22 research outputs found
After Actavis: Seven Ways Forward
No full textThe Supreme Court’s decision in FTC v. Actavis is one of the most important antitrust decisions in the modern era. This symposium in the Rutgers University Law Review, which accompanied a live conference at the University of San Francisco Law School, consists of seven articles that provide guidance on Actavis.
This foreword introduces the articles, which (1) explain why courts have misconstrued Actavis (Davis & McEwan); (2) articulate the “Actavis inference” and show how it reveals errors in court opinions and scholarship (Edlin, Hemphill, Hovenkamp, & Shapiro); (3) offer a set of jury instructions that courts can use in reverse-payment cases (Sorenson & Shadowen); (4) explain why brand promises not to introduce their own generics constitute payment (Carrier); (5) show how state law can target reverse-payment settlements (Johnson); (6) explain why the Noerr-Pennington doctrine does not immunize reverse-payment settlements (Garcia); and (7) demonstrate how Actavis can apply beyond the pharmaceutical industry (Ghosh)
Quasi-experimental design in the evaluation of outcomes of health services in New Zealand
No full textBackground:
The New Zealand health system constantly needs to adapt its services to address changes in population needs, technology, or models of care. It is important to be able to determine if the changes made are achieving the outcomes desired. Frequently a randomised controlled trial is not acceptable, feasible, or the best choice for undertaking outcome evaluations. A quasi-experimental evaluation may be an alternative, but there are important concerns about their internal validity. Outcome evaluations that are not accurate may lead to poor decisions which will adversely impact our health services.
Aims:
This thesis aims to determine the role Quasi-Experimental approaches should take in improving information for making decisions in New Zealand health services.
Its goal is to answer four questions:
1. What is the place of quasi-experimental outcome evaluation in the New Zealand health service?
2. What is current New Zealand health service quasi-experimental outcome evaluation practice?
3. Do quasi-experimental methods lead to results with strong internal validity, and in what circumstances?
4. How should we undertake quasi-experimental outcome evaluations, and how should we assess our evaluations internal validity?
The thesis has a focus on internal validity, whilst acknowledging that other validities, in particular construct validity and statistical conclusion validity, also play a vital role in determining the usefulness of quasi-experimental approaches.
Methods:
Three substantial pieces of work are described in the thesis. Each of these provides information to answer one or more of the above questions.
Firstly, current New Zealand practice of quasi-experimental outcome evaluation is examined through a review of 50 evaluations. The review determines the types of study designs used, and then critiques each study for risk of bias against a 15-item tool developed by the author.
Secondly, it reviews the literature on quasi-experiments; in particularly undertaking a systematic review of the published within-study-comparison studies. These studies provide an empirical way of examining quasi-experiments’ internal validity by comparing their results with Randomised Controlled Trials (RCTs) done under similar conditions. I examine the degree to which different quasi-experimental study designs can achieve unbiased intervention effect estimates, and what other design features are associated with reducing bias.
Finally, I report on six quasi-experimental outcome evaluations, that I have led in Waitemata and Auckland District Health Boards (DHBs). These are analysed as case-studies using a structure similar to the tool discussed above. In particular, the case studies examine the utility of these evaluations, and the difficulties of undertaking quasi-experiments in the New Zealand health service setting.
Results:
Currently, most New Zealand quasi-experimental outcome evaluations use weak designs, particularly uncontrolled before-and-after designs. They also frequently use methodology that cannot effectively address bias risks. There is a considerable risk that these evaluations provide incorrect information to decision makers.
Strong study designs; including controlled before-and-after designs, interrupted time series, and regression discontinuity designs, will usually produce intervention effect estimates that are similar to an RCT. Controlled-after only studies are at greater risk of bias. However, not uncommonly, even these strong designs will deliver biased estimates. There is considerable evidence on how to best undertake these designs to reduce risk of bias. However, it is not possible to say, from the evidence presented, that following this advice will guarantee unbiased results.
The case studies found that quasi-experimental outcome evaluations are acceptable, feasible and valued by the DHBs. It was possible to use strong designs and follow recommended methodology, with reasonable expectation of strong internal validity in some cases. However,
a wide range of difficulties were also experienced. Particularly important limitations are the lack of opportunity for the evaluator to influence the project being studied to strengthen the proposed evaluation, and limitations in the type of outcome data available for evaluation.
