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 <title>Data access and the NHS - more research versus patient privacy?</title>
 <link>http://feeds.feedburner.com/~r/plos/MedicineBlog/~3/458645783/421</link>
 <description>&lt;p&gt;The Guardian's &lt;a href="http://www.guardian.co.uk/society/2008/nov/17/nhs-patient-privacy-medical-research" rel="nofollow"&gt;front page story&lt;/a&gt; from a couple of days ago ("NHS medical research plan threatens patient privacy") looks like it has generated some healthy and opinionated responses from readers, but the &lt;a href="http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_085814" rel="nofollow"&gt;government consultation&lt;/a&gt; that led up to it has now closed. The story here is that the proposed UK National Health Service constitution - enshrining the principles and values of the NHS - contained, buried amongst other important stuff on issues such as access to services, quality of care, and informed choice, a crucial nugget which could change the way that medical researchers get access to patients' data. &lt;/p&gt;
&lt;p&gt;The &lt;a href="http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_085814?IdcService=GET_FILE&amp;amp;dID=169445&amp;amp;Rendition=Web" rel="nofollow"&gt;Constitution Handbook&lt;/a&gt; says (p24): "...Therefore, the NHS will do all it can to give patients, from every part of England, with any illness or disease, a right to know about research that is of particular relevance to them and, if they choose, to take part in approved medical research that is appropriate for them. Patients can therefore expect that a health professional or a research professional who owes the same duty of confidentiality as a health professional may use care records, in confidence, to identify whether they are suitable to participate in approved clinical trials..."&lt;/p&gt;
&lt;p&gt;According to the Guardian, Harry Cayton, the new chairman of the &lt;a href="http://www.connectingforhealth.nhs.uk/nigb" rel="nofollow"&gt;National Information Governance Board for Health and Social Care&lt;/a&gt;, has billed the proposal as "ethically unacceptable". &lt;/p&gt;
&lt;p&gt;It's not obvious from the Handbook how it would be decided which researchers, and which research projects, could directly get access to medical records. It's also not stated whether researchers involved in commercially funded projects (eg, trials funded by drug companies) would be able to screen databases and directly contact patients. As some respondents have argued, the current system of recruiting patients may result in bias for some types of research. But if the proposals are to go ahead, it would be crucial to develop a secure framework to establish which research questions are in the greatest public interest and most in need of a broader approach to recruitment. This does seem to have been recognised by the National Health Service's own &lt;a href="http://www.advisorybodies.doh.gov.uk/piag/" rel="nofollow"&gt;Patient Information Advisory Group&lt;/a&gt;, which has advised that the proposal be removed until fuller discussion has taken place. &lt;/p&gt;
&lt;p&gt;Clearly, with centralised and (virtually) universal computerised medical records, the UK has enormous potential to strengthen its medical research culture; but I'd be interested to hear whether similar proposals are being developed in other countries, and what public reaction is developing.&lt;/p&gt;

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 <category domain="http://www.plos.org/cms/plosmedicine">PLoS Medicine</category>
 <pubDate>Wed, 19 Nov 2008 10:00:51 -0800</pubDate>
 <dc:creator>Emma Veitch</dc:creator>
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 <title>"There's no easy way to say this. . ."</title>
 <link>http://feeds.feedburner.com/~r/plos/MedicineBlog/~3/447268066/419</link>
 <description>&lt;p&gt;A &lt;a href="http://medicine.plosjournals.org/perlserv/?request=get-document&amp;amp;doi=10.1371/journal.pmed.0050213" rel="nofollow"&gt; Health in Action paper&lt;/a&gt; published in &lt;em&gt;PLoS Medicine&lt;/em&gt; recently describes the success of an innovative project called &lt;a href="http://www.inspot.org" rel="nofollow"&gt;inSPOT&lt;/a&gt; – an e-card notification system that enables people who have been diagnosed with a sexually transmitted disease to inform their sexual partners that they may also be at risk.&lt;/p&gt;
&lt;p&gt;Whilst news coverage reveled in the dark humour of some of the cards (“Roses are red, violets are blue. I've got the clap, and you may have too”, said &lt;a href="http://www.timesonline.co.uk/tol/life_and_style/health/article5007974.ece" rel="nofollow"&gt;&lt;em&gt;The Times&lt;/em&gt;&lt;/a&gt;), it recognized that an easy and anonymous way of informing casual sex partners can help circumvent the stigma and embarrassment attached to sexually transmitted diseases and spread awareness of possible infections.&lt;/p&gt;
&lt;p&gt;"We know inSPOT works," Dr. Jeffrey Klausner, one of the authors of the paper, told the &lt;a href="http://www.washingtonpost.com/wp-dyn/content/article/2008/10/21/AR2008102102020.html" rel="nofollow"&gt;&lt;em&gt;Washington Post&lt;/em&gt;&lt;/a&gt;. "I see patients, they come in and say they've been notified [about having an STD], and their contact is through inSPOT." And as the &lt;a href="http://www.sciam.com/blog/60-second-science/post.cfm?id=the-e-mail-from-hell-had-fun-last-n-2008-10-20" rel="nofollow"&gt;&lt;em&gt;Scientific American&lt;/em&gt;&lt;/a&gt; noted – with one of the e-cards illustrating its report - the e-cards provide specific and up to date disease information: 15.4% of the e-cards were sent for gonorrhea, 14.9% for syphilis, 9.3% for HIV, 11.6% for chlamydia, and 48.8% for other STDs. Given that 19 million new STD cases are diagnosed annually in the United States, this information is desperately needed.&lt;/p&gt;
