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

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

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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 Kids Water Bottle 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 Sailing Vests 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.