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The goal of the Choosing Wisely campaign launched in 2009 by the American Board of Internal Medicine (ABIM) Foundation is to promote dialog on avoiding wasteful or unnecessary medical tests, treatments and procedures. Originating in 2009, the Choosing Wisely initiative involved three primary care specialties in a project aiming to develop “Top Five” lists, which were to be “specialty-specific enumerations of achievable practice changes to improve patient health through better treatment choices, reduced risks and reduced costs. The initiative soon became global, many specialty societies outside the US joining. Some time later, however, data collected demonstrated that a reduction had been achieved only for a few low-value tests and procedures, thus highlighting the need for a more evidence-based approach for identifying low-value practices and for evaluating the efficacy of this initiative over time.

Purpose – The purpose of this paper is to investigate the significant features that characterize these projects: organizational aspects, phases and activities, tools, techniques, practices and key factors for successful implementation. No studies in the academic literature have yet focused on the relation between healthcare lean management (HLM) and clinical risk management (CRM) to enhance multiple aspects of performance, although the possibility of implementing “lean & safety” projects has been highlighted. Design/methodology/approach – Two significant projects have been selected from the same Italian hospital in two different fields of application. Within- and cross-case analyses have been performed to obtain useful findings. Findings – The results suggest that HLM can provide support for CRM, and an integrated methodology should be considered. The first indications concerning how this new synergistic methodology may be developed are provided and these should stimulate future research, testing and exploiting the methodology in other contexts. Originality/value – From the results of this paper, guidelines for the implementation of a “lean & safety” project could be developed to improve the management of clinical processes pursuing multiple objectives. This study could contribute to the development of safer and more sustainable health care systems for the benefit of the entire community.

Patient and sample misidentification may cause significant harm or discomfort to the patients, especially when incorrect data is used for performing specific healthcare activities. It is hence obvious that efficient and quality care can only start from accurate patient identification. There are many opportunities for misidentification in healthcare and laboratory medicine, including homonymy, incorrect patient registration, reliance on wrong patient data, mistakes in order entry, collection of biological specimens from wrong patients, inappropriate sample labeling and inaccurate entry or erroneous transmission of test results through the laboratory information system. Many ongoing efforts are made to prevent this important healthcare problem, entailing streamlined strategies for identifying patients throughout the healthcare industry by means of traditional and innovative identifiers, as well as using technologic tools that may enhance both the quality and efficiency of blood tubes labeling. The aim of this article is to provide an overview about the liability of identification errors in healthcare, thus providing a pragmatic approach for diverging the so-called patient identification crisis.Pogrešno identifikovanje pacijenata i uzoraka može naneti značajnu štetu ili neprijatnost pacijentima, naročito ako se netačni podaci koriste za izvođenje specifičnih zdravstvenih aktivnosti. Otud je jasno da efikasna i kvalitetna nega može početi samo od tačne identifikacije pacijenata. Postoji mnogo prilika za pogrešnu identifikaciju u zdravstvenoj nezi i laboratorijskoj medicini, uključujući homonimiju, netačnu registraciju pacijenta, oslanjanje na pogrešne podatke o pacijentu, greške u unošenju naloga, uzimanje bioloških uzoraka od pogrešnih pacijenata, neodgovarajuće obeleza- vanje uzoraka i netačan unos ili pogrešno prenošenje rezultata testova kroz laboratorijski informacioni sistem. Trenutno se mnogo radi na otklanjanju ovih važnih problema uz zdravstvu, što podrazumeva organizovane strategije za identifikovanje pacijenata u čitavoj zdravstvenoj industriji putem tradicionalnih i inovativnih identifikatora, kao i pomoću tehnoloških alatki koje mogu poboljšati kako kvalitet tako i efikasnost označavanja krvnih epruveta. Cilj ovog rada je da se pruži pregled o odgovornosti za greške u identifikaciji u okviru zdravstvene nege, kako bi se omogučio pragmatičan pristup za rešavanje takozvane krize identifikacije pacijenata.

The identification of reliable quality indicators (QIs) is a crucial step in enabling users to quantify the quality of laboratory services. The current lack of attention to extra-laboratory factors is in stark contrast to the body of evidence pointing to the multitude of errors that continue to occur, particularly in the pre-analytical phase. The ISO 15189: 2012 standard for laboratory accreditation defines the pre-analytical phase, and recognizes the need to evaluate, monitor and improve all the procedures and processes in the initial phase of the testing cycle, including those performed in the phase of requesting tests and collecting samples, the so-called "pre-pre-analytical phase". Therefore, QIs should allow the identification of errors and non-conformities that can occur in all steps of the pre-analytical phase. Traditionally, pre-analytical errors are grouped into identification and sample problems. However, appropriate test requesting and complete request forms are now recognized as fundamental components in providing valuable laboratory services. The model of QIs developed by the Working Group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) includes indicators related to both identification and sample problems as well as all other pre-analytical defects, including those in test requesting and request forms. It, moreover, provides the framework (with objective criteria) necessary for promoting the harmonization of available QIs in the pre-analytical phase.