&lt;p&gt;In their evaluation of the project, which was conducted in 20 health jurisdictions in the United States, the authors analyzed rates at which e-card recipients clicked a link embedded in the card that connected to STD information, a map of local testing sites, and links to online resources. Of e-cards sent since December 2005 the “click-through” rates averaged at 26.8%, ranging from 20.4% in Los Angeles to 48.2% in Idaho, resulting in 29,137 people accessing STD testing information as a result of receiving an e-card.&lt;/p&gt;
&lt;p&gt;Coverage in &lt;a href="http://edition.cnn.com/2008/HEALTH/conditions/10/21/std.e-cards/" rel="nofollow"&gt;&lt;em&gt;CNN&lt;/em&gt;&lt;/a&gt; and the &lt;a href="http://www.telegraph.co.uk/news/newstopics/howaboutthat/3248717/Sexual-disease-e-cards-break-news-of-infection-with-humour.html" rel="nofollow"&gt;&lt;em&gt;Daily Telegraph&lt;/em&gt;&lt;/a&gt; report on the &lt;a href="http://www.inspot.org/tell-them/tell-them.aspx?regionid=2&amp;amp;sitelvl=1" rel="nofollow"&gt;variety of styles&lt;/a&gt; that cards can be sent in: from the direct and serious (“Who? What? When? Where? It doesn't matter. I got an STD; you might have it too”) to those that use puns to catch the attention of the recipient (“I got screwed while screwing, you might have too”). College students across America at &lt;a href="http://www.collegeotr.com/vanderbilt_university/how_to_tell_that_random_sigma_nu_you_may_have_given_him_herpes_13586" rel="nofollow"&gt;Vanderbilt&lt;/a&gt;, &lt;a href="http://www.northbynorthwestern.com/2008/10/12750/web-site-makes-it-easy-to-tell-your-partner-about-your-herpes/" rel="nofollow"&gt;Northwestern&lt;/a&gt;, &lt;a href="http://www.collegeotr.com/university_of_southern_california/website_offers_std_e-postcards_to_anonymously_inform_past_partners_about_stds__13489" rel="nofollow"&gt;USC&lt;/a&gt; and &lt;a href="http://www.yaledailynews.com/articles/view/25971" rel="nofollow"&gt;Yale&lt;/a&gt; discussed the merits of the inSPOT website. And in case you were wondering about the site’s susceptibility to pranks, the &lt;a href="http://latimesblogs.latimes.com/booster_shots/2008/10/if-youve-alread.html" rel="nofollow"&gt;&lt;em&gt;LA Times&lt;/em&gt; health blog&lt;/a&gt; quotes the authors as saying “while we prepared for the possibility of misuse…fewer than 10 recipients have reported receiving a card in error."&lt;/p&gt;
&lt;p&gt;The coverage was so extensive one could even speculate that the e-cards were being sent from news organization to news organization. CNN International’s story ranked as the most emailed and fifth most viewed story on October 21st. It quoted the authors to explain that the traditional system of notification through the public health department was struggling:&lt;/p&gt;
&lt;p&gt;“Resources of the health department have been decimated. They don't have the capacity to do that kind of notification anymore. We needed to come up with something to serve the needs, to notify, that would be used and have an impact."&lt;/p&gt;
&lt;p&gt;The authors believe the inSPOT website can have an international impact. It has been translated into &lt;a href="http://inspot.totalgay.ro/" rel="nofollow"&gt;Romanian&lt;/a&gt; and &lt;a href="http://www.inspotfr.org" rel="nofollow"&gt;French&lt;/a&gt;, and will soon be available in Spanish as well.&lt;/p&gt;
&lt;p&gt;Andrew Hyde, Darcy Gill, Nisha Doshi&lt;/p&gt;

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 <category domain="http://www.plos.org/cms/news">In the News</category>
 <category domain="http://www.plos.org/cms/plosmedicine">PLoS Medicine</category>
 <pubDate>Sun,  9 Nov 2008 01:42:35 -0800</pubDate>
 <dc:creator>Andrew Hyde</dc:creator>
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 <title>New version of the Declaration of Helsinki</title>
 <link>http://feeds.feedburner.com/~r/plos/MedicineBlog/~3/444327037/417</link>
 <description>&lt;p&gt;Last week the &lt;a href="http://www.wma.net" rel="nofollow"&gt;World Association of Medical Editors&lt;/a&gt; announced the new version of the &lt;a href="http://www.wma.net/e/policy/b3.htm" rel="nofollow"&gt;Declaration of Helsinki&lt;/a&gt;. 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 &lt;a href="http://www.publicationethics.org.uk" / rel="nofollow"&gt;Committee on Publication Ethics&lt;/a&gt;, 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. &lt;/p&gt;
&lt;p&gt;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:&lt;/p&gt;
&lt;p&gt;"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 &lt;a href="https://www.plos.org/oa/definition.html" rel="nofollow"&gt;Open Access&lt;/a&gt; incorporated; perhaps next time …&lt;/p&gt;
&lt;p&gt;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.” &lt;/p&gt;
&lt;p&gt;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.”&lt;/p&gt;
&lt;p&gt;What do readers think – is there anything essential missing from this last version?&lt;/p&gt;

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 <category domain="http://www.plos.org/cms/plosmedicine">PLoS Medicine</category>
 <pubDate>Wed,  5 Nov 2008 04:28:16 -0800</pubDate>
 <dc:creator>Virginia Barbour</dc:creator>
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 <title>Guest blog by Richard Smith: More evidence on why we need radical reform of science publishing</title>
 <link>http://feeds.feedburner.com/~r/plos/MedicineBlog/~3/413927273/409</link>
 <description>&lt;p&gt;&lt;em&gt;PLoS Medicine&lt;/em&gt; invited Richard Smith, former editor of the BMJ and&lt;br /&gt;
