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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

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.

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 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.

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.

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.

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

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/

Background The standards of Ayurveda education in India are being questioned in the recent years and many suggestions related to educational reforms are being put forth by educators and health policy experts. However, the Post Graduate Entrance Examinations (PGEEs) that are carried out to select the candidates to pursue postgraduate programs have received little attention in this context. Objectives The objective of this study was to classify the Multiple Choice Questions (MCQs) from Ayurveda PGEEs conducted in different universities of India during the five year period (ranging from 2010 to 2014) into six levels of Bloom's Taxonomy in cognitive domain. Methods This is a retrospective observational study. The sampling method followed was purposive sampling. Totally, 3299 MCQs obtained out of 25 question papers from seven universities spread across four zones of India (North, South, West and East) were included in the study and were classified based on the Bloom's taxonomy. Results About 93.3% of MCQs assessed only the ‘recall’ component whereas 6.2% of the MCQs assessed ‘comprehension’. Percentage of MCQs that assessed ‘application’ level was a mere 0.3% whereas the percentage of MCQs that assessed the ‘analysis’ component was found to be only 0.2%. There was not even a single question to assess the ‘synthesis’ and ‘evaluation’ components. Conclusions We conclude that an appropriate proportion of MCQs assessing ‘higher order thinking’ are required to be included in Ayurveda PGEEs. While it is possible to frame MCQs to assess all six levels of Bloom's taxonomy in cognitive domain, the teachers are required to be trained well in the skills of MCQ writing. We propose that our study may be taken as a lead to introduce the required reforms in PGEEs. Clinical Trial Registration No.: Not applicable.

Non-conventional medical practices that make use of dietary supplements, herbal extracts, physical manipulations, and other practices typically associated with folk and Traditional Medicine are increasingly becoming popular in Western Countries. These practices are commonly referred to by the generic, all-inclusive term “Complementary and Alternative Medicine.” Scientists, practitioners, and medical institutions bear the responsibility of testing and proving the effectiveness of these non-conventional medical practices in the interest of patients. In this context, the number of peer-reviewed journals and published articles on this topic has greatly increased in the recent decades. In this editorial article, we illustrate the policy of the Journal of Traditional and Complementary Medicine for publishing solid and scientifically sound papers in the field of Traditional and Complementary Medicine.

Background The plastic surgery literature is vast, consisting of a plethora of diverse articles written by a myriad of illustrious authors. Despite this considerable archive of published material, it remains nebulous as to which precise papers have had the greatest impact on our specialty. The aim of this study was to identify the most cited papers in the plastic surgery literature and perform a citation analysis paying particular attention to the evidence levels of the clinical studies. Methods We identified the 50 most cited papers published in the 20 highest impact plastic surgery journals through the Web of Science. The articles were ranked in order of number of citations acquired and level of evidence assessed. Results The top 50 cited papers were published in six different journals between the years 1957 and 2007. Forty-two of the papers in the top 50 were considered as level IV or V evidence. No level I or II evidence was present in the top 50 list. The average level of evidence of the top 50 papers was 4.28. Conclusions In the plastic surgery literature, no positive correlation exists between a high number of citations and a high level of evidence. Anatomical reconstructive challenges tend to be the main focus of plastic surgery rather than pathologic diseases and consequently, papers with lower levels of evidence are relatively more valuable in plastic surgery than many other specialties.

Wenchao Gu,1YapingYuan,1 HuaYang,1GuangshengQi,1XiaoyanJin,2JinYan2 1Department of Respiratory Medicine, People’s Hospital of Shanghai, Pudong New Area, 2Department of Respiratory Medicine, Tongren Hospital, Shanghai, People’s Republic of China Objective: We aimed to identify the 100 top-cited articles published on chronic obstructive pulmonary disease (COPD) and to analyze their characteristics so as to provide information on the achievement and development in COPD research over the past decades. Methods and materials: A comprehensive list of citation classics in COPD was generated by searching the Science Citation Index expanded database, using the keywords “COPD” or “chronic obstructive pulmonary disease” or “chronic obstructive pulmonary diseases”. The 100 top-cited research papers were retrieved by reading the abstract or full text if needed. All eligible articles were read for basic information, including country of origin, organizations, article type, journals, research field, and authors.Results: The 100 top-cited articles on COPD were published between 1966 and 2010. The number of citations ranged from 254 to 2,164, with a mean of 450 citations for each article. These citation classics were from 32 countries, with 38 from the United States. The Imperial College London led the list of classics, with 16 papers. The 100 top-cited articles were distributed in 18 journals, with the American Journal of Respiratory, Critical Care Medicine, and Journal of the American Medical Association topping the list. Among the various fields, both respiratory system (63%) and general internal medicine (63%) were the most common fields of study for the 100 articles. Conclusion: Our bibliometric analysis provides a historical perspective on the progress of scientific research on COPD. Articles originating from the United States and published in high-impact specialized respiratory journals are most likely to be cited in the field of COPD research. Keywords: citation analysis, top-cited, chronic obstructive pulmonary disease

