Poster Presentation October 27-29, 2011 Savannah, Georgia (CS-29) Abstract. Methods

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1 Poster Presentation October 27-29, 2011 Savannah, Georgia (CS-29) Abstract Utility of Objective Measures of Activity and Analysis of Attention State in the Assessment of Therapeutic Response to Medications in Patients with ADHD: Community Care Perspective Henry Hasson, MD. Albert Einstein College of Medicine of Yeshiva University, Brooklyn, NY Objective: The NIMH Multimodal Treatment of ADHD Study (MTA) of 579 children with ADHD showed routine community care rendered only about 25% of these patients symptom free. This study is to determine the utility of objective measures of hyperactivity, impulsivity and inattention in a community care setting to achieve optimal therapeutic response to ADHD medications rapidly. Methods: Patients age 6 to 12 years old were evaluated by a board certified child neurologist. Patients with an established diagnosis of ADHD and new patients suspected of having ADHD were tested using the Quotient ADHD System, a 15-minute computer-based test that combines 6 measures of micro-motion with 13 results from an attention task. Patients meeting the DSM-IV criteria for ADHD were treated and re-assessed in 1-2 weeks. Results: Thirty-five children with at least 2 Quotient ADHD Tests were included in this series, including 8 children who were on medication for Test #1. 16 (45.7%) achieved normalized motion and attention metrics at the time of the second assessment; 6 (17.1%) achieved normalized motion control, but excessive inattention remained; 4 (11.4%) achieved normalized attention, but excessive hyperactivity remained; and 9 (25.7%) had excessive hyperactivity and inattention. 5 of the 15 patients with normalized motion and attention scores at the time of the second test, were previously treated, but not well controlled at baseline. Methods Conclusions: It is feasible and practical to implement an objective measurement of hyperactivity and analysis of shifts in attention state using the Quotient ADHD Test in a community care setting. Follow-up studies are needed to determine the time to optimal medication management compared to rating scales, and the impact on compliance, adherence and patient satisfaction. ADHD Assessment Protocol History, physical exam, clinical interview of patient, parent interview Objective, quantitative assessment with the Quotient System Quotient System: Kiosk Motion Tracking System Child Test: 1 target, 1 non-target 15 min. age 6-12, 20 min. ages Older Adolescent/Adult Test: 3 targets, 1 non-target, 20 min. Quotient System: Portable Reflector Motion Tracking System

2 The Quotient ADHD Test Report Motion Analysis Attention Analysis Attention State Analysis Scaled Scores & Global Score Results Total Boys Girls Number Mean Age at Test Range Avg. time between tests Medicated Motion & Attention Dyscontrol Baseline Category Motion Dyscontrol Only Attention Dyscontrol Only Motion & Attention in ref. range Test Motion and Attention 4 20 Motion Only 1 4 Attention Only 0 2 Normalized 3 1 Test days Motion and Attention Motion Only Attention Only Normalized Test days Motion and Attention Motion Only Attention Only Normalized Patients were classified into sub-groups according to the Scaled Scores for each test in order to compare baseline results with subsequent results. A Scaled Score >5 was defined as dyscontrol and <5 was defined as normalized. Examples: Test 1: Medicated (N=8): 4 children had motion and attention dyscontrol, 1 had motion dyscontrol but normal attention, 3 were normalized. Not Medicated: 20 children had attention and motion dyscontrol, 4 had motion dyscontrol only, 2 had attention dyscontrol only, 1 was normalized. Test #2 was 13.1 days (on average) after test 1. Medicated (N=8): 3 children had motion and attention dyscontrol, 5 were normalized. Not Medicated: For the 20 children had attention and motion dyscontrol, 6 had motion and attention dyscontrol, 4 had motion dyscontrol only, 5 had attention deficit only and 5 were normalized. 4 had motion dyscontrol only, 2 had attention dyscontrol only, 1 was normalized.

