Category: Statistics

Int J Pediatr Otorhinolaryngol. 2021 Aug 20;150:110893. doi: 10.1016/j.ijporl.2021.110893. Online ahead of print.

ABSTRACT

BACKGROUND: Neck-related chief complaints are common in the pediatric Emergency Department (ED), and although the incidence of pathology such as retropharyngeal abscesses is rare, the ability to rule out abscesses requiring surgical/procedural intervention is essential. However, there are no clear clinical guidelines regarding work-up and diagnosis in this population, possibly contributing to an excess use of potentially harmful and costly computed tomography (CT) imaging.

OBJECTIVE: In this study we sought to identify historical, physical exam, and laboratory findings associated with surgically significant neck abscesses to better delineate CT neck imaging criteria.

METHODS: We conducted a retrospective chart review of all patients ≤18 years presenting to a pediatric ED between 2013 and 2017 who underwent CT neck imaging. Surgically significant abscesses (SSAs) were defined as abscesses ≥2 cm, retropharyngeal abscesses (RPA), parapharyngeal abscesses (PPA), or peritonsillar abscesses (PTA). Historical factors, physical exam findings, laboratory results, demographics, and CT results were analyzed using univariate statistical analysis and regression models.

RESULTS: A total of 718 patients received neck CTs and 153 SSAs were identified. In children younger than 6 years, factors associated with statistically significant increased odds of an SSA were reported throat pain (OR 1.18; 95% CI 1.05, 1.33), fussiness (OR 1.18; 1.01, 1.39), lethargy (OR 1.43; 1.07, 1.91), tonsillar enlargement (OR 1.17; 1.02, 1.34), C-reactive protein (CRP) > 10 (OR 1.22; 1.07, 1.40), and an ED visit within the preceding week (OR 1.18; 1.04, 1.33). In children older than 6 years, the factors associated with statistically significant increased odds of an SSA included current antibiotic use (OR 1.12; 1.02, 1.22) and a CRP >10 (OR 1.14; 1.03, 1.26).

CONCLUSION: Some historical, physical exam, and laboratory findings are associated with SSAs, and while not definitive in isolation, may be beneficial additions to routine SSA assessment, as a supplement to clinical judgement regarding CT and observation decisions. This may potentially allow for the identification of patients requiring CT versus those who may not, and thus the opportunity to safely reduce the use of CT imaging in select patients.

PMID:34438187 | DOI:10.1016/j.ijporl.2021.110893

Mult Scler Relat Disord. 2021 Aug 14;55:103205. doi: 10.1016/j.msard.2021.103205. Online ahead of print.

ABSTRACT

BACKGROUND: People with Multiple Sclerosis (PwMS) experience a wide range of symptoms that can alter function and limit activity and community participation. Symptoms including sensory changes, weakness, fatigue and others have been well documented. However, symptoms related to changes in vestibular related function, including gaze and postural stability have not been fully explored. While some recent studies have begun to provide insight into these deficits in PwMS and have explored the use of rehabilitation paradigms for their management, much remains unknown about the full extent of these deficits. Therefore, this study aimed to characterize the presence of gaze and postural stability deficits in measures across the World Health Organization International Classification of Functioning, Disability, and Health (WHO ICF) and to examine how deficits in domains of body structure and function and activity contribute to participation level limitations.

METHODS: Baseline data from 41 PwMS (mean(SD) age = 53.9(11.2), 78% female) enrolled as part of a randomized clinical trial were used in this analysis. Measures of gaze and postural stability from the ICF domains of body structure and function (Vestibular ocular reflex [VOR] gain and postural sway area), activity (computerized dynamic visual acuity [cDVA] and MiniBEST test), and participation (Dizziness handicap inventory [DHI] and Activities Balance Confidence [ABC] scale) along with demographic data were used to characterize the sample. To explore relationships between ICF domains for gaze and postural stability, univariate correlations were performed between measures from each domain using Pearson’s correlations. Separate multivariate regression models examined how measures from the body structure and function and activity domains contributed to the variance in the participation level outcomes. Variance explained by the models was quantified using R-squared statistic and contribution of the independent variables were quantified using the beta coefficient (p < 0.05).

