Wallace Entringer Bottacin, Thais Teles de Souza, Walleri Christini Torelli Reis, Ana Carolina Melchiors
{"title":"药物、药物治疗和制药服务中人工智能研究报告指南：medai开发、验证和声明。","authors":"Wallace Entringer Bottacin, Thais Teles de Souza, Walleri Christini Torelli Reis, Ana Carolina Melchiors","doi":"10.1007/s11096-025-01905-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence (AI) applications in medicines, pharmacotherapy, and pharmaceutical services are expanding, yet the lack of standardized reporting guidelines for scientific studies hinders transparency, comparability, and reproducibility in evidence-based healthcare decision-making.</p><p><strong>Aim: </strong>To develop and validate comprehensive reporting guidelines for AI studies in these fields through expert consensus.</p><p><strong>Method: </strong>Following the Guidance for Developers of Health Research Reporting Guidelines (Moher in PLoS Med, https://doi.org/10.1371/journal.pmed.1000217 , 2010), this study was conducted between May and October 2024 in two phases. Phase 1 involved drafting the initial guidelines through literature reviews and structured expert discussions by an internal committee. Phase 2 employed the Delphi method for validation and refinement. Twenty-six experts from nine countries, representing clinical pharmacy, pharmaceutical services, computer science, and AI, participated in the first round, with 21 completing the second round. Items were included if they received a median ≥ 7 on a 9-point evaluation scale, with ≥ 75% agreement defining publication consensus.</p><p><strong>Results: </strong>The final MedinAI guidelines comprise 14 items and 78 sub-items across four domains: core aspects, ethical considerations in medication and pharmacotherapy, medicines as products, and services related to medicines and pharmacotherapy. All items achieved consensus (median = 8, with 95.2% agreement on publication readiness). MedinAI's items adapt to different AI development stages, and its structure operates in parallel with EQUATOR Network reporting guidelines for most study designs (CONSORT, STROBE, PRISMA, SPIRIT, etc.), ensuring versatility.</p><p><strong>Conclusion: </strong>MedinAI provides validated reporting guidelines for AI studies in medicines, pharmacotherapy and pharmaceutical services, promoting transparency, comparability, reproducibility, responsible and ethical AI development for these fields.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Guidelines for reporting artificial intelligence studies in medicines, pharmacotherapy, and pharmaceutical services: MedinAI development, validation and statement.\",\"authors\":\"Wallace Entringer Bottacin, Thais Teles de Souza, Walleri Christini Torelli Reis, Ana Carolina Melchiors\",\"doi\":\"10.1007/s11096-025-01905-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Artificial intelligence (AI) applications in medicines, pharmacotherapy, and pharmaceutical services are expanding, yet the lack of standardized reporting guidelines for scientific studies hinders transparency, comparability, and reproducibility in evidence-based healthcare decision-making.</p><p><strong>Aim: </strong>To develop and validate comprehensive reporting guidelines for AI studies in these fields through expert consensus.</p><p><strong>Method: </strong>Following the Guidance for Developers of Health Research Reporting Guidelines (Moher in PLoS Med, https://doi.org/10.1371/journal.pmed.1000217 , 2010), this study was conducted between May and October 2024 in two phases. Phase 1 involved drafting the initial guidelines through literature reviews and structured expert discussions by an internal committee. Phase 2 employed the Delphi method for validation and refinement. Twenty-six experts from nine countries, representing clinical pharmacy, pharmaceutical services, computer science, and AI, participated in the first round, with 21 completing the second round. Items were included if they received a median ≥ 7 on a 9-point evaluation scale, with ≥ 75% agreement defining publication consensus.</p><p><strong>Results: </strong>The final MedinAI guidelines comprise 14 items and 78 sub-items across four domains: core aspects, ethical considerations in medication and pharmacotherapy, medicines as products, and services related to medicines and pharmacotherapy. All items achieved consensus (median = 8, with 95.2% agreement on publication readiness). MedinAI's items adapt to different AI development stages, and its structure operates in parallel with EQUATOR Network reporting guidelines for most study designs (CONSORT, STROBE, PRISMA, SPIRIT, etc.), ensuring versatility.</p><p><strong>Conclusion: </strong>MedinAI provides validated reporting guidelines for AI studies in medicines, pharmacotherapy and pharmaceutical services, promoting transparency, comparability, reproducibility, responsible and ethical AI development for these fields.</p>\",\"PeriodicalId\":13828,\"journal\":{\"name\":\"International Journal of Clinical Pharmacy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-04-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Clinical Pharmacy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s11096-025-01905-3\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Pharmacy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11096-025-01905-3","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
