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1.
Neth Heart J ; 31(2): 52-60, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35976610

RESUMO

BACKGROUND: Coronary computed tomography angiography (CCTA) is widely used in the diagnostic work-up of patients with stable chest pain. CCTA has an excellent negative predictive value, but a moderate positive predictive value for detecting coronary stenosis. Computed tomography-derived fractional flow reserve (FFRct) is a non-invasive, well-validated technique that provides functional assessment of coronary stenosis, improving the positive predictive value of CCTA. However, to determine the value of FFRct in routine clinical practice, a pragmatic randomised, controlled trial (RCT) is required. We will conduct an RCT to investigate the impact of adding FFRct analysis in the diagnostic pathway of patients with a coronary stenosis on CCTA on the rate of unnecessary invasive coronary angiography, cost-effectiveness, quality of life and clinical outcome. METHODS: The FUSION trial is a prospective, multicentre RCT that will randomise 528 patients with stable chest pain and anatomical stenosis of ≥ 50% but < 90% in at least one coronary artery of ≥ 2 mm on CCTA, to FFRct-guided care or usual care in a 1:1 ratio. Follow-up will be 1 year. The primary endpoint is the rate of unnecessary invasive coronary angiography within 90 days. CONCLUSION: The FUSION trial will evaluate the use of FFRct in stable chest pain patients from the Dutch perspective. The trial is funded by the Dutch National Health Care Institute as part of the research programme 'Potentially Promising Care' and the results will be used to assess if FFRct reimbursement should be included in the standard health care package.

2.
Contemp Clin Trials ; 122: 106928, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36116756

RESUMO

INTRODUCTION: Chronic stress and burnout are highly prevalent among academically trained healthcare professionals, negatively affecting their well-being and capacity to engage in their work. Resilience to stress develops early in one's career path, hence offering resilience training to university students in these professions is one approach to fostering well-being and mental health. The aim of this study is to assess whether offering mindfulness-based resilience training to university students in healthcare professions reduces their perceived chronic stress. METHODS AND ANALYSIS: The study has a hybrid design combining a longitudinal observational cohort with a nested randomized controlled trial (RCT) with sequential multiple assignment and multistage adaptive interventions while taking participants' preferences into account. All students in healthcare related programmes at the Erasmus University Rotterdam are invited to participate. Within the observational cohort, students with a score of 14 or higher on the Perceived Stress Scale (PSS) are invited to take part in the RCT (n = 706). Eligible participants are randomized to control or active intervention in a ratio of 1:6. Those randomized to the control group and non-randomized participants in the cohort receive passive web-based psychoeducation about chronic stress and burnout through referral to specific websites. Participants randomized to the intervention group receive one of 8 active mindfulness-based interventions. They select a rank order of 4 preferred interventions and are randomized across these with equal probability. Non-response to the intervention is followed by sequential randomized assignment to another intervention, for a total maximum of 3 sequential interventions. All participants receive questionnaires at baseline, before and after each 8-week intervention period, and at 1- and 2-year follow-up. The primary outcome is perceived chronic stress measured with the PSS. Secondary outcomes include mental well-being, burnout, quality of life, healthcare utilization, drug use, bodyweight, mental and physical stress-related symptoms, resilience, and study progress. ETHICS AND REGISTRATION: Approval from the Medical Ethics Review Committee was obtained under protocol number MEC-2018-1645. The trial is registered in the Netherlands National Trial Register by registration number NL7623, 22/03/2019, https://www.trialregister.nl/.


Assuntos
Atenção Plena , Humanos , Atenção Plena/métodos , Estudantes/psicologia , Universidades , Saúde Mental , Estudos de Coortes , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Observacionais como Assunto
3.
BMC Pregnancy Childbirth ; 20(1): 515, 2020 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-32894073

RESUMO

BACKGROUND: In recent years it has become clear that fetal anomalies can already be detected at the end of the first trimester of pregnancy by two-dimensional (2D) ultrasound. This is why increasingly in developed countries the first trimester anomaly scan is being offered as part of standard care. We have developed a Virtual Reality (VR) approach to improve the diagnostic abilities of 2D ultrasound. Three-dimensional (3D) ultrasound datasets are used in VR assessment, enabling real depth perception and unique interaction. The aim of this study is to investigate whether first trimester 3D VR ultrasound is of additional value in terms of diagnostic accuracy for the detection of fetal anomalies. Health-related quality of life, cost-effectiveness and also the perspective of both patient and ultrasonographer on the 3D VR modality will be studied. METHODS: Women in the first trimester of a high risk pregnancy for a fetus with a congenital anomaly are eligible for inclusion. This is a randomized controlled trial with two intervention arms. The control group receives 'care as usual': a second trimester 2D advanced ultrasound examination. The intervention group will undergo an additional first trimester 2D and 3D VR ultrasound examination. Following each examination participants will fill in validated questionnaires evaluating their quality of life and healthcare related expenses. Participants' and ultrasonographers' perspectives on the 3D VR ultrasound will be surveyed. The primary outcome will be the detection of fetal anomalies. The additional first trimester 3D VR ultrasound examination will be compared to 'care as usual'. Neonatal or histopathological examinations are considered the gold standard for the detection of congenital anomalies. To reach statistical significance and 80% power with a detection rate of 65% for second trimester ultrasound examination and 70% for the combined detection of first trimester 3D VR and second trimester ultrasound examination, a sample size of 2800 participants is needed. DISCUSSION: First trimester 3D VR detection of fetal anomalies may improve patients' quality of life through reassurance or earlier identification of malformations. Results of this study will provide policymakers and healthcare professionals with the highest level of evidence for cost-effectiveness of first trimester ultrasound using a 3D VR approach. TRIAL REGISTRATION: Dutch Trial Registration number NTR6309 , date of registration 26 January 2017.


