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OBJECTIVE: To estimate and compare the optimal cut-off score of Alcohol Use Disorders Identification Test (AUDIT) and AUDIT-C in identifying at-risk alcohol consumption, heavy episodic alcohol use, ICD-10 alcohol abuse and alcohol dependence in adolescents attending ED in England. DESIGN: Opportunistic cross-sectional survey. SETTING: 10 emergency departments across England. PARTICIPANTS: Adolescents (n = 5377) aged between their 10th and 18th birthday who attended emergency departments between December 2012 and May 2013. MEASURES: Scores on the AUDIT and AUDIT-C. At-risk alcohol consumption and monthly episodic alcohol consumption in the past 3 months were derived using the time-line follow back method. Alcohol abuse and alcohol dependence was assessed in accordance with ICD-10 criteria using the MINI-KID. FINDINGS: AUDIT-C with a score of 3 was more effective for at-risk alcohol use (AUC 0.81; sensitivity 87%, specificity 97%), heavy episodic use (0.84; 76%, 98%) and alcohol abuse (0.98; 91%, 90%). AUDIT with a score of 7 was more effective in identifying alcohol dependence (0.92; 96%, 94%). CONCLUSIONS: The 3-item AUDIT-C is more effective than AUDIT in screening adolescents for at-risk alcohol use, heavy episodic alcohol use and alcohol abuse. AUDIT is more effective than AUDIT-C for the identification of alcohol dependence.
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Alcoolismo/diagnóstico , Escalas de Graduação Psiquiátrica/normas , Adolescente , Alcoolismo/epidemiologia , Criança , Estudos Transversais , Serviço Hospitalar de Emergência , Inglaterra/epidemiologia , Feminino , Humanos , Masculino , Sensibilidade e EspecificidadeRESUMO
We have taken advantage of a natural experiment to measure the impact of the phased abolition of prescription co-payments in Wales. We investigated 3 study periods covering the phased abolition: from £6 to £4, £4 to £3, and £3 to £0. A difference-in-difference modelling was adopted and applied to monthly UK general practice level dispensing data on 14 selected medicines which had the highest percentage of items dispensed subject to a co-payment prior to abolition. Dispensing from a comparator region (North East of England) with similar health and socio-economic characteristics to Wales, and where prescription co-payments continued during the study periods, was used to isolate any non-price effects on dispensing in Wales. Results show a small increase in dispensing of 14 selected medicines versus the comparator. Compared with NE England, monthly average Welsh dispensing was increased by 11.93 items (7.67%; 95% CI [7.2%, 8.1%]), 6.37 items (3.38%; 95% CI [2.9%, 3.7%]) and 9.18 items (4.54%; 95% CI [4.2%, 4.9%]) per practice per 1,000 population during the periods when co-payment was reduced. Price elasticities of the selected medicines utilisation were -0.23, -0.13, and -0.04 in 3 analyses, suggesting the abolition of co-payment had small effect on Welsh dispensing.
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Custo Compartilhado de Seguro/economia , Seguro de Serviços Farmacêuticos/economia , Medicamentos sob Prescrição/economia , Inglaterra , Humanos , Modelos Econométricos , País de GalesRESUMO
BACKGROUND: Alcohol is a major global threat to public health. Although the main burden of chronic alcohol-related disease is in adults, its foundations often lie in adolescence. Alcohol consumption and related harm increase steeply from the age of 12 until 20 years. Several trials focusing upon young people have reported significant positive effects of brief interventions on a range of alcohol consumption outcomes. A recent review of reviews also suggests that electronic brief interventions (eBIs) using internet and smartphone technologies may markedly reduce alcohol consumption compared with minimal or no intervention controls. Interventions that target non-drinking youth are known to delay the onset of drinking behaviours. Web based alcohol interventions for adolescents also demonstrate significantly greater reductions in consumption and harm among 'high-risk' drinkers; however changes in risk status at follow-up for non-drinkers or low-risk drinkers have not been assessed in controlled trials of brief alcohol interventions. DESIGN AND METHODS: The study design comprises two linked randomised controlled trials to evaluate the effectiveness and cost-effectiveness of two intervention strategies compared with screening alone. One trial will focus on high-risk adolescent drinkers attending Emergency Departments (Eds) and the other will focus on those identified as low-risk drinkers or abstinent from alcohol but attending the same ED. Our primary (null) hypothesis is similar for both trials: Personalised Feedback and Brief Advice (PFBA) and Personalised Feedback plus electronic Brief Intervention (eBI) are no more effective than screening alone in alcohol consumed at 12 months after randomisation as measured by the Time-Line Follow-Back 28-day version. Our secondary (null) hypothesis relating to economics states that PFBA and eBI are no more cost-effective than screening alone. In total 1,500 participants will be recruited into the trials, 750 high-risk drinkers and 750 low-risk drinkers or abstainers. Participants will be randomised with equal probability, stratified by centre, to either a screening only control group or one of the two interventions: single session of PFBA or eBI. All participants will be eligible to receive treatment as usual in addition to any trial intervention. Individual participants will be followed up at 6 and 12 months after randomisation. DISCUSSION: The protocol represents an ambitious innovative programme of work addressing alcohol use in the adolescent population. TRIAL REGISTRATION: ISRCTN45300218. Registered 5th July 2014.
