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1.  High prevalence but limited evidence in complementary and alternative medicine: guidelines for future research 
The use of complementary and alternative Medicine (CAM) has increased over the past two decades in Europe. Nonetheless, research investigating the evidence to support its use remains limited. The CAMbrella project funded by the European Commission aimed to develop a strategic research agenda starting by systematically evaluating the state of CAM in the EU. CAMbrella involved 9 work packages covering issues such as the definition of CAM; its legal status, provision and use in the EU; and a synthesis of international research perspectives. Based on the work package reports, we developed a strategic and methodologically robust research roadmap based on expert workshops, a systematic Delphi-based process and a final consensus conference. The CAMbrella project suggests six core areas for research to examine the potential contribution of CAM to the health care challenges faced by the EU. These areas include evaluating the prevalence of CAM use in Europe; the EU cititzens’ needs and attitudes regarding CAM; the safety of CAM; the comparative effectiveness of CAM; the effects of meaning and context on CAM outcomes; and different models for integrating CAM into existing health care systems. CAM research should use methods generally accepted in the evaluation of health services, including comparative effectiveness studies and mixed-methods designs. A research strategy is urgently needed, ideally led by a European CAM coordinating research office dedicated to fostering systematic communication between EU governments, the public, charitable and industry funders, researchers and other stakeholders. A European Centre for CAM should also be established to monitor and further a coordinated research strategy with sufficient funds to commission and promote high quality, independent research focusing on the public’s health needs and pan-European collaboration. There is a disparity between highly prevalent use of CAM in Europe and solid knowledge about it. A strategic approach on CAM research should be established to investigate the identified gaps of knowledge and to address upcoming health care challenges.
doi:10.1186/1472-6882-14-46
PMCID: PMC3931324  PMID: 24499316
Complementary and alternative medicine; Research strategy; Randomized clinical trials; Safety; Qualitative studies; Comparative effectiveness research
2.  Development of the adult and child complementary medicine questionnaires fielded on the National Health Interview Survey 
The 2002, 2007, and 2012 complementary medicine questionnaires fielded on the National Health Interview Survey provide the most comprehensive data on complementary medicine available for the United States. They filled the void for large-scale, nationally representative, publicly available datasets on the out-of-pocket costs, prevalence, and reasons for use of complementary medicine in the U.S. Despite their wide use, this is the first article describing the multi-faceted and largely qualitative processes undertaken to develop the surveys. We hope this in-depth description enables policy makers and researchers to better judge the content validity and utility of the questionnaires and their resultant publications.
doi:10.1186/1472-6882-13-328
PMCID: PMC3882880  PMID: 24267412
Complementary therapies; Complementary medicine; Questionnaire development; Cognitive interviewing; National Health Interview Survey (NHIS)
3.  How to locate and appraise qualitative research in complementary and alternative medicine 
Background
The aim of this publication is to present a case study of how to locate and appraise qualitative studies for the conduct of a meta-ethnography in the field of complementary and alternative medicine (CAM). CAM is commonly associated with individualized medicine. However, one established scientific approach to the individual, qualitative research, thus far has been explicitly used very rarely. This article demonstrates a case example of how qualitative research in the field of CAM studies was identified and critically appraised.
Methods
Several search terms and techniques were tested for the identification and appraisal of qualitative CAM research in the conduct of a meta-ethnography. Sixty-seven electronic databases were searched for the identification of qualitative CAM trials, including CAM databases, nursing, nutrition, psychological, social, medical databases, the Cochrane Library and DIMDI.
Results
9578 citations were screened, 223 articles met the pre-specified inclusion criteria, 63 full text publications were reviewed, 38 articles were appraised qualitatively and 30 articles were included. The search began with PubMed, yielding 87% of the included publications of all databases with few additional relevant findings in the specific databases. CINHAL and DIMDI also revealed a high number of precise hits. Although CAMbase and CAM-QUEST® focus on CAM research only, almost no hits of qualitative trials were found there. Searching with broad text terms was the most effective search strategy in all databases.
Conclusions
This publication presents a case study on how to locate and appraise qualitative studies in the field of CAM. The example shows that the literature search for qualitative studies in the field of CAM is most effective when the search is begun in PubMed followed by CINHAL or DIMDI using broad text terms. Exclusive CAM databases delivered no additional findings to locate qualitative CAM studies.
doi:10.1186/1472-6882-13-125
PMCID: PMC3778880  PMID: 23731997
CAM; Qualitative studies; Meta-Ethnography; Quality appraisal
4.  Effectiveness guidance document (EGD) for acupuncture research - a consensus document for conducting trials 
Background
There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making.
Methods
Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved.
Results
Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.
Conclusion
The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.
doi:10.1186/1472-6882-12-148
PMCID: PMC3495216  PMID: 22953730
Comparative effectiveness research; Effectiveness guidance document; Acupuncture
5.  A qualitative study on the term CAM: is there a need to reinvent the wheel? 
Background
As complementary and alternative medicine (CAM) has developed extensively, uncertainty about the appropriateness of the terms CAM and other CAM-related terms has grown both in the research and practice communities. Various terms and definitions have been proposed over the last three decades, highlighting how little agreement exits in the field. Contextual use of current terms and their respective definitions needs to be discussed and addressed.
Methods
Relying upon the results of a large international Delphi survey on the adequacy of the term CAM, a focus group of 13 international experts in the field of CAM was held. A forum was also set up for 28 international experts to discuss and refine proposed definitions of both CAM and integrative healthcare (IHC) terms. Audio recordings of the meeting and forum discussion threads were analyzed using interpretive description.
