Category: Statistics

Eur J Dermatol. 2021 Aug 26. doi: 10.1684/ejd.2021.4110. Online ahead of print.

ABSTRACT

Non-melanoma skin cancers (NMSCs) are the most frequent group of malignant tumours worldwide. Objectives: The aim of the present research was to analyse mortality associated with NMSC in Spain between 1979 and 2018 and highlight changes regarding trend in mortality and differences according to age groups and gender. Death records and mid-year population data were collected from the National Statistics Institute. Age-standardized mortality rates were calculated. Significant changes in mortality trends were identified using Joinpoint regression. The independent effects of age, period and cohort and potential years of life lost due to NMSC were also analysed. Mortality rates associated with NMSC in Spain were reported as 2.49 per 100,000 inhabitants in 1979 (95% CI: 2.24-2.77) and 1.27 per 100,000 inhabitants in 2018 (95% CI; 1.16-1.39) for the overall population. Women who were born after the 70 s showed a significant increase in relative risk of death due to NMSC. Mortality associated with NMSC in Spain shows a decreasing overall trend that appears to have stabilized since 2005, with the exception of women between 35 and 64 years old.

PMID:34463287 | DOI:10.1684/ejd.2021.4110

Am J Clin Pathol. 2021 Aug 31:aqab107. doi: 10.1093/ajcp/aqab107. Online ahead of print.

ABSTRACT

OBJECTIVES: The Pfizer-BioNTech BNT162b2 vaccine against SARS-CoV-2 infection is now available. This vaccine induces antibody production against the receptor-binding domain (RBD) of the spike glycoprotein S1 (S1-RBD). This study evaluated the performance of new immunoassays to measure this type of antibody.

METHODS: Blood samples were collected at t0 (prime dose), after 21 days (t1, booster dose), and then after another 15 days (t2) from 70 health care professionals who had tested negative for previous SARS-CoV-2 infection and underwent vaccination with BNT162b2.

RESULTS: Antibodies against S1-RBD were measured using 4 commercial assays. At t0, t1, and t2, the median antibody concentrations (interquartile range) were, respectively, 0.2 (0.1-0.4), 49.5 (19.1-95.7), and 888.0 (603.6-1,345.8) U/mL by Maglumi SARS-CoV-2 S-RBD immunoglobulin G (IgG) (Shenzen New Industries Biomedical Engineering, Snibe Diagnostics); 0.0 (0.0-0.0), 7.9 (4.2-15.6), and 112.3 (76.4-205.6) U/mL by Atellica IM SARS-CoV-2 IgG assay (Siemens Healthineers); 0.0 (0.0-0.0), 59.9 (18.3-122.0), and 2,646.0 (1,351.2-4,124.0) U/mL by Elecsys Anti-SARS-CoV-2 S assay (Roche Diagnostics); and 1.8 (1.8-1.8), 184 (94-294), and 1,841.0 (1,080.0-2,900.0) AU/mL by LIAISON SARS-CoV-2 TrimericS IgG assay (DiaSorin). The differences between medians at t0, t1, and t2 were all statistically significant (P < .001).

CONCLUSIONS: Antibodies against nucleocapsid proteins (N) were also measured using Maglumi 2019-nCoV IgG assay, which showed all negative results. All the considered anti-RBD methods detected response to the vaccine, while the method directed against anti-N failed to show response.

PMID:34463321 | DOI:10.1093/ajcp/aqab107

Int J Gynaecol Obstet. 2021 Aug 31. doi: 10.1002/ijgo.13906. Online ahead of print.

ABSTRACT

OBJECTIVE: The study aimed to evaluate the efficacy of the injection of microfragmented adipose tissue in the treatment of women with genitourinary syndrome of menopause (GSM).

METHODS: This observational cohort study included 12 women who received one session of multiple injections of microfragmented adipose tissue using the SEFFIGYN medical device (SEFFILINE S.r.l. Bologna – Italy). Symptoms such as burning, itching, dryness, pain on penetration, pain during deep intercourse, and pain on urination were assessed before the patient’s treatment (T0), after 15 days (T15), and after five months (5Mo) using the Numerical Rating Scale (NRS).

