Informed Consent for Thrombolytic Therapy for Patients With Acute Ischemic Stroke Treated in Routine Clinical Practice

Rosenbaum, Julie R.; Bravata, Dawn M.; Concato, John; Brass, Lawrence M.; Kim, Nancy; Fried, Terri R.

doi:10.1161/01.str.0000136555.28503.55

Cited by 38 publications

(21 citation statements)

References 12 publications

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“…Given the extreme time dependent context and the gravity of the potential risks from thrombolysis, clinicians as well as patients (or their relatives/proxy in situations where a patient lacks capacity) are faced with making rapid decisions about treatment that involve deliberation of trade-offs between the increased likelihood of long-term benefit from thrombolysis (reduced risk of significant post-stroke disability) and the more immediate bleeding risks and consequences [20,21]. Health (outcome) states following stroke are sensitive to patient values [22]; however acute stroke is often experienced by patients and relatives as a shocking and traumatic event, which can encumber their understanding of verbal information conveyed by clinicians [23].…”

Section: Introductionmentioning

confidence: 99%

A review of decision support, risk communication and patient information tools for thrombolytic treatment in acute stroke: lessons for tool developers

Flynn

Ford

Stobbart

et al. 2013

BMC Health Serv Res

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BackgroundTools to support clinical or patient decision-making in the treatment/management of a health condition are used in a range of clinical settings for numerous preference-sensitive healthcare decisions. Their impact in clinical practice is largely dependent on their quality across a range of domains. We critically analysed currently available tools to support decision making or patient understanding in the treatment of acute ischaemic stroke with intravenous thrombolysis, as an exemplar to provide clinicians/researchers with practical guidance on development, evaluation and implementation of such tools for other preference-sensitive treatment options/decisions in different clinical contexts.MethodsTools were identified from bibliographic databases, Internet searches and a survey of UK and North American stroke networks. Two reviewers critically analysed tools to establish: information on benefits/risks of thrombolysis included in tools, and the methods used to convey probabilistic information (verbal descriptors, numerical and graphical); adherence to guidance on presenting outcome probabilities (IPDASi probabilities items) and information content (Picker Institute Checklist); readability (Fog Index); and the extent that tools had comprehensive development processes.ResultsNine tools of 26 identified included information on a full range of benefits/risks of thrombolysis. Verbal descriptors, frequencies and percentages were used to convey probabilistic information in 20, 19 and 18 tools respectively, whilst nine used graphical methods. Shortcomings in presentation of outcome probabilities (e.g. omitting outcomes without treatment) were identified. Patient information tools had an aggregate median Fog index score of 10. None of the tools had comprehensive development processes.ConclusionsTools to support decision making or patient understanding in the treatment of acute stroke with thrombolysis have been sub-optimally developed. Development of tools should utilise mixed methods and strategies to meaningfully involve clinicians, patients and their relatives in an iterative design process; include evidence-based methods to augment interpretability of textual and probabilistic information (e.g. graphical displays showing natural frequencies) on the full range of outcome states associated with available options; and address patients with different levels of health literacy. Implementation of tools will be enhanced when mechanisms are in place to periodically assess the relevance of tools and where necessary, update the mode of delivery, form and information content.

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Section: Introductionmentioning

confidence: 99%

A review of decision support, risk communication and patient information tools for thrombolytic treatment in acute stroke: lessons for tool developers

Flynn

Ford

Stobbart

et al. 2013

BMC Health Serv Res

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“…Ciccone [5] has proposed a practical approach to consent in this setting. A recent study by Rosenbaum et al [6] highlighted that while such consent was often not documented, patients with diminished capacity seemed to have given consent. A systematic review also highlighted difficulties in obtaining informed consent as a barrier to effective delivery of thrombolytic treatment [7].…”

