activated charcoal is the most common form of gastrointestinal decontamination used for the poisoned patient. One limitation to its use is patient tolerability due to palatability. Some recommend mixing activated charcoal with cola to improve palatability. An important question is whether mixing activated charcoal with cola affects the ability of the activated charcoal to adsorb xenobiotic.

METHODS: This was a prospective randomized controlled crossover trial. Five healthy adults aged 18 to 40 years were recruited. Participants received 45 mg/kg acetaminophen rounded down to the nearest whole tablet. One hour later, they were randomized to receive 50 g of an activated charcoal-water premixture alone or mixed with cola. Acetaminophen levels were collected. The area under the curve of acetaminophen concentrations over time was measured as a marker for degree of absorption. Participants also completed an appeal questionnaire in which they rated the activated charcoal preparations. Participants would then return after at least 7 days to repeat the study with the other activated charcoal preparation.

RESULTS: Four male participants and 1 female participant were recruited. There was no statistical difference in preference score for activated charcoal alone versus the cola-activated charcoal mixture. There was no statistical difference in the area under the curve of acetaminophen concentrations over time between activated charcoal alone and the cola-activated charcoal mixture. Of note, the study is limited by the small sample size, limiting its statistical power.

DISCUSSION: The absorption of acetaminophen in an overdose model is no different when participants received activated charcoal alone or a cola-activated charcoal mixture as suggested by area under the curve. In this small study, there was no difference in preference for activated charcoal alone or a cola-activated charcoal mixture across a range of palatability questions. On an individual level, some participants preferred the activated charcoal-cola mixture, and some preferred the activated charcoal alone.

PMID:38583171 | DOI:10.1016/j.jen.2024.03.001

J Surg Oncol. 2024 Apr 7. doi: 10.1002/jso.27618. Online ahead of print.

ABSTRACT

BACKGROUND: The extent of pelvic lymphadenectomy (PLND) as part of radical cystectomy (RC) for bladder cancer (BC) remains unclear. Sentinel-based and lymphangiographic approaches could lead to reduced morbidity without sacrificing oncologic safety.

OBJECTIVE: To evaluate the feasibility and diagnostic value of fluorescence-guided template sentinel region dissection (FTD) using a handheld near-infrared fluorescence (NIRF) camera in open radical cystectomy.

DESIGN, SETTING, AND PARTICIPANTS: After peritumoral cystoscopic injection of indocyanine green (ICG) 21 patients underwent open RC with FTD due to BC between June 2019 and June 2021. Intraoperatively, the FIS-00 Hamamatsu Photonics® NIRF camera was used to identify and resect fluorescent template sentinel regions (FTRs) followed by extended pelvic lymphadenectomy (ePLND) as oncological back-up.

OUTCOME MEASUREMENT AND STATISTICAL ANALYSIS: Descriptive analysis of positive and negative results per template region.

RESULTS AND LIMITATIONS: FTRs were identified in all 21 cases. Median time (range) from ICG injection to fluorescence detection was 75 (55-125) minutes. On average (SD), 33.4 (9.6) lymph nodes were dissected per patient. Considering template regions as the basis of analysis, 67 (38.3%) of 175 resected regions were NIRF-positive, with 13 (7.4%) regions harboring lymph node metastases. We found no metastatic lymph nodes in NIRF-negative template regions. Outside the standard template, two NIRF-positive benign nodes were identified.

CONCLUSION: The concept of NIRF-guided FTD proved for this group all lymph node metastases to be found in NIRF-positive template regions. Pending validation in a larger collective, resection of approximately 40% of standard regions may be sufficient and may result in less morbidity.

PMID:38583145 | DOI:10.1002/jso.27618

J Trauma Stress. 2024 Apr 7. doi: 10.1002/jts.23042. Online ahead of print.

ABSTRACT

Written exposure therapy (WET) is a brief, manualized trauma-focused treatment typically delivered in five individual weekly sessions. Given the brevity and effectiveness of WET, researchers have begun to focus on its delivery in a massed format. However, only one case study examining massed delivery has been published to date. As such, the objective of the current study was to examine the acceptability, feasibility, and preliminary effectiveness of massed WET among veterans with a trauma- and stressor-related disorder receiving care on an acute inpatient mental health unit. Veterans (N = 26) were assessed prior to, immediately after, and 1 month following massed WET. Most veterans found massed WET to be useful and acceptable. Recruitment and retention rates suggested that the treatment was feasible. Notably, the results revealed statistically significant reductions in overall posttraumatic stress symptoms, η_p ² = .81, p < .001; depressive symptoms, η_p ² = .71, p < .001; and functional impairment, η_p ² = .42, p = .002. These findings add to a growing body of literature highlighting the preliminary effectiveness of WET across various settings, populations, and delivery formats. Limitations include the small sample size and uncontrolled design.

