Patient survival following arteriovenous fistula formation

PURPOSE: Efforts to promote arteriovenous fistulas (AVFs) have been successful in increasing the prevalence of AVF use as the primary vascular access for haemodialysis (HD). Sustained preference for AVF use may not be the most appropriate vascular access choice for all patient groups. Arteriovenous grafts (AVGs) offer advantages of earlier use and lower primary failure rates compared to AVFs so may be preferable for patients where short-term vascular access is needed. This study was designed to assess comparative mortality in different age groups following AVF formation.

METHODS: A prospective cohort of patients having AVF creation was recruited. Patients were subdivided into three age groups: Group A: lt;50 years; Group B: 50-74 years and Group C: ≥75 years. Survival curves and Cox regression analysis were performed on each of these groups.

RESULTS: One hundred and thirty-four patients (n = 134) were recruited into the study. The prevalence of diabetes increased significantly with age. As expected, mortality was higher in older age groups (log rank (Mantel-Cox) 19.227; p = 0.0001). Mortality rates at 1 year were 0% in group A, 12.5% in group B and 29.1% in group C. Medium-term mortality at 4 years was 7.9% in group A, 39.1% in group B and 54.8% in group C.

CONCLUSIONS: We found a significantly higher mortality rate in patients ≥75 years in comparison to those lt;75 years. The choice of vascular access modality should be tailored to the individual with particular reference to the patient's expected survival.

Establishing a nurse practitioner collaborative: evolution, development, and outcomes

The first Australian palliative care nurse practitioner (NP) was endorsed in 2003. In 2009 the Victoria Department of Health funded the development of the Victorian Palliative Care Nurse Practitioner Collaborative (VPCNPC). Its aim was to promote the NP role, develop resources, and provide education and mentorship to NPs, nurse practitioner candidates (NPCs), and health service managers. Four key objectives were developed: identify the demographic profile of palliative care NPCs in Victoria; develop an education curriculum and practical resources to support the training and education of palliative care NPCs and NPs; provide mentorship to NPs, NPCs, and service managers; and ensure effective communication with all key stakeholders. An NPC survey was also conducted to explore NPC demographics, models of care, the hours of study required for the role, the mentoring process, and education needs. This paper reports on the establishment of the VPCNPC, the steps taken to achieve its objectives, and the results of the survey. The NP role in palliative care in Australia continues to evolve, and the VPCNPC provides a structure and resources to clearly articulate the benefits of the role to nursing and clinical services. The advanced clinical practice role of the nurse practitioner (NP) has been well established in North America for several decades and across a range of specialties (Ryan-Woolley et al, 2007; Poghosyan et al, 2012). The NP role in Australia and the UK is a relatively new initiative that commenced in the early 2000s (Gardner et al, 2009). There are over 1000 NPs across all states and territories of Australia, of whom approximately 130 work in the state of Victoria (Victorian Government Health Information, 2012). Australian NPs work across a range of specialties, including palliative, emergency, older person, renal, cardiac, respiratory, and mental health care. There has been increasing focus nationally and internationally on developing academic programmes specifically for nurses working toward NP status (Gardner et al, 2006). There has been less emphasis on identifying the comprehensive clinical support requirements for NPs and NP candidates (NPCs) to ensure they meet all registration requirements to achieve and/or maintain endorsement, or on articulating the ongoing requirements for NPs once endorsed. Historically in Australia there has been a lack of clarity and limited published evidence on the benefits of the NP role for patients, carers, and health services (Quaglietti et al, 2004; Gardner and Gardner, 2005; Bookbinder et al, 2011; Dyar et al, 2012). An NP is considered to be at the apex of clinical nursing practice. The NP role typically entails comprehensively assessing and managing patients, prescribing medicines, making direct referrals to other specialists and services, and ordering diagnostic investigations (Australian Nursing and Midwifery Council, 2009). All NPs in Australia are required to meet the following generic criteria: be a registered nurse, have completed a Nursing and Midwifery Board of Australia approved postgraduate university Master's (nurse practitioner) degree programme, and be able to demonstrate a minimum of 3 years' experience in an advanced practice role (Nursing and Midwifery Board of Australia, 2011). An NPC in Victoria is a registered nurse employed by a service or organisation to work toward meeting the academic and clinical requirements for national endorsement as an NP. During the period of candidacy, which is of variable duration, NPCs consolidate their competence to work at the advanced practice level of an NP. The candidacy period is a process of learning the new role while engaging with mentors (medical and nursing) and accessing other learning opportunities both within and outside one's organisation to meet the educational requirements. Integral to the NP role is the development of a model of care that is responsive to identified service delivery gaps that can be addressed by the skills, knowledge, and expertise of an NP. These are unique to each individual service. The practice of an Australian NP is guided by national standards (Nursing and Midwifery Board of Australia 2014). It is defined by four overarching standards: clinical, education, research, and leadership. Following the initial endorsement of four Victorian palliative care NPs in 2005, there was a lull in recruitment. The Victoria Department of Health (DH) recognised the potential benefits of NPs for health services, and in 2008 it provided funding for Victorian public health services to scope palliative care NP models of care that could enhance service delivery and patient outcomes. The scoping strategy was effective and led to the appointment of 16 palliative care nurses to NPC positions over the ensuing 3 years. The NPCs work across a broad range of care settings, including inpatient, community, and outpatient in metropolitan, regional, and rural areas of Victoria. At the same time, the DH also funded the Centre for Palliative Care to establish the Victorian Palliative Care Nurse Practitioner Collaborative (VPCNPC) to support the NPs and NPCs. The Centre is a state-wide service that is part of St Vincent's Hospital Melbourne and a collaborative Centre of the University of Melbourne. Its primary function is to provide training and conduct research in palliative care. The purpose of the VPCNPC was to provide support and mentorship and develop resources targeted at palliative care NPs, NPCs, and health service managers. Membership of the VPCNPC is open to all NPs, NPCs, health service managers, and nurses interested in the NP role. The aim of this paper is to describe the development of the VPCNPC, its actions, and the outcomes of these actions.

