Search results

Estimating the potential impact of the UK salt reduction targets on cardiovascular health outcomes in adults: a modelling study

A service evaluation of the implementation of a novel digital intervention for hypertension self-monitoring and management system in primary care (SHIP): protocol for a mixed methods study.

BACKGROUND: Hypertension is a key risk factor for death and disability, and blood pressure reduction is associated with significant reductions in cardiovascular risk. Large trials have shown that interventions including self-monitoring of blood pressure can reduce blood pressure but real-world data from wider implementation are lacking. AIM: The self-monitoring and management service evaluation in primary care (SHIP) study will evaluate a novel digital intervention for hypertension management and medication titration platform ("Hypertension-Plus") that is currently undergoing initial implementation into primary care in several parts of the UK. METHODS AND ANALYSES: The study will use a mixed methods approach including both quantitative analysis of anonymised electronic health record data and qualitative analyses of interview and customer support log data. Pseudonymised data will be extracted from electronic health records and outcomes compared between those using the digital intervention and their own historical data, as well as to those not registered to the system. The primary outcome will be difference in systolic blood pressure in the 12 months before and after implementation. A further analysis will utilise self-monitored blood pressure data from the Hypertension-Plus system itself. Semi-structured qualitative interviews will be completed with implementation and clinical leads, staff and patients in six general practices located in two different geographical areas in England. Informed by the non-adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework, our analysis will identify the challenges to successful implementation and sustainability of the digital intervention in routine clinical practice and in patients' homes. ETHICS AND DISSEMINATION: The analyses of pseudonymised data were assessed by the sponsor (The University of Oxford) as service evaluation not requiring individual consent and hence did not require ethical approval. Ethics approval for the qualitative analyses was provided by Wales REC 4 (21/WA/0280) and individual written informed consent will be gained for all participants. Results will be published in peer-reviewed journals, presented at national and international conferences and disseminated via patient and health service organisations. DISCUSSION: This study will provide an in-depth analysis of the impact and acceptance of initial implementation of a novel digital intervention, enhancing our understanding and supporting more effective implementation of telemonitoring based hypertension management systems for blood pressure control in England.

Long-Term Blood Pressure Control After Physician Optimised Postpartum Blood Pressure Self-Management: The POP-HT Randomised Clinical Trial

Understanding Measurement of Postural Hypotension (UMPH): a nationwide survey of general practice in England.

Background Postural hypotension (PH) is associated with excess mortality, falls and cognitive decline. PH is poorly recorded in routine general practice (practice) records. Few practice studies have explored measurement and diagnosis of PH. Aim To understand how PH is measured, diagnosed and managed in practice. Design and setting Online survey of practice staff in England. Method Clinical Research Networks distributed the survey to practices, seeking individual responses from any clinical staff involved in routine blood pressure (BP) measurement. Responses were analysed according to role and demographic data using descriptive statistics. Multivariable modelling of undertaking postural BP measurements was performed. Results 703 responses were received from 243 practices (mean practice-level response rate 17%). Half (362; 51%) of respondents were doctors, 196 (28%) practice nurses and 77 (11%) healthcare assistants (HCAs). Eight percent did not routinely check for PH, usually citing time constraints. For the remaining 92%, postural symptoms were the predominant reason for checking (97% respondents); only 24% cited any other guideline indication for PH testing. 77% used sit-to-stand BP measurements; only 25% measured standing BP for more than one minute. On regression modelling, other professionals tested less for PH than doctors (Odds ratios: nurses 0.323 (95% confidence interval 0.117 to 0.894), HCAs 0.102 (0.032 to 0.325), pharmacists 0.986 (0.024 to 0.412)). Conclusion Awareness of reasons, besides symptoms, and adherence to guidelines for PH testing, are low. Time is the key barrier to improved testing for PH. Clarity on pragmatic methods of measuring PH in practice would also facilitate measurement uptake.

