Tag: statistics

Immunotherapy. 2023 Mar 23. doi: 10.2217/imt-2022-0145. Online ahead of print.

ABSTRACT

Aim: Comprehensively characterize the cardiotoxicity of CD19-directed chimeric antigen receptor T-cell (CAR-T) products. Materials & methods: Data between 2017 and 2021 in the US FDA’s Adverse Event Reporting System database were utilized. Disproportionality was measured using reporting odds ratio and information component. Hierarchical clustering analysis was performed to explore the relationships among cardiac events. Results: Tisagenlecleucel exhibited the highest percentage of death (53.24%) and life-threatening (13.39%) outcomes. Axicabtagene ciloleucel and tisagenlecleucel were equal in the number of positive signals (n = 15), while the former had excessive reporting of several cardiac events versus the latter, such as atrial fibrillation, cardiomyopathy, cardiorenal syndrome and sinus bradycardia. Conclusion: Several cardiac risks should be considered for CAR-T treatment and these events might vary in frequency and severity following different CAR-T agents.

PMID:36951157 | DOI:10.2217/imt-2022-0145

Musculoskeletal Care. 2023 Mar 23. doi: 10.1002/msc.1762. Online ahead of print.

ABSTRACT

OBJECTIVES: The primary aim was to investigate the effect of prefabricated foot orthoses on pain and function in people with chronic nonspecific low back pain (LBP). Secondary aims were to report on the recruitment rate, adherence to and safety of these interventions, and the relationship between physical activity and pain and function.

DESIGN: A two-arm parallel group (intervention vs. control) randomised (1:1) controlled trial.

SUBJECTS: Forty-one participants with chronic nonspecific LBP.

INTERVENTION: Twenty participants were randomised to the intervention group (prefabricated foot orthotic and The Back Book) and 21 to the control group (The Back Book). The primary outcomes for this study were change in pain and function from baseline to 12 weeks.

RESULTS: No statistically significant difference in pain was found between the intervention and control group (adjusted mean difference -0.84, 95% CI: -2.09 to 0.41, p = 0.18) at the 12-week follow-up. No statistically significant difference in function was found between the intervention and control group (adjusted mean difference -1.47, 95% CI: -5.51 to 2.57, p = 0.47) at the 12-week follow-up.

CONCLUSION: This study found no evidence of a significant beneficial effect of prefabricated foot orthoses for chronic nonspecific LBP. This study demonstrated that the rate of recruitment, intervention adherence and safety, and participant retention is acceptable and supportive of conducting a larger randomised controlled trial. Australian and New Zealand Clinical Trials Registry (ACTRN12618001298202).

PMID:36951154 | DOI:10.1002/msc.1762

J Prosthodont. 2023 Mar 23. doi: 10.1111/jopr.13680. Online ahead of print.

ABSTRACT

PURPOSE: To investigate the distribution of marginal excess cement in vented and non-vented crowns and evaluate the effect of clinical cleaning procedures on the reduction of excess cement.

MATERIALS AND METHODS: Forty models with implant analogs in the position of the right maxillary first molar were divided into 4 groups (n = 10/group, vented/non-vented crowns with or without cleaning procedures). The abutment finish lines were placed 1 mm below the artificial gingiva buccally, mesially, and distally and at the gingival level palatally. A standardized amount (20 mg) of resin cement was applied in a thin layer to the intaglio surface of zirconia vented and non-vented crowns. The excess cement was removed by a dental explorer in groups with cleaning procedures. The distribution (area and depth) of the marginal excess cement was measured at each quadrant (buccal, mesial, palatal and distal) for all study samples. The data were analyzed using descriptive and analytical statistics (ɑ = 0.05).

RESULTS: The area and depth of the excess cement in each quadrant in the vented group was significantly smaller than that in the non-vented group, both with and without cleaning (p < 0.001). Cleaning procedures significantly reduced the area of excess cement in both vented and non-vented groups (all, p < 0.001 except for p < 0.05 at the buccal aspect of the vented group). The depth of excess cement in the vented group was significantly decreased with cleaning in the buccal quadrant compared with that without cleaning (p < 0.01). However, the depth of excess cement of the non-vented group was significantly increased with cleaning in all quadrants compared with that without cleaning (all, p<0.001 except for p < 0.05 at the distal aspect).

