Monday 30 December 2013

Welcome back!
Following on from my last blog where I talked about the issue of registering clinical trials in dentistry, I find myself galvanised (albeit over a year later - I am aware that these blogs are taking longer to gestate than my children did ...) to follow up blogging about AllTrials.

This campaign (yes, I know this makes me sound like an aging hippie) is raising awareness to get some movement on several problems with clinical trial reporting. 
AllTrials talks about 4 steps in being transparent about what we are doing in clinical research:

1. registering trials with a clinical trials register so that people know the trial has been/ is being conducted before the first participant is recruited.
I blogged about this in my last (aged now) post http://evidentnic.blogspot.co.uk/- registering clinical trials (which is really just the first step in transparency in clinical trials).

However, there are three further steps that need to be fulfilled for us to be able to say we have made the best use of actually been transparent enough and provided enough detail in order to in reporting results following clinical research.

2. providing a brief summary of a trial’s results and this can be in an academic journal article or is sometimes a requirement of the trial regulator or funder and is done through them

3. then the one most people know about - publishing longer details about the trial’s methods and results,

4. reporting data at an individual participant level.  (Note that this does not mean making participant data available).

Having been involved in several Cochrane reviews now, I can attest that this is a real problem. One of the reviews we undertook, Ricketts, we had to exclude one of the trials because, even after contacting the author and gaining access to their PhD, we still could not work down to the actual level of data we needed in order to be able to assess the study for inclusion and, if we had included it, would not have been able to get the level of data we would have needed to add to our meta-analyses.


These three are what AllTrials is calling for to be published.

So, how do dental and oral health related clinical trials stack up?
information on what was done and what was found in trials could be lost forever, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated unnecessarily. - See more at: http://www.alltrials.net/blog/#sthash.M1N4N6aZ.dpuf

Well, we have much less pharma in dentistry (although the problems are likely to still be there) and I don't think anyone has specifically looked at how well we do really in terms of all 4 of the above but it doesn't look good for reporting of randomised trials:  Zoe Marshman published last year on the quality of trials in the dental public health arena and noted that the Consort statement was not being adhered to (and this was despite journals having signed up to it) and paediatric dentistry, implant dentistry and a quality review of randomised control trials in dental specialty journals all report a similarly poor picture.  So, I'm unsure how much has been registered and reported specifically within dental and oral health but what we are reporting isn't even up to a high standard.  So, if it's not reported well, you can't rely on it to use in your own practice and you often can't use it in a good quality systematic review.

So, whilst I'm delighted at All Trials campaign recent news of success with agreement between the Council of the EU, Parliament and Commission in Brussels to hold a central register of all trials carried out in the EU and a number of other steps towards transparency, I can't help thinking that in dental and oral health, we are still lagging a bit behind despite having been given the tools handed to us for high quality trial reporting at least...




(1) knowledge that a trial has been conducted, from a clinical trials register; (2) a brief summary of the trial’s results; (3) full details about the trial’s methods and results; (4) individual patient data from the trial, and discusses the first three in detail. - See more at: http://www.alltrials.net/2013/all-trials-registered-and-results-reported/#sthash.BrzHSHml.dpuf

(1) knowledge that a trial has been conducted, from a clinical trials register; (2) a brief summary of the trial’s results; (3) full details about the trial’s methods and results; (4) individual patient data from the trial, and discusses the first three in detail. - See more at: http://www.alltrials.net/2013/all-trials-registered-and-results-reported/#sthash.BrzHSHml.dpuf
(1) knowledge that a trial has been conducted, from a clinical trials register; (2) a brief summary of the trial’s results; (3) full details about the trial’s methods and results; (4) individual patient data from the trial, and discusses the first three in detail. - See more at: http://www.alltrials.net/2013/all-trials-registered-and-results-reported/#sthash.BrzHSHml.dpuf