Background: Quality indicators (QIs) used as performance measurements are an effective tool in accurately estimating quality, identifying problems that may need to be addressed, and monitoring the processes over time. In Laboratory Medicine, QIs should cover all steps of the testing process, as error studies have confirmed that most errors occur in the pre- and post-analytical phase of testing. Aim of the present study is to provide preliminary results on QIs and related performance criteria in the post-analytical phase. Methods: This work was conducted according to a previously described study design based on the voluntary participation of clinical laboratories in the project on QIs of the Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Results: Overall, data collected highlighted an improvement or stability in performances over time for all reported indicators thus demonstrating that the use of QIs is effective in the quality improvement strategy. Moreover, QIs data are an important source for defining the state-of-the-art concerning the error rate in the total testing process. The definition of performance specifications based on the state-of-the-art, as suggested by consensus documents, is a valuable benchmark point in evaluating the performance of each laboratory. Conclusions: Laboratory tests play a relevant role in the monitoring and evaluation of the efficacy of patient outcome thus assisting clinicians in decision-making. Laboratory performance evaluation is therefore crucial to providing patients with safe, effective and efficient care.

The identification of reliable quality indicators (QIs) in the total testing process (TTP) represents a crucial step in enabling users to quantify the quality of laboratory services, but the current lack of attention to extra-laboratory factors is in stark contrast with the body of evidence showing the multitude of errors that continue to occur in the pre- and post-analytical phases. Although interesting programs on indicators of the extra-analytical phases have been developed in some countries, there is no consensus on the production of joint recommendations for the adoption of universal QIs and the use of common terminology in the total testing process. In view of the different QIs and terminologies currently used, there an urgent need to harmonize proposed QIs, which should comply with three main principles: they must be patient-centered, consistent with the requirements of the International Standard for medical laboratories accreditation, and address all stages of the TTP. A model of quality indicators (MQI), consensually developed by a group of clinical laboratories according to a project launched by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), includes 56 QIs related to key processes (34 pre-, 7 intra- and 15 post-analytical phase) and three to support processes. The scope of harmonization in laboratory medicine, more far-reaching than method harmonization, should cover a wider range of topics, namely all steps of the “brain-to-brain loop”. The identification of valuable QIs is a key step in paving the way towards quality and patient safety in laboratory medicine.

The issue of quality assurance (QA) and quality improvement (QI), being the quality of medical education intimately related to the quality of the health care, is becoming of paramount importance worldwide.To describe a model of implementing a system for internal QA and QI within a post-graduate paediatric training programme based on the ISO 9001:2000 standard.For the ISO 9001:2000 standard, the curriculum was managed as a series of interrelated processes and their level of function was monitored by ad hoc elaborated objective indicators.The training programme was fragmented in 19 interlinked processes, 15 related procedures and 24 working instructions. All these materials, along with the quality policy, the mission, the strategies and the values were made publicly available. Based on the measurable indicators developed to monitor some of the processes, areas of weakness of the system were objectively identified and consequently QI actions implemented. The appropriateness of all this allowed the programme to finally achieve an official ISO 9000:2001 certification.The application of the ISO 9001:2000 standard served to develop an internal QA and QI system and to meet most of the standards developed for QA in higher and medical education.

