Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey

Abstract Background In some acute care trials, immediate informed consent is not possible, but deferred consent is often considered problematic. We investigated the opinions of patients, proxies, and physicians about deferred consent in an acute stroke trial to gain insight into its acceptability and effects. Methods Paper-based surveys were sent to patients who were randomly assigned in the Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage (ULTRA) trial between 2015 and 2018 in two tertiary referral centers and to physicians of centers who agreed or declined to participate. The primary outcome measure was the proportion of respondents who agreed with deferral of consent in the ULTRA trial. Secondary outcomes included respondents’ preferred consent procedure for the ULTRA trial, the effect of deferred consent on trust in physicians and scientific research, and the willingness to participate in future research. Results Eighty-nine of 135 (66%) patients or proxies and 20 of 30 (67%) physicians completed the survey. Of these, 82 of 89 (92%) patients or proxies and 14 of 20 (70%) physicians agreed with deferral of consent in the ULTRA trial. When asked for their preferred consent procedure for the ULTRA trial, 31 of 89 (35%) patients or proxies indicated deferred consent, 15 of 89 (17%) preferred immediate informed consent, and 32 of 89 (36%) had no preference. None of the patients’ or proxies’ trust in physicians or scientific research had decreased because of the deferred consent procedure. Willingness to participate in future studies remained the same or increased in 84 of 89 (94%) patients or proxies. Conclusions A large majority of the surveyed patients and proxies and a somewhat smaller majority of the surveyed physicians agreed with deferred consent in the ULTRA trial. Deferred consent may enable acute care trials in an acceptable manner without decreasing trust in medicine. Future research should investigate factors facilitating the responsible use of deferred consent, such as in-depth interviews, to study the minority of participants who agreed with deferred consent but still preferred immediate informed consent.

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EXPRESS: Factors influencing the use of different methods of consent in a randomised acute stroke trial, the Third International Stroke Trial (IST-3)

International Journal of Stroke ◽

10.1177/17474930211037123 ◽

2021 ◽

pp. 174749302110371

Author(s):

Richard Lindley ◽

Ingrid Kane ◽

Geoff Cohen ◽

Peter Sandercock

Keyword(s):

Informed Consent ◽

Acute Stroke ◽

Data Access ◽

Stroke Onset ◽

Neurological Deficits ◽

Direct Result ◽

The Third ◽

Consent Procedure ◽

Waiver Of Consent ◽

Stroke Trial

Background Obtaining informed consent in people with acute stroke is complex since many, as a direct result of their stroke, lose capacity to make important decisions. Furthermore reperfusion interventions are time dependent necessitating rapid consent. We developed 4 different consent approaches to facilitate recruitment of a broad range of patients in the Third International Stroke Trial (IST-3). Aims To describe the clinical characteristics of patients recruited by different consent methods and the association between these methods and time from stroke onset to randomisation. Methods IST-3 was a randomised controlled trial of thrombolysis for acute ischaemic stroke. Clinicians could use one of four consent procedures: written consent, witnessed consent, assent, or a waiver of consent. We analysed the relationship between consent procedure and baseline variables. The effect of consent procedure on delay time from onset to randomisation was determined using analysis of variance to adjust for confounding effects. Results Of the 3035 patients recruited, the method of consent was known for 3034 (99.9%) and it was: written in 985 subjects (24%), witnessed verbal consent in 280 (9.2%), assent by relative in 1727 (56.9%), and waiver of consent in 42 subjects (1.4%). Assent was required in 63.4% for those presenting 0-3 hours from stroke onset (written consent in 25.3%). Patients with more severe neurological deficits (or with a non-lacunar hemispheric stroke syndrome) were less likely to give written consent. Mean delay between onset and randomisation varied significantly between consent types (one way anova : F=15.7 on 3 df, P<0.0001) (longest at 4.06 hours for signed consent and 3.46 hours for waiver of consent). Conclusions Acute stroke trials requiring written informed consent would result in substantial selection bias. Flexible consent methods will ensure a broad range of patients are recruited, enabling trial results to be widely generalisable. Registration The study is registered number ISRCTN25765518. Data access statement IST-3 Trial dataset is available on Edinburgh Data Share. https://datashare.ed.ac.uk/handle/10283/1931