Does ADHD treatment inefficacy question its diagnostic validity? – Authors' reply

Comparative cardiovascular safety of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis.

BACKGROUND: Concerns about the cardiovascular safety of medications used for the treatment of attention-deficit hyperactivity disorder (ADHD) remain. We aimed to compare the effects of pharmacological treatments for ADHD on haemodynamic values and electrocardiogram (ECG) parameters in children, adolescents, and adults. METHODS: For this systematic review and network meta-analysis, we searched 12 electronic databases, including Cochrane CENTRAL, Embase, PubMed, and the WHO International Clinical Trials Registry Platform, from database inception to Jan 18, 2024, for published and unpublished randomised controlled trials comparing amphetamines, atomoxetine, bupropion, clonidine, guanfacine, lisdexamfetamine, methylphenidate, modafinil, or viloxazine against each other or placebo. Primary outcomes were change in systolic blood pressure (SBP) and diastolic blood pressure (DBP), measured in mm Hg, and pulse, measured in beats per minute, at timepoints closest to 12 weeks, 26 weeks, and 52 weeks. Summary data were extracted and pooled in random-effects network meta-analyses. Certainty of evidence was assessed with the Confidence in Network Meta-Analysis (CINeMA) framework. This study was registered with PROSPERO, CRD42021295352. Before study initiation, we contacted representatives of a UK-based charity of people with lived experience of ADHD-the ADHD Foundation-regarding the relevance of the topic and the appropriateness of the outcomes chosen. FINDINGS: 102 randomised controlled trials with short-term follow-up (median 7 weeks [IQR 5-9]) were included, encompassing 13 315 children and adolescents (aged ≥5 years and <18 years; mean age 11 years [SD 3]; of available data, 9635 [73%] were male and 3646 [27%] were female; of available data, 289 [2%] were Asian, 1719 [15%] were Black, and 8303 [71%] were White) and 9387 adults (≥18 years, mean age 35 years [11]; of available data, 5064 [57%] were male and 3809 [43%] were female; of available data, 488 [6%] were Asian, 457 [6%] were Black, and 6372 [79%] were White). Amphetamines, atomoxetine, lisdexamfetamine, methylphenidate, and viloxazine led to increments in haemodynamic values in children and adolescents, adults, or both. In children and adolescents, mean increase against placebo ranged from 1·07 (95% CI 0·36-1·79; moderate CINeMA confidence) with atomoxetine to 1·81 (1·05-2·57; moderate) with methylphenidate for SBP; from 1·93 (0·74-3·11; high) with amphetamines to 2·42 (1·69-3·15; low) with methylphenidate for DBP; and from 2·79 (1·05-4·53; moderate) with viloxazine to 5·58 (4·67-6·49; high) with atomoxetine for pulse. In adults, mean increase against placebo ranged from 1·66 (95% CI 0·38-2·93; very low) with methylphenidate to 2·3 (0·66-3·94; very low) with amphetamines for SBP; from 1·60 (0·29-2·91; very low) with methylphenidate to 3·07 (0·69-5·45; very low) with lisdexamfetamine for DBP; and from 4·37 (3·16-5·59; very low) with methylphenidate to 5·8 (2·3-9·3; very low) with viloxazine for pulse. Amphetamines, lisdexamfetamine, or methylphenidate were not associated with larger increments in haemodynamic values compared with atomoxetine or viloxazine in either children and adolescents or adults. Guanfacine was associated with decrements in haemodynamic values in children and adolescents (mean decrease against placebo of -2·83 [95% CI -3·8 to -1·85; low CINeMA confidence] in SBP, -2·08 [-3 to -1·17; low] in DBP, and -4·06 [-5·45 -2·68; moderate] in pulse) and adults (mean decrease against placebo of -10·1 [-13·76 to -6·44; very low] in SBP, -7·73 [-11·88 to -3·58; very low] in DBP, and -6·83 [-10·85 to -2·81; very low] in pulse). Only four RCTs informed on effects in the medium term and none on the long term. INTERPRETATION: Practitioners should monitor blood pressure and pulse in patients with ADHD treated with any pharmacological intervention, and not stimulants only. Given the short duration of available randomised controlled trials, new research providing insights on the causal effects of ADHD medications on cardiovascular parameters in the longer term should be funded. FUNDING: National Institute for Health and Care Research.

