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Functional dyspepsia remains a major challenge for clinicians with no approved drugs available in the Western World. In October 2016, a meeting was held in Washington, DC, sponsored by the American Gastroenterological Association's Center for Diagnostics and Therapeutics, which included members of the Food and Drug Administration (FDA) and the pharmaceutical industry, experts in FD, and representatives of patient organizations. This white paper summarizes our current status, progress with a validated patient reported outcome instrument in functional dyspepsia, future directions and needs.

Gastroparesis continues to represent a large unmet clinical need and a major opportunity for new drug development. This has led to increasing interest by federal funding agencies, regulatory bodies, and industry. This article summarizes the proceedings of the gastroparesis section of the “Drug Development Conference: Clinical Endpoints in Upper GI Disorders” organized by the American Gastroenterological Association in Washington, DC, on October 27–28, 2016. The presentation, diagnosis, and current therapeutic strategies are briefly reviewed, followed by a detailed discussion of the regulatory strategy, recommended endpoints, and future directions.

Objective Methods to improve informed consent efficiency and effectiveness are needed for pragmatic clinical trials. We compared informed consent using a tablet computer to a paper approach to assess comprehension and satisfaction of patients and clinic staff for a future osteoporosis clinical trial. Methods Nine community-based practices identified and recruited patients to compare the informed consent processes (tablet vs. paper) in a mock osteoporosis clinical trial. The tablet informed consent included an animation summarizing the trial, complete informed consent document, and questions to assess and reinforce comprehension of the study. Participants were women age ≥55 years with ≥1 year of alendronate use. We surveyed participants to assess comprehension and satisfaction and office staff for satisfaction and perceived time demands. Results The nine practices enrolled 33 participants. There was not a significant difference in comprehension between the tablet vs. paper informed consent [mean (SD) tablet: 12.2 (1.0) vs. paper: 11.4 (1.7)]. Office staff preferred the tablet to the paper informed consent for identifying potential study participants (two-sided t-test p = 0.02) despite an increased perceived time spent to complete the tablet process [tablet: 28.3 min (SD 16.3) vs. paper: 19.0 min (SD 6.9); p = 0.08]. Conclusions Although, there were no significant differences in participant satisfaction and comprehension with the tablet informed consent compared to a paper informed consent, patients and office staff trended towards greater satisfaction with the tablet informed consent. Larger studies are needed to further evaluate the utility of electronic informed consent in pragmatic clinical trials.

UNLABELLED: Poorly controlled pain is a global public health issue. The personal, familial and societal costs are immeasurable. Only a minority of European patients have access to a comprehensive specialist pain clinic. More commonly the responsibility for chronic pain management and initiating opioid therapy rests with the primary care physician and other non-specialist opioid prescribers. There is much confusing and conflicting information available to non-specialist prescribers regarding opioid therapy and a great deal of unjustified fear is generated. Opioid therapy should only be initiated by competent clinicians as part of a multi-faceted treatment programme in circumstances where more simple measures have failed. Throughout, all patients must be kept under close clinical surveillance. As with any other medical therapy, if the treatment fails to yield the desired results and/or the patient is additionally burdened by an unacceptable level of adverse effects, the overall management strategy must be reviewed and revised. No responsible clinician will wish to pursue a failed treatment strategy or persist with an ineffective and burdensome treatment. In a considered attempt to empower and inform non-specialist opioid prescribers, EFIC convened a European group of experts, drawn from a diverse range of basic science and relevant clinical disciplines, to prepare a position paper on appropriate opioid use in chronic pain. The expert panel reviewed the available literature and harnessed the experience of many years of clinical practice to produce these series of recommendations. Its success will be judged on the extent to which it contributes to an improved pain management experience for chronic pain patients across Europe. SIGNIFICANCE: This position paper provides expert recommendations for primary care physicians and other non- specialist healthcare professionals in Europe, particularly those who do not have ready access to specialists in pain medicine, on the safe and appropriate use of opioid medications as part of a multi-faceted approach to pain management, in properly selected and supervised patients. ispartof: European Journal of Pain vol:21 issue:1 pages:3-19 ispartof: location:England status: published

Statins are one of the most commonly prescribed drugs in clinical practice. They are usually well tolerated and effectively prevent cardiovascular events. Most adverse effects associated with statin therapy are muscle-related. The recent statement of the European Atherosclerosis Society (EAS) has focused on statin associated muscle symptoms (SAMS), and avoided the use of the term 'statin intolerance'. Although muscle syndromes are the most common adverse effects observed after statin therapy, excluding other side effects might underestimate the number of patients with statin intolerance, which might be observed in 10-15% of patients. In clinical practice, statin intolerance limits effective treatment of patients at risk of, or with, cardiovascular disease. Knowledge of the most common adverse effects of statin therapy that might cause statin intolerance and the clear definition of this phenomenon is crucial to effectively treat patients with lipid disorders. Therefore, the aim of this position paper was to suggest a unified definition of statin intolerance, and to complement the recent EAS statement on SAMS, where the pathophysiology, diagnosis and the management were comprehensively presented.

