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1.
Neuroepidemiology ; 58(3): 156-165, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38359812

RESUMO

INTRODUCTION: Evidence on the cost-effectiveness of comprehensive post-stroke programs is limited. We assessed the cost-effectiveness of an individualised management program (IMP) for stroke or transient ischaemic attack (TIA). METHODS: A cost-utility analysis alongside a randomised controlled trial with a 24-month follow-up, from both societal and health system perspectives, was conducted. Adults with stroke/TIA discharged from hospitals were randomised by primary care practice to receive either usual care (UC) or an IMP in addition to UC (intervention). An IMP included stroke-specific nurse-led education and a specialist review of care plans at baseline, 3 months, and 12 months, and telephone reviews by nurses at 6 months and 18 months. Costs were expressed in 2021 Australian dollars (AUD). Costs and quality-adjusted life years (QALYs) beyond 12 months were discounted by 5%. The probability of cost-effectiveness of the intervention was determined by quantifying 10,000 bootstrapped iterations of incremental costs and QALYs below the threshold of AUD 50,000/QALY. RESULTS: Among the 502 participants (65% male, median age 69 years), 251 (50%) were in the intervention group. From a health system perspective, the incremental cost per QALY gained was AUD 53,175 in the intervention compared to the UC group, and the intervention was cost-effective in 46.7% of iterations. From a societal perspective, the intervention was dominant in 52.7% of iterations, with mean per-person costs of AUD 49,045 and 1.352 QALYs compared to mean per-person costs of AUD 51,394 and 1.324 QALYs in the UC group. The probability of the cost-effectiveness of the intervention, from a societal perspective, was 60.5%. CONCLUSIONS: Care for people with stroke/TIA using an IMP was cost-effective from a societal perspective over 24 months. Economic evaluations of prevention programs need sufficient time horizons and consideration of costs beyond direct healthcare utilisation to demonstrate their value to society.


Assuntos
Análise Custo-Benefício , Anos de Vida Ajustados por Qualidade de Vida , Acidente Vascular Cerebral , Humanos , Masculino , Feminino , Idoso , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/terapia , Pessoa de Meia-Idade , Austrália , Ataque Isquêmico Transitório/economia , Ataque Isquêmico Transitório/terapia , Idoso de 80 Anos ou mais
2.
Neuroepidemiology ; 58(3): 208-217, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38290479

RESUMO

INTRODUCTION: Little is known about the cost-effectiveness of government policies that support primary care physicians to provide comprehensive chronic disease management (CDM). This paper aimed to estimate the potential cost-effectiveness of CDM policies over a lifetime for long-time survivors of stroke. METHODS: A Markov model, using three health states (stable, hospitalised, dead), was developed to simulate the costs and benefits of CDM policies over 30 years (with 1-year cycles). Transition probabilities and costs from a health system perspective were obtained from the linkage of data between the Australian Stroke Clinical Registry (cohort n = 12,368, 42% female, median age 70 years, 45% had CDM claims) and government-held hospital, Medicare, and pharmaceutical claims datasets. Quality-adjusted life years (QALYs) were obtained from a comparable cohort (n = 512, 34% female, median age 69.6 years, 52% had CDM claims) linked with Medicare claims and death data. A 3% discount rate was applied to costs in Australian dollars (AUD, 2016) and QALYs beyond 12 months. Probabilistic sensitivity analyses were used to understand uncertainty. RESULTS: Per-person average total lifetime costs were AUD 142,939 and 8.97 QALYs for those with a claim, and AUD 103,889 and 8.98 QALYs for those without a claim. This indicates that these CDM policies were costlier without improving QALYs. The probability of cost-effectiveness of CDM policies was 26.1%, at a willingness-to-pay threshold of AUD 50,000/QALY. CONCLUSION: CDM policies, designed to encourage comprehensive care, are unlikely to be cost-effective for stroke compared to care without CDM. Further research to understand how to deliver such care cost-effectively is needed.


