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A point estimate study was conducted at a general teaching hospital in Britain that measured the availability of patients' paper medication administration records (also known as MARs or drug charts) in five surgical and two medical units. The five surgical units kept MARs at patients' bedsides, whereas each of the two medical units kept all MARs at two designated drug trolleys. MARs were readily available 76% (84 of 111 patients) of the time in the surgical units, compared to 94% (45 of 48 patients) of the time in the medical units. The difference in availability was statistically significant (p

We enjoyed our colleagues' paper, and see ourselves as pursuing the same goal: the application of NGS technologies to improve clinical care and promote better health outcomes, particularly where alternative approaches are often inadequate. We find we agree on some points, but on others, regrettably, we're still far apart.

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Objectives Clinical practice guidelines (CPGs) development has evolved over the past decade, with greater emphasis now being placed on transparency, rigor of development, and reporting standards. Our evaluation assesses the quality of the guideline development processes and reporting of selected South African primary care (PC) CPGs. Study Design and Setting CPGs were iteratively identified by two authors, seeking CPGs reflecting common conditions with which patients present in South African PC settings. CPGs could address diagnosis, treatment, or clinical management. Each CPG was independently appraised by two reviewers using the AGREE II (Appraisal of Guideline REsearch and Evaluation) quality checklist, and the weighted scoring algorithm to calculate scores for the six domains. Results We included 16 CPGs from the National Department of Health and clinical professional associations. Overall, the domains of rigor of development, editorial independence, and applicability had the lowest median scores (0, 4%, and 13%, respectively). Clarity of presentation reported the highest median score (69%), with seven CPGs scoring above 70%. Conclusions The methodological quality of the selected South African PC CPGs was generally poor to moderate. Concerted efforts should be made to ensure that transparent, rigorous, and up-to-date evidence assessments are conducted and well reported by CPG developers.

Pragmatic trials offer the opportunity to obtain real-life data on the relative effectiveness and safety of a treatment before or after market authorisation. This is the penultimate paper in a series of eight, describing the impact of design choices on the practical implementation of pragmatic trials. This paper focuses on the practical challenges of collecting and reporting safety data and of monitoring trial conduct while maintaining routine clinical care practice. Current ICH guidance recommends that, all serious adverse events (SAEs) and all drug-related events must be reported in an interventional trial. In line with current guidance, we propose a risk based approach to the collection of non-drug related non-serious AEs, and even serious events not related to treatment based on the risk profile of the medicine/class in the patient population of interest. Different options available to support the collection and reporting of safety data whilst minimizing study-related follow-up visits are discussed. A risk-based approach to monitoring trial conduct is also discussed, highlighting the difference in the balance of risks likely to occur in a pragmatic trial compared to traditional clinical trials, and the careful consideration that must be given to the mitigation and management of these risks in order to maintain routine care.

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

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

Nursing students are often encouraged or required to submit scholarly work for consideration for publication but most manuscripts or course assignment papers do not meet journal standards and consume valuable resources from editors and peer reviewers. The International Academy of Nursing Editors (INANE) is a group of nurse editors and publishers dedicated to promoting best practices in publishing in the nursing literature. In August 2014, editors at INANE's annual meeting voiced frustrations over multiple queries, poorly written student papers, and lack of proper behavior in following through. This article describes the findings of a survey distributed to INANE members to seek feedback about submissions by students. Fifty-three (53) members responded to an online anonymous survey developed by the INANE Student Papers Work Group. Data were analyzed using descriptive statistics for Likert-type questions and content analysis of open-ended questions. Quantitative data revealed that most editors reported problems with student papers across all levels of graduate programs. Six themes emerged from the qualitative data: submissions fail to follow author guidelines; characteristics of student submissions; lack of professional behavior from students; lack of professional behavior from faculty; editor responses to student submissions; and faculty as mentors. These themes formed the basis for recommendations and strategies to improve student scholarly writing. Overall, editors endorsed supporting new scholars in the publication process but faculty engagement was integral to student success.