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Transtornos Relacionados ao Uso de Álcool/prevenção & controle , Transtornos Relacionados ao Uso de Álcool/terapia , Serviço Hospitalar de Emergência/organização & administração , Retroalimentação , Projetos de Pesquisa , Adolescente , Adulto , Transtornos Relacionados ao Uso de Álcool/economia , Intoxicação Alcoólica/prevenção & controle , Intoxicação Alcoólica/terapia , Análise Custo-Benefício , Aconselhamento , Serviço Hospitalar de Emergência/economia , Feminino , Humanos , Internet , Masculino , Adulto JovemRESUMO
BACKGROUND: Complex clinical interventions are increasingly subject to evaluation by randomised trial linked to economic evaluation. However evaluations of policy initiatives tend to eschew experimental designs in favour of interpretative perspectives which rarely allow the economic evaluation methods used in clinical trials. As evidence of the cost effectiveness of such initiatives is critical in informing policy, it is important to explore whether conventional economic evaluation methods apply to experimental evaluations of policy initiatives. METHODS: We used mixed methods based on a quasi-experimental design to evaluate a policy initiative whose aim was to expedite the modernisation of gastroenterology endoscopy services in England. We compared 10 sites which had received funding and support to modernise their endoscopy services with 10 controls. We collected data from five waves of patients undergoing endoscopy. The economic component of the study compared sites by levels of investment in modernisation and patients' use of health service resources, time off work and health related quality of life. RESULTS: We found no statistically significant difference between intervention and control sites in investment in modernisation or any patient outcome including health. CONCLUSIONS: This study highlights difficulties in applying the rigour of a randomised trial and associated technique of economic evaluation to a policy initiative. It nevertheless demonstrates the feasibility of using this approach although further work is needed to demonstrate its generalisability in other applications. The present application shows that the small incentives offered to intervention sites did not enhance modernisation of gastroenterology endoscopy services or improve patient outcomes.
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BACKGROUND: There is much evidence that smoking cessation interventions are both clinically and cost effective but these results relate only to the specific study populations involved in the studies. The present study aimed to compare and contrast results obtained when the effects of smoking cessation are modelled for several different European countries. METHODS: Local investigators collected data relating to several smoking related diseases. Costs and disease rates were then modelled up to 2030 for reductions in smoking of 3%, 15% and 30% using an epidemiological modelling tool, PREVENT. RESULTS: Models could not be constructed for some countries due to lack of data while for others substantial amounts of data had to be imputed. In all cases, disease rates fall when smoking cessation occurs. Overall costs initially fall before eventually rising as lives are saved and the population ages, leading to negative savings in some cases by the end of the modelled period. The speed and magnitude with which these effects occur are diverse for different countries. CONCLUSIONS: Health and economic results for different countries vary significantly for the same reductions in smoking. This suggests that it may be inappropriate to assume that evidence from one country will produce similar health and economic effects if the same levels of smoking cessation were achieved in another country which has evident messages for health policy. Problems with obtaining data also highlight the difficulties associated with modelling such scenarios and underline the need for relevant data to be routinely collected in all countries.
