OBJECTIVES. TO study treatment bias in observational outcomes research
, the authors present a nonlinear classification tree model of clinica
l and psychosocial factors influencing selection for interventional ma
nagement (lower extremity bypass surgery or angioplasty) for patients
with intermittent claudication. METHODS. The study sample includes 532
patients with mild to moderate lower extremity vascular disease, with
out prior peripheral revascularization procedures or symptoms of disea
se progression. All patients were enrolled in a prospective outcomes s
tudy at the time of an initial referral visit for claudication to one
of the 16 Chicago-area vascular surgery offices or clinics in 1993-95.
The influence of baseline sociodemographic, clinical, and patient sel
f-reported health status data on subsequent treatment is analyzed. Stu
dy variables were derived from lower extremity blood flow records and
patient questionnaires. Follow-up home health visits were used to asce
rtain the frequency of lower extremity revasculariztion procedures wit
hin 6 months of study enrollment. Hierarchically optimal classificatio
n tree analysis (CTA) was used to obtain a nonlinear model of treatmen
t selection. The model retains attributes with the highest sensitivity
at each node based on cutpoints that maximize classification accuracy
. Experimentwise Type I error is ensured at P < 0.05 by the Bonferroni
method and jackknife validity analysis is used to assess model stabil
ity. RESULTS. Seventy-one of 532 patients (13.3%) underwent interventi
onal procedures within 6 months; Ten patient attributes were used in t
he CTA model, which had an overall classification accuracy of 89.5% (6
7.6% sensitive and 92.9% specific), achieving 57.7% of the theoretical
possible improvement in classification accuracy beyond chance. Eleven
model prediction endpoints reflected a 33-fold difference in odds of
undergoing lower extremity revasculariztion. CONCLUSIONS. Initial ankl
e-brachial index (100%), leg symptom status over the previous six mont
hs (89%), self-reported community walking distance (74%) and prior wil
lingness to undergo a lower extremity hospital procedure (39%) were us
ed to classify most patients in the sample. These attributes are criti
cal control variables for a valid observational study of treatment eff
ectiveness.