Randomized controlled trial assessing the effect of simvastatin in primary biliary cirrhosis

Background This study evaluated the effect of statins in Primary biliary cirrhosis (PBC) on endothelial function, anti-oxidant status and vascular compliance. Methods Primary biliary cirrhosis patients with hypercholesterolaemia were randomized to receive 20mg simvastatin or placebo in a single blind, randomized controlled trial. Body mass index, blood pressure, glucose, liver function, lipid profile, immunoglobulin levels, serological markers of endothelial function and anti-oxidant status were measured as well as vascular compliance, calculated from pulse wave analysis and velocity, at recruitment and again at 3, 6, 9 and 12months. Results Twenty-one PBC patients (F=20, mean age = 55) were randomized to simvastatin 20mg (n=11) or matched placebo (n=10). At completion of the trial, serum cholesterol levels in the simvastatin group were significantly lower compared with the placebo group (4.91mmol/L vs. 6.15mmol/L, P=0.01). Low-density lipoprotein (LDL) levels after 12months were also significantly lower in the simvastatin group (2.33mmol/L vs. 3.53mmol/L, P=0.01). After 12months of treatment, lipid hydroperoxides were lower (0.49mol/L vs. 0.59mol/L, P=0.10) while vitamin C levels were higher (80.54mol/L vs. 77.40mol/L, P=0.95) in the simvastatin group. Pulse wave velocity remained similar between treatment groups at 12months (8.45m/s vs. 8.80m/s, P=0.66). Only one patient discontinued medication owing to side effects. No deterioration in liver transaminases was noted in the simvastatin group. Conclusions Statin therapy in patients with PBC appears safe and effective towards overall reductions in total cholesterol and LDL levels. Our initial study suggests that simvastatin may also confer advantageous effects on endothelial function and antioxidant status.

Patient-reported outcomes in randomised controlled trials on age-related macular degeneration

BACKGROUND/AIMS: The purpose of this systematic review was to identify the frequency and type of patient-reported outcome measures (PROMs) used in recent randomised controlled trials (RCTs) for age-related macular degeneration (AMD).

