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A current osteopathic tenet inherited from Native American principles involves viewing each person as a dynamic interaction of body-mind-spirit (BMS). Because of its traditional medicine heritage and current evidence-based approach, the osteopathic profession is, arguably, uniquely positioned to promote evidence-informed person-centered approaches that transcend improvements in pain and musculoskeletal function. It may be particularly relevant in the context of integrating the BMS tenet into osteopathic care according to the diversity of patients’ values and sociocultural assumptions towards health, symptoms, and subsequent care, which range from the typical Western to complementary and alternative medicine perspectives. There is currently a lack of robust clinical practice frameworks in this area, confusing patients and practitioners and blurring professional identities. The current commentary provides an opportunity to initiate discussions in the profession with a rationale for creating a roadmap to develop an evidence-informed framework for osteopathic care that integrates the BMS tenet.

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.

The American College of Clinical Pharmacy (ACCP) published an initial white paper on herbal products in 2000. Since then, the global market for natural products has continued to expand, with tens of millions of consumers using such products on an annual basis in the United States alone. However, despite this expansion, natural products remain largely unregulated compared with prescription medications, have moderate- to low-level clinical evidence for efficacy, and continue to have safety concerns, including adulteration and misbranding. As comprehensive medication management experts, clinical pharmacists are uniquely qualified to navigate these concerns and advise patients appropriately. To develop and recommend a suitable care plan involving natural products, clinical pharmacists must establish a strong pharmacist-patient relationship, assess the appropriateness of therapy, educate the patient regarding key issues, and continuously monitor and follow up on the effectiveness of the care plan. This process should not only occur in an individual community or hospital setting, but also whenever a patient transitions from one care setting to another in cooperation with other clinicians.

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.

This review describes standardized ergonomics assessment based on pen-and-paper observational methods for assessing ergonomics risk factors.The three main objectives are to analyze published pen-and-paper observational methods, to extract and understand the risk levels of each method and to identify their associated health effects.The authors searched scientific databases and the Internet for materials from 1970 to 2013 using the following keywords: ergo, posture, method, observational, postural angle, health effects, pain and diseases. Postural assessments of upper arms, lower arms, wrists, neck, back and legs in six pen-and-paper-based observational methods are highlighted, extracted in groups and linked with associated adverse health effects.The literature reviewed showed strengths and limitations of published pen-and-paper-based observational methods in determining the work activities, risk levels and related postural angles to adverse health effects. This provided a better understanding of unsafe work postures and how to improve these postures.Many pen-and-paper-based observational methods have been developed. However, there are still many limitations of these methods. There is, therefore, a need to develop a new pen-and-paper-based observational method for assessing postural problems.

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.

In the United States and other Western countries, dry needling has been a topic in academic and legal fields. This White Paper is to provide the authoritative information of dry needling versus acupuncture to academic scholars, healthcare professionals, administrators, policymakers, and the general public by providing the authoritative evidence and expertise regarding critical issues of dry needling and reaching a consensus. We conclude that Dr. Travell, Dr. Gunn, Dr. Baldry and others who have promoted dry needling by simply rebranding (1) acupuncture as dry needling and (2) acupuncture points as trigger points (dry needling points). Dry needling simply using English biomedical terms (especially using "fascia" hypothesis) in replace of their equivalent Chinese medical terms. Dry needling is an over-simplified version of acupuncture derived from traditional Chinese acupuncture except for emphasis on biomedical language when treating neuromuscularskeletal pain (dry needling promoters redefined it as "myofascial pain"). Trigger points belong to the category of Ashi acupuncture points in traditional Chinese acupuncture, and they are not a new discovery. By applying acupuncture points, dry needling is actually trigger point acupuncture, an invasive therapy (a surgical procedure) instead of manual therapy. Dr. Travell admitted to the general public that dry needling is acupuncture, and acupuncture professionals practice dry needling as acupuncture therapy and there are several criteria in acupuncture profession to locate trigger points as acupuncture points. Among acupuncture schools, dry needling practitioners emphasize acupuncture's local responses while other acupuncturists pay attention to the responses of both local, distal, and whole body responses. For patients' safety, dry needling practitioners should meet standards required for licensed acupuncturists and physicians.

In this study, we compared cancer patients preference for computerised (tablet/web-based) surveys versus paper. We also assessed whether the understanding of a cancer-related topic, pharmacogenomics is affected by the survey format, and examined differences in demographic and medical characteristics which may affect patient preference and understanding. Three hundred and four cancer patients completed a tablet-administered survey and another 153 patients completed a paper-based survey. Patients who participated in the tablet survey were questioned regarding their preference for survey format administration (paper, tablet and web-based). Understanding was assessed with a ‘direct’ method, by asking patients to assess their understanding of genetic testing, and with a ‘composite’ score. Patients preferred administration with tablet (71%) compared with web-based (12%) and paper (17%). 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.

