Long term trends in floating plastic pollution within a marine protected area identifies threats for Endangered northern bottlenose whales.

"The Gully", situated off Nova Scotia, Canada, is the largest submarine canyon in the western North Atlantic. This unique oceanographic feature, which became a Marine Protected Area (MPA) in 2004, is rich in marine biodiversity and is part of the critical habitat of Endangered northern bottlenose whales (Hyperoodon ampullatus). To understand the potential impact of plastic pollution in the MPA and on this Endangered cetacean, we evaluated trends over time in the abundance and composition of plastics and compared these to the stomach contents of recently stranded northern bottlenose whales. From the 1990s-2010s, the median abundance of micro-sized (<5 mm) and small plastics (5 mm-2.5 cm) increased significantly, while the median abundance of large plastics (>2.5 cm) decreased significantly. Plastic abundance from the 2010s for micro-sized and small plastics varied from 5586-438 196 particles km-2, higher than previously measured estimates for surrounding offshore areas. Polymers identified using FTIR spectroscopy included polyethylene, polypropylene, polyethylene terephthalate polyester, nylon, alkyds (paint), and natural and semi-synthetic cellulosic fibers. The abundance of large debris ranged from 0 to 108.6 items km-2 and consisted of plastic sheets and bags, food wrappers and containers, rope, fishing buoys, and small plastic fragments. Whale stomach contents contained fragments of fishing nets, ropes, bottle caps, cups, food wrappers, smaller plastic fragments, fibers, and paint flakes, consistent with the composition and character of items collected from their critical habitat. Despite being far from centres of human population, the unique oceanographic features of The Gully (i.e. currents and bathymetric complexity) may concentrate plastic debris, increasing exposure rates of whales to plastic pollution. The increase in micro-sized and small plastics over time suggests associated health and welfare impacts of ingested plastics should be accounted for in future recovery plans for this Endangered species.

Working with public contributors in Parkinson's research: What were the changes, benefits and learnings? A critical reflection from the researcher and public contributor perspective.

INTRODUCTION: This paper provides a critical reflection from both the researcher and public contributor (PC) perspective on the benefits and the learnings taken from involving PCs in research related to Parkinson's. APPROACH TO PATIENT AND PUBLIC INVOLVEMENT (PPI): This paper reports on how PCs shaped the design and development of the PRIME-UK research programme study materials through input into information leaflets, consent forms and other patient-facing documents used across three studies within the PRIME-UK research programme. The PRIME-UK research programme is designed to improve the quality of life of people with Parkinson's and this project included three studies: a cross-sectional study, a randomised control trial and a qualitative study. We captured these impacts using Public Involvement Impact Logs, which provide a framework allowing researchers and PCs to report on the learnings, immediate outcomes and impacts from PPI. For this project, the impact logs enabled us to provide reflections from PCs and researchers on the process of involving 'the public' in Parkinson's research. FINDINGS: This paper builds on existing evidence of the range of benefits and challenges that emerge from working with patients and the public in Parkinson's research; this includes reflecting on the changes made to the study materials and benefits for the people involved. Four themes emerged from the reflections that were common to the researchers and PCs; these were the importance of providing a supportive environment; recognition of the benefit of the evaluation of the impact of PPI; acknowledgement that engagement of PPI can make a positive difference to the research process and that timely communication and the use of face-to-face communication, where available, is key. Furthermore, we demonstrate how impact logs provide a useful and straightforward tool for evaluating public involvement practices and supporting the feedback process. CONCLUSION: We offer key recommendations for involving patients and the public in Parkinson's research and suggest approaches that could be implemented to capture the impacts of public involvement. PUBLIC CONTRIBUTION: Public contributors (PCs) were involved in the design and development of the participant information leaflets, consent forms and other patient-facing documents used for studies within the PRIME-UK research programme. In addition, PCs evaluated their involvement using impact logs and co-authored this paper.

