[Paediatric Expert Group on the Immunization Programme. Activities focusing on effective immunization in Poland]. / Pediatryczny Zespól Ekspertów ds. Programu Szczepien Ochronnych. Dzialania na rzecz poprawy efektywnosci szczepien w Polsce.

INTRODUCTION: The Paediatric Expert Group on the Immunization Programme was established in January 2007. It is an independent advisory body to the Minister of Health. The Expert Group consists of paediatricians from various sub-specialities. Most of them are members of the Polish Society of Vaccinology (Table I). The Group started their activities informally in 2005. The first project concerned changes in immunization against tuberculosis and prophylaxis of measles, mumps and rubella. The project was fully implemented in 2006. The changes initiated three years ago, gradually implemented in the Immunization Programme are a result of wide cooperation with the Ministry of Health, Department of Health Policy Chief Sanitory Inspector, as well as the Institute of Tuberculosis and Pulmonary Diseases. The aim of the Paediatric Expert Group on the Immunization Programme is to present a unified policy in matters related to vaccination, leading to rapid changes in the prophylaxis of infective diseases which are still a threat to the life and health of children.

Probiotics in gastrointestinal diseases in children: hard and not-so-hard evidence of efficacy.

The use of probiotics, once discussed primarily in the context of alternative medicine, is now entering mainstream medicine. However, only a few of the potential health benefits attributed to probiotics have been confirmed in well-designed, well-conducted, randomized, controlled trials. This is especially true in the pediatric population. We review here the available evidence on efficacy of probiotics in children in the prevention and treatment of gastrointestinal diseases. Although we restrict our analysis to the pediatric age, whenever potentially relevant information is available only from adult studies, they are examined as well. Probiotics have been most extensively studied in the treatment of diarrheal diseases, where their efficacy can be considered well established. Studies documenting effects in other childhood gastrointestinal illnesses are few, although some preliminary results are promising. Furthermore, only a limited number of probiotic strains have been tested, and, as the effects of different probiotic microorganisms are not equivalent, results cannot be generalized. Thus, at present, we have some positive certainties, lots of exciting promises and many unanswered questions.

Rotavirus types in Europe and their significance for vaccination.

The degree of diversity of cocirculating human rotavirus wild-type strains is high. This article reviews the occurrence and frequency of rotavirus types in European children younger than 5 years of age during the past 10-15 years. To enable greater understanding of the overall epidemiologic situation, rotavirus types found in animals in Europe are described. In addition, rotavirus types occurring in children outside Europe are considered. Taken together, these data provide an essential background to the development of rotavirus vaccines. The different concepts of immunization with the 2 main rotavirus candidate vaccines are briefly discussed, and their potential impact on the epidemiology of cocirculating rotavirus wild-type viruses is considered. A case is made for comprehensive surveillance of cocirculating human rotavirus types in Europe after the implementation of rotavirus vaccination.

Burden of rotavirus disease in European Union countries.

Two new rotavirus vaccines are expected to be introduced in the European Union (EU) in coming years. A human rotavirus vaccine has already been licensed in several countries worldwide, and a pentavalent bovine vaccine has been submitted for licensure in the United States and the EU. Few data exist on the burden of rotavirus disease and its associated costs within the EU. To estimate the burden of rotavirus disease in the EU, we adapted a model based on the approach developed by the Centers for Disease Control and Prevention to the European situation and applied it to recent population and mortality data from European countries. Country-specific estimates were added to obtain a global estimate of rotavirus episodes treated at home, clinic visits, hospitalization and death. We estimate that 3.6 million episodes of rotavirus disease occur annually among the 23.6 million children younger than 5 years of age in the EU. Every year, rotavirus accounts for 231 deaths, >87,000 hospitalizations and almost 700,000 outpatient visits. Rotavirus disease constitutes a large public health burden in the EU. Except for deaths, the burden of disease is not dissimilar to that in the developing world. Country-specific studies are required to more accurately understand the burden of disease caused by rotavirus. With the introduction of new rotavirus vaccines in sight, rotavirus gastroenteritis may be regarded as the single most frequent vaccine-preventable disease among children in the EU.

