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Clinical evaluation of a fully electronic microfluidic white blood cell analyzer

by Jianye Sui, Zhongtian Lin, Shahriar Azizpour, Fei Chen, Sunanda Gaur, Kelly Keene, Farzad Soleimani, Tanaya Bhowmick, Zubaid Rafique, Mehdi Javanmard

The White Blood Cell (WBC) count is one of the key parameters signaling the health of the immune system. Abnormal WBC counts often signal a systemic insult to the body such as an underlying infection or an adverse side effect to medication. Typically, the blood collected is sent to a central lab for testing, and results come back within hours, which is often inconvenient and may delay time-sensitive diagnosis or treatment. Here, we present the CytoTracker, a fully electronic, microfluidic based instant WBC analyzer with the potential to be used at point-of-care. The CytoTracker is a lightweight, portable, affordable platform capable of quantifying WBCs within minutes using only 50 μl of blood (approximately one drop of blood). In this study, we clinically evaluated the accuracy and performance of CytoTracker in measuring WBC and granulocyte counts. A total of 210 adult patients were recruited in the study. We validated the CytoTracker against a standard benchtop analyzer (Horiba Point of Care Hematology Analyzer, ABX Micros 60). Linear dynamic ranges of 2.5 k/μl– 35 k/μl and 0.6 k/μl– 26 k/μl were achieved for total WBC count and granulocyte count with correlation coefficients of 0.97 and 0.98. In addition, we verified CytoTracker’s capability of identifying abnormal blood counts with above 90% sensitivity and specificity. The promising results of this clinical validation study demonstrate the potential for the use of the CytoTracker as a reliable and accurate point-of-care WBC analyzer.

Genetic profiling of rat gliomas and cardiac schwannomas from life-time radiofrequency radiation exposure study using a targeted next-generation sequencing gene panel

by Ashley M. Brooks, Andrea Vornoli, Ramesh C. Kovi, Thai Vu T. Ton, Miaofei Xu, Ahmed Mashal, Eva Tibaldi, Federica Gnudi, Jian-Liang Li, Robert C. Sills, John R. Bucher, Daniele Mandrioli, Fiorella Belpoggi, Arun R. Pandiri

The cancer hazard associated with lifetime exposure to radiofrequency radiation (RFR) was examined in Sprague Dawley (SD) rats at the Ramazzini Institute (RI), Italy. There were increased incidences of gliomas and cardiac schwannomas. The translational relevance of these rare rat tumors for human disease is poorly understood. We examined the genetic alterations in RFR-derived rat tumors through molecular characterization of important cancer genes relevant for human gliomagenesis. A targeted next-generation sequencing (NGS) panel was designed for rats based on the top 23 orthologous human glioma-related genes. Single-nucleotide variants (SNVs) and small insertion and deletions (indels) were characterized in the rat gliomas and cardiac schwannomas. Translational relevance of these genetic alterations in rat tumors to human disease was determined through comparison with the Catalogue of Somatic Mutations in Cancer (COSMIC) database. These data suggest that rat gliomas resulting from life-time exposure to RFR histologically resemble low grade human gliomas but surprisingly no mutations were detected in rat gliomas that had homology to the human IDH1 p.R132 or IDH2 p.R172 suggesting that rat gliomas are primarily wild-type for IDH hotspot mutations implicated in human gliomas. The rat gliomas appear to share some genetic alterations with IDH1 wildtype human gliomas and rat cardiac schwannomas also harbor mutations in some of the queried cancer genes. These data demonstrate that targeted NGS panels based on tumor specific orthologous human cancer driver genes are an important tool to examine the translational relevance of rodent tumors resulting from chronic/life-time rodent bioassays.

Effectiveness of concentrated growth factor and laser therapy on wound healing, inferior alveolar nerve injury and periodontal bone defects post‐mandibular impacted wisdom tooth extraction: A randomized clinical trial

