Primary Care Utilization, Preventative Screening, and Control of Metabolic Syndrome in Metabolic Dysfunction-Associated Steatohepatitis Liver Transplant Recipients.

OBJECTIVES: Patients with pre-transplant metabolic dysfunction-associated steatohepatitis (MASH) are at high risk of metabolic syndrome (MetS) after liver transplant. While many patients are co-managed by a transplant team, most preventative screening and MetS management may occur in the primary care setting. We aimed to evaluate primary care utilization by MASH liver transplant recipients as well as MetS screening and control. METHODS: We conducted a retrospective chart review that included adults who underwent liver transplant for MASH or cryptogenic cirrhosis at a single institution from January 2010 to December 2016, had available primary care data, and at least 36-months of follow-up post-transplant. Measures included primary care utilization, adherence to screening guidelines, and control of MetS. We used Fischer's exact test to explore the association of primary care utilization with screening and control. RESULTS: A total of 37 patients met inclusion criteria with 366 visits reviewed. The median time to first visit was 68 days post-transplant and patients had a median of 9 total visits. Few patients met screening guidelines for diabetes (8.1%) or hyperlipidemia (10.8%). The percentage of patients with control of obesity, hypertension, diabetes, and hyperlipidemia decreased over the 36-month follow-up period. Primary care utilization was not associated with adherence to screening recommendations for diabetes (P = .141) or hyperlipidemia (P = .103). Higher primary care utilization was not associated with control of hypertension (P = .107), diabetes (P = .871), or hyperlipidemia (P = .999). CONCLUSION: More research is needed to investigate barriers to screening and management of MetS conditions in this high-risk patient population in the primary care setting as well as to optimize post-transplant care coordination.

Initiating pre-exposure prophylaxis in the inpatient setting: a quality improvement project.

Many patients who are at high risk of HIV transmission do not receive pre-exposure prophylaxis (PrEP). HIV risk counselling and PrEP initiation have historically been limited to outpatient settings. Here we describe a novel quality improvement project at San Francisco's main safety-net hospital designed to incorporate universal screening for active HIV risk factors and PrEP initiation into standard inpatient care. Interventions included education sessions and dissemination of clinical materials to increase providers' knowledge and comfort with HIV risk screening, prevention counselling and prescribing PrEP. We implemented new workflows on the inpatient medicine service to encourage providers to universally screen all patients at the time of admission and initiate PrEP for appropriate patients during their hospitalisation. Over the first 9 months of the initiative, 14 inpatients were started on PrEP during their admission. As PrEP was initiated in particularly vulnerable patients, using inpatient admissions to engage at-risk patients in HIV prevention may help to reduce disparities in HIV outcomes.

Across race, ethnicity, and language: An intervention to improve advance care planning documentation unmasks health disparities.

BACKGROUND: Racial and ethnic minority groups are less likely to have advance directives and living wills, despite the importance of advanced care planning (ACP) in end-of-life care. We aimed to understand the impact of an intervention to improve ACP documentation across race, ethnicity, and language on hospitalized patients at our institution. METHODS: We launched an intervention to improve the rates of ACP documentation for hospitalized patients aged >75 or with advanced illness defined by the International Classification of Diseases 10th Revision codes. We analyzed ACP completion rates, preintervention, and intervention, and used interrupted time-series analyses to measure the differential impact of the intervention across race, ethnicity, and language. KEY RESULTS: A total of 10,220 patients met the inclusion criteria. Overall rates of ACP documentation improved from 13.9% to 43.7% in the intervention period, with a 2.47% monthly increase in ACP documentation compared to baseline (p < .001). During the intervention period, the rate of ACP documentation increased by 2.72% per month for non-Hispanic White patients (p < .001), by 1.84% per month for Latinx patients (p < .001), and by 1.9% per month for Black patients (p < .001). Differences in the intervention trends between non-Hispanic White and Latinx patients (p = .04) and Black patients (p = .04) were significant. CONCLUSIONS: An intervention designed to improve ACP documentation in hospitalized patients widened a disparity across race and ethnicity with Latinx and Black patients having lower rates of improvement. Our findings reinforce the need to measure the impact of quality improvement interventions on existing health disparities and to implement specific strategies to prevent worsening disparities.

Team science: A syllabus for success on big projects.