Conclusions:
Quasi-experimental approaches should play an important role in evaluating the outcomes of changes in New Zealand. Whilst they cannot reach the degree of certainty of internal validity of an RCT, the use of strong designs and good methodology provides useful estimates of intervention effects. There is evidence that current practice usually does not meet these requirements.
Chapter 13 of this thesis provides advice on when and how to undertake a quasi-experimental outcome evaluation, or on how to assess an evaluation done by others. All designs must attribute variation in outcomes between the intervention and comparison group, or variation in outcomes over time, or, preferably, both to the intervention. Better evaluations can be achieved with more outcome data over groups and time, good design, and, by using good methodology. Achieving internal validity through the use of quasi-experimental studies is complex. Therefore every evaluation must systematically consider the elements of the evaluation (participants, intervention, comparison, outcomes, and time), the data and design to be used, and what threats to interval validity are likely.
Limitations and policy implications are discussed
Information Gaps and Misinformation in the 2022 Elections
Get PDFThe problem of election misinformation is vast. Part of the problem occurs when there is high demand for information about a topic, but the supply of accurate and reliable information is inadequate to meet that demand. The resulting information gap creates opportunities for misinformation to emerge and spread.One major election information gap developed in 2020, when the Covid-19 pandemic drove many states to expand access to voting by mail. Inadequate public knowledge about the process left room for disinformation mongers to spread false claims that mail voting would lead to widespread fraud. Election officials could not fill information gaps with accurate information in time. As is now well known, no less than former President Trump promoted these false claims, among others, to deny the 2020 presidential election results and provoke the January 6, 2021, attack on the U.S. Capitol.In 2022, false narratives about a stolen 2020 election persist, even as an unprecedented spate of restrictive voting law changes across the country has created fresh information gaps and, thus, fresh opportunities for misinformation. Since 2020, at least 18 states have shrunk voting access, often in ways that dramatically alter procedures voters might remember from the past. Meanwhile, lies and vitriol about the 2020 election have affected perceptions of election administration in ways that complicate work to defend against misinformation.This paper identifies some of the most significant information gaps around elections in 2022 and new developments in elections oversight that will make it harder to guard against misinformation. Ultimately, it recommends strategies that election officials, journalists, social media companies, civic groups, and individuals can and should use to prevent misinformation from filling gaps in public knowledge. Lessons from other subjects, such as Covid-19 vaccine ingredients and technologies, show how timely responses and proactive "prebunking" with accurate information help to mitigate misinformation
Qualitative social research in addictions publishing: Creating an enabling journal environment.
Get PDFInfrastructure project finance and capital flows : a new perspective
Get PDFThe success with which middle-income indebted developing countries have gained access to private international finance in the 1990s is a tribute to their own domestic economic performance, international policy in dealing with the debt crisis of the 1980s, and innovation in international financial markets. Emphasizing the role of private infrastructure investment as a vehicle for attracting foreign capital to developing countries in the 1990s, the authors develop an analysis model to examine what determines the credit-risk premium on infrastructure projects in the country-risk environment of developing countries. They also provide tentative quantitative evidence of the importance of macroeconomic and project-specific attributes of project risk. Their key finding is that the market seems to impose a high-risk premium on loans to countries with high inflation and to projects in the road sector.Payment Systems&Infrastructure,Banks&Banking Reform,Financial Intermediation,International Terrorism&Counterterrorism,Environmental Economics&Policies,Financial Intermediation,Economic Theory&Research,Environmental Economics&Policies,Public Sector Economics&Finance,Banks&Banking Reform
Evaluating the Effects of an Exercise Program (Staying UpRight) for Older Adults in Long-term Care on Rates of Falls: Study Protocol for a Randomised Controlled Trial
