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1.
Artigo em Inglês | MEDLINE | ID: mdl-31771958

RESUMO

BACKGROUND: Understanding patient perceptions of their spiritual needs when approaching the end of life is essential to support the delivery of patient-centred care. AIM: To conduct a qualitative evidence synthesis on spirituality and spiritual care needs at the end of life in all healthcare settings from the patients' perspective. DESIGN: Studies were included where they were primary qualitative studies exploring spirituality in patients with a life expectancy of 12 months or less in any setting. Two reviewers independently screened titles, extracted data and conducted methodological quality appraisal. A thematic synthesis was conducted. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) - Confidence in the Evidence from Reviews of Qualitative research (CERQual) was used to summarise the certainty of the evidence. DATA SOURCES: Six databases (Medline, Embase, Cochrane, CINAHL, PsycINFO, Applied Social Science Index and Abstracts) were searched from inception up to January 2019. RESULTS: Fifty papers (42 unique datasets), incorporating data from 710 patients were included. Studies recruited from a mix of inpatient, outpatient, hospice and community settings across 12 different countries. Three overarching themes were generated: the concept of spirituality, spiritual needs and distress, and spiritual care resources. Relationships were an intrinsic component of spirituality. CONCLUSION: Meeting patients' spiritual needs is an integral part of end-of-life care. This work emphasises that supporting relationships should be a central focus of spiritual care for patients at the end of life. PROSPERO REGISTRATION NUMBER: CRD42019122062.

2.
Ir J Med Sci ; 188(2): 689-698, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30218291

RESUMO

BACKGROUND: Twelve randomised controlled trials (RCTs) comparing mechanical thrombectomy against traditional treatment options for patients experiencing acute ischaemic stroke (AIS) have been published. AIMS: To evaluate whether this technology is more effective and/or safer than traditional treatment options and to assess the potential for implementation of this technology as a treatment strategy for acute ischaemic stroke in Ireland. METHODS: RCTs published up to February 2017 were included. Meta-analysis was performed for two primary (mortality at 90 days, mRS at 90 days) and four secondary outcomes. Cumulative meta-analysis was used to investigate the point at which a consistent treatment effect was observed for outcomes that had a statistically significant pooled effect. RESULTS: Mechanical thrombectomy was associated with higher likelihood of being independent (mRS, p < 0.01; Barthel index, p < 0.01) at 90 days post-AIS (p < 0.001). Cumulative meta-analysis demonstrated a consistent treatment effect in favour of mechanical thrombectomy after each trial was added to the analysis. There was no evidence of a difference in mortality rates (p = 0.21) or rates of SICH (p = 0.71) between patients randomised to intervention and control arms. Although the intervention appears to be associated with higher rates of any cerebral haemorrhage (p < 0.01) and recurrent ischaemic stroke (p = 0.03), considerable uncertainty remains as to these treatment effects. CONCLUSIONS: The trials published most recently have acted as a 'watershed' for mechanical thrombectomy, and while there are significant caveats, the data suggests that mechanical thrombectomy needs to be factored into the planning and delivery of services for the management of patients with acute ischaemic stroke in Ireland.


Assuntos
Procedimentos Endovasculares/métodos , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Terapia Trombolítica/métodos , Feminino , Humanos , Masculino , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/patologia , Resultado do Tratamento
3.
Ir J Med Sci ; 188(3): 751-759, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30536140

RESUMO

PURPOSE: Although good evidence exists regarding the clinical effectiveness of mechanical thrombectomy for people with acute ischaemic stroke, cost-effectiveness should also be considered. The aim of this study was to systematically review the evidence of cost-effectiveness of emergency endovascular therapy using mechanical thrombectomy in the management of acute ischaemic stroke. METHODS: The search was carried out in PubMed, EMBASE, Cochrane Library, and a grey literature search. Studies were included if they compared the costs and consequences of mechanical thrombectomy added to usual medical care compared to usual care alone for people with acute ischaemic stroke in the anterior and/or posterior region. Study quality was assessed using two appraisal tools tailored to economic evaluations. FINDINGS: Thirteen studies were identified including twelve cost-utility analyses and one cost-benefit analysis. Studies could be dichotomised into those that evaluated first-generation (n = 4) and second-generation (n = 9) mechanical thrombectomy devices. Six studies had low applicability, six had moderate applicability, and one had high applicability to other settings. All cost-utility studies reported incremental cost-effectiveness ratios that would be considered cost-effective under typical willingness-to-pay thresholds. CONCLUSIONS: If the outcomes of the trials underpinning the evidence of clinical effectiveness can be replicated, then mechanical thrombectomy is likely to be cost-effective by typical willingness-to-pay thresholds. This finding holds under the assumption that no investment is required to develop stroke centres to the standard required to provide a safe emergency endovascular service and that additional expenditure on timely patient transport is not required.


