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

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

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

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.

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.

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

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

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]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In this article we signpost readers to 10 papers we consider essential reading for anyone starting out on an evidence-based medicine journey. We have considered papers consisting a mix of old and new, seminal and cutting-edge that offer insight into what evidence-based medicine is, where it came from, why it matters and what it has achieved. This is balanced against some of the common criticisms of evidence-based medicine and efforts to tackle them. We have also highlighted papers acknowledging the importance of teaching and learning of the principles of evidence-based medicine and how health professionals can better use evidence in clinical decisions with patients.

The Research Paper of the Year (RPY), awarded by the Royal College of General Practitioners (RCGP), gives recognition to an individual or group of researchers who have undertaken and published an exceptional piece of research relating to general practice or primary care. The award spans six clinical categories, with one overall winner. We had an excellent response to our call for papers from 2016, with 87 submissions, and I am indebted to the RCGP’s Clinical Innovation and Research Centre (CIRC) for the support provided for the judging process. The winners of all six categories are decided by sub-panels, and the overall winner decided during a teleconference of sub-panel leads. Again, thanks are due to the GPs who give of their time judging all the entries. The key to this award is ‘relevance to clinical practice’. We asked the winners of each category to describe the clinical implications of their work. Here, I consider how the winning papers are relevant to patients I saw in a recent surgery. Mr A, aged 72 years, is someone who I have seen on a fairly regular basis for the past 16 years. I think of him as having recurrent depression. He remains on citalopram, and we often increase the dose from his maintenance dose of 20 mg daily to 30 mg in the autumn. I am aware that the evidence base for this change is limited. The overall winning paper, led by Wiles,1 suggests that I might think of …

Plagiarism refers to “adopting someone else’s words, work or ideas and passing them off as one’s own”. It is potentially considered as the most prevalent form of scientific dishonesty discovered in research papers. The present review aims to provide a thorough account of plagiarism to build awareness about all dimensions of plagiarism.The key words “plagiarism”, “types”, “detection” and “consequences” have been applied to retrieve the articles from electronic references such as MEDLINE database. Around five hundred articles have been retrieved. The articles have been subdivided, each group encompassed a dimension of plagiarism. The major findings and updates have been summarized for each topic. The most important reason behind plagiarism as spotted is lack of knowledge about the subject. And when the researchers are trapped with deficient time, in experienced writing skills and the pressure in order get their work published in some decent journals, the authors surreptitiously take access others’ work and commit plagiarism. Before, detecting plagiarism used to be difficult; however, in recent years, the journals have devised many plagiarism-detection services and software programs. The current article provides the details on how the journals use these services and software tool to effectively check for plagiarism in submitted manuscripts. In academic settings, plagiarism is a potential devastating offense.Plagiarism is taken as the most common problem in research writing. The most critical way to curb it is to build up awareness about how to cope with this ever increasing problem known as research misconduct.

