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Untargeted metabolomics reveals that declined PE and PC in obesity may be associated with prostate hyperplasia

by Guorui Fan, Xiaohai Guan, Bo Guan, Hongfei Zhu, Yongchao Pei, Chonghao Jiang, Yonggui Xiao, Zhiguo Li, Fenghong Cao

Background

Recent studies have shown that obesity may contribute to the pathogenesis of benign prostatic hyperplasia (BPH). However, the mechanism of this pathogenesis is not fully understood.

Methods

A prospective case–control study was conducted with 30 obese and 30 nonobese patients with BPH. Prostate tissues were collected and analyzed using ultra performance liquid chromatography ion mobility coupled with quadrupole time-of-flight mass spectrometry (UPLC-IMS-Q-TOF).

Results

A total of 17 differential metabolites (3 upregulated and 14 downregulated) were identified between the obese and nonobese patients with BPH. Topological pathway analysis indicated that glycerophospholipid (GP) metabolism was the most important metabolic pathway involved in BPH pathogenesis. Seven metabolites were enriched in the GP metabolic pathway. lysoPC (P16:0/0:0), PE (20:0/20:0), PE (24:1(15Z)/18:0), PC (24:1(15Z)/14:0), PC (15:0/24:0), PE (24:0/18:0), and PC (16:0/18:3(9Z,12Z,15Z)) were all significantly downregulated in the obesity group, and the area under the curve (AUC) of LysoPC (P-16:0/0/0:0) was 0.9922. The inclusion of the seven differential metabolites in a joint prediction model had an AUC of 0.9956. Thus, both LysoPC (P-16:0/0/0:0) alone and the joint prediction model demonstrated good predictive ability for obesity-induced BPH mechanisms.

Conclusions

In conclusion, obese patients with BPH had a unique metabolic profile, and alterations in PE and PC in these patients be associated with the development and progression of BPH.

Aspirin versus metformin in pregnancies at high risk of preterm pre-eclampsia in China (AVERT): protocol for a multicentre, double-blind, 3-arm randomised controlled trial

Por: Liu · J. · Shen · L. · Nguyen-Hoang · L. · Zhou · Q. · Wang · C. C. · Lu · X. · Sahota · D. · Chong · K. C. · Ying · H. · Gu · W. · Zhou · R. · Yang · H. · Jiang · Y. · Chen · D. · Li · X. · Poon · L.
Introduction

Pre-eclampsia (PE) affects about 5% of Chinese pregnant women and is a major cause of maternal and perinatal morbidity and mortality. The first trimester screening model developed by the Fetal Medicine Foundation, which uses the Bayes theorem to combine maternal characteristics and medical history together with measurements of biomarkers, has been proven to be effective and has superior screening performance to that of the traditional risk factor-based approach for the prediction of PE. Prophylactic use of low-dose aspirin in women at risk for PE has resulted in a lower incidence of preterm-PE. However, there is no consensus on the preferred aspirin dosage for the prevention of preterm-PE. Evidence has also suggested that metformin has the potential benefit in preventing PE in pregnant women who are at high risk of the disorder.

Method and analysis

We present a protocol (V.2.0, date 17 March 2022) for the AVERT trial, which is a multicentre, double-blinded, 3-arm randomised controlled trial (RCT) that uses an effective PE screening programme to explore the optimal dosage of aspirin and the role of metformin for the prevention of PE among high-risk pregnant women in China. We intend to recruit 66 000 singleton pregnancies without treatment of low-dose aspirin and metformin at 11–13 weeks’ gestation and all eligible women attending for their first trimester routine scan will be invited to undergo screening for preterm-PE by the combination of maternal factors, mean arterial pressure and placental growth factor. Women found to be at high risk of developing preterm-PE will be invited to take part in the RCT. This study will compare the incidence of preterm-PE with delivery at

Ethics and dissemination

Ethical approval for the study was obtained from the Joint Chinese University of Hong Kong–New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No. 2021.406) in Hong Kong and the Ethics Committee of each participating hospital in Mainland China. The study is registered at ClinicalTrials.gov. The results of the AVERT trial will be disseminated at international academic conferences and published in high-impact factor journals.

