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1.
Health Technol Assess ; 28(18): 1-55, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38551218

RESUMO

Background: Allopurinol is a xanthine oxidase inhibitor that lowers serum uric acid and is used to prevent acute gout flares in patients with gout. Observational and small interventional studies have suggested beneficial cardiovascular effects of allopurinol. Objective: To determine whether allopurinol improves major cardiovascular outcomes in patients with ischaemic heart disease. Design: Prospective, randomised, open-label, blinded endpoint multicentre clinical trial. Setting: Four hundred and twenty-four UK primary care practices. Participants: Aged 60 years and over with ischaemic heart disease but no gout. Interventions: Participants were randomised (1 : 1) using a central web-based randomisation system to receive allopurinol up to 600 mg daily that was added to usual care or to continue usual care. Main outcome measures: The primary outcome was the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes were non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, all-cause mortality, hospitalisation for heart failure, hospitalisation for acute coronary syndrome, coronary revascularisation, hospitalisation for acute coronary syndrome or coronary revascularisation, all cardiovascular hospitalisations, quality of life and cost-effectiveness. The hazard ratio (allopurinol vs. usual care) in a Cox proportional hazards model was assessed for superiority in a modified intention-to-treat analysis. Results: From 7 February 2014 to 2 October 2017, 5937 participants were enrolled and randomised to the allopurinol arm (n = 2979) or the usual care arm (n = 2958). A total of 5721 randomised participants (2853 allopurinol; 2868 usual care) were included in the modified intention-to-treat analysis population (mean age 72.0 years; 75.5% male). There was no difference between the allopurinol and usual care arms in the primary endpoint, 314 (11.0%) participants in the allopurinol arm (2.47 events per 100 patient-years) and 325 (11.3%) in the usual care arm (2.37 events per 100 patient-years), hazard ratio 1.04 (95% confidence interval 0.89 to 1.21); p = 0.65. Two hundred and eighty-eight (10.1%) participants in the allopurinol arm and 303 (10.6%) participants in the usual care arm died, hazard ratio 1.02 (95% confidence interval 0.87 to 1.20); p = 0.77. The pre-specified health economic analysis plan was to perform a 'within trial' cost-utility analysis if there was no statistically significant difference in the primary endpoint, so NHS costs and quality-adjusted life-years were estimated over a 5-year period. The difference in costs between treatment arms was +£115 higher for allopurinol (95% confidence interval £17 to £210) with no difference in quality-adjusted life-years (95% confidence interval -0.061 to +0.060). We conclude that there is no evidence that allopurinol used in line with the study protocol is cost-effective. Limitations: The results may not be generalisable to younger populations, other ethnic groups or patients with more acute ischaemic heart disease. One thousand six hundred and thirty-seven participants (57.4%) in the allopurinol arm withdrew from randomised treatment, but an on-treatment analysis gave similar results to the main analysis. Conclusions: The ALL-HEART study showed that treatment with allopurinol 600 mg daily did not improve cardiovascular outcomes compared to usual care in patients with ischaemic heart disease. We conclude that allopurinol should not be recommended for the secondary prevention of cardiovascular events in patients with ischaemic heart disease but no gout. Future work: The effects of allopurinol on cardiovascular outcomes in patients with ischaemic heart disease and co-existing hyperuricaemia or clinical gout could be explored in future studies. Trial registration: This trial is registered as EU Clinical Trials Register (EudraCT 2013-003559-39) and ISRCTN (ISRCTN 32017426). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 11/36/41) and is published in full in Health Technology Assessment; Vol. 28, No. 18. See the NIHR Funding and Awards website for further award information.