RESULTS: An improvement of vulvar trophism was clinically evident already after two weeks from treatment; all symptoms were notably attenuated compared to the initial visit, as demonstrated by statistically significant reductions of the NRS scores (P=0.003 for hitching, P=0.008 for pain on urination, and P<0.001 for the other symptoms, Sign test). Moreover, all symptoms continued to improve over time. All patients reported a positive change in their quality of life and a resumption of sexual life.

CONCLUSION: The use of microfragmented adipose tissue in GSM is promising. Nevertheless, more studies will be fundamental to exclude a potential placebo effect and better understand the underlying molecular mechanism of action.

PMID:34463351 | DOI:10.1002/ijgo.13906

Eur J Dermatol. 2021 Aug 26. doi: 10.1684/ejd.2021.4109. Online ahead of print.

ABSTRACT

General and local anaesthetics alter tumour behaviour in experimental models. Objectives: To investigate the relationship between general anaesthesia and recurrence or survival in patients who received surgery for malignant melanoma. A meta-analysis was performed based on a comprehensive literature search. Controlled and observational studies of patients undergoing surgery for melanoma under general anaesthesia, compared with other types of anaesthesia, were included. The primary outcomes were overall survival and disease-free survival. The secondary outcomes included cancer-specific survival, cost analysis, and adverse events. Risk of bias was assessed. Individual study information was summarized. The meta-analysis was performed using a random-effects model. The GRADE approach was used to summarise the certainty of evidence. Eight studies were included (n = 5,832). The use of general anaesthesia was not associated with any statistical difference in overall survival (p = 0.087; 1 NRS; n= 104; very low certainty of evidence) or disease-free survival (HR: 1.266; 95% CI: 0.904-1.773; p = 0.169; 1 NRS; n = 281; very low certainty of evidence). However, general anaesthesia was associated with worse melanoma-specific survival (HR: 1.46; 95% CI: 1.22-1.68: p < 0.00001; 3 NRS; n = 4654; low certainty of evidence). Three studies reported increased intraoperative costs associated with the use of general anaesthesia (3 NRT; n = 513; very low certainty of evidence). No study adequately reported other primary or secondary outcomes. General anaesthesia may reduce melanoma-specific survival in patients undergoing surgery for treatment of cutaneous melanoma. We are uncertain whether general anaesthesia impacts the other reported outcomes.

PMID:34463285 | DOI:10.1684/ejd.2021.4109

J Acad Nutr Diet. 2021 Aug 24:S2212-2672(21)00831-5. doi: 10.1016/j.jand.2021.07.005. Online ahead of print.

ABSTRACT

BACKGROUND: A food frequency questionnaire (FFQ) for South American children and adolescents was developed, but its validity for assessing dietary iron intake has not been evaluated.

OBJECTIVE: To evaluate the validity of the FFQ and 24-hour dietary recalls (24h-DR) for assessing dietary iron intake in children and adolescents.

DESIGN: The South American Youth/Child Cardiovascular and Environmental study is a multicenter observational study, conducted in five South American cities: Buenos Aires (Argentina), Lima (Peru), Medellin (Colombia), Sao Paulo, and Teresina (Brazil). The FFQ assessed dietary intake over the previous 3 months, and the 24h-DR was completed three times (2 weekdays and 1 weekend day) with a minimum 5-day interval between recalls. Blood samples were collected to assess serum iron, ferritin, and hemoglobin levels.

PARTICIPANTS AND SETTING: Data of 99 children (aged 3 to 10 years) and 50 adolescents (aged 11 to 17 years) from public and private schools were collected during 2015 to 2017.

MAIN OUTCOME MEASURES: Dietary iron intake calculated from the FFQ (using the sum of daily iron intake in all food/food groups) and 24h-DR (mean of 3 days using the multiple source method).

STATISTICAL ANALYSES PERFORMED: Dietary iron intake in relation to blood biomarkers were assessed using Spearman rank correlations adjusted for sex, age, and total energy intake, and the quadratic weighted κ coefficients for agreement.

