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Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial

Por: Brittain · G. · Petrie · J. · Duffy · K. E. M. · Glover · R. · Hullock · K. · Papaioannou · D. · Roldan · E. · Beecher · C. · Bursnall · M. · Ciccarelli · O. · Coles · A. J. · Cooper · C. · Giovannoni · G. · Gabriel · I. · Kazmi · M. · Kyriakou · C. · Nicholas · R. · Paling · D. · Peniket
Introduction

Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, ‘Multiple Sclerosis International Stem Cell Transplant, MIST’, showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS.

Methods and analysis

StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve ‘no evidence of disease activity’ during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs.

Ethics and dissemination

The study was approved by the Yorkshire and Humber—Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences.

Trial registration number

ISRCTN88667898.

Beating the empty pelvis syndrome: the PelvEx Collaborative core outcome set study protocol

Por: PelvEx Collaborative · West · West · Drami · Denys · Glyn · Sutton · Tiernan · Behrenbruch · Guerra · Waters · Woodward · Applin · Charles · Rose · Pape · van Ramshorst · Mirnezami · Aalbers · Abdul Aziz · Abecasis · Abraham-Nordling · Akiyoshi · Alahmadi · Alberda · Albert · And
Introduction

The empty pelvis syndrome is a significant source of morbidity following pelvic exenteration surgery. It remains poorly defined with research in this field being heterogeneous and of low quality. Furthermore, there has been minimal engagement with patient representatives following pelvic exenteration with respect to the empty pelvic syndrome. ‘PelvEx—Beating the empty pelvis syndrome’ aims to engage both patient representatives and healthcare professionals to achieve an international consensus on a core outcome set, pathophysiology and mitigation of the empty pelvis syndrome.

Methods and analysis

A modified-Delphi approach will be followed with a three-stage study design. First, statements will be longlisted using a recent systematic review, healthcare professional event, patient and public engagement, and Delphi piloting. Second, statements will be shortlisted using up to three rounds of online modified Delphi. Third, statements will be confirmed and instruments for measurable statements selected using a virtual patient-representative consensus meeting, and finally a face-to-face healthcare professional consensus meeting.

Ethics and dissemination

The University of Southampton Faculty of Medicine ethics committee has approved this protocol, which is registered as a study with the Core Outcome Measures in Effectiveness Trials Initiative. Publication of this study will increase the potential for comparative research to further understanding and prevent the empty pelvis syndrome.

Trial registration number

NCT05683795.

Studying the effects of stress, mental health and psychological well‐being on wound healing rates after oesophageal varices ligation in liver cirrhosis patients

Abstract

It is of utmost importance to comprehend the impact that psychological factors have on physical rehabilitation, specifically in regards to wound healing following ligation of oesophageal varices in patients with liver cirrhosis. The present study investigated the correlation between wound recovery rates and psychological well-being, stress and mental health. From January 2022 to September 2023, 148 patients from were evaluated as part of this cross-sectional observational study. The psychological well-being of participants was evaluated utilizing the Hospital Anxiety and Depression Scale (HADS), Perceived Stress Scale (PSS) and Psychological General Well-Being Index (PGWBI). The rates of wound recovery were assessed following ligation. The mean duration for wound recovery was 28.37 ± 9.65 days. The mean wounds healing time of patients who obtained higher PSS scores (18.55) was marginally longer. On the contrary, there was a moderate reduction in healing time associated with higher HADS scores (mean 14.10). On average (68.88), PGWBI scores indicated a negligible effect on wound healing. The variance in healing durations between Child-Pugh classifications A, B and C (mean values of 28.65, 26.90 and 29.57 days respectively) suggested that the severity of liver disease has an impact. As a result of ligation of oesophageal varices, the study demonstrated that psychological factors and wound recovery in patients with liver cirrhosis are intricately intertwined. There seems to be the substantial and intricate relationship between stress, mental health and wound recovery. The results of this study supported the notion that psychological evaluation and support should be incorporated into the management of patients with liver cirrhosis.