The purpose of the ALL-HEART study was to determine whether giving allopurinol to people with ischaemic heart disease (also commonly known as coronary heart disease) would reduce their risk of having a heart attack, stroke or of dying from cardiovascular disease. Allopurinol is a medication usually given to patients with gout to prevent acute gout flares. It is not currently used to treat ischaemic heart disease. We randomly allocated people aged over 60 years with ischaemic heart disease to take up to 600 mg of allopurinol daily (in addition to their usual care) or to continue with their usual care. We then monitored participants for several years and recorded any major health events such as heart attacks, strokes and deaths. We obtained most of the follow-up data from centrally held electronic hospital admissions and death records, making the study easier for participants and more cost-efficient. We asked participants in both groups to complete questionnaires to assess their quality of life during the study. We also collected data to determine whether there was any economic benefit to the NHS of using allopurinol in patients with ischaemic heart disease. There was no difference in the risk of heart attacks, strokes or death from cardiovascular disease between the participants given allopurinol and those in the group continuing their usual care. We also found no difference in the risks of other cardiovascular events, deaths from any cause or quality-of-life measurements between the allopurinol and usual care groups. The results of the ALL-HEART study suggest that we should not recommend that allopurinol be given to people with ischaemic heart disease to prevent further cardiovascular events or deaths.


Assuntos
Síndrome Coronariana Aguda , Gota , Infarto do Miocárdio , Isquemia Miocárdica , Acidente Vascular Cerebral , Humanos , Masculino , Pessoa de Meia-Idade , Idoso , Feminino , Alopurinol/uso terapêutico , Análise Custo-Benefício , Qualidade de Vida , Estudos Prospectivos , Ácido Úrico , Isquemia Miocárdica/tratamento farmacológico , Gota/tratamento farmacológico , Acidente Vascular Cerebral/tratamento farmacológico , Infarto do Miocárdio/tratamento farmacológico
2.
Lancet Digit Health ; 3(8): e517-e525, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34238721

RESUMO

BACKGROUND: As the COVID-19 pandemic continues, national-level surveillance platforms with real-time individual person-level data are required to monitor and predict the epidemiological and clinical profile of COVID-19 and inform public health policy. We aimed to create a national dataset of patient-level data in Scotland to identify temporal trends and COVID-19 risk factors, and to develop a novel statistical prediction model to forecast COVID-19-related deaths and hospitalisations during the second wave. METHODS: We established a surveillance platform to monitor COVID-19 temporal trends using person-level primary care data (including age, sex, socioeconomic status, urban or rural residence, care home residence, and clinical risk factors) linked to data on SARS-CoV-2 RT-PCR tests, hospitalisations, and deaths for all individuals resident in Scotland who were registered with a general practice on Feb 23, 2020. A Cox proportional hazards model was used to estimate the association between clinical risk groups and time to hospitalisation and death. A survival prediction model derived from data from March 1 to June 23, 2020, was created to forecast hospital admissions and deaths from October to December, 2020. We fitted a generalised additive spline model to daily SARS-CoV-2 cases over the previous 10 weeks and used this to create a 28-day forecast of the number of daily cases. The age and risk group pattern of cases in the previous 3 weeks was then used to select a stratified sample of individuals from our cohort who had not previously tested positive, with future cases in each group sampled from a multinomial distribution. We then used their patient characteristics (including age, sex, comorbidities, and socioeconomic status) to predict their probability of hospitalisation or death. FINDINGS: Our cohort included 5 384 819 people, representing 98·6% of the entire estimated population residing in Scotland during 2020. Hospitalisation and death among those testing positive for SARS-CoV-2 between March 1 and June 23, 2020, were associated with several patient characteristics, including male sex (hospitalisation hazard ratio [HR] 1·47, 95% CI 1·38-1·57; death HR 1·62, 1·49-1·76) and various comorbidities, with the highest hospitalisation HR found for transplantation (4·53, 1·87-10·98) and the highest death HR for myoneural disease (2·33, 1·46-3·71). For those testing positive, there were decreasing temporal trends in hospitalisation and death rates. The proportion of positive tests among older age groups (>40 years) and those with at-risk comorbidities increased during October, 2020. On Nov 10, 2020, the projected number of hospitalisations for Dec 8, 2020 (28 days later) was 90 per day (95% prediction interval 55-125) and the projected number of deaths was 21 per day (12-29). INTERPRETATION: The estimated incidence of SARS-CoV-2 infection based on positive tests recorded in this unique data resource has provided forecasts of hospitalisation and death rates for the whole of Scotland. These findings were used by the Scottish Government to inform their response to reduce COVID-19-related morbidity and mortality. FUNDING: Medical Research Council, National Institute for Health Research Health Technology Assessment Programme, UK Research and Innovation Industrial Strategy Challenge Fund, Health Data Research UK, Scottish Government Director General Health and Social Care.


