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Br J Gen Pract ; 72(720): e446-e455, 2022 07.
Article in English | MEDLINE | ID: covidwho-1924323


BACKGROUND: Colchicine has been proposed as a COVID-19 treatment. AIM: To determine whether colchicine reduces time to recovery and COVID-19-related admissions to hospital and/or deaths among people in the community. DESIGN AND SETTING: Prospective, multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial (PRINCIPLE). METHOD: Adults aged ≥65 years or ≥18 years with comorbidities or shortness of breath, and unwell for ≤14 days with suspected COVID-19 in the community, were randomised to usual care, usual care plus colchicine (500 µg daily for 14 days), or usual care plus other interventions. The co-primary endpoints were time to first self-reported recovery and admission to hospital/death related to COVID-19, within 28 days, analysed using Bayesian models. RESULTS: The trial opened on 2 April 2020. Randomisation to colchicine started on 4 March 2021 and stopped on 26 May 2021 because the prespecified time to recovery futility criterion was met. The primary analysis model included 2755 participants who were SARS-CoV-2 positive, randomised to colchicine (n = 156), usual care (n = 1145), and other treatments (n = 1454). Time to first self-reported recovery was similar in the colchicine group compared with usual care with an estimated hazard ratio of 0.92 (95% credible interval (CrI) = 0.72 to 1.16) and an estimated increase of 1.4 days in median time to self-reported recovery for colchicine versus usual care. The probability of meaningful benefit in time to recovery was very low at 1.8%. COVID-19-related admissions to hospital/deaths were similar in the colchicine group versus usual care, with an estimated odds ratio of 0.76 (95% CrI = 0.28 to 1.89) and an estimated difference of -0.4% (95% CrI = -2.7 to 2.4). CONCLUSION: Colchicine did not improve time to recovery in people at higher risk of complications with COVID-19 in the community.

COVID-19 , Adult , Bayes Theorem , COVID-19/drug therapy , Colchicine/therapeutic use , Humans , Prospective Studies , SARS-CoV-2 , Treatment Outcome
BJGP Open ; 5(5)2021 Oct.
Article in English | MEDLINE | ID: covidwho-1328146


BACKGROUND: The Platform Randomised trial of INterventions against COVID-19 In older peoPLE (PRINCIPLE) has provided in-pandemic evidence that azithromycin and doxycycline were not beneficial in the early primary care management of coronavirus 2019 disease (COVID-19). AIM: To explore the extent of in-pandemic azithromycin and doxycycline use, and the scope for trial findings impacting on practice. DESIGN & SETTING: Crude rates of prescribing and respiratory tract infections (RTI) in 2020 were compared with 2019, using the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC). METHOD: Negative binomial models were used to compare azithromycin and doxycycline prescribing, lower respiratory tract infections (LRTI), upper respiratory tract infections (URTI), and influenza-like illness (ILI) in 2020 with 2019; reporting incident rate ratios (IRR) between years, and 95% confidence intervals (95% CI). RESULTS: Azithromycin prescriptions increased 7% in 2020 compared with 2019, whereas doxycycline decreased by 7%. Concurrently, LRTI and URTI incidence fell by over half (58.3% and 54.4%, respectively) while ILI rose slightly (6.4%). The overall percentage of RTI-prescribed azithromycin rose from 0.51% in 2019 to 0.72% in 2020 (risk difference 0.214%; 95% CI = 0.211 to 0.217); doxycycline rose from 11.86% in 2019 to 15.79% in 2020 (risk difference 3.93%; 95% CI = 3.73 to 4.14). The adjusted IRR showed azithromycin prescribing was 22% higher in 2020 (IRR = 1.22; 95% CI = 1.19 to 1.26; P<0.0001). For every unit rise in confirmed COVID-19 there was an associated 3% rise in prescription (IRR = 1.03; 95% CI = 1.02 to 1.03; P<0.0001); whereas these measures were static for doxycycline. CONCLUSION: PRINCIPLE demonstrates scope for improved antimicrobial stewardship during a pandemic.

