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Nevin Manimala Statistics

Persistence of ctDNA in breast cancer patients during neoadjuvant treatment is a significant predictor of poor tumour response

Clin Cancer Res. 2021 Dec 3:clincanres.3231.2021. doi: 10.1158/1078-0432.CCR-21-3231. Online ahead of print.

ABSTRACT

PURPOSE: Accurate response assessment during neoadjuvant systemic treatment (NST) poses a clinical challenge. Therefore, a minimally-invasive assessment of tumor response based on cell-free circulating tumor DNA (ctDNA) may be beneficial to guide treatment decisions.

EXPERIMENTAL DESIGN: We profiled 93 genes in tissue from 193 early breast cancer patients. Patient-specific assays were designed for 145 patients to track ctDNA during NST in plasma. ctDNA presence and levels were correlated with complete pathological response (pCR), residual cancer burden (RCB) as well as clinicopathologic characteristics of the tumor to identify potential proxies for ctDNA release.

RESULTS: At baseline, ctDNA could be detected in 63/145 (43.4%) patients and persisted in 25/63 (39.7%) patients at mid-therapy (MT) and 15/63 (23.8%) patients at the end of treatment. ctDNA detection at MT was significantly associated with higher RCB (OR 0.062, 95% CI 0.01-0.48, P=0.0077).Out of 31 patients with detectable ctDNA at MT, 30 patients (96.8%) were non-responders (RCB II, n=8; RCB III, n=22) and only one patient responded to the treatment (RCB I). Considering all 145 patients with baseline (BL) plasma, none of the patients with RCB 0 and only 6.7% of patients with RCB I had ctDNA detectable at MT, while 30.6% and 29.6% of patients with RCB II/III, respectively, had a positive ctDNA result.

CONCLUSION: Overall, our results demonstrate that the detection and persistence of ctDNA at MT may have the potential to negatively predict response to neoadjuvant treatment and identify patients who will not achieve pCR or be classified with RCB II/III.

PMID:34862246 | DOI:10.1158/1078-0432.CCR-21-3231

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The incidence and duration of COVID-19 vaccine-related reactive lymphadenopathy on 18F-FDG PET-CT

Clin Med (Lond). 2021 Nov;21(6):e633-e638. doi: 10.7861/clinmed.2021-0420.

ABSTRACT

OBJECTIVES: Reactive axillary lymph nodes (ALN) may occur post-COVID-19 vaccination. This may be confused with malignant nodal metastases on oncological imaging. We aimed to determine the reactive ALN incidence and duration on 18F-fluorodeoxyglucose positron emission tomography – computed tomography (18F-FDG PET-CT), and its relationship with gender, age and vaccine type.

METHODS: A retrospective study was performed. Two-hundred and four eligible patients had 18F-FDG PET-CT between 01 January 2021 and 31 March 2021, post-vaccination with Pfizer-BioNTech or Oxford-AstraZeneca vaccine. Image analysis was performed on dedicated workstations. SPSS was used for statistical analysis.

RESULTS: Thirty-six per cent of patients had reactive ALN until 10 weeks post-vaccination; reducing in frequency and intensity with time. Women were more likely to have reactive ALN compared with men. The frequency and intensity were higher in patients aged <65 years compared with those aged ≥65 years. However, no difference was found between both vaccine types in our study cohort.

CONCLUSIONS: Physicians’ awareness of COVID-19 vaccine-related reactive ALN on 18F-FDG PET-CT is important to avoid inappropriate upstaging of cancers.

PMID:34862224 | DOI:10.7861/clinmed.2021-0420

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Hyperbaric oxygen therapy for the treatment of long COVID: early evaluation of a highly promising intervention

Clin Med (Lond). 2021 Nov;21(6):e629-e632. doi: 10.7861/clinmed.2021-0462.

ABSTRACT

BACKGROUND: Long COVID is a common occurrence following COVID-19 infection. The most common symptom reported is fatigue. Limited interventional treatment options exist. We report the first evaluation of hyperbaric oxygen therapy (HBOT) for long COVID treatment.

METHODS: A total of 10 consecutive patients received 10 sessions of HBOT to 2.4 atmospheres over 12 days. Each treatment session lasted 105 minutes, consisting of three 30-minute exposures to 100% oxygen, interspersed with 5-minute air breaks. Validated fatigue and cognitive scoring assessments were performed at day 1 and 10. Statistical analysis was with Wilcoxon signed-rank testing reported alongside effect sizes.

RESULTS: HBOT yielded a statistically significant improvement in the Chalder fatigue scale (p=0.0059; d=1.75 (very large)), global cognition (p=0.0137; d=-1.07 (large)), executive function (p=0.0039; d=-1.06 (large)), attention (p=0.0020; d=-1.2 (very large)), information processing (p=0.0059; d=-1.25 (very large)) and verbal function (p=0.0098; d=-0.92 (large)).

