Wikipedia

To get the information you need when you need it there needs to be

Accessible
and
Correct (or good quality)

Nowadays Wikipedia is the 'go to' place for information. It's certainly accessible but is it good quality?

I have been timidly editing Wikipedia dental pages for around 10 years now (very timidly, infrequently and sporadically!).  I've found that the dentally related pages are often out of date, have a skewed (and often commercial) perspective and aren't usually written for the general public. So I was delighted when I heard about the initiative between The Cochrane Collaboration and WikiProject Medicine to improve the medical pages and also the dental pages using the high quality Cochrane evidence.  What is even better is that some of the work for this initiative is coming from the University of Dundee, Dental Students.
I attended a Wikipedia editing training session for the students and early career staff at my University today. I was asked to talk to the Dental DRAMS about evidence and different types/ how we can have confidence in it.
The hierarchy of evidence or pyramid that used to be talked about is considered outdated and too simplistic now. For example, certain questions can only be answered in certain ways. However, I think it still gives a useful framework for those who are quite new to research types to start to hang everything on and give a starting point for appreciating that not all evidence is created equal.   I sit Guidelines along the spine of my pyramid and include Qualitative Evidence as a speech bubble outside (to avoid it getting forgotten about as it so often is).

I find that one of the most difficult concepts to get across is that although we have increasing confidence in certain kinds of evidence some of the 'lower' levels of evidence, if very well carried out, can be better 'quality' than evidence types that might be 'higher' up the pyramid.

Back to the Wikipedia editing event - well, it seemed to be a success and I'm looking forward to reporting on the results of the Dental DRAMS progress in editing Wikipedia and improving the quality of the evidence there.
The Wikipedia editing event went really well and now we just need to keep up  the momentum and get bold with some of those edits!

Getting Outcomes Out Of The Closet!

There are few things more frustrating than completing a systematic review and finding that you have no useful evidence (trials) to be able to draw any conclusions from. But here's one of them; finding that there is some evidence but then finding that you can't actually do anything with it.
So, you've carried out your rigorous search of the literature, you've eliminated what is not relevant,  you have actually found trials that compare the same intervention, you've carried out data extraction, assessed their quality and the risk of bias.  Phew! The next step, to get the most out of these primary studies, is to synthesise their results which will let you look at the overall picture they present across different groups, compare their results or look further into the subgroups and contrast their findings.
BUT...
You find yourself in a position where you can't combine or compare them... each trial has used different outcomes or different outcome measures.

What do I mean?
Well, take for example, a very simple randomised control trial where you think one filling, let's call it X, is better than my newly developed filling, we'll call that one Y.  Both are traditional restorative materials, designed to replace tooth structure following selective caries removal (we'll talk about that another time!).  We work together to design our trial with strict inclusion criteria so that everything is standardised and the 2 filling materials will be allocated to each patient who is eligible and their tooth using a random allocation system. So far, so good. We have similar conditions and neither material will be disadvantaged because we have taken care to eliminate any remaining bias (as far as possible) by random allocation.

We run our trial*.  At the end we assess the performance of the different fillings but what should we use to assess it?  We could:

• count how many fillings needed to be repaired
• count how many needed to be replaced
• use a scale to assess the aesthetics over time if it was an anterior tooth (or even a posterior one)
• count how many of the teeth experienced sensitivity after the restoration was placed
• use a scale to assess sensitivity post-treatment 
• use a scale to assess what the participants thought of the appearance
• use the Ryge criteria to determine using a scoring system for different criteria such as marginal ditching, staining etc

and so on...

You can see the problem here. If our study decides to measure the Ryge criteria, we can't compare the findings for these two materials' performance with a study that has looked at how many needed to be replaced.
Even if we have used a scale to assess the aesthetics, we might have chosen one or made one up but find that all of the other studies that use a scale to assess aesthetics for materials, have chosen a different one to us, so our study cannot be compared.

Trials of interventions for dental caries trials, there are a vast number of outcomes and outcome measures used. In a quick review of the area, we found 18 different outcomes reported for 50 trials of caries management techniques for primary teeth  (a link to the protocol presented at COMET IV can be found here)

So, how do we decide which outcomes to measure or which outcome measures to use. Well, at the moment, it seems that there is no real guidance and researchers will pragmatically choose to use what they consider the most important outcome to be and the outcome measure they are most familiar with.  Is this the best method? Perhaps it would be better to look across the literature at what has been used by other teams and make sure our study will be comparable.  But even that isn't easy - there are so many that sometimes none will dominate or if one does, it may not be an outcome measure that has been reliably tested and so has unknown validity, reproducibility, repeatability when used.

