Helle Johannessen

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.

EU FP7 Project ‘CAMbrella’ to Build European Research Network for Complementary and Alternative Medicine

Background: The status of complementary and alternative medicine (CAM) within the EU needs clarification. The definition and terminology of CAM is heterogeneous. The therapies, legal status, regulations and approaches used vary from country to country but there is widespread use by EU citizens. A coordination project funded by the EU has been launched to improve the knowledge about CAM in Europe. Objectives and Methods: The project aims to evaluate the conditions surrounding CAM use and provision in Europe and to develop a roadmap for European CAM research. Specific objectives are to establish an EU network involving centres of research excellence for collaborative projects, to develop consensus-based terminology to describe CAM interventions, to create a knowledge base that facilitates the understanding of patient demand for CAM and its prevalence, to review the current legal status and policies governing CAM provision, and to explore the needs and attitudes of EU citizens with respect to CAM. Based on this information a roadmap will be created that will enable sustainable and prioritised future European research in CAM. CAMbrella encompasses 16 academic research groups from 12 European countries and will run for 36 months starting from January 2010. The project will be delivered in 9 work packages coordinated by a Management Board and directed by a Scientific Steering Committee with support of an Advisory Board. Output: The outcomes generated will be disseminated through the project’s website, peer review open access publications and a final conference, with emphasis on current and future EU policies, addressing different target audiences.

What Attitudes and Needs Do Citizens in Europe Have in Relation to Complementary and Alternative Medicine

Background: Surveys from several European countries suggest a European-wide increase in the use of Complementary and Alternative Medicine (CAM). To safeguard citizens’ rights concerning their healthcare, it is critical to gain an overview of citizens’ attitudes and to understand their expectations and needs regarding CAM. Methods: A review of literature was undertaken, based on systematic searches of the following electronic databases: PubMed, Web of Science, CINHAL, AMED, PsycINFO and PsycArticles; 189 articles met inclusion criteria. Articles were analysed thematically and their reporting quality assessed. Results: Despite the limited availability of research-based knowledge about citizens’ attitudes and needs concerning CAM in many European countries, some trends can be noted. Many citizens hold positive attitudes to CAM and wish for increasing access to CAM provision. Citizens call for impartial, reliable and trustworthy information to support informed decision-making, and some citizens wish for greater support and involvement of biomedical healthcare professionals in facilitating their healthcare choices. While citizens value distinct aspects of CAM practice, they are also critical consumers and support clear regulatory and educational frameworks to ensure the quality and safety of CAM provision and medicinal products. Conclusion: To gain knowledge on citizens’ needs and attitudes to CAM across Europe further research is required on 3 main issues: i) how citizens across Europe obtain information about CAM and the needs they may have for trustworthy information sources, ii) the local situations for accessing CAM and iii) citizens’ perspectives on the quality of care and safety of CAM provision and products.

Challenges in End-of-Life Decisions in the Intensive Care Unit: An Ethical Perspective

When making end-of-life decisions in intensive care units (ICUs), different staff groups have different roles in the decision-making process and may not always assess the situation in the same way. The aim of this study was to examine the challenges Danish nurses, intensivists, and primary physicians experience with end-of-life decisions in ICUs and how these challenges affect the decision-making process. Interviews with nurses, intensivists, and primary physicians were conducted, and data is discussed from an ethical perspective. All three groups found that the main challenges were associated with interdisciplinary collaboration and future perspectives for the patient. Most of these challenges were connected with ethical issues. The challenges included different assessments of treatment potential, changes and postponements of withholding and withdrawing therapy orders, how and when to identify patients’ wishes, and suffering caused by the treatment. To improve end-of-life decision-making in the ICU, these challenges need to be addressed by interdisciplinary teams.

A Research Roadmap for Complementary and Alternative Medicine - What We Need to Know by 2020

BACKGROUND 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.

Key Issues in Clinical and Epidemiological Research in Complementary and Alternative Medicine - a Systematic Literature Review

Background: In the last 2 decades there has been a large increase in publications on complementary and alternative medicine (CAM). However, CAM research methodology was heterogeneous and often of low quality. The aim of this systematic review was to investigate scientific publications with regards to general issues, concepts and strategies. We also looked at research priorities and methods employed to evaluate the clinical and epidemiological research of CAM in the past to identify the basis for consensus-based research strategies. Methods: We performed a systematic literature search for papers published between 1990 and 2010 in 7 electronic databases (Medline, Web of Science, PsychArticles, PsycInfo, CINAHL, EMBASE and Cochrane Library) on December 16 and 17, 2010. In addition, experts were asked to nominate relevant papers. Inclusion criteria were publications dealing with research methodology, priorities or complexities in the scientific evaluation of CAM. All references were assessed in a multistage process to identify relevant papers. Results: From the 3,279 references derived from the search and 98 references contributed by CAM experts, 170 papers fulfilled the criteria and were included in the analysis. The following key issues were identified: difficulties in past CAM research (e.g., randomisation, blinding), utility of quantitative and qualitative research methods in CAM, priority setting in CAM research and specific issues regarding various CAM modalities. Conclusions: Most authors vote for the use of commonly accepted research methods to evaluate CAM. There was broad consensus that a mixed methods approach is the most suitable for gathering conclusive knowledge about CAM.

