{"id":"https://openalex.org/W7224550352","doi":"https://doi.org/10.2196/94543","title":"Reporting Gaps and Challenges in Randomized Trials of Generative AI for Medical Use: Insights From a Systematic Review","display_name":"Reporting Gaps and Challenges in Randomized Trials of Generative AI for Medical Use: Insights From a Systematic Review","publication_year":2026,"publication_date":"2026-10-28","ids":{"openalex":"https://openalex.org/W7224550352","doi":"https://doi.org/10.2196/94543","pmid":"https://pubmed.ncbi.nlm.nih.gov/42955350","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/13718382"},"language":"en","primary_location":{"id":"doi:10.2196/94543","doi":"https://doi.org/10.2196/94543","is_oa":true,"landing_page_url":"https://doi.org/10.2196/94543","pdf_url":null,"source":{"id":"https://openalex.org/S17147534","display_name":"Journal of Medical Internet Research","issn_l":"1438-8871","issn":["1438-8871","1439-4456"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-scientific","cwts-core","doaj","dongbi-b","doyens","fnege-4","jufo-2","ki-jl-2","medline","norway-2","oarl","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320608","host_organization_name":"JMIR Publications","host_organization_lineage":["https://openalex.org/P4310320608"],"host_organization_lineage_names":["JMIR Publications"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Medical Internet Research","raw_type":"journal-article"},"volume":null,"type":"review","is_traditional":true,"indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.2196/94543","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5072476236","display_name":"Jae Eun Ko","orcid":"https://orcid.org/0009-0003-6260-3077","observed_orcids":["https://orcid.org/0009-0003-6260-3077"]},"institutions":[{"id":"https://openalex.org/I205490536","display_name":"Dongguk University","ror":"https://ror.org/057q6n778","country_code":"KR","type":"education","lineage":["https://openalex.org/I205490536"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Jae Eun Ko","raw_affiliation_strings":["Department of Regulatory Science for Medical Deivce, Dongguk University, Pildong-ro 1gil 30, Jung-gu, Seoul, 04620, Republic of Korea, 82 319615616"],"raw_orcid":"https://orcid.org/0009-0003-6260-3077","affiliations":[{"raw_affiliation_string":"Department of Regulatory Science for Medical Deivce, Dongguk University, Pildong-ro 1gil 30, Jung-gu, Seoul, 04620, Republic of Korea, 82 319615616","institution_ids":["https://openalex.org/I205490536"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5160145994","display_name":"Ji Woo Hwang","orcid":"https://orcid.org/0009-0001-8331-3488","observed_orcids":["https://orcid.org/0009-0001-8331-3488"]},"institutions":[{"id":"https://openalex.org/I205490536","display_name":"Dongguk University","ror":"https://ror.org/057q6n778","country_code":"KR","type":"education","lineage":["https://openalex.org/I205490536"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Ji Woo Hwang","raw_affiliation_strings":["Department of Regulatory Science for Medical Deivce, Dongguk University, Pildong-ro 1gil 30, Jung-gu, Seoul, 04620, Republic of Korea, 82 319615616"],"raw_orcid":"https://orcid.org/0009-0001-8331-3488","affiliations":[{"raw_affiliation_string":"Department of Regulatory Science for Medical Deivce, Dongguk University, Pildong-ro 1gil 30, Jung-gu, Seoul, 04620, Republic of Korea, 82 319615616","institution_ids":["https://openalex.org/I205490536"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5100459300","display_name":"Sung Min Kim","orcid":"https://orcid.org/0000-0001-6457-989X","observed_orcids":["https://orcid.org/0000-0001-6457-989X"]},"institutions":[{"id":"https://openalex.org/I205490536","display_name":"Dongguk University","ror":"https://ror.org/057q6n778","country_code":"KR","type":"education","lineage":["https://openalex.org/I205490536"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Sung Min Kim","raw_affiliation_strings":["Department of Medical AI Engineering, College of Advanced Convergence Engineering, Dongguk University, Seoul, Republic of Korea","Department of Medical Device and Healthcare, Dongguk University, Seoul, Republic of Korea","Department of Regulatory Science for Medical Deivce, Dongguk University, Pildong-ro 