Article
Emergency Medicine
Krista L. L. Snyder, Jon F. F. Merz
Summary: We conducted a census of trials conducted under the U.S. FDA's EFIC rule and found that 30 out of 69 completed trials were terminated early, mainly due to futility (15 trials) and poor recruitment (10 trials). The rate of trial conduct has remained relatively constant since 2001, with approximately 18 trials started in each 5-year period.
ACADEMIC EMERGENCY MEDICINE
(2023)
Article
Clinical Neurology
Felizitas A. Eichner, Joschua M. Reis, Joaquim Dores, Vladimir Pavlovic, Luisa Kress, Naeimeh Daneshkhah, Renate Weinhardt, Armin Grau, Johannes Muehler, Hassan Soda, Christopher J. Schwarzbach, Michael Schuler, Karl Georg Haeusler, Peter U. Heuschmann
Summary: The study found that stroke patients have a relatively high understanding of the informed consent procedure, but face difficulties in recalling other important aspects of the study content and procedures. Younger age, higher education, and allocation to the intervention group were associated with better understanding. The recruitment and retention benefits of an improved informed consent procedure still need to be tested in future randomized trials.
EUROPEAN JOURNAL OF NEUROLOGY
(2021)
Article
Public, Environmental & Occupational Health
Rafael Dal-Re, Teck Chuan Voo, Soren Holm
Summary: The study investigated whether any changes were made to the original participant's information sheet/informed consent form (PIS/ICF) provided by the WHO Solidarity Plus team when transferred to participating countries. The results showed that no edits were made in 8 countries, some elements were added in 8 countries, and 3 countries did not participate. The conclusion suggests that WHO should consider adding three omitted elements in the PIS/ICFs of future similar trials.
JOURNAL OF GLOBAL HEALTH
(2023)
Article
Medicine, General & Internal
Ezekiel J. Emanuel, Connor W. Boyle
Summary: The study found that current informed consent documents for COVID-19 vaccine trials are too long and complex, making them difficult to understand. By shortening the length and simplifying the language, the accessibility for participants can be improved.
Article
Clinical Neurology
Alessandro Perin, Tommaso Francesco Galbiati, Roberta Ayadi, Enrico Gambatesa, Eleonora Francesca Orena, Nicole Irene Riker, Hagit Silberberg, Donatella Sgubin, Torstein Ragnar Meling, Francesco DiMeco
Summary: This study demonstrates that using immersive 3D imaging technologies for informed consent can improve patients' understanding of their condition, enhance communication experience, and reduce anxiety levels. Patients in the experimental groups appreciated this new communication method and showed higher objective comprehension compared to the control group.
ACTA NEUROCHIRURGICA
(2021)
Review
Medicine, General & Internal
Steven R. Cummings
Summary: Clinical trials can either be conducted at clinical sites, requiring face-to-face interactions for exams and data collection, or without clinical sites, utilizing online consent and data collection, telemedicine, and home treatments. Performing trials without clinical sites can expand participation and increase the generalizability of results.
JAMA INTERNAL MEDICINE
(2021)
Article
Medicine, General & Internal
Luke S. Bothun, Scott E. Feeder, Gregory A. Poland
Summary: This study found that the informed consent forms and informational documents from recent phase 3 COVID-19 vaccine clinical trials in the United States did not meet readability standards at the recommended 7th grade level. The average English-speaking vaccine trial volunteer would have great difficulty comprehending the information provided in these documents. To ensure study subjects receive and fully comprehend information and can provide reliable consent, greater attention should be given to simplified consent forms, multimedia formatting, personal discussion, and comprehension assessments.
MAYO CLINIC PROCEEDINGS
(2021)
Article
Oncology
Laura Gangeri, Sara Alfieri, Margherita Greco, Marta Scrignaro, Elisabetta Bianchi, Paolo Casali, Davide Ferraris, Claudia Borreani
Summary: This study aimed to explore cancer patients' understandings, needs, and factors influencing participation in RCTs, as well as physicians' experiences and critical issues regarding IC. The findings revealed discrepancies between patients and physicians in their perceptions and understanding of IC.
