Iodine loaded nanoparticles with commercial applicability increase survival in mice cancer models with low degree of side effects.

BACKGROUND: The recorded use of iodine in medicine, dates to 5000 BC. Molecular iodine (I2 ) has been claimed to exert an antineoplastic effect that triggers apoptotic and re-differentiation mechanisms in different types of cancer cells in animal studies. Hitherto, all experiments published have been carried out with I2 diluted in water preparations resulting in the administration of ionized iodide, either alone or in combination with low levels of I2 . To maximize the levels of I2 by avoiding water solutions we have managed to develop a colloidal nano particle (NP) loaded with I2 with a Z-average of 7-23 nm with remarkable stability, preferable osmolality and commercial applicability. AIMS: Here we report the results from formulation and pre-clinical studies with the rationale: a) to find a tolerable dose of the I2 NP system delivered intravenously or per-orally, and b) to determine if the tolerable doses are efficacious in murine models of cancer. METHODS AND RESULTS: A novel drug delivery system with I2 NP was formulated and murine cancer models with CT26, MDA-MB-231 and LL/2 cells were used to analyse the efficacy. Despite the formulation challenges we were successful in constructing stable NPs loaded with I2 which have convincing commercial applicability. We conclude that administration of the NP I2 drug delivery system: 1. Blunted tumour growth in a xenograft breast cancer model; 2. Had a significant effect on survival in the orthotopic, syngeneic lung metastasis model; 3. Showed reduced tumour burden in post-mortem evaluation and; 4. Was associated with low degree of side effects. CONCLUSIONS: Taken all together, our findings indicate that the NP I2 drug delivery system may serve as a novel effective cancer treatment with low degree of side effects. This is something which needs further exploration including confirmation in future clinical trials.

Integrative nursing in Europe - A competency profile for nursing students validated in a Delphi-study.

BACKGROUND: Integrative nursing is a framework for providing holistic care and includes complementary therapies and non-pharmacological interventions. There is no common European approach on how to educate healthcare professionals on complementary therapies and non-pharmacological interventions for symptom management. Nurses report a lack of formal education as the main barrier to applying integrative nursing. OBJECTIVES: The aim of this study is to develop and validate integrative nursing learning outcomes in a competency profile for bachelor nursing students. METHODS: A two-round Delphi study was conducted with experts on integrative nursing and/or nurse education from eight European countries. The expert panelists rated their level of agreement with learning outcomes in relation to "Knowledge, Skills, Responsibility and Autonomy" on a nine-point Likert scale (1 = strongly disagree/9 = strongly agree) and were invited to add comments in an open text field. The Rand manual's description of levels of appropriateness was used, and experts' suggestions were analyzed thematically and used for reformulating or adding learning outcomes. RESULTS: In the first round, 19 out of 23 experts participated, versus 18 in the second round. In all, thirty-five learning outcomes within the three areas Knowledge, Skills and Responsibility/Autonomy were rated. After two Delphi rounds, twenty-four included learning outcomes were classified as appropriate, with median levels of appropriateness between 7 and 9; none had been classified as inappropriate. The learning outcomes include general knowledge about selected complementary therapies and non-pharmacological interventions, safety, national rules and regulations, communication and ethical skills and competencies for self-care actions and for applying simple evidence-based complementary therapies and non-pharmacological interventions in nursing practice. CONCLUSIONS: The competency profile consist of validated competencies; the high degree of consensus from the expert panelists makes the learning outcomes relevant for structuring a teaching module for nursing students about integrative nursing.

Educational courses on non-pharmacologic complementary interventions for nurses across Europe: The INES mapping pilot study.