Reducing inequalities through greater diversity in clinical trials - As important for medical devices as for drugs and therapeutics.

In medicine and public health, the randomised controlled trial (RCT) is generally considered the key generator of 'gold standard' evidence. However, basic and clinical research and trials are often unrepresentative of real-world populations. Recruiting insufficiently diverse cohorts of participants in trials (e.g. in terms of socioeconomic status, racial and ethnic background, or sex and gender) may not only overstate the general effectiveness of a technology; it may also actively increase health inequalities. We highlight some general issues in this domain, before discussing several specific illustrative examples in the context of medical devices. High quality evidence on factors that would improve trial recruitment is extremely limited. There is a clear need for research on candidate strategies for improving recruitment of under-represented groups in RCTs. These could include, for example, offering various forms of financial incentives; non-monetary incentives, such as preferential access to the technologies that are being tested if they are found to be effective; and various types of informational messages and nudges; as well as involvement of community partners and champions in the recruitment process. Ideally, recruitment practices should ultimately be based on evidence generated from RCTs. Studies Within a Trial (SWAT), where randomised experiments are built into the actual recruitment processes in RCTs, are an ideal way to gain this evidence. SWAT studies are seeing an increase in traction, as indicated by funding streams in bodies such as the UK-based NIHR. Making greater funding available for studies of this kind is needed to improve the evidence base on how best to improve diversity in trial recruitment.

Clinical care for patients at risk of psychosis related violence.

Prediction models of gestational diabetes short- and longer-term outcomes: A systematic review

Homelessness, psychiatric disorders and risk of suicide and self-harm A population based cohort study

Intervention design and adherence to Mediterranean diet in the Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat (CADIMED) randomized trial.

Effective interventions targeting modifiable cardiovascular disease (CVD) risk factors, such as diet, are urgently needed. The Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat study hypothesizes that eliminating red and processed meat in the context of a Mediterranean diet (MD) will significantly modify circulating low-density lipoprotein cholesterol concentration and the fatty acid profile compared to general CVD prevention advice. Here we describe the intervention design and summarize baseline dietary intakes (mean ± standard deviation) related to MD adherence and red/processed meat intakes in a sample of 81 participants. The Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat study is a two-arm, 8-week parallel randomized controlled intervention trial involving a final sample of 156 adults (≥18 years) with dyslipidemia (not undergoing pharmacological treatment) recruited from healthcare and community settings in Granada (Spain). The primary outcome will assess changes in circulating low-density lipoprotein cholesterol and the fatty acid profile, whilst secondary outcomes will measure changes in CVD-related metabolites/biomarkers, gut microbiome, diet/lifestyle, and intervention feasibility/acceptability. Preliminary findings indicate low MD adherence (Mediterranean Diet Adherence Screener score 7.6 ± 1.9), and high consumption of red and processed meat (1.04 ± 0.90) servings/d). These results underscore the need for targeted dietary interventions to address the growing burden of dyslipidemia and CVD. If successful, this intervention holds potential for scalability and significant impact on public health, dietary guidelines, and advancements in nutrition science by improving MD adherence and reducing CVD risk factors in adults with dyslipidemia.

Improving usability of Electronic Health Records in a UK Mental Health setting: a feasibility study.