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Informed Consent in Social Sciences Research: Ethical Challenges

International Journal of Social Science Studies ◽

10.11114/ijsss.v6i5.3106 ◽

2018 ◽

Vol 6 (5) ◽

pp. 13 ◽

Cited By ~ 2

Author(s):

Carlos Miguel Ferreira ◽

Sandro Serpa

Keyword(s):

Social Sciences ◽

Informed Consent ◽

Scientific Research ◽

Research Process ◽

Ethical Dimension ◽

Ethical Challenges ◽

Research Practices ◽

Informed Consent Procedure ◽

Consent Procedure

Informed consent is a critical procedure for the fulfilment of the ethical dimension in scientific research in social sciences. On the basis of a stance centred in Sociology research practices developed by the authors, this paper reflects on informed consent, its relevance in research, and procedures involved in its production and its concomitant implications. The reflection on the research process is stressed, emphasising the need to not consider the informed consent procedure as something that is fulfilled only once, but rather as something that integrates both the research process and its product and that, therefore, should be continuously considered and assessed throughout research.

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Abstract TP289: Legal Authorized Representative Feedback on the use of Smartphone Platform for Electronic Informed Consent in an Acute Stroke Trial

Stroke ◽

10.1161/str.50.suppl_1.tp289 ◽

2019 ◽

Vol 50 (Suppl_1) ◽

Author(s):

Diogo C Haussen ◽

Leah Craft ◽

Shannon Doppelheuer ◽

Kiva Schindler ◽

Gabriel M Rodrigues ◽

...

Keyword(s):

Informed Consent ◽

Acute Stroke ◽

Stroke Trial

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Myriad-Briefing

Reinvention: an International Journal of Undergraduate Research ◽

10.31273/reinvention.v13i1.488 ◽

2020 ◽

Vol 13 (1) ◽

Author(s):

Ptolemy David Willmott Banks

Keyword(s):

Informed Consent ◽

Behaviour Change ◽

Memory Test ◽

Future Research ◽

Willingness To Participate ◽

Potential Solution ◽

Extensive Investigation ◽

Observable Effect ◽

Natural Behaviour ◽

Negative Effect

Briefing a participant is necessary to obtain informed consent. However, briefing can change a participant’s behaviour; for example, knowledge of an upcoming memory test might cause you to attend experimental stimuli more so that you look clever in the test. Studies that try to measure natural behaviour therefore use deception to avoid this behaviour change. This merely flips the problem from a methodological one to an ethical one. This paper guides future research of a potential solution: myriad-briefing is a technique of presenting a collection of possible tasks to ambiguate the nature of the experiment so that participants consent to the experimental tasks without knowing what the experiment will involve. Before more extensive investigation of the application of myriad-briefing, this paper investigated two salient caveats. Part 1 obtains feedback from participants about myriad-briefing to see if more information deters participation. Results find no negative effect of myriad-briefing on participant willingness to participate. Part 2 tests whether participants pay attention to myriad briefing in online studies to see if the technique is applicable. Results find that too few participants read the briefing to produce an observable effect suggesting myriad-briefing is best applied to laboratory settings.

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Abstract WMP66: Enrollment in a Pre-hospital Stroke Trial: Common Reasons for Patient Non- Enrollment

Stroke ◽

10.1161/str.44.suppl_1.awmp66 ◽

2013 ◽

Vol 44 (suppl_1) ◽

Author(s):

Randy Sanoff ◽

Samantha B Cherin ◽

Joan Krause ◽

Fiona Chatfield ◽

Nerses Sanossian ◽

...

