Abstract
Introduction
Recent experiences of the COVID-19 pandemic have reraised long-standing questions in the research of Acupuncture and East Asian Medicine (AEAM). In particular, how do we conceptualize, collect, and share data on acupuncture that are useful for building an evidence base in the modern era, without abandoning all relevance to the medical systems that drive clinical practice? COVID-19 showed us that the international collaborative data sharing protocols for the development of vaccines and treatment methods needed for a global response to the pandemic were entirely feasible, although previously unimagined. 1 Similarly in the acupuncture world, practitioners engaged with clinical and basic research at previously unheard-of levels, as their work was informed by information regarding COVID-19 mechanisms as well as clinical practices in China. As practitioners/researchers of AEAM we ask, how can we best capitalize on this new level of engagement, so as to promote organized and systematic data sharing between practitioners and researchers?
Increased Engagement with Evidence-Informed Medicine
It is difficult to overstate the novelty and extent of acupuncturists' engagement with scientific and other literature on AEAM since the onset of the pandemic. As global understanding of COVID-19 unfolded, acupuncturists around the world followed peer-reviewed studies with unprecedented interest. They utilized information from online continuing education classes, 2 and sourced information disseminated on AEAM usage from China 3,4 that could be translated directly into practice. Data were also shared through collegial 4 –6 and online social networks to inform treatment approaches in real time for symptoms and sequelae of COVID-19. 2
In these ways, many practitioners were effectively practicing evidence-informed medicine 7 –9 to respond to an acute need in largely uncharted territory. Historically, some practitioners of AEAM have indicated that they believe that the evidence from the tradition was all they needed. They felt ill-equipped to access—or are skeptical about the utility of—scientific research for translation into practice. 10 –15 They reason that AEAM constitute whole systems of medicine that have been developed and refined over millennia, with complex pattern-based individualized treatment approaches at their core. 16 Controversy 13 has long surrounded the applicability of reductive single agent trials and other placebo control methods that remain disconnected from real-life practice and traditional case-based methods of clinical reasoning and knowledge building. 17 –21
The Opportunity for a Bidirectional Research Strategy
The present moment thus represents a new level of interest in evidence-informed practice among acupuncturists. It also represents an unprecedented opportunity for improving the evidence base through a “bidirectional research strategy,” 22 one that systematically “uploads” evidence from clinical practice as well as traditional methods of information dissemination that reflect AEAM frameworks, such as case studies and series.
The notion of collaborating to collect and share individual participant (or patient) data (IPD), from multiple studies for prospective analysis, is gaining traction in the biomedical research community. 23 –27 This could be well applied in the context of acupuncture research, especially where conditions or disorders are emerging, are relatively rare, or difficult to treat in practice.
The question for acupuncture researchers remains—how can we effectively collaborate and maintain data sharing protocols, using pragmatic methods of evaluation designed to reflect complex systems of medicine, which respond to current needs? We have seen excellent examples of how collaborative acupuncture networks have been achieved. 27 –30 However, the resource requirements and research designs are not always accessible, practical, or translatable for clinicians, policy-makers, and health systems. The likely clinical and educational benefits of such an initiative, enumerated as follows, are many. Most urgent to determine at this time are immediate next steps, with a view to long-term implications for research.
Implications for Clinical Practice
Considerable gains could be made toward understanding acupuncture's effectiveness, establishing “dosage” standards, or providing treatment strategies for various disorders, by using shared data with agreed common outcomes, collected routinely by clinicians during practice. The collection of real-life (pragmatic) IPD by practitioners with varying levels of practice, experience, and patient demographics could provide robust clinical data sets. These data could then be used to inform clinical practice, as well as further efficacy and effectiveness studies, the results of which would then inform implementation policy for practitioners and payers. * At present, well-meaning clinicians are building their own best practices anecdotally and from continuing education courses, with each patient and even each treatment constituting its own N-of-1 trial. Structuring outcome measures would encourage reflective practice, as well as relating that practice back to the research base.
This type of data collection has been piloted by ACU-Track, an electronic health record (EHR) that uses validated scales to monitor patient-reported outcomes (PRO) from consenting patients (
In addition, clinicians with shared clinical expertise, such as in the areas of pregnancy, as noted, or the menopausal transition, metabolic or autoimmune diseases, or gastrointestinal disease, could organize and share their clinical experiences and data through an agreed data sharing method to describe what is valuable to practice and research. Collaborative groups could guide research inquiry regarding common PRO measures to gather important clinical information and identify symptom clusters for particular developmental transitions or diseases (patterns of disharmony).
