Tag: statistics

Asia Pac J Clin Oncol. 2021 Jun 23. doi: 10.1111/ajco.13595. Online ahead of print.

ABSTRACT

OBJECTIVE: PSMA PET/CT has demonstrated superior sensitivity over conventional imaging in the detection of local and distant recurrence in biochemically relapsed (BCR) prostate cancer. We prospectively investigated the management impact of ⁶⁸ Ga-PSMA PET/CT imaging in men with BCR, with the aim of identifying baseline clinicopathological predictors for management change.

PATIENTS AND METHODS: Men with BCR who met eligibility criteria underwent ⁶⁸ Ga-PSMA-11 PET/CT at Monash Health (Melbourne, Australia). Intended management plans were prospectively documented before and after ⁶⁸ Ga-PSMA PET/CT imaging. Binary logistic regression analysis was performed to identify potential clinicopathological predictors of management change. Descriptive statistics were used to characterize the nature of these changes.

RESULTS: Seventy men underwent ⁶⁸ Ga-PSMA-11 PET/CT imaging. Median age was 67 years (IQR 63-72) and median PSA was 0.48 ng/ml (IQR 0.21-1.9). PSMA-avid disease was observed in 56% (39/70) of patients. Pre-scan management plan was altered following scanning in 43% (30/70) of patients. Management changes were significantly more common in patients with higher baseline PSA levels (PSA≥2 ng/ml, p = 0.01). 18/36 (50%) of the patients initially planned for watchful waiting had their management changed, including the use of salvage pelvic radiotherapy (n = 7) and stereotactic ablative body radiotherapy to oligometastatic disease (n = 6).

CONCLUSION: Management change after ⁶⁸ Ga-PSMA PET/CT for BCR is common and typically resulted in treatment intensification strategies in those planned for a watchful waiting approach. This study adds to the growing pool of evidence supporting the clinical utility of PSMA PET/CT imaging in the care of patients with BCR after definitive therapy.

PMID:34161628 | DOI:10.1111/ajco.13595

Am J Hematol. 2021 Jun 23. doi: 10.1002/ajh.26276. Online ahead of print.

ABSTRACT

Eliglustat, an oral substrate reduction therapy, is approved for eligible adults with Gaucher disease type 1. In the Phase 3 ENGAGE trial of previously untreated adults with Gaucher disease type 1, eliglustat-treated patients had statistically significant improvements in organ volumes and hematologic parameters compared with placebo in the 9-month primary analysis. We report final outcomes by time on eliglustat among all patients who participated in the ENGAGE trial and extension. No patient deteriorated clinically or withdrew due to adverse events; 39/40 patients entered the open-label extension period and 34/40 (85%) remained in the trial until completion or switching to commercial eliglustat after its approval (2.3 to 6 years). Clinically meaningful improvements in Gaucher disease manifestations were seen in all patients concomitant with reductions in pathological lipid substrate levels (glucosylceramide and glucosylsphingosine). Among patients with 4.5 years of eliglustat exposure, mean spleen volume decreased by 66% (from 17.1 to 5.8 multiples of normal [MN], n=13)mean liver volume decreased by 23% (from 1.5 to 1.1 MN, n=13), mean hemoglobin increased 1.4 g/dL (from 11.9 to 13.4 g/dL, n=12), mean platelet count increased by 87% (from 67.6 to 122.6 x 10⁹ /L, n=12), median chitotriosidase decreased by 82% (from 13,394 to 2312 nmol/hr/ml, n=11), median glucosylceramide decreased by 79% (from 11.5 to 2.4 μg/mL, n=11), median glucosylsphingosine decreased by 84% (from 518.5 to 72.1 ng/mL, n=10), and mean spine T-score increased from -1.07 (osteopenia) to -0.53 (normal) (n=9). Together, these outcomes regardless of time on eliglustat showed comparable improvements in Gaucher manifestations and disease biomarkers. Eliglustat was well-tolerated and led to clinically significant improvements in previously untreated patients with Gaucher disease type 1 during 4.5 years of treatment. This article is protected by copyright. All rights reserved.