Assuntos
Feto/anormalidades , Feto/diagnóstico por imagem , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ultrassonografia Pré-Natal/métodos , Realidade Virtual , Feminino , Humanos , Gravidez , Primeiro Trimestre da Gravidez
4.
PLoS One ; 15(5): e0232944, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32392247

RESUMO

OBJECTIVES: Autopsy rates worldwide have dropped significantly over the last five decades. Imaging based autopsies are increasingly used as alternatives to conventional autopsy (CA). The aim of this study was to investigate the effect of the introduction of minimally invasive autopsy, consisting of CT, MRI and tissue biopsies on the overall autopsy rate (of CA and minimally invasive autopsy) and the autopsy rate among different ethnicities. METHODS: We performed a prospective single center before-after study. The intervention was the introduction of minimally invasive autopsy as an alternative to CA. Minimally invasive autopsy consisted of MRI, CT, and CT-guided tissue biopsies. Autopsy rates over time and the effect of introducing minimally invasive autopsy were analyzed with a linear regression model. We performed a subgroup analysis comparing the autopsy rates of two groups: a group of western-European ethnicity versus a group of other ethnicities. RESULTS: Autopsy rates declined from 14.0% in 2010 to 8.3% in 2019. The linear regression model showed a significant effect of both time and availability of minimally invasive autopsy on the overall autopsy rate. The predicted autopsy rate in the model started at 15.1% in 2010 and dropped approximately 0.1% per month (ß = -0.001, p < 0.001). Availability of minimally invasive autopsy increased the overall autopsy rate by 2.4% (ß = 0.024, p < 0.001). The overall autopsy rate of people with an ethnic background other than western-European was significantly higher in years when minimally invasive autopsy was available compared to when it was not (22/176 = 12.5% vs. 81/1014 (8.0%), p = 0.049). CONCLUSIONS: The introduction of the minimally invasive autopsy had a small, but significant effect on the overall autopsy rate. Furthermore, the minimally invasive autopsy appears to be more acceptable than CA among people with an ethnicity other than western-European.


Assuntos
Autopsia/métodos , Autopsia/tendências , Adulto , Causas de Morte , Etnicidade/psicologia , Feminino , Humanos , Biópsia Guiada por Imagem/métodos , Imageamento por Ressonância Magnética/métodos , Masculino , Estudos Prospectivos , Tomografia Computadorizada por Raios X/métodos
5.
Br J Surg ; 105(7): 773-783, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29665028

RESUMO

BACKGROUND: This study aimed to evaluate anxiety and pain following perioperative music interventions compared with control conditions in adult patients. METHODS: Eleven electronic databases were searched for full-text publications of RCTs investigating the effect of music interventions on anxiety and pain during invasive surgery published between 1 January 1980 and 20 October 2016. Results and data were double-screened and extracted independently. Random-effects meta-analysis was used to calculate effect sizes as standardized mean differences (MDs). Heterogeneity was investigated in subgroup analyses and metaregression analyses. The review was registered in the PROSPERO database as CRD42016024921. RESULTS: Ninety-two RCTs (7385 patients) were included in the systematic review, of which 81 were included in the meta-analysis. Music interventions significantly decreased anxiety (MD -0·69, 95 per cent c.i. -0·88 to -0·50; P < 0·001) and pain (MD -0·50, -0·66 to -0·34; P < 0·001) compared with controls, equivalent to a decrease of 21 mm for anxiety and 10 mm for pain on a 100-mm visual analogue scale. Changes in outcome corrected for baseline were even larger: MD -1·41 (-1·89 to -0·94; P < 0·001) for anxiety and -0·54 (-0·93 to -0·15; P = 0·006) for pain. Music interventions provided during general anaesthesia significantly decreased pain compared with that in controls (MD -0·41, -0·64 to -0·18; P < 0·001). Metaregression analysis found no significant association between the effect of music interventions and age, sex, choice and timing of music, and type of anaesthesia. Risk of bias in the studies was moderate to high. CONCLUSION: Music interventions significantly reduce anxiety and pain in adult surgical patients.