Clonal expansion of community-associated meticillin-resistant Staphylococcus aureus (MRSA) in people who inject drugs (PWID): prevalence, risk factors and molecular epidemiology, Bristol, United Kingdom, 2012 to 2017.

BACKGROUND: In 2015, Bristol (South West England) experienced a large increase in cases of meticillin-resistant Staphylococcus aureus (MRSA) infection in people who inject drugs (PWID). AIM: We aimed to characterise and estimate the prevalence of MRSA colonisation among PWID in Bristol and test evidence of a clonal outbreak. METHODS: PWID recruited through an unlinked-anonymous community survey during 2016 completed behavioural questionnaires and were screened for MRSA. Univariable logistic regression examined associations with MRSA colonisation. Whole-genome sequencing used lineage-matched MRSA isolates, comparing PWID (screening and retrospective bacteraemia samples from 2012-2017) with non-PWID (Bristol screening) in Bristol and national reference laboratory database samples. RESULTS: The MRSA colonisation prevalence was 8.7% (13/149) and was associated with frequently injecting in public places (odds ratio (OR): 5.5; 95% confidence interval (CI):1.34-22.70), recent healthcare contact (OR: 4.3; 95% CI: 1.34-13.80) and injecting in groups of three or more (OR: 15.8; 95% CI: 2.51-99.28). People reporting any one of: injecting in public places, injection site skin and soft tissue infection or hospital contact accounted for 12/13 MRSA positive cases (sensitivity 92.3%; specificity 51.5%). Phylogenetic analysis identified a dominant clade associated with infection and colonisation among PWID in Bristol belonging to ST5-SCCmecIVg. CONCLUSIONS: MRSA colonisation in Bristol PWID is substantially elevated compared with general population estimates and there is evidence of clonal expansion, community-based transmission and increased infection risk related to the colonising strain. Targeted interventions, including community screening and suppression therapy, education and basic infection control are needed to reduce MRSA infections in PWID.

Incident Type 2 Myocardial Infarction in a Cohort of Patients Undergoing Coronary or Peripheral Arterial Angiography.

BACKGROUND: Despite growing recognition of type 2 myocardial infarction (T2MI; related to supply/demand mismatch), little is known about its risk factors or its association with outcome. METHODS: A single-center cohort of patients undergoing coronary or peripheral angiography with or without intervention was prospectively enrolled and followed for incident type 1 and T2MI, and major adverse cardiovascular events (MACE, a composite of all-cause death, nonfatal myocardial infarction [MI], heart failure, stroke, transient ischemic attack, peripheral arterial complication, and cardiac arrhythmia), as well. T2MI was adjudicated using criteria from the Third Universal Definition of MI. Baseline characteristics, blood samples, and angiography information were obtained. Major end points subsequent to first MI were assessed using landmark analyses to compare the rates of first events only where everyone with a prior history of any MACE before MI were censored and adjusted for follow-up times. Cox proportional hazard models were used for time-to-event analyses with age and sex forced into all models and additional covariates evaluated by using the stepwise option for the selection. RESULTS: One thousand two hundred fifty-one patients were enrolled and followed for a median of 3.4 years. Of these patients, 152 (12.2%) had T2MI during follow-up; T2MI was frequently recurrent. Multivariable predictors of T2MI were older age, lower systolic blood pressure, history of coronary artery disease, heart failure, chronic obstructive pulmonary disease, diabetes mellitus, nitrate use, and elevated concentrations of glucose, N-terminal pro-B type natriuretic peptide, and cystatin C. Patients with T2MI had higher rates of subsequent adverse events than those without T2MI (per 100 person-years: MACE, 53.7 versus 21.1, P<0.001; all-cause death, 23.3 versus 3.3, P<0.001; cardiovascular death, 17.5 versus 2.6, P<0.001; heart failure events, 22.4 versus 7.4, P<0.001); these rates are similar to those seen in patients with type 1 MI. Incident diagnosis of T2MI strongly predicted risk for subsequent MACE (adjusted hazard ratio, 1.90; 95% confidence interval, 1.46-2.48; P<0.001), all-cause death (adjusted hazard ratio, 2.96; 95% confidence interval, 2.01-4.36; P<0.001), and cardiovascular death (adjusted hazard ratio, 2.16; 95% confidence interval, 1.36-3.43; P=0.001). CONCLUSIONS: T2MI is common and associated with poor prognosis. Studies evaluating treatment strategies for management of T2MI are needed. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00842868.

