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ATTUNE: A groundbreaking UK research programme combining art and science to address adverse childhood experiences. Discover how this initiative is revolutionising mental health support for young people across five regions.
The DESTINIES Study: an online Delphi study to build international consensus on the medical conditions and procedures that confer immunosuppression and their respective COVID-19 risk profiles
Background: The lack of international consensus on defining and categorising immunosuppression has undermined disease surveillance and patient care, particularly during the COVID-19 pandemic. To address this, a global expert panel was recruited to join the eDElphi STudy to fully defiINe and COVID-risk stratify ImmunosupprESsion (DESTINIES) and develop a COVID risk-stratified digital phenotype for ‘adult immunosuppression’ (the DESTINIES phenotype). Methods: Panellists were presented with all medical diagnoses and procedures cited in prevailing immunosuppressed definitions; they evaluated their appropriateness for the DESTINIES phenotype and their risks for severe COVID-19 outcomes through anonymous online questionnaires and discussion. Panel agreement with a series of clinical statements were also assessed; statements incorporated longstanding disputes, including variables that could reverse immunosuppression. Each round of data collection informed and refined a draft phenotype until final ratification. This study was active between May and September 2024. Findings: Sixty-four experts from four continents and 12 international agencies completed two rounds of consensus questionnaire, a discussion group and ratifying vote. Panellists identified candidates posing higher (e.g. Transplantation, Primary Immunodeficiency) and lower COVID-19 risk (e.g. Anorexia nervosa, Cerebral spinal fluid leak) but disagreed on the categorisation of others (e.g. Asplenia, Immune-mediated Inflammatory Disease). Consensus was reached on ten clinical statements, notably removing Drug-managed HIV and Cancer remission from consideration as immunosuppressed. The DESTINIES phenotype was ratified with near unanimous support (94%) for implementation in surveillance. Interpretation: Pending validation, the DESTINIES phenotype provides a clinically meaningful, internationally ratified and digitally practical method for identifying and COVID-19 risk-stratifying adult immunosuppressed patients in healthcare data. Funding: This work was funded by the UK Medical Research Council and EMIS Health.
Truthful communication of mental science: pledge to our patients and profession.
Recent changes in US government priorities have serious negative implications for science that will compromise the integrity of mental health research, which focuses on vulnerable populations. Therefore, as editors of mental science journals and custodians of the academic record, we confirm with conviction our collective commitment to communicating the truth.
Induction of labour versus standard care to prevent shoulder dystocia in fetuses suspected to be large for gestational age in the UK (the Big Baby trial): a multicentre, open-label, randomised controlled trial.
BACKGROUND: The benefits and harms of early induction of labour to reduce shoulder dystocia in fetuses suspected to be large for gestational age (LGA) are uncertain. We aimed to investigate whether early induction of labour is associated with a reduced risk of shoulder dystocia compared with standard care. METHODS: In this open-label, randomised controlled phase 3 trial, women aged ≥18 years with a suspected LGA fetus (estimated fetal weight >90th customised percentile) as identified by ultrasound scan between 35 weeks and 0 days (35+0 weeks) of gestation and 38+0 weeks' gestation, recruited from 106 hospitals across England, Scotland, and Wales in the UK, were randomly assigned (1:1) by web app to standard care or induction of labour between 38+0 weeks' gestation and 38+0 weeks' gestation using minimisation, balancing site, estimated fetal weight percentile (≤95th EFW percentile or >95th EFW percentile), and maternal age (≤35 years or >35 years). Key exclusion criteria included drug-treated diabetes, gestational diabetes, and elective caesarean section or induction already planned or indicated for any reason. Our primary outcome was incidence of shoulder dystocia, assessed by a masked independent expert adjudication panel who reviewed participants' delivery notes. Induction of labour was anticipated to result in birth 10·5 days earlier with a 300 g lower birthweight on average than standard care. We did an intention-to-treat (ITT) analysis in all participants for whom we had primary