There is no doubting that healthcare professionals gave the initial impetus for establishing hospital and laboratory accreditation systems, the main purpose of which is to improve quality and patient safety, as highlighted by eminent physicians, such as Ernest Amory Codman and Avedis Donabedian [1]. After an initial pioneering stage, essentially based on the peer-review concept, some regulatory activities have inevitably gained a footing in accreditation programs. In recent decades laboratory medicine has become increasingly subject to legislation and regulation, so much so that the voluntary and educational aspects of accreditation seem to have been overlooked and displaced by an emphasis on inspection and compliance. In addition, the mounting relevance of models for quality management may shift the focus of the accreditation from its main goal – particularly in health care and in laboratory medicine – of competently providing specific services. The evolution of the accreditation of clinical laboratories in different countries was once based on distinct models, standards, and accreditation bodies, and this led to confusion and disenchantment in the laboratory community. In particular, two distinct lines of International Standard development were applied to the medical laboratory. One, ISO 9001:2000 (the latest version issued in 2008) [2], focused on the “requirements for quality management systems” applicable to any organization, and the other, ISO 17025:1999 (the latest version issued in 2005) [3], originally designed to assess the technical competence of laboratories, is a generic standard used in the accreditation of any type of testing or calibration laboratory [4]. In 2003, after a long journey, the Working Group 1 of the Technical Committee, ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic systems” (established in 1995), issued the first edition of an International Standard, the ISO 15189 “Medical laboratories – Requirements for quality and competence”, specifically designed for the medical laboratory [5]. ISO 15189 brought together the quality system requirements of ISO 9001 and the competency requirements of ISO/IEC 17025, addressing the specific needs of medical laboratory professionals worldwide. In particular, it incorporated sector specific issues of crucial importance in the provision of medical laboratory services. For example, it emphasizes the quality of not only the measurement but also that of the total service (e.g., consultation, turnaround time and cost-effectiveness), highlights important features of pre-and post-examination issues, focuses on patient outcomes and addresses ethics and the information needs of the medical laboratory [6]. The ISO 15189, developed with a significant contribution from the European Communities Confederation of Clinical Chemistry – EC4 – (now merged with the Federation of European Societies of Clinical Chemistry – FESCC – in the European Federation of Clinical Chemistry and Laboratory Medicine – EFLM), has been recognized by both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Laboratory Accreditation Co-operation (ILAC). However, the standards are only one of the four elements of an accreditation system as both the accreditation body and assessors/inspectors play a relevant role. Moreover, the user laboratory represents the fourth element. It is important to bear in mind that accreditation according to the ISO 15189 International Standard was conceived as a voluntary process, as is clearly highlighted by the inclusion of a specific clause (8.4.3 in the latest revision of the International Standard) on “continual improvement”. The evidence that in some countries, such as France and, at least in part, Belgium, accreditation according to the ISO 15189 is mandatory is further proof of its value and may facilitate the efforts of clinical laboratories to comply with a series of consensually developed and harmonized requirements other than with some national or regional standards. Yet, despite its growing global recognition by the main scientific organizations in the field of laboratory medicine, in many countries only a small number of laboratories are currently accredited [7]. The reasons for the variations between countries include differences in experience, competence, the interests of national

The definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for analytical quality specifications.

Purpose: We verify the sodium fraction excretion rate (FE Na) and potassium fraction excretion WE K) rates in monosymptomatic nocturnal enuresis. We also correlate FE Na and FE K to urinary osmolality, nocturnal polyuria and vasopressin in the same population. Materials and Methods: A total of 438 children 6 to 15 years old (mean age 9.7) presenting with monosymptomatic nocturnal enuresis were recruited from different centers. Inclusion criteria were 3 or greater wet nights a week, no daytime incontinence and no treatment in the previous 2 months. Exclusion criteria were cardiopathy, endocrinopathy, psychiatric problems and urinary tract abnormalities. Micturition chart, diurnal (8 am to 8 pm) and nocturnal (8 pm to 8 am) urine collection, including separate diuresis volumes, (Na, K and Ca) electrolytes and osmolality were evaluated, as well as serum electrolytes, creatinine and nocturnal (4 am) vasopressin. Diurnal and nocturnal FE K and FE Na were calculated. ANOVA test, chi-square test, Student's t test and Pearson correlation test were used for statistical analysis. Results: Nocturnal polyuria (diurnal to nocturnal diuresis ratio less than 1) was found in 273 children (62.3%, group I and nocturnal urine volumes were normal in 165 with enuresis (37.7%, group 2). Nocturnal FE Na was abnormal in 179 children (40.8%), including 118 in group 1 (43.2%) and 61 in group 2 (36.9%) (chi-square not significant). FE Na was also increased in nocturnal versus daytime diuresis (Student's t test p < 0.001). In group 1 nocturnal FE Na correlated with nocturnal diuresis (Pearson correlation p = 0.003, r = +0.175), while daytime FE Na and nocturnal FE Na correlated with diurnal diuresis (Pearson correlation p = 0.001, r = +0.225 and Pearson correlation p = 0.001, r = +0.209, respectively). In group 2 nocturnal FE Na did not correlate with diuresis (Pearson correlation p = 0.103, r = +0.128) but correlated with vasopressin values (Pearson correlation p = 0.042, r = -0.205). Urine osmolality was reduced in 140 children (31.9%) and correlated with nocturnal diuresis (Pearson correlation p = 0.003, r = -0.321). Vasopressin was decreased in 332 children (75.8%, 62.6% in group 1 and 13.2% in group 2). No significant difference was found between sexes and age of enuretic subgroups. Conclusions: Nocturnal FE Na correlates with nocturnal diuresis, whereas daytime FE Na does not. FE K in daytime and nighttime diuresis does not statistically differ in nocturnal polyuric and nonpolyuric enuretic groups. Osmolality correlates with nocturnal diuresis, and vasopressin at 4 am was lower in the nocturnal polyuric group. The hypothesis of a subset of enuretic patients presenting with nocturnal polyuria associated with high nocturnal natriuria and low vasopressin values has been confirmed.

