The potential utilization of a cold-contact approach to research recruitment, where members of the research team are unknown to the patient, has grown with the expanded use of electronic health records (EHRs) and affiliated patient portals. Institutions that permit this strategy vary in their implementation and management of it but tend to lean towards more conservative approaches. This process paper describes the Medical University of South Carolina’s transition to an opt-out model of “cold-contact” recruitment (known as patient outreach recruitment or POR), wherein patients can be contacted so long as they do not express an unwillingness to receive such communication. The work highlights the benefits of this model by explaining how it, in many ways, supports and protects autonomy, beneficence, and justice for patients. The paper then describes the process of standing up the recruitment strategy, communicating the change to patients and the community, and documenting study team contact and patient research preference. Data supporting increased access to potentially eligible patients of greater diversity as well as initial researcher feedback on perceived success of POR is also shared. The paper ends with a discussion of next steps to enhance the POR process via more detailed data collection and reengagement with community stakeholders.

In March 2018, the US Food and Drug Administration (FDA), US Centers for Disease Control and Prevention, California Department of Public Health, Los Angeles County Department of Public Health and Pennsylvania Department of Health initiated an investigation of an outbreak of Burkholderia cepacia complex (Bcc) infections. Sixty infections were identified in California, New Jersey, Pennsylvania, Maine, Nevada and Ohio. The infections were linked to a no-rinse cleansing foam product (NRCFP), produced by Manufacturer A, used for skin care of patients in healthcare settings. FDA inspected Manufacturer A's production facility (manufacturing site of over-the-counter drugs and cosmetics), reviewed production records and collected product and environmental samples for analysis. FDA's inspection found poor manufacturing practices. Analysis by pulsed-field gel electrophoresis confirmed a match between NRCFP samples and clinical isolates. Manufacturer A conducted extensive recalls, FDA issued a warning letter citing the manufacturer's inadequate manufacturing practices, and federal, state and local partners issued public communications to advise patients, pharmacies, other healthcare providers and healthcare facilities to stop using the recalled NRCFP. This investigation highlighted the importance of following appropriate manufacturing practices to minimize microbial contamination of cosmetic products, especially if intended for use in healthcare settings.

This session explored the compatibility of some of the world's most prominent international organizations and legal regimes with three Sustainable Development Goals (SDGs): SDG 5 (Achieve gender equality and empower all women and girls); SDG 10 (Reduce inequality within and among countries); and SDG 16 (Promote peaceful and inclusive societies, access to justice, and accountable and inclusive institutions at all levels). Panelists reflected on whether international legal rules and organizations addressed or hindered these goals across three dimensions.

Background: In recent years, there has been growing interest in evaluating the health and economic impact of medical devices. Payers increasingly rely on cost-effectiveness analyses in making their coverage decisions, and are adopting value-based purchasing initiatives. These analytic approaches, however, have been shaped heavily by their use in the pharmaceutical realm, and are ill-adapted to the medical device context.

Methods: This study focuses on the development and evaluation of left ventricular assist devices (LVADs) to highlight the unique challenges involved in the design and conduct of device trials compared with pharmaceuticals.

Results: Devices are moving targets characterized by a much higher degree of post-introduction innovation and “learning by using” than pharmaceuticals. The cost effectiveness ratio of left ventricular assist devices for destination therapy, for example, decreased from around $600,000 per life year saved based on results from the pivotal trial to around $100,000 within a relatively short time period.

Conclusions: These dynamics pose fundamental challenges to the evaluation enterprise as well as the policy-making world, which this paper addresses.

The seventh annual Teaching and Learning Conference (TLC) was held in Philadelphia, Pennsylvania, from February 5 to 7, 2010, with 224 attendees onsite. The theme for the meeting was “Advancing Excellence in Teaching Political Science.” Using the working-group model, the TLC track format encourages in-depth discussion and debate on research dealing with the scholarship of teaching and learning.