Trial registration number

NCT05580523.

Evaluating the effectiveness of echocardiographic guidance in diminishing postoperative wound complications for left atrial appendage closure: A clinical retrospective study

Abstract

Echocardiographic guidance in left atrial appendage (LAA) closure procedures is increasingly recognized for its potential to enhance patient outcomes in atrial fibrillation (AF). This retrospective study assesses its impact on hospital stay duration, readmission rates and surgical site wound complications in 200 AF patients. Divided equally into an echocardiographically guided group (Group E) and a non-guided group (Group N), the analysis focused on detailed patient data encompassing hospital stay, 30-day readmission and wound complications. Findings revealed that Group E experienced a significantly shorter average hospital stay of 3.5 days, compared with 6.5 days in Group N, along with a lower 30-day readmission rate (5% vs. 18% in Group N). Furthermore, Group E showed a considerable reduction in surgical site wound complications, such as infections and hematomas. The study concludes that echocardiographic guidance in LAA closure procedures markedly improves postoperative wound outcomes, underscoring its potential as a standard practice in cardiac surgeries for AF patients. This approach not only optimizes patient safety and postoperative recovery but also enhances healthcare resource utilization.

Metabolic dysfunction-associated profiles and subsequent site-specific risk of obesity-related cancers among Chinese patients with diabetes: a retrospective cohort study

Por: Yau · S. T. Y. · Leung · E. · Wong · M. C. S. · Hung · C. T. · Chong · K. C. · Lee · A. · Yeoh · E. K.
Objectives

To compare metabolic dysfunction-associated profiles between patients with diabetes who developed different obesity-related site-specific cancers and those who remained free of cancer during follow-up.

Design

Retrospective cohort study.

Setting

Public general outpatient clinics in Hong Kong.

Participants

Patients with diabetes without a history of malignancy (n=391 921).

Primary outcome measures

The outcomes of interest were diagnosis of site-specific cancers (colon and rectum, liver, pancreas, bladder, kidney and stomach) during follow-up. Cox proportional hazards regression was applied to assess the associations between metabolic dysfunction and other clinical factors with each site-specific cancer.

Results

Each 0.1 increase in waist-to-hip ratio was associated with an 11%–35% elevated risk of colorectal, bladder and liver cancers. Each 1% increase in glycated haemoglobin was linked to a 4%–9% higher risk of liver and pancreatic cancers. While low-density lipoprotein cholesterol and triglycerides were inversely associated with the risk of liver and pancreatic cancers, high-density lipoprotein cholesterol was negatively associated with pancreatic, gastric and kidney cancers, but positively associated with liver cancer. Furthermore, liver cirrhosis was linked to a 56% increased risk of pancreatic cancer. No significant association between hypertension and cancer risk was found.

Conclusions

Metabolic dysfunction-associated profiles contribute to different obesity-related cancer outcomes differentially among patients with diabetes. This study may provide evidence to help identify cancer prevention targets during routine diabetes care.

Association between deep learning measured retinal vessel calibre and incident myocardial infarction in a retrospective cohort from the UK Biobank

Por: Wong · Y. L. · Yu · M. · Chong · C. · Yang · D. · Xu · D. · Lee · M. L. · Hsu · W. · Wong · T. Y. · Cheng · C. · Cheung · C. Y.
Background

Cardiovascular disease is a leading cause of global death. Prospective population-based studies have found that changes in retinal microvasculature are associated with the development of coronary artery disease. Recently, artificial intelligence deep learning (DL) algorithms have been developed for the fully automated assessment of retinal vessel calibres.

Methods

In this study, we validate the association between retinal vessel calibres measured by a DL system (Singapore I Vessel Assessment) and incident myocardial infarction (MI) and assess its incremental performance in discriminating patients with and without MI when added to risk prediction models, using a large UK Biobank cohort.

