Tag: statistics

Hemodial Int. 2021 Jul 8. doi: 10.1111/hdi.12971. Online ahead of print.

ABSTRACT

INTRODUCTION: Intradialytic hypotension (IDH) is a common complication of hemodialysis (HD) and is associated with excess morbidity and mortality. Higher serum phosphate is associated with adverse cardiovascular outcomes in maintenance HD patients; however, its association with IDH has not previously been assessed.

METHODS: This is an analysis of a prospective cohort of 969 HD patients (80,968 HD sessions) receiving HD at a large dialysis organization (LDO) and a post-hoc analysis of 1838 HD patients (10,594 HD sessions) in the Hemodialysis study (HEMO), a multicenter randomized controlled trial that examined standard or high-dose HD and low-flux or high-flux membranes. Unadjusted and adjusted mixed effects regression models were fit to determine the association of pre-HD serum phosphate with IDH, defined as a nadir intra-HD systolic blood pressure (SBP) <90 mmHg.

FINDINGS: In the LDO cohort, baseline mean pre-HD serum phosphate was 5.2 ± 1.7 mg/dl. IDH occurred in 15.6% of HD sessions. In the adjusted model, higher pre-HD serum phosphate (per 1 mg/dl) was associated with a 12% increased risk of IDH (aOR 1.12, 95% CI 1.10-1.13, p <0.001). In exploratory models where pre-HD laboratory values were available, the effect estimate was attenuated but remained statistically significant (aOR 1.05; 95% CI 1.02-1.08; p <0.01). Participants in the highest (compared with the lowest) quartile of pre-HD serum phosphate had a 56% greater risk of IDH in the adjusted model (aOR Q4:Q1 1.56; 95% CI 1.44-1.68, p <0.001). The association of higher phosphate with IDH was consistent in the HEMO data.

DISCUSSION: Higher pre-HD serum phosphate is independently associated with an increased risk of IDH. As HD may cause an acute decline in serum phosphate, future studies to investigate the mechanisms of this association are warranted.

PMID:34236130 | DOI:10.1111/hdi.12971

Environ Toxicol Chem. 2021 Jul 8. doi: 10.1002/etc.5152. Online ahead of print.

ABSTRACT

Deriving water quality criteria (WQC) for aquatic risk assessment, requires sufficient toxicity data, which can determine the accuracy of WQC. Given that toxicity data varies between test species and endpoints, there is a great need to compare such data to generate the most suitable data set for WQC derivation. In this study, a series of 11 ammonia exposure bioassays were conducted on Chironomidae species in either China or Australia, with test species and test endpoints varied (2 Chironomus sp., enzymatic up to lethal endpoints, and NOEC up to LC50 as endpoint metrics). It was found that there were no statistically significant differences between toxicity results generated from China compared to Australia using Chironomus sp., indicating that published data on native species generated in different countries could be appropriate for inclusion in the development of local Chinese WQC. In addition, Chironomidae larvae laboratory-based toxicity value (LC50 of 384.6 mg/L) was lower than that of the in situ field-based toxicity value (LC50 ≥ 451.2 mg/L) where sensitive life stages are used and, specifically for C. riparius, endpoints linked to biochemical and gene expression effects could be as sensitive, or more sensitive than chronic endpoints, both of which were more sensitive than acute endpoints. These findings help in the development of WQC by demonstrating the suitability of inclusion of toxicity data from a range of sources, as well as adding to the overall pool of knowledge regarding sensitivity to ammonia which can be used in aquatic risk assessment. This article is protected by copyright. All rights reserved.

PMID:34236106 | DOI:10.1002/etc.5152

Environ Toxicol Chem. 2021 Jul 8. doi: 10.1002/etc.5154. Online ahead of print.

ABSTRACT

Bumblebees can be exposed to neonicotinoid pesticides through nectar and pollen collected from treated crops, which can cause lethal and sublethal effects in these non-target pollinators. However, the body distribution of the compound after exposure to neonicotinoids in bumblebees is not well studied. Bumblebee colonies (Bombus terrestris, n = 20) were exposed to field-realistic concentrations of clothianidin through artificial nectar (3.6 µg/L – 13 µg/L) for nine days. Comparison of the nominal- to the measured exposure in nectar indicated good compliance, confirming the applicability of the method. When quantified, clothianidin showed a concentration-dependent occurrence in the head and body of workers (head: <0.2 – 2.17 µg/kg, body: <0.2 – 3.17 µg/kg), and in the body of queens (<0.2 – 2.49 µg/kg), although concentrations were below that measured in the nectar (Bioaccumulation factor = 0.2). Exposure to clothianidin did not affect mortality nor brood production, nor have a statistically significant effect on nectar consumption and size of food storage. However, visual inspection suggests higher nectar consumption of nectar with low clothianidin content compared to nectar with no or high clothianidin content. Our results show that dietary clothianidin is taken up in bumblebees, but does not bioaccumulate to elevated levels compared to exposure. Still, clothianidin may elicit responses that affect feeding behaviour of the pollinator B. terrestris, although our endpoints were not significantly affected. This article is protected by copyright. All rights reserved.