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Política de Saúde , Serviços Preventivos de Saúde/economia , Abandono do Hábito de Fumar/economia , Dispositivos para o Abandono do Uso de Tabaco/economia , Doença Crônica/economia , Doença Crônica/epidemiologia , Doença Crônica/mortalidade , Doença Crônica/terapia , Redução de Custos/estatística & dados numéricos , Análise Custo-Benefício , Europa (Continente)/epidemiologia , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Masculino , Fumar/epidemiologia , Abandono do Hábito de Fumar/métodos , Prevenção do Hábito de FumarRESUMO
OBJECTIVE: To assess effects of abolition of prescription copayments in Wales on rates of dispensing. METHODS: General practice-level monthly dispensing data were compared before/after abolition between Wales and North East (NE) England where the charge was retained. Data for 14 medicines that had most items dispensed subject to charge before abolition were similarly compared with NE England. For those with over-the-counter substitutes, wholesale sales to pharmacies were examined. A survey examined local initiatives, which might differentially affect dispensing between the two areas. RESULTS: Total dispensing rates (items/1000 patients) increased significantly in both areas but significantly less so in Wales (difference = -19.7, P = 0.024, 95% confidence interval [CI] = -36.7 to -2.6). For the 14 selected medicines, combined dispensing rates increased significantly in both areas but significantly more in Wales (difference = 27.51, P < 0.0001, 95% CI = 23.66-31.35). There was much variation for individual drugs, but categories tended to show this same trend except for antibiotics, where rates increased in Wales but decreased in NE England. The survey revealed few local initiatives that could explain these differences. Sales of over-the-counter substitutes did not explain the changes in dispensing. CONCLUSIONS: The Welsh policy was associated with a modest increase in dispensing rates relative to NE England for the 14 medicines with the highest number of items dispensed subject to charge before abolition. Although factors besides the copayment may have influenced these observations, the smaller relative increase in total dispensing rates in Wales suggests that the overall impact of abolition was minimal.
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Política de Saúde/economia , Seguro de Serviços Farmacêuticos/economia , Farmácias/economia , Farmacopeias como Assunto , Medicamentos sob Prescrição/economia , Intervalos de Confiança , Inglaterra , Humanos , Seguro de Serviços Farmacêuticos/estatística & dados numéricos , Farmácias/estatística & dados numéricos , Inquéritos e Questionários , País de GalesRESUMO
OBJECTIVES: patient co-payments for prescription medicines in Wales were abolished in April 2007 and there has been much speculation on the possible effects. We analysed patient-reported use of medicines before and after abolition of the prescription charge, noting changes in the number of items prescribed, number of non-prescription medicines purchased and participants not collecting all prescribed items (primary non-adherence). METHODS: a sample of community pharmacists across Wales (n = 249) issued questionnaires to customers at the point of dispensing who were not exempt from the prescription charge. A second questionnaire was delivered by post to those who returned the first questionnaire (n = 1027) and expressed a willingness to participate further. Paired t-tests were applied to responses from those completing both questionnaires (n = 593). Further analyses were carried out according to gender, age and reported levels of household income. KEY FINDINGS: there was a statistically significant (P = 0.03) rise in the number of items prescribed, and a statistically significant fall (P = 0.02) in the number of non-prescription medicines purchased. Primary non-adherence was also found to fall between pre- and post-abolition periods. Those most affected in terms of increase in number of prescribed items prescribed were the older age group (45-59 years), and those with household income of between £15600 and £36400. The most affected in the fall in number of medicines purchased were males, those in the lower age group (25-34 years) and those with a higher household income (>£36400). CONCLUSIONS: although the rise in number of items prescribed and fall in number of medicines purchased was generally anticipated, there appeared to be little or no effect for those on the lowest incomes.
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Custo Compartilhado de Seguro/economia , Adesão à Medicação/estatística & dados numéricos , Medicamentos sob Prescrição/economia , Honorários por Prescrição de Medicamentos/estatística & dados numéricos , Adulto , Distribuição por Idade , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Renda/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Medicamentos sem Prescrição/economia , Medicamentos sem Prescrição/uso terapêutico , Farmácias/economia , Medicamentos sob Prescrição/uso terapêutico , Distribuição por Sexo , Inquéritos e Questionários , País de GalesRESUMO
Objectives: Metamodels have been used to approximate complex simulations and have many applications with sensitivity analysis, optimization, etc. However, their use in health economics is very limited. Application of artificial neural network (ANN) with a health economic model has never been investigated. The study intends to introduce ANN as a metamodeling method to conduct sensitivity analysis in a total hip replacement decision analytical model and compare its performance with two other counterparts. Methods: First, a nonlinear factor screening method was adopted to screen out unimportant factors from the simulation. Second, an ANN was developed using the important variables to approximate the simulation. Performance of the ANN metamodel was then compared with its Gaussian Process (GP) and multiple linear regression (MLR) counterparts. Results: Out of 31, the factor screening method identified 12 important variables from the simulation. ANN metamodels showed best predictive capabilities in terms of performance measures (mean squared error of prediction, MSEP and mean absolute percentage deviation, MAPD) used for predicting both costs and quality-adjusted life years (QALYs) for two prostheses. Conclusion: The study provides a methodological development in sensitivity analysis and demonstrates that an ANN metamodel is a potential approximation method for computationally expensive health economic simulations.