1gil 30, Jung-gu, Seoul, 04620, Republic of Korea, 82 319615616"],"raw_orcid":"https://orcid.org/0000-0001-6457-989X","affiliations":[{"raw_affiliation_string":"Department of Medical AI Engineering, College of Advanced Convergence Engineering, Dongguk University, Seoul, Republic of Korea","institution_ids":["https://openalex.org/I205490536"]},{"raw_affiliation_string":"Department of Medical Device and Healthcare, Dongguk University, Seoul, Republic of Korea","institution_ids":["https://openalex.org/I205490536"]},{"raw_affiliation_string":"Department of Regulatory Science for Medical Deivce, Dongguk University, Pildong-ro 1gil 30, Jung-gu, Seoul, 04620, Republic of Korea, 82 319615616","institution_ids":["https://openalex.org/I205490536"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5005323908","display_name":"Ji Yean Kwon","orcid":"https://orcid.org/0000-0002-9685-4531","observed_orcids":["https://orcid.org/0000-0002-9685-4531"]},"institutions":[{"id":"https://openalex.org/I205490536","display_name":"Dongguk University","ror":"https://ror.org/057q6n778","country_code":"KR","type":"education","lineage":["https://openalex.org/I205490536"]}],"countries":["KR"],"is_corresponding":true,"raw_author_name":"Ji Yean Kwon","raw_affiliation_strings":["Department of Medical Device and Healthcare, Dongguk University, Seoul, Republic of Korea","Department of Regulatory Science for Medical Deivce, Dongguk University, Pildong-ro 1gil 30, Jung-gu, Seoul, 04620, Republic of Korea, 82 319615616"],"raw_orcid":"https://orcid.org/0000-0002-9685-4531","affiliations":[{"raw_affiliation_string":"Department of Medical Device and Healthcare, Dongguk University, Seoul, Republic of Korea","institution_ids":["https://openalex.org/I205490536"]},{"raw_affiliation_string":"Department of Regulatory Science for Medical Deivce, Dongguk University, Pildong-ro 1gil 30, Jung-gu, Seoul, 04620, Republic of Korea, 82 319615616","institution_ids":["https://openalex.org/I205490536"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5005323908"],"corresponding_institution_ids":["https://openalex.org/I205490536"],"apc_list":{"value":2950,"currency":"USD","value_usd":2950},"apc_paid":{"value":2950,"currency":"USD","value_usd":2950},"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"28","issue":null,"first_page":"e94543","last_page":"e94543"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10206","display_name":"Meta-analysis and systematic reviews","score":0.899399995803833,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T10206","display_name":"Meta-analysis and systematic reviews","score":0.899399995803833,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.061500001698732376,"subfield":{"id":"https://openalex.org/subfields/2718","display_name":"Health Informatics"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.004900000058114529,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/generative-ai","display_name":"generative AI","score":0.8849999904632568},{"id":"https://openalex.org/keywords/consort-ai","display_name":"CONSORT-AI","score":0.8040000200271606},{"id":"https://openalex.org/keywords/reporting-quality","display_name":"reporting quality","score":0.6359999775886536},{"id":"https://openalex.org/keywords/reporting-gaps","display_name":"reporting gaps","score":0.5189999938011169},{"id":"https://openalex.org/keywords/large-language-models","display_name":"large language models","score":0.843999981880188},{"id":"https://openalex.org/keywords/gpt","display_name":"GPT","score":0.6340000033378601},{"id":"https://openalex.org/keywords/clinical-trials","display_name":"clinical trials","score":0.38499999046325684},{"id":"https://openalex.org/keywords/ai-interventions","display_name":"AI interventions","score":0.4429999887943268},{"id":"https://openalex.org/keywords/reporting-guidelines-adherence","display_name":"reporting guidelines adherence","score":0.492000013589859},{"id":"https://openalex.org/keywords/treatment-efficacy-and-safety","display_name":"treatment efficacy and safety","score":0.3790000081062317},{"id":"https://openalex.org/keywords/technical-execution","display_name":"technical