Biofield therapies (BTs) are increasingly employed in contemporary healthcare. In this white paper, we review specific challenges faced by biofield practitioners resulting from a lack of (1) a common scientific definition of BT; (2) common educational standards for BT training (including core competencies for clinical care); (3) collaborative team care education in complementary and alternative medicine (CAM) and in integrative health and medicine (IHM); (4) a focused agenda in BT research; and (5) standardized devices and scientifically validated mechanisms in biofield research. We present a description of BT and discuss its current status and challenges as an integrative healthcare discipline. To address the challenges cited and to enhance collaboration across disciplines, we propose (1) standardized biofield education that leads to professional licensure and (2) interprofessional education (IPE) competencies in BT training required for licensed healthcare practitioners and encouraged for other practitioners using these therapies. Lastly, we discuss opportunities for growth and a potential strategic agenda to achieve these goals. The Academy of Integrative Health and Medicine (AIHM) provides a unique forum to facilitate development of this emerging discipline, to facilitate IPE, and to further increase the availability of BT to patients.

Malnutrition is a frequent problem in cancer patients, which leads to prolonged hospitalization, a higher degree of treatment-related toxicity, reduced response to cancer treatment, impaired quality of life and a worse overall prognosis. The attitude towards this issue varies considerably and many malnourished patients receive inadequate nutritional support. We reviewed available data present in the literature, together with the guidelines issued by scientific societies and health authorities, on the nutritional management of patients with cancer, in order to make suitable and concise practical recommendations for appropriate nutritional support in this patient population. Evidence from the literature suggests that nutritional screening should be performed using validated tools (the Nutritional Risk Screening 2002 [NRS 2002], the Malnutrition Universal Screening Tool [MUST], the Malnutrition Screening Tool [MST] and the Mini Nutritional Assessment [MNA]), both at diagnosis and at regular time points during the course of disease according to tumor type, stage and treatment. Patients at nutritional risk should be promptly referred for comprehensive nutritional assessment and support to clinical nutrition services or medical personnel with documented skills in clinical nutrition, specifically for cancer patients. Nutritional intervention should be actively managed and targeted for each patient; it should comprise personalized dietary counseling and/or artificial nutrition according to spontaneous food intake, tolerance and effectiveness. Nutritional support may be integrated into palliative care programs. “Alternative hypocaloric anti-cancer diets” (e.g. macrobiotic or vegan diets) should not be recommended as they may worsen nutritional status. Well-designed clinical trials are needed to further our knowledge of the nutritional support required in different care settings for cancer patients.

Biosimilars present a necessary and timely opportunity for physicians, patients and healthcare systems. If suitably developed clinically, manufactured to the correct standards and used appropriately, they can positively impact on the financial sustainability of healthcare systems. A critical consideration regarding the introduction of biosimilars into the clinic centres on the required information concerning all the respective procedures. This position paper aims to describe the issues revolving around biosimilars that are relevant to the field of oncology, especially the prescribers. More specifically, we discuss aspects related to definition, forms of biosimilars, labelling, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, responsibilities among prescribers and pharmacists, potential impact on financial burden in healthcare and the current scenario and future prospects of biosimilars in Europe and the rest of the world.

Background Skin diseases constitute up to 40% of all notified occupational diseases in most European countries, predominantly comprising contact dermatitis, contact urticaria, and skin cancer. While insufficient prevention of work-related skin diseases (WRSD) is a top-priority problem in Europe, common standards for prevention of these conditions are lacking. Objective To develop common European standards on prevention and management of WRSD and occupational skin diseases (OSD). Method Consensus amongst experts within occupational dermatology was achieved with regard to the definition of minimum evidence-based standards on prevention and management of WRSD/OSD. Results By definition, WRSDs/OSDs are (partially or fully) caused by occupational exposure. The definition of OSD sensu stricto additionally includes diverging national legal requirements, with an impact on registration, prevention, management, and compensation. With the implementation of the classification of WRSD/OSD in the International Classification of Diseases (ICD) 11th Revision in future, a valid surveillance and comparability across countries will be possible. Currently, WRDS and OSD are still under-reported. Depending on legislation and regulations, huge differences exist in notification procedures in Europe, although notification is crucial to prevent chronic and relapsing disease. Facilities for early diagnosis, essential for individual patient management, should be based on existing guidelines and include a multidisciplinary approach. Patch testing is essential if contact dermatitis persists or relapses. Workplace exposure assessment of WRSD/OSD requires full labelling of product ingredients on material safety data sheets helping to identify allergens, irritants and skin carcinogens. Comparable standards in primary, secondary and tertiary prevention must be established in Europe to reduce the burden of WRSD/OSD in Europe. Conclusion The adoption of common European standards on prevention of WRSD/OSD will contribute to reduce the incidence of OSD and their socio-economic burden.

Item does not contain fulltext Acne causes profound negative psychological and social effects on the quality of life (QoL) of patients. The European Dermatology Forum S3-Guideline for the Treatment of Acne recommended adopting a QoL measure as an integral part of acne management. Because of constantly growing interest in health-related QoL assessment in acne and because of the high impact of acne on patients' lives, the European Academy of Dermatology and Venereology Task Force on QoL and Patient Oriented Outcomes and the Task Force on Acne, Rosacea and Hidradenitis Suppurativa have documented the QoL instruments that have been used in acne patients, with information on validation, purposes of their usage, description of common limitations and mistakes in their usage and overall recommendations.

