Successful Claims Research Articles

A Review of Patient-Reported Outcome Labels in the United States: 2006 to 2010

ObjectiveIn 2004, Willke and colleagues reviewed the efficacy endpoints reported in the labels of new drugs approved in the United States from 1997 through 2002 to evaluate the use of patient-reported outcome (PRO) endpoints. Of the labels reviewed, 30% included PROs. Our study aimed to build on this work by describing the current state of PRO label claims granted for new molecular entities (and biologic license applications since February 2006 after the release of the US Food and Drug Administration (FDA) draft PRO guidance. MethodsAll new molecular entities and biologic license applications approved by the FDA from January 2006 through December 2010 were identified by using the Web page of the FDA Drug Approval Reports. For all identified products, drug approval packages and approved product labels were reviewed to identify PRO endpoint status and to determine the number and type of PRO claims. ResultsOf the 116 products identified, 28 (24%) were granted PRO claims; 24 (86%) were for symptoms, and, of these, 9 (38%) claims were pain related. Of the 28 products with PRO claims, a PRO was a primary endpoint for 20 (71%), all symptom related. ConclusionsThe FDA continues to approve PRO claims, with 24% of new molecular entities and biologic license applications being granted. Successful PRO label claims over the past 5 years have generally supported treatment benefit for symptoms specified as primary endpoints.

THE JANUS FACE OF INSURANCE IN SOUTH AFRICA: FROM COSTS TO RISK, FROM NETWORKS TO BUREAUCRACIES

ABSTRACTThis study examines the consequences of the rapid and unprecedented expansion of insurances for the poor in South Africa. Over the last ten years, South African insurance companies established a myriad of policies in order to incorporate the previously excluded, mostly African, poor and lower middle classes. While poverty, violence and AIDS put state institutions and social relations under pressure, insurances enable people to manage risks in hitherto unthinkable ways. The article examines the development of this new regime of risk as a Janus head, after the Roman god of opening and closing. At the heart of access to insurance were the incongruencies that were caused by the ‘translation’ of risk into the seemingly neutral concept of costs and the inability of brokers and intermediary organizations to navigate these translations successfully. Access to insurance – here not defined as having an insurance policy but as making a successful claim when confronted with the insured risk – was fraught with the contradictions of complex high-tech bureaucracies and the poor's social networks.

Restructuring Sovereign Debt Under Local Law: Are Retrofit Collective Action Clauses Expropriatory?

The European sovereign debt crisis has generated a number of controversial restructuring proposals that would have seemed appropriate only for emerging markets just a few years ago, but now are among the few options available to sustain the Eurozone. The leading proposal involves legislation that would mandate collective action clauses in untendered bonds governed under local law. This Note evaluates whether enacting this legislation and utilizing it in a debt restructuring would engender successful investor claims of invalid expropriation against the sovereign in American courts, and concludes that a successful claim of invalid expropriation is unlikely.

Vaccine Adverse Events

Millions of adults are vaccinated annually against the seasonal influenza virus. An undetermined number of individuals will develop adverse events to the influenza vaccination. Those who suffer substantiated vaccine injuries, disabilities, and aggravated conditions may file a timely, no-fault and no-cost petition for financial compensation under the National Vaccine Act in the Vaccine Court. The elements of a successful vaccine injury claim are described in the context of a claim showing the seasonal influenza vaccination was the cause of Guillain-Barré syndrome.

The Diverging Approach to Price Squeezes in the United States and Europe

Notwithstanding assertions of greater harmonization and convergence between United States and European Union competition law, recent case law has identified significant differences in their approaches to the regulation of a price or margin squeeze. In the US after linkLine the likelihood of a successful claim has been significantly diminished, particularly if there has been no prior course of voluntary dealing and no downstream predatory pricing. In contrast, in a series of decisions in liberalized telecommunications markets, the EU Courts in applying an “as efficient competitor test” have focused on the preservation of competitive rivalry as “equality of opportunity.” This significantly broadens the potential liability for a margin squeeze in the EU and reconstitutes EU competition law as a form of de facto regulation in liberalized markets. Faced with the uncertainty of this standard, the dominant firm has an incentive to avoid liability by raising its retail prices, to the detriment of consumers. This article evaluates this divergence in approach to the regulation of a price or margin squeeze in the US and EU and traces these approaches to differing conceptions of dominant firm regulation which in turn have informed different understandings of the regulation of a “refusal to supply” and the intersection of competition law with sector-specific regulation.

