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Evaluating data quality in the Australian and New Zealand dialysis and transplant registry using administrative hospital admission datasets and data-linkage

Health Inf Manag. 2022 Jun 11:18333583221097724. doi: 10.1177/18333583221097724. Online ahead of print.

ABSTRACT

Background: Clinical quality registries provide rich and useful data for clinical quality monitoring and research purposes but are susceptible to data quality issues that can impact their usage. Objective: This study assessed the concordance between comorbidities recorded in the Australia and New Zealand Dialysis and Transplant (ANZDATA) Registry and those in state-based hospital admission datasets. Method: All patients in New South Wales, South Australia, Tasmania, Victoria and Western Australia recorded in ANZDATA as requiring chronic kidney replacement therapy (KRT) between 01/07/2000 and 31/12/2015 were linked with state-based hospital admission datasets. Coronary artery disease, diabetes mellitus, cerebrovascular disease, chronic lung disease and peripheral vascular disease recorded in ANZDATA at each annual census date were compared overall, over time and between different KRT modalities to comorbidities recorded in hospital admission datasets, as defined by the International Classification of Diseases (ICD-10-AM), using both the kappa statistic and logistic regression analysis. Results: 29, 334 patients with 207,369 hospital admissions were identified. Comparison was made at census date for every patient comparison. Overall agreement was “very good” for diabetes mellitus (92%, k = 0.84) and “poor” to “fair” (21-61%, k = 0.02-0.22) for others. Diabetes mellitus recording had the highest accuracy (sensitivity 93% (±SE 0.2) and specificity 93% (±SE 0.2)), and cerebrovascular disease had the lowest (sensitivity 54% (±SE 0.2) and specificity 21% (±SE 0.3)). The false positive rates for cerebrovascular disease, peripheral vascular disease and chronic airway disease ranged between 18 and 33%. The probability of a false positive was lowest for kidney transplant patients for all comorbidities and highest for patients on haemodialysis. Conclusions and Implications: Agreement between the clinical quality registry and hospital admission datasets was variable, with the prevalence of comorbidities being higher in ANZDATA.

PMID:35695032 | DOI:10.1177/18333583221097724

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First-line chemoimmunotherapy versus chemotherapy in PD-L1-negative patients with non-small-cell lung cancer

Immunotherapy. 2022 Jun 13. doi: 10.2217/imt-2021-0208. Online ahead of print.

ABSTRACT

Background: In PD-L1-negative patients with advanced non-small-cell lung cancer (NSCLC), conclusive evidence in support of specific treatments remains lacking. Objectives: The efficacy of first-line chemoimmunotherapy versus chemotherapy alone was compared. Methods: Eligible randomized studies that included patients with advanced NSCLC irrespective of PD-L1 status who were treated with chemoimmunotherapy as the first line were identified. Kaplan-Meier curves were extracted and analyzed using restricted mean survival time (RMST). Patient-level data were reconstructed from progression-free survival (PFS) graphs. A Bayesian network meta-analysis (NETMA) was carried out. Results: In five trials selected, chemoimmunotherapy regimens, compared with chemotherapy alone, resulted in an improvement in PFS without statistical significance. In the NETMA, chemoimmunotherapy was found to slightly improve PFS. Conclusion: This analysis showed that the incremental benefit of chemoimmunotherapy versus chemotherapy is limited.

PMID:35695029 | DOI:10.2217/imt-2021-0208

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Failure analysis of articulating polymethyl methacrylate spacers in two-stage revision total hip arthroplasty

Bone Jt Open. 2022 Jun;3(6):485-494. doi: 10.1302/2633-1462.36.BJO-2022-0024.R1.

ABSTRACT

AIMS: Two-stage exchange revision total hip arthroplasty (THA) performed in case of periprosthetic joint infection (PJI) has been considered for many years as being the gold standard for the treatment of chronic infection. However, over the past decade, there have been concerns about its safety and its effectiveness. The purposes of our study were to investigate our practice, collecting the overall spacer complications, and then to analyze their risk factors.

