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Multimodality local consolidative treatment versus conventional care of advanced lung cancer after first-line systemic anti-cancer treatment: study protocol for the RAMON multicentre randomised controlled trial with an internal pilot

Por: Beard · C. · Rogers · C. A. · Fleming · L. · Conibear · J. · Evison · M. · Newsom-Davis · T. · Barwick · T. · Mills · N. · Stokes · E. A. · De Sousa · P. · Batchelor · T. · Rawlinson · J. · Baos · S. · Harris · R. · Lim · E.
Introduction

Lung cancer is the most common cause of cancer death worldwide and most patients present with extensive disease. One-year survival is improving but remains low (37%) despite novel systemic anti-cancer treatments forming the current standard of care. Although new therapies improve survival, most patients have residual disease after treatment, and little is known on how best to manage it. Therefore, residual disease management varies across the UK, with some patients receiving only maintenance systemic anti-cancer treatment while others receive local consolidative treatment (LCT), alongside maintenance systemic anti-cancer treatment. LCT can be a combination of surgery, radiotherapy and/or ablation to remove all remaining cancer within the lung and throughout the body. This is intensive, expensive and impacts quality of life, but we do not know if it results in better survival, nor the extent of impact on quality of life and what the cost might be for healthcare providers. The RAMON study (RAdical Management Of Advanced Non-small cell lung cancer) will evaluate the acceptability, effectiveness and cost-effectiveness of LCT versus no LCT after first-line systemic treatment for advanced lung cancer.

Methods and analysis

RAMON is a pragmatic open multicentre, parallel group, superiority randomised controlled trial. We aim to recruit 244 patients aged 18 years and over with advanced non-small-cell lung cancer from 40 UK NHS hospitals. Participants will be randomised in a 1:1 ratio to receive LCT alongside maintenance treatment, or maintenance treatment alone. LCT will be tailored to each patient’s specific disease sites. Participants will be followed up for a minimum of 2 years. The primary outcome is overall survival from randomisation.

Ethics and dissemination

The West of Scotland Research Ethics Committee (22/WS/0121) gave ethical approval in August 2022 and the Health Research Authority in September 2022. Participants will provide written informed consent before participating in the study. Findings will be presented at international meetings, in peer-reviewed publications, through patient organisations and notifications to patients.

Trial registration number

ISRCTN11613852.

Predictive value of machine learning on fracture risk in osteoporosis: a systematic review and meta-analysis

Por: Wu · Y. · Chao · J. · Bao · M. · Zhang · N.
Objectives

Early identification of fracture risk in patients with osteoporosis is essential. Machine learning (ML) has emerged as a promising technique to predict the risk, whereas its predictive performance remains controversial. Therefore, we conducted this systematic review and meta-analysis to explore the predictive efficiency of ML for the risk of fracture in patients with osteoporosis.

Methods

Relevant studies were retrieved from four databases (PubMed, Embase, Cochrane Library and Web of Science) until 31 May 2023. A meta-analysis of the C-index was performed using a random-effects model, while a bivariate mixed-effects model was used for the meta-analysis of sensitivity and specificity. In addition, subgroup analysis was performed according to the types of ML models and fracture sites.

Results

Fifty-three studies were included in our meta-analysis, involving 15 209 268 patients, 86 prediction models specifically developed for the osteoporosis population and 41 validation sets. The most commonly used predictors in these models encompassed age, BMI, past fracture history, bone mineral density T-score, history of falls, BMD, radiomics data, weight, height, gender and other chronic diseases. Overall, the pooled C-index of ML was 0.75 (95% CI: 0.72, 0.78) and 0.75 (95% CI: 0.71, 0.78) in the training set and validation set, respectively; the pooled sensitivity was 0.79 (95% CI: 0.72, 0.84) and 0.76 (95% CI: 0.80, 0.81) in the training set and validation set, respectively; and the pooled specificity was 0.81 (95% CI: 0.75, 0.86) and 0.83 (95% CI: 0.72, 0.90) in the training set and validation set, respectively.

Conclusions

ML has a favourable predictive performance for fracture risk in patients with osteoporosis. However, most current studies lack external validation. Thus, external validation is required to verify the reliability of ML models.

