Fischer Felix, Lewith George, Witt Claudia M, Linde Klaus, von Ammon Klaus, Cardini Francesco, Falkenberg Torkel, Fønnebø Vinjar, Johannessen Helle, Reiter Bettina, Uehleke Bernhard, Weidenhammer Wolfgang, Brinkhaus Benno
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany.
Forsch Komplementmed. 2014;21(2):e1-16. doi: 10.1159/000360744. Epub 2014 Mar 24.
The CAMbrella coordination action was funded within the Framework Programme 7. Its aim is to provide a research roadmap for clinical and epidemiological research for complementary and alternative medicine (CAM) that is appropriate for the health needs of European citizens and acceptable to their national research institutes and healthcare providers in both public and private sectors. One major issue in the European research agenda is the demographic change and its impact on health care. Our vision for 2020 is that there is an evidence base that enables European citizens to make informed decisions about CAM, both positive and negative. This roadmap proposes a strategic research agenda for the field of CAM designed to address future European health care challenges. This roadmap is based on the results of CAMbrella’s several work packages, literature reviews and expert discussions including a consensus meeting.
We first conducted a systematic literature review on key issues in clinical and epidemiological research in CAM to identify the general concepts, methods and the strengths and weaknesses of current CAM research. These findings were discussed in a workshop (Castellaro, Italy, September 7–9th 2011) with international CAM experts and strategic and methodological recommendations were defined in order to improve the rigor and relevance of CAM research. These recommendations provide the basis for the research roadmap, which was subsequently discussed in a consensus conference (Järna, Sweden, May 9–11th 2012) with all CAMbrella members and the CAMbrella advisory board. The roadmap was revised after this discussion in CAMbrella Work Package (WP) 7 and finally approved by CAMbrella’s scientific steering committee on September 26th 2012.
Our main findings show that CAM is very heterogenous in terms of definitions and legal regulations between the European countries. In addition, citizens’ needs and attitudes towards CAM as well as the use and provision of CAM differ significantly between countries. In terms of research methodology, there was consensus that CAM researchers should make use of all the commonly accepted scientific research methods and employ those with utmost diligence combined in a mixed methods framework.
We propose 6 core areas of research that should be investigated to achieve a robust knowledge base and to allow stakeholders to make informed decisions. These are: Research into the prevalence of CAM in Europe: Reviews show that we do not know enough about the circumstances in which CAM is used by Europeans. To enable a common European strategic approach, a clear picture of current use is of the utmost importance. Research into differences regarding citizens’ attitudes and needs towards CAM: Citizens are the driver for CAM utilization. Their needs and views on CAM are a key priority, and their interests must be investigated and addressed in future CAM research. Research into safety of CAM: Safety is a key issue for European citizens. CAM is considered safe, but reliable data is scarce although urgently needed in order to assess the risk and cost-benefit ratio of CAM. Research into the comparative effectiveness of CAM: Everybody needs to know in what situation CAM is a reasonable choice. Therefore, we recommend a clear emphasis on concurrent evaluation of the overall effectiveness of CAM as an additional or alternative treatment strategy in real-world settings. Research into effects of context and meaning: The impact of effects of context and meaning on the outcome of CAM treatments must be investigated; it is likely that they are significant. Research into different models of CAM health care integration: There are different models of CAM being integrated into conventional medicine throughout Europe, each with their respective strengths and limitations. These models should be described and concurrently evaluated; innovative models of CAM provision in health care systems should be one focus for CAM research. We also propose a methodological framework for CAM research. We consider that a framework of mixed methodological approaches is likely to yield the most useful information. In this model, all available research strategies including comparative effectiveness research utilising quantitative and qualitative methods should be considered to enable us to secure the greatest density of knowledge possible. Stakeholders, such as citizens, patients and providers, should be involved in every stage of developing the specific and relevant research questions, study design and the assurance of real-world relevance for the research. Furthermore, structural and sufficient financial support for research into CAM is needed to strengthen CAM research capacity if we wish to understand why it remains so popular within the EU. In order to consider employing CAM as part of the solution to the health care, health creation and self-care challenges we face by 2020, it is vital to obtain a robust picture of CAM use and reliable information about its cost, safety and effectiveness in real-world settings. We need to consider the availability, accessibility and affordability of CAM. We need to engage in research excellence and utilise comparative effectiveness approaches and mixed methods to obtain this data. Our recommendations are both strategic and methodological. They are presented for the consideration of researchers and funders while being designed to answer the important and implicit questions posed by EU citizens currently using CAM in apparently increasing numbers. We propose that the EU actively supports an EU-wide strategic approach that facilitates the development of CAM research. This could be achieved in the first instance through funding a European CAM coordinating research office dedicated to foster systematic communication between EU governments, public, charitable and industry funders as well as researchers, citizens and other stakeholders. The aim of this office would be to coordinate research strategy developments and research funding opportunities, as well as to document and disseminate international research activities in this field. With the aim to develop sustainability as second step, a European Centre for CAM should be established that takes over the monitoring and further development of a coordinated research strategy for CAM, as well as it should have funds that can be awarded to foster high quality and robust independent research with a focus on citizens health needs and pan-European collaboration. We wish to establish a solid funding for CAM research to adequately inform health care and health creation decision-making throughout the EU. This centre would ensure that our vision of a common, strategic and scientifically rigorous approach to CAM research becomes our legacy and Europe’s reality. We are confident that our recommendations will serve these essential goals for EU citizens.
