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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability.
BACKGROUND: There is intense effort to develop cuffless blood pressure (BP) measuring devices, and several are already on the market claiming that they provide accurate measurements. These devices are heterogeneous in measurement principle, intended use, functions, and calibration, and have special accuracy issues requiring different validation than classic cuff BP monitors. To date, there are no generally accepted protocols for their validation to ensure adequate accuracy for clinical use. OBJECTIVE: This statement by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability recommends procedures for validating intermittent cuffless BP devices (providing measurements every >30 sec and usually 30-60 min, or upon user initiation), which are most common. VALIDATION PROCEDURES: Six validation tests are defined for evaluating different aspects of intermittent cuffless devices: static test (absolute BP accuracy); device position test (hydrostatic pressure effect robustness); treatment test (BP decrease accuracy); awake/asleep test (BP change accuracy); exercise test (BP increase accuracy); and recalibration test (cuff calibration stability over time). Not all these tests are required for a given device. The necessary tests depend on whether the device requires individual user calibration, measures automatically or manually, and takes measurements in more than one position. CONCLUSION: The validation of cuffless BP devices is complex and needs to be tailored according to their functions and calibration. These ESH recommendations present specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices to ensure that only accurate devices will be used in the evaluation and management of hypertension.
Requirements for design and function of blood pressure measuring devices used for the management of hypertension: Consensus Statement by the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability and STRIDE BP.
OBJECTIVE: To develop scientific consensus recommendations for the optimal design and functions of different types of blood pressure (BP) measuring devices used in clinical practice for the detection, management, and long-term follow-up of hypertension. METHODS: A scientific consensus meeting was performed by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability and STRIDE BP (Science and Technology for Regional Innovation and Development in Europe) during the 2022 Scientific Meeting of the ESH in Athens, Greece. Manufacturers were also invited to provide their feedback on BP device design and development. Thirty-one international experts in clinical hypertension and BP monitoring contributed to the development of consensus recommendations on the optimal design of BP devices. STATEMENT: International consensus was reached on the requirements for the design and features of five types of BP monitors, including office (or clinic) BP monitors, ambulatory BP monitors, home BP monitors, home BP telemonitors, and kiosk BP monitors for public spaces. For each device type "essential" requirements (must have), and "optional" ones (may have) are presented, as well as additional comments on the optimal device design and features. CONCLUSIONS: These consensus recommendations aim at providing manufacturers of BP devices with the requirements that are considered mandatory, or optional, by clinical experts involved in the detection and management of hypertension. They are also directed to administrative healthcare personnel involved in the provision and purchase of BP devices so that they can recommend the most appropriate ones.
Sexuality and old age
Sexuality in older people is a multifaceted field of study. Ageing may offer opportunities for and restrictions on sexuality. Ageing individuals may have increased time for and may wish to explore their sexuality, for example, by considering a same-sex relationship, after a long-term partner dies. However, they may also lack a partner or autonomy. They may develop or have increased symptoms from chronic diseases. Consequent medication may affect their sexual functioning. Their attitudes to sex often change and their capacity for sexual activity may diminish unless they seek help. However, they may lack the confidence to do so and the health professionals consulted may be disinclined or ill-equipped to assist them. They may have concerns regarding how their sexuality or their sexual orientation would be perceived should they require residential care or start to lose their memory. We consider the recent work relating to this broad range of influences on sexuality in old age and conclude that, whilst the challenge for researchers is to accurately clarify the impact of individual factors on sexuality and identify helpful potential interventions, increased academic and educational focus on this area is enhancing the prospects for a sexually enjoyable old age. © 2013 Springer-Verlag Berlin Heidelberg.
Search for Higgs boson pair production in association with a vector boson in pp collisions at √s=13TeV with the ATLAS detector
This paper reports a search for Higgs boson pair (hh) production in association with a vector boson (WorZ) using 139 fb - 1 of proton–proton collision data at s=13TeV recorded with the ATLAS detector at the Large Hadron Collider. The search is performed in final states in which the vector boson decays leptonically (W→ℓν,Z→ℓℓ,νν with ℓ= e, μ) and the Higgs bosons each decay into a pair of b-quarks. It targets Vhh signals from both non-resonant hh production, present in the Standard Model (SM), and resonant hh production, as predicted in some SM extensions. A 95% confidence-level upper limit of 183 (87) times the SM cross-section is observed (expected) for non-resonant Vhh production when assuming the kinematics are as expected in the SM. Constraints are also placed on Higgs boson coupling modifiers. For the resonant search, upper limits on the production cross-sections are derived for two specific models: one is the production of a vector boson along with a neutral heavy scalar resonance H, in the mass range 260–1000 GeV, that decays into hh, and the other is the production of a heavier neutral pseudoscalar resonance A that decays into a Z boson and H boson, where the A boson mass is 360–800 GeV and the H boson mass is 260–400 GeV. Constraints are also derived in the parameter space of two-Higgs-doublet models.