Assuntos
Análise Custo-Benefício , Anos de Vida Ajustados por Qualidade de Vida , Acidente Vascular Cerebral , Humanos , Feminino , Masculino , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/terapia , Idoso , Austrália , Doença Crônica , Gerenciamento Clínico , Pessoa de Meia-Idade , Cadeias de Markov , Política de Saúde , Idoso de 80 Anos ou mais
3.
Heart ; 109(22): 1698-1705, 2023 10 26.
Artigo em Inglês | MEDLINE | ID: mdl-37553138

RESUMO

OBJECTIVE: To determine the cost-effectiveness and cost-utility of a quadpill containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg and bisoprolol 2.5 mg in comparison with irbesartan 150 mg for people with hypertension who are either untreated or receiving monotherapy. METHODS: We conducted a within-trial and modelled economic evaluation of the Quadruple UltrA-low-dose tReaTment for hypErTension trial. The analysis was preplanned, and medications and health service use captured during the trial. The main outcomes were incremental cost-effectiveness ratios (ICERs) for cost per mm Hg systolic blood pressure (BP) reduction at 3 months, and modelled cost per quality-adjusted life year (QALY) over a lifetime. RESULTS: The within-trial analysis showed no clear difference in cost per mm Hg BP lowering between randomised treatments at 3 months ($A10 (95% uncertainty interval (UI) $A -18 to $A37) per mm Hg per person) for quadpill versus monotherapy. The modelled cost-utility over a lifetime projected a mean incremental cost of $A265 (95% UI $A166 to $A357) and a mean 0.02 QALYs gained (95% UI 0.01 to 0.03) per person with quadpill therapy compared with monotherapy. Quadpill therapy was cost-effective in the base case (ICER of $A14 006 per QALY), and the result was sensitive to the quadpill cost in one-way sensitivity analysis. CONCLUSIONS: Quadpill in comparison with monotherapy is comparably cost-effective for short-term BP lowering. In the long-term, quadpill therapy is likely to be cost-effective. TRIAL REGISTRATION NUMBER: ANZCTRN12616001144404.


Assuntos
Hipertensão , Humanos , Análise Custo-Benefício , Irbesartana , Hipertensão/tratamento farmacológico , Anos de Vida Ajustados por Qualidade de Vida
4.
Int J Stroke ; 18(4): 477-483, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-35770887

RESUMO

RATIONALE: Theoretically, most strokes could be prevented through the management of modifiable risk factors. The Stroke Riskometer™ mobile phone application (hereon "The App") uses an individual's data to provide personalized information and advice to reduce their risk of stroke. AIMS: To determine the effect of The App on a combined cardiovascular risk score (Life's Simple 7®, LS7) of modifiable risk factors at 6 months post-randomization. METHODS AND DESIGN: PERKS-International is a Phase III, multicentre, prospective, pragmatic, open-label, single-blinded endpoint, two-arm randomized controlled trial (RCT). Inclusion criteria are as follows: age ⩾ 35 and ⩽75 years; ⩾2 LS7 risk factors; smartphone ownership; no history of stroke/myocardial infarction/cognitive impairment/terminal illness. The intervention group (IG) will be provided with The App, and the usual care group (UCG) is provided with generic online information about risk factors, but not be informed about The App. Face-to-face assessments will be conducted at baseline and 6 months, and online at 3 and 12 months. The RCT includes a process and economic evaluation. STUDY OUTCOMES AND SAMPLE SIZE: The primary outcome is a difference in the mean change in LS7 (seven individual items: blood pressure, cholesterol, glucose, body mass index (BMI), smoking, physical activity, and diet) from baseline to 6 months post-randomization with intention-to-treat analysis. Secondary outcomes include: change in individual LS7 items, quality of life; stroke awareness, adverse events; health service use; and costs. Based on pilot data, 790 participants (395 IG, 395 UCG) will be required to provide 80% power (two-sided α = 0.05) to detect a mean difference in the LS7 of ⩾0.40 (SD 1.61) in IG compared to 0.01 (SD 1.44) in the UCG at 6 months post-randomization. DISCUSSION: Stroke is largely preventable. This study will provide evidence of the effectiveness of a mobile app to reduce stroke risk. TRIAL REGISTRATION: ACTRN12621000211864.


Assuntos
Infarto do Miocárdio , Acidente Vascular Cerebral , Humanos , Idoso , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Fatores de Risco , Dieta , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto , Ensaios Clínicos Fase III como Assunto
5.
Eur Heart J ; 43(34): 3243-3254, 2022 09 07.
Artigo em Inglês | MEDLINE | ID: mdl-34788414