Abstract

The extraction of wisdom teeth with mandibular impact frequently results in complications including damage to the inferior alveolar nerve (IAN) and malformations of the bone. The objective of this research endeavour was to assess the efficacy of low-level laser therapy and concentrated growth factor (CGF) in facilitating nerve recovery and wound healing in such instances. A total of thirty-one patients (mean age 27.52 ± 5.79 years) who presented with IAN injury after extraction were randomly assigned to one of three groups: control group (which received oral mecobalamin), CGF group (which received CGF gel applied to the extraction sockets) and laser group (which received low-level lasers (808 nm, 30 mW, 10 J/cm2)) at the extraction site. Patients' recovery from IAN paresthesia was evaluated seven times over the course of 14 days utilizing visual analogue scale (VAS) and the pinprick test (PP). At multiple intervals following surgery, periodontal probing and bone level measurements were utilized to assess the recovery of both soft and hard tissues. The findings revealed that, compared with the control group, both the CGF and laser treatment groups exhibited a markedly greater improvement in VAS scores and wound healing of soft tissues, as well as in PP results (p < 0.001), indicating enhanced wound healing processes. Despite these improvements, there was no significant difference in wound healing outcomes between the CGF and laser groups. Notably, the CGF group showed a statistically significant improvement in healing bone defects at 30 and 90 days post-treatment compared with the control group (p = 0.003 and p = 0.004, respectively), underscoring its effectiveness in bone healing as a critical aspect of the overall wound healing process. However, in terms of other wound healing comparisons, no significant differences were observed. CGF and laser therapy significantly enhanced the healing of wounds, including soft tissue and bone recovery, in addition to accelerating the recovery of IAN injuries following mandibular wisdom tooth extraction. Although both treatments were equally effective in nerve recovery, CGF notably excelled in promoting bone healing, suggesting its pivotal role in comprehensive wound healing. This highlights that both CGF and laser therapy are viable options for not only nerve recovery but also for overall wound healing in such dental procedures.

The influence of minimally invasive esophagectomy on wound infection in patients undergoing esophageal cancer surgery: A meta‐analysis

Abstract

The impacts of minimally invasive esophagectomy (MIE) in comparison with open esophagectomy (OE) on postoperative complications, wound infections and hospital length of stay in patients with esophageal carcinoma (ESCA) using meta-analysis to provide reliable evidence for clinical practice. A search strategy was developed and computer searches were performed on Embase, Web of Science, PubMed, Cochrane Library, Wanfang, China Biomedical Literature Database and China National Knowledge Infrastructure databases for clinical studies that reported the effects of MIE in comparison with OE in patients with ESCA. The retrieval time was from their inception to October 2023. Two authors independently performed literature screening, and data extraction and literature quality evaluation were performed separately for the included studies. Meta-analysis was performed using Stata 17.0 software. Overall, 26 studies with 2427 ESCA patients were included in this study, of which 1203 were in the MIE group and 1224 were in the OE group. The results showed that, compared with OE, ESCA patients who underwent MIE were less likely to develop postoperative wound infections (odds ratio [OR] = 0.31, 95% confidence intervals [CIs]: 0.20–0.49, p < 0.001) and complications (OR = 0.23, 95% CI: 0.18–0.30, p < 0.001) and have a shorter hospital stay (standardized mean difference = −1.93, 95% CI: −2.38 to −1.48, p < 0.001). MIE has advantages over OE in terms of shorter hospital stay and reduced incidence of postoperative wound infections and complications.

Wound infection prevention strategies in colorectal endoscopic mucosal resection: A meta‐analysis of prophylactic measures

Abstract

Colorectal endoscopic mucosal resection (EMR) is associated with the risk of postoperative wound infections, prompting investigations into effective prophylactic measures. This meta-analysis aimed to evaluate the efficacy of various prophylactic interventions in reducing the incidence of wound infections following EMR. Adhering to PRISMA guidelines, we conducted a comprehensive search across multiple databases for randomized controlled trials (RCTs) and cohort studies from 2015 to 2022. We included studies that compared the efficacy of antibiotic prophylaxis and antiseptic measures, with clear data on post-procedure infection rates. Eight studies met our inclusion criteria, and data were extracted for meta-analysis. The risk of bias was assessed using the Cochrane Collaboration tool and the Newcastle-Ottawa Scale. The meta-analysis included 3765 patients from eight RCTs. Prophylactic antibiotics (cefixime and cefuroxime) showed moderate to high efficacy, with infection rates as low as 0% and 0.76%. Prophylactic endoscopic closure and clipping showed the highest efficacy, with zero reported infections. The standardized surgical site infection prevention bundle had lower effectiveness, with an infection incidence of 3.83%. The risk of bias assessment indicated potential performance bias due to lack of blinding, but overall evidence quality was upheld by proper random sequence generation and diligent outcome data monitoring. The effectiveness of specific prophylactic measures, notably prophylactic antibiotics and mechanical closure techniques, has been shown in significantly reducing the risk of wound infections following colorectal EMR.