METHODS: We retrospectively included 125 patients with chronic hip PJI who underwent a staged THA revision performed between January 2013 and December 2019. All spacer complications were systematically collected, and risk factors were analyzed. Statistical evaluations were performed using the Student’s t-test, Mann-Whitney U test, and Fisher’s exact test.

RESULTS: Our staged exchange practice shows poor results, which means a 42% mechanical spacer failure rate, and a 20% recurrent infection rate over the two years average follow-up period. Moreover, we found a high rate of spacer dislocation (23%) and a low rate of spacer fracture (8%) compared to the previous literature. Our findings stress that the majority of spacer complications and failures is reflecting a population with high comorbid burden, highlighted by the American Society of Anesthesiology grade, Charlson Comorbidity Index, and Lee score associations, as well as the cardiac, pulmonary, kidney, or hepatic chronic conditions.

CONCLUSION: Our experience of a two-stage hip exchange revision noted important complication rates associated with high failure rates of polymethylmethacrylate spacers. These findings must be interpreted in the light of the patient’s comorbidity profiles, as the elective population for staged exchange has an increasing comorbid burden leading to poor results. In order to provide better results for this specific population, our conclusion suggests that comparative strategy studies are required to improve our therapeutic indication. Cite this article: Bone Jt Open 2022;3(6):485-494.

PMID:35695030 | DOI:10.1302/2633-1462.36.BJO-2022-0024.R1

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Chaplains Work in Primary Care

J Health Care Chaplain. 2022 Jun 11:1-19. doi: 10.1080/08854726.2022.2077555. Online ahead of print.

ABSTRACT

Health is holistic, but health services are often not. Primary care is the first point of contact for patients in the UK, and at least two in every three present with complex bio-psycho-socio-economic issues. In Scotland, the Community Chaplaincy Listening (CCL) service was created to see if chaplains could help. CCL involves specially trained chaplains listening to patients referred to them by general practitioners (GP) for spiritual support. Between 2018 and 2019, 143 people used CCL and completed baseline and post-discharge outcome measures. Mean Scottish PROM scores rose from 7.94 (± 3.4) at baseline to 12 (± 3.5) post discharge, a statistically and clinically significant rise of 4.06 (95% CI, 3-5.12), t(50) = 7.7, p < 0.0001, d = 1.08. The improvement was seen whether patients self-described as religious, spiritual, both, or neither. Health-related quality of life outcomes were mixed but patients referred to the service scored some of the lowest baseline EQ-5D-3L scores ever seen in the literature. Together these results suggest that CCL worked in primary care, especially for patients historically considered “difficult to treat.” Limitations of the study are considered alongside implications for commissioners and service developers.

PMID:35695021 | DOI:10.1080/08854726.2022.2077555

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Contribution of the Ultrasound Techniques in the Evaluation of Knee Joint Damage in the Case of Pigmented Villonodular Synovitis and Rheumatoid Arthritis

J Ultrasound Med. 2022 Jun 13. doi: 10.1002/jum.16040. Online ahead of print.

ABSTRACT

OBJECTIVES: This is a prospective study to evaluate the clinical value of high-frequency ultrasound (HFUS), superb microvascular imaging (SMI), and contrast-enhanced ultrasound (CEUS) in differentiation of pigmented villonodular synovitis (PVNS) and highly active rheumatoid arthritis (RA).

METHODS: Twenty PVNS patients and 24 active RA patients were selected to undergo HFUS, SMI, and CEUS examinations. The characteristics of HFUS, SMI, and CEUS in PVNS and RA were compared, and the differential diagnosis performances of HFUS, SMI, and CEUS in PVNS and RA were evaluated by receiver operating characteristic (ROC) analysis.

