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Clinical attributes and treatment characteristics are associated with work productivity and activity impairment in people with severe haemophilia A

Haemophilia. 2021 Jul 17. doi: 10.1111/hae.14302. Online ahead of print.

ABSTRACT

INTRODUCTION: Few studies have examined the real-world impact of haemophilia on daily activities and work productivity in people with severe haemophilia A (PWSHA).

AIM: To determine clinical attributes and treatment characteristics associated with impairment in daily activities and work among PWSHA using the patient-reported Work Productivity and Activity Impairment-General Health Questionnaire (WPAI-GH).

METHODS: PWSHA were asked to complete the WPAI-GH as part of the Cost of Haemophilia in Europe: A Socioeconomic Survey (CHESS) study. Outcomes were determined for activity impairment (AI), absenteeism, presenteeism and overall work productivity loss (WPL). Descriptive statistics and regression analyses were used to evaluate the association between these outcomes and clinical and treatment attributes.

RESULTS: Overall, 376 participants completed the AI element of WPAI-GH; 175 were employed and thus also reported on work impact. Mean ± standard deviation scores were as follows: AI = 34.2% ± 25.8%; absenteeism = 0.06% ±0.2%; presenteeism = 26.8% ± 22.4%; WPL = 28.6% ± 24.0%. Increased AI and WPL were associated with high haemophilia-related morbidity, measured both as chronic pain (p < .001 for both) and joint synovitis (AI: p <0.001; WPL: p = .017). In descriptive and multivariate analyses, lifelong prophylaxis was associated with reduced AI (p < .001 and p = .031, respectively); high therapy adherence was associated with reduced AI (p = .001 and p = .012, respectively) and with reduced WPL (p < .001 and p = .012, respectively).

CONCLUSION: The WPAI-GH identified haemophilia-related morbidity and treatment characteristics, including therapy regimen and adherence, as key attributes impacting functional impairment and work contributions of PWSHA. Early prophylactic intervention and greater adherence to therapy may lead to lower AI and WPL in PWSHA.

PMID:34273215 | DOI:10.1111/hae.14302

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Seroprevalence of bovine foot and mouth disease (FMD) and its associated risk factors in selected districts of Afar region, Ethiopia

Vet Med Sci. 2021 Jul 17. doi: 10.1002/vms3.574. Online ahead of print.

ABSTRACT

BACKGROUND: A cross-sectional study was conducted from November 2018 to May 2019 to estimate seroprevalence of foot and mouth disease virus for cattle and assess associated risk factors in selected districts of afar region. Simple random sampling technique was employed to select the study areas. A total of 384 bovine sera were collected from 72 herds and seroprevalence of the disease was determined using 3ABC-ELISA technique. Data were recorded and coded using Microsoft Excel spread sheet and analysed using STATA. Potential risk factors of the disease were also assessed using logistic regression analysis.

RESULTS: Out of 384 sera tested at National Veterinary Institute, the overall seroprevalence of foot and mouth disease (FMD) virus was 19.8% (n = 76; 95% CI = 15.8-23.79) at animal level and 56.94% at herd level. The herd level seroprevalence was higher in animals tested from Dubti (85%, n = 17) than Asayita (48.13%, n = 13) and Chifra (44%, n = 11). Among the associated risk factors, age, herd size, district and contact with wild life were statistically associated with foot and mouth disease serostatus (p < 0.05). Medium and large herd size animals were 2.49 (95% CI: 1.33-6.63) and 6.05 (95% CI: 2.54-14.43) times more likely to develop the disease as compared to animals from small herd size, respectively.

CONCLUSIONS: The current study finding revealed that FMD was more prevalent and economically significant disease in the study districts. Hence, further studies ought to be conducted to estimate the region wise serostatus magnitude of the disease, to assess its economic impact and to identify the circulating serotypes and strains in the areas.

PMID:34273244 | DOI:10.1002/vms3.574

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Factors determining the serum 25-hydroxyvitamin D response to vitamin D supplementation: Data mining approach

Biofactors. 2021 Jul 17. doi: 10.1002/biof.1770. Online ahead of print.

