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Summary: Background: A targeted vaccination programme for pandemic H1N1 2009 influenza was introduced in Scotland, UK, in October, 2009. We sought to assess the effectiveness of this vaccine in a sample of the Scottish population during the 2009–10 pandemic. Methods: We assessed the effectiveness of the Scottish pandemic H1N1 2009 influenza vaccination with a retrospective cohort design. We linked data of patient-level primary care, hospital records, death certification, and virological swabs to construct our cohort. We estimated vaccine effectiveness in a nationally representative sample of the Scottish population by establishing the risk of hospital admission and death (adjusted for potential confounders) resulting from influenza-related morbidity in vaccinated and unvaccinated patients and laboratory-confirmed cases of influenza H1N1 2009 in a subset of patients. Findings: Pandemic H1N1 2009 influenza vaccination began in week 43 of 2009 (Oct 21, 2009) and was given to 38 296 (15·5%, 95% CI 15·4–15·6) of 247 178 people by the end of the study period (Jan 31, 2010). 208 882 (85%) people were unvaccinated. There were 5207 emergency hospital admissions and 579 deaths in the unvaccinated population and 924 hospital admissions and 71 deaths in the vaccinated population during 23 893 359 person-days of observation. The effectiveness of H1N1 vaccination for prevention of emergency hospital admissions from influenza-related disorders was 19·5% (95% CI 0·8–34·7). The vaccine''s effectiveness in preventing laboratory-confirmed influenza was 77·0% (95% CI 2·0–95·0). Interpretation: Pandemic H1N1 2009 influenza vaccination was associated with protection against pandemic influenza and a reduction in hospital admissions from influenza-related disorders in Scotland during the 2009–10 pandemic. Funding: National Institute for Health Research Health Technology Assessment Programme (UK). [Copyright &y& Elsevier]

Presents information on a study which compared three scoring methods of risk assessment in primary prevention of coronary heart disease in Scotland. Sheffield table; New Zealand guidelines; Joint British chart; Comparison of the accuracy, ease of use and preference for doctors and nurses.

Background: Little is known about vaccine effectiveness over time among adolescents, especially against the SARS-CoV-2 omicron (B.1.1.529) variant. This study assessed the associations between time since two-dose vaccination with BNT162b2 and the occurrence of symptomatic SARS-CoV-2 infection and severe COVID-19 among adolescents in Brazil and Scotland.Methods: We did test-negative, case-control studies in adolescents aged 12-17 years with COVID-19-related symptoms in Brazil and Scotland. We linked records of SARS-CoV-2 RT-PCR and antigen tests to national vaccination and clinical records. We excluded tests from individuals who did not have symptoms, were vaccinated before the start of the national vaccination programme, received vaccines other than BNT162b2 or a SARS-CoV-2 booster dose of any kind, or had an interval between their first and second dose of fewer than 21 days. Additionally, we excluded negative SARS-CoV-2 tests recorded within 14 days of a previous negative test, negative tests recorded within 7 days after a positive test, any test done within 90 days after a positive test, and tests with missing sex and location information. Cases (SARS-CoV-2 test-positive adolescents) and controls (test-negative adolescents) were drawn from a sample of individuals in whom tests were collected within 10 days of symptom onset. We estimated the adjusted odds ratio and vaccine effectiveness against symptomatic COVID-19 for both countries and against severe COVID-19 (hospitalisation or death) for Brazil across fortnightly periods.Findings: We analysed 503 776 tests from 2 948 538 adolescents in Brazil between Sept 2, 2021, and April 19, 2022, and 127 168 tests from 404 673 adolescents in Scotland between Aug 6, 2021, and April 19, 2022. Vaccine effectiveness peaked at 14-27 days after the second dose in both countries during both waves, and was significantly lower against symptomatic infection during the omicron-dominant period in Brazil (64·7% [95% CI 63·0-66·3]) and in Scotland (82·6% [80·6-84·5]), than it was in the delta-dominant period (80·7% [95% CI 77·8-83·3] in Brazil and 92·8% [85·7-96·4] in Scotland). Vaccine efficacy started to decline from 27 days after the second dose for both countries, reducing to 5·9% (95% CI 2·2-9·4) in Brazil and 50·6% (42·7-57·4) in Scotland at 98 days or more during the omicron-dominant period. In Brazil, protection against severe disease remained above 80% from 28 days after the second dose and was 82·7% (95% CI 68·8-90·4) at 98 days or more after receiving the second dose.Interpretation: We found waning vaccine protection of BNT162b2 against symptomatic COVID-19 infection among adolescents in Brazil and Scotland from 27 days after the second dose. However, protection against severe COVID-19 outcomes remained high at 98 days or more after the second dose in the omicron-dominant period. Booster doses for adolescents need to be considered.Funding: UK Research and Innovation (Medical Research Council), Scottish Government, Health Data Research UK BREATHE Hub, Fiocruz, Fazer o Bem Faz Bem programme, Brazilian National Research Council, and Wellcome Trust.Translation: For the Portuguese translation of the abstract see Supplementary Materials section. [ABSTRACT FROM AUTHOR]

