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1.
Eur J Pediatr ; 183(1): 323-334, 2024 Jan.
Article En | MEDLINE | ID: mdl-37882822

Invasive bacterial disease is associated with significant morbidity and mortality. In winter 2022, there was an apparent increased rate of invasive bacterial disease compared to preceding years. Cross-site retrospective analysis of the three Children's Health Ireland (CHI) hospitals looking at children admitted between 1st October 2022-31st December 2022 (Q4) with community-acquired invasive bacterial disease, defined as an abscess in a normally sterile site in the head, neck and chest or isolation or PCR detection of Streptococcus pneumoniae, Neisseria meningitidis, Streptococcus pyogenes (Group A streptococcus) or Haemophilus influenzae from a normally sterile site. Case numbers were compared to Q4 in each of 2018-2021. Eighty-two children met the case definition in Q4 2022 vs 97 (Q4 2018-2021). In 2022, 42/82 (51%) were female, median age 3.75 years (1.5-8.25 years). Only 2 (2%) were immunosuppressed and 2 others (2%) had underlying neurodisability. Fifty (61%) were admitted on second or subsequent presentation to a healthcare setting. Fifty-six (68%) had an abscess in a sterile site. Bloodstream infection (positive blood culture or PCR: 24 (29%)) was the most common site of infection, followed by neck 22 (27%) and intracranial 12 (15%). Group A streptococcus (GAS) 27 (33%) was the most common organism isolated. Seven cases (9%) died in 2022 compared to 2 patients (2%) from 2018 to 2021 (p < 0.05). More children had Paediatric Overall Performance Category (POPC) scores > 1 in 2022 than 2018-2021 (p = 0.003).  Conclusion: Invasive bacterial diseases increased in Q4 2022 with higher morbidity and mortality than in the preceding 4 years. Group A streptococcal infection was the most significant organism in 2022. What is known: • Invasive bacterial disease is the leading cause of childhood mortality globally. • There was an increase in cases of invasive Group A streptococcus infections reported in many countries (including Ireland) during the winter of 2022/23. What is new: • Head, neck and chest abscesses increased in Q4 of 2022 compared to the previous 4 years combined. • Invasive bacterial infections in Q4 of 2022 were associated with higher rates of mortality (9%), paediatric intensive care unit (PICU) admission (24%) and requirement for surgical drainage or intervention (67%) than in the preceding years.


Neisseria meningitidis , Streptococcal Infections , Child , Humans , Female , Infant , Child, Preschool , Male , Abscess , Retrospective Studies , Streptococcal Infections/epidemiology , Streptococcus pneumoniae
2.
Pediatr Allergy Immunol ; 34(9): e14013, 2023 09.
Article En | MEDLINE | ID: mdl-37747751

INTRODUCTION: The CORAL study is a cohort of infants born during the first weeks of the first SARS-CoV-2 (COVID-19) lockdown. This cohort has had lower antibiotic exposure, higher breastfeeding rates and lower infection rates, especially in the first year of life. We hypothesized that the altered early-life environment of infants born during lockdown would change the incidence of allergic conditions. METHODS: This longitudinal, observational study followed 365 infants born between March and May 2020 from enrolment to the age of 2 years. Infants attended three research appointments at 6-, 12-, and 24-months and completed detailed questionnaires. At research appointments, children had skin prick testing, and atopic dermatitis (AD) assessment. Statistical analysis focused on changes within the group at different time points, the influence of specific environmental factors on allergic risk and compared the incidence of atopic conditions with a pre-pandemic Irish infant cohort, BASELINE. RESULTS: AD was more common in CORAL group at both 12 (26.5% vs. 15.5%; p < .001) and 24 months (21.3% vs. 15.9%; p = .02) compared with pre-pandemic BASELINE cohort. Within the CORAL group, those with AD at both 12- and 24-month appointments had a more severe AD phenotype associated with a higher risk of allergic sensitization. There was less milk (0% vs. 1%; p = .09), peanut (0.6% vs. 1.8%; p = .3), and egg allergy (0% vs. 2.9%; p < .001) in the CORAL group at 24 months compared with the BASELINE cohort. Aeroallergen sensitization increased between 12 and 24 months in the CORAL cohort (1.5% vs. 8.9%; p < .001), as did parent-reported wheezing episodes (9% vs. 24%; p < .001). CONCLUSIONS: Despite higher AD incidence in the CORAL cohort, the incidence of food sensitization and allergy are lower than expected pre-pandemic rates possibly reflecting the early introduction and maintenance of dietary allergens enhanced by changes in infant infections, antibiotic use, and breastfeeding in the first 2 years of life in the group. These beneficial effects of the lockdown could be outweighing the expected risk of less early-life microbial encounters outlined by the hygiene hypothesis.


