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Pediatric medical devices lag behind adult devices due to economic barriers, smaller patient populations, changing anatomy and physiology of patients, regulatory hurdles, and especially difficulties in executing clinical trials. We investigated the requirements, challenges, associated timeline, and costs of conducting a multi-site pivotal clinical trial for a Class II pediatric physiologic monitoring device.
Methods:
This case study focused on the negotiation of clinical trial agreements (CTAs), budgets, and Institutional Review Board (IRB) processing times for a pediatric device trial. We identified key factors contributing to delays in clinical trial execution and potential best practices to expedite the process while maintaining safety, ethics, and efficacy.
Results:
The total time from site contact to first patient enrollment averaged 14 months. CTA and budget negotiations were the most time-consuming processes, averaging nearly 10 and 9 months, respectively. Reliance and local IRB processing also contributed significantly to the timeline, overall adding an average of 6.5 months across institutions. Nearly half of all costs were devoted to regulatory oversight. The COVID-19 pandemic caused significant slowdowns and delays at multiple institutions during study enrollment. Despite these pandemic-induced delays, it is important to note that the issues and themes highlighted remain relevant and have post-pandemic applicability.
Conclusions:
Our case study results underscore the importance of establishing efficient and standardized processing of CTAs, budget negotiations, and use of reliance IRBs to expedite clinical trial execution for pediatric devices. The findings also highlight the need for a national clinical trials network to streamline the clinical trial process.
Outcome-based commissioning – a set of arrangements to define and pay for a service based on pre-agreed outcomes – has been operationalized in some regional care settings (e.g., adult social care). However, it remains largely aspirational due to operational considerations and challenges. Outcomes-based commissioning shares a common goal with economic evaluation alongside health technology appraisal (HTA): to achieve value for money for outcomes from a finite budget.
Methods
We explored the considerations, implications, and challenges regarding the practical role of relevant outcomes in economic evaluation, relative to care commissioning, using England as a case study. Our exploration bridges a gap between economic evaluation evidence and practical resource allocation decision-making, focusing on conceptual (e.g., what are ‘relevant’ outcomes), practical considerations (e.g., quantifying and using relevant endpoints or surrogate outcomes alongside costs), and pertinent issues when linking these to commissioning based payment mechanisms.
Results
Firstly, there is a disconnect between existing economic evaluation approaches and commissioning processes. For example, using a single quality-adjusted life-year (QALY) maximum and limited consideration of affordability relative to cost effectiveness. Secondly, service-focused outcomes (e.g., seeing a specialist team) rather than person-focused outcomes (e.g., QALYs) are often desirable from a practical commissioning and service provider perspective as they make it easier to measure key performance indicators. Thirdly, both person- and service-focused payment structures could lead to market inefficiencies when activity is focused on only people for whom a prespecified outcome can be achieved or service delivered; these approaches require additional efficiency-equity tradeoff considerations (e.g., using distributional cost-effectiveness analyses).
Conclusions
We highlight payment structures as a major and complex consideration for commissioning, for which economic evaluation provides little to no consideration. Service-related outcomes and payments can be used as surrogate outcomes within economic modeling frameworks, while monitoring and evaluation can still be based on economic outcomes (e.g., QALYs and aggregated costs). Accounting for and explaining direct links from payment structures to economic outcomes is a major step to bridging a gap between economic evaluation evidence and practical resource allocation.
Recent research has identified a substantial increase in Indigenous mainstream employment since the mid-1990s, but there has been relatively little regional analysis of such employment. The aim of this article is to build on this previous research using the 2006 and 2011 censuses to provide a more disaggregated descriptive analysis of changes in the character of labour market outcomes for Indigenous Australians aged 15–64 years. One of the new findings in the article is that the employment of Indigenous youth (i.e. those aged 15–24 years) in remote areas is different from that of Indigenous youth in non-remote areas, but older Indigenous residents of such areas are not very different in employment terms. Policy-makers thus need to pay particular attention to Indigenous youth employment in remote areas because the failure to address these differentials may lead to a foreclosure of future labour market options. Policy also needs to facilitate Indigenous engagement in the mainstream economy by assisting Indigenous people to be work-ready, especially in ensuring that Indigenous skills are matched with employer demands, and expediting employment by informing businesses on how to provide an Indigenous-friendly workplace.
There have been a number of labour market programs that have attempted to increase rates of employment of Indigenous Australians by influencing job search behaviour. This paper provides the first ever baseline of data on the job search behaviour of Indigenous job seekers and how it compares to the job search of non-Indigenous job seekers. Clear differences between the job search behaviours of Indigenous and non-Indigenous Australians are apparent. Indigenous Australians rely disproportionately on friends and relatives as a source of information about jobs, although their networks tend to have less employed members, and therefore are less effective than non-Indigenous networks in securing employment. Non-Indigenous job seekers are also more likely to use more proactive search methods than are Indigenous job seekers.
The Pursuit of Style in Early Modern Drama examines how early modern plays celebrated the power of different styles of talk to create dynamic forms of public address. Across the sixteenth and seventeenth centuries, London expanded into an uncomfortably public city where everyone was a stranger to everyone else. The relentless anonymity of urban life spurred dreams of its opposite: of being a somebody rather than a nobody, of being the object of public attention rather than its subject. Drama gave life to this fantasy. Presented by strangers and to strangers, early modern plays codified different styles of talk as different forms of public sociability. Then, as now, to speak of style was to speak of a fantasy of public address. Offering fresh insight for scholars of literature and drama, Matthew Hunter reveals how this fantasy – which still holds us in its thrall – played out on the early modern stage.
The book’s Afterword turns from style to aesthetic judgment, considering how aesthetic judgments do not simply serve to hierarchize styles or render verdicts of approvement or opprobrium. Rather, aesthetic judgments are what allow us to see styles as styles; they are subjective projections on objective forms of aesthetic coherence. It is such interplay between the subjective and the objective that makes both style and judgment into important forms of humanistic knowledge.
Irregular in its rhythms, inventive in diction, and rebarbatively directed against some hapless target, tough talk flourishes in verse satires of the period before making its way onto the stage, enjoying special prominence in Ben Jonson’s Every Man Out of His Humour and John Marston’s Malcontent. In these plays no less than in the poems that precede them, tough talk remedies the alienation of public life in a crucial respect: Through its insistently corporeal language, tough talk gives a virtual body to a public that, as an imaginary entity, necessarily has none of its own. Because it compels vicarious identification by attacking people for their absurdities of comportment, tough talk is a style, but it is also the denuded expression of that judgment we recognize as taste. The vicarious relationship that tough talk, as judgment and style, coordinates between absent witness and present speaker finds its surprising culmination in the figure of the celebrity, a figure of taste whose insistent embodiment likewise invites vicarious identification from a bodiless public, often through pointedly antagonistic means. Early modernity’s great emblem of celebrity is Mary “Moll” Frith, the outspoken, cross-dressing pickpocket who found herself depicted as the outspoken protagonist of The Roaring Girl.
“Love talk” names that style of talk that is only too familiar to scholars of the early modern period: Heavily sonorous, rich in modifiers, and overflowing with figures of physical dissolution, love talk is a style marked above all by cliché. The last of these figures have posed a burden to critics of Romeo and Juliet, who have sought to recover Shakespeare’s tragedy from the deadening grip of the cliché. In so doing, they have suppressed the play’s self-conscious embrace of the cliché. This chapter argues that Romeo and Juliet is a script for following scripts of love. The tragedy shows how love enlists the most publicly circulated linguistic forms so that it might be experienced as a private, self-generated, and formless event. The seduction of this script is thus its central contradiction: Love is an experience that extricates the lover from the social by immersing the lover so completely within its forms that they may be forgotten. Love-talk is central to this dialectic. The style’s insistent, even unbearable artifice recalls earlier love stories for the present one to follow. It also turns Romeo and Juliet itself into another such story for audiences to follow in turn.
Stage talk is a style that makes theater out of one’s own mastery of talk by generating a density of formal coherence in place of the messiness that ordinary conversation entails. As Erving Goffman has proposed, “[e]very transmission … is necessarily subject to ‘noise.’” In conversation, this noise manifests as interruptions, overlaps, false starts, rewinds, and other influencies. And yet we manage to filter out such static as extraneous to the conversation at hand, often with such success that we might be surprised to discover their inclusion in a transcript of what we had just experienced. Stage talk aestheticizes the idealization of form that subtends representations of speech: It purifies the noise that defines ordinary talk – interruptions, false starts, gaffes are gone – in order to impart utterance a conspicuous poetic coherence. The actor who delivers this language to audiences assembled at a playhouse constitutes the early modern period’s animating fantasy of publicness, which is the fantasy that a style of talk can turn one from a stranger into a spectacle for other strangers to imitate.