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Artroplastia de Quadril/economia , Modelos Econômicos , Redes Neurais de Computação , Simulação por Computador , Humanos , Modelos Lineares , Distribuição Normal , Anos de Vida Ajustados por Qualidade de VidaRESUMO
OBJECTIVE: People with diabetes mellitus have a high risk of acquiring respiratory tract infections (RTIs), yet little is known about their utilisation of healthcare services compared with people without diabetes. This study aimed to compare the utilisation of healthcare services for RTIs between individuals with and without diabetes attending primary healthcare centres (PHCCs) in Qatar. DESIGN: A retrospective cross-sectional study was conducted using an electronic database of all individuals who had a diagnosis of RTI. SETTING: PHCCs in Qatar from July 2015 to December 2017. PARTICIPANTS: Participants in the study were all adult individuals (aged ≥18 years) who visited the primary healthcare facilities and were diagnosed with an RTI during the study period. PRIMARY AND OUTCOME MEASURES: For each participant, visits to the healthcare facility, antibiotic use and use of other medications were extracted from the electronic database and compared between participants with and without a diabetes diagnosis. RESULTS: A total of 32 857 participants were included, of whom 7407 (22.5%) had a diabetes diagnosis. Results from a negative binomial regression indicate that diabetes diagnosis was significantly associated with increased visits to the healthcare facility (incidence rate ratio (IRR) 1.10, 95% CI 1.076 to 1.134, p<0.001), antibiotic use (IRR 1.09, 95% CI 1.046 to 1.145, p<0.001) and use of other medications (IRR 1.11, 95% CI 1.078 to 1.143, p<0.001). CONCLUSIONS: A diabetes diagnosis among patients with RTI was associated with higher utilisation of healthcare services. Given the added costs to the healthcare system, prevention of diabetes will have additional benefits to the healthcare system, apart from diabetes-associated costs alone.
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Diabetes Mellitus , Infecções Respiratórias , Adolescente , Adulto , Estudos Transversais , Atenção à Saúde , Diabetes Mellitus/epidemiologia , Diabetes Mellitus/terapia , Humanos , Catar/epidemiologia , Infecções Respiratórias/tratamento farmacológico , Infecções Respiratórias/epidemiologia , Estudos RetrospectivosRESUMO
Information about the socioeconomic drivers of Silurus glanis anglers in the UK were collected using questionnaires from a cross section of mixed cyprinid fisheries to elucidate human dimensions in angling and non-native fisheries management. Respondents were predominantly male (95%), 30-40 years of age with <10 yr angling experience for S. glanis; most had received college rather than university education. The majority (34%) were employed with low-moderate income status (<£30k per annum), which may restrict time and expenditure spent on angling. Highest angling expenditure was on equipment and bait with most from southern England (54%) spending >£500 per annum. The proportion of time spent angling for S. glanis was significantly related to angler motivations; fish size, challenge in catch, tranquil natural surroundings, escape from daily stress and to be alone were considered important drivers of increased time spent angling. Overall, poor awareness of: the risks and adverse ecological impacts associated with introduced S. glanis, non-native fisheries legislation, problems in use of unlimited ground bait and high fish stocking rates in angling lakes were evident, possibly related to inadequate training and information provided by angling organisations to anglers, as many stated that they were insufficiently informed.
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Peixes-Gato , Pesqueiros , Recreação , Inquéritos e Questionários , Adolescente , Adulto , Idoso , Animais , Inglaterra , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Motivação , Fatores Socioeconômicos , Fatores de Tempo , Adulto JovemRESUMO
BACKGROUND AND AIMS: Premises licensed for the sale and consumption of alcohol can contribute to levels of assault-related injury through poor operational practices that, if addressed, could reduce violence. We tested the real-world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. DESIGN: A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. SETTING: All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. PARTICIPANTS: A randomly selected subsample (n = 600) of eligible premises (that had one or more violent incidents recorded in police-recorded crime data; n = 837) were randomized into control and intervention groups. INTERVENTION AND COMPARATOR: Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow-up visits) on how risks could be addressed. Control premises received usual practice. MEASUREMENTS: Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455-day period following randomization. FINDINGS: Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention-to-treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20-1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow-up visits). CONCLUSION: An Environmental Health Practitioner-led intervention in premises licensed for the sale and on-site consumption of alcohol resulted in an increase in police recorded violence.
