APPENDICES. A systematic review and economic model of the ...

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230 Appendix 12 Study Intervention Participants Outcomes Core symptoms Conners’ Parent Questionnaire: hyperactivity, impulsivity Conners’ Teacher Questionnaire: inattentive–passive, hyperactivity Reference Conners and Taylor, 1980 46 Source AHRQ Report Co-existent problems Conners’ Parent Questionnaire: conduct problem, antisocial Conners’ Teacher Questionnaire: conduct problem, sociability Arm 1 PEM 37.5 mg/day up to a maximum of 112.5 mg/day or when side-effects necessitate stabilisation; administered once per day (a.m.). Final mean dosage of 2.25 mg/kg/day or 60.4 mg/day; placebo administered once per day (p.m.) (Administered by parent) Setting USA Design Parallel trial Educational performance Wide Range Achievement: reading; spelling; arithmetic Psychological function WISC Porteus Maze Test Harris–Goodenough Draw-a-Man Test Kagan’s Matching Familiar Figures Test Minnesota Percepto-Diagnostic Test Continuous performance task Goldman–Fristoe–Woodcock Test for Auditory Discrimination Inclusion criteria 1. Between 6 years and 11 years 6 months 2. IQ = 80 (full scale, performance or verbal) 3. Physician-diagnosed hyperkenesis due to minimal brain dysfunction 4. Visual and auditory acuity sufficient for normal learning process 5. Stable family 6. No obsessive, compulsive or phobic behaviour 7. Normal laboratory values in relation to established paediatric norms 8. No current medical illness or history that contraindicates prescribed drug therapy 9. All prior therapy for hyperkinesis discontinued for a minimum of 8 days prior to study (patients receiving phenothiazines within the previous 6 months were excluded) 10. No demonstrable or suspected need for antiseizure medications 11. No concurrent therapy for chronic illness 12. Moderate to severe symptoms of restlessness, inattentiveness, impulsivity, emotional liability and distractibility reported by parent and school 13. Family physician or paediatrician consent Arm 2 MPH 10 mg/day up to a maximum of 60 mg/day or when side effects necessitated stabilisation; administered in two evenly divided doses (a.m., p.m. 30 minutes before evening meal). Final mean dosage of 0.82 mg/kg/day or 22.0 mg/day (Administered by parent) Duration Treatment period: 8 weeks; Study length: 10 weeks Purpose To examine the clinical efficacy, side-effects and toxicity of PEM and to compare it with MPH Depression or anxiety Conners’ Parent Questionnaire: anxiety Conners’ Teacher Questionnaire: anxiety Arm 3 Placebo Dummy tablets administered twice per day (a.m., p.m.) (Administered by parent) Diagnostic criteria Process involving documentation of family history, past developmental and medical status, neurological and psychological function, behaviour in a structured psychiatric examination and symptom ratings from parent and teacher Quality of life Global judgements of improvement (parents, teachers, staff) Adverse events Physician’s Rating Sheet for Side Effects Standardised form (parents): 50-item checklist Conners’ Parent Questionnaire: psychosomatic Number Total randomised = 60 (male = 57) Arm 1 = 19 Arm 2 = 20 Arm 3 = 21 Total withdrawals = 2 Arm 1 = 2 Arm 2 = 0 Arm 3 = 0 continued
Study Intervention Participants Outcomes Additional outcomes Weight Pulse Blood pressure Additional laboratory findings Activity level Conners’ Parent Questionnaire: immaturity, obsessional Age 7 years 11 months (mean); 6 to 11 years 1 month (range) IQ Arm 1: 93.72 (mean); Arm 2: 97.20 (mean); Arm 3: 95.90 (mean) Co-morbid disorders High level of perinatal and developmental anomalies reported Learning problems: 81%. Diagnostic subtypes Not reported Additional information Previous medication: 13% had received prior analeptic therapy. Participants were required to be medication free for 8 days preceding trial. Participants receiving phenothiazines were not included Concurrent medication: no participant receiving concurrent therapy for chronic illness was included in the trial © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 231
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366 Appendix 13 Study characteristi
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