RESULTS: Correlation analysis demonstrated significant relationships in the postural stability measures across domains. Specifically, between postural sway area on a firm surface and MiniBEST test score (r = -.48;p < 0.01) and MiniBEST test score and ABC score (r = 0.5;p < 0.01). Significant correlations were also found between the gaze stability measures of horizontal and vertical VOR gain (r = .68;p < 0.001), horizontal VOR gain and dynamic visual acuity (r = .38;p = 0.02), and vertical VOR gain and dynamic visual acuity (r = .54;p < 0.001). Regression models assessing postural stability, found that only the MiniBEST score significantly contributed to the variance in ABC score (p = 0.01) and the full model explained 34% of the variance in ABC score. Regression modeling of gaze stability outcomes did not produce any variable that significantly contributed to the variance in DHI score and the full model explained 18% of the variance in DHI score.

CONCLUSIONS: PwMS in this sample demonstrated deficits in gaze and postural stability across the domains of the WHO ICF compared to past samples of PwMS and healthy cohorts. Correlation between measures in the different domains were present, but no strong relationship between measures of body structure and function, activity and participation level outcomes were observed. This lack of relationship across the domains is likely contributed to the relatively small sample size, the high level of variability observed in the outcomes, and the diverse presentation often seen in PwMS.

PMID:34438218 | DOI:10.1016/j.msard.2021.103205

J Forensic Leg Med. 2021 Aug 21;83:102244. doi: 10.1016/j.jflm.2021.102244. Online ahead of print.

ABSTRACT

BACKGROUND: Three-dimensional imaging is a rapidly growing technology that has revealed exciting insights in disparate fields of research, especially in medicine, forensics, and archaeology. Recent advancements in this technology have also made a remarkable impact in the field of anthropology and odontology. A major benefit of this technology is that they offer effective methods of creating digital records that can aid in physical documentation and can be digitally stored for later assessment and research.

AIM: The aim of the current study is to evaluate the metric accuracy of 3D models generated using three different 3D acquisition techniques for performing metric analytical procedures.

MATERIALS AND METHOD: Twenty standard craniometric linear measurements (using both sliding and spreading callipers) were taken on two craniums and eight standard measurements were taken on 2 mandibles (using sliding callipers and a mandibulometer); these measurements were then replicated on 3D digital models.

RESULTS: Statistical analysis of these dataset using Analysis of Variance (ANOVA) and post hoc Bonferroni test suggested that the physical and virtual measurements were accurate, comparable, and concordant (p > 0.05).

CONCLUSION: These findings open up numerous avenues for future study, especially in the fields of forensics and clinical studies. However, in order to overcome the limitations faced in using the digital method certain standardised protocols and guidelines must be established to record these data.

PMID:34438227 | DOI:10.1016/j.jflm.2021.102244

Sci Total Environ. 2021 Aug 13;801:149619. doi: 10.1016/j.scitotenv.2021.149619. Online ahead of print.

ABSTRACT

River systems have undergone a massive transformation since the Anthropocene. The natural properties of river systems have been drastically altered and reshaped, limiting the use of management frameworks, their scientific knowledge base and their ability to provide adequate solutions for current problems and those of the future, such as climate change, biodiversity crisis and increased demands for water resources. To address these challenges, a socioecologically driven research agenda for river systems that complements current approaches is needed and proposed. The implementation of the concepts of social metabolism and the colonisation of natural systems into existing concepts can provide a new basis to analyse the coevolutionary coupling of social systems with ecological and hydrological (i.e., ‘socio-ecohydrological’) systems within rivers. To operationalize this research agenda, we highlight four initial core topics defined as research clusters (RCs) to address specific system properties in an integrative manner. The colonisation of natural systems by social systems is seen as a significant driver of the transformation processes in river systems. These transformation processes are influenced by connectivity (RC 1), which primarily addresses biophysical aspects and governance (RC 2), which focuses on the changes in social systems. The metabolism (RC 3) and vulnerability (RC 4) of the social and natural systems are significant aspects of the coupling of social systems and ecohydrological systems with investments, energy, resources, services and associated risks and impacts. This socio-ecohydrological research agenda complements other recent approaches, such as ‘socio-ecological’, ‘socio-hydrological’ or ‘socio-geomorphological’ systems, by focusing on the coupling of social systems with natural systems in rivers and thus, by viewing the socioeconomic features of river systems as being just as important as their natural characteristics. The proposed research agenda builds on interdisciplinarity and transdisciplinarity and requires the implementation of such programmes into the education of a new generation of river system scientists, managers and engineers who are aware of the transformation processes and the coupling between systems.

