How study design affects outcomes in comparisons of therapy. II: Surgical.
We analysed the results of 221 comparisons of an innovation with a standard treatment in surgery published in six leading surgery journals in 1983 to relate features of study design to the magnitude of gain. For each comparison we measured the gain attributed to the innovation over the standard therapy by the Mann-Whitney statistic and the difference in proportion of treatment successes. For primary treatments (aimed at curing or ameliorating a patient's principal disease), an average gain of 0.56 was produced by 20 randomized controlled trials. This was less than the 0.62 average for four non-randomized controlled trials, 0.63 for 19 externally controlled trials, and 0.57 for 73 record reviews (0.50 represents a toss-up between innovation and standard). For secondary therapies (used to prevent or treat complications of therapy), the average gain was 0.53 for 61 randomized controlled trials, 0.58 for eleven non-randomized controlled trials, 0.54 for eight externally controlled trials, and 0.55 for 18 record reviews. Readers of studies evaluating new treatments, particularly for primary treatments, may consider adjustment of the gain according to the study type.
Miller
J N
JN
Center for Science and International Affairs, John F. Kennedy School of Government, Harvard University, Cambridge, MA 02138.
Colditz
G A
GA
Mosteller
F
F
D002986:Clinical Trials as Topic / Q000379:methods*; D004059:Diffusion of Innovation; D004311:Double-Blind Method; D006801:Humans; D011897:Random Allocation; D012107:Research Design; D013223:Statistics as Topic; D013514:Surgical Procedures, Operative / Q000379:methods*