execution","score":0.30399999022483826}],"concepts":[{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.7458999752998352},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.6629999876022339},{"id":"https://openalex.org/C27415008","wikidata":"https://www.wikidata.org/wiki/Q7256382","display_name":"Psychological intervention","level":2,"score":0.6100000143051147},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.5554999709129333},{"id":"https://openalex.org/C2780665704","wikidata":"https://www.wikidata.org/wiki/Q959298","display_name":"Intervention (counseling)","level":2,"score":0.4880000054836273},{"id":"https://openalex.org/C189708586","wikidata":"https://www.wikidata.org/wiki/Q1504425","display_name":"Systematic review","level":3,"score":0.44269999861717224},{"id":"https://openalex.org/C512399662","wikidata":"https://www.wikidata.org/wiki/Q3505712","display_name":"Family medicine","level":1,"score":0.3912000060081482},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.37369999289512634},{"id":"https://openalex.org/C19648533","wikidata":"https://www.wikidata.org/wiki/Q691640","display_name":"Evidence-based medicine","level":3,"score":0.3456999957561493},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.3368000090122223},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.32199999690055847},{"id":"https://openalex.org/C2778805511","wikidata":"https://www.wikidata.org/wiki/Q1713","display_name":"Citation","level":2,"score":0.32120001316070557},{"id":"https://openalex.org/C145642194","wikidata":"https://www.wikidata.org/wiki/Q870895","display_name":"Health informatics","level":3,"score":0.30640000104904175},{"id":"https://openalex.org/C49290038","wikidata":"https://www.wikidata.org/wiki/Q2994654","display_name":"Consolidated Standards of Reporting Trials","level":3,"score":0.2946999967098236},{"id":"https://openalex.org/C2779328685","wikidata":"https://www.wikidata.org/wiki/Q1475557","display_name":"Patient safety","level":3,"score":0.2928999960422516},{"id":"https://openalex.org/C138816342","wikidata":"https://www.wikidata.org/wiki/Q189603","display_name":"Public health","level":2,"score":0.28529998660087585},{"id":"https://openalex.org/C23131810","wikidata":"https://www.wikidata.org/wiki/Q818574","display_name":"Observational study","level":2,"score":0.28060001134872437},{"id":"https://openalex.org/C2779231881","wikidata":"https://www.wikidata.org/wiki/Q5977147","display_name":"Medical literature","level":2,"score":0.2752000093460083},{"id":"https://openalex.org/C204243189","wikidata":"https://www.wikidata.org/wiki/Q1363085","display_name":"Randomization","level":3,"score":0.2736999988555908},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.26010000705718994},{"id":"https://openalex.org/C2779318504","wikidata":"https://www.wikidata.org/wiki/Q1438035","display_name":"Research design","level":2,"score":0.25609999895095825},{"id":"https://openalex.org/C67774102","wikidata":"https://www.wikidata.org/wiki/Q614132","display_name":"Number needed to treat","level":4,"score":0.2549999952316284},{"id":"https://openalex.org/C2984752397","wikidata":"https://www.wikidata.org/wiki/Q3259956","display_name":"Primary care","level":2,"score":0.250900000333786}],"mesh":[{"descriptor_ui":"D000098842","descriptor_name":"Generative Artificial Intelligence","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016032","descriptor_name":"Randomized Controlled Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true}],"locations_count":4,"locations":[{"id":"doi:10.2196/94543","doi":"https://doi.org/10.2196/94543","is_oa":true,"landing_page_url":"https://doi.org/10.2196/94543","pdf_url":null,"source":{"id":"https://openalex.org/S17147534","display_name":"Journal of Medical Internet Research","issn_l":"1438-8871","issn":["1438-8871","1439-4456"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-scientific","cwts-core","doaj","dongbi-b","doyens","fnege-4","jufo-2","ki-jl-2","medline","norway-2","oarl","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320608","host_organization_name":"JMIR Publications","host_organization_lineage":["https://openalex.org/P4310320608"],"host_organization_lineage_names":["JMIR Publications"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Medical Internet