PROSPERO registration number

CRD42022346896.

Efficacy of the combination of Chinese herbal medicine and negative pressure wound therapy in the treatment of patients with diabetic foot ulcer: A meta‐analysis

Abstract

This study aimed to systematically evaluate the clinical efficacy of Chinese herbal medicine combined with negative pressure wound therapy (NPWT) in the treatment of diabetic foot ulcers (DFU). Computerised searches of the China National Knowledge Infrastructure, Wanfang, Chinese BioMedical Literature Database, PubMed, Cochrane Library and Embase databases were conducted for randomised controlled trials on the use of Chinese herbal medicines combined with NPWT for the treatment of DFU. The search period ranged from the time of establishment of each database to July 2023. Literature screening and data extraction were performed independently by two investigators, and the quality of the included studies was assessed. The meta-analysis was performed using Review Manager 5.4 software. A total of 25 studies were analysed, including 1777 DFUs, with 890 and 887 patients in the experimental and control groups, respectively. The results showed that the treatment of DFUs with a Chinese herbal medicine in combination with NPWT increased the overall effectiveness (odds ratio [OR] = 4.32, 95% confidence interval [CI]: 2.96–6.30, p < 0.001), wound healing rate (mean difference [MD] = 18.35, 95% CI: 13.07–23.64, p < 0.001) and ankle brachial index (MD = 0.10, 95% CI: 0.06–0.14, p < 0.001); reduced the wound healing time (MD = −11.01, 95% CI: −13.25 to −8.78, p < 0.001) and post-treatment wound area (MD = −1.73, 95% CI: −2.46 to −1.01, p < 0.001); decreased the C-reactive protein level (MD = −3.57, 95% CI: −5.13 to −2.00, p < 0.001); and increased vascular endothelial growth factor level (MD = 19.20, 95% CI: 8.36–30.05, p < 0.001). Thus, Chinese herbal medicines combined with NPWT can effectively promote wound healing, reduce inflammation and shorten the disease course in patients with DFU, while demonstrating precise clinical efficacy.

Exploring the motivations for rural tourism in China during the COVID-19: The existence of a single motivation

by Songting Zhang, Yichao Wu, Wen Bao

The COVID-19 epidemic had an appropriate impact on tourists’ trip psychology and their subsequent behavior in participating in rural tourism activities. The purpose of this paper is to explore the types of motivations Chinese tourists have for participating in rural tourism in the context of COVID-19, and to comparatively analyze the similarities and differences in motivations for rural tourism during the epidemic and in normal times. An interpretive paradigm qualitative data collection method was used: semi-structured interviews and focus group discussions. Respondents were 21 tourists, who were selected through purposive and snowball sampling. Through content analysis, we found that rural tourism motivations during the epidemic included both diversified and singular motivations. The pull effect of rural destinations is related to distance and ease of realization. For rural areas in close proximity, a single motivation is sufficient to drive tourists. In addition, we found that there was no "altruistic motivation" for rural tourism during the COVID-19 period, but "altruistic feelings" for the preservation of ancient villages were generated during rural tourism. Finally, we discuss the theoretical and practical significance of this study and make suggestions for future research. The study explains tourists’ companionship preferences, activity choices, and affective changes, and provides a basis for the operation and advertising strategies of rural destinations to attract tourists and promote their sustainable development.

Effect of drain placement in short‐level spinal surgery on postoperative wound infection: A meta‐analysis

Abstract

In the meta-analysis, we evaluated the efficacy of placing drainage channels following single- or double-level spine surgery in order to decrease the incidence of postoperative injury. We conducted the analysis with the help of four databases: PubMed, Embase, Cochrane Library and Web of Science. A review of related studies was carried out after evaluating the quality of the literature against the classification and exclusion criteria set for the trial. Calculation of 95% CI, OR and MD was performed with fixed-effect models. A meta-analysis of the data was carried out with RevMan 5.3. Meta-analyses of randomized controlled trial (RCT) did not indicate that there were a statistically significantly different incidence of postoperative wound infections among those who received drainage compared to those who did not receive drainage (OR, 2.29; 95% CI, 0.50, 10.41 p = 0.28). Moreover, there were no statistically significant differences in post-operation hematoma (OR, 1.20; 95% CI, 0.27, 5.28 p = 0.81) and visual analogue scale score (MD, −0.01; 95% CI, −1.34, 1.33 p = 0.99). Thus, placing drainage in short-levels of spine operation did not significantly influence the outcome of postoperative wound complications. Nevertheless, because of the limited sample size chosen for this meta-analysis, caution should be exercised when treating these data. More high-quality RCT trials with a large number of samples are required to confirm the findings.

