Economic evaluation of S. boulardii CNCM I-745 for prevention of antibioticassociated diarrhoea in hospitalized patients.

Interest in administration of probiotics to prevent antibiotic-associated diarrhoea (AAD) in hospitalized patients is increasing. We determined the cost of antibiotic-associated diarrhoea in hospital settings for non-complicated and Clostridium difficile (C.diff) complicated AAD, and performed a health-economic analysis of AAD prevention with S. boulardii CNCM I-745 (S. boulardii) from data collected in 1 university and 3 regional hospitals in Flanders. Using a decision tree analytic model, costs and effects of S. boulardii for AAD prevention are calculated. Incremental costs due to AAD, including increased length of hospitalization, were calculated using bottom-up and top-down costing approaches from a hospital, healthcare payer (HCP) and societal perspective. Model robustness was tested using sensitivity analyses. Additional costs per hospitalized patient range from € 277.4 (hospital) to € 2,150.3 (societal) for non-complicated and from € 588.8 (hospital) to € 2,239.1 (societal) for C. diff. complicated AAD. Using S. boulardii as AAD prevention results in cost savings between € 50.3 (bottom-up) and € 28.1 (topdown) per patient treated with antibiotics from the HCP perspective; and € 95.2 and € 14.7 per patient from the societal and hospital perspectives. Our analysis shows the potential for using S. boulardii as AAD prophylactic treatment in hospitalized patients. Based on 831,655 hospitalizations with antibiotic administration in 2014 and € 50.3 cost saving per patient on antibiotics, generalized use of S. boulardii could result in total annual savings up to € 41.8 million for the Belgian HCP.

Analysing policy interventions to prohibit over-the-counter antibiotic sales in four Latin American countries.

OBJECTIVES: To describe and evaluate policies implemented in Chile, Colombia, Venezuela and Mexico (1995-2009) to prohibit antibiotic OTC sales and explore limitations in available data. METHODS: We searched and analysed legislation, grey literature and peer-reviewed publications on regulatory interventions and implementation strategies to enforce prohibition of OTC antibiotic sales. We also assessed the impact using private sector retail sales data of antibiotics studying changes in level and consumption trends before and after the policy change using segmented time series analysis. Finally, we assessed the completeness and data quality through an established checklist to test the suitability of the data for analysis of the interventions. RESULTS: Whereas Chile implemented a comprehensive package of interventions to accompany regulation changes, Colombia's reform was limited to the capital district and Venezuela's limited to only some antibiotics and without awareness campaigns. In Mexico, no enforcement was enacted. The data showed a differential effect of the intervention among the countries studied with a significant change in level of consumption in Chile (-5.56 DID) and in Colombia (-1.00DID). In Venezuela and Mexico, no significant change in level and slope was found. Changes in population coverage were identified as principal limitations of using sales data for evaluating the reform impact. CONCLUSION: Retail sales data can be useful when assessing policy impact but should be supplemented by other data sources such as public sector sales and prescription data. Implementing regulatory enforcement has shown some impact, but a sustainable, concerted approach will be needed to address OTC sales in the future.

The effects of abrupt antipsychotic discontinuation in cognitively impaired older persons: a pilot study.

BACKGROUND: Antipsychotic use for behavioural and psychological symptoms of dementia (BPSD) is controversial. Guidelines advise to reduce antipsychotics given the adverse effects and limited efficacy, to limit dose and treatment duration as well as to undertake discontinuation. METHODS: A pilot study with 40 hospitalised geriatric cognitively impaired patients, in which the effects of abrupt antipsychotic discontinuation were investigated, using neuropsychiatric inventory (NPI) scores before and one month after discontinuation. Withdrawal symptoms were monitored thrice a day with a checklist during five consecutive days. RESULTS: Participants (n = 40) had a mean age of 84 years (range 67-95) and 53% were male. The total mean baseline NPI score was 21 (SD 12) with predominantly behavioural rather than psychological disturbances. After abrupt discontinuation, mild withdrawal symptoms were observed in 72% of the patients, with frequencies of symptoms peaking on day 2 (53%) and day 3 (48%). After one month, 31 patients (85%) were still off antipsychotics and improved on the majority of NPI domains, with a total mean NPI score decreasing from 18 (SD 13) to 12 (SD 8, p = 0.003). In the relapse group, there was no deterioration associated with the abrupt discontinuation and subsequent resumption of therapy with a total mean NPI score decreasing from 31 (SD 12) at baseline to 27 (SD 8) at one-month follow-up (p = 0.345). CONCLUSION: Abrupt antipsychotic discontinuation appears to be feasible in older individuals with BPSD. Systematically performed discontinuation efforts in clinical practice are needed to differentiate between patients where antipsychotics have no added value and patients where the benefits outweigh the risks.