3 Success to me is......finding the best treatment plan to help Josh get back on track. Henry J. Hasson, MD Pediatric Neurology, Brooklyn, NY History: Josh is a 7 year old boy in the 1st grade. History and exam revealed good health. The mother noted that he kicked a lot more than his siblings. His growth and development are age appropriate. Referral Complaint: His first visit was February 5. He presented with complaints of hyperactivity and inattention at home and at school. He was failing quizzes and tests. Plan of Action: Shortly after Josh s initial visit, our practice acquired the Quotient System. We administered a Quotient ADHD Test while on Concerta 27 mg at the first follow-up visit on 2/27. Motion and attention metrics revealed significant motion dyscontrol, with the disengaged attention state dominating. His mother reported no improvement in behavior at home or school. Clinical interview, parent report and Quotient results all pointed to ineffective medication or sub-therapeutic dose, so we increased dose to Concerta 36 mg. We repeated Quotient Test on 3/13. His mother reported that hyperactivity improved, but he could not pay attention in school or follow directions at home. We increased dose to Concerta 54 mg. On April 3, the Quotient Test confirmed adequate dosing. His mother reported that his teachers were happy with his progress. He is doing wonderfully at school and at home, with good motion control and attention. Conclusions: This case illustrates the value of using data from serial, objective assessments using the Quotient ADHD Test during medication initiation. The reports help the parent and patient see their progress (or lack of progress) in a concrete way, which makes the conversation about next steps more efficient and productive. Objective data helps us to optimize the treatment plan faster.

4 Josh, Age 7 Test #1, 2/27 Concerta 27 mg, 2 hours post-dose Motion Analysis Immobility Duration Test #1 Test #2 Test # ms 94 ms ms ms 95 Movements Displacement m 6.12 m m m 91 Area cm cm cm cm 2 67 Spatial Complexity Temporal Scaling Two of six motion results at baseline were less than the 35 th percentile, which may be clinically significant. Results improved in Test #2 with all metrics above the 50th percentile. Results improved further in Test #3. Metrics were within the reference range. Graphics reveal that performance deteriorated. Attention Analysis Test #1 Test #2 Test #3 Accuracy % 58.4% 11 t 60.9% 15 t 87.1% 76 Omission errors % 43.1% 2 t 36.5% 3 t 3.0% 61 Commission errors % 40.0% % % 70 Latency ms 692 ms ms ms 45 Variability ms 447 ms 1 t 340 ms 2 t 157 ms 63 COV t 74 2 t Test #1: Accuracy, omission errors, variability and COV were <16th percentile at Test #1. The latency score (692 ms) was just outside the reference range and slow for his age group. These results suggest that the medication is at a sub-therapeutic dose. Test #2: With the exception of commission errors and latency, the attention metrics are still more than 1 standard deviation from the mean. Test #3: All metrics are well within the reference range. Attention State Summary Many omission and commission errors throughout the test, with more omission errors at end of the test. Slow and variable responses. Test #1 Test #2 Test #3 # Shifts Attentive % 0.0% 1 t 0.0% 1 t 43.3% 70 Impulsive % 13.3% % % 39 Distracted % 26.7% 14 t 23.3% % 56 Disengaged Random % 26.7% % % 75 Minimal % 33.3% 2 t 26.7% 2 t 0.0% 99 Contrary % 0.0% % % 99 The first two tests, there were 2 parameters <16th percentile and 2 between the 17th and 35th percentile. He had good performance in Test #3. Distracted and disengaged attention states dominate the test. What else might cause this?

