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Effect of antihypertensive deprescribing on hospitalisation and mortality: long-term follow-up of the OPTiMISE randomised controlled trial.
BACKGROUND: Deprescribing of antihypertensive medications is recommended for some older patients with low blood pressure and frailty. The OPTiMISE trial showed that this deprescribing can be achieved with no differences in blood pressure control at 3 months compared with usual care. We aimed to examine effects of deprescribing on longer-term hospitalisation and mortality. METHODS: This randomised controlled trial enrolled participants from 69 general practices across central and southern England. Participants aged 80 years or older, with systolic blood pressure less than 150 mm Hg and who were receiving two or more antihypertensive medications, were randomly assigned (1:1) to antihypertensive medication reduction (removal of one antihypertensive) or usual care. General practitioners and participants were aware of the treatment allocation following randomisation but individuals responsible for analysing the data were masked to the treatment allocation throughout the study. Participants were followed up via their primary and secondary care electronic health records at least 3 years after randomisation. The primary outcome was time to all-cause hospitalisation or mortality. Intention-to-treat analyses were done using Cox regression modelling. A per-protocol analysis of the primary outcome was also done, excluding participants from the intervention group who did not reduce treatment or who had medication reinstated during the initial trial 12-week follow-up period. This study is registered with the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT2016-004236-38) and the ISRCTN Registry (ISRCTN97503221). FINDINGS: Between March 20, 2017, and Sept 30, 2018, a total of 569 participants were randomly assigned. Of these, 564 (99%; intervention=280; control=284) were followed up for a median of 4·0 years (IQR 3·7-4·3). Participants had a mean age of 84·8 years (SD 3·4) at baseline and 273 (48%) were women. Medication reduction was sustained in 109 participants at follow-up (51% of the 213 participants alive in the intervention group). Participants in the intervention group had a larger reduction in antihypertensives than the control group (adjusted mean difference -0·35 drugs [95% CI -0·52 to -0·18]). Overall, 202 (72%) participants in the intervention group and 218 (77%) participants in the control group experienced hospitalisation or mortality during follow-up (adjusted hazard ratio [aHR] 0·93 [95% CI 0·76 to 1·12]). There was some evidence that the proportion of participants experiencing the primary outcome in the per-protocol population was lower in the intervention group (aHR 0·80 [0·64 to 1·00]). INTERPRETATION: Half of participants sustained medication reduction with no evidence of an increase in all-cause hospitalisation or mortality. These findings suggest that an antihypertensive deprescribing intervention might be safe for people aged 80 years or older with controlled blood pressure taking two or more antihypertensives. FUNDING: British Heart Foundation and National Institute for Health and Care Research.
Validation of an acute respiratory infection phenotyping algorithm to support robust computerised medical record-based respiratory sentinel surveillance, England, 2023.
IntroductionRespiratory sentinel surveillance systems leveraging computerised medical records (CMR) use phenotyping algorithms to identify cases of interest, such as acute respiratory infection (ARI). The Oxford-Royal College of General Practitioners Research and Surveillance Centre (RSC) is the English primary care-based sentinel surveillance network.AimThis study describes and validates the RSC's new ARI phenotyping algorithm.MethodsWe developed the phenotyping algorithm using a framework aligned with international interoperability standards. We validated our algorithm by comparing ARI events identified during the 2022/23 influenza season in England through use of both old and new algorithms. We compared clinical codes commonly used for recording ARI.ResultsThe new algorithm identified an additional 860,039 cases and excluded 52,258, resulting in a net increase of 807,781 cases (33.84%) of ARI compared to the old algorithm, with totals of 3,194,224 cases versus 2,386,443 cases. Of the 860,039 newly identified cases, the majority (63.7%) were due to identification of symptom codes suggestive of an ARI diagnosis not detected by the old algorithm. The 52,258 cases incorrectly identified by the old algorithm were due to inadvertent identification of chronic, recurrent, non-infectious and other non-ARI disease.ConclusionWe developed a new ARI phenotyping algorithm that more accurately identifies cases of ARI from the CMR. This will benefit public health by providing more accurate surveillance reports to public health authorities. This new algorithm can serve as a blueprint for other CMR-based surveillance systems wishing to develop similar phenotyping algorithms.
Unravelling Elements of Value of Healthcare and Assessing their Importance Using Evidence from Two Discrete-Choice Experiments in England.