The purpose of this editorial is to highlight the recent ratification as WAO Position Papers of 2 important documents published in the World Allergy Organization Journal (WAO Journal). The "World Allergy Organization (WAO) Guidelines on the Diagnosis and Rationale against Cow's Milk Allergy (DRACMA) Guidelines," ratified as a WAO Position Paper by the WAO House of Delegates, March 21, 2011, involves a significant pediatric food allergy problem and provides invaluable guidelines for the clinician. This impressive collection of information on this worldwide problem will help in the management of cow's milk allergy, which has profound implications for growth and development and the health of children worldwide. Under the able leadership of Professor Alessandro Fiocchi (Italy), the Chair of the WAO Special Committee on Food Allergy, an international group has put together a scholarly and well-appointed review of all the issues related to cow's milk allergy (CMA), ranging from methodology and epidemiology through a variety of other aspects of the clinical syndrome. DRACMA provides the guidelines for diagnosing CMA, and the proper natural history treatment alternatives ranging from avoidance through identification of milk derived from a variety of other sources, including unusual sources, which can be used for dietary supplementation. DRACMA employed evidence-based methodology utilizing the criteria of Grading of Recommendations Assessment, Development and Evaluation (GRADE) in its analysis of the literature. "World Allergy Organization Guidelines for the Assessment and Management of Anaphylaxis," the WAO Position Paper ratified on February 18, 2011, is a thorough, extensive work completed by worldwide anaphylaxis and allergy experts of the WAO Special Committee on Anaphylaxis led by Chair, Professor F. Estelle Simons. In addition to clearly defining, in a concise manner, the syndrome, its severity, and the possibility for treatment, the document has also provided a very clear and detailed management plan for acute anaphylaxis in both high- and low-resource areas. This is an important stride forward and the WAO Journal as always looks to better care for allergy sufferers at risk for anaphylaxis and for significant morbidity and mortality. This position paper is an excellent resource to help those circumstances. The Position Paper series within the WAO Journal is intended to address the needs of the profession worldwide. Along with the 2 most recent documents, and another on the state of sublingual immunotherapy (SLIT), the series also includes a treatise on defining an allergist, basic qualities of an allergist, training required for allergists, and educational requirements--all to impart allergy education to students, residents, and practitioners. The WAO and the WAO Journal will continue to invest in the development and identification of guidelines for treating important, clinically relevant syndromes associated with allergic disease such as cow's milk allergy or anaphylaxis. The recently ratified position papers and other WAO documents published in WAO Journal can be accessed in the following linked list of titles: • World Allergy Organization (WAO) Diagnosis and Rationale for Action against Cow's Milk Allergy (DRACMA) Guidelines • World Allergy Organization Guidelines for the Assessment and Management of Anaphylaxis • Sub-Lingual Immunotherapy: World Allergy Organization Position Paper 2009 • Recommendations for Competency in Allergy Training for Undergraduates Qualifying as Medical Practitioners: A Position Paper of the World Allergy Organization • Requirements for Physician Competencies in Allergy: Key Clinical Competencies Appropriate for the Care of Patients With Allergic or Immunologic Diseases: A Position Statement of the World Allergy Organization • What Is an Allergist?: Reconciled Document Incorporating Member Society Comments, September 3, 2007

In 2014, the European Medicines Agency (EMA) released for comment a draft reflection paper on the use of patient-reported outcome (PRO) measures in oncology studies. A twelve-member International Society for Quality of Life Research (ISOQOL) taskforce was convened to coordinate the ISOQOL response. Twenty-one ISOQOL members provided detailed comments and suggestions on the paper: 81 % from academia and 19 % from industry. Taskforce members consolidated and further refined these comments and shared the recommendations with the wider ISOQOL membership. A final response was submitted to the EMA in November 2014. The impending publication of the EMA reflection paper presents a valuable opportunity for ISOQOL to comment on the current direction of EMA PRO guidance and strategy. The EMA paper, although focused on cancer, could serve as a model for using PROs in other conditions, as it provides a useful update surrounding some of the design issues common to all trial research including PRO endpoints. However, we believe there are a number of additional areas in need of greater consideration. The purpose of this commentary is therefore to highlight the strengths of this timely and potentially useful document, but also to outline areas that may warrant further discussion.

We thank Dr. Harvey for his editorial1 addressing the Royal College white paper on assessment. We are pleased that he read the paper and took time to provide feedback during this consultation phase of the white paper series. We wish to take this opportunity to clarify several points. We agree that assessment is part of the core mission of the Royal College of Physicians and Surgeons of Canada. We also agree that there remains a need for a final national summative assessment, such as certification examinations for physicians. However, Dr. Harvey may have misunderstood the white paper’s emphasis on greater in-training assessment. Formative assessments, using valid and reliable tools, must accompany summative assessments because they lead to enhanced learning and a more robust determination of physician competence. 2,3 Frequent and objective formative assessments can identify weaknesses and provide a target for early educational interventions, thus preventing the case of a final-year resident who “cannot pin a hip.” Effective workplace assessment permits early objective identification of residents who are poorly matched to their specialties and prevents those who are not yet prepared or ready to take the exam from progressing. The authors of this particular white paper argue that the time has come to ensure our profession does better in the in-training assessment area. What areas deserve greater attention? We agree with Dr. Harvey that intraoperative and clinical assessments must focus on both the Medical Expert role, and the other intrinsic CanMEDS roles (Communicator, Collaborator, Manager, Health Advocate, Scholar and Professional), which support core medical expertise. Opinions from public and government consultations, medical regulatory authorities, professional societies and Fellows of the Royal College reiterate that residents must demonstrate competence across all of these domains. The CanMEDS competencies, developed by Fellows like Dr. Harvey, remain the Royal College’s fundamental framework of physician competence.4 Enhanced in-training assessment does not mean increasing formal centralized assessments beyond current practices. Rather, the authors argue for the provision of effective tools to facilitate an increase in valid and reliable formative assessments, conducted in real patient care settings. To successfully and safely practise, residents must be assessed as competent in the clinical settings where they will practise. The example of the Final In-Training Evaluation Report (FITER) offered by Dr. Harvey supports the need for the diligent and timely conduct and recording of these assessments. The final summative examination represents only one portion of an appraisal of a specialist’s competence.5 As challenges to medical education in Canada evolve, the Royal College seeks to anticipate and practically address the needs of educators and the profession. The white papers are one example of the Royal College’s desire for better standards, better physicians and better care. We welcome further correspondence during this consultation period.