Effect of suture closure and staple closure on postoperative wound complications in patients undergoing knee replacement surgery: A meta‐analysis

Abstract

The purpose of this meta-analysis is to determine if the application of stitching in the closed area of the knee arthroplasty remains significantly superior to that of the staples. Data sources: EMBASE, Cochrane Libraryand, publications, and the Web of Science. Patients were treated with staples for closure of their wounds, or with conventional stitches for closure of wounds. The main findings were surgical site infection, wound dehiscence, and cutting time. The secondary results were the time to completion, the duration of the hospitalization, and the time to discharge. We incorporated the SIX trial into the meta-analyses with Review Manager V.5.3. The hazard ratio was computed as a therapeutic outcome with respect to the heterogeneity. For more than 50% of heterogeneous samples, we employed a stochastic effect model. The results showed that there was no significant difference in the degree of infection, the degree of dehiscence, the length of the cut and the degree of satisfaction of the wound. But the time to close the wound and the time to operate were significantly different. The time needed to close the wound was shorter than that of the suture (OR, −227. 22; 95% CI, −238. 74, −215. 69 p < 0. 0001); The time taken to replace the knee was also significantly lower among those who had been stapled sutures (OR, −5.46; 95% CI, −10. 43, −0.49 p = 0. 03). Wound closing materials are an afterthought for many orthopaedic surgeons. Together, the findings from a number of comparative studies indicate that the selection of wound closure materials might affect the outcome of the surgery. The evidence, however, is weak because of the heterogeneous approach adopted in earlier research. This study program is intended to provide guidance on how to select the best wound closure material for the purpose of identifying if there is any difference in the incidence of injuries among traditional stitches and staples.

Reconstruction of foot and ankle defects using the vaccum sealing drainage versus the induced‐membrane the elderly: A retrospective comparative study

Abstract

The purpose of this study was to compare the reconstructive outcomes of soft-tissue defects around foot and ankle with vaccum sealing drainage (VSD) or induction membrane (IM) of cement formation and attempt to provide an optimal strategy for elderly patients. A retrospective review of all continuous patients with foot and ankle reconstruction using different flaps from October of 2016 and October of 2020 was performed. Based on the different way, the patients were divided into two groups: VSD group (n = 26) and IM group (n = 27). Outcomes were assessed according to the size of the defect, frequency of debridement procedures, hospitalization time, duration of healing, the healing rate, major amputation rate, functional outcomes and complications. Immunohistochemistry (IHC) detection of vascular endothelial growth factor (VEGF) was also be completed. We found that there was no difference in demographic characteristics, size of the defect, debridement times and functional outcomes between the two groups (p > 0.05); however, a significant difference in the wound healing time, hospitalization time and complications were noted between them(p < 0.05). The fresh granulation tissue of both groups showed abundant positive expression of VEGF. Thus, the VSD and IM are both available for foot and ankle reconstruction in elderly patients. However, the IM group offers short hospitalization time, duration of healing and lower frequency of postoperative complications. Thus, we advocate the IM for reconstruction of defects of the foot and ankle region in the elderly patients.

Intervention to increase physical activity and healthy eating among under-represented adolescents: GOAL trial protocol

Por: Robbins · L. B. · Ling · J. · Pfeiffer · K. A. · Kerver · J. M. · Resnicow · K. · McCaffery · H. · Hilliard · A. · Hobbs · L. · Donald · S. · Kaciroti · N.
Introduction

To reduce obesity-related disparities, reaching economically disadvantaged and/or minority status adolescents to assist them in meeting physical activity (PA) and nutrition recommendations is important. To address the problem, a 16-week intervention called Guys/Girls Opt for Activities for Life (GOAL) was designed. The purpose of this randomised controlled trial is to evaluate any effect of the intervention, compared with a control condition, on improving: (1) adolescents’ % body fat (primary outcome), moderate-to-vigorous PA (MVPA), diet quality and cardiorespiratory fitness from 0 to 4 months; (2) body mass index (BMI), overweight/obesity percentage and quality of life from 0 to 4 months and to 13 months; and (3) perceived social support, self-efficacy and motivation from 0 to 4 months with evaluation of any mediating effect on adolescent PA and diet quality. An exploratory aim is to evaluate any effect of the intervention, compared with the control, on improving parents’/guardians’ home environment, MVPA and diet quality from 0 to 4 months; and BMI from 0 to 4 months and to 13 months.

