Getting the Most out of Consent: Patient‐Centered Consent for an Acute Stroke Trial

Dickert, Neal W.; Metz, Kathleen E.; Deeds, S Iris; Linke, Michael J.; Mitchell, Amy L.; Speight, Candace; Adeoye, Opeolu

doi:10.1002/eahr.500122

Cited by 9 publications

(5 citation statements)

References 13 publications

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“…In recent years, the disease characteristics of stroke in China have changed with the changing social environment, mainly characterized by an elevated incidence, an early onset age, and an increased recurrence rate [ 12 , 13 ]. Although the upgrading of medical technology has improved the effect of interventional therapy and drug treatment, the one-year recurrence rate as high as 17.7% suggests that China still faces a serious situation of secondary stroke prevention [ 14 ]. The risk factors of stroke can be divided into factors that can be intervened and those that cannot be intervened, in which the former ones are mainly physiological and behavioral factors, while the latter ones mainly include gender, age, and race [ 15 , 16 ].…”

Section: Discussionmentioning

confidence: 99%

Risk Factors of Recurrent Stroke in Young and Middle-Aged Stroke Patients after Interventional Therapy

Dai

Wang

et al. 2022

Computational and Mathematical Methods in Medicine

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Objective. To explore the risk factors of recurrent stroke in young and middle-aged stroke patients after interventional therapy. Methods. Retrospective analysis was conducted on the data of 300 young and middle-aged stroke patients treated in our hospital (February 2015–February 2017). All patients received interventional therapy. They were followed up continuously after the interventional therapy, with recurrent stroke as the only endpoint event, and those who did not have the endpoint events were followed up for 5 years. Then, the patients were divided into the occurrence group and the nonoccurrence group according to whether there was a stroke. The social demographic data and clinical examination data of all patients were collected to analyze the differences between the groups. Logistic regression analysis was performed on the factors with statistically significant differences to verify the factors affecting recurrent stroke in young and middle-aged stroke patients after interventional therapy. Results. Among the 300 patients, 69 (23.0%) had recurrent stroke and 231 (77.0%) had no recurrent stroke. The occurrence group ( n = 69 ) had 12 cases (17.4%) of massive cerebral infarction, 18 cases (26.1%) of cerebral watershed infarction, 5 cases (7.2%) of multiple cerebral infarction, 25 cases (36.2%) of lacunar infarction, and 9 cases (13.0%) of TIA. Notable differences were observed in age, drinking history, marital status, body weight, diastolic pressure, systolic pressure, fasting blood glucose, glycosylated hemoglobin, cholesterol, and fibrinogen between the occurrence group and the nonoccurrence group ( P < 0.05 ). The binary logistic regression analysis showed that age, drinking history, diastolic pressure, fasting blood glucose, glycosylated hemoglobin, cholesterol, and fibrinogen were the influencing factors of recurrent stroke in young and middle-aged stroke patients after interventional therapy. Conclusion. Blood glucose, blood lipid, blood pressure, age, and living habits have an impact on recurrent stroke in young and middle-aged patients after interventional therapy. Therefore, while strictly controlling blood glucose, blood lipid, and blood pressure, patients should improve their living habits and enhance the awareness of prevention after interventional therapy.

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Section: Discussionmentioning

confidence: 99%

Risk Factors of Recurrent Stroke in Young and Middle-Aged Stroke Patients after Interventional Therapy

Dai

Wang

et al. 2022

Computational and Mathematical Methods in Medicine

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“…13 Methods to address this very short-time window include an abbreviated consent form containing only critical information with an accompanying information sheet with much more detailed information that can be read by the patient and family later. 14 In the latter approach used in the TICH-2 trial (Tranexamic Acid for Hyperacute Primary Intracerebral Hemorrhage 2), patients provided initial consent by signing a brief one-page information sheet (288 words) followed by a full written informed consent (4-page information sheet of 2474 words) at the earliest subsequent opportunity after enrollment. 15 The requirements surrounding emergency consent vary by country (Table 1).…”

Section: Participant Enrollment Obtaining Consent From Patient or Larmentioning

confidence: 99%

Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations

Broderick,

Silva,

Selim

et al. 2023

Stroke

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The Stroke Treatment Academic Industry Roundtable (STAIR) convened a session and workshop regarding enrollment in acute stroke trials during the STAIR XII meeting on March 22, 2023. This forum brought together stroke physicians and researchers, members of the National Institute of Neurological Disorders and Stroke, industry representatives, and members of the US Food and Drug Administration to discuss the current status and opportunities for improving enrollment in acute stroke trials. The workshop identified the most relevant issues impacting enrollment in acute stroke trials and addressed potential action items for each. Focus areas included emergency consent in the United States and other countries; careful consideration of eligibility criteria to maximize enrollment and representativeness; investigator, study coordinator, and pharmacist availability outside of business hours; trial enthusiasm/equipoise; site start-up including contractual issues; site champions; incorporation of study procedures into standard workflow as much as possible; centralized enrollment at remote sites by study teams using telemedicine; global trials; and coenrollment in trials when feasible. In conclusion, enrollment of participants is the lifeblood of acute stroke trials and is the rate-limiting step for testing an exciting array of new approaches to improve patient outcomes. In particular, efforts should be undertaken to broaden the medical community’s understanding and implementation of emergency consent procedures and to adopt designs and processes that are easily incorporated into standard workflow and that improve trials’ efficiencies and execution. Research and actions to improve enrollment in ongoing and future trials will improve stroke outcomes more broadly than any single therapy under consideration.

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“…Features of adaptive randomisation or population enrichment have been viewed positively by enrolling participants 58 .…”

Section: Recruitmentmentioning

confidence: 99%

Adaptive trials in stroke: Current use & future directions

Hayward,

Dalton,

Campbell

et al. 2024

Preprint

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Inclusion of adaptive design features in a clinical trial provides pre-planned flexibility to dynamically modify a trial during its conduct, while preserving validity and integrity. Adaptive trials are needed to accelerate the conduct of more efficient, informative, and ethical clinical research in the field of neurology as compared to traditional fixed designs. Stroke is a natural candidate for adoption of these innovative approaches to trial design. This Research Methods in Neurology paper is informed by scoping review that identified 45 completed and ongoing adaptive clinical trials in stroke that were appraised: 14 trials had published results with or without a published protocol, 15 trials had a published protocol, and 16 trials were registered only. Treatments spanned acute (n=28), rehabilitation (n=8), prevention (n=8), and rehabilitation and prevention (n=1) domains. A subsample of these trials were selected to illustrate the utility of adaptive design features and discuss why each adaptive feature(s) were incorporated in the design to best achieve the aim, whether each individual feature was used and if it resulted in expected efficiencies, and any learnings during preparation, conduct or reporting. We then discuss the operational, ethical, and regulatory considerations that warrant careful consideration during adaptive trial planning and reflect on the workforce readiness to deliver adaptive trials in practice. We conclude that adaptive trials can be designed, funded, conducted, and published for a wide range of research questions and offer future directions to support adoption of adaptive trial designs in stroke and neurological research more broadly.

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Getting the Most out of Consent: Patient‐Centered Consent for an Acute Stroke Trial

Cited by 9 publications

References 13 publications

Risk Factors of Recurrent Stroke in Young and Middle-Aged Stroke Patients after Interventional Therapy

Risk Factors of Recurrent Stroke in Young and Middle-Aged Stroke Patients after Interventional Therapy

Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations

Adaptive trials in stroke: Current use & future directions

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