PMID:34236107 | DOI:10.1002/etc.5154

Laryngoscope. 2021 Jul 8. doi: 10.1002/lary.29746. Online ahead of print.

ABSTRACT

OBJECTIVES/HYPOTHESIS: Dermal filler (DF) is a widely used nonsurgical option for facial rejuvenation with a rapidly expanding market. Physician payments by DF industry leaders have yet to be characterized. We sought to investigate trends in physician-industry payments by DF companies over 6 years. Differences in payments based on physician specialty and time were characterized.

STUDY DESIGN: Database review.

METHODS: The Open Payments Database was queried from 2013 to 2018. Payments made by the three largest DF companies by market share to otolaryngologists, plastic surgeons, and dermatologists were analyzed. Total dollars paid, number of payments made, type of payments made, and total number of specialists paid were recorded. One-way ANOVA was used for statistical analysis.

RESULTS: Otolaryngologists, plastic surgeons, and dermatologists received average annual payments of $0.36 million, $6.3 million, and $6.6 million respectively (P < .001). An average of 330 otolaryngologists, 2,128 plastic surgeons, and 5,980 dermatologists were paid annually (P < .001). Accredited speaking arrangements, consulting fees, and royalty/licensing fees comprised the majority of dollars paid to physicians.

CONCLUSIONS: Average physician payment by DF companies exceeds $12 million annually, with otolaryngologists receiving significantly less compared to plastic surgeons and dermatologists.

LEVEL OF EVIDENCE: Not applicable Laryngoscope, 2021.

PMID:34236083 | DOI:10.1002/lary.29746

Mov Disord. 2021 Jul 8. doi: 10.1002/mds.28703. Online ahead of print.

ABSTRACT

BACKGROUND: There are limited data regarding the effectiveness of levodopa-carbidopa intestinal gel (LCIG) for dyskinesia.

OBJECTIVE: Compare the effectiveness of LCIG versus oral optimized medical treatment (OMT) for dyskinesia in patients with advanced Parkinson’s disease (PD) using the Unified Dyskinesia Rating Scale (UDysRS).

METHODS: This phase 3b, open-label, multicenter, 12-week, interventional study (NCT02799381) randomized 63 LCIG naïve patients with advanced PD (UDysRS ≥30) to LCIG (N = 30) or OMT (N = 33) treatment. Dyskinesia impact was assessed at baseline through week 12 using the UDysRS. PD-related motor and non-motor symptoms, and quality of life (QoL) were also assessed.

RESULTS: Dyskinesias measured by UDysRS were significantly reduced in the LCIG group (n = 24; -17.37 ± 2.79) compared with the OMT group (n = 26; -2.33 ± 2.56) after 12 weeks (-15.05 ± 3.20; 95% CI, -21.47 to -8.63; P < 0.0001). At week 12, LCIG versus OMT also demonstrated significant improvements in “On” time without troublesome dyskinesia (P = 0.0001), QoL (P < 0.0001), global impression of change (P < 0.0001), activities of daily living (P = 0.0006), and Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (P = 0.0762). Treatment-emergent adverse events were reported in 27 (44.3%) patients (LCIG, 18 [64.3%]; OMT, 9 [27.3%]). Serious adverse events occurred in 2 (7.1%) LCIG-treated patients.

CONCLUSIONS: LCIG significantly reduced dyskinesia compared with OMT. LCIG showed efficacy for treatment of troublesome dyskinesia in patients with advanced PD while demonstrating benefits in both motor and non-motor symptoms and QoL. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

PMID:34236101 | DOI:10.1002/mds.28703

Curr Med Res Opin. 2021 Jul 8:1. doi: 10.1080/03007995.2021.1947216. Online ahead of print.

ABSTRACT

OBJECTIVE: Onasemnogene abeparvovec, a one-time intravenous gene replacement therapy, and nusinersen, an antisense oligonucleotide that requires ongoing intrathecal administration, have been evaluated as treatments for spinal muscular atrophy (SMA) type 1 in separate Phase III trials, but no head-to-head comparison studies have been conducted. Onasemnogene abeparvovec was compared with nusinersen using a matching-adjusted indirect comparison (MAIC) to estimate the treatment effect of onasemnogene abeparvovec relative to nusinersen for the treatment of symptomatic patients with SMA type 1 for up to 24 months of follow-up.

