HEAL Collaboratory Resource Coordinating Center (PRISM) (U24): Bioethics Supplement

HEAL 合作实验室资源协调中心 (PRISM) (U24)：生物伦理学补充材料

• 批准号: 10364578
• 负责人: LESLEY H CURTIS
• 金额: $ 19.12万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-28 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10364578
• 关键词: Benefits and Risks; Bioethics; Businesses; Calculi; Clinical Trials; Collaborations; Conduct Clinical Trials; Consent; Data; Disclosure; Educational workshop; Empirical Research; Ethics; Foundations; Future; Generations; Goals; Health; Health system; Healthcare Systems; Helping to End Addiction Long-term; Individual; Inferior; Informed Consent; Institution; Institutional Review Boards; Intervention; Interview; Investments; Journals; Knowledge; Learning; Light; Mental Health; Modeling; Outcome; Participant; Patient Care; Patient-Focused Outcomes; Policies; Positioning Attribute; Pragmatic clinical trial; Quality of Care; Reproducibility; Research; Research Institute; Research Personnel; Research Subjects; Resources; Risk; Scholarship; Scientific Advances and Accomplishments; Shapes; Suicide; TimeLine; United States National Institutes of Health; Work; collaboratory; data reuse; data sharing; design; experience; improved; individual patient; innovation; opioid misuse; patient population; policy implication; population health; pragmatic trial; preference; risk sharing; symposium; systematic review; systems research; virtual; waiver

PROJECT SUMMARY/ABSTRACT Numerous arguments have been advanced for the broad sharing of deidentified, participant- level clinical trial data. However, data sharing in the context of pragmatic clinical trials (PCTs) presents particular challenges. For example, prior debates about data sharing have largely focused on risks for individual research participants, yet sharing data from PCTs can also carry risks for health systems and for the clinicians within them—clinicians who may not have made a proactive decision to participate in the PCT, and who, in some cases, may be research subjects themselves. Furthermore, many PCTs are conducted with a waiver or alteration of informed consent, limiting the ability to align sharing decisions with the values and preferences of those individuals about whom information will be shared. Funders of PCTs, including the NIH HCS Collaboratory, NIH HEAL Initiative and the Patient- Centered Outcomes Research Institute, have recently developed policies and related resources to encourage data sharing.Yet how such policies are being implemented within individual PCTs, and the implications of these policies for the likelihood that PCT data will, in fact, be reused, remains poorly understood. The proposed research will develop empirically grounded evidence to support the responsible sharing of PCT data. In Aim 1, we will develop a conceptual model of the specific features of the PCT context that may influence the risk-benefit calculus for data sharing. This model will inform our Aim 2 work, which will explore the trade-offs presenting by data sharing in PCTs, as understood by those responsible for the oversight, creation, and future use of PCT data. In Aim 3, we will use a virtual conference with an expert advisory panel to evaluate the extent to which existing and proposed policies to promote data sharing are responsive to PCT-specific considerations. The contribution of this research will be significant because it will lay the essential groundwork for effective guidance regarding sharing of PCT data. This groundwork will advance the NIH Health Care Systems Research Collaboratory’s commitment to developing best practices for PCTs so as to maximize the National Institute of Health’s investments in embedded health research, and, ultimately to accelerate the pace of learning throughout the nation’s healthcare system.

