Abstract 70: Importance of Both Self-consent and Proxy- consent Enrollments to Avoid Bias in Acute Stroke Randomized Trials

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Kristina Shkirkova ◽  
Nelson Wu ◽  
Sidney Starkman ◽  
Nerses Sanossain ◽  
Scott Hamilton ◽  
...  
Keyword(s):  
Informed Consent ◽  
Acute Stroke ◽  
Randomized Trials ◽  
Proxy Consent ◽  
Long Term Outcomes ◽  
Stroke Population ◽  
Acute Cerebral Ischemia ◽  
Hemorrhage Volume ◽  
Artery Disease

Background: Informed consent options for acute stroke randomized trials include self-consent from patients with retained competency, proxy consent from a legally authorized representative (LAR), and exception from informed consent in emergency circumstances (EFIC). Mechanisms other than self-consent trespass upon the ethical principle of autonomy (respect for persons), and should be used only if self-consent alone would bias the patient population. Methods: We analyzed acute stroke patients enrolled within 2h of symptom onset in the NIH Phase 3 Field Administration of Stroke Therapy - Magnesium (FAST-MAG) trial, comparing entry characteristics and outcomes with different consent mechanisms. Results: Among 1700 patients, median time from onset to study entry was 45 min (IQR 35-62). Overall, 60% of patients were competent and provided self-consent, 39% noncompetent and enrolled by proxy consent from an on-scene LAR, and 1% noncompetent enrolled using EFIC/delayed consent. Compared to self-consented patients, proxy-consented patients were: older, 73.8 vs 66.5, p<0.001; more often female, 47% vs 40%, p<0.02; and a higher frequency of several vascular risk factors, including hypertension, 81% vs 76%, p<0.05, diabetes, 26% vs20%, p<0.01, atrial fibrillation, 29% vs 17%, p<0.001, and coronary artery disease, 24% vs 19%, p<0.01. Proxy consent patients had more severe initial stroke deficits, prehospital LAMS, 4.1 vs 3.5, p<0.001. Proxy consent patients with acute cerebral ischemia had more advanced initial ischemic stroke lesions, ASPECTS 8.3 vs 9.3, p<0.001, and received tPA more often, 35% vs 20%, p<0.001. Proxy consent patients with intracerebral hemorrhage patient had larger initial hemorrhage volume (cc), 42.2 vs 22.6, p<0.001. Proxy consent patients had worse final outcomes, with freedom from disability (mRS 0-1) at 90d, 23.6% vs 44.3%, p<0.001. Conclusions: Proxy-informed consent patients differ systematically from self-consent patients, with older age, more comorbidities, more severe deficits, and worse long term outcomes. To ensure that acute stroke trial cohorts are representative of the general stroke population, it is important that enrollment mechanisms include proxy and/or deferred consent.

scholarly journals Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease

2021 ◽  
Author(s):  
Rutao Wang ◽  
Scot Garg ◽  
Chao Gao ◽  
Hideyuki Kawashima ◽  
Masafumi Ono ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Coronary Revascularization ◽  
Long Term Outcomes ◽  
Vital Status ◽  
Increased Risk ◽  
Artery Disease ◽  
The Impact

Abstract Aims To investigate the impact of established cardiovascular disease (CVD) on 10-year all-cause death following coronary revascularization in patients with complex coronary artery disease (CAD). Methods The SYNTAXES study assessed vital status out to 10 years of patients with complex CAD enrolled in the SYNTAX trial. The relative efficacy of PCI versus CABG in terms of 10-year all-cause death was assessed according to co-existing CVD. Results Established CVD status was recorded in 1771 (98.3%) patients, of whom 827 (46.7%) had established CVD. Compared to those without CVD, patients with CVD had a significantly higher risk of 10-year all-cause death (31.4% vs. 21.7%; adjusted HR: 1.40; 95% CI 1.08–1.80, p = 0.010). In patients with CVD, PCI had a non-significant numerically higher risk of 10-year all-cause death compared with CABG (35.9% vs. 27.2%; adjusted HR: 1.14; 95% CI 0.83–1.58, p = 0.412). The relative treatment effects of PCI versus CABG on 10-year all-cause death in patients with complex CAD were similar irrespective of the presence of CVD (p-interaction = 0.986). Only those patients with CVD in ≥ 2 territories had a higher risk of 10-year all-cause death (adjusted HR: 2.99, 95% CI 2.11–4.23, p < 0.001) compared to those without CVD. Conclusions The presence of CVD involving more than one territory was associated with a significantly increased risk of 10-year all-cause death, which was non-significantly higher in complex CAD patients treated with PCI compared with CABG. Acceptable long-term outcomes were observed, suggesting that patients with established CVD should not be precluded from undergoing invasive angiography or revascularization. Trial registration SYNTAX: ClinicalTrials.gov reference: NCT00114972. SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050. Graphic abstract

