Valuing Health Gain from Composite Response Endpoints for Multisystem Diseases

Objectives: This study aimed to demonstrate how to estimate the value of health gain after patients with a multisystem disease achieve a condition-specific composite response endpoint. Methods: Data from patients treated in routine practice with an exemplar multisystem disease (systemic lupus erythematosus) were extracted from a national register (British Isles Lupus Assessment Group Biologics Register). Two bespoke composite response endpoints (Major Clinical Response and Improvement) were developed in advance of this study. Difference-in-differences regression compared health utility values (3-level version of EQ-5D; UK tariff) over 6 months for responders and nonresponders. Bootstrapped regression estimated the incremental quality-adjusted life-years (QALYs), probability of QALY gain after achieving the response criteria, and population monetary benefit of response. Results: Within the sample (n = 171), 18.2% achieved Major Clinical Response and 49.1% achieved Improvement at 6 months. Incremental health utility values were 0.0923 for Major Clinical Response and 0.0454 for Improvement. Expected incremental QALY gain at 6 months was 0.020 for Major Clinical Response and 0.012 for Improvement. Probability of QALY gain after achieving the response criteria was 77.6% for Major Clinical Response and 72.7% for Improvement. Population monetary benefit of response was £1 106 458 for Major Clinical Response and £649 134 for Improvement. Conclusions: Bespoke composite response endpoints are becoming more common to measure treatment response for multisystem diseases in trials and observational studies. Health technology assessment agencies face a growing challenge to establish whether these endpoints correspond with improved health gain. Health utility values can generate this evidence to enhance the usefulness of composite response endpoints for health technology assessment, decision making, and economic evaluation

Seroprevalence and exposure to risk factors for leptospirosis among veterinary students at Massey University

<div><p>AIMS: To determine the seroprevalence and quantify putative risk factors for exposure to leptospirosis both within and outside the veterinary curriculum among undergraduate veterinary students at Massey University, New Zealand.</p><p>METHODS: A cross-sectional study was conducted from September 2010 to November 2011. In total, 302 students were blood sampled, with serum tested by microscopic agglutination test (MAT) for antibodies to <i>Leptospira borgpetersenii</i> serovars Hardjobovis, <i>Leptospira interrogans</i> Pomona and <i>Leptospira borgpetersenii</i> Ballum. Information on demographic characteristics, potential exposure within and outside the veterinary curriculum in the previous 18 months, and previous leptospirosis-like clinical history were recorded using an online questionnaire.</p><p>RESULTS: All students were MAT negative for each serovar, using a cut-point of ≥1:48. Potential exposure to animal urine within and outside the veterinary curriculum was reported by 259/302 (85.8%) and 150/302 (49.7%) of the students, respectively. The median number of potential exposures to animal urine by each student within the veterinary curriculum in the previous 18 months was 63 (min 1, max 155). The other potential exposures among respondents included home slaughter (63/302; 20.9%), hunting (43/302; 14.2%) and outdoor activities involving exposure to fresh water (241/302; 79.8%).</p><p>CONCLUSIONS: This study demonstrated that these veterinary students were at low risk of contracting leptospirosis, despite frequent exposure to potential sources of infection. The findings in this study contribute to a broader understanding of the occupational risk of leptospirosis. Data describe the level of animal exposure in veterinary students, which can support other zoonotic disease studies in this group.</p></div