Background: The purpose of this study was threefold:
(1) to determine the scientific quality of published randomized
trials in the American Volume of The Journal of Bone and
Joint Surgery from 1988 through 2000, (2) to identify predictors
of study quality, and (3) to evaluate inter-rater agreement in the
scoring of study quality with use of a simple scale.
Methods: Hand searches of The Journal of
Bone and Joint Surgery were conducted in duplicate to identify
randomized clinical trials. Of 2468 studies identified, seventy-two
(2.9%) met all eligibility criteria. Two investigators
each assessed the quality of the study under blinded conditions
and abstracted relevant data.
Results: The mean score (and standard error) for
the quality of the seventy-two randomized trials was 68.1% ±
1.6%; 60% (forty-three) scored <75%.
Drug trials had a significantly higher mean quality score than did
surgical trials (72.8% compared with 63.9%, p < 0.05).
Regression analysis revealed that cited affiliation with an epidemiology
department and cited funding were associated with higher quality
scores. Failure to conceal randomization, to blind outcome assessors,
and to describe why patients were excluded resulted in significantly lower
quality scores (p < 0.05), more than the 5% decrease expected
by removal of each item. A priori calculations of sample size were
rarely performed in the reviewed studies, and only 2% of
the studies with negative results included a post hoc power analysis.
The Detsky quality scale met accepted standards of interobserver
reliability (kappa, 0.87; 95% confidence interval, 0.70
Conclusions: Few studies published in The
Journal of Bone and Joint Surgery were randomized trials.
More than half of the trials were limited by a lack of concealed
randomization, lack of blinding of outcome assessors, or failure
to report reasons for excluding patients. Application of standardized
guidelines for the reporting of clinical trials in orthopaedics
should improve quality.