PMID:38583141 | DOI:10.1002/jts.23042

Geroscience. 2024 Apr 7. doi: 10.1007/s11357-024-01149-5. Online ahead of print.

ABSTRACT

Yoga-based clinical research has shown considerable promise in varied ageing-related health outcomes in older adults. However, robust frameworks have yet to be used in intervention research to endorse yoga as a healthy ageing intervention to test the multidimensional construct of healthy ageing. This was an assessor-masked, randomized controlled trial conducted among 258 sedentary, community-dwelling older adults aged 60-80 years, randomly allocated to 26-week yoga-based intervention (YBI) (n = 132) or waitlist control (WLC) (n = 126). The effectiveness of YBI was assessed through two separate global statistical tests, generalized estimating equations and rank sum-based test, against a comprehensive healthy aging panel comprised of ten markers representing the domains of physiological and metabolic, cognitive, physical capability, psychological, and social well-being. The secondary outcomes were individual primary marker scores, Klotho, inflammatory markers, and auxiliary blood markers. We could establish the healthy aging effect of the 26-week YBI over WLC using two models of global statistical test (GEE, β = 0.29; 95% CI = 0.20 to 0.38, p < 0.001), and rank sum-based test (β = 0.28, 95% CI = 0.19 to 0.36, p < 0.001). There were also significant improvements in direction of benefit at individual levels of all the aging markers. Exploratory evaluation with adopted indices from contemporary clinical trials also validated the potential of YBI for healthy aging; HATICE adapted composite score (mean difference = – 0.18; 95% CI = – 0.26 to – 0.09, p < 0.001) and healthy ageing index (mean difference = – 0.33; 95% CI = – 0.63 to – 0.02, p = 0.03). The global effect of YBI across multiple ageing-related outcomes provides a proof of concept for further large-scale validation. The findings hold a great translational value given the accelerated pace of population aging across the globe. Trial registration: CTRI/2021/02/031373.

PMID:38583114 | DOI:10.1007/s11357-024-01149-5

Pharmacoeconomics. 2024 Apr 7. doi: 10.1007/s40273-024-01372-0. Online ahead of print.

ABSTRACT

Value of Information (VOI) analyses calculate the economic value that could be generated by obtaining further information to reduce uncertainty in a health economic decision model. VOI has been suggested as a tool for research prioritisation and trial design as it can highlight economically valuable avenues for future research. Recent methodological advances have made it increasingly feasible to use VOI in practice for research; however, there are critical differences between the VOI approach and the standard methods used to design research studies such as clinical trials. We aimed to highlight key differences between the research design approach based on VOI and standard clinical trial design methods, in particular the importance of considering the full decision context. We present two hypothetical examples to demonstrate that VOI methods are only accurate when (1) all feasible comparators are included in the decision model when designing research, and (2) all comparators are retained in the decision model once the data have been collected and a final treatment recommendation is made. Omitting comparators from either the design or analysis phase of research when using VOI methods can lead to incorrect trial designs and/or treatment recommendations. Overall, we conclude that incorrectly specifying the health economic model by ignoring potential comparators can lead to misleading VOI results and potentially waste scarce research resources.

PMID:38583100 | DOI:10.1007/s40273-024-01372-0

Intern Emerg Med. 2024 Apr 7. doi: 10.1007/s11739-024-03541-7. Online ahead of print.