&lt;a href="http://www.plos.org/about/board.html" rel="nofollow"&gt; current board member of PLoS&lt;/a&gt;, to discuss an &lt;a href="http://medicine.plosjournals.org/perlserv/?request=get-document&amp;amp;doi=10.1371/journal.pmed.0050201" rel="nofollow"&gt;essay published this week by Neal Young, John Ioannidis and Omar Al-Ubaydli&lt;/a&gt; that argues that the current system of publication in biomedical research provides a distorted view of the reality of scientific data. &lt;/p&gt;
&lt;p&gt;&lt;strong&gt;More evidence on why we need radical reform of science publishing&lt;/strong&gt;, &lt;em&gt;Richard Smith&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;Ask scientists whether they'd prefer an all expenses paid fortnight in the best hotel in San Tropez, a Ferrari, a Cezanne painting, or the publication of one of their original papers in &lt;em&gt;Nature&lt;/em&gt; - and most, I'd bet, would go for &lt;em&gt;Nature&lt;/em&gt;. Getting published in one of the few elite journals is a very big deal for researchers, but, argues a stimulating &lt;a href="http://medicine.plosjournals.org/perlserv/?request=get-document&amp;amp;doi=10.1371/journal.pmed.0050201" rel="nofollow"&gt;paper published in &lt;em&gt;PLoS Medicine&lt;/em&gt;&lt;/a&gt;, (1) the fact that it is so important is distorting science. And I think that the authors are right.&lt;/p&gt;
&lt;p&gt;Neal Young, John Ioannidis, and Omar Al-Ubaydli unusually for a scientific publication use economic concepts to make their case, and by doing so they illustrate the value of crossing disciplinary boundaries. Their argument is built around “the winner's curse.” Imagine many firms competing for a television franchise. Each will try to work out the value of the franchise, and inevitably there will be a range of bids. If the franchise is simply awarded to the highest bidder then there's a high chance that that bid is too high, meaning that the winner will lose money — hence “the winner's curse.” Those who run such bids often recognise the problem of the curse and discount the highest bid or go for a lower bid.&lt;/p&gt;
&lt;p&gt;This phenomenon operates in science publishing because the elite journals that accept only a fraction of papers submitted to them go for the “best” and are thus likely to be publishing papers that are suffering from the winner's curse — for example, in that they give dramatic results that are a considerable distance from the “true” results. They are exciting outliers — and so very attractive to the elite journals. The articles that the high impact journals publish are bound to be atypical and will present a distorted view of science, leading to false conclusions and "misallocation of resources." &lt;/p&gt;
&lt;p&gt;The authors have some empirical evidence to support their argument. A &lt;a href="http://jama.ama-assn.org/cgi/content/full/294/2/218" rel="nofollow"&gt;study&lt;/em&gt;&lt;/a&gt; of the 49 most highly cited papers on medical interventions published in high profile journals between 1990 and 2004 showed that a quarter of the randomised trials and five of six non-randomised studies had been contradicted or found to be exaggerated by 2005. (2) We know too that “positive” drug trials are much more likely to be published than “negative” trials, although we don't know how much this is the result of conscious manipulation by authors and sponsors and how much the result of “the winner's curse.” (3-5)&lt;/p&gt;
&lt;p&gt;Most scientists read a few high profile journals — and so are fed a systematically distorted view of the evidence. It's also these journals that are most widely reported in the media and fed to policy makers, so increasing the impact of the distortion.&lt;/p&gt;
&lt;p&gt;The hope of many is, of course, that the elite journals are selecting “the best” research — hence providing a way of coping with information overload. But we know from good evidence that peer review is a deeply flawed system and that it's very hard to know what will be important in the long term. So readers of &lt;em&gt;Nature&lt;/em&gt;, &lt;em&gt;Science&lt;/em&gt;, and the &lt;em&gt;New England Journal of Medicine&lt;/em&gt; are not reading “the best” but the “systematically distorted.”&lt;/p&gt;
&lt;p&gt;What might we do about this problem? Young and others suggest a range of options, including preferring publication of negative over positive results — a version of those choosing among bids discounting the highest. It's hard to see, however, how building such an explicit bias into the system would be helpful. Better might be for editors to pay no attention to whether the results are positive or negative but rather to concentrate simply on the importance of the question being asked and the rigour of the methods. We tried to do this when I was editor of the BMJ, but I'm not sure how successful we were. Inevitably you are excited by an unusual result, and the winner's curse can surely operate not only in relation to whether the results are positive or negative but also in relation to the “importance” of the question.&lt;/p&gt;
&lt;p&gt;For me this paper simply adds to the growing evidence and argument that we need radical reform of how we publish science. I foresee rapid publication of studies that include full datasets and the software used to manipulate them without prepublication peer review onto a large open access database that can be searched and mined. Instead of a few studies receiving disproportionate attention we will depend more on the systematic reviews that will be updated rapidly (and perhaps automatically) as new results appear.&lt;/p&gt;
&lt;p&gt;References&lt;/p&gt;