Keyword(s):

Informed Consent ◽

Acute Stroke ◽

Outcome Evaluation ◽

Phase 3 ◽

Stroke Treatment ◽

Spanish Speaking ◽

Promising Strategy ◽

Stroke Trial

Background: Enrolling patients in the field is a promising strategy to facilitate entry of subjects within the first 1 to 2 hours after symptom onset into clinical trials for acute stroke treatment. The Field Administration of Stroke Therapy Magnesium (FAST-MAG) Trial is the first multicenter study to implement eliciting informed consent by cell phone between patients or their legally authorized representatives (LARs) and off- site enrolling physician-investigators. Call yield and profile of screen failures observed over the course of the study are reported. Methods: FAST-MAG is a phase 3 trial to evaluate field-initiated magnesium sulfate as a neuroprotective agent to improve the long-term functional outcome in acute stroke. The outcomes of these attempted enrollment calls from 362 participating ambulances to the eight central English and Spanish-speaking enrolling physician-investigators were tracked prospectively from 1/2012 to 1/2005. Results: Over seven years, 3,726 calls were made to enrolling physicians. Of these, 1478 (40%) resulted in trial enrollments. Among 2248 non-enrollment calls, the five most common reasons for were: physician’s determination of last known well time was longer than two hours (19%), pre-existing condition which could confound outcome evaluation (18%), patient deemed not competent to provide informed consent and no LAR available (12%), rapidly improving neurological deficit (9%), patient not English or Spanish speaking (6%). Phone connection difficulties accounted for only 2.7% of screen failures, whereas 4.2% were competent patients and 11% were LARs refusing participation. Yearly enrollment yeilds did not change significantly throughout the study Conclusion: Two of every five calls from the field to FM enrolling physicians resulted in trial enrollment. Enrollment yields were consistent throughout the study.

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Patient and proxies’ attitudes towards deferred consent in randomised trials of acute treatment for stroke: A qualitative survey

European Stroke Journal ◽

10.1177/23969873211057421 ◽

2021 ◽

pp. 239698732110574

Author(s):

Noa van den Bos ◽

Sophie A van den Berg ◽

Catalina MM Caupain ◽

Jeannette AJ Pols ◽

Tessa van Middelaar ◽

...

Keyword(s):

Informed Consent ◽

Acute Stroke ◽

Time Windows ◽

Patient Characteristics ◽

Neurological Deficits ◽

Randomised Trials ◽

Structured Interviews ◽

Treatment Comparison ◽

Deferred Consent ◽

Study Participants

Introduction Deferral of consent for participation in a clinical study is a relatively novel procedure, in which informed consent is obtained after randomisation and study treatment. Deferred consent can be used in emergency situations, where small therapeutic time windows limit possibilities for patients to provide informed consent. We aimed to investigate patients’ or their proxies’ experiences and opinions regarding deferred consent in acute stroke randomised trials. Patients and methods For this qualitative study, Dutch Collaboration for New Treatments of Acute Stroke (CONTRAST) trial participants were selected. Study participants were either patients or their proxies who provided consent and were selected with theoretical sampling based on patient characteristics. Semi-structured interviews were conducted face-to-face or by telephone. Themes and subthemes were iteratively defined. Results Twenty of the 23 interviewed participants (16 patients and 7 proxies) considered deferred consent acceptable. The received study treatment and consent conversation were remembered by 18 participations, although the concept of randomisation and treatment comparison were generally not well understood. Sixteen participants felt capable of overseeing the decision to give deferred consent. Distress in the first days after stroke, lack of understanding and neurological deficits were reasons for feeling incapable of providing consent. Four participants would have preferred a different timing of the consent conversation, of whom two prior to treatment. Conclusion Our study found that deferred consent was considered acceptable by most study participants who provided consent for acute stroke randomised trials. Though they felt capable, the recall and comprehension of consent were overall limited.

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IMPLEMENTASIROTTERDAM CONVENTION ON THE PRIOR INFORMED CONSENT PROCEDURE FOR CERTAIN HAZARDOUS CHEMICALS AND PESTICIDES IN INTERNATIONAL TRADEBAGI PERKEMBANGAN HUKUM LINGKUNGAN DI INDONESIA

Jurnal Komunikasi Hukum (JKH) ◽

10.23887/jkh.v5i1.16754 ◽

2019 ◽

Vol 5 (1) ◽

pp. 90

Author(s):

Elly Kristiani Purwendah ◽

Elisabet Pudyastiwi

Keyword(s):