Assuntos
COVID-19 , Previsões , Hospitalização , Modelos Estatísticos , Adolescente , Adulto , Idoso , COVID-19/epidemiologia , COVID-19/mortalidade , Teste de Ácido Nucleico para COVID-19/estatística & dados numéricos , Teste de Ácido Nucleico para COVID-19/tendências , Criança , Pré-Escolar , Comorbidade/tendências , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Armazenamento e Recuperação da Informação , Masculino , Pessoa de Meia-Idade , Atenção Primária à Saúde/estatística & dados numéricos , Fatores de Risco , Escócia/epidemiologia , Fatores Sexuais
3.
Health Technol Assess ; 24(67): 1-66, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33256892

RESUMO

BACKGROUND: There is good evidence of vaccine effectiveness in healthy individuals but less robust evidence for vaccine effectiveness in the populations targeted for influenza vaccination. The live attenuated influenza vaccine (LAIV) has recently been recommended for children in the UK. The trivalent influenza vaccine (TIV) is recommended for all people aged ≥ 65 years and for those aged < 65 years who are at an increased risk of complications from influenza infection (e.g. people with asthma). OBJECTIVE: To examine the vaccine effectiveness of LAIV and TIV. DESIGN: Cohort study and test-negative designs to estimate vaccine effectiveness. A self-case series study to ascertain adverse events associated with vaccination. SETTING: A national linkage of patient-level general practice (GP) data from 230 Scottish GPs to the Scottish Immunisation & Recall Service, Health Protection Scotland virology database, admissions to Scottish hospitals and the Scottish death register. PARTICIPANTS: A total of 1,250,000 people. INTERVENTIONS: LAIV for 2- to 11-year-olds and TIV for older people (aged ≥ 65 years) and those aged < 65 years who are at risk of diseases, from 2010/11 to 2015/16. MAIN OUTCOME MEASURES: The main outcome measures include vaccine effectiveness against laboratory-confirmed influenza using real-time reverse-transcription polymerase chain reaction (RT-PCR), influenza-related morbidity and mortality, and adverse events associated with vaccination. RESULTS: Two-fifths (40%) of preschool-aged children and three-fifths (60%) of primary school-aged children registered in study practices were vaccinated. Uptake varied among groups [e.g. most affluent vs. most deprived in 2- to 4-year-olds, odds ratio 1.76, 95% confidence interval (CI) 1.70 to 1.82]. LAIV-adjusted vaccine effectiveness among children (aged 2-11 years) for preventing RT-PCR laboratory-confirmed influenza was 21% (95% CI -19% to 47%) in 2014/15 and 58% (95% CI 39% to 71%) in 2015/16. No significant adverse events were associated with LAIV. Among at-risk 18- to 64-year-olds, significant trivalent influenza vaccine effectiveness was found for four of the six seasons, with the highest vaccine effectiveness in 2010/11 (53%, 95% CI 21% to 72%). The seasons with non-significant vaccine effectiveness had low levels of circulating influenza virus (2011/12, 5%; 2013/14, 9%). Among those people aged ≥ 65 years, TIV effectiveness was positive in all six seasons, but in only one of the six seasons (2013/14) was significance achieved (57%, 95% CI 20% to 76%). CONCLUSIONS: The study found that LAIV was safe and effective in decreasing RT-PCR-confirmed influenza in children. TIV was safe and significantly effective in most seasons for 18- to 64-year-olds, with positive vaccine effectiveness in most seasons for those people aged ≥ 65 years (although this was significant in only one season). FUTURE WORK: The UK Joint Committee on Vaccination and Immunisation has recommended the use of adjuvanted injectable vaccine for those people aged ≥ 65 years from season 2018/19 onwards. A future study will be required to evaluate this vaccine. TRIAL REGISTRATION: Current Controlled Trials ISRCTN88072400. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 67. See the NIHR Journals Library website for further project information.