PMID:34161616 | DOI:10.1002/ajh.26276

Am J Intellect Dev Disabil. 2021 Jul 1;126(4):324-340. doi: 10.1352/1944-7558-126.4.324.

ABSTRACT

Young children with developmental disabilities (DD) exhibit a range of strengths and weaknesses in cognitive, language, and adaptive skills. Identifying individual patterns of abilities across these domains is important for informing interventions. This study examines how 129 toddlers with significant developmental delays and less than 10 spoken words perform across different developmental domains and assessment methods (i.e., caregiver report and clinician-administered tests). Children exhibited statistically and clinically meaningful strengths and weaknesses across developmental domains, which may have important implications for differential interventions. Caregiver-reported and clinician-rated measures of cognition, language and adaptive functioning were highly related. However, the relation between caregiver report and clinician ratings was weaker for a subgroup of children with relatively more limited expressive language compared to other children in the sample.

PMID:34161562 | DOI:10.1352/1944-7558-126.4.324

Nicotine Tob Res. 2021 Jun 23:ntab134. doi: 10.1093/ntr/ntab134. Online ahead of print.

ABSTRACT

INTRODUCTION: Evidence suggests that cigarette smokers who switch to electronic nicotine delivery systems (ENDS) reduce their exposure to harmful toxicants and carcinogens. It is unclear if dual use is associated with decreases in exposure to toxicants.

METHODS: This parallel-group confinement study assessed changes in biomarkers of exposure (BOEs) over six days among healthy adult smokers who were randomized into 1 of 11 study groups: eight JUUL-brand System (JUUL) groups (4 JUUL flavors [Virginia Tobacco, Menthol, Mint, Mango] × 2 nicotine concentrations [5.0% or 3.0% by weight]); Dual Use group used preferred JUUL flavor (5.0% nicotine) and ≤50% usual brand (UB) cigarettes/day; UB Cigarette group, and one group abstained from all tobacco/nicotine product use (Abstinence group). Urine and blood analysis assessed changes in primary BOE endpoints (NNAL, 3-HPMA, MHBMA, S-PMA COHb) and secondary BOE endpoints (NNN, HMPMA, CEMA, 1-OHP, O-toluidine, 2-NA, 4-ABP) among 279 adult smokers.

RESULTS: In JUUL groups, median percent reductions in primary BOEs (Day 6-Baseline) were 90%- ≥100% of Abstinence; there were no significant differences between JUUL groups and Abstinence. All reductions in JUUL groups were substantially and statistically significantly greater than reductions in the UB Cigarette group (ps<0.025). Median reductions in primary BOEs in the Dual Use group were 43%-55% of Abstinence. Similar results were observed for secondary BOEs.

CONCLUSION: This study suggests that use of JUUL as a complete or partial substitute (i.e., dual use with ≥50% reduction in cigarette consumption) for combustible cigarettes can substantially reduce exposure to multiple toxins associated with cigarette smoking.

IMPLICATIONS: This study adds to the growing body of evidence supporting the utility of ENDS products as potentially reduced-harm alternatives to cigarettes for adult smokers. Adult smokers who switched completely from cigarette smoking to use of the JUUL System (“JUUL”) in two nicotine concentrations (5.0% and 3.0%) and four flavors significantly reduced their exposure to multiple classes of cigarette-related toxicants. Additionally, smokers who used JUUL and continued smoking but reduced their daily cigarette consumption by ≥50% (dual users) also significantly reduced their toxicant exposure compared to cigarette smoking.

PMID:34161586 | DOI:10.1093/ntr/ntab134

Neurosurgery. 2021 Jun 23:nyab221. doi: 10.1093/neuros/nyab221. Online ahead of print.

ABSTRACT

BACKGROUND: Venous thromboembolism (VTE) represents a rare but preventable postoperative complication. Unfractionated heparin (UH) and low-molecular-weight heparin (LMWH) are used to prevent VTE, but comparative studies of their safety and efficacy in the neurosurgical context are limited.