Effects of rapid rehabilitation nursing on surgical‐site wound infection and postoperative complications of patients undergoing thoracoscopic lung cancer surgery: A meta‐analysis

Abstract

This meta-analysis systematically evaluates the impact of rapid rehabilitation nursing interventions on wound infections and postoperative complications in patients undergoing thoracoscopic lung cancer surgery. A comprehensive literature search was conducted, from database inception to November 2023, using databases including PubMed, Embase, Google Scholar, Cochrane Library, China National Knowledge Infrastructure, and Wanfang databases to identify randomized controlled trials (RCTs) that focused on the application of rapid rehabilitation nursing in the perioperative period of thoracoscopic lung cancer surgery. Two researchers independently screened the literature, extracted data, and assessed the quality based on inclusion and exclusion criteria. Data analysis was performed using Stata 17.0 software. A total of 22 RCTs involving 2319 patients were included in the analysis. The results indicated that the application of rapid rehabilitation nursing in thoracoscopic lung cancer surgery significantly reduced the incidence of wound infections (OR = 0.32, 95% CI: 0.20–0.54, p < 0.001) and postoperative complications (OR = 0.24, 95% CI: 0.18–0.31, p < 0.001). This study demonstrates that implementing rapid rehabilitation nursing interventions during the perioperative period for patients undergoing thoracoscopic lung cancer surgery can significantly decrease the occurrence of wound infections and complications, thereby facilitating rapid patient recovery.

A meta‐analysis of clinical studies of moxibustion for pressure ulcer healing

Abstract

In this study, we aimed to evaluate the effect of moxibustion on pressure ulcers. A thorough search was performed for articles published from database inception up to 14 December 2023. Randomized controlled trials, which evaluated the effects of moxibustion were included. Finally, 11 relevant trails that enrolled a total of 795 participants met inclusion criteria. The results of meta-analysis suggested beneficial effects of moxibustion for pressure ulcer compared with control on the response rate (RR: 1.21; 95% CI: 1.13–1.29; p = 0.82; I 2 = 0%), healing time (MD: −5.69; 95% CI: −9.58 to −1.80; p<0.05; I 2 = 97%) and pressure ulcer scale for healing scores (MD: −1.13; 95% CI: −1.36 to −0.89; p = 0.79; I 2 = 0%). The evidence suggests that moxibustion possesses satisfactory efficacy in promoting healing of pressure ulcers. However, due to the small number of trials included in this study, as well as the small sample size and high risk of bias, we were unable to draw firm conclusions about the effectiveness of moxibustion for pressure ulcers.

Etiological characteristics of wound infection in severe trauma patients and logistic regression analysis of influencing factors of infection

Abstract

To investigate the etiological characteristics of wound infection in severe trauma patients and logistic regression analysis of the influencing factors of infection. The 116 patients with severe trauma who were intervened in our hospital from 22 October 2017 to 9 September 2019 were selected as the subjects of this retrospective study and divided into a control group and an observation group according to whether they were infected or not, 58 cases each. Observe and compare the pathogenic characteristics (pathogen distribution and drug resistance) of the two groups of patients and logistic regression analysis of the influencing factors of infection. The gram-positive bacteria in the observation group were mainly Staphylococcus aureus, accounting for 17.20%; the fungi were mainly Candida tropicalis, accounting for 17.20%; and the gram-negative bacteria were mainly Acinetobacter baumannii, accounting for 20.39%; the control group was gram-positive. The main bacteria are S. aureus, accounting for 8.60%; the fungi are mainly Candida albicans, accounting for 4.3%; and the gram-negative bacteria, which are mainly Pseudomonas aeruginosa, accounting for 14.56%. Gram-positive bacteria Enterococcus faecium, S. aureus, Enterococcus faecalis, Staphylococcus epidermidis. The highest drug resistance of other gram-positive bacteria is penicillin and erythromycin at 85.00% and above. Fungi C. tropicalis, Candida parapsilosis, C. albicans, fluconazole and amphotericin B have the highest resistance to 80.00% and above. Gram-negative bacteria A. baumannii, Ps. aeruginosa, Klebsiella pneumoniae, Escherichia coli, Proteus mirabilis, Enterobacter cloacae and other gram-negative bacteria are the most resistant to ampicillin, and Piperacillin was 70.00% and above. The combined primary diseases of the two groups of patients, ventilator use ≧3 days, long-term use of glucocorticoids, catheter use days ≧5 days, fever days ≧3 days and long-term use of broad-spectrum antimicrobial drugs, the difference is statistically significant academic significance (p < 0.05). Logistic analysis showed that combined with underlying diseases, fever days ≥3 days, long-term use of glucocorticoids and catheter use days ≥5 days are the influencing factors for the occurrence of wound infections in patients with severe trauma. Trauma patients are prone to wound infections, and there are many influencing factors. Close observation of patients should be strengthened. Effective prevention and control measures should be taken for related influencing factors to reduce the incidence of infection.