BACKGROUND: Health systems are moving towards value-based care, implementing new care models that allegedly aim beyond patient outcomes. Therefore, a policy and academic debate is underway regarding the definition of value in healthcare, the inclusion of costs in value metrics, and the importance of each value element. This study aimed to define healthcare value elements and assess their relative importance (RI) to the public in England. METHOD: Using data from 26 semi-structured interviews and a literature review, and applying decision-theory axioms, we selected a comprehensive and applicable set of value-based elements. Their RI was determined using two discrete choice experiments (DCEs) based on Bayesian D-efficient DCE designs, with one DCE incorporating healthcare costs expressed as income tax rise. Respondent preferences were analysed using mixed logit models. RESULTS: Six value elements were identified: additional life-years, health-related quality of life, patient experience, target population size, equity, and cost. The DCE surveys were completed by 402 participants. All utility coefficients had the expected signs and were statistically significant (p
CoDesign of a digital intervention for parents with bipolar disorder informed by integrated knowledge translation principles.
OBJECTIVES: To provide detailed information on the codesign of a digital intervention to support parents with bipolar disorder (BD) who have young children. Each step of this process is reported, as well as a detailed description of the final version of the intervention in line with the TIDieR framework. METHODS: Clinical experience and lived experience experts participated in online workshops, meetings, and remote feedback requests, informed by Integrated Knowledge Translation (IKT) principles. The IKT research group responded to each phase of recommendations from the knowledge users. RESULTS: Five clinical experience experts and six lived experience experts engaged with the codesign process. Their recommendations for principles, content, look, and feel, and functionality of the digital intervention were structured over five iterative phases. This led to a final implemented design that was identified by the clinical and lived experience experts (referred to together as the knowledge users group) as genuinely reflecting their input. CONCLUSIONS: The IKT principles offer an accessible structure for engaging with clinical and lived experience experts throughout a codesign process, in this case for a digital intervention for parents with BD. The resulting intervention is described in detail for transparency to aid further evaluation and development and to help other teams planning codesign approaches to intervention development.
Early findings from the NHS Type 2 Diabetes Path to Remission Programme: a prospective evaluation of real-world implementation.
BACKGROUND: Randomised controlled trials have shown that total diet replacement (TDR) can lead to remission of type 2 diabetes. In 2019, the English National Health Service (NHS) committed to establishing a TDR-based interventional programme delivered at scale within real-world environments; development followed of the NHS Type 2 Diabetes Path to Remission (T2DR) programme, a 12-month behavioural intervention to support weight loss involving an initial 3-month period of TDR. We assessed remission of type 2 diabetes for programme participants. METHODS: In this national prospective service evaluation of programme implementation, people in England aged 18-65 years and diagnosed with type 2 diabetes in the last 6 years were referred to the programme between programme launch on Sept 1, 2020, and Dec 31, 2022. Programme data were linked to the National Diabetes Audit to ascertain HbA1c measurements and glucose-lowering medication prescriptions. The primary outcome was remission of type 2 diabetes at 1 year, defined as two HbA1c measurements of less than 48 mmol/mol recorded at least 3 months apart with no glucose-lowering medications prescribed from 3 months before the first HbA1c measurement, and the second HbA1c measurement recorded 11-15 months after the programme start date. Outcomes were assessed in two ways: for all participants who started TDR on the 12-month programme before January, 2022, for whom there were no missing data; and for all participants who started TDR on the 12-month programme before January, 2022, and had completed the programme (ie, had a valid weight recorded at month 12) by Dec 31, 2022, for whom there were no missing data. FINDINGS: Between Sept 1, 2020, and Dec 31, 2022, 7540 people were referred to the programme; of those, 1740 started TDR before January, 2022, and therefore had a full 12-month opportunity to undertake the programme by the time of data extraction at the end of December, 2022. Of those who started TDR before January, 2022, 960 (55%) completed the programme (defined as having a weight recorded at 12 months). The mean weight loss for the 1710 participants who started the programme before January, 2022 and had no missing data was 8·3% (95% CI 7·9-8·6) or 9·4 kg (8·9-9·8), and the mean weight loss for the 945 participants who completed the programme and had no missing data was 9·3% (8·8-9·8) or 10·3 kg (9·7-10·9). For the subgroup of 710 (42%) of 1710 participants who started the programme before January, 2022, and also had two HbA1c measurements recorded, 190 (27%) had remission, with mean weight loss of 13·4% (12·3-14·5) or 14·8 kg (13·4-16·3). Of the 945 participants who completed the programme, 450 (48%) had two HbA1c measurements recorded; of these, 145 (32%) had remission, with mean weight loss of 14·4% (13·2-15·5) or 15·9 kg (14·3-17·4). INTERPRETATION: Findings from the NHS T2DR programme show that remission of type 2 diabetes is possible outside of research settings, through at-scale service delivery. However, the rate of remission achieved is lower and the ascertainment of data is more limited with implementation in the real world than in randomised controlled trial settings. FUNDING: None.