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Consumo de Bebidas Alcoólicas , Gestão da Segurança/métodos , Violência/prevenção & controle , Bebidas Alcoólicas , Comércio , Humanos , Licenciamento , Modelos de Riscos Proporcionais , Restaurantes , País de GalesRESUMO
BACKGROUND: The efficacy of infliximab and ciclosporin in treating severe ulcerative colitis (UC) is proven, but there has been no comparative evaluation of effectiveness. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of infliximab and ciclosporin in treating steroid-resistant acute severe UC. METHOD: Between May 2010 and February 2013 we recruited 270 participants from 52 hospitals in England, Scotland and Wales to an open-label parallel-group, pragmatic randomised trial. Consented patients admitted with severe colitis completed baseline quality-of-life questionnaires before receiving intravenous hydrocortisone. If they failed to respond within about 5 days, and met other inclusion criteria, we invited them to participate and used a web-based adaptive randomisation algorithm to allocate them in equal proportions between 5 mg/kg of intravenous infliximab at 0, 2 and 6 weeks or 2 mg/kg/day of intravenous ciclosporin for 7 days followed by 5.5 mg/kg/day of oral ciclosporin until 12 weeks from randomisation. Further treatment was at the discretion of physicians responsible for clinical management. The primary outcome was quality-adjusted survival (QAS): the area under the curve (AUC) of scores derived from Crohn's and Ulcerative Colitis Questionnaires completed by participants at 3 and 6 months, and then 6-monthly over 1-3 years, more frequently after surgery. Secondary outcomes collected simultaneously included European Quality of Life-5 Dimensions (EQ-5D) scores and NHS resource use to estimate cost-effectiveness. Blinding was possible only for data analysts. We interviewed 20 trial participants and 23 participating professionals. Funded data collection finished in March 2014. Most participants consented to complete annual questionnaires and for us to analyse their routinely collected health data over 10 years. RESULTS: The 135 participants in each group were well matched at baseline. In 121 participants analysed in each group, we found no significant difference between infliximab and ciclosporin in QAS [mean difference in AUC/day 0.0297 favouring ciclosporin, 95% confidence interval (CI) -0.0088 to 0.0682; p = 0.129]; EQ-5D scores (quality-adjusted life-year mean difference 0.021 favouring ciclosporin, 95% CI -0.032 to 0.096; p = 0.350); Short Form questionnaire-6 Dimensions scores (mean difference 0.0051 favouring ciclosporin, 95% CI -0.0250 to 0.0353; p = 0.737). There was no statistically significant difference in colectomy rates [odds ratio (OR) 1.350 favouring infliximab, 95% CI 0.832 to 2.188; p = 0.223]; numbers of serious adverse reactions (event ratio = 0.938 favouring ciclosporin, 95% CI 0.590 to 1.493; p = 0.788); participants with serious adverse reactions (OR 0.660 favouring ciclosporin, 95% CI 0.282 to 1.546; p = 0.338); numbers of serious adverse events (event ratio 1.075 favouring infliximab, 95% CI 0.603 to 1.917; p = 0.807); participants with serious adverse events (OR 0.999 favouring infliximab, 95% CI 0.473 to 2.114; p = 0.998); deaths (all three who died received infliximab; p = 0.247) or concomitant use of immunosuppressants. The lower cost of ciclosporin led to lower total NHS costs (mean difference -£5632, 95% CI -£8305 to -£2773; p < 0.001). Interviews highlighted the debilitating effect of UC; participants were more positive about infliximab than ciclosporin. Professionals reported advantages and disadvantages with both drugs, but nurses disliked the intravenous ciclosporin. CONCLUSIONS: Total cost to the NHS was considerably higher for infliximab than ciclosporin. Nevertheless, there was no significant difference between the two drugs in clinical effectiveness, colectomy rates, incidence of SAEs or reactions, or mortality, when measured 1-3 years post treatment. To assess long-term outcome participants will be followed up for 10 years post randomisation, using questionnaires and routinely collected data. Further studies will be needed to evaluate the efficacy and effectiveness of new anti-tumour necrosis factor drugs and formulations of ciclosporin. TRIAL REGISTRATION: Current Controlled Trials ISRCTN22663589. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 44. See the NIHR Journals Library website for further project information.