CONCLUSIONS: Crown venting significantly reduced the area and depth of the marginal excess cement in vitro. Cleaning procedure with a dental explorer significantly reduced the area of marginal excess cement in vitro, however, the excess cement can be pushed deeper in the non-vented group. This article is protected by copyright. All rights reserved.

PMID:36951153 | DOI:10.1111/jopr.13680

Haematologica. 2023 Mar 23. doi: 10.3324/haematol.2023.282729. Online ahead of print.

ABSTRACT

Since decades, debates on the role and timing of allogeneic transplantation HSCT in acute myelogenous leukemia (AML) persist. Time to transplant introduces an immortal time and current treatment algorithm mainly relies on the ELN’s disease risk classification. Previous studies are also limited to age groups, remission status and other ill-defined parameters. We studied all patients at diagnosis irrespective of age and comorbidities to estimate the cumulative incidence and potential benefit or disadvantage of HSCT in a single center. As a time-dependent covariate, HSCT improved overall survival in intermediate and poor risk patients (hazard ratio 0.51; p=0.004). In good risk patients only 8 were transplanted in first complete remission. Overall, the 4-year cumulative incidence of HSCT was only 21.9% but was higher (52.1%) for patients in the first age quartile (16-57) and 26.4% in older patients (57-70); p.

PMID:36951151 | DOI:10.3324/haematol.2023.282729

Haematologica. 2023 Mar 23. doi: 10.3324/haematol.2022.281847. Online ahead of print.

ABSTRACT

Survival from extranodal nasal-type NK/T-cell lymphoma (ENKTCL) has substantially improved over the last decade. However, there is little consensus as to whether a population of patients with ENKTCL can be considered “cured” of the disease. We aimed to evaluate the statistical “cure” of ENKTCL in the modern treatment era. This retrospective multicentric study reviewed the clinical data of 1955 patients with ENKTCL treated with non-anthracycline-based chemotherapy and/or radiotherapy between 2008 and 2016 in China Lymphoma Collaborative Group multicenter database. A non-mixture cure model with incorporation of background mortality was fitted to estimate cure fractions, median survival times and cure time points. The relative survival curves attained plateau for the entire cohort and most subsets, indicating that the notion of cure was robust. The overall cure fraction was 71.9%. Median survival was 1.1 years in uncured patients. The cure time was 4.5 years, indicating that beyond this time, mortality in ENKTCL patients was statistically equivalent to that in the general population. Cure probability was associated with B symptoms, stage, performance status, lactate dehydrogenase, primary tumor invasion, and primary upper aerodigestive tract site. Elderly patients (>60 years) had similar cure fraction to that of younger patients. Five-year overall survival rate correlated well with the cure fraction across risk-stratified groups. Thus, statistical cure is possible in ENKTCL patients receiving current treatment strategies. Overall probability of cure is favorable, though it is affected by presence of risk factors. These findings have a high potential impact on clinical practice and patients’ perspective.

PMID:36951150 | DOI:10.3324/haematol.2022.281847

Vet Rec. 2023 Mar 23:e2833. doi: 10.1002/vetr.2833. Online ahead of print.

ABSTRACT

BACKGROUND: Oedema is described in the soft palate of dogs affected by brachycephalic obstructive airway syndrome (BOAS). Activated mast cells (MCs) release vasoactive mediators that temporarily increase vascular permeability.

METHODS: Data and caudal soft palate tissue were prospectively collected from a population of dogs undergoing surgical management of BOAS and a control group of greyhound cadavers with no previous history of respiratory signs. Histological assessment was performed to quantify the number of MCs within the lamina propria of each group.

RESULTS: The mean number of MCs in the BOAS group (53 MCs/10 400× high-power fields [HPF]; standard deviation [SD] = 23) was significantly greater than that in the greyhound group (24 MCs/10 400×HPF; SD = 10).

