Consumer opinions on adverse events associated with medical devices.

INTRODUCTION: Post-market surveillance of medical devices relies on compulsory and voluntary reports. Although direct consumer reporting of medical device-related adverse events (AEs) is available in Australia, the proportion of consumer reports has remained low. Limited qualitative research has previously explored consumer insights on AEs associated with medical devices and in particular, AE reporting. OBJECTIVE: To explore consumer opinions on AEs related to medical devices, and their knowledge of, experiences with, and views on, the reporting of medical device-related AEs. METHODS: Focus groups (n = 4; total of 29 participants) were conducted in metropolitan Sydney, Australia. Focus group discussions of approximately 1.5 h in length centred on consumers' understanding of AEs, opinions on AEs and their previous experiences, views on medical device benefits and harms, and actions taken (or potential actions) in response to AEs. With participant consent, discussions were audio-recorded, transcribed verbatim, and thematically analysed. RESULTS: Participants regarded medical device-related side effects to be unexpected AEs associated with their use. Where there was a clear need for the medical device itself, potential improvement in quality of life took precedence over potential harms. Most participants had not experienced negative issues with their medical device(s). There was poor awareness among participants of an existing direct consumer AE reporting system for medical devices. Despite this, the value of reporting was acknowledged. Severity of the AE was a key motivator for potential AE reporting. CONCLUSIONS: Further efforts are necessary to improve consumer awareness of available AE reporting systems to better support post-market surveillance and safe medical device use.

Consumer opinions on adverse events associated with medicines and vaccines.

INTRODUCTION: Despite the availability of an Australian consumer adverse event (AE) reporting system for over 50 years, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding AEs is needed to further ascertain factors impacting their engagement in AE reporting. AIM: The aim of this study was to explore consumer opinions about AEs potentially associated with medicines and vaccines, and their experiences and understanding of managing and reporting AEs. METHODS: Six focus groups were conducted across metropolitan Sydney with a total of 48 adult participants. A semi-structured focus group topic guide was developed to explore consumers' understanding, experiences, and actions taken in relation to AEs; and perspectives on managing treatment benefits and harms. Discussions were audio-recorded with participant permission and transcribed verbatim. Transcripts were thematically analyzed. RESULTS: Consumers acknowledged the potential for side effects (SEs), however inaccurately estimated SE risk in response to verbal descriptors such as "common." Consumer appraisal of treatment benefits and harms was influenced by factors such as medical condition(s), previous experiences, and beliefs. Although many had experienced SEs, consumers only reported them if considered severe or troublesome. Minimal awareness of consumer AE reporting systems was evident. Doctors were the primary avenue for reporting; consumers preferred doctors to act as the intermediary in reporting AEs to an independent body. CONCLUSION: Consumers' lack of awareness of AE reporting systems was evident. With the complexities inherent in benefit/harm risk appraisal, information seeking, and AE reporting preferences, better consumer understanding of AEs and the systems available for reporting is needed.

Production of recombinant C5a from rainbow trout (Oncorhynchus mykiss): role in leucocyte chemotaxis and respiratory burst.

Activation of the complement system can lead to the formation of the membrane attack complex, in which the component C5 is cleaved into C5a and C5b fragments. The C5a anaphylatoxin is a very potent pro-inflammatory molecule that induces chemotaxis and respiratory burst processes in a variety of mammalian leucocytes. While C5a has been well studied in mammals, little is known about the structure and function of C5a in teleost fish or other non-mammalian species. In the present study, we have produced and purified recombinant rainbow trout C5a (rtC5a), and we have shown that it plays an important role in inducing leucocyte migration as well as in triggering the respiratory burst of peripheral blood (PBLs) and head kidney leucocytes (HKLs). When the carboxy-terminal Arg was removed from rtC5a, its ability to induce cell migration and superoxide production remained intact. Interestingly, we show that leucocytes migrating towards rtC5a attached to the plate with a well-spread circular morphology, whereas those migrating towards activated trout serum displayed more irregular and dendritic-like shapes. Our data suggest that the basic mechanisms of action of the C5a anaphylotoxin have remained conserved for more than 300 million years.

Phenoloxidase and QX disease resistance in Sydney rock oysters (Saccostrea glomerata).

QX is a fatal disease in Sydney rock oysters (Saccostrea glomerata) that results from infection by the protistan parasite, Marteilia sydneyi. Since 1997, the New South Wales Fisheries Service has bred S. glomerata for resistance to QX disease. The current study shows that the QX resistance breeding program has selected oysters with enhanced phenoloxidase (PO) activities. The third generation of QX-selected oysters was compared to S. glomerata that had never been selected for disease resistance. PO enzyme assays showed that oysters bred for resistance had significantly higher PO activities than the non-selected population. There was no difference between populations in the activities of a variety of other enzymes. Native polyacrylamide gel electrophoresis identified a novel form of PO in QX-selected oysters that contributes to their enhanced PO activities. This novel form of PO may represent a specific QX disease resistance factor.

Cloning, expression, cellular distribution, and role in chemotaxis of a C5a receptor in rainbow trout: the first identification of a C5a receptor in a nonmammalian species.

C3a, C4a, and C5a anaphylatoxins generated during complement activation play a key role in inflammation. C5a is the most potent of the three anaphylatoxins in eliciting biological responses. The effects of C5a are mediated by its binding to C5a receptor (C5aR, CD88). To date, C5aR has only been identified and cloned in mammalian species, and its evolutionary history remains ill-defined. To gain insights into the evolution, conserved structural domains, and functions of C5aR, we have cloned and characterized a C5aR in rainbow trout, a teleost fish. The isolated cDNA encoded a 350-aa protein that showed the highest sequence similarity to C5aR from other species. Genomic analysis revealed the presence of one continuous exon encoding the entire open reading frame. Northern blot analysis showed significant expression of the trout C5a receptor (TC5aR) message in PBLs and kidney. Flow cytometric analysis showed that two Abs generated against two different areas of the extracellular N-terminal region of TC5aR positively stained the same leukocyte populations from PBLs. B lymphocytes and granulocytes comprised the majority of cells recognized by the anti-TC5aR. More importantly, these Abs inhibited chemotaxis of PBLs toward a chemoattractant fraction purified from complement-activated trout serum. Our data suggest that the split between C5aR and C3aR from a common ancestral molecule occurred before the emergence of teleost fish. Moreover, we demonstrate that the overall structure of C5aR as well as its role in chemotaxis have remained conserved for >300 million years.