Does the Holland model of occupational choice (HMOC) perpetuate the Beancounter-Bookkeeper (BB) stereotype of accountants?

► Traces the development, validity, and influence of accountants in the Holland model of occupational choice (HMOC). ► The personalities of individuals who enter accountancy partially accord with the Beancounter-Bookkeeper (BB) stereotype. ► HMOC training increases perceptions that accounting work requires a BB personality. ► The HMOC's claim of greater job success and satisfaction among BB accountants lacks validity. ► The HMOC likely lessens the attractiveness of professional accounting to entrants who would best serve the public interest. This article investigates the Holland model of occupational choice's (HMOC) development, influence, and validity in relation to its classification of bookkeepers, accountants, and business professionals. Study 1 reanalyzes published data and provides evidence that the Beancounter-Bookkeeper (BB) stereotype, which is promoted in the HMOC, is partially predictive of the personality characteristics of individuals who choose to enter professional accountancy. Study 2 investigates the influence of HMOC training, and exposure to accounting education, on perceptions of the personality type needed for accounting work; results indicate that: (1) HMOC training is associated with perceptions that accounting work requires a BB personality, and (2) the importance of investigative skills to accounting work increase with accounting education. Following this, we review evidence that suggests low validity in the HMOC's claims of greater job success and satisfaction among BB accountants. Finally, we consider three possible processes that may explain Holland and colleagues’ conjoining of accountants with bookkeepers. Together, the analysis promotes skepticism regarding whether the HMOC's claim that professional accounting success demands a passive, compliant, subservient, i.e., BB, personality supports the public interest obligations of professional accountants.

The State of the Science 2012: building blocks for the future

The State of the Science 2012: building blocks for the future

Final data of the effects of the Neuro Emotional Technique (NET) for pediatric Attention-Deficit/Hyperactivity Disorder (AD/HD): A randomized controlled trial

Introduction: The literature reveals that two treatments have been validated as effective treatment modalities for pediatric AD/HD: psychosocial treatments, pharmacological treatments and their combination. However, controversy exists over the efficacy and safety of pharmacological therapies. As a result of this controversy, parents have been seeking complementary and alternative medicine (CAM) such as chiropractic for their children with AD/HD. The objective of this study was to determine whether the addition of the emotional component of NET therapy to an existing treatment program could improve clinical outcomes (i.e. reduce inattention, hyperactivity and impulsivity) in pediatric AD/HD. The purpose of this study was to test anecdotal claims of treatment success made by chiropractors using NET therapy for pediatric AD/HD. Methods: An approved clinical trial was conducted in four private clinics in Sydney, Australia. Children aged 5–12 years who met inclusion criteria were randomised into three groups: Group A (Sham n = 37), Group B (NET therapy n = 59) and Group C (Control n = 32). All groups continued with their existing treatment regimens (i.e. pharmacological and/or psychosocial). Groups A and B had sham and NET protocols added respectively to existing regimens. Psychometric outcome measures were chosen from the Conners’ Rating Scales (CRS), which were scored and interpreted by independent registered clinical psychologists. The psychologists, participants, parents and teachers of groups A and B were all blinded to group allocation. An analysis of covariance was conducted comparing the changes between baseline and final results (i.e. after seven months and 14 interventions) between the active group (NET) and placebo group (sham). Results: Forty-one participants (10 sham; 21 NET; 10 Control) completed the protocol. CRS classified changes of five or more subscale points as significant and thus -5 was chosen as the minimally clinically important difference (MCID). Decreases in global and behavioral indices were indicative of improvements in participants’ behaviors and were considered clinically meaningful results. At the conclusion of the study, only NET therapy group achieved the MCID (>−5). The intention to treat analysis revealed that NET therapy produced significant results for all primary and secondary outcomes: Conners ADHD Index (p = 0.000, CI: −13.03, −3.96); Conners Global Index (p = 0.006, CI: −13.70, −2.46); DSM-IV:Inattentive (p = 0.031, CI: −9.94, −0.49); DSM-IV:Hyperactive/Impulsive (p = 0.003, CI: −13.91, −2.98) and DSM-IV:Total (p = 0.006, CI: −12.75, −2.23). The Cohen's d coefficient revealed medium to high effect sizes (1.08, 0.82, 0.64, 0.89 and 0.82, respectively). These significant results denote improvements in global and behavioral indices (i.e. reductions in inattention, hyperactivity and impulsivity) in participants who received NET therapy. Conclusions: These results provide the first data towards answering the question: Does NET have a potential role to play in the management of pediatric AD/HD? This study has demonstrated clinically meaningful changes and significant results for the emotional component of NET therapy for pediatric AD/HD. Definitive recommendations cannot be made about the intervention at this time until a protocol using the whole spectrum of NET is undertaken.