In Scotland, a new type of influenza vaccine (live attenuated influenza vaccine), administered via the nose, was introduced in 2014/15 for all children aged between 2 and 11 years. It can be difficult to evaluate any changes in health as a result of new immunisation programmes, given that randomised controlled trials of vaccines are impractical and can also be seen as unethical. These changes are therefore typically not evaluated, making it difficult to inform future policy in this field. Observational studies can be used to assess the effects of health-care interventions without influencing the care that is provided or affecting the people who receive it. An evaluation (effectiveness and safety) of this change in the immunisation programme was conducted. The vaccine programme, an inactivated vaccine administered as an injection, for other groups for whom the evidence available is limited was also evaluated [i.e. for people aged ≥ 65 years and people aged < 65 years who have a medical condition (e.g. asthma) that puts them at risk of severe illness from influenza]. The findings support the view that the intranasal vaccine is effective and safe in preventing influenza in children. The injectable vaccine in people aged < 65 years who are more at risk of complications from flu was safe and effective. Lower effectiveness was found in people aged ≥ 65 years. Both the injectable vaccine and the intranasal vaccine have high levels of uptake in the population offered vaccination. When considering these results, the important limitation of bias in observational study designs should be noted [for instance, residual confounding, whereby it is not possible to measure a characteristic of those people receiving the vaccine (e.g. being healthier)], and this is accounted for in this analysis.


Assuntos
Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Vacinação/estatística & dados numéricos , Vacinas Atenuadas/imunologia , Adulto , Fatores Etários , Idoso , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Escócia , Estações do Ano
4.
J R Soc Med ; 113(11): 444-453, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33012218

RESUMO

OBJECTIVES: Following the outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus and the subsequent global spread of the 2019 novel coronavirus disease (COVID-19), health systems and the populations who use them have faced unprecedented challenges. We aimed to measure the impact of COVID-19 on the uptake of hospital-based care at a national level. DESIGN: The study period (weeks ending 5 January to 28 June 2020) encompassed the pandemic announcement by the World Health Organization and the initiation of the UK lockdown. We undertook an interrupted time-series analysis to evaluate the impact of these events on hospital services at a national level and across demographics, clinical specialties and National Health Service Health Boards. SETTING: Scotland, UK. PARTICIPANTS: Patients receiving hospital care from National Health Service Scotland. MAIN OUTCOME MEASURES: Accident and emergency (A&E) attendances, and emergency and planned hospital admissions measured using the relative change of weekly counts in 2020 to the averaged counts for equivalent weeks in 2018 and 2019. RESULTS: Before the pandemic announcement, the uptake of hospital care was largely consistent with historical levels. This was followed by sharp drops in all outcomes until UK lockdown, where activity began to steadily increase. This time-period saw an average reduction of -40.7% (95% confidence interval [CI]: -47.7 to -33.7) in A&E attendances, -25.8% (95% CI: -31.1 to -20.4) in emergency hospital admissions and -60.9% (95% CI: -66.1 to -55.7) in planned hospital admissions, in comparison to the 2018-2019 averages. All subgroup trends were broadly consistent within outcomes, but with notable variations across age groups, specialties and geography. CONCLUSIONS: COVID-19 has had a profoundly disruptive impact on hospital-based care across National Health Service Scotland. This has likely led to an adverse effect on non-COVID-19-related illnesses, increasing the possibility of potentially avoidable morbidity and mortality. Further research is required to elucidate these impacts.


