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Udoh U, Seeger R, Dewar B, Cummings E, Gocan S, Nicholls S, Fedyk M, Shepherd V, Perry J, Fahed R, Ramsay T, Brehaut J, Hill MD, Poppe AY, Menon BK, Swartz RH, Dowlatshahi D, Shamy M. Advance Consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study. Stroke Vasc Neurol 2024:svn-2023-003029. [PMID: 39357897 DOI: 10.1136/svn-2023-003029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/12/2023] [Accepted: 06/21/2024] [Indexed: 10/04/2024] Open
Abstract
INTRODUCTION Obtaining informed consent for research from patients in medical emergencies remains a challenge, particularly in acute stroke care as treatment must be administered quickly and patients often arrive in the hospital in a state of incapacitation. Adaptations to standard consenting approaches-such as the use of surrogate consent or deferral of consent-have significant limitations. This feasibility study aims to test a new consenting approach in acute stroke care that we call advance consent. Advance consent has the potential to render emergency trial enrolment faster, fairer and more transparent, leading to more generalisable results. METHODS AND DESIGN We will conduct a five-part study at The Ottawa Hospital, a quaternary care stroke centre: (1) administering questionnaires in the Ottawa Hospital Stroke Prevention Clinic that will examine patients' perspectives on research participation and advance consent; (2) inviting participants to consent in advance to any or both currently enrolling acute stroke trials; (3) tracking patient enrolment into these trials over 1 year; (4) administering a follow up questionnaire to participants at 1 year and (5) administering a questionnaire to participating hospital staff in order to interrogate their experiences with advance consent. Outcomes include but are not limited to eligibility rate, recruitment rate, withdrawal rate and the proportion of patients whose advance consent results in trial enrolment. CONCLUSION This study will test the feasibility of enrolling patients at risk of stroke into acute stroke trials using advance consent.
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Affiliation(s)
- Ubong Udoh
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Rena Seeger
- Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Brian Dewar
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Emma Cummings
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Sophia Gocan
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | | | - Mark Fedyk
- School of Medicine, University of California, Davis, Sacramento, California, USA
| | | | - Jeff Perry
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Department of Emergency Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Robert Fahed
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Tim Ramsay
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Jamie Brehaut
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
| | - Michael D Hill
- Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada
| | | | - Bijoy K Menon
- Department of Clinical Neurosciences, University of Calgary, Calgary, Alberta, Canada
| | - Richard H Swartz
- Department of Medicine, University of Toronto, Toronto, Ontario, Canada
| | - Dar Dowlatshahi
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Michel Shamy
- Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
- Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
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Chaiwisitkun A, Muengtaweepongsa S. Platelet-to-neutrophil ratio predicts hemorrhagic transformation and unfavorable outcomes in acute ischemic stroke with intravenous thrombolysis. World J Exp Med 2024; 14:95540. [PMID: 39312695 PMCID: PMC11372743 DOI: 10.5493/wjem.v14.i3.95540] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2024] [Revised: 05/22/2024] [Accepted: 06/12/2024] [Indexed: 08/29/2024] Open
Abstract
BACKGROUND Acute ischemic stroke (AIS) retains a notable stance in global disease burden, with thrombolysis via recombinant tissue plasminogen activator (rtPA) serving as a viable management approach, albeit with variable outcomes and the potential for complications like hemorrhagic transformation (HT). The platelet-to-neutrophil ratio (P/NR) has been considered for its potential prognostic value in AIS, yet its capacity to predict outcomes following rtPA administration demands further exploration. AIM To elucidate the prognostic utility of P/NR in predicting HT and clinical outcomes following intravenous rtPA administration in AIS patients. METHODS Data from 418 AIS patients treated with intravenous rtPA at Thammasat University Hospital from January 2018 to June 2021 were retrospectively analyzed. The relationship between P/NR and clinical outcomes [early neurological deterioration (E-ND), HT, delayed ND (D-ND), and 3-mo outcomes] was scrutinized. RESULTS Notable variables, such as age, diabetes, and stroke history, exhibited statistical disparities when comparing patients with and without E-ND, HT, D-ND, and 3-mo outcomes. P/NR prognostication revealed an optimal cutoff of 43.4 with a 60.3% sensitivity and a 52.5% specificity for 90-d outcomes. P/NR prognostic accuracy was statistically significant for 90-d outcomes [area under the curve (AUC) = 0.562], D-ND (AUC = 0.584), and HT (AUC = 0.607). CONCLUSION P/NR demonstrated an association with adverse 3-mo clinical outcomes, HT, and D-ND in AIS patients post-rtPA administration, indicating its potential as a predictive tool for complications and prognoses. This infers that a diminished P/NR may serve as a novel prognostic indicator, assisting clinicians in identifying AIS patients at elevated risk for unfavorable outcomes following rtPA therapy.
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Affiliation(s)
- Ausanee Chaiwisitkun
- Center of Excellence in Stroke, Faculty of Medicine, Thammasat University, Klonglaung 12120, Pathum Thani, Thailand
| | - Sombat Muengtaweepongsa
- Center of Excellence in Stroke, Faculty of Medicine, Thammasat University, Klonglaung 12120, Pathum Thani, Thailand
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d'Ussel M, Sacco E, Moreau N, Nizard J, Durand G. Assessment of decision-making autonomy in chronic pain patients: a pilot study. BMC Med Ethics 2024; 25:97. [PMID: 39294638 PMCID: PMC11409763 DOI: 10.1186/s12910-024-01096-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/23/2024] [Accepted: 09/02/2024] [Indexed: 09/21/2024] Open
Abstract
BACKGROUND Patient decision-making autonomy refers to the patients' ability to freely exert their own choices and make their own decisions, given sufficient resources and information to do so. In pain medicine, it is accepted that appropriate beneficial management aims to propose an individualized treatment plan shared with the patients, as agents, to help them live as autonomously as possible with their pain. However, are patients in chronic pain centers sufficiently autonomous to participate in the therapeutic decisions that concern them? As this question still remains unanswered, a pilot study was set up to that aim. METHODS Over a 2-month period, first-time patients within a tertiary multidisciplinary pain center underwent a systematic evaluation of their autonomy using the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), considered the benchmark tool for measuring a patient's ability to consent to treatment. Demographic data and pain characteristics of the patients were collected and their respective attending pain physicians were asked to clinically assess their patients' degree of autonomy. Another physician, who had not participated in the initial patient evaluation, subsequently administered the MacCAT-T questionnaire to the same patients. RESULTS Twenty-seven patients were included during the study period (21 women and 6 men), with an average age of 50 years. The average duration of pain was 8 years. Based on their clinical experience, the 4 different pain physicians in charge of these patients considered that out of 25 assessed patients, 22 of them (89%) had full decision-making capacity, with no deficit in autonomy. According to the MacCAT-T results, only 13 of these 25 patients (48%) had no deficit, while 7 (26%) had a major deficit in autonomy. The only patient characteristic that appeared to be related to autonomy was pain type, specifically nociplastic pain. The average time taken to complete the test was 20 min, and patients were very satisfied with the interview. CONCLUSION Results from the present pilot study suggest that patients suffering from chronic pain do not appear to be entirely autonomous in their decision to consent to the proposed treatment plan according to the MacCAT-T questionnaire, and physicians seem to find it difficult to properly assess this competence in a clinical setting. Further studies with larger samples are needed to better evaluate this concept to improve the complex management of these patients.