A position paper on the use of whole bowel irrigation (WBI) was first published in 1997 by the American Academy of Clinical Toxicology (AACT) and the European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) and updated in 2004. The aims of this paper are to briefly summarize the content of the 2004 Position Paper and to present any new data and recommendations.A systematic review of the literature from January 2003 to February 28, 2013 was conducted using multiple online databases for articles concerning WBI for gastrointestinal decontamination. An evidence table was created for applicable articles. The authors produced the initial draft that was reviewed by AACT and EAPCCT.The literature search produced 60 articles with the possibility of applicable human data. Based mainly on volunteer studies, WBI can be considered for potentially toxic ingestions of sustained-release or enteric-coated drugs particularly for those patients presenting later than 2 h after drug ingestion when activated charcoal is less effective. WBI can be considered for patients who have ingested substantial amounts of iron, lithium, or potassium as the morbidity is high and there is a lack of other potentially effective options for gastrointestinal decontamination. WBI can be considered for removal of ingested packets of illicit drugs in "body packers." However, controlled data documenting improvement in clinical outcome after WBI are lacking. WBI is contraindicated in patients with bowel obstruction, perforation, or ileus, and in patients with hemodynamic instability or compromised unprotected airways. WBI should be used cautiously in debilitated patients and in patients with medical conditions that might be further compromised by its use. The concurrent administration of activated charcoal and WBI might decrease the effectiveness of the charcoal. The clinical relevance of this interaction is uncertain.WBI can facilitate removal of select toxicants from the gastrointestinal tract in some patients, but there is no convincing evidence from clinical studies that it improves the outcome of poisoned patients. There is no new evidence that would require a major revision of the conclusions of the 2004 position statement.

Background Techniques in foot and ankle surgery have expanded rapidly in recent years, often presented at national society meetings. It is important that research is published to guide evidence based practice. Many abstracts however do not go on to full text publication. Methods A database was created of all abstracts presented at BOFAS meetings from 2009 to 2013. Computerised searches were performed using PubMed and Google search engines. Results In total 341 papers were presented, with an overall publication rate of 31.7%. Of 251 clinical papers, 200 were case series (79.6%). Factors associated with publication success included basic science studies, papers related to arthroscopic surgery and research performed outside the UK. Conclusion A relatively low conversion rate from presentation to publication could be as a result of papers failing to pass the scrutiny of peer review, or that the work is never formally submitted for publication. The information from this study could be used to prioritise future research and promote higher quality research.

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.

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

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.

Objective.To develop preliminary treat-to-target (T2T) recommendations for psoriasis and psoriatic arthritis (PsA) for Canadian daily practice.Methods.A task force composed of expert Canadian dermatologists and rheumatologists performed a needs assessment among Canadian clinicians treating these diseases as well as an extensive literature search on the outcome measures used in clinical trials and practice.Results.Based on results from the needs assessment and literature search, the task force established 5 overarching principles and developed 8 preliminary T2T recommendations.Conclusion.The proposed recommendations should improve management of psoriasis and PsA in Canadian daily practice. However, these recommendations must be further validated in a real-world observational study to ensure that their use leads to better longterm outcomes.

Antihypertensive, lipid lowering, antidiabetic and antiplatelet treatments all substantially reduce the risk of cardiovascular morbid and fatal events. In real life, however, effective implementation of these treatments is rare, and thus their contribution to cardiovascular prevention is much less than it could be, based on research data. This article reviews the pros and cons of cardiovascular prevention by the polypill approach. It is argued that the high prevalence of individuals with a multifactorial risk profile provides a strong rationale for a therapeutic strategy based on the combination in a single tablet of drugs against different risk factors. It is further argued that other important favourable arguments exist. First, in real-life adherence to all above treatments is very low, leading to a major increase in the incidence and risk of cardiovascular outcomes. Second, although a large number of factors are involved, adherence is adversely affected by the complexity of the prescribed treatment regimen and can be considerably improved by treatment simplification. Third, recent studies in patients with a history of manifest cardiovascular disease have documented that different cardiovascular drugs can be combined in a single tablet with no loss of their individual efficacy or unexpected inconveniences and this does favour adherence to treatment and multiple risk factor control, supporting use of the polypill in secondary cardiovascular prevention. It is finally also mentioned, however, that the polypill may have some drawbacks and that at present no evidence is available that this approach reduces cardiovascular outcome to a greater degree than standard treatment strategies. Trials are under way to provide an answer to this question and thus allow the therapeutic value of this approach to be known.

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 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.