There is a need for researchers to have easy reference to the wide spectrum of different types of quality of life (QoL) instruments that can be used in atopic dermatitis (AD). Previous reviews on QoL in AD do not cover the full spectrum of QoL measures used in studies on AD. This study, on behalf of the European Academy of Dermatology and Venereology (EADV) Task Force on QoL, contains information on instruments available for health-related QoL and family QoL assessment in AD including information on validation, experience of QoL assessment in AD for different purposes, peculiarities of QoL assessment in different age groups, expert analysis of available instruments including data on limitations of their use and recommendations of the Task Force.

There is strong need to develop the current stratified practice of CVD management into a better personalized cardiovascular medicine, within a broad framework of global patient care. Clinical information obtained from history and physical examination, functional and imaging studies, biochemical biomarkers, genetic/epigenetic data, and pathophysiological insights into disease-driving processes need to be integrated into a new taxonomy of CVDs to allow personalized disease management. This has the potential for major health benefits for the population suffering from cardiovascular diseases.

This paper provides recommendations on the treatment of orthostatic hypotension (OH) as reviewed by the American Society of Hypertension. It focuses on recent reports on the evaluation and management of OH and provides practical advice for clinicians on how to screen, diagnose, and treat patients using behavioral, nonpharmacologic, and pharmacologic strategies. The authors also provide a stepwise approach on how to apply new findings to successfully control OH and reduce the risk of syncope and falls in these patients. Treatment of OH is also discussed in special situations such as in hypertensive and hospitalized patients. It should be noted, however, that research in this area is mostly limited to studies in small numbers of patients. Unfortunately, the trials of the type needed to develop evidence‐based guidelines are not available for this condition.

This editorial addresses the following documents published in this and a previous edition of the SAMJ:The Central Drug Authority (CDA)'s position paper on cannabisThe CDA's position paper on harm reductionThe CDA's response to the editorial 'Comment on the CDA's position statement on cannabis'. As there is considerable overlap between the contents of the above documents, this editorial tries to avoid covering all the arguments put forward both in these documents and in the author's 'Comment on the CDA's position statement on cannabis'. Instead, it sets out to inform medical professionals and civil society why the incorporation of illicit drugs into the existing regulatory framework of drug control is the only holistic way to implement comprehensive harm reduction measures and bring an end to the 'war on drugs'.Instead it sets out to inform medical professionals and civil society as to why the incorporation of illicit drugs into the existing regulatory framework of drug control is the only holistic way to both implement comprehensive harm reduction measures and bring an end to the 'war on drugs'.

Pfizer Inc., New York, NY Dainippon Sumitomo Pharma, Tokyo, Japan Innovative Med Concepts LLC (IMC), Tuscaloosa, AL Ironwood Pharmaceuticals, Cambridge, MA Purdue Pharma, Stamford, CT Shire, Lexington, MA Theravance Biopharma, South San Francisco, CA Toray, Tokyo, Japan Eli Lilly and Company, Indianapolis, IN Forest Laboratories, New York, NY Tonix Pharmaceuticals, New York, NY Cerephex Corporation, Los Altos, CA National Institutes of Health, Bethesda, MD National Institutes of Health Grunenthal, Aachen Germany Orion Pharma, Espoo, Finland This manuscript, developed by a group of chronic pain researchers and clinicians from around the world, aims to address the state of knowledge about fibromyalgia (FM) and identify ongoing challenges in the field of FM and other chronic pain syndromes that may be characterized by pain centralization/amplification/hypersensitivity. There have been many exciting developments in research studies of the pathophysiology and treatment of FM and related syndromes that have the potential to improve the recognition and management of patients with FM and other conditions with FM-like pain. However, much of the new information has not reached all clinicians, especially primary care clinicians, who have the greatest potential to use this new knowledge to positively impact their patients' lives. Furthermore, there are persistent misconceptions about FM and a lack of consensus regarding the diagnosis and treatment of FM. This paper presents a framework for future global efforts to improve the understanding and treatment of FM and other associated chronic pain syndromes, disseminate research findings, identify ways to enhance advocacy for these patients, and improve global efforts to collaborate and reach consensus about key issues related to FM and chronic pain in general. Univ Cincinnati, Coll Med, Dept Psychiat & Behav Neurosci, Cincinnati, OH USA Cardiff Inst Infect & Immun, Cardiff, S Glam, Wales Univ Michigan, Ann Arbor, MI 48109 USA Tufts Univ, Sch Med, Boston, MA 02111 USA Univ Fed Sao Paulo, Sao Paulo, Brazil Aarhus Univ, Danish Pain Res Ctr, Aarhus, Denmark Hyogo Coll Med, Nishinomiya, Hyogo, Japan Aichi Med Univ, Multidisciplinary Pain Ctr, Nagakute, Aichi, Japan Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA China Japan Friendship Hosp, Beijing, Peoples R China Univ Fed Sao Paulo, EPM, Sao Paulo, Brazil Web of Science

Purpose To describe the present status and changing patterns of medical papers related to keywords of vaccine and vaccination published in Korea over the last 50 years, and provide basic data for future studies. Materials and Methods 185,603 papers are registered in the medical database KoreaMed, which is run by Korean Association of Medical Journal Editors. Among these papers, a search with the keywords vaccine or vaccination revealed a total of 1,089 articles which were published on vaccine and/or vaccination during the period of September 2, 1962 to April 30, 2012. Our study endeavors to analyze these 1,089 articles. Results Only one article published with the keywords vaccine and/or vaccination was published in the 1960s, and the number of journals steadily increased starting from the 1970s (24 articles) to 2 times, 10 times, 20 times in the 1980s, 1990s, and the 2000s (585 articles), respectively. The articles were classified into reviews (20.2%), original articles with clinical study (40.7%), original articles with experimental study (24.6%), and case reports (8.2%). The review articles mainly dealt with an overview. The original articles with clinical study were on epidemiology, effect and immunogenicity, clinical trial. Original articles with experimental study were mainly comprised of complication and overview. Articles on vaccine, pathogen or disease topics were mostly microorganisms such as bacteria or viruses, and studies on anti-cancer vaccines or vaccines of specific diseases were sparse. Conclusion The above data reflects the clinical uses of vaccines in Korea and the history of vaccine studies. The number of vaccine-related articles is increasing rapidly since the first article was published in 1962. This implies that with the increase of studies of clinical trials, clinical uses and results and analyses of the results, articles relating to basic studies are also on the rise. We intend these findings to be of use to researchers in this active and expanding field.

Objective - Conferences are essential opportunities for professional development and for learning about research. This study analyses papers presented in the Research Forum track of the International Association of School Librarians (IASL) conferences to determine whether the amount of school library research reporting increased or decreased over time; who (i.e., what author roles and affiliations) has written about research; which countries were represented in the research articles; what topics were discussed in research articles; and what research methodologies were used. The aim was to determine the extent to which the Research Forum provides research evidence that relates to practice. Methods - This study continues the longitudinal analysis of published school library research begun by Clyde (1996) by analyzing Research Forum papers published in IASL conference proceedings from 1998-2009 and using the same approaches and metrics as previous studies by Clyde (e.g., 1996; 2002; 2004), Clyde and Oberg (2004), and Oberg (2006). Results - Conference paper topics, author origins, quantities, and research approaches remained static through the 11 years analyzed. The analysis reveals that the papers’ authors, methods, and topics reflected those found in previous studies of school library research. As well as replicating previous studies, the role of academic research at a practitioner-based conference was investigated. Conclusions - Based on long-established imperatives from leaders in the profession, the IASL conferences provide both evidence and evidence -based practice for school librarians from all over the world. However, when scholarly research is shared at practitioner venues, it is possible that school librarians may assume that research results constitute evidence -based practice (EBP), not evidence upon which practice should be based. This distinction is important if considering that the purpose of academic research is to objectively inform, not to advocate a particular position or practice. The Research Forum can be a valuable venue for the presentation of empirical research findings and conclusions and objective program evaluations and provide a valuable complement to the evidence -based practice descriptions shared in the Professional Papers portion of the conference program. It is argued that the Research Forum must be clear in its purpose: to present the results of research; to present effective practice determined by rigorous evaluation; or to present research-supported arguments for the support of school libraries. Through a reconceptualization of EBP, the paper demonstrates how EBP is both a method and a methodology for the presentation of school library research and practice in a conference atmosphere.

Background The Salford Lung Study (SLS) involves two prospective patient cohorts—one patients with asthma; the other patients with COPD. SLS is believed to be the first pre-license, prospective randomised controlled trial (RCT) to use electronic healthcare records to monitor patient safety. Safety events are processed in near real-time, and a linked database system creates daily summaries that alert a specialist safety team to potential treatment-related adverse events. SLS is a ‘world first’ in effectiveness research. To synthesise the learnings from the SLS and experiences from leading experts in real-world research in a White Paper to help guide the future design and feasibility of pragmatic RCTs.

Because of the inflammatory mechanisms of most chronic upper airway diseases such as rhinitis and chronic rhinosinusitis, systemic steroids have been used for their treatment for decades. However, it has been very well documented that - potentially severe - side-effects can occur with the accumulation of systemic steroid courses over the years. A consensus document summarizing the benefits of systemic steroids for each upper airway disease type, as well as highlighting the potential harms of this treatment is currently lacking. Therefore, a panel of international experts in the field of Rhinology reviewed the available literature with the aim of providing recommendations for the use of systemic steroids in treating upper airway disease.

Mesotherapy is a controversial cosmetic procedure which has received publicity among the lay people, in the internet and in the media. It refers to minimally invasive techniques which consist of the use of intra- or subcutaneous injections containing liquid mixture of compounds (pharmaceutical and homeopathic medications, plant extracts, vitamins and other ingredients) to treat local medical and cosmetic conditions. This position paper has examined the available evidence and finds that acceptable scientific evidence for its effectiveness and safety is lacking. IADVL taskforce, therefore would like to state that the use of this technique remains controversial at present. Further research and well-designed controlled scientific studies are required to substantiate the claims of benefit of this mode of therapy.

Because of the inflammatory mechanisms of most chronic upper airway diseases such as rhinitis and chronic rhinosinusitis, systemic steroids have been used for their treatment for decades. However, it has been very well documented that-potentially severe-side-effects can occur with the accumulation of systemic steroid courses over the years. A consensus document summarizing the benefits of systemic steroids for each upper airway disease type, as well as highlighting the potential harms of this treatment is currently lacking. Therefore, a panel of international experts in the field of Rhinology reviewed the available literature with the aim of providing recommendations for the use of systemic steroids in treating upper airway disease. ispartof: CLINICAL AND TRANSLATIONAL ALLERGY vol:10 issue:1 ispartof: location:England status: published

Question Do people with musculoskeletal conditions better adhere to their home exercise programs when these are provided to them on an app with remote support compared to paper handouts? Design Randomised, parallel-group trial with intention-to-treat analysis. Participants Eighty participants with upper or lower limb musculoskeletal conditions were recruited to the trial. Each participant was prescribed a 4-week home exercise program by a physiotherapist at a tertiary teaching hospital in Australia. Participants were randomly assigned via a computer-generated concealed block randomisation procedure to either intervention (n=40) or control (n=40) groups. Intervention Participants in the intervention group received their home exercise programs on an app linked to the freely available website www.physiotherapyexercises.com. They also received supplementary phone calls and motivational text messages. Participants in the control group received their home exercise programs as a paper handout. Outcome measures Blinded assessors collected outcome measures at baseline and 4 weeks. The primary outcome was self-reported exercise adherence. There were five secondary outcomes, which captured functional performance, disability, patient satisfaction, perceptions of treatment effectiveness, and different aspects of adherence. Results Outcomes were available on 77 participants. The mean between-group difference for self-reported exercise adherence at 4 weeks was 1.3/11 points (95% CI 0.2 to 2.3), favouring the intervention group. The mean between-group difference for function was 0.9/11 points (95% CI 0.1 to 1.7) on the Patient-Specific Functional Scale, also favouring the intervention group. There were no significant between-group differences for the remaining outcomes. Conclusion People with musculoskeletal conditions adhere better to their home exercise programs when the programs are provided on an app with remote support compared to paper handouts; however, the clinical importance of this added adherence is unclear. Trial registration ACTRN12616000066482. [Lambert TE, Harvey LA, Avdalis C, Chen LW, Jeyalingam S, Pratt CA, Tatum HJ, Bowden JL, Lucas BR (2017) An app with remote support achieves better adherence to home exercise programs than paper handouts in people with musculoskeletal conditions: a randomised trial. Journal of Physiotherapy 63: 161–167]

Background: In recent years, electronic cigarettes (ECs) have been heavily advertised as an alternative smoking device as well as a possible cessation method. We aimed to review all published scientific literature pertaining to ECs and to present a simple conclusion about their effects for quitting smoking and respiratory health. Methods: This was a cross-sectional study with a search of PubMed, limited to English publications upto September 2014. The total number of papers which had ECs in its title and their conclusions positive or negative regarding ECs effects were computed. The number of negative papers was subtracted from the number of positive ones to make a score. Results: Of the 149 articles, 137 (91.9%) were accessible, of which 68 did not have inclusion criteria. In the 69 remaining articles, 24 studies supported ECs and 45 considered these to be harmful. Finally, based on this evidence, the score of ECs (computed result with positive minus negative) was −21. Conclusion: Evidence to suggest that ECs may be effective and advisable for quitting smoking or a safe alternative for smoking is lacking and may instead harm the respiratory system. However, further studies are needed.

Current Status Since the 1950s, significant advances in the treatment of pain have resulted in greater relief for an increasing number of patients. However, the quality of pain care delivery in the United States continues to fall remarkably short of the current potential for optimal care. Pain medicine remains fragmented, and the absence of a unified organizational model of pain medicine hinders the effective provision of an integrated, cost-effective pain care, causing unnecessary and avoidable human suffering and societal expense. These consequences of fragmented care are unacceptable and threaten patient safety and well-being. Effective treatment of persistent pain requires the highest level of clinical reasoning, selectively coordinated medical skills, the strategic use of resources, and the orchestration of diverse areas of medical expertise. In order to close the gap between existing care and the potential for optimal pain care, significant institutional barriers to this goal must be addressed. To this end, the following position paper describes the history and context of this challenge, proposes recommendations to harness the collective abilities and knowledge within the discipline of pain medicine, and calls upon organized medicine to take action on behalf of patients and for the public health.

The paper by ESMO ‘The current and future role of the medical oncologist in the professional care for cancer patients: a position paper by the European Society for Medical Oncology (ESMO)’ [1] conveys some important key messages for the whole oncology community. A working group (WG) involving 21 oncology and related societies would like to comment on the paper from a multidisciplinary perspective in the conviction that a more transparent and open definition of individual professional roles better supports the patients' care and facilitates best practices and progress in comprehensive cancer care.