Effect of bone grafting on postoperative wound infection and marginal necrosis in patients with calcane fractures

Abstract

This study was conducted to evaluate the impact of bone-transplantation over nonbone transplantation in treating intra-articular fractures of the heel bone on postsurgical complications. Our results were retrieved from the Pubmed, Embase, and Cochrane databases. The data of the injury of the patient and the wound infection were collected. Study were carried out with Revman 5.3 software. Eight operative trials associated with the implant of the heel were selected from a large number of publications. Among the 804 cases that needed operation on the heel, 410 cases were treated with bone grafting while 394 cases were not treated with the operation. Seven trials showed that there was no difference in the risk of post operative wound infection among patients who had received a bone-grafting operation on the heel or had not (OR, 0.87; 95% CI, 0.51, 1.49 p = 0.62). There was no difference in the risk for post-operation marginal necrosis among patients who had received a bone-grafting operation on the heel or had not (OR, 0.75; 95% CI, 0.42, 1.36 p = 0.34). The results of this show that there are no statistically significant differences in the incidence of post-operative necrosis and infection in the case of endarticular surgery of the heel.

The effect of placing prophylactic abdominal drainage tube after hepatobiliary surgery on postoperative infection: A systematic review and meta‐analysis

Abstract

Whether prophylactic abdominal drainage tube is routinely placed in patients after hepatobiliary surgery remains controversial. To evaluate the effect of prophylactic abdominal drainage tube placement after hepatobiliary surgery on postoperative infection. Randomized controlled trials on the placement of prophylactic abdominal drainage tube after hepatobiliary surgery were collected through a computerized search of PubMed, Embase, Conchrane Library and Web of Science databases, with a time range from the establishment of the database to August 2023. After two researchers independently screened the literature, extracted information, and evaluated the quality of the included studies. Finally, 13 studies were included, including 3620 patients, and the results showed that there was no statistically significant difference in postoperative infection rate between the drainage group (1840 patients and the non-drainage group [1783 patients] [relative risk, RR = 1.17, 95% confidence interval, CI: 0.94–1.47, p = 0.16]. Compared with the drainage group, the incidence of infectious abdominal fluid in the non-drainage group was lower (RR = 2.09, 95% CI: 1.57–2.80, p < 0.00001), and the incidence of postoperative bile leakage was lower (RR = 1.77, 95% CI: 1.27–2.47, p < 0.001) and shorter hospital stays after surgery (mean difference = 1.27, 95% CI: 0.32–2.22, p = 0.009). In conclusion, placing a prophylactic abdominal drainage tube after hepatobiliary surgery does not reduce postoperative infection rates compared with no drainage.

Development and validation of a delirium care critical‐thinking scale for intensive care unit nurses: A mixed‐method study

Abstract

Aim and Objectives

To develop a Delirium Care Critical-Thinking Scale for nurses caring for patients in the intensive care unit and examine the scale's psychometric properties.

Background

There is a tool to evaluate nurses' critical thinking skills to determine nursing competency when delirium care is required.

Design

This cross-sectional, mixed-methods study.