Assuntos
Ansiedade/terapia , Musicoterapia , Dor Pós-Operatória/terapia , Adulto , Ansiedade/prevenção & controle , Humanos , Musicoterapia/métodos , Medição da Dor , Dor Pós-Operatória/prevenção & controle
6.
BMC Cancer ; 17(1): 336, 2017 05 17.
Artigo em Inglês | MEDLINE | ID: mdl-28514945

RESUMO

BACKGROUND: Cosmetic result following breast conserving surgery (BCS) for cancer influences quality of life and psychosocial functioning in breast cancer patients. A preoperative prediction of expected cosmetic result following BCS is not (yet) standard clinical practice and therefore the choice for either mastectomy or BCS is still subjective. Recently, we showed that tumour volume to breast volume ratio as well as tumour location in the breast are independent predictors of superior cosmetic result following BCS. Implementation of a prediction model including both factors, has not been studied in a prospective manner. This study aims to improve cosmetic outcome by implementation of a prediction model in the treatment decision making for breast cancer patients opting for BCS. METHODS/DESIGN: Multicentre, single-blinded, randomized controlled trial comparing standard preoperative work-up to a preoperative work-up with addition of the prediction model. Tumour volume to breast volume ratio and tumour location in the breast will be used to predict cosmetic outcome in invasive breast cancer patients opting for BCS. Three dimensional (3D)-ultrasonography will be used to measure the tumour volume to breast volume ratio needed for the prediction model. Sample size was estimated based on a 14% improvement in incidence of superior cosmetic result one year after BCS (71% in the control group versus 85% in the intervention group). Primarily cosmetic outcome will be evaluated by a 6-member independent panel. Secondary endpoints include; (1) patient reported outcome measured by BREAST-Q, EORTC-QLQ-C30/BR23 and EQ-5D-5 L (2) cosmetic outcome as assessed through the BCCT.core software, (3) radiation-induced reaction (4) surgical treatment performed, (5) pathological result and (6) cost-effectiveness. Follow-up data will be collected for 3 years after surgery or finishing radiotherapy. DISCUSSION: This randomized controlled trial examines the value of a preoperative prediction model for the treatment-decision making. It aims for a superior cosmetic result in breast cancer patients opting for BCS. We expect improvement of patients' quality of life and psychosocial functioning in a cost-effective way. TRIAL REGISTRATION: Prospectively registered, February 17th 2015, at 'Nederlands Trialregister - NTR4997 '.


Assuntos
Neoplasias da Mama/cirurgia , Mama/diagnóstico por imagem , Técnicas de Apoio para a Decisão , Mamografia/métodos , Mastectomia Segmentar/métodos , Carga Tumoral , Ultrassonografia Mamária/métodos , Mama/patologia , Neoplasias da Mama/patologia , Feminino , Humanos , Modelos Teóricos
7.
Br J Surg ; 103(12): 1616-1625, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27513296

RESUMO

BACKGROUND: Current guidelines recommend supervised exercise therapy (SET) as the preferred initial treatment for patients with intermittent claudication. The availability of SET programmes is, however, limited and such programmes are often not reimbursed. Evidence for the long-term cost-effectiveness of SET compared with endovascular revascularization (ER) as primary treatment for intermittent claudication might aid widespread adoption in clinical practice. METHODS: A Markov model was constructed to determine the incremental costs, incremental quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio of SET versus ER for a hypothetical cohort of patients with newly diagnosed intermittent claudication, from the Dutch healthcare payer's perspective. In the event of primary treatment failure, possible secondary interventions were repeat ER, open revascularization or major amputation. Data sources for model parameters included original data from two RCTs, as well as evidence from the medical literature. The robustness of the results was tested with probabilistic and one-way sensitivity analysis. RESULTS: Considering a 5-year time horizon, probabilistic sensitivity analysis revealed that SET was associated with cost savings compared with ER (-€6412, 95 per cent credibility interval (CrI) -€11 874 to -€1939). The mean difference in effectiveness was -0·07 (95 per cent CrI -0·27 to 0·16) QALYs. ER was associated with an additional €91 600 per QALY gained compared with SET. One-way sensitivity analysis indicated more favourable cost-effectiveness for ER in subsets of patients with low quality-of-life scores at baseline. CONCLUSION: SET is a more cost-effective primary treatment for intermittent claudication than ER. These results support implementation of supervised exercise programmes in clinical practice.


