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Record W2198086616 · doi:10.1186/1745-6215-16-s2-p16

Improving the reporting of randomised pilot and feasibility studies: a consort statement extension

2015· article· en· W2198086616 on OpenAlex
Sandra Eldridge, Christine Bond, Sally Hopewell, Lehana Thabane, Gill Lancaster, Claire Coleman

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.

Bibliographic record

VenueTrials · 2015
Typearticle
Languageen
FieldSocial Sciences
TopicDelphi Technique in Research
Canadian institutionsMcMaster University
Fundersnot available
KeywordsConsolidated Standards of Reporting TrialsMedicineResearch designDelphi methodAlternative medicineRandomized controlled trialMEDLINEMedical physicsComputer scienceSurgeryStatistics

Abstract

fetched live from OpenAlex

Pilot and feasibility studies underpin much of current health related research, including randomised controlled trials. The number of reports in which authors describe their studies as pilot or feasibility studies is increasing and there is currently a lot of interest in this area. However, in spite of a number of papers that have recommended ways in which the reporting of these studies could be improved, reporting remains poor. Using CONSORT endorsed methodology including a large Delphi study (n=93) and an international consensus meeting (n=26) we have developed a CONSORT extension for randomised pilot and feasibility studies. Much of the existing CONSORT statement for randomised controlled trials does apply to these types of study. However, sometimes the application of the items is different from that in RCTs designed to evaluate the effect of an intervention or therapy and some CONSORT items are not applicable or have needed some alteration. We are currently writing the explanation and elaboration statement for this CONSORT extension. We will present the major issues in reporting these types of randomised studies and use examples to illustrate good and bad practice. This work is part of a larger programme of work on pilot and feasibility studies.

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.

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)0.156
metaresearch head score (Gemma)0.256
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesMetaresearch
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Qualitative · Consensus signal: Qualitative
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.293
Threshold uncertainty score0.869

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.1560.256
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

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 head0.836
GPT teacher head0.631
Teacher spread0.205 · 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