Surgery clinical trial results selectively reported | Reuters

<base href="data:"><div style="font-family: Helvetica; font-size: 14px; color: black; text-align: left; "><span class="focusParagraph" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "><p style="margin: 0px 0px 10px; padding: 0px; font-size: 20px; line-height: 1.5; ">Selective reporting of positive results from drug clinical trials is a well-documented problem, but a new study finds that trials of surgical treatments have an even worse track record.</p></span><span id="midArticle_1" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">Researchers who looked at hundreds of surgery clinical trials found that many set out to answer one question but ended up focusing on something else, leading to less reliable evidence being published. Others never bothered to state a goal for their study or published results while the trial was still going on.</p><span id="midArticle_2" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">"We know that this is a huge problem in medicine, and one that we've known about for three decades," Dr. Ben Goldacre, a UK doctor and founder of <a href="http://Alltrials.net">Alltrials.net</a> told Reuters Health by email.</p><span id="midArticle_3" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">"It's a huge cultural blindspot for doctors, academics, industry, regulators, and policy makers, but it knocks the legs out from underneath evidence based medicine," said Goldacre, who was not involved in the study.</p><span id="midArticle_4" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">It's harder for doctors and patients to make informed decisions about which treatment or, in this case, surgical procedure, is best when the evidence from a study is modified or absent, he said.</p><span id="midArticle_5" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">"If you measure lots of different outcomes, and then allow yourself to select and report the one that flatters the treatment the most, then you're misusing this basic statistical tool," Goldacre said.</p><span id="midArticle_6" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">Gerjon Hannink led a team of researchers at the Radboud University Nijmegen Medical Center in Nijmegen, The Netherlands, comparing the results of 327 published surgical trials with the goals set out when the trials were registered.</p><span id="midArticle_7" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">Putting basic information about the aims of a trial into a clinical trial registry before recruiting participants is generally a prerequisite of publication. The International Committee of Medical Journal Editors began in 2005 requiring clinical trials to be entered into a registry before they begin, and many journals include that policy in their instructions to authors.</p><span id="midArticle_8" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">Despite that rule, the new study found that up to half of surgery clinical trials were still not registered correctly before their results were published, according to the report from Hannink's team in Annals of Surgery.</p><span id="midArticle_9" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">They found that out of 327 trials, fully a third (109 trials) had never been registered and another 48 were only registered after the study was completed. Of 152 trials that had been entered into a registry in advance with an end goal clearly defined, half changed that goal when the results were published, or left it out entirely.</p><span id="midArticle_10" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">That's a 50 percent rate of reporting bias in surgical trials, compared to estimates of 30 or 40 percent in general medical studies for drugs and other treatments, according to the authors.</p><span id="midArticle_11" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">"We expected the situation to be worse for surgical trials as compared to internal medicine," Hannink told Reuters Health by email. "However, the difference found was larger than we had expected."</p><span id="midArticle_12" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">Hannink acknowledged that it's harder to do the gold-standard, double-blind studies for surgeries than for pills because it's difficult to keep the surgeon or the patients from knowing whether they're involved in a new procedure or getting the usual treatment for comparison.</p><span id="midArticle_13" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">With drugs, pharmaceutical companies tightly control most testing of their medications and they know that regulatory agencies will scrutinize the results closely, he added, but there's no equivalent oversight for surgical procedures.</p><span id="midArticle_14" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">Incomplete or modified publication of results can have serious consequences, Hannink said. It can lead to the promotion of ineffective or harmful treatments or to expensive therapies seeming better than cheaper alternatives when in fact they are not, and that's "the worst possible situation for patients, health care professionals, and policy makers," he said.</p><span id="midArticle_15" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">"Sometimes this is about money, or reputation: people may not want to publish a trial that undermines their product, or the cherished theory that underpins their career," Goldacre said. "But equally, sometimes it's simply thoughtless, or what we might have to call incompetence."</p><span id="midArticle_0" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">"This problem has been well documented for three decades, and everything we have tried so far has failed, laws have been ignored, codes of conduct likewise," Goldacre said.</p><span id="midArticle_1" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">There's no clear solution, except to provide incentives for researchers to follow the rules and for journals and their editors to enforce those rules, experts said.</p><span id="midArticle_2" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin: 0px 0px 10px; padding: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); ">Goldacre and several partners launched a petition at <a href="http://Alltrials.net">Alltrials.net</a> in January to campaign for full publication of all results of clinical trials in the future and all those going on now or already completed, mainly by urging regulators and governments to enact legislation requiring publication.</p><span id="midArticle_3" style="color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-size: medium; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; line-height: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); "></span><p style="margin-top: 0px; margin-right: 0px; margin-bottom: 10px; margin-left: 0px; padding-top: 0px; padding-right: 0px; padding-bottom: 0px; padding-left: 0px; font-size: 14px; line-height: 1.6; color: rgb(0, 0, 0); font-family: arial, helvetica, sans; font-style: normal; font-variant: normal; font-weight: normal; letter-spacing: normal; orphans: 2; text-align: -webkit-auto; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-size-adjust: auto; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); position: static; z-index: auto; ">"Full publication of complete trial results is essential if clinicians, patients, policy makers and others are to make well-informed decisions about health care," Hannink said.</p></div><a href="http://www.reuters.com/article/2013/03/14/us-surgery-clinical-trial-idUSBRE92D0Y620130314">http://www.reuters.com/article/2013/03/14/us-surgery-clinical-trial-idUSBRE92D0Y620130314</a><div style="font-family: Helvetica; font-size: 14px; color: black; text-align: left; 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Surgery clinical trial results selectively reported | Reuters

Selective reporting of positive results from drug clinical trials is a well-documented problem, but a new study finds that trials of surgica...

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