National quality standards for neuro rehabilitation in a community setting: Do they achieve their purpose?
Rationale: There is known variation in neuro-rehabilitation service provision, however, the extent of service variation and impact on people who experience an acquired brain injury (ABI) is not articulated in the literature. The aim of this study was to assess and determine the extent to which neuro-rehabilitation services in one part of the United Kingdom (UK) are meeting national quality standards. Method: A mixed method design, across five community neuro-rehabilitation providers and six districts in South London, comprised of ABI population incidence data, web-based surveys to determine compliance with the National Institute for Health and Care Excellence (NICE) Head Injury Quality Standard, and focus groups to understand the patient perspective of community neuro-rehabilitation service provision. Results: The population incidence of ABI amongst districts demonstrated differences between the datasets analyzed, resulting in an inability to determine whether service variation was based on population need. The web-based surveys revealed that five community neuro-rehabilitation providers have variations between the models of care provided, including clinical referral criteria, duration, intensity of therapy interventions, and overall cost per patient, which was correlated with workforce capacity and patient waiting times. Focus group discussion highlighted current key challenges of service restraints, disconnect between services and limited professional support, as well as improvement opportunities pertaining to access, flexible, local and timely health and social care services. Conclusion: This study indicates that despite the publication of the NICE Head Injury Quality Standard, there is variation in the local provision of community neuro-rehabilitation across six districts in South London. Each district partly meets the recommendations, highlighting variability in the model of care delivered, that impacts consumers/carers accessing quality neuro-rehabilitation services. A disconnect remains between evidence-based quality standards and implementation. No standardized ABI data set is available in the UK, which impacts planning for future clinical service delivery.
GP delivered brief weight loss advice: associations between in-consultation behaviour change techniques and patient weight loss in recorded primary care discussions
Background: Primary care clinicians are encouraged to intervene opportunistically, offering weight-loss advice to people living with obesity. The BWeL trial showed patients receiving brief weight-loss advice from their general practitioner lost weight at one year follow-up. We examined the behaviour change techniques (BCTs) clinicians used to identify which BCTs are associated with this weight loss. Methods: We coded 224 audio recorded interventions from the BWeL trial using the behavioural change techniques version one taxonomy (BCTTv1) and the ‘refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours’ (CALOR-RE taxonomy). Linear and logistic regressions were performed to analyse associations between behaviour change techniques used in these taxonomies and patient weight loss. Results: Mean intervention length was 86 s. We identified 28 different BCTs BCTTv1 and 22 from CALOR-RE. No BCTs or BCT domains were associated with mean weight loss at 12 months, loss of 5% bodyweight, or action taken at 3 months. The BCT ‘Feedback on outcomes of behaviour (future)’ was associated with an increased likelihood that the patient reported taking action to lose weight by 12 months (OR = 6.10, 95%CI = 1.20, 31.0). Conclusion: Although we found no evidence to support the use of particular BCTs, our results suggest that it is the brief intervention itself, rather than specific content, which may motivate weight loss. This can support clinicians to confidently intervene without needing complex training. Offering follow-up appointments can support positive changes to health behaviours, even if these are not associated with weight loss.
Protocol for an OpenSAFELY cohort study collecting patient-reported outcome measures using the TPP Airmid smartphone application and linked big data to quantify the health and economic costs of long COVID (OpenPROMPT)
Introduction The impact of long COVID on health-related quality of-life (HRQoL) and productivity is not currently known. It is important to understand who is worst affected by long COVID and the cost to the National Health Service (NHS) and society, so that strategies like booster vaccines can be prioritised to the right people. OpenPROMPT aims to understand the impact of long COVID on HRQoL in adults attending English primary care. Methods and analysis We will ask people to participate in this cohort study through a smartphone app (Airmid), and completing a series of questionnaires held within the app. Questionnaires will ask about HRQoL, productivity and symptoms of long COVID. Participants will be asked to fill in the questionnaires once a month, for 90 days. Questionnaire responses will be linked, where possible, to participants' existing health records from primary care, secondary care, and COVID testing and vaccination data. Analysis will take place using the OpenSAFELY data platform and will estimate the impact of long COVID on HRQoL, productivity and cost to the NHS. Ethics and dissemination The Proportionate Review Sub-Committee of the South Central - Berkshire B Research Ethics Committee has reviewed and approved the study and have agreed that we can ask people to take part (22/SC/0198). Our results will provide information to support long-term care, and make recommendations for prevention of long COVID in the future. Trial registration number NCT05552612.
