{"id":"W4220938665","doi":"10.1136/bmjopen-2021-057656","title":"Proactive infliximab optimisation using a pharmacokinetic dashboard versus standard of care in patients with Crohn’s disease: study protocol for a randomised, controlled, multicentre, open-label study (the OPTIMIZE trial)","year":2022,"lang":"en","type":"article","venue":"BMJ Open","topic":"Inflammatory Bowel Disease","field":"Biochemistry, Genetics and Molecular Biology","cited_by":29,"is_retracted":false,"has_abstract":true,"ca_institutions":"Western University","funders":"Genentech; F. Hoffmann-La Roche; Ironwood Pharmaceuticals, Incorporated; Grifols; Sun Pharma; Mitsubishi Tanabe Pharma Corporation; Celltrion; Mylan; Crohn's and Colitis Foundation; Takeda Pharmaceuticals U.S.A.; Teva Pharmaceutical Industries; Leona M. and Harry B. Helmsley Charitable Trust; Boston Pharmaceuticals; Gilead Sciences; Sanofi; GlaxoSmithKline; Allergan; AstraZeneca; Seres Therapeutics; Amgen; Pfizer; Celgene; Celltrion Healthcare; Eli Lilly and Company; Bristol-Myers Squibb","keywords":"Medicine; Protocol (science); Infliximab; Crohn's disease; Open label; Clinical trial; Disease; Standard of care; Randomized controlled trial; Dashboard; Open label study; Physical therapy; Alternative medicine; Internal medicine; Adverse effect; Pathology; Data science","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":[],"domain":null,"study_design":"randomized_trial","genre":"protocol","about_ca_system":false,"about_ca_topic":false,"confidence":"low","status":"direct model label, unvalidated"},{"model":"gpt","categories":[],"domain":null,"study_design":"randomized_trial","genre":"protocol","about_ca_system":false,"about_ca_topic":false,"confidence":"high","status":"direct model label, unvalidated"}],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0228515,0.004985123,0.009332073,0.001565678,0.002240376,0.003958461,0.003264086,0.006037516,0.05081744],"category_scores_gemma":[0.02189978,0.002235147,0.005548667,0.002295682,0.003725984,0.003527209,0.002124671,0.007481232,0.01137134],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003527411,"about_ca_system_score_gemma":0.009063333,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001319102,"about_ca_topic_score_gemma":0.002539908,"domain_scores_codex":[0.9870471,0.007937009,0.001301476,0.001248561,0.001117142,0.001348785],"domain_scores_gemma":[0.9915856,0.001777022,0.00234144,0.001127783,0.001485335,0.001682808],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.9654397,0.00676077,0.0005232759,0.00645854,0.0008876471,0.000112255,0.0001744757,0.0008728463,0.001273549,0.00132896,0.005849438,0.01031844],"study_design_scores_gemma":[0.9551685,0.02860264,0.001398238,0.001216279,0.0004657819,0.00003756809,0.0000613272,0.0006708772,0.0003478764,0.001069319,0.01090948,0.00005210772],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"protocol","genre_gemma":"protocol","genre_scores_codex":[0.00586474,0.0006206643,0.001352876,0.0003145605,0.0004533599,0.9885502,0.001445977,0.00009321581,0.001304395],"genre_scores_gemma":[0.004906596,0.0002767809,0.001516656,0.0002254504,0.00009693663,0.992061,0.0003288312,0.000009128443,0.0005785487],"genre_candidate":"protocol","genre_consensus":"protocol","teacher_disagreement_score":0.05081744,"threshold_uncertainty_score":0.1700013,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.06247995127016755,"score_gpt":0.4139081632995086,"score_spread":0.3514282120293411,"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."}}