Methods and analysis

Adolescents (fifth to eighth grade) in 14 schools located in underserved urban communities are randomly assigned to the intervention or usual school offerings. One parent per adolescent is enrolled (882 dyads total). Cohort 1 includes four schools (2022–2023). Cohorts 2 and 3 include 5 schools in 2023–2024 and 2024–2025, respectively. The 16-week intervention has three components: (1) after-school GOAL club for adolescents to engage in PA and healthy eating/cooking activities; (2) three parent–adolescent meetings to empower parents to assist adolescents; and (3) GOAL social networking website for parents to share how they helped their adolescent.

Ethics and dissemination

The Michigan State University Biomedical Institutional Review Board provided ethical approval for the study. Findings will be shared via the trial registration database, peer-reviewed publications, conferences and community-oriented strategies.

Trial registration number

NCT04213014.

Comparative efficacy of silver alginate dressings versus standard gauze in enhancing wound healing post‐mastectomy for triple‐negative breast cancer: A systematic review and meta‐analysis

Abstract

This meta-analysis evaluates the efficacy of silver alginate dressings (SAD) compared to standard gauze (SG) in enhancing wound healing and reducing scar formation post-mastectomy in patients with triple-negative breast cancer. From an initial pool of 1245 articles, five studies met the inclusion criteria. The analysis revealed that SAD significantly improve early wound healing 1 week post-mastectomy, as indicated by lower Redness, Edema, Ecchymosis, Discharge, and Approximation (REEDA) scales (I 2 = 85%; Random: SMD: −7.08, 95% CI: −8.26 to −5.98, p < 0.01), compared to SG. Additionally, long-term scar outcomes measured by the Manchester Scar Scale (MSS) 5 months post-mastectomy showed a notable reduction in scar formation (I 2 = 95%; Random: SMD: −12.97, 95% CI: −16.20 to −9.75, p < 0.01)) in the silver alginate group. The findings support the use of SAD in post-mastectomy care for triple-negative breast cancer patients but highlight the need for further research on long-term safety and cost-effectiveness.

The knowledge and attitude on the prevention of pressure ulcers in Chinese nurses: A cross‐sectional study in 93 tertiary and secondary hospitals

Abstract

Although pressure ulcers are related to substantial health burdens, they may be preventable. Since nurses play a fundamental role in pressure ulcer prevention, their knowledge and attitude are of great importance. This study aims to investigate the current situation and associated factors of nurses' knowledge and attitude on the prevention of pressure ulcers from both tertiary and secondary hospitals. A total of 11 347 nurses were recruited including 7108 nurses (62.6%) from tertiary hospitals and 4239 nurses (37.4%) from secondary hospitals. The median (interquartile range) of the pressure ulcer knowledge score was 51% (38%, 90%) for all the participants with the lowest scores on prevention of pressure ulcers (51.33%). The mean (standard deviation) of attitude towards pressure ulcer prevention was 39.64 (4.65) with the lowest scores on personal competency to prevent pressure ulcers (mean 3.09). The results of multivariate linear regression showed that hospital level, nurses' age, years of work experience, initial education level at work and time of last training significantly associated with nurses' knowledge of pressure ulcer prevention. Meanwhile, hospital level, job title, previous training, time of last training and subjective needs for further training had significant association with nurses' attitude towards pressure ulcer prevention (all p < 0.05). Results showed inadequate knowledge but relative positive attitudes in nurses indicating the importance to deliver continuing education and training regarding pressure ulcer prevention in practice to improve the quality of care.

Evaluating a technologically enhanced rehabilitation programme for wound healing in patients with coronary heart disease

