One of the contexts in which the need for a focused CAM research agenda has been extensively discussed is IN-CAM (Canadian Interdisciplinary Network for CAM Research 2003). IN-CAM is an interdisciplinary research network of over 1,000 members, funded by the Canadian Institutes of Health Research (CIHR) and the Natural Health Products Directorate of Health Canada (Health Canada 2005), with the mission to create a sustainable, well-connected, highly trained Canadian CAM research community. It has two primary objectives: to build research capacity and to facilitate high-quality CAM health services and policy research in Canada. In order to provide direction for the development of high-quality CAM research, IN-CAM has engaged in a strategic planning process to (1) identify unanswered questions, (2) identify the most important/relevant questions and (3) develop a plan of action to answer those questions. This strategic planning process consisted of three stages:
- Modified Delphi Process to obtain consensus from those interested and involved in CAM research across Canada regarding priority research areas. The more than 400 individuals who were IN-CAM members at the time were asked for their input.
- Consultations with Advisory Board1 members to determine which topics identified through the Delphi Process should become IN-CAM priorities, based on perceived importance to Canadian health services and policy.
- Strategic planning sessions: two one-day meetings of established researchers, practitioners, policy makers and funders to identify and prioritize specific research questions and projects within the identified priority research areas and to develop a plan to begin answering those questions based on the interest and expertise available in the Network.
Three priority research areas were identified: CAM healthcare delivery and policy; the development of methods to study the safety, efficacy and effectiveness of CAM; and knowledge transfer/translation as it relates to these two areas. (See Table .) A research agenda within each of these areas is described in more detail below.
CAM research priority areas identified in IN-CAM Delphi Consultation
CAM healthcare delivery and policy
Canada has new natural health product regulations, and several provinces are currently debating the possible regulation of CAM practitioner groups. Thus, research in the area of CAM regulation is needed immediately to help guide new policy development. Most CAM practices are not currently regulated in Canada, a situation that has led to a proliferation of practitioners – only some of whom have extensive knowledge and expertise – who offer a variety of services, including acupuncture,2
advice about the medicinal use of herbs and homeopathy.3
It appears that many practitioners offer advice with little or no training, raising concerns about potential interactions between these therapies and conventional treatments and delays in individuals’ seeking appropriate medical care for serious conditions. Regulation changes being undertaken by individual jurisdictions can serve as case studies that provide a unique opportunity for Canadian researchers to address CAM policy questions. For example, British Columbia is in the process of implementing regulation for traditional Chinese medicine (TCM) and acupuncture (the first Canadian province to do so). Lessons learned from this experience would be very instructive for the rest of the country (especially Ontario, where the Ministry of Health has pledged to regulate TCM and acupuncture as early as 2006), yet little research appears to be under way.
While evidence is a very complex concept, there is no doubt that healthcare decisions should be based on evidence of some sort. Determining what constitutes acceptable evidence of safety, efficacy and quality of CAM practice, and establishing that evidence base, are crucial for rational policy development. For example, Health Canada (2005) has developed “standards of evidence” for deciding which health claims (e.g., “product X treats symptom Y”) will be accepted on labels of licensed natural health products. Although these standards were developed as part of a national consultation process, they remain controversial. For example, there is ongoing debate about the role of historical “evidence” and the need for randomized controlled trials. Healthy debate in this area should be encouraged; as new standards of evidence are implemented, their impact needs to be assessed to inform future policy development.
With the large number of innovative healthcare initiatives that are emerging, process and outcome evaluation of the organization and delivery of “integrative”4
healthcare is essential. As provinces increasingly move to more interdisciplinary models of care, especially in the field of primary care, questions are being asked about who should be part of the care team. Canadians are increasingly seeking the services of chiropractors, massage therapists, naturopaths and others who are primary-contact healthcare practitioners. Whether CAM providers should be integrated into emerging models of team-based primary care, and the impact such integration would have on insurers and the health of Canadians, are just two issues that need to be addressed. At least three different demonstration projects funded by the Primary Healthcare Transition Fund5
are beginning to provide preliminary answers to some of these questions using chiropractic care as an example service, but much more work is needed in other disciplines. The new natural health product regulations and the expanding regulation of CAM practices in some provinces are likely to spark renewed efforts by users to have these products and services declared “medical expenses” and to seek compensation from public and private insurers. Proponents of such coverage argue that CAM, with its minimally invasive focus on preventive care, is a cost-effective option, yet little research has been done in this area to inform policy decisions.
