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首个旨在促进针对非药物干预措施进行高质量临床试验的国际研究网络(TRACTION网络)的介绍。

Presentation of the first international research network to foster high-quality clinical trials testing non-pharmacological interventions (TRACTION network).

作者信息

Ferreira Ricardo J O, Henriques Adriana, Moe Rikke H, Matos Cristiano, Tveter Anne-Therese, Osteras Nina, Nogueira Paulo, Costa Andreia Silva, Haavardsholm Espen A, Carmona Loreto, Richards David

机构信息

Nursing Research Innovation and Development Centre of Lisbon (CIDNUR), Nursing School of Lisbon (ESEL), Lisbon, Portugal

Instituto de Saúde Ambiental (ISAMB), Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal.

出版信息

BMJ Open. 2024 Jul 17;14(7):e081864. doi: 10.1136/bmjopen-2023-081864.

Abstract

Clinical trials are essential for evaluating the efficacy and safety of new treatments and health interventions. However, while pharmacological trials are well-established, non-pharmacological trials face unique challenges related to their complexity and difficulties such as recruitment, retention, intervention standardisation, selection of outcome measures and blinding of clinicians, participants and data collectors. This communication paper describes the objectives, implementation steps and bylaws of the 'Trials foR heAlth Care inTerventIONs' Network (TRACTION), established by an international multiprofessional task force of experts to foster high-quality non-pharmacological research, ultimately improving patient care and healthcare outcomes.The TRACTION research network will provide information and resources through a collaborative hub for researchers, health professionals, patient research partners and stakeholders in diverse biomedical and healthcare areas, connecting people with different levels of expertise but with the same interests (eg, to evaluate the effect of non-pharmacological interventions, recruiting participants). This open network will support researchers in optimising trial design, participant recruitment, data management and analysis, and disseminating and implementing trial results.The network will also facilitate specialisation training and provide educational materials and mentoring.

摘要

临床试验对于评估新治疗方法和健康干预措施的疗效和安全性至关重要。然而,虽然药物试验已很成熟,但非药物试验因其复杂性和困难(如招募、保留、干预标准化、结局指标选择以及临床医生、参与者和数据收集者的盲法)面临独特挑战。本交流文件描述了由国际多专业专家工作组建立的“医疗保健干预试验”(TRACTION)网络的目标、实施步骤和章程,以促进高质量的非药物研究,最终改善患者护理和医疗保健结局。TRACTION研究网络将通过一个协作中心为不同生物医学和医疗保健领域的研究人员、卫生专业人员、患者研究伙伴及利益相关者提供信息和资源,将具有不同专业水平但兴趣相同的人联系起来(例如评估非药物干预措施的效果、招募参与者)。这个开放网络将支持研究人员优化试验设计、参与者招募、数据管理与分析,以及传播和实施试验结果。该网络还将促进专业化培训并提供教育材料和指导。

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