Heart ; 108(7): 543-549, 2022 04.
Article in English | MEDLINE | ID: covidwho-1286748


OBJECTIVE: Heart failure (HF) is a malignant condition requiring urgent treatment. Guidelines recommend natriuretic peptide (NP) testing in primary care to prioritise referral for specialist diagnostic assessment. We aimed to assess association of baseline NP with hospitalisation and mortality in people with newly diagnosed HF. METHODS: Population-based cohort study of 40 007 patients in the Clinical Practice Research Datalink in England with a new HF diagnosis (48% men, mean age 78.5 years). We used linked primary and secondary care data between 1 January 2004 and 31 December 2018 to report one-year hospitalisation and 1-year, 5-year and 10-year mortality by NP level. RESULTS: 22 085 (55%) participants were hospitalised in the year following diagnosis. Adjusted odds of HF-related hospitalisation in those with a high NP (NT-proBNP >2000 pg/mL) were twofold greater (OR 2.26 95% CI 1.98 to 2.59) than a moderate NP (NT-proBNP 400-2000 pg/mL). All-cause mortality rates in the high NP group were 27%, 62% and 82% at 1, 5 and 10 years, compared with 19%, 50% and 77%, respectively, in the moderate NP group and, in a competing risks model, risk of HF-related death was 50% higher at each timepoint. Median time between NP test and HF diagnosis was 101 days (IQR 19-581). CONCLUSIONS: High baseline NP is associated with increased HF-related hospitalisation and poor survival. While healthcare systems remain under pressure from the impact of COVID-19, research to test novel strategies to prevent hospitalisation and improve outcomes-such as a mandatory two-week HF diagnosis pathway-is urgently needed.

COVID-19 , Heart Failure , Aged , Biomarkers , COVID-19/diagnosis , COVID-19/epidemiology , Cohort Studies , Female , Heart Failure/drug therapy , Heart Failure/therapy , Hospitalization , Humans , Male , Natriuretic Peptide, Brain/therapeutic use , Peptide Fragments , SARS-CoV-2
BMJ ; 373: n1262, 2021 05 19.
Article in English | MEDLINE | ID: covidwho-1236438

COVID-19 , Humans , SARS-CoV-2
Lancet ; 397(10285): 1646-1657, 2021 05 01.
Article in English | MEDLINE | ID: covidwho-1201750


BACKGROUND: The BNT162b2 mRNA (Pfizer-BioNTech) and ChAdOx1 nCoV-19 (Oxford-AstraZeneca) COVID-19 vaccines have shown high efficacy against disease in phase 3 clinical trials and are now being used in national vaccination programmes in the UK and several other countries. Studying the real-world effects of these vaccines is an urgent requirement. The aim of our study was to investigate the association between the mass roll-out of the first doses of these COVID-19 vaccines and hospital admissions for COVID-19. METHODS: We did a prospective cohort study using the Early Pandemic Evaluation and Enhanced Surveillance of COVID-19-EAVE II-database comprising linked vaccination, primary care, real-time reverse transcription-PCR testing, and hospital admission patient records for 5·4 million people in Scotland (about 99% of the population) registered at 940 general practices. Individuals who had previously tested positive were excluded from the analysis. A time-dependent Cox model and Poisson regression models with inverse propensity weights were fitted to estimate effectiveness against COVID-19 hospital admission (defined as 1-adjusted rate ratio) following the first dose of vaccine. FINDINGS: Between Dec 8, 2020, and Feb 22, 2021, a total of 1 331 993 people were vaccinated over the study period. The mean age of those vaccinated was 65·0 years (SD 16·2). The first dose of the BNT162b2 mRNA vaccine was associated with a vaccine effect of 91% (95% CI 85-94) for reduced COVID-19 hospital admission at 28-34 days post-vaccination. Vaccine effect at the same time interval for the ChAdOx1 vaccine was 88% (95% CI 75-94). Results of combined vaccine effects against hospital admission due to COVID-19 were similar when restricting the analysis to those aged 80 years and older (83%, 95% CI 72-89 at 28-34 days post-vaccination). INTERPRETATION: Mass roll-out of the first doses of the BNT162b2 mRNA and ChAdOx1 vaccines was associated with substantial reductions in the risk of hospital admission due to COVID-19 in Scotland. There remains the possibility that some of the observed effects might have been due to residual confounding. FUNDING: UK Research and Innovation (Medical Research Council), Research and Innovation Industrial Strategy Challenge Fund, Health Data Research UK.

