IRE1α Mediates the Hypertrophic Growth of Cardiomyocytes Through Facilitating the Formation of Initiation Complex to Promote the Translation of TOP-Motif Transcripts.

BACKGROUND: Cardiomyocyte growth is coupled with active protein synthesis, which is one of the basic biological processes in living cells. However, it is unclear whether the unfolded protein response transducers and effectors directly take part in the control of protein synthesis. The connection between critical functions of the unfolded protein response in cellular physiology and requirements of multiple processes for cell growth prompted us to investigate the role of the unfolded protein response in cell growth and underlying molecular mechanisms. METHODS: Cardiomyocyte-specific inositol-requiring enzyme 1α (IRE1α) knockout and overexpression mouse models were generated to explore its function in vivo. Neonatal rat ventricular myocytes were isolated and cultured to evaluate the role of IRE1α in cardiomyocyte growth in vitro. Mass spectrometry was conducted to identify novel interacting proteins of IRE1α. Ribosome sequencing and polysome profiling were performed to determine the molecular basis for the function of IRE1α in translational control. RESULTS: We show that IRE1α is required for cell growth in neonatal rat ventricular myocytes under prohypertrophy treatment and in HEK293 cells in response to serum stimulation. At the molecular level, IRE1α directly interacts with eIF4G and eIF3, 2 critical components of the translation initiation complex. We demonstrate that IRE1α facilitates the formation of the translation initiation complex around the endoplasmic reticulum and preferentially initiates the translation of transcripts with 5' terminal oligopyrimidine motifs. We then reveal that IRE1α plays an important role in determining the selectivity and translation of these transcripts. We next show that IRE1α stimulates the translation of epidermal growth factor receptor through an unannotated terminal oligopyrimidine motif in its 5' untranslated region. We further demonstrate a physiological role of IRE1α-governed protein translation by showing that IRE1α is essential for cardiomyocyte growth and cardiac functional maintenance under hemodynamic stress in vivo. CONCLUSIONS: These studies suggest a noncanonical, essential role of IRE1α in orchestrating protein synthesis, which may have important implications in cardiac hypertrophy in response to pressure overload and general cell growth under other physiological and pathological conditions.

Gastrointestinal Complications of Intra-Abdominal Desmoid Tumors: A Case Report and Review of the Literature.

A 15-year-old male with a mesenteric desmoid tumor and underlying familial adenomatous polyposis presented 2 weeks after initiating sorafenib with severe abdominal pain and chills and was found to have an acute abdomen. Exploratory laparotomy revealed a necrotic, ruptured tumor with impending small bowel obstruction. The patient was later able to resume sorafenib and experienced sustained a radiographic response. It is possible that sorafenib toxicity contributed to tumor rupture yet later provided clinical benefit. Here we review the gastrointestinal complications that are associated with intra-abdominal desmoid tumors and their therapies.

The inactivated infectious bronchitis virus (IBV) vaccine used as booster in layer hens influences the breadth of protection against challenge with IBV variants.

To achieve long term protection of laying and breeding hens against aberrant egg production caused by infectious bronchitis virus (IBV), a vaccination programme incorporating both live-attenuated and inactivated IBV vaccines is required. High quality IBV vaccines of both types are widely available, but the number of IBV variants of global importance continues to increase and it is not possible to develop vaccines against each one of them. Therefore, it is desirable to perform studies under controlled conditions to determine which IBV vaccine(s) provide the best protection for laying hens against different IBV challenges. Previous vaccination and challenge studies have shown that it is possible to obtain relevant data in a small number of laying hens housed under conditions of strict isolation. The present work extends this finding by investigating the efficacy, against challenge with five IBV strains of global importance, of an IBV vaccination programme including two live-attenuated IBV vaccines (Massachusetts and 793B types) and three different commercially available inactivated vaccines each containing antigen against at least one IBV strain. The results reported here confirm the importance of IBV vaccination for laying hens, show that efficient live priming makes a beneficial contribution to this protection and confirm that inactivated IBV vaccines contribute significantly to effective protection against at least the five IBV challenge strains used here. Furthermore, we provide data to support the "protectotype concept", long-established using different live-attenuated IBV vaccines in young chickens, is valid in broadening protection against IBV challenges in laying birds.RESEARCH HIGHLIGHTSIBV vaccination is essential as an aid in protecting laying hens against IBV infection.Live priming is a beneficial part of the IBV vaccination programme.IBV inactivated vaccine improves IBV protection.Heterologous IBV protection is confirmed in laying hens.