Assuntos
COVID-19/epidemiologia , Serviço Hospitalar de Emergência/tendências , Análise de Séries Temporais Interrompida , Admissão do Paciente/tendências , SARS-CoV-2 , COVID-19/terapia , Feminino , Humanos , Masculino , Inovação Organizacional , Admissão do Paciente/estatística & dados numéricos , Escócia , Medicina Estatal
5.
Br J Gen Pract ; 66(646): e337-46, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26965029

RESUMO

BACKGROUND: There has been no comprehensive examination of the public's understanding of, and attitudes towards, NHS 24. AIM: To investigate the public's use of NHS 24 and explore their understanding of, and beliefs about, the service. DESIGN AND SETTING: Population-based cross-sectional study of adults in Scotland. METHOD: Quantitative data were collected by self-completion postal questionnaire and qualitative data by follow-up telephone interviews. RESULTS: A corrected response rate of 34.1% (n = 1190) was obtained. More than half (51.0%, n = 601) of responders had used NHS 24. Callers were more likely to be female, have at least one child, and be aged 25-34 years. Most calls (92.4%, n = 549) were made out of hours, and 54.6% (n = 327) were made on behalf of someone else. The main reason for calling was to get advice about a new symptom (69.0%, n = 414). A total of 38.6% (n = 219) of users contacted another health professional following their call, mostly on NHS 24 advice (71.7%, n = 157). Over 80.0% (n = 449) of callers were satisfied with the service and 93.9% (n = 539) would use it again.Only 8.4% (n = 78) of responders had used the NHS 24 website and 4.6% (n = 53) the NHS inform service. The main reasons for non-use were not needing the service, a preference to see their own GP, and not knowing the telephone number. NHS 24 was mainly viewed as an out-of-hours alternative to the GP. It was not considered an appropriate service for minor symptoms. The main facilitator to use was convenience, whereas the main barrier to use was not knowing how and when to use the service. CONCLUSION: Although most people who used NHS 24 were satisfied, others were unclear about how and when to use the service. Further education about the full range of services that NHS 24 offers should be considered.


Assuntos
Plantão Médico , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Linhas Diretas , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Atenção Primária à Saúde , Triagem/normas , Plantão Médico/estatística & dados numéricos , Estudos Transversais , Pesquisa sobre Serviços de Saúde , Humanos , Satisfação do Paciente , Atenção Primária à Saúde/estatística & dados numéricos , Avaliação de Programas e Projetos de Saúde , Pesquisa Qualitativa , Escócia/epidemiologia , Medicina Estatal , Inquéritos e Questionários , Telefone , Fatores de Tempo
6.
Health Technol Assess ; 19(79): 1-32, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26450686

RESUMO

BACKGROUND: After the introduction of any new pandemic influenza, population-level surveillance and rapid assessment of the effectiveness of a new vaccination will be required to ensure that it is targeted to those at increased risk of serious illness or death from influenza. OBJECTIVE: We aimed to build a pandemic influenza reporting platform that will determine, once a new pandemic is under way: the uptake and effectiveness of any new pandemic vaccine or any protective effect conferred by antiviral drugs once available; the clinical attack rate of pandemic influenza; and the existence of protection provided by previous exposure to, and vaccination from, A/H1N1 pandemic or seasonal influenza/identification of susceptible groups. DESIGN: An observational cohort and test-negative study design will be used (post pandemic). SETTING: A national linkage of patient-level general practice data from 41 Practice Team Information general practices, hospitalisation and death certification, virological swab and serology-linked data. PARTICIPANTS: We will study a nationally representative sample of the Scottish population comprising 300,000 patients. Confirmation of influenza using reverse transcription polymerase chain reaction and, in a subset of the population, serology. INTERVENTIONS: Future available pandemic influenza vaccination and antivirals will be evaluated. MAIN OUTCOME MEASURES: To build a reporting platform tailored towards the evaluation of pandemic influenza vaccination. This system will rapidly measure vaccine effectiveness (VE), adjusting for confounders, estimated by determining laboratory-confirmed influenza; influenza-related morbidity and mortality, including general practice influenza-like illnesses (ILIs); and hospitalisation and death from influenza and pneumonia. Once a validated haemagglutination inhibition assay has been developed (and prior to the introduction of any vaccination), cross-reactivity with previous exposure to A/H1N1 or A/H1N1 vaccination, other pandemic influenza or other seasonal influenza vaccination or exposure will be measured. CONCLUSIONS: A new sentinel system, capable of rapidly determining the estimated incidence of pandemic influenza, and pandemic influenza vaccine and antiviral uptake and effectiveness in preventing influenza and influenza-related clinical outcomes, has been created. We have all of the required regulatory approvals to allow rapid activation of the sentinel systems in the event of a pandemic. Of the 41 practices expressing an interest in participating, 40 have completed all of the necessary paperwork to take part in the reporting platform. The data extraction tool has been installed in these practices. Data extraction and deterministic linkage systems have been tested. Four biochemistry laboratories have been recruited, and systems for serology collection and linkage of samples to general practice data have been put in place. FUTURE WORK: The reporting platform has been set up and is ready to be activated in the event of any pandemic of influenza. Building on this infrastructure, there is now the opportunity to extend the network of general practices to allow important subgroup analyses of VE (e.g. for patients with comorbidities, at risk of serious ILI) and to link to other data sources, in particular to test for maternal outcomes in pregnant patients. STUDY REGISTRATION: This study is registered as ISRCTN55398410. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Assuntos
Vírus da Influenza A Subtipo H1N1/imunologia , Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Pandemias/prevenção & controle , Antivirais/uso terapêutico , Estudos de Coortes , Coleta de Dados , Feminino , Testes de Inibição da Hemaglutinação/métodos , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Influenza Humana/imunologia , Influenza Humana/mortalidade , Masculino , Avaliação de Resultados em Cuidados de Saúde , Gravidez , Características de Residência , Escócia/epidemiologia , Vigilância de Evento Sentinela
7.
BMJ Open ; 5(8): e007293, 2015 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-26310396