Assuntos
Isquemia Encefálica/economia , Isquemia Encefálica/terapia , Tratamento de Emergência/métodos , Procedimentos Endovasculares/métodos , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/terapia , Trombectomia/métodos , Isquemia Encefálica/mortalidade , Análise Custo-Benefício , Humanos , Acidente Vascular Cerebral/mortalidade , Análise de Sobrevida , Resultado do Tratamento
4.
Pediatr Infect Dis J ; 37(8): 759-767, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29432385

RESUMO

BACKGROUND: In Western Europe, currently only Ireland and Portugal continue to provide universal neonatal bacillus Calmette-Guérin (BCG) vaccination programs, despite not being considered as high tuberculosis (TB) incidence countries. Other European countries only vaccinate infants considered at high risk of contracting TB. We evaluated the cost-effectiveness of selective BCG vaccination compared with strategies of universal and no vaccination. METHODS: An economic model was used to simulate a cohort from birth to life expectancy, taking the perspective of the publicly funded healthcare system. BCG protection was modeled to last 15 years. International vaccine efficacy data were combined with Irish epidemiologic and cost data. The model took into account long-term sequelae associated with TB meningitis and severe adverse reactions relating to the BCG vaccine. A fully probabilistic model was used to incorporate uncertainty across all parameters. RESULTS: At &OV0556;139,557 per quality-adjusted life year, selective vaccination was not cost-effective relative to a program of no vaccination. The incremental cost-effectiveness of universal vaccination was &OV0556;2.55 million per quality-adjusted life year relative to selective vaccination. There was substantial uncertainty regarding the effectiveness of BCG vaccination. The cost-effectiveness of selective vaccination could be substantially improved by reducing the cost of administering the vaccine. CONCLUSIONS: In the absence of changes to other aspects of TB control, a switch to selective vaccination will result in increased cases of childhood TB. Although not considered cost-effective, selective vaccination may be preferable to no vaccination until other changes to TB control may be implemented to reduce the risk of TB in children.


Assuntos
Vacina BCG/administração & dosagem , Análise Custo-Benefício , Programas de Imunização , Tuberculose/prevenção & controle , Cobertura Vacinal/economia , Vacina BCG/economia , Estudos de Coortes , Simulação por Computador , Humanos , Incidência , Lactente , Irlanda/epidemiologia , Modelos Econômicos , Fatores de Risco , Tuberculose/epidemiologia , Cobertura Vacinal/estatística & dados numéricos
5.
Int J Technol Assess Health Care ; 33(4): 424-429, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29032786

RESUMO

OBJECTIVES: The aim of this study was to illustrate the contribution of stakeholder engagement to the impact of health technology assessment (HTA) using an Irish HTA of a national public access defibrillation (PAD) program. BACKGROUND: In response to draft legislation that proposed a PAD program, the Minister for Health requested that Health Information and Quality Authority undertake an HTA to inform the design and implementation of a national PAD program and the necessary underpinning legislation. The draft legislation outlined a program requiring widespread installation and maintenance of automatic external defibrillators in specified premises. METHODS: Stakeholder engagement to optimize the impact of the HTA included one-to-one interviews with politicians, engagement with an Expert Advisory Group, public and targeted consultation, and positive media management. RESULTS: The HTA quantified the clinical benefits of the proposed PAD program as modest, identified that substantial costs would fall on small/medium businesses at a time of economic recession, and that none of the programs modeled were cost-effective. The Senator who proposed the Bill actively publicized the HTA process and its findings and encouraged participation in the public consultation. Participation of key stakeholders was important for the quality and acceptability of the HTA findings and advice. Media management promoted public engagement and understanding. The Bill did not progress. CONCLUSIONS: The HTA informed the decision not to progress with legislation for a national PAD program. Engagement was tailored to ensure that key stakeholders including politicians and the public were informed of the HTA process, the findings, and the advice, thereby maximizing acceptance. Appropriate stakeholder engagement optimizes the impact of HTA.


Assuntos
Participação da Comunidade , Desfibriladores/provisão & distribução , Avaliação da Tecnologia Biomédica/organização & administração , Análise Custo-Benefício , Tomada de Decisões , Desfibriladores/economia , Política de Saúde , Humanos , Irlanda
6.
Chron Respir Dis ; 14(3): 276-288, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28774200

RESUMO

Self-management (SM) is defined as the provision of interventions to increase patients' skills and confidence, empowering the individual to take an active part in their disease management. There is uncertainty regarding the optimal format and the short- and long-term benefits of chronic obstructive pulmonary disease (COPD) SM interventions in adults. Therefore, a high-quality overview of reviews was updated to examine their clinical effectiveness. Sixteen reviews were identified, interventions were broadly classified as education or action plans, complex interventions with an SM focus, pulmonary rehabilitation (PR), telehealth and outreach nursing. Systematic review and meta-analysis quality and the risk of bias of underlying primary studies were assessed. Strong evidence was found that PR is associated with significant improvements in health-related quality of life (HRQoL). Limited to moderate evidence for complex interventions (SM focus) with limited evidence for education, action plans, telehealth interventions and outreach nursing for HRQoL was found. There was strong evidence that education is associated with a significant reduction in COPD-related hospital admissions, moderate to strong evidence that telehealth interventions and moderate evidence that complex interventions (SM focus) are associated with reduced health care utilization. These findings from a large body of evidence suggesting that SM, through education or as a component of PR, confers significant health gains in people with COPD in terms of HRQoL. SM supported by telehealth confers significant reductions in healthcare utilization, including hospitalization and emergency department visits.


