Mindfulness-Based Stress Reduction: An Implementation Science-Informed Systematic Review and Meta-Analysis

项目摘要/摘要 基于正念的压力减轻(MBSR)是治疗重大健康问题的一种很有前途的方法，例如 抑郁、焦虑和慢性疼痛。最后一次广泛的MBSR系统评价是为了试验(k=101 研究；N= 8,135人)，截止到2015年。它显示出中等证据水平使用等级 (评估、发展和评价建议等级)制度，并呼吁更多和 更高质量的随机对照试验。这篇文献已经扩展了数百项临床试验。它是 过去进行系统回顾和荟萃分析的时间，以确定证据有多有力。这将是 告知是否以及如何将MBSR纳入医疗保险覆盖范围，以减轻全球 并帮助开发更好的MBSR相关治疗方法。为此，科学家们建议将 知识转化是研究人员和知识使用者共同创造知识的过程。尽管IKT有 它被用于系统评估，还没有被用于正念系统评估。主要目标是： 1.执行利益相关者评估，以确定：(A)他们必须就是否、如何、 以及MBSR应在何时纳入医疗保险；(B)他们最优先的证据是什么 对MBSR的效力和成本效益的需要；(C)了解和 解决这一问题，以便医疗保险覆盖MBSR。 2.通过系统回顾和荟萃分析，确定MBSR对关键健康相关领域的影响 目标1b中的iKT战略所提供的结果，例如：(A)焦虑、(B)抑郁、(C)压力、(D) (E)生活质量；(F)与阿片类药物使用相关的疼痛；(G)成本效益。 3.评估元分析效果是否因实施相关因素而有所不同 利益相关者，如时长坚持(例如，课程时长)、计划保真度(例如，教师培训、家庭 实践)、交付方式(面对面与在线)、环境和人群(例如，临床与非临床， 具体的性别和种族/民族群体)，以及效果的可持续性(例如，受益是否持续≥1年)。 目标1方法包括利益相关者会议，以进行包括定性访谈的形成性评估 以及改进的德尔菲法。目标2和目标3的方法将成为最先进的系统证据 综合。这些将利用所有主要数据库来确定针对初级健康的MBSR试验 结果：检查随机对照试验和非对照试验证据的稳健性 (由全面的行为改变技术分类促进，以表征活跃内容)；以及 按照最佳标准分析效果大小。在整个审查过程中，我们将与利益相关者接触， 在精神指导下(通过研究支持健康政策：干预试验)行动框架。 总体而言，这些证据合成将提供的证据不仅可能改变MBSR的科学，而且 这不仅增加了医疗保险的覆盖面，也增加了数百万人获得医疗保险的机会。

PROJECT SUMMARY/ABSTRACT Mindfulness-Based Stress Reduction (MBSR) is a promising approach to treat major health problems, such as depression, anxiety, and chronic pain. The last extensive MBSR systematic review was for trials (k=101 studies; N= 8,135 participants) available through 2015. It showed a moderate evidence level using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system, with a call for more and higher quality randomized controlled trials. This literature has expanded with hundreds of clinical trials. It is past time to conduct a systematic review and meta-analysis to determine how strong the evidence is. This will inform whether and how MBSR should be included in health insurance coverage to reduce the global burden of disease and to aid development of better MBSR-related treatments. To do so, scientists recommend integrated knowledge translation (iKT), where researchers and knowledge users co-create knowledge. Although iKT has been used in systematic reviews, it has not been used in a mindfulness systematic review. Primary aims are: 1. Perform stakeholder evaluations to identify: (a) Key questions they have to make decisions about if, how, and when MBSR should be covered by health insurance; (b) what is the highest priority evidence they need on MBSR’s effectiveness and cost-effectiveness; (c) barriers that are important to understand and resolve in order for MBSR to be covered by health insurance. 2. Through a systematic review and meta-analysis, determine the impacts of MBSR on key health-related outcomes informed by the iKT strategy in Aim 1b, such as: (a) anxiety, (b) depression, (c) stress, (d) physical functioning, (e) quality of life, (f) pain with related opioid use, and (g) cost effectiveness. 3. Evaluate whether meta-analytic effects differ based on implementation-related factors informed by stakeholders, such as length adherence (e.g., session length), program fidelity (e.g., teacher training, home practice), delivery modality (in-person vs. online), setting and population (e.g., clinical vs. non-clinical, specific genders and racial/ethnic groups), and effect sustainability (e.g., whether benefits last ≥1 year). Aim 1 methods include stakeholder meetings to conduct formative evaluations involving qualitative interviews and a modified Delphi approach. Methods for Aims 2 and 3 will be state-of-the-science systematic evidence syntheses. These will utilize all major databases to identify MBSR trials that address the primary health outcomes; examine the robustness of evidence across both randomized controlled trials and uncontrolled trials (facilitated by a comprehensive behavior change technique taxonomy to characterize active content); and analyze effect sizes following the best standards. Throughout the review process, we will engage stakeholders, guided by the SPIRIT (Supporting Policy In health with Research: an Intervention Trial) Action Framework. Overall, these evidence syntheses will provide evidence that may transform not only the science of MBSR and related treatments but also increase health insurance coverage and access for millions of people.