Virginia Barbour's blog

New version of the Declaration of Helsinki

Virginia Barbour — Wed, 5 Nov 2008 04:28:16 -0800

Last week the World Association of Medical Editors announced the new version of the Declaration of Helsinki. This document, which was first drawn up in 1964, is essential reading for everyone doing research on human participants. The revision was the result of a huge amount of international consultation, and along with many other organisations, PLoS and the Committee on Publication Ethics, which I am also involved with, provided input into this document. Everyone involved in research on humans, as a researcher, author, editor or reviewer should look at this new document but I’d particularly highlight some of the new additions to the text.

Paragraph 30 now makes editors’ duty clear on the publication of research including the duty to make it “publicly” available. The paragraph in full is:

"Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication." We were keen to have some wording on Open Access incorporated; perhaps next time …

Another key point made is in paragraph 19, “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject.”

And, finally, in these days of samples often ending up being used for studies far removed from the original reason for collection, the text in paragraph 25 notes that “For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse.”

What do readers think – is there anything essential missing from this last version?

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Why accurate reporting is an ethical duty

Virginia Barbour — Wed, 2 Jul 2008 01:04:35 -0700

Last week saw the EQUATOR network launch meeting at the Royal Society of Medicine and its first inaugural lecture, given by Iain Chalmers. EQUATOR is the first systematic attempt to bring together all the myriad guidelines that are available for reporting studies. If you’ve been puzzled by CONSORT, STARD, MOOSE, etc then this is the place for you.

And if you think that reporting guidelines are only of relevance to a small number of academics and editors, the meeting would have disabused you of that. The day’s speakers eloquently made the case for accurate and complete reporting as being not just a scientific duty, but also a moral one that everyone involved in research - funders, researchers, ethics committees, editors and, most importantly, authors - need to take responsibility for. These are not new ideas. As Doug Altman, one of the leaders of the EQUATOR initiative and others have said, back in 1938 Donald Mainland, an eminent statistician, noted that “incompleteness of evidence is not merely a failure to satisfy a few highly critical readers. It not infrequently makes the data that are presented of little or no value.” In 1990 Iain Chalmers similarly noted that “Failure to publish an adequate account of a well-designed clinical trial is a form of scientific misconduct which can lead to those caring for patients to make inappropriate treatment decisions.”

In his lecture at the meeting Doug Altman said that accurate and complete reporting is not the norm must be considered a system failure that a number of parties must take responsibility for. However, the good news is that things are changing, and rapidly. EQUATOR is just one of a number of initiatives that are changing how research, especially clinical research, is reported. The days of only positive studies being incompletely reported in journals that restrict access seem to be coming to an end. The EQUATOR initiative comes at a time when trial registration is now required, when results reporting, as required by the FDA Amendment Act 2008
will shortly be mandatory, and when funders such as the Wellcome, NIH, ERC are increasingly requiring open access to the work they fund .

An excellent end to the day and a reminder of the wider context of reporting of research was the inaugural lecture given by Iain Chalmers entitled “Meeting the research information needs of patients and clinicians more effectively” Iain is now director of the James Lind Library, named after James Lind, the 18th century British doctor who in 1747 did a controlled trial of potential treatments for scurvy in 12 seamen and who went onto publish a systematic review - possibly the first one - of the published evidence for treating scurvy. Sadly though, despite this systematic review and the trial, it was more than 40 years before Naval ships were systematically supplied with lemon juice. The story in the end is a reminder that even if initiatives such as EQUATOR address the systems failure of poor reporting, then, as now, transferring evidence into practice is not simple.

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MSF's Scientific Day

Virginia Barbour — Fri, 13 Jun 2008 04:39:42 -0700

Last week I went to the Médecins Sans Frontières Scientific Day in London. Though MSF is of course primarily a humanitarian organisation, it conducts a large amount of research, with the ultimate aim of improving the services they offer to the populations they work with. PLoS Medicine recently published a paper looking back at 20 years of research from MSF and Epicentre.
The scientific day featured research from across the organisation and some from outside. Specific things I’d highlight were the first talk of the day from Samuel Hauenstein Swan from Action Against Hunger UK
who spoke on cycles of starvation among the world’s rural poor and who emphasized the need to work for systematic solutions integrated with whole programmes of social protection measures. Another talk also addressed an issue of longer term planning. Daniel Orozco from MSF spoke on the need for, and practicalities of, setting up robust laboratory quality control strategies for the resource-constrained settings that MSF works in. Also presented was MSF’s new website of its published research. And alongside these talks were very sobering presentations that reflected the reality of the MSF’s work globally in very vulnerable populations such as one on the mental health assessment of adults and children in Mogadishu, Somalia and another of a report of a sexual violence programme in Monrovia, Liberia.