Neuroimaging and Clinical Findings in Healthy Middle-Aged Adults With Mild Traumatic Brain Injury in the PREVENT Dementia Study.
IMPORTANCE: Traumatic brain injuries (TBI) represent an important, potentially modifiable risk factor for dementia. Despite frequently observed vascular imaging changes in individuals with TBI, the relationships between TBI-associated changes in brain imaging and clinical outcomes have largely been overlooked in community cases of TBI. OBJECTIVE: To assess whether TBI are associated with and interact with midlife changes in neuroimaging and clinical features in otherwise healthy individuals. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional analysis used baseline data from the PREVENT Dementia program collected across 5 sites in the UK and Ireland between 2014 and 2020. Eligible participants were cognitively healthy midlife adults aged between 40 and 59 years. Data were analyzed between January 2023 and April 2024. EXPOSURE: Lifetime TBI history was assessed using the Brain Injury Screening Questionnaire. MAIN OUTCOMES AND MEASURES: Cerebral microbleeds and other markers of cerebral small vessel disease (white matter hyperintensities [WMH], lacunes, perivascular spaces) were assessed on 3T magnetic resonance imaging. Clinical measures were cognition, sleep, depression, gait, and cardiovascular disease (CVD) risk, assessed using Computerized Assessment of Information Processing (COGNITO), Pittsburgh Sleep Quality Index, Center for Epidemiologic Studies Depression Scale, clinical interviews, and the Framingham Risk Score, respectively. RESULTS: Of 617 participants (median [IQR] age, 52 [47-56] years; 380 female [61.6%]), 223 (36.1%) had a history of TBI. TBI was associated with higher microbleed count (β = 0.10; 95% CI, 0.01-0.18; P = .03), with a dose-response association observed with increasing number of TBI events (β = 0.05; 95% CI, 0.01-0.09; P = .03). Conversely, TBI was not associated with other measures of small vessel disease, including WMH. Furthermore, TBI moderated microbleed associations with vascular risk factors and clinical outcomes, such that associations were present only in the absence of TBI. Importantly, observations held when analyses were restricted to individuals reporting only mild TBI. CONCLUSIONS AND RELEVANCE: In this cross-sectional study of healthy middle-aged adults, detectable changes in brain imaging and clinical features were associated with remote, even mild, TBI in the general population. The potential contribution of vascular injury to TBI-related neurodegeneration presents promising avenues to identify potential targets, with findings highlighting the need to reduce TBI through early intervention and prevention in both clinical care and policymaking.
COVID-19 and influenza vaccine uptake among pregnant women in national cohorts of England and Wales.
Vaccines against COVID-19 and influenza can reduce the adverse outcomes caused by infections during pregnancy, but vaccine uptake among pregnant women has been suboptimal. We examined the COVID-19 and influenza vaccine uptake and disparities in pregnant women during the COVID-19 pandemic to inform vaccination interventions. We used data from the Oxford-Royal College of General Practitioners Research and Surveillance Centre database in England and the Secure Anonymised Information Linkage Databank in Wales. The uptake of at least one dose of vaccine was 40.2% for COVID-19 and 41.8% for influenza among eligible pregnant women. We observed disparities in COVID-19 and influenza vaccine uptake, with socioeconomically deprived and ethnic minority groups showing lower vaccination rates. The suboptimal uptake of COVID-19 and influenza vaccines, especially in those from socioeconomically deprived backgrounds and Black, mixed or other ethnic groups, underscores the necessity for interventions to reduce vaccine hesitancy and enhance acceptance in pregnant women.
Associations between dietary patterns and incident colorectal cancer in 114,443 individuals from the UK Biobank: a prospective cohort study.