RESUMO

AIMS: The aim of this study was to assess the impact and cost-effectiveness of offering population genomic screening to all young adults in Australia to detect heterozygous familial hypercholesterolaemia (FH). METHODS AND RESULTS: We designed a decision analytic Markov model to compare the current standard of care for heterozygous FH diagnosis in Australia (opportunistic cholesterol screening and genetic cascade testing) with the alternate strategy of population genomic screening of adults aged 18-40 years to detect pathogenic variants in the LDLR/APOB/PCSK9 genes. We used a validated cost-adaptation method to adapt findings to eight high-income countries. The model captured coronary heart disease (CHD) morbidity/mortality over a lifetime horizon, from healthcare and societal perspectives. Risk of CHD, treatment effects, prevalence, and healthcare costs were estimated from published studies. Outcomes included quality-adjusted life years (QALYs), costs and incremental cost-effectiveness ratio (ICER), discounted 5% annually. Sensitivity analyses were undertaken to explore the impact of key input parameters on the robustness of the model. Over the lifetime of the population (4 167 768 men; 4 129 961 women), the model estimated a gain of 33 488years of life lived and 51 790 QALYs due to CHD prevention. Population genomic screening for FH would be cost-effective from a healthcare perspective if the per-test cost was ≤AU$250, yielding an ICER of

Assuntos
Doença das Coronárias , Hiperlipoproteinemia Tipo II , Análise Custo-Benefício , Feminino , Humanos , Hiperlipoproteinemia Tipo II/diagnóstico , Hiperlipoproteinemia Tipo II/epidemiologia , Hiperlipoproteinemia Tipo II/genética , Masculino , Metagenômica , Pró-Proteína Convertase 9 , Anos de Vida Ajustados por Qualidade de Vida , Adulto Jovem
6.
PLoS One ; 16(8): e0256589, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34415963

RESUMO

BACKGROUND: The mid-life emergence of higher levels of total cholesterol (TC) for women than for men has been observed in different Western and Asian populations. The aim of this study was to investigate whether there is evidence of this in Vietnam and, if so, whether it can be explained by ageing, by body size and fatness, or by socio-demographic characteristics and behavioural factors. METHODS: Participants (n = 14706, 50.9% females) aged 25-64 years were selected by multi-stage stratified cluster sampling from eight provinces each representing one of the eight geographical regions of Vietnam. Measurements were made using the World Health Organization STEPS protocols. Linear regression was used to assess the independent contributions of potential explanatory factors to mean levels of TC. Data were analysed using complex survey methods. RESULTS: Men and women had similar mean levels of body mass index (BMI), and men had modestly higher mean levels of waist circumference (WC), in each 5-year age category. The mean TC of women increased more or less continuously across the age range but with a step-up at age 50 years to reach higher concentrations on average than those of their male counterparts. The estimated step-up was not eliminated by adjustment for anthropometric indices including BMI or WC, or by adjustment for socio-demographic characteristics or behavioural factors. The estimated step-up was least for women with the greatest weight. CONCLUSION: There is a marked step-up in TC at age 50 years for Vietnamese women that cannot be explained by their age, or by their body fatness or its distribution, or by their socio-demographic characteristics or behavioural factors, and which results in greater mean levels of TC for middle-aged women than for their male counterparts in Vietnam.


Assuntos
Índice de Massa Corporal , Circunferência da Cintura , Adulto , Idoso , Povo Asiático , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Caracteres Sexuais
7.
J Eval Clin Pract ; 27(6): 1353-1360, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-33851486

RESUMO

BACKGROUND: Absolute cardiovascular disease (aCVD) risk assessment is recommended in CVD prevention guidelines. Yet, General Practitioners (GPs) often focus on single risk factors, including blood pressure (BP). Pathology services may be suitable to undertake high-quality automated unobserved BP (AOBP) measurement and aCVD risk assessment. This study explored GP attitudes towards AOBP measurement via pathology services and the role of BP in aCVD risk management. METHODS: A brief survey was completed, after which a focus group (n = 8 GPs) and interviews (n = 10 GPs) explored attitudes to AOBP and aCVD risk via pathology services with an example pathology report discussed. Verbatim transcripts were thematically coded. RESULTS: GPs predominantly used doctor-measured BP despite low levels of confidence. High BP measured by AOBP reported with aCVD risk via pathology services, would prompt a follow-up response. However, GPs focused on BP management. GPs were concerned about AOBP equivalency to routine BP measurements. After protocol explanation, GPs reported AOBP could value-add to care delivery. CONCLUSION: GPs lacked familiarity of AOBP and maintained a focus on BP management in the context of absolute CVD risk. Targeted education on AOBP and BP management as part of absolute CVD risk is needed to support guideline-directed care in practice.