Assuntos
Procedimentos Endovasculares/economia , Terapia por Exercício/economia , Claudicação Intermitente/terapia , Idoso , Redução de Custos , Análise Custo-Benefício , Terapia por Exercício/métodos , Feminino , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Reperfusão/economia , Reperfusão/métodos , Caminhada/economia , Caminhada/fisiologia
8.
Int J Cardiol ; 215: 332-7, 2016 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-27128556

RESUMO

BACKGROUND/OBJECTIVES: The aims of the study were to examine (i) the association between cardiovascular disease (CVD) or diabetes and exit from paid employment via disability benefits, unemployment, early retirement or other exit routes; and (ii) the impact of work-related factors on exit from paid employment among individuals with CVD or diabetes. METHODS: Respondents of the longitudinal Survey of Health and Retirement in Europe (SHARE) were included if they were aged >50years, had paid employment at baseline, and a known employment status after 2 or 6years (n=5182). A baseline-interview provided information on the presence of diagnosed CVD and diabetes, and physical and psychosocial work-related factors. During follow-up interviews information on work status was collected. Multinomial regression analyses were used to investigate the association between CVD, diabetes and exit from paid employment, and the impact of work-related factors. RESULTS: Workers with CVD or diabetes had significantly increased probabilities of disability benefits (OR 2.50, 95% CI 1.69-3.70) and early retirement (OR 1.34, 95% CI 1.05-1.74), but a comparable probability of unemployment (OR 1.10, 95% CI 0.71-1.71). Regarding disability benefits, individuals who had a stroke had the highest probability (OR 3.48, 95% CI 1.31-9.23). Perceived high job demands with low rewards or with low control at work further increased the probability of early exit among individuals with CVD or diabetes. CONCLUSIONS: Our study shows a prominent role of CVD and diabetes in premature losses to the workforce, and it shows that optimizing psychosocial work-related factors could be beneficial in people with CVD or diabetes.


Assuntos
Doenças Cardiovasculares/psicologia , Diabetes Mellitus/psicologia , Emprego/estatística & dados numéricos , Aposentadoria/estatística & dados numéricos , Licença Médica/estatística & dados numéricos , Doenças Cardiovasculares/epidemiologia , Diabetes Mellitus/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Nível de Saúde , Inquéritos Epidemiológicos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Análise de Regressão , Apoio Social , Desemprego
9.
Int J Cardiovasc Imaging ; 31(8): 1663-75, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26369642

RESUMO

To estimate the probability of ≥ 50% coronary stenoses based on computed tomography (CT) segmental calcium score (SCS) and clinical factors. The Institutional Review Board approved the study. A training sample of 201 patients underwent CT calcium scoring and conventional coronary angiography (CCA). All patients consented to undergo CT before CCA after being informed of the additional radiation dose. SCS and calcification morphology were assessed in individual coronary segments. We explored the predictive value of patient's symptoms, clinical history, SCS and calcification morphology. We developed a prediction model in the training sample based on these variables then tested it in an independent test sample. The odds ratio (OR) for ≥ 50% coronary stenosis was 1.8-fold greater (p = 0.006) in patients with typical chest pain, twofold (p = 0.014) greater in patients with acute coronary syndromes, twofold greater (p < 0.001) in patients with prior myocardial infarction. Spotty calcifications had an OR for ≥ 50% stenosis 2.3-fold (p < 0.001) greater than the absence of calcifications, wide calcifications 2.7-fold (p < 0.001) greater, diffuse calcifications 4.6-fold (p < 0.001) greater. In middle segments, each unit of SCS had an OR 1.2-fold (p < 0.001) greater than in distal segments; in proximal segments the OR was 1.1-fold greater (p = 0.021). The ROC curve area of the prediction model was 0.795 (0.95 confidence interval 0.602-0.843). Validation in a test sample of 201 independent patients showed consistent diagnostic performance. In conjunction with calcification morphology, anatomical location, patient's symptoms and clinical history, SCS can be helpful to estimate the probability of ≥ 50% coronary stenosis.


Assuntos
Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Estenose Coronária/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Técnicas de Apoio para a Decisão , Tomografia Computadorizada Multidetectores , Calcificação Vascular/diagnóstico por imagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Área Sob a Curva , Distribuição de Qui-Quadrado , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Valor Preditivo dos Testes , Curva ROC , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Adulto Jovem
10.
Int J Cardiol ; 184: 71-78, 2015 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-25705007

RESUMO

BACKGROUND: Stress is considered a modifiable risk factor for cardiovascular disease. Scalp hair analysis is a tool to assess long-term exposure to the stress hormone cortisol. We aimed to determine the association between hair cortisol concentrations (HCC) and clinical characteristics in patients with structural heart disease. Additionally, we investigated potential predictors for longitudinal change in HCC. METHODS: The study consisted of 261 patients with structural heart disease from a randomized controlled trial of mindfulness training. One sample of scalp hair was used to determine HCC both at baseline and at 12-week follow-up. In 151 patients, HCC was available (mean age: 41.3 years, range 18-65). We investigated the association between HCC at baseline and several physiological measures (BMI, blood pressure, heart rate, respiratory rate, 6-minute walk test), as well as psychological parameters (physical and mental component summary measures (SF-36), emotional distress (HADS), and perceived stress). Additionally, we used these clinical parameters to predict HCC change over time. RESULTS: The median HCC was 22.3 pg/mg of hair (23.5 interquartile range). In multivariable linear regression analyses, an association was observed between log-transformed HCC and BMI (ß 0.171, p=0.037), respiratory rate (ß 0.194, p=0.016), and the physical summary score (ß -0.163, p=0.054). Independent predictors of log-transformed HCC change after 12 weeks were mental summary score (ß -0.200, p=0.019) and diastolic blood pressure (ß -0.171, p=0.049). CONCLUSIONS: In patients with structural heart disease a positive association exists between HCC and BMI. Mental health status may predict a change in long-term cortisol over time.