ABSTRACT

Early resuscitation using blood products is critical for patients with severe hemorrhagic shock. We aimed to develop and validate a new scoring system, hemorrhagic shock transfusion prediction (HSTP) score, to predict the need for massive transfusion (MT) in these patients, compared to the widely used Assessment of Blood Consumption (ABC) score. Trauma patients admitted to Emtiaz Hospital in Iran from 2017 to 2021 were retrospectively included. Patients assigned a code 1 or 2 according to the Emergency severity index (ESI) triage system have been divided into MT and non-MT groups. MT was defined as receiving ≥ 10 units of packed cells (PCs) in 24 h. Demographic information, admission vital signs, and lab results available within 15 min were compared between the groups. A new predictive score was developed using logistic regression of statistically significant parameters. Out of 1029 patients, 651 (63.3%) required MT. An arrival, diastolic blood pressure < 79.5 mm Hg, absolute lymphocyte count > 1850/μL, base excess < – 4.25, and blood glucose > 156 mg/dL were independent predictors included in the HSTP score. The sensitivity and specificity were 74.36% and 53.87% for the HSTP score, compared to 31.03% and 76.16% for the ABC score. Moreover, the positive and negative predictive values were 77.88% and 49.03% for the HSTP score, versus 74.15% and 33.66% for ABC. The new scoring system demonstrated higher sensitivity and improved positive and negative predictive values compared to the ABC score. This score can assist physicians in making accurate transfusion decisions quickly, but further prospective studies are warranted to validate its clinical utility.

PMID:38583098 | DOI:10.1007/s11739-024-03541-7

JAMA Cardiol. 2024 Apr 7. doi: 10.1001/jamacardio.2024.0959. Online ahead of print.

ABSTRACT

IMPORTANCE: Severe hypertriglyceridemia (sHTG) confers increased risk of atherosclerotic cardiovascular disease (ASCVD), nonalcoholic steatohepatitis, and acute pancreatitis. Despite available treatments, persistent ASCVD and acute pancreatitis-associated morbidity from sHTG remains.

OBJECTIVE: To determine the tolerability, efficacy, and dose of plozasiran, an APOC3-targeted small interfering-RNA (siRNA) drug, for lowering triglyceride and apolipoprotein C3 (APOC3, regulator of triglyceride metabolism) levels and evaluate its effects on other lipid parameters in patients with sHTG.

DESIGN, SETTING, AND PARTICIPANTS: The Study to Evaluate ARO-APOC3 in Adults With Severe Hypertriglyceridemia (SHASTA-2) was a placebo-controlled, double-blind, dose-ranging, phase 2b randomized clinical trial enrolling adults with sHTG at 74 centers across the US, Europe, New Zealand, Australia, and Canada from May 31, 2021, to August 31, 2023. Eligible patients had fasting triglyceride levels in the range of 500 to 4000 mg/dL (to convert to millimoles per liter, multiply by 0.0113) while receiving stable lipid-lowering treatment.

INTERVENTIONS: Participants received 2 subcutaneous doses of plozasiran (10, 25, or 50 mg) or matched placebo on day 1 and at week 12 and were followed up through week 48.

MAIN OUTCOMES AND MEASURES: The primary end point evaluated the placebo-subtracted difference in means of percentage triglyceride change at week 24. Mixed-model repeated measures were used for statistical modeling.

RESULTS: Of 229 patients, 226 (mean [SD] age, 55 [11] years; 176 male [78%]) were included in the primary analysis. Baseline mean (SD) triglyceride level was 897 (625) mg/dL and plasma APOC3 level was 32 (16) mg/dL. Plozasiran induced significant dose-dependent placebo-adjusted least squares (LS)-mean reductions in triglyceride levels (primary end point) of -57% (95% CI, -71.9% to -42.1%; P < .001), driven by placebo-adjusted reductions in APOC3 of -77% (95% CI, -89.1% to -65.8%; P < .001) at week 24 with the highest dose. Among plozasiran-treated patients, 144 of 159 (90.6%) achieved a triglyceride level of less than 500 mg/dL. Plozasiran was associated with dose-dependent increases in low-density lipoprotein cholesterol (LDL-C) level, which was significant in patients receiving the highest dose (placebo-adjusted LS-mean increase 60% (95% CI, 31%-89%; P < .001). However, apolipoprotein B (ApoB) levels did not increase, and non-high-density lipoprotein cholesterol (HDL-C) levels decreased significantly at all doses, with a placebo-adjusted change of -20% at the highest dose. There were also significant durable reductions in remnant cholesterol and ApoB48 as well as increases in HDL-C level through week 48. Adverse event rates were similar in plozasiran-treated patients vs placebo. Serious adverse events were mild to moderate, not considered treatment related, and none led to discontinuation or death.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of patients with sHTG, plozasiran decreased triglyceride levels, which fell below the 500 mg/dL threshold of acute pancreatitis risk in most participants. Other triglyceride-related lipoprotein parameters improved. An increase in LDL-C level was observed but with no change in ApoB level and a decrease in non-HDL-C level. The safety profile was generally favorable at all doses. Additional studies will be required to determine whether plozasiran favorably modulates the risk of sHTG-associated complications.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04720534.

