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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.

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]

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.

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 …

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.

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.

Background In 2007, the European Society of Physical and Rehabilitation Medicine (ESPRM) established the European Physical and Rehabilitation Medicine Journal Network (EPRMJN) with a view to increase scientific knowledge among physical and rehabilitation medicine (PRM) specialists and to foster collaboration among the national, regional (multinational) and European PRM journals. In this connection, this paper gives the readers of national and regional, and European PRM journals a complete overview of the European Journal of Physical and Rehabilitation Medicine (EJPRM), the official ESPRM journal, and a review of the papers published in 2008. Methods The evolution of the EJPRM in the last five years was analyzed, and the papers published in 2008 were systematically reviewed and classified by content and discussed. Results The EJPRM is listed in PubMed and Current Contents; at now the unofficial 2008 Impact Factor is 1.14, like the Impact Factor, also the independent SCImago Journal Rate and Cites per Doc (two years) have increased steadily since 2005. The EJPRM published 72 papers in 2008, with a well balanced coverage of different rehabilitation topics. The rejection rate is around 40%; the review and publication times are 1.2 and 10.0 months, respectively. The published papers are presented here by topic, highlighting multi-journal initiatives (such as the EPRMJN and the Euro-American Focus with the American Journal of PRM), monographic Special Sections, systematic Cochrane PRM reviews, original papers and case reports, and other contents including the Internet Bookshelf. Conclusion This paper represents the start of the EPRMJN collaborative efforts to increase scientific knowledge among PRM specialists in Europe, independently of the language in which papers are published.

Education and health are two of the most valued goods of human existence. The wellbeing of society is largely determined by the content and quality of health and education passed from one generation to the next. Upon the education of present and future osteopaths the fate of osteopathy and osteopathic medicine depends. We are asking you to share your ideas about education in the pages of the International Journal of Osteopathic Medicine. Osteopathy exists in its practitioners. The culture that we have and outwardly express publicly defines us. Osteopathic education and the institutions are where that dynamic culture exists and are at the heart of the osteopathic profession. These institutions have a fundamental

The most appropriate primary outcome measure for reproductive medicine has been discussed frequently. In 2003 the European Society for Human Reproduction and Embryology recommended that the outcome measure of assisted reproductive technology (ART) and non-ART should be singleton live birth. Although live birth is indeed the aim of clinical practice, and there is no discussion that it should be reported in infertility trials, we hereby provide arguments that plead for using ongoing pregnancy as the primary outcome in such trials. We feel that ongoing pregnancy best serves the many purposes of a primary outcome and best reflects the effectiveness of a treatment.

This paper supports the "Position of the Academy of Nutrition and Dietetics: Oral Health and Nutrition" published in the May 2013 Journal of the Academy of Nutrition and Dietetics. It is the position of the Academy of Nutrition and Dietetics that nutrition is an integral component of oral health. The Academy supports integration of oral health with nutrition services, education, and research. Collaboration between registered dietitian nutritionists (RDNs); dietetic technicians, registered (DTRs); and oral health care professionals is recommended for oral health promotion and disease prevention and intervention. There is a synergistic multidirectional association between diet, nutrition, and oral health. Given that the mouth is the portal of entry into the body, it is essential that RDNs and DTRs include the oral cavity in their assessment for nutritional risk factors and deficiencies. Nutrition assessment is vital to identifying dietary intake and nutritional factors impacting oral health. Conversely, decreased salivary flow, compromised oral integrity, tooth decay, or poor periodontal health can impact an individual's ability to consume an adequate diet. A poor diet can result in limited intake of nutrients crucial to systemic health and well-being. The provision of medical nutrition therapy that incorporates total health, including oral health, is a component of the Standards of Practice for RDNs and DTRs. Inclusion of didactic and clinical practice concepts that illustrate the role of nutrition in oral health is essential in education programs for both professional groups. The multifaceted interactions between diet, nutrition, and oral health in practice, education, and research in both dietetics and dentistry merit the need for collaborative efforts to ensure comprehensive patient care.

