The publication of ethically uncertain research: attitudes and practices of journal editors

<p>Abstract</p> <p>Background</p> <p>Publication of ethically uncertain research occurs despite well-published guidelines set forth in documents such as the Declaration of Helsinki. Such guidelines exist to aide editorial staff in making decisions regarding ethical acceptability of manuscripts submitted for publication, yet examples of ethically suspect and uncertain publication exist. Our objective was to survey journal editors regarding practices and attitudes surrounding such dilemmas.</p> <p>Methods</p> <p>The Editor-in-chief of each of the 103 English-language journals from the 2005 Abridged Index Medicus list publishing original research were asked to complete a survey sent to them by email between September-December 2007.</p> <p>Results</p> <p>A response rate of 33% (n = 34) was obtained from the survey. 18% (n = 6) of respondents had published ethically uncertain or suspect research within the last 10 years. 85% (n = 29) of respondents stated they would always reject ethically uncertain articles submitted for publication on ethical grounds alone. 12% (n = 4) of respondents stated they would approach each submission on a case-by-case basis. 3% (n = 1) stated they would be likely to publish such research, but only with accompanying editorial. Only 38% (n = 13) give reviewers explicit instruction to reject submissions on ethical grounds if found wanting.</p> <p>Conclusions</p> <p>Editorial compliance with the Declaration of Helsinki in rejecting research that is conducted unethically was difficult to ascertain because of a poor response rate despite multiple attempts using different modalities. Of those who did respond, the majority do reject ethically suspect research but few explicitly advise reviewers to do so. In this study editors did not take advantage of the opportunity to describe their support for the rejection of the publication of unethical research.</p

From theoretical concepts to policies and applied programmes: the landscape of integration of oral health in primary care

Background: Despite its importance, the integration of oral health into primary care is still an emerging practice in the field of health care services. This scoping review aims to map the literature and provide a summary on the conceptual frameworks, policies and programs related to this concept. Methods: Using the Levac et al. six-stage framework, we performed a systematic search of electronic databases, organizational websites and grey literature from 1978 to April 2016. All relevant original publications with a focus on the integration of oral health into primary care were retrieved. Content analyses were performed to synthesize the results. Results: From a total of 1619 citations, 67 publications were included in the review. Two conceptual frameworks were identified. Policies regarding oral heath integration into primary care were mostly oriented toward common risk factors approach and care coordination processes. In general, oral health integrated care programs were designed in the public health sector and based on partnerships with various private and public health organizations, governmental bodies and academic institutions. These programmes used various strategies to empower oral health integrated care, including building interdisciplinary networks, training nondental care providers, oral health champion modelling, enabling care linkages and care coordinated process, as well as the use of e-health technologies. The majority of studies on the programs outcomes were descriptive in nature without reporting long-term outcomes. Conclusions: This scoping review provided a comprehensive overview on the concept of integration of oral health in primary care. The findings identified major gaps in reported programs outcomes mainly because of the lack of related research. However, the results could be considered as a first step in the development of health care policies that support collaborative practices and patient-centred care in the field of primary care sector

Ética na publicação de pesquisas sobre leishmaniose visceral humana em periódicos nacionais

OBJETIVO: Analisar os aspectos éticos dos artigos nacionais sobre leishmaniose visceral humana publicados após a Resolução CNS 196/1996 e analisar a política de periódicos brasileiros sobre ética em pesquisa. MÉTODOS: Estudo exploratório de natureza bibliográfica e documental. A seleção das publicações sobre pesquisas envolvendo seres humanos foi realizada na base SciELO Brasil a partir de 1996. Foram analisadas lacunas relacionadas às políticas editoriais dos periódicos médicos a partir de informações obtidas da seção "Instruções aos autores" de cada periódico. RESULTADOS: Observou-se que, enquanto no primeiro quadriênio (1997 a 2000) nenhum artigo mencionou o cumprimento dos aspectos éticos, no ano de 2009 do quadriênio (2009 a 2012), 75% cumpriram pelo menos uma das orientações éticas avaliadas. Seis em 11 periódicos indicaram que as informações sobre os aspectos éticos deveriam ser citadas no corpo do artigo. Três periódicos fizeram exigências quanto ao envio de carta ou documento assinado pelo(s) autor(es) informando o cumprimento dos aspectos; dois solicitaram cópia do documento de obtenção do termo de consentimento livre e esclarecido; um explicitou a necessidade do envio de cópia da autorização da aprovação pelo comitê de ética em pesquisa; e em quatro periódicos analisados não foi identificada nenhuma exigência sobre aspectos éticos. CONCLUSÕES: Houve melhora em relação à descrição do cumprimento dos aspectos éticos nos artigos. Sugere-se a padronização das orientações éticas relacionadas à pesquisa com seres humanos nos periódicos nacionais. Isso pode estimular o cumprimento dos pressupostos de documentos que regem a experimentação humana

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure &lt; 100 mmHg (n = 1127), estimated glomerular filtration rate &lt; 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation