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Use of consecutive transcutaneous oxygen measurement when assessing the need for revascularization and association with the outcomes of ischemic diabetic ulcers

Abstract

This study compared the ankle-brachial index (ABI) with transcutaneous oxygen pressure (TcPO2) in assessing peripheral vascular disease (PVD) prevalence in 100 diabetic foot ulcer (DFU) patients. Patients were categorized into vascular or nonvascular reconstruction groups and underwent both ABI and TcPO2 measurements four times over 6 months. Predictive validity for PVD diagnosis was analysed using the area under the receiver-operating characteristic curve (AUC). The study found TcPO2 to be a superior predictor of PVD than ABI. Among the DFU patients, 51 with abnormal TcPO2 values underwent vascular reconstruction. Only TcPO2 values showed significant pretreatment differences between the groups and increased post-reconstruction. These values declined over a 6-month follow-up, whereas ABI values rose. For those with end-stage renal disease (ESRD), TcPO2 values saw a sharp decrease within 3 months. Pre-reconstruction TcPO2 was notably lower in amputation patients versus limb salvage surgery patients. In conclusion, TcPO2 is more effective than ABI for evaluating ischemic limb perfusion and revascularization necessity. It should be prioritized as the primary follow-up tool, especially for ESRD patients.

Effects of operating room nursing intervention on wound infection in patients undergoing ovarian cysts surgery: A meta‐analysis

Abstract

We conducted this study aimed to explore the effect of operating room nursing intervention on wound infection in patients undergoing ovarian cysts surgery. A computer system was used to search PubMed, Web of Science, EMBASE, Cochrane Library, Wanfang, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure databases, from database inception to October 2023, for randomised controlled trials (RCTs) on the application of operating room nursing intervention to ovarian cyst surgery. Literature that met the requirements was independently screened by two researchers, and data were extracted and assessed for literature quality. RevMan 5.4 software was applied for data analysis. Fifteen RCTs involving 1187 patients were finally included. The analyses revealed that, compared with routine nursing, the implementation of operating room nursing intervention had a significant advantage in reducing the incidence of wound infections (1.17% vs. 5.44%, odds ratio [OR]: 0.30, 95% confidence interval [CI]: 0.15–0.58, p = 0.0004) and postoperative complications (6.34% vs. 25.17%, OR: 0.20, 95%CI: 0.13–0.29, p < 0.00001), as well as being able to shorten the operative time (standardised mean difference [SMD]: -3.93, 95%CI: −5.67 to −2.20, p < 0.00001), hospital length of stay (SMD: −2.54, 95%CI: −3.19 to −1.89, p < 0.00001) and gastrointestinal recovery time (SMD: −1.61, 95%CI: −2.24 to −0.98, p < 0.00001) in patients undergoing ovarian cysts surgery. This study confirmed by meta-analysis that the operating room nursing intervention can significantly reduce the incidence of wound infection and complications, shorten the operative time, gastrointestinal recovery time, and hospital length of stay after ovarian cyst surgery.

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.

Vitamin D and wound healing: Assessing skin barrier function and implications for chloasma treatment

Abstract

Chloasma, which is distinguished by irregularities in the pigmentation of skin, poses substantial challenge in the field of dermatology. The regulatory influence of vitamin D on the functions of skin cells implies that it may have the capacity to effectively treat chloasma and promote wound healing. To assess the efficacy of vitamin D in chloasma treatment and its impact on the function of skin barrier during the process of wound healing. The research spanned from April 2022 to September 2023, in Shanghai, China, examined 480 individuals who had been diagnosed with chloasma. A double-blind, placebo-controlled clinical trial was utilized to evaluate effectiveness of topical vitamin D3 in treatment of chloasma. Concurrently, randomized control trial investigated the effects of ingested vitamin D3 supplements on the process of wound healing. Transepidermal water loss (TEWL), chloasma severity score changes, wound size reduction and skin hydration levels were critical performance indicators. Statistically, the severity scores of chloasma decreased significantly in the vitamin D treatment group at 3 and 6 months compared with the placebo (p < 0.05). The Vitamin D group exhibited superior wound healing outcomes, including more substantial reduction in lesion size and enhanced skin barrier function, as evidenced by increased skin hydration and decreased TEWL (p < 0.05). Vitamin D substantially mitigated the severity of chloasma and has beneficial effect on wound healing and integrity of the skin barrier. Based on the results obtained, vitamin D exhibited promise as a therapeutic intervention in the field of dermatology, specifically in treatment of chloasma and promotion of wound recovery.

Effect of tumour necrosis factor‐a inhibitors exposure on surgical site infections in rheumatoid arthritis patients undergoing elective orthopaedic surgery: A meta‐analysis

Abstract

A meta-analysis investigation was executed to evaluate the effect of tumour necrosis factor-a inhibitor exposure on surgical site infections in rheumatoid arthritis patients undergoing elective orthopaedic surgery. A comprehensive literature investigation till October 2023 was applied, and 82 470 individuals with orthopaedic surgery were in the chosen investigations' starting point. Odds ratio (OR) in addition to 95% confidence intervals (CIs) was utilized to compute the value of the effect of tumour necrosis factor-a inhibitors exposure on surgical site infections in rheumatoid arthritis patients undergoing elective orthopaedic surgery by the dichotomous approaches and a fixed or random model. Tumour necrosis factor uses had significantly higher surgical site infections (OR, 1.65; 95% CI, 1.21–2.25, p = 0.001) compared with tumour necrosis factor non-use in rheumatoid arthritis patients undergoing elective orthopaedic surgery. However, no significant difference was found between discontinued and continued tumour necrosis factor on surgical site infections (OR, 0.61; 95% CI, 0.35–1.05, p = 0.07) in rheumatoid arthritis patients undergoing elective orthopaedic surgery.Significantly higher surgical site infections was found comparing tumour necrosis factor uses to non-use; however, no significant difference was found between discontinued and continued tumour necrosis factor on surgical site infections in rheumatoid arthritis patients undergoing elective orthopaedic surgery. However, care must be exercised when dealing with its values because of the low sample size of some of the nominated investigations for the meta-analysis.

AGO2-RIP-Seq reveals miR-34/miR-449 cluster targetome in sinonasal cancers

by Marco Tomasetti, Federica Monaco, Corrado Rubini, Marzia Rossato, Concetta De Quattro, Cristina Beltrami, Giacomo Sollini, Ernesto Pasquini, Monica Amati, Gaia Goteri, Lory Santarelli, Massimo Re

Sinonasal tumours are heterogeneous malignancies, presenting different histological features and clinical behaviour. Many studies emphasize the role of specific miRNA in the development and progression of cancer, and their expression profiles could be used as prognostic biomarkers to predict the survival. Recently, using the next-generation sequencing (NGS)-based miRNome analysis the miR-34/miR-449 cluster was identified as miRNA superfamily involved in the pathogenesis of sinonasal cancers (SNCs). In the present study, we established an Argonaute-2 (AGO2): mRNA immunoprecipitation followed by high-throughput sequencing to analyse the regulatory role of miR-34/miR-449 in SNCs. Using this approach, we identified direct target genes (targetome), which were involved in regulation of RNA-DNA metabolic, transcript and epigenetic processes. In particular, the STK3, C9orf78 and STRN3 genes were the direct targets of both miR-34c and miR-449a, and their regulation are predictive of tumour progression. This study provides the first evidence that miR-34/miR-449 and their targets are deregulated in SNCs and could be proposed as valuable prognostic biomarkers.

Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids

Por: Al-Hendy · A. · Segars · J. H. · Taylor · H. S. · Gonzalez · F. · Siblini · H. · Zamah · M. · Alkelani · H. · Singh · B. · Flores · V. A. · Christman · G. M. · Johnson · J. J. · Huang · H. · Zhang · H.
Introduction

Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.

Methods and analysis

This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.

Ethics and dissemination

The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.

Trial registration number

NCT05364008.