METHODS: In the absence of studies for both onasemnogene abeparvovec and nusinersen with a common comparator, a Bayesian naïve indirect treatment comparison (ITC) and MAIC between onasemnogene abeparvovec and nusinersen were conducted to compare efficacy and safety of onasemnogene abeparvovec with nusinersen. Outcomes of interest were event-free survival (EFS), overall survival (OS), and motor milestone achievements (independent sitting and independent walking). Relative treatment effects were expressed as relative risk (RR) and risk difference.

RESULTS: Pooled and weighted patient-level data illustrated a favorable effect toward onasemnogene abeparvovec, suggesting longer EFS for patients compared with nusinersen (HR of onasemnogene abeparvovec vs. nusinersen: 0.19 [95% CI: 0.07-0.54; 99% CI: 0.05-0.74]). At 24 months of follow-up, patients receiving onasemnogene abeparvovec were statistically significantly more likely to achieve the motor milestone of sitting independently compared with patients treated with nusinersen. Although statistically significant differences were not observed at 6 to 18 months between treatment options, the likelihood of sitting independently at 12 and 18 months numerically favored onasemnogene abeparvovec. A numerically greater likelihood of walking by 18 and 24 months was also observed for patients treated with onasemnogene abeparvovec compared with nusinersen. Onasemnogene abeparvovec therapy was also associated with a favorable (but statistically nonsignificant) outcome for OS and may be associated with prolonged survival compared with nusinersen (HR of onasemnogene abeparvovec vs. nusinersen: 0.35 [95% CI: 0.09-1.32; 99% CI: 0.06-2.01]). Bayesian naïve ITC results were similar to the MAIC analysis for EFS, OS, and motor milestone achievements. Small sample size limited covariate matching to baseline CHOP INTEND and nutritional support requirement, leading to wider CIs and statistically inconclusive outcomes for some of the results.

CONCLUSIONS: Despite limitations of the current MAIC analysis (mainly a small sample size for statistical testing, even for the pooled onasemnogene abeparvovec trials, and potential differences in prognostic and predictive factors between studies), the relative treatment effects in EFS, OS, and motor milestone achievement indicate that onasemnogene abeparvovec may offer continued benefit compared with nusinersen through 24 months of follow-up.

PMID:34236007 | DOI:10.1080/03007995.2021.1947216

Ultrason Imaging. 2021 Jul 8:1617346211029542. doi: 10.1177/01617346211029542. Online ahead of print.

ABSTRACT

To compare microvascular flow imaging (MVFI) to conventional Color-Doppler (CDI) and Power-Doppler (PDI) imaging in the detection of vascularity of Focal Breast Lesions (FBLs). A total of 180 solid FBLs (size: 3.5-45.2 mm) detected in 180 women (age: 21-87 years) were evaluated by means of CDI, PDI, and MVFI. Two blinded reviewers categorized lesion vascularity in absent or present, and vascularity pattern as (a) internal; (b) vessels in rim; (c) combined. The presence of a “penetrating vessel” was assessed separately. Differences in vascularization patterns (chi² test) and intra- and inter-observer agreement (Fleiss method) were calculated. ROC analysis was performed to assess performance of each technique in differentiating benign from malignant lesions. About 103/180 (57.2%) FBLs were benign and 77/180 (42.8%) were malignant. A statistically significant (p < .001) increase in blood flow detection was observed for both readers with MVFI in comparison to either CDI or PDI. Benign FBLs showed mainly absence of vascularity (p = .02 and p = .01 for each reader, respectively), rim pattern (p < .001 for both readers) or combined pattern (p = .01 and p = .04). Malignant lesions showed a statistically significant higher prevalence of internal flow pattern (p < .001 for both readers). The prevalence of penetrating vessels was significantly higher with MVFI in comparison to either CDI or PDI (p < .001 for both readers) and in the malignant FBLs (p < .001). ROC analysis showed MVFI (AUC = 0.70, 95%CI = [0.64-0.77]) more accurate than CDI (AUC = 0.67, 95%CI = [0.60-0.74]) and PDI (AUC = 0.67, 95%CI = [0.60-0.74]) though not significantly (p = .5436). Sensitivity/Specificity values for MVFI, PDI, and CDI were 76.6%/64.1%, 59.7%/73.8% and 58.4%/74.8%, respectively. Inter-reader agreement with MVFI was always very good (k-score 0.85-0.96), whereas with CDI and PDI evaluation ranged from good to very good. No differences in intra-observer agreement were noted. MVFI showed a statistically significant increase in the detection of the vascularization of FBLs in comparison to Color and Power-Doppler.

PMID:34236008 | DOI:10.1177/01617346211029542

Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2021 Aug;37(8):736-740.