Impact of ileostomy on postoperative wound complications in patients after laparoscopic rectal cancer surgery: A meta‐analysis

Abstract

To prevent anastomotic leakage and other postoperative complications after laparoscopic rectal cancer surgery, a protective ileostomy is often used. However, the necessity of performing ileostomy after laparoscopic rectal cancer remains controversial. The aim of this meta-analysis was to assess the benefit of ileostomy on wound infection after laparoscopic rectal cancer. The Cochrane Library, EMBASE, Web of Science, and PubMed were used to retrieve all related documents up to September 2023. Completion of the trial literature was submitted once the eligibility and exclusion criteria were met and the literature quality assessment was evaluated. This study compared the post-operative post-operative complications of an ileostomy with that of non-ileostomy in a laparoscope. We used Reman 5.3 to analyse meta-data. Controlled studies were evaluated with ROBINS-I. The meta-analyses included 525 studies, and 5 publications were chosen to statistically analyse the data according to the classification criteria. There was no statistically significant difference in the rate of postoperative wound infections among ostomate and nonostomate (odds ratio [OR], 1.79; 95% confidence interval [CI], 0.66, 4.84; p = 0.25). In 5 trials, the incidence of anastomotic leak was increased after surgery in nonostomate patients (OR, 0.26; 95% CI, 0.12, 0.57; p = 0.0009). Two studies reported no significant difference in the length of operation time when nonstomal compared to stomal operations in patients with rectal cancer (mean difference, 0.87; 95% CI, −2.99, 4.74; p = 0.66). No significant difference was found in the rate of wound infection and operation time after operation among the two groups, but the incidence of anastomosis leak increased after operation. Protective ileostomy after laparoscopic rectal cancer was effective in reducing the risk of anastomotic leakage in patients, and we found no additional risk of infection. We cautiously conclude that protective ileostomy is active and necessary for patients with a high risk of anastomotic leakage after surgery, which needs to be further confirmed by high-quality studies with larger samples.

Machine learning and single‐cell transcriptome profiling reveal regulation of fibroblast activation through THBS2/TGFβ1/P‐Smad2/3 signalling pathway in hypertrophic scar

Abstract

Hypertrophic scar (HS) is a chronic inflammatory skin disorder characterized by excessive deposition of extracellular matrix, and the mechanisms underlying their formation remain poorly understood. We analysed scRNA-seq data from samples of normal skin and HS. Using the hdWGCNA method, key gene modules of fibroblasts in HS were identified. Non-negative matrix factorization was employed to perform subtype analysis of HS patients using these gene modules. Multiple machine learning algorithms were applied to screen and validate accurate gene signatures for identifying and predicting HS, and a convolutional neural network (CNN) based on deep learning was established and validated. Quantitative reverse transcription-polymerase chain reaction and western blotting were performed to measure mRNA and protein expression. Immunofluorescence was used for gene localization analysis, and biological features were assessed through CCK8 and wound healing assay. Single-cell sequencing revealed distinct subpopulations of fibroblasts in HS. HdWGCNA identified key gene characteristics of this population, and pseudotime analysis was conducted to investigate gene variation during fibroblast differentiation. By employing various machine learning algorithms, the gene range was narrowed down to three key genes. A CNN was trained using the expression of these key genes and immune cell infiltration, enabling diagnosis and prediction of HS. Functional experiments demonstrated that THBS2 is associated with fibroblast proliferation and migration in HS and affects the formation and development of HS through the TGFβ1/P-Smad2/3 pathway. Our study identifies unique fibroblast subpopulations closely associated with HS and provides biomarkers for the diagnosis and treatment of HS.