Assuntos
Doenças Cardiovasculares , Clínicos Gerais , Hipertensão , Pressão Sanguínea , Determinação da Pressão Arterial , Doenças Cardiovasculares/prevenção & controle , Humanos , Hipertensão/diagnóstico , Hipertensão/terapia , Gestão de Riscos
8.
Med J Aust ; 214(6): 266-271, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33622026

RESUMO

OBJECTIVES: To assess the efficacy of a pro-active, absolute cardiovascular risk-guided approach to opportunistically modifying cardiovascular risk factors in patients without coronary ischaemia attending a chest pain clinic. DESIGN: Prospective, randomised, open label, blinded endpoint study. SETTING: The rapid access chest pain clinic of Royal Hobart Hospital, a tertiary hospital. PARTICIPANTS: Patients who presented to the chest pain clinic between 1 July 2014 and 31 December 2017 who had intermediate to high absolute cardiovascular risk scores (5-year risk ≥ 8%). Patients with known cardiac disease or from groups with clinically determined high risk of cardiovascular disease were excluded. MAIN OUTCOME MEASURES: The primary endpoint was change in 5-year absolute risk score (Australian absolute risk calculator) at follow-up (at least 12 months after baseline assessment). Secondary endpoints were changes in lipid profile, blood pressure, smoking status, and body mass index, and major adverse cardiovascular events. RESULTS: The mean change in risk at follow-up was +0.4 percentage points (95% CI, -0.8 to 1.5 percentage points) for the 98 control group patients and -2.4 percentage points (95% CI, -1.5 to -3.4 percentage points) for the 91 intervention group patients; the between-group difference in change was 2.7 percentage points (95% CI, 1.2-4.1 percentage points). Mean changes in lipid profile, systolic blood pressure, and smoking status were larger for the intervention group, but not statistically different from those for the control group. CONCLUSIONS: An absolute cardiovascular risk-guided, pro-active risk factor management strategy employed opportunistically in a chest pain clinic significantly improved 5-year absolute cardiovascular risk scores. TRIAL REGISTRATION: Australia New Zealand Clinical Trial Registry, ACTRN12617000615381 (retrospective).


Assuntos
Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Medição de Risco/métodos , Idoso , Dor no Peito , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Clínicas de Dor , Estudos Prospectivos , Gestão de Riscos
9.
Fam Pract ; 38(2): 173-180, 2021 03 29.
Artigo em Inglês | MEDLINE | ID: mdl-33002138

RESUMO

BACKGROUND: Guidelines for cardiovascular disease (CVD) prevention recommend assessment of absolute CVD risk to guide clinical management. Despite this, use among general practitioners (GPs) remains limited. OBJECTIVE: Pathology services may provide an appropriate setting to assess and report absolute CVD risk in patients attending for cholesterol measurement. This study aimed to explore GPs perceptions of such a service. METHODS: A focus group and semi-structured interviews were conducted with GPs (n = 18) in Tasmania, Australia, to identify perceptions of assessment and reporting of absolute CVD risk via pathology services. An example pathology report including absolute CVD risk was provided and discussed. Audio-recordings were transcribed and thematically coded by two researchers. RESULTS: Almost all GPs identified that absolute CVD risk assessed and reported via pathology services could address deficits in practice. First, by reducing the number of appointments required to collect risk factors. Second, by providing a systematic (rather than opportunistic) approach for assessment of absolute CVD risk. Third, by reducing misclassification of patient CVD risk caused by overreliance on clinical intuition. All GPs reported they would order absolute CVD risk when issuing a cholesterol referral if such a service was offered. GPs recommended improving the service by providing information on methods used to measure risk factors on the pathology report. CONCLUSIONS: Absolute CVD risk assessed and reported via pathology services may address challenges of screening CVD risk experienced by GPs in practice and encourage dedicated follow-up care for CVD prevention.


Assuntos
Doenças Cardiovasculares , Clínicos Gerais , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/prevenção & controle , Humanos , Percepção , Pesquisa Qualitativa , Medição de Risco
10.
Pulse (Basel) ; 8(1-2): 40-46, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32999877