Implementation and evaluation of multilayered pressure injury prevention strategies in an Australian intensive care unit setting.

BACKGROUND: Pressure injuries are a ubiquitous, yet largely preventable, hospital acquired complication commonly seen in critically ill patients in the intensive care unit. OBJECTIVES: The objectives of this study were to implement targeted evidence-based pressure injury prevention strategies and evaluate their effect through measurement of patient pressure injury observations. METHODS: A prospective multiphased design was used in the intensive care unit of an Australian tertiary referral hospital using three study periods (period 1, weeks 1-18; period 2, weeks 19-28; and period 3, weeks 29-52). The interventions included staff-focused interventions and patient-focused interventions, with the latter defined in a work unit guideline. Weekly visual observations of critically ill patients' skin integrity were conducted by trained research nurses over 52 weeks from November 2015 to November 2016. The primary outcome measure was a pressure injury of any stage, identified at the weekly observation, and the effect of the intervention was evaluated through logistic regression. Reporting rigour has been demonstrated using the Standards for Quality Improvement Reporting Excellence checklist. RESULTS: Over the whole study, 15.4% (95% confidence interval [CI] = 12.6, 18.2%, 97/631) of patients developed a pressure injury, with the majority of these injuries (73.2%, 95% CI = 64.4%, 82.0%, 71/97) caused by medical devices. After adjustment for covariates known to influence hospital-acquired pressure injury development, pressure injury rates for period 3 compared with period 1 were reduced (odds ratio = 0.41, 95% CI = 0.20-0.97, p = 0.0126). CONCLUSIONS: We found the use of defined pressure injury prevention strategies targeted at both staff and patients reduced pressure injury prevalence.

Exploring medical device-related pressure injuries in a single intensive care setting: A longitudinal point prevalence study.

OBJECTIVES: To report longitudinal prevalence rates of device-related pressure injuries in critically ill adult patients in the intensive care unit and to explore the patient characteristics associated with the development of device related pressure injuries. RESEARCH DESIGN: A prospective observational design where observations of patients' skin integrity were conducted on one day each week for 52 weeks. SETTING: The study was conducted in the 36-bed intensive care unit of a major metropolitan tertiary referral hospital in Queensland, Australia. The sample included all patients aged 18 years or older admitted to the intensive care unit before midnight on the day preceding the observation, with a medical device in situ. MAIN OUTCOME MEASURES: The primary outcome measure was device related pressure injuries identified at the weekly observations and defined as a pressure injury found on the skin or mucous membrane with a history of medical device in use at the location of the injury. Patient demographic and clinical characteristics were recorded. RESULTS: Over the study period, 11.3% (71/631) of patients developed at least one hospital-acquired DRPI. The most common devices associated with injury were nasogastric/nasojejunal tubes (41%) and endotracheal tubes (27%). Significant predictors of device related pressure injuries were the total number of devices (OR 1.230, 95% CI 1.09-1.38, p < 0.001), the length of time in the ICU (OR 1.05, 95% CI 1.02-1.09, p = 0.003), male sex, (OR 2.099, 95% CI 1.18-3.7, p = 0.012), and increased severity of illness score on admission (OR 1.044, 95% CI 1.01-1.09, p = 0.013). CONCLUSION: Device related pressure injuries are an all-too-common iatrogenic problem for this vulnerable patient cohort.

REVOLUTION (Routine EValuatiOn of people LivIng with caNcer)-Protocol for a prospective characterisation study of patients with incurable cancer.

