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					       ADHD
Evaluation & Treatment


     Edward J. Coll, M.D.
     COL, MC
     Chief, Developmental Pediatrics
     Walter Reed Army Medical Center
          Practice Guidelines

• Primary care clinicians

• Children 6-12 years old

• Framework for diagnostic decisionmaking

• Evidence based review
Review and Recommendations
• Strong recommendation: high-quality
  scientific evidence or strong expert
  consensus

• Fair/weak: lesser quality, limited data, or
  expert consensus

• Clinical Options: reasonable provider
          Recommendation #1
• If inattention, hyperactivity, impulsivity,
  academic underachievement, behavior
  problems

• Primary care clinician needs to initiate the
  evaluation

• Good evidence       Strong recommendation
        Screening Questions
• How is __ doing in school?

• Are there any problems with learning that
  you/teacher see?
• Is your child happy in school?
• Are you concerned…behaviors at
  home/school/play with friends?
• Is your child having problems completing
  classwork or homework
        Recommendation #2
• ADHD diagnosis must meet DSM-IV
  criteria
• Symptoms and functional impairment
• Criteria remain subjective and no reliable
  measures in primary care

• Good evidence      Strong recommendation
          DSM-IV Criteria
• 6 of 9 symptoms often
  – Inattentive
  – Hyperactive/Impulsive
  – Combined (both)


• causes distress or impairment

• inconsistent with developmental level
               DSM-IV Criteria
•   starts before 7 years old
•   lasts over 6 months
•   two or more situations
•   not due to:
    –   Autism, Pervasive Dev Disorder
    –   Mood or Anxiety Disorder
    –   Psychotic Disorder
    –   Dissociative or Personality Disorder
            DSM-IV Criteria
               Inattention

• fails to give close attention to details, makes
  careless mistakes in schoolwork or other
  activities
• has difficulty sustaining attention to task or
  play activities
• does not seem to listen what is said to
  him/her
           DSM-IV Criteria
              Inattention

• not follows through on instructions; fail to
  finish schoolwork, chores, duties in
  workplace (not due to oppositional behavior
  or failure to understand)
• difficulty organizing tasks/activities
• avoids/dislikes tasks that require sustained
  mental effort
            DSM-IV Criteria
               Inattention

• loses things necessary for tasks or activities
  (school assignments, pencils, books, tools,
  toys)
• easily distracted by extraneous stimuli
• forgetful in daily activities
         DSM-IV Criteria
       Hyperactivity/Impulsivity

• often fidgets with hands/feet or squirms in
  seat
• leaves seat in classroom or in other
  situations in which remaining seated is
  expected
• runs about or climbs excessively where
  inappropriate (teens or adults may be
  limited to subjective feelings of restlessness
         DSM-IV Criteria
       Hyperactivity/Impulsivity

• difficulty playing or engaging in leisure
  activities quietly

• talks excessively

• acts as if “driven by a motor” and cannot
  remain still
         DSM-IV Criteria
       Hyperactivity/Impulsivity

• blurts out answers before questions
  completed

• difficulty waiting in lines or for turn in
  games or group situations

• interrupts or intrudes on others
   Dr. Barkley’s ADHD Graph *


                                       “Normal”



Work                                        ADHD




                            X
                   Level of Interest
       Recommendation #3
• Evidence of core symptoms from parents and
  caregivers
• various settings
• age onset; duration of symptoms
• degree of functional impairment
• Good evidence      Strong recommendation
      Recommendation #3A

• Rating scales are an option
  – Questions subjective and subject to bias
  – ? If additional benefit


• Strong evidence; strong recommendation
      Recommendation #3B

• Broad-band scales/questionnaires
  not recommended

• May be useful for other purposes

• Strong evidence Strong recommendation
       Recommendation #4

• School evidence required

• Core symptoms, duration
• Functional impairment
• Coexisting conditions

• Good evidence    Strong recommendation
       Recommendation #4A

• Rating scales a clinical option

• sensitivity/specificity >94%

• ? If any added benefit

• Strong evidence    Strong recommendation
      Recommendation #4B

• Global scales not recommended
• May be useful for other purposes
• Frequent discrepancies
• Can use other informants