Anthozoa , COVID-19 , Dermatitis, Atopic , Egg Hypersensitivity , Child , Infant , Female , Animals , Humans , Child, Preschool , COVID-19/epidemiology , SARS-CoV-2 , Communicable Disease Control , Dermatitis, Atopic/epidemiology , Anti-Bacterial Agents
3.
BMC Health Serv Res ; 23(1): 195, 2023 Feb 24.
Article En | MEDLINE | ID: mdl-36823599

BACKGROUND: Recent research, which explored the use of Quality Improvement (QI) methods in the Covid-19 pandemic response, found that Quality Improvement principles were utilised during the crisis management period, albeit without direct intention. Following on from this work, the aim of this paper extends that study by investigating the sustainability and resilience of not only the changes implemented by healthcare staff during Covid-19 in Ireland, but the resilience of the wellbeing of healthcare staff themselves through the various waves of Covid-19. METHODS: To explore healthcare staffs experience of Quality Improvement and the sustainability and resilience of both Quality Improvement initiatives and healthcare staff, a qualitative design was implemented. Semi-structured interviews took place online over Zoom with 11 healthcare staff members from the Irish healthcare service in the Spring of 2022. An analysis of the narratives was conducted using thematic analysis supported by NVivo12. RESULTS: Four key themes were evident from the data: (i) From fear to exhaustion; (ii) maintaining person-centred approaches to care; (iii) Covid-19 as a medium for change, and; (iv) staff resilience and appetite for Quality Improvement. DISCUSSION: The results of this work identified three key learnings; (i) integrating learning into policies and practice: (ii) the role of collective leadership and devolving/sharing power; and (iii) key drivers/factors that promote sustainability of QI interventions. Despite the challenges in recruitment of research participants experienced during the pandemic, a narrative approach supported the collation of rich and nuanced insights into the experiences of healthcare staff during this time. CONCLUSION: A growing body of literature currently exists on how healthcare staff felt during the Covid-19 pandemic. However, as the waves of Covid-19 have declined, it is vital to examine how the feelings of burnout and disillusionment will affect engagement with Quality Improvement in the future. It is also worth noting and examining the feeling of purpose and pride participants expressed from working through the Covid-19 pandemic. This study has helped to address this gap.


COVID-19 , Humans , COVID-19/epidemiology , Pandemics , Quality Improvement , Health Facilities , Delivery of Health Care
4.
Allergy ; 77(9): 2760-2769, 2022 09.
Article En | MEDLINE | ID: mdl-35403213

BACKGROUND: Cow's milk protein allergy (CMPA) is one of the most common food allergies in infancy. Most infants with CMPA tolerate baked milk from diagnosis and gradually acquire increased tolerance. Nevertheless, parents often display significant anxiety about this condition and a corresponding reluctance to progress with home introduction of dairy due to concerns about possible allergic reactions. OBJECTIVE: To evaluate the impact on gradual home introduction of foods containing cows' milk after a supervised, single low-dose exposure to whole milk at time of diagnosis. METHODS: Infants less than 12 months old referred with suspected IgE-mediated cow's milk allergy were recruited to an open-label randomized, controlled trial of intervention-a single dose of fresh cow's milk, using the validated dose of milk that would elicit reactions in 5% of CMPA subjects-the ED05 - vs routine care. Both groups implemented graded exposure to CM (using the 12 step MAP Milk Tolerance Induction Ladder), at home. Parents completed food allergy quality of life questionnaires and State and Trait Anxiety Inventories (STAI). Main outcome measures were milk ladder position at 6 months and 12 months post-randomization. RESULTS: Sixty patients were recruited, 57 (95%) were followed to 6 months. By 6 months, 27/37 (73%) intervention subjects had reached step 6 or above on the milk ladder compared to 10/20 (50%) control subjects (p = .048). By 6 months, 11/37 (30%) intervention subjects had reached step 12 (i.e. drinking unheated cow's milk) compared to 2/20 (10%) of the controls (p = .049). Twelve months post-randomization, 31/36(86%) of the intervention group and 15/19(79%) of the control group were on step 6 or above. However, 24/37 (65%) of the intervention group were at step 12 compared to 7/20 (35%) of the control group (p = .03). Maternal STAIs were significantly associated with their infants' progress on the milk ladder and with changes in skin prick test and spIgE levels at 6 and 12 months. CONCLUSION: This study demonstrates the safety and effectiveness of introduction of baked milk implemented immediately after diagnosis of cows' milk allergy in a very young cohort. A supervised single dose of milk at the ED05  significantly accelerates this further, probably by giving parents the confidence to proceed. Maternal anxiety generally reflects infants' progress towards completion of the milk ladder, but pre-existing high levels of maternal anxiety are associated with poorer progress.