Purpose: Desmopressin may not be effective for nocturnal enuresis associated with polyuria and hypercalciuria. Nighttime hypercalciuria in an enuretic population from 5 centers and its correlation with nighttime polyuria were verified. Materials and Methods: A total of 450 enuretic patients (278 males, 172 females, mean age 9.7 years) were evaluated with 72-hour micturition charts, urinalysis, serum creatinine and osmolarity, diurnal and nocturnal electrolytes with fractional Na+ and K+ urinary excretion, and nocturnal (4 a.m.) plasma vasopressin. Creatinine electrolytes and osmolarity were measured in daytime (8 a.m. to 8 p.m.) and nighttime (8 p.m. to 8 a.m.) urine volumes. Patients were divided into group 1 with nocturnal polyuria and group 2 without nocturnal polyuria. Hypercalciuria was defined as urinary calcium-to-urinary creatinine ratio greater than 0.21. Statistic evaluation was performed using chi-square, Pearson correlation and ANOVA tests. Results: Nighttime polyuria was demonstrated in 292 bedwetters (65% group 1). Nocturnal hypercalciuria was present in 179 of the 450 children (39.7%), including 125 in group 1 (42.8%) and 54 in group 2 (34.2%), which was statistically significant (chi-square p = 0.008, Pearson correlation test r = 0.157). Daytime calciuria was not statistically modified in either group (group 1 p = 0.054, group 2 p = 0.56). Adrenocorticotropic hormone (ADH) was normal in 18.5% and low in 81.5% of enuretics with nocturnal hypercalciuria. ADH levels and nocturnal hypercalciuria significantly correlated (p = 0.003, r = 0.148). Conversely, the group 2 patients had normal ADH levels. Conclusions: Nocturnal hypercalciuria has a pivotal role in nocturnal enuresis, as it is significantly associated with low ADH levels and nocturnal polyuria. A new classification of nocturnal enuresis subtypes based on nighttime calciuria levels is mandatory to address treatment properly.

Objective To assess the features of adolescent bedwetters, as few data are available on enuresis in this age group. Patients and methods A specific database for adolescents and young adults was created with the collaboration of various specialists (paediatricians, urologists, gynaecologists, psychiatrists). Questions focused on family and personal history, stressful events, age of attaining urinary and fecal control, characteristics of enuresis (primary vs secondary, monosymptomatic vs enuresis associated with daytime urinary symptoms), school performance, diagnostic examination and physical examinations, and treatment and its response. Results Data were collected from 107 enuretic adolescents (mean age 15.3 years, median 14, range 13–23; 63 males and 44 females). A positive family history for enuresis was recorded in 82%. Enuresis was primary in 79 patients (74%), secondary in 28 (26%), monosymptomatic in 76 (71%) and associated with daytime urinary symptoms in 31 (29%). In males monosymptomatic enuresis was significantly more frequent than in females (P

Quality indicators (QIs) measure the extent to which set targets are attained and provide a quantitative basis for achieving improvement in care and, in particular, laboratory services. A body of evidence collected in recent years has demonstrated that most errors fall outside the analytical phase, while the pre- and post-analytical steps have been found to be more vulnerable to the risk of error. However, the current lack of attention to extra‑laboratory factors and related QIs prevent clinical laboratories from effectively improving total quality and reducing errors. Errors in the pre-analytical phase, which account for 50% to 75% of all laboratory errors, have long been included in the ‘identification and sample problems’ category. However, according to the International Standard for medical laboratory accreditation and a patient-centered view, some additional QIs are needed. In particular, there is a need to measure the appropriateness of all test request and request forms, as well as the quality of sample transportation. The QIs model developed by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is a valuable starting point for promoting the harmonization of available QIs, but further efforts should be made to achieve a consensus on the road map for harmonization.