Background: Allopurinol is a urate-lowering therapy used to treat patients with gout. Previous studies have shown that allopurinol has positive effects on several cardiovascular parameters. The ALL-HEART study aimed to determine whether allopurinol therapy improves major cardiovascular outcomes in patients with ischaemic heart disease.Methods: ALL-HEART was a multicentre, prospective, randomised, open-label, blinded-endpoint trial done in 18 regional centres in England and Scotland, with patients recruited from 424 primary care practices. Eligible patients were aged 60 years or older, with ischaemic heart disease but no history of gout. Participants were randomly assigned (1:1), using a central web-based randomisation system accessed via a web-based application or an interactive voice response system, to receive oral allopurinol up-titrated to a dose of 600 mg daily (300 mg daily in participants with moderate renal impairment at baseline) or to continue usual care. The primary outcome was the composite cardiovascular endpoint of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death. The hazard ratio (allopurinol vs usual care) in a Cox proportional hazards model was assessed for superiority in a modified intention-to-treat analysis (excluding randomly assigned patients later found to have met one of the exclusion criteria). The safety analysis population included all patients in the modified intention-to-treat usual care group and those who took at least one dose of randomised medication in the allopurinol group. This study is registered with the EU Clinical Trials Register, EudraCT 2013-003559-39, and ISRCTN, ISRCTN32017426.Findings: Between Feb 7, 2014, and Oct 2, 2017, 5937 participants were enrolled and then randomly assigned to receive allopurinol or usual care. After exclusion of 216 patients after randomisation, 5721 participants (mean age 72·0 years [SD 6·8], 4321 [75·5%] males, and 5676 [99·2%] white) were included in the modified intention-to-treat population, with 2853 in the allopurinol group and 2868 in the usual care group. Mean follow-up time in the study was 4·8 years (1·5). There was no evidence of a difference between the randomised treatment groups in the rates of the primary endpoint. 314 (11·0%) participants in the allopurinol group (2·47 events per 100 patient-years) and 325 (11·3%) in the usual care group (2·37 events per 100 patient-years) had a primary endpoint (hazard ratio [HR] 1·04 [95% CI 0·89-1·21], p=0·65). 288 (10·1%) participants in the allopurinol group and 303 (10·6%) participants in the usual care group died from any cause (HR 1·02 [95% CI 0·87-1·20], p=0·77).Interpretation: In this large, randomised clinical trial in patients aged 60 years or older with ischaemic heart disease but no history of gout, there was no difference in the primary outcome of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death between participants randomised to allopurinol therapy and those randomised to usual care.Funding: UK National Institute for Health and Care Research. [ABSTRACT FROM AUTHOR]