BACKGROUND: Pharmacological interventions still form the mainstay of the management of pain, anxiety, sleep problems and discomfort. In Europe, an estimated 100 million people use complementary non-pharmacological interventions (NPIs) for these conditions. In their pre-registration education, nurses do not generally learn about the various types of NPIs and how patients and health care professionals can include NPIs complementary to their standard care. Some nursing schools in Europe offer elective courses on NPIs, often relying on individual initiatives. Little is publicly available about the content of these programmes and how they relate to the current nursing curriculum for EU countries. OBJECTIVES: This pilot study aims to explore and map the field of nursing education with regard to complementary NPIs for nurses in Europe. DESIGN: A web-based open-access questionnaire administered through the online survey tool LimeSurvey® was designed by the authors. PARTICIPANTS: The questionnaire was sent to a purposive sample of 49 experts on nurse education and complementary NPIs from 16 European countries. All levels of education were eligible for inclusion. METHODS: The questionnaire consisted of 35 items regarding course content, teaching material, teaching methods and methods of assessment. In addition, respondents were invited to perform a strengths, weaknesses, opportunities and threats (SWOT) analysis in relation to their education programme. Qualitative data was analyzed using a directive content analysis approach. RESULTS: Between January and May 2020, thirty-one completed questionnaires from ten different countries were returned (response rate 63.3%). Massage, meditation, mindfulness and relaxation are the most taught interventions. Anxiety, stress, chronic pain, depression and sleep problems are the most common symptoms addressed. CONCLUSIONS: Currently, a consistent and European approach to education for nurses on complementary NPIs and integrative nursing is lacking. Although taught at regular nursing educational institutes, the courses discussed here are not yet embedded in mainstream education for nurses.

Investigating the Long-Term Effect of an Interdisciplinary Multimodal Rehabilitation Program on Levels of Bioactive Lipids and Telomerase Activity in Blood from Patients with Chronic Pain.

Mechanism-based diagnosis and therapies for chronic pain are lacking. However, bio-psycho-social interventions such as interdisciplinary multimodal rehabilitation programs (IPRPs) have shown to be relatively effective treatments. In this context we aim to investigate the effects of IPRP on the changes in levels of bioactive lipids and telomerase activity in plasma, and if these changes are associated with changes in pain intensity and psychological distress. This exploratory study involves 18 patients with complex chronic pain participating in an IPRP. Self-reports of pain, psychological distress, physical activity, and blood samples were collected before the IPRP and at a six-month follow-up. Levels of arachidonoylethanolamide (AEA) and 2-arachidonoylglycerol (2-AG), palmitoylethanolamide (PEA), oleoylethanolamide (OEA), stearoylethanolamide (SEA), and telomerase activity were measured. Pain intensity was decreased, and SEA levels were increased at the six-month follow up. A significant correlation existed between changes in SEA levels and pain intensity. AEA levels, were inversely correlated with physical activity. Furthermore, 2-AG and telomerase activity was significantly correlated at the six-month follow-up. This study confirms that IPRP is relatively effective for reduction in chronic pain. Changes in SEA were correlated with changes in pain intensity, which might indicate that SEA changes reflect the pain reduction effects of IPRP.

Legislative landscape for traditional health practitioners in Southern African development community countries: a scoping review.

