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Unit Eight: Principles of Critical Appraisal - Cochrane Public Health ...

Unit Eight: Principles of Critical Appraisal - Cochrane Public Health ...

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Allocation bias<br />

Need comparable groups<br />

Concealed allocation?<br />

Randomisation = similar groups at baseline<br />

Allocation schedule should not be administered<br />

by person who is responsible for the study to<br />

prevent manipulation<br />

Lancet 2002; 359:614-18.<br />

Allocation bias<br />

Reduced by:<br />

centralised randomisation<br />

on-site computer system with group<br />

assignments in a locked file<br />

sequentially numbered, sealed, opaque<br />

envelopes<br />

any statement that provides reassurance<br />

that the person who generated the<br />

allocation scheme did not administer it<br />

Not: alternation, dates <strong>of</strong> birth, day <strong>of</strong><br />

week.<br />

Question Two: checklist<br />

• Allocation bias: Type <strong>of</strong> study design<br />

• RCT<br />

• Quasi-experimental<br />

• Uncontrolled study<br />

Confounding<br />

Need similar groups at baseline<br />

Determine which factors could confound the<br />

association <strong>of</strong> the intervention and outcome<br />

Non-randomised studies – can never adjust for<br />

unknown confounding factors (and difficulties in<br />

measuring known confounding factors)<br />

If confounding – adjusted for in analysis<br />

Question Three: checklist<br />

Confounders:<br />

• Prior to intervention, were there<br />

differences for important confounders<br />

reported?<br />

• Were the confounders adequately<br />

managed in the analysis?<br />

• Were there important confounders not<br />

reported?<br />

3

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