Interdisciplinary teams are on the rise as scientists attempt to address complex environmental issues. While the benefits of team science approaches are clear, researchers often struggle with its implementation, particularly for new team members. The challenges of large projects often weigh on the most vulnerable members of a team: trainees, including undergraduate students, graduate students, and post-doctoral researchers. Trainees on big projects have to navigate their role on the team, with learning project policies, procedures, and goals, all while also training in key scientific tasks such as co-authoring papers. To address these challenges, we created and participated in a project-specific, graduate-level team science course. The purposes of this course were to: (1) introduce students to the goals of the project, (2) build trainees' understanding of how big projects operate, and (3) allow trainees to explore how their research interests dovetailed with the overall project. Additionally, trainees received training regarding: (1) diversity, equity & inclusion, (2) giving and receiving feedback, and (3) effective communication. Onboarding through the team science course cultivated psychological safety and a collaborative student community across disciplines and institutions. Thus, we recommend a team science course for onboarding students to big projects to help students establish the skills necessary for collaborative research. Project-based team science classes can benefit student advancement, enhance the productivity of the project, and accelerate the discovery of solutions to ecological issues by building community, establishing a shared project vocabulary, and building a workforce with collaborative skills to better answer ecological research questions.

A blended model to support brief interventions in primary care: A qualitative study of usability and acceptability of HealthEir in community pharmacy.

BACKGROUND: Brief interventions for lifestyle behaviour change are effective health promotion interventions. Primary care settings, including pharmacies, are the most frequently visited healthcare facilities and are well placed to provide brief health interventions. However, despite the evidence-based and policy guidance, barriers to brief interventions have limited their implementation. OBJECTIVES: This study aimed to explore the usability and acceptability of HealthEir, a blended model with digital, print, and communication elements designed to support the delivery of brief health-promoting interventions in pharmacy practice. METHODS: Usability tests using a think aloud protocol and set tasks (to assess usability) and semi-structured interviews (to assess acceptability) were conducted with fifteen patients and twelve pharmacists. Usability data were analysed deductively using Nielsen's five quality components of usability as a framework. Acceptability data were analysed using inductive thematic analysis. FINDINGS: All participants found HealthEir straightforward to use and completed the required tasks without assistance. A small number of patient and pharmacist participants identified opportunity for improvement of the digital element. Acceptability was also high, with individual comments from participants identifying opportunity for improvements to HealthEir, and two patients identifying privacy or safety concerns. The majority of comments regarding acceptability reflected wider social and cultural challenges such as perceptions of the roles of pharmacists and pharmacies and the low priority of preventative health interventions. CONCLUSION: HealthEir has been demonstrated to be a usable and acceptable support that has the potential to overcome barriers to delivery of brief interventions in pharmacies. Usability and acceptability testing identified minor changes that may further improve its design prior to piloting and implementation.

Pharmacokinetic Evaluation of a Single 5-Gram Bolus of Creatine Monohydrate Versus Two Other Creatine-Containing Investigational Products.

The purpose of this study was to determine the relative pharmacokinetics of creatine monohydrate delivered as a formula or as a pure powder (all mixed in solution). A single 5 g bolus of creatine monohydrate was ingested as CreaBev 1, CreaBev 2, or creatine monohydrate. Participants we assigned a test product and monitored in a supervised laboratory setting for ingestion and all blood draws starting 30 min post-ingestion to the 6-h mark. Standard pharmacokinetic analysis was undertaken to determine relative maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the curve (AUC) for the products. Cmax data indicate that CreaBev 1 10.55±4.10, CreaBev 2 15.45±5.48, and creatine monohydrate 12.77±4.0 nmol/h/µL. The Tmax analysis demonstrated CreaBev 1 1.20±1.01, CreaBev 2 1.23±0.65, and creatine monohydrate 0.91±0.2 h. The AUC data indicate that CreaBev 1 22.90±9.17, CreaBev 2 33.92±9.52, and creatine monohydrate 29.58±11.93 nmol/h/µL. When examining the data for pharmacokinetics, the AUC and Cmax pharmacokinetics were greatest for CreaBev 2 (p<0.021 and 0.020). Within the confines of this study, CreaBev 2 produced the highest blood concentrations of creatine as compared to creatine monohydrate and CreaBev 1.

An Evaluation of the Effects of a Non-caffeinated Energy Dietary Supplement on Cognitive and Physical Performance: A Randomized Double-Blind Placebo-Controlled Study.