Cumulative live-birth delivery after IVF/ICSI since the progressive introduction of single-embryo transfer.

The only way to decrease the incidence of multiple pregnancies in the IVF/intracytoplasmic sperm injection (ICSI) population is to introduce single-embryo transfer (SET). This study investigated the impact of the progressive introduction of SET for the whole IVF/ICSI population from the patients' point of view by calculating the cumulative live-birth delivery rate. During a 5-year period (2001-2005), the outcome of 2164 cycles with oocyte aspiration in 1047 patients was analysed. A subanalysis was made to calculate the additional effect of frozen-thawed cycles. Survival analysis was performed with the Kaplan-Meier method and the endpoint was live-birth delivery. In this 5-year period, the cumulative live-birth delivery rate per patient was 51% after three IVF/ICSI cycles and 58% after six cycles. With a more permissive method of survival analysis, these results were 64% and 85%, respectively. The additional effect of the frozen-thawed cycles since reimbursement was only 5%. SET was progressively introduced in this period leading to a twin live-birth delivery rate of only 6.7%. It is concluded that a favourable outcome was observed for the cumulative live-birth delivery rate since the introduction of SET but with a disappointing additional effect of the frozen-thawed cycles.

Hospital consumption of antibiotics in 15 European countries: results of the ESAC Retrospective Data Collection (1997-2002).

OBJECTIVES: To collect reliable, comparable and publicly available data on hospital use of antibiotics in Europe aggregated at the national level (1997-2002). METHODS: Consumption data of systemic antibiotics in Anatomical Therapeutic Chemical (ATC) class J01 were collected and expressed in defined daily doses (DDD) per 1000 inhabitants per day. Valid data for 2002 were available for 15 countries, and 6 year trends for 10 countries. Comparison with ambulatory care (AC) consumption data was possible in 14 countries. RESULTS: In 2002, median national hospital antibiotic consumption in Europe was 2.1 DDD/1000 inhabitants/day in Europe, ranging from 3.9 in Finland and France to 1.3 in Norway and Sweden. Hospital care (HC) consumption as a proportion of total antibiotic consumption ranged from 17.8% to 6.4%. The consumption of hospital-specific antibiotics ranged from 0.43 DDD/1000 inhabitants/day in Greece and 0.08 in Sweden. Six-year trends in consumption were stable, except for rising co-amoxiclav exposure and more rapid market penetration of new antibiotics (e.g. levofloxacin) in some countries. There was a strong, positive correlation between the extent of antibiotic use in AC and in HC (Spearman coefficient 0.745; P = 0.002), both for overall use and for use of five main classes (not macrolides and 'others'). In contrast to AC consumption no substantial seasonal variation in consumption was observed. CONCLUSIONS: It was cumbersome but feasible to collect ecological data on hospital antibiotic consumption in a set of 15 European countries on a retrospective basis, illustrating substantial cross-national variations in the extent and distribution of exposure to antibiotics in hospital care.

Comparison of renal care practice in Europe: centre and patient characteristics.

The European Practice Database (EPD) contains data from 8 countries including 276 centres and 21,861 dialysis patients. Comparing patients and centre characteristics, remarkable similarities and pronounced differences in renal practice between different European countries and between centres within each country were found.

Development of indicators to measure European variation of nursing activities.

This paper describes a study to capture the key roles and activities of nephrology nurses across different countries in Europe. The concept of the study and the need to clarify the activities of the nephrology nurse arose as part of a larger study to develop the European Practice Database (EPD) (1). The Research Board (EDTNA/ERCA) needed to identify key questions that would detect significant differences in the role and responsibilities of nephrology nurses in different countries and monitor the evolution over time of nephrology nursing practice in Europe. It was therefore appropriate to devise a separate small study to generate evidence based questions for the EPD and confirm the reliability and usefulness of the information captured.

European practice in haemodialysis: results of the EPD.

The European Practice Database (EPD) project, developed by the EDTNA/ERCA Research Board, collects data on renal practice at centre level in different European countries. Results presented in this paper focus on the European Practice in Haemodialysis centres from 8 European countries or regions following data collection from 2002 to 2004. These results will enable international comparison in practice and will stimulate further research and the development of new practice recommendations.

The Research Board of EDTNA/ERCA: research activities and deliverables.