Practical Indicators for Risk of Airborne Transmission in Shared Indoor Environments and Their Application to COVID-19 Outbreaks
Some infectious diseases, including COVID-19, can undergo airborne transmission. This may happen at close proximity, but as time indoors increases, infections can occur in shared room air despite distancing. We propose two indicators of infection risk for this situation, that is, relative risk parameter (Hr) and risk parameter (H). They combine the key factors that control airborne disease transmission indoors: virus-containing aerosol generation rate, breathing flow rate, masking and its quality, ventilation and aerosol-removal rates, number of occupants, and duration of exposure. COVID-19 outbreaks show a clear trend that is consistent with airborne infection and enable recommendations to minimize transmission risk. Transmission in typical prepandemic indoor spaces is highly sensitive to mitigation efforts. Previous outbreaks of measles, influenza, and tuberculosis were also assessed. Measles outbreaks occur at much lower risk parameter values than COVID-19, while tuberculosis outbreaks are observed at higher risk parameter values. Because both diseases are accepted as airborne, the fact that COVID-19 is less contagious than measles does not rule out airborne transmission. It is important that future outbreak reports include information on masking, ventilation and aerosol-removal rates, number of occupants, and duration of exposure, to investigate airborne transmission.
A body shape index (ABSI) is associated inversely with post-menopausal progesterone-receptor-negative breast cancer risk in a large European cohort
Background: Associations of body shape with breast cancer risk, independent of body size, are unclear because waist and hip circumferences are correlated strongly positively with body mass index (BMI). Methods: We evaluated body shape with the allometric “a body shape index” (ABSI) and hip index (HI), which compare waist and hip circumferences, correspondingly, among individuals with the same weight and height. We examined associations of ABSI, HI, and BMI (per one standard deviation increment) with breast cancer overall, and according to menopausal status at baseline, age at diagnosis, and oestrogen and progesterone receptor status (ER+/-PR+/-) in multivariable Cox proportional hazards models using data from the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. Results: During a mean follow-up of 14.0 years, 9011 incident breast cancers were diagnosed among 218,276 women. Although there was little evidence for association of ABSI with breast cancer overall (hazard ratio HR = 0.984; 95% confidence interval: 0.961–1.007), we found borderline inverse associations for post-menopausal women (HR = 0.971; 0.942-1.000; n = 5268 cases) and breast cancers diagnosed at age ≥ 55 years (HR = 0.976; 0.951–1.002; n = 7043) and clear inverse associations for ER + PR- subtypes (HR = 0.894; 0.822–0.971; n = 726) and ER-PR- subtypes (HR = 0.906; 0.835–0.983 n = 759). There were no material associations with HI. BMI was associated strongly positively with breast cancer overall (HR = 1.074; 1.049–1.098), for post-menopausal women (HR = 1.117; 1.085–1.150), for cancers diagnosed at age ≥ 55 years (HR = 1.104; 1.076–1.132), and for ER + PR + subtypes (HR = 1.122; 1.080–1.165; n = 3101), but not for PR- subtypes. Conclusions: In the EPIC cohort, abdominal obesity evaluated with ABSI was not associated with breast cancer risk overall but was associated inversely with the risk of post-menopausal PR- breast cancer. Our findings require validation in other cohorts and with a larger number of PR- breast cancer cases.
Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure
Background: Informed consent is an accepted ethical and legal prerequisite for trial participation, yet there is no standardised method of assessing patient understanding for informed consent. The participatory and informed consent (PIC) measure was developed for application to recruitment discussions to evaluate recruiter information provision and evidence of patient understanding. Preliminary evaluation of the PIC indicated the need to improve inter-rater and intra-rater reliability ratings and conduct further psychometric evaluation. This paper describes the assessment, revision and evaluation of the PIC within the context of OPTiMISE, a pragmatic primary care-based trial. Methods: This study used multiple methods across two phases. In phase one, one researcher applied the existing PIC measure to 18 audio-recorded recruitment discussions from the OPTiMISE study and made detailed observational notes about any uncertainties in application. Appointments were sampled to be maximally diverse for patient gender, study centre, recruiter and before and after an intervention to optimise information provision. Application uncertainties were reviewed by the study team, revisions made and a coding manual developed and agreed. In phase two, the coding manual was used to develop tailored guidelines for applying the PIC to appointments within the OPTiMISE trial. Two researchers then assessed 27 further appointments, purposively sampled as above, to evaluate inter-rater and intra-rater reliability, content validity and feasibility. Results: Application of the PIC to 18 audio-recorded OPTiMISE recruitment discussions resulted in harmonisation of the scales rating recruiter information provision and evidence of patient understanding, minor amendments to clarify wording and the development of detailed generic coding guidelines for applying the measure within any trial. Application of the revised measure using these guidelines to 27 further recruitment discussions showed good feasibility (time to complete), content validity (completion rate) and reliability (inter- and intra-rater) of the measure. Conclusion: The PIC provides a means to evaluate the content of information provided by recruiters, patient participation in recruitment discussions and, to some extent, evidence of patient understanding. Future work will use the measure to evaluate recruiter information provision and evidence of patient understanding both across and within trials.
First-trimester ultrasound detection of fetal heart anomalies: systematic review and meta-analysis
Objectives: To determine the diagnostic accuracy of ultrasound at 11–14 weeks' gestation in the detection of fetal cardiac abnormalities and to evaluate factors that impact the detection rate. Methods: This was a systematic review of studies evaluating the diagnostic accuracy of ultrasound in the detection of fetal cardiac anomalies at 11–14 weeks' gestation, performed by two independent reviewers. An electronic search of four databases (MEDLINE, EMBASE, Web of Science Core Collection and The Cochrane Library) was conducted for studies published between January 1998 and July 2020. Prospective and retrospective studies evaluating pregnancies at any prior level of risk and in any healthcare setting were eligible for inclusion. The reference standard used was the detection of a cardiac abnormality on postnatal or postmortem examination. Data were extracted from the included studies to populate 2 × 2 tables. Meta-analysis was performed using a random-effects model in order to determine the performance of first-trimester ultrasound in the detection of major cardiac abnormalities overall and of individual types of cardiac abnormality. Data were analyzed separately for high-risk and non-high-risk populations. Preplanned secondary analyses were conducted in order to assess factors that may impact screening performance, including the imaging protocol used for cardiac assessment (including the use of color-flow Doppler), ultrasound modality, year of publication and the index of sonographer suspicion at the time of the scan. Risk of bias and quality assessment were undertaken for all included studies using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Results: The electronic search yielded 4108 citations. Following review of titles and abstracts, 223 publications underwent full-text review, of which 63 studies, reporting on 328 262 fetuses, were selected for inclusion in the meta-analysis. In the non-high-risk population (45 studies, 306 872 fetuses), 1445 major cardiac anomalies were identified (prevalence, 0.41% (95% CI, 0.39–0.43%)). Of these, 767 were detected on first-trimester ultrasound examination of the heart and 678 were not detected. First-trimester ultrasound had a pooled sensitivity of 55.80% (95% CI, 45.87–65.50%), specificity of 99.98% (95% CI, 99.97–99.99%) and positive predictive value of 94.85% (95% CI, 91.63–97.32%) in the non-high-risk population. The cases diagnosed in the first trimester represented 63.67% (95% CI, 54.35–72.49%) of all antenatally diagnosed major cardiac abnormalities in the non-high-risk population. In the high-risk population (18 studies, 21 390 fetuses), 480 major cardiac anomalies were identified (prevalence, 1.36% (95% CI, 1.20–1.52%)). Of these, 338 were detected on first-trimester ultrasound examination and 142 were not detected. First-trimester ultrasound had a pooled sensitivity of 67.74% (95% CI, 55.25–79.06%), specificity of 99.75% (95% CI, 99.47–99.92%) and positive predictive value of 94.22% (95% CI, 90.22–97.22%) in the high-risk population. The cases diagnosed in the first trimester represented 79.86% (95% CI, 69.89–88.25%) of all antenatally diagnosed major cardiac abnormalities in the high-risk population. The imaging protocol used for examination was found to have an important impact on screening performance in both populations (P < 0.0001), with a significantly higher detection rate observed in studies using at least one outflow-tract view or color-flow Doppler imaging (both P < 0.0001). Different types of cardiac anomaly were not equally amenable to detection on first-trimester ultrasound. Conclusions: First-trimester ultrasound examination of the fetal heart allows identification of over half of fetuses affected by major cardiac pathology. Future first-trimester screening programs should follow structured anatomical assessment protocols and consider the introduction of outflow-tract views and color-flow Doppler imaging, as this would improve detection rates of fetal cardiac pathology. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.