&lt;p&gt;1. Young NS, Ioannidis JPA, Al-Ubaydli O (2008) Why Current Publication Practices May Distort Science. PLoS Med 5(10): e201 doi:10.1371/journal.pmed.0050201. &lt;a href="http://medicine.plosjournals.org/perlserv/?request=get-document&amp;amp;doi=10.1371/journal.pmed.0050201" rel="nofollow"&gt;Find this paper online&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;2. Ioannidis JPA (2005) Contradicted and initially stronger effects in highly cited clinical research. JAMA 2005: 294:218-28. &lt;a href="http://jama.ama-assn.org/cgi/content/full/294/2/218" rel="nofollow"&gt;Find this paper online&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;3. Lee K, Bacchetti P, Sim I (2008) Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis PLoS Medicine Vol. 5, No. 9, e191 doi:10.1371/journal.pmed.0050191. &lt;a href="http://medicine.plosjournals.org/perlserv/?request=get-document&amp;amp;doi=10.1371/journal.pmed.0050191" rel="nofollow"&gt;Find this paper online&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;4. Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R (2008) Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. NEJM 2008; 358: 252-60.  &lt;a href="http://content.nejm.org/cgi/content/full/358/3/252" rel="nofollow"&gt;Find this paper online&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;5. Melander H,  Ahlqvist-Rastad J, Meijer G, Beermann B (2003) Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ  2003;326:1171-1173 (31 May), doi:10.1136/bmj.326.7400.1171 &lt;a href="http://www.bmj.com/cgi/content/full/326/7400/1171" rel="nofollow"&gt;Find this paper online&lt;/a&gt;.&lt;/p&gt;

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&lt;rdf:Description rdf:about="http://www.plos.org/cms/node/409" dc:identifier="http://www.plos.org/cms/node/409" dc:title="Guest blog by Richard Smith: More evidence on why we need radical reform of science publishing" trackback:ping="http://www.plos.org/cms/trackback/409" /&gt;
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 <category domain="http://www.plos.org/cms/plosmedicine">PLoS Medicine</category>
 <category domain="http://www.plos.org/cms/pub">Publishing</category>
 <pubDate>Tue,  7 Oct 2008 08:57:12 -0700</pubDate>
 <dc:creator>Andrew Hyde</dc:creator>
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 <title>UK sets out guidance on research misconduct</title>
 <link>http://feeds.feedburner.com/~r/plos/MedicineBlog/~3/394377379/399</link>
 <description>&lt;p&gt;The US has its &lt;a href="http://ori.dhhs.gov/" rel="nofollow"&gt;Office of Research Integrity&lt;/a&gt; (ORI), and many &lt;a href="http://www.councilscienceeditors.org/editorial_policies/whitepaper/3-2_international.cfm" rel="nofollow"&gt;Nordic countries&lt;/a&gt; (for example, Denmark, Norway, and Sweden) have national bodies that respond to cases of scientific misconduct; but the UK, and very many other countries, have nothing similar. Now the &lt;a href="http://www.ukrio.org" rel="nofollow"&gt;UK Research Integrity Office&lt;/a&gt; (UKRIO) has released guidance about what to do in cases of suspected research misconduct for "all organisations engaged in research using funds from funders such as the Research Councils and other government bodies, as well as from charities, overseas funding bodies and the commercial sector". A PDF copy of the guidance can be downloaded &lt;a href="http://www.ukrio.org/resources/UKRIO%20Procedure%20for%20the%20Investigation%20of%20Misconduct%20in%20Research.pdf" rel="nofollow"&gt;here &lt;/a&gt;(PDF file). &lt;/p&gt;
&lt;p&gt;The UKRIO's definition of misconduct is broader than that &lt;a href="http://ori.dhhs.gov/misconduct/definition_misconduct.shtml" rel="nofollow"&gt;outlined by ORI&lt;/a&gt;, covering misrepresentation of data or interests and failure to follow accepted procedures in carrying out various aspects of research, as well as the key three areas ORI considers important (fabrication, falsification, and plagiarism). Although the guidance outlines standard procedures that universities should follow when faced with allegations of misconduct, UKRIO has no power to investigate or impose sanctions (unlike ORI or some other national bodies). &lt;/p&gt;
&lt;p&gt;As highlighted in a recent &lt;a href="http://www.timeshighereducation.co.uk/story.asp?sectioncode=26&amp;amp;storycode=403288&amp;amp;c=2" rel="nofollow"&gt;Times Higher Education&lt;/a&gt; article, it'll be interesting to see what impact the guidance has and whether self-regulation by universities and other research bodies really is the answer to investigating misconduct. The model followed here is similar to that used by COPE (the &lt;a href="http://www.publicationethics.org.uk/" rel="nofollow"&gt;Committee on Publication Ethics&lt;/a&gt;), which offers guidance and support to editors on handling ethical breaches in publication practice, but which cannot itself take action.&lt;/p&gt;

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 <category domain="http://www.plos.org/cms/plosmedicine">PLoS Medicine</category>
 <pubDate>Tue, 16 Sep 2008 10:06:49 -0700</pubDate>
 <dc:creator>Emma Veitch</dc:creator>
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 <title>Open access anxiety in the publish or perish world</title>
 <link>http://feeds.feedburner.com/~r/plos/MedicineBlog/~3/382565302/397</link>
 <description>&lt;p&gt;I gave research rounds at a university hospital yesterday on a topic that seems to simultaneously inspire and provoke: open access publishing.&lt;/p&gt;
&lt;p&gt;My sense—having socialized as a medical academic before defecting to the editorial world—is that one thing alone matters: Publish or Perish. (Or as my former colleague &lt;a href="http://www.stmichaelshospital.com/research/profile.php?id=ray&amp;amp;" rel="nofollow"&gt; Joel Ray&lt;/a&gt; says, “PubMed-ish or perish.”). This will come as no surprise to anyone in the academic health sciences. Publishing is the chief currency in this universe, the main source of validation of one’s research, and often the key indicator of academic success. Promotion and tenure committees (and colleagues, chairs, deans) value peer-reviewed publications above all;...that is, regrettably, even above clinical performance or community service.&lt;/p&gt;