Synthesising conceptual frameworks for patient and public involvement in research - a critical appraisal of a meta-narrative review.

BACKGROUND: A number of conceptual frameworks for patient and public involvement (PPI) in research have been published in recent years. Although some are based on empirical research and/or existing theory, in many cases the basis of the conceptual frameworks is not evident. In 2015 a systematic review was published by a collaborative review group reporting a meta-narrative approach to synthesise a conceptual framework for PPI in research (hereafter 'the synthesis'). As the first such synthesis it is important to critically scrutinise this meta-narrative review. The 'RAMESES publication standards for meta-narrative reviews' provide a framework for critically appraising published meta-narrative reviews such as this synthesis, although we recognise that these were published concurrently. Thus the primary objective of this research was to appraise this synthesis of conceptual frameworks for PPI in research in order to inform future conceptualisation. METHODS: Four researchers critically appraised the synthesis using the RAMESES publication standards as a framework for assessment. Data were extracted independently using a data extraction form closely based on the RAMESES publication standards. Each item from the standards was assessed on a four point scale (0 = unmet, 1 = minimally met, 2 = partly met, 3 = fully met). The four critical appraisals were then compared and any differences resolved through discussion. RESULTS: A good degree of inter-rater reliability was found. A consensus assessment of the synthesis as a meta-narrative review of PPI conceptual frameworks was achieved with an average of '1' (minimally met) across all 20 items. Two key items ('evidence of adherence to guiding principles of meta-narrative review' and 'analysis and synthesis processes') were both wholly unmet. Therefore the paper did not meet our minimum requirements for a meta-narrative review. We found the RAMESES publication standards were a useful tool for carrying out a critical appraisal although some minor improvements are suggested. CONCLUSIONS: Although the aims of the authors' synthesis were commendable, and the conceptual framework presented was coherent and attractive, the paper did not demonstrate a transparent and replicable meta-narrative review approach. There is a continuing need for a more rigorous synthesis of conceptual frameworks for PPI.

Spatial distribution and risk assessment of microplastics in surface waters of the St. Lawrence Estuary.

Development of effective prevention and mitigation strategies for marine plastic pollution requires a better understanding of the pathways and transport mechanisms of plastic waste. Yet the role of estuaries as a key interface between riverine inputs of plastic pollution and delivery to receiving marine environments remains poorly understood. This study quantified the concentration and distribution of microplastics (MPs) (50-3200 µm) in surface waters of the St. Lawrence Estuary (SLE) in eastern Canada. Microplastics were identified and enumerated based on particle morphology, colour, and size class. Fourier Transform Infrared (FTIR) spectroscopy was used on a subset of particles to identify polymers. Generalized linear models (Gamma distribution with log-link) examined the relationship between MP concentrations and oceanographic variables and anthropogenic sources. Finally, a risk assessment model, using MP concentrations and chemical hazards based on polymer types, estimated the MP pollution risk to ecosystem health. Mean surface MP concentration in the SLE was 120 ± 42 SD particles m-3; MP concentrations were highest in the fluvial section and lowest in the Northwest Gulf of St. Lawrence. However, MP concentrations exhibited high heterogeneity along the length and width of the SLE. Microplastics were elevated at stations located closer to wastewater treatment plant outflows and downstream sites with more agricultural land. Black, blue, and transparent fibers and fragments ≤250 µm were most commonly encountered. Predominant polymer types included polyethylene terephthalate, regenerated cellulose, polyethylene, and alkyds. While the overall risk to ecosystem health in the entire estuary was considered low, several stations, particularly near urban centres were at high or very high risk. This study provides new insights into the quantification and distribution of MPs and first estimates of the risk of MP pollution to ecosystem health in one of the world's largest estuaries.