Assuntos
Doenças Cardiovasculares/metabolismo , Cabelo/química , Hidrocortisona/análise , Couro Cabeludo/química , Estresse Psicológico/metabolismo , Adolescente , Adulto , Idoso , Biomarcadores/análise , Biomarcadores/metabolismo , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/psicologia , Feminino , Seguimentos , Inquéritos Epidemiológicos , Humanos , Masculino , Pessoa de Meia-Idade , Atenção Plena , Fatores de Risco , Estresse Psicológico/diagnóstico , Estresse Psicológico/psicologia , Adulto Jovem
11.
AJNR Am J Neuroradiol ; 35(9): 1714-20, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-24812015

RESUMO

BACKGROUND AND PURPOSE: Delayed cerebral ischemia and vasospasm are significant complications following SAH leading to cerebral infarction, functional disability, and death. In recent years, CTA and CTP have been used to increase the detection of delayed cerebral ischemia and vasospasm. Our aim was to perform comparative-effectiveness and cost-effectiveness analyses evaluating CTA and CTP for delayed cerebral ischemia and vasospasm in aneurysmal SAH from a health care payer perspective. MATERIALS AND METHODS: We developed a decision model comparing CTA and CTP with transcranial Doppler sonography for detection of vasospasm and delayed cerebral ischemia in SAH. The clinical pathways were based on the "Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage: A Guideline for Healthcare Professionals from the American Heart Association/American Stroke Association" (2012). Outcome health states represented mortality and morbidity according to functional outcomes. Input probabilities of symptoms and serial test results from CTA and CTP, transcranial Doppler ultrasound, and digital subtraction angiography were directly derived from an SAH cohort by using a multinomial logistic regression model. Expected benefits, measured as quality-adjusted life years, and costs, measured in 2012 US dollars, were calculated for each imaging strategy. Univariable, multivariable, and probabilistic sensitivity analyses were performed to determine the independent and combined effect of input parameter uncertainty. RESULTS: The transcranial Doppler ultrasound strategy yielded 13.62 quality-adjusted life years at a cost of $154,719. The CTA and CTP strategy generated 13.89 quality-adjusted life years at a cost of $147,097, resulting in a gain of 0.27 quality-adjusted life years and cost savings of $7622 over the transcranial Doppler ultrasound strategy. Univariable and multivariable sensitivity analyses indicated that results were robust to plausible input parameter uncertainty. Probabilistic sensitivity analysis results yielded 96.8% of iterations in the right lower quadrant, representing higher benefits and lower costs. CONCLUSIONS: Our model results suggest that CTA and CTP are the preferred imaging strategy in SAH, compared with transcranial Doppler ultrasound, leading to improved clinical outcomes and lower health care costs.


Assuntos
Isquemia Encefálica/diagnóstico , Angiografia Cerebral/economia , Imagem de Perfusão/economia , Hemorragia Subaracnóidea/complicações , Hemorragia Subaracnóidea/diagnóstico , Vasoespasmo Intracraniano/diagnóstico , Angiografia Digital , Isquemia Encefálica/etiologia , Angiografia Cerebral/métodos , Análise Custo-Benefício , Humanos , Modelos Logísticos , Imagem de Perfusão/métodos , Tomografia Computadorizada por Raios X/economia , Tomografia Computadorizada por Raios X/métodos , Ultrassonografia Doppler Transcraniana/economia , Ultrassonografia Doppler Transcraniana/métodos , Estados Unidos , Vasoespasmo Intracraniano/etiologia
12.
Eur J Prev Cardiol ; 21(3): 310-20, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24367001

RESUMO

BACKGROUND: The ankle brachial index (ABI) is related to risk of cardiovascular events independent of the Framingham risk score (FRS). The aim of this study was to develop and evaluate a risk model for cardiovascular events incorporating the ABI and FRS. DESIGN: An analysis of participant data from 18 cohorts in which 24,375 men and 20,377 women free of coronary heart disease had ABI measured and were followed up for events. METHODS: Subjects were divided into a development and internal validation dataset and an external validation dataset. Two models, comprising FRS and FRS + ABI, were fitted for the primary outcome of major coronary events. RESULTS: In predicting events in the external validation dataset, C-index for the FRS was 0.672 (95% CI 0.599 to 0.737) in men and 0.578 (95% CI 0.492 to 0.661) in women. The FRS + ABI led to a small increase in C-index in men to 0.685 (95% CI 0.612 to 0.749) and large increase in women to 0.690 (95% CI 0.605 to 0.764) with net reclassification improvement (NRI) of 4.3% (95% CI 0.0 to 7.6%, p = 0.050) and 9.6% (95% CI 6.1 to 16.4%, p < 0.001), respectively. Restricting the FRS + ABI model to those with FRS intermediate 10-year risk of 10 to 19% resulted in higher NRI of 15.9% (95% CI 6.1 to 20.6%, p < 0.001) in men and 23.3% (95% CI 13.8 to 62.5%, p = 0.002) in women. However, incorporating ABI in an improved newly fitted risk factor model had a nonsignificant effect: NRI 2.0% (95% CI 2.3 to 4.2%, p = 0.567) in men and 1.1% (95% CI 1.9 to 4.0%, p = 0.483) in women. CONCLUSIONS: An ABI risk model may improve prediction especially in individuals at intermediate risk and when performance of the base risk factor model is modest.