Background: Reports suggest that COVID-19 vaccine effectiveness is decreasing, but whether this reflects waning or new SARS-CoV-2 variants-especially delta (B.1.617.2)-is unclear. We investigated the association between time since two doses of ChAdOx1 nCoV-19 vaccine and risk of severe COVID-19 outcomes in Scotland (where delta was dominant), with comparative analyses in Brazil (where delta was uncommon).Methods: In this retrospective, population-based cohort study in Brazil and Scotland, we linked national databases from the EAVE II study in Scotland; and the COVID-19 Vaccination Campaign, Acute Respiratory Infection Suspected Cases, and Severe Acute Respiratory Infection/Illness datasets in Brazil) for vaccination, laboratory testing, clinical, and mortality data. We defined cohorts of adults (aged ≥18 years) who received two doses of ChAdOx1 nCoV-19 and compared rates of severe COVID-19 outcomes (ie, COVID-19 hospital admission or death) across fortnightly periods, relative to 2-3 weeks after the second dose. Entry to the Scotland cohort started from May 19, 2021, and entry to the Brazil cohort started from Jan 18, 2021. Follow-up in both cohorts was until Oct 25, 2021. Poisson regression was used to estimate rate ratios (RRs) and vaccine effectiveness, with 95% CIs.Findings: 1 972 454 adults received two doses of ChAdOx1 nCoV-19 in Scotland and 42 558 839 in Brazil, with longer follow-up in Scotland because two-dose vaccination began earlier in Scotland than in Brazil. In Scotland, RRs for severe COVID-19 increased to 2·01 (95% CI 1·54-2·62) at 10-11 weeks, 3·01 (2·26-3·99) at 14-15 weeks, and 5·43 (4·00-7·38) at 18-19 weeks after the second dose. The pattern of results was similar in Brazil, with RRs of 2·29 (2·01-2·61) at 10-11 weeks, 3·10 (2·63-3·64) at 14-15 weeks, and 4·71 (3·83-5·78) at 18-19 weeks after the second dose. In Scotland, vaccine effectiveness decreased from 83·7% (95% CI 79·7-87·0) at 2-3 weeks, to 75·9% (72·9-78·6) at 14-15 weeks, and 63·7% (59·6-67·4) at 18-19 weeks after the second dose. In Brazil, vaccine effectiveness decreased from 86·4% (85·4-87·3) at 2-3 weeks, to 59·7% (54·6-64·2) at 14-15 weeks, and 42·2% (32·4-50·6) at 18-19 weeks.Interpretation: We found waning vaccine protection of ChAdOx1 nCoV-19 against COVID-19 hospital admissions and deaths in both Scotland and Brazil, this becoming evident within three months of the second vaccine dose. Consideration needs to be given to providing booster vaccine doses for people who have received ChAdOx1 nCoV-19.Funding: UK Research and Innovation (Medical Research Council), Scottish Government, Research and Innovation Industrial Strategy Challenge Fund, Health Data Research UK, Fiocruz, Fazer o Bem Faz Bem Programme; Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro.Translation: For the Portuguese translation of the abstract see Supplementary Materials section. [ABSTRACT FROM AUTHOR]

Abstract Objectives: To evaluate the effects of nurse led clinics in primary care on secondary prevention, total mortality, and coronary event rates after four years. Design: Follow up of a randomised controlled trial by postal questionnaires and review of case notes and national datasets. Setting: Stratified, random sample of 19 general practices in north east Scotland Participants: 1343 patients (673 intervention and 670 control) under 80 years with a working diagnosis of coronary heart disease but without terminal illness or dementia and not housebound. Intervention: Nurse led secondary prevention clinics promoted medical and lifestyle components of secondary prevention and offered regular follow up for one year. Main outcome measures: Components of secondary prevention (aspirin, blood pressure management, lipid management, healthy diet, exercise, non-smoking), total mortality, and coronary events (non-fatal myocardial infarctions and coronary deaths). Results: Mean follow up was at 4.7 years. Significant improvements were shown in the intervention group in all components of secondary prevention except smoking at one year, and these were sustained after four years except for exercise. The control group, most of whom attended clinics after the initial year, caught up before final follow up, and differences between groups were no longer significant. At 4.7 years, 100 patients in the intervention group and 128 in the control group had died: cumulative death rates were 14.5% and 18.9%, respectively (P=0.038). 100 coronary events occurred in the intervention group and 125 in the control group: cumulative event rates were 14.2% and 18.2%, respectively (P=0.052). Adjusting for age, sex, general practice, and baseline secondary prevention, proportional hazard ratios were 0.75 for all deaths (95% confidence intervals 0.58 to 0.98; P=0.036) and 0.76 for coronary events (0.58 to 1.00; P=0.049) Conclusions: Nurse led secondary prevention improved medical and lifestyle... [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic and ensuing national lockdowns have dramatically changed the healthcare landscape. The pandemic's impact on people with chronic obstructive pulmonary disease (COPD) remains poorly understood. We hypothesised that the UK-wide lockdown restrictions were associated with reductions in severe COPD exacerbations. We provide the first national level analyses of the impact of the COVID-19 pandemic and first lockdown on severe COPD exacerbations resulting in emergency hospital admissions and/or leading to death as well as those recorded in primary care or emergency departments.Methods: Using data from Public Health Scotland and the Secure Anonymised Information Linkage Databank in Wales, we accessed weekly counts of emergency hospital admissions and deaths due to COPD over the first 30 weeks of 2020 and compared these to the national averages over the preceding 5 years. For both Scotland and Wales, we undertook interrupted time-series analyses to model the impact of instigating lockdown on these outcomes. Using fixed-effect meta-analysis, we derived pooled estimates of the overall changes in trends across the two nations.Results: Lockdown was associated with 48% pooled reduction in emergency admissions for COPD in both countries (incidence rate ratio, IRR 0.52, 95% CI 0.46 to 0.58), relative to the 5-year averages. There was no statistically significant change in deaths due to COPD (pooled IRR 1.08, 95% CI 0.87 to 1.33). In Wales, lockdown was associated with 39% reduction in primary care consultations for acute exacerbation of COPD (IRR 0.61, 95% CI 0.52 to 0.71) and 46% reduction in COPD-related emergency department attendances (IRR 0.54, 95% CI 0.36 to 0.81).Conclusions: The UK-wide lockdown was associated with the most substantial reductions in COPD exacerbations ever seen across Scotland and Wales, with no corresponding increase in COPD deaths. This may have resulted from reduced transmission of respiratory infections, reduced exposure to outdoor air pollution and/or improved COPD self-management. [ABSTRACT FROM AUTHOR]