American Society of Echocardiography COVID-19 Statement Update: Lessons Learned and Preparation for Future Pandemics.

The COVID-19 pandemic has evolved since the publication of the initial American Society of Echocardiography (ASE) statements providing guidance to echocardiography laboratories. In light of new developments, the ASE convened a diverse, expert writing group to address the current state of the COVID-19 pandemic and to apply lessons learned to echocardiography laboratory operations in future pandemics. This statement addresses important areas specifically impacted by the current and future pandemics: (1) indications for echocardiography, (2) application of echocardiographic services in a pandemic, (3) infection/transmission mitigation strategies, (4) role of cardiac point-of-care ultrasound/critical care echocardiography, and (5) training in echocardiography.

Bleeding risk in patients prescribed dual antiplatelet therapy and triple therapy after coronary interventions: the ADAPTT retrospective population-based cohort studies.

Background: Bleeding among populations undergoing percutaneous coronary intervention or coronary artery bypass grafting and among conservatively managed patients with acute coronary syndrome exposed to different dual antiplatelet therapy and triple therapy (i.e. dual antiplatelet therapy plus an anticoagulant) has not been previously quantified. Objectives: The objectives were to estimate hazard ratios for bleeding for different antiplatelet and triple therapy regimens, estimate resources and the associated costs of treating bleeding events, and to extend existing economic models of the cost-effectiveness of dual antiplatelet therapy. Design: The study was designed as three retrospective population-based cohort studies emulating target randomised controlled trials. Setting: The study was set in primary and secondary care in England from 2010 to 2017. Participants: Participants were patients aged ≥ 18 years undergoing coronary artery bypass grafting or emergency percutaneous coronary intervention (for acute coronary syndrome), or conservatively managed patients with acute coronary syndrome. Data sources: Data were sourced from linked Clinical Practice Research Datalink and Hospital Episode Statistics. Interventions: Coronary artery bypass grafting and conservatively managed acute coronary syndrome: aspirin (reference) compared with aspirin and clopidogrel. Percutaneous coronary intervention: aspirin and clopidogrel (reference) compared with aspirin and prasugrel (ST elevation myocardial infarction only) or aspirin and ticagrelor. Main outcome measures: Primary outcome: any bleeding events up to 12 months after the index event. Secondary outcomes: major or minor bleeding, all-cause and cardiovascular mortality, mortality from bleeding, myocardial infarction, stroke, additional coronary intervention and major adverse cardiovascular events. Results: The incidence of any bleeding was 5% among coronary artery bypass graft patients, 10% among conservatively managed acute coronary syndrome patients and 9% among emergency percutaneous coronary intervention patients, compared with 18% among patients prescribed triple therapy. Among coronary artery bypass grafting and conservatively managed acute coronary syndrome patients, dual antiplatelet therapy, compared with aspirin, increased the hazards of any bleeding (coronary artery bypass grafting: hazard ratio 1.43, 95% confidence interval 1.21 to 1.69; conservatively-managed acute coronary syndrome: hazard ratio 1.72, 95% confidence interval 1.15 to 2.57) and major adverse cardiovascular events (coronary artery bypass grafting: hazard ratio 2.06, 95% confidence interval 1.23 to 3.46; conservatively-managed acute coronary syndrome: hazard ratio 1.57, 95% confidence interval 1.38 to 1.78). Among emergency percutaneous coronary intervention patients, dual antiplatelet therapy with ticagrelor, compared with dual antiplatelet therapy with clopidogrel, increased the hazard of any bleeding (hazard ratio 1.47, 95% confidence interval 1.19 to 1.82), but did not reduce the incidence of major adverse cardiovascular events (hazard ratio 1.06, 95% confidence interval 0.89 to 1.27). Among ST elevation myocardial infarction percutaneous coronary intervention patients, dual antiplatelet therapy with prasugrel, compared with dual antiplatelet therapy with clopidogrel, increased the hazard of any bleeding (hazard ratio 1.48, 95% confidence interval 1.02 to 2.12), but did not reduce the incidence of major adverse cardiovascular events (hazard ratio 1.10, 95% confidence interval 0.80 to 1.51). Health-care costs in the first year did not differ between dual antiplatelet therapy with clopidogrel and aspirin monotherapy among either coronary artery bypass grafting patients (mean difference £94, 95% confidence interval -£155 to £763) or conservatively managed acute coronary syndrome patients (mean difference £610, 95% confidence interval -£626 to £1516), but among emergency percutaneous coronary intervention patients were higher for those receiving dual antiplatelet therapy with ticagrelor than for those receiving dual antiplatelet therapy with clopidogrel, although for only patients on concurrent proton pump inhibitors (mean difference £1145, 95% confidence interval £269 to £2195). Conclusions: This study suggests that more potent dual antiplatelet therapy may increase the risk of bleeding without reducing the incidence of major adverse cardiovascular events. These results should be carefully considered by clinicians and decision-makers alongside randomised controlled trial evidence when making recommendations about dual antiplatelet therapy. Limitations: The estimates for bleeding and major adverse cardiovascular events may be biased from unmeasured confounding and the exclusion of an eligible subgroup of patients who could not be assigned an intervention. Because of these limitations, a formal cost-effectiveness analysis could not be conducted. Future work: Future work should explore the feasibility of using other UK data sets of routinely collected data, less susceptible to bias, to estimate the benefit and harm of antiplatelet interventions. Trial registration: This trial is registered as ISRCTN76607611. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 8. See the NIHR Journals Library website for further project information.