Elevated levels of vasopressin (AVP) have been found in premature infants with bronchopulmonary dysplasia (BPD), and may be related to abnormalities of water handling, and to non-pulmonary signs of edema. Dexamethasone treatment improves pulmonary function in infants with BPD, and is frequently associated with a significant increase in diuresis and a decrease in weight gain. To determine whether this diuresis is primarily the result of AVP inhibition (potentially induced by steroid treatment), we measured endogenous AVP levels in nine premature babies with BPD [birth weight 802 +/- 141 (SD) g; gestation 26 +/- 2 weeks, age 26 +/- 17 days], before initiation, and 3 and 7 days after the start of dexamethasone therapy (0.5 mg/kg/day). All study infants required mechanical ventilation, and none was receiving diuretics or cardiac inotropes during the study. Results indicated that premature infants with BPD have functionally unmodified AVP levels after 3 and 7 days of dexamethasone therapy (pre-dexamethasone 5.9 +/- 2.1 ng/l vs post-dexamethasone 7.0 +/- 3.0 and 8.0 +/- 1.9 ng/l at 3 and 7 days, respectively). Pulmonary function improved with oxygenation indexes decreasing (pre-dexamethasone 14 +/- 7 vs post-dexamethasone 9 +/- 7 and 7 +/- 4 at 3 and 7 days, respectively). A concurrent reduction in weight gain occurred (pre-dexamethasone 12 +/- 10 g/kg/day vs post-dexamethasone 7 +/- 3 g/kg/day and 3 +/- 1.5 g/kg/day on days 3 and 7, respectively). These data suggest that the improvement in lung function with dexamethasone treatment for BPD in premature infants does not correlate with a diuresis that results from vasopressin inhibition, and potentially induced by dexamethasone.

In the present era of resource management, there is increasing emphasis on the need to make the best possible use of available resources. We therefore measured the productive factors directly involved in performance of 59 evoked potential examinations (brainstem auditory evoked potentials, BAEPs; flash visual evoked potentials, F-VEPs; and electroretinograms, ERGs) in different pediatric age groups. In order to ascertain the gap between the costs of instrumental examinations performed in our service on children and the fees reimbursed by the Italian national health service (NHS) a breakdown was made of the costs of tests and their scheduling in relation to the different age variables involved. It was found that the fees reimbursed do not cover the real costs, because they underestimate the actual consumption of resources. The findings recorded indicate that for pediatric tests the economic audit should be graded according to the ages of the children examined and should include an analysis of different test phases. The economic audit should also be considered a preliminary step in clinical audit. It is concluded that it is financially punitive to reimburse a pediatric service with a fee based on the examination of adults, because in pediatrics the variable ``age'' influences the duration and complexity of tests and also their interpretation.

Objectives The identification of reliable quality indicators (QIs) is a crucial step in enabling users to quantify the quality of laboratory services. The current lack of attention to extra-laboratory factors is in stark contrast with the body of evidence pointing to the multitude of errors that continue to occur in the pre- and post-analytical phases. Design and methods Different QIs and terminologies are currently used and, therefore, there is the need to harmonize proposed QIs. Results A model of quality indicators (MQI) has been consensually developed by a group of clinical laboratories according to a project launched by a working group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The model includes 57 QIs related to key processes (35 pre-, 7 intra- and 15 post-analytical phases) and 3 to support processes. Conclusions The developed MQI and the data collected provide evidence of the feasibility of the project to harmonize currently available QIs, but further efforts should be done to involve more clinical laboratories and to collect a more consistent amount of data.

Widened pulse pressure is a classic sign of significant left-to-right shunting patent ductus arteriosus (PDA), but little evidence supports this statement in the early life of premature infants with respiratory distress syndrome (RDS) needing nonsteroidal anti-inflammatory drugs (NSAIDs), the pharmacological treatment for PDA. Pulse pressure and urinary endothelin-1 (ET-1) and arginine vasopressin (AVP) vasoactive factors involved in the transitional circulation were measured before and after the NSAIDs treatment of 46 RDS premature infants receiving either ibuprofen (n = 22) or indomethacin (n = 24), with 28 responders and 18 nonresponders to the first NSAIDs course. We found that following pharmacological PDA closure, systolic and diastolic blood pressure significantly increased, maintaining a stable pulse pressure. However, when pharmacological closure failed, the trend (nonsignificant) was for a more consistent increase in systolic than in diastolic blood pressure, which determined a statistically significant widening pulse pressure. In addition, urinary ET-1 excretion rates decreased significantly after PDA closure, whereas persistent more aggressive pharmacological therapy failed. Urinary AVP excretion rates decreased insignificantly after therapy, uninfluenced by the efficacy of the drugs. We concluded that widened pulse pressure is a clinical sign of failed PDA pharmacological closure in RDS premature infants. ET-1 levels remain elevated when NSAIDs fail to interrupt left-to-right PDA shunting that complicates recovery from RDS.

Purpose: The aim of the study is to promote, through this toll-free number (TFN) service, a health communication program providing information on nocturnal enuresis (NE) and related problems by a subspecialty-trained physician and to collect the callers’ characteristics too. All phone calls were scheduled to data collections. Methods: The telephone service operated as follows: the TFN was available from March 1 to May 31, 2000, and from April 1 to June 30, 2001. People called the free telephone line and received information needs. Results: A total of 12,806 calls were received by the help line during the two study periods (7,046 in 2000 and 5,760 in 2001). Of the calls, 61% came from subjects with NE without pharmacological or non-pharmacological treatment, 16% (2000) and 13% (2001) came from subjects >12 years old. Conclusions: A TFN for NE can be both accessible and effective in order to provide information on NE and related problems. Finally, such a service should be included in a national program to improve health and well-being.