Methods

The Delphi method was applied for collection and analysis of data during conceptualization and item generation of the tool (Phase I). Item analysis, assessment of validity and reliability of the scale (Phase II) involved 318 nurses recruited by convenience sampling from nine adult intensive care units in medicine and surgery at one medical centre. Confirmatory factor analysis assessed construct validity. Internal consistency and 2-week test–retest stability measured reliability. A Critical Thinking Disposition Inventory Scale examined concurrent validity.

Results

After three rounds, the Delphi method resulted in 31 scale items. Item analysis demonstrated construct reliability ranged from 9.23 to 16.18. Confirmatory factor analysis eliminated one item and extracted five factors: applying knowledge, confirming the problem and accuracy of information, reasoning logically, choosing appropriate strategies and remaining open-minded. Average variance extracted values of all factors indicated good convergent validity. Cronbach's α for internal consistency was .96 with good test-retest reliability. The correlation coefficient for concurrent validity was .301.

Conclusion

The new Delirium Care Critical-Thinking Scale for intensive care nurses was demonstrated to be a reliable and valid tool for evaluating their ability to assess patients with delirium.

Relevance to Clinical Practice

This new scale could be used to assess outcomes of education interventions and the effectiveness of nursing care quality involving patients with delirium in intensive and critical care units.

Reporting Method

The COSMIN checklist was used as the reporting guideline for this study.

Patient or Public Contribution

None.

‘It's very values driven’: A qualitative systematic review of the meaning of compassion according to healthcare professionals

Abstract

Aims and Objectives

To explore the meaning ascribed to the concept of compassion by healthcare professionals.

Background

Compassion is universally regarded as the foundation of healthcare, a core value of healthcare organisations, and essential to the provision of quality care. Despite increasing research on compassion in healthcare, how healthcare professionals understand compassion remains unclear.

Design

A systematic review of qualitative studies was conducted and is reported following PRISMA guidelines.

Method

Medline, Emcare, PsychINFO and CINAHL were searched to November 2021 for qualitative studies in English that explored healthcare professionals' understandings of compassion. Included studies were appraised for quality before data were extracted and thematically analysed.

Findings

Seventeen papers met the inclusion criteria. An overarching theme, ‘It's very values driven’ underpins the four main themes identified: (1) ‘It's about people and working with them’: Compassion as being human, (2) ‘There is this feeling’: Compassion as being present, (3) ‘If I don't understand them, I won't be able to help’: Compassion as understanding, (4) ‘Wanting to help in some way’: Compassion as action.

Conclusions

Healthcare professional participants reported compassion as motivated by values and inherent to humanistic healthcare practice. The meanings healthcare professions described were varied and contextual. Qualitative research should further explore healthcare practitioners' experiences of compassion as part of their practice to inform health professions education, policy, and practice.

Relevance to Clinical Practice

To practice with compassion, healthcare professionals require supportive and humanistic organisations that honour each person's humanity and encourage people to be human and compassionate to each other as well as to patients, their families and/or carers.

Healthcare professionals need to reflect on what compassion means to them, how it is situated within their unique practice context, and how compassion can enhance clinical practice.

No Patient or Public Contribution

This systematic review had no patient or public contribution.

The impact of different antibiotic injection regimens on patients with severe infections: A meta‐analysis

Abstract

Severe infection is a critical health threat to humans, and antibiotic treatment is one of the main therapeutic approaches. Nevertheless, the efficacy of various antibiotic injection regimens in severe infection patients remains uncertain. This study aimed to comprehensively evaluate the impact of various antibiotic injection strategies on patients with severe infection through a meta-analysis. Relevant research literature was collected by searching databases such as PubMed, Embase, and Cochrane Library. The retrieved literature was screened according to inclusion and exclusion criteria. Relevant data, including study design, sample size, and antibiotic regimens, were extracted from the included studies. The Cochrane Collaboration's Risk of Bias tool was employed to assess the risk of bias in each study. Statistical analysis was performed based on the results of the included studies. A total of 15 articles were included, covering various types of severe infection patients, including pulmonary and abdominal infections. The analysis provided insights into mortality rates, treatment efficacy, adverse reactions (ARs), Acute Physiology and Chronic Health Evaluation (APACHE) scores, among other outcomes. The results indicated that combination therapy was superior to monotherapy in terms of mortality rate, treatment efficacy, and APACHE scores, while the incidence of ARs was lower in the monotherapy group compared to the combination therapy group (p < 0.05). Combination therapy showed better treatment efficacy compared to monotherapy, although it was associated with a higher incidence of ARs.