The Research Board (RB) of EDTNA/ERCA was formed ten years ago to provide opportunities for our members to participate in collaborative research projects at a European level. It provides educational support in research methodology via workshops at conference and in articles published in the Journal. The group has completed a total of seven collaborative research projects in diverse areas of renal care and has recently developed an ambitious new project, the European Practice Database (EPD). The EPD project aims to capture the current practice of renal care professionals in European centres on a three-year repeating cycle. The results of projects are presented at conference and at international scientific meetings by invitation and abstract submission. Recommendations, guidelines or educational material are produced collaboratively with the renal multi-disciplinary community.

European study on epidemiology and management of hepatitis C virus (HCV) infection in the haemodialysis population. Part 3: prevalence and incidence.

An analysis of the literature showed a high prevalence of HCV in the European dialysis population in the nineties. The prevalence was similar in most countries in northern Europe, but infection was more common in France, Italy, Spain, Portugal and Greece (1) and in Eastern European countries (2). The reported prevalence of anti-HCV-positive patients in the EDTA registry was 21% in 1992 and 18% in 1993 (3) ranging from 1% in Finland to 42% in Egypt (4). The incidence of HCV, in new patients starting renal replacement therapy, ranged from 3% to 7% (5,6) and reported seroconversion rates during dialysis treatment varied between 1% (7) and 16% (8) per year.

Transplant practice in Europe: selection of patients.

This paper reports the findings from the European Practice Database project (1) providing an overview of transplant practice in Europe and patient selection. From the 276 centres surveyed 25 recorded performing patient transplants across eight different countries. The overall figures indicate that the waiting list for transplants is made up of 38% women and 9% of patients above the age of 65 years. All countries offered pre-transplant counselling and screening and post-transplant follow-up, but the extent to which these activities occurred varied. The waiting/transplant ratio ranged from one in Norway to eight in Slovakia. Differences still exist as a result of country specific policies and legislation regarding transplantation.

Technical aspects of haemodialysis treatment: comparative results of Scotland and Belgium.

This paper reports the findings from the European Practice Database project providing an overview of the technical aspects of haemodialysis treatment, comparing practice in Scotland and Belgium. Findings identified that in Scotland almost all centres (95%) employed renal technicians compared to 67% of centres in Belgium. There was also a higher level of technical duties performed by technicians in Scotland compared with Belgium, and marked differences in the disinfection protocols of dialysis machines between the two countries. The study highlights the need for further investigation to discover why technical practice varies somuch between the two countries.

European Practice Database in Belgium.

After the successful pilot EPD Project in 2002-2003, we decided to perform the EPD project in four additional countries: Belgium, Greece, Norway and Scotland. Before starting the EPD Project in Belgium, we installed a Belgium National EPD Board in order to support the practical organisation of this project. National coordinators were Luc Picavet (Chair) and Sylviane Boullé (Wallonia). The members of the Belgium National EPD Board were Jean-Yves De Vos (President of National Association, ORPADT Flanders), Hichem Marzougui (Link member, Association of Dialysis Technicians) and Luc Vonckx (President of Association of Dialysis Technicians).

Sero-conversion of HCV negative patients: a European study on the epidemiology and management of HCV haemodialysis patients.

This paper reports part of the findings from a larger study reported earlier, the European study on epidemiology and the management of HCV in the haemodialysis population (1). Centres recruited to the larger study were monitored for a further one year observation period to measure and generate a deeper understanding of HCV sero-conversion. From 4724 patients who were studied at the baseline, in 68 centres, only 13 patients were found to have sero-converted. These sero-conversions occurred in 7 hospitals within 5 different countries. Possible routes of transmission and risk factors are described with respect to the individual centres and good practice recommendations based on current evidence presented.

Infection control practice across Europe: results of the EPD.

The European Practice Database (EPD) project, developed by the EDTNA/ERCA Research Board, collects data on renal practice at centre level in different European countries. Results presented in this paper focus on infection control practice in haemodialysis centres from 8 different European countries or regions following data collection from 2002 up to 2004. The prevalence of hepatitis B (HBV), hepatitis C (HCV), human immune deficiency (HIV) and methicillin-resistant staphylococcus Aureus (MRSA) was studied as well as the use of screening and preventive actions. These results will enable international comparison in practice and will stimulate further research and the development of new practice recommendations.

The organisation of paediatric renal care in different European countries: results of the PAC project.

The Paediatric Access Care (PAC) project, organised by the Research Board of EDTNA/ERCA, aimed to study the organisation of paediatric renal care in Europe and to investigate the practice of access care for both haemodialysis (HD) and peritoneal dialysis (PD) paediatric patients. This paper reports on the organisation of paediatric renal care. The majority of paediatric renal care units were located in specific paediatric units of university hospitals. Most of the centres had offered HD, PD and transplantation (Tx) for more than 20 years. Half of nursing staff had qualifications in paediatric and renal nursing. Most of the centres offered an extended multidisciplinary team approach with the family actively involved in the care of the patient. PD and HD were equally used. Automatic Peritoneal Dialysis (APD) was offered as the standard PD treatment in 2 out of 3 centres. The HD schedule mostly utilised was 3 x 4 hours a week. Half of the patients were on the Tx waiting list and one third of registered patients were transplanted in 2004.