Results

Retinal arteriolar narrowing was significantly associated with incident MI in both the age, gender and fellow calibre-adjusted (HR=1.67 (95% CI: 1.19 to 2.36)) and multivariable models (HR=1.64 (95% CI: 1.16 to 2.32)) adjusted for age, gender and other cardiovascular risk factors such as blood pressure, diabetes mellitus (DM) and cholesterol status. The area under the receiver operating characteristic curve increased from 0.738 to 0.745 (p=0.018) in the age–gender-adjusted model and from 0.782 to 0.787 (p=0.010) in the multivariable model. The continuous net reclassification improvements (NRIs) were significant in the age and gender-adjusted (NRI=21.56 (95% CI: 3.33 to 33.42)) and the multivariable models (NRI=18.35 (95% CI: 6.27 to 32.61)). In the subgroup analysis, similar associations between retinal arteriolar narrowing and incident MI were observed, particularly for men (HR=1.62 (95% CI: 1.07 to 2.46)), non-smokers (HR=1.65 (95% CI: 1.13 to 2.42)), patients without DM (HR=1.73 (95% CI: 1.19 to 2.51)) and hypertensive patients (HR=1.95 (95% CI: 1.30 to 2.93)) in the multivariable models.

Conclusion

Our results support DL-based retinal vessel measurements as markers of incident MI in a predominantly Caucasian population.

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

‘Been there, experienced that’: A qualitative study on the experiences and perceptions of online peer volunteers in supporting Singaporean mothers at risk of depression

Abstract

Background

Online peer support is a useful source of support for parents during the perinatal period, associated with improved psychological outcomes. Past research has found that peer support providers themselves gain from providing peer support as well, making it mutually beneficial. As current maternity care services are insufficient to meet the support needs of parents, the Supportive Parenting App (SPA) intervention was developed to offer them informational, appraisal and emotional support during the perinatal period. It consists of mobile health application-based educational support and online peer support provided by trained peer volunteers, to prevent the development of postnatal depression.

Objective

To explore the experiences of peer volunteers with providing online peer support to parents during the perinatal period, as well as to identify areas of improvement for the SPA intervention.

Methods

A qualitative descriptive design was adopted. This study took place from October 2020 to August 2021 in two tertiary public healthcare institutions in Singapore. A total of 18 peer volunteers were invited for individual semi-structured interviews. The interviews were audio recorded and transcribed verbatim, and thematic analysis was used to analyse the data.

Results

Four themes were emerged as follows: (1) ‘Being there’: Reminiscing about and healing of own postnatal depression experience; (2) Building rapport with parents; (3) Parents in mind: Mutual sharing of knowledge and how to support new parents better; (4) Ensuring good quality peer support.

Conclusions

The peer volunteers felt that their experience was fulfilling and healing. Frequent contact, sharing of SPA resources and self-disclosure were found to help engage the new parents and build rapport between peer volunteers and parents. Challenges described by the peer volunteers have identified possible areas in which the SPA intervention can be improved.

Implications for care

Communication between peer program facilitators, managers and peer volunteers can be enhanced to ensure that peer volunteers are more sensitive and precise when providing support or information. This can improve rapport building between parents and peer volunteers, which will in turn maximize the benefits that parents can reap through online peer-to-peer support.

Impact

This study explored the perceptions of peer volunteers who provided online peer support to parents across the perinatal period. Peer volunteers felt that the SPA intervention was meaningful and that providing peer support was a healing experience. They were able to learn about the experiences of other mothers with postpartum depression while sharing their own past experiences. Thus, both parents and peer volunteers can benefit from engaging in online peer support programs. Technology-based interventions like the Supportive Parenting App (SPA) can be a suitable complement to maternity care services by providing parents access to medically accurate information and social support. Additionally, more experienced mothers can engage in fulfilling experiences through volunteering for new mothers who may benefit from informational, appraisal and emotional support.

Reporting method

This study follows the reporting guidelines as stated by the Consolidated criteria for reporting qualitative research (COREQ) checklist.