People who have a heart attack are treated with a stent to open up the blocked artery that caused the heart attack, with surgery to bypass the blocked artery or with medication only. Whatever the treatment, they are prescribed one or more antiplatelet drugs, either aspirin only or aspirin and an additional antiplatelet (clopidogrel, prasugrel or ticagrelor), for 12 months after the heart attack. Antiplatelets are given to prevent another heart attack, but increase the risk of bleeding. We used a large general practice database and a database describing patients' attendances and admissions to hospital to determine how many people bleed with different antiplatelet combinations. We found that, overall, up to 1 in 10 people taking antiplatelets (rising to 2 in 10 if also taking an anticoagulant such as warfarin or dabigatran) reported a bleed. Among patients treated with surgery or medication only, we compared aspirin only (which is a less potent therapy) with aspirin and clopidogrel (a more potent therapy). Among patients treated with stents, we compared aspirin and clopidogrel (less potent therapy) with aspirin and prasugrel or ticagrelor (more potent therapy). In all three populations, the more potent therapy increased the risk of bleeding by about one and a half times, but this was not offset by a reduced risk of having a subsequent heart attack. This may be explained by low adherence to the medication: between one-third and almost half of all patients did not adhere to their regimen, and non-adherence was generally higher among patients taking a more potent therapy. It may also be explained by bias inherent in the study, for example if the groups prescribed different antiplatelet regimens had different risks of having another heart attack. Nevertheless, the results show that doctors should be cautious about prescribing more potent antiplatelet therapy because it may increase serious bleeds without necessarily reducing the number of heart attacks.

Formal consensus study on surgery to replace the aortic valve in adults aged 18-60 years.