Milk Hypersensitivity , Milk , Allergens , Animals , Cattle , Female , Humans , Milk/adverse effects , Milk Hypersensitivity/diagnosis , Milk Proteins , Quality of Life , Skin Tests
9.
Pediatr Allergy Immunol ; 32(8): 1756-1763, 2021 11.
Article En | MEDLINE | ID: mdl-34152649

BACKGROUND: Internationally, the COVID-19 pandemic severely curtailed access to hospital facilities for those awaiting elective/semi-elective procedures. For allergic children in Ireland, already waiting up to 4 years for an elective oral food challenge (OFC), the restrictions signified indefinite delay. At the time of the initiative, there were approx 900 children on the Children's Health Ireland (CHI) waiting list. In July 2020, a project was facilitated by short-term (6 weeks) access to an empty COVID stepdown facility built, in a hotel conference centre, commandeered by the Health Service Executive (HSE), Ireland. The aim of this study was to achieve the rapid roll-out of an offsite OFC service, delivering high throughput of long waiting patients, while aligning with existing hospital policies and quality standards, international allergy guidelines and national social distancing standards. METHODS: The working group engaged key stakeholders to rapidly develop an offsite OFC facility. Consultant paediatric allergists, consultant paediatricians, trainees and allergy clinical nurse specialists were seconded from other duties. The facility was already equipped with hospital beds, bedside monitors (BP, pulse and oxygen saturation) and bedside oxygen. All medication and supplies had to be brought from the base hospital. Daily onsite consultant anaesthetic cover was resourced and a resuscitation room equipped. Standardized food challenge protocols were created. Access to the onsite hotel chef facilitated food preparation. A risk register was established. RESULTS: After 6 weeks of planning, the remote centre became operational on 7/9/2020, with the capacity of 27 OFC/day. 474 challenges were commenced: 465 (98%) were completed and 9 (2%) were inconclusive. 135 (29%) OFCs were positive, with 25 (5%) causing anaphylaxis. No child required advanced airway intervention. 8 children were transferred to the base hospital. The CHI allergy waiting list was reduced by almost 60% in only 24 days. CONCLUSIONS: Oral food challenges remain a vital tool in the care of allergic children, with their cost saving and quality-of-life benefits negatively affected by a delay in their delivery. This project has shown it is possible to have huge impacts on a waiting list efficiently, effectively and safely with good planning and staff buy-in-even in a pandemic. Adoption of new, flexible and efficient models of service delivery will be important for healthcare delivery in the post-COVID-19 era.


COVID-19 , Pandemics , Allergens , Allergists , Child , Humans , SARS-CoV-2
10.
Int J Qual Health Care ; 33(1)2021 Mar 05.
Article En | MEDLINE | ID: mdl-32400860

The COVID-19 pandemic has required health systems to change much faster than normal. Many staff have experienced training in quality improvement and patient safety methods which can be used to support the design of new systems and to accelerate learning about new and adapted practices. This article sets out the principles of quality improvement and patient safety science, applying them in a selection of approaches, methods and tools, which may be useful in crisis situations such as the current pandemic. The article also makes reference to several resources which may be of use to those keen to advance their knowledge.


