A multistage mixed methods study protocol to evaluate the implementation and impact of a reconfiguration of acute medicine in Ireland's hospitals.

BACKGROUND: To address deficits in the delivery of acute services in Ireland, the National Acute Medicine Programme (NAMP) was established in 2010 to optimise the management of acutely ill medical patients in the hospital setting, and to ensure their supported discharge to primary and community-based care. NAMP aims to reduce inappropriate hospital admissions, reduce length of hospital stay and ensure patients receive timely treatment in the most appropriate setting. It does so primarily via the development of Acute Medical Assessment Units (AMAUs) for the rapid assessment and management of medical patients presenting to hospitals, as well as streamlining the care of those admitted for further care. This study will examine the impact of this programme on patient care and identify the factors influencing its implementation and operation. METHODS: We will use a multistage mixed methods evaluation with an explanatory sequential design. Firstly, we will develop a logic model to describe the programme's outcomes, its components and the mechanisms of change by which it expects to achieve these outcomes. Then we will assess implementation by measuring utilisation of the Units and comparing the organisational functions implemented to that recommended by the NAMP model of care. Using comparative case study research, we will identify the factors which have influenced the programme's implementation and its operation using the Consolidated Framework for Implementation Research to guide data collection and analysis. This will be followed by an estimation of the impact of the programme on reducing overnight emergency admissions for potentially avoidable medical conditions, and reducing length of hospital stay of acute medical patients. Lastly, data from each stage will be integrated to examine how the programme's outcomes can be explained by the level of implementation. DISCUSSION: This formative evaluation will enable us to examine whether the NAMP is improving patient care and importantly draw conclusions on how it is doing so. It will identify the factors that contribute to how well the programme is being implemented in the real-world. Lessons learnt will be instrumental in sustaining this programme as well as planning, implementing, and assessing other transformative programmes, especially in the acute care setting.

EUROPEAN CARDIAC RESYNCHRONIZATION THERAPY SURVEY II: COMPARISON OF RESULTS IN GEORGIA WITH OTHER COUNTRIES.

Cardiac resynchronization therapy (CRT) is an important treatment modality for patients with heart failure with a reduced ejection fraction and interventricular conduction delay which is supported by current guidelines from major medical societies. One of the largest international clinical practice surveys regarding the CRT - CRT Survey II was conducted from October 2015 to December 2016 in 42 ESC member countries. We compared the outcome data of the CRT Survey II with the Georgian cohort, where 24 patients were enrolled from 2 participating medical centers of Georgia. Despite CRT II Survey analysis did show us some similarities, there were also multiple, notable differencies between Georgian population and all other European countries' data, which can be explained by a number of socio-economic or healthcare-related factors.

RAS mutation analysis in circulating tumor DNA from patients with metastatic colorectal cancer: the AGEO RASANC prospective multicenter study.

Background: RAS mutations are currently sought for in tumor samples, which takes a median of almost 3 weeks in western European countries. This creates problems in clinical situations that require urgent treatment and for inclusion in therapeutic trials that need RAS status for randomization. Analysis of circulating tumor DNA might help to shorten the time required to determine RAS mutational status before anti-epidermal growth factor receptor antibody therapy for metastatic colorectal cancer. Here we compared plasma with tissue RAS analysis in a large prospective multicenter cohort. Patients and methods: Plasma samples were collected prospectively from chemotherapy-naive patients and analyzed centrally by next-generation sequencing (NGS) with the colon lung cancer V2 Ampliseq panel and by methylation digital PCR (WIF1 and NPY genes). Tumoral RAS status was determined locally, in parallel, according to routine practice. For a minimal κ coefficient of 0.7, reflecting acceptable concordance (precision ± 0.07), with an estimated 5% of non-exploitable data, 425 subjects were necessary. Results: From July 2015 to December 2016, 425 patients were enrolled. For the 412 patients with available paired plasma and tumor samples, the κ coefficient was 0.71 [95% confidence interval (CI), 0.64-0.77] and accuracy was 85.2% (95% CI, 81.4% to 88.5%). In the 329 patients with detectable ctDNA (at least one mutation or one methylated biomarker), the κ coefficient was 0.89 (95% CI, 0.84-0.94) and accuracy was 94.8% (95% CI, 91.9% to 97.0%). The absence of liver metastases was the main clinical factor associated with inconclusive circulating tumor DNA results [odds ratio = 0.11 (95% CI, 0.06-0.21)]. In patients with liver metastases, accuracy was 93.5% with NGS alone and 97% with NGS plus the methylated biomarkers. Conclusion: This prospective trial demonstrates excellent concordance between RAS status in plasma and tumor tissue from patients with colorectal cancer and liver metastases, thus validating plasma testing for routine RAS mutation analysis in these patients. Clinical Trial registration: Clinicaltrials.gov, NCT02502656.

