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Trials. 2009 Jan 7;10:1. doi: 10.1186/1745-6215-10-1.

No short-cut in assessing trial quality: a case study.

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1
Department of Epidemiology and Biostatistics, Muhimbili University of Health and Allied Sciences, P O Box 65015, Dar es Salaam, Tanzania. kfhirji@aol.com

Abstract

BACKGROUND:

Assessing the quality of included trials is a central part of a systematic review. Many check-list type of instruments for doing this exist. Using a trial of antibiotic treatment for acute otitis media, Burke et al., BMJ, 1991, as the case study, this paper illustrates some limitations of the check-list approach to trial quality assessment.

RESULTS:

The general verdict from the check list type evaluations in nine relevant systematic reviews was that Burke et al. (1991) is a good quality trial. All relevant meta-analyses extensively used its data to formulate therapeutic evidence. My comprehensive evaluation, on the other hand, brought to the surface a series of serious problems in the design, conduct, analysis and report of this trial that were missed by the earlier evaluations.

CONCLUSION:

A check-list or instrument based approach, if used as a short-cut, may at times rate deeply flawed trials as good quality trials. Check lists are crucial but they need to be augmented with an in-depth review, and where possible, a scrutiny of the protocol, trial records, and original data. The extent and severity of the problems I uncovered for this particular trial warrant an independent audit before it is included in a systematic review.

Comment in

PMID:
19128475
PMCID:
PMC2636799
DOI:
10.1186/1745-6215-10-1
[Indexed for MEDLINE]
Free PMC Article
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