Purpose: To supply further references by analyzing the status of research on mild cognitive impairment nursing in China. Methods: Papers on mild cognitive impairment nursing published between 2005 and 2014 were collected from China National Knowledge Infrastructure, Wanfang Data, and China Biological Medicine database, while their publication dates, journals, and types were subjected to a bibliometric analysis using NoteExpress and Excel. Results: A total of 68 papers were collected from the selected databases. The number of papers on mild cognitive impairment nursing increased annually. The selected papers were published in 44 journals, 55.88% of them were published in core journals, 35.29% received funding support, 35.29% were published by hospitals affiliated to colleges, 47.06% were published by other local hospitals, author collaboration is 2.66, and 66.18% showed co-authorship. These papers covered a wide range of topics, but were only conducted based on clinical interventions. Around 29.41% of these papers had a citation frequency of over 5, the highest citation frequency was 29, and the highest h-index was 23. Conclusion: Beijing and Shanghai established core author groups for mild cognitive impairment nursing research. These studies should focus on the community and psychological nursing of such impairment. Targeted nursing interventions on different types of mild cognitive impairment should be adopted, new avenues for research should be opened, and various research methods should be introduced. Keywords: Mild cognitive impairment, Nursing, Bibliometric

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

Though protection of human research subjects is universally recognized as a critical requirement for the ethical conduct of research, few studies have examined retractions of medical articles through apparent noncompliance with that requirement. From our survey of 99 retracted papers published from 1981 to 2011, we found that the basis for those decisions was poorly explained in retraction notices and that most of the articles continued to be cited. In retraction notices, the current manner of explaining failure to protect human subjects is misleading and confusing.

Background: Literature on the health-related quality of life (HRQoL) for men with localized prostate cancer (PCa) on active surveillance (AS) shows a need for methodological guidance regarding HRQoL issues and how to address them. Objective: The European School of Oncology Task Force (ESO TF) aimed to identify a core set of research questions and related measures to include in AS HRQoL studies. Design, setting, and participants: A modified Delphi study was used to reach consensus on AS HRQoL research topics and tools between 2014 and 2015. Data were collected by engaging a multidisciplinary team of 15 experts. Outcome measurements and statistical analysis: An open-ended questionnaire was used to collect information from ESO TF members regarding issues in AS HRQoL research. Then a structured questionnaire was used to collect ratings on the usefulness/importance of different AS HRQoL aspects. Items that ≥80% of ESO TF members rated as useful/important were retained. Items with a 50-80% rating were discussed to reach final agreement. Results and limitations: Six main research questions concerning the selection of outcome measures, measurement tools, and comparison groups were identified as relevant. The core set of measures identified were related to individual characteristics, psychological dimensions; decision-making-related issues, and physical functioning. The multidisciplinary expertise of ESO TF members was a significant asset, even if bringing different backgrounds to the discussion table represented a challenge. Conclusions: HRQoL measures have to be sensitive to the specific needs of men on AS. The definition of HRQoL outcomes will enhance a broader understanding of the HRQoL of men on AS and sustain patient-centered medicine. Patient summary: An international panel agreed on a set of health-related quality-of-life aspects to be assessed among men on active surveillance for prostate cancer. Valid relevant questionnaires were identified. The experts' indications lay a foundation for future research and clinical practice. A multidisciplinary team of experts on active surveillance for prostate cancer defined a set of health-related quality-of-life outcomes and measures to be used to design future studies. Such studies will eventually provide information to guide treatment decision-making and more closely address patient well being.

In this age of expanding choices of therapy for psoriasis, topical therapies still play an important part in the management of patients. There are many knowledge gaps in topical therapy for psoriasis with regard to efficacy and safety as well as various combinations including topical therapy with phototherapy or with systemic agents. Councillors of the International Psoriasis Council comprised a topical therapy working group to describe these gaps in order to help direct future research endeavours. Herein, we present the results of this analysis, discuss topical agents in clinical development and the attributes of the ideal topical treatment for psoriasis.