 In my next blog I'm going to talk about a different approach to addressing this problem...

*Strictly speaking we should, of course, have decided our primary outcome before we ran the trial because our power calculation is based on expected success/failure rates for us to work out the number of fillings we need to compare to see a difference but just give me a bit of leeway here.

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

Clinical Trial Registration(a regulatory hinderance or a help?)

Welcome! Another blog appears at last …

One of the dental trials I am currently working on is being carried out in several countries (we are in the process of getting it off the ground here in the UK). The trial is a comparison of different treatments for decay in children’s teeth and their outcomes.
I've been challenged by a couple of my fellow researchers to justify one of the particular aspects of trial beaurocracy - Clinical Trial Registration - that I have suggested is important. Although widespread in medical trials (especially for trials of medicinal products), it's really not really the norm yet to register dental trials.
Often, the bureaucracy associated with setting up and running clinical trials (although necessary) is often seen as a hindrance, especially as it’s a bit of a ‘one size fits all’. So no allowance is made for trials comparing two ‘standard’ non-dangerous treatments as opposed to those testing a ‘new’ treatment with unknown and potentially damaging side effects.
However, rather than being a hindrance, Trial Registration is actually one of the things that is a help. It's an international move that has been encouraged from a number of fronts. The idea behind obligatory registration of all clinical trials (drugs, devices, surgical procedures, dental treatments etc etc) is to create a publicly available database of trials being carried out. But really - why bother? Well, I'm going to have a stab at that justification to my co-researchers now...

Publishing

Many biomedical, and a very few dental, journals do require a trial registration number for manuscript publication in line with the International Committee of Medical Journal Editors 'Uniform Requirements for Manuscripts Submitted to Biomedical Journals'. So after completing your trial you could find that you can’t publish your findings in certain journals without a prospectively registered trial number. In dentistry/ oral health, these journals include BMC Oral Health and Journal of Dental Research (I know from personal experience that both these journals insist on a trial registration number being submitted before a research article on a trial will be accepted for peer review). The British Dental Journal is registered on the ICMJE website as following the Uniform Requirements, but there is no evidence of it in their author guidelines and unfortunately, clinical trial registration numbers are not visible in the published RCTs I looked at. There are other journals who state that they are signed up, through the Uniform Requirements, to these high standards of publication that we should be (as researchers) not only striving to reach but driving upwards. However, despite this signing up process, it seems that some journals are poor at ensuring that such things as CONSORT is adhered to for RCTs, conflicts of interest are disclosed and overlapping publications are clarified. I think we have some obligation as researchers and the users of the journals to help make these things a standard part of our manuscripts.

Future proofing

As we all know, trials take an absolute age to set up, carry out well, follow up and then publish the findings of.  Standards in publication in dental journals are improving (reporting guidelines such as CONSORT are slowly becoming more widely used).  Should journals that we might be expecting to publish in, have a change in editorship or policy, and the Uniform Requirements for Manuscripts Submitted to Biomedical Journals be adhered to, it would be wise to be prepared.

Transparency

Registering your trial makes it more visible and means that if someone else wants to do the same trial or a similar trial to you, when they check on the standard clinical trial databases before starting theirs (or when their funding body do), they will see what you are doing and may request to join forces, improving the generalisability of the trial.  Alternatively, they may decide their work is unnecessary (and thus avoid patients being pointlessly entered into a trial that you are going to find the answer to anyway!).  The other advantage of visibility is that if someone is going to do a similar type of trial, they will be aware of your expertise and can contact you to help avoid the pitfalls you will no doubt have encountered, find out what worked well in terms of outcome measures, patient preferences etc and maybe use similar tools to enable comparisons between trials (something that is currently pretty poor in Dentistry).

Overlapping publications

When the trial registration number is attached to the end of every manuscript associated with that trial, it means that readers will always know the data (whether it's different datasets or similar datasets at different times), all came from the same trial.  It also makes life much easier for those of us undertaking systematic reviews.

And last but should really be first – Patients

One of the (perhaps future) benefits of trials being registered on a publically accessible database is that patients can see the kind of research being carried out in Oral Health and Dentistry.  This helps raise awareness of what is available to them or at least, what we are testing to try to improve treatments.  This can only help the informed dialogue all clinicians should be having with patients/ public about treatment options.

If you are peer reviewing a paper for a journal then and it’s a prospective clinical trial, check to see if it’s been registered anywhere, and if it has, check that the authors have stuck to their original stated aim.  Also, if the journal you are reviewing for is registered with the ICMJE, as being signed up to the Uniform Requirements, check that they are encouraging authors to adhere to these standards.  Although it will take time, this will help to improve the quality of the trials in dentistry and therefore ultimately the care we provide for our patients.