METHODS: The authors conducted a systematic search between January 2010 and November 2013 in MEDLINE, EMBASE, Scopus, Cochrane Library (Central) and the clinical trials registries (http://www.controlled-trials.com and http://www.ClinicalTrials.gov) according to defined inclusion criteria (RCTs on AMD in English). Two independent reviewers evaluated studies for inclusion. One reviewer extracted data of included studies, and a second masked reviewer assessed 10% to confirm accuracy in data collection. Reference lists of included papers and appendices of relevant Cochrane systematic reviews were scanned to identify other relevant RCTs. Information collected on extracted outcomes was analysed using descriptive statistics.

RESULTS: Literature and registry search yielded 3816 abstracts of journal articles and 493 records from trial registries. A total of 177 RCTs were deemed to have met inclusion criteria. Of the 858 outcomes reported, 38 outcomes were identified as PROMs (4.4%). Of the 177 RCTs examined, PROMs were used in 25 trials (14.1%). The National Eye Institute Visual Function Questionnaire-25 was the most frequently used PROM instrument (64% of RCTs with PROMs included).

CONCLUSIONS: This review highlights that a small proportion of AMD RCTs included PROMs as outcome measures and that there was a variety in the instruments used.

SWAT-1: The effectiveness of a 'site visit' intervention on recruitment rates in a multi-centre randomised trial

Background: Recruitment rates in multi-centre randomised trials often fall below target recruitment rates, causing problems for study outcomes. The Studies Within A Trial (SWAT) Programme, established by the All-Ireland Hub for Trials Methodology Research in collaboration with the Medical Research Council Network of Hubs in the United Kingdom and others, is developing methods for evaluating aspects of trial methodology through the conduct of research within research. A recently published design for a SWAT-1 provides a protocol for evaluating the effect of a site visit by the principal investigator on recruitment in multi-centre trials.

Methods: Using the SWAT-1 design, the effect of a site visit, with the sole purpose of discussing trial recruitment, on recruitment rates in a large multicentre trial in the Republic of Ireland was evaluated. A controlled before and after intervention comparison was used, where the date of the site visit provides the time point for the intervention, and for the comparison to control sites. Site A received the intervention. Site B and Site C acted as the controls. Z-scores for proportions were calculated to determine within site recruitment differences. Odds ratios and 95% confidence intervals were calculated to determine between site recruitment differences.

Results: Recruitment rates were increased in Site A post-intervention (17% and 14% percentage point increases at 1 and 3 months, respectively). No differences in recruitment occurred in Site B or in Site C. Comparing between site differences, at 3 months post-intervention, a statistically significant difference was detected in favour of higher recruitment in Site A (34% versus 25%; odds ratio 1.57, 95% confidence interval 1.09 to 2.26).

Conclusions: This is the first reported example of a study in the SWAT programme.. It provides evidence that a site visit, combined with a scheduled meeting, increases recruitment in a clinical trial. Using this example, other researchers might be encouraged to consider conducting a similar study, allowing the findings of future SWAT-1s to be compared and combined, so that higher level evidence on the effect of a site visit by the principal investigator can be obtained.

Cultivating Compassion through analysis of online patient narratives

Compassion is at the forefront of national and international healthcare policy, practice and educational debates as a result of a series of recent reports (Mid Staffordshire NHS Foundation Trust Inquiry, 2010, Lown et al 2011, Mannion, 2014). Arguably, this emphasis on compassion is in juxtaposition to an increasingly complex technological healthcare system focused upon outcomes, efficiency, productivity and competence. Within this fast paced and time pressured environment innovative strategies are required to cultivate and sustain compassion among healthcare professionals.

Understanding the person’s experience of illness and making an emotional connection are key processes in cultivating compassion (Dewar, 2013). The exponential growth in unsolicited patient narratives has the potential to provide invaluable insight into what matters to patients and their experience of illness. For many patients these stories ‘reclaim’ their illnesses from the traditional biomedical model of disease and reveal otherwise hidden aspects of their experience. The content though freely accessible, is however unedited and lacks safeguards in relation to the quality or accuracy of the information provided. Despite these concerns, healthcare professionals are now challenged to pay attention to these unsolicited patient stories and to consider how they can inform and improve patient care.

This paper discusses the use of online patient narratives in undergraduate nurse education to cultivate compassion. Critical analysis of online patient narratives is advocated as a potential educational strategy to cultivate compassion among future health care professionals.