This is a continuation of last month’s Editor’s Page presenting the consensus opinions of the Journal of the American College of Cardiology (JACC) editors regarding how to prepare a manuscript to optimize chances of acceptance. In this Page, I will present 10 specific recommendations to

Informative white papers such as that of Becker et al. ([1][1]) are often helpful, although they could assist practitioners further by suggesting that clinical trials could and should be done when there is a reasonable consideration. For example, although the authors and others ([2][2]) state that

I read with great interest the recent Editor’s Pages presenting issues that the editors of JACC have found to be of importance in the preparation of a manuscript ([1,2][1]). As a junior research fellow, I found all of these recommendations particularly useful and I wish I knew all of these back

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Background Hypertensive patients have been using complementary and alternative medicine (CAM) to meet their primary healthcare needs within Ethiopia. The use of plant-based medicine is not only common rather it is also a culturally accredited practice, among the people of Ethiopia. However, studies conducted on the prevalence and correlates of herbal medicine (HM) use among hypertensive patients are lacking. Thus, this study aimed to assess CAM use and its associated factors among hypertensive patients. Methods An institutional-based cross-sectional study was conducted on 450 hypertensive patients, visiting the hypertensive care service of Debre Tabor General Hospital from November 1 to December 28, 2020. Interview-guided self-administered questionnaires were used for data collection. Statistical Package for the Social Sciences (SPSS) software version 24.0 was used for data analysis. Univariate and multivariate logistic regression was computed to identify associated factors of CAM use (age, sex, religion, residence, marital status, educational level, monthly income, presence of HTN complication, duration of HTN, and family history of HTN). Results Out of the 450 hypertensive patients, 275 (67.8%) participants used complementary and alternative medicine. Herbal medicines used among hypertensive patients were M. stenoptela 105 (62.9%), O. lamiifolium 81 (48.5%), C. aurea 62 (37.1%), R. nepalensis 44 (26.3%), M. piperata 36 (21.6%), H. abyssinica 24 (14.4%), T. schimperi 19 (11.4%), R. abyssinicus 15 (9.0%), and T. foenumgraecum 9 (5.4%). Majority of CAM users 202 (73.5) did not discuss with health professionals about their CAM use. Families and friends 91 (33.1%) were the frontline source of information about CAM use. In a multivariate analysis, female gender patients over 45 years old, rural residence, higher educational level, high average monthly income, presence of complications, greater than 5 years duration of hypertension (HTN), and having a family history of HTN were the independent predictors of CAM use. Conclusion The prevalence of CAM use among hypertensive patients was high 275 (67.8%). Factors associated with CAM use are similar to those observed in previous studies, but further research is required to further clarify the opportunities and challenges correlated to CAM use in Ethiopia.

Patients and families living with metabolic disorders face challenging dietary and drug treatment regimens. On the hypothesis that poor palatability, volume and frequency of drug/formula administration contribute to treatment non-adherence and hyperammonemic episodes, a survey was conducted of patient, caregiver (CG) and physician perspectives on treatments used in urea cycle disorders (UCD). Methods A paper and online survey assessed experience with UCD medications, medical foods and dietary supplements. Results 25 physicians, 52 adult patients and 114 CG responded. In 2009, the most common UCD-specific intervention reported by patients included sodium phenylbutyrate (60%), followed by l -citrulline (46%), amino acid medical foods (15%), l -arginine preparations (18%), and sodium benzoate (8%). Only 36% of patients reported experiencing no hyperammonemic episodes in the last 2 years. The most commonly reported cause of hyperammonemic episodes was infection or other acute illnesses, followed by dietary indiscretion, side effects of medications, and drug non-adherence. Most patients, caregivers and physicians (> 75%) ranked nitrogen-scavenging medications, l -citrulline, l -arginine, and medical foods as “effective” or “very effective.” Non-adherence was common (e.g. 18% of patients admitted to missing sodium phenylbutyrate “at least once a week” and “at least one a day”). Barriers to adherence included taste of medications, frequency of drug administration, number of pills, difficulty swallowing pills, side effects, forgetting to take medications, and high cost. Strategies to mitigate the gastrointestinal side effects of medications included the use of gastric tubes and acid reflux medications. Physicians indicated that 25% and 33% of pediatric and adult patients, respectively, were given less than the recommended dose of sodium phenylbutyrate due to concerns of tolerance, administration, and cost. Conclusions Despite positive views of their effectiveness, respondents found medications, medical foods and dietary supplements difficult to take and viewed adherence as inadequate, thus contributing to hyperammonemic episodes.

A biosimilar (BS) is a biological drug that contains a version of the active substance of an already authorized original biological product. The BSs are marketed after patent period of the original drug has ended and once it has been demonstrated that the differences regarding the innovative medicine have no relevant effect on its safety or clinical efficacy. The Spanish Society of Rheumatology, in line with the European Medicines Agency, considers that because of its nature and complexity of production, a BS cannot be considered to be the same as a generic drug. The Spanish Society of Rheumatology expresses an unequivocal commitment to the sustainability of the health system in our country and our steadfast alignment with all measures designed to ensure continuity, without reducing the quality of care. Therefore, we believe that the advent of BSs will likely facilitate access of patients with rheumatic diseases to the biological drugs. This article reviews the European Medicines Agency requirements for authorization, the Spanish legal framework and controversies on BS and presents the position paper of the Spanish Society of Rheumatology on these drugs.

