Heart of England: HEFT Repository
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A quality improvement project reducing adverse events and improving adherence to guidelines surrounding VRIII usage.
No full textVariable rate intravenous insulin infusions (VRIII) are frequently used in hospitals and incorrect use can lead to electrolyte imbalance, hypoglycaemia and adverse outcomes. The Joint British Diabetes Societies (JDBS) published guidelines in 2014 and recommended the use of a balanced fluid as substrate. There was no published data to demonstrate the superiority of this fluid in reducing adverse events. This quality improvement project aimed to review the existing practice at our Trust in accordance with JDBS guidelines. We predicted introducing this fluid would reduce adverse events and demonstrating this was a prerequisite condition from our Trust Medicines Management Committee to approve its long-term availability. We carried out an audit of our practice in 2015, at which time the JBDS recommended fluid (0.45% sodium chloride/5% dextrose with 0.15% potassium chloride) was not available in our Trust. Our VRIII guideline was re-written with recommendation for use of the balanced fluid, after procurement from pharmacy. Our primary areas for improvement as highlighted from the 2015 audit were correct substrate prescription and rate reduction of hypokalaemia (potassium <3.5 mmol/L) and hypoglycaemia (glucose <4 mmol/L) during VRIII use. Analysis of the pre-intervention (December 2016) and post-intervention (September-November 2017) data showed a significant increase in correct fluid use; 11% pre-intervention to 76% post-intervention (χ, p<0.0001). The number of hypoglycaemic events per VRIII reduced from 0.73 (±1.78) to 0.28 (±0.84) (p<0.05) peri-intervention. Similarly, the number of hypokalaemic events per VRIII reduced from 0.15 (±0.54) pre-intervention to 0.05 (±0.25) post-intervention. There was also a significant reduction in number of VRIII episodes associated with a hyponatraemia event from 26% at baseline to 12% post-intervention (p<0.01). Some of these marked improvements were not sustained at 1-year post follow-up. We reduced adverse outcomes with a substantial net-cost saving during this period, through implementation of new and accessible guidelines, trust-wide education programmes and posters to raise awareness
Why are women considering ovarian tissue cryopreservation to preserve reproductive and hormonal ovarian function? A qualitative study protocol.
No full textINTRODUCTION
Current fertility preservation options available to women are oocyte cryopreservation (egg freezing) or embryo cryopreservation. A newer procedure, ovarian tissue cryopreservation (OTC), has become available in some centres, which offers another option for women and girls considering fertility preservation. These procedures are commonly offered to women about to undergo treatments for cancer. OTC involves removing sections of ovarian tissue and cryopreserving it for future reimplantation, often several years later. OTC offers girls and women who may become infertile with optionality and the possibility of pregnancy. OTC has potential for other applications, including restoring ovarian endocrine function beyond biological menopause. This is not without controversy but has led to some women considering undergoing the procedure for purposes of ovarian hormonal preservation (conservation of ovarian endocrine function). OTC is invasive, involves two surgical procedures with concomitant risks and can be costly. Understanding why women may consider and ultimately undergo OTC is timely, so that evidence-based and women-centred care can be provided.
METHODS
A pragmatic narrative qualitative design will be used. A purposive sample of women aged 18-45 who are considering, or have sought, OTC will be recruited over 1-year period. Potential participants will be approached via a clinic that offers OTC on a private basis or via social media.
ANALYSIS
Participant interviews will be audio and, if consented, video recorded. These will be conducted face-to-face or virtually. The recordings will be transcribed verbatim and analysed using a thematic analysis approach supported by NVivo software.
ETHICS AND DISSEMINATION
Ethical approval has been granted by the Institutional Ethical Review ERN_19-1578A. We expect to disseminate the findings of this study through journal articles, conference presentations and multimedia to public
Opportunities and Risks of UK Medical Device Reform.
No full textOBJECTIVES
To identify the potential opportunities and risks around future UK regulatory reform of medical devices.
DESIGN
A mixed methods approach, comprising a rapid literature review, one-to-one, semi-structured interviews with key stakeholders, a multidisciplinary stakeholder workshop, and a post-workshop survey.