• Strong evidence    Strong recommendation
         Recommendation #5

• Assess for coexisting conditions
  –   ODD 35 %
  –   Conduct Disorder 26%
  –   Anxiety Disorder 26 %
  –   Depressive Disorder 18%


• Strong evidence      Strong recommendation
        Recommendation #6

• Other diagnostic tests
  not routinely indicated
  – Pb; resistance to thyroid hormone
  – Brain imaging; EEG
  – Continuous performance testing
     • sensitivity/specificity <70%


• Strong evidence         Strong recommendation
      Diagnosis Guidelines
          Conclusions

• Use explicit DSM-IV criteria

• Symptoms in >1 setting

• Search for coexisting conditions
            Objectives
     of the Literature Review

• Effectiveness (short and long-term) and
  safety of therapies
• Medication and non-medication therapies
• Single therapy vs combination
• 6-12 year olds
          Sources for Review

• Agency for Healthcare Research & Quality
  – McMaster Univ. Evidence-based Practice Center
• Canadian Office for Health Technology
  Assessment Study (CCOHTA)

• Multimodal Treatment Study (MTA Study)
• Pelham et al. review of psychosocial therapies
       Recommendation 1:
      Management Program

• Primary care clinicians should establish a
  management program that recognizes
  ADHD as a chronic condition

• Strong evidence
• Strong recommendation
       Recommendation 1:
      Management Program

• Prevalence 4-12% of school-age children
• 60-80% persist into adolescence

• Inform, educate, counsel, demystify
  – family, child
• Resources
  – local, national (CHADD, ADDA)
       Recommendation 1:
      Management Program

• What distinguishes this condition from
 most other conditions managed by primary
 care clinicians is the important role that the
 educational system plays in the treatment
 and monitoring of children with ADHD.
       Recommendation 2:
    Target Outcomes by Team

•     The treating clinician, parents, and the
    child, in collaboration with school
    personnel, should specify appropriate target
    outcomes to guide management.

• Strong evidence
• Strong recommendation
    Recommendation 2:
Outcomes- maximize function
• Relationships
  – parents, siblings, peers
• Disruptive behaviors
• Academic performance
  – work volume, efficiency, completion, accuracy
• Individual
  – self-care, self-esteem
• Safety in the community
     Recommendation 2:
  developing target outcomes

• Input
  – parents, children (patient), teachers
• 3-6 key targets
• realistic, attainable, measurable
• methods will change over time
             School Interventions
    Individual Education Plan              504 Plan

• IDEA = Individuals with       • Section 504 of the
  Disabilities Education Act      Rehabilitation Act
• ADHD under “Other             • ADHD medical diagnosis
  Health Impaired”
• Educational Disability        • Medical Disability with
                                  educational impact
• Services                      • Accommodations
   Recommendation 3:
make some recommendations

• The clinician should recommend stimulant
  medication and/or behavior therapy as
  appropriate, to improve target outcomes in
  children with ADHD
• Strong evidence (medication),
  Fair evidence (behavior therapy)
• Strong recommendation
       Recommendation 3:
      Efficacy of Stimulants

• Short-term benefits well established

• Core symptoms: attention, hyperactivity,
  and impulsivity
• observable social and classroom behaviors
• IQ and achievement testing- less effect
         Recommendation 3:
            MTA Study

• Effects over 14 months
• 579 children 7-9.9 years old
• 4 randomized groups
  –   medication alone
  –   medication and behavior management
  –   behavior management
  –   standard community care
       Recommendation 3:
          MTA Study

•   Medication management alone
• == Medication + behavior therapy*

•   > Community management
•   > Behavior management alone
         The Stimulants
       Nobody does it better