Focuses on a study that evaluated the effects of secondary prevention clinics run by nurses in general practice on the health of patients with coronary heart disease in northeast Scotland. Methodology of the study; Results and discussion; Conclusions.

Focuses on a study that aimed to determine secondary preventive treatment and habits among patients with coronary heart disease in general practice. Health promotions of British general practitioners; Subjects and methodology of the study; Results and discussion; Conclusion.

Background Influenza infection is a trigger of asthma attacks. Influenza vaccination can potentially reduce the incidence of influenza in people with asthma, but uptake remains persistently low, partially reflecting concerns about vaccine effectiveness (VE). Methods We conducted a test-negative designed case-control study to estimate the effectiveness of influenza vaccine in people with asthma in Scotland over 6 seasons (2010/2011 to 2015/2016). We used individual patient–level data from 223 practices, which yielded 1 830 772 patient-years of data that were linked with virological (n = 5910 swabs) data. Results Vaccination was associated with an overall 55.0% (95% confidence interval [CI], 45.8–62.7) risk reduction of laboratory-confirmed influenza infections in people with asthma over 6 seasons. There were substantial variations in VE between seasons, influenza strains, and age groups. The highest VE (76.1%; 95% CI, 55.6–87.1) was found in the 2010/2011 season, when the A(H1N1) strain dominated and there was a good antigenic vaccine match. High protection was observed against the A(H1N1) (eg, 2010/2011; 70.7%; 95% CI, 32.5–87.3) and B strains (eg, 2010/2011; 83.2%; 95% CI, 44.3–94.9), but there was lower protection for the A(H3N2) strain (eg, 2014/2015; 26.4%; 95% CI, −12.0 to 51.6). The highest VE against all viral strains was observed in adults aged 18–54 years (57.0%; 95% CI, 42.3–68.0). Conclusions Influenza vaccination gave meaningful protection against laboratory-confirmed influenza in people with asthma across all seasons. Strategies to boost influenza vaccine uptake have the potential to substantially reduce influenza-triggered asthma attacks. [ABSTRACT FROM AUTHOR]

Background High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices. Methods The NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: + educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study. Results Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2x). Conclusions The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings. Trial registration ClinicalTrials.gov: NCT01602705 [ABSTRACT FROM AUTHOR]