International Journal of Environmental Research and Public Health started to institute an annual award in 2013 to recognize outstanding papers related to environmental health sciences and public health that meet the aims, scope and high standards of this journal. We are pleased to announce the third “International Journal of Environmental Research and Public Health Best Paper Awards” for 2015. Nominations were solicited from the Editor-in-Chief and Editorial Board members, with all papers published in 2011 eligible for consideration. The following nine papers were selected for recognition awards:[...]

Objectives: To organize a common approach on the management of patent foramen ovale (PFO) and cryptogenic stroke that may be shared by different specialists. Background: The management of PFO related to cryptogenic stroke is controversial, despite an increase in interventional closure procedures. Methods: A consensus statement was developed by approaching Italian national cardiological, neurological, and hematological scientific societies. Task force members were identified by the president and/or the boards of each relevant scientific society or working group, as appropriate. Drafts were outlined by specific task force working groups. To obtain a widespread consensus, these drafts were merged and distributed to the scientific societies for local evaluation and revision by as many experts as possible. The ensuing final draft, merging all the revisions, was reviewed by the task force and finally approved by scientific societies. Results: Definitions of transient ischemic attack and both symptomatic and asymptomatic cryptogenic strokes were specified. A diagnostic workout was identified for patients with candidate event(s) and patient foramen ovale to define the probable pathogenesis of clinical events and to describe individual PFO characteristics. Further recommendations were provided regarding medical and interventional therapy considering individual risk factors of recurrence. Finally, follow-up evaluation was appraised. Conclusions: Available data provided the basis for a shared approach to management of cryptogenic ischemic cerebral events and PFO among different Italian scientific societies. Wider international initiatives on the topic are awaited. © 2013 Wiley Periodicals, Inc.

This is the introductory paper in a series of eight papers. In this series, we integrate the theoretical design options with the practice of conducting pragmatic trials. For most new market-approved treatments, the clinical evidence is insufficient to fully guide physicians and policy makers in choosing the optimal treatment for their patients. Pragmatic trials can fill this gap, by providing evidence on the relative effectiveness of a treatment strategy in routine clinical practice, already in an early phase of development, while maintaining the strength of randomized controlled trials. Selecting the setting, study population, mode of intervention, comparator, and outcome are crucial in designing pragmatic trials. In combination with monitoring and data collection that does not change routine care, this will enable appropriate generalization to the target patient group in clinical practice. To benefit from the full potential of pragmatic trials, there is a need for guidance and tools in designing these studies while ensuring operational feasibility. This paper introduces the concept of pragmatic trial design. The complex interplay between pragmatic design options, feasibility, stakeholder acceptability, validity, precision, and generalizability will be clarified. In this way, balanced design choices can be made in pragmatic trials with an optimal chance of success in practice.

Background: Communication in cancer care has become a major topic of interest. Since there is evidence that ineffective communication affects both patients and oncology clinicians (physicians and nurses), so-called communication skills trainings (CSTs) have been developed over the last decade. While these trainings have been demonstrated to be effective, there is an important heterogeneity with regard to implementation and with regard to evidence of different aspects of CST. Methods: In order to review and discuss the scientific literature on CST in oncology and to formulate recommendations, the Swiss Cancer League has organised a consensus meeting with European opinion leaders and experts in the field of CST, as well as oncology clinicians, representatives of oncology societies and patient organisations. On the basis of a systematic review and a meta-analysis, recommendations have been developed and agreed upon. Results: Recommendations address (i) the setting, objectives and participants of CST, (ii) its content and pedagogic tools, (iii) organisational aspects, (iv) outcome and (v) future directions and research. Conclusion: This consensus meeting, on the basis of European expert opinions and a systematic review and meta-analysis, defines key elements for the current provision and future development and evaluation of CST in oncology.

This report updates concepts on hypertension management in patients with diabetes. It focuses on clinical outcomes literature published within the last 3 years and incorporates these observations into modifications of established guidelines. While the fundamentals of treatment and goal blood pressures remain unchanged, approaches to specific patient-related issues has changed. This update focuses on questions such as what to do when a patient has an elevated potassium level when therapy is initiated and whether combinations of agents that block the renin-angiotensin system still be used. In addition, there are updates from trials, just published and in press, that focus on related management issues influencing cardiovascular outcomes in persons with diabetes. Last, an updated algorithm is provided that incorporates many of the new findings and is suggested as a starting point to achieve blood pressure goals.