Previous models of how to organize this can be taken from Practice-Based Research Networks (PBRNs), 31,32 with particular reference to BraveNet, a PBRN of 19 integrative medicine clinical sites in the United States that is designed to collect clinical outcomes and cost data, 33 and Practitioner Research and Collaboration Initiative, a practitioner researcher collaborative network in Australia. 34 Organizations such as the Society for Acupuncture Research could lead the organization and implementation of such collaborative efforts, using an online platform to enhance connection between, and access to, providers and institutions around the world.
Implications for Education
A common de-identified portal would provide several opportunities for the education of AEAM providers. First, we propose that acupuncture school clinics use common reporting standards through the EHR portal. This would provide at least two benefits. First, acupuncture students attending university- or college-administered student clinics would learn about robust data collection, data cleaning, and analysis methods. Second, with collaborative data sharing arrangements between schools, a large data set would be quickly amassed. These de-identified data would need to be maintained by data custodians. Students could access these data for research capstone projects for primary and secondary data analyses. This would not only establish basic research skills for students and their supervisors, but also potentially encourage students to undertake higher degree research programs by demystifying the research process.
Current models of education suffer because students are not trained to regularly review charts or write comprehensive histories. Collecting and then reviewing IPDs each week or month could help students learn about systematically monitoring patient status, thus learning evidence-informed practice habits. This notion rests on the success of collaborative networks and robust agreements about data custodianship. We would anticipate that such implementation would significantly advance engagement with evidence-informed medicine in the next generations of acupuncture clinicians.
Implications and Next Steps for a Formal Research Agenda
As discussed earlier, collecting IPD using agreed common outcome measures can provide useful raw data. It can also inform the design of subsequent effectiveness and efficacy studies of AEAM for a given condition. This would increase the “bandwidth” of communication between research and practice, providing robust data on AEAM's identification and treatment of symptom clusters in novel and complex illnesses, which would be of use to payers and policy-makers.
A necessary first step toward this end is to collaboratively determine what the priority areas for research investigation are. A set of common outcome measures (and associated coding) could be agreed upon by a consensus panel of experts for each clinical area. As essential to determining priority areas is the establishment of an ethical and agreed method of data collection and sharing, potentially by engaging a third-party neutral data custodian. Understanding the barriers and facilitators (acceptability and feasibility outcomes, including cost data), to data sharing to optimize its utility is also imperative to the success of such a proposal. 26
Collaborative data collection and data sharing can bring together disparate information to compile treatment options for emerging conditions, conditions that are relatively rare or difficult to treat, such as when COVID-19 first occurred, and inform practitioners about treatment options, including effectiveness and safety. While setting research agendas and priorities for acupuncture is not new, capturing agreed common outcomes data that reflect real-life clinical practice and AEAM frameworks that informs both research and practice contexts is novel.
We propose the development of a protocol for the collection of an international data set, which uses AEAM frameworks for data collection and dissemination. We would in addition recommend first focusing on women's health across the lifespan with a focus on key hormonal and life transitions: puberty, pregnancy, and the menopausal transition. Research suggests that women are more likely to seek out complementary and alternative medicine, including acupuncture, 35 and, therefore, are a good starting point for research priority areas. Collecting consistent IPD across the lifespan would generate a massive longitudinal data set (with cross-sectional data opportunities as well).
We propose, to realize this direction, the development of a working group of a deliberately selected panel of experts in women's health across the lifespan to participate in a Delphi consensus process. 36 –38 The process would consist of the following: (1) an idea-generating phase during a 1-day in-person meeting in conjunction with the Society for Acupuncture Research conference in 2023, (2) iterative online Delphi rounds with the anonymity of panelists and responses, and (3) establishment of consensus criteria, 39 including the determination of relevant and agreed common outcome measures for IPD sets across the lifespan.
As mentioned, a data safety and monitoring board, and robust agreements for sharing and custodianship of the database would be required. Lead researchers in various countries would serve as principal investigators and collaboratively lead and steward the amassment of a large repository of de-identified IPD sets to be used for research and practice implementation purposes to answer myriad research questions.
These are our initial thoughts and directions. Where will such a global Delphi process guide us? Now is the time to utilize modern research to inform the practice, research design and execution, and education practices regarding AEAM.
Footnotes
Author Disclosure Statement
The authors have no conflicts to disclose.
Funding Information
No funding was received in support of this article.