Patient or Public Contribution

Parents and peer volunteers contributed ideas that aided with the design of the mobile app. Many topics added to the educational materials were suggested by these parents as well.

What does this paper contribute to the wider global clinical community?

This study showed that sufficient training can be provided to lay peer volunteers to help them support other parents, buffering the pressure exerted on the healthcare industry due to the rising demand for healthcare services. The provision of such support is also beneficial for the peer volunteers themselves, as they find it meaningful and educational. Program developers of parenting and peer volunteering interventions can draw on the findings of this study to improve the effectiveness of these programs.

Application of maple leaf‐shaped flap combined with negative pressure wound therapy in the perianal circular skin defect reconstruction

Abstract

We aimed to explore the efficacy of maple leaf-shaped flap in the repair of perianal circular skin defect. This study is a retrospective review of patients with perianal circular skin defect after skin tumour resection and repaired with maple leaf-shaped flap. Patients included in this study were admitted in our department between January 2010 and January 2023. A standardized data collection template was used to collect related variables. The design and surgical procedures of maple leaf-shaped flap are carefully described in this study. Negative pressure wound therapy (NPWT) was applied to assist wound healing postoperatively. Twenty-seven patients were included in this study. The average wound size after tumour resection measured 4 × 5 cm2–10 × 10 cm2. The circular skin defect was repaired by maple leaf-shaped flap, and NPWT was used after surgery. Twenty-five patients achieved primary wound healing and flaps were well-survived. Slight infection occurred in two patients, and both were cured after dressing change. During the follow-up period of 6–24 months, no tumour recurrence occurred. The perianal morphology can be well-restored by maple leaf-shaped flap, and the defecation control function of anus was not impaired. The application of maple leaf-shaped flap and NPWT is a promising way in the repair of perianal circular skin defect with little complication and satisfying outcomes.

Simplified and modified Limberg flap plus vacuum‐assisted closure for treatment of sacrococcygeal pilonidal sinus disease

Abstract

Background

Pilonidal sinus disease (PSD), a chronic inflammatory disease, affects the sacrococcygeal soft tissue, especially in young adults. The ideal treatment for PSD remains divergence. This study evaluated the application of a simplified modified Limberg flap combined with vacuum-assisted closure for treating PSD.

Methods

This prospective study was conducted from 1 June 2017 to 31 March 2022 in Changhai Hospital, Naval Military Medical University, Shanghai, China. The study included 88 male patients (91.7%) and 8 female patients (8.3%). The 96 patients ranged in age from 15 to 34 years (mean ± SD, 23 ± 4.4). Under general anaesthesia, all patients underwent simplified modified Limberg flap reconstruction with vacuum-assisted closure. The patient's weight, surgical time, extubation time, hospital stay, time to return to normal life or work, wound infection, wound dehiscence and recurrence rate were recorded. The visual analogue scale (VAS) score and the Vancouver scar score were used to score patients' pain and scars in the surgical area.

Results

The volume of resected diseased tissue was 13.5–120 (mean ± SD, 34.993 ± 24.406) cm2. The average surgical time during the treatment period was 97.68 ± 18.72 min, and the average extubation time was (6.36 ± 1.55) days, the mean hospital stay was 19.4 days; no patients were lost to follow-up. None of the patients experienced post-operative recurrence, wound infection, seroma or hematoma. Six patients (6.3%) experienced wound dehiscence at the flap tip around the natal cleft. The mean time to the resumption of daily activities was 26.3 days. The average VAS pain score was (6.00 ± 1.53) points, and the average Vancouver scar score was (5.96 ± 1.51) points, 12 patients (12.5%) were dissatisfied with their aesthetic results, and the average beauty satisfaction score is (6.64 ± 1.28) points.

Conclusions

Simplified modified Limberg flap reconstruction with vacuum-assisted closure surgery is an effective and innovative method for the treatment of PSD, with a low recurrence rate and rapid recovery.

