Gastro-Enterologists - acceptable risk in CD
paper on acceptable risk survey in Crohn's
INTRODUCTION: The goal of this study was to quantify gastroenterologists' maximum acceptable risk (MAR) for treatment-related serious adverse events (SAEs) in Crohn's disease (CD) patients.
AIMS & METHODS: A panel of gastroenterologists completed a series of choice-format conjoint trade-off tasks. Each involved choosing 1 of 2 treatments for a patient in each of three age categories (young, middle-aged, elderly) with a randomly assigned gender and number of prior surgeries (0, 1, 4). Treatment attributes included daily symptom severity and activity limitations, potential for CD complications, time between flare-ups, oral steroid use, and varying levels of three SAE mortality risks: serious infection (SI), progressive multifocal leukoencephalopathy (PML) and lymphoma. The data were analyzed using random-parameters logit to obtain relative trade-off weights for treatment attributes and calculate the annual SAE-specific maximum acceptable risk (MAR) for various levels of clinical benefit.
RESULTS: A total of 315 gastroenterologists provided usable data for analysis. The mean (SD) age and years in practice were 48 (9) and 15 (3) years, respectively. They treated a mean (SD) of 29 (31) patients in a typical month. Improvement in daily symptom severity was the most important factor in treatment preferences, particularly for elderly patients. Greater risk tolerance was seen for treatments with higher levels of clinical benefit. For middle-aged patients, the range of MARs from the smallest clinical benefit (moderate CD to mild CD) to largest (severe CD to remission) was 0.27% to 1.42% for death or disability from PML, 0.39% to 1.24% for death from SI, and 0.67% to 2.5% for death due to lymphoma. Risk tolerance was similar for PML, SI and lymphoma within the young and middle-aged age groups. However, physicians had a two-fold greater acceptance of risk of death from lymphoma compared to PML and SI for the elderly. Patients' preferences obtained from a parallel study are similar to that of physicians prescribing for middle-aged patients across most benefit levels, but patients were generally twice as willing to accept risk of death to avoid moderate CD symptoms
CONCLUSION: Medical interventions carry risks of adverse outcomes that must be evaluated relative to their clinical benefits. Gastroenterologists indicated they are willing to accept defined mortality risks in exchange for clinical efficacy and that acceptance is affected by the degree of benefit, the patient's characteristics and the nature of the SAE. Compared to prescribing physicians, patients are more willing to accept risk to avoid moderate CD symptoms.
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