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Train the Trainer Course book - Cochrane Public Health Group

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Randomised controlled trial – critical appraisal exercise<br />

Sahota P, Rudolf CJ, Dixey R, Hill AJ, Barth JH, Cade J. Randomised controlled trial of primary<br />

school based intervention to reduce risk factors for obesity. BMJ 2001;323:1029-32.<br />

Selection bias<br />

(Q1) Are <strong>the</strong> individuals selected to participate<br />

in <strong>the</strong> study likely to be representative of <strong>the</strong><br />

target population?<br />

Not likely<br />

Somewhat likely<br />

Not likely<br />

(Q2) What percentage of selected individuals<br />

agreed to participate?<br />

80-100% agreement<br />

60-79% agreement<br />

less than 60% agreement<br />

Not reported<br />

Not Applicable<br />

RATE THIS SECTION<br />

Strong Moderate Weak<br />

Study design<br />

Indicate <strong>the</strong> study design<br />

Is <strong>the</strong> method of random allocation stated?<br />

No<br />

Yes<br />

If <strong>the</strong> method of random allocation is stated is it<br />

appropriate?<br />

No<br />

Yes<br />

Was <strong>the</strong> method of random allocation reported<br />

as concealed?<br />

No<br />

Yes<br />

RATE THIS SECTION<br />

Strong Moderate Weak<br />

Confounders<br />

(Q1) Prior to <strong>the</strong> intervention were <strong>the</strong>re<br />

between group differences for important<br />

confounders reported in <strong>the</strong> paper?<br />

Yes<br />

No<br />

Can’t tell<br />

(Q2) If <strong>the</strong>re were differences between groups<br />

for important confounders, were <strong>the</strong>y<br />

adequately managed in <strong>the</strong> analysis?<br />

Yes<br />

No<br />

Not applicable<br />

(Q3) Were <strong>the</strong>re important confounders not<br />

reported in <strong>the</strong> paper?<br />

Yes<br />

Somewhat likely<br />

All of <strong>the</strong> schools were state primary schools<br />

sited outside <strong>the</strong> inner city area. Slight bias<br />

towards more advantaged children – 1-42% of<br />

children from ethnic minorities, 7-29% entitled<br />

to free school meals.<br />

Not reported<br />

We are only told that 10 schools took part in <strong>the</strong><br />

intervention; we do not know how many<br />

schools were approached.<br />

Weak<br />

Randomised controlled trial<br />

Yes<br />

<strong>Group</strong> randomised controlled trial<br />

Yes<br />

Schools were first paired (size, ethnicity, level of<br />

social disadvantaged) and <strong>the</strong>n randomised<br />

using <strong>the</strong> toss of a coin.<br />

No (no information reported)<br />

Strong<br />

No<br />

The groups were similar in terms of age, school<br />

year, BMI, etc. There were no significant<br />

differences found between any of <strong>the</strong><br />

intervention and comparison pupils for any of<br />

<strong>the</strong> measures.<br />

No differences, but still adjusted results.<br />

Calculations adjusted for sex, age, initial BMI<br />

SD score, and type of school.<br />

No<br />

94

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