COVID-19/epidemiology , Patient Safety/standards , Quality Improvement/organization & administration , Total Quality Management/organization & administration , Group Processes , Humans , Models, Psychological , Pandemics , Quality Improvement/standards , SARS-CoV-2 , Time Factors
11.
BMJ Open ; 10(8): e036729, 2020 08 13.
Article En | MEDLINE | ID: mdl-32792440

INTRODUCTION: The aim of this project is to determine the patterns, decision-making processes and parental preferences associated with unscheduled paediatric healthcare utilisation in Ireland. Unscheduled paediatric healthcare is outpatient care provided within primary care settings by general practitioners (GPs), emergency departments (EDs) located in paediatric and general hospitals, and out-of-hours services provided by cooperatives of GPs operating on a regional basis. This project will take a multimethod approach to analysing the utilisation of unscheduled paediatric healthcare nationally within the context of a significant change to the provision of healthcare for young children in Ireland-the introduction of free at the point of delivery GP care for all children aged under 6. METHODS AND ANALYSIS: A multimethod approach consisting of three work packages will be employed. Using patient-level data, work package 1 will describe patterns of attendance at primary care, out-of-hours medical services and at EDs. Applying a difference-in-difference methodology, the impact of the introduction of free GP care for children under 6 on attendance will be assessed. Work package 2 will explore geospatial trends of attendance at EDs, identifying disparities in ED attendance by local area and demographic characteristics. Work package 3 will employ two discrete choice experiments to examine parental preferences for unscheduled paediatric healthcare and GP decision making when referring a child to the ED. The insights gained by each of the work packages individually and collectively will inform evidence-based health policy for the organisation of paediatric care and resource allocation. ETHICS AND DISSEMINATION: Ethical approval for this research has been granted by University College Dublin, The Irish College of General Practitioners and the five participating hospitals. Results will be disseminated via publication in peer-reviewed journals, national and international conferences, and to relevant stakeholders and interest groups.


Emergency Medical Services , Aged , Child , Child, Preschool , Decision Making , Emergency Service, Hospital , Humans , Ireland , Parents
14.
HRB Open Res ; 2: 11, 2019.
Article En | MEDLINE | ID: mdl-32104777

There is a plethora of factors that dictate where parents and families choose to seek unscheduled healthcare for their child; and the complexity of these decisions can present a challenge for policy makers and healthcare planners as these behaviours can have a significant impact on resources in the health system. The systematic review will seek to identify the factors that influence parents' and families' preferences and decision making when seeking unscheduled paediatric healthcare.  Five databases will be searched for published studies (CINAHL, PubMed, SCOPUS, PsycInfo, EconLit) and grey literature will also be searched. Inclusion and exclusion criteria will be applied and articles assessed for quality. A narrative approach will be used to synthesise the evidence that emerges from the review. By collating the factors that influence decision-making and attendance at these services, the review can inform future health policies and strategies seeking to expand primary care to support the provision of accessible and responsive care. The systematic review will also inform the design of a discrete choice experiment (DCE) which will seek to determine parental and family preferences for unscheduled paediatric healthcare. Policies such as Sláintecare that seek to expand primary care and reduce hospital admissions from emergency departments need to be cognisant of the nuanced and complex factors that govern patients' behaviour.

15.
Article En | MEDLINE | ID: mdl-29874883

While co-design methods are becoming more popular in healthcare; there is a gap within the peer-reviewed literature on how to do co-design in practice. This paper addresses this gap by delineating the approach taken in the co-design of a collective leadership intervention to improve healthcare team performance and patient safety culture. Over the course of six workshops healthcare staff, patient representatives and advocates, and health systems researchers collaboratively co-designed the intervention. The inputs to the process, exercises and activities that took place during the workshops and the outputs of the workshops are described. The co-design method, while challenging at times, had many benefits including grounding the intervention in the real-world experiences of healthcare teams. Implications of the method for health systems research are discussed.


Leadership , Patient Care Team/organization & administration , Patient Safety/standards , Safety Management/organization & administration , Delivery of Health Care , Humans , Pilot Projects
16.
BMJ Open ; 7(11): e017569, 2017 Nov 03.
Article En | MEDLINE | ID: mdl-29101137