Effect of laparoscopic versus open surgery on postoperative wound complications in patients with low rectal cancer: A meta‐analysis

Abstract

This meta-analysis was conducted to evaluate the effect of microinvasive and open operations on postoperative wound complications in low rectal carcinoma patients. Research on limited English has been conducted systematically in PubMed, Embase, Cochrane Library and Web of Science. The date up to the search was in August 2023. Following review of the classification and exclusion criteria for this research and the evaluation of its quality in the literature, there were a total of 266 related papers, which were reviewed for inclusion in the period from 2004 to 2017. A total of 1774 cases of low rectal cancer were enrolled. Of these 913 cases, the laparoscopic operation was performed on 913 cases, while 861 cases were operated on low rectal carcinoma. The overall sample was between 10 and 482. Five trials described the efficacy of laparoscopy have lower risk than open on postoperative wound infection in patients with low rectal cancer (OR, 0.72;95 % CI, 0.48,1.09 p = 0.12). Three studies results showed that the anastomotic leak was not significantly different between open and laparoscopy (OR, 0.86; 95% CI, 0.58,1.26 p = 0.44). Six surgical trials in low rectal cancer patients reported haemorrhage, and five cases of surgical time were reported, with laparoscopy having fewer bleeding compared with open surgery (MD, −188.89; 95% CI, −341.27, −36.51 p = 0.02). Compared with laparoscopy, the operation time was shorter for the open operation (MD, 33.06; 95% CI, 30.56, 35.57 p < 0.0001). Overall, there is no significant difference between laparoscopy and open surgery in terms of incidence of infection and anastomosis leak. However, the rate of haemorrhage in laparoscopy is lower,and operation time in open surgery is lower.

Análisis de los componentes de la Red de Atención Psicosocial en el cuidado al adolescente usuario de crack

Objetivo: analizar los componentes de la Red de Atención Psicosocial (RAPS) orientadas a la atención de adolescentes usuarios de crack. Método: estudio exploratorio y descriptivo con enfoque cualitativo de los datos, desarrollado en el Centro de Atención Psicosocial Alcohol y Drogas (CAPSad) y en el Centro de Atención Psicosocial Infanto-juvenil (CAPSi). Participaron 20 profesionales del CAPSad y 10 del CAPSi. Los datos se recopilaron mediante entrevistas semiestructuradas y se analizaron conforme al Análisis Temático. Resultados: se identificaron como componentes de la RAPS orientadas a la atención de los adolescentes usuarios de crack: Atención Psicosocial Especializada; Atención Residencial de Carácter Transitorio; Atención Hospitalaria – Hospital Psiquiátrico y Atención Primaria – Unidad de Atención Primaria. Conclusión: el desempeño del CAPSad se subrayó en la atención de los adolescentes usuarios de crack, con acciones dirigidas a rescatar los lazos escolares y en entornos más saludables, así como la atención a la familia de estos jóvenes.

Influencia de los cambios de posición y la aspiración de secreciones en la presión intracraneal de los pacientes neurocríticos

Introducción: El manejo del paciente neurocrítico precisa un estrecho control de la presión de perfusión cerebral y de la presión intracraneal. A lo largo de los años, se ha estudiado la relación entre las intervenciones y los cuidados de enfermería, con la alteración de las cifras de presión intracraneal, demostrándose que, algunas de ellas como los cambios posturales y la aspiración de secreciones, producen un importante impacto. Objetivo: Determinar la influencia de los cambios de posición y la aspiración de secreciones en la presión intracraneal y encontrar un consenso de actuación para mejorar la calidad de la práctica diaria. Método: Se realizó una búsqueda en varias bases de datos, entre abril y mayo de 2017, para recuperar el mayor número de evidencias recientes posibles. Se establecieron criterios de inclusión y exclusión. Tras los procesos de cribado de los artículos, diez de ellos se incluyeron en la revisión sistemática. Resultados y conclusiones: El personal de enfermería constituye una pieza clave en el cuidado de estos pacientes. Todos los estudios coincidieron en que tanto los cambios de posición como la aspiración de secreciones tienen influencia sobre la PIC.

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