Introduction Although American Indians/Alaska Natives (AI/ANs) have exhibited high rates of alcohol and drug use disorders, there is a paucity of substance use disorder treatment outcome research. In addition, there exists controversy about whether evidence-based treatments (EBTs) are culturally appropriate given that they were derived mainly by and for non-Hispanic White populations and do not explicitly include aspects of AI/AN culture and worldview. Methods In this pilot study, we collaboratively culturally adapted two EBTs, Motivational Interviewing and Community Reinforcement Approach (MICRA), and evaluated substance use and psychological outcomes at 4- and 8-months post-baseline assessment. In preparation for a larger randomized clinical trial (RCT), eight tribal members (75% male) participated in this pilot treatment study. Measures included substance use, urine screens, self-efficacy, psychological distress, and hopelessness. All participants completed follow-up assessments at 4- and 8-months. Due to small sample size, effect sizes were calculated to evaluate outcomes pre- and post-treatment. Results Despite high rates of abstinence at baseline, percent days abstinent (PDA) increased at the 8-month time point for the most commonly used substances (alcohol, Hedges's g = 0.59, and marijuana, g = 0.60) and for all substances combined (excluding tobacco, g = 0.56). Improvements in psychological distress (g = − 0.66) and 5 of the 7 Addiction Severity Index domains (range of g = − 0.42 to − 0.98) also emerged. Conclusions Results suggest that culturally adapted EBTs yield significant improvements in alcohol use, psychological distress, and legal problems among AI/ANs. Future research using RCT methodology is needed to examine efficacy and effectiveness., Highlights • A pilot study of evidence-based treatment outcomes with American Indians with 8-month follow-ups • Medium to large effect sizes for increased percent days abstinent at 4- and 8-month follow-ups • Medium to large effect sizes for improvements in psychological distress and 5 of 7 ASI domains. • Small effect size for improvement in self-efficacy

Background Evidence for the use of telephone consultation in childhood inflammatory bowel disease (IBD) is lacking. We aimed to assess the effectiveness and cost consequences of telephone consultation compared with the usual out-patient face-to-face consultation for young people with IBD. Methods We conducted a randomised-controlled trial in Manchester, UK, between July 12, 2010 and June 30, 2013. Young people (aged 8–16 years) with IBD were randomized to receive telephone consultation or face-to-face consultation for 24 months. The primary outcome measure was the paediatric IBD-specific IMPACT quality of life (QOL) score at 12 months. Secondary outcome measures included patient satisfaction with consultations, disease course, anthropometric measures, proportion of consultations attended, duration of consultations, and costs to the UK National Health Service (NHS). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02319798. Findings Eighty six patients were randomised to receive either telephone consultation (n = 44) or face-to-face consultation (n = 42). Baseline characteristics of the two groups were well balanced. At 12 months, there was no evidence of difference in QOL scores (estimated treatment effect in favour of the telephone consultation group was 5.7 points, 95% CI − 2.9 to 14.3; p = 0.19). Mean consultation times were 9.8 min (IQR 8 to 12.3) for telephone consultation, and 14.3 min (11.6 to 17.0) for face-to-face consultation with an estimated reduction (95% CI) of 4.3 (2.8 to 5.7) min in consultation times (p, Highlights • This is the first randomised controlled trial that has formally investigated the role of telephone consultation in paediatric inflammatory bowel disease. • This study contributes evidence showing that telephone consultation as a substitute for routine outpatient follow-up is feasible and effective. • There was no suggestion of inferiority of telephone consultation compared with face-to-face consultation with regard to improvements in quality of life scores, and telephone consultation reduced consultation time and NHS costs. • Telephone consultation is a cost-effective alternative to face-to-face consultation for the routine outpatient follow-up of children and adolescents with inflammatory bowel disease.

