Non-publication of large randomized clinical trials: cross sectional analysis

Source: British Medical Journal

Full Text

 

Objective To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public.

Design Cross sectional analysis

Setting Trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009.

Data sources PubMed, Google Scholar, and Embase were searched to identify published manuscripts containing trial results. The final literature search occurred in November 2012. Registry entries for unpublished trials were reviewed to determine whether results for these studies were available in the ClinicalTrials.gov results database.

Main outcome measures The frequency of non-publication of trial results and, among unpublished studies, the frequency with which results are unavailable in the ClinicalTrials.gov database.

Results Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299 763 study participants. The median time between study completion and the final literature search was 60 months for unpublished trials. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%), P=0.003. Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov.

Conclusions Among this group of large clinical trials, non-publication of results was common and the availability of results in the ClinicalTrials.gov database was limited. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results.

End of the scandal of free Medical Education

BMJ (Photo credit: Wikipedia)

A great article that you can read in the British Medical Journal today..........of course....if you pay first. So which is the scandal ? If you work hard, you could be a revisor of some papers in the BMJ......actually I was there for a couple of years......no credits for my resumee, no fees, and not avalaible to see the same articles I used to work on it.........no pay, but also not information for that. Happy for Fiona Heath, and many important people there. But.....are these people aware that medical information must be also free ? They don't write the papers, they have a lot of revisor for free, and there are no costs (or low costs ), for post an article in internet.......so....be serious. The only scandal here is the tittle and the BMJ itself. Free Medical Education from BMJ........ ?????

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Newspaper and reliable medical information

Public release date: 31-Jan-2012

Contact: Annmarie Christensen
annmarie.christensen@dartmouth.edu
603-653-0897
Dartmouth-Hitchcock Medical Center 

Quality medical journal news releases can help newspapers do a better job informing public

LEBANON, N.H. -- Medical journal press releases are the most direct way that journals communicate with the news media about new research. According to a study in the British Medical Journal, press release quality appears to have an important effect on the quality of subsequent newspaper stories. With high quality press releases, key information –basic study facts, quantification of results, acknowledgment of limitations – is substantially more likely to appear in newspaper stories. Low quality press releases, those omitting such key information, may actually make newspaper stories worse than if there were no press release at all.
"The news media matter: medical reporting not only educates but also influences health beliefs and behaviors," said Steven Woloshin and Lisa Schwartz, principal co-investigators of the study. "Our study shows that press releases are important as well."
The investigators, co-directors of the Center for Medicine and the Media at The Dartmouth Institute of Health Policy and Clinical Practice, reviewed consecutive issues of five major medical journals that frequently receive news coverage but have different editorial practices. Two of the journals (Annals of Internal Medicine, Journal of the National Cancer Institute) include editorial notes highlighting study cautions in the studies, two do not (JAMA, British Medical Journal), and one journal in the group does not issue press releases (New England Journal of Medicine).
The authors reviewed consecutive issues of each medical journal (going backwards from January 2009) to identify 100 original research articles that generated newspaper coverage. A total of 759 newspaper stories (a median of three per journal article) were identified through searches of news article databases, Lexis Nexis and Factiva. The investigators did not examine broadcast, web and social media platforms.
All associated medical journal press releases – a total of 68 – were identified using the press release database http://www.eurekalert.org. Two independent research assistants assessed the quality of journal articles, press releases, and a stratified random sample of associated newspaper stories by using a structured coding scheme for the presence of specific quality measures: basic study facts, quantification of the main result, harms and limitations. In their analyses, the authors took into account whether the quality measures were available in the associated abstract of the medical journal article.
Of the 343 newspaper stories analyzed, 71 percent reported on articles for which medical journals had issued press releases. Some 9 percent of stories quantified the main result with absolute risks when this information was not in the press release, 53 percent did so when it was in the press release, and 20 percent when no press release was issued.
Of the total analyzed, 133 stories reported on research describing beneficial interventions. Some 24 percent mentioned harms (or specifically declared no harms) when harms were not mentioned in the press release; 68 percent when mentioned in the press release; and 36 percent when no press release was issued.
Some 256 stories reported on research with important limitations. Of these, 16 percent reported any limitations when limitations were not mentioned in the press release; 48 percent when mentioned in the press release, and 21 percent if no press release was issued.
The Dartmouth Institute investigators reported several limitations of their own study. They noted that since they did not conduct a randomized trial, it is possible that other factors besides the press release accounted for newspaper story quality. For example, medical journals that issue high quality press releases might take other steps that improve subsequent newspaper coverage (but they found no evidence for this). Other limitations: only newspaper print articles were analyzed even though web-based media is gaining in impact; subjectivity is inherent in any content analysis; and the investigators could have introduced bias in their use of stratified random sampling to select newspaper stories.
"Media coverage of medical research often fails to provide the information needed for the public to understand the findings and to decide whether to believe them. Although it is easy to blame journalists for poor quality reporting, problems with coverage could begin with the journalists' sources."
The investigators concluded that high quality press releases are a simple way for medical journals to increase the chance of newspapers reporting key information.
There is substantial room for improving press releases, the investigators noted. They believe medical journals should make the effort to do better and use press releases not simply to make medical news but to make news reporting better.

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Editor's Note: Please see the article http://www.bmj.com/content/344/bmj.d8164 for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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There' s no free launch

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This  is the today's  editorial of  BMJ, one of  the most  reliable medical  journal  all over the world. The title deals about ....."provision of health information for all"..........but I can't explain it because I can not read it, because at the end of this abstract says "Full Text of this Article"........of course, to read the full article I need to pay first. So it doesn't matter what the editorial says, if you want information, in the information age..........you have to pay....at least for the famous British Medical Journal. Anyway, I think you can read more about this in another blog's o newspaper like "guardian", in   related articles.
BMJ 2011; 342:d4151 doi: 10.1136/bmj.d4151 (Published 30 June 2011)

Cite this as: BMJ 2011; 342:d4151

• Editorial

Provision of health information for all

1. Richard Smith, director1, 
2. Tracey Pérez Koehlmoos, programme head2

+Author Affiliations

1. ¹UnitedHealth Chronic Disease Initiative, London SW4 0LD, UK
2. ²Health and Family Planning Systems Programme, ICDDR,B, Dhaka, Bangladesh

1. richardswsmith@yahoo.co.uk

A major organisation should support global efforts

High quality information is essential for good health, yet many individuals, practitioners, and health organisations—particularly in low and middle income countries—lack access to information. This problem has been highlighted many times, 1 2 3 4 and Health Information for All 2015 (HIFA2015) was founded in 2006 with the aim that “by 2015 every person worldwide will have access to an informed healthcare provider—lack of relevant, reliable healthcare information will no longer be a major contributor to avoidable death and suffering” (www.hifa2015.org/ ). It is unlikely that this ambitious goal will be achieved.

In HIFA2015’s definition, the term “healthcare providers” includes mothers and family caregivers, in recognition that their basic knowledge and decisions are crucial to survival. In many countries in Africa more than 80% of children die before they even reach a health facility. The term “healthcare information” refers to health knowledge for prevention and treatment of disease rather than routine statistical data.

HIFA2015 now has 5000 members from 2000 organisations in 158 countries, and it has four global forums—HIFA2015, CHILD2015, HIFA-Portuguese, and HIFA-EVIPNet. Most of those who contribute to the forums come from low and middle income countries. The organisation has a three pronged strategy of communication (bringing together a critical …

[Full text of this article]

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