Background The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered. Methods We present data from three single-blind randomised controlled trials—one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)—and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 10 10 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 10 10 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov , NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005). Findings Between April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more t...
ObjectiveTo describe the accuracy of ethnicity coding in contemporary National Health Service (NHS) hospital records compared with the ‘gold standard’ of self-reported ethnicity.DesignSecondary analysis of data from a cross-sectional survey (2011).SettingAll NHS hospitals in England providing cancer treatment.Participants58 721 patients with cancer for whom ethnicity information (Office for National Statistics 2001 16-group classification) was available from self-reports (considered to represent the ‘gold standard’) and their hospital record.MethodsWe calculated the sensitivity and positive predictive value (PPV) of hospital record ethnicity. Further, we used a logistic regression model to explore independent predictors of discordance between recorded and self-reported ethnicity.ResultsOverall, 4.9% (4.7–5.1%) of people had their self-reported ethnic group incorrectly recorded in their hospital records. Recorded White British ethnicity had high sensitivity (97.8% (97.7–98.0%)) and PPV (98.1% (98.0–98.2%)) for self-reported White British ethnicity. Recorded ethnicity information for the 15 other ethnic groups was substantially less accurate with 41.2% (39.7–42.7%) incorrect. Recorded ‘Mixed’ ethnicity had low sensitivity (12–31%) and PPVs (12–42%). Recorded ‘Indian’, ‘Chinese’, ‘Black-Caribbean’ and ‘Black African’ ethnic groups had intermediate levels of sensitivity (65–80%) and PPV (80–89%, respectively). In multivariable analysis, belonging to an ethnic minority group was the only independent predictor of discordant ethnicity information. There was strong evidence that the degree of discordance of ethnicity information varied substantially between different hospitals (p<0.0001).DiscussionCurrent levels of accuracy of ethnicity information in NHS hospital records support valid profiling of White/non-White ethnic differences. However, profiling of ethnic differences in process or outcome measures for specific minority groups may contain a substantial and variable degree of misclassification error. These considerations should be taken into account when interpreting ethnic variation audits based on routine data and inform initiatives aimed at improving the accuracy of ethnicity information in hospital records.
Infectious disease crises have substantial economic impact. Yet mainstream macroeconomic forecasting rarely takes account of the risk of potential pandemics. This oversight contributes to persistent underestimation of infectious disease risk and consequent underinvestment in preparedness and response to infectious disease crises. One reason why economists fail to include economic vulnerability to infectious disease threats in their assessments is the absence of readily available and digestible input data to inform such analysis. In this Viewpoint we suggest an approach by which the global health community can help to generate such inputs, and a framework to use these inputs to assess the economic vulnerability to infectious disease crises of individual countries and regions. We argue that incorporation of these risks in influential macroeconomic analyses such as the reports from the International Monetary Fund's Article IV consultations, rating agencies and risk consultancies would simultaneously improve the quality of economic risk forecasting and reinforce individual government and donor incentives to mitigate infectious disease risks.
Background:Exploring variation in patients' experiences of involvement in treatment decision making can identify groups needing extra support, such as additional consultation time, when considering treatment options.Methods:We analysed data from the 2010 English National Cancer Patient Experience Survey, a national survey of all patients attending hospitals in England for cancer treatment over a 3-month period, to examine how experience of involvement in decisions about treatment varied between patients with 38 different primary cancers using logistic regression. We analysed responses from 41 411 patients to a single question examining patient experience of involvement in treatment decision making. We calculated unadjusted odds ratios of reporting the most positive experience between patients of different sociodemographic and tumour characteristics and explored the effects of adjusting for age, gender, ethnicity, deprivation, cancer type and hospital of treatment.Results:Of the 41 441 respondents, 29 776 (72%) reported positive experiences of decision-making involvement. Younger patients reported substantially less positive experiences of involvement in decision making (adjusted OR=0.49 16–24 vs 65–74; P<0.001), as did ethnic minorities (adjusted ORs=0.52, 0.62 and 0.73 for Black, Chinese and Asian vs White patients, respectively; P<0.001). Experience varied considerably between patients with different cancers ( e.g., OR=0.52 for anal and 1.37 for melanoma vs colon cancer; P<0.001), with ovarian, myeloma, bladder and rectal cancer patients reporting substantially worse experiences compared with other patients with gynaecological, haematological, urological and colorectal cancers, respectively. Clustering of different patient groups within hospitals with outlying performance report scores could not account for observed differences.Conclusion:Efforts to improve involvement in treatment decision making can focus on those who report the worst experience, in particular younger patients, ethnic minorities and patients with rectal, ovarian, multiple myeloma and bladder cancer.
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