RESUMO

BACKGROUND: Blood collection and blood pressure (BP) measurements are routinely performed during the same consultation to assess absolute cardiovascular disease (CVD) risk. This study aimed to determine the effect of blood collection on BP and subsequent calculation of the absolute CVD risk. METHODS: Forty-five participants aged 58 ± 9 years (53% male) had systolic BP (SBP) measured using clinical guideline methods (clinic SBP). Then, on a separate visit, BP was measured immediately before, during, and after blood collection. Absolute CVD risk scores were calculated (Framingham equation) using SBP from each measurement condition and compared. RESULTS: The prevalence of low (<10%), moderate (10-15%), and high (≥15%) absolute CVD risks among the participants was 67%, 22%, and 11%, respectively, using clinic SBP. SBP values before and during blood collection were significantly higher compared to values after blood collection (130 ± 18 and 132 ± 19 vs. 126 ± 18 mm Hg; p = 0.010 and p = 0.003, respectively). However, there were no significant differences between clinic SBP (128 ± 18 mm Hg) and blood collection SBP (p = 0.99) or the absolute CVD risk scores (7.3 ± 6.5; 7.6 ± 5.9; 7.7 ± 6.1; and 7.1 ± 5.7%, respectively; p = 0.995 for all). The mean intraclass correlation (95% CI) indicated good agreement between absolute CVD risk scores calculated with clinic SBP and each blood collection SBP (0.86 [95% CI 0.74-0.92], 0.85 [95% CI 0.71-0.91], and 0.87 [95% CI 0.76-0.93], respectively; p < 0.001, for all). CONCLUSION: Absolute CVD risk calculation is not affected by use of SBP measurements recorded at the time of blood collection. Therefore, it is acceptable to collect blood and measure BP during the same consultation for absolute CVD risk assessment.

11.
Heart Lung Circ ; 29(11): 1588-1595, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32839116

RESUMO

BACKGROUND: Cardiovascular disease is the leading cause of death in Australia. Investment in research solutions has been demonstrated to yield health and a 9.8-fold return economic benefit. The sector, however, is severely challenged with success rates of traditional peer-reviewed funding in decline. Here, we aimed to understand the perceived challenges faced by the cardiovascular workforce in Australia prior to the COVID-19 pandemic. METHODS: We used an online survey distributed across Australian cardiovascular societies/councils, universities and research institutes over a period of 6 months during 2019, with 548 completed responses. Inclusion criteria included being an Australian resident or an Australian citizen who lived overseas, and a current or past student or employee in the field of cardiovascular research. RESULTS: The mean age of respondents was 42±13 years, 47% were male, 85% had a full-time position, and 40% were a group leader or laboratory head. Twenty-three per cent (23%) had permanent employment, and 82% of full-time workers regularly worked >40 hours/week. Sixty-eight per cent (68%) said they had previously considered leaving the cardiovascular research sector. If their position could not be funded in the next few years, a staggering 91% of respondents would leave the sector. Compared to PhD- and age-matched men, women were less likely to be a laboratory head and to feel they had a long-term career path as a cardiovascular researcher, while more women were unsure about future employment and had considered leaving the sector (all p<0.05). Greater job security (76%) and government and philanthropic investment in cardiovascular research (72%) were highlighted by responders as the main changes to current practices that would encourage them to stay. CONCLUSION: Strategic solutions, such as diversification of career pathways and funding sources, and moving from a competitive to a collaborative culture, need to be a priority to decrease reliance on government funding and allow cardiovascular researchers to thrive.


Assuntos
Pesquisa Biomédica , Doenças Cardiovasculares , Infecções por Coronavirus/epidemiologia , Administração Financeira , Pneumonia Viral/epidemiologia , Pesquisadores , Apoio à Pesquisa como Assunto , Recursos Humanos , Adulto , Austrália , Betacoronavirus , Pesquisa Biomédica/economia , Pesquisa Biomédica/organização & administração , Pesquisa Biomédica/tendências , COVID-19 , Emprego/economia , Emprego/psicologia , Feminino , Administração Financeira/métodos , Administração Financeira/organização & administração , Administração Financeira/estatística & dados numéricos , Financiamento Governamental , Humanos , Masculino , Cultura Organizacional , Pandemias , Técnicas de Planejamento , Pesquisadores/economia , Pesquisadores/psicologia , Pesquisadores/estatística & dados numéricos , Apoio à Pesquisa como Assunto/organização & administração , Apoio à Pesquisa como Assunto/tendências , SARS-CoV-2 , Inquéritos e Questionários , Recursos Humanos/estatística & dados numéricos
12.
Fam Pract ; 37(5): 675-681, 2020 10 19.
Artigo em Inglês | MEDLINE | ID: mdl-32296818

