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Record W2725530226 · doi:10.1093/geroni/igx004.2337

ETHICAL CHALLENGES IN PRAGMATIC COMPARATIVE EFFECTIVENESS TRIALS

2017· article· en· W2725530226 on OpenAlexaff
Charles Weijer

Bibliographic record

VenueInnovation in Aging · 2017
Typearticle
Languageen
FieldEconomics, Econometrics and Finance
TopicHealth Systems, Economic Evaluations, Quality of Life
Canadian institutionsWestern University
Fundersnot available
KeywordsInformed consentIntervention (counseling)Randomized controlled trialClinical trialOutcome (game theory)MedicineRandomizationEngineering ethicsPsychologyAlternative medicineNursingSurgeryEngineering

Abstract

fetched live from OpenAlex

Pragmatic RCTs raise ethical issues that have not yet been adequately addressed. Consider a trial allocating nursing homes to high dose versus standard dose influenza vaccine: if designed as an individual patient RCT, informed consent would need to be sought for randomization, intervention and outcome assessment; but if treatments are implemented institution-wide as a policy intervention, is it acceptable to proceed without patient consent? Do patients need to be informed about the trial and if so, how? Some reject the research-practice distinction by advocating that low or no-risk pragmatic RCTs do not require more stringent oversight than clinical practice. Modifications to traditional consent models have been proposed, but it is unclear if they adequately protect patients’ rights. The lack of adequate ethical guidance for pragmatic RCTs presents a practical threat to the conduct of socially valuable research. If important research is to proceed, novel guidance is required.

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)0.751
metaresearch head score (Gemma)0.832
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: Theoretical or conceptual
GenreCandidate signal: Commentary · Consensus signal: Commentary
Teacher disagreement score0.751
Threshold uncertainty score0.307

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.7510.832
Meta-epidemiology (narrow)0.0030.004
Meta-epidemiology (broad)0.0080.004
Bibliometrics0.0050.006
Science and technology studies0.0050.045
Scholarly communication0.0150.020
Open science0.0090.010
Research integrity0.0330.030
Insufficient payload (model declined to judge)0.0070.003

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 head0.764
GPT teacher head0.566
Teacher spread0.198 · 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 source (direct Gemma or distilled Codex), not a consensus.

Study designTheoretical or conceptual
Domainnot available
GenreCommentary

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

Citations0
Published2017
Admission routes1
Has abstractyes

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