Summary Objective This white paper constitutes an overview of presentations and discussions from the fifth Annual Workshop on Imaging in Osteoarthritis (OA) held in Salzburg June eighth to eleventh 2011. Design This workshop brought together the communities of basic OA researchers, orthopedists and rheumatologists, imaging scientists, instrument manufacturers, and pharmaceutical representatives to focus on three overlapping themes of joint anatomy, cartilage repair and clinical validation of imaging biomarkers. Results The workshop was held on the campus of the Paracelsus Medical University in Salzburg, Austria from June 8–11, 2011; 133 attendees participated, representing 17 countries. The meeting was successful in facilitating discussion, raising awareness and consolidating knowledge about application of imaging in OA research studies and cartilage repair. Conclusions The OA research communities need to work alongside the regulatory, pharmaceutical, and MRI industries to support the new ideas and engage in the positive reinforcement of resources to further the new studies. A number of new initiatives were discussed to further break down obstacles to clinical trial utility of imaging biomarkers.

Summary Objective This white paper constitutes an overview of presentations and discussions from the 2nd annual osteoarthritis (OA) imaging workshop. Design This workshop brought together the communities of basic OA researchers, orthopedists and rheumatologists, imaging scientists, instrument manufacturers, and pharmaceutical and regulatory representatives to try to identify those factors that have limited imaging [focusing mostly on magnetic resonance imaging (MRI)] from making larger inroads into understanding and treating OA ("why aren't we there yet"), and to delineate future directions for success. Results The meeting was successful in raising awareness and questions about how we may proceed in this process. There was a general consensus that a change in direction is needed for OA imaging research to succeed in yielding a better understanding of OA and development of preventive and therapeutic procedures. Conclusions Our current paradigms are limiting the potential for MRI, by limiting how trials are designed and interpreted. Many basic questions remain in biology, pathophysiology, pain, and biomechanics; these questions need to be identified and specific imaging protocols need to be developed to address them. The OA research communities need to work alongside the regulatory, pharmaceutical, and MRI industries to support the new ideas and engage in the positive reinforcement of resources to further the new studies.

Although the use of oral anticoagulants (vitamin K antagonists) has been abandoned in primary cardiovascular prevention due to lack of a favorable benefit-to-risk ratio, the indications for aspirin use in this setting continue to be a source of major debate, with major international guidelines providing conflicting recommendations. Here, we review the evidence in favor and against aspirin therapy in primary prevention based on the evidence accumulated so far, including recent data linking aspirin with cancer protection. While awaiting the results of several ongoing studies, we argue for a pragmatic approach to using low-dose aspirin in primary cardiovascular prevention and suggest its use in patients at high cardiovascular risk, defined as ≥2 major cardiovascular events (death, myocardial infarction, or stroke) projected per 100 person-years, who are not at increased risk of bleeding.

Summary This short paper looks at the doctor's role in meeting the increasing demand for complementary and alternative medicine (CAM). As CAM develops a growing presence within the National Health Service (NHS), doctors' and complementary practitioners' (CP) knowledge of and their attitudes toward one another's work will need to adapt. The probability is considered that non-conventional therapies (NCT) techniques adopted from CAM will eventually be widely used by doctors and a brief account of the challenges of collaboration between CPs and GPs given. The author, a doctor and complementary practitioner with experience as a GP trainer, researcher and postgraduate teacher, considers educational approaches that would familiarise doctors with CAM, preparing them for cooperation with CPs, and outlines a model postgraduate curriculum introducing CAM to mainstream health care workers.