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 influence of direct anterior approach and postero‐lateral approach on wound complications after total hip arthroplasty: A meta‐analysis

Abstract

To date, we have reviewed the synthesis literature critically through four databases: PubMed, Embase, Cochrane Library and Web of Science. Eight relevant studies were examined after compliance with the criteria for inclusion and exclusion, as well as documentation quality evaluation. This report covered all randomised, controlled studies of total hip arthroplasty (THA) comparing the direct anterior approach (DAA) with the postero-lateral approach (PLA). The main result was surgical site infection rate. The secondary results were duration of the operation, length of the incision and VAS score after surgery. The results of the meta-analyses of wound infections in the present trial did not show any statistically significant difference in DAA versus PLA (between DAA and PLA) (OR = 1.42, 95%CI: 0.5 to 4.04, p = 0.51). Compared with PLA, DAA had shorter surgical incision (WMD = −3.2, 95%CI: −4.00 to −2.41; p < 0.001) and longer operative times(WMD = 14. 67, 95%CI: 9.24 to 20.09; p < 0.001). Postoperative VAS scores were markedly lower in DAA compared with PLA within 6 weeks of surgery (p < 0.05), with low heterogeneities(I 2 = 0). We found that DAA did not differ significantly from PLA in terms of the risk of wound infection for THA and that the surgical incisions was shorter and less postoperative pain after surgery, even though DAA surgery takes longer.

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.

Climate footprint of industry-sponsored clinical research: an analysis of a phase-1 randomised clinical study and discussion of opportunities to reduce its impact

Por: LaRoche · J. K. · Alvarenga · R. · Collins · M. · Costelloe · T. · De Soete · W. · Faludi · J. · Rens · K.
Objective

This study aims to calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from all in-scope activities involved in a phase-1 clinical study.

Design

Retrospective analysis.

Data source

Internal data held by Janssen Pharmaceuticals.

Studies included

Janssen-sponsored TMC114FD1HTX1002 study conducted between 2019 and 2021.

Main outcome

Measure CO2 equivalents (CO2e) for in-scope clinical trial activities calculated according to intergovernmental panel on climate change 2021 impact assessment methodology.

Results

The CO2e emissions generated by the trial were 17.65 tonnes. This is equivalent to the emissions generated by driving an average petrol-fueled family car 71 004 km or roughly 1.8 times around the circumference of the Earth. Commuting to the clinical site by the study participants generated the most emissions (5419 kg, 31% of overall emissions), followed by trial site utilities (2725 kg, 16% of overall emissions) and site staff travel (2560 kg, 15% of overall emissions). In total, the movement of people (participant travel, site staff travel and trial site staff travel) accounted for 8914 kg or 51% of overall trial emissions.

Conclusions

Decentralised trial models which seek to bring clinical trial operations closer to the participant offer opportunities to reduce participant travel. The electrification of sponsor vehicle fleets and society’s transition towards electric vehicles may result in further reductions.

Trial registration number

NCT04208061.

COVID-19 masks and limited number of shoppers as determinants of shop assistants’ (dis)honesty

by Maciej Koscielniak, Dorota Marciniak, Dariusz Doliński

Previous laboratory and field studies have demonstrated that the dishonesty of commercial transaction participants may depend on subtle cues. In this field study conducted on a sample of 216 shop assistants in Poland, we planned to demonstrate that coronavirus disease-related factors could result in an increased propensity for dishonesty among shop assistants. This investigation is unique in its application of social psychological theories to illuminate hitherto unexplored side effects of combating the coronavirus disease 2019 pandemic. Our supposition was that the potential detriment encountered by individuals wearing solid surgical masks would involve being viewed as more abstract and remote, thereby heightening the likelihood of being deceived by a vendor. Moreover, we examined the potential relationship between the limited number of customers in retail establishments (related to pandemic restrictions) and the unscrupulous practices of sellers—specifically the act of retaining change. The effect of wearing masks was statistically non-significant, whereas the impact of other customers’ absence was significant. Moreover, unexpected results related to transaction parties’ genders were obtained, showing that shop assistants tended to be more honest when dealing with customers of the same gender. The results are discussed in the context of empathy toward masked customers, self-awareness theory, social norms of honesty, and identification with gender groups.