INTRODUCTION: There is accumulating evidence implicating the role of leadership in system failures that have resulted in a range of errors in healthcare, from misdiagnoses to failures to recognise and respond to patient deterioration. This has led to concerns about traditional hierarchical leadership structures and created an interest in the development of collective ways of working that distribute leadership roles and responsibilities across team members. Such collective leadership approaches have been associated with improved team performance and staff engagement. This research seeks to improve our understanding of collective leadership by addressing two specific issues: (1) Does collective leadership emerge organically (and in what forms) in a newly networked structure? and (2) Is it possible to design and implement collective leadership interventions that enable teams to collectively improve team performance and patient safety? METHODS AND ANALYSIS: The first phase will include a social network analysis, using an online survey and semistructured interviews at three time points over 12 months, to document the frequency of contact and collaboration between senior hospital management staff in a recently configured hospital group. This study will explore how the network of 11 hospitals is operating and will assess whether collective leadership emerges organically. Second, collective leadership interventions will be co-designed during a series of workshops with healthcare staff, researchers and patient representatives, and then implemented and evaluated with four healthcare teams within the hospital network. A mixed-methods evaluation will explore the impact of the intervention on team effectiveness and team performance indicators to assess whether the intervention is suitable for wider roll-out and evaluation across the hospital group. ETHICS AND DISSEMINATION: Favourable ethical opinion has been received from the University College Dublin Research Ethics Committee (HREC-LS-16-116397/LS-16-20). Results will be disseminated via publication in peer-reviewed journals, national and international conferences, and to relevant stakeholders and interest groups.


Leadership , Patient Safety/standards , Safety Management/organization & administration , Hospitals , Humans , Ireland , Patient Care Team/organization & administration , Pilot Projects , Research Design
17.
BMJ Open ; 7(3): e014497, 2017 03 13.
Article En | MEDLINE | ID: mdl-28289051

OBJECTIVE: To systematically review the available evidence on paediatric early warning systems (PEWS) for use in acute paediatric healthcare settings for the detection of, and timely response to, clinical deterioration in children. METHOD: The electronic databases PubMed, MEDLINE, CINAHL, EMBASE and Cochrane were searched systematically from inception up to August 2016. Eligible studies had to refer to PEWS, inclusive of rapid response systems and teams. Outcomes had to be specific to the identification of and/or response to clinical deterioration in children (including neonates) in paediatric hospital settings (including emergency departments). 2 review authors independently completed the screening and selection process, the quality appraisal of the retrieved evidence and data extraction; with a third reviewer resolving any discrepancies, as required. Results were narratively synthesised. RESULTS: From a total screening of 2742 papers, 90 papers, of varied designs, were identified as eligible for inclusion in the review. Findings revealed that PEWS are extensively used internationally in paediatric inpatient hospital settings. However, robust empirical evidence on which PEWS is most effective was limited. The studies examined did however highlight some evidence of positive directional trends in improving clinical and process-based outcomes for clinically deteriorating children. Favourable outcomes were also identified for enhanced multidisciplinary team work, communication and confidence in recognising, reporting and making decisions about child clinical deterioration. CONCLUSIONS: Despite many studies reporting on the complexity and multifaceted nature of PEWS, no evidence was sourced which examined PEWS as a complex healthcare intervention. Future research needs to investigate PEWS as a complex multifaceted sociotechnical system that is embedded in a wider safety culture influenced by many organisational and human factors. PEWS should be embraced as a part of a larger multifaceted safety framework that will develop and grow over time with strong governance and leadership, targeted training, ongoing support and continuous improvement.


Awareness , Clinical Deterioration , Communication , Emergency Medical Services , Emergency Service, Hospital , Hospitals, Pediatric , Severity of Illness Index , Child , Child, Preschool , Humans , Infant , Infant, Newborn
18.
Ecol Evol ; 6(21): 7727-7741, 2016 Nov.
Article En | MEDLINE | ID: mdl-30128124