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Affiliation(s)
| | - Emmanuelle Sacco
- Département de recherche clinique, Hôpital Paris Saint-Joseph, Paris, France
| | - Nathan Moreau
- Consultation Douleurs Chroniques Oro-Faciales - Service de Médecine bucco-dentaire, Hôpital Bretonneau, AP-HP, Paris, France
- UFR d'Odontologie, Faculté de Santé, Université Paris Cité, Paris, France
| | - Julien Nizard
- Service Douleur, Soins Palliatifs et de Support, CHU de Nantes, Éthique Clinique et UIC 22, Nantes, France
- Regenerative Medicine and Skeleton, UMRS INSERM-Oniris, Nantes Université, 1229-RMeS, Nantes, France
| | - Guillaume Durand
- Centre Atlantique de PHIlosophie (UR7463), Nantes Université , Nantes, France
- Consultation d'Éthique Clinique - Centre Hospitalier de Saint-Nazaire/Clinique Mutualiste de l'Estuaire, Saint-Nazaire, France
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Jia W, Jiang Y, Ma R, Huang X, Gu H, Meng X, Li H, Zhao X, Wang Y, Wang Y, Li Z, Wang C. 10-year Temporal Trends of Intravenous Thrombolysis in Acute Ischemic Stroke: Analysis of the China National Stroke Registry I-Ⅲ. J Stroke Cerebrovasc Dis 2024; 33:107431. [PMID: 37951082 DOI: 10.1016/j.jstrokecerebrovasdis.2023.107431] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2023] [Revised: 10/12/2023] [Accepted: 10/12/2023] [Indexed: 11/13/2023] Open
Abstract
OBJECTIVES To investigate the 10-year trend in healthcare quality of intravenous thrombolysis (IVT) with recombinant tissue plasminogen activator in acute ischemic stroke (AIS) in China. MATERIALS AND METHODS We analyzed 42,188 AIS within 7 days of onset from the China National Stroke Registry (CNSR) Ⅰ-Ⅲ. Primary outcomes were temporal changes in the proportion of patients arriving at the hospital within 3.5 hours (and 2 hours) of onset and receiving IVT within 4.5 hours (and 3 hours), stratified by region and hospital tier. Secondary outcomes included temporal changes in door-to-needle time (DNT), DNT ≤60 min and favorable outcome defined as a 90-day modified Rankin Scale (mRS) of 0-1. RESULTS Among patients arriving at the hospital within 3.5 hours of onset, 13.5%, 7.1% and 33.4% patients received IVT within 4.5 hours in CNSR Ⅰ, Ⅱ and Ⅲ, respectively, including a higher proportion from eastern China (37.0%) and tertiary hospitals (36.5%). The median DNT was shorter in CNSR Ⅲ (60.0 min) than those in Ⅱ (95.0 min) and I (94.0 min). The proportion of patients with DNT ≤60 min was greater in Ⅲ (53.4%) than those in Ⅱ (26.7%) and Ⅰ (13.4%). The proportion of favorable outcomes was higher in CNSR Ⅲ (72.8%) than those in Ⅱ (49.6%) and Ⅰ (49.4%). Similar trends were observed for patients arriving at the hospital within 2 hours and receiving IVT within 3 hours of onset. CONCLUSIONS The healthcare quality of IVT has improved remarkably in the past decade, notably in eastern China and tertiary hospitals.
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Affiliation(s)
- Weili Jia
- Department of Neurology, Beijing Tiantan Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases, Beijing, China.
| | - Yong Jiang
- Department of Neurology, Beijing Tiantan Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases, Beijing, China.
| | - Ruihua Ma
- Department of Neurology, Beijing Tiantan Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases, Beijing, China.
| | - Xinying Huang
- China National Clinical Research Center for Neurological Diseases, Beijing, China.
| | - Hongqiu Gu
- China National Clinical Research Center for Neurological Diseases, Beijing, China.
| | - Xia Meng
- Department of Neurology, Beijing Tiantan Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.
| | - Hao Li
- Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; China National Clinical Research Center for Neurological Diseases, Beijing, China.
| | - Xingquan Zhao
- Department of Neurology, Beijing Tiantan Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases; Center of Stroke, Beijing Institute for Brain Disorders; Advanced Innovation Center for Human Brain Protection, Capital Medical University; Research Unit of Artificial Intelligence in Cerebrovascular Disease, Chinese Academy of Medical Sciences, Beijing, China.
| | - Yilong Wang
- Department of Neurology, Beijing Tiantan Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases; Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
| | - Yongjun Wang
- Department of Neurology, Beijing Tiantan Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases; Center of Stroke, Beijing Institute for Brain Disorders; Advanced Innovation Center for Human Brain Protection, Capital Medical University; Research Unit of Artificial Intelligence in Cerebrovascular Disease, Chinese Academy of Medical Sciences, Beijing, China.
| | - Zixiao Li
- Department of Neurology, Beijing Tiantan Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases; Research Unit of Artificial Intelligence in Cerebrovascular Disease, Chinese Academy of Medical Sciences; Chinese Institute for Brain Research, Beijing, China.
| | - Chunjuan Wang
- Department of Neurology, Beijing Tiantan Hospital, Capital Medical University; China National Clinical Research Center for Neurological Diseases; Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.
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Holland E, Richards JL, Langlois WO, Zhu J, Achu-Lopes RA, Brook K. Ethical and Medicolegal Issues: When Obstetric Patients Who Refuse Blood Products Change Their Minds. Anesth Analg 2024; 138:89-95. [PMID: 38100802 DOI: 10.1213/ane.0000000000006517] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2023]
Affiliation(s)
- Erica Holland
- From the Division of Maternal-Fetal Medicine
- the Department of Obstetrics and Gynecology, Boston Medical Center, Boston, Massachusetts
- Department of Obstetrics and Gynecology, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts
| | | | | | - Jialing Zhu
- Department of Anesthesiology, Boston Medical Center, Boston, Massachusetts
| | - Rachel A Achu-Lopes
- Department of Anesthesiology, Boston Medical Center, Boston, Massachusetts
- Department of Anesthesiology, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts
| | - Karolina Brook
- Department of Anesthesiology, Boston Medical Center, Boston, Massachusetts
- Department of Anesthesiology, Boston University Chobanian & Avedisian School of Medicine, Boston, Massachusetts
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Hester DM, Bunch L. Careful Considerations for Midcrisis Consent to and Refusal of Blood Products. Anesth Analg 2024; 138:85-88. [PMID: 38100801 DOI: 10.1213/ane.0000000000006704] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2023]
Affiliation(s)
- D Micah Hester
- From the Department of Medical Humanities & Bioethics, University of Arkansas for Medical Sciences College of Medicine, Little Rock, Arkansas
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Faris H, Dewar B, Fedyk M, Dowlatshahi D, Menon B, Swartz RH, Hill MD, Shamy M. Protocol for Deferral of Consent in Acute Stroke Trials. Neurology 2023; 100:292-300. [PMID: 36414423 PMCID: PMC9946194 DOI: 10.1212/wnl.0000000000201533] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/10/2022] [Accepted: 09/23/2022] [Indexed: 11/23/2022] Open
Abstract
The challenges of conducting hyperacute stroke research and obtaining informed consent have been increasingly recognized within the stroke research community in recent years. Deferral of consent, in which a patient is enrolled in a trial and then provides consent at some point thereafter, is increasingly used to enroll patients into hyperacute stroke trials in Canada and Europe, although it is not permitted in the United States. Deferral of consent offers several potential advantages-quicker door-to-randomization, increased enrolment, decreased selection bias-but these must be balanced against the risk of enrolling patients against their wishes. We seek to minimize the attendant risks of deferral of consent by offering practical guidance regarding how to conduct acute stroke trials using deferral of consent. Building on existing guidelines and recent experiences with deferral of consent in acute stroke trials, we have developed a protocol for the use of deferral of consent that aims to maximize patient involvement while minimizing ethical and scientific risks.
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Affiliation(s)
| | | | | | | | | | | | | | - Michel Shamy
- From the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada.
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Schuster L, Essig F, Daneshkhah N, Herm J, Hellwig S, Endres M, Dirnagl U, Hoffmann F, Michalski D, Pfeilschifter W, Urbanek C, Petzold GC, Rizos T, Kraft A, Haeusler KG. Ability of patients with acute ischemic stroke to recall given information on intravenous thrombolysis: Results of a prospective multicenter study. Eur Stroke J 2023; 8:241-250. [PMID: 37021170 PMCID: PMC10069168 DOI: 10.1177/23969873221143856] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/03/2022] [Accepted: 11/20/2022] [Indexed: 01/09/2023] Open
Abstract
Introduction: Intravenous thrombolysis (IVT) is an on label treatment for selected patients with acute ischemic stroke (AIS). As major bleeding or allergic shock may occur, the need to ensure patients’ informed consent for IVT is a matter of debate. Patients and methods: Prospective investigator-initiated multi-center observational study to assess the ability of AIS patients to recall information, provided by a physician during a standardized educational talk (SET) on IVT use. The recall of 20 pre-defined items was assessed in AIS after 60–90 min ( n = 93) or 23–25 h ( n = 40) after SET. About 40 patients with subacute stroke, 40 non-stroke patients, and 23 relatives of AIS patients served as controls, and were surveyed 60–90 min after SET. Results: Within 60–90 min after SET, AIS patients (median age 70 years, 31% female, median NIHSS score on admission 3 points) who were considered capable to provide informed consent recalled 55% (IQR 40%–66.7%) of the provided SET items. In multivariable linear regression analysis recapitulation by AIS patients was associated with their educational level (β = 6.497, p < 0.001), self-reported excitement level (β = 1.879, p = 0.011) and NIHSS score on admission (β = −1.186, p = 0.001). Patients with subacute stroke (70 years, 40% female, median NIHSS = 2) recalled 70% (IQR 55.7%–83.6%), non-stroke patients (75 years, 40% female) 70% (IQR 60%–78.7%), and AIS relatives (58 years, 83% female) 70% (IQR 60%–85%). Compared to subacute stroke patients, AIS patients less often recalled the frequency of IVT-related bleeding (21% vs 43%), allergic shock (15% vs 39%), and bleeding-related morbidity and mortality (44% vs 78%). AIS patients recalled 50% (IQR 42.3%–67.5%) of the provided items 23–25 h after SET. Conclusion: AIS patients eligible for IVT remember about half of all SET-items after 60–90 min or 23–25 h, respectively. The fact that the recapitulation of IVT-associated risks is particularly poor should be given special consideration.