The authors consider acute problems in the quality and management of medical services challenging health care systems worldwide. This actuality has motivated the representatives of the European Association for Predictive, Preventive and Personalised Medicine and European Federation of Clinical Chemistry and Laboratory Medicine to consider the efforts in promoting an integrative approach based on multidisciplinary expertise to advance health care. The current paper provides a global overview of the problems related to medical services: pandemic scenario in the progression of common chronic diseases, delayed interventional approaches of reactive medicine, poor economy of health care systems, lack of specialised educational programmes, problematic ethical aspects of treatments as well as inadequate communication among professional groups and policymakers. Further, in the form of individual paragraphs, the article presents a consolidated position of the represented European organisations. This position is focused on the patients' needs, expert recommendations for the relevant medical fields and plausible solutions which have a potential to advance health care services if the long-term strategies were to be effectively implemented as proposed here.

Scoring systems to recognise the most ill patients, or those at risk of deterioration, are increasingly utilised in hospitals that look after paediatric inpatients. There have been efforts to implement these systems in emergency and urgent care settings, but they have yet unproven value. This is because the child or young person presenting acutely is a different cohort than the 'treated' ward-based group. The majority of children presenting to emergency and urgent care settings are discharged home, and so, scoring systems need to recognise the most unwell but also assist in safe and appropriate discharge as well as highlighting those patients in need of more senior review. This article explores this conundrum, suggesting how cognitive factors have a role to play, and how scoring systems can have wider effects than just individual patient care.

Aims This paper, the first of four emanating from the International Continence Society's 2011 State-of-the-Science Seminar on pelvic-floor-muscle training (PFMT) adherence, aimed to summarize the literature on theoretical models to promote PFMT adherence, as identified in the research, or suggested by the seminar's expert panel, and recommends future directions for clinical practice and research. Methods Existing literature on theories of health behavior were identified through a conventional subject search of electronic databases, reference-list checking, and input from the expert panel. A core eligibility criterion was that the study included a theoretical model to underpin adherence strategies used in an intervention to promote PFM training/exercise. Results A brief critique of 12 theoretical models/theories is provided and, were appropriate, their use in PFMT adherence strategies identified or examples of possible uses in future studies outlined. Conclusion A better theoretical-based understanding of interventions to promote PFMT adherence through changes in health behaviors is required. The results of this scoping review and expert opinions identified several promising models. Future research should explicitly map the theories behind interventions that are thought to improve adherence in various populations (e.g., perinatal women to prevent or lessen urinary incontinence). In addition, identified behavioral theories applied to PFMT require a process whereby their impact can be evaluated. Neurourol. Urodynam. 34:???–???, 2015. © 2015 Wiley Periodicals, Inc.

Background The purpose of this study was to evaluate the frequency with which free papers presented at the 2008 and 2010 European Society of Sports Traumatology Knee Surgery and Arthroscopy (ESSKA) congress were ultimately published in peer-reviewed journals. Moreover, this study evaluated whether any correlations exist between the level of evidence of the free papers and their frequency of publication or the impact factor of the journals in which they are published. Methods Free papers presented at the 2008 and 2010 ESSKA congresses were included for assessment. Clinical papers (observational studies and trials involving direct interaction between an investigator and human subjects) were graded for level of evidence by two independent reviewers. A comprehensive strategy was used to search the databases PubMed, Ovid (MEDLINE), and EMBASE for all publications corresponding to the included free papers. Results Three hundred-ninety presentations were evaluated, of which 215 (55%) were ultimately published in a peer-reviewed journal within five years of the presentation date. The mean time from presentation to publication was 16 months (SD 25 months). There was no significant difference in the distribution of the level of evidence between studies that were ultimately published, versus those that were not published (n.s.). The level of evidence of the published study was not a significant predictor of the impact factor of the journal in which it was published (n.s.). Presentations were most commonly published in Knee Surgery, Sports Traumatology, Arthroscopy (24%) and The American Journal of Sports Medicine (22%). Conclusion Free papers at the 2008 and 2010 ESSKA congress were published at a frequency that is comparable to that at other orthopaedic meetings. The publication rate was similar across all levels of evidence. Further encouragement of manuscript preparation and submission following these meetings could help to ensure important research findings are disseminated to large audiences.