Copula models for insurance claim numbers with excess zeros and time-dependence

This paper develops two copula models for fitting the insurance claim numbers with excess zeros and time-dependence. The joint distribution of the claims in two successive periods is modeled by a copula with discrete or continuous marginal distributions. The first model fits two successive claims by a bivariate copula with discrete marginal distributions. In the second model, a copula is used to model the random effects of the conjoint numbers of successive claims with continuous marginal distributions. Zero-inflated phenomenon is taken into account in the above copula models. The maximum likelihood is applied to estimate the parameters of the discrete copula model. A two-step procedure is proposed to estimate the parameters in the second model, with the first step to estimate the marginals, followed by the second step to estimate the unobserved random effect variables and the copula parameter. Simulations are performed to assess the proposed models and methodologies.

HR Update: Get ready for changes to unfair dismissal

Nursery WorldVol. 2011, No. 10 FeatureHR Update: Get ready for changes to unfair dismissalPublished Online:4 Mar 2014https://doi.org/10.12968/nuwa.2011.31.10.1096651AboutSectionsView articleView Full TextView EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View articleAbstractThe current qualification period for employees to bring an unfair dismissal claim to an employment tribunal is one year. From 6 April 2012 employees will require two years’ service to do so. However, employers need to understand the power of other staff rights which might result in a successful early claim, says Jacqui Mann, managing director of HR4Nurseries (www.hr4nurseries.co.uk) FiguresReferencesRelatedDetails 1 October 2011Volume 2011Issue 10ISSN (print): 0029-6422ISSN (online): 2059-9358 Metrics History Published online 4 March 2014 Published in print 1 October 2011 Information© MA Education Ltd

Toward safer practice in otology: A report on 15 years of clinical negligence claims

To determine the characteristics of medical negligence claims arising from otological practice. Retrospective analysis of medical negligence claims contained in the National Health Service Litigation Authority (NHSLA) database. Claims relating to otology and neurotology between 1995 and 2010 were obtained from the NHSLA database and analyzed for cause of injury, type of injury, outcome of claim and costs. Over 15 years there were 137 claims in otology, representing 26% of all the claims in otolaryngology. Of these, 116 have been closed, and 84% of closed claims resulted in payment. Of the 97 successful claims, 63 were related to operative complications. This included six cases of wrong side/site surgery, and 15 cases of inadequate informed consent. The most common injuries claimed were hearing loss, facial paralysis, and additional/unnecessary surgery. Middle ear ventilation and mastoid surgery were the procedures most commonly associated with a successful claim. There were 15 successful claims of misdiagnosis/delayed diagnosis, with chronic suppurative otitis media the condition most frequently missed. There were nine successful claims related to outpatient procedures, of which seven were for aural toilet and six claims of medical mismanagement, including three cases of ototoxicity from topical medications. There were also four successful claims for morbidity due to delayed surgery. This is the first study to report outcomes of negligence claims in otology. Claims in otology are associated with a high success rate. A significant proportion of claims are not related to surgery and represent areas where safety should also be addressed.