BACKGROUND: Electronic Health Records (EHRs) can help clinicians to plan, document and deliver care for patients in healthcare services. When used consistently, EHRs can advance patient safety and quality, and reduce clinician's workload. However, usability problems can make it difficult for clinicians to use EHRs effectively, which can negatively impact both healthcare professionals and patients. OBJECTIVE: To improve usability of EHRs within a mental health service in the UK. METHODS: This was a feasibility study conducted with two mental health teams. A mixed-methods approach was employed. Focus group discussions with clinicians identified existing usability problems in EHRs and changes were made to address these problems. Updated EHR assessment forms were evaluated by comparing the following measures pre and post changes: (1) usability testing to monitor time spent completing and duplicating patient information in EHRs, (2) clinician's experience of using EHRs, and (3) proportion of completed EHR assessment forms. RESULTS: Usability testing with clinicians (n = 3) showed that the time taken to complete EHR assessment forms and time spent duplicating patient information decreased. Clinician's experience of completing EHR assessment forms also significantly improved post changes compared to baseline (n = 71; p 

COVID-19: The dark side and the sunny side for patient safety

Does duration of donor brain injury affect outcome after orthotopic pediatric heart transplantation?

EFFECT OF ANTIBODIES AGAINST A STRUCTURE CHEMICALLY DIFFERENT FROM LYMPHOCYTE MEMBRANE - BETA 2 MICROGLOBULIN

Presence of HL-A antigens and beta2-microglobulin in tubular proteinuria.

Human migration inhibition factor: a preliminary report.

Postscript: insights for policymakers and practitioners

CHILDREN'S EXPERIENCES OF WELFARE IN MODERN BRITAIN Introduction

Paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN): a randomised, double-blind, phase 3 trial

Background: Paramedics frequently administer analgesic medications for pain following trauma. Morphine is the most commonly administered strong analgesic. However, it may not be the best option as it may lower blood pressure, depress respiration and there is a risk of dependency. Ketamine might be a better option due to speed of onset and favourable side-effect profile. We sought to compare clinical effectiveness of paramedic administered ketamine and morphine in patients with severe pain following trauma. Methods: PACKMaN was a double-blinded, randomised controlled, superiority trial, conducted in two regional ambulance services in the UK. Eligible patients were 16 years of age or over, had an acute injury, and articulated a pain score of 7 or greater on a 0–10 numeric rating score (NRS). We excluded pregnant patients, prisoners, those unable to articulate a pain score and anyone lacking capacity. The randomisation list prepared by the study programmer, utilised a permuted, unstratified, block randomisation system (variable size blocks) to achieve an overall ratio of 1:1 control (morphine): intervention (ketamine). Treatment packs were identical in appearance, apart from their unique sequential number. Individual participant randomisation occurred when the attending paramedic opened the treatment pack. The maximum available dose of morphine was 20 mg while the maximum available dose of ketamine was 30 mg. The treating paramedic administered the trial drug slowly, in regular small aliquots, via the intravenous (or intraosseous) route, titrating treatment until the patient reported adequate analgesia or requested that treatment stop due to undesired side effects. Timing of drug administration was not prespecified. The primary outcome was the Sum of Pain Intensity Difference (SPID) score on arrival to the hospital, calculated using patient reported NRS scores. Analysis was performed on an intention to treat basis. PACKMaN is registered with the International Clinical Trials Registry (ISRCTN14124474). Findings: PACKMaN recruited its first patient on 10/11/2021 and achieved its recruitment target on 16/05/2023. We randomised 449 participants: 219 (49%) received ketamine and 230 (51%) received morphine. The SPID score was 3.5 (SD 2.8) for ketamine and 3.4 (SD 3.0) for morphine. We found no significant difference in efficacy between drugs (adjusted mean difference 0.1, 95%CI −0.4 to 0.6, p = 0.74). There was no significant difference in the incidence of serious adverse events [4 (2%) ketamine; 8 (3%) morphine]. There were no treatment related deaths. Interpretation: Ketamine did not provide superior analgesia than morphine when used by paramedics to treat acute severe trauma pain. Unexpected adverse events occurred infrequently. Despite analgesia, many patients still experienced pain on arrival at hospital, highlighting the need for further research. Funding: PACKMaN was funded by the National Institute for Health and Care Research.