Assuntos
Índice Tornozelo-Braço , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/fisiopatologia , Europa (Continente)/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Valor Preditivo dos Testes , Prognóstico , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Estados Unidos/epidemiologia , População Branca , Adulto Jovem
13.
Br J Surg ; 100(9): 1164-71, 2013 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-23842830

RESUMO

BACKGROUND: Long-term comparisons of supervised exercise therapy (SET) and endovascular revascularization (ER) for patients with intermittent claudication are scarce. The long-term clinical effectiveness of SET and ER was assessed in patients from a randomized trial. METHODS: Consenting patients with intermittent claudication were assigned randomly to either SET or ER. Outcome measures on functional performance (pain-free and maximum walking distance, ankle : brachial pressure index), quality of life (QoL) and number of secondary interventions were measured at baseline and after approximately 7 years of follow-up. Repeated-measurement and Kaplan-Meier methods were used to analyse the data on an intention-to treat-basis. RESULTS: A total of 151 patients were randomized initially to either SET or ER. After 7 years, functional performance (P < 0.001) and QoL (P ≤ 0.005) had improved after both SET and ER. Long-term comparison showed no differences between the two treatments, except in the secondary intervention rate, which was significantly higher after SET (P = 0.001). Nevertheless, the total number of endovascular and surgical interventions (primary and secondary) remained higher after ER (P < 0.001). CONCLUSION: In the longer term, SET-first or ER-first treatment strategies were equally effective in improving functional performance and QoL in patients with intermittent claudication. The substantially higher number of invasive interventions in the ER-first group supports a SET-first treatment strategy for intermittent claudication. REGISTRATION NUMBER: NTR199 (http://www.trialregister.nl).


Assuntos
Angioplastia com Balão/métodos , Terapia por Exercício/métodos , Claudicação Intermitente/terapia , Stents , Qualidade dos Alimentos , Humanos , Claudicação Intermitente/fisiopatologia , Estimativa de Kaplan-Meier , Reperfusão/métodos , Resultado do Tratamento , Caminhada/fisiologia
14.
Br J Surg ; 98(11): 1546-55, 2011 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-21725968

RESUMO

BACKGROUND: The aim of this study was to determine the cost-effectiveness of ultrasound screening for abdominal aortic aneurysm (AAA) in men aged 65 years, for both the Netherlands and Norway. METHODS: A Markov model was developed to simulate life expectancy, quality-adjusted life-years, net health benefits, lifetime costs and incremental cost-effectiveness ratios for both screening and no screening for AAA. The best available evidence was retrieved from the literature and combined with primary data from the two countries separately, and analysed from a national perspective. A threshold willingness-to-pay (WTP) of €20,000 and €62,500 was used for data from the Netherlands and Norway respectively. RESULTS: The additional costs of the screening strategy compared with no screening were €421 (95 per cent confidence interval 33 to 806) per person in the Netherlands, and the additional life-years were 0·097 (-0·180 to 0·365), representing €4340 per life-year. For Norway, the values were €562 (59 to 1078), 0·057 (-0·135 to 0·253) life-years and €9860 per life-year respectively. In Norway the results were sensitive to a decrease in the prevalence of AAA in 65-year-old men to 1 per cent, or lower. Probabilistic sensitivity analyses indicated that AAA screening has a 70 per cent probability of being cost-effective in the Netherlands with a WTP threshold of €20,000, and 70 per cent in Norway with a threshold of €62,500. CONCLUSION: Using this model, screening for AAA in 65-year-old men would be highly cost-effective in both the Netherlands and Norway.