OBJECTIVE: There is uncertainty about surgical procedures for adult patients aged 18-60 years undergoing aortic valve replacement (AVR). Options include conventional AVR (mechanical, mAVR; tissue, tAVR), the pulmonary autograft (Ross) and aortic valve neocuspidisation (Ozaki). Transcatheter treatment may be an option for selected patients. We used formal consensus methodology to make recommendations about the suitability of each procedure. METHODS: A working group, supported by a patient advisory group, developed a list of clinical scenarios across seven domains (anatomy, presentation, cardiac/non-cardiac comorbidities, concurrent treatments, lifestyle, preferences). A consensus group of 12 clinicians rated the appropriateness of each surgical procedure for each scenario on a 9-point Likert scale on two separate occasions (before and after a 1-day meeting). RESULTS: There was a consensus that each procedure was appropriate (A) or inappropriate (I) for all clinical scenarios as follows: mAVR: total 76% (57% A, 19% I); tAVR: total 68% (68% A, 0% I); Ross: total 66% (39% A, 27% I); Ozaki: total 31% (3% A, 28% I). The remainder of percentages to 100% reflects the degree of uncertainty. There was a consensus that transcatheter aortic valve implantation is appropriate for 5 of 68 (7%) of all clinical scenarios (including frailty, prohibitive surgical risk and very limited life span). CONCLUSIONS: Evidence-based expert opinion emerging from a formal consensus process indicates that besides conventional AVR options, there is a high degree of certainty about the suitability of the Ross procedure in patients aged 18-60 years. Future clinical guidelines should include the option of the Ross procedure in aortic prosthetic valve selection.

Outcomes of a smartphone-based application with live health-coaching post-percutaneous coronary intervention.

BACKGROUND: The interval between inpatient hospitalization for symptomatic coronary artery disease (CAD) and post-discharge office consultation is a vulnerable period for adverse events. METHODS: Content was customized on a smartphone app-based platform for hospitalized patients receiving percutaneous coronary intervention (PCI) which included education, tracking, reminders and live health coaches. We conducted a single-arm open-label pilot study of the app at two academic medical centers in a single health system, with subjects enrolled 02/2018-05/2019 and 1:3 propensity-matched historical controls from 01/2015-12/2017. To evaluate feasibility and efficacy, we assessed 30-day hospital readmission (primary), outpatient cardiovascular follow-up, and cardiac rehabilitation (CR) enrollment as recorded in the health system. Outcomes were assessed by Cox Proportional Hazards model. FINDINGS: 118 of 324 eligible (36·4%) 21-85 year-old patients who underwent PCI for symptomatic CAD who owned a smartphone or tablet enrolled. Mean age was 62.5 (9·7) years, 87 (73·7%) were male, 40 of 118 (33·9%) had type 2 diabetes mellitus, 68 (57·6%) enrolled underwent PCI for MI and 59 (50·0%) had previously known CAD; demographics were similar among matched historical controls. No significant difference existed in all-cause readmission within 30 days (8·5% app vs 9·6% control, ARR -1.1% absolute difference, 95% CI -7·1-4·8, p = 0·699) or 90 days (16·1% app vs 19·5% control, p = 0.394). Rates of both 90-day CR enrollment (HR 1·99, 95% CI 1·30-3·06) and 1-month cardiovascular follow up (HR 1·83, 95% CI 1·43-2·34) were greater with the app. Weekly engagement at 30- and 90-days, as measured by percentage of weeks with at least one day of completion of tasks, was mean (SD) 73·5% (33·9%) and 63·5% (40·3%). Spearman correlation analyses indicated similar engagement across age, sex, and cardiovascular risk factors. INTERPRETATIONS: A post-PCI smartphone app with live health coaches yielded similarly high engagement across demographics and safely increased attendance in cardiac rehabilitation. Larger prospective randomized controlled trials are necessary to test whether this app improves cardiovascular outcomes following PCI. FUNDING: National Institutes of Health, Boston Scientific. CLINICAL TRIAL REGISTRATION: NCT03416920 (https://clinicaltrials.gov/ct2/show/NCT03416920).

A Bayesian risk assessment framework for microcystin violations of drinking water and recreational standards in the Bay of Quinte, Lake Ontario, Canada.