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To our readers, wherever you are: results from our readership survey.

Virginia Barbour — Wed, 11 Jun 2008 04:03:26 -0700

At PLoS we have a number of ways of finding out about our readership but none are perfect: the fact that we are open access and so place no barriers on access to the content sadly, but necessarily, limits how much we can easily find out about our readers. One way is via Google Analytics which only gives numbers without any comment. Reader surveys are another tack and earlier this year we did our first reader survey. We’d like to thank everyone who took part and let you know the results, which were also presented at the 2008 meeting of the Council of Science Editors
by Jocalyn Clark and Gavin Yamey.

An email invitation to complete the survey was sent to 18 937 table of content subscribers (2421 completed the survey) and 25 000 researchers in the areas of HIV, public health, paediatrics, and surgery (610 completed the survey). In addition, we posted ads on our websites; 78 people took the survey in part and 70 completed it. The low response rate from our casual site visitors was disappointing and probably reflected the fact that we made no attempt to block content, even temporarily, to those who did not take the survey. So how generalisable the results are has to be considered.

Bearing that in mind, here are some headline results:
Most of the respondents were North American or European medical academics. 56% identified their primary discipline as research, followed by 29% as medicine (not surgery). Among other journals read regularly, respondents cited Nature (54%), Science (50%), PLoS Biology (51%), and New England Journal of Medicine (48%).

Most respondents reported that the balance of coverage between the basic sciences and public health in PLoS Medicine is adequate, but still 28% and 24% said we should publish more basic and clinical research, respectively.

Among the extra features available with research articles, respondents felt the most useful were: abstracts (99%), editors’ summaries (86%), and perspectives (64%).

The magazine (non-original research) section of PLoS Medicine was judged by over 90% of respondents to be easy to understand, relevant, topical, and well presented.

34% found the reader responses feature useful, but almost half were unaware of the feature. Most respondents were unaware of or had not read our blogs. When asked to identify the correct definition of open access, 70% got it right (“It's freely available and I can re-use it for any purpose without asking provided I cite it correctly”, in case you’re wondering).

Open ended responses suggest that the open access nature of PLoS Medicine is a key strength of the journal; we had some lovely comments submitted about that.

There are clearly issues we need to work on including the lack of knowledge about reader responses and blogs (is anyone out there reading this? – let me know) and getting the word out about the journal beyond North America and Europe.

Which brings me back to Google analytics. One of the delights of this site is the way it allows us to look at what people are reading, which site brought them to us and where they are from. It does not tell us who people are, of course. But browsing last month we saw that as well as the many thousands of readers in the USA and Europe, the statistics show how many readers we have in far flung places, even if it’s just one person. So in addition to the 414 readers in Indonesia, 259 in Saudi Arabia, 64 in Zimbabwe, and 15 in Iraq we also see that we have single readers in Niger and Sierra Leone. We’re delighted we’re being read in so many places – and we’d be even more delighted to hear back from them. So let us know what you think - either on the blog or to medicine_editors@plos.org.