项目总结/摘要 许多论点已经提出了广泛的共享去识别，参与者- 水平的临床试验数据。然而，在实用临床试验（PCT）背景下的数据共享 提出了特别的挑战。例如，以前关于数据共享的辩论在很大程度上 关注个体研究参与者的风险，但共享来自PCT的数据也可能带来 卫生系统和其中的临床医生的风险-临床医生可能没有做出 主动决定参加PCT，在某些情况下，可能是研究对象 自己此外，许多PCT是在放弃或改变知情同意的情况下进行的。 同意，限制了将共享决策与这些人的价值观和偏好相结合的能力 将被共享信息的个人。 PCT的资助者，包括NIH HCS合作实验室，NIH HEAL倡议和患者- 中心成果研究所最近制定了政策和相关的 资源，以鼓励数据共享。然而，这些政策是如何在 个别PCT，以及这些政策对PCT数据可能性的影响， 事实上，被重复使用，仍然知之甚少。 拟议中的研究将开发基于经验的证据，以支持负责任的 PCT数据共享。在目标1中，我们将开发一个概念模型， 可能影响数据共享的风险-收益计算的PCT背景。该模型将告知 我们的目标2的工作，这将探讨在多氯联苯的数据共享提出的权衡， PCT数据的监督、创建和未来使用的负责人应了解这些信息。在Aim中 3，我们将使用一个虚拟会议与专家咨询小组，以评估在多大程度上， 现有和拟议的促进数据共享的政策是针对具体的 注意事项。这项研究的贡献将是重大的，因为它将奠定 在PCT数据共享方面提供有效指导的必要基础。这些基础工作将 推进NIH卫生保健系统研究合作实验室的承诺， 最佳做法，以最大限度地提高国家卫生研究所在以下方面的投资： 嵌入式健康研究，并最终加快整个学习的步伐， 国家的医疗体系。

项目成果

Acupuncture Intervention Protocol: Consensus Process for a Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults: An NIH HEAL Initiative Funded Project.

• DOI: 10.1177/21649561211007091
• 发表时间: 2021
• 期刊: Global advances in health and medicine
• 作者: Nielsen A;Ocker L;Majd I;Draisin JA;Taromina K;Maggenti MT;Long J;Nolting M;Sherman KJ
• 通讯作者: Sherman KJ

The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain.

• DOI: 10.1016/j.cct.2021.106545
• 发表时间: 2021-10
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Greco CM;Gaylord SA;Faurot K;Weinberg JM;Gardiner P;Roth I;Barnhill JL;Thomas HN;Dhamne SC;Lathren C;Baez JE;Lawrence S;Neogi T;Lasser KE;Castro MG;White AM;Simmons SJ;Ferrao C;Binda DD;Elhadidy N;Eason KM;McTigue KM;Morone NE
• 通讯作者: Morone NE

The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial.

物理治疗中的纤维肌痛经皮电神经刺激研究方案：多站点嵌入式实用试验。

• DOI: 10.1093/ptj/pzac116
• 发表时间: 2022
• 期刊: Physical therapy
• 影响因子: 3.2
• 作者: Post,AndrewA;Dailey,DanaL;Bayman,EmineO;Chimenti,RuthL;Costigan,Michele;Franck,Carla;Huff,Trevis;Johnson,Elizabeth;Koepp,Maxine;Lafontant,David-Erick;McCabe,MeganE;Neill-Hudson,Tina;Vance,CarolGT;VanGorp,Barb;Zimmerman,
• 通讯作者: Zimmerman,

A Brief Measure of Fidelity for Mindfulness Programs: Development and Evaluation of the Concise Fidelity for Mindfulness-Based Interventions Tool.

• DOI: 10.1177/27536130231174234
• 发表时间: 2023-01
• 期刊: Global advances in integrative medicine and health
• 作者: Greco, Carol M.;Dore, Graham A.;Weinberg, Janice M.;Roth, Isabel;Thomas, Holly N.;Lawrence, Suzanne;Rodriguez, Ruth;McGillis, Megan;Morone, Natalia E.
• 通讯作者: Morone, Natalia E.

Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain.

为 NIH HEAL Initiative GRACE 试验制定实施蓝图：针灸和引导放松治疗慢性镰状细胞病疼痛的观点。

• DOI: 10.1089/jicm.2022.0781
• 发表时间: 2023
• 期刊: Journal of integrative and complementary medicine
• 作者: Knisely,MitchellR;Rivera,Eleanor;deMartelly,VictoriaA;Abdulkadir,Aisha;Doorenbos,ArdithZ;Ezenwa,MiriamO;Molokie,RobertE;Li,Hongjin;Shah,Nirmish;Schlaeger,JudithM;Patil,CrystalL
• 通讯作者: Patil,CrystalL