Freshwater ecosystems can experience harmful algal blooms, which negatively impact recreational uses, aesthetics, taste, and odor in drinking water. Cyanobacterial toxins can have dire repercussions on aquatic wildlife and human health, and the most ubiquitous worldwide are the hepatotoxic compounds known as microcystins. The factors that influence the occurrence and magnitude of cyanobacteria blooms and toxin production vary in space and time and remain poorly understood. It is within this context that we present a suite of statistical models, parameterized with Bayesian inference techniques, to link the retrospective analysis of important environmental factors with the probability of exceedance of threshold microcystin levels. Our modelling framework is applied to the Bay of Quinte, Lake Ontario, Canada; a system with a long history of eutrophication problems. Collectively, 16.1% of the samples of the system collected during the study period (2003-2016) exceeded the drinking water guideline of 1.5 µgL-1, while approximately 3% of recorded values exceeded the recommended recreational threshold of 20 µgL-1. Using a segmented regression model with a stochastic breakpoint of microcystin concentrations estimated at 0.54 µg L-1, we demonstrate that the environmental conditions associated with increased probability of exceedance of the drinking water standard are chlorophyll a concentration ≥7 µg L-1, water temperature ≥20 °C, ammonium concentration ≤40 µgL-1, total phosphorus concentration ≥25 µg L-1, and wind speed ≤37 km h-1. Considering the multitude of factors that can influence the ambient levels of toxins, our study argues that the adoption of probabilistic water quality criteria offers a pragmatic approach to accommodate the associated uncertainty by permitting a realistic frequency of violations. In this context, we present a framework to evaluate the confidence of compliance with probabilistic standards that stipulate less than 10% violations of microcystin threshold ambient levels.

Considerations and recommendations for conducting qualitative research interviews with palliative and end-of-life care patients in the home setting: a consensus paper.

OBJECTIVES: To present and discuss the views of researchers at an academic palliative care research centre on research encounters with terminally ill patients in the home setting and to generate a list of recommendations for qualitative researchers working in palliative and end-of-life care. METHODS: Eight researchers took part in a consensus meeting to discuss their experiences of undertaking qualitative interviews. The researchers were of varying backgrounds and all reported having experience in interviewing terminally ill patients, and all but one had experience of interviewing patients in their home environment. RESULTS: The main areas discussed by researchers included: whether participation in end-of-life research unintentionally becomes a therapeutic experience or an ethical concern; power relationships between terminally ill patients and researchers; researcher reflexivity and reciprocity; researchers' training needs. Qualitative methods can complement the home environment; however, it can raise ethical and practical challenges, which can be more acute in the case of research undertaken with palliative and patients at the end-of-life. CONCLUSIONS: The ethical and practical challenges researchers face in this context has the potential to place both participant and researcher at risk for their physical and psychological well-being. We present a set of recommendations for researchers to consider prior to embarking on qualitative research in this context and advocate researchers in this field carefully consider the issues presented on a study-by-study basis.

Palliative care research centre's move into social media: constructing a framework for ethical research, a consensus paper.

BACKGROUND: Social media (SM) have altered the way we live and, for many, the way we die. The information available on even the rarest conditions is vast. Free from restrictions of mobility, time and distance, SM provides a space for people to share experiences of illness, death and dying, and potentially benefit from the emotional and practical support of others n similar positions. The communications that take place in these spaces also create large amounts of 'data' which, for any research centre, cannot be ignored. However, for a palliative care research centre the use of this 'data' comes with specific ethical dilemmas. METHODS: This paper details the process that we, as a research, went through in constructing a set of ethical guidelines by which to work. This involved conducting two consensus days; one with researchers from within the centre, and one with the inclusion of external researchers with a specific interest in SM. RESULTS: The primary themes that emerged from the consensus meetings includes; SM as a public or private space; the status of open and closed groups; the use of historical data; recruiting participants and obtaining informed consent and problems of anonymity associated with dissemination. CONCLUSIONS: These are the themes that this paper will focus on prior to setting out the guidelines that we subsequently constructed.