RESULTS: There were statistically significant in joint effusion, synovial thickness, synovial morphology, synovial echo, synovial vessel shape, synovial enhanced direction, and enhanced pattern between PVNS and RA (P < .05). However, no statistically significant were found in bone erosion, synovial boundary, blood signal grading of synovium, synovial enhanced strength, and CEUS quantitative parameters (including PI, TTP, S, MTT, and AUC) (P > .05). The AUC of HFUS, SMI, and CEUS for differential diagnosis PVNS and RA were 0.832, 0.675, and 0.817, respectively. The AUC of HFUS + SMI, HFUS + CEUS, SMI + CEUS, HFUS + SMI + CEUS were 0.923, 0.940, 0.817, and 0.940, respectively. The AUC of HFUS + SMI and HFUS + CEUS was higher than that of each alone (P < .05).

CONCLUSIONS: HFUS, SMI, and CEUS can be used as supplementary methods for diagnosis and differential diagnosis in PVNS and active RA. What is more, the combination of HFUS + SMI and HFUS + CEUS was suggested.

PMID:35695018 | DOI:10.1002/jum.16040

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Revacept, an Inhibitor of Platelet Adhesion in Symptomatic Carotid Stenosis: A Multicenter Randomized Phase II Trial

Stroke. 2022 Jun 13:STROKEAHA121037006. doi: 10.1161/STROKEAHA.121.037006. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with symptomatic internal carotid artery (ICA) stenosis are at high risk of recurrent ischemic stroke and require early interventional treatment and antiplatelet therapy. Increased bleeding rates might counterbalance the periprocedural efficacy of intensified platelet inhibition. We aim to investigate, whether Revacept, a competitive antagonist of glycoprotein VI, adjunct to standard antiplatelet therapy reduces the occurrence of ischemic lesions in patients with symptomatic ICA stenosis.

METHODS: International, multicenter (16 sites), 3-arm, randomized (1:1:1), double-blind, and placebo-controlled study with parallel groups, including patients with symptomatic ICA stenosis. A single infusion over 20 minutes of either placebo, 40 mg or 120 mg Revacept in addition to guideline-conform antiplatelet therapy was evaluated with regard to the exploratory efficacy end point: Number of new ischemic lesions on diffusion-weighted magnetic resonance imaging after treatment initiation. Main clinical outcome was the combined safety and efficacy end point including any stroke or death, transient ischemic attack, myocardial infarction, coronary intervention, and bleeding complications during follow-up.

RESULTS: Out of 160 randomized patients, 158 patients (68±10.1 years, 24% female) received study medication (51 patients placebo, 54 patients 40 mg Revacept and 53 patients 120 mg Revacept) and were followed for 11.2±2.3 months. A total of 1.16 (95% CI, 0.88-1.53)/1.05 (95% CI, 0.78-1.42; P=0.629)/0.63 (95% CI, 0.43-0.93) new diffusion-weighted magnetic resonance imaging lesions per patient were detected in the placebo/40 mg/120 mg Revacept groups, without statistical evidence of a difference. A reduction of the combined safety and efficacy end point during the study period was observed in patients who received 120 mg (HR, 0.46 [95% CI, 0.21-0.99]; P=0.047), but not 40 mg Revacept compared with placebo (HR, 0.72 [95% CI, 0.37-1.42]; P=0.343).

CONCLUSIONS: Revacept 120 mg reduced the combined safety and efficacy end point in patients with symptomatic ICA stenosis.

REGISTRATION: URL: https://www.

CLINICALTRIALS: gov; Unique Identifier: NCT01645306.

PMID:35695006 | DOI:10.1161/STROKEAHA.121.037006

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HLA Genotyping in Romanian Adult Patients with Celiac Disease, their First-degree Relatives and Healthy Persons

J Gastrointestin Liver Dis. 2022 Jun 12;31(2):191-197. doi: 10.15403/jgld-4187.