• Short, intermediate (the “old” long-lasting),
  truly long acting
• 22 studies show NO difference between
  methylphenidate, dextroamphetamine, or
  mixed amphetamine salts (Adderal)
• Individual’s response may vary
• NO serologic, hematologic, EKG needed
          Non-stimulants
        Second rate-only 2

• Tricyclic antidepressants
  – 9 studies alone
  – 4 studies =/< methylphenidate
• Bupropion (Wellbutrin, Zyban)
• Clonidine
  – limited studies
  – > placebo
            Stimulants
        Dose determination

• NOT weight dependent
• Optimal effects with minimal side effects
  – nothing ventured, nothing gained
• Match target outcomes and timing
  – crucial step prior to starting
                Stimulants
               Side effects

•   appetite suppression
•   stomachache, headache
•   delayed sleep onset
•   jitteriness
•   overfocused, dull demeanor
•   mood disturbances
             Stimulants
         Side effects- NOT
• seizures- NO increased frequency with mph
• growth delay- at least one negative study
• Tourette syndrome
  – 15-20% of patients have motor tics
  – 50% of TS have ADHD
  – 7 studies comparing stimulants vs placebo/other
    show NO increase in tics with stimulants
 Short            Intermediate Extended
 3-4 hours         5-6 hours         8-10 (12)hours



Methylphenidate      Ritalin 20 SR   Concerta
Ritalin              Metadate ER     Metadate CD
Focalin                              Ritalin LA
Dextroamphetamine Dexedrine
Dexedrine         spansule
Dextrostat

                     Adderal         Adderal XR
   Atomoxetine Strattera

• Selective norepinephrine uptake inhibitor
• Little effect on dopamine or serotonin
  uptake
• Little effect on Ach, H1, alpha-2, DA
  receptors
• Well-tolerated in adult and pediatric studies
       Atomoxetine...Randomized,
       Placebo-Controlled, Dose-
              Response...
 • 297 children and adolescents
 •   8-18 years old; 71 % male
 •   70% had prior stimulant therapy
 •   Combined/Inattentive/Hyper-impulsive
 •   63/33/2 %
 •   37 % Oppositional-defiant disorder
 •   1 depression, 1 anxiety disorder
Atomoxetine…AD/HD…Study. Pediatrics 108:e83, 2001
                Side Effects
• Small samples:
   – dizziness 9% vs 1% placebo
   – vomiting 6% vs 7%
• Weight loss dose dependent
   – mean 0.4kg at 1.2 mg/kg/d
• small pulse, BP changes
• no EKG changes
• <5% dropout rate atmx and placebo

Atomoxetine…AD/HD…Study. Pediatrics 108:e83, 2001
       Efficacy of Atomoxetine vs
    Placebo in School-Age Girls with
                AD/HD
•   52 children and adolescents
•   7-13 years old
•   Combined/Inattentive/Hyper-impulsive
•   79/21/0 %
•   38.5 % Oppositional-defiant disorder
•   13.5% phobias
Efficacy…Girls...AD/HD. Pediatrics 110:e75, 2002
                    Measures

 • ADHD Rating Scale- Parent
 • Conners’ Parent RS-Revised

 • No Teacher ratings

 • Clinical Global Impressions of ADHD
   Severity- Clinician
Efficacy…Girls...AD/HD. Pediatrics 110:e75, 2002
                 Side Effects

 • Small sample size subset here (279 total);
   so no significant differences
 • Vomiting 19% vs 0%
 • Abdominal pain 29% vs 14%
 • Nausea 6.5% vs 14%
 • ?Weight, cardiac...
 • Increased cough 16% vs 4.8%
Efficacy…Girls...AD/HD. Pediatrics 110:e75, 2002
            Atomoxetine and
       Methylphenidate... Prospective
        Randomized, Open-Label Trial
•   228 children and adolescents
•   184 atomoxetine, 44 mph; 10 weeks
•   7-15 year old boys; 7-9 year old girls
•   Most/all had prior stimulant therapy
•   Combined/Inattentive/Hyper-impulsive
•   76/23/1 %
•   53% ODD, 7% major depression
Atomoxetine and Methylphenidate... Prospective Randomized, Open-Label   Trial
JAACAP 41:7, 2002
                          Measures
• ADHD Rating Scale- Parent Completed
• ADHD Rating Scale- Parent Interview
• Conners’ Parent RS-Revised