Developing methods to study the safety, efficacy and effectiveness of CAM
Evidence of the safety and efficacy of CAM is needed to underpin policy and treatment decisions. Yet, the complexity and individualized nature of many CAM interventions make obtaining this evidence challenging. For example, the patient–practitioner relationship and the healing environment are often integral components of the healing process; the patient is usually an active participant in the treatment and treatment decision-making; treatments are individualized; and expected and intended outcomes extend beyond the relief of disease-based symptoms. This complexity has led to the need to develop and study methods to assess complex interventions or “whole systems”6
of healthcare. Assessment methods used in biomedicine may be useful but do not always transfer easily to the study of CAM products and therapies. It is generally agreed that no single method will suffice and that interdisciplinary teams employing multi-method programs of research (including both qualitative and quantitative methods) are needed (Verhoef et al. 2005). The same applies to the evaluation of new models of delivering care in both CAM and conventional medicine. Interdisciplinary stroke units, diabetes clinics and integrative medicine clinics, where CAM and conventional practitioners work together in teams, present the same methodological challenges.
One of the most important issues when designing methods of evaluation is choosing outcomes that are relevant to patients, practitioners and policy makers. Capturing patients’ experiences means not only assessing disease-specific signs and symptoms such as blood pressure, tumour growth, perceptions of pain and range of motion, but also information about the severity of the disease condition, overall mental, emotional and spiritual well-being and treatment experiences. In most cases, traditional quality-of-life measures do not capture the wide range of changes and experiences that patients report in qualitative interviews. Practitioners need to know how the CAM intervention affects traditional disease markers, but also the ways in which it changes how people feel and cope with their disease process. A given intervention may not decrease the size of a tumour or increase survival rates, but it may decrease feelings of depression or the amount of sleeping medication a patient needs and may enhance patients’ abilities to interact and connect with family and friends. Appropriate outcome measures will capture this wide range of patient-driven outcomes so that the full potential of CAM may be realized, while at the same time recognizing the need for objective endpoints to underpin policy decisions. Finally, policy makers need to weigh the wide range of potential benefits of CAM interventions against their costs, a task that can be challenging when dealing with intangible benefits such as personal transformation (Mulkins and Verhoef 2004) compared to, say, reduced need for pain medication.
The transfer of CAM research knowledge to key stakeholders, including CAM and conventional practitioners, consumers and decision-makers, is of paramount importance for evidence-based practice, informed decision-making and rational policy development. In order to encourage evidence-based CAM practice, education and training of CAM practitioners is of paramount importance. CAM practitioners must understand how to appraise CAM research and how to apply that knowledge effectively in their practice. Further, because CAM practitioners may be the most appropriate individuals to conduct culturally appropriate CAM research, research is required to understand how best to teach busy practitioners the necessary research skills.
At the same time, conventional practitioners need to be educated about CAM: many patients ask them about CAM alternatives, and these practitioners may recognize potential CAM–conventional medicine interactions. Research is needed to evaluate different models of integrating CAM education into already-packed conventional medical training programs.
Last, the provision of research-based information to the public, practitioners and policy makers must be a priority. Research is needed to understand the types and formats of information that each group prefers and to develop and evaluate information provision strategies.
However, knowledge transfer is more than simply the dissemination of research findings. It should also include dialogue with the users of knowledge (i.e., patients, practitioners and policy makers) to ensure that the questions researchers ask are relevant to real-world problems and that programs of research are designed to provide the information needed for decision-making. For example, information from research projects designed to assess the rate and types of adverse events associated with acupuncture in an unregulated jurisdiction, compared to those in a jurisdiction where acupuncture practice is regulated, would be very useful to policy makers trying to decide whether to regulate acupuncture. IN-CAM provides a forum for policy makers, decision-makers and practitioners to share research questions and results. It is the opportunity for dialogue, and for connecting people asking questions to people who may have answers (or at least the skills to find answers), that makes a research network so important.