Abstract

Wound healing symptoms in patients with coronary heart disease (CHD) are frequently problematic, potentially resulting in complications. In order to tackle this concern, a state-of-the-art rehabilitation programme was created, which incorporated telehealth, virtual reality and robotics in an effort to optimize wound healing in patients with coronary heart disease. The purpose of this research was to assess the efficacy of a rehabilitation programme that utilized cutting-edge technology in enhancing the outcomes of wound recovery for individuals diagnosed with (CHD). Data from 120 CHD patients who participated in this longitudinal randomized controlled trial of a specialized rehabilitation programme intended to promote wound repair were utilized in a cross-sectional analysis. Anthropometric measurements, sociodemographical factors, exercise capacity and the progression of wound recovery were gathered as data. The research participants were primarily comprised of older males from various socioeconomic backgrounds. Age, gender, BMI, socio-educational orientation, physical activity, identified regulation and identified regulation were all significant determinants of wound healing. The significance of customized strategies in cardiac rehabilitation programmes that aim to achieve favourable wound healing outcomes is underscored by these results. In conclusion, this study emphasized the importance of incorporating unique patient attributes when designing technologically advanced rehabilitation protocols aimed at facilitating wound recovery in patients with coronary heart disease. Personalized interventions that consider these variables could potentially result in improved outcomes for wound healing among this particular group of patients.

Shared decision-making improving efficacy in diarrhoea-dominant irritable bowel syndrome in Chinese outpatient setting: protocol of a prospective, randomised controlled trial

Por: Song · K. · Fan · Z. · Chen · Y. · Fei · G. · Li · X. · Wu · D.
Introduction

Diarrhoea-dominant irritable bowel syndrome (IBS-D) is a disorder with multiple pathogenesis; many people with IBS-D may have psychosocial issues which can make assessment and treatment more difficult. Routine treatment procedure might not always achieve the desired outcome. Therefore, patients may not be satisfied with the conventional experience and would like to be more involved in clinical decision-making. A shared decision-making (SDM) model, that requires patient participation, has been demonstrated to have a powerful effect on the diagnosis and treatment of other diseases, which improves patients’ compliance, satisfaction, thus refining the clinical outcome. However, there is no corresponding evidence in IBS-D. Herein, we hope to verify the effect of SDM through clinical studies, and we anticipate that SDM can improve the therapeutic effect in patients with IBS-D.

Methods

The study is a prospective, randomised, single-centre trial. 166 IBS-D outpatients who attend Peking Union Medical College Hospital will be allocated into routine treatment group and SDM group. The primary endpoint is the severity of bowel symptoms, measured by the IBS symptom severity scale. Secondary endpoints include impact of disease and quality of life, negative psychology and the evaluation of diagnosis and treatment process.

Ethics and dissemination

Ethical approval has been obtained from the research ethics committee of Peking Union Medical College Hospital (I-23PJ470). This protocol has been approved by Chinese Clinical Trial Register (ChiCTR2300073681) in July 2023. The results of this trial will be published in an open-access way and disseminated among gastrointestinal physicians.

Trial registration number

Chinese Clinical Trial Register (ChiCTR2300073681).

Risk factors associated with surgical site infections in patients undergoing cardiothoracic surgery: A systematic review and meta‐analysis

Abstract

Surgical site infections (SSIs) following cardiothoracic surgery can pose significant challenges to patient recovery and outcome. This systematic review and meta-analysis aim to identify and quantify the risk factors associated with SSIs in patients undergoing cardiothoracic surgery. A comprehensive literature search adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and based on the PICO paradigm was conducted across four databases: PubMed, Embase, Web of Science and the Cochrane Library, without any temporal restrictions. The meta-analysis incorporated studies detailing the risk factors for post-operative sternal infections, especially those reporting odds ratios (OR) or relative risks with 95% confidence intervals (CI). Quality assessment of the studies was done using the Newcastle-Ottawa Scale. Statistical analysis was executed using the chi-square tests for inter-study heterogeneity, with further analyses depending on I 2 values. Sensitivity analyses were performed, and potential publication bias was also assessed. An initial dataset of 2442 articles was refined to 21 articles after thorough evaluations based on inclusion and exclusion criteria. Patients with diabetes mellitus have an OR of 1.80 (95% CI: 1.40–2.20) for the incidence of SSIs, while obese patients demonstrate an OR of 1.63 (95% CI: 1.40–1.87). Individuals who undergo intraoperative blood transfusion present an OR of 1.13 (95% CI: 1.07–1.18), and smokers manifest an OR of 1.32 (95% CI: 1.03–1.60). These findings unequivocally indicate a pronounced association between these factors and an elevated risk of SSIs post-operatively. This meta-analysis confirms that diabetes, obesity, intraoperative transfusion and smoking heighten the risk of SSIs post-cardiac surgery. Clinicians should be alert to these factors to optimise patient outcomes.