Clinical trials, systematic reviews and guidelines compare beneficial and non-beneficial outcomes following interventions. Often, however, various studies on a particular topic do not address the same outcomes, making it difficult to draw clinically useful conclusions when a group of studies is looked at as a whole [1]. This problem was recently thrown into sharp focus by a systematic review of interventions for preterm birth prevention, which found that among 103 randomised trials, no fewer than 72 different outcomes were reported [2]. There is a growing recognition among clinical researchers that this variability undermines consistent synthesis of the evidence, and that what is needed is an agreed standardised collection of outcomes – a “core outcomes set” – for all trials in a specific clinical area [1]. Recognising that the current inconsistency is a serious hindrance to progress in our specialty, the editors of over 50 journals related to women’s health have come together to support The CROWN (CoRe Outcomes in WomeN’s health) Initiative (see Figure 1). Figure 1 Aims of The CROWN Initiative. Development of consensus is required around a set of well-defined, relevant and feasible outcomes for all trials concerning particular obstetric and gynaecologic health conditions, such as preterm birth, incontinence, infertility and menstrual problems. With so many subspecialties involved, this is no easy task. Duplication of effort can be avoided by working with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative, which is working towards core data sets for all medical specialties [3]. Production of trustworthy core outcome sets will require engagement with patients, healthcare professionals, researchers, industry and regulators, and the employment of scientifically robust consensus methods [1]. The data for these core outcome sets, once agreed upon, should be collected in trials and reported in publications as standard practice in the future. Journal editors now invite researchers to take the lead in beginning this work. What will we do as editors to support them and their colleagues? First, we are drawing wide attention to The CROWN Initiative by publishing this editorial in the journals listed below. We shall ensure that the global research community, which includes our many reviewers, is aware of the need for core outcome sets. Submissions which describe development of core outcome sets, if deemed acceptable after peer review, will be effectively disseminated. Our collaboration is not for enforcing harmony at the expense of innovation. To quote from the COMET home page (www.comet-initiative.org): “The existence or use of a core outcome set does not imply that outcomes in a particular trial should be restricted to those in the relevant core outcome set. Rather, there is an expectation that the core outcomes will be collected and reported, making it easier for the results of trials to be compared, contrasted and combined as appropriate; while researchers continue to explore other outcomes as well”. We also expect that as new or superior ways of capturing outcomes emerge, core outcome sets will themselves need updating. Producing, disseminating and implementing core outcome sets will ensure that critical and important outcomes with good measurement properties are incorporated and reported. We believe this is the next important step in advancing the usefulness of research, in informing readers, including guideline and policy developers, who are involved in decision-making, and in improving evidence-based practice.

Eating Disorders (EDs) are serious psychiatric illnesses marked by psychiatric comorbidity, medical complications, and functional impairment. Research indicates that female athletes are often at greater risk for developing ED pathology versus non-athlete females. The Female Athlete Body (FAB) study is a three-site, randomized controlled trial (RCT) designed to assess the efficacy of a behavioral ED prevention program for female collegiate athletes when implemented by community providers. This paper describes the design, intervention, and participant baseline characteristics. Future papers will discuss outcomes.Female collegiate athletes (N=481) aged 17-21 were randomized by site, team, and sport type to either FAB or a waitlist control group. FAB consisted of three sessions (1.3h each) of a behavioral ED prevention program. Assessments were conducted at baseline (pre-intervention), post-intervention (3weeks), and six-, 12-, and 18-month follow-ups.This study achieved 96% (N=481) of target recruitment (N=500). Few group differences emerged at baseline. Total sample analyses revealed moderately low baseline instances of ED symptoms and clinical cases.Health risks associated with EDs necessitate interventions for female athletes. The FAB study is the largest existing RCT for female athletes aimed at both reduction of ED risk factors and ED prevention. The methods presented and population recruited for this study represent an ideal intervention for assessing the effects of FAB on both the aforementioned outcomes. We anticipate that findings of this study (reported in future papers) will make a significant contribution to the ED risk factor reduction and prevention literature.

Objective To determine the number of articles published by Indian authors related to spine surgery and to enumerate the 15 most influential articles from India published in the field of spine surgery in national & international journals based on the citations they have received both in pubmed and google scholar. Material and methods A retrospective study using Pubmed database was performed for the years between 1960 and 2015, for the articles published from India in the field of spine surgery in various national and international journals. A total of 3181 citations were received for top 15 most influential articles in the field of spine surgery from India. Results A total of 885 papers from India were identified which were published by Indian authors related to spine surgery between year 1960 to 2015. The largest numbers of papers were published in International journals such as Spine (82) and in European Spine Journal (47). Conclusion There are an increasing number of papers from India in the field of spine surgery literature. Most of the highly cited papers were related to tuberculosis. We expect further contributions from our country to the medical literature in the future.

