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2012 ADHD Gideline Update Part 1/3

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Regina Bussing, MD, MSHS Professor, Det. Psychiatry, University of Florida

This also should be somewhat easier because it’s an adhd guideline update and to put in perspective who is talking i also have to disclose grant support from federal agencies ni-mh and agency for healthcare research and quality i have participated in pharmaceutical trials currently getting support from otsuka have in the past been a consultant to shire and have

Several non-paid honorary positions what i want to do is look over things that are new since two years ago but we are operating under some new guidelines we are operating with the benefit of several new reviews that have come out and then i try to close the gap between these reviews or guidelines and now so there’s also a literature review from a 2010 to present

Some brief comments on aggression and adhd but we’ve already really addressed that so in the interest of time that will be fast and then the potential implications for updating our current medication guidelines for adhd the time frame is basically such that for the guidelines by the american academy of pediatrics they reviewed the literature from 1998 to 2009 and

Then came out in 2011 with their product i will review that briefly then alice chirac and her group conducted this incredibly extensive review that reviewed literature from the beginning of time to may 2010 for children under six and from 1997 to may of 2010 for children six years and older that’s an incredibly superduper resource that i’ll briefly touch on there

Were cochrane reviews released in the period from 2008 to july of 2012 and they basically reviewed whatever literature was there also kind of going back in time for a long time period and then the lit review that i did covers this time period so first especially for our colleagues that are in the area of pediatrics they would basically currently be operating

Under the under the new guidelines released in november which took two previous guidelines and wrapped them into one and then also expanded the the reach into younger children ages four onward and up through h18 they did a very extensive evidence-based review they had help from the cdc from ahrq the university of oklahoma and what they did was they reviewed

Pubmed psycinfo and eric reviewed over 8,000 citations and then sifted that into six action statements that were meant for implementation in a process of care algorithm and i’m briefly reviewing those here because i think we would like to overlap those with with our current guidelines so basically they’re saying a primary care provider should initiate an evaluation

They shouldn’t dodge it they should initiate it if a child presents with problems and symptoms that this evaluation should be based on dsm-4 guidelines but they’re also hinting at of course this will change when dsm-5 comes along that there should be an active assessment for comorbid conditions and then that the care should be planned in the context of a chronic

Care medical home model pre-planned anticipating that some extra actions have to be put into place to do it well and that here’s where it gets kind of more the rubber hits the road treatment choices interestingly the way they worded is for preschoolers prescribe evidence-based behavioral treatment first and may prescribe methylphenidate as how they’re putting it

There actually spelling out that they don’t see enough of evidence to use em feta means for school-age children 6 to 11 the recommendation is for an fda-approved adhd medication which covers stimulants atomoxetine and then the extended versions of alpha agonists and then here see this and or evidenced behavior therapy and then the recommendation for adolescents

An fda-approved adhd medication with ascent by the adolescent and may prescribe evidenced based behavior therapy and then the recommendation titrate doses to achieve maximum benefit at minimal side effects so that seems all kind of to overlap pretty well with the guidelines that we have in place with maybe a little bit of tweaking required to get us in line with

This now the 2011 comparative effectiveness review i would like you to be aware of it is it’s an incredibly fantastic resource that comes packaged in several products and they did this extensive lit review identifying 233 studies and have produced for us a full over 300 page report an executive summary and beautifully targeted summaries for clinicians targeted

Summaries for parents and caregivers you can also get slide deck downloads and see any activity so it’s kind of a family of products that has come out of it and i’ve put some of those into your handouts because they i think are meant to be very user-friendly and might have some potential also to link to of from the from the florida guidelines now 300 pages here’s

What they did they basically said we’re going to classify this into a system that says we either have high strength of evidence further research is very unlikely to change the confidence in estimated estimated effects or moderate further research may change the confidence a low strength of evidence would be further research is likely to change the confidence and

Insufficient evidence would be evidence is either unavailable or does not does not really permit estimation of an effect yet so this this was the methodology that they used and then let’s condense a the bottom line of 300 plus pages is basically that they said for children under age of six we have f effectiveness and safety information parental behavior training

Its efficacious with the standardized mean difference of improving things lowering problems minus point six eight for preschoolers methylphenidate not if the a approved under six also efficacious here you see the standard mean difference and then they also are making reference to school based intervention for children that come from lower socio-economic strata