CONCLUSION: Long COVID-related fatigue can be debilitating, and may affect young people who were previously in economic employment. The results presented here suggest potential benefits of HBOT, with statistically significant results following 10 sessions.

PMID:34862223 | DOI:10.7861/clinmed.2021-0462

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Stakeholder Perspectives on Limiting Residency Applications and Interviews in Obstetrics and Gynecology

J Surg Educ. 2021 Nov 30:S1931-7204(21)00312-3. doi: 10.1016/j.jsurg.2021.10.012. Online ahead of print.

ABSTRACT

PURPOSE: Application inflation in the current residency application process leads to congestion, inefficiency, and perceptions of inequity. The authors aimed to assess the interest of key stakeholders on the topic of capping applications and interviews, and their perceptions regarding equity of the process.

METHODS: An anonymous survey was electronically distributed in March 2021 to Obstetrics and Gynecology (OBGYN) residency applicants, clerkship directors, program directors, and student affairs deans after the submission of the rank order list for the 2021 application cycle and prior to the release of final Match results. Participants answered questions regarding the perceived equity of the current process (no limits on applications submitted or interviews completed) compared with limiting the number of applications and interviews students could submit or complete. Respondents supporting caps reported the number they considered a reasonable cap for applications and interviews. Associations between the profiles of applicants and program directors and their interest in application and interview caps were explored using chi-squared tests for non-parametric statistics and t-tests for normally distributed interval data. The University of Michigan determined the study exempt from IRB review.

RESULTS: The overall response rate was 36.0% (1167/3243), including 34.0% of applicants (879/2579), 50.3% of program directors (143/284), 41.8% of clerkship directors (94/225) and 32.9% of student affairs deans (51/155). All groups reported application caps for either all applicants or the most competitive applicants to be more equitable than the current process, and suggested a median application cap ranging from 25 (clerkship directors and program directors) to 40 (applicants). All groups also believed interview caps to be more equitable than the current process, and suggested a median interview cap ranging from 12 (clerkship directors) to 15 (applicants, program directors, and student affairs deans).

CONCLUSIONS: Stakeholders in the OBGYN application process consider caps to applications and interviews a promising means to improve equity in the Match.

PMID:34862152 | DOI:10.1016/j.jsurg.2021.10.012

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Modified Broström With and Without Suture Tape Augmentation: A Systematic Review

J Foot Ankle Surg. 2021 Oct 16:S1067-2516(21)00383-5. doi: 10.1053/j.jfas.2021.09.027. Online ahead of print.

ABSTRACT

The Modified Broström has become the gold standard for operative management of chronic lateral ankle instability. Despite overall good clinical outcomes with this procedure, recent biomechanical data have called into question the strength and durability of this technique. Accordingly, the addition of suture tape to the Modified Broström construct has been described in an attempt to more closely recreate the natural biomechanical properties of the ankle lateral ligament complex. We performed a systematic review of the literature was using PubMed, Embase, and CINAHL to identify English-language articles from 2009 to present discussing outcomes with the augmented Modified Broström technique. A total of 4 studies (2 retrospective cohort studies, 2 case series) involving 156 patients with Modified Broström with augmentation met inclusion criteria. Average follow-up time was 13.8 months. Of the 3 studies reporting patient-reported outcome measures both pre- and postoperatively, there was a significant improvement in all measures (p < .05). Two studies compared the Modified Broström directly with and without augmentation, one of which found a statistically significant difference in the Foot and Ankle Ability Measure in favor of the augmentation group (93.1 vs 90.5, p = .027), while American Orthopaedic Foot and Ankle Society score was not significantly different (p > .05) between the 2 procedures across studies. There were no significant differences in complications between techniques. Modified Broström with suture tape augmentation for chronic lateral ankle instability can produce good short-term clinical outcomes with few complications, comparable to the Modified Broström alone.

PMID:34862125 | DOI:10.1053/j.jfas.2021.09.027

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Engagement with young people as partners in health research: four case studies from Sub-Saharan Africa

Trop Med Int Health. 2021 Dec 3. doi: 10.1111/tmi.13702. Online ahead of print.

ABSTRACT

OBJECTIVES: Existing health services for young people (10-24 years), which are predominantly designed for but not with young people, often do not meet young people’s needs. The 2018 Global Consensus Statement on meaningful adolescent and youth engagement affirms that young people have a fundamental right to actively and meaningfully engage in all matters that affect their lives. We present four case studies from three countries in sub-Saharan Africa as practical examples of the engagement of young people as partners in health research. We critically reflect on best practices to inform and guide the increasing adoption of collaborative approaches.

