{"id":"W4408233328","doi":"10.1093/ehjqcco/qcaf007","title":"Inclusion and reporting by age, sex, and ethnicity in clinical studies of high-risk medical devices approved in the European Union","year":2025,"lang":"en","type":"article","venue":"European Heart Journal - Quality of Care and Clinical Outcomes","topic":"Health Systems, Economic Evaluations, Quality of Life","field":"Economics, Econometrics and Finance","cited_by":2,"is_retracted":false,"has_abstract":true,"ca_institutions":"St. Stephen's University","funders":"European Commission","keywords":"Ethnic group; Inclusion (mineral); European union; Medicine; Family medicine; Demography; Psychology; Political science; Law; Business; Sociology; Social psychology","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.2650707,0.0001816858,0.002155194,0.0001869188,0.0002615924,0.00004851259,0.0002815086,0.0001315044,0.000005338872],"category_scores_gemma":[0.08163852,0.0001463001,0.0002593388,0.0001644534,0.0005331377,0.0001793881,0.0006174125,0.0009820987,0.000002721727],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00004842438,"about_ca_system_score_gemma":0.00008554773,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001267446,"about_ca_topic_score_gemma":0.00171037,"domain_scores_codex":[0.9561399,0.024724,0.01795436,0.0006013155,0.0002934733,0.000286954],"domain_scores_gemma":[0.9753795,0.01736836,0.006624348,0.0003499827,0.0001043369,0.0001735282],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.00002534598,0.0001276017,0.9812394,0.0003710661,0.0000974276,0.00001076736,0.004308308,0.000001527308,3.651651e-7,0.0008734351,0.001288641,0.0116561],"study_design_scores_gemma":[0.001631054,0.0002363928,0.9824771,0.0003786406,0.00002045659,0.000007011464,0.008093231,0.00003076168,3.793571e-7,0.002922105,0.004070754,0.0001320733],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9630364,0.01176594,0.0001757829,0.02319232,0.0002854262,0.0002675329,0.00002962407,0.000008041674,0.001238994],"genre_scores_gemma":[0.9825504,0.009299827,0.0005909664,0.007357282,0.0001333424,0.000001267548,0.000005256588,0.0000136884,0.00004795455],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1834321,"threshold_uncertainty_score":0.9260972,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.5261844512167837,"score_gpt":0.5723338832953008,"score_spread":0.04614943207851707,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}