A generalist strategy, as an adaptation to environmental heterogeneity, is common in Arctic freshwater systems, often accompanied, however, by intraspecific divergence that promotes specialization in niche use. To better understand how resources may be partitioned in a northern system that supports intraspecific diversity of Lake Trout, trophic niches were compared among four shallow-water morphotypes in Great Bear Lake (N65° 56' 39″, W120° 50' 59″). Bayesian mixing model analyses of stable isotopes of carbon and nitrogen were conducted on adult Lake Trout. Major niche overlap in resource use among four Lake Trout morphotypes was found within littoral and pelagic zones, which raises the question of how such polymorphism can be sustained among opportunistic generalist morphotypes. Covariances of our morphological datasets were tested against δ13C and δ15N values. Patterns among morphotypes were mainly observed for δ15N. This link between ecological and morphological differentiation suggested that selection pressure(s) operate at the trophic level (δ15N), independent of habitat, rather than along the habitat-foraging opportunity axis (δ13C). The spatial and temporal variability of resources in Arctic lakes, such as Great Bear Lake, may have favored the presence of multiple generalists showing different degrees of omnivory along a weak benthic-pelagic gradient. Morphs 1-3 had more generalist feeding habits using both benthic and pelagic habitats than Morph 4, which was a top-predator specialist in the pelagic habitat. Evidence for frequent cannibalism in Great Bear Lake was found across all four morphotypes and may also contribute to polymorphism. We suggest that the multiple generalist morphs described here from Great Bear Lake are a unique expression of diversity due to the presumed constraints on the evolution of generalists and contrast with the development of multiple specialists, the standard response to intraspecific divergence.

19.
BMJ Open ; 4(7): e005066, 2014 Jul 03.
Article En | MEDLINE | ID: mdl-24993759

UNLABELLED: The measurement and examination of adverse events (AEs) that occur in children during hospital admissions is essential if we are to prevent, reduce or ameliorate the harm experienced. The UK Paediatric Trigger Tool (UKPTT) is a method of retrospective case note review that measures harm in hospitalised children. OBJECTIVES: To examine the harm resulting from the processes of healthcare in hospitalised children from centres providing data to the National Health Service (NHS) Institute UKPTT data portal, to understand the positive predictive values of triggers and to make recommendations for the further development of the trigger tool. SETTING: 25 hospitals across the UK, including secondary, tertiary and quaternary paediatric centres. PARTICIPANTS: Randomly selected children who were admitted to hospital for longer than 24 h. OUTCOME MEASURES: The primary outcome measure was the rate of harm (the percentage of children experiencing one or more AEs during a hospital admission). Secondary measures were the severity of harm and performance of triggers. RESULTS: Data from 3992 patient admissions were reviewed across the hospitals and submitted to the trigger tool portal from February 2008 to November 2011. At least one AE was reported for 567 (14.2%) patients, with 211 (5.3%) experiencing more than one event. There were 1001 AEs identified. Where harm occurred, it was considered temporary for 923 (92.2%) AEs; however, 43 (4.3%) AEs resulted in the need for life-sustaining interventions, 18 (1.8%) AEs led to permanent harm and for 17 children (1.7% of AEs) the AE was believed to have contributed to death. CONCLUSIONS: There is a significant, measurable level of harm experienced by children admitted to hospitals in the UK. While most of this harm is temporary, some of it is serious. The UKPTT offers organisations the means to measure and examine the AEs occurring in their hospital in order to reduce harm.


Patient Harm/statistics & numerical data , Child , Child, Hospitalized , Humans , Prevalence , Retrospective Studies , Severity of Illness Index , United Kingdom
20.
BMJ Open ; 2(4)2012.
Article En | MEDLINE | ID: mdl-22893666

OBJECTIVES: Anaphylaxis is an important, potentially life-threatening paediatric emergency. It is responsible for considerable morbidity and, in some cases, death. Poor outcomes may be associated with an inability to differentiate between milder and potentially more severe reactions and an associated reluctance to administer self-injectable adrenaline. This study aims to assess the effectiveness of a 24-h telephone access to specialist paediatric allergy expert advice in improving the quality of life of children and their families with potentially life-threatening food allergy (ie, anaphylaxis) compared with usual clinical care. METHODS AND ANALYSIS: Children aged less than 16 years with food allergy and who carry an adrenaline autoinjector will be recruited from the Paediatric Allergy Clinic at Cork University Hospital, Ireland and baseline disease-specific quality of life will be ascertained using the validated Food Allergy Quality of Life Questionnaire (FAQLQ). Participants will be randomised for a period of 6 months to the 24-h telephone specialist support line or usual care. The primary outcome measure of interest is a change in FAQLQ scores, which will be assessed at 0, 1 and 6 months postrandomisation. Analysis will be on an intention-to-treat basis using a 2×3 repeated measures within-between analysis of variance. Although lacking power, we will in addition assess the impact of the intervention on a range of relevant process and clinical endpoints. ETHICS AND DISSEMINATION: This trial protocol has been approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. The findings will be presented at international scientific conferences and will be reported on in the peer-reviewed literature in early 2013.

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