Assuntos
Aneurisma da Aorta Abdominal/prevenção & controle , Ruptura Aórtica/prevenção & controle , Programas de Rastreamento/economia , Idoso , Aneurisma da Aorta Abdominal/economia , Ruptura Aórtica/economia , Análise Custo-Benefício , Custos de Cuidados de Saúde , Humanos , Masculino , Cadeias de Markov , Países Baixos , Noruega , Anos de Vida Ajustados por Qualidade de Vida
15.
Eur J Vasc Endovasc Surg ; 42(4): 510-6, 2011 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-21795080

RESUMO

OBJECTIVES: The objective was to evaluate the impact of gender on long-term survival of patients who underwent non-cardiac vascular surgery. DESIGN, MATERIAL AND METHODS: Our prospectively collected data contained information on 560 patients undergoing carotid endarterectomy (CEA), 923 elective abdominal aortic aneurysm repairs (AAA) and 1046 lower limb reconstructions (LLR). Patient characteristics and long-term mortality of women were compared to that of men. Kaplan-Meier (KM) survival curves were constructed for men and women, on which we superimposed age- and sex-matched KM survival curves of the general population. Cox proportional hazards regression was used to identify risk factors for mortality. RESULTS: Men in the CEA group had statistically significant higher all-cause mortality, hazard rate ratio (HRR) 1.41 (95% CI 1.01-1.98) No differences in mortality between the genders were observed in the AAA and LLR groups. Overall, men had more co-morbidities but received more disease-specific medication compared to women. Women retained their higher life expectancy after CEA but lost it in the AAA and LLR groups. CONCLUSION: Women retain their higher life expectancy after CEA; however, after AAA repair and LLR, this advantage is lost. Both men and women received too little disease-specific medication, but women were worse off.


Assuntos
Procedimentos Cirúrgicos Vasculares/mortalidade , Idoso , Aneurisma da Aorta Abdominal/mortalidade , Aneurisma da Aorta Abdominal/cirurgia , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/mortalidade , Estenose das Carótidas/cirurgia , Causas de Morte , Endarterectomia das Carótidas , Feminino , Humanos , Perna (Membro)/irrigação sanguínea , Expectativa de Vida , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/cirurgia , Prognóstico , Modelos de Riscos Proporcionais , Fatores Sexuais , Taxa de Sobrevida
16.
Br J Surg ; 97(8): 1169-79, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20564307

RESUMO

BACKGROUND: The aim of this study was to assess possible differences in mortality between men and women with an abdominal aortic aneurysm (AAA) treated either by elective repair or following aneurysm rupture. METHODS: A systematic literature search was performed using the MEDLINE, Cochrane and Embase databases. Data were analysed by means of bivariate random-effects meta-analysis. Data were pooled and odds ratios (ORs) calculated for women compared with men. RESULTS: Sixty-one studies (516 118 patients) met the predetermined inclusion criteria. Twenty-six reported on elective open AAA repair, 21 on elective endovascular repair, 25 on open repair for ruptured AAA and one study on endovascular repair for ruptured AAA. Mortality rates for women compared with men were 7.6 versus 5.1 per cent (OR 1.28, 95 per cent confidence interval (c.i.) 1.09 to 1.49) for elective open repair, 2.9 versus 1.5 per cent (OR 2.41, 95 per cent c.i. 1.14 to 5.15) for elective endovascular repair, and 61.8 versus 42.2 per cent (OR 1.16, 95 per cent c.i. 0.97 to 1.37) in the group that had open repair for rupture. The group that had endovascular repair for ruptured AAA was too small for meaningful analysis. CONCLUSION: Women with an AAA had a higher mortality rate following elective open and endovascular repair.


Assuntos
Aneurisma da Aorta Abdominal/mortalidade , Ruptura Aórtica/mortalidade , Idoso , Aneurisma da Aorta Abdominal/cirurgia , Ruptura Aórtica/cirurgia , Procedimentos Cirúrgicos Eletivos/mortalidade , Endarterectomia/mortalidade , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Distribuição por Sexo , Fatores Sexuais , Resultado do Tratamento
17.
J Hum Hypertens ; 24(2): 86-92, 2010 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-19494836

RESUMO

This study was performed to examine the association of cardiovascular risk factors with calcification in the coronary arteries, aortic arch and carotid arteries, assessed by multislice computed tomography (MSCT). This study was embedded in the Rotterdam Study, a population-based study in subjects aged 55 years and over. From October 2003 until December 2004, subjects were invited to undergo a MSCT scan. Coronary, aortic arch and carotid calcification were quantified according to the Agatston score. Analyses were performed in the first 1003 subjects. Age and current smoking were the strongest independent risk factors for arterial calcification. The odds ratio (OR) for age in women, irrespective of the vessel bed, was 1.1 (P<0.001) and in men it was 1.2 with aortic arch and 1.1 with carotid calcification (both P<0.001). Current smoking was associated with aortic arch calcification with an OR of 3.5 in women and of 4.7 in men (both P<0.001); and with carotid calcification with an OR of 2.1 in women (P<0.05) and of 4.1 in men (P<0.01). Hypertension, hypercholesterolemia and diabetes were also independently related to calcification, although not consistent across all vessel beds and for men and women. Obesity tended to be inversely related to arterial calcification in women, whereas low high-density lipoprotein-cholesterol showed no relation with arterial calcification. In conclusion, although associations were not completely consistent across the different vessel beds and for men and women, our results indicate that generally the same risk factors are present for atherosclerosis in the coronary, aortic arch and carotid circulation.