PMID:34438150 | DOI:10.1016/j.scitotenv.2021.149619

J Am Coll Surg. 2021 Aug 23:S1072-7515(21)01927-X. doi: 10.1016/j.jamcollsurg.2021.07.687. Online ahead of print.

ABSTRACT

BACKGROUND: Peri-operative thromboprophylaxis guidelines offer conflicting recommendations on when to start thromboprophylaxis. As a result, there is significant variation in clinical practice which may lead to worse patient outcomes. The objective of this study was to evaluate the association between the start time of peri-operative thromboprophylaxis with venous thromboembolism (VTE) and bleeding outcomes.

STUDY DESIGN: EMBASE, MEDLINE and CENTRAL databases were searched on October 23, 2020. Randomized controlled trials that evaluated VTE and/or bleeding between groups receiving the initial dose of pharmacological thromboprophylaxis at different times pre-operatively, intra-operatively or post-operatively were included. Only trials that randomized patients to the same medication between groups were eligible. Studies on any type of surgery were included. The PRISMA guidelines were followed. The Cochrane Collaboration Risk of Bias tool was used. The review was registered with PROSPERO (CRD42019142079). The outcomes of interest were VTE and bleeding. Pre-specified subgroup analyses of studies including orthopedic and non-orthopedic surgery were performed.

RESULTS: A total of 22 trials (n=17,124 patients) met eligibility criteria. Pooled results showed a non-statistically significant decrease in the rate of VTE with pre-operative initiation of thromboprophylaxis when compared to post-operative initiation (RR 0.77, 95% CI 0.55-1.08, I²=0%, n=1,933). There was also a non-statistically significant increase in the rate of bleeding with pre-operative initiation compared to post-operative (RR 1.17, 95% CI 0.94-1.46, I²=35%, n=2,752). The risk of bias was moderate. Heterogeneity between studies was low (I² 0-35%).

CONCLUSIONS: This meta-analysis found a non-statistically significant decrease in the rate of VTE and increase in the rate of bleeding when thromboprophylaxis was initiated pre-operatively compared to post-operatively.

PMID:34438079 | DOI:10.1016/j.jamcollsurg.2021.07.687

J Acad Consult Liaison Psychiatry. 2021 Aug 23:S2667-2960(21)00144-0. doi: 10.1016/j.jaclp.2021.08.004. Online ahead of print.

ABSTRACT

PURPOSE: Psychological distress and manifest mental disorders are overlooked in 30 to 50% of patients with cancer. Accordingly, international cancer treatment guidelines recommend routine screening for distress in order to provide psychological support to those in need. Yet, institutional and patient related factors continue to hinder implementation. This study aims to investigate factors, which are associated with no screening for distress in cancer patients.

METHODS: Using machine learning, factors associated with lack of distress screening were explored in 6,491 patients with cancer between 2011 and 2019 at a large cancer treatment center. Parameters were hierarchically ordered based on statistical relevance. Nested resampling and cross validation were performed to avoid overfitting and to comply with assumptions for machine learning approaches.

RESULTS: Patients unlikely to be screened were not discussed at a tumor board, had inpatient treatment of less than 28 days, did not consult with a psychiatrist or clinical psychologist, had no (primary) nervous system cancer, no head and neck cancer, and did have breast or skin cancer. The final validated model was optimized to maximize sensitivity at 83.9% and achieved a balanced accuracy of 68.9, AUC of 0.80, and specificity of 53.9%.

CONCLUSION: Findings of this study may be relevant to stakeholders at both a clinical and institutional level in order to optimize distress screening rates.

