Abstract 3769: Barriers to Obtaining Informed Consent in Acute Stroke Clinical Trials

Background Identification of barriers to enrollment in acute stroke clinical trials may identify ways to improve enrollment and expedite completion of clinical research trials. In this exploratory analysis we sought to evaluate the differences in presenting characteristics between patients who are able to provide informed consent (IC) compared with those who were enrolled by the legal authorized representative (LAR). Methods From our single center, prospectively collected registry, we identified consecutive patients with acute ischemic stroke (AIS) who presented to our emergency department and were enrolled into acute (<8hrs from symptom onset) prospective clinical treatment trials. Data collected included arrival time, thrombolysis time, IC time, source of IC (LAR or patient), aphasia or neglect and method of arrival. For analysis, the patients who were consented by a LAR were compared with patients who provided their own IC. Results From 2003 - 2011, we identified 124 patients who met inclusion criteria. There were no differences in age, sex, presentation or door to needle times (Table 1). Patients who were able to provide IC presented with less severe stroke (p<0.0001). Aphasia and neglect were significantly more common when a LAR provided IC (p<0.0001). LAR consent required a significantly longer amount of time (90 vs. 71 min., p=0.04). Conclusions In our single center study, we found that patients with milder stroke are able to provide IC and the presence of aphasia or neglect can hinder enrollment in the absence of a LAR. In addition, when patients are able to provide IC, they do so almost on average 20 minutes faster than the LAR. Additional evaluation is necessary to determine the reasons for delay. Since good outcomes with investigational therapies for AIS treatment are likely to be time dependent, further efforts should target improvement of the IC process to minimize delay in clinical trial enrollment.

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Abstract 16910: High-Frequency In-Person Visits During Clinical Trial Enrollment is Associated With Relative Reduction in Event Rates in Heart Failure Patients Followed Longitudinally

Circulation ◽

10.1161/circ.142.suppl_3.16910 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Liana C Brooks ◽

Rohan R Bhat ◽

Robyn F Farrell ◽

Mark W Schoenike ◽

John A Sbarbaro ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

High Frequency ◽

Trial Participation ◽

Trial Period ◽

Single Center ◽

Hospitalization Rates ◽

Visit Frequency ◽

Clinical Trial Enrollment ◽

Event Rates

Introduction: The COVID-19 Pandemic has mandated limiting routine visit frequency for patients with chronic cardiovascular (CV) diseases. In patients with heart failure (HF) followed longitudinally, the period of clinical trial participation provides an opportunity to evaluate the influence of high-frequency per-protocol in-person visits compared to less frequent routine visits during longitudinal clinical care. Hypothesis: Patients enrolled in clinical trials will have a lower CV and HF event rates during periods of trial enrollment than during non-trial periods. Methods: We examined clinical characteristics, CV and HF hospitalization rates, and outcomes in patients with HF receiving longitudinal HF care at a single center. We evaluated hospitalization rates during the 1-year preceding trial enrollment and hospitalization and death rates during enrollment in clinical trials and for up to 1 year following trial completion. Results: Among the 121 patients enrolled in HF clinical trials, 72% were HFrEF (age 62±11, 19% females, BMI 30.4±6.0, LVEF 25±7, NYHA 2.7±0.6, NT-proBNP 2336±2671) and 28% were HFpEF (age 69±9, BMI 32.1±5.5, 29% females, LVEF 60±10, NYHA 2.4±0.5, NT-proBNP 957±997). Average clinical trial exposure was 8±6.6 months. Per-protocol visit frequency was 16±7 per year during clinical trial enrollment. In the one-year pre-trial period, compared to the within-trial period, CV hospitalizations were 0.88/patient-year vs. 0.32/patient-year (p<0.001) and HF hospitalizations were 0.63/patient-year and 0.24/patient-year (p<0.001), with a mortality rate of 0.04/patient-year during trial participation. In the period of up-to 1 year following the end of trial enrollment CV and HF hospitalizations were intermediate at 0.51/patient-year and 0.27/patient-year with an annualized incremental mortality rate of 0.03/patient-year. Conclusion: In HF patients followed longitudinally at a single center, periods of clinical trial enrollment were associated with high visit frequency and lower CV and HF hospitalization rates. These findings highlight the potential benefits of trial enrollment and high-frequency visits for HF patients at a time when routine visit frequency is being carefully considered during the COVID-19 Pandemic.