BACKGROUND: Diet-disease association studies increasingly use dietary patterns (DPs) to account for the complexity of the exposure. We assessed if a DP associated with type 2 diabetes mellitus, CVD, and all-cause mortality is also associated with colorectal cancer (CRC). METHODS: We used reduced rank regression on 24-h recall data to identify DPs explaining the maximum variation in four nutrient-response variables: energy density, saturated fatty acids, free sugars and fibre density. Cox-proportional hazards models examined prospective associations between DP adherence (coded in a continuous scale as z-scores as well as in quintiles) and incident CRC. Subgroup analyses were conducted for tumour site, age, and sex. RESULTS: Post-exclusions, 1,089 CRC cases occurred in 114,443 participants over a median follow-up of 8.0 years. DP1 was characterised by increased intake of chocolate and confectionery, butter, low-fibre bread, red and processed meats and alcohol, as well as low fruit, vegetable, and high-fibre cereal intake. After accounting for confounders, including body mass, there were positive linear associations between DP1 and incident overall CRC (HR of quintile 5 vs. 1: 1.34, 95%CI 1.16-1.53, PTrend=0.005) and rectal cancer (HR of quintile 5 vs. 1: 1.58, 95%CI 1.27-1.96, PTrend=0.009), but not for proximal or distal colon cancers. No DP2-CRC association was observed. CONCLUSION: A DP previously associated with cardio-metabolic disease is also associated with incident CRC, especially rectal cancers. IMPACT: These consistent associations of particular food groups with both cardiometabolic disease and this diet-related cancer strengthen the evidence base for holistic population dietary guidelines to prevent ill-health.
Sublime and extended reality experiences to enhance emotional wellbeing for autistic people: A state of the art review and narrative synthesis.
BACKGROUND: Sublime is a centuries old concept of emergent experience arising from immense and threatening awareness provoked by overwhelming fear and dread when faced with an incomprehensible situation as is common to autistic people. Extended Reality (XR) technologies have been used since the mid-1990s, in regulating emotions, behaviour and supporting social skill development for autistic people. AIMS: To understand utility of XR technologies in creating immersive experiences for autistic people to alleviate anxiety and the relationship to the sublime. METHOD: A State of the Art literature review and narrative synthesis was conducted. PubMed, CINAHL, EMBASE, Cochrane Library, Scopus, Web of Science were searched with terms Autism AND Technology. In addition, fields of digital technologies and wellbeing, digital art and mental health, generative arts and the sublime were explored through web searches of grey literature, conversations with digital designers and explorations of extended reality platforms. No time limits were placed. Searches were done in English. Papers were screened and shortlisted using the inclusion criteria applied by two reviewers. RESULTS: Fifty-eight papers/articles met the preliminary inclusion criteria for in-depth review of which 31 were found suitable for the narrative synthesis related to XR technologies and sublime experiences as related to autistic people. Narrative synthesis lent itself to four themes that is current utility of XR Technologies in autism, the impact of immersive experiences on Behavioural, phenomenological and biological markers of autistic people, the Benefits of increased sensory stimulation using XR on autism and an inquiry into the potential of the sublime for autism. CONCLUSIONS: Mixed reality environments that experiment with a broad range of XR technologies including incorporating notions of the sublime, might be beneficial in reducing emotional dysregulation and improving social development in autistic people especially if co-designed with them.
Effect of nature on the mental health and well-being of children and adolescents: meta-review.
BACKGROUND: Urbanisation is taking place worldwide and rates of mental illness are rising. There has been increasing interest in 'nature' and how it may benefit mental health and well-being. AIMS: To understand how the literature defines nature; what the characteristics of the nature intervention are; what mental health and well-being outcomes are being measured; and what the evidence shows, in regard to how nature affects the mental health and well-being of children and adolescents. METHOD: A meta-review was conducted, searching three databases for relevant primary and secondary studies, using key search terms including 'nature' and 'mental health' and 'mental well-being'. Inclusion criteria included published English-language studies on the child and adolescent population. Authors identified the highest quality evidence from studies meeting the inclusion criteria. Data were extracted and analysed using descriptive content analysis. RESULTS: Sixteen systematic reviews, two scoping reviews and five good quality cohort studies were included. 'Nature' was conceptualised along a continuum (the 'nature research framework') into three categories: a human-designed environment with natural elements; a human-designed natural environment; and a natural environment. The nature 'intervention' falls into three areas (the 'nature intervention framework'): access, exposure and engagement with nature, with quantity and quality of nature relevant to all areas. Mental health and well-being outcomes fit along a continuum, with 'disorder' at one end and 'well-being' at the other. Nature appears to have a beneficial effect, but we cannot be certain of this. CONCLUSIONS: Nature appears to have a beneficial effect on mental health and well-being of children and adolescents. Evidence is lacking on clinical populations, ethnically diverse populations and populations in low- and middle-income countries. Our results should be interpreted considering the limitations of the included studies and confidence in findings.