“CAMbrella协调行动”是在第七框架计划内获得资助的。其目标是为补充和替代医学(CAM)的临床和流行病学研究提供一个研究路线图,该路线图要适合欧洲公民的健康需求,并为其公共和私营部门的国家研究机构及医疗服务提供者所接受。欧洲研究议程中的一个主要问题是人口结构变化及其对医疗保健的影响。我们对2020年的愿景是,建立一个证据基础,使欧洲公民能够就是否使用CAM做出明智的决策,无论是积极的还是消极的决策。本路线图为CAM领域提出了一项战略研究议程,旨在应对未来欧洲医疗保健方面的挑战。该路线图基于CAMbrella的多个工作包、文献综述以及包括一次共识会议在内的专家讨论结果。
我们首先对CAM临床和流行病学研究的关键问题进行了系统的文献综述,以确定当前CAM研究的一般概念、方法以及优势和劣势。这些研究结果在一次研讨会(2011年9月7 - 9日,意大利卡斯特拉罗)上与国际CAM专家进行了讨论,并确定了战略和方法建议,以提高CAM研究的严谨性和相关性。这些建议为研究路线图提供了基础,随后在一次共识会议(2012年5月9 - 11日,瑞典耶尔纳)上与所有CAMbrella成员及CAMbrella咨询委员会进行了讨论。在CAMbrella工作包7中进行此次讨论后,路线图得到修订,最终于2012年9月26日获得CAMbrella科学指导委员会的批准。
我们的主要研究结果表明,在欧洲国家之间,CAM在定义和法律法规方面差异很大。此外,各国公民对CAM的需求和态度以及CAM的使用和提供情况也存在显著差异。在研究方法方面,大家达成的共识是,CAM研究人员应运用所有普遍接受的科学研究方法,并在混合方法框架中极其勤勉地结合使用这些方法。
我们提出了6个核心研究领域,应进行调查以建立坚实的知识库,并使利益相关者能够做出明智决策。这些领域包括:欧洲CAM的流行情况研究:综述表明,我们对欧洲人使用CAM的情况了解不足。为了采取共同的欧洲战略方法,清楚了解当前的使用情况至关重要。公民对CAM的态度和需求差异研究:公民是CAM使用的驱动因素。他们对CAM的需求和看法是关键优先事项,其利益必须在未来的CAM研究中得到调查和关注。CAM的安全性研究:安全性是欧洲公民关注的关键问题。CAM被认为是安全的,但可靠数据稀缺,尽管评估CAM的风险和成本效益比迫切需要这些数据。CAM的比较有效性研究:每个人都需要知道在何种情况下CAM是合理选择。因此,我们建议明确强调在现实环境中对CAM作为附加或替代治疗策略的整体有效性进行同步评估。背景和意义的影响研究:必须调查背景和意义的影响对CAM治疗结果的作用;其影响可能很大。CAM医疗保健整合的不同模式研究:在欧洲各地,有不同的将CAM整合到传统医学中的模式,每种模式都有其各自的优势和局限性。应描述并同步评估这些模式;医疗保健系统中CAM提供的创新模式应成为CAM研究的一个重点。我们还为CAM研究提出了一个方法框架。我们认为,混合方法框架可能会产生最有用的信息。在这个模式中,应考虑所有可用的研究策略,包括利用定量和定性方法的比较有效性研究,以便我们能够获取尽可能多的知识。利益相关者,如公民、患者和提供者,应参与制定具体且相关的研究问题、研究设计以及确保研究与现实世界相关性的每个阶段。此外,如果我们希望了解为什么CAM在欧盟仍然如此受欢迎,就需要为CAM研究提供结构性和充足的资金支持,以加强CAM研究能力。为了考虑将CAM作为解决我们在2020年面临的医疗保健、健康促进和自我保健挑战的一部分,至关重要的是要全面了解CAM的使用情况以及关于其在现实环境中的成本、安全性和有效性的可靠信息。我们需要考虑CAM的可获得性、可及性和可承受性。我们需要追求卓越研究并利用比较有效性方法和混合方法来获取这些数据。我们的建议兼具战略性和方法性。它们供研究人员和资助者参考,同时旨在回答目前越来越多使用CAM的欧盟公民提出的重要且隐含的问题。我们建议欧盟积极支持一项全欧盟范围的战略方法,以促进CAM研究发展。首先可以通过资助一个欧洲CAM协调研究办公室来实现这一目标,该办公室致力于促进欧盟各国政府、公共、慈善和行业资助者以及研究人员、公民和其他利益相关者之间的系统沟通。该办公室的目标是协调研究战略发展和研究资助机会,以及记录和传播该领域的国际研究活动。作为第二步,为了实现可持续发展,应设立一个欧洲CAM中心,该中心负责监督和进一步发展CAM的协调研究战略,并且应有资金可用于资助高质量且有力的独立研究,重点关注公民健康需求和泛欧合作。我们希望为CAM研究建立稳固的资金支持,以便为整个欧盟的医疗保健和健康促进决策提供充分信息。该中心将确保我们对CAM研究采取共同、战略且科学严谨方法的愿景成为我们的遗产和欧洲的现实。我们相信我们的建议将有助于实现欧盟公民的这些重要目标。