SETTING
United Kingdom.
PARTICIPANTS
32 key stakeholders across the medical device sector were identified both from the public and private sectors.
RESULTS
Opportunities relating to regulatory independence were identified, including the potential to create and implement a regulatory framework that ensures availability of medical devices; innovation and investment potential; and safety to the citizens of the UK. The most significant risks identified included threats to the safety of individual patients and the wider health system arising from the delay in awaiting regulatory approval due to the shortage of approved bodies; and reduced competitiveness of UK market and device manufacturers. Recommendations were identified to mitigate risks, centred on harnessing broader cross-sector collaborations, promoting patient and public partnership, and maximizing international engagement.
CONCLUSIONS
The UK's medical device sector is at a time-critical juncture to construct a regulatory framework to navigate its exit of Europe and respond to Europe's transition to new medical device regulations whilst also addressing the ongoing demand for rapid approval for new devices in response to the global pandemic. Investment, capacity-building, and international engagement will play a central role in mitigating risks and maximizing opportunities for medical device regulation
Non-pharmacological therapies for postviral syndromes, including Long COVID: a systematic review and meta-analysis protocol.
No full textINTRODUCTION
Postviral syndromes (PVS) describe the sustained presence of symptoms following an acute viral infection, for months or even years. Exposure to the SARS-CoV-2 virus and subsequent development of COVID-19 has shown to have similar effects with individuals continuing to exhibit symptoms for greater than 12 weeks. The sustained presence of symptoms is variably referred to as 'post COVID-19 syndrome', 'post-COVID condition' or more commonly 'Long COVID'. Knowledge of the long-term health impacts and treatments for Long COVID are evolving. To minimise overlap with existing work in the field exploring treatments of Long COVID, we have only chosen to focus on non-pharmacological treatments.
AIMS
This review aims to summarise the effectiveness of non-pharmacological treatments for PVS, including Long COVID. A secondary aim is to summarise the symptoms and health impacts associated with PVS in individuals recruited to treatment studies.
METHODS AND ANALYSIS
Primary electronic searches will be performed in bibliographic databases including: Embase, MEDLINE, PyscINFO, CINAHL and MedRxiv from 1 January 2001 to 29 October 2021. At least two independent reviewers will screen each study for inclusion and data will be extracted from all eligible studies onto a data extraction form. The quality of all included studies will be assessed using Cochrane risk of bias tools and the Newcastle-Ottawa grading system. Non-pharmacological treatments for PVS and Long COVID will be narratively summarised and effect estimates will be pooled using random effects meta-analysis where there is sufficient methodological homogeneity. The symptoms and health impacts reported in the included studies on non-pharmacological interventions will be extracted and narratively reported.
ETHICS AND DISSEMINATION
This systematic review does not require ethical approval. The findings from this study will be submitted for peer-reviewed publication, shared at conference presentations and disseminated to both clinical and patient groups.
PROSPERO REGISTRATION NUMBER
The review will adhere to this protocol which has also been registered with PROSPERO (CRD42021282074)
Greyzone myocardial fibrosis and ventricular arrhythmias in patients with a left ventricular ejection fraction >35.
No full textAIMS
To determine whether myocardial fibrosis and greyzone fibrosis (GZF) on cardiovascular magnetic resonance (CMR) is associated with ventricular arrhythmias in patients with coronary artery disease (CAD) and a left ventricular ejection fraction (LVEF) >35%.
METHODS AND RESULTS
In this retrospective study of CAD patients, GZF mass using the 3SD method (GZF3SD) and total fibrosis mass using the 2SD method (TF2SD) on CMR were assessed in relation to the primary, combined endpoint of sudden cardiac death, ventricular tachycardia, ventricular fibrillation, or resuscitated cardiac arrest. Among 701 patients [age: 65.8 ± 12.3 years (mean ± SD)], 28 (3.99%) patients met the primary endpoint over 5.91 years (median; interquartile range 4.42-7.64). In competing risks analysis, a GZF3SD mass ≥5.0 g was strongly associated with the primary endpoint [subdistribution hazard ratio (sHR): 17.4 (95% confidence interval, CI 6.64-45.5); area under receiver operator characteristic curve (AUC): 0.85, P < 0.001]. A weaker association was observed for TF2SD mass ≥23 g [sHR 10.4 (95% CI 4.22-25.8); AUC: 0.80, P < 0.001]. The range of sHRs for GZF3SD mass (1-527) was wider than for TF2SD mass (1-37.6).