Assuntos
Doença Pulmonar Obstrutiva Crônica/terapia , Autocuidado , Terapia por Exercício , Recursos em Saúde/estatística & dados numéricos , Enfermagem Domiciliar , Humanos , Admissão do Paciente , Educação de Pacientes como Assunto , Doença Pulmonar Obstrutiva Crônica/reabilitação , Literatura de Revisão como Assunto , Telemedicina
7.
Value Health ; 20(7): 1000-1002, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28712610

RESUMO

A review of the Health Information and Quality Authority's (HIQA) assessment of breast cancer surveillance cancer criticized how the results were presented and interpreted. The health technology assessment (HTA) investigated surveillance options for women aged less than 50 years who were at elevated risk of breast cancer. Surveillance strategies using digital mammography, magnetic resonance imaging, or a combination of the two modalities were modeled on the basis of diagnostic test accuracy. The HTA faced a number of issues, including the use of diagnostic test accuracy as a surrogate for long-term outcomes; modeling interventions that were not considered acceptable to clinicians; and extrapolating for screening intervals and age ranges not directly supported by available evidence. The evaluation of screening programs gives rise to challenges in terms of balancing an adequate exploration of the possible options while also being cognizant of what is appropriately supported by evidence. In this article, the authors of the HIQA report discuss the challenges posed by this particular HTA.


Assuntos
Neoplasias da Mama/diagnóstico por imagem , Imagem por Ressonância Magnética/métodos , Mamografia/métodos , Avaliação da Tecnologia Biomédica/métodos , Detecção Precoce de Câncer/métodos , Feminino , Humanos , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Modelos Teóricos , Fatores de Risco
8.
Value Health ; 19(8): 985-995, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27987649

RESUMO

OBJECTIVES: To evaluate the cost-effectiveness of a national atrial fibrillation screening program in Ireland involving annual opportunistic pulse palpation of all those older than 65 years during general practitioner consultations, with an electrocardiogram being performed if an irregular pulse is detected. METHODS: A probabilistic Markov model was used to simulate costs and clinical outcomes in a hypothetical cohort of men and women with and without screening over the course of 25 years, using a societal perspective. RESULTS: Screening was associated with an incremental cost-effectiveness ratio of €23,004/quality-adjusted life-year compared with routine care. Nevertheless, if the relative risk of stroke and systematic embolism in screen-detected patients is more than 12% lower than that in patients with atrial fibrillation identified through routine practice, then screening would not be considered cost-effective at a willingness-to-pay threshold of €45,000/quality-adjusted life-year. An analysis comparing alternative combinations of start age and screening interval found that less frequent screening with a later start age may be more cost-effective than an annual screening from age 65 years. CONCLUSIONS: Annual opportunistic screening of men and women aged 65 years and older in primary care in Ireland is likely to be cost-effective using conventional willingness-to-pay thresholds, assuming that those detected through screening have a comparable stroke risk profile as those detected through routine practice. Raising the start age of screening or increasing the screening interval may improve the cost-effectiveness of a prospective screening program.


Assuntos
Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Programas de Rastreamento/economia , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/etiologia , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/tratamento farmacológico , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Eletrocardiografia , Feminino , Fibrinolíticos/economia , Humanos , Incidência , Irlanda , Masculino , Cadeias de Markov , Atenção Primária à Saúde , Estudos Prospectivos , Anos de Vida Ajustados por Qualidade de Vida , Fatores de Risco , Acidente Vascular Cerebral/prevenção & controle , Índices de Gravidade do Trauma
9.
Cochrane Database Syst Rev ; (6): CD009586, 2016 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-27258214

