{"id":"W2756291568","doi":"10.1186/s13063-017-2168-0","title":"Specific barriers to the conduct of randomised clinical trials on medical devices","year":2017,"lang":"en","type":"review","venue":"Trials","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":93,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"FP7 Research infrastructures; Health Technology Assessment international; Gemeinsame Bundesausschuss; European Commission","keywords":"Blinding; Medicine; Clinical trial; Context (archaeology); Transparency (behavior); Alternative medicine; Randomized controlled trial; Systematic review; MEDLINE; Medical education; Surgery; Pathology","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","research_integrity","insufficient_payload"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.1810213,0.0004325478,0.01301468,0.0002344197,0.0001779074,0.00005461549,0.000772494,0.002058953,0.003928442],"category_scores_gemma":[0.2429745,0.0001752473,0.003715435,0.0002101205,0.00121843,0.00002133882,0.0001044542,0.00140572,0.0002249775],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00004643922,"about_ca_system_score_gemma":0.003420267,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0000120649,"about_ca_topic_score_gemma":0.000004886316,"domain_scores_codex":[0.974662,0.01486876,0.007668359,0.0006239483,0.001870983,0.0003059582],"domain_scores_gemma":[0.9384652,0.05196836,0.005904852,0.001797726,0.000261642,0.001602216],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.002688054,0.00006296636,3.314239e-7,0.002840044,0.0009401049,0.00001680045,0.00003920623,3.420461e-8,9.987604e-7,0.0007138426,0.03285441,0.9598432],"study_design_scores_gemma":[0.01787239,0.0003507466,0.000004364701,0.02038426,0.00329882,0.00001555107,0.00001374153,0.000001795013,0.000004918738,0.0001376639,0.9577475,0.0001683087],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.000004175356,0.9687945,0.00006116199,0.01656311,0.004624842,0.008156766,0.0001081929,0.00002465342,0.001662577],"genre_scores_gemma":[0.0000648327,0.9904693,0.00007853427,0.001057845,0.007301722,0.0001828335,0.0001305561,0.0000457819,0.0006686471],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9596749,"threshold_uncertainty_score":0.9992366,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.8063391379613241,"score_gpt":0.6450609872594926,"score_spread":0.1612781507018315,"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."}}