COVID-19 Vaccines , COVID-19/prevention & control , Hospitalization/statistics & numerical data , Mass Vaccination , Pandemics/prevention & control , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/epidemiology , Female , Humans , Male , Middle Aged , Prospective Studies , Risk Factors , Scotland/epidemiology , Social Class , Young Adult
Br J Gen Pract ; 70(701): e890-e898, 2020 12.
Article in English | MEDLINE | ID: covidwho-881363


BACKGROUND: The SARS-CoV-2 pandemic has passed its first peak in Europe. AIM: To describe the mortality in England and its association with SARS-CoV-2 status and other demographic and risk factors. DESIGN AND SETTING: Cross-sectional analyses of people with known SARS-CoV-2 status in the Oxford RCGP Research and Surveillance Centre (RSC) sentinel network. METHOD: Pseudonymised, coded clinical data were uploaded from volunteer general practice members of this nationally representative network (n = 4 413 734). All-cause mortality was compared with national rates for 2019, using a relative survival model, reporting relative hazard ratios (RHR), and 95% confidence intervals (CI). A multivariable adjusted odds ratios (OR) analysis was conducted for those with known SARS-CoV-2 status (n = 56 628, 1.3%) including multiple imputation and inverse probability analysis, and a complete cases sensitivity analysis. RESULTS: Mortality peaked in week 16. People living in households of ≥9 had a fivefold increase in relative mortality (RHR = 5.1, 95% CI = 4.87 to 5.31, P<0.0001). The ORs of mortality were 8.9 (95% CI = 6.7 to 11.8, P<0.0001) and 9.7 (95% CI = 7.1 to 13.2, P<0.0001) for virologically and clinically diagnosed cases respectively, using people with negative tests as reference. The adjusted mortality for the virologically confirmed group was 18.1% (95% CI = 17.6 to 18.7). Male sex, population density, black ethnicity (compared to white), and people with long-term conditions, including learning disability (OR = 1.96, 95% CI = 1.22 to 3.18, P = 0.0056) had higher odds of mortality. CONCLUSION: The first SARS-CoV-2 peak in England has been associated with excess mortality. Planning for subsequent peaks needs to better manage risk in males, those of black ethnicity, older people, people with learning disabilities, and people who live in multi-occupancy dwellings.

COVID-19 , Noncommunicable Diseases/epidemiology , SARS-CoV-2/isolation & purification , Age Factors , COVID-19/diagnosis , COVID-19/epidemiology , Electronic Health Records/statistics & numerical data , England/epidemiology , Family Characteristics , Female , Humans , Male , Middle Aged , Mortality , Risk Assessment/methods , Risk Factors , Sentinel Surveillance , Sex Factors
Br J Gen Pract ; 70(697): e540-e547, 2020 08.
Article in English | MEDLINE | ID: covidwho-653992


BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has resulted in a rapid change in workload across healthcare systems. Factors related to this adaptation in UK primary care have not yet been examined. AIM: To assess the responsiveness and prioritisation of primary care consultation type for older adults during the COVID-19 pandemic. DESIGN AND SETTING: A cross-sectional database study examining consultations between 17 February and 10 May 2020 for patients aged ≥65 years, drawn from primary care practices within the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network, UK. METHOD: The authors reported the proportion of consultation type across five categories: clinical administration, electronic/video, face-to-face, telephone, and home visits. Temporal trends in telephone and face-to-face consultations were analysed by polypharmacy, frailty status, and socioeconomic group using incidence rate ratios (IRR). RESULTS: Across 3 851 304 consultations, the population median age was 75 years (interquartile range [IQR] 70-82); and 46% (n = 82 926) of the cohort (N = 180 420) were male. The rate of telephone and electronic/video consultations more than doubled across the study period (106.0% and 102.8%, respectively). Face-to-face consultations fell by 64.6% and home visits by 62.6%. This predominantly occurred across week 11 (week commencing 9 March 2020), coinciding with national policy change. Polypharmacy and frailty were associated with a relative increase in consultations. The greatest relative increase was among people taking ≥10 medications compared with those taking none (face-to-face IRR 9.90, 95% CI = 9.55 to 10.26; telephone IRR 17.64, 95% CI = 16.89 to 18.41). CONCLUSION: Primary care has undergone an unprecedented in-pandemic reorganisation while retaining focus on patients with increased complexity.

Betacoronavirus , Coronavirus Infections/therapy , House Calls/statistics & numerical data , Pneumonia, Viral/therapy , Primary Health Care/organization & administration , Aged , COVID-19 , Coronavirus Infections/epidemiology , Cross-Sectional Studies , Female , General Practitioners/organization & administration , Humans , Male , Pandemics , Pneumonia, Viral/epidemiology , SARS-CoV-2 , United Kingdom/epidemiology