SUPPORTIVE CARE IN CANCER
(2022)
Article
Medicine, Research & Experimental
Nahathai Dukaew, Mingkwan Na Takuathung, Wannachai Sakuludomkan, Kanyarat Chairaksa, Preeyaporn Klinjan, Nimit Morakote, Nut Koonrungsesomboon
Summary: This study evaluated the regulatory compliance and readability of informed consent forms used in industry-sponsored drug development clinical trials. The findings showed that the informed consent forms were long but incomplete, with some missing information. These results highlight the ongoing challenges in industry-sponsored drug development clinical trials regarding the quality of informed consent forms.
Article
Clinical Neurology
Mayank Goyal, Johanna Maria Ospel, Aravind Ganesh, Martha Marko, Marc Fisher
Summary: Informed consent in the context of the COVID-19 pandemic has posed challenges, prompting a reassessment of consent processes to ensure maximal patient benefit without compromising patient autonomy.
Article
Health Care Sciences & Services
Katie Gillies, Paula R. Williamson, Vikki A. Entwistle, Heidi Gardner, Shaun Treweek, Marion K. Campbell
Summary: The ELICIT Study developed a core outcome set for interventions aimed at improving decision-making about participation in randomized controlled trials, through a mixed-method study involving literature review, interviews, Delphi survey, and consensus meeting. Consensus was reached on 12 core outcomes essential for evaluating interventions to improve decision-making about participating in randomized controlled trials.
JOURNAL OF CLINICAL EPIDEMIOLOGY
(2021)
Article
Medicine, Research & Experimental
Julia Wade, Elka Humphrys, Alba X. Realpe, Daisy M. Gaunt, Jenni Burt
Summary: The participatory and informed consent (PIC) measure was developed to assess recruiter information provision and patient understanding in recruitment discussions. The measure was evaluated and revised within the context of the OPTiMISE trial, demonstrating good feasibility, content validity, and reliability.
Article
Oncology
Nina Mogensen, Ulrika Kreicbergs, Birgitte Klug Albertsen, Paivi Lahteenmaki, Mats Heyman, Arja Harila
Summary: This study investigated parents' experiences of the informed consent process in randomized clinical trials (RCTs) within the Nordic ALL2008 trial. The results showed that most parents were satisfied with the process, but many found it burdensome to make the decision, and fewer school-aged children were involved in the decision-making process than expected.
PEDIATRIC BLOOD & CANCER
(2023)
Review
Clinical Neurology
Emily J. Dalton, Natasha A. Lannin, Bruce C. Campbell, Leonid Churilov, Kathryn S. Hayward
Summary: This study examined the generalizability of findings in upper-limb motor trials conducted early post-stroke. The results showed that key information to support the generalizability of trial findings was insufficiently reported, and broadening eligibility criteria alone may not be enough to improve trial inclusivity due to internal validity constraints.
INTERNATIONAL JOURNAL OF STROKE
(2023)
Article
Clinical Neurology
Joseph P. Broderick, Yasmin N. Aziz, Opeolu M. Adeoye, James C. Grotta, Andrew M. Naidech, Andrew D. Barreto, Colin P. Derdeyn, Heidi J. Sucharew, Jordan J. Elm, Pooja Khatri
Summary: Randomized clinical trials of acute stroke have resulted in significant progress in acute stroke therapy, but recruitment of participants remains challenging. In this article, the challenges in recruitment for acute stroke trials are discussed, along with potential solutions to expedite the identification of new treatments. These solutions include expanding the inclusion criteria, improving availability of study investigators, utilizing telemedicine, enhancing prehospital notification, simplifying study protocols, and educating physicians. Successful recruitment is crucial for advancing scientific knowledge and improving clinical outcomes for acute stroke patients.
Article
Clinical Neurology
T. Hashimoto, T. Kunieda, T. Honda, F. Scalzo, L. Ali, J. D. Hinman, N. M. Rao, M. Nour, M. Bahr-Hosseini, J. L. Saver, R. Raychev, D. Liebeskind
Summary: This study found that reduced leukoaraiosis, noncardiac embolisms, and shorter thrombus length in cardioembolism are indicators of good collateral flow in patients with embolic large-vessel occlusion.