Use of probiotics in children with acute diarrhea.

Probiotics, defined as microbial cell preparations or components of microbial cells that have a beneficial effect on the health and well being of the host, have traditionally been used to treat and prevent a variety of infections. Beneficial effects of probiotics in acute infectious diarrhea in children seem to be: (i) moderate; (ii) strain-dependent; (iii) dose dependent; (iv) significant in watery diarrhea and viral gastroenteritis, but non-existent in invasive, bacterial diarrhea; and (v) more evident when treatment with probiotics is initiated early in the course of disease. Three large, randomized controlled trials (RCTs) provide evidence of a very modest effect (statistically significant, but of questionable clinical importance) of some probiotic strains (Lactobaccillus GG, Lactobaccillus reuteri, Bifodobacterium lactis) on the prevention of community-acquired diarrhea. We have found conflicting evidence from four RCTs on the efficacy of Lactobacillus GG and B. bifidum and Streptococcus thermophilus in the prevention of nosocomial diarrhea in children. Two RCTs in children provide evidence of a moderate beneficial effect of Lactobacillus GG in the prevention of antibacterial-associated diarrhea (AAD), but results in adults are conflicting. Data on the efficacy of other probiotic strains in AAD in children are very limited. In conclusion, to date, the most extensively studied and best documented clinical application of probiotics in children is for the treatment of acute watery diarrhea of rotaviral or presumably viral etiology. Studies documenting effects in other types of diarrheal diseases in children are limited, although some preliminary results are promising. The effects of different probiotic microorganisms are not equal. Only very few probiotic strains have been tested rigorously in RCTs. Many questions remain to be answered. Future clinical trials should evaluate carefully selected, precisely defined probiotic strains and address clinically important endpoints.

Microbiological and genetic analysis of probiotic products licensed for medicinal purposes.

BACKGROUND: The purpose of our study was to investigate both qualitatively and quantitatively the microbial content of probiotic products licensed for medicinal purposes. MATERIAL/METHODS: Microbiological analysis was performed on five different brands of probiotic products that claimed to contain lactobacilli and/or bifidobacteria. The species were determined based on phenotypic characters, using API 50CH, API 20A, and API rapid ID 32A kits. Bacterial strains belonging to the Bifidobacterium genus were further identified using genotypic methods (amplification of specific DNA fragments by PCR and analysis of their nucleotide sequences). The products were also analyzed for pathogenic bacteria. The number of microorganisms contained in four of the products was determined using the plate-count method and the most-probable-number method. The actual and claimed content of probiotic products was analyzed statistically. RESULTS: Microbiological and genetic analysis showed that, in terms of quality, only three of the five products contained the bacterial strains claimed on the label. None of the tested products contained pathogens. Quantitative analysis demonstrated that 57 of 64 samples (89% [95% CI: 81-97]) contained bacterial counts at the cell densities (doses) claimed on the label. CONCLUSIONS: Our study demonstrates unsatisfactory qualitative microbiological specification in the tested products. However, there was good quantitative agreement with the labeling. Our findings indicate that regulations governing the labeling of probiotic products are urgently required.

Grading quality of evidence and strength of recommendations.

Users of clinical practice guidelines and other recommendations need to know how much confidence they can place in the recommendations. Systematic and explicit methods of making judgments can reduce errors and improve communication. We have developed a system for grading the quality of evidence and the strength of recommendations that can be applied across a wide range of interventions and contexts. In this article we present a summary of our approach from the perspective of a guideline user. Judgments about the strength of a recommendation require consideration of the balance between benefits and harms, the quality of the evidence, translation of the evidence into specific circumstances, and the certainty of the baseline risk. It is also important to consider costs (resource utilisation) before making a recommendation. Inconsistencies among systems for grading the quality of evidence and the strength of recommendations reduce their potential to facilitate critical appraisal and improve communication of these judgments. Our system for guiding these complex judgments balances the need for simplicity with the need for full and transparent consideration of all important issues.