OBJECTIVE: To determine the relative safety and efficacy of UH and LMWH for prophylaxis after cranial surgery.

METHODS: We performed a retrospective analysis of 3204 elective intracranial surgical admissions in 2901 patients over the period 2013 to 2018. From chart review, we extracted demographic and clinical features, including diagnosis and procedure, drugs administered, and the occurrence of VTE events. To compare postoperative outcomes, we performed propensity score matching of patients receiving different drugs, and reviewed postoperative cranial imaging. To contextualize our results, we selected 14 prior neurosurgical studies of VTE prophylaxis to compare our outcomes to the existing literature.

RESULTS: In our sample of 3204 admissions, the overall rate of VTE was 0.8% (n = 27). Rates of VTE were not statistically different in matched cohorts receiving UH and LMWH (1.7% vs 1.0%, respectively); however, LMWH was associated with a higher rate of clinically significant intracranial hemorrhage (ICH) (3.4% vs 0.5%, P = .008). Literature review and meta-analysis supported these findings. Across studies, UH and LMWH were associated with similar rates of VTE. Studies in which patients received LMWH reported significantly higher rates of ICH (4.9% higher, P = .005).

CONCLUSION: We find that LMWH and UH show similar efficacy in preventing VTE; however, LMWH is associated with higher rates of ICH.

PMID:34161594 | DOI:10.1093/neuros/nyab221

Sao Paulo Med J. 2021 Jun 11:S1516-31802021005014203. doi: 10.1590/1516-3180.2020.0738.R1.0402021. Online ahead of print.

ABSTRACT

BACKGROUND: Back pain is a normal symptom during pregnancy and is expected to become worse beyond the first three months after childbirth.

OBJECTIVES: To determine the effectiveness of wearing unstable shoes instead of conventional shoes, regarding pain intensity, low back mobility and stability, among women with lumbopelvic pain (LPP) during the postpartum period.

DESIGN AND SETTING: Prospective, single-blinded, randomized clinical trial conducted at a podiatry and physiotherapy clinical center.

METHODS: A nine-week program of wearing either unstable shoes (A) or conventional shoes (B) was implemented. The following outcomes were measured in three assessments: pain intensity, using a visual analogue scale (VAS); low-back mobility, using a modified Schober test; and stability, using a pressure platform.

RESULTS: The lateral stability speed, anterior stability speed and anterior center of pressure (COP) showed significant (P < 0.05) decreases in the unstable shoes group after nine weeks, in relation to the conventional group. Intra-group measurements showed significant differences (P < 0.05) in VAS between the second and third assessments and between the first and third assessments in both groups. Intra-group evaluations also showed statistically significant differences (P < 0.05) in the lateral stability speed and anterior stability speed.

CONCLUSIONS: Unstable shoes were effective in decreasing the pain intensity at five and nine weeks in women with postpartum LPP. In addition, their use produced decreases in lateral stability speed, anterior stability speed and anterior COP at nine weeks.

PMID:34161523 | DOI:10.1590/1516-3180.2020.0738.R1.0402021

Arq Neuropsiquiatr. 2021 May;79(5):384-389. doi: 10.1590/0004-282X-ANP-2020-0018.

ABSTRACT

BACKGROUND: Nonconvulsive status epilepticus (NCSE) is a condition that needs timely diagnosis and treatment. It has insignificant clinical features and presents high risk of misdiagnosis.

OBJECTIVE: To investigate NCSE among patients with stroke, given that stroke plays an important role in the etiology of NCSE.

METHODS: In this retrospective study, acute stroke patients who were admitted and followed up at a stroke outpatient clinic between January 2013 and March 2016 were included. Patients with previous histories of epilepsy, brain tumor, head trauma, hypertensive encephalopathy, arteriovenous malformation, subarachnoid hemorrhage or cerebral venous thrombosis were excluded. Demographic properties, stroke etiology, imaging method, EEG findings, stroke severity according to the NIHSS score, functional disability and modified Rankin Scale were recorded for all patients.

