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CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration

2015· article· en· W1524110242 on OpenAlexafffund
Larissa Shamseer, Margaret Sampson, Cecilia Bukutu, Christopher H. Schmid, Jane Nikles, Robyn Tate, Bradley C. Johnston, Deborah R. Zucker, William R. Shadish, Richard L. Kravitz, Gordon Guyatt, Douglas G. Altman, David Moher, Sunita Vohra, Douglas G. Altman, Jocalyn Clark, Elise Cogo, Nicole B. Gabler, Janine E. Janosky, Bradley C. Johnston, Bob T. Li, Jeff Mahon, Robin J. Marles

Bibliographic record

VenueJournal of Clinical Epidemiology · 2015
Typearticle
Languageen
FieldDecision Sciences
TopicMeta-analysis and systematic reviews
Canadian institutionsUniversity of AlbertaMcMaster UniversityHospital for Sick ChildrenUniversity of TorontoSickKids FoundationPolicyWise for Children & FamiliesChildren's Hospital of Eastern OntarioOttawa HospitalUniversity of Ottawa
FundersFaculty of Medicine and Dentistry, University of AlbertaMedical Research CouncilTufts University School of MedicineHealth CanadaPerelman School of Medicine, University of PennsylvaniaOffice of ScienceInternational Centre for Diarrhoeal Disease Research, BangladeshSydney Medical SchoolUniversity of TorontoAlberta InnovatesUniversity of OxfordNational Health and Medical Research CouncilCancer Research UKMinistry of Advanced Education, Government of AlbertaMcMaster UniversityOttawa Hospital Research InstituteCentral Michigan UniversityFondation pour la Recherche MédicaleUniversity of OttawaUniversity of PennsylvaniaUniversity of AlbertaUniversity of California, DavisBrown UniversityHospital for Sick ChildrenPfizer
KeywordsChecklistConsolidated Standards of Reporting TrialsClinical trialMedicineResearch designProtocol (science)Family medicineAlternative medicineMedical physicsPsychologyStatisticsMathematicsPathology

Abstract

fetched live from OpenAlex

N-of-1 trials are a useful tool for clinicians who want to determine the effectiveness of a treatment in a particular individual. The reporting of N-of-1 trials has been variable and incomplete, hindering their usefulness in clinical decision making and by future researchers. This document presents the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015). CENT 2015 extends the CONSORT 2010 guidance to facilitate the preparation and appraisal of reports of an individual N-of-1 trial or a series of prospectively planned, multiple, crossover N-of-1 trials. CENT 2015 elaborates on 14 items of the CONSORT 2010 checklist, totalling 25 checklist items (44 sub-items), and recommends diagrams to help authors document the progress of one participant through a trial or more than one participant through a trial or series of trials, as applicable. Examples of good reporting and evidence based rationale for CENT 2015 checklist items are provided.

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)0.363
metaresearch head score (Gemma)0.741
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: Reporting · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Methods · Consensus signal: Methods
Teacher disagreement score0.637
Threshold uncertainty score0.785

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.3630.741
Meta-epidemiology (narrow)0.0060.008
Meta-epidemiology (broad)0.0110.018
Bibliometrics0.0250.022
Science and technology studies0.0030.007
Scholarly communication0.0110.009
Open science0.0060.011
Research integrity0.0130.020
Insufficient payload (model declined to judge)0.0750.036

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 head0.988
GPT teacher head0.777
Teacher spread0.212 · 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
DomainReporting
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

Citations148
Published2015
Admission routes2
Has abstractyes

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