Focus on sharing individual patient data distracts from other ways of improving trial transparency

The International Committee of Medical Journal Editors (ICMJE) recently reiterated its commitment to improving trial transparency by sharing individual patient data from randomised trials.1 2 But, although sharing individual patient data contributes to transparency, it is not sufficient by itself. Trial transparency requires a data sharing package, which begins with trial registration and contains other elements such as protocols, summary results, and other trial materials. Valuable as sharing individual patient data can be,3 discussion about it has hijacked the broader conversation about data sharing and trial transparency.4-6 For example, we identified 76 articles published in the six leading general medical journals that had “data” and “sharing” in their title and were about clinical trials. In 64 (84%) articles, the content was focused on individual patient data and did not mention any of the other components of trial transparency (see appendix on bmj.com). Much of the discussion has focused on the complexities and practical problems associated with sharing individual patient data and on the processes and systems needed for responsible data sharing.6-9 However, many of the data sharing activities that are needed for trial transparency are not complex. We believe that trying to solve the complex issues around availability of individual patient data should not eclipse or distract from a more pressing problem: the unavailability of even summary data and protocols from all controlled trials. Current estimates are that around 85% of research is avoidably “wasted” because of design flaws, poor conduct, non-publication, and poor reporting.10 Focusing efforts and attention on making individual patient data accessible might paradoxically exacerbate this waste in research. We argue that simpler and more cost efficient activities should be prioritised.</p

Resistance decay in individuals after antibiotic exposure in primary care: A systematic review and meta-analysis

Abstract Background Antibiotic resistance is an urgent global problem, but reversibility is poorly understood. We examined the development and decay of bacterial resistance in community patients after antibiotic use. Methods This was a systematic review and meta-analysis. PubMed, EMBASE and CENTRAL (from inception to May 2017) were searched, with forward and backward citation searches of the identified studies. We contacted authors whose data were unclear, and of abstract-only reports, for further information. We considered controlled or times-series studies of patients in the community who were given antibiotics and where the subsequent prevalence of resistant bacteria was measured. Two authors extracted risk of bias and data. The meta-analysis used a fixed-effects model. Results Of 24,492 articles screened, five controlled and 20 time-series studies (total 16,353 children and 1461 adults) were eligible. Resistance in Streptococcus pneumoniae initially increased fourfold after penicillin-class antibiotic exposure [odds ratio (OR) 4.2, 95% confidence interval (CI) 3.5–5.4], but this fell after 1 month (OR 1.7, 95% CI 1.3–2.1). After cephalosporin-class antibiotics, resistance increased (OR 2.2, 95%CI 1.7-2.9); and fell to (OR 1.6, 95% CI 1.2-2.3) at 1 month. After macrolide-class antibiotics, resistance increased (OR 3.8, 95% CI 1.9–7.6) and persisted for 1 month (OR 5.2, 95% CI 2.6–10.3) and 3 months (OR 8.1, 95% CI 4.6–14.2, from controlled studies and OR 2.3, 95% CI 0.6–9.4, from time-series studies). Resistance in Haemophilus influenzae after penicillins was not significantly increased (OR 1.3, 95% CI 0.9–1.9) initially but was at 1 month (OR 3.4, 95% CI 1.5–7.6), falling after 3 months (OR 1.0, 95% CI 0.5–2.2). Data were sparse for cephalosporins and macrolides. Resistance in Enterobacter increased post-exposure (OR 3.2, 95% CI 0.9–10.8, from controlled studies and OR 7.1, 95% CI 4.2–12, from time-series studies], but was lower after 1 month (OR 1.8, 95% CI 0.9–3.6). Conclusions Resistance generally increased soon after antibiotic use. For some antibiotic classes and bacteria, it partially diminished after 1 and 3 months, but longer-term data are lacking and urgently needed. Trial registration PROSPERO CRD42015025499

Interventions to facilitate shared decision making to address antibiotic use for acute respiratory infections in primary care

Background: Shared decision making is an important component of patient-centred care. It is a set of communication and evidence-based practice skills that elicits patients' expectations, clarifies any misperceptions and discusses the best available evidence for benefits and harms of treatment. Acute respiratory infections (ARIs) are one of the most common reasons for consulting in primary care and obtaining prescriptions for antibiotics. However, antibiotics offer few benefits for ARIs, and their excessive use contributes to antibiotic resistance - an evolving public health crisis. Greater explicit consideration of the benefit-harm trade-off within shared decision making may reduce antibiotic prescribing for ARIs in primary care. Objectives: To assess whether interventions that aim to facilitate shared decision making increase or reduce antibiotic prescribing for ARIs in primary care. Search methods: We searched CENTRAL (2014, Issue 11), MEDLINE (1946 to November week 3, 2014), EMBASE (2010 to December 2014) and Web of Science (1985 to December 2014). We searched for other published, unpublished or ongoing trials by searching bibliographies of published articles, personal communication with key trial authors and content experts, and by searching trial registries at the National Institutes of Health and the World Health Organization. Selection criteria: Randomised controlled trials (RCTs) (individual level or cluster-randomised), which evaluated the effectiveness of interventions that promote shared decision making (as the focus or a component of the intervention) about antibiotic prescribing for ARIs in primary care. Data collection and analysis: Two review authors independently extracted and collected data. Antibiotic prescribing was the primary outcome, and secondary outcomes included clinically important adverse endpoints (e.g. re-consultations, hospital admissions, mortality) and process measures (e.g. patient satisfaction). We assessed the risk of bias of all included trials and the quality of evidence. We contacted trial authors to obtain missing information where available. Main results: We identified 10 published reports of nine original RCTs (one report was a long-term follow-up of the original trial) in over 1100 primary care doctors and around 492,000 patients. The main risk of bias came from participants in most studies knowing whether they had received the intervention or not, and we downgraded the rating of the quality of evidence because of this. We meta-analysed data using a random-effects model on the primary and key secondary outcomes and formally assessed heterogeneity. Remaining outcomes are presented narratively. There is moderate quality evidence that interventions that aim to facilitate shared decision making reduce antibiotic use for ARIs in primary care (immediately after or within six weeks of the consultation), compared with usual care, from 47% to 29%: risk ratio (RR) 0.61, 95% confidence interval (CI) 0.55 to 0.68. Reduction in antibiotic prescribing occurred without an increase in patient-initiated re-consultations (RR 0.87, 95% CI 0.74 to 1.03, moderate quality evidence) or a decrease in patient satisfaction with the consultation (OR 0.86, 95% CI 0.57 to 1.30, low quality evidence). There were insufficient data to assess the effects of the intervention on sustained reduction in antibiotic prescribing, adverse clinical outcomes (such as hospital admission, incidence of pneumonia and mortality), or measures of patient and caregiver involvement in shared decision making (such as satisfaction with the consultation; regret or conflict with the decision made; or treatment compliance following the decision). No studies assessed antibiotic resistance in colonising or infective organisms. Authors' conclusions: Interventions that aim to facilitate shared decision making reduce antibiotic prescribing in primary care in the short term. Effects on longer-term rates of prescribing are uncertain and more evidence is needed to determine how any sustained reduction in antibiotic prescribing affects hospital admission, pneumonia and death