ABSTRACT

Vitamin D supplementation has been shown to prevent vitamin D deficiency, but various factors can affect the response to supplementation. Data mining is a statistical method for pulling out information from large databases. We aimed to evaluate the factors influencing serum 25-hydroxyvitamin D levels in response to supplementation of vitamin D using a random forest (RF) model. Data were extracted from the survey of ultraviolet intake by nutritional approach study. Vitamin D levels were measured at baseline and at the end of study to evaluate the responsiveness. We examined the relationship between 76 potential influencing factors on vitamin D response using RF. We found several features that were highly correlated to the serum vitamin D response to supplementation by RF including anthropometric factors (body mass index [BMI], free fat mass [FFM], fat percentage, waist-to-hip ratio [WHR]), liver function tests (serum gamma-glutamyl transferase [GGT], total bilirubin, total protein), hematological parameters (mean corpuscular volume [MCV], mean corpuscular hemoglobin concentration [MCHC], hematocrit), and measurement of insulin sensitivity (homeostatic model assessment of insulin resistance). BMI, total bilirubin, FFM, and GGT were found to have a positive relationship and homeostatic model assessment for insulin resistance, MCV, MCHC, fat percentage, total protein, and WHR were found to have a negative correlation to vitamin D concentration in response to supplementation. The accuracy of RF in predicting the response was 93% compared to logistic regression, for which the accuracy was 40%, in the evaluation of the correlation of the components of the data set to serum vitamin D.

PMID:34273212 | DOI:10.1002/biof.1770

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High rate of self-improving phenotypes in children with non-syndromic congenital ichthyosis: case series from South-Western Germany

J Eur Acad Dermatol Venereol. 2021 Jul 17. doi: 10.1111/jdv.17524. Online ahead of print.

ABSTRACT

BACKGROUND: Non-syndromic congenital ichthyosis describes a heterogeneous group of hereditary skin disorders associated with erythroderma and scaling at birth. Although both severe and mild courses are known, the prediction of the natural history in clinical practice may be challenging.

OBJECTIVES: To determine clinical course and genotype-phenotype correlations in children affected by non-syndromic congenital ichthyosis in a case series from south-western Germany.

METHODS: We performed a retrospective observational study of 32 children affected by non-syndromic congenital ichthyoses seen in our genodermatosis clinic between 2011 and 2020. Follow-ups included assessment of weight and severity of skin involvement utilizing a modified Ichthyosis Area Severity Index (mIASI). mIASI was calculated as a sum comprising the previously published IASI score and an additional novel score to evaluate palmoplantar involvement. Linear regression was assessed using Pearson correlation and statistical analysis was performed using the Wilcoxon-Mann-Whitney-Test.

RESULTS: This study included 23 patients with autosomal recessive congenital ichthyosis, seven with keratinopathic ichthyosis and two with harlequin ichthyosis. Cutaneous manifestations improved in more than 70% of the children during the follow-up. Especially in patients with mutations in ALOXE3 and ALOX12B, mIASI scores dropped significantly. The most common phenotype observed in this study was designated “mild fine scaling ichthyosis”. Severe palmoplantar involvement occurred in patients with KRT1 and ABCA12 mutations; most patients demonstrated hyperlinearity as a sign of dryness and scaling. Weight was mainly in the normal range, and negatively correlated with the severity of skin involvement.

CONCLUSIONS: Congenital ichthyosis that self-improves and evolves with mild fine scaling ichthyosis was the most common phenotype observed in our patients. This type might be underdiagnosed if the genetic diagnosis is not performed in the first year of life. mIASI is an easy and fast instrument for scoring disease severity, and adding additional points for palmoplantar involvement might be valuable.

PMID:34273205 | DOI:10.1111/jdv.17524

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Leadership Training in Medicine-12 Years of Experience From the Feagin Leadership Program

Mil Med. 2021 Jul 17:usab293. doi: 10.1093/milmed/usab293. Online ahead of print.

ABSTRACT

INTRODUCTION: Increasingly, physicians find themselves in demanding leadership positions. However, leadership education for medical trainees remains lacking with most physicians reporting that they are ill-equipped to tackle the challenges of leadership. Here, we set out to describe the Feagin Leadership Program (FLP) and assess its reception and impact on trainees over the past 12 years.

MATERIALS AND METHODS: During the 1-year FLP, selected scholars from Duke University, Wake Forest University, and the University of North Carolina participate in five leadership sessions, individual coaching, a leadership forum, and a multidisciplinary team-based capstone project. A 28-question survey with six optional free-response questions was distributed to the Feagin Alumni Network, and descriptive statistics were assessed.

RESULTS: Since its founding, 212 scholars have graduated from the FLP and 117 (55%) alumni have gone on to surgical specialties. A survey was distributed among all Feagin alumni. A total of 56 (26%) surveys were completed. Forty-three percent (n = 24) had held at least one leadership position since completing the FLP. When asked about the impact of their experience, 96% (n = 54) said that the program encouraged them to pursue a position of leadership within their field, 95% (n = 53) stated that it prepared them for such a position, and 93% (n = 52) stated that the program positively influenced their decision to be involved with current or future positions of leadership.

