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Record W2288495628 · doi:10.3899/jrheum.150461

Common Design and Analysis Issues in Clinical Trials

2015· letter· en· W2288495628 on OpenAlexaffvenueabout
Kevin E. Thorpe

Bibliographic record

VenueThe Journal of Rheumatology · 2015
Typeletter
Languageen
FieldDecision Sciences
TopicMeta-analysis and systematic reviews
Canadian institutionsUniversity of Toronto
Fundersnot available
KeywordsBaseline (sea)ComparabilityNull hypothesisMedicineRandomizationConsolidated Standards of Reporting TrialsStatistical significanceClinical trialPopulationRandomized controlled trialStatisticsMathematicsSurgeryInternal medicine

Abstract

fetched live from OpenAlex

Because I review manuscripts and protocols for clinical trials, I observe a number of recurring issues. These issues mostly relate to the statistical analysis but also include appropriate characterization of the trial itself. Many reports of randomized controlled trials contain a table showing the baseline characteristics for each of the treatment groups, and some journals advocate use of significance tests to compare the groups at baseline. Indeed, the CONSORT (consolidated standards of reporting trials) statement supports inclusion of a baseline table; it also warns of the inappropriateness of using significance tests for comparison1. In statistics, hypothesis/significance tests concern population variables, and if indeed the allocation was randomized, a null hypothesis of no difference is true. Moreover, as Senn points out, an imbalance does not necessarily imply a problem with randomization; nor does a lack of imbalance prove randomization was successful2. Often, the results of baseline testing are used to decide which variables, if any, to include in an adjusted analysis of the outcome. Pocock, et al point out that baseline imbalance does not dictate the need for adjustment but rather it is the strength of the relationship between a baseline variable and the outcome3. Instead of p values, baseline comparability should be considered from the standpoint of clinical significance. Even then, imbalance should not be the criterion for inclusion in an adjusted model. In … Address correspondence to K.E. Thorpe, Dalla Lana School of Public Health, 155 College St., 6th floor, Toronto, Ontario M5T 3M7, Canada. E-mail: kevin.thorpe{at}utoronto.ca

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)0.759
metaresearch head score (Gemma)0.882
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Methods · Consensus signal: Methods
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Commentary · Consensus signal: none
Teacher disagreement score0.241
Threshold uncertainty score0.297

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.7590.882
Meta-epidemiology (narrow)0.0060.007
Meta-epidemiology (broad)0.0150.012
Bibliometrics0.0180.027
Science and technology studies0.0070.038
Scholarly communication0.0260.016
Open science0.0140.013
Research integrity0.0340.035
Insufficient payload (model declined to judge)0.0160.010

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 head0.854
GPT teacher head0.614
Teacher spread0.240 · 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 designNot applicable
DomainMethods
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
Published2015
Admission routes3
Has abstractyes

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