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Background: Previous studies have shown sex differences in stroke care. Female patients have both lower thrombolytic treatment rates with OR reported as low as 0.57 and worse outcomes. With updated standards of care and improved access to care through telestroke, there is potential to reduce or alleviate these disparities. Methods: Acute stroke consultations seen by TeleSpecialists, LLC physicians in the emergency department in 203 facilities (23 states) from January 1, 2021 to April 30, 2021 were extracted from the Telecare by TeleSpecialists™ database. The encounters were reviewed for demographics, stroke time metrics, thrombolytics candidate, premorbid modified Rankin Score, NIHSS score, stroke risk factors, antithrombotic use, admitting diagnosis of suspected stroke, and reason not treated with thrombolytic. The treatment rates, door to needle (DTN) times, stroke metric times, and variables of treatment were compared for females and males. Results: There were 18,783 (10,073 female and 8,710 male) total patients included. Of the total, 6.9% of females received thrombolytics compared to 7.9% of males (OR 0.86, 95% CI 0.75-0.97, p = 0.006). Median DTN times were shorter for males than females (38 vs. 41 min, p < 0.001). Male patients were more likely to have an admitting diagnosis of suspected stroke, p < 0.001. Analysis by age showed the only decade with significant difference in thrombolytics treatment rate was 50-59 with increased treatment of males, p = 0.047. When multivariant logistic regression analysis was performed with stroke risk factors, NIHSS score, age, and admitting diagnosis of suspected stroke, the adjusted odds ratio for females was 0.9 (95% CI 0.8, 1.01), p = 0.064. Conclusion: While treatment differences between sexes existed in the data and were apparent in univariate analysis, no significant difference was seen in multivariate analysis once stroke risk factors, age, NIHSS score and admitting diagnosis were taken into consideration in the telestroke setting. Differences in rates of thrombolysis between sexes may therefore be reflective of differences in risk factors and symptomatology rather than a healthcare disparity.
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INTRODUCTION: Previous analyses suggest that ethnic and racial differences exist in acute stroke care including thrombolytic treatment rates. The current study evaluates ethnic or racial differences in acute stroke treatment within a multi-state telestroke program. METHODS: Acute telestroke consultations seen in the Emergency Department in 203 facilities and 23 states were extracted from the Telecare by TeleSpecialistsTM database. Cases were reviewed for age, race, ethnicity, sex, last known normal time, arrival time, treatment with thrombolytic therapy, door-to-needle (DTN) time, and baseline National Institutes of Health Stroke Scale score. Race was defined as Black, White, or Other; ethnicity was defined as Hispanic or non-Hispanic. RESULTS: The current study included 13,221 acute telestroke consultations consisting of 9890 White, 2048 Black, and 1283 patients classified as Other. A total of 934 patients were Hispanic and 12,287 patients were non-Hispanic. There were no statistically significant differences noted in thrombolytic treatment rates when comparing White (7.9%) patients with non-White patients (7.4%), p = 0.36, or comparing Black (8.1%) with non-Black patients (7.8%), p = 0.59. In addition, there were no statistically significant differences in treatment rates comparing Hispanic (6.3%) with non-Hispanic (7.9%) patients, p = 0.072. We noted no measurable differences in DTN times by race or ethnicity. CONCLUSIONS: Contrary to previous reports, we failed to detect any significant differences in thrombolytic treatment rates and DTN times by race or ethnicity among stroke patients in a multistate telestroke program. These findings support the hypothesis that telestroke may mitigate racial and ethnic disparities which may be attributable to local variability in stroke procedures or access to healthcare.
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BACKGROUND AND PURPOSE: Clinical trials have demonstrated improved 90-day outcomes for patients with acute ischemic stroke treated with stent retriever thrombectomy plus tissue-type plasminogen activator (SST+tPA) compared with tPA. Previous studies suggested that this strategy may be cost-effective, but models were derived from pooled data and older assumptions. METHODS: In this prospective economic substudy conducted alongside the SWIFT-PRIME trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke), in-trial costs were measured for patients using detailed medical resource utilization and hospital billing data. Utility weights were assessed at 30 and 90 days using the EuroQol-5 dimension questionnaire. Post-trial costs and life-expectancy were estimated for each surviving patient using a model based on trial data and inputs derived from a contemporary cohort of ischemic stroke survivors. RESULTS: Index hospitalization costs were $17 183 per patient higher for SST+tPA than for tPA ($45 761 versus $28 578; P<0.001), driven by initial procedure costs. Between discharge and 90 days, costs were $4904 per patient lower for SST+tPA than for tPA ($11 270 versus $16 174; P=0.014); total 90-day costs remained higher with SST+tPA ($57 031 versus $44 752; P<0.001). Higher utility values for SST+tPA led to higher in-trial quality-adjusted life years (0.131 versus 0.105; P=0.005). In lifetime projections, SST+tPA was associated with substantial gains in quality-adjusted life years (6.79 versus 5.05), cost savings of $23 203 per patient and was economically dominant when compared with tPA in 90% of bootstrap replicates. CONCLUSIONS: Among patients with acute ischemic stroke enrolled in the SWIFT-PRIME trial, SST increased initial treatment costs, but was projected to improve quality-adjusted life-expectancy and reduce healthcare costs over a lifetime horizon compared with tPA. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01657461.
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Isquemia Encefálica/economia , Análise Custo-Benefício , Procedimentos Endovasculares/economia , Stents/economia , Acidente Vascular Cerebral/economia , Trombectomia/economia , Idoso , Idoso de 80 Anos ou mais , Isquemia Encefálica/cirurgia , Estudos de Coortes , Análise Custo-Benefício/métodos , Falha de Equipamento/economia , Feminino , Seguimentos , Hospitalização/economia , Hospitalização/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Acidente Vascular Cerebral/cirurgia , Resultado do TratamentoRESUMO
OBJECTIVE: To update a 2005 review of the reasons researchers have given for the use of unequal randomisation in randomised controlled trials (RCTs). MAIN MEASURES: Intervention being tested; type of study; number of participants; randomisation ratio; sample size calculation and reason given for using unequal randomisation. METHODS: Review of trials using unequal randomisation. DATABASES AND SOURCES: Cochrane library, Medline and CINAHL. RESULTS: A total of 86 trials were identified. Of these 82 trials (95%) recruited patients in favour of the experimental group. Various reasons for the use of unequal randomisation were given including: gaining treatment experience; identification of adverse events; ethical; logistic and enhancing recruitment. No trial reported explicitly used it for cost-effectiveness. Most of the papers (i.e. 47, 55%) did not state why they had used unequal randomisation and only 38 trials (44%) appeared to have taken the unequal randomisation into account in their sample size calculation. CONCLUSION: Most studies did not mention the rationale for unequal allocation, and a significant proportion did not appear to account for it in the sample size calculations. Unlike the previous review economic considerations were not stated as a rationale for its use. A number of trials used it to enhance recruitment, although this has not been tested.