Trainees seeking membership of the Royal College of Psychiatrists must, through Paper B examinations, demonstrate understanding of critical review, statistical methods and evidence-based practice. This ensures that no psychiatrist progresses through training without an appreciation of how the

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

Clinical guidelines, defined as ‘systematically developed statements to assist both practitioner and patient decisions in specific circumstances, have become an increasingly familiar part of clinical care. A central challenge in Primary Care is the question of how do we act in the field of atypical courses of diseases or clinical symptoms beside the spectrum of EBM and how could this gap be measured in scientific literature. Main purpose of this paper is a brief analysis of the actual role and evidence of clinical case reports and case series in primary care as a basis for a scientific discussion. According to the scientific-accepted Oxford levels of evidence case reports and case series belong to the level 4 of evidence. At present a significant majority of published case reports deal with descriptions of physician’s care following their clinical intuition beside the pathways of randomized controlled trials (RCT) or guidelines. Clinical symptoms of many cases will add up to what we would recognize as a ‘medical’ condition, but in up to 19% they are vague, non-specific and/or contradictory and the management of patients with such undefined symptoms can pose a daunting challenge. Even randomized controlled trials are the gold standard in clinical research and systematic reviews and meta-analysis have the highest level of evidence, there is still a need for well-prepared case reports; for instance to describe rare adverse drug effects.

The Research Paper of the Year, awarded by the Royal College of General Practitioners, highlights the best research published in the previous year across six clinical categories, with one overall winner. One theme that was evident this year was the importance of partnership with patients. The overall winner of the Research Paper of the Year 2014 was a fascinating study by Jon Banks and colleagues.1 They presented 3469 people with vignettes describing different sets of symptoms, giving them information about the risk that these symptoms represented cancer, along with details of likely treatment and prognosis if cancer was identified. This is very topical, given the recently published National Institute for Health and Care Excellence guidelines on investigation of suspected cancer, which are based on a general principle of recommending investigation for …

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

Objective: To encourage psychiatrists to publish high-quality articles in peer-reviewed journals by demystifying the publishing process. Methods: This paper will describe the publishing process and outline key factors that ensure that publishing is an achievable goal for psychiatrists. Results: The publishing process can be long and often this is related to delays associated with obtaining reviewers and their comments. Negative reviewer comments often relate to grammatical and typographical errors, an insufficient literature review, failure to adequately discuss limitations and conclusions that are not adequately supported by the results. Authors who systematically respond to their paper’s reviewer comments are usually successful in having their papers accepted. Success in publishing is usually determined by a topic that appeals to the readership of a journal, a credible methodology and a paper that is well-written. Conclusions: Publishing is achievable for all psychiatrists providing they can write a paper that delivers a clear and concise message, are willing to address reviewer comments and that their paper is tailored to the readership of the journal.

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

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

We have concerns about the editorial process involved in the publication of Sharma and colleagues’ article.1 The article is fundamentally flawed in presentation and logic, and the results were further misrepresented by The BMJ press release. The BMJ is highly regarded and anything it publishes will probably be taken as fact by journalists and the public. It is therefore crucial that The BMJ operates with the highest levels of peer review scrutiny and editorial comment. Depression in young people is underdiagnosed and undertreated.2 Parents often feel conflicted or guilty. Suicide is a highly emotional topic and the claim that antidepressants increase suicide in young people is likely to …

Academics need to beware of the dangers of flattery, says Per Aspenberg In February 2015, I was invited to join an academic working group to analyse procedures for increasing bone mass, structure, and strength through “intraosseous interventions.” The group, which included some of the world’s most prominent osteoporosis researchers, was meeting at a luxury hotel in Switzerland as part of the preparations for the world congress on osteoporosis. I was asked to give a presentation on “currently available orthopaedic procedures for bone enhancement.” The subject puzzled me, because there are no such procedures. But I was flattered by the invitation so rather than decline I spent several days preparing a presentation in which I concluded that prophylactic surgery in osteoporosis was not a good idea. One week before the meeting I received an email from a professional medical writer, attaching a synopsis for the meeting in which I …