We have prepared this document, “Sublingual Immunotherapy: World Allergy Organization Position Paper 2013 Update”, according to the evidence-based criteria, revising and updating chapters of the originally published paper, “Sublingual Immunotherapy: World Allergy Organization Position Paper 2009”, available at http://www.waojournal.org. Namely, these comprise: “Mechanisms of sublingual immunotherapy;” “Clinical efficacy of sublingual immunotherapy” – reporting all the data of all controlled trials published after 2009; “Safety of sublingual immunotherapy” – with the recently published Grading System for adverse reactions; “Impact of sublingual immunotherapy on the natural history of respiratory allergy” – with the relevant evidences published since 2009; “Efficacy of SLIT in children” – with detailed analysis of all the studies; “Definition of SLIT patient selection” – reporting the criteria for eligibility to sublingual immunotherapy; “The future of immunotherapy in the community care setting”; “Methodology of clinical trials according to the current scientific and regulatory standards”; and “Guideline development: from evidence-based medicine to patients' views” – including the evolution of the methods to make clinical recommendations.Additionally, we have added new chapters to cover a few emerging crucial topics: “Practical aspects of schedules and dosages and counseling for adherence” – which is crucial in clinical practice for all treatments; “Perspectives and new approaches” – including recombinant allergens, adjuvants, modified allergens, and the concept of validity of the single products. Furthermore, “Raising public awareness about sublingual immunotherapy”, as a need for our patients, and strategies to increase awareness of allergen immunotherapy (AIT) among patients, the medical community, all healthcare stakeholders, and public opinion, are also reported in detail. Keywords: Sublingual immunotherapy, Allergen-specific immunotherapy, Mechanisms of SLIT, Safety of SLIT, Efficacy of SLIT, Clinical trials methodology in SLIT

This paper addresses challenges of identifying, enrolling and retaining participants in a in a trial conducted within a routine care setting. All patients that are potential candidates for the treatments in routine clinical practice should be considered eligible for a pragmatic trial. To ensure generalizability, the recruited sample should have a similar distribution of the treatment effect modifiers as the target population. In practice this can be best achieved by including - within the selected sites - all patients without further selection. If relevant heterogeneity between subgroups is expected, increasing the relative proportion of the subgroup of patients in the heterogeneous trial could be considered (oversampling), or a separate trial in this subgroup can be planned. Selection will nevertheless occur. Low enrolment and loss to follow-up can introduce selection and can jeopardize validity as well as generalizability. Pragmatic trials are conducted in clinical practice rather than in a dedicated research setting, which could reduce recruitment rates. However, if a trial poses a minimal burden to the physician and the patient, and routine clinical practice is maximally adhered to, the participation rate may be high and loss to follow-up will not be a specific problem for pragmatic trials.

Jose Zamorano discusses the need for and what cardiology can expect in the ESC position paper One of the changes that we have recently seen in the European Society of Cardiology (ESC) Core Curriculum, is the presence of a chapter entitled Cardio Oncology. Such topic has also been considered for an ESC Committee of Practice Guidelines position paper. We may wonder about the need for such a new topic. There is no doubt however that malignancy is a worldwide health and social problem. Advances in treatment have led to improved survival of cancer patients, but morbidity and mortality has also increased due to the side effects of treatment. This means that as survival rates in cancer patients improve, there is an increased interest in preventing or treating potential complications related to cancer therapies. If we look to the major potential side effects of anticancer drugs, cardiovascular diseases (CVD) are one of the most frequent complications that may lead to abandoning of the treatment. We need to differentiate cardiotoxicity (direct effects of the cancer treatment) to the new appearance of CVD due to accelerated development of CVD in …

In 2008, the National Institutes of Health's (NIH) Undiagnosed Disease Program (UDP) was initiated to provide diagnoses for individuals who had long sought one without success. As a result of two international conferences (Rome 2014 and Budapest 2015), the Undiagnosed Diseases Network International (UDNI) was established, modeled in part after the NIH UDP. Undiagnosed diseases are a global health issue, calling for an international scientific and healthcare effort. To meet this demand, the UDNI has built a consensus framework of principles, best practices and governance; the Board of Directors reflects its international character, as it includes experts from Australia, Canada, Hungary, Italy, Japan and the USA. The UDNI involves centers with internationally recognized expertise, and its scientific resources and know-how aim to fill the knowledge gaps that impede diagnosis. Consequently, the UDNI fosters the translation of research into medical practice. Active patient involvement is critical; the Patient Advisory Group is expected to play an increasing role in UDNI activities. All information for physicians and patients will be available at the UDNI website.