RESUMO

OBJECTIVES: To examine the type, duration and outcome of the symptoms and health problems Scotland's nurse-led telephone advice service (NHS 24) is contacted about and explore whether these vary by time of contact and patient characteristics. DESIGN: Analysis of routinely collected NHS 24 data. SETTING: Scotland, UK. PARTICIPANTS: Users of NHS 24 during 2011. MAIN OUTCOME MEASURES: Proportion of the type, duration and outcome of the symptoms and health problems NHS 24 is contacted about. RESULTS: 82.6% of the calls were made out-of-hours and 17.4% in-hours. Abdominal problems accounted for the largest proportion of calls (12.2%) followed by dental (6.8%) and rash/skin problems (6.0%). There were differences in the type of problems presented in-hours and out-of-hours. Most problems (62.9%) had lasted <24 h before people contacted NHS 24. Out-of-hours calls tended to be for problems of shorter duration. Problems reported out-of-hours most commonly resulted in advice to visit an out-of-hours centre and in-hours advice to contact a general practitioner. Most of the service users were female and from more affluent areas. Use of the service declined with age in those over 35 years. The characteristics of users varied according to when NHS 24 was contacted. The number of calls made by an individual in the year ranged from 1 to 866, although most users (69.2%) made only one call. The type of problem presented varied by age and deprivation, but was broadly similar by gender, rural/urban status and geographic area. Call outcomes also varied by user characteristics. CONCLUSIONS: This is the first study to examine how the public uses NHS 24. It has identified the patterns of problems which the service must be equipped to deal with. It has also provided important information about who uses the service and when. This information will help future planning and development of the service.


Assuntos
Plantão Médico , Serviços de Saúde Comunitária , Características de Residência , Telefone , Triagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Coleta de Dados , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Escócia , Fatores Socioeconômicos , Fatores de Tempo , Adulto Jovem
8.
Implement Sci ; 9: 133, 2014 Oct 11.
Artigo em Inglês | MEDLINE | ID: mdl-25304255

RESUMO

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.


Assuntos
Prescrições de Medicamentos/normas , Retroalimentação , Segurança do Paciente , Atenção Primária à Saúde/métodos , Técnica Delphi , Educação Médica Continuada/métodos , Grupos Focais , Humanos , Atenção Primária à Saúde/normas , Melhoria de Qualidade , Medicina Estatal , Inquéritos e Questionários
9.
Lancet Infect Dis ; 12(9): 696-702, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22738894

RESUMO

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).