Facilitating change in undergraduate STEM instructional practices: An analytic review of the literature

AbstractThis article reviews current scholarship about how to promote change in instructional practices used in undergraduate science, technology, engineering, and mathematics (STEM) courses. The review is based on 191 conceptual and empirical journal articles published between 1995 and 2008. Four broad categories of change strategies were developed to capture core differences within this body of literature: disseminating curriculum and pedagogy, developing reflective teachers, enacting policy, and developing shared vision. STEM education researchers largely write about change in terms of disseminating curriculum and pedagogy. Faculty development researchers largely write about change in terms of developing reflective teachers. Higher education researchers largely write about change in terms of enacting policy. New work often does not build on prior empirical or theoretical work. Although most articles claim success of the change strategy studied, evidence presented to support these claims is typically not strong. For example, only 21% of articles that studied implementation of a change strategy were categorized as presenting strong evidence to support claims of success or failure of the strategy. These analyses suggest that the state of change strategies and the study of change strategies are weak, and that research communities that study and enact change are largely isolated from one‐another. In spite of the weak state of the literature, some conclusions related to the design of change strategies can be drawn from this review. Two commonly used change strategies are clearly not effective: developing and testing “best practice” curricular materials and then making these materials available to other faculty and “top‐down” policy‐making meant to influence instructional practices. Effective change strategies: are aligned with or seek to change the beliefs of the individuals involved; involve long‐term interventions, lasting at least one semester; require understanding a college or university as a complex system and designing a strategy that is compatible with this system. © 2011 Wiley Periodicals, Inc. J Res Sci Teach 48: 952–984, 2011

Trends in joint arthroplasty litigation over five years: the British experience

Increasing numbers of joint arthroplasty are performed in Britain. While associated complications are well documented, it is not known which of those initiate malpractice claims. A five-year period was assessed for trends to highlight areas for further improvement in patient information and surgical management. The National Health Service paid out almost £14 million for 598 claims. Forty per cent of this was for legal costs. The number of claims increased over time while the rate of successful claims decreased. A failure to consent adequately and to adhere to policies and standard practice can result in a successful malpractice claim. Protecting patients intraoperatively and maintaining high technical expertise while implementing policies and obtaining informed consent decreases the litigation burden.

Predator Interference with the Cinnabar Moth (Tyria jacobaeae) for the Biological Control of Tansy Ragwort (Senecio jacobaea)

AbstractQuantification of interference with biological control agents can provide support for anecdotal claims of success or failure of agent establishment and efficacy. This study was initiated because of observed predation of cinnabar moth larvae by carpenter ants when releasing larvae for the control of tansy ragwort, an invasive plant in Montana. Biotic and abiotic factors were compared among three sites with historically variable moth population establishment. Two experiments were developed to (1) observe and document insect activity, predation, or disappearance on tansy ragwort stems either protected or accessible to ants; and (2) quantify the effects of ant exclusion on herbivory of tansy ragwort. Site comparisons indicated that ant colony density was highest at the driest of three sites, and, interestingly, no ant colonies were detected at the site with higher observed numbers of moth larvae and adults and lower densities of tansy ragwort. Available substrate (logs and stumps) for ant colonization did not differ between the three sites. In the ant exclusion experiments, a larger number of larvae were missing on plants accessible to ants (63%) compared with plants where ants were excluded (39%) after 36 h. Direct observation of predation of larvae by carpenter ants accounted for 9% of missing larvae on stems accessible to ants. Larvae were able to consume 81% of original flowers or buds on ant-excluded stems, compared with 18% consumption on ant-accessible stems, suggesting that ant predation could limit the efficacy of cinnabar moth larvae. These results provide one of many possible explanations for the anecdotal observations of large, persistent populations of cinnabar moths in moist areas. This work emphasizes the importance of post-release observation and monitoring to detect and, ideally, quantify factors to support anecdotal perceptions regarding the fate and subsequent efficacy of insect biological-control agents.

Assessing the Director’s Duty of Care and Skill in the UK in the Light of the Financial Crisis

Based on publicly available information it appears that any claims against directors in the UK arising out of the financial crisis would most likely be based on breach of their duty of care, skill and diligence, rather than breach of fiduciary duties. However as yet no claims have materialised. The aims of this paper are to demonstrate that the manner in which the courts have applied the common law duty of care means that claims against bank directors face substantial obstacles. Moreover, the case-law suggests that codification of the duty of care in the Companies Act 2006 s.174 will not necessarily increase the likelihood of successful claims against directors in the future, save where the directors have wholly abnegated their responsibilities or breached their fiduciary duties. Even then, causation poses a considerable hurdle to success. This has contributed to an accountability gap with the result that overly risky behaviour may be insufficiently deterred.