RESULTS: Spearman correlations showed very good coefficients (range = 0.78 to 0.85) for the FFQ in both age groups; for the 24h-DR, the coefficients were weak in children and adolescents (range = 0.23 to 0.28). The agreement ranged from 59.9% to 72.9% for the FFQ and from 63.9% to 81.9% for the 24h-DR.

CONCLUSION: The South American Youth/Child Cardiovascular and Environmental study FFQ exhibited good validity to rank total dietary iron intake in children and adolescents, and as well as the 24h-DR, presented good strength of agreements when compared with serum iron and ferritin levels.

PMID:34463258 | DOI:10.1016/j.jand.2021.07.005

J Vasc Surg Venous Lymphat Disord. 2021 Jul 8:S2213-333X(21)00301-2. doi: 10.1016/j.jvsv.2021.06.006. Online ahead of print.

ABSTRACT

OBJECTIVE: Dermal backflow (DBF) and reduced lymphatic visualization are common findings of lymphedema on various imaging modalities. However, there is a lack of knowledge about how these findings vary with the anatomic location and severity of lymphedema, and previous reports using indocyanine green lymphography or lymphoscintigraphy show variable results. Magnetic resonance lymphangiography (MRL) is expected to clarify this clinical question due to its superior ability for lymphatic visualization. This retrospective study aimed to investigate the following: (1) Are there any characteristic patterns for DBF and lymphatics’ visualization, depending on the anatomic location within lower limbs and severity of lymphedema? (2) Is it possible to classify the severity of lymphedema based on MRL findings?

METHODS: Two radiologists performed consensus readings of MRL of 56 patients (112 limbs) with lower-limb lymphedema. The frequency of visualized DBF and lymphatics was analyzed in six regions in each lower limb. The results were compared with the International Society of Lymphology clinical stages and etiology of lymphedema. Characteristic findings were categorized and compared with the clinical stage and duration of lymphedema.

RESULTS: DBF and lymphatics were observed more frequently in the distal regions than the proximal regions of lower limbs. DBF appeared more frequently as the clinical stage increased, reaching statistical significance (P < 10^-3) between stages 0 or I and II. DBF above the knee joint was rarely observed (0.48%) in early stages (0 and I) but appeared more frequently (13.5%, P < 10^-5) in stage II. Lymphatics appeared less frequently as the stage progressed, with significant differences (P < .05) between stages I and II and between II and III. The frequency of lymphatics above the knee joint decreased significantly (P < .05) between stages I and II and between II and III as the stage progressed, reaching 0% in stage III. An MRL staging was proposed and showed significant positive correlations with the clinical stage (r = 0.79, P < .01) and the duration of lymphedema (r = 0.57, P < .01).

CONCLUSIONS: MRL-specific patterns of DBF and lymphatics that depended on the site within the lower limb and clinical stage were shown. The DBF pattern differed from those observed in previous studies with other imaging techniques. The proposed MRL staging based on these characteristic findings allows new stratification of patients with lymphedema. Combined with its excellent ability to visualize lymphatic anatomy, MRL could enable a more detailed understanding of individual patient’s pathology, useful for determining the most appropriate treatment.

PMID:34463259 | DOI:10.1016/j.jvsv.2021.06.006

J Biomol Struct Dyn. 2021 Aug 31:1-20. doi: 10.1080/07391102.2021.1970624. Online ahead of print.