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Affiliation(s)
- Luzie Schuster
- Department of Neurology, University of Leipzig, Leipzig, Germany
| | - Fabian Essig
- Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany
| | - Naeimeh Daneshkhah
- Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany
| | - Juliane Herm
- Klinik und Hochschulambulanz für Neurologie, Charité - Universitätsmedizin Berlin, Berlin, Germany
- Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany
- German Center for Cardiovascular Diseases (DZHK), Partner Site Berlin, Germany
| | - Simon Hellwig
- Klinik und Hochschulambulanz für Neurologie, Charité - Universitätsmedizin Berlin, Berlin, Germany
- Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany
- Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin, Germany
| | - Matthias Endres
- Klinik und Hochschulambulanz für Neurologie, Charité - Universitätsmedizin Berlin, Berlin, Germany
- Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Berlin, Germany
- German Center for Cardiovascular Diseases (DZHK), Partner Site Berlin, Germany
- Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin, Germany
- German Center for Neurodegenerative Diseases (DZNE), Partner Site Berlin, Germany
| | - Ulrich Dirnagl
- Klinik und Hochschulambulanz für Neurologie, Charité - Universitätsmedizin Berlin, Berlin, Germany
- QUEST Center, Berlin Institute of Health (BIH), Berlin, Germany
| | - Frank Hoffmann
- Department of Neurology, Martha-Maria Hospital, Halle/Saale, Germany
| | | | - Waltraud Pfeilschifter
- Department of Neurology, University of Frankfurt, Frankfurt/Main, Germany
- Department of Neurology, Hospital Lüneburg, Lüneburg, Germany
| | - Christian Urbanek
- Department of Neurology, Hospital Ludwigshafen, Ludwigshafen am Rhein, Germany
| | - Gabor C Petzold
- Division of Vascular Neurology, Department of Neurology, University of Bonn, Bonn, Germany
- German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany
| | - Timolaos Rizos
- Department of Neurology, University of Heidelberg, Heidelberg, Germany
| | - Andrea Kraft
- Department of Neurology, Martha-Maria Hospital, Halle/Saale, Germany
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9
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Appelros P, Svensson E, Heidenreich K, Svantesson M. Ethical issues in stroke thrombolysis revisited. Acta Neurol Scand 2021; 144:611-615. [PMID: 34725820 DOI: 10.1111/ane.13530] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/27/2021] [Accepted: 08/30/2021] [Indexed: 11/27/2022]
Affiliation(s)
- Peter Appelros
- Faculty of Medicine and Health University Health Care Research CenterÖrebro University Örebro Sweden
| | - Elisabeth Svensson
- Faculty of Medicine and Health University Health Care Research CenterÖrebro University Örebro Sweden
| | - Kaja Heidenreich
- Faculty of Medicine and Health University Health Care Research CenterÖrebro University Örebro Sweden
| | - Mia Svantesson
- Faculty of Medicine and Health University Health Care Research CenterÖrebro University Örebro Sweden
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Sokol LL, Hauser JM, Lum HD, Forlizzi J, Cerf M, Caprio FZ, Young MJ. Goal-Concordant Care in the Era of Advanced Stroke Therapies. J Palliat Med 2020; 24:297-301. [PMID: 32407220 PMCID: PMC7840300 DOI: 10.1089/jpm.2019.0667] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022] Open
Abstract
Stroke is a leading cause of disability and mortality worldwide. Recent advances in stroke care now enable patients with severe ischemic stroke owing to large vessel occlusion to safely undergo endovascular thrombectomy (EVT) up to 24 hours since their time of last known well, with the goal of improving functional outcomes by recanalization of the occluded vessel and reperfusion of downstream ischemic brain tissue. The objective of this analysis is to highlight clinical and ethical challenges related to ensuring goal-concordant care in this era of unprecedented advances in acute stroke care. Specifically, there is a salient challenge of whether advanced therapies such as EVT may be justifiably considered comfort focused, given their potential to preempt accumulated neurologic disability and suffering at the end of life. Through the lens of a patient case, we discuss key challenges, lessons learned, and suggestions for future care and research endeavors at the intersection of acute stroke care and palliative care principles. Although therapies such as thrombolysis and EVT may be considered aggressive prima facie, their potential to ameliorate additional disability and potential suffering at the end of life prompt close consideration of the proper role of these therapies on a case-by-case basis in the context of comfort-focused care. Modification to the workflow for EVT evaluations may facilitate goal-concordant care and timely resource allocation, especially for cases that involve hospital-to-hospital transfers for advanced stroke care.
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Affiliation(s)
- Leonard L Sokol
- The Ken and Ruth Davee Department of Neurology, The Ken and Ruth Davee Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.,McGaw Bioethics Scholars Program, Center for Bioethics and Humanities, The Ken and Ruth Davee Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
| | - Joshua M Hauser
- Center for Bioethics and Medical Humanities, Institute for Public Health and Medicine, The Ken and Ruth Davee Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.,Section of Palliative Medicine, Department of Medicine, The Ken and Ruth Davee Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.,Palliative Care Service, Jesse Brown VA Medical Center, Chicago, Illinois, USA
| | - Hillary D Lum
- Division of Geriatric Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.,Eastern Colorado VA Geriatric Research Education and Clinical Center, Rocky Mountain Regional VA Medical Center, Aurora, Colorado, USA
| | - Jodi Forlizzi
- Human-Computer Interaction Institute, School of Computer Science, Carnegie Mellon University, Pittsburgh, Pennsylvania, USA
| | - Moran Cerf
- Interdepartmental Neuroscience Program, Northwestern University, Evanston, Illinois, USA.,Kellogg School of Management, Northwestern University, Evanston, Illinois, USA
| | - Fan Z Caprio
- Division of Stroke and Neurocritical Care, The Ken and Ruth Davee Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
| | - Michael J Young
- Department of Neurology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA
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11
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Sabau M, Bungau S, Buhas CL, Carp G, Daina LG, Judea-Pusta CT, Buhas BA, Jurca CM, Daina CM, Tit DM. Legal medicine implications in fibrinolytic therapy of acute ischemic stroke. BMC Med Ethics 2019; 20:70. [PMID: 31610781 PMCID: PMC6792206 DOI: 10.1186/s12910-019-0412-8] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2019] [Accepted: 09/26/2019] [Indexed: 01/01/2023] Open
Abstract
Background Before the advent of fibrinolytic therapy as a gold standard method of care for cases of acute ischemic stroke in Romania, issues regarding legal medicine aspects involved in this area of medical expertise were already presented and, in the majority of cases, the doctors seem to be unprepared for these situations. Main text The present research illustrates some of the cases in which these aspects were involved, that adressed a clinical center having 6 years of professional experience in the application of fibrinolytic treatment for stroke. The following cases report either situations in which the afore mentioned therapy was not rightfully administrated or legal aspects regarding the obtainment of informed consent. Conclusion Obtaining informed consent is a mandatory procedure, which takes time, to the detriment of application of fibrinolytic treatment.