A large and growing body of research shows that non-caffeinated plant-based nutritional supplements can increase cognitive and physical performance. This study aimed to build on this work by investigating the possibility that a specific botanical blend (consisting of Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins) could improve cognitive and physical performance. To this end, we carried out a randomized, double-blind, placebo-controlled 21-day parallel study on 36 healthy adults. We compared the effects of the botanical blend at baseline to a caffeine and a placebo condition on 1) self-reported alertness, anxiety, and headaches; 2) multiple measures of attention and cognition; 3) physical performance; and 4) stress biomarkers. We found that relative to baseline and compared to the Caffeine and Placebo groups, the botanical blend increased alertness and improved cognitive performance. The cognitive effects were most robust for attention measures. The botanical blend did not improve physical performance on a time to exhaustion (TTE) test. Of note, there was not the expected increase in catecholamine response after the TTE on Day 21, suggesting that long-term botanical blend use decreases the catecholamine stress response of a physical endurance task. In conclusion, we show that, within the confines of this study, a combination of the botanical blend could serve as a safe and effective nutritional supplement to improve cognitive performance.

Sociodemographic inequalities in patients' experiences of primary care: an analysis of the General Practice Patient Survey in England between 2011 and 2017.

OBJECTIVE: Younger people, minority ethnic groups, sexual minorities and people of lower socioeconomic status report poorer experiences of primary care. In light of NHS ambitions to reduce unwarranted variations in care, we aimed to investigate whether inequalities in patient experience of primary care changed between 2011 and 2017, using data from the General Practice Patient Survey in England. METHODS: We considered inequalities in relation to age, sex, deprivation, ethnicity, sexual orientation and geographical region across five dimensions of patient experience: overall experience, doctor communication, nurse communication, access and continuity of care. We used linear regression to explore whether the magnitude of inequalities changed between 2011 and 2017, using mixed models to assess changes within practices and models without accounting for practice to assess national trends. RESULTS: We included 5,241,408 responses over 11 survey waves from 2011-2017. There was evidence that inequalities changed over time (p < 0.05 for 27/30 models), but the direction and magnitude of changes varied. Changes in gaps in experience ranged from a 1.6 percentage point increase for experience of access among sexual minorities, to a 5.6 percentage point decrease for continuity, where experience worsened for older ages. Inequalities in access in relation to socio-economic status remained reasonably stable for individuals attending the same GP practice; nationally inequalities in access increased 2.1 percentage points (p < 0.0001) between respondents living in more/less deprived areas, suggesting access is declining fastest in practices in more deprived areas. CONCLUSIONS: There have been few substantial changes in inequalities in patient experience of primary care between 2011 and 2017.

The potential application of electrochemical biosensors in the COVID-19 pandemic: A perspective on the rapid diagnostics of SARS-CoV-2.

Electrochemical biosensors combine the selectivity of electrochemical signal transducers with the specificity of biomolecular recognition strategies. Although they have been broadly studied in different areas of diagnostics, they are not yet fully commercialized. During the COVID-19 pandemic, electrochemical platforms have shown the potential to address significant limitations of conventional diagnostic platforms, including accuracy, affordability, and portability. The advantages of electrochemical platforms make them a strong candidate for rapid point-of-care detection of SARS-CoV-2 infection by targeting not only viral RNA but antigens and antibodies. Herein, we reviewed advancements in electrochemical biosensing platforms towards the detection of SARS-CoV-2 through studying similar viruses.

Clinical Remission of Treatment-Resistant Depression, Polysubstance Abuse, and Antidepressant Discontinuation Syndrome Through Engagement of Lifestyle Interventions.

BACKGROUND: This case illustrates the relationship between gut, hormonal, and brain function in that dietary changes, mindfulness interventions, and detoxification led to resolution of disabling psychiatric symptoms and protracted psychotropic medication withdrawal symptoms. SUMMARY: A 50-year-old partnered, unemployed, Caucasian female with a history of major depressive disorder, multiple suicide attempts, extensive trauma and abuse, and substance abuse presented for outpatient management. The patient reported limited benefit from over two decades of conventional treatment with psychotropic medications. She presented with depression and symptoms of protracted withdrawal after self-discontinuation of multiple psychiatric medications and was prescribed a dietary, detoxification, and supplementation regimen by the primary author. Additional lifestyle interventions implemented included daily meditation, dry-skin brushing, and coffee enemas. CONCLUSION: This case exemplifies dramatic clinical remission after cessation of medication treatment and engagement of lifestyle interventions, which include dietary change, meditation, and detoxification. As such, when limited results are achieved by psychotropic medication, tapering combined with dietary interventions as the first-line therapy should be considered. This case is also evidence of the role of lifestyle interventions in treating protracted withdrawal symptoms associated with discontinuing psychotropic medications.