References
Dewar,B. (2013) Cultivating compassionate care Nursing Standard 27, (34) 48-55

Lown B, Rosen J, Martilla J.(2011) An agenda for improving compassionate care: a survey shows about half of patients say such care is missing. Health Affairs (Millwood) 30, 1772–8.
Mannion,R. (2014) Enabling compassionate healthcare: perils, prospects and perspectives International Journal of Health Policy and Management 2, 115-7
Mid Staffordshire NHS Foundation Trust Inquiry (2010). Independent Inquiry into care provided by Mid Staffordshire NHS Foundation London: Stationery Office.

Late effects of cancer and cancer treatment-the perspective of the patient

PURPOSE: Understanding the experience of late effects from the perspective of cancer survivors is essential to inform patient-centred care. This study investigated the nature and onset of late effects experienced by survivors and the manner in which late effects have affected their lives.

METHODS: Sixteen purposively selected cancer survivors participated in a qualitative interview study. The data were analysed inductively using a narrative schema in order to derive the main themes that characterised patients' accounts of late effects.

RESULTS: Individual survivors tended to experience more than one late effect spanning a range of physical and psychological effects. Late effects impacted on relationships, working life, finances and the ability to undertake daily activities. Survivors reported experiencing psychological late effects from around the end of treatment whereas the onset of physical effects occurred later during the post-treatment period. Late effects were managed using formal health services, informal social support and use of 'wellbeing strategies'. Survivors engaged in a process of searching for reasons for experiencing late effects and struggled to make sense of their situation. In particular, a process of 'peer-patient comparison' was used by survivors to help them make sense of, or cope with, their late effects. There appeared to be an association between personal disposition and adaptation and adjustment to the impact of late effects.

CONCLUSIONS: Cancer survivors identified potential components for supported self-management or intervention programmes, as well as important considerations in terms of peer comparisons, personal disposition and making sense of experienced late effects.

The significance of combining VEGFA, FLT1, and KDR expressions in colon cancer patient prognosis and predicting response to bevacizumab

Targeting angiogenesis through inhibition of the vascular endothelial growth factor (VEGF) pathway has been successful in the treatment of late stage colorectal cancer. However, not all patients benefit from inhibition of VEGF. Ras status is a powerful biomarker for response to anti-epidermal growth factor receptor therapy; however, an appropriate biomarker for response to anti-VEGF therapy is yet to be identified. VEGF and its receptors, FLT1 and KDR, play a crucial role in colon cancer progression; individually, these factors have been shown to be prognostic in colon cancer; however, expression of none of these factors alone was predictive of tumor response to anti-VEGF therapy. In the present study, we analyzed the expression levels of VEGFA, FLT1, and KDR in two independent colon cancer datasets and found that high expression levels of all three factors afforded a very poor prognosis. The observation was further confirmed in another independent colon cancer dataset, wherein high levels of expression of this three-gene signature was predictive of poor prognosis in patients with proficient mismatch repair a wild-type KRas status, or mutant p53 status. Most importantly, this signature also predicted tumor response to bevacizumab, an antibody targeting VEGFA, in a cohort of bevacizumab-treated patients. Since bevacizumab has been proven to be an important drug in the treatment of advanced stage colon cancer, our results suggest that the three-gene signature approach is valuable in terms of its prognostic value, and that it should be further evaluated in a prospective clinical trial to investigate its predictive value to anti-VEGF treatment.

Myeloproliferative neoplasm patient symptom burden and quality of life: evidence of significant impairment compared to controls

The myeloproliferative neoplasms (MPN) including polycythaemia vera (PV), essential thrombocythaemia and primary myelofibrosis (PMF) are rare diseases contributing to significant morbidity. Symptom management is a prime treatment objective but current symptom assessment tools have not been validated compared to the general population. The MPN-symptom assessment form (MPN-SAF), a reliable and validated clinical tool to assess MPN symptom burden, was administered to MPN patients (n = 106) and, for the first time, population controls (n = 124) as part of a UK case–control study. Mean symptom scores were compared between patients and controls adjusting for potential confounders. Mean patient scores were compared to data collected by the Mayo Clinic, USA on 1,446 international MPN patients to determine patient group representativeness. MPN patients had significantly higher mean scores than controls for 25 of the 26 symptoms measured (P < 0.05); fatigue was the most common symptom (92.4% and 78.1%, respectively). Female MPN patients suffered worse symptom burden than male patients (P < 0.001) and substantially worse burden than female controls (P < 0.001). Compared to the Mayo clinic patients, MPN-UK patients reported similar symptom burden but lower satiety (P = 0.046). Patients with PMF reported the worst symptom burden (88.3%); significantly higher than PV patients (P < 0.001). For the first time we report quality of life was worse in MPN-UK patients compared with controls (P < 0.001).