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Colite Ulcerativa/tratamento farmacológico , Ciclosporina/economia , Ciclosporina/uso terapêutico , Imunossupressores/economia , Imunossupressores/uso terapêutico , Infliximab/economia , Infliximab/uso terapêutico , Adulto , Colite Ulcerativa/mortalidade , Colite Ulcerativa/cirurgia , Análise Custo-Benefício , Ciclosporina/administração & dosagem , Ciclosporina/efeitos adversos , Feminino , Humanos , Imunossupressores/administração & dosagem , Imunossupressores/efeitos adversos , Infliximab/administração & dosagem , Infliximab/efeitos adversos , Masculino , Pessoa de Meia-Idade , Modelos Econométricos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal , Reino UnidoRESUMO
BACKGROUND: Obesity has significant health and NHS cost implications. Relatively small reductions in weight have clinically important benefits, but long-term weight loss maintenance (WLM) is challenging. Behaviour change interventions have been identified as key for WLM. Motivation is crucial to supporting behaviour change, and motivational interviewing (MI) has been identified as a successful approach to changing health behaviours. The study was designed as an adequately powered, pragmatic randomised controlled trial (RCT); however, owing to recruitment issues, the study became a feasibility trial. OBJECTIVES: To assess recruitment, retention, feasibility, acceptability, compliance and delivery of a 12-month intervention to support WLM. Secondary objectives were to assess the impact of the intervention on body mass index (BMI) and other secondary outcomes. DESIGN: Three-arm individually randomised controlled trial comprising an intensive arm, a less intensive arm and a control arm. SETTING: Community setting in South Wales and the East Midlands. PARTICIPANTS: Individuals aged 18-70 years with a current or previous BMI of ≥ 30 kg/m(2) who could provide evidence of at least 5% weight loss during the previous 12 months. INTERVENTION: Participants received individually tailored MI, which included planning and self-monitoring. The intensive arm received six face-to-face sessions followed by nine telephone sessions. The less intensive arm received two face-to-face sessions followed by two telephone sessions. The control arm received a leaflet advising them on healthy lifestyle. MAIN OUTCOME MEASURES: Feasibility outcomes included numbers recruited, retention and adherence. The primary effectiveness outcome was BMI at 12 months post randomisation. Secondary outcomes included waist circumference, waist-to-hip ratio, physical activity, proportion maintaining weight loss, diet, quality of life, health service resource usage, binge eating and well-being. A process evaluation assessed intervention delivery, adherence, and participants' and practitioners' views. Economic analysis aimed to assess cost-effectiveness in terms of quality-adjusted life-years (QALYs). RESULTS: A total of 170 participants were randomised. Retention was good (84%) and adherence was excellent (intensive, 83%; less intensive, 91%). The between-group difference in mean BMI indicated the intensive arm had BMIs 1.0 kg/m(2) lower than the controls [95% confidence interval (CI) -2.2 kg/m(2) to 0.2 kg/m(2)]. Similarly, a potential difference was found in weight (average difference of 2.8 kg, 95% CI -6.1 kg to 0.5 kg). The intensive arm had odds of maintaining on average 43% [odds ratio(OR) 1.4, 95% CI 0.6 to 3.5] higher than controls. None of these findings were statistically significant. Further analyses controlling for level of adherence indicated that average BMI was 1.2 kg/m(2) lower in the intensive arm than the control arm (95% CI -2.5 kg/m(2) to 0.0 kg/m(2)). The intensive intervention led to a statistically significant difference in weight (mean -3.7 kg, 95% CI -7.1 kg to -0.3 kg). The other secondary outcomes showed limited evidence of differences between groups. The intervention was delivered as planned, and both practitioners and participants were positive about the intervention and its impact. Although not powered to assess cost-effectiveness, results of this feasibility study suggest that neither intervention as currently delivered is likely to be cost-effective in routine practice. CONCLUSION: This is the first trial of an intervention for WLM in the UK, the intervention is feasible and acceptable, and retention and adherence were high. The main effectiveness outcome showed a promising mean difference in the intensive arm. Owing to the small sample size, we are limited in the conclusions we can draw. However, findings suggest that the intensive intervention may facilitate long-term weight maintenance and, therefore, further testing in an effectiveness trial may be indicated. Research examining WLM is in its infancy, further research is needed to develop our understanding of WLM and to expand theory to inform the development of interventions to be tested in rigorously designed RCTs with cost-effectiveness assessed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN35774128. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 50. See the NIHR Journals Library website for further project information.