• No Teacher ratings
• Clinical Global Impressions of ADHD
  Severity- Clinician

Atomoxetine and Methylphenidate... Prospective Randomized, Open-Label   Trial
JAACAP 41:7, 2002
                             Findings
 • Comparable improvement between the two

 • mean dose 1.4 mg/kg/d extensive mtb,
             0.5mg/kg/d slow mtb
 • mph       0.85 mg/kg/d, (31mg/d)

 • High rate of dropouts

Atomoxetine and Methylphenidate... Prospective Randomized, Open-Label   Trial
JAACAP 41:7, 2002
                               Findings

• 43% of mph, 36 % atmx dropped out!
• 11%; 5 % because of adverse effects comparable

• atomoxetine wt loss avg 0.6 kg; (mph 0.1)
• small changes both in pulse, BP
• EKG, labs no problems, no differences

  Atomoxetine and Methylphenidate... Prospective Randomized, Open-Label   Trial
  JAACAP 41:7, 2002
                        Side Effects

 •   Generally comparable
 •   Vomiting 12% vs 0%
 •   Abdominal pain 23% vs 17.5% (NS)
 •   Nausea 10% vs 5% (NS)
 •   ?Weight, cardiac...
 •   Cough 5% same
 •   “Thinking abnormal” 0% vs 5% (N=2)
Atomoxetine and Methylphenidate... Prospective Randomized, Open-Label   Trial
JAACAP 41:7, 2002
   Pros                     and              Cons
• No abuse potential          • Little data head to head vs
   – adolescent usage           stimulants
   – adult usage              • Weight loss/vomiting
• 24/7 coverage               • Takes week(s) to effects
• (No tic relationship)       • Tolerance
• Novel class of med              – “starter kit” issue
   – use with stimulants,         – adjust if SSRI added
     too                      • Cost $3 vs 1/2 that
            Modafinil
•   ProVigil in ProAthletes
       Modafinil (ProVigil)
• A non-stimulant stimulant
• Narcolepsy, daytime drowsiness in...
• Mechanism ?
  – Alter balance of GABA and glutamate which
    activates the hypothalamus
  – Increases metabolic rate of amygdala and
    hippocampus
  – activates hypocretin(orexin)-containing neurons,
    (which are disrupted in narcolepsy)
         Modafinil in AD/HD
          Open-label study

• Once daily dosing

• Start 100 mg titrated to maximum 400 mg

• Length of time avg 4.6 weeks (range 2-7 wks)

J of Am Acad of Child and Adol Psychiatry 2001; 40:230-235
         Modafinil in AD/HD
          Open-label study
• 11 5-15 years old, M:F = 9:6 started
• Combined/inattentive/hyper-impulsive
• 12/2/1 started
  – 2 noncompliant with protocol
  – 1 hand-foot-mouth disease
  – 1 adverse rxn: episodic hand tremor + MS change
• very mixed bag of comorbidities: PDD, TS...
J of Am Acad of Child and Adol Psychiatry 2001; 40:230-235
         Modafinil in AD/HD
          Open-label study
• AD/HD measures
  – Conners’ Parent and Teacher
  – ADHD Rating Scale IV for Parent and Teacher
  – Test of Variables of Attention (TOVA)
• Side effects
• Vital signs, weight


J of Am Acad of Child and Adol Psychiatry 2001; 40:230-235
         Modafinil in AD/HD
          Open-label study
• AM dose effect into afternoon
• Improved Conners’ and ADHD Rating Scales
• Improved TOVA impulsivity scores
  – but not inattention scores
• Delayed sleep (3), stomachache, headache,
  lightheadedness, tremors, finger-biting (1)


