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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.
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.
Estimating the costs of blindness and moderate to severe visual impairment among people with diabetes in India.
OBJECTIVES: This study provides an estimate of the annual cost of blindness and moderate to severe visual impairment (MSVI) among people with diabetes aged 40 years and above in India in the year 2019. DESIGN: A cost of illness study. SETTING: India. PARTICIPANTS: People with diabetes aged 40 years and above in India in the year 2019. PRIMARY AND SECONDARY OUTCOME MEASURES: Estimates are provided for the total costs of screening for most common vision-threatening eye conditions, treatment of these conditions, economic activity lost by these people and their family carers whose ability to work is affected, and loss of quality of life experienced by people with diabetes and blindness or MSVI. RESULTS: It is estimated that for people with diabetes aged 40 years or above, annual screening followed by eye examination where required would cost around 42.3 billion Indian rupees (INR) (4230 crores) per year; treating sight problems around 2.87 billion INR (287 crores) per year if 20% of those needing treatment receive it; and lost economic activity around 472 billion INR (47 200 crores). Moreover, 2.86 million (0.286 crores) quality-adjusted life years (QALYs) are lost annually due to blindness and MSVI. The estimate of lost production is highly sensitive to the proportion of people with MSVI able to work and how their output compares with that of a person with no visual impairment. CONCLUSIONS: This is the first study to estimate the cost of blindness and MSVI for people aged 40 years and over with diabetes in India. The annual cost to the Indian economy is substantial. This cost will be expected to fall if a successful screening and treatment plan is introduced in India. Further work is suggested using more robust data, when available, to estimate the loss of productivity and loss of QALYs, as this would be worthwhile.
The Stroke Prevention Programme: a programme of research to inform optimal stroke prevention in primary care
BackgroundThe management of cardiovascular (CV) risk factors in community populations is suboptimal. The aim of this programme was to explore the role of three approaches [use of a ‘polypill’; self-management of hypertension; and more intensive targets for blood pressure (BP) lowering after stroke] to improve prevention of CV disease (CVD) in the community.Research questions(1) Is it more cost-effective to titrate treatments to target levels of cholesterol and BP or to use fixed doses of statins and BP-lowering agents (polypill strategy)? (2) Will telemonitoring and self-management improve BP control in people on treatment for hypertension or with a history of stroke/transient ischaemic attack (TIA) in primary care and are they cost-effective? (3) In people with a history of stroke/TIA, can intensive BP-lowering targets be achieved in a primary care setting and what impact will this have on health outcomes and cost-effectiveness?DesignMixed methods, comprising three randomised controlled trials (RCTs); five cost-effectiveness analyses; qualitative studies; analysis of electronic general practice data; a screening study; a systematic review; and a questionnaire study.SettingUK general practices, predominantly from the West Midlands and the east of England.ParticipantsAdults registered with participating general practices. Inclusion criteria varied from study to study.InterventionsA polypill – a fixed-dose combination pill containing three antihypertensive medicines and simvastatin – compared with current practice and with optimal implementation of national guidelines; self-monitoring of BP with self-titration of medication, compared with usual care; and an intensive target for systolic BP of ResultsFor patients known to be at high risk of CVD, treatment as per guidelines was the most cost-effective strategy. For people with unknown CV risk aged ≥ 50 years, offering a polypill is cost-effective [incremental cost-effectiveness ratio (ICER) of £8115 per quality-adjusted life-year (QALY)] compared with a strategy of screening and treating according to national guidelines. Both results were sensitive to the cost of the polypill. Self-management in people with uncontrolled hypertension led to a 5.4 mmHg [95% confidence interval (CI) 2.4 to 8.5 mmHg] reduction in systolic BP at 1 year, compared with usual care. It was cost-effective for men (ICER of £1624 per QALY) and women (ICER of £4923 per QALY). In people with stroke and other high-risk groups, self-management led to a 9.2 mmHg (95% CI 5.7 to 12.7 mmHg) reduction in systolic BP at 1 year compared with usual care and dominated (lower cost and better outcome) usual care. Aiming for the more intensive BP target after stroke led to a 2.9 mmHg (95% CI 0.2 to 5.7 mmHg) greater reduction in BP and dominated the 140 mmHg target.ConclusionsPotential for a polypill needs to be further explored in RCTs. Self-management should be offered to people with poorly controlled BP. Management of BP in the post-stroke population should focus on achieving a Trial registrationCurrent Controlled Trials ISRCTN17585681, ISRCTN87171227 and ISRCTN29062286.FundingThe National Institute for Health Research (NIHR) Programme Grants for Applied Research programme. Additional funding was provided by the NIHR National School for Primary Care Research, the NIHR Career Development Fellowship and the Department of Health Policy Research Programme.