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The control function model takes the form of a two-stage estimation. The first stage, the selection, predicts the probabilities of having no usual source of care, having a regular doctor, and having a regular site, respectively, given predisposing, enabling, and need factors. The second-stage estimation incorporates the transformations of the predicted probabilities from the first stage. Let [I.sub.0], [I.sub.d], and [I.sub.s], be binary dummy variables indicating having no usual source of care, having a regular doctor, and having a regular site. Without the control for selection, the prediction of service use can be written as

The ASUI was significantly correlated with [FEV.sub.1] percent predicted and [FEV.sub.1]/FVC. In addition, the measure was capable of differentiating patient groups of known disease severity. Similar results were demonstrated using physician-generated ratings of severity of asthma and an asthma disease severity rating system based on emergency medical service use, spirometry, and symptoms. ASUI scores produced a stair-step pattern of decreasing scores with increasing disease severity. Patients categorized as having mild disease according to the physician rating scheme scored the highest on the ASUI at 0.88 and were distinguishable from the groups with moderate and moderate-to-severe disease by 0.24 and 0.41 points, respectively. Patients with mild/ moderate, moderate, and moderate/severe disease were also distinguishable with a value of 0.30 separating the mild/moderate from the moderate/severe. This suggests the instrument is sensitive to subtle differences in disease severity, a characteristic necessary for responsiveness to change with treatment and meaningful cost-effectiveness studies. Further research is needed to quantify the responsiveness of the ASUI to clinically meaningful change.

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. (1) The cases described were disturbing. They involved physicians engaged in excessive "enrollment activities" in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. (2) One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade. (3) Another article reported the role of finder''s fees and payments to parents in increasing the enrollment of children in medical research in the United States from 16,000 in 1997 to 45,000 in 2001. (4) It also highlighted the fact that subjects may be exposed to serious harm through referrals by zealous and inexperienced physicians, drawn to recruitment activity by offers of up to $5,000 per patient referred. Finally, several other "disturbing recruitment practices" were reported by the U.S. Department of Health and Human Services'' Office of Inspector General in its report on subject recruitment practices. These include many cases of patients being harassed for participation; a nursing home resident being told to participate in research or leave the home; and a subject who died and was later found not to have met the inclusion criteria for the study. (5)

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