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

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256<br />

Appendix 12<br />

Core symptoms Educational performance Quality <strong>of</strong> life Adverse events<br />

STESS (parents)<br />

Frequency (%) for sleep problem/appetite<br />

decrease/crying/sadness/unhappiness/anger/headaches/<br />

increased thirst/dry mouth/nausea/stomach<br />

aches/shakiness:<br />

MPH, st<strong>and</strong>ard:<br />

41.1/15.8/15.8/10.5/5.3/10.5/10.5/0.0/0.0/5.3/5.3/0.0<br />

MPH, SR:<br />

36.8/36.8/21.0/0.0/21.0/31.6/10.5/5.3/0.0/0.0/0.0/0.0<br />

MPH, st<strong>and</strong>ard + SR:<br />

63.2/26.3/26.3/0.0/15.8/26.3/5.3/0.0/0.0/0.0/0.0/5.3<br />

Placebo:<br />

15.8/5.3/31.6/5.3/26.3/42.1/10.5/10.5/0.0/0.0/0.0/0.0<br />

Sleep problems increased with MPH:<br />

F(93,42) = 5.38, p < 0.01 (only significant for<br />

combined versus placebo)<br />

No significant differences for o<strong>the</strong>r side-effects<br />

Not reported Parent comments ratings<br />

MPH, st<strong>and</strong>ard: 0.17 (0.44)<br />

MPH, SR: –0.05 (0.55)<br />

MPH, st<strong>and</strong>ard + SR: 0.18 (0.41)<br />

Placebo: –0.43 (0.42)<br />

Teacher comments ratings<br />

MPH, st<strong>and</strong>ard: 0.19 (0.48)<br />

MPH, SR: 0.20 (0.44)<br />

MPH, st<strong>and</strong>ard + SR: 0.40 (0.37)<br />

Placebo: –0.40 (0.54)<br />

TOTS Attention: F(3,42) = 17.19,<br />

p < 0.0001 (Patients were rated by<br />

both teachers <strong>and</strong> parents as behaving<br />

better in all MPH conditions than<br />

placebo, but MPH conditions did not<br />

differ from one ano<strong>the</strong>r)<br />

Conners’ Hyperactivity Index (parents) ( ?mean,<br />

?SD)<br />

(range 0–3, lower scores = better behaviour)<br />

MPH, st<strong>and</strong>ard: 0.96 (0.50)<br />

MPH, sustained release (SR): 0.98 (0.72)<br />

MPH, st<strong>and</strong>ard + SR: 0.81 (0.46)<br />

Placebo: 1.75 (0.67)<br />

Wilcoxon pairwise comparisons did not identify<br />

significant differences among MPH conditions,<br />

but indicated that placebo was ranked lower<br />

than all <strong>of</strong> <strong>the</strong> active conditions (all p < 0.006)<br />

Weight (kg)<br />

MPH, st<strong>and</strong>ard: 31.41 (6.82)<br />

MPH, SR: 31.59 (7.25)<br />

MPH, st<strong>and</strong>ard + SR: 31.33 (7.00)<br />

Placebo: 31.94 (7.39)<br />

F(3,41)=10.29, p < 0.0006 (Placebo weights<br />

significantly higher than combined <strong>and</strong> st<strong>and</strong>ard)<br />

Parent improvement rankings<br />

MPH, st<strong>and</strong>ard: 2.18 (0.78)<br />

MPH, SR: 2.16 (1.09)<br />

MPH, st<strong>and</strong>ard + SR: 1.87 (0.86)<br />

Placebo: 3.79 (0.38)<br />

2 (3) = 25.97, p < 0.0001 (No<br />

differences among MPH conditions, but<br />

placebo ranked lower than all active<br />

conditions: all p < 0.006)<br />

Conners’ Hyperactivity Index (teacher)<br />

(range 0–3, lower scores = better behaviour)<br />

MPH, st<strong>and</strong>ard: 0.73 (0.65)<br />

MPH, SR: 0.77 (0.63)<br />

MPH, st<strong>and</strong>ard + SR: 0.58 (0.40)<br />

Placebo: 1.36 (0.80)<br />

Conners’ Hyperactivity: F (3,42) = 21.96,<br />

p < 0.0001 (Patients were rated by both<br />

teachers <strong>and</strong> parents behaving better in all MPH<br />

conditions than placebo, but MPH conditions<br />

did not differ from one ano<strong>the</strong>r)<br />

IOWA Inattention/Overactivity Scale (parents)<br />

(range 0–3, lower scores = better behaviour)<br />

MPH, st<strong>and</strong>ard: 1.01 (0.46)<br />

MPH, SR: 0.98 (0.61)<br />

MPH, st<strong>and</strong>ard + SR: 0.79 (0.48)<br />

Placebo: 1.90 (0.63)<br />

IOWA Inattention/Overactivity Scale (teacher)<br />

(range 0–3, lower scores = better behaviour)<br />

MPH, st<strong>and</strong>ard: 0.87 (0.63)<br />

MPH, SR: 0.92 (0.68)<br />

MPH, st<strong>and</strong>ard + SR: 0.70 (0.56)<br />

Placebo: 1.65 (0.90)<br />

IOWA Inattention/Overactivity Scale:<br />

F(3,42) = 23.82, p < 0.0001 (Patients were<br />

rated by both teachers <strong>and</strong> parents as behaving<br />

better in all MPH conditions than placebo, but<br />

MPH conditions did not differ from one ano<strong>the</strong>r)<br />

continued

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