BACKGROUND AND OBJECTIVES: Globally, contemporary legislation surrounding traditional health practitioners (THPs) is limited. This is also true for the member states of the Southern African Development Community (SADC). The main aim of this study is to map and review THP-related legislation among SADC countries. In order to limit the scope of the review, the emphasis is on defining THPs in terms of legal documents. METHODS: This scoping review follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews methods. Two independent reviewers reviewed applicable legal definitions of THPs by searching the Southern African Legal Information Institute (SAFLII) database in April 2018 for legislation and bills. To identify additional legislation applicable in countries not listed on SAFLII and/or further relevant SADC legislation, the search engines, Google and PubMed, were used in August 2018 and results were reviewed by two independent reviewers. Full texts of available policy and legal documents were screened to identify policies and legislation relating to the regulation of THPs. Legislation was deemed relevant if it was a draft of or promulgated legislation relating to THPs. RESULTS: Four of 14 Southern African countries have legislation relating to THPs. Three countries, namely South Africa, Namibia and Zimbabwe, have acknowledged the roles and importance of THPs in healthcare delivery by creating a council to register and formalise practices, although they have not operationalised nor registered and defined THPs. In contrast, Tanzania has established a definition couched in terms that acknowledge the context-specific and situational knowledge of THPs, while also outlining methods and the importance of local recognition. Tanzanian legislation; thus, provides a definition of THP that specifically operationalises THPs, whereas legislation in South Africa, Namibia and Zimbabwe allocates the power to a council to decide or recognise who a THP is; this council can prescribe procedures to be followed for the registration of a THP. CONCLUSIONS: This review highlights the differences and similarities between the various policies and legislation pertaining to THPs in SADC countries. Legislation regarding THPs is available in four of the 14 SADC countries. While South Africa, Tanzania, Namibia and Zimbabwe have legislation that provides guidance as to THP recognition, registration and practices, THPs continue to be loosely defined in most of these countries. Not having an exact definition for THPs may hamper the promotion and inclusion of THPs in national health systems, but it may also be something that is unavoidable given the tensions between lived practices and rigid legalistic frameworks.

Changes in inflammatory plasma proteins from patients with chronic pain associated with treatment in an interdisciplinary multimodal rehabilitation program - an explorative multivariate pilot study.

It has been suggested that alterations in inflammation molecules maintain chronic pain although little is known about how these factors influence homeostatic and inflammatory events in common chronic pain conditions. Nonpharmacological interventions might be associated with alterations in inflammation markers in blood. This study of patients with chronic pain investigates whether an interdisciplinary multimodal rehabilitation program (IMMRP) was associated with significant alterations in the plasma pattern of 68 cytokines/chemokines 1 year after rehabilitation and whether such changes were associated with clinical changes. Blood samples and self-reports of pain, psychological distress, and physical activity of 25 complex chronic pain patients were collected pre-IMMRP and at 12-month follow-up. Analyses of inflammatory proteins (cytokines/chemokines/growth factors) were performed directly in plasma using the multiplex immunoassay technology Meso Scale Discovery. This explorative pilot study found that 12 substances, mainly pro-inflammatory, decreased after IMMRP. In two other relatively small IMMRP studies, four of these proinflammatory markers were also associated with decreases. The pattern of cytokines/chemokines pre-IMMRP was associated with changes in psychological distress but not with pain or physical activity. The present study cannot impute cause and effect. These results together with the results of the two previous IMMRP studies suggest that there is a need for larger and more strictly controlled studies of IMMRP with respect to inflammatory markers in blood. Such studies need to consider responders/non-responders, additional therapies, involved pain mechanisms and diagnoses. This and the two other studies open up for developing biologically measurable outcomes from plasma. Such biomarkers will be an important tool for further development of IMMRP and possibly other treatments for patients w ith chronic pain.

Exploring Sick Leave in Integrative Care-Retrospective Observations and Future Study Recommendations.

OBJECTIVES: To describe and contrast the prevalence and trends of sick leave in patients with pain or stress disorders referred to inpatient care that integrates conventional and complementary therapies, that is, integrative care (IC). METHODS: County council and social insurance data were used to retrospectively observe cross-sectional sick leave prevalence at four time points: 1 year before the first registered inpatient visit with the target diagnosis, after referral at index, and at 1 and 2 years after index. To contrast the IC findings, observations of patients with similar background characteristics referred to conventional care (CC) were used. RESULTS: The sick leave prevalence of IC pain patients and IC stress patients increased from the preceding year to peak at index, where after it decreased back toward preindex levels over 2 years. Overall sick leave prevalence was higher in IC than in CC, where analogous but lower prevalence trends of sick leave changes were observed. CONCLUSIONS: Observed sick leave prevalences, which were higher in IC than in CC, gradually decreased over time following IC or CC referral. While natural recovery or other reasons for change of sick leave cannot be excluded, future prospective and randomized clinical trials are recommended.