PMID:38583092 | DOI:10.1001/jamacardio.2024.0959

Zhonghua Yan Ke Za Zhi. 2024 Apr 11;60(4):352-358. doi: 10.3760/cma.j.cn112142-20231122-000246.

ABSTRACT

Objective: To investigate the differences in reading efficiency and visual fatigue between the use of augmented reality (AR) glasses and laptops. Methods: A prospective self-controlled study was conducted. Healthy students from Capital Medical University who frequently engaged in long-term near work and used laptops and other digital display devices were recruited as subjects at Beijing Tongren Hospital, Capital Medical University between November 1 and November 15, 2023. LogMAR visual acuity, visual functions (accommodation, convergence, and fusion), and visual fatigue scores (Likert visual fatigue scale) of the participants were assessed. The order of using the laptop and AR glasses for each participant was determined by a coin toss. Reading efficiency (reading speed and error rate multiplied by the detection rate of incorrect numbers) with different devices for 10 minutes at the same time on different dates and visual fatigue scores after watching a 20-minute video were measured. Statistical analyses were performed using paired t-tests and Wilcoxon signed-rank tests. Results: A total of 20 eligible subjects were included, comprising 7 males and 13 females, with a mean age of (25.45±2.27) years. There was no significant change in binocular visual acuity before and after using AR glasses and laptops (both P>0.05). The reading speed and reading efficiency of using AR glasses [(34.03±9.25) and (29.19±7.62) digits/min, respectively] were significantly lower than those of using laptops [(39.43±10.36) and (35.67±9.87) digits/min, respectively] (t=4.36, P<0.001), while the difference in error detection rate was not statistically significant (t=1.29, P=0.213). There was no statistically significant difference in visual fatigue scores before watching videos with the two devices (Z=-0.71, P=0.480). However, the visual fatigue score after watching videos with AR glasses [(20.55±5.04) points] was significantly higher than that with laptops [16.50 (13.00, 19.75) points] (Z=-2.85, P=0.004). The visual fatigue scores after watching videos with both devices were significantly higher than before (P<0.05), with a more significant increase observed with AR glasses [(6.05±3.50) points] (Z=-3.41, P<0.001). Conclusion: Compared with using laptops, the reading speed and efficiency were lower, and the visual fatigue was more pronounced with the use of AR glasses at the current technical level. Further optimization and improvement of AR glasses are warranted.

PMID:38583059 | DOI:10.3760/cma.j.cn112142-20231122-000246

Zhonghua Yan Ke Za Zhi. 2024 Apr 11;60(4):343-351. doi: 10.3760/cma.j.cn112142-20231211-00283.

