Thesis (Ph. D.)--University OF MICHIGAN. / CO-CHAIRMEN: ISADORE A. BERNSTEIN; RAJ S. MITRA.

Thesis (Ph. D.)--University OF MICHIGAN.

Thesis (Ph. D.)--University OF MICHIGAN.

Thesis (Ph. D.)--University OF MICHIGAN.

Thesis (Ph. D.)--University OF MICHIGAN.

DISSERTATION (PH.D.)--THE UNIVERSITY OF MICHIGAN / CO-CHAIRMEN: ISADORE A. BERNSTEIN; RAJ S. MITRA

The underlying theme of this dissertation is the effects of clinical and federal policy on health, utilization, and expenditures among children and young adults. In Chapter 1, I evaluate the clinical and economic benefits of clinical practice guidelines recommending universal cerebrospinal fluid testing in the emergency department for febrile infants aged 29-56 days. Using a difference-in-differences approach and administrative data from 31 U.S. children’s hospitals, I find that these guidelines are not associated with better clinical outcomes or lower health care spending, suggesting that many families of older infants could be spared the stress associated with cerebrospinal fluid testing without harm. The optimal management of older febrile infants in the emergency department has been debated for decades, and results from this study have the potential to change clinical practice at the hospital level. In Chapter 2, I assess the impact of the Affordable Care Act dependent coverage provision on health care utilization, health, and health care expenditures among young adults aged 19-25 years. Using a difference-in-differences analysis of nationally representative data, I find that implementation of the provision was associated with improved self-reported health and improved financial protection against the costs of health care among young adults. These findings highlight the importance of continued efforts to expand insurance coverage in this population. In Chapter 3, I investigate whether insurance coverage loss drives differences in access and health care utilization between older adolescents and young adults with asthma. I find that young adults with asthma are less likely to have a usual source of care, to use outpatient care, and to fill asthma medication prescriptions compared with older adolescents with asthma. Differences in insurance coverage account for large proportions of these differences. In a longitudinal analysis, I also find that older adolescents with asthma who lose insurance coverage as they transition to young adulthood are less likely to have a usual source of care. Taken as a whole, these results suggest that insurance coverage plays a crucial role in ensuring access to care and encouraging optimal health care utilization patterns for adolescents and young adults with asthma. / Health Policy