RESUMO

BACKGROUND: Atrial fibrillation (AF), the most common arrhythmia in clinical practice, is a leading cause of morbidity and mortality. Screening for AF in asymptomatic patients has been proposed as a way of reducing the burden of the disease by detecting people who would benefit from prophylactic anticoagulation therapy before the onset of symptoms. However, for screening to be an effective intervention, it must improve the detection of AF and provide benefit for those detected earlier as a result of screening. OBJECTIVES: This review aims to answer the following questions.Does systematic screening increase the detection of AF compared with routine practice? Which combination of screening population, strategy and test is most effective for detecting AF compared with routine practice? What safety issues and adverse events may be associated with individual screening programmes? How acceptable is the intervention to the target population? What costs are associated with systematic screening for AF? SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid) and EMBASE (Ovid) up to 11 November 2015. We searched other relevant research databases, trials registries and websites up to December 2015. We also searched reference lists of identified studies for potentially relevant studies, and we contacted corresponding authors for information about additional published or unpublished studies that may be relevant. We applied no language restrictions. SELECTION CRITERIA: Randomised controlled trials comparing screening for AF with routine practice in people 40 years of age and older were eligible. Two review authors (PM and CT) independently selected trials for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors (PM and CT) independently assessed risk of bias and extracted data. We used odds ratios (ORs) and 95% confidence intervals (CIs) to present results for the primary outcome, which is a dichotomous variable. As we identified only one study for inclusion, we performed no meta-analysis. We used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation Working Group) method to assess the quality of the evidence and GRADEPro to create a 'Summary of findings' table. MAIN RESULTS: One cluster-randomised controlled trial met the inclusion criteria for this review. This study compared systematic screening (by invitation to have an electrocardiogram (ECG)) and opportunistic screening (pulse palpation during a general practitioner (GP) consultation for any reason, followed by an ECG if pulse was irregular) versus routine practice (normal case finding on the basis of clinical presentation) in people 65 years of age or older.Results show that both systematic screening and opportunistic screening of people over 65 years of age are more effective than routine practice (OR 1.57, 95% CI 1.08 to 2.26; and OR 1.58, 95% CI 1.10 to 2.29, respectively; both moderate-quality evidence). We found no difference in the effectiveness of systematic screening and opportunistic screening (OR 0.99, 95% CI 0.72 to 1.37; low-quality evidence). A subgroup analysis found that systematic screening and opportunistic screening were more effective in men (OR 2.68, 95% CI 1.51 to 4.76; and OR 2.33, 95% CI 1.29 to 4.19, respectively) than in women (OR 0.98, 95% CI 0.59 to 1.62; and OR 1.2, 95% CI 0.74 to 1.93, respectively). No adverse events associated with screening were reported.The incremental cost per additional case detected by opportunistic screening was GBP 337, compared with GBP 1514 for systematic screening. All cost estimates were based on data from the single included trial, which was conducted in the UK between 2001 and 2003. AUTHORS' CONCLUSIONS: Evidence suggests that systematic screening and opportunistic screening for AF increase the rate of detection of new cases compared with routine practice. Although these approaches have comparable effects on the overall AF diagnosis rate, the cost of systematic screening is significantly greater than the cost of opportunistic screening from the perspective of the health service provider. Few studies have investigated effects of screening in other health systems and in younger age groups; therefore, caution needs to be exercised in relation to transferability of these results beyond the setting and population in which the included study was conducted.Additional research is needed to examine the effectiveness of alternative screening strategies and to investigate the effects of the intervention on risk of stroke for screened versus non-screened populations.


Assuntos
Fibrilação Atrial/diagnóstico , Eletrocardiografia , Programas de Rastreamento/métodos , Palpação/métodos , Idoso , Doenças Assintomáticas , Feminino , Humanos , Masculino , Pulso Arterial/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto
11.
Resuscitation ; 91: 48-55, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25828922

RESUMO

AIM: Proposed Irish legislation aimed at increasing survival from out-of-hospital-cardiac-arrest (OHCA) mandates the provision of automated external defibrillators (AEDs) in a comprehensive range of publicly accessible premises in urban and rural areas. This study estimated the clinical and cost effectiveness of the legislation, compared with alternative programme configurations involving more targeted AED placement. METHODS: We used a cost-utility analysis to estimate the costs and consequences of public access defibrillation (PAD) programmes from a societal perspective, based on AED deployment by building type. Comparator programmes ranged from those that only included building types with the highest incidence of OHCA, to the comprehensive programme outline in the proposed legislation. Data on OHCA incidence and outcomes were obtained from the Irish Out-of-Hospital-Cardiac-Arrest Register (OHCAR). Costs were obtained from the Irish health service, device suppliers and training providers. RESULTS: The incremental cost effectiveness ratio (ICER) for the most comprehensive PAD scheme was €928,450/QALY. The ICER for the most scaled-back programme involving AED placement in transport stations, medical practices, entertainment venues, schools (excluding primary) and fitness facilities was €95,640/QALY. A 40% increase in AED utilisation when OHCAs occur in a public area could potentially render this programme cost effective. CONCLUSION: National PAD programmes involving widespread deployment of static AEDs are unlikely to be cost-effective. To improve cost-effectiveness any prospective programmes should target locations with the highest incidence of OHCA and be supported by efforts to increase AED utilisation, such as improving public awareness, increasing CPR and AED training, and establishing an EMS-linked AED register.


Assuntos
Desfibriladores/provisão & distribução , Cardioversão Elétrica/métodos , Acesso aos Serviços de Saúde/economia , Parada Cardíaca Extra-Hospitalar/terapia , Idoso , Análise Custo-Benefício , Desfibriladores/economia , Cardioversão Elétrica/economia , Feminino , Acesso aos Serviços de Saúde/legislação & jurisprudência , Humanos , Irlanda , Masculino , Pessoa de Meia-Idade , Parada Cardíaca Extra-Hospitalar/mortalidade , Taxa de Sobrevida
12.
Vasc Med ; 20(1): 41-50, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25270409