CONCLUSIONS: Over the last 12 years, the FLP has demonstrated a high perceived impact on personal growth, leadership proficiency, and the decision to pursue leadership positions in medicine. The current dearth of leadership education for surgical trainees can best be addressed with models such as the FLP, with adoption benefiting medical trainees, the medical community, and patients they serve.

PMID:34273171 | DOI:10.1093/milmed/usab293

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Coinfection with severe acute respiratory syndrome coronavirus-2 and other respiratory viruses at a tertiary hospital in Korea

J Clin Lab Anal. 2021 Jul 17:e23868. doi: 10.1002/jcla.23868. Online ahead of print.

ABSTRACT

BACKGROUND: Studies have reported coinfection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the cause of coronavirus disease-2019 (COVID-19), with other viruses that cause respiratory tract infections (RTIs). We investigated the coinfection rate of SARS-CoV-2 and other RTI-causing viruses, and whether the cycle threshold (Ct) value of a real-time reverse transcriptase PCR (RT-PCR) differed when the coinfection occurred during the first wave of COVID-19 in Daegu, Republic of Korea, in 2020.

METHODS: After performing PCR for SARS-CoV-2, we additionally tested for the presence of RTI-causing viruses to check for coinfection. Subsequently, we identified the specific coexisting respiratory viruses and calculated the coinfection rate. In addition, based on the coinfection status, we compared the Ct values obtained from RT-PCR for SARS-CoV-2 in patients who tested positive for COVID-19 PCR.

RESULTS: Of 13,717 patients, 123 had positive results on COVID-19 PCR testing and six tested positive for an RTI-causing virus. Thus, the coinfection rate was 4.9%. There were no statistically significant differences in the mean Ct values of SARS-CoV-2 RT-PCR between coinfected and non-coinfected patients.

CONCLUSION: This study computed the coinfection rate of SARS-CoV-2 and RTI-causing viruses and revealed that the mean Ct values in SARS-CoV-2 real-time RT-PCR did not differ according to the coinfection status.

PMID:34273182 | DOI:10.1002/jcla.23868

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Age- and sex-specific reference intervals for superoxide dismutase enzyme and several minerals in a healthy adult cohort

J Clin Lab Anal. 2021 Jul 17:e23897. doi: 10.1002/jcla.23897. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of this study was to establish RIs for clinically important markers including superoxide dismutase (SOD), serum copper, zinc, calcium, magnesium, and phosphate in a cohort of healthy Iranian adults.

MATERIALS: A subsample from MASHAD cohort study was used to assess serum SOD, copper, zinc, calcium, magnesium and phosphate. Serum SOD was measured according to its inhibitory potential of pyrogallol oxidation. Micro- and macro-minerals were measured using flame atomic absorption spectrometry and a BT3000 autoanalyzer, respectively. Sex- and age-specific RIs were then calculated based on CLSI Ep28-A3 guidelines.

RESULTS: Reference value distributions for studied parameters did not demonstrate any age-specific differences that were statistically significant. In addition, sex partitioning was not required for all parameters, apart from serum magnesium, which showed a wider range in females (0.81-1.26 mg/dl) compared with males (0.82-1.23 mg/dl).

CONCLUSION: The RIs established in this study can be expected to improve mineral assessment and clinical decision-making in the Iranian adult population.

PMID:34273186 | DOI:10.1002/jcla.23897

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OBSIDIAn – real world evidence of Originator to BioSImilar Drug switch in juvenile idiopathic arthritis

Rheumatology (Oxford). 2021 Jul 17:keab572. doi: 10.1093/rheumatology/keab572. Online ahead of print.

ABSTRACT

OBJECTIVES: Limited data about use of biosimilars are available in children with Juvenile Idiopathic Arthritis (JIA). This study therefore aimed to evaluate long-term efficacy and safety of switching from etanercept (ETA) and adalimumab (ADA) originators to their biosimilars, in children with JIA, in a real-world setting.

METHODS: This is a retro-prospective non-interventional multicentre Italian comparative cohort study. Medical charts of JIA children treated with biosimilars of ETA or ADA were included. Efficacy and safety of TNF-inhibitors therapy was evaluated at last follow-up during originator and at 3, 6 and 12 months following the switch to biosimilar.

RESULTS: 59 children (42 female, median age at onset 88 months) were treated with biosimilar of ETA (21) and ADA (38). Forty-five switched from the originator to the BIO (17 ETA, 28 ADA). At time of switch, 12/17 patients on ETA and 18/28 on ADA were in remission. No significant difference has been found at 3, 6 and 12 months after the switch. Ten patients discontinued biosimilars due to disease remission (4 ETA, 3 ADA), family willing (1 ETA), occurrence of burning at injection site (1 ETA), and persistent activity (1 ADA). No statistically significant difference was observed between originator and BIOs, nor between originator and BIOs, and between ADA and ETA in time to disease remission achievement, time to relapse and number of patients who experienced AE.