NOTA: NOT A GOOD ACT FOR TISSUES TO FOLLOW The National Organ Transplant Act of 1984 (NOTA) articulates the U.S. federal policy for organ transplantation. It seeks to ensure equitable allocation of donor organs and strives to increase the number of organs available for transplant. A trio of ethical concerns—commodification, exploitation, and coercion—motivated passage of NOTA broadly and the prohibition on organ sales in particular. Notably, NOTA does not distinguish between organs and tissues, a devastating oversight given the differences between the two, which include: who can donate; when donation can occur; how donated items are procured, processed, and stored; who receives the donated item and why; and government oversight. Tissues are not like organs in the ways that made NOTA an appropriate legislative solution to commodification, exploitation, and coercion. Rather, NOTA failed to address tissue-specific concerns both ethical and practical in nature. Thus, there is an acute need to develop tissue-specific legislation that enhances informed consent to protect donor autonomy; sets a schedule of payments for donors and intermediaries to promote distributive justice; and improves tracking of donated tissues to address patient safety concerns. REGULATORY UNCERTAINTY, CONCEPTUAL CONFUSION, AND A PATH FORWARD ON OFFERS OF PAYMENT TO RESEARCH PARTICIPANTS The practice of offering payment to individuals in exchange for their participation in clinical research is widespread and longstanding. Nevertheless, such payment remains the source of substantial debate, in particular about whether or the extent to which offers of payment coerce and/or unduly induce individuals to participate. Yet, the various laws, regulations, and ethical guidelines that govern the conduct of human subjects research offer relatively little in the way of specific guidance regarding what makes a payment offer ethically acceptable. This paper systematically examines the legal and ethical dimensions of offering payment to research participants. It argues that concerns about offers of payment to research participants can be attributed to the misguided view that such offers ought to be treated differently than offers of payment in other contexts, a form of “research exceptionalism.” We show that rejection of research exceptionalism with respect to payment helps settle open debates about both how best to define coercion and undue influence, and how to understand the relation between these concepts and offers of payment. We argue for adoption of our preferred definitions, ideally by regulatory authorities, and against the conventional conservatism toward payment of research participants. Instead, we draw attention to the rarely asked, even radical, question: are research participants paid enough? We conclude by arguing that we ought to change the default to favor, rather than encourage suspicion of, offers of payment to research participants. EBOLA & FDA: REVIEWING THE RESPONSE TO FIND LESSONS FOR THE FUTURE In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in history. At the onset of the outbreak—as now—there were no therapies approved by the U.S. Food and Drug Administration (FDA) for prevention of, post-exposure prophylaxis against, or treatment of EVD. As a result, the outbreak spurred interest in developing novel treatments and vaccines; sparked calls to use experimental interventions in the field; and highlighted challenges to the standard approach to FDA approval of new drugs. Although the outbreak was geographically centered in West Africa, it brought to the fore issues of food and drug law and showcased FDA’s global role in drug development, approval, and access. FDA’s response to EVD highlights the panoply of Agency powers and demonstrates the flexibility of FDA’s regulatory framework. This paper evaluates the strengths and weaknesses of FDA’s response and makes policy recommendations regarding how FDA should respond to new and re-emerging public health threats going forward. The current pandemic of Zika virus infection is but one example of an emerging health threat that will require FDA involvement in order to achieve a successful response. / Health Policy

Peak fingertip blood lactate values obtained following maximal intensity simulated double poling ski exercise (PBLa(A)), were compared with peak fingertip blood lactate values obtained following maximal intensity simulated combined arm and leg ski striding exercise (PBLa(A + L)). The combined arm and leg protocols were performed on two different types of treadmills, a walking treadmill and a ski treadmill. Phase one combined arms and legs ski striding protocol (A + L)$\sb1$, involved ski walking on a treadmill with simultaneous arm poling movements achieved through a rope pulley system. Phase two combined arms and legs ski striding protocol (A + L)$\sb2$, whereby skiers using skis and poles performed a diagonal stride on a carpeted treadmill. The arms only double poling exercise protocol(A), was conducted identically in both test phases. Kneeling on a trolley or rollerboard, skiers pulled themselves up a 95 inch inclined track using rope pulleys at a cadence of one pull every 2.5 seconds. Peak blood lactate values represented the highest blood lactate value obtained from the post exercise samples. Differences in phase one and two PBLa(A + L) and MVO$\sb2$ values were related to the degree of sports specificity of the A + L protocol to cross-country skiing. (Abstract shortened by UMI.)

This study was performed in two phases. The goal of Phase 0 was to determine the current use of radiography in ankle injury patients in two large university hospitals. The goal of Phase I was to develop clinical decision rules that are sensitive for detecting significant fractures in adult ankle injury patients. All 70 significant fractures found in the 689 ankle x-ray series performed were identified among people who had pain near the malleoli and who either: (1) were age 55 or greater, or (2) had localized bone tenderness of the posterior edge or tip of either malleolus, or (3) were unable to bear weight both immediately after the injury and in the emergency department. Combining these four predictors yielded a decision rule that was 100% sensitive and 40.1% specific for detecting ankle fractures, and would allow a reduction of 36.0% of ankle x-ray series ordered. This study confirmed that the majority of ankle injury patients are currently being referred for radiography but that the yield of the x-rays for fracture is relatively low. Decision rules may permit clinicians to confidently reduce the number of x-rays ordered in adult ankle injury patients and thereby reduce unnecessary costs to the health care system. (Abstract shortened by UMI.)