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Knowledge, attitudes, and perception of 398 cancer patients toward participation in clinical trials: A single-center study from New Delhi, India

Perspectives in Clinical Research ◽

10.4103/picr.picr_177_19 ◽

2021 ◽

Vol 0 (0) ◽

pp. 0

Author(s):

SK Gupta ◽

VishalKumar Biswkarma ◽

Nitesh Rohatgi ◽

Rajesh Saxena

Keyword(s):

Clinical Trials ◽

Cancer Patients ◽

New Delhi ◽

Single Center ◽

Single Center Study ◽

Center Study

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Adolescent angst: enrollment on clinical trials

Hematology ◽

10.1182/asheducation-2018.1.154 ◽

2018 ◽

Vol 2018 (1) ◽

pp. 154-160 ◽

Cited By ~ 5

Author(s):

Theresa H. M. Keegan ◽

Helen M. Parsons

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Community Setting ◽

Treatment Setting ◽

System Level ◽

Trial Participation ◽

Cancer Type ◽

Enrollment Rates ◽

Clinical Trial Enrollment ◽

Barriers To Enrollment

Abstract Survival among adolescents and young adults (AYAs) ages 15 to 39 with cancer has not improved to the same extent as that of pediatric and older adult cancer patients, which is thought to relate, in part, to the lower participation of AYAs in clinical trials. Because significant efforts have been made to improve clinical trial enrollment for AYAs, we (1) present contemporary clinical trial enrollment rates by cancer type, sociodemographic characteristics, and treatment setting and (2) discuss provider-, patient-, and system-level barriers to clinical trial participation. Contemporary studies examining clinical trial enrollment among AYAs have continued to find low overall participation relative to pediatric populations, with most studies observing no significant improvements in enrollment over time. In addition to age and cancer type, enrollment varies by treatment setting, health insurance, and race/ethnicity. Access to available clinical trials may be increased by appropriate referral of AYAs to pediatric and adult specialty cancer centers with studies relevant to the AYA population because most AYAs are treated in the community setting. Even with similar access to trials, however, AYAs may be less likely to participate, and therefore, future efforts should focus on better understanding and addressing barriers to enrollment as well as improving education and outreach regarding clinical trials.

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Study of clinical profile and management of varicose veins in the department of surgery

International Surgery Journal ◽

10.18203/2349-2902.isj20213136 ◽

2021 ◽

Vol 8 (8) ◽

pp. 2399

Author(s):

Ritvik D. Jaykar ◽

Sachin C. Jadhav ◽

Vivek M. Chaudhari

Keyword(s):

Risk Factors ◽

Informed Consent ◽

Selection Criteria ◽

Varicose Veins ◽

Lower Limbs ◽

Age Group ◽

Single Center ◽

Younger Age ◽

Single Center Study ◽

Center Study

Background: Varicose veins are common problem and are present in at least 10% of the general population. So far as the aetiology is concerned varicose veins mostly occur due to incompetence of their valves. Risk factors for varicose veins include obesity, female sex, inactivity, and family history. Varicose veins do not threaten life and are seldom disabling, but it causes a considerable demand on medical care.Methods: The study was prospective observational single center study. 30 patients were selected for the study which fit in the selection criteria laid down at the beginning of the study. Informed consent was obtained from each patient before any investigations and treatment.Results: The study revealed that the varicose veins of lower limbs are a disease of younger age group, occurring more commonly during third and fifth decades of life. The involvement of long saphenous system was more common.Conclusions: Results of our study are comparable with various other studies in literature.

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