PMID:34438098 | DOI:10.1016/j.jaclp.2021.08.004

World Neurosurg. 2021 Aug 23:S1878-8750(21)01243-2. doi: 10.1016/j.wneu.2021.08.073. Online ahead of print.

ABSTRACT

BACKGROUND: Serum biomarkers have gained significant popularity as an adjunctive measure in the evaluation and prognostication of traumatic brain injury (TBI). However, a concise and clinically oriented report of the major markers in function of TBI severity is lacking.

OBJECTIVE: This systematic review aims to report current data on the diagnostic and prognostic utility of blood-based biomarkers across the spectrum of TBI.

METHODS: A literature search of the PubMed/Medline electronic database was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. We excluded systematic reviews and meta-analyses that did not provide novel data. The American College of Cardiology/American Heart Association criteria were used to assess levels of evidence.

RESULTS: An initial 1463 studies were identified. 115 full-text articles reporting on 94 distinct biomarkers met the inclusion criteria. Glasgow Coma Scale scores, computed tomography/magnetic resonance imaging abnormalities, and injury severity scores were the most used clinical diagnostic variables. Glasgow Outcome Scores, 1, 3, and 6-month mortality were the most used clinical prognostic variables. Several biomarkers significantly correlated with these variables and had statistically significant different levels in TBI subjects when compared to healthy, orthopedic, and polytrauma controls. The biomarkers also displayed significant variability across mild, moderate, and severe TBI categories, as well as in concussion cases.

CONCLUSION: This review summarizes existing high-quality evidence that supports the use of severity-specific biomarkers in the diagnostic and prognostic evaluation of TBI. This data can be used as a launching platform for the validation of upcoming clinical studies.

PMID:34438102 | DOI:10.1016/j.wneu.2021.08.073

Ann Oncol. 2021 Aug 23:S0923-7534(21)04275-7. doi: 10.1016/j.annonc.2021.08.1991. Online ahead of print.

ABSTRACT

BACKGROUND: Diffuse large B-cell lymphoma (DLBCL) is a heterogeneous disease with respect to outcome. Features of the tumor microenvironment are associated with prognosis when assessed by gene expression profiling. However, it is uncertain whether assessment of the microenvironment can add prognostic information to the most relevant and clinically well-established molecular subgroups when analyzed by immunohistochemistry.

PATIENTS AND METHODS: We performed a histopathologic of biomarkers related to tumor microenvironment in a very large cohort (n=455) of DLBCL treated in prospective trials and correlated with clinic-pathologic and molecular data, including chromosomal rearrangements and gene expression profiles for cell-of-origin and tumor microenvironment.

RESULTS: The content of PD1+, FoxP3+ and CD8+, as well as vessel density, was not associated with outcome. However, we found a low content of CD68+ macrophages to be associated with inferior progression-free (PFS) and overall survival (OS) (p=0.023 and p=0.040, respectively) both at univariable and multivariable analysis, adjusted for the factors of the international prognostic index (IPI), MYC break and BCL2/MYC and BCL6/MYC double hit status. The subgroup of PDL1+ macrophages was not associated with survival. Instead, Secreted Protein Acidic And Cysteine Rich (SPARC)-positive macrophages were identified as the subtype of macrophages most associated with survival. SPARC-positive macrophages and stromal cells directly correlated with favorable PFS and OS (both, p[log rank] <0.001, p[trend]<0.001). The association of SPARC with prognosis was independent of the factors of the IPI, MYC double/triple hit status, Bcl2/c-myc double expression, cell of origin subtype and a recently published gene expression signature (LAMIS).

CONCLUSIONS: SPARC expression in the tumor microenvironment detected by a single immunohistochemical staining with fair-to-good inter-observer reproducibility is a powerful prognostic parameter. Thus, SPARC expression is a strong candidate for risk assessment in DLBCL in daily practice.

PMID:34438040 | DOI:10.1016/j.annonc.2021.08.1991

Clin Microbiol Infect. 2021 Aug 23:S1198-743X(21)00423-7. doi: 10.1016/j.cmi.2021.07.031. Online ahead of print.