Objective To determine the effect of long-term desmopressin therapy in enuretic patients on the levels of antidiuretic hormone (ADH) during and after the end of therapy. Patients and methods The study comprised 25 outpatients (18 boys and seven girls) aged 8–12 years at the start of therapy and 12–16 years at the end. The morning (08.00 hours) plasma ADH level was determined before treatment (T0) with desmopressin and 2 years after (T1) ending the therapy. Seven of the 25 patients evaluated had monosymptomatic (simple enuresis, SE) and 18 had other symptoms (complex enuresis, CE). Results In the patients with SE, the mean (SD) duration of therapy was 305 (183) days and they were re-evaluated 2.5 (0.67) years later. Of 18 patients with CE, eight were treated only with desmopressin for 204 (117) days. In 10 with an incomplete response after 30 days with only desmopressin, oxybutynin (5 mg twice daily) was added; the duration of their therapy was 255 (152) days and they were re-evaluated 3.9 (0.6) years later. The mean (SD) ADH level in those with SE and CE was 2.14 (0.93) ng/L and 2.53 (1.16) ng/L), respectively, both significantly lower (P< 0.001) than in controls, at 5.1 (1.6) ng/L. On re-evaluation at T1, there was a significant (P

Reducing medical errors has become an international concern. Population-based studies from a number of nations around the world have consistently demonstrated unacceptably high rates of medical injury and preventable deaths. The introduction of effective reporting systems is a cornerstone of safe practice within hospitals and other healthcare organisations. Reporting can help to identify hazards and risks. However, reporting in itself does not improve safety. It is the response to reports that leads to change. Clinical teams must feel empowered to change the way in which they deliver their services, promoting effective clinical risk management. Process analysis, implementation of evidence-based practices, and a clear accountability system are effective tools not only for decreasing error rates, but also for improving effectiveness. Clinical Governance represents the context in which effective clinical risk management should be promoted and continuously improved. It should not be regarded as a separate activity, but should form part of the everyday practice of all healthcare professionals. It requires good multidisciplinary working and a willingness to reflect on and learn from errors to achieve a patient-centred and safer system.

Objective: To compare the effects of intravenous ibuprofen and indomethacin for treatment of patent ductus arteriosus (PDA) on urinary antidiuretic hormone (ADH) excretion, as a cause of oliguria. Study Design: Forty-four respiratory distress syndrome prematures (≤34 weeks’ gestation) with PDA received either ibuprofen (n = 22) in an initial dose of 10 mg/kg followed by two doses of 5 mg/kg each after 24 and 48 h or three doses at 12-hour intervals of indomethacin (n = 24), 0.2 mg/kg, both infused continuously over a period of 15 min. Urinary ADH excretion, diuresis, serum creatinine, urinary sodium, fractional excretion of sodium, and urinary osmolality were measured before and after treatment. Results: Indomethacin treatment caused a significant decrease in urinary ADH excretion (21.8 ± 20.8 vs. 13.8 ± 12.9 pg/ml; p < 0.05), along with a significant reduction in urinary sodium (92.1 ± 36.1 vs. 64.8 ± 35.6; p < 0.05), fractional excretion of sodium (68.5 ± 37.1 vs. 45.6 ± 37.1; p < 0.05), and urinary osmolality (276.2 ± 103.9 vs. 226.4 ± 60.3; p < 0.05). Ibuprofen treatment did not modify urinary ADH excretion and caused a statistically insignificant decrease in urinary sodium and in fractional excretion of sodium. Conclusions: Compared with ibuprofen, indomethacin caused a significant reduction in urinary ADH excretion and a significant decrease in urinary sodium and osmolality.

We describe a case of synovitis, acne, pustulosis, hyperostosis, osteitis (SAPHO syndrome) in an 8-year-old boy with an unusual presentation of acute transitory hemiparesis. SAPHO syndrome has been reported in association with inflammatory bowel diseases, chest complications, and pulmonary involvement. No patient with both SAPHO syndrome and neurologic complaints has been previously described. Further observations are needed to confirm if SAPHO syndrome and hemiparesis represent a coincidence or a new association.

