UNIFORM REQUIREMENTS FOR MANUSCRIPTS SUBMITTED TO BIOMEDICAL JOURNALS

In the 15 years since it was first published the "Uniform Requirements for Manuscripts Submitted to Biomedical journals H (the Vancouver style), developed by the International Committee of Medical JournalEditors, has been widely accepted by both authors and editors; over 400 journal have stated that they will consIder manuscripts that conform to its requirements. This is the fourth edition of the Uniform Requirements, the first to be published in the Journal, which now serves as coordinator of ICMJE in North America. In January 1978 a group of editors from some major biomedical journals published in English met in Vancouver, British Columbia, and decided on uniform technical requirements for manuscripts to be submitted to their journals. These requirements, including formats for bibliographic references developed for the Vancouver group by the National Library of Medicine, were published in three of the journal early in 1979. The Vancouver group evolved info the International Committee of Medical Journal Editors. Over the years, the group has revised the requirements slightly; this is the fourth edition

Enabling meta-analysis in systematic reviews on carpal tunnel syndrome

Possible solutions to the problems of clinical heterogeneity of outcome measures and inadequate reporting of results for randomized controlled trials (RCTs) on carpal tunnel syndrome (CTS) are presented. Meta-analysis was impeded by these problems in 2 systematic reviews concerning conservative and surgical treatment options for CTS. A solution to the problem of inadequate data presentation is to add explicit information on minimal requirements with regard to data presentation to guidelines for the reporting of studies. To resolve the problem of clinical heterogeneity of the outcomes there should be consensus on the (validated) outcomes that should be used in RCTs. For CTS there is little evidence available on the reliability, validity, and responsiveness to change of the commonly used outcomes in RCTs. Resolving both problems will increase the comparability of RCTs, enabling the calculation of a pooled estimate of effect in a meta-analysi

Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

<p>Abstract</p> <p>Background</p> <p>International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC) approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka.</p> <p>Methods</p> <p>We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM) library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized.</p> <p>Results</p> <p>Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent.</p> <p>Conclusion</p> <p>Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.</p

How to spot a statistical problem: advice for a non-statistical reviewer

Statistical analyses presented in general medical journals are becoming increasingly sophisticated. BMC Medicine relies on subject reviewers to indicate when a statistical review is required. We consider this policy and provide guidance on when to recommend a manuscript for statistical evaluation. Indicators for statistical review include insufficient detail in methods or results, some common statistical issues and interpretation not based on the presented evidence. Reviewers are required to ensure that the manuscript is methodologically sound and clearly written. Within that context, they are expected to provide constructive feedback and opinion on the statistical design, analysis, presentation and interpretation. If reviewers lack the appropriate background to positively confirm the appropriateness of any of the manuscript’s statistical aspects, they are encouraged to recommend it for expert statistical review

Reporting of ethical approval and informed consent in clinical research published in leading nursing journals : a retrospective observational study

Background: Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals. Methods: This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. Results: A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P<0.05). Conclusion: The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required

Investigator experiences with financial conflicts of interest in clinical trials

<p>Abstract</p> <p>Background</p> <p>Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.</p> <p>Methods</p> <p>Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.</p> <p>Results</p> <p>844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.</p> <p>Conclusion</p> <p>Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.</p

Ethics and images of suffering bodies in humanitarian medicine

Media representations of suffering bodies from medical humanitarian organisations raise ethical questions, which deserve critical attention for at least three reasons. Firstly, there is a normative vacuum at the intersection of medical ethics, humanitarian ethics and the ethics of photojournalism. Secondly, the perpetuation of stereotypes of illness, famine or disasters, and their political derivations are a source of moral criticism, to which humanitarian medicine is not immune. Thirdly, accidental encounters between members of the health professions and members of the press in the humanitarian arena can result in misunderstandings and moral tension. From an ethics perspective the problem can be specified and better understood through two successive stages of reasoning. Firstly, by applying criteria of medical ethics to the concrete example of an advertising poster from a medical humanitarian organisation, I observe that media representations of suffering bodies would generally not meet ethical standards commonly applied in medical practice. Secondly, I try to identify what overriding humanitarian imperatives could outweigh such reservations. The possibility of action and the expression of moral outrage are two relevant humanitarian values which can further be spelt out through a semantic analysis of 'témoignage' (testimony). While the exact balance between the opposing sets of considerations (medical ethics and humanitarian perspectives) is difficult to appraise, awareness of all values at stake is an important initial standpoint for ethical deliberations of media representations of suffering bodies. Future pragmatic approaches to the issue should include: exploring ethical values endorsed by photojournalism, questioning current social norms about the display of suffering, collecting empirical data from past or potential victims of disasters in diverse cultural settings, and developing new canons with more creative or less problematic representations of suffering bodies than the currently accepted stereotypes