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Record W2920912113 · doi:10.1161/strokeaha.118.024096

Deferral of Consent in Acute Stroke Trials

2019· article· en· W2920912113 on OpenAlexafffund
Michel Shamy, Brian Dewar, Stephanie Chevrier, Chu-Qi Wang, Stacey Page, Mayank Goyal, Andrew M. Demchuk, Michael D. Hill

Bibliographic record

VenueStroke · 2019
Typearticle
Languageen
FieldMedicine
TopicEthics in Clinical Research
Canadian institutionsPeace Arch HospitalUniversity of CalgaryOttawa HospitalUniversity of Ottawa
FundersHealth Research BoardUniversity of Calgary
KeywordsMedicineInformed consentRandomizationStroke (engine)Randomized controlled trialAcute strokeClinical trialDeferralEmergency medicinePhysical therapyFamily medicineSurgeryInternal medicineEmergency departmentAlternative medicinePsychiatry

Abstract

fetched live from OpenAlex

Background and Purpose- The ESCAPE trial (The Endovascular Treatment for Small Core and Anterior Circulation Proximal Occlusion With Emphasis on Minimizing CT to Recanalization Times) was a multicentre, randomized controlled trial of endovascular thrombectomy versus standard care for patients with acute ischemic stroke that allowed patients to be enrolled with deferred consent. We investigated the knowledge and opinions of these patients or their authorized third parties about the consent process. Methods- All patients (or their authorized third parties) enrolled with deferral of consent in ESCAPE were invited to complete a 12-question survey within the first 4 days of enrollment and again at 90 days. Questions investigated knowledge of the ESCAPE trial and opinions on deferral of consent. Results- Of 56 patients enrolled with deferred consent, 33 (59%) completed the initial survey, and of these, 27 (81%) completed the 90-day follow-up. Enrollment with deferred consent was not associated with a significant difference in door-to-randomization times (50.5 versus 57 minutes; P=0.29) but allowed these 56 patients to participate in the trial. Only 52% of respondents understood that patients could be randomized to thrombectomy or standard care, although most understood the other basic principles of the trial. At baseline and at 90 days, respondents disagreed or strongly disagreed with deferred consent in acute stroke trials generally (82% and 78%) and in the ESCAPE trial specifically (93% and 91%). Conclusions- Respondents generally disagreed with the use of deferred consent for enrollment in the ESCAPE trial and in stroke trials more generally.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.006
metaresearch head score (Gemma)0.016
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.150
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0060.016
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0010.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.598
GPT teacher head0.607
Teacher spread0.009 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations39
Published2019
Admission routes2
Has abstractyes

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