RESUMO

BACKGROUND: Absolute cardiovascular disease (CVD) risk assessment is recommended for primary prevention of CVD, yet uptake in general practice is limited. Cholesterol requests at pathology services provide an opportunity to improve uptake by integrating absolute CVD risk assessment with this service. OBJECTIVE: This study aimed to assess the feasibility of such an additional service. METHODS: Two-hundred and ninety-nine patients (45-74 years) referred to pathology services for blood cholesterol had measurement of all variables required to determine absolute CVD risk according to Framingham calculator (blood pressure, age, sex, smoking and diabetes status via self-report). Data were recorded via computer-based application. The absolute risk score was communicated via the report sent to the referring medical practitioner as per usual practice. Evaluation questionnaires were completed immediately post visit and at 1-, 3- and 6-month follow-up via telephone (n = 262). RESULTS: Absolute CVD risk reports were issued for 90% of patients. Most patients (95%) reported that the length of time for the pathology service assessment was acceptable, and 91% that the self-directed computer-based application was easy to use. Seventy-eight per cent reported a preference for pathology services to conduct absolute CVD risk assessment. Only 2% preferred a medical practitioner. Of follow-up patients, 202 (75%) had a consultation with a medical practitioner, during which, aspects of CVD risk prevention were discussed (cholesterol and blood pressure 74% and 69% of the time, respectively). CONCLUSIONS: Measurement of absolute CVD risk in pathology services is feasible, highly acceptable among middle-to-older adults and may increase uptake of guideline-directed care in general practice.


Assuntos
Doenças Cardiovasculares , Idoso , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/prevenção & controle , Colesterol , Humanos , Prevenção Primária , Medição de Risco , Fatores de Risco
13.
Trials ; 20(1): 686, 2019 Dec 09.
Artigo em Inglês | MEDLINE | ID: mdl-31815652

RESUMO

BACKGROUND: Large-scale studies risk generating inaccurate and missing data due to the complexity of data collection. Technology has the potential to improve data quality by providing operational support to data collectors. However, this potential is under-explored in community-based trials. The Aspirin in reducing events in the elderly (ASPREE) trial developed a data suite that was specifically designed to support data collectors: the ASPREE Web Accessible Relational Database (AWARD). This paper describes AWARD and the impact of system design on data quality. METHODS: AWARD's operational requirements, conceptual design, key challenges and design solutions for data quality are presented. Impact of design features is assessed through comparison of baseline data collected prior to implementation of key functionality (n = 1000) with data collected post implementation (n = 18,114). Overall data quality is assessed according to data category. RESULTS: At baseline, implementation of user-driven functionality reduced staff error (from 0.3% to 0.01%), out-of-range data entry (from 0.14% to 0.04%) and protocol deviations (from 0.4% to 0.08%). In the longitudinal data set, which contained more than 39 million data values collected within AWARD, 96.6% of data values were entered within specified query range or found to be accurate upon querying. The remaining data were missing (3.4%). Participant non-attendance at scheduled study activity was the most common cause of missing data. Costs associated with cleaning data in ASPREE were lower than expected compared with reports from other trials. CONCLUSIONS: Clinical trials undertake complex operational activity in order to collect data, but technology rarely provides sufficient support. We find the AWARD suite provides proof of principle that designing technology to support data collectors can mitigate known causes of poor data quality and produce higher-quality data. Health information technology (IT) products that support the conduct of scheduled activity in addition to traditional data entry will enhance community-based clinical trials. A standardised framework for reporting data quality would aid comparisons across clinical trials. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Register, ISRCTN83772183. Registered on 3 March 2005.


Assuntos
Aspirina/uso terapêutico , Ensaios Clínicos como Assunto , Confiabilidade dos Dados , Idoso , Ensaios Clínicos como Assunto/economia , Análise Custo-Benefício , Coleta de Dados , Bases de Dados Factuais , Humanos , Informática Médica
14.
CNS Drugs ; 33(7): 685-694, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31062260

RESUMO

BACKGROUND: Statin use has been frequently associated with depressive symptoms in an older population. However, the nature of this association is uncertain in the literature. In this study, we aimed to investigate the association of statin intake and the prevalence of depressive symptoms in healthy community-dwelling older adults living in Australia and the USA. METHODS: We analysed baseline data from 19,114 participants, over 70 years of age (over 65 years of age, if from an ethnic minority). The association of self-reported statin use and prevalence of depressive symptoms, as measured by a validated depression scale [Center for Epidemiological Studies Depression Scale (CES-D 10)], was determined using logistic regression models. Multivariable logistic models were implemented to account for important demographics and other lifestyle and socioeconomic factors, such as sex, age, living status, education and smoking history. RESULTS: A total of 5987 individuals were statin users. Of those, 633 (10.6%) had depressive symptoms (CES-D 10 cut-off ≥ 8), compared with 1246 (9.5%) of the non-statin users. In the unadjusted model, statin use was associated with an increase in prevalence of depressive symptoms (odds ratio 1.13, confidence interval 1.02-1.25, p = 0.02). However, after adjusting for important demographic and socioeconomic factors, the use of statins was not significantly associated with depressive symptoms (odds ratio 1.09, confidence interval 0.98-1.20, p = 0.11). In secondary analyses, only simvastatin was marginally associated with an increased prevalence of depressive symptoms. Statins were associated with a decreased prevalence of depressive symptoms in individuals with severe obesity (body mass index > 35 kg/m2) and an increased prevalence in participants between 75 and 84 years of age. CONCLUSION: This study in a large community-dwelling older population did not show any association of statins with late-life depressive symptoms, after accounting for important socioeconomic and demographic factors. Confounding by indication is an important issue to be addressed in future pharmacoepidemiologic studies of statins.