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MSF launches new website of all its research

Virginia Barbour — Thu, 15 May 2008 01:46:32 -0700

Médecins Sans Frontières today launches a new website MSF Field Research that will be a tremendous resource for everyone interested in the research that they do as part of their humanitarian work with vulnerable populations. The website aims eventually to be a complete record of all of MSF’s published work; at launch the site has more than 350 articles. Publishers of all the papers have agreed to make them freely available, so the site does not just include open-access papers but many others that normally would require subscriptions to read. As Tony Reid, the editor coordinating the site, says: “We were concerned that health professionals in developing countries would not be able to pay for access to our medical research and would miss information that could be highly relevant to their work”.
Two recent papers are a PLoS Medicine policy forum Research in complex humanitarian emergencies: the Médecins Sans Frontières/Epicentre experience and a research paper on Reasons for unsatisfactory acceptance of antiretroviral treatment in the urban Kibera slum, Kenya, from AIDS Care.
As well as published research and commentary it includes conference abstracts, information on MSF's Ethics Review Board, and in future will have programme descriptions that give lessons learned from the field.
And they are keen to get feedback…

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EQUATOR - a new site for reporting guidelines

Virginia Barbour — Fri, 2 Nov 2007 07:58:28 -0700

Last week saw the launch of the EQUATOR website that aims to provide resources for good reporting of health research. EQUATOR pulls together in one place the bewildering number of guidelines that are now available. These guidelines now cover a huge range of study designs. CONSORT (for reporting of clinical trials) and its offspring for other trial designs are probably the best known; other lesser known, but more charmingly named ones include MOOSE for Meta-analyses of observational studies) and STARLITE for proposed standards for reporting of literature searches. Whatever your study design, it’s likely someone has suggested standards for it. So, like many other journals we ask authors to consider guidelines before submitting studies. Some such as CONSORT we think are essential, others are for advice only. In the end, though, all the guidelines have the same aim: to help authors write clearer papers so that readers can understand the work more fully.
In future the site will also include other resources for authors, editors and developers of other guidelines. The site’s developers are keen to get feedback from users of the site.

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Setting better standards in reporting - and doing - animal research

Virginia Barbour — Tue, 18 Sep 2007 14:35:33 -0700

Last week I gave a talk at the British Association for the Advancement of Science (BA) BA Festival of Science as part of a session organised by CAMARADES, a collaboration that provides a supporting framework for groups involved in the systematic review and meta-analysis of data from animal studies in experimental stroke. The basic premise of the session was that animal experiments, in stroke research at least, are not being done to the level of rigour that we have come to expect of human studies: for example sample size calculations, true randomization to experimental groups and blinding of those who assess outcomes to the experimental group are all rare. The problem is that studies that don’t adhere to such best practice are more likely to come up with positive findings. Other speakers discussed best practice in human studies, the specific problems in investigating stroke, and other perspectives on the problem. The issue I was speaking on is what journals can do here and I summarised this in two points:
1. Make sure that what’s reported is the truth, the whole truth, and nothing but the truth
2. Make all the studies available for all to read and reuse.
For the first point we need to have a record of what research is being done, such as the registration that now happens for all clinical trials; good reporting guidelines – such as CONSORT and its offspring for clinical trials; and - this is where journals especially have a crucial role - we need to ensure that there is a place for all papers whether the findings are new and exciting or simply need to be recorded. PLoS ONE is one place for these latter studies. The second point comes down to the need to ensure that all these studies can be read and assimilated either by humans or machines into the totality of evidence; open access to the published literature then becomes an absolute necessity.
So the answers seem fairly straightforward but are those that do animal experiments and the journals that report them ready to accept that better standards are needed?

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Medical editor wanted to join PLoS Medicine

Virginia Barbour — Tue, 10 Jul 2007 15:15:28 -0700

Since its launch PLoS Medicine has had a stable core of professional editors, which we have gradually added to as the journal expanded. However, Barbara Cohen, one of our original editors, is sadly leaving us at the end of August - to travel the world - and so we are looking for a new editor to join the team. We’re looking for someone with experience in the editorial handling and peer review of research papers, but there are also opportunities to get involved in other parts of the journal. You’ll also need to be good at writing anything from editorials to press releases to short blurbs about papers. Oh, and you’ll need to be passionate about Open Access. If you’re interested see our job ad for further information.