ABSTRACT

BACKGROUND AND AIMS: Celiac disease is characterized by an inappropriate T-cell-mediated response to gluten in small bowel in genetically predisposed individuals, carriers of the DQ2 and/or DQ8 haplotypes of the human leukocyte antigen. The aim of our study was to asses HLA typing in adult patients with celiac disease, in their first degree relatives and in a healthy control group.

METHODS: We conducted a prospective observational study on three cohorts: 117 patients diagnosed with celiac disease, 41 first-degree relatives of celiac patients and 57 asymptomatic healthy volunteers. Low resolution HLA typing for DQ alleles was performed in all study subjects with DNA extracted from peripheral blood, using SSP HLA-DQB1 kit (Innotrain Diagnostik GmbH, Germany). Next Generation Sequencing (NGS) was used only in 18 patients for typing confirmation of DQB1 and DQA1 loci and whole gene sequencing.

RESULTS: Prevalence of HLA-DQ2 was significantly higher in the CD group compared to the healthy subjects group (95.6% vs 29.8%, p <0.001), with no statistically significant differences in HLA-DQ8 and combined HLA-DQ2/DQ8 prevalences.Several HLA DQA1 and DQB1 alleles (HLA-DQA1* 05:01, HLA-DQB1*02:01, HLA-DQB1*02:02) and haplotypes (DQA1*02:01-DQB1*02:02,DQA1*05:01-DQB1*02:01) were strongly associated with celiac disease in our group: OR 4.28, 4.28, 4.67 and 5.43 and 4.28 respectively. Predominantly, patients presented with typical symptoms and iron deficiency anemia. 95.5% of them had histological Marsh type modifications ≥3a. A relatively poor response to gluten-free diet was observed and 9.4% developed complications (refractory celiac disease, enteropathy-associated T cell lymphoma, intestinal adenocarcinoma), with a death rate of 6.8%. 23% associated other autoimmune diseases.Screening adherence for 1st degree relatives was very low: only 16%. Familial screening diagnosed 4 cases of asymptomatic celiac disease. 32 relatives (78%) had HLA-DQ2 haplotype, 5 carried HLA-DQ8, 4 didn’t carry any risk haplotype.

CONCLUSIONS: This study demonstrated a higher prevalence of the HLA-DQ2 genotype in patients with celiac disease compared to the healthy population but not of HLA-DQ8 or combined HLA-DQ2/DQ8. Alleles HLA-DQA1* 05:01, HLA-DQB1*02:01, HLA-DQB1*02:02 and haplotypes (DQA1*02:01-DQB1*02:02,DQA1*05:01-DQB1*02:01) were strongly associated with celiac disease in our cohort.

PMID:35694992 | DOI:10.15403/jgld-4187

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Alkylation of Benz[a]anthracene Affects Toxicity to Early Life-Stage Zebrafish and In Vitro AhR2 Transactivation in a Position-Dependent Manner

Environ Toxicol Chem. 2022 Jun 13. doi: 10.1002/etc.5396. Online ahead of print.

ABSTRACT

Polycyclic aromatic hydrocarbons (PAHs) are structurally diverse organic chemicals that can have adverse effects on the health of fishes through activation of the aryl hydrocarbon receptor 2 (AhR2). PAHs are ubiquitous in the environment, but alkyl PAHs are more abundant in some environmental matrices. However, relatively little is known regarding the effects of alkylation on the toxicity of PAHs to fishes in vivo and how this relates to potency for activation of the AhR2 in vitro. Therefore, objectives of this study were to determine the toxicity of benz[a]anthracene (BAA) and three alkylated homologues representing various alkylation positions to early life-stages of zebrafish (Danio rerio), and to assess the potency of each for activation of the zebrafish AhR2 in a standardized in vitro AhR transactivation assay. Exposure of embryos to each of the PAHs caused a dose-dependent increase in mortality and malformations characteristic of AhR2 activation. Each alkyl homolog had in vivo toxicities and in vitro AhR2 activation potencies different than the parent PAH in a position-dependant manner. However, there was no statistically significant linear relationship between responses measured in these assays. Results suggest a need for further investigation into the effect of alkylation on the toxicity of PAHs to fishes and greater consideration of the contribution of alkylated homologues in ecological risk assessments. This article is protected by copyright. All rights reserved.© 2022 SETAC.