Aprendizaje generado a partir de la pandemia COVID-19 en enfermeros

Introducción: La enfermería brasileña parece haber alcanzado importantes niveles de aprendizaje durante la pandemia, no solo por la necesidad de controlar la circulación del nuevo coronavirus y cuidar a los enfermos. Objetivo: Conocer los aprendizajes generados a partir de la pandemia de COVID-19 entre las enfermeras. Métodos: estudio exploratorio y cualitativo, realizado en agosto y septiembre de 2021, con enfermeros de tercer nivel de salud que estuvieron en primera línea durante la pandemia, en el Estado de Mato Grosso, Brasil. Se realizaron entrevistas individuales, a partir de preguntas orientadoras. Para el análisis de los datos se utilizó el discurso del sujeto colectivo. Resultados: Como aprendizajes generados, los participantes señalaron aspectos profesionales (teórico/práctico), así como aspectos personales (reflejo del valor del ser humano, familia y realización profesional). Conclusión: Los aprendizajes proporcionados por la pandemia, si bien contribuye a la percepción de que ante la inseguridad y la incertidumbre es posible aprender y desarrollarse, enfatiza la condición de fortaleza del enfermero, que inicialmente durante la pandemia se vio debilitado, pero que se potenció la sensibilidad a nuevos descubrimientos, confrontaciones y fortalecimiento de sus recursos individuales y colectivos.

Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England

Por: Smith · T. O. · Khoury · R. · Hanson · S. · Welsh · A. · Grant · K. · Clark · A. B. · Ashford · P.-A. · Hopewell · S. · Pfeiffer · K. · Logan · P. · Crotty · M. · Costa · M. L. · Lamb · S. · The HIP HELPER Study Collaborators · Clifford · Freeman · Gray · Cunningham · Langford · Baxter
Objectives

To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery.

Design

Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.

Setting

National Health Service (NHS) providers in five English hospitals.

Participants

Community-dwelling adults, aged 60 years and over, who undergo hip fracture surgery and their informal caregivers.

Intervention

Usual care: usual NHS care. Experimental: usual NHS care plus a caregiver–patient dyad training programme (HIP HELPER). This programme comprised three, 1 hour, one-to-one training sessions for a patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist in the hospital setting predischarge. After discharge, patients and caregivers were supported through three telephone coaching sessions.

Randomisation and blinding

Central randomisation was computer generated (1:1), stratified by hospital and level of patient cognitive impairment. There was no blinding.

Main outcome measures

Data collected at baseline and 4 months post randomisation included: screening logs, intervention logs, fidelity checklists, acceptability data and clinical outcomes. Interviews were conducted with a subset of participants and health professionals.

Results

102 participants were enrolled (51 patients; 51 caregivers). Thirty-nine per cent (515/1311) of patients screened were eligible. Eleven per cent (56/515) of eligible patients consented to be randomised. Forty-eight per cent (12/25) of the intervention group reached compliance to their allocated intervention. There was no evidence of treatment contamination. Qualitative data demonstrated the trial and HIP HELPER programme was acceptable.

Conclusions

The HIP HELPER programme was acceptable to patient–caregiver dyads and health professionals. The COVID-19 pandemic impacting on site’s ability to deliver the research. Modifications are necessary to the design for a viable definitive RCT.

Trial registration number

ISRCTN13270387.

Cohort profile: evaluation of immune response and household transmission of SARS-CoV-2 in Costa Rica: the RESPIRA study

Por: Loria · V. · Aparicio · A. · Hildesheim · A. · Cortes · B. · Barrientos · G. · Retana · D. · Sun · K. · Ocampo · R. · Prevots · D. R. · Zuniga · M. · Waterboer · T. · Wong-McClure · R. · Morera · M. · Butt · J. · Binder · M. · Abdelnour · A. · Calderon · A. · Gail · M. H. · Pfeiffer · R. M.
Purpose

The RESPIRA cohort aims to describe the nature, magnitude, time course and efficacy of the immune response to SARS-CoV-2 infection and vaccination, population prevalence, and household transmission of COVID-19.

Participants

From November 2020, we selected age-stratified random samples of COVID-19 cases from Costa Rica confirmed by PCR. For each case, two population-based controls, matched on age, sex and census tract were recruited, supplemented with hospitalised cases and household contacts. Participants were interviewed and blood and saliva collected for antibodies and PCR tests. Participants will be followed for 2 years to assess antibody response and infection incidence.