A Nanostructured Gold/Graphene Microfluidic Device for Direct and Plasmonic-Assisted Impedimetric Detection of Bacteria.

Hierarchical 3D gold nano-/microislands (NMIs) are favorably structured for direct and probe-free capture of bacteria in optical and electrochemical sensors. Moreover, their unique plasmonic properties make them a suitable candidate for plasmonic-assisted electrochemical sensors, yet the charge transfer needs to be improved. In the present study, we propose a novel plasmonic-assisted electrochemical impedimetric detection platform based on hybrid structures of 3D gold NMIs and graphene (Gr) nanosheets for probe-free capture and label-free detection of bacteria. The inclusion of Gr nanosheets significantly improves the charge transfer, addressing the central issue of using 3D gold NMIs. Notably, the 3D gold NMIs/Gr detection platform successfully distinguishes between various types of bacteria including Escherichia coli (E. coli) K12, Pseudomonas putida (P. putida), and Staphylococcus epidermidis (S. epidermidis) when electrochemical impedance spectroscopy is applied under visible light. We show that distinguishable and label-free impedimetric detection is due to dissimilar electron charge transfer caused by various sizes, morphologies, and compositions of the cells. In addition, the finite-difference time-domain (FDTD) simulation of the electric field indicates the intensity of charge distribution at the edge of the NMI structures. Furthermore, the wettability studies demonstrated that contact angle is a characteristic feature of each type of captured bacteria on the 3D gold NMIs, which strongly depends on the shape, morphology, and size of the cells. Ultimately, exposing the platform to various dilutions of the three bacteria strains revealed the ability to detect dilutions as low as ∼20 CFU/mL in a wide linear range of detection of 2 × 101-105, 2 × 101-104, and 1 × 102-1 × 105 CFU/mL for E. coli, P. putida, and S. epidermidis, respectively. The proposed hybrid structure of 3D gold NMIs and Gr, combined by novel plasmonic and conventional impedance spectroscopy techniques, opens interesting avenues in ultrasensitive label-free detection of bacteria with low cost and high stability.

Experimental bottom trawling finds resilience in large-bodied infauna but vulnerability for epifauna and juveniles in the Frisian Front.

In this study, we analysed the benthic effects of two in situ fisheries disturbance experiments using a combination of side-scan sonar, high definition underwater video, sediment profile imagery, and box core sampling techniques after conventional beam trawling and box core sampling after electric pulse trawling in a southern North Sea habitat. Acoustic and optical methods visualised the morphological changes induced by experimental beam trawling, showing the flattening and homogenisation of surface sediments. Video transects found a 94% decrease in epibenthos in beam trawled sediments compared to an untrawled control site and a 74% decrease in untrawled sediments of the same transect. Box core samples taken 5.5 h, 29 h and 75 h after trawling detected a downward trend in infaunal densities and species richness that continued after the initial impact with small-bodied and juvenile taxa being especially prone to depletion. Data from shallow sediment samples showed trawl resilience in large mud shrimps and evidence of their upward movement towards the sediment surface after disturbance. Both trawl gears induced significant changes to infaunal communities, with no differential effect between the two gears. Our results suggest that in the Frisian Front, trawling may favour the survival of deep burrowers while removing surficial macrofauna.

Hypertension Self-management in Socially Disadvantaged African Americans: the Achieving Blood Pressure Control Together (ACT) Randomized Comparative Effectiveness Trial.