RESUMO

Intermittent pneumatic compression (IPC) is designed to aid wound healing and limb salvage for patients with critical limb ischaemia who are not candidates for revascularisation. We conducted a systematic review of the literature to identify and critically appraise the evidence supporting its use in this population. A search was conducted in Embase, MEDLINE and clinical trial registries up to the end of March 2013. No date or language restrictions were applied. Quality assessment was performed by two people independently. Quality was assessed using the Cochrane risk of bias tool and the NICE case-series assessment tool. Two controlled before-and-after (CBA) studies and six case series were identified. One retrospective CBA study involving compression of the calf reported improved limb salvage and wound healing (OR 7.00, 95% CI 1.82 to 26.89, p<0.01). One prospective CBA study involving sequential compression of the foot and calf reported statistically significant improvements in claudication distances and SF-36 quality of life scores. No difference in all-cause mortality was found. Complications included pain associated with compression, as well as skin abrasion and contact rash as a result of the cuff rubbing against the skin. All studies had a high risk of bias. In conclusion, the limited available results suggest that IPC may be associated with improved limb salvage, wound healing and pain management. However, in the absence of additional well-designed analytical studies examining the effect of IPC in critical limb ischaemia, this treatment remains unproven.


Assuntos
Claudicação Intermitente/terapia , Dispositivos de Compressão Pneumática Intermitente , Isquemia/terapia , Amputação , Estado Terminal , Teste de Esforço , Tolerância ao Exercício , Humanos , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/mortalidade , Claudicação Intermitente/fisiopatologia , Dispositivos de Compressão Pneumática Intermitente/efeitos adversos , Isquemia/diagnóstico , Isquemia/mortalidade , Isquemia/fisiopatologia , Salvamento de Membro , Medição da Dor , Qualidade de Vida , Recuperação de Função Fisiológica , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Cicatrização
13.
Int J Technol Assess Health Care ; 30(1): 44-9, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24472222

RESUMO

OBJECTIVES: When incorporating treatment effect estimates derived from a random-effect meta-analysis it is tempting to use the confidence bounds to determine the potential range of treatment effect. However, prediction intervals reflect the potential effect of a technology rather than the more narrowly defined average treatment effect. Using a case study of robot-assisted radical prostatectomy, this study investigates the impact on a cost-utility analysis of using clinical effectiveness derived from random-effects meta-analyses presented as confidence bounds and prediction intervals, respectively. METHODS: To determine the cost-utility of robot-assisted prostatectomy, an economic model was developed. The clinical effectiveness of robot-assisted surgery compared with open and conventional laparoscopic surgery was estimated using meta-analysis of peer-reviewed publications. Assuming treatment effect would vary across studies due to both sampling variability and differences between surgical teams, random-effects meta-analysis was used to pool effect estimates. RESULTS: Using the confidence bounds approach the mean and median ICER was €24,193 and €26,731/QALY (95%CI: €13,752 to €68,861/QALY), respectively. The prediction interval approach produced an equivalent mean and median ICER of €26,920 and €26,643/QALY (95%CI: -€135,244 to €239,166/QALY), respectively. Using prediction intervals, there is a probability of 0.042 that robot-assisted surgery will result in a net reduction in QALYs. CONCLUSIONS: Using prediction intervals rather than confidence bounds does not affect the point estimate of the treatment effect. In meta-analyses with significant heterogeneity, the use of prediction intervals will produce wider ranges of treatment effect, and hence result in greater uncertainty, but a better reflection of the effect of the technology.


Assuntos
Metanálise como Assunto , Modelos Econômicos , Prostatectomia/economia , Prostatectomia/instrumentação , Robótica/economia , Avaliação da Tecnologia Biomédica , Análise Custo-Benefício , Humanos , Laparoscopia/economia , Masculino , Anos de Vida Ajustados por Qualidade de Vida
14.
AIDS ; 27(5): 675-86, 2013 Mar 13.
Artigo em Inglês | MEDLINE | ID: mdl-23719345

RESUMO

The group of infections known as the neglected tropical diseases (NTDs) collectively affect one billion people worldwide, equivalent to one-sixth of the world's population. The NTDs cause severe physical and emotional morbidity, and have a profound effect on cycles of poverty; it is estimated that NTDs account for 534 000 deaths per year. NTDs such as soil-transmitted helminth infections and the vector-borne protozoal infections leishmaniasis and trypanosomiasis occur predominantly in the most economically disadvantaged and marginalized communities. It is estimated that all low-income countries harbour at least five of the NTDs simultaneously. NTDs are neglected because they do not individually rank highly in terms of mortality data, and because they affect populations with little political voice. There is considerable geographic overlap between areas with high prevalence of NTDs and HIV, raising the possibility of complex polypharmacy and drug-drug interactions. Antiretrovirals pose a particularly high risk for potential drug-drug interactions, which may be pharmacokinetic or pharmacodynamic in nature and can result in raising or lowering plasma or tissue concentrations of co-prescribed drugs. Elevated drug concentrations may be associated with drug toxicity and lower drug concentrations may be associated with therapeutic failure. The aim of this paper is to review the currently available data on interactions between antiretrovirals and drugs used in the management of NTDs. It is intended to serve as a resource for policy makers and clinicians caring for these patients, and to support the recent WHO 2020 Roadmap and the 2012 London Declaration on NTDs.


