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Antiemetics for reducing vomiting related to acute ... - Update Software

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Cubeddu 1997 (Continued)<br />

Risk of bias<br />

Bias Authors’ judgement Support <strong>for</strong> judgement<br />

Random sequence generation (selection<br />

bias)<br />

Unclear risk Quote: “Patients were randomly assigned<br />

<strong>to</strong> receive either....” Pg 186<br />

Comment: unclear.<br />

Allocation concealment (selection bias) Low risk Quote: “The study medication was prepared<br />

by a pharmacist not involved in patient<br />

care...” Pg 186<br />

Comment: probably done.<br />

Blinding of participants and personnel<br />

(per<strong>for</strong>mance bias)<br />

All outcomes<br />

Blinding of outcome assessment (detection<br />

bias)<br />

All outcomes<br />

Incomplete outcome data (attrition bias)<br />

All outcomes<br />

Unclear risk Participants: not applicable.<br />

Healthcare providers:<br />

Comment: unclear how knowledge of the<br />

allocated interventions by the personnel<br />

was adequately prevented during the study<br />

Unclear risk Outcomes assessors & data analysts: not reported<br />

if persons assessing the outcomes of<br />

care were blinded <strong>to</strong> which treatment the<br />

participants received<br />

Low risk All data appear <strong>to</strong> have been reported in the<br />

study outcomes.<br />

Selective reporting (reporting bias) Low risk No evidence of selective reporting. Outcomes<br />

listed in the methods section were<br />

comparable <strong>to</strong> those reported<br />

Other bias High risk The authors reported a baseline imbalance<br />

in age; weight; and height between the<br />

ondansetron and placebo treatment arm.<br />

Mean age yrs (range); ondansetron 1.0 (0.<br />

5 <strong>to</strong> 2), me<strong>to</strong>clopramide 1.8 (0.5 <strong>to</strong> 8) and<br />

placebo 2.5 (0.5 <strong>to</strong> 8). (See Table 18).<br />

This imbalance was not adjusted <strong>for</strong> in the<br />

analysis.<br />

The trialists reported that the study was<br />

supported by Glaxo Wellcome and although<br />

the level of support was unclear two<br />

of the investiga<strong>to</strong>rs were in the employment<br />

of Glaxo Wellcome<br />

<strong>Antiemetics</strong> <strong>for</strong> <strong>reducing</strong> <strong>vomiting</strong> <strong>related</strong> <strong>to</strong> <strong>acute</strong> gastroenteritis in children and adolescents (Review)<br />

Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.<br />

29

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