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4.
PLoS One ; 13(3): e0193706, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29509775

RESUMO

BACKGROUND: The harmful effects of marijuana on health and in particular cardiovascular health are understudied. To develop such knowledge, an efficient method of developing an informative cohort of marijuana users and non-users is needed. METHODS: We identified patients with a diagnosis of coronary artery disease using ICD-9 codes who were seen in the San Francisco VA in 2015. We imported these patients' medical record notes into an informatics platform that facilitated text searches. We categorized patients into those with evidence of marijuana use in the past 12 months and patients with no such evidence, using the following text strings: "marijuana", "mjx", and "cannabis". We randomly selected 51 users and 51 non-users based on this preliminary classification, and sent a recruitment letter to 97 of these patients who had contact information available. Patients were interviewed on marijuana use and domains related to cardiovascular health. Data on marijuana use collected from the medical record was compared to data collected as part of the interview. RESULTS: The interview completion rate was 71%. Among the 35 patients identified by text strings as having used marijuana in the previous year, 15 had used marijuana in the past 30 days (positive predictive value = 42.9%). The probability of use in the past month increased from 8.8% to 42.9% in people who have these keywords in their medical record compared to those who did not have these terms in their medical record. CONCLUSION: Methods that combine text search strategies for participant recruitment with health interviews provide an efficient approach to developing prospective cohorts that can be used to study the health effects of marijuana.


Assuntos
Algoritmos , Registros Eletrônicos de Saúde , Fumar Maconha , Ferramenta de Busca , Idoso , Estudos de Coortes , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/epidemiologia , Diagnóstico por Computador/métodos , Humanos , Entrevistas como Assunto , Abuso de Maconha/complicações , Abuso de Maconha/diagnóstico , Abuso de Maconha/epidemiologia , Fumar Maconha/epidemiologia , Maconha Medicinal/efeitos adversos , Maconha Medicinal/uso terapêutico , Seleção de Pacientes , Ferramenta de Busca/métodos , Autorrelato , Veteranos
5.
BMJ Open ; 8(2): e019831, 2018 02 08.
Artigo em Inglês | MEDLINE | ID: mdl-29439079

RESUMO

OBJECTIVES: To determine the relationship between manufacturer-related financial ties among investigators of published drug trials and rates of discrepant registered and published primary trial outcomes. DESIGN: Cross-sectional study. SETTING: Human subjects drug trials published in 'core clinical' MEDLINE journals in 2013. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary study endpoint was the presence of a prospectively registered, clearly defined primary outcome that matched the published primary outcome for each included trial. Secondary outcomes included assessments of registration timing and quality, and the impact of outcome discrepancies between registration and publication on the statistical significance of the included trials. RESULTS: Of 192 included trials, 134 (70%) were positive and 58 (30%) were negative. Financial ties were present between first or last authors and drug manufacturers for 130 trials (68%), of which 78% were positive, versus 53% of trials with no financial ties that were positive. Clearly defined, prospectively registered outcomes that matched the published outcomes were present in just 76 of the 192 trials (40%). After adjusting for study start date and sample size, the observed relationship between investigator financial ties and the presence of a match between prospectively registered and published primary outcomes was of borderline statistical significance (OR 2.12, 95% CI 0.998 to 4.50). Studies with financial ties present were more likely than studies without ties to have been prospectively registered (78%vs48%, P<0.001) and were more likely to have prospectively registered a clearly defined primary outcome(62%vs35%, P<0.001). CONCLUSIONS: Less than half of the trials in this cohort were prospectively registered with a clear primary outcome that was consistent with the primary outcome reported in the published manuscript. The presence of investigator financial ties was associated with higher quality registration practices, though this association diminished after adjusting for factors that impact registration quality.


Assuntos
Ensaios Clínicos como Assunto/economia , Indústria Farmacêutica/economia , Pesquisadores/economia , Apoio à Pesquisa como Assunto/economia , Conflito de Interesses , Estudos Transversais , Ética em Pesquisa , Humanos , Modelos Logísticos , Sistema de Registros , Relatório de Pesquisa
7.
BMJ ; 356: i6770, 2017 Jan 17.
Artigo em Inglês | MEDLINE | ID: mdl-28096109

RESUMO

OBJECTIVE:  To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding. DESIGN:  Cross sectional study of randomized controlled trials (RCTs). SETTING:  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013. PARTICIPANTS:  Random sample of RCTs focused on drug efficacy. MAIN OUTCOME MEASURE:  Association between financial ties of principal investigators and study outcome. RESULTS:  A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9). CONCLUSIONS:  Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.


Assuntos
Conflito de Interesses , Indústria Farmacêutica/economia , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Pesquisadores/economia , Apoio à Pesquisa como Assunto/economia , Conflito de Interesses/economia , Estudos Transversais , Ética em Pesquisa , Humanos , Avaliação de Resultados em Cuidados de Saúde
8.
JAMA Intern Med ; 176(5): 626-33, 2016 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-27088224

RESUMO

IMPORTANCE: National guidelines do not agree on the role of carotid screening in asymptomatic patients (ie, patients who have not had a stroke or transient ischemic attack). Recently, several physician organizations participating in the Choosing Wisely campaign have identified carotid imaging in selected asymptomatic populations as being of low value. However, the majority of patients who are evaluated for carotid stenosis and subsequently revascularized are asymptomatic. OBJECTIVE: To better understand why asymptomatic patients who undergo revascularization receive initial carotid imaging. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of 4127 Veterans Health Administration patients 65 years and older undergoing carotid revascularization for asymptomatic carotid stenosis between 2005 and 2009. MAIN OUTCOMES AND MEASURES: Indications for carotid ultrasounds were extracted using trained abstractors. Frequency of indications and appropriateness of initial carotid ultrasound imaging for patients within each rating category after the intervention were reported. RESULTS: The mean (SD) age of this cohort of 4127 patients was 73.6 (5.9) years; 4014 (98.8%) were male. Overall, there were 5226 indications for 4063 carotid ultrasounds. The most common indications listed were carotid bruit (1578 [30.2% of indications]) and follow-up for carotid disease (stenosis/history of carotid disease) in patients who had previously documented carotid stenosis (1087 [20.8% of indications]). Multiple vascular risk factors were the next most common indication listed. Rates of appropriate, uncertain, and inappropriate imaging were 5.4% (227 indications), 83.4% (3387 indications), and 11.3% (458 indications), respectively. Among the most common inappropriate indications were dizziness/vertigo and syncope. Among the 4063 patients, 3373 (83.0%) received a carotid endarterectomy. Overall, 663 procedures were performed in patients 80 years and older. CONCLUSIONS AND RELEVANCE: Carotid bruit and follow-up for carotid disease accounted for approximately half of all indications provided by physicians for carotid testing. Strong consideration should be given to improving the evidence base around carotid testing, especially around monitoring stenosis over long periods and evaluating carotid bruits. Targeting carotid ultrasound ordering with decision support tools may also be an important step in reducing use of low-value imaging.


Assuntos
Artérias Carótidas/diagnóstico por imagem , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas , Seleção de Pacientes , Acidente Vascular Cerebral/prevenção & controle , Veteranos , Idoso , Idoso de 80 Anos ou mais , Estenose das Carótidas/diagnóstico , Estudos de Coortes , Progressão da Doença , Endarterectomia das Carótidas/métodos , Medicina Baseada em Evidências , Feminino , Seguimentos , Guias como Assunto , Humanos , Masculino , Medicina Militar , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Resultado do Tratamento
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