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Record W2903093502 · doi:10.1136/bmj.k5105

Doctors demand to see evidence on safety of medical devices approved in Europe

2018· article· en· W2903093502 on OpenAlexaff
Simon Bowers

Bibliographic record

VenueBMJ · 2018
Typearticle
Languageen
FieldHealth Professions
TopicHealthcare Systems and Challenges
Canadian institutionsWorld Federation of Science Journalists
Fundersnot available
KeywordsTransparency (behavior)GuardianEuropean unionEuropean commissionCommissionMedical deviceBusinessPolitical scienceLawMedicineInternational trade

Abstract

fetched live from OpenAlex

Senior doctors, consumer groups, and campaigners for transparency are urging the European Commission to force the manufacturers of high risk medical devices to make public all the evidence they hold on the safety of their products. The calls came just days after a global investigation into the industry by the International Consortium of Investigative Journalists, The BMJ , BBC Panorama , the Guardian , and others called the Implant Files, which uncovered thousands of documents showing the rising number of malfunctions and injuries from a range of medical devices.1 A new law for medical device regulation in the European Union was passed last year and comes into effect from 2020. It sets data transparency as one of its main goals, but the European Commission, which has been the subject of intense lobbying from the device industry, has said that it plans to withhold …

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)0.088
metaresearch head score (Gemma)0.191
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Commentary · Consensus signal: Commentary
Teacher disagreement score0.088
Threshold uncertainty score0.463

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0880.191
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0020.002
Bibliometrics0.0030.002
Science and technology studies0.0030.011
Scholarly communication0.0160.014
Open science0.0020.009
Research integrity0.0400.028
Insufficient payload (model declined to judge)0.0140.007

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 head0.218
GPT teacher head0.527
Teacher spread0.309 · 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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNot applicable
Domainnot available
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

Citations4
Published2018
Admission routes1
Has abstractyes

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