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CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

2015· article· en· W1510288999 on OpenAlexafffund
Sunita Vohra, Larissa Shamseer, Margaret Sampson, Cecilia Bukutu, Christopher H. Schmid, Robyn Tate, Jane Nikles, Deborah R. Zucker, Richard L. Kravitz, Gordon Guyatt, Douglas G. Altman, David Moher, Jocalyn Clark, Elise Cogo, Nicole B. Gabler, Janine E. Janosky, Bradley C. Johnston, Bob T. Li, Jeff Mahon, Robin J. Marles, William R. Shadish

Bibliographic record

VenueJournal of Clinical Epidemiology · 2015
Typearticle
Languageen
FieldDecision Sciences
TopicMeta-analysis and systematic reviews
Canadian institutionsMcMaster UniversityUniversity of OttawaChildren's Hospital of Eastern OntarioOttawa HospitalPolicyWise for Children & FamiliesUniversity of Alberta
FundersFaculty of Medicine and Dentistry, University of AlbertaHealth CanadaMedical Research CouncilTufts University School of MedicineUniversity of TorontoUniversity of OttawaFondation pour la Recherche MédicaleNational Health and Medical Research CouncilMinistry of Advanced Education, Government of AlbertaCancer Research UKOffice of SciencePfizerOttawa Hospital Research InstituteUniversity of AlbertaBrown University
KeywordsConsolidated Standards of Reporting TrialsChecklistClinical trialMedicineCLARITYResearch designMedical physicsFamily medicinePsychologyStatisticsInternal medicineMathematics

Abstract

fetched live from OpenAlex

N-of-1 trials provide a mechanism for making evidence-based treatment decisions for an individual patient. They use key methodological elements of group clinical trials to evaluate treatment effectiveness in a single patient, for situations that cannot always accommodate large-scale trials: rare diseases, comorbid conditions, or in patients using concurrent therapies. Improvement in the reporting and clarity of methods and findings in N-of-1 trials is essential for reader to gauge the validity of trials and to replicate successful findings. A Consolidated Standards of Reporting Trials (CONSORT) extension for N-of-1 trials (CENT 2015) provides guidance on the reporting of individual and series of N-of-1 trials. CENT provides additional guidance for 14 of the 25 items of the CONSORT 2010 checklist, recommends a diagram for depicting an individual N-of-1 trial, and modifies the CONSORT flow diagram to address the flow of a series of N-of-1 trials. The rationale, development process, and CENT 2015 checklist and diagrams are reported in this document.

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)0.963
metaresearch head score (Gemma)0.992
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (broad), Insufficient payload (model declined to judge)
Consensus categoriesMetaresearch
DomainCandidate signal: Reporting · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.265
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.9630.992
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0300.010
Bibliometrics0.0000.000
Science and technology studies0.0000.000
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 head0.993
GPT teacher head0.800
Teacher spread0.193 · 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 designNot applicable
DomainReporting
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

Citations142
Published2015
Admission routes2
Has abstractyes

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