INTRODUCTION: There is a pressing need for a holistic characterisation of people with incurable cancer. In this group, where quality of life and improvement of symptoms are therapeutic priorities, the physical and biochemical manifestations of cancer are often studied separately, giving an incomplete picture. In order to improve care, spur therapeutic innovation, provide meaningful endpoints for trials and set priorities for future research, work must be done to explore how the tumour influences the clinical phenotype. Characterisation of the host-tumour interaction may also provide information regarding prognosis, allowing appropriate planning of investigations, treatment and referral to palliative medicine services. METHODS: Routine EValuatiOn of people LivIng with caNcer (REVOLUTION) is a prospective observational study that aims to characterise people with incurable cancer around five key areas, namely body composition, physical activity, systemic inflammatory response, symptoms, and quality of life by developing a bio-repository. Participants will initially be recruited from a single centre in the UK and will have assessments of body composition (bio-impedance analysis [BIA] and computed tomography [CT]), assessment of physical activity using a physical activity monitor, measurement of simple markers of inflammation and plasma cytokine proteins and three symptom and quality of life questionnaires. DISCUSSION: This study aims to create a comprehensive biochemical and clinical characterisation of people with incurable cancer. Data in this study can be used to give a better understanding of the 'symptom phenotype' and quality of life determinants, development of a profile of the systemic inflammatory response and a detailed characterisation of body composition.

A randomized, feasibility trial of an exercise and nutrition-based rehabilitation programme (ENeRgy) in people with cancer.

BACKGROUND: Despite rehabilitation being increasingly advocated for people living with incurable cancer, there is limited evidence supporting efficacy or component parts. The progressive decline in function and nutritional in this population would support an approach that targets these factors. This trial aimed to assess the feasibility of an exercise and nutrition based rehabilitation programme in people with incurable cancer. METHODS: We randomized community dwelling adults with incurable cancer to either a personalized exercise and nutrition based programme (experimental arm) or standard care (control arm) for 8 weeks. Endpoints included feasibility, quality of life, physical activity (step count), and body weight. Qualitative and health economic analyses were also included. RESULTS: Forty-five patients were recruited (23 experimental arm, 22 control arm). There were 26 men (58%), and the median age was 78 years (IQR 69-84). At baseline, the median BMI was 26 kg/m2 (IQR: 22-29), and median weight loss in the previous 6 months was 5% (IQR: -12% to 0%). Adherence to the experimental arm was >80% in 16/21 (76%) patients. There was no statistically significant difference in the following between trial arms: step count - median % change from baseline to endpoint, per trial arm (experimental -18.5% [IQR: -61 to 65], control 5% [IQR: -32 to 50], P = 0.548); weight - median % change from baseline to endpoint, per trial arm (experimental 1%[IQR: -3 to 3], control -0.5% [IQR: -3 to 1], P = 0.184); overall quality of life - median % change from baseline to endpoint, per trial arm (experimental 0% [IQR: -20 to 19], control 0% [IQR: -23 to 33], P = 0.846). Qualitative findings observed themes of capability, opportunity, and motivation amongst patients in the experimental arm. The mean incremental cost of the experimental arm versus control was £-319.51 [CI -7593.53 to 6581.91], suggesting the experimental arm was less costly. CONCLUSIONS: An exercise and nutritional rehabilitation intervention is feasible and has potential benefits for people with incurable cancer. A larger trial is now warranted to test the efficacy of this approach.

Mobility improvement of patients with peripheral visual field losses using novel see-through digital spectacles.

PURPOSE: To evaluate see-through Augmented Reality Digital spectacles (AR DSpecs) for improving the mobility of patients with peripheral visual field (VF) losses when tested on a walking track. DESIGN: Prospective Case Series. PARTICIPANTS: 21 patients with peripheral VF defects in both eyes, with the physical ability to walk without assistance. METHODS: We developed the AR DSpecs as a wearable VF aid with an augmented reality platform. Image remapping algorithms produced personalized visual augmentation in real time based on the measured binocular VF with the AR DSpecs calibration mode. We tested the device on a walking track to determine if patients could more accurately identify peripheral objects. MAIN OUTCOME MEASURES: We analyzed walking track scores (number of recognized/avoided objects) and eye tracking data (six gaze parameters) to measure changes in the kinematic and eye scanning behaviors while walking, and assessed a possible placebo effect by deactivating the AR DSpecs remapping algorithms in random trials. RESULTS: Performance, judged by the object detection scores, improved with the AR DSpecs (P<0.001, Wilcoxon rank sum test) with an average improvement rate of 18.81%. Two gaze parameters improved with the activated algorithm (P<0.01, paired t-test), indicating a more directed gaze on the central path with less eye scanning. Determination of the binocular integrated VF with the DSpecs correlated with the integrated standard automated perimetry (R = 0.86, P<0.001), mean sensitivity difference 0.8 ± 2.25 dB (Bland-Altman). CONCLUSIONS: AR DSpecs may improve walking maneuverability of patients with peripheral VF defects by enhancing detection of objects in a testing environment.