 

There are a number of different trials registries which are acceptable to the ICMJE including: www.anzctr.org.au, www.clinicaltrials.gov, www.ISRCTN.org, www.umin.ac.jp/ctr/index/htm, www.trialregister.nl, https://eudract.ema.europa.eu/ and although some have a cost attached, others don’t.

Evidence based dentistry or exclusive based dentistry?

Hello, and welcome!

I'm planning to blog here about dentistry, evidence, research, teaching, patient care and other stuff.  Hopefully it will be of interest to someone and if not, maybe just by getting some of this stuff down on e-paper it will be (at the very least) fun to feel like I'm sharing some of the amusing stuff and maybe it will stop me feeling so narked about some of it!

Please forgive any inaccuracies (and let me know about them), they are unintentional...

Let's just start with last week - well last week was a funny old week.

Evidence-wise, it began with a Sunday Times article on the Hall Technique (and mentioning the FiCTION Trial ) being picked up by several other papers (Daily Mail Deccan Herald and Topnewshealth).  The numerous inaccuracies were despite my best efforts to send information that was short, to the point (uninflammatory!) and accurate.  This is something we apparently just have to live with; there is no way of seeing these articles before they are actually out in the public domain.

But what does it matter?

Well, I think it does.

Take the Hall Technique (since I know it well!), and yes, since you ask, I probably am biased as I have researched it but I try to present the evidence with (as Ben Goldacre would put it) sunlight on it,  we are asking dentists to consider changing their practice and seal in decay.

Here are 2 perspectives:

The general public's point of view.  A look at the comments at the end of the Mail online article linked to above, shows the limited understanding people have of what is actually going on in their mouth when we're 'doing' dentistry.  Here's just one of these comments:

"Sealing in bacteria is a recipe for a health disaster! We already have root canal work doing the same thing - infection sealed in seeps bacteria into your blood stream and will attack the heart in particular! A decaying tooth is decaying because of bacteria - there is huge amounts of research indicating just how dangerous that can be!"

Yes, it's anecdote and I've picked it out particularly, but it is difficult for us to imagine we can suddenly jump into full blown Evidence Based Dentistry and expect our patients to have a deep and considered understanding of why we might consider changing our practice, especially with something we've been doing for a long, long time (I think it's around 150 years that we've been getting decay out of teeth one way or another before plugging the hole with something).

Taking the evidence into practice idea further and some of the barriers (this time from the profession's perspective) - I was given, today, a copy of an editorial from the American Association of Paediatric Dentistry by the CEO of the AAPD called "What Distinguishes the United States".  It follows on from a joint meeting in September between the AAPD  and the Royal College of Surgeons in Edinburgh.  By all accounts the meeting was a great success and there was much sharing of ideas.  But Dr John Rutkauskas says

"Yes, we know that bad British and Scottish teeth is a good joke, but it is not an unfounded stereotype"

(Just a cheap jibe and of no real consequence).  What is interesting is that he dismisses the idea of sealing caries into teeth saying:

"Can we imagine informing our parents that we are placing a crown over an untreated, decayed tooth...".

 In the AAPD society's journal a systematic review of partial caries removal in primary teeth expresses this perspective well, with the text:

"Since the maintenance of carious tissue beneath restorations after partial removal of demineralized dentin is still seen with caution and skepticism by most professionals, the objective of the present review was to discuss the rationale for the use of this technique as an alternative for the control of dentinal caries in primary teeth."

(Ribeiro CCC et al. Pediatr Dent 2012;34:39-41).  Ribeiro's conclusion will come as no surprise to cariologists and falls in line with a growing number of systematic reviews, all pointing in the same direction:

"The favorable outcomes of partial caries removal in a single session support the indication of this modality as a definitive alternative restorative treatment for the primary dentition."

As healthcare providers, we have a duty to see beyond our prejudices and consider the evidence and its relationship to our patients wishes (and in the case of children their ability to cope with different treatments).  So when 39% of children with Early Childhood Caries, who have had a general anaesthetic to have their dental treatment carried out, require further treatment within a year, (Pediatr Dent 2012;33(7):510-514), perhaps those authors' conclusions

"The R rate (39%) observed is consistent with earlier reports.  Novel approaches are needed to improve relapse prevention".

should resonate more strongly than they are likely to, if history is anything to go by...

PS I promise I will not blog about the Hall Technique incessantly!!!!