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

项目总结/摘要 正念减压（MBSR）是治疗主要健康问题的一种很有前途的方法， 抑郁焦虑和慢性疼痛最近一次广泛的正念减压疗法系统评价是针对试验（k=101 研究; N= 8，135名参与者）。使用GRADE，它显示出中等证据水平 （建议评估、发展和评价分级）制度，并呼吁建立更多的 更高质量的随机对照试验。这些文献已经扩展到数百个临床试验。是 过去的时间进行系统的审查和荟萃分析，以确定证据有多强。这将 告知是否以及如何将MBSR纳入健康保险范围，以减轻全球的负担。 并帮助开发更好的MBSR相关治疗。为了做到这一点，科学家们建议， 知识转化（iKT），研究人员和知识使用者共同创造知识。虽然iKT 它已经被用于系统评价，但尚未被用于正念系统评价。主要目标是： 1.进行利益攸关方评价，以确定：（a）他们必须就是否、如何、 以及何时MBSR应该被医疗保险所覆盖;（B）什么是最优先的证据， 需要MBSR的有效性和成本效益;（c）重要的障碍，以了解和 为了使MBSR能够被医疗保险所覆盖。 2.通过系统回顾和荟萃分析，确定正念减压疗法对关键健康相关 目标1B中iKT策略告知的结果，例如：（a）焦虑，（B）抑郁，（c）压力，（d） 身体功能，（e）生活质量，（f）与阿片类药物使用相关的疼痛，以及（g）成本效益。 3.评估荟萃分析的效果是否基于实施相关因素而有所不同， 利益相关者，例如长度遵守（例如，会话长度），节目保真度（例如，教师培训，家庭 实践）、交付方式（面对面与在线）、设置和人群（例如，临床与非临床， 具体性别和种族/族裔群体），并影响可持续性（例如，是否获益持续≥1年）。 目标1的方法包括利益相关者会议，以进行包括定性访谈在内的形成性评估 和改进的德尔菲法。目标2和3的方法将是最先进的系统证据 合成。这些将利用所有主要的数据库，以确定MBSR试验，解决初级健康 结果;检查随机对照试验和非对照试验的证据稳健性 （通过全面的行为改变技术分类来表征活动内容）;以及 根据最佳标准分析效应量。在整个审查过程中，我们将让利益攸关方参与， 在SPIRIT（支持政策与研究健康：干预试验）行动框架的指导下。 总的来说，这些证据综合将提供证据，不仅可以改变正念减压疗法的科学， 此外，它还增加了医疗保险的覆盖面，并使数百万人能够获得医疗服务。

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.