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Intention-to-Treat Analysis but for Treatment Intention: How should Consumer Product Randomized Controlled Trials be Analyzed?

2016· article· en· W2469474306 on OpenAlexvenueno aff
Rolf Weitkunat, Gizelle Baker, Frank LÃ ⁄ dicke

Bibliographic record

VenueInternational Journal of Statistics in Medical Research · 2016
Typearticle
Languageen
FieldMathematics
TopicAdvanced Causal Inference Techniques
Canadian institutionsnot available
FundersPhilip Morris International
KeywordsBlindingRandomized controlled trialRandomizationProtocol (science)Product (mathematics)De factoPopulationIntention-to-treat analysisMarketingMedicinePsychologyBusinessAlternative medicineMathematicsSurgery

Abstract

fetched live from OpenAlex

Background: Experimental study design, randomization, blinding, control, and the analysis of such data according to the intention-to-treat (ITT) principle are de-facto “gold standards” in pharmacotherapy research. While external treatment allocation under conditions of medical practice is conceptually reflected by in-study randomization in randomized controlled trials (RCTs) of therapeutic drugs, actual product use is based on self-selection in a consumer product setting. Discussion: With in-market product allocation being consumer-internal, there is no standard against which protocol adherence can be attuned, and the question arises, as to whether compliance-based analysis concepts reflect the real-world effects of consumer products. Summary: The lack of correspondence between RCTs and consumer market conditions becomes evident by the fact that even if, theoretically, all data would be available from all members of the real-world target population, it would be impossible to calculate either an ITT or a per-protocol effect. This renders the calculation of such estimates meaningless in consumer product research contexts.

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)0.038
metaresearch head score (Gemma)0.372
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Insufficient payload (model declined to judge)
Consensus categoriesMetaresearch
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Theoretical or conceptual · Consensus signal: Theoretical or conceptual
GenreCandidate signal: Methods · Consensus signal: none
Teacher disagreement score0.808
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0380.372
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0030.001
Bibliometrics0.0020.001
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0000.000
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 head0.418
GPT teacher head0.585
Teacher spread0.167 · 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; both teacher heads agree on what is shown here.

Study designTheoretical or conceptual
Domainnot available
GenreMethods

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

Citations4
Published2016
Admission routes1
Has abstractyes

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