Assuntos
Vírus da Influenza A Subtipo H1N1/imunologia , Vírus da Influenza A Subtipo H1N1/patogenicidade , Vacinas contra Influenza/imunologia , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Lactente , Recém-Nascido , Vacinas contra Influenza/administração & dosagem , Influenza Humana/imunologia , Influenza Humana/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Escócia/epidemiologia , Análise de Sobrevida , Adulto Jovem
10.
Br J Gen Pract ; 62(595): e113-20, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22520788

RESUMO

BACKGROUND: Anticipatory care for older patients who are frail involves both case identification and proactive intervention to reduce hospitalisation. AIM: To identify a population who were at risk of admission to hospital and to provide an anticipatory care plan (ACP) for them and to ascertain whether using primary and secondary care data to identify this population and then applying an ACP can help to reduce hospital admission rates. DESIGN AND SETTING: Cohort study of a service intervention in a general practice and a primary care team in Scotland. METHOD: The ACP sets out patients' wishes in the event of a sudden deterioration in health. If admitted, a proactive approach was taken to transfer and discharge patients into the community. Cohorts were selected using the Nairn Case Finder, which matched patients in two practices for age, sex, multiple morbidity indexes, and secondary care outpatient and inpatient activity; 96 patients in each practice were studied for admission rate, occupied bed days and survival. RESULTS: Survivors from the ACP cohort (n = 80) had 510 fewer days in hospital than in the 12 months pre-intervention: a significant reduction of 52.0% (P = 0.020). There were 37 fewer admissions of the survivors from that cohort post-intervention than in the preceding 12 months, with a significant reduction of 42.5% (P = 0.002). Mortality rates in the two cohorts were similar, but the number of patients who died in hospital and the hospital bed days used in the last 3 months of life were significantly lower for the decedents with an ACP than for the controls who had died (P = 0.007 and P = 0.045 respectively). CONCLUSION: This approach produced statistically significant reductions in unplanned hospitalisation for a cohort of patients with multiple morbidities. It demonstrates the potential for providing better care for patients as well as better value for health and social care services. It is of particular benefit in managing end-of-life care.


Assuntos
Medicina Geral/organização & administração , Hospitalização/estatística & dados numéricos , Planejamento de Assistência ao Paciente/organização & administração , Equipe de Assistência ao Paciente/organização & administração , Idoso de 80 Anos ou mais , Ocupação de Leitos , Efeitos Psicossociais da Doença , Feminino , Custos Hospitalares , Mortalidade Hospitalar , Hospitalização/economia , Humanos , Tempo de Internação , Masculino , Preferência do Paciente , Transferência de Pacientes , Projetos Piloto , Escócia
11.
Br J Gen Pract ; 61(588): e443-51, 2011 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-21722469

RESUMO

BACKGROUND: The 2004 introduction of the pay-for-performance contract has increased the proportion of income that GPs are able to earn by targeting quality care to patients with chronic diseases such as hypertension. AIM: To investigate the impact of pay for performance on the management of patients with hypertension in Scottish primary care. DESIGN AND SETTING: A population-based repeated cross-sectional study in Scottish primary care practices (n = 315) contributing to the Primary Care Clinical Informatics Unit database. METHOD: A dataset was extracted on 826 973 patients aged ≥40 years including, age, sex, socioeconomic deprivation status, hypertension diagnosis, recorded blood pressure measurement, attainment of target blood pressure levels, and provision of hypertension-related prescribing for each year from 2001 until 2006. RESULTS: Increasing treatment for hypertension (absolute difference [AD] 9.2%; 95% confidence interval [CI] = 9.0 to 9.5) occurred throughout the study period. The majority of increases found in blood pressure measurement (AD 46.8%; 95% CI = 46.5 to 47.1) and recorded hypertension (AD 5.9%; 95% CI = 5.7 to 6.0) occurred prior to 2004. Blood pressure control increased throughout the study period (absolute increase ≤140/90 mmHg; 18.9%; 95% CI = 18.5 to 19.4). After 2004, the oldest female, as well as the male and female patients with the greatest socioeconomic deprivation status, became less likely than their youngest (<40 years) and most affluent counterparts to have a blood pressure measurement recorded (P<0.05). Patients not prescribed therapy were younger and had higher blood pressure levels (P<0.001). CONCLUSION: It is likely that the continued efforts of general practice to improve hypertension diagnosis, monitoring, and treatment will reduce future cardiovascular events and mortality in those with hypertension. However, there is a need to follow up patients who are older and more socioeconomically deprived once they are diagnosed, as well as prescribing antihypertensive therapy to younger patients, who are likely to benefit from early intervention.