Occurrence and characteristics of extended-spectrum-β-lactamase- and pAmpC-producing <i>Klebsiella pneumoniae</i> isolated from companion animals with urinary tract infections

by Megan Min Yi Lee, Nan-Ling Kuan, Zhi-Yi Li, Kuang-Sheng Yeh

This study examined 70 Klebsiella pneumoniae isolates derived from companion animals with urinary tract infections in Taiwan. Overall, 81% (57/70) of the isolates carried extended-spectrum β-lactamase (ESBL) and/or plasmid-encoded AmpC (pAmpC) genes. ESBL genes were detected in 19 samples, with blaCTX-M-1, blaCTX-M-9, and blaSHV being the predominant groups. pAmpC genes were detected in 56 isolates, with blaCIT and blaDHA being the predominant groups. Multilocus sequence typing revealed that sequence types (ST)11, ST15, and ST655 were prevalent. wabG, uge, entB, mrkD, and fimH were identified as primary virulence genes. Two isolates demonstrated a hypermucoviscosity phenotype in the string test. Antimicrobial susceptibility testing exhibited high resistance to β-lactams and fluoroquinolones in ESBL-positive isolates but low resistance to aminoglycosides, sulfonamides, and carbapenems. Isolates carrying pAmpC genes exhibited resistance to penicillin-class β-lactams. These findings provide valuable insights into the role of K. pneumoniae in the context of the concept of One Health.

Fabrication of Cu/ZnO‐loaded chitosan hydrogel for an effective wound dressing material to advanced wound care and healing efficiency after caesarean section surgery

Abstract

Wound infections and delayed complications after caesarean section surgical procedure to mothers would have a prevalence of discomfort, stress and dissatisfaction in the postpartum period. In this report, one-pot synthesis is used for the preparation of chitosan (CS)-based copper nanoparticles (nCu), which was used for the preparation of zinc oxide (ZnO) hydrogel as wound dressing materials after surgery. The antibacterial activity of (CS-nCu/ZnO) developed hydrogels was studied zone of inhibition, against gram-positive and gram-negative bacteria. The antibacterial activity of the CS-nCu/ZnO hydrogel demonstrated that nanoformulated hydrogel materials have provided excellent bactericidal action against clinically approved bacterial pathogens. The biocompatibility and in vitro wound healing potential of the developed wound closure materials were studied by MTT assay and wound scratch assay methods, respectively. The MTT assay and cell migration assay results demonstrated that CS-nCu/ZnO hydrogel material induces cell compatibility and effective cell proliferation ability. These findings suggest that the CS-nCu/ZnO hydrogel outperforms CS-ZnO in terms of wound healing and could be used as a wound closure material in caesarean section wound treatment.

The effects of scar in psychological disorder: A bibliometric analysis from 2003 to 2022

Abstract

Scars are fibrous tissues that replace normal tissue during the wound healing process. Scarring can lead to low self-esteem, social impairment, depression, anxiety, and other psychiatric and psychological distress, necessitating a comprehensive understanding of the latest perspectives, topical research, and directions in scarring-mental health. This is a biblioshiny and VOSviewer based bibliometric analysis study. All data were obtained from the Web of Science, and a total of 664 articles from 2003 to 2022 met the criteria. The last 7 years have been a period of rapid growth in the field, with 2022 having the highest number of articles. The United States is the core country with the highest production and citation rate. The most cited literature was written in 2003 by Van Loey NE et al. Van Loey NE is the most prolific and influential author in this field. The top five popular keywords include “quality of life”, “depression”, “management”, “anxiety”, and “prevalence”. The paper concludes that the current focus of scholars in the field is on the treatment of scars and that multidisciplinary treatment of such patients is worth exploring. These findings provide relevant researchers with the current state of research and possible future directions in this field.