Measuring patients' health and suffering - the first stages of instrument development.

BACKGROUND: Patients have reported unanticipated and transformative health changes in existential character after integrative healthcare rehabilitation. Although there are several instruments measuring patients' experiences of health, identified instruments do not sufficiently capture patients' experiences of health and suffering after integrative health care. From a caring science perspective, health and suffering are understood as an integral part of human life. The objective of this study was to develop a first version of an instrument to measure patients' experiences of health and suffering, focusing on existential signs. METHODS: This Swedish study used a methodological design with three iterative phases for instrument development. Firstly, an item pool was developed based on qualitative patient interviews (n = 64). Subsequently, the relevance of the items was explored in two rounds of cognitive patient interviews (n = 5 and n = 3). Finally, expert consultations (n = 5) were used to further refine the instrument. The construct of the instrument, its dimensions and domains emerged through the iterative development process. RESULTS: The first phase development of the instrument resulted in two inter-related overarching dimensions: existential signs of 'Health' and 'Suffering', characterised by five domains: 'Life passion and energy', 'Personal freedom', 'Relationships', 'Presence in life' and 'Meaning'. Instrument items were formulated using contemporary language and word pairs to reflect a movement and relation between health and suffering. The cognitive interviews and expert opinions helped refine items and domains. CONCLUSIONS: The dimensions, domains and items of the instrument 'Existential signs of health and suffering' are well represented in caring science theories. Further clinical implementation and evaluation of the instrument, including psychometric properties, will allow for greater diversity in terms of context generalisability and patient characteristics. The instrument is anticipated to be of value for evaluations in research, development of healthcare practice and theory development in caring science.

Effect of traditional yoga, mindfulness-based cognitive therapy, and cognitive behavioral therapy, on health related quality of life: a randomized controlled trial on patients on sick leave because of burnout.

BACKGROUND: To explore if health related quality of life(HRQoL) increased after traditional yoga(TY), mindfulness based cognitive therapy(MBCT), or cognitive behavioral therapy(CBT), in patients on sick leave because of burnout. METHODS: Randomized controlled trial, blinded, in ninety-four primary health care patients, block randomized to TY, MBCT or CBT (active control) between September 2007 and November 2009. Patients were living in the Stockholm metropolitan area, Sweden, were aged 18-65 years and were on 50%-100% sick leave. A group treatment for 20 weeks, three hours per week, with homework four hours per week. HRQoL was measured by the SWED-QUAL questionnaire, comprising 67 items grouped into 13 subscales, each with a separate index, and scores from 0 (worse) to 100 (best). SWED-QUAL covers aspects of physical and emotional well-being, cognitive function, sleep, general health and social and sexual functioning. Statistics: Wilcoxon's rank sum and Wilcoxon's sign rank tests, Bonett-Price for medians and confidence intervals, and Cohen's D. RESULTS: Twenty-six patients in the TY (21 women), and 27 patients in both the MBCT (24 women) and in the CBT (25 women), were analyzed. Ten subscales in TY and seven subscales in MBCT and CBT showed improvements, p < 0.05, in several of the main domains affected in burnout, e.g. emotional well-being, physical well-being, cognitive function and sleep. The median improvement ranged from 0 to 27 points in TY, from 4 to 25 points in CBT and from 0 to 25 points in MBCT. The effect size was mainly medium or large. Comparison of treatments showed no statistical differences, but better effect (small) of both TY and MBCT compared to CBT. When comparing the effect of TY and MBCT, both showed a better effect (small) in two subscales each. CONCLUSIONS: A 20 week group treatment with TY, CBT or MBCT had equal effects on HRQoL, and particularly on main domains affected in burnout. This indicates that TY, MBCT and CBT can be used as both treatment and prevention, to improve HRQoL in patients on sick leave because of burnout, reducing the risk of future morbidity. TRIAL REGISTRATION: July 22, 2012, retrospectively registered. ClinicalTrails.gov NCT01168661 . FUNDING: Stockholm County Council, grant 2003-5.