Get PDFBackground: Falls are two to four times more frequent amongst older adults living in long-term care (LTC) than community-dwelling older adults and have deleterious consequences. It is hypothesised that a progressive exercise program targeting balance and strength will reduce fall rates when compared to a seated exercise program and do so cost effectively. Methods/design: This is a single blind, parallel-group, randomised controlled trial with blinded assessment of outcome and intention-to-treat analysis. LTC residents (age ≥ 65 years) will be recruited from LTC facilities in New Zealand. Participants (n = 528 total, with a 1:1 allocation ratio) will be randomly assigned to either a novel exercise program (Staying UpRight), comprising strength and balance exercises designed specifically for LTC and acceptable to people with dementia (intervention group), or a seated exercise program (control group). The intervention and control group classes will be delivered for 1 h twice weekly over 1 year. The primary outcome is rate of falls (per 1000 person years) within the intervention period. Secondary outcomes will be risk of falling (the proportion of fallers per group), fall rate relative to activity exposure, hospitalisation for fall-related injury, change in gait variability, volume and patterns of ambulatory activity and change in physical performance assessed at baseline and after 6 and 12 months. Cost-effectiveness will be examined using intervention and health service costs. The trial commenced recruitment on 30 November 2018. Discussion: This study evaluates the efficacy and cost-effectiveness of a progressive strength and balance exercise program for aged care residents to reduce falls. The outcomes will aid development of evidenced-based exercise programmes for this vulnerable population. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12618001827224. Registered on 9 November 2018. Universal trial number U1111-1217-7148
Intimidation of State and Local Officeholders: The Threat to Democracy
Get PDFThe January 6 insurrection at the Capitol seemed to mark a new peak in extremist intimidation targeting public officials. But it was hardly the only act of political violence to break the period of relative stability that followed the assassinations of the 1960s. There was the 2017 shooting of U.S. Rep. Steve Scalise and colleagues by a Trump detractor. There was the hammer attack on U.S. Rep. Nancy Pelosi's husband by a right-wing conspiracy theorist who sought the then House speaker in her home. Then there were threats by Republican extremists against Republican members of Congress for refusing to support their preferred candidate for speaker. These acts grabbed headlines and spurred increases in security for federal officials.Yet over the same period, with far less attention and often little recourse, officeholders serving in local and state government across the country have faced a barrage of intimidating abuse. Threats and attacks constrain how freely officeholders interact with constituents, narrow the spectrum of policy positions they feel safe to support, and make them less willing to continue in public service. Unaddressed, the problem stands to endanger not just individual politicians but, more broadly, the free and fair functioning of representative democracy — at every level of government."Last fall was the last really serious death threat I got," one state legislator told the Brennan Center. "It was like date, time, location specific. They were going to kill me and then go to the police station and blow themselves up and take as many officers with them as possible."A series of national surveys completed in October 2023 — one of state legislators and four quarterly surveys of local officeholders — and three dozen in-depth interviews reveal how significantly abuse affects the tenure of these officeholders and shapes their decisions. Taken together, the data sets represent more than 1,700 officials from all 50 states and include a range of ages, party affiliations, ideologies, genders, sexual orientations, racial and ethnic identities, and religions
Of good use or serious pleasure : Vitruvius Britannicus and early eighteenth century architectural discourse
Get PDFThe central thesis of this work is that Colen Campbell's
three volume Vitruvius Britannicus (1715-25) is not, as it has been frequently seen, a Palladian manifesto designed to change architectural practice in England (and in the process Campbell's own fortunes as an architect), but rather a publication celebrating architectural achievements, consumed by polite society.
The twentieth century view of Vitruvius Britannicus, stems from John Surnmerson's seminal work, Architecture in Britain 1530-1830. It posits Vitruvius Britannicus as a stylistic manifesto that served the particular interests of Colen Campbell and his associates as advocates of and builders in the Palladian style, and foregrounds the idea of the author. This view has been incorporated almost unquestioningly into subsequent interpretations not least
because it conforms to a powerful 'Whig' interpretation of history emphasising periodisation, style, revolution, development, and the search for origins. In contrast I argue that Vitruvius Britannicus met the demands of a market interested in architecture as a topic of polite
conversation. The subscription lists for Vitruvius Britannicus show that it was neither priced to be, nor received as, a builder's manual, nor was it a stylistic manifesto. Rather, it was a celebration of contemporary British architecture that gave pleasure and some instruction to polite society. Drawing on disciplines outside of art and architectural history, I consider
Vitruvius Britannicus as an object of consumption offering an alternative reading of the publication that highlights a number of important avenues for further research.