Informed Consent ◽

Hazardous Chemicals ◽

Informed Consent Procedure ◽

Prior Informed Consent ◽

Consent Procedure

Konvensi ini memang tidak langsung memberikan efek yang signifikan namun dengan meratifikasi konvensi ini akan memberikan pengaruh terhadap kelangsungan ekspor bahan mentah terlebih sumber daya alam seperti bahan obat-obatan, bahan pangan dan bahan lainnya yang terkontaminasi oleh bahan kimia dan pestisida berbahaya. Ratifikasi konvensi ini akan mempersempit kemungkinan menurunnya kualitas keanekaragaman hayati yang sering dimanfaatkan untuk kebutuhan hidup. Selain itu adanya konvensi ini akan mencegah munculnya masalah terhadap lapangan pekerjaan bagi pihak-pihak yang terkontaminasi limbah maupun bahan kimia dan pestisida yang berbahaya seperti para petani, nelayan dan masyarakat pada umumnya. Jika ditelaah secara mendalam jumlah ekpor pada sektor pertanian setiap tahun terus mengalami penurunan, hal ini disebabkan oleh menurunya kualitas ekosistem persawahan akibat pemakaian pestisida yang berlebihan. Kata kunci : Konvensi Rotterdam, ratifikasi, hukum lingkungan.

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A Taxonomy for Psycho-Oncological Intervention Techniques in an Acute Care Hospital in Germany

Oncology Research and Treatment ◽

10.1159/000517532 ◽

2021 ◽

pp. 1-7

Author(s):

Martina Madl ◽

Marietta Lieb ◽

Katharina Schieber ◽

Tobias Hepp ◽

Yesim Erim

Keyword(s):

Acute Care ◽

Interrater Reliability ◽

Acute Care Hospital ◽

Future Research ◽

Systematic Research ◽

Care Hospital ◽

Certification System ◽

Stepwise Procedure ◽

Further Development

Background: Due to the establishment of a nationwide certification system for cancer centers in Germany, the availability of psycho-oncological services for cancer patients has increased substantially. However, little is known about the specific intervention techniques that are applied during sessions in an acute care hospital, since a standardized taxonomy is lacking. With this study, we aimed at the investigation of psycho-oncological intervention techniques and the development of a comprehensive and structured taxonomy thereof. Methods: In a stepwise procedure, a team of psycho-oncologists generated a data pool of interventions and definitions that were tested in clinical practice during a pilot phase. After an adaptation of intervention techniques, interrater reliability (IRR) was attained by rating 10 previously recorded psycho-oncological sessions. A classification of interventions into superordinate categories was performed, supported by cluster analysis. Results: Between April and June 2017, 980 psycho-oncological sessions took place. The experts agreed on a total number of 22 intervention techniques. An IRR of 89% for 2 independent psycho-oncological raters was reached. The 22 techniques were classified into 5 superordinate categories. Discussion/Conclusion: We developed a comprehensive and structured taxonomy of psycho-oncological intervention techniques in an acute care hospital that provides a standardized basis for systematic research and applied care. We expect our work to be continuously subjected to further development: future research should evaluate and expand our taxonomy to other contexts and care settings.

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Cohort profile of Acutelines: a large data/biobank of acute and emergency medicine

BMJ Open ◽

10.1136/bmjopen-2020-047349 ◽

2021 ◽

Vol 11 (7) ◽

pp. e047349

Author(s):

Ewoud ter Avest ◽

Barbara C van Munster ◽

Raymond J van Wijk ◽

Sanne Tent ◽

Sanne Ter Horst ◽

...

Keyword(s):