Abstract. Although exit polling has not been used to study Canadian elections before, such polls have methodological features that make them a potentially useful complement to data collected through more conventional designs. This paper reports on an experiment with exit polling in one constituency in the 2003 Ontario provincial election. Using student volunteers, a research team at Wilfrid Laurier University conducted an exit poll in the bellwether constituency of Kitchener Centre to assess the feasibility of mounting this kind of study on a broader scale. The experiment was successful in a number of respects. It produced a sample of 653 voters that broadly reflected the partisan character of the constituency, and which can hence be used to shed light on patterns of vote-switching and voter motivations in that constituency. It also yielded insights about best practices in mounting an exit poll in the Ontario context, as well as about the potential for using wireless communication devices to transmit respondent data from the field. The researchers conclude that exit polling on a limited basis (selected constituencies) is feasible, but the costs and logistics associated with this methodology make a province-wide or country-wide study unsupportable at present.

Résumé. Bien que les sondages “sortie des urnes” n'aient pas été utilisés jusqu'ici dans l'étude des élections au Canada, de tels sondages possèdent certaines caractéristiques qui en font un complément potentiellement très utile des méthodes plus traditionnelles de cueillette des données. Cet article rend compte d'un sondage “sortie des urnes” expérimental effectué dans une circonscription lors de l'élection provinciale de 2003 en Ontario. Utilisant des bénévoles étudiants, une équipe de recherche de l'Université Wilfrid Laurier a conduit un sondage “sortie des urnes” à Kitchener Centre, une circonscription indicatrice de tendance, afin de déterminer la faisabilité de ce type d'étude au niveau fédéral. L'expérience a réussi à plusieurs égards. Elle a fourni un échantillon de 653 électeurs qui reflétaient en gros le caractère partisan de la circonscription, ce qui a rendu possible l'étude des motivations des électeurs et des revirements de vote dans la région. L'expérience a aussi fourni des renseignements sur les pratiques exemplaires concernant l'utilisation des sondages “sortie des urnes” au niveau provincial, ainsi que sur la possibilité d'employer des techniques de communication sans fil pour transmettre les données recueillies des répondants. Les chercheurs ont conclu que les sondages “sortie des urnes” sont réalisables dans un cadre restreint, dans certaines circonscriptions sélectionnées, mais que les coûts et la logistique nécessités par cette méthodologie la rendent actuellement impraticable pour une étude à l'échelle provinciale ou nationale.

We report the synthesis of water soluble, monodisperse Fe/Au bimetallic nanoparticles with an average diameter of 7nm. Synthesis involves simultaneous reduction of Fe3+ and Au3+ in water to yield bimetallic nanoparticles. The elemental content of Fe is 1.5%. Nanoparticles exhibit ferromagnetic behavior as measured by SQUID. These particles can be easily conjugated to thiolated DNA, as evidenced by mobility shifts in agarose gel electrophoresis. Nanoparticles heat in solution to temperatures above 40°C, indicating suitability for hyperthermia.

A method for heating multiple types of magnetic nanoparticles independently is described. This technique exploits tuning of the size and material dependent properties of magnetic field heating of nanoparticles to allow independent heating by application of the field at different frequencies. Magnetic field heating experiments as a function of field frequency show that there is potential for this technique in vitro.

An intra-articular polymeric controlled release system was developed that is tailored to, and responsive to, the intensity of joint inflammation. Microspheres composed of the naturally occurring polyelectrolytes, gelatin and chondroitin sulfate, were synthesized by complex coacervation and the kinetics of release of encapsulated 14C-catalase was evaluated in vitro in the presence of inflammatory and non-inflammatory human joint fluids. The relative activity of gelatinase, a metalloprotease enzyme, was quantified in each of the joint fluids. Rate of degradation of the microspheres, and consequent release of 14C-catalase, was found to parallel the relative gelatinase activities in the joint fluids. Furthermore, various methods of crosslinking were found to affect the kinetics of microsphere degradation in the fluids. A catalase loading level of up to 28% was achieved, and the encapsulated catalase was found to retain up to 58 % of its biological activity.