METHODS: We developed a narrative summary of each case study through review of study documentation and discussions with research staff and young people. A youth engagement framework was used to describe partnership activities according to the following dimensions: purpose, process, positioning, perspective, power relations, place and protection. We reflected on innovative practices used, overall level of participation achieved, and strategies to address ethical, logistical and/or financial barriers.

RESULTS: In all case studies we found evidence of engagement activities that aligned with the Global Consensus Statement on Meaningful Youth Engagement. However, access to participation was often uneven and despite efforts, marginalised young people continue to have insufficient opportunities to engage. Furthermore, although young people had some opportunity to influence the research methods, many of the key design decisions had been determined prior to their involvement. In our case studies researchers had built in insufficient opportunities to evaluate the level and impact of youth engagement.

CONCLUSIONS: We therefore recommend early involvement of young people in the research process so that they can contribute to setting the research agenda, the design of planned studies and thus increase the scope of their engagement from the beginning. Youth engagement activities need to be evaluated from the perspective of all stakeholders including young people themselves with a focus on opportunities to engage, the level of engagement achieved, and impact of engagement. From the beginning, researchers should provide space for learning, and involve young people in encouraging critical reflection of what does not yet work, as well as what does, to enable improvements.

PMID:34861086 | DOI:10.1111/tmi.13702

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Holistic evaluation of long-term earthworm field studies with a fungicide

Integr Environ Assess Manag. 2021 Dec 2. doi: 10.1002/ieam.4562. Online ahead of print.

ABSTRACT

Plant protection products for placing on the market in the European Union need to meet rigorous safety criteria including the testing of lumbricid earthworms, the functionally most important soil organism group in Central European agricultural ecosystems. To address uncertainties and investigate the potential long-term in-crop effects of the fungicide Cantus® containing 50% boscalid as active substance, a series of standardized earthworm field studies with an overall duration of 5 years per study program was carried out in four German agricultural fields under realistic crop rotation conditions. A two-step approach was chosen to analyze the potential overall long-term effects on earthworms in agricultural fields: i) an assessment of the earthworm abundance development in the course of the four study programs in relation to the determined actual content of boscalid in soil and ii) an effect size meta-analysis of earthworm abundance one year after treatment for each consecutive year and study program. Measured boscalid concentrations in soil after multiple applications were well above the maximum boscalid residues observed in agricultural soils across Central Europe. There were isolated statistically significant reductions of earthworm abundance for some species and groups at some timepoints during the studies, but no consistent relationship to the Cantus® treatments was observed. These results were supported by the meta-analysis indicating no adverse effects on earthworm populations. Therefore, fluctuations of abundance are rather reflecting natural variation of the populations than a concentration-related response. Based on this comprehensive analysis we conclude that there is no application rate-related effect of the 5-year use of Cantus® on the earthworm communities’ development. The four study programs, paired with a comprehensive evaluation, directly address the concerns about potential long-term effects of boscalid on earthworms in the field and suggest that multi-year applications do not adversely affect earthworm populations. This article is protected by copyright. All rights reserved.

PMID:34861099 | DOI:10.1002/ieam.4562

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Clinical study of autoantibodies in type 1 diabetes mellitus children with ketoacidosis or microalbuminuria

J Clin Lab Anal. 2021 Dec 3:e24164. doi: 10.1002/jcla.24164. Online ahead of print.

ABSTRACT

AIMS: The study aimed to investigate the value of autoantibodies in predicting the risk of ketoacidosis or microalbuminuria in children with type 1 diabetes mellitus.

METHODS: Clinical data and laboratory indicators of 80 patients with type 1 diabetes admitted to the Department of Endocrinology in Tianjin Children’s Hospital, from June 2017 to March 2019, were retrospectively analyzed. The patients were divided into two groups: diabetes without ketoacidosis group (n = 20) and diabetes with ketoacidosis group (n = 60). The differences in general data, laboratory test indexes, and autoantibodies between the two groups were analyzed. Finally, ROC curves and multivariate logistic regression analysis were used to explore the value of autoantibodies in patients with ketoacidosis or microalbuminuria.

RESULTS: A total of 80 children with type 1 diabetes were assessed, including 35 boys and 45 girls, ranging in age from 10 months to 15 years. The concentration of GADA, IA2A, and ZnT8A was not statistically different between the two groups, but the positive rate of ZnT8A was statistically significant (p = 0.038) and had a diagnostic value for the occurrence of ketoacidosis (p = 0.025). ZnT8A-positive patients had a higher titer of IA2A and a more frequent prevalence of GADA and IA2A than ZnT8A-negative patients (p < 0.01). In multivariate logistic regression analyses, the presence of positive ZnT8A was associated with a higher risk of microalbuminuria independent of age, sex, and BMI (OR = 4.184 [95% CI 1.034~16.934], p = 0.045).