Court talk is not the style that early modern courtiers use to speak to one another. It is an ersatz substitute for that style, an outsider’s fantasy about insider talk. Taken from conduct manuals, prose romances, poems, and plays, court talk is an overdone approximation of how courtiers are imagined to speak. Tracking the efflorescence of this style, this chapter turns to the still-neglected plays of John Lyly, which sell to their audiences the fantasy that their highly decorated style was the argot of the Elizabethan court. It is a fantasy that prompts aspirants from the period to weave Lyly’s style into their own conversations, even though it is only an exaggerated version, an erudite caricature, of the way Elizabethan barons and lords actually spoke. The failure of court talk to approximate courtliness is exactly what makes it into a synecdoche for a burgeoning social imaginary that I call the courtly public sphere. Through its relentless isocola, court talk expresses what Lauren Berlant might call the “cruel optimism” of this social imaginary: the emptiness of its promise of belonging, and the impossibility of ever letting that promise go.
Celebrated as one of the foundational stylistic achievements of early modernity, plain talk is characterized primarily in terms of what it is not: not conspicuous, not decorated, not Latinate, not complicated. Plain talk is the most unmarked style imaginable. Scholars have generally consulted written works like Bacon’s essays for examples of this paradoxically styleless style, but this chapter turns to drama because drama stages the effects that the plain style has – or was hoped to have – on others. In city comedies like Ben Jonson’s Every Man in His Humour, Thomas Middleton’s A Chaste Maid at Cheapside, and John Marston’s Dutch Courtesan, plain talk projects a speaker who is, or seems to be, in public exactly as they are in private. But there is also a palpable anxiety that swirls around dramatic depictions of plain talk. It is a style that gains its full meaning and force from its relation to other styles. But it is also the result of plain talk’s distinguishing lack of distinguishing features. Brimming beneath any iteration of this unmarked style is the dread that it will go unremarked, lost in the anonymity of public life.
Blood glucose level (BGL) is routinely assessed by paramedics in the out-of-hospital setting. Most commonly, BGL is measured using a blood sample of capillary origin analyzed by a hand-held, point-of-care glucometer. In some clinical circumstances, the capillary sample may be replaced by blood of venous origin. Given most point-of-care glucometers are engineered to analyze capillary blood samples, the use of venous blood instead of capillary may lead to inaccurate or misleading measurements.
Hypothesis/Problem:
The aim of this prospective study was to compare mean difference in BGL between venous and capillary blood from healthy volunteers when measured using a capillary-based, hand-held, point-of-care glucometer.
Methods:
Using a prospective observational comparison design, 36 healthy participants provided paired samples of blood, one venous and the other capillary, taken near simultaneously. The BGL values were similar between the two groups. The capillary group had a range of 4.3mmol/l, with the lowest value being 4.4mmol/l and 8.7mmol/l the highest. The venous group had a range of 2.7mmol/l, with the lowest value being 4.1mmol/l and 7.0mmol/l the highest.
For the primary research question, the mean BGL for the venous sample group was 5.3mmol/l (SD = 0.6), compared to 5.6mmol/l (SD = 0.8) for the capillary group. This represented a statistically significant difference of 0.3mmol/l (P = .04), but it did not reach the a priori established point of clinical significance (1.0mmol/l). Pearson’s correlation coefficient for capillary versus venous indicated moderate correlation (r = 0.42).
Conclusion:
In healthy, non-fasted people in a non-clinical setting, a statistically significant, but not clinically significant, difference was found between venous- and capillary-derived BGL when measured using a point-of-care, capillary-based glucometer. Correlation between the two was moderate. In this context, using venous samples in a capillary-based glucometer is reasonable providing the venous sample can be gathered without exposure of the clinician to risk of needle-stick injury. In clinical settings where physiological derangement or acute illness is present, capillary sampling would remain the optimal approach.