Over the past decade, innovations in the field of pediatric imaging have been largely based on single center and retrospective studies, which provided limited advances for the benefit of pediatric patients. In order to identify opportunities for potential quantum leap progress to the field of Pediatric Imaging, the American College of Radiology - Pediatric Imaging Research (ACR - PIR) Committee has identified high impact research directions related to the P4 Concept of Predictive, Preventive, Personalized, and Participatory Diagnosis and Intervention. Input from 237 members of the Society for Pediatric Radiology was clustered towards ten priority areas, which will be discussed in this article. Needs of each priority area have been analyzed in detail by dedicated ACR-PIR experts in these topics. By facilitating work on these priority areas, we hope to revolutionize the care of children by shifting our efforts from unilateral reaction to clinical symptoms to interactive maintenance of child health.

In oncology, as in other clinical fields, different treatments are often approved for the same therapeutic indication. In many cases, no direct comparisons are available to inform the choice in clinical practice. In 2015, the Italian Association of Medical Oncology (AIOM) instructed a working group, including both clinicians and methodologists, to discuss the issue of the best choice among different treatments available for the same indication. The working group discussed 3 different scenarios: (1) biosimilar drugs; (2) different drugs with same mechanism of action; (3) different drugs with different mechanism of action. For each scenario, methodological issues were discussed, along with the priority for investment of resources in the conduct of clinical trials testing direct comparison. As for biosimilar drugs, the panel recommended that, following comparability exercise and approval by regulatory agencies, they should be widely used, considered that their use allows financial savings. As for different drugs (with either the same or a different mechanism of action), the panel agreed that indirect comparisons and network meta-analyses are associated with relevant risk of bias and imprecision, and direct comparisons should be encouraged. The priority of these direct comparisons should be higher when the potential differences in efficacy and/or toxicity are clinically relevant. The choice of the study design (superiority vs non-inferiority) depends on the toxicity profiles and also on the presumed difference in efficacy. Scientific societies should put pressure on public bodies to identify all the administrative and financial mechanisms useful to facilitate the conduct of trials testing direct comparisons, when needed. Decision about therapeutic equivalence can have important consequences on innovation: the availability of drugs characterised by the same effectiveness, but at a lower cost, could enable non-negligible savings of economic resources that could be used to guarantee access to innovative, high-cost drugs.

The Research Paper of the Year award is given annually by the Royal College of General Practitioners (RCGP) to showcase the best research published in the previous year by primary care researchers in the UK. The overall winning study is chosen from the top papers in each of the six research categories used by the National Institute for Health Research. Over 80 entries were received for this year’s award, and the standard was very high. For the first time the award was sponsored by Primary Care People (a medical recruitment consultancy). The five runners up presented summaries of their work in the ‘winners’ enclosure’ at the RCGP Conference in Harrogate, and the winning entry was presented during the closing plenary session of the Conference. The overall winner of the RCGP and Primary Care People Research Paper of …

This report is the collective product of word-leading experts working in the branches of integrative medicine by predictive, preventive and personalised medicine (PPPM) under the coordination of the European Association for Predictive, Preventive and Personalised Medicine. The general report has been prepared as the consortium document proposed at the EPMA World Congress 2011 which took place in Bonn, Germany. This forum analyzed the overall deficits and trends relevant for the top-science and daily practice in PPPM focused on the patient. Follow-up consultations resulted in a package of recommendations for consideration by research units, educators, healthcare industry, policy-makers, and funding bodies to cover the current knowledge deficit in the field and to introduce integrative approaches for advanced diagnostics, targeted prevention, treatments tailored to the person and cost-effective healthcare.