Assuntos
Síndrome de Imunodeficiência Adquirida/tratamento farmacológico , Antirretrovirais/efeitos adversos , Infecções por HIV/tratamento farmacológico , Doenças Negligenciadas/tratamento farmacológico , Medicina Tropical/métodos , Antirretrovirais/farmacocinética , Interações de Medicamentos , Saúde Global , Humanos , Organização Mundial da Saúde
15.
AIDS ; 27(6): 961-5, 2013 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-23698061

RESUMO

OBJECTIVE: To investigate the pharmacokinetics of artemether, dihydroartemisinin and lumefantrine during rifampicin intake and after stopping rifampicin. STUDY DESIGN: An open-label, two-phase, longitudinal drug interaction study with patients serving as their own controls. METHODS: We recruited HIV-1-seropositive Ugandan adults who were receiving rifampicin-based tuberculosis treatment and who did not have malaria. Pharmacokinetic sampling after six doses of artemether-lumefantrine was performed during rifampicin-based tuberculosis treatment (phase 1) and repeated at least 3 weeks after stopping rifampicin-based tuberculosis treatment (phase 2). RESULTS: Six and five patients completed phases 1 and 2, respectively. Median age and weight were 30 years and 64 kg. Artemether and dihydroartemisinin area under the concentration-time curve (AUC(0-12h)) were significantly lower by 89% [geometric mean ratio (GMR) 90% confidence interval (CI) 0.11, 0.05-0.26] and 85% (0.15, 0.10-0.23), respectively, during rifampicin-based treatment when compared to AUC(0-12h) after stopping rifampicin intake. Similarly, artemether and dihydroartemisinin C(max) were 83% (0.17, 0.08-0.39) and 78% (0.22, 0.15-0.33) lower, respectively, during rifampicin treatment. For artemether, mean (±SD) C(12) was 0.5(±1.0) and 5.9(±2.5) ng/ml in phases 1 and 2, respectively. Corresponding values for dihydroartemisinin (DHA) were 0.3(±0.4) and 4.7(±2.0) ng/ml, respectively. Day 8 lumefantrine concentration was significantly lower by 84% (GMR 90% CI 0.16, 0.09-0.27), and AUC(Day3-Day25) was significantly lower by 68% (GMR 90% CI 0.32, 0.21-0.49) during rifampicin-based treatment when compared to exposure values after stopping rifampicin. CONCLUSION: Pharmacokinetic parameters for artemether-lumefantrine were markedly lower during rifampicin-based tuberculosis treatment. Artemether-lumefantrine should not be co-administered with rifampicin.


Assuntos
Antimaláricos/administração & dosagem , Antituberculosos/administração & dosagem , Antagonismo de Drogas , Tuberculose/tratamento farmacológico , Adulto , Antimaláricos/farmacocinética , Antituberculosos/farmacocinética , Artemeter , Artemisininas/administração & dosagem , Artemisininas/farmacocinética , Etanolaminas/administração & dosagem , Etanolaminas/farmacocinética , Feminino , Fluorenos/administração & dosagem , Fluorenos/farmacocinética , Infecções por HIV/complicações , Humanos , Estudos Longitudinais , Lumefantrina , Masculino , Rifampina/administração & dosagem , Rifampina/farmacocinética , Tuberculose/complicações , Uganda
16.
Cochrane Database Syst Rev ; (4): CD009586, 2013 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-23633374