The aim of the study was to compare the efficacy and safety of different doses of DDAVP spray treatment (20 to 40 mcg/day) in patients with primary monosymptomatic nocturnal enuresis (defined as three or more wet nights per week).237 patients (152 males, 75 females; age range 5-17 years), with no infections or organic abnormalities of the urinary apparatus and no neurological disorders, were admitted into the trial. The experimental design was planned as an "open study" with five different treatments schedules (5 groups). The daily doses of DDAVP at bedtime in groups 1 and 2 were 20 and 30 mcg, respectively, for 6 weeks. In groups 3 and 4 the daily doses for the first 2 weeks were 20 and 30 mcg, respectively, and then, after a washout period of 2 weeks, the daily doses for the two groups were 30 and 20 mcg, respectively. A dose-response study (20 to 40 mcg/day) was carried out in group 5.DDAVP spray therapy in primary monosymptomatic nocturnal enuresis was found to be resolutive in 70-75% of treated patients. No difference in response was found between the patients treated with the daily dose of 20 and those on 30 mcg. No important reactions were observed in patients treated with DDAVP spray at the different daily dose (20 to 40 mcg) or for different periods of time (up to 6 weeks).DDAVP spray therapy at a dose of 20 mcg/day was effective in 70-75% of primary monosymptomatic nocturnal enuretics. In non-responders the daily dose of DDAVP should be increased to 30 to 40 mcg.

To assess the diagnostic efficiency and direct costs of electrophysiologic tests, times and clinical data (admittance, diagnosis, final diagnosis and clinical reports) of 144 patients were recorded and statistically analyzed. Capital outlay on equipment and personnel costs were also evaluated to determine the economic impact of the tests. Electrophysiologic tests were found to play an important role in diagnosis and choice of therapy. It is important to improve collaboration between the referring ophthalmologist and the electrophysiology staff to inform patients better and to optimize the cost-benefit standards of the service. The current reimbursement by the Regional Public Health Service underestimates the costs of electrophysiologic tests.

Objective To determine variations in the amount of glycosaminoglycans (GAGs) excreted by patients with nocturnal enuresis and/or diurnal incontinence. Patients, subjects and methods The study included 27 patients (aged 5–15 years) with nocturnal enuresis and/or diurnal incontinence, and 27 healthy age-matched children. Their urinary GAG excretion was assessed over 24 h using the sodium tetraborate-carbazole method. Results Patients with nocturnal enuresis and/or diurnal incontinence had higher mean values of urinary GAG excretion than age-matched controls. There were significant differences in GAG excretion between those with nocturnal enuresis and diurnal incontinence and those with nocturnal enuresis alone. Conclusions GAG excretion in patients with nocturnal enuresis and/or diurnal incontinence was significantly higher than in normal children, suggesting that measuring urinary GAGs may be useful in evaluating physiopathological conditions of the bladder wall, and hence in monitoring potential damage in the bladder mucosa.

To date, no previous studies have described the association between primary nocturnal enuresis and left-handedness. In our series of enuretic patients, the prevalence of left-handedness was significantly higher than the control group. These data suggest a new correlation which needs further investigation.

Primary monosymptomatic nocturnal enuresis is a common complaint in paediatrics. Treatment with desmopressin nasal spray is one of the most often used pharmacological approaches, but concerning therapy interruption, to date no guidelines have yet been established. The aim of this study was to report the use of desmopressin in two monozygotic twin sisters to establish if tolerability and efficacy of treatment can be affected by different modalities of therapy interruption.

Melatonin assay has proved to be clinically useful for the diagnosis and investigation of several diseases (e.g., Cushing's syndrome, depressive disorders). We have evaluated the analytical performance of a radioimmunoassay for the determination of melationin in plasma. The interference of some anticoagulants has been investigated, as well as the preliminary extraction of the hormone using a liquid-liquid and a solid-phase extraction method. The variation coefficients of the assay, within and between runs, were between 3.8% and 9.2% and between 4.1% and 10.5%, respecitively. The well-documented circadian rhythm of melatonin secretion was confirmed in our healthy subjects. Preliminary results appear to confirm the significance of melatonin measurement in neurosurgical patients.

The effect of hypothalamic phospholipids on the maturation of foetal lung was investigated in a series of experiments in rabbits. Sixteen pregnant does were injected with hypothalamic phospholipids (2 mg day −1 kg −1 ) from day 21 of gestation. A second group of 16 does was injected with saline, and served as controls. The foetuses were delivered at gestational ages between 27 and 28 days by means of caesarean section under intravenous pentothal anaesthesia. Foetuses born from treated mothers were more active, breathed better, and their lungs expanded to a greater extent compared with the foetuses born to control mothers. In the animals of treated mothers there was, on electron microscopy, evidence of accelerated maturation of alveolar epithelial cells.