Background Increasingly, Government and Charity funders require public engagement in research. Invariably these research outputs describe the condition of someone with the disease of interest. We therefore sought to identify the preferred descriptor of someone with a disease, such as multiple sclerosis (MS) and to determine what descriptors are currently used by academics. Methods Several surveys were undertaken: one from the Research Network of the MS Society (MSSRN), a major MS Charity within the United Kingdom, who are involved in reviewing grant applications, priority setting and research governance (n=146), and surveys from both the United Kingdom MS register (MSR; n=1713) and the North American Research Committee on Multiple Sclerosis (NARCOMS) registry (n=518). People were asked to rate descriptors of someone affected with MS. These were compared to that used by academic experimenters in basic science and clinical science research papers. Results Although the frequency of responses varied between surveys the overall findings showed many consistencies. This included use of person/people with MS (pwMS ) as the preferred descriptor for someone with MS for social media and scientific publications. This was the preferred choice in about 55–60% people from the MRS and in over 70% in the NARCOMS and the MSSRN, respectively. Although MSer was the second preferred–choice for use in social media, there was as a large range of preferences from the ‘most-preferred' to the ‘most-disliked.' This reflected an earlier survey by UK-based research blogs using the term MSer (n=173). In contrast, pwMS had few ‘dislikes' and results were skewed towards the ‘liked' and ‘most-preferred' choices. Client and sufferer were generally disliked terms, although there was some regional variation in levels of choice. Patient was generally seen as a neutral term that was neither strongly liked nor disliked. However, patient gained more public support for use within scientific publications (~20–25%) compared to social media (~10–15%). This descriptor was however most commonly used (98–99%) within both pre-clinical (searched in 6-month output of preclinical autoimmune MS models; n=161) and in clinical publications (specialist MS journals; n=220), whereas pwMS was not reported in over 75% of papers published in some specialised MS journals, and did not appear in the pre-clinical animal studies examined. Conclusion There is a clear disconnection between preferences by individuals living with MS and current academic practise. As pwMS are increasingly reading primary research publications and are involved in patient and public involvement in research and grant review activities, the sensitivities of lay readers should be considered when writing research outputs. This issue may affect other diseases and a change in writing style could be adopted to show that we respect the wishes of the people that we study and wish to help.

Objectives Research has shown that mobile applications provide a powerful alternative to traditional paper diaries; however, little data exists in comparing apps to the traditional mode of paper as a patient education and engagement tool in the clinical setting. This study was designed to compare the effectiveness of a mobile app versus a spiral-notebook guide throughout prenatal care. Methods This randomized ( n =173) controlled pilot was conducted at an East Coast community hospital. Chi-square and repeated-measures analysis of variance was used to test intervention effects in the sample of 127 pregnant mothers who completed their prenatal care in the healthcare system. Results Patients who were distributed the mobile application used the tool to record information about pregnancy more frequently ( p =.04) and developed greater patient activation ( p =.02) than patients who were distributed notebooks. No difference was detected on interpersonal clinical communication. Conclusion A mobile application successfully activated a patient population in which self-management is a critical factor. Practice implications This study shows that mobile apps can prompt greater use and result in more activated patients. Findings may be translated to other patient populations who receive recurring care for chronic disease.

Background: \ud \ud To date, our programme of systematic reviews has assessed randomised controlled trials (RCTs) of individualised homeopathy separately for risk of bias (RoB) and for model validity of homeopathic treatment (MVHT).\ud \ud Objectives: \ud \ud The purpose of the present paper was to bring together our published RoB and MVHT findings and, using an approach based on GRADE methods, to merge the quality appraisals of these same RCTs, examining the impact on meta-analysis results.\ud \ud Design: \ud \ud Systematic review with meta-analysis.\ud \ud Methods: \ud \ud As previously, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were the subject of study.\ud \ud Main outcome measures: \ud \ud For each trial, the separate ratings for RoB and MVHT were merged to obtain a single overall quality designation (‘high’, ‘moderate, “low”, ‘very low’), based on the GRADE principle of ‘downgrading’.\ud \ud Results: \ud \ud Merging the assessment of MVHT and RoB identified three trials of ‘high quality’, eight of ‘moderate quality’, 18 of ‘low quality’ and three of ‘very low quality’. There was no association between a trial’s MVHT and its RoB or its direction of treatment effect (P > 0.05). The three ‘high quality’ trials were those already labelled ‘reliable evidence’ based on RoB, and so no change was found in meta-analysis based on best-quality evidence: a small, statistically significant, effect favouring homeopathy.\ud \ud Conclusion: \ud \ud Accommodating MVHT in overall quality designation of RCTs has not modified our pre-existing conclusion that the medicines prescribed in individualised homeopathy may have small, specific, treatment effects.

This research study explored the anti-cancer effects of natural materials in South Korea. Although South Korea has a long history of traditional medicine, many natural materials of South Korea have not yet been introduced to the rest of the world because of language barriers and inconsistent study conditions. In the past 3 years, 56 papers introducing 56 natural materials, which have anti-cancer effects, have been published by scientists in South Korea. Further, these studies have introduced five kinds of natural materials presented in research papers that were written in Korean and are therefore virtually unknown overseas. The anti-cancer effects were confirmed by 2-3 cancer markers in the majority of the studies, with the most common targets being breast cancer cells and gastric cancer cells. These cancers have the greatest incidence in South Korea. The natural materials studied not only exhibit anti-cancer activity but also display anti-inflammatory, anti-oxidative stress, and anti-diabetic activities. They have not yet been used for the direct treatment of disease but have potential as medicinal materials for alternative and complementary medicine for the treatment of many modern diseases. Many natural materials of South Korea are already known all over the world, and with this study, we hope to further future research to learn more about these natural medicines.

