ehealth digital library

Digital library of
the Tanzania

No Short-Cut in Assessing Trial Quality: A Case Study.

Hirji, K. F. (2009) No Short-Cut in Assessing Trial Quality: A Case Study. Trials, 10. p. 1. ISSN 1745-6215

Karim_F_Hirji.pdf - Published Version
Available under License Creative Commons Attribution Non-commercial.

Download (579kB)


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. 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. 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.

Item Type: Article
Keywords: Trial Quality, Antibiotic Treatment
Subjects: Health Systems > Surveillance, monitoring & evaluation
Divisions: Muhimbili University of Health and Allied Sciences (MUHAS)
Depositing User: Mr Joseph Madata
Date Deposited: 06 Aug 2013 09:12
Last Modified: 06 Aug 2013 09:12

Actions (login required)

Edit Item Edit Item


Downloads per month over past year

View more statistics