Securement to prevent device-related pressure injuries in the intensive care unit: A randomised controlled feasibility study.

Medical device-related pressure injuries are the most common cause of pressure injuries within the intensive care unit, in particular those caused by nasogastric tubes and endotracheal tubes. There are several known methods, which can alleviate the pressure of these devices on the skin surface to reduce the rate of these injuries. To determine the feasibility of conducting a larger, adequately powered trial testing, several clinically effective interventions to reduce the incidence of medical device-related pressure injuries caused by these devices. Patients were recruited into both study arms and received one of three different methods of skin protection for both arms. Outcome measures included fidelity to the processes of care protocol, recruitment potential, and the number of medical device-related pressure injuries. Recruitment (n = 87) was slower than expected with less than 10% of screened potential patients available for enrolment. Fidelity to the process of care for each subgroup was variable with better adherence in the nasogastric tube arm compared to the endotracheal tube arm. This feasibility study has revealed concerns about the intervention designs and effectiveness as well as challenges for the adherence of the nursing staff to the protocol.

Spotlight on avian coronaviruses.

Coronaviruses (CoVs) mainly cause enteric and/or respiratory signs. Mammalian CoVs including COVID-19 (now officially named SARS-CoV-2) belong to either the Alphacoronavirus or Betacoronavirus genera. In birds, the majority of the known CoVs belong to the Gammacoronavirus genus, whilst a small number are classified as Deltacoronaviruses. Gammacoronaviruses continue to be reported in an increasing number of avian species, generally by detection of viral RNA. Apart from infectious bronchitis virus in chickens, the only avian species in which CoV has been definitively associated with disease are the turkey, pheasant and guinea fowl. Whilst there is strong evidence for recombination between gammacoronaviruses of different avian species, and between betacoronaviruses in different mammals, evidence of recombination between coronaviruses of different genera is lacking. Furthermore, the recombination of an alpha or betacoronavirus with a gammacoronavirus is extremely unlikely. For recombination to happen, the two viruses would need to be present in the same cell of the same animal at the same time, a highly unlikely scenario as they cannot replicate in the same host!

How do they measure up? Differences in stakeholder perceptions of quality measures used in English community nursing.

OBJECTIVES: To establish how quality indicators used in English community nursing are selected and applied, and their perceived usefulness to service users, commissioners and service providers. METHODS: A qualitative multi-site case study was conducted with five commissioning organizations and their service providers. Participants included commissioners, provider organization managers, nurses and service users. RESULTS: Indicator selection and application often entail complex processes influenced by wider health system and cross-organizational factors. All participants felt that current indicators, while useful for accountability and management purposes, fail to reflect the true quality of community nursing care and may sometimes indirectly compromise care. CONCLUSIONS: Valuable resources may be better used for comprehensive system redesign, to ensure that patient, carer and nurse priorities are given equivalence with those of other stakeholders.

Diagnostic Performance of Three-Dimensional Endothelium/Descemet Membrane Complex Thickness Maps in Active Corneal Graft Rejection.