&lt;p&gt;That “publish or perish” (PorP) generates perverse incentives and sometimes bad publication behaviour is a topic for another day.&lt;/p&gt;
&lt;p&gt;But as the broader scientific landscape is shifting toward the importance of open access to the literature, the traditions of medical publishing—which prop up PorP—persist: the &lt;a href="http://www.bmj.com/cgi/content/full/317/7174/1733" rel="nofollow"&gt;“top five” hierarchy&lt;/a&gt;, the importance of the &lt;a href="http://en.wikipedia.org/wiki/Impact_factor" rel="nofollow"&gt;impact factor&lt;/a&gt;, the codified order of &lt;a href="http://www.cmaj.ca/cgi/content/abstract/176/1/41" rel="nofollow"&gt;authorship&lt;/a&gt; etcetera. To succeed in medical academia means to play by these rules, but these rules work to eclipse an interest in disseminating one’s work widely, the central benefit of open access (OA). &lt;/p&gt;
&lt;p&gt;They do so partly because traditional medical publishers (except for the &lt;a href="http://blogs.bmj.com/bmj/2008/08/15/free-v-open-access/#more-439/" rel="nofollow"&gt;BMJ&lt;/a&gt;) do not as of yet provide OA. But these rules also create anxiety among medical academics because of some common misconceptions about open access publishing: OA publications don’t use peer review, OA journals are of lesser quality and reputation, authors “buy” their OA publications, and anyone can publish in an OA journal.&lt;/p&gt;
&lt;p&gt;Debunking these misconceptions surely is one of the key challenges to the open access movement in medicine.&lt;/p&gt;
&lt;p&gt;So after a lively discussion with colleagues during research rounds I was grateful this morning to receive &lt;a href="http://www.earlham.edu/~peters/fos/newsletter/09-02-08.htm" rel="nofollow"&gt;this week’s edition&lt;/a&gt; of Peter Suber’s outstanding newsletter. In it he takes on this idea that OA cannot equate with prestige.&lt;/p&gt;
&lt;p&gt;Peter’s treatise is long but well worth reading. I was particularly interested in the following arguments that have relevance to publishing in medicine: &lt;/p&gt;
&lt;p&gt;&lt;em&gt;On incentives:&lt;/em&gt;&lt;br /&gt;
- As OA proponents we have to “start working with the existing system of incentives”.... and that “researchers are not so preoccupied by their research that they can’t be induced to pay attention to relevant differences among journals, or at least the differences which universities make relevant. This gives hope to a strategy to &lt;em&gt;get faculty to pay attention to access issues&lt;/em&gt;.” [my emphasis]&lt;/p&gt;
&lt;p&gt;&lt;em&gt;On prestige:&lt;/em&gt;&lt;br /&gt;
- “If most OA journals are lower in prestige than [traditional] journals, it’s not because they are OA. A large [part] of the explanation is that &lt;em&gt;they are newer and younger&lt;/em&gt;” ... “There is already a growing number of high-prestige OA journals.” &lt;/p&gt;
&lt;p&gt;(OA journals like &lt;em&gt;PLoS Medicine&lt;/em&gt;, whose impact factors have consistently put it among the top 5 of general medical journals and whose influence means its articles are regularly cited in media and policy discussions).&lt;/p&gt;
&lt;p&gt;&lt;em&gt;On promotion and tenure reviews:&lt;/em&gt;&lt;br /&gt;
- “Universities tend to use journal prestige and impact as surrogates for quality.  &lt;em&gt;The excuses for doing so are getting thin&lt;/em&gt;” ... “If you've ever had to consider a candidate for hiring, promotion, or tenure, you know that it's much easier to tell whether she has published in high-impact or high-prestige journals than to tell whether her articles are actually good.” ... “&lt;em&gt;When we want to assess the quality of articles or people&lt;/em&gt;, and not the citation impact of journals, then we need measurements that are more nuanced, more focused on the salient variables, more fair to the variety of scholarly resources, more comprehensive, more timely, and with luck more automated and fully OA.”&lt;/p&gt;
&lt;p&gt;What I take from this is that we need in medical academia to &lt;em&gt;care more about quality than prestige&lt;/em&gt;: the quality of our research, of our publication and dissemination goals, of the impact of our work, and of our hiring and promotion decisions. So instead of “Publish or Perish,” perhaps our mantra ought to be “Quality or Quit.”&lt;/p&gt;

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 <category domain="http://www.plos.org/cms/plosmedicine">PLoS Medicine</category>
 <pubDate>Wed,  3 Sep 2008 11:31:39 -0700</pubDate>
 <dc:creator>Jocalyn Clark</dc:creator>
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 <title>When do we stop stating the obvious?</title>
 <link>http://feeds.feedburner.com/~r/plos/MedicineBlog/~3/377459689/395</link>
 <description>&lt;p&gt;Inequality is an area I’m very interested in but I’m always frustrated by headlines like this: &lt;a href="http://www.cbc.ca/health/story/2008/08/27/who-socdet.html "&gt;“Social injustice is killing people on a grand scale”&lt;/a&gt;&lt;/p&gt;
&lt;p&gt;To me this seems to state the obvious.&lt;/p&gt;
&lt;p&gt;In this case, the headline belongs to a news article about a report released yesterday by the World Health Organization’s Commission on Social Determinants of Health called &lt;a href="http://www.who.int/entity/social_determinants/final_report/csdh_finalreport_2008.pdf"&gt;“Closing the gap in a generation: Health equity through action on the social determinants of health.”&lt;/a&gt; &lt;/p&gt;
&lt;p&gt;According to the press release, the report “shows how the conditions in which people live and work directly affects the quality of their health.” &lt;/p&gt;