Success of transmetatarsal amputation for limb salvage in patients with peripheral artery disease

Abstract

Limb salvage is a difficult path for patients to travel as there is no guarantee of the outcome, often the major factor is perfusion. For patients who underwent transmetatarsal amputation (TMA), success rate is crucial as the next option is most likely a major amputation. We performed a 10 years (2010–2020) retrospective review of patients that underwent a TMA and had an angiogram or computed tomography angiography (CTA) perioperatively at the Dallas VA Medical Center. Failure after TMA was defined as a patient requiring a proximal amputation within 1 year. There were 125 TMAs performed between 2010 and 2020 at the institution. Forty-four (35.2%) patients had an angiogram/CTA peri-operative and met the inclusion criteria. Seventeen subjects (38.6%) had a higher level of amputation. Of the 17 failures, 2 (11.8%) patients had no patent vessel runoff to the foot, 9 (52.9%) had one vessel, 4 (23.5%) had two vessels, and 2 (11.8%) had three vessels runoff. One vessel runoff to the foot yielded a high rate of poor outcomes (56.3%) defined as a higher level of amputation. Two or more vessels runoff to the foot had over 75% success of limb salvage with a TMA.

Effect of accelerated rehabilitation nursing programmes on surgical site wound infection in patients undergoing laparoscopic cholecystectomy: A meta‐analysis

Abstract

This study aims to evaluate the effect of an accelerated rehabilitation nursing programme on the incidence of surgical site wound infections in patients undergoing laparoscopic cholecystectomy. Relevant studies regarding the use of an accelerated rehabilitation nursing programme in laparoscopic cholecystectomy were retrieved from databases, including PubMed, Web of Science, the Cochrane Library, EMBASE, CNKI and Wanfang Database. The search was conducted from the inception of each database until June 2023. Two independent researchers performed the literature screening, data collection and quality assessment of the included studies. Odds ratio (OR) and 95% confidence interval (CI) were used as the measures of effect. Statistical analysis was conducted using Stata 17.0, and a sensitivity analysis and publication bias evaluation were performed. A total of 21 studies involving 2480 patients (1179 in the intervention group and 1301 in the control group) were included. The meta-analysis revealed that the incidence of surgical site wound infections in the intervention group was significantly lower than in the control group (1.18% vs. 5.99%, OR: 0.322, 95% CI: 0.168–0.556, p < 0.001). Current evidence suggests that implementing accelerated rehabilitation nursing programmes for patients undergoing laparoscopic cholecystectomy has a clinically significant effect, leading to a substantial reduction in the incidence of surgical site wound infections. However, owing to the low quality of some of the included studies, further high-quality, multicentre, large-sample randomised controlled trials are required to validate the conclusions of this study.

Pre‐hospital symptom clusters and symptom network analysis in decompensated cirrhotic patients: A cross‐sectional study

Abstract

Aims

To generate pre-hospital symptom networks, explore core, bridge and sentinel symptoms, identify pre-hospital symptom clusters and analyse relationship between influencing factors and symptom clusters in decompensated cirrhosis patients.

Design

A cross-sectional study design using the Strengthening the Reporting of Observational Studies in Epidemiology checklist.

Methods

Demographical, physiological, psychological and sociological characteristics and the pre-hospital symptoms of 292 decompensated cirrhotic patients were collected from October 2021 to March 2023 in China. Frequencies, percentages, means, standard deviations, independent samples t-tests, one-way analysis of variance, exploratory factor analysis, multiple stepwise regression analysis and network analysis were used for data analysis.

Results

‘I don't look like myself’ and itching were core and bridge symptoms, while bloating and lack of energy were sentinel symptoms in decompensated cirrhotic patients. Monthly family income, anxiety, depression, social support and disease duration influenced the neuropsychological symptom cluster, with worrying as the strongest predictor symptom. Influential factors for cirrhosis-specific symptom cluster included Child-Pugh class, monthly family income, disease duration, anxiety and depression, with itching being the strongest predictor symptom. Monthly family income, disease duration and depression were influential factors for gastrointestinal symptom cluster, with loss of appetite as the strongest predictor symptom.