Section: Introductionmentioning

confidence: 99%

Impact of Stroke Syndrome and Stroke Severity on the Process of Consent in the Third International Stroke Trial

et al. 2006

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Background: Obtaining informed consent for a patient’s participation in a randomized trial of treatment for use in a medical emergency may be achieved in a variety of ways. We sought to assess the process of consent and to evaluate the influence of the patient’s neurological deficit on the method used to obtain consent in the first 300 patients recruited into the Third International Stroke Trial (IST-3). Methods: IST-3 is the first large-scale randomized controlled trial of intravenous thrombolysis in acute ischaemic stroke. The clinician could use one of four procedures to recruit the patient: written consent, witnessed consent, assent, or a waiver of consent. The patient’s neurological deficits were recorded at baseline. We analysed the relationship between the neurological deficits at baseline and the consent procedure. Results: The method of consent used was written consent in 71 subjects (24%), witnessed verbal consent in 30 subjects (10%), assent by a relative in 197 subjects (66%), and waiver of consent in 2 subjects (1%). Patients with severe neurological deficits (as measured either by their stroke syndrome or their lower predicted probability of being alive and independent at 6 months) were more likely to be recruited by assent. Patients able to give written consent had less severe strokes. Conclusions: Patients with non-lacunar hemispheric stroke syndromes or with a more severe neurological deficit were less likely to give written consent. Excluding such patients from acute stroke treatment trials would eliminate many otherwise eligible subjects, who have a poor predicted outcome without treatment and yet might benefit from acute treatments such as thrombolysis. Flexible consent procedures developed for IST-3 have made it feasible to recruit the target population.

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“…Aphasia has also been cited as a reason for patients being excluded from providing consent to participate in research studies into acute stroke (e.g., Demarquay et al, 2005;Rosenbaum et al, 2004). Despite the potential for cognitive competence to be masked by linguistic difficulties, people with aphasia remain largely cognitively intact (Kagan, 1995).…”

Section: Clinical Expertise As a Component Of Evidence-based Practicementioning

confidence: 99%

Turning the tide: Putting acute aphasia management back on the agenda through evidence-based practice

Foster¹,

Worrall²,

Rose³

et al. 2013

Aphasiology

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Background: The role of speech pathologists working in the acute hospital setting has evolved away from service provision to people with aphasia and their families towards a stronger focus on dysphagia. Evidence-based practice (EBP) can be conceptualised as the integration of four streams of evidence: research-based clinical evidence, clinical expertise, patient preferences and values, and the practice context. EBP is an important tenet in current healthcare. However, it is not clear whether speech pathologists in the acute setting are using EBP to support their aphasia management. Not adopting evidence-based approaches to care has the potential to result in a negative impact on people with aphasia and their families, healthcare services, and speech pathologists, who experience a sense of dissonance related to their current service provision This paper explores acute aphasia management through an EBP lens in an attempt to better understand this dilemma. Aims: This paper applies the conceptual framework of EBP to acute aphasia management. An extensive, systematically conducted review of the international literature relating to health professionals was undertaken. The findings are presented as a narrative literature review. Main Contribution: This paper describes and evaluates how the different streams of research evidence, clinical expertise, patient preferences and values, and the practice context contribute to speech pathologists' management of acute aphasia. Further, the paper identifies current gaps in the literature and suggests a research agenda for the field. Conclusions: Little is known about how speech pathologists integrate and implement the different streams of evidence in EBP, and how these contribute to acute aphasia practice. Speech pathologists report that clinical guidelines containing low-level evidence are the main source of research information. Other sources of knowledge include colleagues, professional development events, and websites. Additional challenges to the management of people with aphasia in the acute hospital setting may be posed by the physical environment, the culture of the acute hospital setting, and the provision of leadership to support evidence-based approaches to care. The challenge of using a person-centred approach to care for people with aphasia is acknowledged. Further research exploring speech pathologists' perceptions of their role in acute aphasia management, the clinical decision-making process of speech pathologists in relation to acute aphasia management, and the experiences of people with aphasia and their families in the acute setting is required. This will

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Informed Consent for Thrombolytic Therapy for Patients With Acute Ischemic Stroke Treated in Routine Clinical Practice

Cited by 38 publications

References 12 publications

A review of decision support, risk communication and patient information tools for thrombolytic treatment in acute stroke: lessons for tool developers

A review of decision support, risk communication and patient information tools for thrombolytic treatment in acute stroke: lessons for tool developers

Impact of Stroke Syndrome and Stroke Severity on the Process of Consent in the Third International Stroke Trial

Turning the tide: Putting acute aphasia management back on the agenda through evidence-based practice

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