ABSTRACT

Objective To detect and analyze the distribution characteristics of platelet antibodies in inpatients and explore the causes of platelet antibodies, so as to provide data support for improving the quality of blood transfusion. Methods A total of 38 840 patients were selected. The platelet-related antibodies were detected by Capture-P solid-phase detection system, and the positive rate of antibodies was analyzed statistically. Results Of the 38840 inpatients, 3989 were positive for platelet antibodies, with a positive rate of 10.27%. The positive rates of male and female patients were 8.7% and 11.5%, respectively. The positive rate of platelet antibodies in patients under 18 years old was 6.98% which was significantly lower than that in patients ≥66 years old and 18~65 years old. The positive rates of patients with pregnancy history and blood transfusion history increased significantly, which were 14.4% and 14.7%, respectively. The positive rate of patients with blood system diseases and liver cirrhosis with gastrointestinal bleeding diseases was over 20%. The positive rates of patients in the Hematology Department, Intensive Care Department and Obstetrics Department ranked the top three, with the positive rates of 15.17%, 14.97%, and 13.67%, respectively. The positive rates of platelet antibodies in patients with blood types B and AB were lower than those in patients with blood types A and O. Conclusion In clinical platelet transfusion, the influence of the patients’ age, gender, hospitalized diseases, hospitalized department and other factors on platelet antibodies should be considered to reduce the occurrence of platelet transfusion refractoriness.

PMID:34236034

Global Spine J. 2021 Jul 8:21925682211029867. doi: 10.1177/21925682211029867. Online ahead of print.

ABSTRACT

STUDY DESIGN: Prospective single-cohort analysis.

OBJECTIVES: To compare the outcomes/complications of 2 robotic systems for spine surgery.

METHODS: Adult patients (≥18-years-old) who underwent robot-assisted spine surgery from 2016-2019 were assessed. A propensity score matching (PSM) algorithm was used to match Mazor X to Renaissance cases. Preoperative CT scan for planning and an intraoperative O-arm for screw evaluation were preformed. Outcomes included screw accuracy, robot time/screw, robot abandonment, and radiation. Screw accuracy was measured using Vitrea Core software by 2 orthopedic surgeons. Screw breach was measured according to the Gertzbein/Robbins classification.

RESULTS: After PSA, a total of 65 patients (Renaissance: 22 vs. X: 43) were included. Patient/operative factors were similar between robot systems (P > .05). The pedicle screw accuracy was similar between robots (Renaissance: 1.1%% vs. X: 1.3%, P = .786); however, the S2AI screw breach rate was significantly lower for the X (Renaissance: 9.5% vs. X: 1.2%, P = .025). Robot time per screw was not statistically different (Renaissance: 4.6 minutes vs. X: 3.9 minutes, P = .246). The X was more reliable with an abandonment rate of 2.3% vs. Renaissance:22.7%, P = .007. Radiation exposure were not different between robot systems. Non-robot related complications including dural tear, loss of motor/sensory function, and blood transfusion were similar between robot systems.

CONCLUSION: This is the first comparative analyses of screw accuracy, robot time/screw, robot abandonment, and radiation exposure between the Mazor X and Renaissance systems. There are substantial improvements in the X robot, particularly in the perioperative planning processes, which likely contribute to the X’s superiority in S2AI screw accuracy by nearly 8-fold and robot reliability by nearly 10-fold.

PMID:34235996 | DOI:10.1177/21925682211029867

J Geriatr Psychiatry Neurol. 2021 Jul 8:8919887211023592. doi: 10.1177/08919887211023592. Online ahead of print.

ABSTRACT

BACKGROUND: Pain in Parkinson’s is problematic but under treated in clinical practice. Healthcare professionals must understand the impact of pain in Parkinson’s and patient preferences for management.

OBJECTIVE: To understand the impact of pain in Parkinson’s and to understand current management and preferences for pain management.

METHODS: We conducted a national survey with 115 people with Parkinson’s (PwP) and 10 carers. Both closed and open questions were used. The questions focused on how pain affected the individual, healthcare professional involvement in supporting pain management, current pain management strategies and views on future pain management interventions. We used descriptive statistics to summarize closed responses and thematic analysis to summarize open question responses.

RESULTS: 70% of participants reported pain impacted their daily life. Pain had a multifactorial impact on participants, affecting movement, mood and quality of life. Improved pain management was viewed to have the potential to address each of these challenges. Pain affected a number of different sites, with low back pain and multiple sites being most frequently reported. Exercise was the most frequently noted strategy (38%) recommended by healthcare professionals for pain management. PwP would value involvement from healthcare professionals for future pain management, but also would like to self-manage the condition. Medication was not suggested as a first line strategy.

CONCLUSIONS: Despite reporting engagement in some strategies to manage pain, pain still has a wide-ranging impact on the daily life of PwP. Results from this survey highlight the need to better support PwP to manage the impact of pain.

PMID:34235999 | DOI:10.1177/08919887211023592