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Affiliation(s)
- Monica Sabau
- County Clinical Emergency Hospital, Oradea, Romania.,Faculty of Medicine and Pharmacy, Department of Psycho-Neurosciences and Rehabilitation, University of Oradea, Oradea, Romania
| | - Simona Bungau
- Faculty of Medicine and Pharmacy, Department of Pharmacy, University of Oradea, Oradea, Bihor, Romania
| | - Camelia Liana Buhas
- Faculty of Medicine and Pharmacy, Department of Morphological Disciplines, University of Oradea, 50 Clujului St., 410060, Oradea, Bihor, Romania. .,Bihor County Forensic Service, 50 Clujului St, 410060, Oradea, Bihor, Romania.
| | - Gheorghe Carp
- County Clinical Emergency Hospital, Oradea, Romania.,Faculty of Medicine and Pharmacy, Department of Surgical Disciplines, University of Oradea, Oradea, Romania
| | - Lucia-Georgeta Daina
- County Clinical Emergency Hospital, Oradea, Romania.,Faculty of Medicine and Pharmacy, Department of Psycho-Neurosciences and Rehabilitation, University of Oradea, Oradea, Romania
| | - Claudia Teodora Judea-Pusta
- Faculty of Medicine and Pharmacy, Department of Morphological Disciplines, University of Oradea, 50 Clujului St., 410060, Oradea, Bihor, Romania.,Bihor County Forensic Service, 50 Clujului St, 410060, Oradea, Bihor, Romania
| | | | - Claudia Maria Jurca
- Faculty of Medicine and Pharmacy, Department of Preclinical Disciplines, University of Oradea, Oradea, Romania.,Department of Genetics, Municipal Clinical Hospital, Dr. Gavril Curteanu, Oradea, Romania
| | - Cristian Marius Daina
- County Clinical Emergency Hospital, Oradea, Romania.,Faculty of Medicine and Pharmacy, Department of Psycho-Neurosciences and Rehabilitation, University of Oradea, Oradea, Romania
| | - Delia Mirela Tit
- Faculty of Medicine and Pharmacy, Department of Pharmacy, University of Oradea, Oradea, Bihor, Romania
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12
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Majersik JJ, Morgenstern LB. Informed consent in acute ischemic stroke: It's on us. Neurology 2018; 90:203-204. [PMID: 29298850 DOI: 10.1212/wnl.0000000000004903] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022] Open
Affiliation(s)
- Jennifer J Majersik
- From Neurology (J.J.M.), University of Utah, Salt Lake City; and Neurology (L.B.M.), University of Michigan, Ann Arbor.
| | - Lewis B Morgenstern
- From Neurology (J.J.M.), University of Utah, Salt Lake City; and Neurology (L.B.M.), University of Michigan, Ann Arbor
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13
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Grady A, Carey M, Bryant J, Sanson-Fisher R, Hobden B. A systematic review of patient-practitioner communication interventions involving treatment decisions. PATIENT EDUCATION AND COUNSELING 2017; 100:199-211. [PMID: 27682739 DOI: 10.1016/j.pec.2016.09.010] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/08/2016] [Revised: 09/20/2016] [Accepted: 09/20/2016] [Indexed: 06/06/2023]
Abstract
OBJECTIVES To examine the: 1) methodological quality of interventions examining strategies to improve patient-practitioner communication involving treatment decisions; 2) effectiveness of strategies to improve patient-practitioner communication involving treatment decisions; and 3) types of treatment decisions (emergency/non-emergency) in the included studies. METHODS Medline, PsychINFO, CINAHL, and Embase were searched to identify intervention studies. To be included, studies were required to examine patient-practitioner communication related to decision making about treatment. Study methodological quality was assessed using Cochrane's Effective Practice and Organisation of Care risk of bias criteria. Study design, sample characteristics, intervention details, and outcomes were extracted. RESULTS Eleven studies met the inclusion criteria. No studies were rated low risk on all nine risk of bias criteria. Two of the three interventions aimed at changing patient behaviour, two of the five practitioner directed, and one of the three patient-practitioner directed interventions demonstrated an effect on decision-making outcomes. No studies examined emergency treatment decisions. CONCLUSIONS Existing studies have a high risk of bias and are poorly reported. There is some evidence to suggest patient-directed interventions may be effective in improving decision-making outcomes. PRACTICE IMPLICATIONS It is imperative that an evidence-base is developed to inform clinical practice.
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Affiliation(s)
- Alice Grady
- Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, NSW, Australia; Public Health, Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.
| | - Mariko Carey
- Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, NSW, Australia; Public Health, Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.
| | - Jamie Bryant
- Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, NSW, Australia; Public Health, Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.
| | - Rob Sanson-Fisher
- Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, NSW, Australia; Public Health, Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.
| | - Breanne Hobden
- Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, NSW, Australia; Public Health, Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.
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14
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Prabhakaran S, Khorzad R, Brown A, Nannicelli AP, Khare R, Holl JL. Academic-Community Hospital Comparison of Vulnerabilities in Door-to-Needle Process for Acute Ischemic Stroke. CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES 2016; 8:S148-54. [PMID: 26515203 DOI: 10.1161/circoutcomes.115.002085] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND Although best practices have been developed for achieving door-to-needle (DTN) times ≤60 minutes for stroke thrombolysis, critical DTN process failures persist. We sought to compare these failures in the Emergency Department at an academic medical center and a community hospital. METHODS AND RESULTS Failure modes effects and criticality analysis was used to identify system and process failures. Multidisciplinary teams involved in DTN care participated in moderated sessions at each site. As a result, DTN process maps were created and potential failures and their causes, frequency, severity, and existing safeguards were identified. For each failure, a risk priority number and criticality score were calculated; failures were then ranked, with the highest scores representing the most critical failures and targets for intervention. We detected a total of 70 failures in 50 process steps and 76 failures in 42 process steps at the community hospital and academic medical center, respectively. At the community hospital, critical failures included (1) delay in registration because of Emergency Department overcrowding, (2) incorrect triage diagnosis among walk-in patients, and (3) delay in obtaining consent for thrombolytic treatment. At the academic medical center, critical failures included (1) incorrect triage diagnosis among walk-in patients, (2) delay in stroke team activation, and (3) delay in obtaining computed tomographic imaging. CONCLUSIONS Although the identification of common critical failures suggests opportunities for a generalizable process redesign, differences in the criticality and nature of failures must be addressed at the individual hospital level, to develop robust and sustainable solutions to reduce DTN time.
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Affiliation(s)
- Shyam Prabhakaran
- From the Division of Neurology (S.P.), Center for Healthcare Studies (S.P., R.K., A.B., A.P.N., J.L.H.), Feinberg School of Medicine, Northwestern University, Chicago, IL; and Private Practice, Chicago, IL (R.K.).
| | - Rebeca Khorzad
- From the Division of Neurology (S.P.), Center for Healthcare Studies (S.P., R.K., A.B., A.P.N., J.L.H.), Feinberg School of Medicine, Northwestern University, Chicago, IL; and Private Practice, Chicago, IL (R.K.)
| | - Alexandra Brown
- From the Division of Neurology (S.P.), Center for Healthcare Studies (S.P., R.K., A.B., A.P.N., J.L.H.), Feinberg School of Medicine, Northwestern University, Chicago, IL; and Private Practice, Chicago, IL (R.K.)
| | - Anna P Nannicelli
- From the Division of Neurology (S.P.), Center for Healthcare Studies (S.P., R.K., A.B., A.P.N., J.L.H.), Feinberg School of Medicine, Northwestern University, Chicago, IL; and Private Practice, Chicago, IL (R.K.)
| | - Rahul Khare
- From the Division of Neurology (S.P.), Center for Healthcare Studies (S.P., R.K., A.B., A.P.N., J.L.H.), Feinberg School of Medicine, Northwestern University, Chicago, IL; and Private Practice, Chicago, IL (R.K.)
| | - Jane L Holl
- From the Division of Neurology (S.P.), Center for Healthcare Studies (S.P., R.K., A.B., A.P.N., J.L.H.), Feinberg School of Medicine, Northwestern University, Chicago, IL; and Private Practice, Chicago, IL (R.K.)
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15
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Demaerschalk BM, Kleindorfer DO, Adeoye OM, Demchuk AM, Fugate JE, Grotta JC, Khalessi AA, Levy EI, Palesch YY, Prabhakaran S, Saposnik G, Saver JL, Smith EE. Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke. Stroke 2016; 47:581-641. [DOI: 10.1161/str.0000000000000086] [Citation(s) in RCA: 480] [Impact Index Per Article: 53.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Purpose—
To critically review and evaluate the science behind individual eligibility criteria (indication/inclusion and contraindications/exclusion criteria) for intravenous recombinant tissue-type plasminogen activator (alteplase) treatment in acute ischemic stroke. This will allow us to better inform stroke providers of quantitative and qualitative risks associated with alteplase administration under selected commonly and uncommonly encountered clinical circumstances and to identify future research priorities concerning these eligibility criteria, which could potentially expand the safe and judicious use of alteplase and improve outcomes after stroke.
Methods—
Writing group members were nominated by the committee chair on the basis of their previous work in relevant topic areas and were approved by the American Heart Association Stroke Council’s Scientific Statement Oversight Committee and the American Heart Association’s Manuscript Oversight Committee. The writers used systematic literature reviews, references to published clinical and epidemiology studies, morbidity and mortality reports, clinical and public health guidelines, authoritative statements, personal files, and expert opinion to summarize existing evidence and to indicate gaps in current knowledge and, when appropriate, formulated recommendations using standard American Heart Association criteria. All members of the writing group had the opportunity to comment on and approved the final version of this document. The document underwent extensive American Heart Association internal peer review, Stroke Council Leadership review, and Scientific Statements Oversight Committee review before consideration and approval by the American Heart Association Science Advisory and Coordinating Committee.