RESUMO

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia in clinical practice and is a leading cause of morbidity and mortality. Screening for AF in asymptomatic patients has been proposed as a way of reducing the burden of the disease by detecting people who would benefit from prophylactic anticoagulation therapy prior to the onset of symptoms. However, for screening to be an effective intervention it must improve the detection of AF and provide benefit for those who are detected earlier as a result of screening. OBJECTIVES: The primary objective of this review was to examine whether screening programmes increase the detection of new cases of AF compared to routine practice. The secondary objectives were to identify which combination of screening strategy and patient population is most effective, as well as assessing any safety issues associated with screening, its acceptability within the target population and the costs involved. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, MEDLINE (Ovid) and EMBASE (Ovid) up to March 2012. Other relevant research databases, trials registries and websites were searched up to June 2012. Reference lists of identified studies were also searched for potentially relevant studies and we contacted corresponding authors for information about additional published or unpublished studies that may be relevant. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials, controlled before and after studies and interrupted time series studies comparing screening for AF with routine practice in people aged 40 years and over were eligible. Two authors (PM, CT or MF) independently selected the trials for inclusion. DATA COLLECTION AND ANALYSIS: Assessment of risk of bias and data extraction were performed independently by two authors (PM, CT). Odds ratios (OR) and 95% confidence intervals (CI) were used to present the results for the primary outcome, which is a dichotomous variable. Since only one included study was identified, no meta-analysis was performed. MAIN RESULTS: One cluster randomised controlled trial met the inclusion criteria for this review. This study compared systematic screening (by invitation to have an electrocardiogram (ECG)) and opportunistic screening (pulse palpation during a general practitioner (GP) consultation for any reason followed by an ECG if pulse was irregular) to routine practice (normal case finding on the basis of clinical presentation) in people aged 65 years or older. The risk of bias in the included study was judged to be low.Both systematic and opportunistic screening of people over the age of 65 years are more effective than routine practice (OR 1.57, 95% CI 1.08 to 2.26 and OR 1.58, 95% CI 1.10 to 2.29, respectively). The number needed to screen in order to detect one additional case compared to routine practice was 172 (95% CI 94 to 927) for systematic screening and 167 (95% CI 92 to 806) for opportunistic screening. Both systematic and opportunistic screening were more effective in men (OR 2.68, 95% CI 1.51 to 4.76 and OR 2.33, 95% CI 1.29 to 4.19, respectively) than in women (OR 0.98, 95% CI 0.59 to 1.62 and OR 1.2, 95% CI 0.74 to 1.93, respectively). No data on the effectiveness of screening in different ethnic or socioeconomic groups were available. There were insufficient data to compare the effectiveness of screening programmes in different healthcare settings.Systematic screening was associated with a better overall uptake rate than opportunistic screening (53% versus 46%) except in the ≥ 75 years age group where uptake rates were similar (43% versus 42%). In both screening programmes men were more likely to participate than women (57% versus 50% in systematic screening, 49% versus 41% in opportunistic screening) and younger people (65 to 74 years) were more likely to participate than people aged 75 years and over (61% versus 43% systematic, 49% versus 42% opportunistic). No adverse events associated with screening were reported.The incremental cost per additional case detected by opportunistic screening was GBP 337, compared to GBP 1514 for systematic screening. All cost estimates were based on data from the single included trial, which was conducted in the UK between 2001 and 2003. AUTHORS' CONCLUSIONS: Systematic and opportunistic screening for AF increase the rate of detection of new cases compared with routine practice. While both approaches have a comparable effect on the overall AF diagnosis rate, the cost of systematic screening is significantly more than that of opportunistic screening from the perspective of the health service provider. The lack of studies investigating the effect of screening in other health systems and younger age groups means that caution needs to be exercised in relation to the transferability of these results beyond the setting and population in which the included study was conducted.Additional research is needed to examine the effectiveness of alternative screening strategies and to investigate the effect of the intervention on the risk of stroke for screened versus non-screened populations.


Assuntos
Doenças Assintomáticas , Fibrilação Atrial/diagnóstico , Programas de Rastreamento/métodos , Idoso , Eletrocardiografia , Feminino , Humanos , Masculino , Palpação/métodos , Pulso Arterial/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto
17.
Arch Gynecol Obstet ; 287(5): 907-18, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23291924

RESUMO

PURPOSE: To review the safety and effectiveness of robot-assisted hysterectomy compared to traditional open and conventional laparoscopic surgery, differentiating radical, simple total with node staging, and simple total hysterectomy. METHODS: Medline, Embase, the Cochrane library, and the Journal of Robotic Surgery were searched for controlled trials and observational studies with historic or concurrent controls. Data were pooled using random effects meta-analysis. RESULTS: Compared to open surgery, robot-assisted radical hysterectomy is associated with reduced hospital stay and blood transfusions. For simple total hysterectomy with node staging, robot-assisted surgery is associated with reduced hospital stay, complications, and blood transfusions compared to open surgery. Compared to conventional laparoscopic surgery, robot-assisted simple total hysterectomy with node staging is associated with complications and conversions. CONCLUSIONS: Compared to open surgery, robot-assisted hysterectomy offers benefits for reduced length of hospital stay and blood transfusions. The best evidence of improved outcomes is for simple total hysterectomy with node staging. Study quality was poor.


Assuntos
Histerectomia/métodos , Laparoscopia , Robótica , Transfusão de Sangue , Feminino , Humanos , Histerectomia/efeitos adversos , Tempo de Internação , Linfonodos/patologia , MEDLINE , Complicações Pós-Operatórias , Resultado do Tratamento
18.
Int J Urol ; 20(3): 312-21, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23311943

RESUMO

Medline and Embase were searched for studies comparing robot-assisted radical prostatectomy with open prostatectomy and conventional laparoscopic prostatectomy. Random effects meta-analysis was used to calculate a pooled estimate of effect. The 95% prediction intervals are also reported. One randomized study and 50 observational studies were identified. The results show that compared with open surgery, robot-assisted surgery is associated with fewer positive surgical margins for pT2 tumors (relative risk 0.63, 95% confidence interval 0.49-0.81, P < 0.001) and improved outcomes for sexual function at 12 months (relative risk 1.60, 95% confidence interval 1.33-1.93, P = <0.001), and, to a lesser extent, urinary function at 12 months (relative risk 1.06, 95% confidence interval 1.02-1.11, P < 0.01). Compared with conventional laparoscopic prostatectomy, robot-assisted surgery is associated with a slight increase in urinary function at 12 months (relative risk 1.09, 95% confidence interval 1.02 to 1.17, P = 0.013). The overall methodological quality of the included studies was low, with high levels of heterogeneity. The use of prediction intervals as an aid to decision making in regard to the introduction of this technology is examined. Clinically significant improvements in positive surgical margins rates for pT2 tumors and sexual function at 12 months associated with robot-assisted surgery in comparison with open surgery should be interpreted with caution given the limitations of the evidence. Differences between robot-assisted and conventional laparoscopic surgery are minimal.