CONCLUSIONS: The positive ZnT8A had diagnostic value for ketoacidosis in children with type 1 diabetes and had the highest specificity among the three kinds of autoantibodies. Moreover, ZnT8A positivity was related to a higher titer of IA2A and more frequent occurrence of multiple diabetes-related autoantibodies. Besides, the presence of positive ZnT8A was an independent risk factor of microalbuminuria in children with type 1 diabetes. Therefore, we can infer that positive ZnT8A may be related to ketoacidosis and microalbuminuria, accelerating the progression of T1DM.

PMID:34861060 | DOI:10.1002/jcla.24164

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Translation, validity, and reliability of NUTRISCORE: the nutrition risk assessment screening test for Turkish cancer patients

Nutr Clin Pract. 2021 Dec 3. doi: 10.1002/ncp.10804. Online ahead of print.

ABSTRACT

PURPOSE: The aim was to determine the validity and the reliability of the Turkish version of the screening test named NUTRISCORE in cancer patients.

METHODS: The language validity of the Turkish form of the study scale was provided by the translationback-translation method. NUTRISCORE and nutritional risk screening (NRS)-2002, malnutrition screening tool (MST), and European Diagnostic Criteria (EDC) were administered to 240 volunteers in oncology clinics, and receiver operating characteristic curves (ROC) were calculated for the validity and reliability analysis. Cohen’s kappa coefficient was used to determine the fit between the screening tests.

RESULTS: Thirteen experts were consulted for scale content validity, and the content validity index was found to be 0.94. The scale was administered to 67 patients with 4-week intervals for test-retest reliability, and a positive, high-level and statistically significant relationship was found between the two measurements (r = 0.971, P < 0.01). Compared with the reference test NRS-2002, the specificity values of NUTRISCORE, MST, and EDC screening tests were found to be 100%, 83%, and 91%, whereas the sensitivity values of same screening tests were calculated as 85%, 91% and 81%, respectively. According to Cohen’s kappa statistics, the kappa agreement between NRS-2002 and NUTRISCORE was 0.88, the kappa agreement between NRS-2002 and MST was 0.34, and it was found to be 0.73 for NRS-2002 and EDC.

CONCLUSION: The nutrition screening test named NUTRISCORE showed adequate validity and reliability in Turkish and can detect malnutrition risk of cancer patients treated in oncology clinics as a screening tool.

PMID:34861067 | DOI:10.1002/ncp.10804

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Knowledge, Awareness, and Practices (KAP) towards COVID-19 among the marine fishers of Maharashtra State of India: An online cross-sectional Analysis

PLoS One. 2021 Dec 3;16(12):e0261055. doi: 10.1371/journal.pone.0261055. eCollection 2021.

ABSTRACT

The knowledge, awareness, and practices (KAP) about COVID-19 among the marine fishers who are engaged in the high-risk occupations and depend on the vulnerable sources of income in the Maharashtra state of India, were investigated to understand the behavioral changes and vulnerability among the respondents because of COVID-19. Data were collected through an online survey from 1st July to 30th July 2020 during the first peak of COVID-19 in the study area by using the questionnaire. Authors based on the latest recommendations by the World Health Organization (WHO) developed the questionnaire and covered the KAP aspects under study. The questionnaire was administered through Google form link and the link was disseminated through social media such as Facebook and What’s App. The completed responses (n = 533) received from the eligible sample, excluding those outsides of the fisher community and duplicate entries were considered for analysis. Appropriate statistical tools were used to analyze the data. Among the respondents, 447 men (83.86%) and 86 women (16.14%), with a mean age of 45.4 years (M = 45.4, SD = 1.18). The results revealed that 70.92% of respondents perceived a low risk of infection because of COVID-19 with M = 1.77 and SD = 0.583, but authors found the perceived severity score high (M = 3.95, SD = 1.21) among the 60.97% of respondents. Around 95% of respondents were aware of the COVID-19, while almost all respondents knew the medium of infection and symptoms of COVID-19. The behavior of respondents towards COVID-19 infection was positive and was following sufficient precautionary measures suggested by WHO to protect themselves from COVID-19 infection. The results of multiple regression analysis revealed that the demographic features of respondents like age, education were significantly contributing to the KAP of the fisher community. The results confirmed the importance of KAP which is reflected in the behavioral responses of the fishers while tackling the COVID-19 pandemic situation. The results regarding the risk perception, severity, KAP about COVID-19 provide a collective understanding of the emerging infectious disease among the marine fishers of Maharashtra state of India.

PMID:34860859 | DOI:10.1371/journal.pone.0261055