Does the abolition of copayment increase ambulatory care utilization?: a quasi-experimental study in Germany

The European Journal of Health Economics - Due to a problematic situation with public finances, Germany introduced a copayment scheme for ambulatory care visits in 2004. In 2012, Germany achieved a...     

Diffusion MRI changes in the anterior subventricular zone following chemoradiation in glioblastoma with posterior ventricular involvement

Journal of Neuro-Oncology - There is growing evidence that the subventricular zone (SVZ) plays a key role in glioblastoma (GBM) tumorigenesis. However, little is known regarding how the SVZ, which...     

The Experts Are Not Enough

As Achim Rosemann and colleagues rightly suggest in their article “Heritable Genome Editing in Global Context: National and International Policy Challenges,” in this issue of the Hastings Center Report, the scientific, ethical, and governance challenges associated with heritable genome editing are global in scope. Both the genetic interventions and the social and moral judgments about human identity and integrity associated with them will affect all humanity. Yet the worries, problems, and solutions that the study illuminates reflect only a partial picture of those challenges. That is to be expected from a study of this sort: the “stakeholders” who were consulted are a limited group and as such are bound to provide a particular, limited picture. One of the important contributions that such a study can make is in providing a picture of what problems particular kinds of experts see as the primary problems and how the framing of those problems may displace other questions and perspectives, especially when such parochial framings of problems are elevated to the level of the “global.” Rosemann et al. do not explain how participants were identified as stakeholders or, indeed, how the study identified the stakes. This is a missed opportunity, and it points toward a set of questions that themselves need to be asked about how the stakeholders—and the stakes—of global governance of heritable genome editing are identified.     

Pediatric Drug Labeling and Imperfect Information

I first became aware of bioethics in the spring of 1980. I had spent a thirty-six-hour shift shadowing a medical resident, and I was struck that many of the resident's decisions had ethical dimensions. The next day, I came across the Hastings Center Report, and I realized I wanted to explore ethical issues I found implicit in clinical care, even though I still wanted to become a pediatrician. In September 2019, when I attended my first meeting of the U.S. Food and Drug Administration's Pediatric Advisory Committee, as a pediatric pulmonologist, I had the same sense of awe and curiosity that I had forty years ago. What had appeared initially as somewhat technical decisions about the regulation of drug labeling was suffused with ethical questions. The committee was asked to discuss possible changes to the labeling of two previously approved drugs.     

A bronchial-airway gene-expression classifier to improve the diagnosis of lung cancer: Clinical outcomes and cost-effectiveness analysis

Bronchoscopy is the safest procedure for lung cancer diagnosis when an invasive evaluation is required after imaging procedures. However, its sensitivity is relatively low, especially for small and peripheral lesions. We assessed benefits and costs of introducing a bronchial gene-expression classifier (BGC) to improve the performance of bronchoscopy and the overall diagnostic process for early detection of lung cancer. We used discrete-event simulation to compare clinical and economic outcomes of two different strategies with the standard practice in former and current smokers with indeterminate nodules: (i) location-based strategy—integrated the BGC to the bronchoscopy indication; (ii) simplified strategy—extended use of bronchoscopy plus BGC also on small and peripheral lesions. Outcomes modeled were rate of invasive procedures, quality-adjusted-life-years (QALYs), costs and incremental cost-effectiveness ratios. Compared to the standard practice, the location-based strategy (i) reduced absolute rate of invasive procedures by 3.3% without increasing costs at the current BGC market price. It resulted in savings when the BGC price was less than $3,000. The simplified strategy (ii) reduced absolute rate of invasive procedures by 10% and improved quality-adjusted life expectancy, producing an incremental cost-effectiveness ratio of $10,109 per QALY. In patients with indeterminate nodules, both BGC strategies reduced unnecessary invasive procedures at high risk of adverse events. Moreover, compared to the standard practice, the simplified use of BGC for central and peripheral lesions resulted in larger QALYs gains at acceptable cost. The location-based is cost-saving if the price of classifier declines.