5 Test #2, 3/13 Concerta 36 mg, 2 hours post-dose Test #3 4/3 Concerta 54 mg, 5 hours post-dose Motion Scaled Score improved, but is above the mean for subjects without ADHD (4.0). Motion control is good for a 7 year old (high percentile scores, tight motion pattern throughout.) Response Results Motion Results Many omission errors at the beginning and end of the test. Slow/variable correct responses. Omission errors reduced. Many commission errors. Improved accuracy from 3-12 minutes. Distracted and disengaged attention states dominate the test. Medication is sub-therapeutic. Much better on-task behavior (43.3%, 70th %ile). Room for improvement. Attention State Results

6 Quotient ADHD Composite Scores Test #1 Test #2 Test #3 Test Date 2/27/2011 3/13/2011 4/3/2011 Age Medication Concerta 27 mg Concerta 36 mg Concerta 54 mg System Index Likely Likely Unlikely Scaled Scores Motion System Index Key Unlikely Possible Probable Likely Scaled Scores Key Attention Global mean non-adhd=4 mean ADHD=7 Case Summary February 5: This boy was a new patient. Presented with complaints of hyperactivity and inattention at home and at school. He was failing quizzes and tests. Started Concerta 27 mg February 27: The first Quotient ADHD Test was administered 3 weeks later while on medication. Motion and attention metrics revealed significant motion dyscontrol, with Disengaged attention state dominating. Mother reported no improvement in behavior at home or school. Clinical interview, parent report and Quotient results pointed to ineffective or sub-therapeutic medication. Increased dose to Concerta 36 mg. March 13: Repeated Quotient Test. Mother reported that hyperactivity improved, but he still cannot pay attention in school or follow directions at home. Increased dose to Concerta 54 mg. April 3: Quotient Test confirmed adequate dosing. Mother reported that his teachers were happy with his progress. He is doing wonderfully at school and at home, with good motion control and attention. 1- AAP ADHD Clinical Practice Guideline. Pediatrics, (5). 2- AACAP Practice Parameter. J. Am. Acad. Child Adoles. Psychiatry, (7). 3- Data on file. 4- Teicher, J of Child and Adol. Psychopharmacology, (1). Copyright 2011 F8060 (2011/12/26) Quotient is a registered trademark of BioBehavioral Diagnostics Company. Concerta is a registered trademark of McNeil Pharmaceuticals

7 Success to me is......finding medication to help Scott focus after school. Henry J. Hasson, MD Pediatric Neurology, Brooklyn, NY History: Scott is a 12 year old boy in the 7th grade. He has been a patient since July 2010 when I made a diagnosis of ADHD. Referral Complaint: Scott was doing fairly well on 15 mg Focalin XR, but his mother noticed that he became distracted late in the afternoon and had trouble finishing homework. Plan of Action: We asked Scott to refrain from taking his medication on the day of his next visit so we could do a baseline Quotient ADHD Test. A baseline test on a new patient gives us quantitative severity measures in each symptom domain and serves as a benchmark to guide decision-making about patient management. The baseline test is also valuable for established patients to determine if deficits are severe enough to continue medication. Scott s baseline test showed good motion control in the first five minutes, but performance degraded progressively. The mean motion metrics were all at the low end of the reference range. There were 21 attention shifts. Distraction and disengagement were the predominant attention states at the end of the test. We re-started Focalin XR 15 mg and repeated the Quotient assessment on March 14. He had excellent motion control, but still some inattention at school. Inattention was worse at the end of the day, which suggested that the medication may be wearing off too early. We switched to Concerta 54 mg to cover late afternoon. At Scott s back-to-school visit on October 2, the Quotient Test confirmed adequate dosing. He returned to school in September taking his medication. Although I was unaware of it at the time, because he had a new teacher, the parents decided to try a no medication experiment. The teacher immediately saw a difference in behavior and called the parents to report the problems. Conclusions: This case illustrates the value of using data from serial, objective assessments using the Quotient ADHD Test to inform medical management of the patient and help to achieve better clinical efficacy. We can confirm suspicions of medication wearing off and adjust by adding a dose later in the day or by changing to a longer acting medication, as we decided for Scott.