Patients/consumers are end user of medicines and should play important role in reporting the Adverse Drug Reactions (ADRs) to pharmacovigilance system. Consumers can provide detailed first-hand in formation about their experiences with medicines and how these medicines have affected their life. Direct consumer reporting leads to earlier identification and accumulation of signals and may provide neglected details related to psychiatric feelings and quality of life. Consumers may report ADRs due to “over the counter” (OTC) medicines, herbal medicines, and ADRs related to excipients and potential interactions. Direct patient/ consumer reporting will also rectify the under-reporting by patients to physician and will change the attitude related to importance of patient’s experience. NCC-PvPI (National Coordination Centre-Pharmacovigilance Programme of India), IPC (Indian Pharmacopoeia Commission) had launched “Medicines Side Effect Reporting form for Consumer” (blue form) at the National level conference on “Participation of patient/consumer organization in PvPI” on 1st August, 2014, which encourages patient or his/her representative (relative) to report ADRs directly either by submitting the form to the NCC-PvPI or to the nearest AMC (Adverse Drug Reaction Monitoring Centres) under PvPI. Consumers can also reports through toll free helpline number: 1800-180-3024 or email id: pvpi.compat@gmail.com to NCC-PvPI.

Rheumatic and musculoskeletal diseases (RMDs) represent a multitude of degenerative, inflammatory and auto-immune conditions affecting millions of people worldwide. Persons with these diseases may potentially experience severe chronic pain, joint damage, increasing disability and even death. With an increasingly ageing population, the prevalence and burden of RMDs are predicted to increase, placing greater demands on the global practice of rheumatology and related healthcare budgets. Effective treatment of RMDs currently faces a number of challenges in both the developed and developing world, and individual countries may face more specific local challenges. However, limited understanding of the burden of RMDs amongst public health professionals and policy-makers means that these diseases are often not considered a public health priority. The objective of this review is to increase awareness of the RMDs and to identify opportunities to address RMD challenges on both a local and global scale. On 26 September 2014, rheumatology experts from five different continents met at the World Forum on Rheumatic and Musculoskeletal Diseases (WFRMD) to discuss and identify some key challenges for the RMDs community today. The outcomes are presented in this review, focusing on access to rheumatology services, diagnostics and therapies, rheumatology education and training and on clinical trials, as well as investigator-initiated and epidemiological research. The long-term vision of the WFRMD is to increase perception of the RMDs as a major burden to society and to explore potential opportunities to improve global and local RMD care.

The purpose of this study was to examine the characteristics of domestic research into breast-feeding intervention education geared toward mothers and the content of the intervention based on the existing literature in an effort to provide information on how to offer the best intervention. Domestic studies reported between January 1993 and December 2014 were analyzed using four different databases. Fifteen studies were selected from 76 studies included in the databases after performing the searches. How long breast-feeding intervention remains effective should be studied to secure scientific rationales, which is one of the proper nursing interventions to boost breast feeding. As a result of analyzing the papers according to Whittmore and Knaf`s integrative review method, the individual educational intervention was offered in two papers, and the individual education and group education were both provided in four. In nine papers, individual education, group education, phone counseling and education by home visits were all offered. Follow-up studies should be conducted by adopting a systematic research design to find more scientific evidence for appropriate nursing interventions to boost breast-feeding. These results will be useful for the development of educational programs for breast-feeding if more accurate information on breast-feeding education for mothers can be obtained.

We welcome the position paper by the European Society for Medical Oncology on issues surrounding biosimilars.1 After recent approval of the first biosimilars of monoclonal antibodies (mAbs) in oncology, the input of medical oncology societies to an open discussion of medical opinion and provision of guidance regarding the introduction of these drugs into clinical practice are urgently needed. As pointed out by Tabernero et al , safety and efficacy of biosimilars are the shared responsibility of manufacturers and regulatory bodies. We agree that a robust regulatory framework for authorisation of biosimilars is in place in Europe, and properly developed and approved biosimilars can be considered a valid treatment option.2 In line with the authors and the whole pharmaceutical industry,3 we advocate that …

Atrial fibrillation (AF) is one of the major morbidity and health economic factors in Europe and often associated with several co-morbidities. This paper (1) underlines the importance of highly professional AF management utilising a multi-disciplinary expertise, especially considering the role of AF regarding the stroke risk and prevention, (2) demonstrates the consolidated position of CVD professionals and (3) emphasises those research aspects that could deepen the understanding of the emergence and the treatment of AF and therefore helps to provide a personalised preventive and more effective management of AF. Specialised calls are considered for that within the new European Programme 'Horizon 2020'.

Although the description and interpretation of cancer genetics has been at the core of cancer research for more than a century, in this decade genomic medicine is set to profoundly transform every aspect of cancer care. Already, the anecdotal cases of individuals who have not responded to conventional chemotherapy but for whom whole genome sequencing has identified a gene target for directed therapy with remarkable clinical effect [1], point to a time in the not-too-distant future when cancer genome sequencing will be a routine adjunct to the clinico-pathological 'work-up' of a newly diagnosed cancer. For now, the identification of genes central to cancer biology is generating highly relevant diagnostic, prognostic and therapeutic information that has already translated to the clinic. The extraordinary pace of change is set to continue. The new era of personalised cancer medicine will touch every aspect of cancer care-from patient counselling, to cancer diagnosis, tumour classification, treatment and outcome-that demands a new level of in-depth education and collaboration between researchers, cancer specialists, patients and other stakeholders. In this position paper, ESMO sets out the current status in the field of personalised cancer medicine and addresses issues and challenges for the medical oncology community.