摘要
背景：人工智能（AI）在药物、药物治疗和制药服务中的应用正在扩大，但缺乏科学研究的标准化报告指南阻碍了循证医疗保健决策的透明度、可比性和可重复性。目的：通过专家共识，为这些领域的人工智能研究制定和验证综合报告指南。方法：根据《卫生研究报告编写指南》（Moher in PLoS Med, https://doi.org/10.1371/journal.pmed.1000217, 2010），本研究于2024年5月至10月分两个阶段进行。第一阶段包括通过文献综述和内部委员会有组织的专家讨论起草初步指南。第二阶段采用德尔菲法进行验证和细化。来自9个国家的26名专家，分别代表临床药学、药学服务、计算机科学和人工智能，参加了第一轮，其中21人完成了第二轮。如果项目在9分评价量表中获得中位数≥7分，且≥75%的一致性定义出版共识，则纳入。最终的MedinAI指南包括14个项目和78个子项目，涵盖四个领域：核心方面、药物和药物治疗中的伦理考虑、药物作为产品以及与药物和药物治疗相关的服务。所有项目都达成了共识（中位数= 8,95.2%的人同意发表准备情况）。MedinAI的项目适应不同的人工智能开发阶段，其结构与赤道网络报告指南并行运行，适用于大多数研究设计（CONSORT， STROBE， PRISMA， SPIRIT等），确保多功能性。结论：MedinAI为药物、药物治疗和药学服务领域的人工智能研究提供了经过验证的报告指南，促进了这些领域人工智能开发的透明度、可比性、可重复性、负责任和合乎道德。
Guidelines for reporting artificial intelligence studies in medicines, pharmacotherapy, and pharmaceutical services: MedinAI development, validation and statement.
Background: Artificial intelligence (AI) applications in medicines, pharmacotherapy, and pharmaceutical services are expanding, yet the lack of standardized reporting guidelines for scientific studies hinders transparency, comparability, and reproducibility in evidence-based healthcare decision-making.
Aim: To develop and validate comprehensive reporting guidelines for AI studies in these fields through expert consensus.
Method: Following the Guidance for Developers of Health Research Reporting Guidelines (Moher in PLoS Med, https://doi.org/10.1371/journal.pmed.1000217 , 2010), this study was conducted between May and October 2024 in two phases. Phase 1 involved drafting the initial guidelines through literature reviews and structured expert discussions by an internal committee. Phase 2 employed the Delphi method for validation and refinement. Twenty-six experts from nine countries, representing clinical pharmacy, pharmaceutical services, computer science, and AI, participated in the first round, with 21 completing the second round. Items were included if they received a median ≥ 7 on a 9-point evaluation scale, with ≥ 75% agreement defining publication consensus.
Results: The final MedinAI guidelines comprise 14 items and 78 sub-items across four domains: core aspects, ethical considerations in medication and pharmacotherapy, medicines as products, and services related to medicines and pharmacotherapy. All items achieved consensus (median = 8, with 95.2% agreement on publication readiness). MedinAI's items adapt to different AI development stages, and its structure operates in parallel with EQUATOR Network reporting guidelines for most study designs (CONSORT, STROBE, PRISMA, SPIRIT, etc.), ensuring versatility.
Conclusion: MedinAI provides validated reporting guidelines for AI studies in medicines, pharmacotherapy and pharmaceutical services, promoting transparency, comparability, reproducibility, responsible and ethical AI development for these fields.
期刊介绍：
The International Journal of Clinical Pharmacy (IJCP) offers a platform for articles on research in Clinical Pharmacy, Pharmaceutical Care and related practice-oriented subjects in the pharmaceutical sciences.
IJCP is a bi-monthly, international, peer-reviewed journal that publishes original research data, new ideas and discussions on pharmacotherapy and outcome research, clinical pharmacy, pharmacoepidemiology, pharmacoeconomics, the clinical use of medicines, medical devices and laboratory tests, information on medicines and medical devices information, pharmacy services research, medication management, other clinical aspects of pharmacy.
IJCP publishes original Research articles, Review articles , Short research reports, Commentaries, book reviews, and Letters to the Editor.
International Journal of Clinical Pharmacy is affiliated with the European Society of Clinical Pharmacy (ESCP). ESCP promotes practice and research in Clinical Pharmacy, especially in Europe. The general aim of the society is to advance education, practice and research in Clinical Pharmacy .
Until 2010 the journal was called Pharmacy World & Science.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