Prevention is a very topical issue that any modern health system cannot ignore. The discussion about the concept of cardiovascular (CV) prevention is very wide and has been lasting for a long time. In this context, the research has never been stopped. A schematic classification of different types of prevention, as well as raised by the literature, implies some limitations, not always suitable to our complex patients. According to evidence-based medicine we should refer to the best available guidelines. Unfortunately the quality of evidence-based guidelines is far from optimal. The Federation of Associations of Hospital Doctors on Internal Medicine (FADOI) faced the problem of CV prevention in the higher risk complex patients with its experts in ischemic heart disease, heart failure, stroke, chronic kidney disease, peripheral arterial disease and diabetes mellitus, by asking the following questions: i) which are the methods of risk assessment and prognostic stratification (also with respect to the existing comorbidities)?; ii) which are the tailored actions to implement for the individual patient? For the purposes of a CV risk evaluation in complex patient we cannot be satisfied with a single high baseline risk strategy: we should resize our assessment parameters to the real world, implementing a high multidimensional CV complexity risk assessment strategy, in respect of an anthropological approach to the complexity of our patients. Essentially, hospital internists are called to exercise a proactive role of experts for each single complex patient, also in CV prevention.

Six months, four issues, processed 231 manuscripts, indexed and abstracted in more than 18 databases and many more. Journal of Young Pharmacists (JYP) (an addendum to InPharm Communique) is an official quarterly Journal published by the InPharm Association, URL: www.inpharm.org (a Young Pharmacists Group of India). JYP is a peer-reviewed open-access quarterly journal featuring research articles of exceptional significance in all areas of pharmaceutical sciences. JYP provides comprehensive coverage of issues affecting pharmaceutical education and career.Read more...

The AACT/EAPCCT Position Statements published between 1997 and 19991–5 were a major attempt to summarise the evidence on gastrointestinal decontamination and to develop recommendations based on this evidence. Launched with some fanfare, they were an important landmark in cooperation between European and North American societies and their conclusions have been widely cited. Seven years later, the first updated versions of the position statements are now being published.6–8 Perhaps it is time for the clinical toxicology community to take stock of what has happened in research on gastrointestinal decontamination since these position statements were published, and since they concluded that there was insufficient clinical trial evidence to support the use of any form of gastrointestinal decontamination in any situation. The strongest recommendations for changes in practice were directed against ipecac, gastric lavage, and cathartics. The use of activated charcoal more than one hour after ingestion was also strongly questioned. Undoubtedly, there have been substantial changes in practice over the last decade and the position statements have provided the necessary collegiate support for this to occur. However, implications about the need for further research that should have been drawn from these documents have not lead to an increase in high quality clinical research in this area. On the contrary, in the last seven years we believe that only three controlled clinical trials of gastrointestinal decontamination have been published. One of these has been published only in abstract,9 one was of a twelve year old trial 10 that had flaws in design and analysis,11 and one addressed the very specific question of the role of MDAC in yellow oleander poisoning.12 Therefore, unless a doctor treats oleander poisoning, the published clinical evidence has not progressed over the last seven years. The three updates published to date conclude their abstracts with ‘A review of the literature since the preparation of the 1997 ___ Position Statement revealed no new evidence that would require a revision of the conclusions of that Statement.” While not intended as such, this is a sad indictment on the progress of research in clinical toxicology, because the published evidence is very weak indeed. The methodology of the clinical trials reviewed was poor and should not preclude anyone from conducting a better designed study to address the same hypotheses. Future trials will need to pay closer attention in particular to ensuring random allocation, allocation concealment, and avoidance of selection or outcome bias. For example, the 2004 AACT/EAPCCT Position Paper on the use of ipecac syrup6 described five studies as randomized controlled trials (RCTs). In a two arm trial, randomisation ensures that there is equal probability of a patient being allocated to either arm.13 Allocation concealment then prevents prediction of allocation.14 Systematic biases occur when allocation is not concealed – if a doctor is able to predict the allocation, then s/he may decide not to recruit a patient if they would get an intervention the doctor does not favour.15 Methods to ensure this does not happen are embedded in current standards for clinical trials.16,17 Four of the cited studies used alternate day allocation18–21 – or pseudo randomisation. 13 Allocation was not ‘randomized’ because there was not an equal probability of allocation to either arm – if the patient arrived on a Wednesday, according to the protocol, s/he could only have been allocated one specific intervention. There was also no allocation concealment – the enrolling doctor knew what the patient was going to receive from the day of presentation. If the doctor’s non favoured intervention was indicated, s/he could have not recruited the patient or (if late in the day) delayed the patient in the waiting room until midnight had passed and the other intervention became available. Such practices have been recorded in many studies,13,15 and therefore pseudo-randomised studies are considered weaker evidence than RCTs. Saetta’s study did not even pseudo-randomise patients.22 The control patients in this study were specifically selected because they were considered to be either too well for gastric decontamination or presenting too late for it to have an effect.23 The surrogate primary outcome selected was also biased against the use of ipecac as the vomited tablets were excluded from statistical consideration in measuring the effectiveness of ipecac in preventing tablet movement into the small bowel. This systematic bias in selection of control patients and outcome assessment prevents any meaningful conclusion being drawn from this study.23 Similar problems of quasi-random allocation without concealment beset most studies on other methods of gastric decontamination and many have other design flaws. In order for the field to progress, it is important that the clinical studies that have been done are critically and rigorously evaluated (particularly in authoritative position papers). We sincerely commend the authors of these studies for providing the best available evidence, but we also need to critique their studies to highlight the problems and move the clinical toxicology community to provide more and better research evidence.24,25 The evidence for many interventions in clinical toxicology is weak. It will only improve if we make the first step of recognising that we have a problem.26