LIMITATIONS: The small size of the control group and the heterogeneous nature of the dogs in the BOAS group limit the generalisability of the findings. The use of different surgical techniques in the BOAS group may have also affected the degree of inflammation present within the samples. The cohort was not screened for concurrent disease processes that could potentially increase the number of circulating MCs.

CONCLUSION: This study demonstrated a statistically significant difference between the numbers of MCs in the soft palate of brachycephalic dogs with clinically significant BOAS and the greyhound control group.

PMID:36951103 | DOI:10.1002/vetr.2833

J Intern Med. 2023 Mar 23. doi: 10.1111/joim.13633. Online ahead of print.

ABSTRACT

BACKGROUND: Although classic heat stroke (HS) is one of the most ancient conditions known to humans, the description of its early clinical manifestations, natural course, and complications remains uncertain.

OBJECTIVES: A systematic review of the demographics, clinical characteristics, biomarkers, therapy, and outcomes of HS during the Muslim (Hajj) pilgrimage in the desert climate of Makkah, Saudi Arabia.

METHODS: We searched the MEDLINE, Embase, Web of Science Core Collection, SCOPUS, and CINAHL databases from inception to April 2022. We summarized the data from eligible studies and synthesized them in narrative form using pooled descriptive statistics.

RESULTS: Forty-four studies, including 2,632 patients with HS, met the inclusion criteria. Overweight or obesity, diabetes, and cardiovascular disease were prevalent among cases of HS. Evidence suggests that extreme hyperthermia (pooled mean = 42.0°C [95%CI: 41.9, 42.1], range 40-44.8°C) with hot and dry skin (>99% of cases) and severe loss of consciousness (mean GCS<8 in 53.8% of cases) were the dominant clinical characteristics of classic HS. Hypotension, tachypnea, vomiting, diarrhea, and biochemical biomarkers indicating mild to moderate rhabdomyolysis, acute kidney, liver, and heart injury, and coagulopathy were frequent at the onset. Concomitantly, stress hormones (cortisol and catecholamines) and biomarkers of systemic inflammation and coagulation activation were increased. HS was fatal in 1 in 18 cases (pooled case fatality rate = 5.6% [95%CI: 4.6, 6.5]).

CONCLUSIONS: The findings of this review suggest that HS induces an early multiorgan injury that can progress rapidly to organ failure, culminating in death, if it is not recognized and treated promptly.

PROSPERO REGISTRATION: CRD42022325759. This article is protected by copyright. All rights reserved.

PMID:36951097 | DOI:10.1111/joim.13633

Stat Methods Med Res. 2023 Mar 23:9622802231160551. doi: 10.1177/09622802231160551. Online ahead of print.

ABSTRACT

Screening mammography is the primary preventive strategy for early detection of breast cancer and an essential input to breast cancer risk prediction and application of prevention/risk management guidelines. Identifying regions of interest within mammogram images that are associated with 5- or 10-year breast cancer risk is therefore clinically meaningful. The problem is complicated by the irregular boundary issue posed by the semi-circular domain of the breast area within mammograms. Accommodating the irregular domain is especially crucial when identifying regions of interest, as the true signal comes only from the semi-circular domain of the breast region, and noise elsewhere. We address these challenges by introducing a proportional hazards model with imaging predictors characterized by bivariate splines over triangulation. The model sparsity is enforced with the group lasso penalty function. We apply the proposed method to the motivating Joanne Knight Breast Health Cohort to illustrate important risk patterns and show that the proposed method is able to achieve higher discriminatory performance.

PMID:36951095 | DOI:10.1177/09622802231160551

Stroke. 2023 Mar 23. doi: 10.1161/STROKEAHA.122.041660. Online ahead of print.

ABSTRACT

BACKGROUND: Randomized controlled trials (RCTs) proved that short-term (21-90 days) dual antiplatelet therapy (DAPT) reduces the risk of early ischemic recurrences after a noncardioembolic minor stroke or high-risk transient ischemic attack (TIA) without substantially increasing the hemorrhagic risk. We aimed at understanding whether and how real-world use of DAPT differs from RCTs.