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Terapia Comportamental/métodos , Manutenção do Peso Corporal , Entrevista Motivacional/métodos , Obesidade/terapia , Programas de Redução de Peso/métodos , Adulto , Atitude do Pessoal de Saúde , Terapia Comportamental/economia , Índice de Massa Corporal , Análise Custo-Benefício , Inglaterra , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Entrevista Motivacional/economia , Obesidade/complicações , Obesidade/economia , Avaliação de Processos e Resultados em Cuidados de Saúde/economia , Avaliação de Processos e Resultados em Cuidados de Saúde/métodos , Cooperação do Paciente/estatística & dados numéricos , Satisfação do Paciente , Medicina Estatal/economia , País de Gales , Programas de Redução de Peso/economiaRESUMO
INTRODUCTION: Many patients with ulcerative colitis (UC) present with acute exacerbations needing hospital admission. Treatment includes intravenous steroids but up to 40% of patients do not respond and require emergency colectomy. Mortality following emergency colectomy has fallen, but 10% of patients still die within 3 months of surgery. Infliximab and ciclosporin, both immunosuppressive drugs, offer hope for treating steroid-resistant UC as there is evidence of their short-term effectiveness. As there is little long-term evidence, this pragmatic randomised trial, known as Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: a Trial (CONSTRUCT), aims to compare the clinical and cost-effectiveness of infliximab and ciclosporin for steroid-resistant UC. METHODS AND ANALYSIS: Between May 2010 and February 2013, 52 UK centres recruited 270 patients admitted with acute severe UC who failed to respond to intravenous steroids but did not need surgery. We allocated them at random in equal proportions between infliximab and ciclosporin.The primary clinical outcome measure is quality-adjusted survival, that is survival weighted by Crohn's and Colitis Questionnaire (CCQ) participants' scores, analysed by Cox regression. Secondary outcome measures include: the CCQ-an extension of the validated but community-focused UK Inflammatory Bowel Disease Questionnaire (IBDQ) to include patients with acute severe colitis and stoma; two general quality of life measures-EQ-5D and SF-12; mortality; survival weighted by EQ-5D; emergency and planned colectomies; readmissions; incidence of adverse events including malignancies, serious infections and renal disorders; disease activity; National Health Service (NHS) costs and patient-borne costs. Interviews investigate participants' views on therapies for acute severe UC and healthcare professionals' views on the two drugs and their administration. ETHICS AND DISSEMINATION: The Research Ethics Committee for Wales has given ethical approval (Ref. 08/MRE09/42); each participating Trust or Health Board has given NHS Reseach & Development approval. We plan to present trial findings at international and national conferences and publish in high-impact peer-reviewed journals. TRIAL REGISTRATION NUMBER ISRCTN: 22663589; EudraCT number: 2008-001968-36.
Assuntos
Colite Ulcerativa/tratamento farmacológico , Ciclosporina/uso terapêutico , Imunossupressores/uso terapêutico , Infliximab/uso terapêutico , Corticosteroides/uso terapêutico , Colectomia , Colite Ulcerativa/fisiopatologia , Colite Ulcerativa/cirurgia , Análise Custo-Benefício , Ciclosporina/economia , Progressão da Doença , Custos de Medicamentos , Resistência a Medicamentos , Humanos , Imunossupressores/economia , Infliximab/economia , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Reino UnidoRESUMO
OBJECTIVES: To evaluate the effect of training primary care health professionals in behaviour change counselling on the proportion of patients self reporting change in four risk behaviours (smoking, alcohol use, exercise, and healthy eating). DESIGN: Cluster randomised trial with general practices as the unit of randomisation. SETTING: General practices in Wales. PARTICIPANTS: 53 general practitioners and practice nurses from 27 general practices (one each at all but one practice) recruited 1827 patients who screened positive for at least one risky behaviour. INTERVENTION: Behaviour change counselling was developed from motivational interviewing to enable clinicians to enhance patients' motivation to change health related behaviour. Clinicians were trained using a blended learning programme called Talking Lifestyles. MAIN OUTCOME MEASURES: Proportion of patients who reported making beneficial changes in at least one of the four risky behaviours at three months. RESULTS: 1308 patients from 13 intervention and 1496 from 14 control practices were approached: 76% and 72% respectively agreed to participate, with 831 (84%) and 996 (92%) respectively screening eligible for an intervention. There was no effect on the primary outcome (beneficial change in behaviour) at three months (362 (44%) v 404 (41%), odds ratio 1.12 (95% CI 0.90 to 1.39)) or on biochemical or biometric measures at 12 months. More patients who had consulted with trained clinicians recalled consultation discussion about a health behaviour (724/795 (91%) v 531/966 (55%), odds ratio 12.44 (5.85 to 26.46)) and intended to change (599/831 (72%) v 491/996 (49%), odds ratio 2.88 (2.05 to 4.05)). More intervention practice patients reported making an attempt to change (328 (39%) v 317 (32%), odds ratio 1.40 (1.15 to 1.70)), a sustained behaviour change at three months (288 (35%) v 280 (28%), odds ratio 1.36 (1.11 to 1.65)), and reported slightly greater improvements in healthy eating at three and 12 months, plus improved activity at 12 months. Training cost £1597 per practice. DISCUSSION: Training primary care clinicians in behaviour change counselling using a brief blended learning programme did not increase patients reported beneficial behaviour change at three months or improve biometric and a biochemical measure at 12 months, but it did increase patients' recollection of discussing behaviour change with their clinicians, intentions to change, attempts to change, and perceptions of having made a lasting change at three months. Enduring behaviour change and improvements in biometric measures are unlikely after a single routine consultation with a clinician trained in behaviour change counselling without additional intervention. TRIAL REGISTRATION: ISRCTN 22495456.