scholarly journals Treatments and outcomes of untreated cerebral cavernous malformations in China: study protocol of a nationwide multicentre prospective cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e037957
Author(s):  
Fuxin Lin ◽  
Qiu He ◽  
Zhuyu Gao ◽  
Lianghong Yu ◽  
Dengliang Wang ◽  
...  
Keyword(s):  
Informed Consent ◽  
Natural History ◽  
Study Protocol ◽  
Treated Group ◽  
Secondary Outcome ◽  
Long Term Outcomes ◽  
Cavernous Malformations ◽  
Electronic Data Capture System

IntroductionThe treatment decision and long-term outcomes of previously untreated cerebral cavernous malformation (U-CCM) are still controversial. Therefore, we are conducting a nationwide multicentre prospective registry study in China to determine the natural history and effect of surgical treatment on long-term outcomes in Chinese people with U-CCM.Methods and analysisThis study was started on 1 January 2018 and is currently ongoing. It is a cohort follow-up study across a 5-year period. Patients will be followed up for at least 3 years after inception. Patients with U-CCM will be enrolled from 24 Grade III, level A hospitals distributed all over China. The cohort size is estimated to be 1200 patients. Patients are registered in surgically treated group and conservatively treated group. Clinical characteristics, radiology information and laboratory data are prospectively collected using an electronic case report form through an electronic data capture system. The primary outcome of this study is poor clinical outcome at the last follow-up (modified Rankin Scale score >2 lasting at least 1 year). The secondary outcome includes symptomatic haemorrhage, drug refractory epilepsy, focal neurological deficits, morbidity and all-cause mortality during follow-up. Univariate and multivariate regression analysis will be performed to determine the risk factors for poor outcomes in all patients, and to estimate the effect of surgery. Life tables, Kaplan-Meier estimates, log-rank test and proportional hazards Cox regression will be used to analyse the follow-up data of conservatively treated patients to determine the natural history of U-CCM. Initial presentation and location of U-CCM are prespecified subgroup factors.Ethics and disseminationThe study protocol and informed consent form have been reviewed and approved by the Research Ethical Committee of First Affiliated Hospital of Fujian Medical University (FAHFMU-2018-003).Written informed consent will be obtained from each adult participant or from the guardian of each paediatric participant. The final results will be published in peer-reviewed journals.Trial registration numberNCT03467295.

scholarly journals Results of surgical treatment of moderate ischemic mitral regurgitation: A propensity analysis

2020 ◽  
Author(s):  
Jiyoung Lee ◽  
Kan Kajimoto ◽  
Taira Yamamoto ◽  
Kenji Kuwaki ◽  
Yuki Kamikawa ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Surgical Treatment ◽  
Mitral Valve ◽  
Propensity Score ◽  
Artery Bypass ◽  
Long Term Outcomes ◽  
Artery Disease ◽  
The Impact

Background and Aim of the Study: Ischemic mitral valve regurgitation (IMR) in patients undergoing coronary artery bypass grafting (CABG) is associated with worse long-term outcomes. The aim of this study was to assess the impact of mitral valve repair with CABG in patients with moderate IMR. Method: This observational study enrolled 3,215 consecutive patients from the Juntendo CABG registry with moderate IMR and multivessel coronary artery disease who underwent CABG between 2002 and 2017. The CABG alone and CABG with mitral valve surgery (MVs) groups were compared. The propensity score was calculated for each patient. Long-term all-cause death, cardiac death, and major adverse cardiac and cerebrovascular events (MACCEs) were compared between the two groups. Results: A total of 101 patients who underwent CABG had moderate IMR in our database. Propensity score matching selected 40 pairs for final analysis. MVs was associated with increased risks of postoperative atrial fibrillation, blood transfusion, and longer hospitalization. There were no differences between the two groups in long-term outcomes, including all-cause mortality, cardiac mortality, and the incidence of MACCEs. Conclusions: Surgical treatment of moderate IMR combined with CABG was as safe as CABG alone, with no differences in long-term outcomes. Further studies are needed to determine the effects of MVs in patients with moderate IMR and severe coronary artery disease.

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