PURPOSE: To evaluate the performance of 3-dimensional (3D) endothelium/Descemet membrane complex thickness (En/DMT) maps vs total corneal thickness (TCT) maps in the diagnosis of active corneal graft rejection. DESIGN: Cross-sectional study. METHODS: Eighty-one eyes (32 clear grafts and 17 with active rejection, along with 32 age-matched control eyes) were imaged using high-definition optical coherence tomography (HD-OCT), and a custom-built segmentation algorithm was used to generate 3D color-coded maps of TCT and En/DMT of the central 6-mm cornea. Regional En/DMT and TCT were analyzed and compared between the studied groups. Receiver operating characteristic curves were used to determine the accuracy of En/DMT and TCT maps in differentiating between studied groups. Main outcome measures were regional En/DMT and TCT. RESULTS: Both regional TCT and En/DMT were significantly greater in actively rejecting grafts compared to both healthy corneas and clear grafts (P < .001). Using 3D thickness maps, central, paracentral, and peripheral En/DMT achieved 100% sensitivity and 100% specificity in diagnosing actively rejecting grafts (optimal cut-off value [OCV] of 19 µm, 24 µm, and 26 µm, respectively), vs only 82% sensitivity and 96% specificity for central TCT, OCV of 587 µm. Moreover, central, paracentral, and peripheral En/DMT correlated significantly with graft rejection severity (r = 0.972, r = 0.729, and r = 0.823, respectively; P < .001). CONCLUSION: 3D En/DMT maps can diagnose active corneal graft rejection with excellent accuracy, sensitivity, and specificity. Future longitudinal studies are required to evaluate the predictive and prognostic role of 3D En/DMT maps in corneal graft rejection.

Exploring Incontinence-Associated Dermatitis in a Single Center Intensive Care Unit: A Longitudinal Point Prevalence Survey.

PURPOSE: The purpose of this study was to provide longitudinal prevalence rates of incontinence-associated dermatitis (IAD) in patients in an intensive care unit (ICU) and to identify patient characteristics associated with IAD development. DESIGN: Prospective observational. SUBJECTS AND SETTING: The sample comprised 351 patients aged 18 years and older in a major metropolitan public hospital ICU in Queensland, Australia. METHODS: All consenting, eligible participants at risk of developing IAD underwent weekly skin inspections to determine the presence of IAD. Data were collected weekly for 52 consecutive weeks. Descriptive statistics described the study sample and logistic regression analysis was used to identify patient characteristics associated with development of IAD. RESULTS: The weekly IAD prevalence ranged between 0% and 70%, with IAD developing in 17% (n = 59/351) of ICU patients. The odds of IAD developing increased statistically significantly with increasing age (odds ratio [OR]: 1.029, 95% confidence interval [CI]: 1.005-1.054, P = .016), time in the ICU (OR = 1.104; 95% CI: 1.063-1.147, P < .001), and Bristol Stool chart score (OR = 4.363, 95% CI: 2.091-9.106, P < .001). Patients with respiratory (OR = 3.657, 95% CI: 1.399-9.563, P = .008) and sepsis (OR = 3.230, 95% CI: 1.281-8.146, P = .013) diagnoses had increased odds of developing IAD. CONCLUSIONS: These data show the high variability of IAD prevalence over a 1-year period. Characteristics associated with the development of IAD in patients in the ICU included older age, longer lengths of ICU stay, incontinent of liquid feces, and having respiratory or sepsis diagnoses.

Spotlight on avian pathology: infectious bronchitis virus.

Infectious bronchitis is a highly infectious disease of the domestic chicken of all ages and type, affecting the respiratory, renal and reproductive systems. Secondary bacterial infections are common and have a serious economic and welfare impact. Many genotypic and serotypic variants of infectious bronchitis virus (IBV) exist worldwide, making diagnosis difficult, and challenging control strategies. Vaccination, requiring the use of both live-attenuated and inactivated vaccines, is needed to control IBV infections; to date, attempts to develop vectored vaccines as effective as the traditional vaccines have been unsuccessful.

Combined exercise and nutritional rehabilitation in outpatients with incurable cancer: a systematic review.

