{"id":"W4416799561","doi":"10.1136/bmjopen-2025-111418","title":"Comparison of intention-to-treat and per-protocol results in non-inferiority trials: a methodological review protocol","year":2025,"lang":"en","type":"review","venue":"BMJ Open","topic":"Statistical Methods in Clinical Trials","field":"Mathematics","cited_by":1,"is_retracted":false,"has_abstract":true,"ca_institutions":"McMaster University; Impact","funders":"","keywords":"Protocol (science); Research ethics; Health services research; Systematic review; MEDLINE; Register (sociolinguistics); Research design","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[{"model":"gemma","categories":["metaresearch"],"domain":"methods","study_design":"systematic_review","genre":"protocol","about_ca_system":false,"about_ca_topic":false,"confidence":"low","status":"direct model label, unvalidated"},{"model":"gpt","categories":["metaresearch"],"domain":"methods","study_design":"systematic_review","genre":"protocol","about_ca_system":false,"about_ca_topic":false,"confidence":"high","status":"direct model label, unvalidated"}],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","metaepi_narrow","metaepi_broad"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.1282312,0.0007764761,0.01975213,0.0002816432,0.00006221809,0.0001421216,0.001814161,0.0008580895,0.0004650831],"category_scores_gemma":[0.7654327,0.0004929962,0.001027913,0.0009716501,0.0001919436,0.00008075483,0.002827627,0.0009796682,0.00003525479],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001527515,"about_ca_system_score_gemma":0.0008260443,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0000733401,"about_ca_topic_score_gemma":0.00003451455,"domain_scores_codex":[0.9345495,0.04803298,0.01453466,0.001583221,0.0007818668,0.0005177527],"domain_scores_gemma":[0.6754065,0.3152979,0.006252234,0.002283776,0.0004395789,0.0003199727],"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":[0.001213283,0.0003716248,0.000008310099,0.3844548,0.00007483688,0.000008171214,0.0000197206,1.512865e-8,1.83682e-7,0.002012576,0.00931477,0.6025217],"study_design_scores_gemma":[0.003796565,0.0006903591,0.00001310304,0.4040886,0.001236843,0.000006278379,0.00001302302,0.000004631947,0.000004383401,0.07187348,0.5177606,0.0005122018],"study_design_candidate":"systematic_review","study_design_consensus":null,"genre_codex":"protocol","genre_gemma":"protocol","genre_scores_codex":[8.702893e-9,0.0272986,0.009934803,0.0002009958,0.0001168844,0.9548379,0.0004247403,0.00002937599,0.007156723],"genre_scores_gemma":[1.067453e-9,0.07495113,0.4032038,0.00005937252,0.00005775169,0.5213714,0.000005977849,0.00002498788,0.0003256746],"genre_candidate":"protocol","genre_consensus":"protocol","teacher_disagreement_score":0.6372015,"threshold_uncertainty_score":0.9997522,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.9570146823012856,"score_gpt":0.8138797967877078,"score_spread":0.1431348855135778,"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."}}