Pediatric tuberculosis (TB) is known to have a wide range of presentations, and if left untreated, primary TB may lead to bone and joint involvement. The literature on this topic is very scarce, and no comprehensive systematic review or meta-analysis of the current knowledge is available to date. The aim of this study is to identify and analyze the literature with highest impact based on citation rate analysis. All databases of the Thomson and Reuters "Web of Knowledge" were used to conduct our search of the 100 most cited articles on this topic published between 1950 and 2014. The included articles were analyzed in terms of citation rate, age, study type, area of research, level of evidence (LOE), and more. All 100 articles were published between 1967 and 2011 in 51 different journals. The average citation rate was 74.26, all articles were on average 23.1 years, and most studies were originated from India (n = 22), followed by the USA (n = 21). The majority of publications were review articles (42%), described clinical course (n = 48), and assigned an LOE IV (44%). TB infection is a high burden disease in low-income countries but widely studied in a fi rst world setup. This research gap between the geographic distribution of disease burden and origin of publications could initiate possibilities for high-burden countries to share their opinion. Their experience is of a high level of importance and relevance which furthermore is necessary to create a more accurate picture of pediatric musculoskeletal TB burden in literature.

A vision of a future NHS offering personalised health care that is based on a person's genetic profile was painted in the government's genetics white paper, announced this week. The health secretary, John Reid, told the House of Commons: “Genetics promises a more personalised approach to health care, with interventions tailored to each person's own genetic profile.” He proclaimed, “We are standing on the threshold of a revolution in health care.” An estimated six out of ten people will, by the age of 60, develop a disease that is at least partially genetically determined. The white paper lays out a future NHS where patients are routinely …

Doctors' and patients' groups fear that the UK government's new style public consultation exercise on what the health secretary, Patricia Hewitt, has called “health outside hospitals” has not been sufficiently inclusive. They also say that it will raise unrealistic expectations among staff and the public for service delivery and quality. Views from the exercise, which the government has called “Your health, your care, your say,” will shape the white paper on improving primary care, community and social care services, which is due to be published in December. Mrs Hewitt announced in June that she wanted to adopt a method of consultation that was different from the usual procedure of just …

Objective : The paper highlights the extent of pharmaceutical drug misuse problems in Australia and explores how pharmaceutical opioid misuse could be reduced by implementation of a technological tool: a prescription co-ordination program (PCP). The paper explores how enhancements to existing computer-assisted clinical decision support systems through real-time, on-line information to prescribers, pharmacists and regulators could address drug-seeking and improve the quality use of medicines. Approach : Trends in national and international prescription opioid use and related harms are examined with attention directed to drug-seeking behaviour and intentional misuse. The international literature concerning PCPs is reviewed and implications for technological advances in Australia are outlined. Conclusion : Australia has a burgeoning problem associated with the misuse of pharmaceutical opioids. There is increased recognition of a range of iatrogenic harms. A number of factors limit Australia's response capacity including lack of technological capacity to provide on-line, real-time information for prescribers and pharmacists. Implications : Providing prescribers, pharmacists and regulators with on-line, real-time information about patients’ prescription opioid use will improve the quality use of medicines. A national system is required to co-ordinate data on Pharmaceutical Benefits Scheme, Repatriation Pharmaceutical Benefits Scheme and unsubsidised medicines, including private prescriptions. Pharmaceutical opioids are not the only medicines subject to misuse and therefore the need to capture data on other relevant medicines is also addressed.

Objectives: To develop a methodology for evaluating the impact of research on health care, and to characterise the papers cited on clinical guidelines. Design: The bibliographic details of the papers cited in 15 clinical guidelines, developed in and for the United Kingdom, were collated and analysed with applied bibliometric techniques. Results: The median age of papers cited in clinical guidelines was eight years; most papers were published by authors living in either the United States (36%) or the United Kingdom (25%)—this is two and a half times more than expected as about 10% of all biomedical outputs are published in the United Kingdom; and clinical guidelines do not cite basic research papers. Conclusion: Analysis of the evidence base of clinical guidelines may be one way of tracking the flow of knowledge from the laboratory to the clinic. Moreover, such analysis provides a useful, clinically relevant method for evaluating research outcomes and different strategies in research and development.