Caring touch as a bodily anchor for patients after sustaining a motor vehicle accident with minor or no physical injuries - a mixed methods study.

BACKGROUND: Patients who sustain a motor vehicle accident may experience long-term distress, even if they are uninjured or only slightly injured. There is a risk of neglecting patients with minor or no physical injuries, which might impact future health problems. The aim of this study was to explore patients' subjective experiences and perspectives on pain and other factors of importance after an early nursing intervention consisting of "caring touch" (tactile massage and healing touch) for patients subjected to a motor vehicle accident with minor or no physical injuries. METHODS: A mixed method approach was used. The qualitative outcomes were themes derived from individual interviews. The quantitative outcomes were measured by visual analogue scale for pain (VAS, 0-100), sense of coherence (SOC), post-traumatic stress (IES-R) and health status (EQ-5D index and EQ-5D self-rated health). Forty-one patients of in total 124 eligible patients accepted the invitation to participate in the study. Twenty-seven patients completed follow-up after 6 months whereby they had received up to eight treatments with either tactile massage or healing touch. RESULTS: Patients reported that caring touch may assist in trauma recovery by functioning as a physical "anchor" on the patient's way of suffering, facilitating the transition of patients from feeling as though their body is "turned off" to becoming "awake". By caring touch the patients enjoyed a compassionate care and experience moments of pain alleviation. The VAS pain ratings significantly decreased both immediately after the caring touch treatment sessions and over the follow-up period. The median scores for VAS (p < 0.001) and IES-R (p 0.002) had decreased 6 months after the accident whereas the EQ-5D index had increased (p < 0.001). There were no statistically significant differences of the SOC or EQ-5D self-rated health scores over time. CONCLUSIONS: In the care of patients suffering from a MVA with minor or no physical injuries, a caring touch intervention is associated with patients' report of decreased pain and improved wellbeing up to 6 months after the accident. TRIAL REGISTRATION: ClinicalTrials.gov Id: NCT02610205 . Date 25 November 2015.

Tactile Massage as Part of the Caring Act: A Qualitative Study in Short-Term Emergency Wards.

AIMS AND OBJECTIVES: The aim of this study was to illuminate the nursing staff's lived experiences and meaning in giving tactile massage (TM) while caring for patients in short-term emergency ward. METHOD: Data were collected through individual qualitative interviews with six nurses and eight assistant nurses working with TM in short-term emergency wards in two hospitals in Sweden. The narratives were analyzed using a phenomenological hermeneutical method. FINDINGS: Nurses experienced providing TM to patients as a present awareness in connection with compassion for the patient. TM provided the nurses with a tool to ease patient suffering and pain. Three dimensions were found where touch became a tool of doing, was an aware presence as a mindful being, and was embodied in a human-to-human connection with a changed caregiver. CONCLUSION: Given the current high-tech health care system with overcrowded units and a shortage of nursing staff, TM could be included as a caring tool to improve the caring in caregiving, allowing nurses to act in aware presence by touch to encourage health and well-being for both the patient and themselves.

Usage and cost of first-line drugs for patients referred to inpatient anthroposophic integrative care or inpatient conventional care for stress-related mental disorders--a register based study.