Acute Care ◽

De Novo ◽

Medical Center ◽

Large Data ◽

Future Research ◽

Imaging Data ◽

Novel Studies ◽

Long Term Follow Up ◽

Registration Number

PurposeResearch in acute care faces many challenges, including enrolment challenges, legal limitations in data sharing, limited funding and lack of singular ownership of the domain of acute care. To overcome these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data, image and biobank named ‘Acutelines’.ParticipantsClinical data, imaging data and biomaterials (ie, blood, urine, faeces, hair) are collected from patients presenting to the emergency department (ED) with a broad range of acute disease presentations. A deferred consent procedure (by proxy) is in place to allow collecting data and biomaterials prior to obtaining written consent. The digital infrastructure used ensures automated capturing of all bed-side monitoring data (ie, vital parameters, electrophysiological waveforms) and securely importing data from other sources, such as the electronic health records of the hospital, ambulance and general practitioner, municipal registration and pharmacy. Data are collected from all included participants during the first 72 hours of their hospitalisation, while follow-up data are collected at 3 months, 1 year, 2 years and 5 years after their ED visit.Findings to dateEnrolment of the first participant occurred on 1 September 2020. During the first month, 653 participants were screened for eligibility, of which 180 were approached as potential participants. In total, 151 (84%) provided consent for participation of which 89 participants fulfilled criteria for collection of biomaterials.Future plansThe main aim of Acutelines is to facilitate research in acute medicine by providing the framework for novel studies and issuing data, images and biomaterials for future research. The protocol will be extended by connecting with central registries to obtain long-term follow-up data, for which we already request permission from the participant.Trial registration numberNCT04615065.

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273. Comparative Effectiveness of Ampicillin in the Treatment of Enterococcus faecalis Bloodstream Infections in Patients With Cancer

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.317 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S137-S138

Author(s):

J P Sanchez ◽

German Contreras ◽

Truc T Tran ◽

Shelby Simar ◽

Blake Hanson ◽

...

Keyword(s):

Research Study ◽

Scientific Research ◽

Kidney Injury ◽

Bloodstream Infections ◽

Definitive Treatment ◽

Cancer Center ◽

Future Research ◽

Research Support ◽

Patients With Cancer ◽

Study Investigator

Abstract Background E. faecalis (Efc) isolates are usually susceptible to ampicillin (AMP). AMP-based regimens are the standard of care for enterococcal infections, although other antibiotics are often used as definitive treatment. We thus compared outcomes of patients with cancer and Efc bacteremia treated with AMP-containing (ACR) and non-AMP-containing antibiotic regimens (NACR). Methods A multicenter, prospective, observational cohort study conducted at MD Anderson Cancer Center, Henry Ford Hospital, and Memorial Hermann Health System. Eligible patients were ≥ 18 years old, diagnosed with cancer, and had at least one Efc bloodstream isolate collected from 12/2015 to 12/2018. Patients with polymicrobial infections were excluded. Patients were divided into two groups: i) ACR and ii) NACR. ACR included patients who received AMP at any time during treatment; other antimicrobials were permitted. NACR patients did not receive AMP at any time. The primary outcome compared desirability of outcome ranking (DOOR) between ACR and NACR at day 14. The DOOR consisted of six hierarchical levels: 1 - death; 2 - inpatient without microbiological cure (MC) and with acute kidney injury (AKI); 3 - inpatient without MC and without AKI; 4 - inpatient admitted with MC and with AKI; 5 - inpatient with MC and without AKI; 6 - alive and discharged. Comparison of DOORs between ACR and NACR was performed using inverse probability of treatment weighted (IPTW) ordered logistic regression. Results Seventy-one patients were included (ACR, n = 35; NACR, n = 36). No difference was seen in DOORs at day 14 between ACR and NACR (odds ratio [OR] 1.14, 95% Confidence Interval [CI] 0.45 – 2.92, p=0.78). No difference was observed for all-cause mortality at day 14 (OR 0.6, 95% CI 0.09 – 3.77, p=0.58) or day 30 (OR 0.42, 95% CI 0.09 – 1.94, p=0.27). Patients treated with ACR received a lower median duration of other antibiotics at any point during treatment compared to NACR: daptomycin (2 v 4 days) vancomycin (2 v 4 days), and linezolid (1 v 2 days). Conclusion Patients with cancer and Efc bloodstream infections had similar outcomes when treated with ACR and NACR. ACR were associated with less use of broad-spectrum antimicrobials. Future research should focus on the ecologic impact of use of NACR. Disclosures Marcus Zervos, MD, Melinta Therapeutics (Grant/Research Support) Cesar A. Arias, MD, MSc, PhD, FIDSA, Entasis Therapeutics (Scientific Research Study Investigator)MeMed (Scientific Research Study Investigator)Merck (Grant/Research Support)

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