The Patient Safety Subcommittee requested a review of the science and policy issues regarding the rapidly emerging public health epidemic of prescription opioid-related morbidity and mortality in the United States. Over 100,000 persons have died, directly or indirectly, from prescribed opioids in the United States since policies changed in the late 1990s. In the highest-risk group (age 35–54 years), these deaths have exceeded mortality from both firearms and motor vehicle accidents. Whereas there is evidence for significant short-term pain relief, there is no substantial evidence for maintenance of pain relief or improved function over long periods of time without incurring serious risk of overdose, dependence, or addiction. The objectives of the article are to review the following: (1) the key initiating causes of the epidemic; (2) the evidence for safety and effectiveness of opioids for chronic pain; (3) federal and state policy responses; and (4) recommendations for neurologists in practice to increase use of best practices/universal precautions most likely to improve effective and safe use of opioids and to reduce the likelihood of severe adverse and overdose events. Neurology® 2014;83:1277–1284

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 …

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.

This American College of Physicians position paper, initiated and written by its Health and Public Policy Committee and approved by the Board of Regents on 16 February 2016, reports policy recommendations from the American College of Physicians to address the escalating costs of prescription drugs in the United States. Prescription drugs play an important part in treating and preventing disease. However, the United States often pays more for some prescription drugs than other developed countries, and the high price and increasing costs associated with prescription medication is a major concern for patients, physicians, and payers. Pharmaceutical companies have considerable flexibility in how they price drugs, and the costs that payers and patients see are dependent on how payers are able to negotiate discounts or rebates. Beyond setting list prices are issues of regulatory approval, patents and intellectual property, assessment of value and cost-effectiveness, and health plan drug benefits. These issues are linked, and comprehensive efforts will be needed to affect how drugs are priced in the United States.

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.

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.

Informed consent is an ethical concept that is codified in the law and is in daily practice at every health care institution. Three fundamental criteria are needed for clinical informed consent: the patient must be competent, adequately informed and not coerced. Physician-patient interaction is rooted in the ethical concept of beneficence, but over the 19th and 20th centuries, case law and societal changes brought respect for autonomy and with it--informed consent. This article briefly reviews the basics of informed consent, when is it required, how did informed consent evolve into what it is today and what can the surgeon do to truly achieve informed consent.

The United States (U.S.) is facing a national opioid epidemic, and medical systems are in need of non-pharmacologic strategies that can be employed to decrease the public's opioid dependence. Acupuncture has emerged as a powerful, evidence-based, safe, cost-effective, and available treatment modality suitable to meeting this need. Acupuncture has been shown to be effective for the management of numerous types of pain conditions, and mechanisms of action for acupuncture have been described and are understandable from biomedical, physiologic perspectives. Further, acupuncture's cost-effectiveness can dramatically decrease health care expenditures, both from the standpoint of treating acute pain and through avoiding addiction to opioids that requires costly care, destroys quality of life, and can lead to fatal overdose. Numerous federal regulatory agencies have advised or mandated that healthcare systems and providers offer non-pharmacologic treatment options for pain. Acupuncture stands out as the most evidence-based, immediately available choice to fulfil these calls. Acupuncture can safely, easily, and cost-effectively be incorporated into hospital settings as diverse as the emergency department, labor and delivery suites, and neonatal intensive care units to treat a variety of commonly seen pain conditions. Acupuncture is already being successfully and meaningfully utilized by the Veterans Administration and various branches of the U.S. Military, in some studies demonstrably decreasing the volume of opioids prescribed when included in care.

Quasi-experiments have been infrequently used in the health sciences. Focusing on health systems implementation research, this article details key advantages of quasi-experiments and argues that they can complement (but not replace) randomized evaluations. Specifically, it may be possible to use a quasi-experiment to study the causal effect of an intervention that cannot feasibly be randomized or that would be unethical (e.g., because the intervention has become the standard of care) to test in a randomized controlled trial (RCT). In addition, because they usually take advantage of routinely collected data, quasi-experiments may be feasible when it is too costly (either financially or in terms of the required time) to carry out a RCT - an important advantage in research on health systems, which vary widely between settings. Nonetheless, we argue that RCTs will continue to be indispensable for implementation research because i) the assumptions needed to establish causality with a quasi-experiment are often unverifiable, ii) available data frequently do not allow for a rigorous quasi-experiment, and iii) randomized designs tend to lend themselves more to informing policy makers of causal effects prior to (or during) the full-scale rollout of an intervention than quasi-experiments.

Program Description:Key aspects of thyroid surgery have been addressed by published clinical practice guidelines, consensus statements, and position papers from the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO-HSNF), the American Head and Neck Society (AHNS), and the American Thyroid Association (ATA). This miniseminar efficiently presents these society publications, focusing on their content, interpretation, and limitations. Specific topics include surgery for invasive carcinoma, imaging selection, improving postoperative voice outcomes, nerve monitoring, outpatient surgery, and goiter management. These documents will also be used to highlight the important overall differences between practice guidelines, consensus statements, and position papers and their respective influence on clinical decisions.Educational Objectives:(1) Differentiate between a clinical practice guideline, clinical consensus statement, and position paper. (2) Analyze the content, interpretation, and limita...

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.