Health-related quality of life as measured by the EQ-5D in the prevention, screening and management of cervical disease: A systematic review.

PURPOSE: Cost-effectiveness analyses (CEAs) of screening can be highly sensitive to the health-related quality of life (HRQoL) effects of screen tests and subsequent treatment. Accordingly, accurate assessment of HRQoL is essential. We reviewed the literature regarding HRQoL in cervical prevention and management in order to appraise the current evidence regarding this important input to CEA. METHODS: We searched the MEDLINE, Scopus and EconLit databases for studies that estimated HRQoL in cervical cancer prevention and management published January 1995-December 2015. The primary inclusion criterion was for studies that assess HRQoL using the EQ-5D. Data were abstracted from eligible studies on setting, elicitation group, sample size, elicitation instruments, health state valuations, study design and follow-up. We assessed the quality and comparability of the studies with a particular focus on the HRQoL reported across states and groups. RESULTS: Fifteen papers met the inclusion criteria. Most used patient elicitation groups (n = 11), 2 used the general public and 2 used a mix of both. Eight studies were cross-sectional and seven were longitudinal. Six studies used both the EQ-5D-3L and the EQ-VAS together with other measures of overall HRQoL or condition-specific instruments. Extensive heterogeneity was observed across study characteristics. CONCLUSIONS: Our results reveal the challenges of sourcing reliable estimates of HRQoL for use in CEAs of cervical cancer prevention and treatment. The EQ-5D appears insufficiently sensitive for some health states. A more general problem is the paucity of HRQoL estimates for many health states and their change over time.

Potential of Earlier Detection and Treatment of Disease-Related Malnutrition with Oral Nutrition Supplements to Release Acute Care Bed Capacity.

A recent systematic review and meta-analysis shows that appropriate use of oral nutrition supplements (ONS) in community patients is associated with a significant reduction in hospitalisations. Given higher use of acute care resource by malnourished versus normally nourished patients, this paper examines the potential to reduce bed utilisation by applying these results to Irish inpatient and malnutrition prevalence data. In 2013, adults admitted to hospital with medium or high malnutrition risk scores used an estimated 36% of adult acute inpatient bed days. Targeted use of ONS in community patients might reduce hospitalisation by 168,438 adult bed days per year, equivalent to 460 beds per day. This is particularly important, given high bed occupancy rates and twelve month daily averages of 254 patients on trolleys. Relevant stakeholders should consider strategies to ensure effective ONS use with a view to improving outcomes and reducing pressure on the acute care system.

A systematic review of the cost and cost effectiveness of using standard oral nutritional supplements in community and care home settings.

