Trusting relationships between patients with non-curative cancer and healthcare professionals create ethical obstacles for informed consent in clinical trials: a grounded theory study.

BACKGROUND: Clinical trial participation for patients with non-curative cancer is unlikely to present personal clinical benefit, which raises the bar for informed consent. Previous work demonstrates that decisions by patients in this setting are made within a 'trusting relationship' with healthcare professionals. The current study aimed to further illuminate the nuances of this relationship from both the patients' and healthcare professionals' perspectives. METHODS: Face-to-face interviews using a grounded theory approach were conducted at a regional Cancer Centre in the United Kingdom. Interviews were performed with 34 participants (patients with non-curative cancer, number (n) = 16; healthcare professionals involved in the consent process, n = 18). Data analysis was performed after each interview using open, selective, and theoretical coding. RESULTS: The 'Trusting relationship' with healthcare professionals underpinned patient motivation to participate, with many patients 'feeling lucky' and articulating an unrealistic hope that a clinical trial could provide a cure. Patients adopted the attitude of 'What the doctor thinks is best' and placed significant trust in healthcare professionals, focusing on mainly positive aspects of the information provided. Healthcare professionals recognised that trial information was not received neutrally by patients, with some expressing concerns that patients would consent to 'please' them. This raises the question: Within the trusting relationship between patients and healthcare professionals, 'Is it possible to provide balanced information?'. The theoretical model identified in this study is central to understanding how the trusting professional-patient relationship influences the decision-making process. CONCLUSION: The significant trust placed on healthcare professionals by patients presented an obstacle to delivering balanced trial information, with patients sometimes participating to please the 'experts'. In this high-stakes scenario, it may be pertinent to consider strategies, such as separation of the clinician-researcher roles and enabling patients to articulate their care priorities and preferences within the informed consent process. Further research is needed to expand on these ethical conundrums and ensure patient choice and autonomy in trial participation are prioritised, particularly when the patient's life is limited.

Exploring the prevalence, impact and experience of cardiac cachexia in patients with advanced heart failure and their caregivers: A sequential phased study.

BACKGROUND: Cardiac Cachexia is a wasting syndrome that has a significant impact on patient mortality and quality of life world-wide, although it is poorly understood in clinical practice. AIM: Identify the prevalence of cardiac cachexia in patients with advanced New York Heart Association (NYHA) functional class and explore its impact on patients and caregivers. DESIGN: An exploratory cross-sectional study. The sequential approach had two phases, with phase 1 including 200 patients with NYHA III-IV heart failure assessed for characteristics of cardiac cachexia. Phase 2 focussed on semi-structured interviews with eight cachectic patients and five caregivers to ascertain the impact of the syndrome. SETTING/PARTICIPANTS: Two healthcare trusts within the United Kingdom. RESULTS: Cardiac Cachexia was identified in 30 out of 200 participants, giving a prevalence rate of 15%. People with cachexia had a significantly reduced average weight and anthropometric measures (p < 0.05). Furthermore, individuals with cachexia experienced significantly more fatigue, had greater issues with diet and appetite, reduced physical wellbeing and overall reduced quality of life. C-reactive protein was significantly increased, whilst albumin and red blood cell count were significantly decreased in the cachectic group (p < 0.05). From qualitative data, four key themes were identified: (1) 'Changed relationship with food and eating', (2) 'Not me in the mirror', (3) 'Lack of understanding regarding cachexia' and (4) 'Uncertainty regarding the future'. CONCLUSIONS: Cardiac cachexia has a debilitating effect on patients and caregivers. Future work should focus on establishing a specific definition and clinical pathway to enhance patient and caregiver support.

The varied role, scope of practice, and education of cardiovascular nurses in ESC-affiliated countries: an ACNAP survey.

AIMS: Cardiovascular disease burden is increasing globally, pressuring nursing staff to deliver high-quality care across a diverse range of treatment areas. As such, an evaluation of the educational preparation of nurses is needed. To determine the current role, scope of practice, education level, and needs of cardiovascular nurses working across the European Society of Cardiology (ESC)-affiliated countries. METHODS AND RESULTS: A short survey was distributed in paper (EuroHeartCare 2018) or electronic format to nurses delivering cardiovascular care. A total of 876 cardiovascular nurses from 26 ESC-affiliated countries completed the survey. Most respondents (79%), were educated to at least bachelor level, with 46% having a masters or doctorate, and were highly motivated to continue their educational development. Despite this, a large number (44.3%) of respondents believed they were not fully prepared for their job. The main areas where further education was requested included acute care in cardiovascular disease (CVD) and CVD risk factor management. Face-to-face courses/training were the most requested delivery mode, followed by E-learning-which appears to be underutilized in this population. Awareness of the existing curricula for cardiovascular nurse education was minimal, and therefore these resources require further promotion and implementation. CONCLUSIONS: This international sample of cardiovascular nurses was generally educated to degree level and motivated to improve their cardiovascular knowledge. Many believed they were underprepared for their role, highlighting the need for increased investment in education. This should be focused on specific needs and delivered using a face-to-face, E-learning, or blended-learning format. Furthermore, increased signposting of existing resources is required.