Assuntos
Medicina Geral/organização & administração , Clínicos Gerais/educação , Comportamentos Relacionados com a Saúde , Estilo de Vida , Profissionais de Enfermagem/educação , Adulto , Atitude Frente a Saúde , Análise por Conglomerados , Intervalos de Confiança , Aconselhamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Cooperação do Paciente/estatística & dados numéricos , Relações Médico-Paciente , Atenção Primária à Saúde/organização & administração , Avaliação de Programas e Projetos de Saúde , Medição de Risco , Fatores de Tempo , Resultado do Tratamento , País de GalesRESUMO
OBJECTIVE: To evaluate the effectiveness and costs of a multifaceted flexible educational programme aimed at reducing antibiotic dispensing at the practice level in primary care. DESIGN: Randomised controlled trial with general practices as the unit of randomisation and analysis. Clinicians and researchers were blinded to group allocation until after randomisation. SETTING: 68 general practices with about 480,000 patients in Wales, United Kingdom. PARTICIPANTS: 34 practices were randomised to receive the educational programme and 34 practices to be controls. 139 clinicians from the intervention practices and 124 from control practices had agreed to participate before randomisation. Practice level data covering all the clinicians in the 68 practices were analysed. INTERVENTIONS: Intervention practices followed the Stemming the Tide of Antibiotic Resistance (STAR) educational programme, which included a practice based seminar reflecting on the practices' own dispensing and resistance data, online educational elements, and practising consulting skills in routine care. Control practices provided usual care. MAIN OUTCOME MEASURES: Total numbers of oral antibiotic items dispensed for all causes per 1000 practice patients in the year after the intervention, adjusted for the previous year's dispensing. Secondary outcomes included reconsultations, admissions to hospital for selected causes, and costs. RESULTS: The rate of oral antibiotic dispensing (items per 1000 registered patients) decreased by 14.1 in the intervention group but increased by 12.1 in the control group, a net difference of 26.1. After adjustment for baseline dispensing rate, this amounted to a 4.2% (95% confidence interval 0.6% to 7.7%) reduction in total oral antibiotic dispensing for the year in the intervention group relative to the control group (P=0.02). Reductions were found for all classes of antibiotics other than penicillinase-resistant penicillins but were largest and significant individually for phenoxymethylpenicillins (penicillin V) (7.3%, 0.4% to 13.7%) and macrolides (7.7%, 1.1% to 13.8%). There were no significant differences between intervention and control practices in the number of admissions to hospital or in reconsultations for a respiratory tract infection within seven days of an index consultation. The mean cost of the programme was £2923 (3491, $4572) per practice (SD £1187). There was a 5.5% reduction in the cost of dispensed antibiotics in the intervention group compared with the control group (-0.4% to 11.4%), equivalent to a reduction of about £830 a year for an average intervention practice. CONCLUSION: The STAR educational programme led to reductions in all cause oral antibiotic dispensing over the subsequent year with no significant change in admissions to hospital, reconsultations, or costs. Trial registration ISRCT No 63355948.
Assuntos
Antibacterianos/uso terapêutico , Educação Médica Continuada/métodos , Padrões de Prática Médica/estatística & dados numéricos , Antibacterianos/economia , Análise Custo-Benefício , Método Duplo-Cego , Educação Médica Continuada/economia , Medicina de Família e Comunidade/economia , Humanos , Padrões de Prática Médica/economia , Atenção Primária à Saúde/economia , País de GalesRESUMO
The emergence of antibiotic resistance is a major threat to public health. In the UK, most antibiotics are prescribed in general practice but the extra costs to general practice of resistant infections have not previously been well described. We compared the costs of treating patients presenting with resistant Escherichia coli urinary tract infections (UTIs) (resistant to ampicillin, trimethoprim or at least one antibiotic) with the costs of treating patients with UTIs that were sensitive to all six tested antibiotics (ampicillin, trimethoprim, amoxicillin/clavulanic acid, cefalexin, ciprofloxacin and nitrofurantoin) with regard to re-consultations and antibiotics prescribed. There were significantly higher antibiotic costs (mean extra antibiotic cost 1.19 pounds/1.75 euros), re-consultation costs ( 2.42 pounds/3.55 euros) and total costs ( 3.62 pounds/5.31euros) for patients whose infections were resistant to at least one antibiotic compared with those with sensitive infections even after accounting for potentially confounding factors. Although these per-patient costs may appear small, they do not take into account the full additional costs of resistant UTIs in the community and, given the high prevalence of UTIs, the overall costs to the health service are substantial.