Morphological characteristics of facial scars: A retrospective analysis according to scar location, onset, age, and cause

Abstract

The morphology of facial scars shows a wide variation in terms of texture and colour. To date, there are no reliable predictors of aberrant scarring. We conducted a retrospective analysis to identify factors associated with specific scar features and types. Photographs and medical records of 428 patients with facial scars were retrospectively reviewed. Patients with keloids were excluded. The mean age of the patients was 45.43 ± 23.13 years with a male-to-female ratio of 1:1.36. Atrophic scars were the most common (42.8%), followed by flat scars (38.7%) and hypertrophic scars (18.5%). Scars on the forehead were more likely to be atrophic, whereas scars on the chin/jaw and around the mouth were more likely to be hypertrophic. Hypopigmentation was significantly more common in scars located on the forehead. Redness (erythema) was significantly more common in scars located on the chin/jaw. Old scars were less likely to be erythematous, and hypertrophic. Atrophic scars were more common in younger patients. Scars caused by dermatologic conditions, such as acne, were more likely to be atrophic, whereas surgical scars had the lowest risk of being atrophic or hypertrophic. In conclusion, the location, onset, and cause of facial scars were associated with specific features of scars.

Insights of healthcare professionals regarding waterbirths and water immersion during labour: A mixed studies review

Abstract

Aim

To consolidate healthcare professionals' insights about waterbirths and water immersion during labour.

Design

Mixed studies review.

Data Sources

Seven electronic databases were searched from their inception dates till June 2023: PubMed, Embase, CINAHL, PsycINFO, Web of Science, Scopus, ProQuest Dissertations and Theses Global.

Methods

The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines and Pluye and Hong's mixed studies review framework guided this review. The quality of included studies was evaluated using the Mixed Methods Appraisal Tool. Findings were synthesized using the convergent qualitative synthesis method, and results were thematically analysed using Braun and Clarke's framework.

Results

Three main themes were identified from the 22 included studies: (1) believing in waterbirths, (2) opposing forces and (3) plotting the course ahead.

Conclusion

Healthcare professionals reported different views about waterbirths and water immersion practices; midwives were most likely to support these practices, followed by nurses and lastly, few physicians supported them. Reasons for opposing waterbirths include insufficient training and support from colleagues as well as concerns about work efficiency, waterbirth safety and litigation issues.

Impact

The available evidence suggests the need to provide waterbirth training for healthcare professionals, equip healthcare facilities with necessary waterbirth-related infrastructure and develop appropriate waterbirth policies/guidelines. Healthcare professionals could also consider providing antenatal waterbirth education to women and obtain women's feedback to improve current policies/guidelines. Future research should explore the views of different types of healthcare professionals from more diverse cultures.

Reporting Method

The PRISMA guidelines.

No Patient or Public Contribution

Systematic review.

The Canadian Study of Arterial Inflammation in Patients with Diabetes and Recent Vascular Events, Evaluation of Colchicine Effectiveness (CADENCE): protocol for a randomised, double-blind, placebo-controlled trial

Por: Boczar · K. E. · Shin · S. · deKemp · R. A. · Dowlatshahi · D. · Tavoosi · A. · Wiefels · C. · Liu · P. · Lochnan · H. · MacPherson · P. A. · Chong · A. Y. · Torres · C. · Leung · E. · Tawakol · A. · Ahmadi · A. · Garrard · L. · Lefebvre · C. · Kelly · C. · MacPhee · P. · Tilokee · E. · Ragg
Background

Inflammation is a key mediator in the development and progression of the atherosclerotic disease process as well as its resultant complications, like myocardial infarction (MI), stroke and cardiovascular (CV) death, and is emerging as a novel treatment target. Trials involving anti-inflammatory medications have demonstrated outcome benefit in patients with known CV disease. In this regard, colchicine appears to hold great promise. However, there are potential drawbacks to colchicine use, as some studies have identified an increased risk of infection, and a non-significant trend for increased all-cause mortality. Thus, a more thorough understanding of the underlying mechanism of action of colchicine is needed to enable a better patient selection for this novel CV therapy.