Research","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:13718382","doi":null,"is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13718382/","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13718382/pdf/jmir-v28-e94543.pdf","source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"J Med Internet Res","raw_type":"Text"},{"id":"pmid:42955350","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/42955350","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of medical Internet research","raw_type":"Journal Article"},{"id":"pmh:oai:doaj.org/article:961d0394522a433c970856b0197ee202","doi":null,"is_oa":false,"landing_page_url":"https://doaj.org/article/961d0394522a433c970856b0197ee202","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"Journal of Medical Internet Research, Vol 28, Pp e94543-e94543 (2026)","raw_type":"article"}],"best_oa_location":{"id":"doi:10.2196/94543","doi":"https://doi.org/10.2196/94543","is_oa":true,"landing_page_url":"https://doi.org/10.2196/94543","pdf_url":null,"source":{"id":"https://openalex.org/S17147534","display_name":"Journal of Medical Internet Research","issn_l":"1438-8871","issn":["1438-8871","1439-4456"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-scientific","cwts-core","doaj","dongbi-b","doyens","fnege-4","jufo-2","ki-jl-2","medline","norway-2","oarl","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320608","host_organization_name":"JMIR Publications","host_organization_lineage":["https://openalex.org/P4310320608"],"host_organization_lineage_names":["JMIR Publications"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Medical Internet Research","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.9476000070571899,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[{"id":"https://openalex.org/study-designs/systematic-review","display_name":"Systematic Review"}],"awards":[{"id":"https://openalex.org/G179739784","display_name":null,"funder_award_id":"RS-2024-00331775","funder_id":"https://openalex.org/F4320322014","funder_display_name":"Ministry of Food and Drug Safety"}],"funders":[{"id":"https://openalex.org/F4320322014","display_name":"Ministry of Food and Drug Safety","ror":"https://ror.org/01f7dp456"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7224550352.pdf","grobid_xml":"https://content.openalex.org/works/W7224550352.grobid-xml"},"referenced_works_count":122,"referenced_works":["https://openalex.org/W2093038967","https://openalex.org/W2990648940","https://openalex.org/W3008058947","https://openalex.org/W3118615836","https://openalex.org/W3123497531","https://openalex.org/W3136552952","https://openalex.org/W4226227340","https://openalex.org/W4294636892","https://openalex.org/W4297997268","https://openalex.org/W4365143687","https://openalex.org/W4377565325","https://openalex.org/W4383876504","https://openalex.org/W4384071683","https://openalex.org/W4384665268","https://openalex.org/W4386554921","https://openalex.org/W4386693657","https://openalex.org/W4387500346","https://openalex.org/W4388625750","https://openalex.org/W4388753652","https://openalex.org/W4389083111","https://openalex.org/W4389253133","https://openalex.org/W4389359039","https://openalex.org/W4389518671","https://openalex.org/W4389573101","https://openalex.org/W4391826804","https://openalex.org/W4392058364","https://openalex.org/W4392681182","https://openalex.org/W4393058771","https://openalex.org/W4394807113","https://openalex.org/W4400324908","https://openalex.org/W4400526126","https://openalex.org/W4400657362","https://openalex.org/W4400948229","https://openalex.org/W4402430962","https://openalex.org/W4403813762","https://openalex.org/W4404523826","https://openalex.org/W4404799616","https://openalex.org/W4404958988","https://openalex.org/W4405386631","https://openalex.org/W4406152263","https://openalex.org/W4406453339","https://openalex.org/W4406571986","https://openalex.org/W4406945070","https://openalex.org/W4407119846","https://openalex.org/W4407150885","https://openalex.org/W4407189609","https://openalex.org/W4407593496","https://openalex.org/W4407861126","https://openalex.org/W4407912494","https://openalex.org/W4408135766","https://openalex.org/W4408155297","https://openalex.org/W4408180360","https://openalex.org/W4408182242","https://openalex.org/W4408515159","https://openalex.org/W4408735159","https://openalex.org/W4408885154","https://openalex.org