AMERICAN JOURNAL OF NEURORADIOLOGY
(2022)
Article
Cardiac & Cardiovascular Systems
Raed A. Joundi, Jie-Lena Sun, Ying Xian, Brooke Alhanti, Raul G. Nogueira, Deepak L. Bhatt, Gregg C. Fonarow, Jeffrey Saver, Lee H. Schwamm, Eric E. Smith
Summary: This study investigated the relationship between time to endovascular therapy (EVT) and treatment outcomes in patients with basilar artery occlusion (BAO). The results showed that early treatment after symptom onset was associated with improved outcomes. Therefore, rapid implementation of EVT is crucial for patients with BAO.
Editorial Material
Neuroimaging
Jeffrey L. Saver, Eva Mistry
JOURNAL OF NEUROINTERVENTIONAL SURGERY
(2023)
Letter
Neuroimaging
Chun-Hsien Lin, Jeffrey L. Saver, Meng Lee
JOURNAL OF NEUROINTERVENTIONAL SURGERY
(2023)
Article
Clinical Neurology
Scott J. Mendelson, Shuaiqi Zhang, Roland Matsouaka, Ying Xian, Shreyansh Shah, Barbara L. Lytle, Nicole Solomon, Lee H. Schwamm, Eric E. Smith, Jeffrey L. Saver, Gregg Fonarow, Jane Holl, Shyam Prabhakaran
Summary: This study aimed to investigate the prevalence of tPA declination among patients with acute ischemic stroke (AIS) and the differences by race/ethnicity. The study found that although the overall prevalence of tPA declination is low, non-Hispanic Black patients are more likely to decline tPA, while Asian patients are less likely. Reducing rates of tPA declinations among non-Hispanic Black patients may provide an opportunity to address disparities in stroke care.
Article
Emergency Medicine
Nichole Bosson, Jeffrey Eric Rollman, Robert A. Kloner, David M. Shavelle, Jeffrey L. Saver, James T. Niemann, Asim M. Rafique, Xiaoyan Wang, Christine Clare, Marianne Gausche-Hill
Summary: This study evaluated the correlation between COVID-19 hospitalizations and EMS responses for time-sensitive emergencies in a large EMS system in Los Angeles County. The study found a significant correlation between COVID-19 hospitalizations and the frequency of EMS responses for time-sensitive emergencies, with an increase in EMS responses corresponding to an increase in COVID-19 hospitalizations.
PREHOSPITAL EMERGENCY CARE
(2023)
Article
Clinical Neurology
Johanna M. Ospel, Wolfgang G. Kunz, Rosalie McDonough, Wim van Zwam, Floor Pinckaers, Jeffrey L. Saver, Michael D. Hill, Andrew M. Demchuk, Tudor G. Jovin, Peter Mitchell, Bruce C. Campbell, Phil White, Keith Muir, Hamza Achit, Serge Bracard, Scott Brown, Mayank Goyal
Summary: This study aimed to investigate the clinical and economic benefit of endovascular treatment (EVT) in stroke patients with mild preexisting symptoms/disability. The results showed that EVT, in addition to best medical management, was a superior treatment strategy, resulting in cost savings and improved quality of life.
Article
Cardiac & Cardiovascular Systems
Shumei Man, Nicole Solomon, Brian Mac Grory, Brooke Alhanti, Ken Uchino, Jeffrey L. Saver, Eric E. Smith, Ying Xian, Deepak L. Bhatt, Lee H. Schwamm, Muhammad Shazam Hussain, Gregg C. Fonarow
Summary: Shorter door-to-needle times are associated with better long-term functional outcomes and lower mortality among older stroke patients treated with IVT only or IVT+EVT. These findings support efforts to accelerate thrombolytic administration in all eligible patients, including those receiving EVT.