CONCLUSION: Our real-life results seem to confirm the efficacy and safety profile of switching from originator of ADA and ETA to their respective BIOs also in paediatric patients with JIA.

PMID:34273158 | DOI:10.1093/rheumatology/keab572

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Subjective loss of clinical response to TNFi in axSpA relates to recurrence of MRI bone marrow oedema particularly with long-acting agents

Rheumatology (Oxford). 2021 Jul 17:keab571. doi: 10.1093/rheumatology/keab571. Online ahead of print.

ABSTRACT

OBJECTIVES: Subjective loss of response immediately prior to routine TNFi therapy can occur in axial spondyloarthritis (axSpA). We investigated clinical outcomes in patients taking the first 3 licenced TNFis and correlated this with recurrence of MRI bone marrow oedema (MRI-BMO).

METHODS: Proof-of-concept study including axSpA patients established on etanercept (ETA), adalimumab (ADA) or infliximab (IFX) reporting symptom deterioration prior to next dose. MRI/clinical data were collected prior to scheduled dose (v1), 4 days post-dose (v2) and at the time of patient-reported symptom return (v3). MRI spine/sacroiliac joints utilising 3 T were scored using the semi-quantitative Leeds MRI scoring system.

RESULTS: 113 clinical assessments and MRIs were performed in 38 participants (ADA = 16, ETA = 12, IFX = 10), mean age 42.1 years ± 24.4(2SD, n = 38), 71.1% male (n = 27/38), 69.7% HLA-B27 positive (n = 23/33). At v1 all patients had high disease activity [ASDAS-CRP = 3 (2.7-3.7)] and 57.9% had MRI-BMO (number of MRI-BMO: ETA = 26, ADA = 59, IFX = 28). Improved clinical responses were seen at v2 [ASDAS-CRP -0.41(-0.81-0.30), p= 0.018; BASDAI -0.58(-2.2-0.52), p= 0.024]. Despite just a 4-day interval between v1 and v2, a numerical reduction in MRI-BMO lesions between v1/v2 was observed (ETA=-6, ADA=-10, IFX=-3). By v3 comparatively fewer new BMO lesions were detected in the ETA and ADA groups compared with IFX (ETA=-1, ADA = +3, IFX = +8), although the numbers were too small to enable testing for statistical significance.

CONCLUSIONS: Short-lived fluctuations in MRI-BMO were commoner with longer-acting agents and corresponded with subjective loss of clinical response before next scheduled TNFi dose. Larger studies are need to confirm the possible pathogenic implications of this phenomenon.

PMID:34273162 | DOI:10.1093/rheumatology/keab571

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Occurrence of hypertension during third-line anlotinib is associated with progression-free survival in patients with squamous cell lung cancer (SCC): A post hoc analysis of the ALTER0303 trial

Thorac Cancer. 2021 Jul 17. doi: 10.1111/1759-7714.14076. Online ahead of print.

ABSTRACT

BACKGROUND: There is a lack of targeted therapeutic options for squamous cell lung cancer (SCC). Accelerated hypertension is an issue with many targeted therapies for lung cancer. This study aimed to analyze the efficacy of anlotinib, based on progression-free survival (PFS) and overall survival (OS) in patients with SCC, stratified by hypertension and Eastern Cooperative Oncology Group (ECOG) score.

METHODS: This was a post hoc analysis of a multicenter, double-blind, phase III ALTER0303 randomized controlled trial. Only patients with SCC were included. The occurrence of hypertension during the study period was defined according to CTCAE 4.03. OS and PFS were the primary and secondary endpoints, respectively. The patients were stratified according to hypertension and ECOG score, respectively.

RESULTS: The median PFS in the patients who developed hypertension was longer than in those who did not (7.2 (95% CI: 3.5-11.0) versus 3.2 (95% CI: 1.2-5.3) months, p = 0.001; HR (95% CI), 0.4 (0.2-0.8)). In the ECOG 0 patients, the median PFS in the patients who developed hypertension versus those who did not was 5.6 vs. 1.8 months, respectively (Figure 2(d)). In the ECOG 1 patients, the median PFS in the patients who developed hypertension versus those who did not was 7.0 (95% CI: 3.0-11.0) vs. 4.8 (95% CI: 1.2-8.5) months (p = 0.043). No statistically significant differences were found in OS in the stratified analyses.

CONCLUSIONS: The occurrence of hypertension might be a clinical indicator predicting the efficacy of third-line anlotinib treatment in patients with SCC.

PMID:34273139 | DOI:10.1111/1759-7714.14076