Diagnostic intervention improved health-related quality of life among teenagers with food allergy

by Linnéa Hedman, Åsa Strinnholm, Sven-Arne Jansson, Anna Winberg

Objectives

The aim was to examine if a diagnostic intervention set up to assess current food allergy to cow’s milk, hen’s egg, fish, or wheat among teenagers had an impact on generic and disease specific health-related quality of life (HRQL). The study compared HRQL scoring before and two years after the intervention, and in relation to age matched controls without reported food allergy.

Methods

The study was performed within the Obstructive Lung Disease in Northern Sweden (OLIN) studies where a cohort study on asthma and allergic diseases among 8-year-old schoolchildren was initiated in 2006. At age 12 years, the 125/2612 (5%) children who reported allergy to cow’s milk, hen’s egg, fish, or wheat were invited to a diagnostic intervention including clinical examination, blood tests and evaluation by a pediatric allergist. Of 94 participants, 79 completed generic and disease specific HRQL questionnaires. Additionally, a random sample of 200 (62% of invited) children without food allergy from the OLIN cohort answered the generic HRQL questionnaire. The respondents of the HRQL questionnaires were re-examined two years later and 57 teenagers with and 154 without reported allergy participated.

Results

There were no significant differences in generic HRQL scores between teenagers with and without reported food allergy at study entry, or after the intervention. Among those with reported food allergy, we found a significant improvement in disease specific HRQL after the intervention (mean values: 3.41 vs 2.80, p Conclusion

The diagnostic intervention showed a long-term improvement of disease specific HRQL but not generic HRQL.

Investigation of morbidity, length of stay, and healthcare costs of inpatient paediatric burns

Abstract

Burn injuries are the third most common cause of death in children due to trauma. Hospitalizations related to burn injuries are common. Prolonged hospitalization associated with burn treatment can result in increased resource utilization, leading to higher costs. Thus, it is essential to investigate these areas to reduce costs. The study investigated the morbidity and length of hospital stay of paediatric burn patients, as well as calculated the social security costs of hospitalization and treatment. The retrospective observational descriptive study examined the medical records of 774 paediatric patients treated in a burn intensive care unit at a tertiary medical faculty hospital between 01 March 2019 and 31 March 2022. The invoice records of payments made by the Social Security Institution to the hospital in return for health services provided to patients were examined. The healthcare costs were calculated. A total of 57.6% of the participants were boys and 79.2% were between the ages of 1–4. About 90% of the cases involved burns with a total body surface area (TBSA) of less than 20% and a 2nd-degree burn depth. Scalding was the most common cause of burns (88.2%). Among all patients, the mortality rate was 2.1% (n = 16). The mean length of hospital stay was 10.29 ± 9.59 days. The mean cost per day was 212.02 ± 190.94 US dollars ($US), and the cost per 1% TBSA was 241.70 ± 301.32 $US. According to the causes of burn injury, the mean cost of electricity was 5000.77 ± 8101.85 $US, fire 4818.02 ± 5852.22 $US, and chemical 3285.49 ± 4503.2 $US were observed in the first 3 ranks respectively. According to this study, paediatric burn cases occur due to preventable causes, and even though the mortality rate was low, the severity of burns, TBSA%, and presence of complications caused prolonged lengths of hospital stays, which caused social security costs to rise.

Effect of intramedullary fixation and plate fixation on postoperative wound complications in clavicle fractures: A meta‐analysis

Abstract

More and more meta-analyses have been conducted to compare the effects of intramedullary fixation (IF) and plate fixation (PF) on the outcome of midshaft clavicle fractures. It can affect the doctors' treatment decisions. A number of studies have been conducted in order to assist surgeons in selecting optimal operative procedures and to recommend operative treatment of clavicle fractures in accordance with the best available research. Our analysis of the IF and PF of clavicle fractures was done through a search for PubMed, Emabase, Web of Science, and Cochrane Library. Two different researchers analysed the research literature for quality of analysis and data extraction. The analysis of the data was done with RevMan 5.3. The 95% CI and OR models have been computed by means of either fixed-dose or randomize. In addition, RCT in 114 references have been reviewed and added for further analysis. It is concluded that the application of plate and intramedullary fixation in the middle clavicle operation has remarkable influence on the outcome of post-operation. There was a lower risk of postoperative wound infection in IF (OR, 5.92; 95% CI, 2.46, 14.27 p < 0.0001), smaller surgical incisions (MD, 6.57; 95% CI, 4.90, 8.25 p < 0.0001), and shorter operative time (MD, 17.09; 95% CI 10.42, 23.77 p < 0.0001), less blood loss (MD, 63.62; 95% CI, 55.84, 71.39 p < 0.0001) and shorter hospital stay (MD, 1.05; 95% CI, 0.84, 1.25 p < 0.0001). However, there is no statistical significance in the incidence of wound dehiscence. Thus, the effect of IF on the incidence of injury is better than that of the inner plate in the middle of the clavicle.