Nothing to lose: a grounded theory study of patients' and healthcare professionals' perspectives of being involved in the consent process for oncology trials with non-curative intent.

BACKGROUND: Clinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. As such, the decision-making and consent process for patient participation is often challenging. AIM: To gain understanding of how patients make decisions regarding clinical trial participation, from the perspective of both the patient and healthcare professionals involved. METHODS: In-depth, face to face interviews using a grounded theory approach. This study was conducted in a regional Cancer Centre in the United Kingdom. Of the 36 interviews, 16 were conducted with patients with cancer that had non-curative intent and 18 with healthcare professionals involved in the consent process. RESULTS: 'Nothing to lose' was identified as the core category that underpinned all other data within the study. This highlighted the desperation articulated by participants, who asserted trial participation was the 'only hope in the room'. The decision regarding participation was taken within a 'trusting relationship' that was important to both patients and professionals. Both were united in their 'fight against cancer'. These two categories are critical in understanding the decision-making/consent process and are supported by other themes presented in the theoretical model. CONCLUSION: This study presents an important insight into the complex and ethically contentious situation of consent in clinical trials that have non-curative intent. It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process.

Secondary prevention and cardiovascular care across Europe: A survey of European Society of Cardiology members' views.

INTRODUCTION: Secondary prevention of cardiovascular disease is a significant clinical challenge and despite European Society of Cardiology (ESC) Guidelines, evidence confirms sub-optimal patient care. AIM: The aim of this study was to evaluate ESC members' opinions on the current provision of cardiovascular prevention and rehabilitation services across Europe and explore barriers to guideline implementation. METHOD: Electronic surveys using a secure web link were sent to members of the ESC in eight purposively selected ESC affiliated countries. RESULTS: A total of 479 professionals completed the survey, of whom 67% were cardiologists, 8.6% general physicians, 8.2% nurses and 16.2% other healthcare professionals. Respondents were predominantly (91%) practising clinicians, generally highly motivated regarding cardiovascular disease prevention, but most reported that secondary prevention in their country was sub-optimal. The main barriers to prevention were lack of available cardiac rehabilitation programmes and long-term follow-up, patients' disease perception and professional attitudes towards prevention. While knowledge of the prevention guidelines was generally good, practices such as motivational counselling and better educational tools were called for to promote exercise, smoking cessation and for nutritional aspects. CONCLUSIONS: The provision of services focusing on the secondary prevention of cardiovascular disease varies greatly across Europe. Furthermore, despite ESC Guidelines and a strong evidence base supporting the efficacy of secondary prevention, the infrastructure and co-ordination of such care is lacking. In addition patient motivation is considered poor and some professionals remain unconvinced about the merits of prevention. The disappointing results outlined in this survey emphasise that improved tools are urgently required to educate both patients and professionals and confirm the priority of cardiovascular prevention internationally.

Care plans for the older heart failure patient.

Heart failure (HF) professionals are managing an older population with multiple, often interconnected comorbidities. The average age of the HF patient has increased substantially and many have a number of comorbidities. For the older HF patient, diligent planning of care has the potential to reduce hospitalization, improve quality of life and mortality; nevertheless, this vital component is often overlooked. Frailty, cachexia, sarcopenia, and cognitive impairment are all common in the older HF patient and require special care considerations. Many older HF patients live for many years with troublesome symptoms that could be better addressed through the incorporation of a palliative approach to care. Effective care plans can help patients maximize their health potential through both lifestyle and pharmacological interventions. However, current evidence remains scarce on what constitutes an optimal plan, therefore further studies are urgently needed. We review the care that could be implemented for the complex older HF patient with comorbidities.

An exploration of the prevalence and experience of cardiac cachexia: protocol for a mixed methods cross-sectional study.