Results—
After a review of the current literature, it was clearly evident that the levels of evidence supporting individual exclusion criteria for intravenous alteplase vary widely. Several exclusionary criteria have already undergone extensive scientific study such as the clear benefit of alteplase treatment in elderly stroke patients, those with severe stroke, those with diabetes mellitus and hyperglycemia, and those with minor early ischemic changes evident on computed tomography. Some exclusions such as recent intracranial surgery are likely based on common sense and sound judgment and are unlikely to ever be subjected to a randomized, clinical trial to evaluate safety. Most other contraindications or warnings range somewhere in between. However, the differential impact of each exclusion criterion varies not only with the evidence base behind it but also with the frequency of the exclusion within the stroke population, the probability of coexistence of multiple exclusion factors in a single patient, and the variation in practice among treating clinicians.
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16
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Flatharta TÓ, Khan A, Walsh T, O'Donnell M, O'Keefe ST. Advance preferences regarding thrombolysis in patients at risk for stroke: a cross-sectional study. QJM 2015; 108:27-31. [PMID: 24996769 DOI: 10.1093/qjmed/hcu142] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/14/2022] Open
Abstract
BACKGROUND It is difficult to obtain informed consent for thrombolysis in stroke patients given the emergency setting, the need for a speedy decision and the effects of neurological deficits. AIM To determine the advance preferences for thrombolysis of patients at risk for stroke following discussion of the potential risks and benefits. DESIGN Cross-sectional survey. METHODS Data on benefits and risks of thrombolysis within 3 h and between 3 and 4.5 h after stroke were presented orally, in writing and pictorially to patients attending geriatric and stroke services in a teaching hospital with specified stroke risk factors and preferences for thrombolysis were recorded. RESULTS Of the 121 participants, 108 (89.3%; 95% confidence interval [CI] 82.4-93.7) would opt for thrombolysis within the 3-h period and 100 (82.6%; 95% CI 74.9-88.4) within the 3- to 4.5-h period after acute stroke (P = 0.04, McNemar's test for correlated proportions). Previous stroke or transient ischaemic attack was more common among those who agreed to thrombolysis (54.1% vs. 30.4%, P = 0.04) and those who opted for thrombolysis were significantly more likely to agree to have their preferences recorded and used in the event of a stroke than those who refused thrombolysis (88.8% vs. 30.4%, P = 0.002). CONCLUSION Advance discussion of the potential risks and benefits of thrombolysis in at-risk patients may improve decision making if thrombolysis is being considered and the patient can no longer make a decision.
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Affiliation(s)
- T Ó Flatharta
- From the Department of Medicine, National University of Ireland-Galway, Department of Geriatric Medicine, Galway University Hospitals and National University of Ireland, Galway, HRB Clinical Research Facility, Galway, Ireland
| | - A Khan
- From the Department of Medicine, National University of Ireland-Galway, Department of Geriatric Medicine, Galway University Hospitals and National University of Ireland, Galway, HRB Clinical Research Facility, Galway, Ireland
| | - T Walsh
- From the Department of Medicine, National University of Ireland-Galway, Department of Geriatric Medicine, Galway University Hospitals and National University of Ireland, Galway, HRB Clinical Research Facility, Galway, Ireland
| | - M O'Donnell
- From the Department of Medicine, National University of Ireland-Galway, Department of Geriatric Medicine, Galway University Hospitals and National University of Ireland, Galway, HRB Clinical Research Facility, Galway, Ireland
| | - S T O'Keefe
- From the Department of Medicine, National University of Ireland-Galway, Department of Geriatric Medicine, Galway University Hospitals and National University of Ireland, Galway, HRB Clinical Research Facility, Galway, Ireland
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17
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Feng KL, Person C, Phillips-Sabol J, Williams B, Cai C, Jacobs AN, Indupuru H, Aramburo-Maldonado L, Shen L, Grotta JC, Barreto AD. Comparison between a standardized questionnaire and expert clinicians for capacity assessment in stroke clinical trials. Stroke 2014; 45:e229-32. [PMID: 25270630 DOI: 10.1161/strokeaha.114.006395] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Affiliation(s)
- Kimberly L Feng
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
| | - Cheryl Person
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
| | - Jacqueline Phillips-Sabol
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
| | - Bethany Williams
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
| | - Chunyan Cai
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
| | - Amber N Jacobs
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
| | - Hari Indupuru
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
| | - Linda Aramburo-Maldonado
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
| | - Loren Shen
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
| | - James C Grotta
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
| | - Andrew D Barreto
- From the Stroke Program, Department of Neurology (K.L.F., J.P.-S., B.W., A.N.J., H.I., L.A.-M., L.S., A.D.B.), Department of Psychiatry and Behavioral Sciences (C.P.), and Department of Internal Medicine (C.C.), University of Texas Health Science Center at Houston; and Stroke Research Division, Clinical Innovation and Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston, TX (J.C.G.)
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18
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Chiong W, Kim AS, Huang IA, Farahany NA, Josephson SA. Inability to consent does not diminish the desirability of stroke thrombolysis. Ann Neurol 2014; 76:296-304. [PMID: 24980651 DOI: 10.1002/ana.24209] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/18/2014] [Revised: 06/27/2014] [Accepted: 06/27/2014] [Indexed: 01/08/2023]
Abstract
OBJECTIVE Some have argued that physicians should not presume to make thrombolysis decisions for incapacitated patients with acute ischemic stroke because the risks and benefits of thrombolysis involve deeply personal values. We evaluated the influence of the inability to consent and of personal health-related values on older adults' emergency treatment preferences for both ischemic stroke and cardiac arrest. METHODS A total of 2,154 US adults age ≥50 years read vignettes in which they had either suffered an acute ischemic stroke and could be treated with thrombolysis, or had suffered a sudden cardiac arrest and could be treated with cardiopulmonary resuscitation. Participants were then asked (1) whether they would want the intervention, or (2) whether they would want to be given the intervention even if their informed consent could not be obtained. We elicited health-related values as predictors of these judgments. RESULTS Older adults were as likely to want stroke thrombolysis when unable to consent (78.1%) as when asked directly (76.2%), whereas older adults were more likely to want cardiopulmonary resuscitation when unable to consent (83.6% compared to 75.9%). Greater confidence in the medical system and reliance on statistical information in decision making were both associated with desiring thrombolysis. INTERPRETATION Older adults regard thrombolysis no less favorably when considering a situation in which they are unable to consent. These findings provide empirical support for recent professional society recommendations to treat ischemic stroke with thrombolysis in appropriate emergency circumstances under a presumption of consent.
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Affiliation(s)
- Winston Chiong
- Department of Neurology, University of California, San Francisco, San Francisco, CA
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19
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Aldous K, Tolmie R, Worrall L, Ferguson A. Speech-language pathologists' contribution to the assessment of decision-making capacity in aphasia: a survey of common practices. INTERNATIONAL JOURNAL OF SPEECH-LANGUAGE PATHOLOGY 2014; 16:231-241. [PMID: 24400775 DOI: 10.3109/17549507.2013.871751] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/03/2023]
Abstract
Speech-language pathologists' scope of practice is currently unclear in relation to their contribution to the multi-disciplinary assessment of decision-making capacity for clients with aphasia and related neurogenic communication disorders. The primary aim of the current research study was to investigate the common practices of speech-language pathologists involved in assessments of decision-making capacity. The study was completed through the use of an online survey. There were 51 of 59 respondents who indicated involvement in evaluations of decision-making. Involvement in this kind of assessment was most commonly reported by speech-language pathologists working in inpatient acute and rehabilitation settings. Respondents reported using a variety of formal and informal assessment methods in their contributions to capacity assessment. Discussion with multidisciplinary team members was reported to have the greatest influence on their recommendations. Speech-language pathologists reported that they were dissatisfied with current protocols for capacity assessments in their workplace and indicated they would benefit from further education and training in this area. The findings of this study are discussed in light of their implications for speech-language pathology practice.