ABSTRACT

A positive association between oxidative stress and hyper-thyroid conditions is well established. Vitamin E (VIT-E) and curcumin (CRM) are considered as potent antioxidant small molecules. Nuclear factor erythroid 2-related factor 2(NRF-2) is known to bind with antioxidant response element and subsequently activate expression of antioxidant enzymes. However, the activation of NRF-2 depends on removal of its regulator Kelch-like ECH-associated protein 1(NRF-2). In the current study, an attempt is made to demonstrate whether effects of VIT-E and CRM are due to direct interaction with the target proteins (i.e. NRF-2, NRF-2, SOD, catalase and LDH) or by possible interaction with the flanking region of their promoters by in silico analysis. Further, these results were corroborated by pretreatment of H9C2 cells (1 x 10⁶ cells per mL of media) with VIT-E (50 μM) and/or CRM (20 μM) for 24 h followed by induction of oxidative stress via T4 (100 nm) administration and assaying the active oxygen metabolism. Discriminant function analyses (DFA) indicated that T4 has a definite role in increasing oxidative stress as evidenced by induction of ROS generation, increase in mitochondrial membrane potential and elevated lipid peroxidation (LPx). Pretreatment with the two antioxidants have ameliorative effects more so when given in combination. The decline in biological activities of the principal antioxidant enzymes SOD and CAT with respect to T4 treatment and its restoration in antioxidant pretreated group further validated our in silico data.Communicated by Ramaswamy H. Sarma.

PMID:34463220 | DOI:10.1080/07391102.2021.1970624

J Acad Nutr Diet. 2021 Aug 24:S2212-2672(21)01037-6. doi: 10.1016/j.jand.2021.07.011. Online ahead of print.

ABSTRACT

BACKGROUND: The Global Leadership Initiative on Malnutrition (GLIM) approach to diagnose malnutrition was published in 2018. An important next step is to use the GLIM criteria in clinical investigations to assess their validity and feasibility.

OBJECTIVE: To compare the validity and feasibility of the GLIM criteria with Patient-Generated Subjective Global Assessment (PG-SGA) in hospitalized patients and to assess the association between malnutrition and 1-year mortality.

DESIGN: Post hoc analysis of a prospective cohort study.

PARTICIPANTS/SETTING: Hospitalized patients (n = 574) from the Departments of Gastroenterology, Gynecology, Urology, and Orthopedics at the Radboudumc academic facility in Nijmegen, The Netherlands, were enrolled from July 2015 through December 2016.

MAIN OUTCOME MEASURES: The GLIM criteria and PG-SGA were applied to identify malnourished patients. Mortality rates were collected from electronic patient records. Feasibility was assessed by evaluating the amount of and reasons for missing data.

STATISTICAL ANALYSES PERFORMED: Concurrent validity was evaluated by assessing the sensitivity, specificity, and Cohen’s kappa coefficient for the GLIM criteria compared with PG-SGA. Cox regression analysis was used for the association between the GLIM criteria and PG-SGA and mortality.

RESULTS: Of 574 patients, 160 (28%) were classified as malnourished according to the GLIM criteria and 172 (30.0%) according to PG-SGA (κ = 0.22, low agreement). When compared with PG-SGA, the GLIM criteria had a sensitivity of 43% and a specificity of 79%. Mortality of malnourished patients was more than two times higher than for non-malnourished patients according to the GLIM criteria (hazard ratio [HR], 2.68; confidence interval [CI], 1.33-5.41). Data on muscle mass was missing in 454 of 574 (79%) patients because of practical problems with the assessment using bioimpedance analysis (BIA).

CONCLUSIONS: Agreement between GLIM criteria and PG-SGA was low when diagnosing malnutrition, indicating that the two methods do not identify the same patients. This is supported by the GLIM criteria showing predictive power for 1-year mortality in hospitalized patients in contrast to PG-SGA. The assessment of muscle mass using BIA was difficult to perform in this clinical population.

PMID:34463257 | DOI:10.1016/j.jand.2021.07.011

Vector Borne Zoonotic Dis. 2021 Aug 31. doi: 10.1089/vbz.2021.0027. Online ahead of print.