If you prescribe drugs, the pharmaceutical industry is interested in you and is investing a staggering sum of money trying to influence you. The most effective way of changing the prescribing habits of a clinician is through personal representatives (known in Britain as “drug reps” and in North America as “detailers”), who travel round with a briefcase full of “evidence” in support of their wares.1 Pharmaceutical “reps” do not tell nearly as many lies as they used to (drug marketing has become an altogether more sophisticated science), but they have been known to cultivate a shocking ignorance of basic epidemiology and clinical trial design when it suits them.2 It often helps their case, for example, to present the results of uncontrolled trials and express them in terms of before and after differences in a particular outcome measure.3 The recent correspondence in the Lancet and BMJ on placebo effects should remind you why uncontrolled before and after studies are the stuff of teenage magazines, not hard science.4 5 6 7 8 9 10 11 12 Sackett and colleagues have argued that before giving a drug to a patient the doctor should: #### Summary points Pharmaceutical “reps” are now much more informative than they used to be, but they may show ignorance of basic epidemiology and clinical trial design The value of a drug should be expressed in terms of safety, tolerability, efficacy, and price The efficacy of a drug should ideally be measured in terms of clinical end points that are relevant to patients; if surrogate end points are used they should be valid Promotional literature of low scientific validity (such as uncontrolled before and after trials) should not be allowed to influence practice

It has long been assumed by the medical–scientific fraternitythat the intended end-point of research is publication of resultsin a respected journal, there to be read and examined in perpe-tuity. This has been challenged by a distinguished ex-editor ofthis journal, who concluded that the primary aim of manyauthors was not to have their paper accepted for publication[1]. He outlined numerous creative opportunities in the pres-entation of the manuscript to antagonize the reviewer andeditor. We contend that there are simpler, more compellingand less demanding means of antagonizing the statisticalreviewer, thus ensuring certain rejection of the paper. We haveoutlined some of the possibilities available to the novice andexperienced researcher alike, recognizing that it is never toolate to learn and, indeed, Continuing Professional Developmentrequires you to do so.

Purpose Over 20 years ago the term non-specific low back pain became popular to convey the limitations of our knowledge of the pathological source of most people's low back pain. Knowledge of underlying pathology has advanced little since then, despite limited improvements in outcomes for patients with low back pain. Methods This paper discusses potential misunderstandings related to diagnostic studies in the field of low back pain and argues that future diagnostic studies should include and investigate pathological sources of low back pain. Results Six potential misunderstandings are discussed. (1) Until diagnosis is shown to improve outcomes it is not worth investigating; (2) without a gold standard it is not possible to investigate diagnosis of low back pain; (3) the presence of pathology in some people without low back pain means it is not important; (4) dismissal of the ability to diagnose low back pain in clinical guidelines is supported by the same level of evidence as recommendations for therapy; (5) suggesting use of a diagnostic test in research is misinterpreted as endorsing its use in current clinical practice; (6) we seem to have forgotten the 'bio' in biopsychosocial low back pain. Conclusions We believe the misunderstandings presented in this paper partly explain the lack of investigation into pathology as an important component of the low back pain experience. A better understanding of the biological component of low back pain in relation, and in addition, to psychosocial factors is important for a more rational approach to management of low back pain.

The scientific literature has demonstrated that probiotics have a broad spectrum of activity, although often the results are contradictory. This study provides a critical overview of the current meta-analyses that have evaluated the efficacy of probiotics in physiologic and pathological conditions, such as metabolic disease, antibiotic-associated and Clostridium difficile-associated diarrhea, IBS, constipation, IBD, chemotherapy-associated diarrhea, respiratory tract infection, ventilator-associated pneumonia, NAFLD, liver encephalopathy, periodontitis, depression, vaginosis, urinary tract infections, pancreatitis, incidence of ventilator-associated pneumonia, hospital infection and stay in ICU, mortality of post-trauma patients, necrotising enterocolitis in premature infants. Only for antibiotic- and Clostridium difficile-associated diarrhea, and respiratory tract infections the effects of probiotics are considered "evidence-based." Concerning other fields, meta-analyses lacks to define type and biologic effect of probiotic strains, as well as the outcome in a disease state. Therefore, the results presented should be a stimulus for further studies which will provide clinical recommendations.

