The case for better research standards in peripheral thrombolysis: poor quality of randomized trials during the past decade.
OBJECTIVE
We assessed how well published randomized controlled trials (RCTs) of peripheral thrombolysis have been designed and how they adjusted for patient characteristics that may influence responses to therapy.


METHODS
RCT studies published between 1984 and 1994 were reviewed to determine whether they included nine crucial elements: sample size calculations, description of unenrolled eligible participants, homogeneous samples, balanced experimental groups, equal potency therapies, equal follow-up of outcomes, appropriate statistical inference, multivariable or subgroup analyses, and anonymous review of subjective endpoints.


RESULTS
The nine RCTs complied with a median of three of nine standards (range = 2-6). Each report exhibited serious flaws that may affect generalizability and external validity. None adequately adjusted for sample heterogeneity or sought to identify characteristics that may affect responses to therapy.


CONCLUSIONS
Failure to address prognostic or confounding variables restricts the utility of peripheral thrombolysis RCTs and helps explain why contentious debates about this therapy persist. A model for future thrombolysis trials is proposed.
Egglin
T K
TK
Department of Diagnostic Radiology, Yale University School of Medicine, New Haven, CT 06520-8042, USA.
Horwitz
R I
RI
D001157:Arterial Occlusive Diseases / Q000188:drug therapy; D006801:Humans; D015999:Multivariate Analysis; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D015912:Thrombolytic Therapy; D016896:Treatment Outcome