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20
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Jayes M, Palmer R. Initial evaluation of the Consent Support Tool: a structured procedure to facilitate the inclusion and engagement of people with aphasia in the informed consent process. INTERNATIONAL JOURNAL OF SPEECH-LANGUAGE PATHOLOGY 2014; 16:159-168. [PMID: 23826849 DOI: 10.3109/17549507.2013.795999] [Citation(s) in RCA: 28] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 06/02/2023]
Abstract
This study evaluated the Consent Support Tool (CST), a procedure developed to identify the optimum format in which to present research information to people with different severities of aphasia, in order to support their understanding during the informed consent process. Participants were a convenience sample of 13 people with aphasia who had mixed comprehension ability. The CST was used to profile each participant's language ability and identify an information format that should maximize her/his understanding. Next, participants were shown information presented in three formats: standard text and two 'aphasia-friendly' versions providing different levels of support. Participants' understanding of the information was measured for each format. The format recommended by the CST was compared with the format observed to maximize understanding for each participant. The CST accurately predicted the optimum format for 11/13 participants and differentiated people who could understand fully with support from those who could not in 12/13 cases. All participants interviewed (10/10) found the adapted formats helpful and 9/10 preferred them to the standard version. These findings suggest that the CST could usefully support researchers to determine whether a person with aphasia is likely to be able to provide informed consent, and which information format will maximize that individual's understanding. The CST and different information formats are available as Supplementary Appendices to be found online at http://www.informahealthcare.com/doi/abs/10.3109/17549507.2013.795999 .
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Affiliation(s)
- Mark Jayes
- Sheffield Teaching Hospitals NHS Foundation Trust , Sheffield , UK
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21
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Rincon F, Lee K. Ethical considerations in consenting critically ill patients for bedside clinical care and research. J Intensive Care Med 2013; 30:141-50. [PMID: 24019298 DOI: 10.1177/0885066613503279] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
Care of critically ill patients, as in any other field, demands the exercise of ethical principles related to respect of patient's autonomy, beneficence, nonmaleficence, and distributive justice. Professional duty and the common law require doctors to obtain consent before giving treatment or for requesting participation in clinical research. A procedure or research study must be adequately explained, and the patient must have the capacity to consent. If a patient does not have decision-making capacity, treatment must be given using alternative forms of consent or using principles of implied consent in emergency or life-threatening situations. In the case of clinical research, informed consent must always be sought. Exemptions to this rule are morally justified in circumstances related to research in life-threatening conditions or life-saving interventions in which the investigator departs from sound principles of equipoise. This usually implies the imposition of safeguards such as consultation with the community in which the study were to take place, oversight in patient screening and recruitment process by institutional review boards, special study designs, retrospective and prospective consent processes, and independent safety monitoring.
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Affiliation(s)
- Fred Rincon
- Divisions of Critical Care and Neurotrauma, Department of Neurology and Neurosurgery, Thomas Jefferson University, Philadelphia, PA, USA
| | - Kiwon Lee
- Department of Neurology and Neurosurgery, The Mischer Neuroscience Institute, Memorial Hermann of Texas Medical Center, Houston, TX, USA
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22
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Bajd F, Serša I. A concept of thrombolysis as a corrosion-erosion process verified by optical microscopy. Microcirculation 2013; 19:632-41. [PMID: 22612378 DOI: 10.1111/j.1549-8719.2012.00198.x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/01/2022]
Abstract
OBJECTIVE Outcome of the thrombolytic treatment is dependent on biochemical reactions of the fibrinolytic system as well as on hemodynamic conditions. However, understanding of the interaction between these two processes is still deficient. METHODS Model blood clot thrombolysis in an artificial perfusion system was studied by stroboscopic optical microscopy. The obtained images were analyzed by particle-tracking software for clot size distributions of removed clot fragments, and for non-lysed blood clot areas as function of time. Based on the experimental results, a probabilistic phenomenological model of blood clot dissolution was developed, in which mechanical forces of streaming plasma are in balance with binding forces of blood cells to the remaining clot. RESULTS The clot dissolution rate and maximum size of removed clot fragments were increased with greater flow rate. A 3.3-fold flow rate increase resulted in a two-fold clot dissolution rate increase, while sizes of the removed fragments were in the range of single blood cells, up to thousand-cell clusters. Our phenomenological microscale model of clot dissolution suggests that thrombolysis is a corrosion-erosion-like process. CONCLUSIONS The findings of this study provide a possible explanation for the origin of clot fragment formation in the blood clot dissolution process.
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Affiliation(s)
- Franci Bajd
- Jožef Stefan Institute, Ljubljana, Slovenia EN-FIST Centre of Excellence, Ljubljana, Slovenia
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23
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Jauch EC, Saver JL, Adams HP, Bruno A, Connors JJB, Demaerschalk BM, Khatri P, McMullan PW, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2013; 44:870-947. [PMID: 23370205 DOI: 10.1161/str.0b013e318284056a] [Citation(s) in RCA: 3286] [Impact Index Per Article: 273.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
BACKGROUND AND PURPOSE The authors present an overview of the current evidence and management recommendations for evaluation and treatment of adults with acute ischemic stroke. The intended audiences are prehospital care providers, physicians, allied health professionals, and hospital administrators responsible for the care of acute ischemic stroke patients within the first 48 hours from stroke onset. These guidelines supersede the prior 2007 guidelines and 2009 updates. METHODS Members of the writing committee were appointed by the American Stroke Association Stroke Council's Scientific Statement Oversight Committee, representing various areas of medical expertise. Strict adherence to the American Heart Association conflict of interest policy was maintained throughout the consensus process. Panel members were assigned topics relevant to their areas of expertise, reviewed the stroke literature with emphasis on publications since the prior guidelines, and drafted recommendations in accordance with the American Heart Association Stroke Council's Level of Evidence grading algorithm. RESULTS The goal of these guidelines is to limit the morbidity and mortality associated with stroke. The guidelines support the overarching concept of stroke systems of care and detail aspects of stroke care from patient recognition; emergency medical services activation, transport, and triage; through the initial hours in the emergency department and stroke unit. The guideline discusses early stroke evaluation and general medical care, as well as ischemic stroke, specific interventions such as reperfusion strategies, and general physiological optimization for cerebral resuscitation. CONCLUSIONS Because many of the recommendations are based on limited data, additional research on treatment of acute ischemic stroke remains urgently needed.
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Della-Morte D, Guadagni F, Palmirotta R, Ferroni P, Rundek T. Research Highlights: Highlights from the latest articles in stroke pharmacogenomics. Pharmacogenomics 2013; 14:13-4. [DOI: 10.2217/pgs.12.184] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
Affiliation(s)
- David Della-Morte
- Department of Neurology, Miller School of Medicine, University of Miami, Clinical Research Building, 1120 NW 14th Street, Room 1363, Miami, FL 33136, USA
| | - Fiorella Guadagni
- Department of Advanced Biotechnologies & Bioimaging, IRCCS San Raffaele Pisana, 00163 Rome, Italy
| | - Raffaele Palmirotta
- Department of Advanced Biotechnologies & Bioimaging, IRCCS San Raffaele Pisana, 00163 Rome, Italy
| | - Patrizia Ferroni
- Department of Advanced Biotechnologies & Bioimaging, IRCCS San Raffaele Pisana, 00163 Rome, Italy
| | - Tatjana Rundek
- Department of Neurology, Miller School of Medicine, University of Miami, Clinical Research Building, 1120 NW 14th Street, Room 1363, Miami, FL 33136, USA
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Thomas L, Viswanathan A, Cochrane TI, Johnson J, O'Brien J, McMahon M, Santimauro JM, Schwamm LH. Variability in the Perception of Informed Consent for IV-tPA during Telestroke Consultation. Front Neurol 2012; 3:128. [PMID: 23015805 PMCID: PMC3449489 DOI: 10.3389/fneur.2012.00128] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/17/2012] [Accepted: 08/04/2012] [Indexed: 11/25/2022] Open
Abstract
Objective: To study the perception of informed consent among various raters for thrombolysis in acute ischemic stroke patients receiving intravenous tissue plasminogen activator (IV-tPA). Methods: Twenty randomly selected videotaped telestroke consultations of acute stroke patients administered IV-tPA were retrospectively reviewed. Adequacy of informed consent was reviewed by five raters: a neurologist and emergency physician who routinely treat stroke, a medical risk management paralegal, a bioethicist, and a lay person. Raters assessed the quality of the informed consent presentation by the treating physician and the degree of understanding demonstrated by the patient/family authorizing consent. Factors associated with adequacy of consent were analyzed. Results: Consent was rated as adequately understood by the patient-family in 78.6% cases. Agreement between all five raters with regard to the patient-family understanding of consent was poor and also between the subgroups of non-physician and physician (all k < 0.20). Similarly, the quality of the physician consent process was poor for agreement between all five raters (k = 0.07) or between the subgroup of the three non-physician raters (k = −0.06) and fair between the two physician raters (k = 0.24). The legal reviewer and the bioethicist rated the physician consent process as being of lower quality than did the two physicians and the layperson. Conclusion: Despite high variability in the perception of informed consent among raters in this time-sensitive clinical situation, almost 80% of patients were rated by all reviewers as having adequate understanding of risks and benefits of tPA. This suggests the need for a standardized but brief tPA consent process that includes patient/family demonstration of understanding.