BACKGROUND: Cachexia is a complex and multifactorial syndrome defined as severe weight loss and muscle wasting which frequently goes unrecognised in clinical practice [1]. It is a debilitating syndrome, resulting in patients experiencing decreased quality of life and an increased risk of premature death; with cancer cachexia alone resulting in 2 million deaths per annum [2]. Most work in this field has focused on cancer cachexia, with cardiac cachexia being relatively understudied - despite its potential prevalence and impact in patients who have advanced heart failure. We report here the protocol for an exploratory study which will: 1. focus on determining the prevalence and clinical implications of cardiac cachexia within advanced heart failure patients; and 2. explore the experience of cachexia from patients' and caregivers' perspectives. METHODS: A mixed methods cross-sectional study. Phase 1: A purposive sample of 362 patients with moderate to severe heart failure from two Trusts within the United Kingdom will be assessed for known characteristics of cachexia (loss of weight, loss of muscle, muscle mass/strength, anorexia, fatigue and selected biomarkers), through basic measurements (i.e. mid-upper arm circumference) and use of three validated questionnaires; focusing on fatigue, quality of life and appetite. Phase 2: Qualitative semi-structured interviews with patients (n = 12) that meet criteria for cachexia, and their caregivers (n = 12), will explore their experience of this syndrome and its impact on daily life. Interviews will be digitally recorded and transcribed verbatim, prior to qualitative thematic and content analysis. Phase 3: Workshops with key stakeholders (patients, caregivers, healthcare professionals and policy makers) will be used to discuss study findings and identify practice implications to be tested in further research. DISCUSSION: Data collected as part of this study will allow the prevalence of cardiac cachexia in a group of patients with moderate to severe heart failure to be determined. It will also provide a unique insight into the implications and personal experience of cardiac cachexia for both patients and carers. It is hoped that robust quantitative data and rich qualitative perspectives will promote crucial clinical discussions on implications for practice, including targeted interventions to improve patients' quality of life where appropriate.

Correction: Screening for osteogenic activity in extracts from Irish marine organisms: The potential of Ceramium pallidum.

[This corrects the article DOI: 10.1371/journal.pone.0207303.].

Screening for osteogenic activity in extracts from Irish marine organisms: The potential of Ceramium pallidum.

Extracts and compounds derived from marine organisms have reportedly shown some osteogenic potential. As such, these bioactives may aid in the treatment of musculoskeletal conditions such as osteoporosis; helping to address inefficacies with current treatment options. In this study, 72 fractions were tested for their in vitro osteogenic activity using a human foetal osteoblast (hFOB) cell line and bone marrow derived mesenchymal stem cells (MSCs), focusing on their cytotoxic, proliferative and differentiation effects. Extracts dissolved in dimethyl sulfoxide and ethanol showed no significant osteogenic potential. However, two extracts derived from powder residues (left over from original organic extractions) caused a significant promotion of MSC differentiation. Bioactivity from powder residues derived from the epiphytic red algae Ceramium pallidum is described in detail to highlight its treatment potential. In vitro, C. pallidum was shown to promote MSC differentiation and extracellular matrix mineralisation. In vivo, this extract caused a significant increase in opercular bone growth of zebrafish larvae and a significant increase in bone density of regenerated adult caudal fins. Our findings therefore show the importance of continued screening efforts, particularly of novel extract sources, and the presence of bioactive compounds in C. pallidum extract.

Bioactive Compounds from Marine Organisms: Potential for Bone Growth and Healing.

Marine organisms represent a highly diverse reserve of bioactives which could aid in the treatment of a wide range of diseases, including various musculoskeletal conditions. Osteoporosis in particular would benefit from a novel and effective marine-based treatment, due to its large disease burden and the inefficiencies of current treatment options. Osteogenic bioactives have been isolated from many marine organisms, including nacre powder derived from molluscan shells and fucoidan-the sulphated polysaccharide commonly sourced from brown macroalgae. Such extracts and compounds are known to have a range of osteogenic effects, including stimulation of osteoblast activity and mineralisation, as well as suppression of osteoclast resorption. This review describes currently known soluble osteogenic extracts and compounds from marine invertebrates and algae, and assesses their preclinical potential.

Red algal extracts from Plocamium lyngbyanum and Ceramium secundatum stimulate osteogenic activities in vitro and bone growth in zebrafish larvae.

Through the current trend for bioprospecting, marine organisms - particularly algae - are becoming increasingly known for their osteogenic potential. Such organisms may provide novel treatment options for osteoporosis and other musculoskeletal conditions, helping to address their large healthcare burden and the limitations of current therapies. In this study, extracts from two red algae - Plocamium lyngbyanum and Ceramium secundatum - were tested in vitro and in vivo for their osteogenic potential. In vitro, the growth of human bone marrow stromal cells (hBMSCs) was significantly greater in the presence of the extracts, particularly with P. lyngbyanum treatment. Osteogenic differentiation was promoted more by C. secundatum (70 µg/ml), though P. lyngbyanum had greater in vitro mineralisation potential. Both species caused a marked and dose-dependent increase in the opercular bone area of zebrafish larvae. Our findings therefore indicate the presence of bioactive components in P. lyngbyanum and C. secundatum extracts, which can promote both in vitro and in vivo osteogenic activity.