Findings to date

Recruitment included 3860 individuals: 1150 COVID-19 cases, 1999 population controls and 719 household contacts from 304 index cases. The age and regional distribution of cases was as planned, including four age strata, 30% rural and 70% urban. The control cohort had similar sex, age and regional distribution as the cases according to the study design. Among the 1999 controls recruited, 6.8% reported at enrolment having had COVID-19 and an additional 12.5% had antibodies against SARS-CoV-2. Compliance with visits and specimens has been close to 70% during the first 18 months of follow-up. During the study, national vaccination was implemented and nearly 90% of our cohort participants were vaccinated during follow-up.

Future plans

RESPIRA will enable multiple analyses, including population prevalence of infection, clinical, behavioural, immunological and genetic risk factors for SARS-CoV-2 acquisition and severity, and determinants of household transmission. We are conducting retrospective and prospective assessment of antibody levels, their determinants and their protective efficacy after infection and vaccination, the impact of long-COVID and a series of ancillary studies. Follow-up continues with bimonthly saliva collection for PCR testing and biannual blood collection for immune response analyses. Follow-up will be completed in early 2024.

Trial registration number

NCT04537338.

Association between burnout and post‐traumatic stress disorder among frontline nurse during COVID‐19 pandemic: A moderated mediation analysis

Abstract

Aims and Objectives

The aim of this study was to investigate the relationship between burnout and post-traumatic stress disorder (PTSD) among frontline nurses who went to assist the epidemic situation in Wuhan, China, during the outbreak in 2020. The study also explored the mediating role of depression and the moderating role of age in the main relationship.

Background

The relationship between burnout and PTSD in nurse has rarely been investigated in the context of the COVID-19 pandemic. Understand the relationship between these variables can provide empirical evidence for developing interventions and protocols that improve the health of nurses in future public health emergencies.

Design

An online cross-sectional survey of targeted local 327 nurses who went to assist the COVID-19 epidemic situation in Wuhan during the initial outbreak.

Methods

This study was conducted in August 2020, the burnout scale, the PTSD scale and the depression scale were used to survey participants. The moderated mediation model was used to test research hypotheses.

Results

Burnout could affect the PTSD symptoms in nursing staffs and depression could mediate this relationship. Age moderated the relationship between burnout/depression and PTSD, and the effects was strong and significant among younger participants in the relationship between burnout and PTSD.

Conclusions

Burnout was identified as a core risk factor of PTSD in nurses. Depression and age played significant roles in the relationship between burnout and PTSD.

Relevance to Clinical Practice

PTSD, as a symptom that manifests after experiencing a stressful event, should be a key concern among frontline healthcare professionals. This study suggests that PTSD in nurses can be further reduced by reducing burnout. Attention should also be paid to the PTSD status of nurses of different age groups.

Patient or Public Contribution

Patients and the public were not involved in the design and implementation of this study. Frontline nurses completed an online questionnaire for this study.

Prediction models of incontinence and sexual function one year after radical prostatectomy based on data from 20 164 prostate cancer patients

by Nora Tabea Sibert, Tobias Kurth, Clara Breidenbach, Simone Wesselmann, Günther Feick, Ernst-Günter Carl, Sebastian Dieng, Mohamad Hatem Albarghouth, Atiqullah Aziz, Stefan Baltes, Elisabeth Bartolf, Jens Bedke, Andreas Blana, Marko Brock, Stefan Conrad, Christopher Darr, Florian Distler, Konstantinos Drosos, Gregor Duwe, Amr Gaber, Markus Giessing, Nina Natascha Harke, Axel Heidenreich, Sameh Hijazi, Andreas Hinkel, Björn Theodor Kaftan, Shatlyk Kheiderov, Thomas Knoll, Gerd Lümmen, Inga Peters, Bülent Polat, Valentin Schrodi, Jens-Uwe Stolzenburg, Zoltan Varga, Julius von Süßkind-Schwendi, Vahudin Zugor, Christoph Kowalski

Background

Incontinence and sexual dysfunction are long-lasting side effects after surgical treatment (radical prostatectomy, RP) of prostate cancer (PC). For an informed treatment decision, physicians and patients should discuss expected impairments. Therefore, this paper firstly aims to develop and validate prognostic models that predict incontinence and sexual function of PC patients one year after RP and secondly to provide an online decision making tool.

