Developing a research strategy for the acupuncture profession: research questions, resources necessary to answer them and guidelines for matching resources to types of research

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Introduction

The acupuncture field has only peripherally been involved with scientific research in the West. As the field matures and becomes a more integral part of the mainstream it will be necessary for it to increasingly engage in scientific research,5 either directly by initiating research projects or indirectly by consulting to research projects initiated by others.

To date much of the clinical research has not been rigorously done.[1], [7] Problems have resulted from either inadequate information about acupuncture on the part of interested researchers, or inadequate knowledge about scientific research on the part of acupuncturists. These problems have been magnified by the application of often-questionable scientific methods on the part of the scientific community and the application of inadequate or faulty knowledge of the nature and history of acupuncture on the part of the acupuncture profession.3 It will be necessary to overcome considerable problems if better quality and more meaningful clinical research is to be done on acupuncture in the future. Additionally, there are many less complex levels of research that can be initiated by the profession that require less resources and which can guide the design of more resource demanding studies.2

A lot of basic science research has been done on acupuncture in efforts to understand how it might work. However, very little of this work examined acupuncture as practiced in the clinic. Rather it examined isolated and often non-clinically based models of practice or models only peripherally used in practice. In particular the methods investigated were chosen for their reproducibility and convenience rather than their relevance to acupuncture practice.5 More complete and clinically relevant research is necessary that pays attention to the investigation of acupuncture following models of how it is normally practiced. Additionally research will need to be initiated that pays attention to the theories of acupuncture. Many problems have hampered these avenues of research. Translations between theory and clinical practice and between clinical practice and the requirements for rigorous laboratory science need improvement. More fundamental research needs to be conducted if a better understanding of how acupuncture might work is to be achieved and if its theories are to be properly investigated.

This brief paper presents a series of general research areas that are important for the field and which need to be investigated. The basic research model necessary for each is listed along with the resources probably necessary for it. The resources necessary include whether access to an ethics committee will be necessary, what levels of expertise may be necessary, what levels of funding may be necessary, and the likely context a practitioner wishing to engage in this kind of research will need to work within.

Table 1 describes the types of research model and resources necessary to answer general questions about the nature of practice, demographic questions concerning patients and practitioners, and general results from clinical practice. Literature reviews can be conducted by anyone with a sufficient command of the literature to be reviewed and at little cost.6 Expert panels are important to guide decisions for other studies when there is disagreement about how to proceed or where there is not yet much recorded literature on a given subject. Such panels play secondary roles to other studies and will probably require minimal funding. Demographic surveys often require large sample sizes, the participation of at least an expert in statistics, support staff and reasonably large financial resources. Clinical audits can be undertaken by an individual practitioner or by a group of practitioners. They are generally not difficult or expensive and are ideal for acupuncture organizations to support. A targeted population audit might involve the coordinated efforts of a group of practitioners auditing their clinical records for a selected group of patients, such as asthma patients. Statistical consultation and collaboration with relevant medical experts would probably be necessary. Depending on the size of the study, medical condition and outcome assessment, the financial resources needed could be extensive, but in most cases will probably be minimal. Qualitative studies can be conducted through acupuncture organizations such as schools[8], [9] and can be conducted with minimal expenses involved. At least an appropriately trained expert such as a medical anthropologist is necessary for such studies. Adverse effect and safety studies of normal clinical practice can be conducted. It is advantageous for such studies to be undertaken by practitioners working with national organizations and consulting with appropriate medical experts such as statistical consultants.[11], [12], [13] When such studies are undertaken their results will probably be more readily accepted if such academic consultation is sought. The costs of such studies may be not very extensive but depending upon size and duration of the studies could require quite large financial resources.

Table 2 describes the types of research model and resources necessary for addressing specific questions and issues around consistency and validity of methods used in clinical practice. Practitioners through acupuncture schools or other organizations can conduct reliability and validity of diagnosis and treatment selection studies, often with relatively small sample size requirements.[10], [14] Most likely the funding requirements will not be too great for these studies. The development of assessment and outcome tools for traditional forms of diagnosis will require extensive participation from within the profession, extensive collaboration with relevant experts such as biometricians, statisticians, and will entail numerous studies, time and financial resources. This may be one of the more important and difficult to accomplish areas of research in the field.

Table 3 describes the types of research model and resources necessary for conducting different types of controlled clinical trials addressing health service type questions and different types of clinical effectiveness or efficacy type questions, including the most complex type of study, that which attempts to assess the specific effects of a treatment. All forms of clinical trials are expensive and require larger scale funding resources with extensive collaboration with relevant experts. The more complex the study design the greater the staffing and consultation needs. It is generally better to conduct pre-clinical and pilot clinical studies before attempting to conduct a controlled clinical trial.4 The type of clinical question asked determines the type of study design to be used. The complexities of the placebo-controlled study and the sample size requirements of pragmatic comparative studies make both types of study generally quite expensive. The health services, economic and comparative outcome type pragmatic studies can usually be conducted by acupuncture organizations such as schools or national organizations provided appropriate consultation with relevant experts is sought. The placebo controlled, explanatory studies require such carefully controlled environments and are sufficiently complex that it is probably better that they be conduced through academic research centers, with the collaboration of properly trained clinicians under the advice of research-knowledgeable clinicians from the acupuncture field.

Table 4 describes the types of research model and resources necessary for addressing mechanism and theoretical type questions from clinical practice. Generally researchers from the specific area of bio-medical research under investigation are needed for such studies. This requires access to appropriate laboratories for making the needed measurements and assessments, access to the laboratory staff, permission of the director of the laboratory, often ethical committee approval and sufficient funds to pay for the resources needed. These studies are very difficult for the profession to conduct without the needed academic collaborations and funding. The more that the study requires collaboration or leadership from academically based experts, the more the practitioners in the study need to be conversant with the language, frameworks and methods to be employed by these experts. Table 1, Table 2, Table 3, Table 4 list practitioners under the following contexts: single practice, group practice, acupuncture school based, national organization based and led, academically based or strongly affiliated to an academic organization.

It is hoped that the presentation of these general areas of research, models, practitioner context and necessary resources will contribute to the development of a comprehensive strategy for addressing these questions. At present there are few resources available for acupuncture research. Much of the research that is funded and conducted is of questionable value and quality, yielding results that often discourage some from continuing research in the field or which merely add more un-interpretable information in an already controversial area. It is becoming increasingly urgent for the field to develop its own research agenda and take charge of it. This will require a large-scale internationally coordinated strategy and implementation process. This too will need to be developed. Significant portions of the field will need to come together to achieve these things. Before such a large scale collaboration is sought and achieved, practitioners, schools and institutions of acupuncture can begin to lay the ground work for such efforts by conducting some of the less resource demanding studies, especially those listed in Table 1, Table 2, Table 3.

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