Results
Multiple terms to describe the therapies, products, and disciplines often referred to as CAM, were considered. Even though participants generally agreed there is a lack of optimal definitions for popular CAM-related umbrella terms and that all terms that have so far been introduced are to some extent problematic, CAM and IHC remained the most popular and accepted terms by far. The names of the specific disciplines were also deemed adequate in certain contexts. Focus group participants clarified the context in which those three terms are appropriate. Existing and emergent definitions of both CAM and integrative healthcare terms were discussed.
Conclusions
CAM and other related terms could be used more effectively, provided they are used in the proper context. It appears difficult for the time being to reach a consensus on the definition of the term CAM due to the uncertainty of the positioning of CAM in the contemporary healthcare systems. While umbrella terms such as CAM and IHC are useful in the context of research, policy making and education, relevant stakeholders should limit the use of those terms.
doi:10.1186/1472-6882-12-131
PMCID: PMC3462712  PMID: 22909051
Definition; Term; Focus group; International experts; Integrative healthcare
6.  An investigation of multidisciplinary complex health care interventions - steps towards an integrative treatment model in the rehabilitation of People with Multiple Sclerosis 
Background
The Danish Multiple Sclerosis Society initiated a large-scale bridge building and integrative treatment project to take place from 2004–2010 at a specialized Multiple Sclerosis (MS) hospital. In this project, a team of five conventional health care practitioners and five alternative practitioners was set up to work together in developing and offering individualized treatments to 200 people with MS. The purpose of this paper is to present results from the six year treatment collaboration process regarding the development of an integrative treatment model.
Discussion
The collaborative work towards an integrative treatment model for people with MS, involved six steps: 1) Working with an initial model 2) Unfolding the different treatment philosophies 3) Discussing the elements of the Intervention-Mechanism-Context-Outcome-scheme (the IMCO-scheme) 4) Phrasing the common assumptions for an integrative MS program theory 5) Developing the integrative MS program theory 6) Building the integrative MS treatment model. The model includes important elements of the different treatment philosophies represented in the team and thereby describes a common understanding of the complexity of the courses of treatment.
Summary
An integrative team of practitioners has developed an integrative model for combined treatments of People with Multiple Sclerosis. The model unites different treatment philosophies and focuses on process-oriented factors and the strengthening of the patients’ resources and competences on a physical, an emotional and a cognitive level.
doi:10.1186/1472-6882-12-50
PMCID: PMC3475037  PMID: 22524586
7.  An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials 
Background
Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting.
Methods
Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section.
Results
Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting.
For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045).
Conclusions
An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement.
doi:10.1186/1472-6882-11-67
PMCID: PMC3176483  PMID: 21859470
8.  The use of economic evaluation in CAM: an introductory framework 
Background
For CAM to feature prominently in health care decision-making there is a need to expand the evidence-base and to further incorporate economic evaluation into research priorities.
In a world of scarce health care resources and an emphasis on efficiency and clinical efficacy, CAM, as indeed do all other treatments, requires rigorous evaluation to be considered in budget decision-making.
Methods
Economic evaluation provides the tools to measure the costs and health consequences of CAM interventions and thereby inform decision making. This article offers CAM researchers an introductory framework for understanding, undertaking and disseminating economic evaluation. The types of economic evaluation available for the study of CAM are discussed, and decision modelling is introduced as a method for economic evaluation with much potential for use in CAM. Two types of decision models are introduced, decision trees and Markov models, along with a worked example of how each method is used to examine costs and health consequences. This is followed by a discussion of how this information is used by decision makers.
Conclusions
Undoubtedly, economic evaluation methods form an important part of health care decision making. Without formal training it can seem a daunting task to consider economic evaluation, however, multidisciplinary teams provide an opportunity for health economists, CAM practitioners and other interested researchers, to work together to further develop the economic evaluation of CAM.
doi:10.1186/1472-6882-10-66
PMCID: PMC2992473  PMID: 21067622
9.  Does pharmaceutical advertising affect journal publication about dietary supplements? 
Background
Advertising affects consumer and prescriber behaviors. The relationship between pharmaceutical advertising and journals' publication of articles regarding dietary supplements (DS) is unknown.
Methods
We reviewed one year of the issues of 11 major medical journals for advertising and content about DS. Advertising was categorized as pharmaceutical versus other. Articles about DS were included if they discussed vitamins, minerals, herbs or similar products. Articles were classified as major (e.g., clinical trials, cohort studies, editorials and reviews) or other (e.g., case reports, letters, news, and others). Articles' conclusions regarding safety and effectiveness were coded as negative (unsafe or ineffective) or other (safe, effective, unstated, unclear or mixed).
Results
Journals' total pages per issue ranged from 56 to 217 while advertising pages ranged from 4 to 88; pharmaceutical advertisements (pharmads) accounted for 1.5% to 76% of ad pages. Journals with the most pharmads published significantly fewer major articles about DS per issue than journals with the fewest pharmads (P < 0.01). Journals with the most pharmads published no clinical trials or cohort studies about DS. The percentage of major articles concluding that DS were unsafe was 4% in journals with fewest and 67% among those with the most pharmads (P = 0.02). The percentage of articles concluding that DS were ineffective was 50% higher among journals with more than among those with fewer pharmads (P = 0.4).
Conclusion
These data are consistent with the hypothesis that increased pharmaceutical advertising is associated with publishing fewer articles about DS and publishing more articles with conclusions that DS are unsafe. Additional research is needed to test alternative hypotheses for these findings in a larger sample of more diverse journals.
doi:10.1186/1472-6882-8-11
PMCID: PMC2322947  PMID: 18400092

Results 1-9 (9)