BACKGROUND & AIMS: Despite the clinical benefits of using standard (non-disease specific) oral nutritional supplements (ONS) in the community and care homes, there is uncertainty about their economic consequences. METHODS: A systematic review was undertaken according to recommended procedures to assess whether ONS can produce cost savings and cost-effective outcomes. RESULTS: 19 publications with and without a hospital component were identified: 9 full text papers, 9 abstracts, and 1 report with retrospective analyses of 6 randomised controlled trials. From these publications a total of 31 cost and 4 cost-effectiveness analyses were identified. Most were retrospective analyses based on clinical data from randomised controlled trials (RCTs). In 9 studies/economic models involving ONS use for <3 months, there were consistent cost savings compared to the control group (median cost saving 9.2%; P < 0.01). When used for ≥3 months, the median cost saving was 5% (P > 0.05; 5 studies). In RCTs, ONS accounted for less than 5% of the total costs and the investment in the community produced a cost saving in hospital. Meta-analysis indicated that ONS reduced hospitalisation significantly (16.5%; P < 0.001; 9 comparisons) and mortality non-significantly (Relative risk 0.86 (95% CI, 0.61, 1.22); 8 comparisons). Many clinically relevant outcomes favouring ONS were reported: improved quality of life, reduced infections, reduced minor post-operative complications, reduced falls, and functional limitations. Of the cost-effectiveness analyses involving quality adjusted life years or functional limitations, most favoured the ONS group. The care home studies (4 cost analyses; 2 cost-effectiveness analyses) had differing aims, designs and conclusions. CONCLUSIONS: Overall, the reviewed studies, mostly based on retrospective cost analyses, indicate that ONS use in the community produce an overall cost advantage or near neutral balance, often in association with clinically relevant outcomes, suggesting cost effectiveness. There is a need for prospective studies designed to examine primary economic outcomes.

A systematic review of the cost and cost effectiveness of using standard oral nutritional supplements in the hospital setting.

BACKGROUND & AIMS: There is limited information about the economic impact of nutritional support despite its known clinical benefits. This systematic review examined the cost and cost effectiveness of using standard (non-disease specific) oral nutritional supplements (ONS) administered in the hospital setting only. METHODS: A systematic literature search of multiple databases, data synthesis and analysis were undertaken according to recommended procedures. RESULTS: Nine publications comprising four full text papers, two abstracts and three reports, one of which contained 11 cost analyses of controlled cohort studies, were identified. Most of these were based on retrospective analyses of randomised controlled trials designed to assess clinically relevant outcomes. The sample sizes of patients with surgical, orthopaedic and medical problems and combinations of these varied from 40 to 1.16 million. Of 14 cost analyses comparing ONS with no ONS (or routine care), 12 favoured the ONS group, and among those with quantitative data (12 studies) the mean cost saving was 12.2%. In a meta-analysis of five abdominal surgical studies in the UK, the mean net cost saving was £746 per patient (se £338; P = 0.027). Cost savings were typically associated with significantly improved outcomes, demonstrated through the following meta-analyses: reduced mortality (Risk ratio 0.650, P < 0.05; N = 5 studies), reduced complications (by 35% of the total; P < 0.001, N = 7 studies) and reduced length of hospital stay (by ∼2 days, P < 0.05; N = 5 surgical studies) corresponding to ∼13.0% reduction in hospital stay. Two studies also found ONS to be cost effective, one by avoiding development of pressure ulcers and releasing hospital beds, and the other by gaining quality adjusted life years. CONCLUSION: This review suggests that standard ONS in the hospital setting produce a cost saving and are cost effective. The evidence base could be further strengthened by prospective studies in which the primary outcome measures are economic.

Health workforce planning and service expansion during an economic crisis: A case study of the national breast screening programme in Ireland.

This article aims to estimate the workforce and resource implications of the proposed age extension of the national breast screening programme, under the economic constraints of reduced health budgets and staffing levels in the Irish health system. Using a mixed method design, a purposive sample of 20 participants were interviewed and data were analysed thematically (June-September 2012). Quantitative data (programme-level activity data, screening activity, staffing levels and screening plans) were used to model potential workload and resource requirements. The analysis indicates that over 90% operational efficiency was achieved throughout the first six months of 2012. Accounting for maternity leave (10%) and sick leave (3.5%), 16.1 additional radiographers (whole time equivalent) would be required for the workload created by the age extension of the screening programme, at 90% operational efficiency. The results suggest that service expansion is possible with relatively minimal additional radiography resources if the efficiency of the skill mix and the use of equipment are improved. Investing in the appropriate skill mix should not be limited to clinical groups but should also include administrative staff to manage and support the service. Workload modelling may contribute to improved health workforce planning and service efficiency.