CONCLUSIONS
In CAD patients with an LVEF >35%, GZF3SD mass was strongly associated with the arrhythmic endpoint. These findings hold promise for its use in identifying patients with CAD and an LVEF >35% at risk of arrhythmic events
Hypoxia Increases the Potential for Neutrophil-mediated Endothelial Damage in Chronic Obstructive Pulmonary Disease.
No full textPatients with chronic obstructive pulmonary disease (COPD) experience excess cardiovascular morbidity and mortality, and exacerbations further increase the risk of such events. COPD is associated with persistent blood and airway neutrophilia and systemic and tissue hypoxia. Hypoxia augments neutrophil elastase release, enhancing capacity for tissue injury. To determine whether hypoxia-driven neutrophil protein secretion contributes to endothelial damage in COPD. The healthy human neutrophil secretome generated under normoxic or hypoxic conditions was characterized by quantitative mass spectrometry, and the capacity for neutrophil-mediated endothelial damage was assessed. Histotoxic protein concentrations were measured in normoxic versus hypoxic neutrophil supernatants and plasma from patients experiencing COPD exacerbation and healthy control subjects. Hypoxia promoted PI3Kγ-dependent neutrophil elastase secretion, with greater release seen in neutrophils from patients with COPD. Supernatants from neutrophils incubated under hypoxia caused pulmonary endothelial cell damage, and identical supernatants from COPD neutrophils increased neutrophil adherence to endothelial cells. Proteomics revealed differential neutrophil protein secretion under hypoxia and normoxia, and hypoxia augmented secretion of a subset of histotoxic granule and cytosolic proteins, with significantly greater release seen in COPD neutrophils. The plasma of patients with COPD had higher content of hypoxia-upregulated neutrophil-derived proteins and protease activity, and vascular injury markers. Hypoxia drives a destructive "hypersecretory" neutrophil phenotype conferring enhanced capacity for endothelial injury, with a corresponding signature of neutrophil degranulation and vascular injury identified in plasma of patients with COPD. Thus, hypoxic enhancement of neutrophil degranulation may contribute to increased cardiovascular risk in COPD. These insights may identify new therapeutic opportunities for endothelial damage in COPD
Assessment of Textbook Oncologic Outcomes Following Proctectomy for Rectal Cancer.
No full textBACKGROUND
Outcomes of rectal adenocarcinoma vary considerably. Composite "textbook oncologic outcome" (TOO) is a single metric that estimates optimal clinical performance for cancer surgery.
METHODS
Patients with stage II/III rectal adenocarcinoma who underwent single-agent neoadjuvant chemoradiation and proctectomy within 5-12 weeks were identified in the National Cancer Database (NCDB). TOO was defined as achievement of negative distal and circumferential resection margin (CRM), retrieval of ≥ 12 nodes, no 90-day mortality, and length of stay (LOS) < 75th percentile of corresponding year's range. Multivariable logistic regression was used to identify predictors of TOO.
RESULTS
Among 318,225 patients, 8869 met selection criteria. Median age was 62 years (IQR 54-71), and 5550 (62.6%) were males. Low anterior resection was the most common procedure (LAR, 6,037 (68.1%) and 3084 (34.8%) were treated at a high-volume center (≥ 20 rectal resections/year). TOO was achieved in 3967 patients (44.7%). Several components of TOO were achieved commonly, including negative CRM (87.4%), no 90-day mortality (98.0%), no readmission (93.0%), and no prolonged hospitalization (78.8%). Logistic regression identified increasing age, non-private insurance, low-volume centers, open approach, Black race, Charlson score ≥ 3, and abdominoperineal resection (APR) as predictors of failure to achieve TOO. Over time, TOOs were attained more commonly which correlated with increased minimally invasive surgery (MIS) adoption. TOO achievement was associated with improved survival.