BACKGROUND: Effective hypertension self-management interventions are needed for socially disadvantaged African Americans, who have poorer blood pressure (BP) control compared to others. OBJECTIVE: We studied the incremental effectiveness of contextually adapted hypertension self-management interventions among socially disadvantaged African Americans. DESIGN: Randomized comparative effectiveness trial. PARTICIPANTS: One hundred fifty-nine African Americans at an urban primary care clinic. INTERVENTIONS: Participants were randomly assigned to receive (1) a community health worker ("CHW") intervention, including the provision of a home BP monitor; (2) the CHW plus additional training in shared decision-making skills ("DoMyPART"); or (3) the CHW plus additional training in self-management problem-solving ("Problem Solving"). MAIN MEASURES: We assessed group differences in BP control (systolic BP (SBP) < 140 mm Hg and diastolic BP (DBP) < 90 mmHg), over 12 months using generalized linear mixed models. We also assessed changes in SBP and DBP and participants' BP self-monitoring frequency, clinic visit patient-centeredness (i.e., extent of patient-physician discussions focused on patient emotional and psychosocial concerns), hypertension self-management behaviors, and self-efficacy. KEY RESULTS: BP control improved in all groups from baseline (36%) to 12 months (52%) with significant declines in SBP (estimated mean [95% CI] - 9.1 [- 15.1, - 3.1], - 7.4 [- 13.4, - 1.4], and - 11.3 [- 17.2, - 5.3] mmHg) and DBP (- 4.8 [- 8.3, - 1.3], - 4.0 [- 7.5, - 0.5], and - 5.4 [- 8.8, - 1.9] mmHg) for CHW, DoMyPART, and Problem Solving, respectively). There were no group differences in BP outcomes, BP self-monitor use, or clinic visit patient-centeredness. The Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 18.7 [4.0, 87.3]) and self-efficacy scores (OR [95% CI] 4.7 [1.5, 14.9]) at 12 months compared to baseline, while other groups did not. Compared to DoMyPART, the Problem Solving group had higher odds of high hypertension self-care behaviors (OR [95% CI] 5.7 [1.3, 25.5]) at 12 months. CONCLUSION: A context-adapted CHW intervention was correlated with improvements in BP control among socially disadvantaged African Americans. However, it is not clear whether improvements were the result of this intervention. Neither the addition of shared decision-making nor problem-solving self-management training to the CHW intervention further improved BP control. TRIAL REGISTRY: ClinicalTrials.gov Identifier: NCT01902719.

Calcineurin signaling as a target for the treatment of alcohol abuse and neuroinflammatory disorders.

Converging lines of evidence point to a significant role of neuroinflammation in a host of psychiatric conditions, including alcohol use disorder, TBI, and PTSD. A complex interaction of both peripheral and central signaling underlies processes involved in neuroinflammation. Calcineurin is a molecule that sits at the nexus of these processes and has been clearly linked to a number of psychiatric disorders including alcohol use disorder (AUD). Like its role in regulating peripheral immune cells, calcineurin (CN) plays an integral role in processes regulating neuroimmune function and neuroinflammatory processes. Targeting CN or elements of its signaling pathways at critical points may aid in the functional recovery from neuroinflammatory related disorders. In this review we will highlight the role of neuroinflammation and calcineurin signaling in AUD, TBI and stress-induced disorders and discuss recent findings demonstrating a therapeutic effect of immunosuppressant-induced calcineurin inhibition in a pre-clinical model of binge alcohol drinking.

Safety Assessment of Ubiquinol Acetate: Subchronic Toxicity and Genotoxicity Studies.

Coenzyme Q10 (CoQ10) is a lipid soluble, endogenous antioxidant present at highest levels in the heart followed by the kidney and liver. The reduced CoQ10 ubiquinol is well known for its chemical instability and low bioavailability. The present study was designed to synthesize ubiquinol acetate, which is more stable and biologically active, and further evaluate its safety and genotoxic potential. Synthesized ubiquinol acetate showed better stability than that of ubiquinol at the end of 3 months. In vitro genotoxicity studies (AMES test, in vitro micronucleus and chromosomal aberration) showed ubiquinol acetate as nongenotoxic with no clastogenic or aneugenic effects at high dose of 5000 and 62.5 µg/mL, respectively. In subchronic toxicity study, ubiquinol acetate was administered orally to Sprague Dawley rats at 150, 300, and 600 mg/kg/day for 90 days. No treatment related adverse effects were observed in males at 600 mg/kg/day; however, females showed treatment related increase in AST and ALT with small focal irregular white-yellow spots in liver on gross necropsy examination. Histopathological evaluation revealed hepatocellular necrosis in high dose females which was considered as adverse. Based on the results, the No-Observed-Adverse-Effect Level (NOAEL) of ubiquinol acetate in males and females was determined as 600 and 300 mg/kg/day, respectively.

Functional consumers regulate the effect of availability of subsidy on trophic cascades in the Yellow River Delta, China.