This is the second of two companion papers proposing priority problems for research on mental disorders. Whereas the first paper focuses on questions of nosology and diagnosis, this Personal View concerns pathogenesis and aetiology of psychiatric diseases. We hope that this (non-exhaustive and subjective) list of problems, nominated by scientists and clinicians from different fields and institutions, provides guidance and perspectives for choosing future directions in psychiatric science.

This paper is a practical guide to the essentials of statistical analysis and reporting of randomized clinical trials (RCTs). It is the first in a series of 4 educational papers on statistical issues for RCTs, which will also include statistical controversies in RCT reporting and interpretation, the fundamentals of design for RCTs, and statistical challenges in the design and monitoring of RCTs. Here, we concentrate on displaying results in tables and figures, estimating treatment effects, expressing uncertainty using confidence intervals, and using p values wisely to assess the strength of evidence for a treatment difference. The various methods and their interpretation are illustrated by recent, topical cardiology trial results.

Objective To determine the volume and scope of research output examining preparation of patients for people undergoing cancer-related surgical treatment, and the impact of pre-operative education on patient outcomes and health care utilisation. Methods Medline, EMBASE, PsychINFO databases were systematically searched. Eligible papers were coded as data-based or non-data-based. Data-based papers were further classified as descriptive, measurement or intervention studies. Methodological quality and effectiveness of intervention studies were assessed using Cochrane Effective Practice and Organisation of Care (EPOC) criteria. Results We identified 121 eligible papers. The number of publications significantly increased over time. Most were data-based ( n =99) and descriptive ( n =83). Fourteen intervention studies met EPOC design criteria. Face-to-face interventions reported benefits for anxiety (5/7), satisfaction (1/1), knowledge (3/3) and health care costs (1/1). Audio-visual and multi-media interventions improved satisfaction (1/1) and knowledge (2/3), but not anxiety (0/3). Written interventions were mixed. Conclusion Descriptive studies dominate the literature examining preoperative education in oncology populations, with few rigorous intervention studies. Pre-operative education can improve satisfaction, knowledge and reduce anxiety. Practice implications Further work should be directed at multi-modal interventions, and those that include the caregiver, given their role in assisting patients to prepare and recover from surgery.

Summary Scientific publishing is an essential aspect of medical progress. New advances in human knowledge are communicated to the outside world through publications. It is essential that this knowledge is accurate, valid, reproducible, and clinically useful. Many aspiring clinicians and scientists dream of publishing their work in high-impact journals. For these dreams to become reality, it is essential to follow the basic principles of scientific research and publishing. In this paper, I outline my own personal view on how to publish your paper in such high-impact journals. I discuss the strategy for high-impact research, the logistics of manuscript submission, the likely outcomes, and the reasons for failure or success. I provide an insider's view of what editors look for in a successful manuscript and I offer advice on how to achieve this success.

There is limited application and evaluation of health information systems in the management of vaso-occlusive pain crises in sickle cell disease (SCD) patients. This study evaluates the impact of digitization of paper-based individualized pain plans on process efficiency and care quality by examining both objective patient data and subjective clinician insights.Retrospective, before and after, mixed methods evaluation of digitization of paper documents in Children's Hospital of Pittsburgh of UPMC. Subjective perceptions are analyzed using surveys completed by 115 clinicians in emergency department (ED) and inpatient units (IP). Objective effects are evaluated using mixed models with data on 1089 ED visits collected via electronic chart review 28 months before and 22 months after the digitization.Surveys indicate that all clinicians perceived the digitization to improve the efficiency and quality of pain management. Physicians overwhelmingly preferred using the digitized plans, but only 44% of the nurses had the same response. Analysis of patient records indicates that adjusted time from analgesic order to administration was significantly reduced from 35.50 to 26.77 min (p.05). However, time to first dose and some of the objective quality measures (time from administration to relief, relief rate, admission rate, and ED re-visit rate) were not significantly affected.The relatively simple intervention, high baseline performance, and limited accommodation of nurses' perspectives may account for the marginal improvements in process efficiency and quality outcomes. Additional efforts, particularly improved communication between physicians and nurses, are needed to further enhance quality of pain management.This study highlights the important role of health information technology (HIT) on vaso-occlusive pain management for pediatric patients with sickle cell disease and the critical challenges in accommodating human factor considerations in implementing and evaluating HIT effects.

