Government Sponsored Studies Not Getting Published

Yale researchers published a study on whether NIH-funded studies get published after research completion.

The researchers examined all clinical trials after Sept 30, 2005 funded by NIH and registered within ClinicalTrials.gov maintained by the US National Library of Medicine.

Shockingly, among 635 clinical trials completed by 31 December 2008, only 46% (294 studies) were published in a peer reviewed biomedical journal within 30 months of trial completion. The median period of follow-up after trial completion was 51 months (25th-75th centiles 40-68 months) and 68% (432) were published overall.

Why aren't more of these completed studies being published???

It was already known that industry-sponsored studies had only a 40% publication rate. One can rationalize that such pharmaceutical-sponsored studies that do not reveal promising results do not get green-lighted for publication, but such a bias should not technically occur with government sponsored trials.

However, it just may be that there may be political pressure that may influence whether one study gets published and another does not (much like what has happened with climate research which allegedly has gotten smothered by unfriendly political forces).

It is also possible that researchers just do not prioritize publishing being more interested in doing the research and not so much the writing up of their results... OR their research findings have gotten rejected by journals for publication.

OR... maybe the unpublished studies are just THAT bad such that the research is literally unpublishable... which I find hard to believe given getting NIH grants to do the research is difficult and highly competitive.

In any case, there MUST be more effort to publish research findings for many reasons, key among them being:

1) Even if the study shows no results, that in itself is meaningful (if a drug did not work, than everyone should know that)

2) Duplicate studies would not occur which one can argue would be wasteful. Why reinvent the wheel when it already has been done? (there is a role for repeating studies, but should be done in a setting of being AWARE of repeating the research)


Reference:
Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012 Jan 3;344:d7292. doi: 10.1136/bmj.d7292.

Publish or... Don't. Yale Alumni Magazine. Page 32. March/April 2012.

Clinical Guidelines For Tonsillectomy in Children Published

This month, the American Academy of Otolaryngology-Head & Neck Surgery published clinical guidelines for tonsillectomy in kids. No big surprises in the guidelines, but everything is nicely summarized in one document.

In summary:
• Strong recommendation that clinicians should administer a single, intraoperative dose of intravenous dexamethasone to children undergoing tonsillectomy.
• Strong recommendation against clinicians routinely administering or prescribing perioperative antibiotics to children undergoing tonsillectomy.
• Recommendations for:

1. watchful waiting for recurrent throat infection if there have been fewer than 7 episodes in the past year or fewer than 5 episodes per year in the past 2 years or fewer than 3 episodes per year in the past 3 years
2. assessing the child with recurrent throat infection who does not meet criteria in statement 2 for modifying factors that may nonetheless favor tonsillectomy, which may include but are not limited to multiple antibiotic allergy/intolerance; PFAPA (periodic fever, aphthous stomatitis, pharyngitis and adenitis); or history of peritonsillar abscess
3. asking caregivers of children with sleep-disordered breathing and tonsil hypertrophy about comorbid conditions that might improve after tonsillectomy
4. counseling caregivers about tonsillectomy as a means to improve health in children with abnormal polysomnography who also have tonsil hypertrophy and sleep-disordered breathing
5. counseling caregivers that sleep-disordered breathing may persist or recur after tonsillectomy and may require further management
6. advocating for pain management after tonsillectomy and educating caregivers about the importance of managing and reassessing pain
7. clinicians who perform tonsillectomy should determine their rate of primary and secondary post-tonsillectomy hemorrhage at least annually.

References:
Clinical Practice Guideline: Tonsillectomy in Children. Otolaryngology– Head and Neck Surgery 144(1S) S1–S30