PMID:35694968 | DOI:10.1002/etc.5396

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Longitudinal Cohort Study of Verbatim-Reported Postural Instability Symptoms as Outcomes for Online Parkinson’s Disease Trials

J Parkinsons Dis. 2022 Jun 6. doi: 10.3233/JPD-223274. Online ahead of print.

ABSTRACT

BACKGROUND: The Parkinson’s Disease Patient Report of Problems (PD-PROP) captures the problems and functional impact that patients report verbatim. Online research participation and advances in language analysis have enabled longitudinal collection and classification of symptoms as trial outcomes.

OBJECTIVE: Analyze verbatim reports longitudinally to examine postural-instability symptoms as 1) precursors of subsequent falling and 2) newly occurring symptoms that could serve as outcome measures in randomized controlled trials.

METHODS: Problems reported by >25,000 PD patients in their own words were collected online in the Fox Insight observational study and classified into symptoms by natural language processing, clinical curation, and machine learning. Symptoms of gait, balance, falling, and freezing and associated reports of having fallen in the last month were analyzed over three years of longitudinal observation by a Cox regression model in a cohort of 8,287 participants. New onset of gait, balance, falling, and freezing symptoms was analyzed by Kaplan-Meier survival techniques in 4,119 participants who had not previously reported these symptoms.

RESULTS: Classified verbatim symptoms of postural instability were significant precursors of subsequent falling among participants who were older, female, and had longer PD duration. New onset of symptoms steadily increased and informed sample size estimates for clinical trials to reduce the onset of these symptoms.

CONCLUSION: The tools to analyze symptoms reported by PD patients in their own words and capacity to enroll large numbers of research participants online support the feasibility and statistical power for conducting randomized clinical trials to detect effects of therapeutic interventions.

PMID:35694935 | DOI:10.3233/JPD-223274

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Effects of an active hand exoskeleton on forearm muscle activity in industrial assembly grips

Work. 2022 Jun 10. doi: 10.3233/WOR-211272. Online ahead of print.

ABSTRACT

BACKGROUND: The Bioservo Ironhand ® is a commercially available active hand exoskeleton for reducing grip-induced stress.

OBJECTIVES: The study aimed at quantifying the effect of the Ironhand ® exoskeleton on the myoelectric muscle activity of forearm flexor and extensor muscles in three relevant assembly grip tasks: 2-Finger-grip (2Finger), 5-Finger-grip (5Finger) and Full grip (FullGrip).

METHODS: Twenty-two subjects were tested in three different exoskeleton conditions for each grip task (overall 3×3×10 = 90 repetitions in randomized order): Exoskeleton off (Off), Exoskeleton on, “locking tendency” 0% (On_LT0), and Exoskeleton on, “locking tendency” 85% (On_LT85). Muscle activity was measured at 25% of the participant’s maximum grip force using two EMG sensors at the M. flexor digitorum superficialis (M.FDS) and one at the M. extensor digitorum (M.ED).

RESULTS: The effect of the Ironhand ® exoskeleton varied depending on the grip task and the participant’s sex. A statistically significant reduction in muscle activity of the M.FDS was found only for male subjects in the FullGrip condition. No reduction of muscular activity in the M.FDS was found for the other grip tasks (2Finger, 5Finger). For the females in the 2Finger condition, mean muscle activity of M.FDS even increased significantly in On_LT0 compared to Off. Besides differences between grip tasks and sex, the current study revealed substantial individual differences.

CONCLUSIONS: In addition to testing for statistical significance, a detailed exploratory analysis of exoskeleton effects at subject level should be performed to evaluate these from a safety and regulatory perspective.

PMID:35694945 | DOI:10.3233/WOR-211272