Understanding the environmental context where heterogeneous ecological processes affect biotic interactions is a key aim of ecological research. However, mechanisms underlying spatial variation in trophic interactions linked to resource availability across ecosystem gradients remains unclear. We experimentally manipulated the interactive effects of predator fish and quantitative gradient of leaf detritus on macroinvertebrates and benthic algae. We found that non-linear changes in the strength of trophic cascades were strongly linked to the retention rates of experimental leaf detritus and also determined by predatory consumers. Retention rate of leaf detritus influenced the recruitment of predatory invertebrates and foraging preference of predators, accounting for largely the variations in shift of strengthening and weakening trophic cascades. Our results highlight the importance to identify joint processes of recruitment and foraging responses of functional consumer in understanding the impacts of both anthropogenic and natural alterations in subsidy on trophic interaction of coastal food webs.

Maternal Cerebrospinal Fluid Glutamate in Response to Variable Foraging Demand: Relationship to Cerebrospinal Fluid Serotonin Metabolites in Grown Offspring.

BACKGROUND: Maternal response to allostatic overload during infant rearing may alter neurobiological measures in grown offspring, potentially increasing susceptibility to mood and anxiety disorders. We examined maternal cerebrospinal fluid (CSF) glutamate response during exposure to variable foraging demand (VFD), a bonnet macaque model of allostatic overload, testing whether activation relative to baseline predicted concomitant CSF elevations of the stress neuropeptide, corticotropin-releasing factor. We investigated whether VFD-induced activation of maternal CSF glutamate affects maternal-infant attachment patterns and offspring CSF 5-hydroxyindoleacetic acid concentrations. METHODS: Mother-infant dyads were exposed to the "VFD stressor," a paradigm in which mothers experience 16 weeks of foraging uncertainty while rearing their infant offspring. Through staggering the infant age of VFD onset, both a cross-sectional design and a longitudinal design were used. Maternal CSF glutamate and glutamine concentrations post-VFD exposure were cross-sectionally compared to maternal VFD naive controls. Proportional change in concentrations of maternal glutamate (and glutamine), a longitudinal measure, was evaluated in relation to VFD-induced elevations of CSF corticotropin-releasing factor. The former measure was related to maternal-infant proximity scores obtained during the final phases of VFD exposure. Maternal glutamatergic response to VFD exposure was used as a predictor variable for young adolescent offspring CSF metabolites of serotonin, dopamine, and norepinephrine. RESULTS: Following VFD exposure, maternal CSF glutamate concentrations correlated positively with maternal CSF CRF concentrations. Activation relative to baseline of maternal CSF glutamate concentrations following VFD exposure correlated directly with a) increased maternal-infant proximity during the final phases of VFD and b) offspring CSF concentrations of monoamine metabolites including 5-hydroxyindoleacetic acid, which was elevated relative to controls. CONCLUSIONS: Activation of maternal CSF glutamate in response to VFD-induced allostasis is directly associated with elevations of maternal CSF corticotropin-releasing factor. Maternal CSF glutamate alterations induced by VFD potentially compromise serotonin neurotransmission in grown offspring, conceivably modeling human vulnerability to treatment-resistant mood and anxiety disorders.

Evaluating the effectiveness and reliability of the Vibrant Soundbridge and Bonebridge auditory implants in clinical practice: Study design and methods for a multi-centre longitudinal observational study.

BACKGROUND: The Vibrant Soundbridge middle ear implant and the Bonebridge bone conducting hearing device are hearing implants that use radio frequency transmission to send information from the sound processor to the internal transducer. This reduces the risk of skin problems and infection but requires a more involved surgical procedure than competitor skin penetrating devices. It is not known whether more complex surgery will lead to additional complications. There is little information available on the reliability of these systems and adverse medical or surgical events. The primary research question is to determine the reliability and complication rate for the Vibrant Soundbridge and Bonebridge. The secondary research question explores changes in quality of life following implantation of the devices. The tertiary research question looks at effectiveness via changes in auditory performance. METHOD: The study was designed based on a combination of a literature search, two clinician focus groups and expert review.A multi-centre longitudinal observational study was designed. There are three study groups, two will have been implanted prior to the start of the study and one group, the prospective group, will be implanted after initiation of the study. Outcomes are surgical questionnaires, measures of quality of life, user satisfaction and speech perception tests in quiet and in noise. CONCLUSION: This is the first multi-centre study to look at these interventions and includes follow up over time to understand effectiveness, reliability, quality of life and complications.