Can’t really produce an effect size or estimate but they thought it was important enough to mention it and so we might want to tuck that away for our consideration because there was a request for perhaps making more reference to non-medication interventions for age six and older they focused specifically on long-term effectiveness not not on short-term trials and

They’re things look as follows for methylphenidate they identified this at the level of this was one bullet was less than moderate was with the strength effect size minus point five for over a period of 14 months there were data for atomoxetine with a slightly larger standard mean difference and they said for the extended release guanfacine insufficient standard

Strength of evidence because of a lack of completion of follow-up and also for long-term effectiveness for behavioral parent training or academic interventions currently in sufficient strength of evidence really important because adhd is a chronic condition so really we need chronic treatments so even though we have a bunch of studies and we have immediate efficacy

For longer term treatments there still is actually a fair bit of work to do moving on i had looked at the cochrane reviews because adhd also prompts interest in other interventions so i was actually surprised i had not done this before i sat down to do this work here so they had done reviews for meditation therapy homeopathy mixed in social skills training parent

Training but note here that’s parent training not for the preschoolers but for includes older youth family therapy risperidone for adhd and persons with intellectual disability and fatty acid research and pharmacological treatment for adhd in tic and i would say for purposes of our guidelines update we can say that really none of these are currently strong enough to

Draw conclusions from for the parent training here we see some support for effects of parents stress and general child behavior why is this different from the results that came out of the shock review because she had looked at preschoolers younger age group so we get more bang for our buck when we do parent training with younger children and don’t wait until they’re

Already school-aged but otherwise really either no support or or here little evidence to support limited data showing improvement on combinations this is something were we we have some emerging newer literature that might challenge that but i i don’t think it’s of any strength to where i would recommend that we put that into into our updated guidelines currently

The literature review but that i did looking at literature from 2010 to present i focused on pubmed because this was supposed to be focused on drug studies and used these filters for it and basically for studies focusing on children under the age of six identified 58 records potentially promising and then when i screen them excluded the majority of them because

They were not apropos did a full text review of 10 of them and identified one study that i will talk to you about in a little bit more detail and that is the optim-ox attend study double-blind placebo-controlled study of atomoxetine in young children with adhd this was a three site a double-blind placebo-controlled trial they had one to one random assignment were

Supervised by an independent data safety monitoring board and were able to enroll 93 subjects expectedly mostly male 39 caucasians and these were five and six-year-old children at enrollment 18 of those withdrew before completion they required that the this is typical for young children that the adhd was present for at least nine months the symptomatology that they

Were of at least had an iq estimate of above 70 and they needed to be in an out-of-home peer group at least two days to have days a week so that you could get teacher ratings they did a flexible titration of atomoxetine to a maximum of one point eight milligrams per kilogram and then also delivered concurrent psychoeducation so everyone received psychoeducation along

With the medication so they didn’t try and give them psychoeducation first as a sn a rule out if you get better than you don’t participate in the trial like in the past study did fairly traditional outcome measurements adhd rs total score cgi’s global assessment of functioning and then this is kind of going to be like a litany of the same safety aes height weight

Pulse blood pressure lab screening physical exam and we’re basically able to to document that treatment with atomoxetine separated from placebo and we can see this happening by about week 4 in the efficacy outcomes they reach the mean final dose of 1.4 milligram per kilogram which is great that’s the that’s the allowed amount so even though they could go higher

They actually found that they didn’t if you if you allow to take a titration apparent ratings they were able to get in sorry but able to get an effect size of 0.7 and for teachers slightly lower 0.6 number needed to treat here was six so relatively respectable i will say personally i tend to still when i do informed consents maybe not have high enough expectations

Of atomoxetine this seemed to be a quite respectable and that’s one reason why i took a little bit more time to present this here because when we’re updating our under six guidelines you know we’re really skating on thin ice so we have a little bit more ice to skate on i would say safety outcomes no differences in labs ekg or mean change and in a heart rate or

Blood pressure they did observe differences in weight as expected with a slight amount of weight loss on atomoxetine and some gi symptomatology decreased appetite gi upset some sedation interestingly the way the article is written up there they’re emphasizing that this was generally well tolerated duced chorus symptoms but that despite the benefit the children

Remain on average a significantly impaired at end of study that was highlighted and also highlighted that these were children that had gotten the mcmahons forehand parent training along with it so this was not a magic bullet even though there was respectable symptom improvement

Transcribed from video
2012 ADHD Gideline Update Part 1/3 By medicaiddrug