CONCLUSIONS
Rectal adenocarcinoma patients achieve TOO uncommonly. Treatment at high-volume centers and MIS approach were among modifiable factors associated with TOO in this study
UK 2022 Consensus on Normal Tissue Dose-Volume Constraints for Oligometastatic, Primary Lung and Hepatocellular Carcinoma Stereotactic Ablative Radiotherapy.
No full textThe use of stereotactic ablative radiotherapy (SABR) in the UK has expanded over the past decade, in part as the result of several UK clinical trials and a recent NHS England Commissioning through Evaluation programme. A UK SABR Consortium consensus for normal tissue constraints for SABR was published in 2017, based on the existing literature at the time. The published literature regarding SABR has increased in volume over the past 5 years and multiple UK centres are currently working to develop new SABR services. A review and update of the previous consensus is therefore appropriate and timely. It is hoped that this document will provide a useful resource to facilitate safe and consistent SABR practice
Changing concepts in heart muscle disease: the evolving understanding of hypertrophic cardiomyopathy.
No full textSixty years ago, hypertrophic cardiomyopathy (HCM) was considered a rare lethal disease that affected predominantly young adults and for which there were few treatment options. Today, it is recognised to be a relatively common disorder that presents throughout the life course with a heterogeneous clinical phenotype that can be managed effectively in the majority of individuals. A greater awareness of the condition and less reluctance from healthcare practitioners to make the diagnosis, coupled with improvements in cardiac imaging, including greater use of artificial intelligence and improved yields from screening efforts, have all helped facilitate a more precise and timely diagnosis. This enhanced ability to diagnose HCM early is being paired with innovations in treatment, which means that the majority of patients receiving a contemporary diagnosis of HCM can anticipate a normal life expectancy and expect to maintain a good functional status and quality of life. Indeed, with increasing translation of molecular genetics from bench to bedside associated with a growing number of randomised clinical trials of novel therapies aimed at ameliorating or perhaps even preventing the disease, the next chapter in the story for HCM will provide much excitement and more importantly, offer much anticipated reward for our patients
Angiotensin-converting enzyme inhibitors and risk of age-related macular degeneration in individuals with hypertension.
No full textAIM
Several observational studies have examined the potential protective effect of angiotensin-converting enzyme inhibitor (ACE-I) use on the risk of age-related macular degeneration (AMD) and have reported contradictory results owing to confounding and time-related biases. We aimed to assess the risk of AMD in a base cohort of patients aged 40 and above with hypertension among new users of ACE-I compared to an active comparator cohort of new users of calcium channel blockers (CCB) using data obtained from IQVIA Medical Research database, a primary care database in the UK.
METHODS
In this study, 53,832 and 43,106 new users of ACE-I and CCB were included between 1995 and 2019, respectively. In an on-treatment analysis, patients were followed up from the time of index drug initiation to the date of AMD diagnosis, loss to follow-up, discontinuation or switch to the comparator drug. A comprehensive range of covariates were used to estimate propensity scores to weight and match new users of ACE-I and CCB. Standardized mortality ratio (SMR) weighted Cox proportional hazards model was used to estimate hazard ratios (HRs) of developing AMD.
RESULTS
During a median follow-up of 2 years (interquartile range 1-5 years), the incidence rate of AMD was 2.4 (95% CI 2.2-2.6) and 2.2 (2.0-2.4) per 1,000 person-years among the weighted new users of ACE-I and CCB, respectively. There was no association of ACE-I use on the risk of AMD compared to CCB use in either the propensity score weighted or matched, on-treatment analysis (aHR: 1.07 (95% CI 0.90-1.27) and 0.87 (0.71-1.07) respectively).
CONCLUSION
We found no evidence that the use of ACE-I is associated with risk of AMD in patients with hypertension