Assuntos
Laparoscopia/métodos , Prostatectomia/métodos , Neoplasias da Próstata/cirurgia , Intervalos de Confiança , Disfunção Erétil/etiologia , Disfunção Erétil/fisiopatologia , Humanos , Laparoscopia/efeitos adversos , Masculino , Neoplasia Residual , Prostatectomia/efeitos adversos , Recuperação de Função Fisiológica , Robótica , Incontinência Urinária/etiologia , Incontinência Urinária/fisiopatologia
19.
J Antimicrob Chemother ; 68(1): 1-3, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-22915459

RESUMO

Scale-up of HIV treatment services may have contributed to an increase in functional health facilities available in resource-limited settings and an increase in patient use of facilities and retention in care. As more patients are reached with medicines, monitoring patient safety is increasingly important. Limited data from resource-limited settings suggest that medication error and antiretroviral drug-drug interactions may pose a significant risk to patient safety. Commonly cited causes of medication error in the developed world include the speed and complexity of the medication use cycle combined with inadequate systems and processes. In resource-limited settings, specific factors may contribute, such as inadequate human resources and high disease burden. Management of drug-drug interactions may be complicated by limited access to alternative medicines or laboratory monitoring. Improving patient safety by addressing the issue of antiretroviral drug-drug interactions has the potential not just to improve healthcare for individuals, but also to strengthen health systems and improve vital communication among healthcare providers and with regulatory agencies.


Assuntos
Fármacos Anti-HIV/economia , Fármacos Anti-HIV/metabolismo , Antirretrovirais/economia , Antirretrovirais/metabolismo , Saúde Global/economia , Recursos em Saúde/economia , Segurança do Paciente/economia , Animais , Fármacos Anti-HIV/efeitos adversos , Antirretrovirais/efeitos adversos , Interações de Medicamentos , Humanos
20.
J Antimicrob Chemother ; 67(9): 2213-21, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22687893

RESUMO

OBJECTIVES: Co-administration of artemether/lumefantrine with antiretroviral therapy has potential for pharmacokinetic drug interactions. We investigated drug-drug interactions between artemether/lumefantrine and efavirenz or nevirapine. METHODS: We performed a cross-over study in which HIV-infected adults received standard six-dose artemether/lumefantrine 80/480 mg before and at efavirenz or nevirapine steady state. Artemether, dihydroartemisinin, lumefantrine, efavirenz and nevirapine plasma concentrations were measured and compared. RESULTS: Efavirenz significantly reduced artemether maximum concentration (C(max)) and plasma AUC (median 29 versus 12 ng/mL, P < 0.01, and 119 versus 25 ng ·â€Šh/mL, P < 0.01), dihydroartemisinin C(max) and AUC (median 120 versus 26 ng/mL, P < 0.01, and 341 versus 84 ng ·â€Šh/mL, P < 0.01), and lumefantrine C(max) and AUC (median 8737 versus 6331 ng/mL, P = 0.03, and 280 370 versus 124 381 ng ·â€Šh/mL, P < 0.01). Nevirapine significantly reduced artemether C(max) and AUC (median 28 versus 11 ng/mL, P < 0.01, and 123 versus 34 ng ·â€Šh/mL, P < 0.01) and dihydroartemisinin C(max) and AUC (median 107 versus 59 ng/mL, P < 0.01, and 364 versus 228 ng ·â€Šh/mL, P < 0.01). Lumefantrine C(max) and AUC were non-significantly reduced by nevirapine. Artemether/lumefantrine reduced nevirapine C(max) and AUC (median 8620 versus 4958 ng/mL, P < 0.01, and 66 329 versus 35 728 ng ·â€Šh/mL, P < 0.01), but did not affect efavirenz exposure. CONCLUSIONS: Co-administration of artemether/lumefantrine with efavirenz or nevirapine resulted in a reduction in artemether, dihydroartemisinin, lumefantrine and nevirapine exposure. These drug interactions may increase the risk of malaria treatment failure and development of resistance to artemether/lumefantrine and nevirapine. Clinical data from population pharmacokinetic and pharmacodynamic trials evaluating the impact of these drug interactions are urgently needed.


Assuntos
Fármacos Anti-HIV/farmacocinética , Antimaláricos/farmacocinética , Artemisininas/farmacocinética , Benzoxazinas/farmacocinética , Interações de Medicamentos , Etanolaminas/farmacocinética , Fluorenos/farmacocinética , Nevirapina/farmacocinética , Adulto , Fármacos Anti-HIV/administração & dosagem , Antimaláricos/administração & dosagem , Combinação Arteméter e Lumefantrina , Artemisininas/administração & dosagem , Benzoxazinas/administração & dosagem , Estudos Cross-Over , Combinação de Medicamentos , Etanolaminas/administração & dosagem , Feminino , Fluorenos/administração & dosagem , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Humanos , Malária/complicações , Malária/tratamento farmacológico , Masculino , Nevirapina/administração & dosagem , Plasma/química , Uganda
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