Energy Healing for Cancer: A Critical Review

Background: This article explores the evidence base of efficacy and effectiveness of ‘energy healing’ for cancer patients. The term ‘energy healing’ refers to a wide variety of therapies which are based on the premise that the healer transfers energy to the patient. Among the most researched forms of energy healing are reiki, therapeutic touch and healing touch. Material and Methods: PubMed, AMED, JStor, Social Science Citation Index and PsycInfo databases were searched, and articles were rated according to the SIGN (Scottish Intercollegiate Guidelines Network) quality scale. Six quantitative and two qualitative studies on the efficacy and effectiveness of energy healing for cancer patients met the inclusion criteria. Results: None of the studies are of a size or quality that allows to draw reliable conclusions. The results of the studies are, however, interesting and should be considered when developing new studies and hypotheses on working mechanisms. Conclusion: The existing research does not allow conclusions regarding the efficacy or effectiveness of energy healing. Future studies should adhere to existing standards of research on the efficacy and effectiveness of a treatment, and given the complex character of potential outcomes, cross-disciplinary methodologies may be relevant. To extend the scope of clinical trials, psychosocial processes should be taken into account and explored, rather than dismissed as placebo.

Medical adherence to topical corticosteroid preparations prescribed for psoriasis: A systematic review.

Abstract Objective: Topical corticosteroids and corticosteroid combinations are the principal treatments in psoriasis. The aim of this study was to investigate published literature dealing with medical adherence to topical corticosteroid or corticosteroid combinations in patients with psoriasis. Materials and methods: Systematic electronic searches in English language literature were done until September 2015 without publication date restriction. Results: We identified 11 studies consisting of five surveys, two prospective studies, one qualitative study, one mixed-method study, one register study, and one interventional study. Observation periods varied and rates of nonadherence ranged from 8% to 88.3%. The rates were reported by patients on eight nonvalidated scales and one validated scale, measured by medication weight in two studies, and in two studies rates of nonadherence were measured using prescription registers. Thirty-four multifactorial determinants of nonadherence were found. One designed intervention consisted of a disease management program, which improved adherence in the study period. Overall, the studies included were heterogeneous in design and had a high risk of bias. Conclusion: To improve health outcome in topical treatment of psoriasis, further studies should be conducted addressing determinants of nonadherence and test interventions to improve adherence. Validated measurements of medical nonadherence, prescription registers, or medication-weight are needed.

Worldwide utilization of topical remedies in treatment of psoriasis: a systematic review.

Abstract Objective: To review published literature describing the global use of topical antipsoriatics. Materials and methods: Search for English-language articles in Embase, Pubmed, PsycINFO and Cochrane Library. Results: Fifty-four selected publications were found, describing psoriasis patients’ use of topical antipsoriatics, using six different methods to collect data. The eight most frequently used topical treatments from the regions North/South America, North/Central/South Europe, Asia, Middle East and Australia were: corticosteroids used by 16–79%, complementary and alternative medicines used by 10–62%, phototherapies used by 0.4–75%, calcipotriol used by 4.2–73%, corticosteroid/calcipotriol combinations used by 3.3–71%, tar used by 0.8–66%, anthralin used by 15% and emollients used as monotherapy by 1–23%. Rates of patient-reported adherence to topical remedies ranged from 51% to 90% and rates of patient-reported satisfaction with topical as it pertains to symptom control ranged from 12% to 52%. Conclusion: The identified use patterns are varying and reflect a lack of data from large parts of the world and noncomparable studies using heterogeneous study designs. However, this study emphasizes the importance of medical professionals involvement of the patient with respect to choosing prescribed topical treatment and the possibility of patients’ use of alternative treatments. More drug utilization studies, both survey and register based, from different parts of the world are needed to provide more conclusive evidence about patients’ use of topical antipsoriatics.

How can we assess the burden of muscle, bone and joint conditions in rural Botswana: context and methods for the MuBoJo focused ethnography

BackgroundMusculoskeletal diseases are the most common causes of long-term pain and disability worldwide and a growing international public health concern. However, the everyday burden and impact of musculoskeletal conditions are not well understood, especially among people living in low- and middle-income countries in Africa. Since 2011, World Spine Care, a nongovernmental organisation, has collaborated with the Botswana Ministry of Health to open spine care centres and to conduct research. The broad aim of the Muscle, Bone and Joint (MuBoJo) research project is to examine the sociocultural, organisational and clinical characteristics for the burden of living with and caring for people living with musculoskeletal conditions in rural Botswana. In this paper, we describe the community context, theoretical framework, and research methods to address the project aim with a qualitative study.Methods/DesignThis focused ethnography is based on eight months (November 2011, April 2013, October 2013-March 2014) of fieldwork in Botswana. The project was theoretically informed by the concepts of explanatory models of illness, social suffering, and biographical disruption. Data collection included fieldnotes, non-participant and participant observations, and informal and in-depth interviews with villagers and healthcare providers. Villager interviews were typically conducted in Setswana with an interpreter. Audio recordings were transcribed verbatim in the language spoken with Setswana contextually translated into English. Computer software supported qualitative data management. Analysis is ongoing using constant comparison and a template organising style to facilitate pattern-finding and reveal insights for the burden and care of musculoskeletal conditions.DiscussionFindings from the MuBoJo Project will document the context of musculoskeletal burden, illness beliefs, self-care behaviours, and healthcare options in a Botswana rural village. These data will inform ongoing efforts to establish spine care clinics for underserved populations in low-middle income countries and sustain these healthcare services through local providers and volunteer health professionals. This study also will generate new knowledge about the burden and impact of muscle, bone and joint disorders for cross-cultural comparisons and patient-centred interventions.ConclusionsOur systematic and transparent methodology to conduct musculoskeletal research in more than one language and in a cross-cultural setting may be useful for investigators and NGO healthcare personnel.