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A Systematic Review of Surgical Randomized Controlled Trials

2016· review· en· W2414126461 on OpenAlexaff
Sophocles H. Voineskos, Christopher J. Coroneos, Natalia Ziolkowski, Manraj Kaur, Laura Banfield, Maureen O. Meade, Kevin C. Chung, Achilleas Thoma, Mohit Bhandari

Bibliographic record

VenuePlastic & Reconstructive Surgery · 2016
Typereview
Languageen
FieldPharmacology, Toxicology and Pharmaceutics
TopicPharmaceutical industry and healthcare
Canadian institutionsHamilton Health SciencesMcMaster Children's HospitalMcMaster UniversityUniversity of Toronto
Fundersnot available
KeywordsRandomized controlled trialSample size determinationMedicineClinical trialSurgeryInternal medicineStatistics

Abstract

fetched live from OpenAlex

BACKGROUND: The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. METHODS: An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. RESULTS: The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). CONCLUSIONS: Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

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

Direct model labels (unvalidated)

Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.

Model armCategoriesStudy designConfidence
gemmaMetaresearch
Domain: Methods · Genre: Review
About the Canadian research system: no · About a Canadian topic: no
Systematic reviewlow
gptno category
Domain: not available · Genre: Review
About the Canadian research system: no · About a Canadian topic: no
Systematic reviewhigh
models splitAgreement compares identical category sets and study designs across arms.

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)0.056
metaresearch head score (Gemma)0.162
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (narrow), Meta-epidemiology (broad), Research integrity, Insufficient payload (model declined to judge)
Consensus categoriesMetaresearch, Meta-epidemiology (narrow), Meta-epidemiology (broad), Research integrity
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Systematic review · Consensus signal: Systematic review
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.380
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0560.162
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0630.013
Bibliometrics0.0010.001
Science and technology studies0.0000.002
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0020.003
Insufficient payload (model declined to judge)0.0110.001

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 head0.425
GPT teacher head0.551
Teacher spread0.125 · 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

Labeled directly by 2 models reading the full record.

Metaresearch

The models disagree on parts of this classification; every voice is preserved in the section at the end of the page.

Study designSystematic review
DomainMethods
GenreReview

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

Citations21
Published2016
Admission routes1
Has abstractyes

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