/W4408886672","https://openalex.org/W4409148667","https://openalex.org/W4409187918","https://openalex.org/W4409235802","https://openalex.org/W4409283601","https://openalex.org/W4409283616","https://openalex.org/W4409423955","https://openalex.org/W4409787177","https://openalex.org/W4409892054","https://openalex.org/W4409954495","https://openalex.org/W4410070766","https://openalex.org/W4410160686","https://openalex.org/W4410225737","https://openalex.org/W4410531793","https://openalex.org/W4410643456","https://openalex.org/W4410874666","https://openalex.org/W4411137799","https://openalex.org/W4411661410","https://openalex.org/W4412202274","https://openalex.org/W4412491182","https://openalex.org/W4412535374","https://openalex.org/W4412632356","https://openalex.org/W4412790899","https://openalex.org/W4412826533","https://openalex.org/W4412877946","https://openalex.org/W4413299387","https://openalex.org/W4413408952","https://openalex.org/W4413772050","https://openalex.org/W4413814109","https://openalex.org/W4414016157","https://openalex.org/W4414849058","https://openalex.org/W4414981190","https://openalex.org/W4415128218","https://openalex.org/W4415220628","https://openalex.org/W4416229632","https://openalex.org/W4416259577","https://openalex.org/W4416715916","https://openalex.org/W4417213087","https://openalex.org/W6950101330","https://openalex.org/W7117157394","https://openalex.org/W7117313356","https://openalex.org/W7117468638","https://openalex.org/W7117991688","https://openalex.org/W7118554562","https://openalex.org/W7118779673","https://openalex.org/W7124311477","https://openalex.org/W7124445936","https://openalex.org/W7124567182","https://openalex.org/W7124597927","https://openalex.org/W7124752358","https://openalex.org/W7124767556","https://openalex.org/W7124833872","https://openalex.org/W7128081203","https://openalex.org/W7128168528","https://openalex.org/W7128444586","https://openalex.org/W7128589295","https://openalex.org/W7128910437","https://openalex.org/W7130580750","https://openalex.org/W7131098274","https://openalex.org/W7133137245","https://openalex.org/W7133214447","https://openalex.org/W7135045184","https://openalex.org/W7139120435","https://openalex.org/W7147676212","https://openalex.org/W7148287196","https://openalex.org/W7169857863"],"related_works":["https://openalex.org/W4392058364","https://openalex.org/W4294636892","https://openalex.org/W6906194799","https://openalex.org/W7134655555","https://openalex.org/W4411521355","https://openalex.org/W6906597428","https://openalex.org/W4403721106","https://openalex.org/W4408216127","https://openalex.org/W4411747972","https://openalex.org/W3175858446"],"abstract_inverted_index":{"Background:":[0],"Generative":[1],"AI":[2,39,388],"(GenAI)":[3],"is":[4,35,431],"being":[5],"deployed":[6],"rapidly":[7],"in":[8,131,275,413,457],"medicine,":[9],"and":[10,16,49,76,109,127,150,162,187,223,278,291,321,352,399,417,451,459],"evidence":[11,430],"of":[12,22,31,106,192,207,254,337,360,436],"its":[13,50],"clinical":[14,447],"safety":[15,453],"efficacy":[17],"depends":[18],"on":[19],"transparent":[20],"reporting":[21,201,263,286,411,426],"randomized":[23],"controlled":[24],"trials":[25,416],"(RCTs).":[26],"The":[27],"CONSORT-AI":[28,68,164,378],"(Consolidated":[29],"Standards":[30],"Reporting":[32],"Trials-AI)":[33],"extension":[34,423],"a":[36,140,144,182,421],"benchmark":[37],"for":[38,46,73,113,143,251,289,350,420],"trial":[40,308,442],"reporting,":[41],"but":[42],"it":[43,390],"was":[44,194,200,204,215,287,331],"drafted":[45],"conventional":[47],"AI,":[48],"applicability":[51],"to":[52,62,66,77,81,86,92,120,269,381,424],"GenAI":[53,72,94,141,383,415],"has":[54],"not":[55,90,170,173,195],"been":[56],"examined.":[57],"Objective:":[58],"This":[59,363],"study":[60],"aimed":[61],"assess":[63],"item-level":[64,213],"adherence":[65,214,264,273],"the":[67,198,205,366,429,434],"among":[69],"RCTs":[70,116,237],"evaluating":[71],"medical":[74,145,414],"purposes":[75],"distinguish":[78],"deficiencies":[79],"attributable":[80,85],"nonadherence":[82,372],"from":[83,118,235,266,373,386,403],"those":[84],"items":[87,165,281,379],"that":[88,392,446],"do":[89],"correspond":[91],"how":[93],"interventions":[95],"are":[96,455],"specified":[97],"or":[98,137,172],"delivered.":[99],"Methods:":[100],"PubMed,":[101],"CENTRAL":[102],"(Cochrane":[103],"Central":[104],"Register":[105],"Controlled":[107],"Trials),":[108],"Embase":[110],"were":[111,153,244],"searched":[112],"peer-reviewed,":[114],"English-language":[115],"published":[117],"2022":[119],"April":[121],"3,":[122],"2026,":[123],"supplemented":[124],"by":[125,181,433],"backward":[126],"forward":[128],"citation":[129],"searching,":[130],"which":[132],"patients,":[133],"health":[134],"care":[135],"professionals,":[136],"laypeople":[138],"received":[139],"intervention":[142],"purpose;":[146],"non-GenAI,":[147],"nonmedical,":[148],"nonrandomized,":[149],"non-peer-reviewed":[151],"reports":[152,208,234,340,346],"excluded.":[154],"Two":[155],"reviewers":[156],"independently":[157],"screened":[158],"studies,":[159],"extracted":[160],"data,":[161],"rated":[163,209],"as":[166,197],"reported,":[167,169,171],"partially":[168],"applicable":[174],"using":[175,220,259],"signaling":[176,438],"questions,":[177],"with":[178,256],"disagreements":[179],"resolved":[180],"third":[183],"reviewer":[184],"(Cohen":[185],"\u03ba=0.81":[186],"prevalence-adjusted,":[188],"bias-adjusted":[189],"\u03ba=0.84).":[190],"Risk":[191],"bias":[193],"assessed,":[196],"target":[199],"adherence.":[202],"Adherence":[203],"proportion":[206],"\"reported\"":[210],"per":[211],"item;":[212],"compared":[216],"across":[217],"9":[218,336],"characteristics":[219],"Fisher":[221],"exact":[222],"Freeman-Halton":[224],"tests":[225],"(2-sided":[226],"\u03b1=.05).":[227],"Results:":[228],"From":[229],"16,485":[230],"retrieved":[231],"records,":[232],"74":[233,338],"73":[236],"(24,150":[238],"participants;":[239],"median":[240],"100,":[241],"IQR":[242],"50.0-247.0)":[243],"included.":[245],"Large":[246],"language":[247],"models":[248],"(LLMs)":[249],"accounted":[250],"98.6%":[252,270],"(73/74)":[253],"interventions,":[255],"60.8%":[257],"(45/74)":[258],"GPT-family":[260],"models.":[261],"Item-level":[262],"ranged":[265],"0%":[267],"(0/72)":[268],"(73/74).":[271],"High":[272],"occurred":[274],"general":[276,371],"metadata":[277],"output":[279],"specification":[280],"(range":[282],"59-73,":[283],"79.7%-98.6%).":[284],"Conversely,":[285],"poor":[288],"input":[290,295,300],"technical":[292,356],"execution":[293],"domains,":[294],"data":[296,353],"eligibility":[297],"(3/73,":[298],"4.1%),":[299],"acquisition/selection":[301],"(9/74,":[302],"12.2%),":[303],"algorithm":[304],"versioning":[305],"(17/74,":[306],"23.0%),":[307],"setting":[309],"integration":[310],"(21/74,":[311],"28.4%),":[312],"human-AI":[313],"interaction":[314,351],"(25/74,":[315],"33.8%),":[316],"performance":[317],"error":[318],"(27/74,":[319],"36.5%),":[320],"open":[322],"access/code":[323],"(31/74,":[324],"41.9%).":[325],"Input":[326],"quality":[327],"handling":[328],"(Item":[329],"5[iii])":[330],"completely":[332],"unreported":[333],"(0/72).":[334],"Only":[335],"(12.2%)":[339],"explicitly":[341],"cited":[342],"CONSORT-AI.":[343],"While":[344],"citing":[345],"showed":[347],"higher":[348],"compliance":[349],"sharing,":[354],"major":[355],"gaps":[357,412],"persisted":[358],"regardless":[359],"citation.":[361],"Conclusions:":[362],"review":[364],"provides":[365],"first":[367],"empirical":[368,407],"audit":[369],"distinguishing":[370],"structural":[374],"mismatches":[375],"where":[376],"deterministic":[377],"fail":[380],"capture":[382],"mechanics.":[384],"Differing":[385],"traditional":[387],"evaluations,":[389],"reveals":[391],"key":[393],"reproducibility":[394],"drivers-system":[395],"prompts,":[396],"inference":[397],"settings,":[398],"access":[400],"modalities-are":[401],"omitted":[402],"current":[404,425],"standards.":[405],"These":[406],"findings":[408],"highlight":[409],"critical":[410],"identify":[418],"domains":[419],"tailored":[422],"standards,":[427],"although":[428],"limited":[432],"use":[435],"nonvalidated":[437],"questions.":[439],"Establishing":[440],"GenAI-specific":[441],"guidelines":[443],"will":[444],"ensure":[445],"decisions,":[448],"regulatory":[449],"approvals,":[450],"patient":[452],"safeguards":[454],"grounded":[456],"reproducible":[458],"trustworthy":[460],"evidence.":[461]},"counts_by_year":[],"updated_date":"2026-11-08T12:12:28.789561","created_date":"2026-10-30T00:00:00"}