PURPOSE: The optimal components for rehabilitation in patients with incurable cancer are unclear. However, principles of exercise and nutrition-based interventions used in cancer cachexia may be applied usefully to this population of cancer patients. This systematic review examines current evidence for rehabilitation combining exercise and nutritional support in patients with incurable cancer. METHODS: MEDLINE, EMBASE and Cochrane databases were searched. Eligible studies included patients with incurable cancer and rehabilitation programmes combining exercise and nutritional interventions. Studies of cancer survivors, curative treatments, reviews, case note reviews, protocols and abstracts were excluded. Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria were applied to patient-important outcomes. RESULTS: Of the 2424 search results, 67 abstracts were reviewed and 24 full texts examined. Eight studies (n = 685) were included comprising two randomised control trials, three prospective, one exploratory and two secondary analyses. All examined multi-modal outpatient programmes. GRADE analysis revealed moderate evidence (B) for improvements in depression and physical endurance, low-quality evidence (C) for quality of life and fatigue and very low-quality evidence (D) for overall function and nutritional status. CONCLUSION: There are limited data for multi-modal rehabilitation programmes combining exercise and nutritional interventions in patients with incurable cancer. However, studies to date report improvements in multiple domains, most notably physical endurance and depression scores. This supports the concept that multi-modal rehabilitation incorporating principles of cachexia management may be appropriate for the wider group of patients with incurable cancer. Further, high-quality studies are needed to define the optimal approach and outcome measures.

Safety culture in intensive care internationally and in Australia: A narrative review of the literature.

OBJECTIVE: Assessment of safety culture in health care is of particular relevance in the complex intensive care setting, where the effects of human error can have catastrophic consequences. The aim of this review was to examine the literature on safety culture in intensive care units (ICUs) and specifically, to explore the state of knowledge regarding safety culture in the context of Australian ICUs. METHODS: A search was conducted of key databases for studies published in English between January 2008 and December 2017 using terms 'safety culture', 'safety climate', 'safety attitude', 'intensive care', 'ICU' and 'critical care'. Studies were included if they presented original research, utilised the teamwork and safety climate factors of a quantitative survey tool to assess safety culture, the sample population included participants working in an adult intensive care, and the findings were reported in the context of intensive care. RESULTS: Of the 36 studies identified, two were conducted in Australia. The studies demonstrate a rapid expansion in safety culture assessment globally. Three levels of safety culture application in intensive care were identified, including safety culture assessment, effect of an intervention on safety culture, and evaluation of the association between safety culture and structural, process and outcomes measures. The use of targeted safety culture domains is emerging. Common findings included variation in perceptions of safety culture between ICUs, unit and hospital management, and professional groups. CONCLUSION: Though the assessment of safety culture in ICUs has been an area of prolific research internationally over the past ten years, the Australian context is limited and could be advanced through further research, including the effect on safety culture of interventions, and to establish the association between safety culture and patient safety outcomes. Longitudinal studies to demonstrate sustained intervention effects on safety culture should be considered.

Understanding contextual barriers and enablers to pressure injury prevention practice in an Australian intensive care unit: An exploratory study.

BACKGROUND: Skin integrity management is often a low clinical priority in the intensive care environment, possibly resulting in high pressure injury (PI) prevalence. This article reports the results of the first phase of a multiphased project, "Translating evidence-based pressure injury prevention strategies to the intensive care environment (SUSTAIN study)". The SUSTAIN study used a research translation framework to guide the assessment of research uptake, development, and monitoring of translational strategies to reduce PIs. OBJECTIVE: The objective was to assess the enablers and barriers to research translation of evidence-based skin integrity management in one Australian tertiary referral intensive care unit (ICU). METHODS: This exploratory study was conducted in an Australian metropolitan tertiary ICU on a sample of 204 registered nurses. Data were collected using (i) a descriptive cross-sectional cohort survey of barriers, enablers, and attitudes to PI prevention, (ii) a cross-sectional survey of PI knowledge, and (iii) focus groups to understand the local contextual factors impacting registered nurses' PI prevention practice. RESULTS: Participants reported a moderate to high ability to rise above barriers in PI prevention, a positive attitude towards PI prevention, and considered this a priority in their care of patients. High patient acuity emerged as a barrier to implementing timely PI prevention strategies. In the knowledge, test participants with postgraduate qualifications answered more statements correctly. Focus group data revealed four themes: (i) team ICU, (ii) processes of care, (iii) education for consistency, and (iv) the patient. CONCLUSIONS: It is essential that evidence-based PI prevention strategies are provided in the intensive care environment. Our findings indicate that despite positive attitudes and sound knowledge levels, high patient acuity is a significant barrier to evidence implementation.

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.