ABSTRACT

Three tick species that can transmit pathogen causing disease are commonly found parasitizing people and animals in the mid-Atlantic United States: the blacklegged tick (Ixodes scapularis Say), the American dog tick (Dermacentor variabilis [Say]), and the lone star tick (Amblyomma americanum [L.]) (Acari: Ixodidae). The potential risk of pathogen transmission from tick bites acquired at schools in tick-endemic areas is a concern, as school-aged children are a high-risk group for tick-borne disease. Integrated pest management (IPM) is often required in school districts, and continued tick range expansion and population growth will likely necessitate IPM strategies to manage ticks on school grounds. However, an often-overlooked step of tick management is monitoring and assessment of local tick species assemblages to inform the selection of control methodologies. The purpose of this study was to evaluate tick species presence, abundance, and distribution and the prevalence of tick-borne pathogens in both questing ticks and those removed from rodent hosts on six school properties in Maryland. Overall, there was extensive heterogeneity in tick species dominance, abundance, and evenness across the field sites. A. americanum and I. scapularis were found on all sites in all years. Overall, A. americanum was the dominant tick species. D. variabilis was collected in limited numbers. Several pathogens were found in both questing ticks and those removed from rodent hosts, although prevalence of infection was not consistent between years. Borrelia burgdorferi, Ehrlichia chaffeensis, Ehrlichia ewingii, and Ehrlichia “Panola Mountain” were identified in questing ticks, and B. burgdorferi and Borrelia miyamotoi were detected in trapped Peromyscus spp. mice. B. burgdorferi was the dominant pathogen detected. The impact of tick diversity on IPM of ticks is discussed.

PMID:34463140 | DOI:10.1089/vbz.2021.0027

Blood Adv. 2021 Aug 30:bloodadvances.2021004341. doi: 10.1182/bloodadvances.2021004341. Online ahead of print.

ABSTRACT

BACKGROUND: Allogeneic blood or marrow transplant (BMT) recipients are at risk for venous-thromboembolism (VTE) because of high-intensity therapeutic exposures, comorbidities and a pro-inflammatory state due to chronic graft vs. host disease (GvHD). The long-term risk of VTE in allogeneic BMT survivors remains unstudied.

METHODS: Participants were drawn from the BMT Survivor Study (BMTSS), a retrospective cohort study that included patients who underwent transplantation between 1974 and 2014 and survived ≥2y after BMT. The BMTSS survey collected information on sociodemographics, health behaviors and chronic health conditions along with age at diagnosis. Details regarding primary cancer diagnosis, transplant preparative regimens, type of transplant and stem cell source were obtained from institutional databases and medical records. We analyzed the risk of VTE in 1,554 2y survivors of allogeneic BMT compared to 907 siblings. Using backward variable selection guided by minimizing Akaike’s information criterion, we created a prediction model for risk of late-occurring VTE.

RESULTS: Allogeneic BMT survivors had a 7.3-fold higher risk of VTE compared to siblings (95%CI: 4.69-11.46, p<0.0001). After a median follow-up of 11y (inter-quartile range: 6-18y), and conditional on surviving the first 2y after BMT, the cumulative incidence of late-occurring VTE was 2.4% at 5y, 4.9% at 10y and 7.1% at 20y after BMT. Older age at BMT (hazard ratio [HR]=1.02/y, 95%CI=1.01-1.04, p=0.002), use of immunosuppressive medications (HR=2.28, 95%CI=1.41-3.38, p=0.0008), obesity (HR=1.06/unit increase in body mass index, 95%CI=1.02-1.10, p=0.002), history of stroke (HR=3.71, 95%CI=1.66-8.27, p=0.001), chronic GvHD (HR=1.62, 95%CI=1.00-2.60, p=0.049), and use of peripheral blood stem cells (PBSCs) as source of stem cells compared to bone marrow (HR=2.73, 95%CI=1.65-4.50, p<0.0001) were associated with increased VTE risk. The final model for VTE risk applied at 2y post-BMT (“HiGHS2”) included History of stroke, chronic GvHD, Hypertension, Sex (male vs. female) and Stem cell source (PBSCs vs. other) (corrected C-statistics: 0.73; 95%CI=0.67-0.79), and was able to classify patients at high and low VTE risk (10y cumulative incidence 9.3% vs. 2.4%, p<0.0001).

CONCLUSIONS: The BMTSS HiGHS2 risk model when applied at 2y post-BMT can be used to inform targeted prevention strategies for patients at high risk for late-occurring VTE.

PMID:34461633 | DOI:10.1182/bloodadvances.2021004341