Background: For winter 2003/2004 in Scotland, it was recommended that all those aged 65 and over be eligible to receive 23-valent polysaccharide pneumococcal vaccine (23vPPV), which has been shown to be effective in reducing the risk of invasive pneumococcal disease (IPD). We assessed the success of the vaccination programme by examining the age specific incidence rates of IPD compared to four previous winter seasons and estimating vaccination effectiveness. Methods: Winter season incidence rates of IPD for vaccine targeted (65 years and over) and non-targeted (0-4, 5-34, 35-49, 50-64) age bands were examined for the Scottish population in a retrospective cohort design for winter 2003/2004. Details of all IPD cases were obtained from the central reference laboratory and population vaccine uptake information was estimated from a GP sentinel practice network. Based on the preceding four winter seasons, standardised incidence ratios (SIR) for invasive pneumococcal disease were determined by age-band and sex during winter 2003/2004. Vaccination effectiveness (VE) was estimated using both screening and indirect cohort methods. Numbers needed to vaccinate were derived from VE results using equivalent annual incidence estimates for winter 2003/2004. Results: Overall vaccination effectiveness using the screening method (adjusted for age and sex) in those aged 65 and over was 61.7% (95%CI: 45.1, 73.2) which corresponded to a number needed to vaccinate of 5206 (95%CI: 4388, 7122) per IPD case prevented. Estimated effectiveness for the same age group using the indirect cohort method was not significant at 51% (95%CI: -278, 94). Reductions in the winter season incidence rate of IPD were highly significant for all those aged 75+: males SIR = 58.8 (95%CI: 41.6, 80.8); females SIR = 70.0 (95%CI: 55.1, 87.8). In the 65-74 years age-group, the reduction for females was significant: SIR = 60.3 (95%CI: 39.3, 88.4), but not for males: SIR = 74.8 (95%CI: 50.8, 106.3). There was no significant protective effect on mortality. Conclusion: The introduction of 23vPPV for those aged 65 and over in Scotland during winter 2003/2004, was accompanied with a reduction of around one third in the incidence of IPD in this age group. Vaccination effectiveness estimates were comparable with those from other developed countries. [ABSTRACT FROM AUTHOR]

Objective To establish the cost effectiveness of nurse led secondary prevention clinics for coronary heart disease based on four years' follow up of a randomised controlled trial. Design Cost effectiveness analysis. Setting 19 general practices in north east Scotland. Participants 1343 patients (673 in intervention group and 670 in control group, as originally randomised) aged under 80 years with a diagnosis of coronary heart disease but without terminal illness or dementia and not housebound. Objective To establish the cost effectiveness of nurse led secondary prevention clinics for coronary heart disease based on four years' follow up of a randomised controlled trial. Design Cost effectiveness analysis. Setting 19 general practices in north east Scotland. Participants 1343 patients (673 in intervention group and 670 in control group, as originally randomised) aged under 80 years with a diagnosis of coronary heart disease but without terminal illness or dementia and not housebound. Intervention Nurse led clinics to promote medical and lifestyle components of secondary prevention. Main outcome measures Costs of clinics; overall costs to health service; and cost per life year and per quality adjusted life year (QALY) gained, expressed as incremental gain in intervention group compared with control group. Results The cost of the intervention (clinics and drugs) was £136 ($254; 195) per patient higher (1998-9 prices) in the intervention group, but the difference in other NHS costs, although lower for the intervention group, was not statistically significant. Overall, 28 fewer deaths occurred in the intervention group leading to a gain in mean life years per patient of 0.110 and of 0.124 QALYs. The incremental cost per life year saved was £1236 and that per QALY was £1097. Conclusion Nurse led clinics for the secondary prevention of coronary heart disease in primary care seem to be cost effective compared with most interventions in health care, with the main gains in life years saved. [ABSTRACT FROM AUTHOR]

Background: High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices.Methods: The NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: (1) educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study.Results: Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2×).Conclusions: The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings.Trial Registration: ClinicalTrials.gov: NCT01602705. [ABSTRACT FROM AUTHOR]

This article focuses on a study to establish the cost effectiveness of nurse led secondary prevention clinics for coronary heart disease based on four years' follow up of a randomised controlled trial. 1343 patients aged under 80 years with a diagnosis of coronary heart disease but without terminal illness or dementia participated in the study. Nurse led clinics for the secondary prevention of coronary heart disease in primary care seem to be cost effective compared with most interventions in health care, with the main gains in life years saved.

Focuses on the proposed screening model for the prevention of cardiovascular disease in general practice. Efficacy of the model to treat the disease; Administration of opportunistic screening on the patients; Incorporation of deidentified database to allow epidemiological studies.