&lt;p&gt;Sound familiar? &lt;/p&gt;
&lt;p&gt;The report runs over 250 pages long and essentially reminds us that social determinants (housing, nutrition, physical activity, the environment) are more important to health than biomedical ones (medical care, drugs, hospitals, technological interventions). The Commission's three recommendations to reduce health equity are to 1) improve daily living conditions; 2) tackle the inequitable distribution of power, money and resources, especially between the genders; and 3) measure, understand, and evaluate the problem of health inequity. &lt;/p&gt;
&lt;p&gt;I have no doubt a lot of time and effort was involved in the Commission’s work, and I do hope it succeeds in raising awareness about social injustice. But I feel like this message about the social determinants of health has been out there a long time with little action or progress.&lt;/p&gt;
&lt;p&gt;I dusted off my copy of the &lt;a href="http://www.hc-sc.gc.ca/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/1974-lalonde/lalonde_e.pdf"&gt;Lalonde Report&lt;/a&gt;, a Canadian governmental report that is considered by many to be the first acknowledgment by a major industrialised nation that health is determined by more than just biological factors. &lt;em&gt;It was produced in 1974.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;The Lalonde report was seminal, and led to other important international documents like the &lt;a href="http://www.who.int/hpr/NPH/docs/declaration_almaata.pdf"&gt;WHO’s Declaration of Alma-Ata&lt;/a&gt;. This for the first time internationally asserted the importance of primary health care, but is also credited with advancing the notion of health as a human right. &lt;/p&gt;
&lt;p&gt;Alma-Ata also declared the inequity between the developed and the developing world to be unacceptable, stated that economic and social development was necessary for health, and that in turn health contributes to economic and social development and world peace. &lt;em&gt;Alma-Ata was released in 1978.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;Given the conclusions of yesterday’s report, it’s fascinating to look back over these declarations and see how prescient they were. The Lalonde report, for example, begins with these words: &lt;em&gt;“Good health is the bedrock on which social progress is built. A nation of healthy people can do those things that make life worthwhile, and as the level of health increases so does the potential for happiness.”&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;It goes on to state &lt;em&gt;“The health care system, however, is only one of many ways of maintaining and improving health....For these environmental and behavioural threats to health [environmental pollution, city living, habits of indolence, the abuse of alcohol, tobacco and drugs, and eating patterns which put the pleasing of the senses above the needs of the human body], the organized health care system can do little more than serve as a catchment net for the victims.”&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;Thirty four years later we have a new report, with seemingly no new messages. Regrettably I think we can assume no new progress on social justice.&lt;/p&gt;
&lt;br class="clear" /&gt;
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 <category domain="http://www.plos.org/cms/plosmedicine">PLoS Medicine</category>
 <pubDate>Thu, 28 Aug 2008 13:23:53 -0700</pubDate>
 <dc:creator>Jocalyn Clark</dc:creator>
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 <title>To screen or not to screen?</title>
 <link>http://feeds.feedburner.com/~r/plos/MedicineBlog/~3/356828691/390</link>
 <description>&lt;p&gt;To screen or not to screen?  One of the more “interesting” experiences of my journalistic career was co-authoring an &lt;a href="http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2002/01/18/ED135201.DTL" rel="nofollow"&gt;Op-Ed&lt;/a&gt; for the San Francisco Chronicle in 2002 on the lack of evidence for prostate cancer screening using the PSA test.  &lt;/p&gt;
&lt;p&gt;The piece caused quite a reaction, which we later &lt;a href="http://www.bmj.com/cgi/content/full/324/7334/431" rel="nofollow"&gt;discussed&lt;/a&gt; in the BMJ:  &lt;/p&gt;
&lt;p&gt;“Within hours of our piece being published, prostate cancer charities, support groups, and urologists around the country had circulated a &amp;quot;Special Alert&amp;quot; by e-mail. This community has huge faith in PSA tests, and it did not care for our opinion. The e-mail, under the header &amp;quot;ATTENTION MEN!!&amp;quot; urged the community to take action.  By the end of the day, accusations, abuse, and personal threats jammed our e-mail inboxes. We were compared to Josef Mengele, and accused of having the future deaths of hundreds of thousands of men on our hands.”   &lt;/p&gt;
&lt;p&gt;I suspect that this same community will now be up in arms about the latest &lt;a href="http://www.ahrq.gov/clinic/uspstf08/prostate/prostaters.htm" rel="nofollow"&gt;guidance&lt;/a&gt; from the US Preventive Services Task Force (&lt;a href="http://www.ahrq.gov/clinic/uspstfix.htm" rel="nofollow"&gt;USPSTF&lt;/a&gt;), one of the best respected independent health agencies in the country.    &lt;/p&gt;
&lt;p&gt;As the New York Times &lt;a href="http://www.nytimes.com/2008/08/05/health/research/05prostate.html?em" rel="nofollow"&gt;reports&lt;/a&gt; in a huge cover story today, headlined &lt;em&gt;Panel Urges End to Prostate Screening at Age 75&lt;/em&gt;, the task force has systematically reviewed the best evidence on the value of such screening and concludes:   &lt;/p&gt;
&lt;p&gt;“The USPSTF recommends against screening for prostate cancer in men age 75 years or older.”    &lt;/p&gt;