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.

Protection against Incidences of Serious Cardiovascular Events Study with daily fish oil supplementation in dialysis patients (PISCES): protocol for a randomised controlled trial

Por: Lok · C. E. · Hemmelgarn · B. R. · Moist · L. M. · Polkinghorne · K. · Tomlinson · G. · Tonelli · M.
Introduction

Patients with kidney failure with replacement therapy (KFRT) suffer premature cardiovascular (CV) mortality and events with few proven pharmacological interventions. Omega-3 polyunsaturated essential fatty acids (n-3 PUFAs) are associated with a reduced risk of CV events and death in non-dialysis patients and in patients with established CV disease but n-3 PUFAs have not been evaluated in the high risk KFRT patient population.

Methods and analysis

This multicentre randomised, placebo controlled, parallel pragmatic clinical trial tests the hypothesis that oral supplementation with n-3 PUFA, when added to usual care, leads to a reduction in the rate of serious CV events in haemodialysis patients when compared with usual care plus matching placebo. A target sample size of 1100 KFRT patients will be recruited from 26 dialysis units in Canada and Australia and randomised to n-3 PUFA or matched placebo in a 1:1 ratio with an expected intervention period of at least 3.5 years. The primary outcome to be analysed and compared between intervention groups is the rate of all, not just the first, serious CV events which include sudden and non-sudden cardiac death, fatal and non-fatal myocardial infarction, stroke, and peripheral vascular disease events.

Ethics and dissemination

This study has been approved by all institutional ethics review boards involved in the study. Participants could only be enrolled following informed written consent. Results will be published in peer-reviewed journals and presented at scientific and clinical conferences.

Trial registration number

ISRCTN00691795

Towards system redesign: An exploratory analysis of neurodivergent traits in a childhood population referred for autism assessment

by Jason Lang, Georgia Wylie, Caroline Haig, Christopher Gillberg, Helen Minnis

Background

Children’s health services in many countries are moving from single condition diagnostic silo assessments to considering neurodevelopment in a more holistic sense. There has been increasing recognition of the importance of clinical overlap and co-occurrence of different neurotypes when assessing neurodivergent children. Using a cross-sectional service evaluation design, we investigated the overlap of neurodivergences in a cohort of children referred for autism assessment, focusing on motor, learning, and attention/activity level domains. We aimed to determine what proportion of children in a cohort referred for an autism assessment showed traits of additional neurodivergences, and what proportion were further investigated.

Methods

We evaluated anonymised medical records of children aged between two and 17 years referred for autism assessment. We used validated questionnaires to assess for neurodivergent traits. A weighted scoring system was developed to determine traits in each neurodevelopmental domain and a score above the median was considered to indicate a neurodivergent trait. Evidence of further investigations were recorded. We then examined the relationships between autism traits and traits of additional neurodivergence.

Results

114 participants were included for evaluation. 62.3% (n = 71) had completed questionnaires for analysis. Of these, 71.8% (n = 51) scored greater than the median for at least one additional neurotype, indicating the presence of other neurodivergent traits, and 88.7% (n = 64) attracted a diagnosis of autism. Only 26.3% of children with evidence of additional neurotypes were further investigated beyond their autism assessment.

Conclusions

Our results demonstrate the extensive overlap between additional neurodivergent traits in a population of children referred with suspected autism and show that only a small proportion were further investigated. The use of standardised questionnaires to uncover additional neurodivergences may have utility in improving the holistic nature of neurodevelopmental assessments.

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