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3.
JAMA Intern Med ; 2020 Mar 23.
Artigo em Inglês | MEDLINE | ID: mdl-32202590
4.
Lancet ; 395(10228): 986-997, 2020 03 21.
Artigo em Inglês | MEDLINE | ID: mdl-32199486

RESUMO

Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment options at the time of regulatory approval in Europe and the USA. Even when active-comparator trials exist, they might not produce meaningful data to inform decisions in clinical practice and health policy. The uncertainty associated with the paucity of well designed active-comparator trials has been compounded by legal and regulatory changes in Europe and the USA that have created a complex mix of expedited programmes aimed at facilitating faster access to new drugs. Comparative evidence generation is even sparser for medical devices. Some have argued that the current process for regulatory approval needs to generate more evidence that is useful for patients, clinicians, and payers in health-care systems. We propose a set of five key principles relevant to the European Medicines Agency, European medical device regulatory agencies, US Food and Drug Administration, as well as payers, that we believe will provide the necessary incentives for pharmaceutical and device companies to generate comparative data on drugs and devices and assure timely availability of evidence that is useful for decision making. First, labelling should routinely inform patients and clinicians whether comparative data exist on new products. Second, regulators should be more selective in their use of programmes that facilitate drug and device approvals on the basis of incomplete benefit and harm data. Third, regulators should encourage the conduct of randomised trials with active comparators. Fourth, regulators should use prospectively designed network meta-analyses based on existing and future randomised trials. Last, payers should use their policy levers and negotiating power to incentivise the generation of comparative evidence on new and existing drugs and devices, for example, by explicitly considering proven added benefit in pricing and payment decisions.


Assuntos
Aprovação de Equipamentos/normas , Aprovação de Drogas/métodos , Segurança de Equipamentos , Segurança , Biomarcadores Farmacológicos/análise , Tolerância a Medicamentos , Medicina Baseada em Evidências , Humanos , Estados Unidos , United States Food and Drug Administration
5.
J Am Heart Assoc ; 9(5): e014940, 2020 Mar 03.
Artigo em Inglês | MEDLINE | ID: mdl-32079480

RESUMO

Background Noninvasive cardiac tests, including exercise treadmill tests (ETTs), are commonly utilized in the evaluation of patients in the emergency department with suspected acute coronary syndrome. However, there are ongoing debates on their clinical utility and cost-effectiveness. It is important to be able to use ETT results for research, but manual review is prohibitively time-consuming for large studies. We developed and validated an automated method to interpret ETT results from electronic health records. To demonstrate the algorithm's utility, we tested the associations between ETT results with 30-day patient outcomes in a large population. Methods and Results A retrospective analysis of adult emergency department encounters resulting in an ETT within 30 days was performed. A set of randomly selected reports were double-blind reviewed by 2 physicians to validate a natural language processing algorithm designed to categorize ETT results into normal, ischemic, nondiagnostic, and equivocal categories. Natural language processing then searched and categorized results of 5214 ETT reports. The natural language processing algorithm achieved 96.4% sensitivity and 94.8% specificity in identifying normal versus all other categories. The rates of 30-day death or acute myocardial infarction varied (P<0.001) by categories for normal (0.08%), ischemic (1.9%), nondiagnostic (0.77%), and equivocal (0.58%) groups achieving good discrimination (C-statistic, 0.81; 95% CI, 0.7-0.92). Conclusions Natural language processing is an accurate and efficient strategy to facilitate large-scale outcome studies of noninvasive cardiac tests. We found that most patients are at low risk and have normal ETT results, while those with abnormal, nondiagnostic, or equivocal results have slightly higher risks and warrant future investigation.

7.
JAMA Intern Med ; 2020 Jan 13.
Artigo em Inglês | MEDLINE | ID: mdl-31930356
11.
JACC Cardiovasc Imaging ; 12(7 Pt 1): 1254-1278, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31272608

RESUMO

There has been a tremendous growth quantity of high-quality imaging evidence in the area of acute and stable ischemic heart disease (SIHD). A number of recent comparative effectiveness trials have spurned significant controversies in the field of cardiovascular imaging. The result of this evidence is that many health care policies and national guidelines have undergone significant revisions. With all of this evidence, many challenges remain and the optimal evaluation strategy for evaluation of patients presenting with chest pain remains ill-defined. This paper enlisted the guidance of numerous experts in the field of cardiovascular imaging to garner their perspective on available imaging research in chest pain syndromes. Each of these vignettes represent editorial perspectives and diverse opinions as to which, if any, should be the primary test in the evaluation of stable chest pain. These perspectives are not meant to be all inclusive but to highlight many of the commonly discussed controversies in the evaluation of chest pain symptoms. These perspectives are presented as a pre-amble to an upcoming American College of Cardiology/American Heart Association clinical practice guideline that is undergoing revision from the previous report published in 2012. The evidence has changed considerably since the 2012 SIHD guideline, and the current perspectives represent the diversity of available evidence as to the optimal imaging strategy for evaluation of the symptomatic patient.

15.
Ann Emerg Med ; 74(2): 216-223, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-30955986

RESUMO

STUDY OBJECTIVE: Professional guidelines recommend 72-hour cardiac stress testing after an emergency department (ED) evaluation for possible acute coronary syndrome. There are limited data on actual compliance rates and effect on patient outcomes. Our aim is to describe rates of completion of noninvasive cardiac stress testing and associated 30-day major adverse cardiac events. METHODS: We conducted a retrospective analysis of ED encounters from June 2015 to June 2017 across 13 community EDs within an integrated health system in Southern California. The study population included all adults with a chest pain diagnosis, troponin value, and discharge with an order for an outpatient cardiac stress test. The primary outcome was the proportion of patients who completed an outpatient stress test within the recommended 3 days, 4 to 30 days, or not at all. Secondary analysis described the 30-day incidence of major adverse cardiac events. RESULTS: During the study period, 24,459 patients presented with a chest pain evaluation requiring troponin analysis and stress test ordering from the ED. Of these, we studied the 7,988 patients who were discharged home to complete diagnostic testing, having been deemed appropriate by the treating clinicians for an outpatient stress test. The stress test completion rate was 31.3% within 3 days and 58.7% between 4 and 30 days, and 10.0% of patients did not complete the ordered test. The 30-day rates of major adverse cardiac events were low (death 0.0%, acute myocardial infarction 0.7%, and revascularization 0.3%). Rapid receipt of stress testing was not associated with improved 30-day major adverse cardiac events (odds ratio 0.92; 95% confidence interval 0.55 to 1.54). CONCLUSION: Less than one third of patients completed outpatient stress testing within the guideline-recommended 3 days after initial evaluation. More important, the low adverse event rates suggest that selective outpatient stress testing is safe. In this cohort of patients selected for outpatient cardiac stress testing in a well-integrated health system, there does not appear to be any associated benefit of stress testing within 3 days, nor within 30 days, compared with those who never received testing at all. The lack of benefit of obtaining timely testing, in combination with low rates of objective adverse events, may warrant reassessment of the current guidelines.

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