&lt;p&gt;It also concludes that “the current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening in men younger than age 75 years.”&lt;/p&gt;
&lt;p&gt;  The New York Times notes that the new guidance, which now clearly advises &lt;em&gt;against&lt;/em&gt; screening men aged 75 and older, represents &amp;quot;an abrupt policy change by an influential panel,&amp;quot; a panel that had previously withheld giving specific advice regarding screening for prostate cancer.  &lt;/p&gt;
&lt;p&gt;In a terrific &lt;a href="http://www.npr.org/templates/story/story.php?storyId=93313794" rel="nofollow"&gt;NPR commentary&lt;/a&gt; today on the new guidance, Doug Kamerow says:  &lt;/p&gt;
&lt;p&gt;“There just aren&amp;#39;t any good studies to show that men who get screened and treated for prostate cancer live longer than those who don&amp;#39;t. So the benefits are unknown. But the harms of screening and treatment are real and well documented. They include not just the costs and pain of treatment, but also the incontinence and impotence that some men get after surgery. The problem is that some prostate cancer grows quickly and is lethal. Some, especially in older men, is slow-growing and never causes a problem. That is why people say that more older men die with prostate cancer than of prostate cancer.”&lt;/p&gt;
&lt;p&gt;I suspect that despite the new USPSTF guidance, the “great prostate debate” is far from over.  It is merely, &lt;a href="http://dailynightly.msnbc.msn.com/archive/2008/08/05/1247958.aspx" rel="nofollow"&gt;says&lt;/a&gt; NBC news’ chief science correspondent Robert Bazell, “the latest shot in an ongoing war among many factions who hold various positions on this disease.”  &lt;/p&gt;
&lt;p&gt;Hopefully the war will be settled when we have the results of two ongoing clinical trials of prostate cancer screening, one in the U.S. and one in Europe.&lt;/p&gt;

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 <category domain="http://www.plos.org/cms/plosmedicine">PLoS Medicine</category>
 <pubDate>Tue,  5 Aug 2008 16:08:55 -0700</pubDate>
 <dc:creator>Gavin Yamey</dc:creator>
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 <title>To IRB or not to IRB?</title>
 <link>http://feeds.feedburner.com/~r/plos/MedicineBlog/~3/349614787/387</link>
 <description>&lt;p&gt;The Committee on Publication Ethics (&lt;a href="http://www.publicationethics.org.uk/" rel="nofollow"&gt;COPE&lt;/a&gt;), of which PLoS Medicine, and other PLoS journals, are members, has recently released guidance for editors on the thorny topic of "research, audit and service evaluations". This guidance aims to help editors decide how to handle their journal's requirement for ethical review in relation to these types of studies. As outlined by COPE, most journals require that for any research involving human subjects, the study has been approved by a properly constituted &lt;a href="http://en.wikipedia.org/wiki/Institutional_Review_Board" rel="nofollow"&gt;ethics committee&lt;/a&gt;. &lt;/p&gt;
&lt;p&gt;However, for some types of studies and in some countries, ethical approval is not required (or, may not even be possible). For example, the &lt;a href="http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm" rel="nofollow"&gt;&lt;br /&gt;
US Department of Health and Human Services&lt;/a&gt; exempts research from review if it involves studying existing data or specimens, providing data is anonymised and delinked from the participant it originated from; exemptions also apply for five other major categories of research. In the UK, the National Research Ethics Service issues its own &lt;a href="http://www.nres.npsa.nhs.uk/rec-community/guidance/#researchoraudit" rel="nofollow"&gt;guidelines &lt;/a&gt; to help people to work out whether what they are planning to do is research (which requires ethical review) versus audit or service evaluation (which don't). &lt;/p&gt;
&lt;p&gt;The PLoS Medicine editors recently discussed the COPE guidance. That guidance suggests that editors think about four key components, quite apart from the "box-ticking" exercise of checking that ethical review and informed consent have been obtained. Those four areas are: 1) scientific validity; 2) minimisation of harm; 3) whether benefits outweigh harms; and to 4) the need to seek clarification from authors or ethics committees regarding local laws and regulations, as necessary.&lt;/p&gt;
&lt;p&gt;At PLoS Medicine, our &lt;a href="http://journals.plos.org/plosmedicine/policies.php#human" rel="nofollow"&gt;journal policy&lt;/a&gt; is that "All research involving humans and animals must have been approved by the authors’ institutional review board or equivalent committee...". We do however recognise that many studies may be exempt from ethical review, and therefore our overriding approach is that authors describe clearly in their paper how ethical oversight for the study was obtained, and how the informed consent of participants was handled. This means that reviewers, and readers, will be able to judge for themselves whether the protection of human participants in the study was appropriate. &lt;/p&gt;
&lt;p&gt;At the same time, we recognise that "journals should not automatically defer to ethics committees", as Kamran Abbasi and Iona Heath have pointed out in a &lt;a href="http://www.bmj.com/cgi/content/full/330/7489/431" rel="nofollow"&gt;BMJ editorial&lt;/a&gt;, and we consider the key areas outlined by COPE as part of our editorial review process. If we do have concerns regarding the protection of human participants in a study, irrespective of whether that study was approved by an ethics committee (or exempt from ethical review), the editors reserve the right to follow up, under the guidance of our &lt;a href="http://dx.doi.org/10.1371/journal.pmed.0040081" rel="nofollow"&gt;advisory group on publication ethics&lt;/a&gt;, as necessary.&lt;/p&gt;