METHODS: READAPT (Real-Life Study on Short-Term Dual Antiplatelet Treatment in Patients With Ischemic Stroke or TIA) is a prospective cohort study including >18-year-old patients treated with DAPT after a noncardioembolic minor ischemic stroke or high-risk TIA from 51 Italian centers. The study comprises a 90-day follow-up from symptom onset. In the present work, we reported descriptive statistics of baseline data of patients recruited up to July 31, 2022, and proportions of patients who would have been excluded from RCTs. We compared categorical data through the χ² test.

RESULTS: We evaluated 1070 patients, who had 72 (interquartile range, 62-79) years median age, were mostly Caucasian (1045; 97.7%), and were men (711; 66.4%). Among the 726 (67.9%) patients with ischemic stroke, 226 (31.1%) did not meet the RCT inclusion criteria because of National Institutes of Health Stroke Scale score >3 and 50 (6.9%) because of National Institutes of Health Stroke Scale score >5. Among the 344 (32.1%) patients with TIA, 69 (19.7%) did not meet the RCT criteria because of age, blood pressure, clinical features, duration of TIA, presence of diabetes score <4 and 252 (74.7%) because of age, blood pressure, clinical features, duration of TIA, presence of diabetes score <6 and no symptomatic arterial stenosis. Additionally, 144 (13.5%) patients would have been excluded because of revascularization procedures. Three hundred forty-five patients (32.2%) did not follow the RCT procedures because of late (>24 hours) DAPT initiation; 776 (72.5%) and 676 (63.2%) patients did not take loading doses of aspirin and clopidogrel, respectively. Overall, 84 (7.8%) patients met the RCT inclusion/exclusion criteria.

CONCLUSIONS: The real-world use of DAPT is broader than RCTs. Most patients did not meet the RCT criteria because of the severity of ischemic stroke, lower risk of TIA, late DAPT start, or lack of antiplatelet loading dose.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique identifier: NCT05476081.

PMID:36951052 | DOI:10.1161/STROKEAHA.122.041660

Emerg Med Australas. 2023 Mar 23. doi: 10.1111/1742-6723.14201. Online ahead of print.

ABSTRACT

OBJECTIVE: In Queensland, where a person experiences a major disturbance in their mental capacity, and is at risk of serious harm to self and others, an emergency examination authority (EEA) authorises Queensland Police Service (QPS) and Queensland Ambulance Service (QAS) to detain and transport the person to an ED. In the ED, further detention for up to 12 h is authorised to allow the examination to be completed. Little published information describes these critical patient encounters.

METHODS: Queensland’s Public Health Act (2005), amended in 2017, mandates the use of the approved EEA form. Data were extracted from a convenience sample of 942 EEAs including: (i) patient age, sex, address; (ii) free text descriptions by QPS and QAS officers of the person’s behaviour and any serious risk of harm requiring urgent care; (iii) time examination period commenced; and (iv) outcome upon examination.

RESULTS: Of 942 EEA forms, 640 (68%) were retrieved at three ‘larger central’ hospitals and 302 (32%) at two ‘smaller regional’ hospitals in non-metropolitan Queensland. QPS initiated 342 (36%) and QAS 600 (64%) EEAs for 486 (52%) males, 453 (48%) females and two intersexes (<1%), aged from 9 to 85 years (median 29 years, 17% aged <18 years). EEAs commonly occurred on weekends (32%) and between 2300 and midnight (8%), characterised by ‘drug and/or alcohol issues’ (53%), ‘self-harm’ (40%), ‘patient aggression’ (25%) and multiple prior EEAs (23%). Although information was incomplete, most patients (78%, n = 419/534) required no inpatient admission.

CONCLUSIONS: EEAs furnish unique records for evaluating the impacts of Queensland’s novel legislative reforms.

PMID:36951038 | DOI:10.1111/1742-6723.14201