OBJECTIVES: There is an important need to evaluate therapeutic approaches for osteoarthritis (OA) in terms of cost-effectiveness as well as efficacy. METHODS: The ESCEO expert working group met to discuss the epidemiological and economic evidence that justifies the increasing concern of the impact of this disease and reviewed the current state-of-the-art in health economic studies in this field. RESULTS: OA is a debilitating disease; it is increasing in frequency and is associated with a substantial and growing burden on society, in terms of both burden of illness and cost of illness. Economic evaluations in this field are relatively rare, and those that do exist, show considerable heterogeneity of methodological approach (such as indicated population, comparator, decision context and perspective, time horizon, modeling and outcome measures used). This heterogeneity makes comparisons between studies problematic. CONCLUSIONS: Better adherence to guidelines for economic evaluations is needed. There was strong support for the definition of a reference case and for what might constitute "standard optimal care" in terms of best clinical practice, for the control arms of interventional studies.

BACKGROUND: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website.OBJECTIVES: This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis.METHODS: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy.RESULTS: FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34) except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61) pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55) pairwise comparisons and were statistically significant in 5. The "signal" in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical.CONCLUSION: There was no empirical evidence to suggest biased estimates between the two sources. Increased and detailed transparency in publications would improve the understanding and credibility of published results. Further, the FDA report was found to be a useful source when data are missing in the published report (i.e. reporting bias).

More than 500 journals have adopted the uniform requirements of the International Committee of Medical Journal Editors, which stipulate that authors should “indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation.”1 One major purpose of institutional review is to ensure that informed consent is obtained when possible. We investigated how often research publications about child health report ethics committee approval or informed consent. We reviewed all research reports related to child health (involving patients

Osteoporosis is a systemic disease of the bone that affects millions of people and causes burden for both the affected individual and health systems and societies worldwide. Since the 1970s much research has been done in the field of osteoporosis. The number of citations of a paper reflects its influence and importance to the field. Thomson ISI Web of Science database was searched to retrieve a list of the fifty most cited articles related to osteoporosis and its research. The fifty most cited articles in absolute numbers in the field of osteoporosis were cited from 877 to 3056 times (mean1141±537). Most papers were published in the basic science category(n=23). 395 authors contributed; a single paper had between one and 62 authors (mean:10.02±9.9authors). 12 authors (3.04%) contributed between 7 and 4 papers; 340 authors (86.1%) were at least named once. Corresponding authors were from eight countries with most contributions from the United States (n=34, 68%). The majority of papers were published in the 1990s(n=29). The list of 50 most cited papers presents citation classics in the field of osteoporosis and related research.

BACKGROUND: The Canadian Clinical Practice Guidelines (CPGs) for the management of asthmatic patients were last published in 1999, with updates in 2001 and June 2004. Large disparities exist in the implementation of these guidelines into clinical practice.OBJECTIVE: The present study evaluated the knowlege of Quebec-based primary care physicians regarding the CPGs, as well as patient outcomes before and after introducing physicians to a new clinical tool – a memory aid in the form of a self-inking paper stamp checklist summarizing CPG criteria and guidelines for assessing asthmatic patient control and therapy. The primary objective of the present study was to assess whether the stamp would improve physicians’ knowledge of the CPGs, and as a secondary objective, to assess whether it would decrease patient emergency room visits and hospitalizations.METHODS: A prospective, randomized, controlled study of 104 primary care physicians located in four Quebec regions was conducted. Each physician initially responded to questions on their knowledge of the CPGs, and was then randomly assigned to one of four groups that received information about the CPGs while implementing an intervention (the stamp tool) aimed at supporting their decision-making process at the point of care. Six months later, the physicians were retested, and patient outcomes for approximately one year were obtained from the Régie de l’assurance maladie du Québec.RESULTS: The stamp significantly improved physicians’ knowledge of the CPGs in all Quebec regions tested, and reduced emergency room visits and hospitalizations in patients who were followed for at least one year.CONCLUSION: A paper stamp summarizing CPGs for asthma can be used effectively to increase the knowledge of physicians and to positively affect patient outcomes.

Journal publication of material presented at medical conferences is vital in propagating research to the global community. The peer review process provides a rigorous assessment and critique of scientific methodology and helps ensure research remains relevant. Therefore, journal publication rates of material presented at meetings is a significant marker of the research quality of the meetings and their participants (1). Impact factors (IF) of journals are determined by dividing the number of citations articles receive by the number of citable articles over a period of time and is considered a marker of the scientific quality of a journal (2). The IF of the journal in which an article is published is therefore a partial marker of the scientific quality of that study.

Medical journals, unlike their basic science cousins, are the link between medical science and practice. Not only do they seek to disseminate new knowledge, but they also intend to influence outcomes - the application of new knowledge to the treatment of patients. But this laudable goal creates a dilemma: who are medical journals actually for? The scientists or the doctors? Or perhaps the small group of specialists who are both?