Article
Clinical Neurology
Hongfei Sang, Dongjing Xie, Yan Tian, Thanh N. Nguyen, Jeffrey L. Saver, Raul G. Nogueira, Junxiong Wu, Chen Long, Zhenxuan Tian, Zhizhou Hu, Tao Wang, Rongzong Li, Yingbing Ke, Xiurong Zhu, Daizhou Peng, Mingze Chang, Lingfei Li, Jie Ruan, Deping Wu, Wenjie Zi, Qingwu Yang, Fengli Li, Zhongming Qiu
Summary: This study investigated the efficacy and safety of IV infusion of tirofiban before endovascular thrombectomy for patients with large vessel occlusion due to intracranial atherosclerotic disease. The results showed that patients in the tirofiban group had higher rates of functional independence at 90 days without increased risk of mortality or symptomatic intracranial hemorrhage. The reduction of thrombectomy passes mediated a significant portion of the effect of tirofiban on functional independence.
Letter
Clinical Neurology
Mersedeh Bahr-Hosseini, Nina Meissner, Paul Reidler, Jeffrey L. Saver, Steffen Tiedt
Article
Clinical Neurology
Jeffrey B. Saver, Elizabeth M. Klerman, Alastair Buchan, Patricia Calleja, Ignacio Lizasoain, Mersedeh Bahr-Hosseini, Sarah S. Lee, David Liebeskind, Philipp T. Mergenthaler, Katherine Mun, MingMing Ning, David Pelz, David M. Ray, Peter Rothwell, Pierre Seners, Anirudh Sreekrishnan, Eleanor Mina Sung, Steffen Tiedt, Alastair J. S. Webb, Teresa W. Woelfer, Gregory Albers
Summary: There is increasing evidence that circadian and diurnal rhythms have a strong influence on stroke onset, mechanism, progression, recovery, and response to therapy. To enhance our understanding, standardized definitions and coding guides for data collection are needed, as well as advanced imaging techniques and large data registries. The development of standardized data structures will aid researchers in studying the impact of circadian/diurnal biology on stroke.
Article
Clinical Neurology
Jian Miao, Hongfei Sang, Fengli Li, Jeffrey L. Saver, Bo Lei, Jinglun Li, Raul Gomes Nogueira, Bo Song, Shudong Liu, Thanh N. Nguyen, Zhenglong Jin, Hongliang Zeng, Changming Wen, Guangxiong Yuan, Weilin Kong, Weidong Luo, Shuai Liu, Dongjing Xie, Jiacheng Huang, Chang Liu, Jie Yang, Jinrong Hu, Jiaxing Song, Chengsong Yue, Linyu Li, Yan Tian, Xiao Zhang, Dan Feng, Yani Gao, Huiying Fu, Wenjie Zi, Qingwu Yang, Zhongming Qiu, Shaojun Wang
Summary: This study pooled data from two randomized clinical trials in China to assess the impact of basic imaging versus advanced imaging on clinical outcomes after endovascular thrombectomy in patients with acute ischemic stroke. The results showed no significant differences between the two imaging modalities in both the early and extended time windows.
Review
Neuroimaging
Nien-chen Liao, Mersedeh Bahr Hosseini, Jeffrey L. Saver
Summary: This study aimed to determine the correlation between the effect size of infarct growth reduction and clinically meaningful differences in clinical global disability outcomes. The results showed that each 1 mL reduction in infarct growth was associated with an increase in functional independence, providing guidance for clinical trials of neuroprotective agents.
JOURNAL OF NEUROINTERVENTIONAL SURGERY
(2023)
Article
Neuroimaging
Diego J. Ojeda, Malik Ghannam, Sebastian Sanchez, Mohammad Almajali, Prateeka Koul, Jeffrey L. Saver, Rishi Gupta, Santiago Ortega-Gutierrez, Edgar A. Samaniego
Summary: The Tigertriever device shows high success rate and short puncture to reperfusion time in patients with large vessel occlusion and underlying intracranial atherosclerotic disease, without device-related complications.
JOURNAL OF NEUROINTERVENTIONAL SURGERY
(2023)
Review
Clinical Neurology
Joachim Fladt, Johanna M. Ospel, Nishita Singh, Jeffrey L. Saver, Marc Fisher, Mayank Goyal
Summary: In recent decades, with continuous technological advances and the availability of novel therapies, there has been a growing interest in shifting advanced acute care from hospitals to the prehospital setting. However, there are challenges related to conducting clinical trials, ambulance design and costs. Utilizing new technologies and customized software applications can help overcome these challenges and establish efficient, targeted care strategies in the prehospital setting.