{"id":"W4304202818","doi":"10.1136/bmjopen-2022-064304","title":"Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE","year":2022,"lang":"en","type":"article","venue":"BMJ Open","topic":"Health Systems, Economic Evaluations, Quality of Life","field":"Economics, Econometrics and Finance","cited_by":21,"is_retracted":false,"has_abstract":true,"ca_institutions":"SickKids Foundation; Hospital for Sick Children; Women's College Hospital; University of Toronto","funders":"National Heart, Lung, and Blood Institute; NIHR Oxford Biomedical Research Centre; Medical Research Council; Cancer Research UK; Agency for Healthcare Research and Quality; National Center for Advancing Translational Sciences; University of Glasgow; U.S. Food and Drug Administration; National Institute for Health and Care Research","keywords":"Medicine; Consolidated Standards of Reporting Trials; Protocol (science); Surrogate endpoint; Clinical endpoint; Delphi method; Clinical trial; Research ethics; External validity; Randomized controlled trial; Alternative medicine; Family medicine; Medical education; Psychology; Pathology; Psychiatry; Social psychology; Artificial intelligence","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":[0.2584614,0.005951458,0.01035362,0.01233186,0.004609655,0.01170447,0.007119163,0.01312653,0.1452638],"category_scores_gemma":[0.5091161,0.007406936,0.01124728,0.01560568,0.01134863,0.01003503,0.007187984,0.02805206,0.05328421],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01448166,"about_ca_system_score_gemma":0.04264511,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001922644,"about_ca_topic_score_gemma":0.002699124,"domain_scores_codex":[0.6952699,0.2236918,0.04974742,0.01379173,0.01343146,0.004067704],"domain_scores_gemma":[0.4585125,0.3083941,0.04869299,0.06975503,0.1052878,0.009357655],"domain_codex":null,"domain_gemma":"reporting","domain_candidate":"reporting","domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.02518821,0.001403561,0.001154667,0.1454332,0.002410906,0.0007055504,0.009087812,0.004262525,0.002772738,0.08541492,0.5838327,0.1383333],"study_design_scores_gemma":[0.0833684,0.002057701,0.004409717,0.1307227,0.001262687,0.0007786063,0.002622102,0.01315594,0.004477192,0.1105286,0.6454262,0.001190118],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"protocol","genre_gemma":"methods","genre_scores_codex":[0.0007617692,0.000709419,0.04175856,0.003758983,0.00425242,0.9285036,0.01465018,0.002496989,0.003108183],"genre_scores_gemma":[0.0006777795,0.0001578703,0.02695226,0.0004358134,0.0001326955,0.9697409,0.001026199,0.0001451345,0.0007313707],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.7415386,"threshold_uncertainty_score":0.9144492,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.6436065727159339,"score_gpt":0.5410917249706829,"score_spread":0.102514847745251,"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."}}