Assuntos
Depressão/induzido quimicamente , Depressão/epidemiologia , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Austrália/epidemiologia , Estudos Transversais , Etnicidade , Feminino , Nível de Saúde , Humanos , Vida Independente , Modelos Logísticos , Masculino , Grupos Minoritários , Razão de Chances , Prevalência , Escalas de Graduação Psiquiátrica , Fatores de Risco , Fatores Socioeconômicos , Estados Unidos/epidemiologia
15.
Qual Life Res ; 28(4): 935-946, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30411180

RESUMO

PURPOSE: To explore the relationship between sociodemographic and lifestyle variables with health-related quality of life (HRQoL) of a large cohort of 'healthy' older individuals. METHODS: The sample included individuals aged 65+ years from Australia (N = 16,703) and the USA (N = 2411) enrolled in the ASPirin in Reducing Events in the Elderly (ASPREE) multicentre placebo-controlled trial study and free of cardiovascular disease, dementia, serious physical disabilities or 'fatal' illnesses. The associations with the physical (PCS) and mental component scores (MCS) of HRQoL (SF-12 questionnaire) were explored using multiple linear regression models from data collected at baseline (2010-2014). RESULTS: The adjusted PCS mean was slightly higher in the USA (49.5 ± 9.1) than Australia (48.2 ± 11.6; p < 0.001), but MCS was similar in both samples (55.7 ± 7.5 and 55.7 ± 9.6, respectively; p = 0.603). Males, younger participants, better educated, more active individuals, or those currently drinking 1-2 alcoholic drinks/day showed a better HRQoL (results more evident for PCS than MCS), while current heavy smokers had the lowest physical HRQoL in both countries. Neither age, walking time, nor alcohol intake was associated with MCS in either cohort. CONCLUSIONS: Baseline HRQoL of ASPREE participants was higher than that reported in population-based studies of older individuals, but the associations between sociodemographic and lifestyle variables were consistent with the published literature. As the cohort ages and develops chronic diseases, ASPREE will be able to document HRQoL changes.


Assuntos
Aspirina/uso terapêutico , Qualidade de Vida/psicologia , Idoso , Aspirina/farmacologia , Feminino , Humanos , Estilo de Vida , Masculino , Fatores de Risco , Inquéritos e Questionários
16.
Neurology ; 89(1): 68-75, 2017 Jul 04.
Artigo em Inglês | MEDLINE | ID: mdl-28566545

RESUMO

OBJECTIVE: To extensively investigate long-term unmet needs in survivors of stroke or TIA and to identify factors associated with these unmet needs. METHODS: Community-dwelling adults were invited to participate in a survey ≥2 years after discharge for stroke/TIA. Unmet needs were assessed across 5 domains: activities and participation, environmental factors, body functions, post-acute care, and secondary prevention. Factors associated with unmet needs were determined with multivariable negative binomial regression. RESULTS: Of 485 participants invited to complete the survey, 391 (81%) responded (median age 73 years, 67% male). Most responders (87%) reported unmet needs in ≥1 of the measured domains, particularly in secondary prevention (71%). Factors associated with fewer unmet needs included older age (incident rate ratio [IRR] 0.62, 95% confidence interval [CI] 0.50-0.77), greater functional ability (IRR 0.33, 95% CI 0.17-0.67), and reporting that the general practitioner was the most important in care (IRR 0.69, 95% CI 0.57-0.84). Being depressed (IRR 1.61, 95% CI 1.23-2.10) and receiving community services after stroke (IRR 1.45, 95% CI 1.16-1.82) were associated with more unmet needs. CONCLUSIONS: Survivors of stroke/TIA reported considerable unmet needs ≥2 years after discharge, particularly in secondary prevention. The factors associated with unmet needs could help guide policy decisions, particularly for tailoring care and support services provided after discharge.