Objective

The primary objective of the Canadian Study of Arterial Inflammation in Patients with Diabetes and Recent Vascular Events, Evaluation of Colchicine Effectiveness (CADENCE) trial is to assess the effect of colchicine on vascular inflammation in the carotid arteries and ascending aorta measured with 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT in patients with type 2 diabetes mellitus (T2DM) or pre-diabetes who have experienced a recent vascular event (acute coronary syndrome (ACS)/MI, transient ischaemic attack (TIA) or stroke). Secondary objectives include determining colchicine’s effect on inflammatory biomarkers (high-sensitivity C reactive protein (hs-CRP) and interleukin-6 (IL-6)). Additionally, we will assess if baseline inflammation imaging or biomarkers are associated with a treatment response to colchicine determined by imaging. Exploratory objectives will look at: (1) the difference in the inflammatory response to colchicine in patients with coronary events compared with patients with cerebral events; (2) the difference in the inflammatory response to colchicine in different vascular beds; (3) the relationship of FDG-PET imaging markers with serum biomarkers and (4) assessment of quality-of-life changes.

Methods and design

CADENCE is a multicentre, prospective, randomised, double-blinded, placebo-controlled study to determine the effect of colchicine on arterial inflammation as assessed with imaging and circulatory biomarkers, specifically carotid arteries and aortic FDG uptake as well as hs-CRP and IL-6 among others. Patients with T2DM or pre-diabetes who have recently experienced a CV event (within 30–120 days after an ACS (ie, ST-elevation MI (STEMI) or non-STEMI)) or TIA/stroke with documented large vessel atherosclerotic disease will be randomised to treatment with either colchicine 0.6 mg oral daily or placebo. Participants will undergo baseline clinical evaluation including EQ5D assessment, blood work for inflammatory markers and FDG PET/CT scan of the ascending aorta and left and right carotid arteries. Patients will undergo treatment for 6 months and have repeat clinical evaluation including EQ5D assessment, blood work for inflammatory markers and FDG PET/CT scan at the conclusion of the study. The primary outcome will be the change in the maximum target to background ratio (TBRmax) in the ascending aorta (or carotid arteries) from baseline to follow-up on FDG PET/CT imaging.

Discussion

Colchicine is an exciting potential new therapy for CV risk reduction. However, its use is associated with side effects and greater understanding of its underlying mechanism of action is needed. Importantly, the current study will determine whether its anti-inflammatory action is an indirect systemic effect, or a more local plaque action that decreases inflammation. The results will also help identify patients who will benefit most from such therapy.

Trial registration number

NCT04181996.

Intravenous immunoglobulin treatment in childhood encephalitis (IgNiTE): a randomised controlled trial

Por: Hill · M. · Iro · M. · Sadarangani · M. · Absoud · M. · Cantrell · L. · Chong · K. · Clark · C. · Easton · A. · Gray · V. · Kneen · R. · Lim · M. · Liu · X. · Pike · M. · Solomon · T. · Vincent · A. · Willis · L. · Yu · L.-M. · Pollard · A. J. · The IgNiTE study team · Pollard · Lim · Solomon
Objective

To investigate whether intravenous immunoglobulin (IVIG) improves neurological outcomes in children with encephalitis when administered early in the illness.

Design

Phase 3b multicentre, double-blind, randomised placebo-controlled trial.

Setting

Twenty-one hospitals in the UK.

Participants

Children aged 6 months to 16 years with a diagnosis of acute or subacute encephalitis, with a planned sample size of 308.

Intervention

Two doses (1 g/kg/dose) of either IVIG or matching placebo given 24–36 hours apart, in addition to standard treatment.

Main outcome measure

The primary outcome was a ‘good recovery’ at 12 months after randomisation, defined as a score of≤2 on the Paediatric Glasgow Outcome Score Extended.

Secondary outcome measures

The secondary outcomes were clinical, neurological, neuroimaging and neuropsychological results, identification of the proportion of children with immune-mediated encephalitis, and IVIG safety data.