A Human Rights-Based Approach (HRBA) in Practice: Evaluating NGO Development Efforts

Human rights-based approaches (HRBAs) promise greater alignment of development efforts with universal norms, as well as a focus on the root causes of poverty. While HRBAs have been widely adopted across the development sector, there is little systematic evidence about the actual impact of this strategic shift. Evaluating the effectiveness of HRBAs is challenging because various non-governmental and other organizations have developed very different understandings of how to apply a rights-based framework in the development context. This essay takes a step toward the rigorous evaluation of HRBAs by offering a comprehensive review of rights-based programming implemented by Plan International, a child-centered organization. It shows that Plan's adoption of HRBA-inspired strategies has transformed its interactions with local communities and added an explicit focus on the state as the primary duty bearer. There is evidence for a systematic increase in individual rights awareness, greater ownership exercised by community organizations, and the application of evidence-based advocacy aimed at scaling up proven program activities. But Plan's peculiar brand of HRBA neglects collaboration with domestic social movements and civil society, largely avoids a more confrontational approach towards the state, and has yet to produce evidence for regular successful rights claims by disadvantaged communities against governmental representatives at local, regional, or national levels. The study also reveals a limited ability of Plan to address disparities and discrimination within local communities, as well as a need to define clearly the organization's own accountability and duties deriving from its presence in local communities across more than fifty developing nations.

Single Entity Tests in US Antitrust and EU Competition Law

Competition law structures economic entities’ market behaviour. The notion of economic entity potentially captures distinct corporate legal persons within a single economic enterprise. To the extent that these distinct corporate legal entities present a single entity, competition law enforcement profoundly alters in scope.On the one hand, single entity notions provide a defense for multiple corporate entities to avoid antitrust scrutiny. On the other, they embolden competition authorities to impute fines for competition law infringements committed by subsidiaries or affiliates to parent or otherwise affiliated companies. The U.S. Supreme Court opinion in American Needle seems to have curbed enthusiasm for single entity defenses, whereas increasing reliance on parent company liability transformed EU single entity claims into powerful prosecutorial devices.This article explores the conditions to establish successful single entity claims in U.S. antitrust and EU competition law. Both legal orders apply similar conceptions of (corporate) control and (market) conduct to determine the scope of single entity claims. In so doing, control and conduct have been operationalized in different ways, leaving significant gaps or inconsistencies in the development of a true single entity test. The juxtaposition of both single entity approaches aims to contribute to remedying those inconsistencies.

An analysis of successful litigation claims in children in England

ObjectiveTo analyse the number of successful claims against the National Health Service (NHS) involving children, the nature and outcome of incidents leading to litigation and the costs of claims.MethodUnder the...

Injunctive Relief and Private Antitrust Enforcement

The paper analyses the role of injunctions in the private enforcement of competition law. Most commentators deal predominantly with damages actions and the European policy proposals only discuss the conditions for successful compensation claims. However, damages claims are likely to be the most expensive and time consuming remedy available. In many cases injunctive relief may be cheaper and, thus, be preferred by the victim. Asking the court to order the perpetrator to either cease from certain behaviour or to undertake certain actions, plaintiffs might be willing to forego compensation in exchange for a quicker dispute solution with effect for the future. The variety and flexibility of injunctive relief–injunctions can be granted on a preliminary basis or permanently, contain a prohibition or being mandatory–provides victims of anticompetitive conduct with a multi-functional tool to seek relief. The paper compares the usage of and the legal framework for injunctive relief in England and Wales and Germany. The antitrust litigation data available for both jurisdictions indicate that the use of injunctive relief in English and German courts differs greatly. Analysing the legal framework for injunctive relief, I will look at the judicial approach that is taken with respect to injunctions and the possible reason for a varying usage of this remedy.

Political Reparationists and the Moral Case for Reparations to Africa for Colonialism

This article is situated within the context of present discourse on reparations to Africa. It theoretically engages with one kind of the arguments for reparations to Africa for colonialism that have been made by political reparationists; namely the moral argument for reparations. The core of the moral argument is that colonialism developed the West and underdeveloped Africa, and for this Western nations have particular moral obligations to pay reparations. The article argues generally that political reparationists need to pay attention to the moral force with which the reparations argument is framed, and in particular that it would enhance and contribute to the overall pursuit of successful reparations claims if political reparationists endeavour to clearly articulate the normative framework