Background Allergen immunotherapy (AIT) has been thoroughly documented in randomized controlled trials (RCTs). It is the only immune-modifying and causal treatment available for patients suffering from IgE-mediated diseases such as allergic rhinoconjunctivitis, allergic asthma and insect sting allergy. However, there is a high degree of clinical and methodological heterogeneity among the endpoints in clinical studies on AIT, for both subcutaneous and sublingual immunotherapy (SCIT and SLIT). At present, there are no commonly accepted standards for defining the optimal outcome parameters to be used for both primary and secondary endpoints. Methods As elaborated by a Task Force (TF) of the European Academy of Allergy and Clinical Immunology (EAACI) Immunotherapy Interest Group, this Position Paper evaluates the currently used outcome parameters in different RCTs and also aims to provide recommendations for the optimal endpoints in future AIT trials for allergic rhinoconjunctivitis. Results Based on a thorough literature review, the TF members have outlined recommendations for nine domains of clinical outcome measures. As the primary outcome, the TF recommends a homogeneous combined symptom and medication score (CSMS) as a simple and standardized method that balances both symptoms and the need for antiallergic medication in an equally weighted manner. All outcomes, grouped into nine domains, are reviewed. Conclusion A standardized and globally harmonized method for analysing the clinical efficacy of AIT products in RCTs is required. The EAACI TF highlights the CSMS as the primary endpoint for future RCTs in AIT for allergic rhinoconjunctivitis. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The Japanese Society of Hypertension (JSH) has announced the winners of the 9th Hypertension Research Award at the 41st Annual Scientific Meeting held on 14-16 September 2018 in Asahikawa, Hokkaido, Japan. This award was established in 2010 to recognize significant contributions of researchers to the advancement of researches in hypertension and related studies. Among the first or main authors of the articles published in Hypertension Research, official journal of JSH, from April 2017 (Vol. 40, No. 4) to March 2018 (Vol. 41, No. 3) the journal's editorial committee members selected the following winners.

Aims.Leucht et al. in 2012 described an overview of meta-analyses of the efficacy of medication in psychiatry and general medicine, concluding that psychiatric drugs were not less efficacious than other drugs. Our goal was to explore the dissemination of this highly cited paper, which combined a thought provoking message with a series of caveats.Methods.We conducted a prospectively registered citation content analysis. All papers published before June 1st citing the target paper were independently rated by two investigators. The primary outcome coded dichotomously was whether the citation was used to justify a small or modest effect observed for a given treatment. Secondary outcomes regarded mentioning any caveats when citing the target paper, the point the citation was making (treatment effectiveness in psychiatry closely resembles that in general medicine, others), the type of condition (psychiatric, medical or both), specific disease, treatment category and specific type. We also extracted information about the type of citing paper, financial conflict of interest (COI) declared and any industry support. The primary analysis was descriptive by tabulating the extracted variables, with numbers and percentages where appropriate. Co-authorship networks were constructed to identify possible clusters of citing authors. An exploratory univariate logistic regression was used to explore the relationship between each of a subset of pre-specified secondary outcomes and the primary outcome.Results.We identified 135 records and retrieved and analysed 120. Sixty-three (53%) quoted Leucht et al.’s paper to justify a small or modest effect observed for a given therapy, and 113 (94%) did not mention any caveats. Seventy-two (60%) used the citation to claim that treatment effectiveness in psychiatry closely resembles that in general medicine; 110 (91%) paper were about psychiatric conditions. Forty-one (34%) papers quoted it without pointing towards any specific treatment category, 28 (23%) were about antidepressants, 18 (15%) about antipsychotics. Forty (33%) of the citing papers included data. COIs were reported in 55 papers (46%). Univariate and multivariate regressions showed an association between a quote justifying small or modest effects and the point that treatment effectiveness in psychiatry closely resembles that in general medicine.Conclusions.Our evaluation revealed an overwhelmingly uncritical reception and seemed to indicate that beyond defending psychiatry as a discipline, the paper by Leucht et al. served to lend support and credibility to a therapeutic myth: trivial effects of mental health interventions, most often drugs, are to be expected and therefore accepted.Protocol registration: https://osf.io/9dqat/

Functional foods can be considered to be those whole, fortified, enriched or enhanced foods that provide health benefits beyond the provision of essential nutrients (e.g., vitamins and minerals), when they are consumed at efficacious levels as part of a varied diet on a regular basis. Linking the consumption of functional foods or food ingredients with health claims should be based on sound scientific evidence, with the "gold standard" being replicated, randomized, placebo-controlled, intervention trials in human subjects. However, not all foods on the market today that are claimed to be functional foods are supported by enough solid data to merit such claims. This review categorizes a variety of functional foods according to the type of evidence supporting their functionality, the strength of that evidence and the recommended intakes. Functional foods represent one of the most intensively investigated and widely promoted areas in the food and nutrition sciences today. However, it must be emphasized that these foods and ingredients are not magic bullets or panaceas for poor health habits. Diet is only one aspect of a comprehensive approach to good health.