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Affiliation(s)
- Lisa Thomas
- Department of Emergency Medicine, Mount Auburn Hospital Cambridge, MA, USA
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Diana RB, Carlos CC, Marle DG, Santiago J. [From the Principle of Beneficence to the Principle of Autonomy. Assessment of Patients' Mental Competency in the General Hospital]. REVISTA COLOMBIANA DE PSIQUIATRIA 2012; 41:395-407. [PMID: 26573502 DOI: 10.1016/s0034-7450(14)60013-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/28/2012] [Accepted: 05/02/2012] [Indexed: 06/05/2023]
Abstract
INTRODUCTION Refusing a medical procedure is a valid way of exercising every patient's right to autonomy. From the legal point of view, autonomy is based on the right to privacy. In recent decades the legal right to self-determination has gradually expanded and today patients in full possession of their mental faculties, have the moral and legal right to make their own decisions and these decisions take precedence over physician and family. Often liaison psychiatrists are called in to assess the mental competence of patients in the general hospital. OBJECTIVE To determine the psychiatrist's role in evaluating these patients. DISCUSSION AND CONCLUSIONS The assessment of a patient's ability to decide and self-determine is a common clinical problem in general hospitals. Evaluation of these patients requires a proper understanding of the philosophical, ethical, and legal issues that guide the appropriate treatment of these complex clinical problems.
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Affiliation(s)
- Restrepo B Diana
- Médica(o) psiquiatra de Enlace, Hospital Universitario San Vicente Fundación, Medellín, Colombia.
| | - Cardeño C Carlos
- Médica(o) psiquiatra de Enlace, Hospital Universitario San Vicente Fundación, Medellín, Colombia
| | - Duque G Marle
- Médico residente de Psiquiatría de III año, Universidad de Antioquia, Medellín, Colombia
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Burges Watson DL, Sanoff R, Mackintosh JE, Saver JL, Ford GA, Price C, Starkman S, Eckstein M, Conwit R, Grace A, Murtagh MJ. Evidence from the scene: paramedic perspectives on involvement in out-of-hospital research. Ann Emerg Med 2012; 60:641-50. [PMID: 22387089 DOI: 10.1016/j.annemergmed.2011.12.002] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/22/2011] [Revised: 11/21/2011] [Accepted: 12/05/2011] [Indexed: 11/16/2022]
Abstract
STUDY OBJECTIVE In the context of calls to develop better systems for out-of-hospital clinical research, we seek to understand paramedics' perceptions of involvement in research and the barriers and facilitators to that involvement. METHODS This was a qualitative study using semistructured focus groups with 58 United Kingdom paramedics and interviews with 30 US firefighter-paramedics. The study focused on out-of-hospital research (trials of out-of-hospital treatment for stroke), whereby paramedics identified potential study subjects or obtained consent and administered study treatment in the field. Data were analyzed with a thematic and discourse approach. RESULTS Three key themes emerged as significant facilitators and barriers to paramedic involvement in research: patient benefit, professional identity and responsibility, and time. Paramedics showed willingness and capacity to engage in research but also some reticence because of the perceived sacrifice of autonomy and challenge to their identity. Paramedics work in a time-sensitive environment and were concerned that research would increase time taken in the field. CONCLUSION Awareness of these perspectives will help with development of out-of-hospital research protocols and potentially facilitate greater participation.
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Meurer WJ, Majersik JJ, Frederiksen SM, Kade AM, Sandretto AM, Scott PA. Provider perceptions of barriers to the emergency use of tPA for acute ischemic stroke: a qualitative study. BMC Emerg Med 2011; 11:5. [PMID: 21548943 PMCID: PMC3112102 DOI: 10.1186/1471-227x-11-5] [Citation(s) in RCA: 44] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/19/2010] [Accepted: 05/06/2011] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND Only 1-3% of ischemic stroke patients receive thrombolytic therapy. Provider barriers to adhering with guidelines recommending tPA delivery in acute stroke are not well known. The main objective of this study was to describe barriers to thrombolytic use in acute stroke care. METHODS Twenty-four hospitals were randomly selected and matched into 12 pairs. Barrier assessment occurred at intervention sites only, and utilized focus groups and structured interviews. A pre-specified taxonomy was employed to characterize barriers. Two investigators independently assigned themes to transcribed responses. Seven facilitators (three emergency physicians, two nurses, and two study coordinators) conducted focus groups and interviews of emergency physicians (65), nurses (62), neurologists (15), radiologists (12), hospital administrators (12), and three others (hospitalists and pharmacist). RESULTS The following themes represented the most important external barriers: environmental and patient factors. Important barriers internal to the clinician included familiarity with and motivation to adhere to the guidelines, lack of self-efficacy and outcome expectancy. The following themes were not substantial barriers: lack of awareness of the existence of acute stroke guidelines, presence of conflicting guidelines, and lack of agreement with the guidelines. CONCLUSIONS Healthcare providers perceive environmental and patient-related factors as the primary barriers to adherence with acute stroke treatment guidelines. Interventions focused on increasing physician familiarity with and motivation to follow guidelines may be of highest yield in improving adherence. Improving self-efficacy in performing guideline concordant care may also be useful.
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Affiliation(s)
- William J Meurer
- Department of Emergency Medicine, University of Michigan, Ann Arbor, Michigan, USA.
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Abstract
The requirement that doctors obtain valid consent from patients before providing medical treatment has long been ingrained in both legal doctrine and medical ethics. We summarize the foundations of the informed consent doctrine and discuss the recent evolution in thinking about consent and medical decision making. We show how consent has evolved from physicians merely providing patients information to shared decision making between patients and physicians. We then address three specific examples of situations common in neurological practice that pose challenges in obtaining valid consent: the administration of intravenous tPA following ischemic stroke, consideration of carotid endarterectomy for carotid artery stenosis, and implementation of do-not-resuscitate orders.
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Affiliation(s)
- Emily B Rubin
- Departments of Internal Medicine and Pediatrics, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA.
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Bajd F, Vidmar J, Blinc A, Sersa I. Microscopic clot fragment evidence of biochemo-mechanical degradation effects in thrombolysis. Thromb Res 2010; 126:137-43. [PMID: 20580981 DOI: 10.1016/j.thromres.2010.04.012] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/11/2010] [Revised: 04/22/2010] [Accepted: 04/23/2010] [Indexed: 11/29/2022]
Abstract
INTRODUCTION Although fibrinolytic treatment has been used for decades, the interactions between the biochemical mechanisms and the mechanical forces of the streaming blood remain incompletely understood. Analysis of the blood clot surface in vitro was employed to study the concomitant effect of blood plasma flow and recombinant tissue plasminogen activator (rt-PA) on the degradation of retracted, non-occlusive blood clots. Our hypothesis was that a faster tangential plasma flow removed larger fragments and resulted in faster overall thrombolysis. MATERIALS AND METHODS Retracted model blood clots were prepared in an optical microscopy chamber and connected to an artificial perfusion system with either no-flow, or plasma flow with a velocity of 3 cm/s or 30 cm/s with or without added rt-PA at 2 microg/ml. The clot surface was dynamically imaged by an optical microscope for 30 min with 15s intervals. RESULTS The clot fragments removed during rt-PA mediated thrombolysis ranged in size from that of a single red blood cell to large agglomerates composed of more than a thousand red blood cells bound together by partly degraded fibrin. The average and the largest discrete clot area change between images in adjacent time frames were significantly higher with the faster flow than with the slow flow (14,000 microm(2) and 160,000 microm(2) vs. 2200 microm(2) and 10,600 microm(2)). CONCLUSIONS On the micrometer scale, thrombolysis consists of sequential removal of clot fragments from the clot surface. With increasing tangential plasma flow velocity, the size of the clot fragments and the overall rate of thrombolysis increases.
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Affiliation(s)
- Franci Bajd
- Jozef Stefan Institute, Jamova 39, Ljubljana 1000, Slovenia
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Lu-Emerson C, Likosky D, Amin A, Tirschwell D. Management of ischemic stroke: Part 1. Emergency room management. J Hosp Med 2010; 5:33-40. [PMID: 20063394 DOI: 10.1002/jhm.518] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/31/2022]
Abstract
BACKGROUND Acute ischemic stroke is commonly encountered by the hospitalist. There have been dramatic changes in our ability to care for these patients acutely. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) primary stroke center certification has become progressively more important to institutions nationally and includes many aspects of initial evaluation and treatment. PURPOSE Acute treatment involves the rapid assimilation of patient characteristics, laboratory results, and imaging results. There are a growing number of potential acute therapies with a range of risk, benefit, necessary time windows, and specific eligibility criteria. DATA SOURCES Primary trials, current guidelines. CONCLUSIONS The hospitalist is well-positioned to play a major role in the treatment of stroke patients as well as the systems work that aids in the management of this population.