Single-Molecule Counting of High-Sensitivity Troponin I in Patients Referred for Diagnostic Angiography: Results From the CASABLANCA (Catheter Sampled Blood Archive in Cardiovascular Diseases) Study.

BACKGROUND: The meaning of high-sensitivity troponin I (hsTnI) concentrations in patients without acute myocardial infarction (MI) requires clarity. We hypothesized that among patients referred for diagnostic coronary angiography without acute MI, hsTnI concentrations would correlate with prevalent coronary artery disease (CAD) and predict incident cardiovascular events and mortality. METHODS AND RESULTS: We measured hsTnI using a single-molecule counting assay (99th percentile, 6 ng/L) in samples from 991 patients obtained at the time of angiography. Concentrations of hsTnI were assessed relative to the severity of CAD and prognosis during mean follow-up of 3.7 years. Median hsTnI concentration was 4.19 ng/L; 38% of patients had hsTnI concentrations ≥99th percentile. Across increasing hsTnI quartiles, patients had higher prevalence of angiographic CAD; in multivariate models, hsTnI ≥99th percentile independently predicted obstructive CAD (odds ratio: 2.57; P<0.001) and incident MI (hazard ratio [HR]: 2.68; P<0.001), cardiovascular death (HR: 2.29; P=0.001), and all-cause death (HR: 1.84; P=0.004). In those with >70% coronary stenosis, hsTnI ≥99th percentile independently predicted incident MI (HR: 1.87; P=0.01), cardiovascular mortality (HR: 2.74; P=0.001), and the composite end point of MI and all-cause death (HR: 2.06; P<0.001). In participants with coronary stenosis <70%, hsTnI ≥99th percentile even more strongly predicted incident MI (HR: 8.41; P<0.001), cardiovascular mortality (HR: 3.60; P=0.03), and the composite end point of MI and all-cause death (HR: 3.62; P<0.001). CONCLUSIONS: In a large prospective cohort of patients who were free of prevalent MI and undergoing diagnostic coronary angiography, hsTnI concentrations were associated with higher prevalence of CAD and predicted incident MI, cardiovascular death, and all-cause death. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00842868.

Predicting new-onset HF in patients undergoing coronary or peripheral angiography: results from the Catheter Sampled Blood Archive in Cardiovascular Diseases (CASABLANCA) study.

AIMS: Methods to identify patients at risk for incident HF would be welcome as such patients might benefit from earlier interventions. METHODS AND RESULTS: From a registry of 1251 patients referred for coronary and/or peripheral angiography, we sought to identify independent predictors of incident HF during follow-up and develop a clinical and biomarker strategy to predict this outcome. There were 991 patients free of prevalent HF at baseline. Cox proportional hazard models were developed to predict adjudicated diagnosis of incident HF. Model discrimination and reclassification were evaluated. At follow-up, 177 (18%) developed new-onset HF. Independent predictors of new-onset HF included five clinical variables (age, male sex, heart rate, history of atrial fibrillation/flutter, and history of hypertension) and two biomarkers (amino-terminal pro-B type natriuretic peptide and ST2). The c-statistic for the model without biomarkers was 0.69; including biomarkers increased the c-statistic to 0.76 (P < 0.001). A score was developed from the model. Patients in the highest score quintile had shortest time to incident HF compared with lower quintiles (log-rank P < 0.001). Following 100 bootstrap iterations, internal validation was confirmed with Harrell's c-statistic of 0.77. Use of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and beta-blockers at enrollment was associated with substantial attenuation of predictive value of the risk score. CONCLUSIONS: Patients undergoing coronary/peripheral angiographic procedures are a population at high risk for incident HF. We describe an accurate clinical and biomarker strategy for predicting incident HF and possibly intervening in such patients (NCT00842868).