Paediatric access care in Europe: results of the Paediatric Access Care (PAC) project.

Part two of the Paediatric Access Care (PAC) project, a research project of EDTNA/ERCA, investigated PAC in HD and PD patients including the policy for the creation and maintenance of access, and the registration of access related complications that occurred during the registration year of 2004. Data were collected from 39 centres of 13 European countries and included 379 paediatric patients. Fatal complications, resulting in terminating the use of the access, were noted in 59 HD and 22 PD patients. Paediatric access care varied considerably between European centres and in many areas consensus or best practice evidence is still lacking. There is a need for recommendations for the paediatric renal nurse, handling access care in the paediatric renal population.

The obstetrical and neonatal outcome of babies born after single-embryo transfer in IVF/ICSI compares favourably to spontaneously conceived babies.

BACKGROUND: Recently, concern has risen about poor obstetrical and neonatal outcome of singletons after IVF/ICSI. Because the population of patients receiving single-embryo transfer (SET) resulting in singleton pregnancies is different from the one that would have become pregnant (with a singleton) before SET was introduced, we wanted to investigate whether the outcome of singleton pregnancies after SET differed from spontaneously conceived singletons. METHODS: The obstetrical and early neonatal outcome of all pregnancies originating from SET after IVF/ICSI procedures between 1 January 1998 and 31 December 2003, was prospectively collected and analyzed. RESULTS: Data from 251 singleton pregnancies and births after SET were analyzed and compared to data from 59,535 spontaneously conceived singletons retrieved from the Centre for Perinatal Epidemiology. The mean birthweight of the singletons after SET was 3322 g (+/-538 SD) versus 3330 g (+/-531 SD) for the spontaneously conceived singletons (P = 0.82). The mean gestational age was 38.7 weeks (+/-1.9 SD) for SET and 38.9 weeks (+/-1.8 SD) for spontaneously conceived singletons (P = 0.06). The proportion of very preterm birth (<32 weeks) was 0.8% in each group, and the proportion of preterm birth (<37 weeks) was 10.0% for SET singletons and 6.24% for spontaneous singletons (P = 0.03). However, mean birthweight of very preterm, preterm and term SET singleton babies was similar to the mean birthweight in every category of gestational age in the spontaneous conceived control group. Stillbirth was 0.4% for both populations (P = 0.99). CONCLUSIONS: Good prognosis patients, in whom SET is applied, do not only have a higher chance of conception but do not have an unfavourable outcome of their singleton baby when compared to spontaneous singletons.

European practice database: results from Greece.

The survey (EPD) took place during December 2002-January 2003 and presents renal care in Greece. A questionnaire, structured at European level and translated into Greek, was sent to all dialysis centres (114) by post. The questionnaire was returned from 74 centres (64.9%). Some important results were: low use of peritoneal dialysis (13.3%), half of PD patients over 65 years old, one ninth of patients on transplantation waiting list, isolation for HBV positive patients (less for HCV and HIV), high use of AV fistulae (71.2%), maintenance and repair of dialysis machines by company technicians, absence of renal dieticians and social workers (but availability from hospital employees) one nurse every 5.54 patients (3.72 if nurse assistants are included), disinfection between shifts carried out chemically (hot or cold) and puncturing of vascular access performed mainly by nurses and nurse assistants. Data can be used to pressurise government for more scientists in the multidisciplinary team to be hired in hospitals, develop further research topics and to develop continuous education programmes.

The European practice database (EPD): results of the study in thte North-East of Italy.

The survey, realized in 2002-03 in the North-East of Italy, describes renal care in dialysis services. A questionnaire, structured at European level, was sent to all dialysis centres by mail. The questionnaire was returned from 21 centres (61.8%) and related satellite units. Results show nonhomogeneity in renal care. Some important results were: low use of peritoneal dialysis (18%), compared to the rest of Europe, elevated presence of older people on haemodialysis, reduced percentage of patients on transplantation waiting list, diffused use of isolation for HCV positive patients, high use of AV fistulae (84%), low employment of renal technicians, absence of renal dieticians and social workers and nurses performing prevalently direct care. Data can be used for different goals: benchmarking activities, selection of deeper research topics and development of more oriented continuous education activities.