Results

18 participants were recruited from 12 hospitals and randomised to receive either IVIG (n=10) or placebo (n=8) between 23 December 2015 and 26 September 2017. The study was terminated early following withdrawal of funding due to slower than anticipated recruitment, and therefore did not reach the predetermined sample size required to achieve the primary study objective; thus, the results are descriptive. At 12 months after randomisation, 9 of the 18 participants (IVIG n=5/10 (50%), placebo n=4/8 (50%)) made a good recovery and 5 participants (IVIG n=3/10 (30%), placebo n=2/8 (25%)) made a poor recovery. Three participants (IVIG n=1/10 (10%), placebo n=2/8 (25%)) had a new diagnosis of epilepsy during the study period. Two participants were found to have specific autoantibodies associated with autoimmune encephalitis. No serious adverse events were reported in participants receiving IVIG.

Conclusions

The IgNiTE (ImmunoglobuliN in the Treatment of Encephalitis) study findings support existing evidence of poor neurological outcomes in children with encephalitis. However, the study was halted prematurely and was therefore underpowered to evaluate the effect of early IVIG treatment compared with placebo in childhood encephalitis.

Trial registration number

Clinical Trials.gov NCT02308982; ICRCTN registry ISRCTN15791925.

Barriers to cardiac rehabilitation and patient perceptions on the usage of technologies in cardiac rehabilitation: A cross‐sectional study

Abstract

Aims and Objectives

The study aimed to identify factors associated with participation in Phase II cardiac rehabilitation and to assess patient perceptions towards the usage of technologies in cardiac rehabilitation.

Background

Despite efforts to promote utilisation of cardiac rehabilitation (CR), participation among patients remains unsatisfactory. Little is known of patient decision to participate Phase II CR in a multi-ethnic country.

Design

A cross-sectional study design.

Methods

A consecutive sampling of 240 patients with coronary heart disease completed Coronary Artery Disease Education Questionnaire (CADE-Q) II, Hospital Anxiety and Depression Scale (HADS), Multidimensional Scale of Perceived Social Support (MSPSS) and Cardiac Rehabilitation Barriers Scale (CRBS).

Results

Seventy per cent of patients (mean age 60.5 [SD = 10.6] years, 80.8% male) participated in phase II cardiac rehabilitation. Self-driving to cardiac rehabilitation centres, higher barriers in perceived need/health care and logistical factors were significantly associated with decreased odds of participation. Patients with more barriers from comorbidities/functional status, higher perceived social support from friends, and anxiety were more likely to participate. Chinese and Indians were less likely to participate when compared with Malays. More than 80% of patients used both home and mobile broadband internet, and 72.9% of them would accept the usage of technologies, especially educational videos, instant messenger, and video calls to partially replace the face-to-face, centre-based cardiac rehabilitation approach.

Conclusion

Several barriers were associated with non-participation in phase II cardiac rehabilitation. With the high perceived acceptance of technology usage in cardiac rehabilitation, home-based and hybrid cardiac rehabilitation may represent potential solutions to improve participation.

Relevance to clinical practice

By addressing the barriers to cardiac rehabilitation, patients are more likely to be ready to adopt health behaviour changes and adhere to the cardiac rehabilitation programme. The high perceived acceptance of using technologies in cardiac rehabilitation may provide insights into new delivery models that can improve and overcome barriers to participation.

Neonatal outcomes and its association among gestational diabetes mellitus with and without depression, anxiety and stress symptoms in Malaysia: A cross-sectional study

Prevalence of depression, anxiety and stress symptoms in gestational diabetes mellitus ranges from 10.2% to 39.9% based on previous studies in Malaysia. Presence of depression, anxiety or stress in pregnancy may increase the risk of neonatal morbidity and mortality. The aim of this study was to determine the prevalence of neonatal outcomes and its association among mothers with gestational diabetes mellitus with and without the presence of depression, anxiety and stress symptoms in Malaysia.
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