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Record W4319345066 · doi:10.1136/bmjopen-2022-066742

Advance consent for participation in randomised controlled trials for emergency conditions: a scoping review

2023· review· en· W4319345066 on OpenAlexaff
Naomi Niznick, Ronda Lun, Brian Dewar, Jeffrey J. Perry, Dar Dowlatshahi, Michel Shamy

Bibliographic record

VenueBMJ Open · 2023
Typereview
Languageen
FieldMedicine
TopicEthics in Clinical Research
Canadian institutionsOttawa Hospital
Fundersnot available
KeywordsMedicineAlternative medicineInformed consentRandomized controlled trialFamily medicinePublic healthNursingSurgeryPathology

Abstract

fetched live from OpenAlex

OBJECTIVE: Advance consent is a recognised method of obtaining informed consent for participation in research, whereby a potential participant provides consent for future involvement in a study contingent on qualifying for the study's inclusion criteria on a later date. The goal of this study is to map the existing literature on the use of advance consent for enrolment in randomised controlled trials (RCTs) for emergency conditions. DESIGN: Scoping review designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Extension for Scoping Reviews guidelines. DATA SOURCES: We searched electronic databases including MEDLINE, Embase, Web of Science and the Cochrane Register of Clinical Trials from inception to 10 February 2020. ELIGIBILITY CRITERIA: Eligible studies included articles that discussed or employed the use of advance consent for enrolment in RCTs related to emergency conditions. There were no restrictions on the type of eligible study. Data were extracted directly from included papers using a standardised data charting form. We produced a narrative review including article type and authors' dispositions towards advance consent. RESULTS: Our search yielded 1039 titles with duplicates removed. Six articles met inclusion criteria. Three articles discussed the theoretical use of research advance directives in emergency conditions; one article evaluated stakeholders' perceptions of advance consent; and one article described a method for patients to document their preferences for participation in future research. Only one study employed advance consent to enrol participants into a clinical trial for an emergency condition. CONCLUSION: Our review demonstrates that there has been minimal exploration of advance consent for enrolment in RCTs for emergency conditions. Future studies could aim to assess the acceptability of advance consent to participants, along with the feasibility of enrolling research participants using this method of consent. PROTOCOL: The protocol for this scoping review was published a priori.

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 machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.357
metaresearch head score (Gemma)0.700
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Systematic review · Consensus signal: Systematic review
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.643
Threshold uncertainty score0.793

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.3570.700
Meta-epidemiology (narrow)0.0030.004
Meta-epidemiology (broad)0.0120.012
Bibliometrics0.0300.028
Science and technology studies0.0040.010
Scholarly communication0.0150.025
Open science0.0070.009
Research integrity0.0140.009
Insufficient payload (model declined to judge)0.0110.003

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 head0.946
GPT teacher head0.806
Teacher spread0.140 · 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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.

Study designSystematic review
DomainMethods
GenreReview

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

Citations5
Published2023
Admission routes1
Has abstractyes

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