Hammerschlag Richard, Sprengel Meredith L, Baldwin Ann L
Consciousness and Healing Initiative, La Jolla, CA, USA; NOVA Institute for Health, Baltimore, MD, USA.
Human Factors, Netherlands Organisation for Applied Scientific Research (TNO), Soesterberg, the Netherlands; Subtle Energy Collective, San Francisco, CA, USA.
Complement Ther Med. 2024 Jun;82:103011. doi: 10.1016/j.ctim.2023.103011. Epub 2024 Feb 1.
A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.
已制定了一套指南，以帮助改进生物场疗法临床试验的报告。在对这些研究的系统评价中，有人主张在报告这类综合健康实践（如外气疗法、治疗性触摸、灵气疗法和抚触疗法）的试验时提高透明度。这些指南称为《生物场疗法：报告证据指南》（BiFi REGs），通过纳入与生物场疗法试验相关的干预方案细节，对《CONSORT 2010》进行了补充。BiFi REGs是由一个核心小组创建的一份文件草案、与一组国际主题专家进行的两轮德尔菲法以及两个通过Zoom召开会议的小组（其中包括补充与整合医学期刊的编辑）共同发展而来的。BiFi REGs包括一份15项的干预检查表。还对《CONSORT》的其他两个主题领域提出了修改建议，以增强其与生物场疗法试验的相关性。每项内容都包括解释以及生物场疗法试验同行评审发表报告中的报告示例。我们预计，当与《CONSORT 2010》的所有其他内容一起使用时，BiFi REGs将加快生物场疗法试验的同行评审过程，促进试验复制的尝试，并有助于为生物场疗法临床实践中的决策提供信息。