Calculating the costs of an 8-week, physiotherapy-led exercise intervention in deconditioned cancer survivors in the early survivorship period (the PEACH trial).

Strong evidence exists for rehabilitation programmes following a cancer diagnosis, although little is known about their cost. The effects of an 8-week, physiotherapy-led, structured group intervention during the early survivorship phase were evaluated. Significant changes in quality of life and fatigue, and promising changes in fitness were found. The overall cost for this programme was €196 per participant, including the salaries of the clinicians, overheads and equipment costs. The modest costs associated with this programme may support more routine 'cancer rehabilitation', although more robust analyses are required.

Is roll-your-own tobacco substitute for manufactured cigarettes: evidence from Ireland?

BACKGROUND: When tax policies increase tobacco prices some smokers may switch to smoking cheaper roll-your-own (RYO) tobacco. To reduce the harm from smoking, this substitution effect should be avoided. This study analyses whether RYO tobacco is a substitute for manufactured cigarettes (MCs) in Ireland, a country with relatively high price for both products. METHODS: Data on duty-paid consumption of RYO tobacco from 1978 to 2011 are used to estimate the demand by applying seemingly unrelated regression and error correction models. Covariates include prices of tobacco in Ireland and in the UK, income and a variable describing tobacco-related health policies. RESULTS: We failed to find evidence of RYO tobacco being a substitute for MC due to price differences. However, an increase in incomes (1%) is associated with a reduction in the consumption of RYO tobacco (-0.4%), which can be due to substitution towards MCs in addition to quitting or cutting back. Also, an increase in the price of RYO tobacco (1%) is associated with a reduction in its consumption (-1%). CONCLUSIONS: Increasing prices via taxation is an effective way of reducing the consumption of RYO tobacco but due to associations between RYO tobacco smoking and lower incomes, these policies should be accompanied by measures aimed at helping smokers to quit.

Towards the development of integrated epilepsy services: an audit of documented epilepsy care.

Effective chronic disease management (CDM) requires the ready availability and communication of accurate, clinical disease specific information. Using epilepsy as a probe into CDM, we report on the availability and reliability of clinical information in the primary care records of people with epilepsy (PWE). The medical records of 374 PWE from 53 general practices in the Mid-West region of Ireland were examined. Confirmation of an epilepsy diagnosis by a neurologist was documented for 132 (35%) patients. 282 (75%) patients had no documented evidence of receiving specialist neurology review while 149 (40%) had not been reviewed by their GP in the previous two years for their epilepsy. Significant variation in documentation of epilepsy specific information together with an inadequacy and inconsistency of existing epilepsy services was highlighted.

The health care journeys experienced by people with epilepsy in Ireland: what are the implications for future service reform and development?

Opportunities exist to significantly improve the quality and efficiency of epilepsy care in Ireland. Historically, epilepsy research has focused on quantitative methodologies that often fail to capture the invaluable insight of patient experiences as they negotiate their health care needs. Using a phenomenological approach, we conducted one-to-one interviews with people with epilepsy, reporting on their understanding of their health care journey from onset of symptoms through to their first interaction with specialist epilepsy services. Following analysis of the data, five major themes emerged: delayed access to specialist epilepsy review; uncertainty regarding the competency and function of primary care services; significant unmet needs for female patients with epilepsy; disorganization of existing epilepsy services; and unmet patient information needs. The findings reveal important insights into the challenges experienced by people with epilepsy in Ireland and identify the opportunities for future service reorganization to improve the quality and efficiency of care provided.

Mass-spectroscopic observations of glycine subjected to strong shock loading.