outcome data, and a per-protocol analysis in participants in the induction group who went into labour or were induced at 38+0 to 38+0 weeks' gestation versus participants in the standard care group who had not started labour, been induced, or had an elective caesarean section before 38+0 weeks' gestation. This study was registered with ISRCTN (18229892) and is no longer recruiting. FINDINGS: Between June 8, 2018, and Oct 25, 2022, 2893 women were randomly assigned to induction of labour (n=1447) or standard care (n=1446); the trial was terminated before the target of 4000 participants was reached on advice of the data monitoring committee following the lower-than-expected incidence of shoulder dystocia in the standard care group. Two participants in the induction group and seven in the standard care group had missing data for the primary outcome and were excluded from the ITT analysis. In the ITT analysis, 33 (2·3%) of 1445 babies in the induction group versus 44 (3·1%) of 1439 in the standard care group had shoulder dystocia (risk ratio [RR] 0·75 [95% CI 0·51-1·09]; p=0·14) with a mean difference of -6·0 days' (95% CI -6·3 to -5·6) gestation and -163·6 g (-190·0 to -137·1) birthweight between trial groups. 355 (24·6%) of 1446 mothers in the standard care group were induced, delivered, or went into labour at or before 38+0 weeks' gestation. In the per-protocol analysis, 27 (2·3%) of 1180 babies in the induction group versus 40 (3·7%) of 1074 in the standard care group had shoulder dystocia (RR 0·62 [0·41-0·92]; p=0·019), and there was a mean difference of -8·1 days' (-8·4 to -7·9) gestation and -213·3 g (-242·0 to -184·6) birthweight between trial groups. One neonatal death occurred from perinatal asphyxia after shoulder dystocia in the standard care group, and one neonatal death occurred following sepsis and congenital pneumonia in the induction group. 88 (6·1%) of 1447 mothers in the induction group had an adverse event versus 108 (7·5%) of 1446 in the standard care group (RR 0·81 [0·62 to 1·06]; p=0·13). Similar numbers of serious adverse events were reported in both groups. INTERPRETATION: No significant difference in incidence of shoulder dystocia was found between trial groups in the ITT analysis, probably due to the high proportion of earlier-than-expected deliveries in the standard care group reducing the intended between-group differences in gestational age and birthweight. However, in the per-protocol analysis, compared with all deliveries after 38+0 weeks' gestation, induction of labour between 38+0 weeks' gestation and 38+0 weeks' gestation did show a significant reduction in shoulder dystocia. This study provides pregnant women with suspected LGA fetuses and their clinicians important information about choices and decision making for timing and mode of birth. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme.
Is It Cost-Effective to Induce Labour Early to Prevent Shoulder Dystocia? Evidence From the Big Baby Trial.
BACKGROUND: The cost-effectiveness of early induction of labour for suspected large-for-gestational-age foetuses to prevent shoulder dystocia is unknown. METHODS: A within-trial economic evaluation of induction at 38 + 0 to 38 + 4 weeks' gestation for suspected large-for-gestational-age foetuses. Resource use and costs were measured to 6 months postpartum. We estimated incremental cost per case of shoulder dystocia prevented and incremental cost per maternal quality-adjusted life year (QALY) gained. We collected data for planned caesarean sections in a cohort study. FINDINGS: Mean combined woman and infant costs in the induction arm were £89 (95% confidence interval (CI): -£79, £257) higher than the standard care arm, driven by increased neonatal costs. The incremental cost of preventing one case of shoulder dystocia was £11 879 and the incremental cost per maternal QALY gained was £39 518. The probability of early induction being cost-effective was 0.65 at a cost-effectiveness threshold of £20 000 per case of shoulder dystocia prevented, but 0.36 at a cost-effectiveness threshold of £20 000 per maternal QALY gained. The cohort study found the mean cost was £310 (95% CI: £74, £545) higher in the induction arm than in the planned caesarean group. INTERPRETATION: Early induction of labour increased neonatal care costs. It is not a cost-effective approach when effects are restricted to maternal QALYs. Planned caesarean section might be cost-saving when compared to early induction, although we did not assess longer-term effects such as an increased risk of repeat caesarean sections. Assessments of long-term effects on the mother and infant should be incorporated into future studies. TRIAL REGISTRATION: ISRCTN18229892.