Tecnologias Digitais na formação Docente:Tecnologias e o estudante.

TCC (especialização) - Universidade Federal de Santa Catarina. Linguagem e Educação a DistânciaA presente pesquisa foi desenvolvida com o intuito de criar um blog no qual constarão informações sobre o aporte que as tecnologias digitais oferecem para a formação docente, o que os docentes que utilizam recursos tecnológicos para auxiliar no desenvolvimento de suas aulas falam sobre isso e como se aperfeiçoam diante de tantos avanços tecnológicos. Através de estudo exploratório, pois, como já possuímos conhecimento sobre a formação de professores por meio de tecnologias digitais em virtude de nossas experiências profissionais, exploraremos as entrevistas que serão realizadas e postadas no blog com o intuito de compartilhar experiências com os demais formadores que desenvolvem suas atividades com o auxílio de recursos midiáticos.This research was developed with the purpose of creating a blog that will contain information on the contribution that digital technologies offer to teacher education, what teachers who use technological resources to assist in the development of their classes talk about it and how perfect in the face of so many technological advances. Through exploratory study, because, as we already have knowledge about teacher education through digital technologies due to our professional experiences, we will explore the interviews that will be conducted and posted on the blog in order to share experiences with other trainers who develop its activities with the aid of media resources

Neurofibroma plexiforme de cólon transverso : relato de caso

Tumores neurogênicos de cólon são raros na população geral, mas podem ocorrer em 11 a 25% dos pacientes com doença de von Recklinghausen. Apresentamos o caso de uma paciente de 24 anos de idade com neurofibroma plexiforme 'do intestino grosso cuja manifestação inicial caracterizou-se por aparecimento de massa no hipocôndrio e flanco esquerdos. A paciente não apresentava, ao exame físico, sinais de neurofibromatose.Neurogenic colon tumors are rare in the general population but may occur in 11 to 25% of von Recklinghausen's disease patients. This is a case report of a 24 years old patient with large bowel plexiform neurofibroma whose initial manifestations was a left upper quadrant and flank mass. On physical exam, the patient did not show signals of neurofibromatosis

Sucesso e satisfação na carreira: uma análise com docentes do ensino superior

Objective: This study seeks to identify the perceptions of teachers at a Higher Education Institution concerning career satisfaction. Methodology: a survey was carried out on how much quantitative and adapted study by Costa (2014). The results show the need for constant improvement of the face of the teaching career, and the results show that the required competencies are associated with the perception of justice regarding the occupation of new associated hierarchical and evaluation systems, in addition, it stands out for the perception of stability career. Results: from an inferential point of view, the results show that happiness in professional life and hair positively affected shared teamwork through a good network of professional contacts and happiness in personal and family life. Practical implications: for future studies, it is suggested the expansion or scope of the research for teachers of all courses of the Institution under analysis. Originality/value: reflected on aspects related to the career, highlighting that professional identity is associated with the feeling of pride provided by the exercise of the profession, since the effects generated have an impact on the development and evolution of society.Objetivo: O presente estudo procura identificar as percepções dos docentes da Instituição Ensino Superior em relação a satisfação na carreira. Metodologia: a pesquisa foi de cunho quantitativo e o estudo foi adaptado de Costa (2014). Os resultados evidenciam que a necessidade de constante aprimoramento faz parte da carreira docente e os resultados evidenciam que as competências requeridas estão associadas à percepção de justiça quanto à ocupação de níveis hierárquicos e sistemas de avaliação associados, além disso, destaca-se à percepção de estabilidade na carreira. Resultados: do ponto de vista inferencial, os resultados mostram que a felicidade na vida profissional é afetada positivamente pelo trabalho em equipe compartilhado, por uma boa rede de contatos profissionais e pela felicidade na vida pessoal e familiar. Implicações práticas: para estudos futuros, sugere-se ampliar o escopo da pesquisa para os docentes de todos os cursos da Instituição analisada. Originalidade/valor: refletiu sobre aspectos relacionados à carreira, destacando-se que a identidade profissional está associada ao sentimento de orgulho propiciado pelo exercício da profissão, visto que os efeitos gerados têm impacto no desenvolvimento e evolução da sociedade