We have made time-of-flight mass-spectroscopic observations of 85/15 wt % water/glycine solutions and of crystalline alpha-glycine subjected to strong shock loading. The shockwaves were produced by placing the materials in contact with detonating solid explosives. In the solution observations, we have done experiments with glycine molecules composed of ordinary isotopes and with molecules labeled with (13)C, (15)N, and D atoms. The primary reason for conducting this research was to examine whether glycine molecules can survive exposure to strong shock loading, e.g., as might occur in the entry of a meteor into the earth's atmosphere. Our results show that glycine molecules can withstand the rigors of shock environments that generate pressure and temperature up to 180 kbar and 3200 K. Glycine in a 85 H(2)O/15 glycine wt % solution (i.e., one molecule of glycine to ca. 24 H(2)O molecules) exists primarily in its zwitterionic form. In both the solution and crystal experiments, we observed zwitterionic dimers, trimers, and, possibly, tetramers, after the materials were shocked. This implies that the solvating water molecules in the solution experiments must reside on the exterior of groups of solvated glycine molecules. We report quantum-chemical calculations, using density functional theory, that predict that two glycine zwitterions are bound together by ca. 15.72 kcal when immersed in an Onsager model of water. Our observations allow us to place lower-bound estimates on the lifetime of glycine zwitterions under our conditions. We have examined our data to determine whether dipeptide formation has occurred and found no evidence that it has. Compressible fluid-mechanical calculations were performed to estimate the pressures, temperatures, and the time scales present in the experiments.

Epilepsy care in general practice.

Epilepsy care in Ireland is shared between primary, secondary and tertiary care services with the General Practitioner (GP) managing the process. Barriers to effective epilepsy care in Irish general practice remain undocumented although sub-optimal and fragmented services are frequently anecdotally reported. This survey of Irish GPs reports on such barriers to epilepsy care and on the Information & Communication Technology (ICT) issues potentially relevant to the use of an epilepsy specific Electronic Patient Record (EPR). The response rate was 247/700 (35.3%). Respondents supported the concept of shared care for epilepsy 237 (96%) however they were very dissatisfied with existing neurology services, including pathways of referral 207 (84%) and access to specialist neurology advice and investigations 232 (94%). They reported that neurology services and investigations may be accessed more expeditiously by patients with private health insurance than those without 178 (72%). Consequently many patients are referred to the emergency department for assessment and treatment 180 (73%). A deficit in epilepsy care expertise among GPs was acknowledged 86 (35%). While computerisation of GP practices appears widespread 230 (93%), just over half the respondents utilise available electronic functionalities specific to chronic disease management. GP specific electronic systems infrequently link or communicate with external electronic sources 133 (54%). While the current pathways of care for epilepsy in Ireland appear fragmented and inadequate, further investigations to determine the quality and cost effectiveness of the current service are required.

Translating Dutch: challenges and opportunities in reforming health financing in Ireland.

In 2006, Dutch authorities introduced a new health financing system of compulsory private for-profit insurance with strong government regulation. This system has recently attracted attention in Ireland. This paper assesses the theoretical arguments and evidence for applying the Dutch ideas to Ireland. In particular, the authors address how it would help the stated health system policy objectives of improving value for money, fairness and capacity. While the current Dutch reform is still a work in progress, it offers the headline attraction of a single tier system with few waiting lists. Nevertheless, the Dutch system of managed competition may entail risks for Ireland relating to ensuring sufficient system capacity, protecting those on low-incomes and ensuring cost control.

Health management program: factors influencing completion of therapy with high-dose interferon alfa-2b for high-risk melanoma.

The goal of the 1-year observational, multicentre, open-label study reported here was to identify factors influencing adherence to high-dose interferon alfa-2b adjuvant therapy in patients at high risk of recurrence following surgical excision of malignant melanoma. The study was carried out in 23 tertiary-care centres across Canada.The 225 patients enrolled in the study all had malignant melanoma that was surgically excised and that required adjuvant treatment with interferon alfa-2b. Of these patients, 64% were men. Mean age was 51.7 years. All patients received interferon alfa-2b treatment during a 4-week induction phase (20 MU/m(2) intravenously 5 days per week) followed by a 48-week maintenance phase (10 MU/m(2) subcutaneously 3 days per week).Oncology nurses reviewed side-effect management with the patients before the induction and maintenance phases. Patients were provided with daily diaries, comprehensive educational materials, and ongoing nursing support. Data on side effects and discontinuations were obtained from patient interviews and diaries. THE MAIN OUTCOME MEASUREMENTS WERE RELATED TO TREATMENT DISCONTINUATION: rate, timing, reason, and prevention. Of the 225 patients, 75 (33.3%) discontinued interferon during the induction phase, and 58 (25.8%) discontinued during the maintenance phase. The main reasons for discontinuation were adverse events (58%) and disease progression (26%). Patients with a daily fluid intake greater than 1.5 L were more likely to complete therapy than were those with an intake less than 1.5 L (64% vs. 36%, p < 0.0001).Of 225 patients enrolled in the interferon alfa-2b health management program, 41% completed the 1-year treatment course. Higher fluid intake (>1.5 L daily) was associated with increased adherence to therapy.

