{"id":"W4413805698","doi":"10.1186/s12874-025-02652-9","title":"Development of a protocol complexity tool: a framework designed to stimulate discussion and simplify study design","year":2025,"lang":"en","type":"article","venue":"BMC Medical Research Methodology","topic":"Statistical Methods in Clinical Trials","field":"Mathematics","cited_by":1,"is_retracted":false,"has_abstract":true,"ca_institutions":"AstraZeneca (Canada)","funders":"AstraZeneca","keywords":"Clinical trial; Protocol (science); Medicine; Computer science; Research design; Medical physics; Statistics; Internal medicine; Alternative medicine; Pathology; Mathematics","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":[0.4501879,0.005528399,0.003346337,0.01691966,0.004163911,0.01262719,0.009492059,0.007537861,0.009534758],"category_scores_gemma":[0.4237522,0.005090529,0.007043346,0.008578697,0.008024521,0.01155779,0.01484757,0.01117084,0.005818421],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0120309,"about_ca_system_score_gemma":0.05104709,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003637146,"about_ca_topic_score_gemma":0.004657835,"domain_scores_codex":[0.6413177,0.2826294,0.04492725,0.008555857,0.01996175,0.002608043],"domain_scores_gemma":[0.4194497,0.4393694,0.03349616,0.04235244,0.05556053,0.00977177],"domain_codex":null,"domain_gemma":"methods","domain_candidate":"methods","domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.001085501,0.001508748,0.005714449,0.02436915,0.001192183,0.001248012,0.0385716,0.0243663,0.009597599,0.1619582,0.0681804,0.6622078],"study_design_scores_gemma":[0.002872818,0.002361897,0.004655974,0.0329462,0.00117318,0.00146789,0.006951229,0.09760936,0.01214817,0.2454842,0.5912454,0.001083709],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.001075307,0.0002635986,0.9669549,0.002250826,0.000201782,0.02406842,0.0006182708,0.003087677,0.001479151],"genre_scores_gemma":[0.002561739,0.00009466969,0.9768267,0.0002514501,0.00004153433,0.01950238,0.0003175351,0.0001851426,0.0002188471],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.5498121,"threshold_uncertainty_score":0.6780162,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.9486650995424512,"score_gpt":0.7577932577158293,"score_spread":0.1908718418266219,"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."}}