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In the May issue of PLoS Medicine

Virginia Barbour — Tue, 29 May 2007 01:47:34 -0700

A prominent theme in this month’s issue is that of the importance of the development and dissemination of guidelines. In a health in action paper Holger Schunemann and colleagues describe the development and pilot testing of a systematic and transparent approach by WHO to develop rapid advice guidelines about the pharmacological management of H5N1 avian influenza infection; the editorial comments on this paper and the new revision of the International Health Regulations. Incidentally, the WHO paper has an unprecedented number of translations also available – 17 in total, in languages ranging from German to Laos. This is the highest number of translations we have seen for a single article since we started encouraging them; sadly we don’t have any for the editorial yet - if anyone feels moved to translate it themselves, under our license they are of course free to do so. The dissemination and development of guidelines also comes up in another health in action article from Italy which discusses the Italian Drug Agency’s effort to ensure that physicians have access to reliable independent evidence on drug effectiveness and safety. Another paper by Geoffrey Lomax and colleagues discusses the principles that guided the medical and ethical standards of the California Institute for Regenerative Medicine, which recently received $3 billion over 10 years in public funding of stem cell research. Guidelines are also important in the promotion of diseases that can tend to be overlooked; in an essay Peter Barnes discusses one such disease, COPD.

Two articles point out practical issues in delivering health care. One, from a group of authors at Médecins Sans Frontières graphically describes the difficulty of providing HIV care in conflict settings. One important factor, for HIV infected patients as well as many others, is nutrition, a topic further discussed by Ulrich Schaible and Stefan Kaufmann in their research in translation article on malnutrition and infection.

HIV and other infections are prominent topics in the research articles this month. Three articles explore various aspects of HIV and AIDS: the role of HIV in phagocytic clearance of pregnancy-associated malaria parasites; cost-effectiveness of rapid syphilis screening in prenatal HIV testing programs in Haiti; and the depletion of memory CD4+ T Cells in HIV infection.

Reflecting the intense current research interest in influenza - as discussed in the WHO guidelines paper - this topic comes up in two papers, one on the modeling of vaccination strategies and a second on the development of human monoclonal antibodies against H5N1 influenza.

Other research papers reflect the breath of papers submitted to us. Endocrinology is represented by three papers: how childhood conditions may influence adult progesterone levels, and what the implications are of that for age at menarche and ovarian function; the role of muscle mitochondrial ATP Synthesis and glucose transport and phosphorylation in type 2 diabetes; and TXNIP as a marker and regulator of peripheral glucose homeostasis.

Other papers document clinically relevant relationships: one on an important interaction of traditional non-steroidal anti-inflammatory drugs and postmenopausal hormone therapy; another on how the potentially deleterious consequences of 100% oxygen therapy can be mitigated by the addition of 5% CO2.

Neurology is the subject of two papers: one on an association of Human Herpesvirus-6B with Mesial Temporal Lobe Epilepsy; another on lithium as a potential therapy for Spinocerebellar Ataxia Type 1, tested in a mouse model of that disease.

Finally, two oncology papers tackle topics of great clinical importance: the first suggests that one particular isoform of the transcription factor AML1 can potentiate stem and progenitor cell engraftment after bone marrow transplantation; the second paper looks at the role of the interferon signaling pathway in T Lymphocytes from patients with metastatic melanoma.

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20 years of Epicentre

Virginia Barbour — Mon, 28 May 2007 11:19:11 -0700

It’s 20 years since a number of individuals at Médecins Sans Frontières, (MSF), the international humanitarian aid organisation that provides emergency medical assistance to populations in danger in more than 70 countries, came up with the idea of Epicentre, (allegedly after a few bottles of wine!) to give scientific support to MSF field activities through research and epidemiology. Since then Epicentre has expanded to also have a role in training field workers in public health and epidemiology. To celebrate 20 years Epicentre organized two days of scientific presentations covering a wide range of topics, from the results of a trial of Artemether/Lumefantrine in uncomplicated malaria during pregnancy in Epicentre’s research centre in Mbarara, Uganda, to the outcome of mental health treatment for street children and adolescents at an MSF Day care centre in
Tegucigalpa, Honduras. The two day programme gave an idea of the enormous range of work covered by Epicentre and many topics were the subject of spirited debate, including whether there was a role for prophylactic nutrition to prevent severe malnutrition, and the role of MSF/Epicentre in gathering mortality data. The whole conference was also webcast. There’s no doubt that Epicentre has had a tremendously important role in aiding MSF in the assessment and better delivery of its humanitarian work. In June, 2007 MSF UK will host its own scientific day.

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