Prediction Models for Maternal and Offspring Short- and Long-Term Outcomes Following Gestational Diabetes: A Systematic Review.
OBJECTIVES: Gestational diabetes mellitus (GDM), affecting one in seven pregnant women worldwide, can have short- and long-term adverse outcomes for both the mother and her baby. Despite a raft of prognostic models aiming to predict adverse GDM outcomes, very few have impacted clinical practice. This systematic review summarizes and critically evaluates prediction models for GDM outcomes, to identify promising models for further evaluation. METHODS: We searched EMBASE, MEDLINE, Web of Science, CINAHL, and CENTRAL for studies that reported the development or validation of predictive models for GDM outcomes in mother or offspring (PROSPERO: CRD42023396697). RESULTS: Sixty-four articles detailing 103 developed and 12 validated models were included in this review. Of these, 45% predicted long term, 31% birth, and 23% pregnancy outcomes. Most models (87%) had a high risk of bias, lacking sufficient outcome events, internal validation, or proper calibration. Only eight models were found at low risk of bias. CONCLUSIONS: Our findings highlight a gap in rigorously developed prediction models for adverse GDM outcomes. There is a need to further validate existing models and evaluate their clinical utility to generate risk prediction tools capable of improving clinical decision-making for women with GDM and their children.
Investigating the association between recorded smoking cessation interventions and smoking cessation in people living with cardiovascular disease using UK general practice data.
BACKGROUND: Smoking significantly increases the risk of cardiovascular diseases (CVD), yet quitting smoking after diagnosis of CVD can mitigate further negative impacts. However, encouraging smoking cessation remains a challenge for General Practitioners (GPs) with concerns regarding mental health. Since 2004, the UK's Quality and Outcomes Framework (QOF) incentivises GP smoking cessation support. Despite this, a significant proportion of individuals diagnosed with CVD continue to smoke after diagnosis. This study aims to investigate the frequencies and types of smoking cessation interventions offered to people with CVD (defined as coronary heart disease (CHD) and stroke), with and without mental illness, and assess their association with successful cessation. METHODS: This retrospective cohort study examined adults diagnosed with CHD or stroke using the QResearch general practice records database (1996-2019). We evaluated the frequency and types of smoking cessation interventions documented in patients' records, including education, brief interventions, pharmacological support, referrals, and counselling. Logistic regression assessed the relationship between recorded interventions and smoking abstinence rates within the one-year post-index event, considering QOF incentives and mental illness presence. RESULTS: While smoking cessation education was common in general practice settings, prescriptions for nicotine replacement therapy or other evidence-based interventions were comparatively low. CHD and stroke populations showed a significant association between any intervention and smoking cessation within one year (CHD: OR 1.41, 95% CI 1.36-1.45; stroke: OR 1.49, 95% CI 1.43-1.55). Education consistently correlated with higher cessation likelihoods, while other interventions were linked to lower rates. Individuals with common and serious mental illness were less likely to quit, irrespective of intervention. QOF implementation led to increased documentation of advice but not intensive support or treatment, with pre-QOF interventions associated with significantly increased abstinence likelihoods (CHD: OR 5.09, 95% CI 4.84-5.35; stroke: OR 4.44, 95% CI 4.07-4.86). CONCLUSIONS: Financial incentives for GP smoking cessation support outlined in QOF may not suffice to enhance methods that are more efficacious or improve cessation rates, especially among people with mental illness. Practical strategies that provide tangible support and treatment are needed for CVD patients, including those with mental illness, to facilitate successful cessation.
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.
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.
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.