Over the past 2 decades, there have been numerous stem cell studies focused on cardiac diseases, ranging from proof-of-concept to phase 2 trials. This series of papers focuses on the legacy of these studies and the outlook for future treatment of cardiac diseases with stem cell therapies. The first section by Drs. Rosen and Myerburg is an independent review that analyzes the basic science and translational strategies supporting the rapid advance of stem cell technology to the clinic, the philosophies behind them, trial designs, and means for going forward that may impact favorably on progress. The second and third sections were collected as responses to the initial section of this review. The commentary by Drs. Francis and Cole discusses the review by Drs. Rosen and Myerburg and details how trial outcomes can be affected by noise, poor trial design (particularly the absence of blinding), and normal human tendencies toward optimism and denial. The final, independent paper by Dr. Marban takes a different perspective concerning the potential for positive impact of stem cell research applied to heart disease and future prospects for its clinical application. (Compiled by the JACC editors)

Background The number of papers published in the field of nursing practice has greatly increased in recent years in Mainland China, yet the quality of these papers is highly variable. There has been no attempt to comprehensively estimate the overall quantity and quality of these papers. Objectives To systematically retrieve nursing intervention studies published in simplified Chinese from 1979 to 2012, critically appraise their quality, and provide suggestions for future development. Methods All of the papers were retrieved from China Biology Medicine disc database. The preliminary screening of retrieved publications was performed prior to conducting a rigorous quality evaluation of the remaining publications. 10 characteristics would be included in consideration in quality evaluations. Results 69,150 papers were retrieved according to searching strategy. 7391 of them were included after preliminary screening and appraised critically. Among the 10 characteristics considered in quality evaluations, the lowest ratings were observed for the factors of “utilisation of blind method” (13 articles), “description of loss of follow-up” (499 articles), “appropriate calculation of sample size” (511 articles) and “randomised assignment of patients to treatments” (652 articles). Conclusions Chinese papers published in the field of nursing practice have increased over time, but improvements remain needed to ensure that thorough studies with high-quality research methodologies are being performed. Future nursing researchers should not only improve the design of their intervention studies but also clearly describe the methodology they used, especially in group randomisation, blinded research designs, and estimations of required sample sizes.

The objectives of this study were to summarize the curriculum, history, and clinical researches of Chuna in Korea and to ultimately introduce Chuna to Western medicine. Information about the history and insurance coverage of Chuna was collected from Chuna-related institutions and papers. Data on Chuna education in all 12 Korean medicine (KM) colleges in Korea were reconstructed based on previously published papers. All available randomized controlled trials (RCTs) of Chuna in clinical research were searched using seven Korean databases and six KM journals. As a result, during the modern Chuna era, one of the three periods of Chuna, which also include the traditional Chuna era and the suppressed Chuna era, Chuna developed considerably because of a solid Korean academic system, partial insurance coverage, and the establishment of a Chuna association in Korea. All of the KM colleges offered courses on Chuna-related subjects (CRSs); however, the total number of hours dedicated to lectures on CRSs was insufficient to master Chuna completely. Overall, 17 RCTs were reviewed. Of the 14 RCTs of Chuna in musculoskeletal diseases, six reported Chuna was more effective than a control condition, and another six RCTs proposed Chuna had the same effect as a control condition. One of these 14 RCTs made the comparison impossible because of unreported statistical difference; the last RCT reported Chuna was less effective than a control condition. In addition, three RCTs of Chuna in neurological diseases reported Chuna was superior to a control condition. In conclusion, Chuna was not included in the regular curriculum in KM colleges until the modern Chuna era; Chuna became more popular as the result of it being covered by Korean insurance carriers and after the establishment of a Chuna association. Meanwhile, the currently available evidence is insufficient to characterize the effectiveness of Chuna in musculoskeletal and neurological diseases.

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy).This article has been retracted at the request of the Editor.The authors have plagiarized part of a paper that had already appeared in Journal of Youth and Adolescence (2007) 36: 835–848. http://dx.doi.org/10.1007/s10964-006-9107-9. One of the conditions of submission of a paper for publication is that authors declare explicitly that their work is original and has not appeared in a publication elsewhere. Re-use of any data should be appropriately cited. As such this article represents a severe abuse of the scientific publishing system. The scientific community takes a very strong view on this matter and apologies are offered to readers of the journal that this was not detected during the submission process.