ABSTRACT

Objective: The aim of this paper is to compare the refractive correction effects of rigid gas permeable contact lenses (RGPCL) and spectacle correction in children with aphakia after congenital cataract surgery. Methods: This was a prospective non-randomized controlled trial. Children with aphakic eyes after congenital cataract surgery, who underwent vision correction in the Strabismus and Pediatric Ophthalmology Clinic of Beijing Tongren Hospital affiliated with Capital Medical University from April 2012 to November 2019, were continuously collected. Those who voluntarily chose to wear RGPCL for refractive correction were included in the experimental group. Patients with monocular disease were in trial group 1, and patients with binocular disease were in trial group 2. Patients who chose to wear frame glasses for refractive correction were included in the control group. Patients with monocular disease were in control group 1, and patients with binocular disease were in control group 2. Regional origin, medical history, and family information were collected at the first diagnosis. During the follow-up, adverse reactions occurring during the process of wearing glasses were recorded. The Teller acuity card was used for visual examination to obtain the best-corrected visual acuity and convert it into the logarithm of the minimum resolution angle. The degree of nystagmus was determined according to the amplitude and frequency of nystagmus. Treatment cost, treatment compliance, and the reasons for adopting or not adopting RGPCL were analyzed through a questionnaire completed by the parents of children with RGPCL. Results: A total of 203 children (344 eyes) who underwent congenital cataract surgery were included, including 124 males (210 eyes) and 79 females (134 eyes). The age range was 3 to 36 months. There were 28 cases in the experimental group, including 19 cases in trial group 1 and 9 cases in trial group 2. There were 175 cases in the control group, including 43 cases in control group 1 and 132 cases in control group 2. Except for 6 months of age, the visual acuity of the experimental group was better than that of the control group, and the differences were statistically significant (P<0.05). The visual acuity of children in trial group 1 was better than that of children in control group 1 at the same age. Among them, at 12 months of age [1.54 (1.27, 1.97), 1.84 (0.97, 2.12)], 18 months of age [1.27 (0.97, 1.84), 1.84 (0.97, 2.12)], 24 months of age [1.54 (1.27, 1.84), 1.84 (0.97, 2.12)], and 30 months old [0.97 (0.66, 1.27), 1.54 (0.66, 2.12)], the difference was statistically significant (P<0.001). The visual acuity of children in trial group 2 was better than that in control group 2 at the same age. Among them, at 18 months old [1.27 (0.97, 1.54), 1.27 (0.66, 2.12)], 24 months old [0.97 (0.66, 1.27), 1.27 (0.66, 2.12)], and 30 months old [1.27 (0.66, 2.12)], the difference was statistically significant (P<0.05). The remission rate of nystagmus in the experimental group was 8/9 (8 cases), the remission rate of nystagmus in the control group was 34.40% (32 cases), and the exacerbation rate was 29.03% (27 cases). The average annual cost of the experimental group was 25 125 yuan, and that of the control group was 2 511 yuan. Conclusions: RGPCL is a well-tolerated, safe, and effective treatment for infants and young children. The visual acuity and degree of nystagmus were significantly improved in children who wore RGPCL for aphakia refractive correction after congenital cataract surgery compared with spectacle correction.

PMID:38583058 | DOI:10.3760/cma.j.cn112142-20231211-00283

Zhonghua Yan Ke Za Zhi. 2024 Apr 11;60(4):330-336. doi: 10.3760/cma.j.cn112142-20231122-00245.

ABSTRACT

Objective: To investigate the influence of corneal e-value on the effectiveness of orthokeratology in controlling myopia in children and adolescents. Methods: A retrospective cohort study was conducted, involving the data from 1 563 myopic patients (1 563 eyes) who underwent orthokeratology at the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine from June 2015 to August 2021 and adhered to lens wear for at least 2 years. The cohort consisted of 737 males and 826 females with an average age of (10.84±2.13) years. Based on corneal e-value parameters obtained from corneal topography, patients were categorized into a low e-value group (n=425) and a high e-value group (n=1 138). Data on gender, age, parental myopia history, and baseline measures such as spherical equivalent (SE), axial length, and corneal e-value were collected. Differences in axial length change and corneal fluorescein staining rates were compared between the two groups at 1 and 2 years after the start of lens wear. A generalized linear mixed model was established with axial length change as the dependent variable to analyze the correlation between axial length change and baseline corneal e-value. Results: The initial age of the 1 563 myopic patients was (10.84±2.13) years, with a baseline SE of (-3.05±1.30) D. After 1 year of lens wear, the axial length change was (0.20±0.19) mm in the low e-value group and (0.24±0.20) mm in the high e-value group. After 2 years, the changes were (0.38±0.25) mm and (0.43±0.27) mm, respectively, with statistically significant differences (all P<0.05). The incidence of corneal staining after 1 year of lens wear was 9.2% (39/425) in the low e-value group and 14.1% (160/1 138) in the high e-value group. After 2 years, the rates were 15.8% (67/425) and 21.8% (248/1 138), respectively, with statistically significant differences (all P<0.05). After adjusting for parental myopia history, age, SE, and baseline axial length, the baseline corneal e-value was positively correlated with axial length change at 1 and 2 years after lens wear (all P<0.05). Conclusions: Corneal e-value is an independent factor influencing the effectiveness of orthokeratology in controlling myopia. A smaller corneal e-value is associated with slower axial length growth after orthokeratology, indicating better control of myopia in treated eyes.

PMID:38583056 | DOI:10.3760/cma.j.cn112142-20231122-00245