J of Am Acad of Child and Adol Psychiatry 2001; 40:230-235
                      Modafinil
          BE AWAKE all you can be!
                        • WRAIR

•   3 doses of modafinil vs 600 mg caffeine
•   Performance testing in sleep deprivation
•   Enhances performance and alertness
•   No advantages over caffeine


    Psychopharmacology (Berl) 2002 Jan;159(3):238-47
                      Modafinil
          BE AWAKE all you can be!
• Aeromedical Research Lab., Ft. Rucker, AL
• Aviator alertness and performance
• 6 pilots, 40 hour wakeful periods compared
• Placebo vs 3 x 200 mg modafinil
• 4/6 performance measures improved, reduced
  slow wave EEG, better mood, alertness
• side effects: vertigo, nausea, dizziness

    Psychopharmacology (Berl) 2000 Jun;150(3):272-82
        Behavior Therapy
       accept no substitutes

• Behavior therapy
• Emotions-based therapy
  – e.g. play therapy-NOT efficacious in ADHD
• Thought patterns directed
  – cognitive, cognitive-behavioral therapy
  – NOT efficacious in ADHD
          Behavior Therapy
           Parent Training

•   8-12 weeks with trained therapist
•   teaches parent skills
•   incorporates maintenance and relapses
•   improves child’s functioning and behavior
•   not necessarily achieves normal behavior
       Behavior Therapy
     Examples of Techniques
• Positive reinforcement
  – reward for performance
• Time-out
  – removing positive reinforcement
• Response cost
  – losing advance rewards
• Token economy
  – combination
     Behavior Therapy
Meta-analyses difficult and few
• Must be maintained to be effective
• Stimulant effects much > behavioral therapy
  – MTA study: combination > med alone, but not
    a statistically significant difference
  – However, parents and teachers more satisfied
• Schools can implement
  – 504 Plan
  – IEP
       Recommendation 4:
       When to re-evaluate

• When the selected management for a child
  with ADHD has not met target outcomes,
  clinicians should evaluate the original
  diagnosis, use of all appropriate treatments,
  adherence to the treatment plan, and
  presence of coexisting conditions
• Weak evidence
• Strong recommendation
        Recommendation 4:
        Ddx in re-evaluation

•   unrealistic target symptoms
•   poor information regarding child’s behavior
•   incorrect diagnosis and/or
•   coexisting condition interfering
    – ODD, conduct disorder, mood, anxiety, LD
• poor adherence/compliance
• treatment failure
      Recommendation 4:
     Steps in re-evaluation

• Re-establish target symptoms
  – “team” communication
• Gather further information, other sources

• Consider consultation
• Consider psycho-educational testing
      Recommendation 4:
     True treatment failure
• Lack of response to 2-3 stimulants
  – maximum dose without side effects
  – any dose with intolerable side effects
• Inability to control child’s behavior
• Interference of coexisting condition

• Engage vs refer to mental health
       Recommendation 5:
       follow-up guidelines
• The clinician should periodically provide a
  systematic follow-up for the child with
  ADHD. Monitoring should be directed to
  target outcomes and adverse effects by
  obtaining specific information from parents,
  teachers, and the child.
• Fair evidence
• Strong recommendation
       Recommendation 5:
       follow-up guidelines
• Team management plan
  – not just : “What does the doctor recommend?”
• Recording clinical data
  – flow sheet, progress note
• Interview, T-Con, teacher reports, report
  cards, checklists
      Recommendation 5:
     frequency of follow-up

• NO controlled trials document the
  appropriate frequency

• MTA study: more frequent did better, BUT

• Once stable, visit every 3-6 months
          Conclusion nuggets


•   ADHD as a chronic condition
•   Explicit negotiations re target outcomes
•   Stimulant and behavior therapy use
•   Close
    – treatment outcomes
    – failures

				
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