Parents’ and young people’s involvement in designing a trial of ventilator weaning

Consulting with users is considered best practice and is highly recommended in designing new trials. As part of our feasibility work, we undertook a consultation exercise with parents, ex-patients and young people prior to designing a trial of protocol-based ventilator weaning. Our aims were to (1) ascertain views on the relevance and importance of the trial; (2) determine the important parent/patient outcome measures; and (3) ascertain views on informed consent in a cluster randomized controlled trial. We conducted audio-recorded face-to-face, telephone and focus group interviews with parents and young people. Data were content analysed to generate information to address our specific consultation objectives. The setting was the north-western region of England. A total of 16 participants were interviewed: 2 parents of paediatric intensive care unit (PICU) survivors; 1 PICU survivor; and 13 young people from the former Medicines for Children Research Network. The trial objectives were deemed important and relevant, and participants considered the most important outcome measure to be the length of time on ventilation. Parents and young people did not consider written informed consent to be a necessary requirement in the context of this trial, rather awareness of unit participation in the trial was important with the opportunity of opting out of data collection. This consultation provided useful, pragmatic insights to inform trial design. We encountered significant challenges in recruiting parents and young people for this consultation exercise, and novel recruitment methods need to be considered for future work in this field. Patient and public involvement is essential to ensure that future trials answer parent-relevant questions and have meaningful outcome measures, as well as involving parents and young people in the general development of health care services.

Cataract extraction and patient vision-related quality of life: a cohort study

Aims: Cataract surgery is one of the most common surgeries performed, but its overuse has been reported. The threshold for cataract surgery has become increasingly lenient; therefore, the selection process and surgical need has been questioned. The aim of this study was to evaluate the changes associated with cataract surgery in patient-reported vision-related quality of life (VR-QoL).

Methods: A prospective cohort study was conducted. Consecutive patients referred to cataract clinics in an NHS unit in Scotland were identified. Those listed for surgery were invited to complete a validated questionnaire (TyPE) to measure VR-QoL pre- and post-operatively. TyPE has five different domains (near vision, distance vision, daytime driving, night-time driving, and glare) and a global score of vision. The influence of pre-operative visual acuity (VA) levels, vision, and lens status of the fellow eye on changes in VR-QoL were explored. 

Results: A total of 320 listed patients were approached, of whom 36 were excluded. Among the 284 enrolled patients, 229 (81%) returned the questionnaire after surgery. Results revealed that the mean overall vision improved, as reported by patients. Improvements were also seen in all sub-domains of the questionnaire.

Conclusion: The majority of patients appear to have improvement in patient-reported VR-QoL, including those with good pre-operative VA and previous surgery to the fellow eye. VA thresholds may not capture the effects of the quality of life on patients. This information can assist clinicians to make more informed decisions when debating over the benefits of listing a patient for cataract extraction.

Patient safety and beyond: what should we expect from microneedle arrays in the transdermal delivery arena?

Research based upon microneedle (MN) arrays has intensified recently. While the initial focus was on biomolecules, the field has expanded to include delivery of conventional small-molecule drugs whose water solubility currently precludes transdermal administration. Much success has been achieved, with peptides, proteins, vaccines, antibodies and even particulates delivered by MN in therapeutic/prophylactic doses. Recent innovations have focused on enhanced formulation design, scalable manufacture and extension of exploitation to minimally invasive patient monitoring, ocular delivery and enhanced administration of cosmeceuticals. Only two MN-based drug/vaccine delivery products are currently marketed, partially due to limitations with older MN designs based upon silicon and metal. Even the more promising polymeric MN have raised a number of regulatory and manufacturability queries that the field must address. MN arrays have tremendous potential to yield real benefits for patients and industry and, through diligence, innovation and collaboration, this will begin to be realised over the next 3-5 years.