Effectiveness of behavioural interventions with motivational interviewing on physical activity outcomes in adults: systematic review and meta-analysis.
OBJECTIVE: To evaluate the effectiveness of behavioural interventions that include motivational interviewing on physical activity outcomes in adults. DESIGN: Systematic review and meta-analysis. STUDY SELECTION: A search of seven databases for randomised controlled trials published from inception to 1 March 2023 comparing a behavioural intervention including motivational interviewing with a comparator without motivational interviewing on physical activity outcomes in adults. Outcomes of interest were differences in change in quantitative measures of total physical activity, moderate to vigorous physical activity (MVPA), and sedentary time. DATA EXTRACTION AND SYNTHESIS: Two reviewers extracted data and assessed risk of bias. Population characteristics, intervention components, comparison groups, and outcomes of studies were summarised. For overall main effects, random effects meta-analyses were used to report standardised mean differences (SMDs) and 95% confidence intervals (CIs). Differential effects based on duration of follow-up, comparator type, intervention duration, and disease or health condition of participants were also examined. RESULTS: 129 papers reporting 97 randomised controlled trials totalling 27 811 participants and 105 comparisons were included. Interventions including motivational interviewing were superior to comparators for increases in total physical activity (SMD 0.45, 95% CI 0.33 to 0.65, equivalent to 1323 extra steps/day; low certainty evidence) and MVPA (0.45, 0.19 to 0.71, equivalent to 95 extra min/week; very low certainty evidence) and for reductions in sedentary time (-0.58, -1.03 to -0.14, equivalent to -51 min/day; very low certainty evidence). Evidence for a difference in any outcome compared with comparators of similar intensity was lacking. The magnitude of effect diminished over time, and evidence of an effect of motivational interviewing beyond one year was lacking. Most interventions involved patients with a specific health condition, and evidence of an effect of motivational interviewing to increase MVPA or decrease sedentary time was lacking in general population samples. CONCLUSIONS: Certainty of the evidence using motivational interviewing as part of complex behavioural interventions for promoting total physical activity in adults was low, and for MVPA and sedentary time was very low. The totality of evidence suggests that although interventions with motivational interviewing increase physical activity and decrease sedentary behaviour, no difference was found in studies where the effect of motivational interviewing could be isolated. Effectiveness waned over time, with no evidence of a benefit of motivational interviewing to increase physical activity beyond one year. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020219881.
Explaining the mixed findings of a randomised trial of telehealth with centralised remote support for heart failure: qualitative evaluation
Background: Centralised specialist remote support, in which a clinician responds promptly to biomarker changes, could potentially improve outcomes in heart failure. The SUPPORT-HF2 trial compared telehealth technology alone with the same technology combined with centralised remote support. The intervention was implemented differently in different sites; no significant impact was found overall. We sought to explain these findings in a qualitative evaluation. Methods: 51 people (25 patients, 3 carers, 18 clinicians and 4 additional research staff) were interviewed and observed in 7 SUPPORT-HF sites across UK between 2016 and 2018. We also collected 110 pages of documents. Analysis was informed by sociotechnical theory. Results: Patients’ experiences of the technology were largely positive; staff engaged with the intervention to a variable degree. Existing services, staffing levels, technical capacity and previous experience with telehealth all influenced how the complex intervention of ‘telehealth technology plus centralised specialist remote support’ was interpreted and the extent to which it was adopted and used to its full potential. In some settings, the intervention was quickly mobilised to fill significant gaps in service provision. In others, it was seen as usefully extending the existing care model for selected patients. However, in some settings, the new care model was actively resisted and the technology little used. In one setting, centralised provision of specialist advice aligned awkwardly with an existing community-based heart failure support service. Conclusions: The introduction of a telehealth programme rests not only on the technological intervention but also on the individuals involved and numerous subtle aspects of local service design. An iterative approach that attends to patients’ illness experiences, clinicians’ professional values, work practices and care pathways could lead to more effective telehealth support for patients with heart failure.