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 <category domain="http://www.plos.org/cms/plosmedicine">PLoS Medicine</category>
 <pubDate>Tue, 29 Jul 2008 09:46:58 -0700</pubDate>
 <dc:creator>Emma Veitch</dc:creator>
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 <title>Is the NIH open access policy regressive?</title>
 <link>http://feeds.feedburner.com/~r/plos/MedicineBlog/~3/345999301/385</link>
 <description>&lt;p&gt;I was thrilled that several &lt;a href="http://www.plos.org/about/people/community.html" rel="nofollow"&gt;PLoS colleagues&lt;/a&gt; attended the ISMB conference this past week in Toronto, where I live. The &lt;a href="http://www.iscb.org/ismb2008/" rel="nofollow"&gt;massive event&lt;/a&gt; is the official conference of the International Society for Computational Biology, and &lt;a href="http://www.ploscompbiol.org/home.action" rel="nofollow"&gt;PLoS Computational Biology&lt;/a&gt; is the official journal of the Society.&lt;/p&gt;
&lt;p&gt;My friends asked me: “What is computational biology?”&lt;/p&gt;
&lt;p&gt;I said: “Good question!”&lt;/p&gt;
&lt;p&gt;&lt;a href="http://en.wikipedia.org/wiki/Computational_biology" rel="nofollow"&gt;Wikipedia&lt;/a&gt; tells me it’s an intoxicating mix of computer science, applied mathematics, and statistics applied to biology. (ok, I added the intoxicating bit).&lt;/p&gt;
&lt;p&gt;My &lt;em&gt;PLoS Biology&lt;/em&gt; colleague &lt;a href="http://www.plos.org/about/people/biology.html#rshields" rel="nofollow"&gt;Robert Shields&lt;/a&gt; tells me it’s “the biology that counts.” (ba dum dum).&lt;/p&gt;
&lt;p&gt;Definitions aside, I took two things away from the conference that matter to &lt;em&gt;PLoS Medicine&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;First, &lt;a href="http://www.gersteinlab.org" rel="nofollow"&gt;Mark Gerstein&lt;/a&gt; from Yale University gave an outstanding talk in a session called &lt;em&gt;The Future of Scientific Publication&lt;/em&gt;, remarking that it was unusual (but inspiring) for a computational biology conference to include a session on publishing.  &lt;/p&gt;
&lt;p&gt;He emphasised the use of text mining to study the “structure of science.” He says this is Science 2.0 (or, the science of science), which uses network theory and technologies to discover new scientific relationships. Whereas conventional challenges have us struggling to keep up with the volume and growth of scientific papers (this reminds me of Muir Gray’s &lt;a href="http://www.bmj.com/cgi/content/full/317/7162/832" rel="nofollow"&gt;information paradox in medicine&lt;/a&gt; - overwhelmed with information but unable to find the knowledge when we need it), new technologies to structure and text mine scientific publications  can help scientists share information and foster collaboration.  (Including using publications as the annotation for the genome).&lt;/p&gt;
&lt;p&gt;Gerstein and colleagues' fascinating maps of publication patterns, gene names, topic clusters within whole research areas, and the emergence of new scientific fields are reminiscent of the recent &lt;em&gt;PLoS Medicine&lt;/em&gt; &lt;a href="http://medicine.plosjournals.org/perlserv/?request=get-document&amp;amp;doi=10.1371/journal.pmed.0050071" rel="nofollow"&gt;editorial&lt;/a&gt; in which we argue that everything in medicine is connected through networks. (When I chatted with Gerstein after his session he agreed that network guru &lt;a href="http://www.nd.edu/~alb/" rel="nofollow"&gt;Albert-Lásló Barabási&lt;/a&gt; is a genius.)&lt;/p&gt;
&lt;p&gt;But none of this is possible without open access, countered Matt Cockerill from BioMed Central.  He said that we absolutely need the raw material (whether it be biological data or bibliometric information) freely and openly available to apply the network algorithms so we can visualise the structure of science. Currently, much information is behind access controls thus disrupting the whole vision of an interconnected and collaborative scientific world.&lt;/p&gt;
&lt;p&gt;The second issue of note was raised during the session’s Publishers’ Panel, populated by Catherine Nancarrow (PLoS), Claire Bird (Oxford University Press), and Matt Cockerill (BioMed Central). Panellists noted that the recent &lt;a href="http://publicaccess.nih.gov/" rel="nofollow"&gt;NIH public access policy&lt;/a&gt; emphasises &lt;em&gt;free&lt;/em&gt; not &lt;em&gt;open&lt;/em&gt; access. That is, the policy may lead to freely accessible publications (for which publishers or organisations may reap profits from charging authors a fee to deposit their manuscripts), but these will remain under restrictive licenses (thus limiting text-mining).&lt;/p&gt;
&lt;p&gt;This, Cockerill argued, makes the NIH policy regressive.&lt;/p&gt;

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&lt;div class="title"&gt;&lt;a href="http://scienceblogs.com/clock/2008/07/ins_and_outs_of_academia.php"&gt;In(s) and Out(s) of Academia&lt;/a&gt;&lt;/div&gt;
&lt;div class="author"&gt;from A Blog Around The Clock on Fri, 2008-07-25 18:52&lt;/div&gt;
&lt;div class="content"&gt;&lt;p&gt;Bjoern Brembs is on a roll! Check all of these out: Incentivizing open scientific discussion: Apart from the question of whether the perfect scientist is the one who only spends his time writing papers and doing experiments, what incentives can...&lt;/p&gt;
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 <comments>http://www.plos.org/cms/node/385#comment</comments>
 <category domain="http://www.plos.org/cms/plosmedicine">PLoS Medicine</category>
 <pubDate>Fri, 25 Jul 2008 13:31:04 -0700</pubDate>
 <dc:creator>Jocalyn Clark</dc:creator>
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