Conclusions

Neuropsychological, cirrhosis-specific and gastrointestinal symptom clusters were formed in decompensated cirrhotic patients. Through network analysis, direct connections between symptoms, symptom clusters and their influencing factors were revealed, thereby offering clinicians a foundation for effectively managing patients' pre-hospital symptoms.

Impact

Decompensated cirrhosis patients commonly have multiple symptoms, while the management of pre-hospital symptoms is often suboptimal. This study identified neuropsychological, cirrhosis-specific, gastrointestinal symptom clusters and recognized core, bridge and sentinel symptoms in these patients. It also revealed the most prominent symptoms within each cluster. This provides insight into the hierarchy of symptoms, improving symptom management in decompensated cirrhosis.

Patient and Public Involvement

There was no patient or public involvement.

PIK3CA regulates development of diabetes retinopathy through the PI3K/Akt/mTOR pathway

by Ruijuan Guan, Zefeng Kang, Ling Li, Xin Yan, Tianpeng Gao

Objective

To explore their association with the development of diabetes retinopathy (DR), single nucleotide polymorphism (SNP) mutations were screened out by high-throughput sequencing and validated in patients diagnosed with DR. To understand the role of PIK3CA in the pathogenesis of DR and explore the relationship between PIK3CA,phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR),and DR, the effect of PIK3CA.rs17849079 mutation was investigated in a DR cell model.

Methods

Twelve patients diagnosed with DR at the Qinghai Provincial People’s Hospital from September 2020 to June 2021 were randomly selected as the case group, while 12 healthy subjects of similar age and gender who underwent physical examination in Qinghai Provincial People’s Hospital physical examination center during the same period were randomly selected as the control group. Blood samples (2 mL) were collected from both groups using EDTA anticoagulant blood collection vessels and frozen at −20°C for future analysis. SNP mutations were detected by high-throughput sequencing, and the shortlisted candidates were subjected by Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses. The detected SNP candidates were verified by expanding the sample size (first validation: 56 patients in the case group and 58 controls; second validation: 157 patients in the case group and 96 controls). A lentivirus vector carrying mutated or wild-type PIK3CA.rs17849079 was constructed. ARPE-19 cells were cultured in a medium supplemented with 10% fetal bovine serum (FBS) to establish a DR cell model. PIRES2-PIK3CA-MT and PIRES2-PIK3CA-WT vectors were transfected into DR model cells, which were categorized into control, mannitol, model, empty vector, PIK3CA wild-type, and PIK3CA mutant-type groups. Cell activity was detected by the cell counting kit (CCK)-8 assay, and cellular apoptosis was evaluated by flow cytometry. Glucose concentration and levels of cytokines tumor necrosis factor (TNF)-α and interleukin (IL)-1β were detected using enzyme-linked immunosorbent assay kits. The expression of PIK3CA, AKT1, mTOR, and VEGF genes was detected by real-time quantitative polymerase chain reaction (RT-qPCR), while the expression of PI3K, p-PI3K, AKT1, p-AKT1, mTOR, p-mTOR, and VEGF proteins was detected by western blotting.

Results

The mutated SNPs were mainly enriched in the PI3K/AKT pathway, calcium ion pathway, and glutamatergic synaptic and cholinergic synaptic signaling pathways. Seven SNPs, including PRKCE.rs1533476, DNAH11.rs10485983, ERAP1.rs149481, KLHL1.rs1318761, APOBEC3C.rs1969643, FYN.rs11963612, and KCTD1.rs7240205, were not related to the development of DR. PIK3CA.rs17849079 was prone to C/T mutation. The risk of DR increased with the presence of the C allele and decreased in the presence of the T allele. High glucose induced the expression of PIK3CA and VEGF mRNAs as well as the expression of PI3K, p-PI3K, p-AKT1, p-mTOR, and VEGF proteins in ARPE-19 cells, which led to secretion of inflammatory factors TNF-αand IL-1, cell apoptosis, and inhibition of cell proliferation. The PIK3CA.rs17849079 C allele accelerated the progression of DR. These biological effects were inhibited when the C allele of PIK3CA.rs17849079 was mutated to T allele.