RESULTS: Thirty-nine out of 792 stoke patients experienced NCSE. The mean age of the study population was 70±1.2 years (min-max: 46‒90). The study population was composed of 28 females (71.8%) and 11 males (28.2%). NCSE had early onset in 23 patients (59%) and late onset in 16 (41%). The early-onset NCSE patients were older and this was statistically significant between the groups (early onset: 73.5±11.5; late onset: 65.9±12.1; p=0.04). A history of previous stroke was more frequent in the late-onset NCSE group (14; 87,5%) than in the early-onset group (11; 47.8%) (p=0.01). The prognosis was worse in the early-onset group, but without statistical significance.

CONCLUSION: Changes in mental status in the early stages of stroke are mostly attributed to stroke itself, but NCSE should be suspected in the right clinical setting, such as in older patients with suspicious anatomical and clinical associations.

PMID:34161526 | DOI:10.1590/0004-282X-ANP-2020-0018

Rev Bras Enferm. 2021 Jun 16;74(2):e20190663. doi: 10.1590/0034-7167-2019-0663. eCollection 2021.

ABSTRACT

OBJECTIVES: to analyze the average direct cost of PICC insertion by nurses.

METHODS: this is a unique case study with a quantitative approach. The observation took place in a public hospital, collecting information on inputs used and procedure length. For the calculation of costs, time was multiplied by nurses’ costs plus supplies. The US dollar was used to present the calculations. In the analysis, descriptive statistics of measures of central tendency and variability were used.

RESULTS: the sample corresponded to 139 observations. The average cost of PICC insertion totaled US$286.04, with 90.8% of materials, mainly catheter, and 9.2% of the labor. The procedure took an average of 50 minutes, at US$0.26 per minute for nurses. Conclusions: the average direct cost of PICC insertion was US$286.04, with emphasis on the catheter. The results can support management decisions for adequate material and professional sizing.

PMID:34161537 | DOI:10.1590/0034-7167-2019-0663

Rev Bras Enferm. 2021 Jun 18;74(3):e20200770. doi: 10.1590/0034-7167-2020-0770. eCollection 2021.

ABSTRACT

OBJECTIVE: to verify the association between social network and functional disability in elderly Brazilians.

METHODS: a cross-sectional study with secondary data of 11,177 elderly people, available on Brazilian Institute of Geography and Statistics’ website. Social network components were having trusted friends/relative, living with their spouse, practicing social activity, performing voluntary or paid work. The outcome was functional disability, measured by the difficulty in performing instrumental and basic activities of daily living. Logistic regression models were used.

RESULTS: disability prevalence for instrumental activities was 28.0% (95%CI: 26.7-29.4), and for basic activities, 15.5% (95%CI: 14.4-16.6). Not having components social network components was associated with greater chances of functional disability, especially among women.

CONCLUSION: there was an association between not having social network components with functional disability. There are differences in this association according to sex. Strengthening actions that expand social network can reduce the chance of this outcome in elderly people.

PMID:34161502 | DOI:10.1590/0034-7167-2020-0770

Rev Bras Enferm. 2021 Jun 18;74(3):e20201101. doi: 10.1590/0034-7167-2020-1101. eCollection 2021.

ABSTRACT

OBJECTIVES: to analyze the spatial-temporal distribution of leprosy in a priority municipality for leprosy control.

METHODS: ecological study, conducted in a city in the Northeast of Brazil, whose analysis units were census sectors. The study used compulsory notification data for cases registered between 2008 and 2017. TerraView software and the Batch Geocode tool was used for geocoding. The detection of spatial-temporal agglomerations of high relative risks was done by scanning statistics.

RESULTS: the spatial-temporal distribution of cases was heterogeneous, creating four agglomerations of high relative risks in the urban area of the municipality between the years 2008 and 2012; and annual prevalence rates classified from high to hyperendemic.

CONCLUSIONS: areas of higher risk and concentration of the disease in space-time were linked to the characteristics of high population density and social vulnerability of these spaces, raising the prioritization of health professionals’ actions, systems, and services for control, and monitoring the disease.

PMID:34161506 | DOI:10.1590/0034-7167-2020-1101