Chapter 1 positions the thesis within critiques of stylistic history. Chapter 2 briefly introduces
some historiographic issues, and then considers the contents and style of the publication, and
the nature of its subscribers. This highlights issues neglected in histories of Vilruvius Britannicus and challenges many of the commonly held conceptions of the publication. These conceptions are then examined in Chapter 3 in the light of evidence and issues raised in the
previous chapter. Chapter 4 considers other architectural and illustrated books and positions Campbell's work within wider publishing paradigms such as cartography and a literature of tourism. Chapter 5 outlines some of the intellectual ideas that influenced the way in which
publications such as Vitruvius Britannicus were understood. This is developed in Chapter 6 which considers the way in which Vitruvius Britannicus functioned within a contemporary
architectural discourse that codified the group identity of a polite elite
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Seafood, fatty acid biosynthesis genes, and multiple sclerosis susceptibility
Get PDFBackground:
The role of omega-3 fatty acid in multiple sclerosis (MS) susceptibility is unclear.
Objective:
To determine whether fish/seafood intake or genetic factors that regulate omega-3 fatty acids levels are associated with MS risk.
Methods:
We examined the association of fish and shrimp consumption and 13 tag single nucleotide polymorphisms (SNPs) in FADS1, FADS2, and ELOV2 with risk of MS in 1153 individuals from the MS Sunshine Study, a case-control study of incident MS or clinically isolated syndrome (CIS), recruited from Kaiser Permanente Southern California.
Results:
Consuming fish/seafood at least once a week or at least once a month with regular fish oil use was associated with 44% reduced odds of MS/CIS (adjusted OR = 0.56; 95% CI = 0.41–0.76; p = 0.0002) compared with consuming fish/seafood less than once a month and no fish oil supplementation. Two FADS2 SNPs (rs174611 and rs174618) were independently associated with a lower risk of MS (adjusted ORs = 0.74, 0.79, p = 0.0056, 0.0090, respectively). Association of FADS2 SNPs with MS risk was confirmed in an independent dataset.
Conclusion:
These findings suggest that omega-3 fatty acid intake may be an important modifiable risk factor for MS. This is consistent with the other known health benefits of fish consumption and complementary genetic studies supporting a key role for omega-3 regulation.The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The research was supported by NIH (NINDS 1R01NS075308, A.L.-G.; NIH/NIEHS R01 ES017080, L.F.B.; NINDS R01NS071463, E.W.). The funding sources had no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication
個別性と普遍性 : Jude the Obscureのひとつの問題点
Get PDFapplication/pdfIt is a remarkable lack of development that we can regard as one of the most important features of the characters in Thomas Hardy's fictions. His characters maintain their fixity of their view of life or values against the outer world even after they have passed through plenty of hard affairs and obstacles. When we appreciate his last novel, Jude the Obscure, in that light, we can see rather a peculiar fact in this work which does not exist in Hardy's other works. It is the fact that the hero, Jude, unlike the fixed characters of the earlier works, develop through some of his experiences in life and that this is the main element of the work. Jude's experiences are explained by the author himself in the Postscript added to the First Edition; which are the problem of marriage, the difficulties "of acquiring knowledge in letters without pecuniary means" and the struggle of personal life against social conventions. These problems have various kind of influences on the hero's development. But we cannot overlook another fact that there is a certain kind of abstractness in this work. The world which Jude throws himself into has not the sense of concreteness of everyday life that has made real and solid the world of the English novel since Defoe. The problem besetting Jude's life is that antinomy of the conflict between social life and private, personal life which is one of the important themes of the English Bildungsroman. After the failure of his married life with Arabella and the frustration of his ambition of a college education in Christminster, he succeeds in flinging away his subjective dreams and illusions, and discovers a real life. When he glimpses "his destiny among the manual toilers", he grasps the chance of growing "a working-class hero". But he cannot retain this destiny to the last, because the author generalizes Jude's private affliction to the universal fate of man, instead of giving him any real foundation of a civil life. The unsubstantially of this work grows out of such an unreal and generalized description of the relations between the hero and the outer world. This fact is brought to light more radically in his last self-recognition. After losing realistic and struggling relation with Sue, Jude, who has discovered a real life and has recognized the significance of his existence as a victim in the society whose "formulas have something wrong", suddenly begins to be an unreasonably spiritualized man. He tells Mrs. Edlin in a form of monologue about the gap between the time's and his (and Sue's) ideas. His recognition presented in this monologue is not the natural result of the inner development through his real experiences but is derived from a certain generalized view point based on the universal interpretation of man and society