BACKGROUND: Stress-related mental disorders (SRMD) are common and costly. Rehabilitation strategies, including pharmacotherapy, may be complicated to evaluate. Previous research has indicated increased quality of life and self-rated health for SRMD patients that receive a combination of conventional and complementary therapies, i.e. integrative care. The aim of this retrospective registry study was to explore and contrast the prescription of first-line drugs for SRMD patients referred to hospital inpatient anthroposophic integrative care (AIC) or inpatient conventional care (CC). METHODS: SRMD patients that had received AIC or CC were identified through high-quality inpatient registry data from Stockholm County Council and matched by available background characteristics including diagnosis (ICD-10: F43), age, gender and socio-economics. General disease load was estimated by analysis of ICD-10 chapter data. The Swedish Prescribed Drug Register was then used to investigate purchased defined daily doses (DDD) and cost of drugs from 90-days before/after, and 180-days before/after, the first visits (index) to AIC and CC respectively. First-line drug categories were Anatomical Therapeutic Chemical classification codes N05A (antipsychotics), N05B (anxiolytics), N05C (hypnotics and sedatives) and N06A (antidepressants). RESULTS: There were no statistically significant differences between the AIC (n = 161) and the CC (n = 1571) cohorts in terms of background characteristics and the overall disease loads were similar between the groups the preceding year. At baseline, the prescription of first-line anxiolytics and antidepressants were not statistically different between groups whereas the prescription of antipsychotics and hypnotics/sedatives were lower for the AIC cohort. The overall change in drug prescriptions and costs during the investigated periods, both for the 90-days before/after and for the 180-days before/after the index visit, showed a general decrease within the AIC cohort with significantly less prescribed anxiolytics and hypnotics/sedatives. During the same time periods there was a general increase in prescriptions and costs of first-line drugs within the CC cohort. The overall disease loads were generally stable within both cohorts over time, except that the CC cohort had increased visits registered with an ICD-10 F-chapter diagnosis the year after index. CONCLUSIONS: The results suggests that there may be different drug utilization patterns for SRMD patients referred to AIC or CC. Different management strategies between AIC and CC providers, different SRMD disease severities and different preferences of patients referred to AIC and CC are hypothetical differentiating factors that may influence drug outcomes over time. Additional studies including prospective and randomized clinical trials are warranted to determine if there is a causal link between inpatient AIC and reduced drug utilization.

Capitalizing on synergies-a discourse analysis of the process of collaboration among providers of integrative health care.

BACKGROUND: Integrative health care (IHC) combines therapies and providers from complementary and conventional health care. Previous studies on IHC have shown power relations between providers but few studies have explored how the interaction develops over time. The objective of this study was to explore the development of IHC collaboration and interaction among participating providers during a series of consensus case conferences for managing patients with back and neck pain. METHODS: This qualitative study was conducted within a pragmatic randomized controlled clinical trial in primary care. Patients' treatment plans were developed based on IHC provider consensus conferences (n = 26) of which 15 (5 of the first, 5 in the middle, and 5 of the last in the clinical trial) were selected for analysis. Findings were derived by means of discourse analysis, focusing on the participants' use of subject positions during the conferences. FINDINGS: The IHC team in this study gradually formed a group identity, moving their subject positions from individual treating subjects to members of a team and were able to make consensus-based decisions about patients' individual treatment plans. In the discourse, the IHC team identified collaborative shortcomings and problematized the provision of IHC. They were able to capitalize on the synergies in their collaboration and developed a shared vision of IHC provision. CONCLUSIONS: The process of IHC collaboration involved the gradual formation of an IHC team identity, which facilitated interdisciplinary, non-hierarchical consensus-based decision-making in the team. The discourse further suggests that a reform of some legal and organizational health sector barriers might be needed to realize sustainable implementation of IHC services in Sweden.

Using hospital data and routines to estimate costs and effects of integrative care programmes for chronic pain and stress disorders--a feasibility study.