Background. Answering clinical questions arising from patient care can improve that care and offers an opportunity for adult learning. It is also a vital component in practising evidence-based medicine. GPs' sources of in-consultation information can be human or non-human (either hard copy or electronic). Objectives. To establish the prevalence and associations of GP trainees' in-consultation information-seeking, and to establish the prevalence of use of different sources of information (human, hard copy and electronic) and the associations of choosing particular sources. Methods. A cross-sectional analysis of data (2010-13) from an ongoing cohort study of Australian GP trainees' consultations. Once each 6-month training term, trainees record detailed data of 60 consecutive consultations. The primary outcome was whether the trainee sought in-consultation information for a problem/diagnosis. Secondary outcomes were whether information-seeking was from a human (GP, other specialist or other health professional) or from a non-human source (electronic or hard copy), and whether a non-human source was electronic or hard copy. Results. Six hundred forty-five trainees (response rate 94.3%) contributed data for 84 723 consultations including 131 583 problems/diagnoses. In-consultation information was sought for 15.4% (95% confidence interval = 15.3-15.6) of problems/diagnoses. Sources were: GP in 6.9% of problems/diagnoses, other specialists 0.9%, other health professionals 0.6%, electronic sources 6.5% and hard-copy sources 1.5%. Associations of information-seeking included younger patient age, trainee full-time status and earlier training stage, longer consultation duration, referring the patient, organizing follow-up and generating learning goals. Associations of choosing human information sources (over non-human sources) were similar, but also included the trainee's training organization. Associations of electronic rather than hard-copy information-seeking included the trainee being younger, the training organization and information-seeking for management rather than diagnosis. Conclusion. Trainee information-seeking is mainly from GP colleagues and electronic sources. Human information-sources are preferentially sought for more complex problems, even by these early-career GPs who have trained in the 'internet era'.

Aims This review aims to locate and summarize the findings of qualitative studies exploring the experience of and adherence to pelvic floor muscle training (PFMT) to recommend future directions for practice and research. Methods Primary qualitative studies were identified through a conventional subject search of electronic databases, reference-list checking, and expert contact. A core eligibility criterion was the inclusion of verbatim quotes from participants about PFMT experiences. Details of study aims, methods, and participants were extracted and tabulated. Data were inductively grouped into categories describing “modifiers” of adherence (verified by a second author) and systematically displayed with supporting illustrative quotes. Results Thirteen studies (14 study reports) were included; eight recruited only or predominantly women with urinary incontinence, three recruited postnatal women, and two included women with pelvic organ prolapse. The quality of methodological reporting varied. Six “modifiers” of adherence were described: knowledge; physical skill; feelings about PFMT; cognitive analysis, planning, and attention; prioritization; and service provision. Conclusions Individuals' experience substantial difficulties with capability (particularly knowledge and skills), motivation (especially associated with the considerable cognitive demands of PFMT), and opportunity (as external factors generate competing priorities) when adopting and maintaining a PFMT program. Expert consensus was that judicious selection and deliberate application of appropriate behavior change strategies directed to the “modifiers” of adherence identified in the review may improve PFMT outcomes. Future research is needed to explore whether the review findings are congruent with the PFMT experiences of antenatal women, men, and adults with fecal incontinence. Neurourol. Urodynam. 34:???–???, 2015. © 2015 Wiley Periodicals, Inc.