8 Scott, Age 12, Grade 7 Test #1, 3/6 No medication Motion Analysis Immobility Duration Baseline Test #2 Test # ms 146 ms ms ms 91 Movements Displacement m 3.59 m m m 94 Area cm 2 91 cm cm cm 2 96 Spatial Complexity Temporal Scaling Four of six motion results at baseline were less than the 35 th percentile, which may be clinically significant. The age/gender matched percentile scores improved to >90th percentile in Test #2 and Test #3. Metrics were at the low end of the reference range. Area increased over time. Attention Analysis Baseline Test #2 Test #3 Accuracy % 79.3% % % 81 Omission errors % 15.2% 15 t 5.3% % 48 Commission errors % 25.7% % % 81 Latency ms 486 ms ms ms 76 Variability ms 164 ms ms ms 70 COV Test #1: Omission errors were <16th percentile at Test #1. Test #2: Attention metrics improved, but the graphic reveals that the number of omission errors increased at in the last 5 minutes of the test. Test #3: All metrics are within the reference range. Attention State Summary Appropriately attentive responses in the first 5 minutes, with some commission errors. Latency and omission errors increase at end. Baseline Test #2 Test #3 # Shifts t Attentive % 26.7% % % 83 Impulsive % 40.0% % % 79 Distracted % 20.0% 11 t 16.7% 16 t 6.7% 56 Disengaged Random % 6.7% % % 99 Minimal % 6.7% 12 t 0.0% % 99 Contrary % 0.0% % % 99 In Test #1, there were many attention state shifts (21, 7th percentile) and the percentage of time in the Attentive state was low (26.7%, 28th percentile. Metrics improved in Test #2 and was excellent in Test #3. The Impulsive state results from many commission errors. The patient was Distracted/Disengaged for most of the last 5 minutes.

9 Test #2, 3/14 Focalin XR 15 mg, 4 hrs post-dose Test #3, 10/2 Concerta 54 mg, 1.5 hrs post-dose Excellent motion control. Excellent motion control. Response Results Motion Results Improved attentive behavior, with omission errors at the low end of the reference range for age/gender. Very good attentive behavior. 16 ttention state shifts is a pattern consistent with ADHD. Distracted state is at the 16th %ile for a 12 year-old boy. Very good Attentive behavior. Attention State Results

10 Quotient ADHD Composite Scores Test #1 Test #2 Test #3 Test Date 3/6/2011 3/14/ /2/2011 Age Medication None Focalin XR 15 mg Concerta 54 mg System Index Likely Unlikely Unlikely Scaled Scores Motion System Index Key Unlikely Possible Probable Likely Scaled Scores Key Attention Global mean non-adhd=4 mean ADHD=7 Case Summary This boy has been in the practice since July. He was stable on Focalin XR 15 mg. Teacher and parent reports were positive. March 6: A baseline Quotient ADHD test was administered without medication. Mother wanted to confirm that medication was still needed. The motion pattern showed good control in the first five minutes with progressive degradation. The mean motion metrics were all at the low end of the reference range. There were 21 attention shifts. Distraction and Disengagement were the predominant attention states at the end of the test. We re-started Focalin XR 15 mg. March 14: Repeated Quotient Test. Excellent motion control, but still some inattention at school. Inattention was worse at the end of the day, which indicated that the medication may be wearing off early. Switched medication to Concerta 54 mg to cover late afternoon. October 2: Quotient Test confirmed adequate dosing. The boy returned to school taking his medication. Because he had a new teacher, the parents decided to try a no medication experiment. The teacher immediately saw a difference in behavior and called the parents to report the problems. Conclusions Objective testing reduced time to medication optimization from approximately 3-6 months to 4-8 weeks Baseline testing off medication quantifies the severity of deficit and makes the conversation with the parent and patient more efficient and productive. Reassessments at 1-2 week intervals during medication initiation helps to guide treatment decisions and can help to achieve optimal dosing faster. Repeat tests inform decisions when considering changing medication or adjusting dose. Back-to-school assessments confirm that medication is still needed to control symptoms. Copyright 2012 F8074 (2012/04/05) Quotient is a registered trademark of BioBehavioral Diagnostics Company. Focalin is a registered trademark of Novartis Pharmaceuticals. Concerta is a registered trademark of McNeil Pharmaceuticals