ABSTRACT

OBJECTIVES: The immunogenicity and safety of the Pfizer-BioNTech BNT162b2 mRNA vaccine in people living with HIV-1 (PLWH) are unknown. We thus aimed to assess the immunogenicity and safety of this vaccine in PLWH.

METHODS: In this prospective open study, we enrolled 143 PLWH, aged ≥18 years, who attended our clinic and 261 immunocompetent health care workers (HCWs). SARS-CoV-2 receptor binding domain (RBD) IgG and neutralizing antibodies were measured. Adverse events, viral load and CD4 cell counts were monitored.

RESULTS: At a median of 18 days (IQR 14-21) after the second dose, anti-RBD IgG was positive in 139/141 (98%) PLWH. Among HCWs, 258/261 (98.9%) developed anti-RBD IgG at a median of 26 (IQR 24-27) days after the second dose. Following the second dose, immune sera neutralized SARS-CoV-2 pseudo-virus in 97% and 98% of PLWH and HCW, respectively. Adverse events were reported in 60% of PLWH, mainly pain at the injection site, fatigue, and headache. AIDS-related adverse events were not reported. HIV viral load increased in 3/143 (2%) patients from < 40 copies/mL to ≤ 100 copies/mL. CD4+ T cell count decreased from a geometric mean of 700 (95% CI 648-757) cells per μL to 633.8 (95% CI 588-683) cells per μL (P<0.01).

CONCLUSIONS: BNT162b2 mRNA vaccine appears immunogenic and safe in PLWH who are on ART with unsuppressed CD4 count and suppressed viral load.

PMID:34438069 | DOI:10.1016/j.cmi.2021.07.031

J Ethnopharmacol. 2021 Aug 23:114549. doi: 10.1016/j.jep.2021.114549. Online ahead of print.

ABSTRACT

ETHNOPHARMACOLOGICAL RELEVANCE: Kaixinsan (KXS) decoction, as an herbal formula, was used to treat the diseases, such as insomnia, amnesia, emotional disorders in ancient china. It has been demonstrated to be active in various animal models resembling human depression with multitarget effects. However, effective verification on the clinical application of KXS is still lacking. Supplements in this knowledge field are urgently needed.

AIM OF THE STUDY: This very first study evaluated the efficacy and tolerability of ShenZhiLing (SZL) tablets (KXS preparation), compared with fluoxetine (FLX, positive comparator), in patients with mild to moderate depressive disorder.

MATERIALS AND METHODS: In this randomized, double-blind, parallel-group study, 156 patients with mild to moderate depression without taken any antidepressants in the past 6 months or 4 continuous weeks were randomized to receive either 3.2g/d SZL plus 20mg/d FLX placebo (SZL group) or 20mg/d FLX plus 3.2g/d SZL placebo (FLX group), for 8 weeks. Their clinical presentations and some metabolic indexes were assessed during the 8 weeks’ visiting period.

RESULTS: Patients in SZL group showed a statistically significant improvement after 8 weeks of treatment in HAM-D17 score (18.79±2.09 to 4.43±4.71, p<0.001) and self-rating depression scale (SDS) score (58.49±8.89 to 39.84±12.09, p<0.001), but not in N-back total respond time (1145.55±608.26 to 1128.47±387.49, p>0.05). In addition, no significant difference at 8 weeks of treatment was found between SZL and FLX groups in SDS score (39.84±12.09 vs. 36.63±12.44) and N-back respond time (1128.47±387.49 vs. 1089.43±352.08) as well as reduction of HAM-D17 score (14.79±4.88 vs. 15.24±4.29) (p>0.05 for all). However, the serum APOB, APOC3 and ALB levels and LDL-C/HDL-C ratio decreased significantly in patients after SZL treatment, while only APOB/APOA1 ratio decreased significantly in FLX group. Other metabolic indexes did not alter significantly after treated with SZL or FLX.

CONCLUSION: The efficacy and safety profile of SZL are comparable to that of fluoxetine in patients with mild to moderate depression. The beneficial effect of SZL is probably associated with improvement of lipid metabolic balance.

PMID:34438029 | DOI:10.1016/j.jep.2021.114549