Assuntos
Assistência ao Convalescente/estatística & dados numéricos , Serviços de Saúde Comunitária/estatística & dados numéricos , Depressão/epidemiologia , Necessidades e Demandas de Serviços de Saúde/estatística & dados numéricos , Ataque Isquêmico Transitório/terapia , Satisfação do Paciente/estatística & dados numéricos , Prevenção Secundária/estatística & dados numéricos , Acidente Vascular Cerebral/terapia , Sobreviventes/estatística & dados numéricos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Prevenção Secundária/normas
17.
BMC Public Health ; 16: 498, 2016 06 10.
Artigo em Inglês | MEDLINE | ID: mdl-27286818

RESUMO

BACKGROUND: To estimate the prevalence of non-communicable disease (NCD) risk factors at a provincial level in Vietnam, and to assess whether the summary estimates allow reliable inferences to be drawn regarding regional differences in risk factors and associations between them. METHODS: Participants (n = 14706, 53.5 % females) aged 25-64 years were selected by multi-stage stratified cluster sampling from eight provinces each representing one of the eight geographical regions of Vietnam. Measurements were made using the World Health Organization STEPS protocols. Data were analysed using complex survey methods. RESULTS: Differences by sex in mean years of schooling (males 8.26 ± 0.20, females 7.00 ± 0.18), proportions of current smokers (males 57.70 %, females 1.73 %), and binge-drinkers (males 25.11 %, females 0.63 %), and regional differences in diet, reflected the geographical and socio-cultural characteristics of the country. Provinces with a higher proportion of urban population had greater mean levels of BMI (r = 0.82), and lesser proportions of active people (r = -0.89). The associations between the summary estimates were generally plausible (e.g. physical activity and BMI, r = -0.80) but overstated, and with some anomalous findings due to characterisation of smoking and hypertension by STEPS protocols. CONCLUSIONS: This report provides an extensive description of the sex-specific and regional distribution of NCD risk factors in Vietnam and an account of some health-related consequences of industrialisation in its early stages. The STEPS protocols can be utilized to provide aggregate data for valid between-population comparisons, but with important caveats identified.


Assuntos
Hipertensão/epidemiologia , Inquéritos e Questionários/normas , Adulto , Demografia , Feminino , Humanos , Hipertensão/etiologia , Masculino , Pessoa de Meia-Idade , Prevalência , Reprodutibilidade dos Testes , Fatores de Risco , Fatores Socioeconômicos , Vietnã/epidemiologia
18.
Int J Stroke ; 9(5): 652-7, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23231528

RESUMO

BACKGROUND: Comprehensive community care has the potential to improve risk factor management of patients with stroke or transient ischaemic attack. AIM: The primary aim is to determine the effectiveness of an individualized management program on risk factor management for patients discharged from hospital after stroke. DESIGN: Multicentre, cluster-randomized, controlled trial, with clusters by general practice. Participants are randomized to receive intervention or control after a baseline assessment undertaken after discharge from hospital. The general practice they attend is marked as an intervention or control accordingly. All subsequent participants attending those practices are automatically assigned as intervention or control. Baseline and all outcome assessments, including an analysis of risk factors, are undertaken by assessors blinded to patient randomization. INTERVENTION DETAILS: Based on the results of blinded assessments, the individualized management program group will receive targeted advice on how to manage their risk factors using a standardized, evidence-based template to communicate 'ideal' management with their general practitioner. In addition, patients randomized to the individualized management program group will receive counselling and education about stroke risk factor management by an intervention study nurse. Individualized management programs will be reviewed at three-months, six-months, 12 months, and 18 months after stroke, at which times they will be modified if appropriate. Stroke risk management will be evaluated using changes in the Framingham cardiovascular risk score. Analysis will be on an intention-to-treat basis using analysis of covariance or generalized linear model to adjust for baseline risk score and other relevant confounding factors.


Assuntos
Assistência Ambulatorial/métodos , Protocolos Clínicos , Gestão de Riscos/métodos , Acidente Vascular Cerebral/terapia , Assistência Ambulatorial/economia , Austrália , Método Duplo-Cego , Humanos , Avaliação de Resultados em Cuidados de Saúde/métodos , Seleção de Pacientes , Medicina de Precisão/economia , Medicina de Precisão/métodos , Fatores de Risco , Gestão de Riscos/economia
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