BACKGROUND: Evidence of cost and effects for comprehensive hospital-based integrative care (IC) is scarce. The aim of this study was to explore the feasibility of using local hospital data and routines to estimate costs and effects of anthroposophic IC programmes for chronic pain and stress disorders in Sweden. METHODS: Retrospective analysis of one IC hospital's local administrative registry data. Main outcomes embraced patient demographics, programme duration and costs, patients' health status (EQ-5D index, 0-1) and self-rated health (EQ-5D VAS, 0-100), from hospital admittance to discharge. The use of postal questionnares for collecting follow-up data after hospital discharge was assessed. RESULTS: The IC pain programme had 461 records, all with complete data on costs and duration: average programme cost, EUR 5,925 (95% CI 5,780-6,070), and duration, 17.8 (SD 4.7) days. The IC stress programme had 263 records, all with complete cost and duration data: programme cost, EUR 5,494 (95%CI 5,318-5,671); duration 18.0 (SD 4.7) days. From admittance to discharge, health status improved by 0.23 (95% CI 0.19-0.27) in the pain, and by 0.16 (95% CI 0.12-0.20) in the stress programme. Improvements in self-rated health were 20 (95% CI 18-22), and 21 (95% CI 18-23), respectively. There was a general decrease in questionnaire response rate after hospital discharge, whereby 27-32% of respondents had completed data after 9 months. CONCLUSIONS: It was feasible to use hospital registry data to estimate costs and show positive effects of anthroposophic IC programmes for pain and stress disorders in Sweden. Clinical implications and the need for long-term follow-up are discussed.

[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 7­9th 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 9­11th 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.

Opposite drug prescription and cost trajectories following integrative and conventional care for pain--a case-control study.

OBJECTIVES: Pharmacotherapy may have a limited role in long-term pain management. Comparative trajectories of drug prescriptions and costs, two quality-of-care indicators for pain conditions, are largely unknown subsequent to conventional or integrative care (IC) management. The objectives of this study were to compare prescribed defined daily doses (DDD) and cost of first line drugs for pain patients referred to conventional or anthroposophic IC in Stockholm County, Sweden. METHODS: In this retrospective high quality registry case-control study, IC and conventional care patients were identified through inpatient care registries and matched on pain diagnosis (ICD-10: M79), age, gender and socio-demographics. National drug registry data was used to investigate changes in DDD and costs from 90/180 days before, to 90/180 days after, index visits to IC and conventional care. The primary selected drug category was analgesics, complemented by musculo-skeletal system drugs (e.g. anti-inflammatories, muscle relaxants) and psycholeptics (e.g. hypnotics, sedatives). RESULTS: After index care visits, conventional care pain patients (n = 1050) compared to IC patients (n = 213), were prescribed significantly more analgesics. The average (95% CI) group difference was 15.2 (6.0 to 24.3), p = 0.001, DDD/patient after 90 days; and 21.5 (7.4 to 35.6), p = 0.003, DDD/patient after 180 days. The cost of the prescribed and sold analgesics was significantly higher for conventional care after 90 days: euro/patient 10.7 (1.3 to 20.0), p = 0.025. Changes in drug prescription and costs for the other drug categories were not significantly different between groups. CONCLUSIONS: Drug prescriptions and costs of analgesics increased following conventional care and decreased following IC, indicating potentially fewer adverse drug events and beneficial societal cost savings with IC.

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.

A narrative review of factors influencing detection and treatment of depression in Vietnam.

Depression is among the most common psychiatric conditions in primary health care, and constitutes an important part of the global disease burden. However, it is difficult to obtain comparable data on depression worldwide and models for treatment and intervention need to be locally adapted. We conducted a narrative review of research literature on factors that influence depression screening, diagnosis and treatment among the Vietnamese population. This explorative approach included studies describing: a) culturally or contextually specific risk-factors for depression; b) any depression treatment seeking or treatment acceptability/adherence aspects or; c) depression screening among Vietnamese patients. We searched the PubMed and Cinahl databases, as well as relevant Vietnamese peer-reviewed journals and this produced 20 articles that were included in the review. Our findings indicate the importance of considering somatic symptoms when screening for depression in Vietnam as well as the use of culturally adapted and dimensional screening instruments. Our study confirms that depression reflects chronic social adversity, and thus an approach to mental health management that focuses solely on individual pathology will fail to address its important social causes. Further studies should elucidate whether neurasthenia is a commonly used illness label among Vietnamese patients that coincides with depression. The tendency among Vietnamese to seek traditional Vietnamese medicine and meditation practice when experiencing emotional distress was supported by our findings.