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Affiliation(s)
- Christine Lu-Emerson
- Department of Neurology, School of Medicine, University of Washington, Seattle, Washington, USA
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Grunwald IQ, Walter S, Papanagiotou P, Krick C, Hartmann K, Dautermann A, Fassbender K, Haass A, Bolar LJ, Reith W, Roth C. Revascularization in acute ischaemic stroke using the penumbra system: the first single center experience. Eur J Neurol 2009; 16:1210-6. [PMID: 19659754 DOI: 10.1111/j.1468-1331.2009.02750.x] [Citation(s) in RCA: 53] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
Abstract
BACKGROUND AND PURPOSE This is the first single center experience illustrating the effectiveness of the penumbra system (PS) in the treatment of large vessel occlusive disease in the arena of acute ischaemic stroke. The PS is an innovative mechanical thrombectomy device, employed in the revascularization of large cerebral vessel occlusions in patients via the utilization of an aspiration platform. METHODS This is a prospective, non-randomized controlled trial evaluating the clinical and functional outcome in 29 patients with acute intra-cranial occlusions consequent to mechanical thrombectomy by the PS either as mono-therapy or as an adjunct to current standard of care. Patients were evaluated by a neurologist and treated by our in house interventional neuro-radiologists. Primary end-points were revascularization of the occluded target vessel to TIMI grade 2 or 3 and neurological outcome as measured by an improvement in the NIH Stroke Scale (NIHSS) score after the procedure. RESULTS Complete revascularization (TIMI 3) was achieved in 21/29 (72.4%) of patients. Partial revascularization (TIMI 2) was established in 4/29 (13.8%) of patients. Revascularization failed in four (13.8%) patients. Nineteen (19) patients (65.5%) had at least a four-point improvement in NIHSS scores. Modified Rankin scale scores of < or =2 were seen in 37.9% of patients. There were no device-related adverse events. Symptomatic intra-cranial hemorrhage occurred in 7% of patients. CONCLUSIONS The PS has the potential of exercising a significant impact in the interventional treatment of ischaemic stroke in the future.
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Affiliation(s)
- I Q Grunwald
- Department for International and Diagnostic Neuroradiology, University of Saarland, Homburg, Germany.
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Helmchen H. [Ethical questions in clinical research with the mentally ill]. DER NERVENARZT 2008; 79:1036-50. [PMID: 18633585 DOI: 10.1007/s00115-008-2523-1] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/01/2022]
Abstract
The review deals with present problems of protecting mentally ill patients who are incompetent to give informed consent to participating in clinical research, and of assessment of the capacity to consent. 1. Clinical trials of drugs on efficacy and safety in incompetent patients are ethically justified and legally admissible if the investigational drug can be expected to exert a direct potential individual benefit and if such trials will be performed under defined criteria to protect these vulnerable patients. In Germany it is questionable how far these prescriptions of the German Drug Law (AMG) are transferable to other than drug research. 2. Research with no direct potential individual benefit or only a group-specific benefit in incompetent patients is controversially discussed. However, it may be ethically justified as an exception, and is in Germany legally admissible only in minors, but not in adults. 3. However, internationally there exists a wide range of legal regulations, terms, interpretations, and practices of research with vulnerable persons. In the past years a shift seems to have developed from normatively oriented discussions to more empirically based investigations. Especially vague but clinically relevant terms in protection declarations or guidelines have been better specified, put in concrete form by anchor examples, and empirically studied. 4. In general the criteria of protecting the dignity and, even if impaired, the autonomy of incompetent patients as subjects for research appear to guarantee a high standard of protection. However, the application of these criteria must be improved by practicable procedures. This is valid particularly for the assessment of the basic criterion whether a patient is capable of consenting or not. 5. Open Questions are formulated as need of research.
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Affiliation(s)
- H Helmchen
- Klinik für Psychiatrie und Psychotherapie, CBF, Charite - Universitätsmedizin Berlin, Eschenallee 3, 14050, Berlin, Deutschland.
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Iwanowski P, Budaj A, Członkowska A, Wąsek W, Kozłowska-Boszko B, Olędzka U, Masełbas W. Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes. Trials 2008; 9:45. [PMID: 18644120 PMCID: PMC2517587 DOI: 10.1186/1745-6215-9-45] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/30/2007] [Accepted: 07/21/2008] [Indexed: 11/10/2022] Open
Abstract
BACKGROUND During clinical trials in emergency medicine, providing appropriate oral and written information to a patient is usually a challenge. There is little published information regarding patients' opinions and competence to provide informed consent, nor on physicians' attitudes towards the process. We have investigated the problem of obtaining consent from patients in emergency-setting clinical trials (such as acute coronary syndromes (ACS) and stroke) from a physicians' perspective. METHODS A standardised anonymous 14-item questionnaire was distributed to Polish cardiac and stroke centres. RESULTS Two hundred and fourteen informative investigator responses were received. Of these investigators, 73.8% had experience with ACS and 25.2% had experience with acute stroke trials (and 1% with both fields). The complete model of informed consent (embracing all aspects required by Good Clinical Practice (GCP) and law) was used in 53.3% of cases in emergency settings, whereas the legal option of proxy consent was not used at all. While less than 15% of respondents considered written information to have been fully read by patients, 80.4% thought that the amount of information being given to emergency patients is too lengthy. Although there is no legal obligation, more than half of the investigators sought parallel consent (assent) from patients' relatives. Most investigators confirmed that they would adopt the model proposed by the GCP guidelines: abbreviated verbal and written consent in emergency conditions with obligatory "all-embracing" deferred consent to continue the trial once the patient is able to provide it. However, this model would not follow current Polish and European legislation. CONCLUSION An update of national and European regulations is required to enable implementation of the emergency trial consent model referred to in GCP guidelines.
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Affiliation(s)
- Piotr Iwanowski
- Association for Good Clinical Practice in Poland, ul. Postępu 18B (Neptun), 02-676 Warszawa, Poland
- International Centre for Therapeutic Research, Servier Poland, ul. Jana Kazimierza 10, 01-248 Warszawa, Poland
| | - Andrzej Budaj
- Centre of Postgraduate Medical Education, Department of Cardiology, Grochowski Hospital, ul. Grenadierów 51/59, 04-073 Warszawa, Poland
| | - Anna Członkowska
- Institute of Psychiatry and Neurology, 2nd Department of Neurology, ul. Sobieskiego 9, 02-957 Warszawa, Poland
- Department of Experimental and Clinical Pharmacology, Medical University, Warsaw, ul. Krakowskie Przedmieście 26/28, 00-325 Warszawa, Poland
| | - Wojciech Wąsek
- Centre of Postgraduate Medical Education, Department of Cardiology, Grochowski Hospital, ul. Grenadierów 51/59, 04-073 Warszawa, Poland
| | - Beata Kozłowska-Boszko
- Association for Good Clinical Practice in Poland, ul. Postępu 18B (Neptun), 02-676 Warszawa, Poland
- Bayer HealthCare, Medical Department, Al. Jerozolimskie 158, 02-326 Warszawa, Poland
| | - Urszula Olędzka
- Association for Good Clinical Practice in Poland, ul. Postępu 18B (Neptun), 02-676 Warszawa, Poland
- International Centre for Therapeutic Research, Servier Poland, ul. Jana Kazimierza 10, 01-248 Warszawa, Poland
| | - Wojciech Masełbas
- Association for Good Clinical Practice in Poland, ul. Postępu 18B (Neptun), 02-676 Warszawa, Poland
- PPD Development, ul. Postępu 18B (Orion), 02-676 Warszawa, Poland
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Grobelnik B, Vidmar J, Tratar G, Blinc A, Serša I. Flow-induced permeation of non-occlusive blood clots: an MRI study and modelling. EUROPEAN BIOPHYSICS JOURNAL: EBJ 2008; 37:1229-33. [DOI: 10.1007/s00249-008-0342-8] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Received: 09/12/2007] [Revised: 04/22/2008] [Accepted: 04/28/2008] [Indexed: 11/28/2022]
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Affiliation(s)
- Paul S Appelbaum
- Division of Law, Ethics, and Psychiatry, Department of Psychiatry, College of Physicians and Surgeons, Columbia University and New York State Psychiatric Institute, New York 10032, USA.
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