Assuntos
Anti-Hipertensivos/economia , Medicina de Família e Comunidade/economia , Hipertensão/tratamento farmacológico , Reembolso de Incentivo/economia , Adulto , Distribuição por Idade , Idoso , Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Estudos Transversais , Medicina de Família e Comunidade/normas , Feminino , Humanos , Hipertensão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Qualidade da Assistência à Saúde , Escócia , Distribuição por Sexo , Fatores Socioeconômicos
12.
Br J Gen Pract ; 55(516): 522-8, 2005 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-16004737

RESUMO

BACKGROUND: A randomised trial of nurse-led secondary prevention clinics for coronary heart disease resulted in improved secondary prevention and significantly lowered all-cause mortality at 4-year follow-up. This qualitative trial was conducted to explore the experience of health professionals that had been involved in running the clinics. AIM: To identify the barriers and facilitators to establishing secondary prevention clinics for coronary heart disease within primary care. DESIGN OF STUDY: Semi-structured audiotaped telephone interviews with GPs and nurses involved in running clinics. SETTING: A stratified, random sample of 19 urban, suburban, and rural general practices in north-east Scotland. METHOD: Semi-structured telephone interviews with 19 GPs and 17 practice-based nurses involved in running nurse-led clinics for the secondary prevention of coronary heart disease. RESULTS: Eight practices had run clinics continuously and 11 had stopped, with eight subsequently restarting. Participants accounted for these patterns by referring to advantages and disadvantages of the clinics in four areas: patient care, development of nursing skills, team working, and infrastructure. Most practitioners perceived benefits for patients from attending secondary prevention clinics, but some, from small rural practices, thought they were unnecessary. The extended role for nurses was welcomed, but was dependent on motivated staff, appropriate training and support. Clinics relied on, and could enhance, team working, however, some doctors were wary of delegating. With regard to infrastructure, staff shortages (especially nurses) and accommodation were as problematic as lack of funds. CONCLUSIONS: Nurse-led secondary prevention clinics were viewed positively by most healthcare professionals that had been involved in running them, but barriers to their implementation had led most to stop running them at some point. Lack of space and staff shortages are likely to remain ongoing problems, but improvements in funding training and communication within practices could help clinics to be put into practice and sustained.


Assuntos
Doença das Coronárias/enfermagem , Medicina de Família e Comunidade/organização & administração , Profissionais de Enfermagem/estatística & dados numéricos , Atitude do Pessoal de Saúde , Doença das Coronárias/economia , Doença das Coronárias/prevenção & controle , Educação Continuada em Enfermagem/métodos , Medicina de Família e Comunidade/economia , Seguimentos , Humanos , Profissionais de Enfermagem/educação , Relações Enfermeiro-Paciente , Satisfação do Paciente , Escócia
13.
BMJ ; 330(7493): 707, 2005 Mar 26.
Artigo em Inglês | MEDLINE | ID: mdl-15716289

RESUMO

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 pounds sterling (254 dollars; 195 euros) 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 pounds sterling and that per QALY was 1097 pounds sterling. 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.


Assuntos
Doença das Coronárias/enfermagem , Medicina de Família e Comunidade/economia , Adulto , Idoso , Doença das Coronárias/economia , Doença das Coronárias/prevenção & controle , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Seguimentos , Hospitalização/economia , Humanos , Pessoa de Meia-Idade , Anos de Vida Ajustados por Qualidade de Vida , Escócia
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