Conclusion

The mutated SNP sites in patients with DR were mainly enriched in PI3K/AKT, calcium ion, and glutamatergic synaptic and cholinergic synaptic signaling pathways. The rs17849079 allele of PIK3CA is prone to C/T mutation where the C allele increases the risk of DR. High glucose activates the expression of PIK3CA and promotes the phosphorylation of PI3K, which leads to the phosphorylation of AKT and mTOR. These effects consequently increase VEGF expression and accelerate the development of DR. The C to T allele mutation in PIK3CA.rs17849079 can play a protective role and reduce the risk of DR.

Factors associated with facial pressure injury in patients receiving non‐invasive positive pressure ventilation mask: A retrospective case–control study

Abstract

Aims and Objectives

This study aimed to investigate factors associated with facial pressure injury (FPI) in patients receiving non-invasive positive pressure ventilation (NIPPV) during hospitalisation in the intensive care unit (ICU) and to identify predictors of FPI.

Background

Non-invasive positive pressure ventilation is a method of treating patients with acute and chronic respiratory failure. However, FPI may occur due to unsuitable nasal-oral NIPPV masks and discomfort in contact with the skin surface.

Design

A retrospective case–control study.

Methods

From January 2018 to October 2020, a total of 397 patients admitted to a national hospital in Taiwan were enrolled. Patients received NIPPV and routinely used under-mask prophylactic dressings during hospitalisation. Patients were divided into the non-FPI group (n = 357) and the FPI group (n = 40). Demographic, clinical characteristics, acute physiology and chronic health evaluation II scores, and Braden Scale scores were collected from medical records. Logistic regression analysis was performed to examine the contribution of each factor to the FPI, and odds ratios were reported. The STROBE checklist was used in this retrospective case–control study.

Results

There were significant differences between the groups in age, serum albumin, C-reactive protein, body mass index (BMI), disease severity, Braden Scale score, length of stay, duration of mechanical ventilation and use of corticosteroids. Logistic regression analysis revealed that the risk factor for FPI was the Braden Scale score [OR = 1.630 (1.176–2.260)], BMI [OR = 0.396 (0.210–1.784)] and corticosteroids [OR = 0.394 (0.159–1.811)], which were predictors of FPI in patients with NIPPV.

Conclusions

Facial pressure injury may still occur in patients who routinely use prophylactic dressings under NIPPV masks. This study provides information on continuing education training for FPI to more accurately identify high-risk and timely preventive measures to reduce FPI.

Relevance to Clinical Practice

Addressing FPI-related factors to prevent facial skin damage and reduce comorbidities in patients using NIPPV masks.

Cost and utilization analysis of concurrent versus staged testicular prosthesis implantation for radical orchiectomy

by Vi Nguyen, Arman Walia, Joshua J. Horns, Niraj Paudel, Aditya Bagrodia, Darshan P. Patel, Tung-Chin Hsieh, James M. Hotaling

Purpose

American Urological Association guidelines recommend testicular prosthesis discussion prior to orchiectomy. Utilization may be low. We compared outcomes and care utilization between concurrent implant (CI) and staged implant (SI) insertion after radical orchiectomy.

Materials & methods

The MarketScan Commercial claims database (2008–2017) was queried for men ages >18 years who underwent radical orchiectomy for testicular mass, stratified as orchiectomy with no implant, CI, or SI. 90-day outcomes included rate of reoperation, readmission, emergency department (ED) presentation, and outpatient visits. Regression models provided rate ratio comparison.

Results

8803 patients (8564 no implant, 190 CI, 49 SI; 2.7% implant rate) were identified with no difference in age, Charlson Comorbidity Index, insurance plan, additional cancer treatment, or metastasis. Median perioperative cost at orchiectomy (+/- implant) for no implant, CI, and SI were $5682 (3648–8554), $7823 (5403–10973), and $5380 (4130–10521), respectively (p Conclusions

CI placement has less total perioperative cost, lower explant rate, and similar postoperative utilization to SI.

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