Mass spectroscopic observation of shock-induced chemistry in liquid CS2.

We have observed, via time-of-flight mass spectrometry, 13 chemical species more massive than CS2 produced by shocking liquid CS2 to very high pressure/temperature. The stoichiometry of three of these species is uniquely determined from the 12CS2 experiments; these species are C2S2, C3S2, and C4S2. The stoichiometry of the other 10 structures cannot be uniquely determined from 12CS2 experiments. However, by redoing the experiments using isotopically labeled CS2 (i.e., 13CS2), we determined the stoichiometry of nine of the remaining structures. The nine structures are Sn (n = 3-8) and CS3, C2S5, and C4S6. A structure with mass 297.1 amu was also observed in the 12CS2 experiments but was not detected in the 13CS2 experiments. This structure must be C6S7, C14S4, or C22S; given the low carbon content of the other observed carbon species, it is probably C6S7. The shockwaves to which the CS2 molecules were subjected were produced by the detonation of high mass-density solid explosives. The explosives used were either a plastic bonded form of cyclotetramethlylene tetranitramine or pure hexanitrostilbene. Numerical compressible fluid-mechanical simulations were done to estimate the pressures, temperatures, and time scales of the processes that occurred in the shocked CS2. The results obtained in the present experiments are related to earlier work on CS2's chemical reactivity that used both shockwave methods and static techniques to produce very high pressure.

Neonatal ventilation with inhaled nitric oxide vs. ventilatory support without inhaled nitric oxide for infants with severe respiratory failure born at or near term: the INNOVO multicentre randomised controlled trial.

BACKGROUND: Evidence from European centres to support the use of nitric oxide (NO) in mature newborns with evidence of severe respiratory failure is sparse. METHODS: Infants of >33 weeks' gestation, <28 days old, and with severe respiratory failure requiring ventilatory support were randomised to receive or not to receive inhaled NO (iNO). The study was not blinded. RESULTS: Sixty infants were recruited (29 allocated iNO, 31 no iNO) from 15 neonatal units in the UK, Finland, Belgium and the Republic of Ireland. 15/60 recruited babies died, and 8.1% of the survivors (4/45) were classified as severely disabled at 1 year. There was no statistically significant difference between the randomised groups in terms of the primary outcome of death or severe disability by the corrected age of 1 year (relative risk = 0.96 (95% confidence interval = 0.46-2.03); p = 0.86) (Fisher's exact p = 1.00). The costs of NO were outweighed by reduced extra corporeal membrane oxygenation costs in the iNO group. The mean total hospitalisation costs were lower in the iNO group, although the mean difference (1,697 pounds) was not statistically significant (95% confidence interval = -14,472 to 11,478). CONCLUSIONS: The results complement those of previous studies that suggest NO is cost-effective and reduces the need for extra corporeal membrane oxygenation in this group of babies. Overall survival rates compare unfavourably with results of US trials.

A case of adrenal haemorrhage after minor trauma in a young child: think of neuroblastoma.

We report a case of neuroblastoma diagnosed after adrenal haemorrhage following a minor trauma in a thirteen-month-old boy. Minor trauma is not commonly described as a cause of AH in the literature. Therefore when no accepted cause for AH can be found in a young child below the age of 5 years, it is important to look for a neuroblastoma and discuss the necessity of surgical exploration.