{"id":"W3165355211","doi":"10.1007/s40264-021-01065-z","title":"Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR","year":2021,"lang":"en","type":"review","venue":"Drug Safety","topic":"Psoriasis: Treatment and Pathogenesis","field":"Immunology and Microbiology","cited_by":16,"is_retracted":false,"has_abstract":true,"ca_institutions":"Probity Medical Research; Dalhousie University; Innovaderm (Canada)","funders":"Janssen Scientific Affairs; University of Pennsylvania","keywords":"Medicine; Term (time); Medical physics","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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.767701,0.001789611,0.003308849,0.004604357,0.001630103,0.008595021,0.00721534,0.003945637,0.002110786],"category_scores_gemma":[0.8833571,0.001616181,0.007181657,0.004704124,0.009789865,0.006909493,0.005687344,0.007920526,0.0005222696],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004291277,"about_ca_system_score_gemma":0.009266363,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002063754,"about_ca_topic_score_gemma":0.001496536,"domain_scores_codex":[0.1343073,0.7808239,0.04557617,0.01383856,0.0245757,0.0008784218],"domain_scores_gemma":[0.03706961,0.8571851,0.0412517,0.04516628,0.01853245,0.0007948157],"domain_codex":"methods","domain_gemma":"methods","domain_candidate":"methods","domain_consensus":"methods","study_design_codex":"design_other","study_design_gemma":"observational","study_design_scores_codex":[0.005706212,0.0005478789,0.1671279,0.03061557,0.03620875,0.00125678,0.01276785,0.02510608,0.002379847,0.1415992,0.02693491,0.5497491],"study_design_scores_gemma":[0.004894718,0.009810669,0.1448816,0.04121132,0.02269473,0.003711418,0.00404509,0.1358201,0.01404255,0.4837334,0.1336199,0.001534421],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"review","genre_scores_codex":[0.03529104,0.02975807,0.8808618,0.04054689,0.004006891,0.004269867,0.001111648,0.0005530898,0.003600704],"genre_scores_gemma":[0.5282632,0.007186974,0.4185101,0.02177275,0.005574219,0.01626021,0.0009460402,0.0006138145,0.0008727674],"genre_candidate":"review","genre_consensus":null,"teacher_disagreement_score":0.232299,"threshold_uncertainty_score":0.2864661,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3266899675499887,"score_gpt":0.4281687764952196,"score_spread":0.1014788089452309,"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."}}