Category: Nevin Manimala

BMJ Open. 2021 Dec 3;11(12):e048830. doi: 10.1136/bmjopen-2021-048830.

ABSTRACT

INTRODUCTION: Approximately 38% of haemodialysis patients carry Staphylococcus aureus in their noses, and carriers have a nearly four-fold increased risk of S. aureus access-related bloodstream infections (BSIs) compared with non-carriers. Our objective is to determine the clinical efficacy and effectiveness of a novel intervention using nasal povidone-iodine (PVI) to prevent BSIs among patients in haemodialysis units. We will survey patients and conduct qualitative interviews with healthcare workers to identify barriers and facilitators to implementing the intervention.

METHODS AND ANALYSIS: We will perform an open-label, stepped-wedge cluster randomised trial to assess the effectiveness of nasal PVI compared with standard care. Sixteen outpatient haemodialysis units will participate in the study. The 3-year trial period will be divided into a 4-month baseline period and eight additional 4-month time blocks. The primary outcome of the study will be S. aureus BSI, defined as a S. aureus positive blood culture collected in the outpatient setting or within one calendar day after a hospital admission. The study team will evaluate characteristics of individual patients and the clusters by exposure status (control or intervention) to assess the balance between groups, and calculate descriptive statistics such as average responses separately for control and intervention survey questions.

ETHICS AND DISSEMINATION: This study has received IRB approval from all study sites. A Data Safety and Monitoring Board will monitor this multicentre clinical trial. We will present our results at international meetings. The study team will publish findings in peer-reviewed journals and make each accepted peer-reviewed manuscript publicly available.

TRIAL REGISTRATION NUMBER: NCT04210505.

PMID:34862278 | DOI:10.1136/bmjopen-2021-048830

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

Clin Med (Lond). 2021 Nov;21(6):e639-e644. doi: 10.7861/clinmed.2021-0325.

ABSTRACT

BACKGROUND: The decision to admit patients to hospital in low-resource settings have been poorly investigated.

AIM: We aimed to determine the association of a disposition score determined on arrival with the decision subsequently made to admit or discharge the patient. The score awarded one point for altered mental status, one point for impaired mobility and one point for low oxygen saturation.

METHODS: The mental status, mobility and oxygen saturation on arrival of 5,334 consecutive patients attending a combined emergency and outpatient department in a low-resource Ugandan hospital were recorded. Admission decisions were subsequently made independently by clinicians unaware to the score.

RESULTS: Most patients (n=3,876; 73%) had a disposition score of zero and only 25 of these patients (0.6%) were subsequently admitted. A total of 646 (12.1%) patients were admitted. Only 301 (5.6%) patients had a score of 3 points and 263 (87.4%) of these were admitted. The C statistic for the discrimination of the score for admission was 0.953 (95% confidence interval 0.941-0.964).

CONCLUSION: In a low-resource setting, a simple score based on mental status, mobility and oxygen saturation identified outpatient and emergency department patients most and least likely to be subsequently admitted to hospital with a high degree of discrimination.

PMID:34862225 | DOI:10.7861/clinmed.2021-0325

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

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

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

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

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

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

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