Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study.
Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study.
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DOI：
10.1186/s12916-023-02937-0
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发表时间：
2023-07-05
期刊：
影响因子：
9.3
通讯作者：
Yap, Christina
中科院分区：
文献类型：
--
作者：
Solovyeva, Olga;Dimairo, Munyaradzi;Weir, Christopher J.;Hee, Siew Wan;Espinasse, Aude;Ursino, Moreno;Patel, Dhrusti;Kightley, Andrew;Hughes, Sarah;Jaki, Thomas;Mander, Adrian;Evans, Thomas R. Jeffry;Lee, Shing;Hopewell, Sally;Rantell, Khadija Rerhou;Chan, An-Wen;Bedding, Alun;Stephens, Richard;Richards, Dawn;Roberts, Lesley;Kirkpatrick, John;de Bono, Johann;Yap, Christina
早期剂量发现（EPDF）试验对于新干预措施的开发至关重要，并影响是否应在进一步试验中对其进行调查。在SPIRIT和CONSORT指南中分别存在关于临床试验方案和完成试验报告的指导。然而，这两个指南及其扩展并没有充分解决EPDF试验的特点。在SPIRIT和CONSORT检查清单的基础上，DEFINE研究旨在为EPDF试验方案（SPIRIT-DEFINE）和报告（CONSORT-DEFINE）制定国际共识驱动的指导方针。候选项目的最初产生是通过审查已发表的EPDF试验报告来确定的。通过对已发表文献和灰色文献的回顾、对现实世界实例的分析、引用和参考文献的搜索以及专家建议，随后进行了两轮修改的德尔菲过程，进一步完善了早期草案项目。患者和公众参与和参与（PPIE）与德尔菲参与者反馈的定量和专题分析同时进行。德尔菲调查包括79个新的或修改的SPIRIT-DEFINE （n = 36）和conder - define （n = 43）扩展候选项目。在第一轮中，来自24个国家的206个跨学科利益相关者参与了投票，在第二轮中有151个利益相关者参与了投票。在第一轮反馈之后，第二轮中增加了一个concur - define项目。在80个项目中，60个达到了纳入的门槛（≥70%的受访者投票为关键：26个SPIRIT-DEFINE， 34个CONSORT-DEFINE），其余20个项目将在共识会议上进一步讨论。与此同时，PPIE工作的结果是开发了EPDF概要工具包，该工具包由一个带有指导说明的模板和一个范例组成。通过详细介绍DEFINE研究的发展历程和所做的决定，我们设想这将增进理解并帮助研究人员制定未来的指南。SPIRIT-DEFINE和conber - define指南将允许研究者有效地处理EPDF试验方案和报告中应该出现的基本项目，从而促进透明度、全面性和可重复性。SPIRIT-DEFINE和CONSORT-DEFINE在EQUATOR Network （https://www.equator-network.org/）注册。在线版本包含补充材料，可在10.1186/s12916-023-02937-0获得。
Early phase dose-finding (EPDF) trials are crucial for the development of a new intervention and influence whether it should be investigated in further trials. Guidance exists for clinical trial protocols and completed trial reports in the SPIRIT and CONSORT guidelines, respectively. However, both guidelines and their extensions do not adequately address the characteristics of EPDF trials. Building on the SPIRIT and CONSORT checklists, the DEFINE study aims to develop international consensus-driven guidelines for EPDF trial protocols (SPIRIT-DEFINE) and reports (CONSORT-DEFINE). The initial generation of candidate items was informed by reviewing published EPDF trial reports. The early draft items were refined further through a review of the published and grey literature, analysis of real-world examples, citation and reference searches, and expert recommendations, followed by a two-round modified Delphi process. Patient and public involvement and engagement (PPIE) was pursued concurrently with the quantitative and thematic analysis of Delphi participants’ feedback. The Delphi survey included 79 new or modified SPIRIT-DEFINE (n = 36) and CONSORT-DEFINE (n = 43) extension candidate items. In Round One, 206 interdisciplinary stakeholders from 24 countries voted and 151 stakeholders voted in Round Two. Following Round One feedback, one item for CONSORT-DEFINE was added in Round Two. Of the 80 items, 60 met the threshold for inclusion (≥ 70% of respondents voted critical: 26 SPIRIT-DEFINE, 34 CONSORT-DEFINE), with the remaining 20 items to be further discussed at the consensus meeting. The parallel PPIE work resulted in the development of an EPDF lay summary toolkit consisting of a template with guidance notes and an exemplar. By detailing the development journey of the DEFINE study and the decisions undertaken, we envision that this will enhance understanding and help researchers in the development of future guidelines. The SPIRIT-DEFINE and CONSORT-DEFINE guidelines will allow investigators to effectively address essential items that should be present in EPDF trial protocols and reports, thereby promoting transparency, comprehensiveness, and reproducibility. SPIRIT-DEFINE and CONSORT-DEFINE are registered with the EQUATOR Network (https://www.equator-network.org/). The online version contains supplementary material available at 10.1186/s12916-023-02937-0.
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影响因子：
2
作者：
Tighiouart, Mourad;Piantadosi, Steven;Rogatko, Andre
通讯作者：
Rogatko, Andre
影响因子：
2.2
作者：
Chen Z;Yuan Y;Li Z;Kutner M;Owonikoko T;Curran WJ;Khuri F;Kowalski J
通讯作者：
Kowalski J
影响因子：
2.9
作者：
Breithaupt-Groegler K;Coch C;Coenen M;Donath F;Erb-Zohar K;Francke K;Goehler K;Iovino M;Kammerer KP;Mikus G;Rengelshausen J;Sourgens H;Schinzel R;Sudhop T;Wensing G
通讯作者：
Wensing G
影响因子：
4.2
作者：
Dalton, Emily J.;Churilov, Leonid;Hayward, Kathryn S.
通讯作者：
Hayward, Kathryn S.
影响因子：
8.6
作者：
Kimmelman, Jonathan;London, Alex John;Ravina, Bernard;Ramsay, Tim;Bernstein, Mark;Fine, Alan;Stahnisch, Frank W.;Emborg, Marina Elena
通讯作者：
Emborg, Marina Elena