Methods

Observational cohorts of PC patients treated between July 2016 and March 2021 in Germany were used. Models to predict functional outcomes one year after RP measured by the EPIC-26 questionnaire were developed using lasso regression, 80–20 splitting of the data set and 10-fold cross validation. To assess performance, R2, RMSE, analysis of residuals and calibration-in-the-large were applied. Final models were externally temporally validated. Additionally, percentages of functional impairment (pad use for incontinence and firmness of erection for sexual score) per score decile were calculated to be used together with the prediction models.

Results

For model development and internal as well as external validation, samples of 11 355 and 8 809 patients were analysed. Results from the internal validation (incontinence: R2 = 0.12, RMSE = 25.40, sexual function: R2 = 0.23, RMSE = 21.44) were comparable with those of the external validation. Residual analysis and calibration-in-the-large showed good results. The prediction tool is freely accessible: https://nora-tabea.shinyapps.io/EPIC-26-Prediction/.

Conclusion

The final models showed appropriate predictive properties and can be used together with the calculated risks for specific functional impairments. Main strengths are the large study sample (> 20 000) and the inclusion of an external validation. The models incorporate meaningful and clinically available predictors ensuring an easy implementation. All predictions are displayed together with risks of frequent impairments such as pad use or erectile dysfunction such that the developed online tool provides a detailed and informative overview for clinicians as well as patients.

Risk factor analysis for diabetic foot ulcer‐related amputation including Controlling Nutritional Status score and neutrophil‐to‐lymphocyte ratio

Abstract

Diabetic foot ulcer often leads to amputation, and both nutritional status and immune function have been associated with this process. We aimed to investigate the risk factors of diabetic ulcer-related amputation including the Controlling Nutritional Status score and neutrophil-to-lymphocyte ratio biomarker. We evaluated data from hospital in patients with diabetic foot ulcer, performing univariate and multivariate analyses to screen for high-risk factors and Kaplan–Meier analysis to correlate high-risk factors with amputation-free survival. Overall, 389 patients underwent 247 amputations over the follow-up period. After correction to relevant variables, we identified five independent risk factors for diabetic ulcer-related amputation: ulcer severity, ulcer site, peripheral arterial disease, neutrophil-to-lymphocyte ratio and nutritional status. Amputation-free survival was lower for the moderate-to-severe versus mild cases, for the plantar forefoot versus hindfoot location, for the concomitant peripheral artery disease versus without and in the high versus low neutrophil-to-lymphocyte ratio (all p < 0.01). The results showed that ulcer severity (p < 0.01), ulcer site (p < 0.01), peripheral artery disease (p < 0.01), neutrophil-to-lymphocyte ratio (p < 0.01) and Controlling Nutritional Status score (p < 0.05) were independent risk factors for amputation in diabetic foot ulcer patients and have predictive values for diabetic foot ulcer progression to amputation.

Preclinical study of diabetic foot ulcers: From pathogenesis to vivo/vitro models and clinical therapeutic transformation

Abstract

Diabetic foot ulcer (DFU), a common intractable chronic complication of diabetes mellitus (DM), has a prevalence of up to 25%, with more than 17% of the affected patients at risk of amputation or even death. Vascular risk factors, including vascular stenosis or occlusion, dyslipidemia, impaired neurosensory and motor function, and skin infection caused by trauma, all increase the risk of DFU in patients with diabetes. Therefore, diabetic foot is not a single pathogenesis. Preclinical studies have contributed greatly to the pathogenesis determination and efficacy evaluation of DFU. Many therapeutic tools are currently being investigated using DFU animal models for effective clinical translation. However, preclinical animal models that completely mimic the pathogenesis of DFU remain unexplored. Therefore, in this review, the preparation methods and evaluation criteria of DFU animal models with three major pathological mechanisms: neuropathy, angiopathy and DFU infection were discussed in detail. And the advantages and disadvantages of various DFU animal models for clinical sign simulation. Furthermore, the current status of vitro models of DFU and some preclinical studies have been transformed into clinical treatment programs, such as medical dressings, growth factor therapy, 3D bioprinting and pre-vascularization, Traditional Chinese Medicine treatment. However, because of the complexity of the pathological mechanism of DFU, the clinical transformation of DFU model still faces many challenges. We need to further optimize the existing preclinical studies of DFU to provide an effective animal platform for the future study of pathophysiology and clinical treatment of DFU.

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