Assuntos
Aorta Torácica , Doenças da Aorta/etiologia , Calcinose/etiologia , Doenças das Artérias Carótidas/etiologia , Doença da Artéria Coronariana/etiologia , Fatores Etários , Idoso , Aorta Torácica/diagnóstico por imagem , Doenças da Aorta/diagnóstico por imagem , Doenças da Aorta/epidemiologia , Aortografia/métodos , Calcinose/diagnóstico por imagem , Calcinose/epidemiologia , Doenças das Artérias Carótidas/diagnóstico por imagem , Doenças das Artérias Carótidas/epidemiologia , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/epidemiologia , Complicações do Diabetes/etiologia , Feminino , Humanos , Hipercolesterolemia/complicações , Hipertensão/complicações , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Obesidade/complicações , Razão de Chances , Vigilância da População , Medição de Risco , Fatores de Risco , Fatores Sexuais , Fumar/efeitos adversos , Tomografia Computadorizada por Raios X
18.
JAMA ; 300(2): 197-208, 2008 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-18612117

RESUMO

CONTEXT: Prediction models to identify healthy individuals at high risk of cardiovascular disease have limited accuracy. A low ankle brachial index (ABI) is an indicator of atherosclerosis and has the potential to improve prediction. OBJECTIVE: To determine if the ABI provides information on the risk of cardiovascular events and mortality independently of the Framingham risk score (FRS) and can improve risk prediction. DATA SOURCES: Relevant studies were identified. A search of MEDLINE (1950 to February 2008) and EMBASE (1980 to February 2008) was conducted using common text words for the term ankle brachial index combined with text words and Medical Subject Headings to capture prospective cohort designs. Review of reference lists and conference proceedings, and correspondence with experts was conducted to identify additional published and unpublished studies. STUDY SELECTION: Studies were included if participants were derived from a general population, ABI was measured at baseline, and individuals were followed up to detect total and cardiovascular mortality. DATA EXTRACTION: Prespecified data on individuals in each selected study were extracted into a combined data set and an individual participant data meta-analysis was conducted on individuals who had no previous history of coronary heart disease. RESULTS: Sixteen population cohort studies fulfilling the inclusion criteria were included. During 480,325 person-years of follow-up of 24,955 men and 23,339 women, the risk of death by ABI had a reverse J-shaped distribution with a normal (low risk) ABI of 1.11 to 1.40. The 10-year cardiovascular mortality in men with a low ABI (< or = 0.90) was 18.7% (95% confidence interval [CI], 13.3%-24.1%) and with normal ABI (1.11-1.40) was 4.4% (95% CI, 3.2%-5.7%) (hazard ratio [HR], 4.2; 95% CI, 3.3-5.4). Corresponding mortalities in women were 12.6% (95% CI, 6.2%-19.0%) and 4.1% (95% CI, 2.2%-6.1%) (HR, 3.5; 95% CI, 2.4-5.1). The HRs remained elevated after adjusting for FRS (2.9 [95% CI, 2.3-3.7] for men vs 3.0 [95% CI, 2.0-4.4] for women). A low ABI (< or = 0.90) was associated with approximately twice the 10-year total mortality, cardiovascular mortality, and major coronary event rate compared with the overall rate in each FRS category. Inclusion of the ABI in cardiovascular risk stratification using the FRS would result in reclassification of the risk category and modification of treatment recommendations in approximately 19% of men and 36% of women. CONCLUSION: Measurement of the ABI may improve the accuracy of cardiovascular risk prediction beyond the FRS.


Assuntos
Tornozelo , Pressão Sanguínea , Artéria Braquial , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/fisiopatologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Aterosclerose/fisiopatologia , Estudos de Coortes , Intervalos de Confiança , Feminino , Saúde Global , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Valor Preditivo dos Testes , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença
19.
Med Decis Making ; 28(5): 621-38, 2008.
Artigo em Inglês | MEDLINE | ID: mdl-18591542

RESUMO

Meta-analysis of receiver operating characteristic (ROC)-curve data is often done with fixed-effects models, which suffer many shortcomings. Some random-effects models have been proposed to execute a meta-analysis of ROC-curve data, but these models are not often used in practice. Straightforward modeling techniques for multivariate random-effects meta-analysis of ROC-curve data are needed. The 1st aim of this article is to present a practical method that addresses the drawbacks of the fixed-effects summary ROC (SROC) method of Littenberg and Moses. Sensitivities and specificities are analyzed simultaneously using a bivariate random-effects model. The 2nd aim is to show that other SROC curves can also be derived from the bivariate model through different characterizations of the estimated bivariate normal distribution. Thereby the authors show that the bivariate random-effects approach not only extends the SROC approach but also provides a unifying framework for other approaches. The authors bring the statistical meta-analysis of ROC-curve data back into a framework of relatively standard multivariate meta-analysis with random effects. The analyses were carried out using the software package SAS (Proc NLMIXED).


Assuntos
Metanálise como Assunto , Modelos Estatísticos , Curva ROC , Interpretação Estatística de Dados , Testes Diagnósticos de Rotina/normas , Humanos
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