Eight boys with congenital urethral hypoplasia and atresia are described, including 5 with a patent urachus, 2 with an "H" type urethral perineal duplication and 1 with a rectovesical fistula. Of the boys 5 had the prune belly syndrome. The technique of gradual progressive indwelling soft catheter or stent dilation achieved excellent results in 6 boys. This technique is believed to offer the slow stimulus necessary for urethral dilation that is missing in boys with a patient urachus or urethral duplication. The remaining 2 boys were treated with more conventional techniques of urethrotomy or rapid urethral dilation. They eventually achieved a satisfactory result but after significant morbidity. This clinical experience serves to describe and demonstrate how the application of gradual progressive soft, small catheter or stent dilation of severe urethral hypoplasia and atresia results in a functionally normal urethra with minimal morbidity.

In a retrospective, double-blind study, we analyzed, utilizing an immunohistochemical technique, the distribution of Endothelin (Et) in 20 renal biopsies of 17 children with nephrotic syndrome (NS): 9 cases of steroid-responsive and 8 of steroid-resistant minimal-change disease (MCD) and 3 cases of focal segmental glomerulosclerosis (FSGS). Thirteen out of 20 biopsies (9/9 steroid-responsive MCD and 4/8 steroid-resistant MCD) showed a weak positivity of the vascular endothelial cells, as the normal renal tissue samples obtained from tumor nephrectomies. Seven out of 20 biopsies, all steroid-resistant NS, showed a marked positivity of the vascular endothelium and of the tubules and/or interstitial cells. In 4 of these 7 cases (1 MCD, 3 FSGS) a positivity of glomeruli was also revealed. The positivity of vascular endothelium seems to confirm its central role in Et production. The marked immunoreactivity detected in the endothelial cells and other renal components reveals a local increase in Et in some steroid-resistant MCD and, particularly, in FSGS. These preliminary observations suggest that Et may participate (cause or epiphenomenon) in the mechanisms underlying the development of glomerulosclerosis and the progression of renal damage.

This study examined the hypothesis that nocturnal enuresis might be paralleled by aquaporin 2 (AQP2) urinary excretion. Eighty children who experienced nocturnal enuresis were studied and compared with 9 healthy children. The 24-h urine samples were divided into two portions: night collections and day collections. Creatinine equivalents of urine samples from each patient were analyzed by Western blotting. AQP2 levels were semiquantified by densitometric scanning and reported as a ratio between the intensity of the signal in the day urine sample versus the night urine sample (D/N AQP2 ratio). The D/N AQP2 ratio was 0.59 ± 0.11 ( n = 9) in healthy children and increased to 1.27 ± 0.24 ( n = 10) in a subpopulation of enuretic children who had low nocturnal vasopressin levels. In enuretic children who displayed hypercalciuria and had normal vasopressin levels, the D/N AQP2 ratio was 1.05 ± 0.27 ( n = 8). These data indicate that reduced secretion of vasopressin and absorptive hypercalciuria are independently associated with an approximately twofold increase in the urinary D/N AQP2 ratio. When low nocturnal vasopressin levels were associated with hypercalciuria, a nearly threefold increase in the D/N AQP2 ratio was observed (1.67 ± 0.41, n = 11). In addition, in all enuretic patients tested, the urinary D/N AQP2 ratio correlates perfectly with the severity of the disorder (nocturnal polyuria). The findings reported in this article indicate that urinary AQP2 correlates with the severity of enuresis in children.

Objective To estimate the prevalence of enuresis in schoolchildren in Italy. Subjects and methods The Italian Club of Nocturnal Enuresis promoted a prevalence study of nocturnal enuresis using a self-administered questionnaire in seven cities in Northern, Central and Southern Italy. The association between enuresis and potential risk factors, e.g. a family history of enuresis, stress, socio-economic status and abnormal diurnal voiding habits, was investigated. The perceived impact on the child and on the family was also evaluated. A random-cluster sampling scheme was used to obtain a sample of primary and secondary schoolchildren from each city. One primary school and one secondary school for each socio-economic level was sampled in each city, giving a total of 42 schools surveyed; 9086 children were covered by the survey. In a cluster sampling method, the variance of prevalence is divided into two components, binomial and extra-binomial variability. Both the DSM III and DSM IV definitions of enuresis were used because at present, there is no consensus on the diagnostic criteria. Results Completed questionnaires were received from 7012 children, an overall response rate of 77.2%. Those aged 6–14 years were analysed, restricting the sample to 6892 children. There were 250 enuretic children using the DSM III definition of enuresis and 112 using the DSM IV definition. The overall prevalence was 3.8% and showed a decreasing trend with increasing age. Bedwetting was more frequent in boys than in girls. The prevalence of enuresis was higher when the child was from a family of low socio-economic status despite the child’s age group. The logistic analysis showed that familiality, stress, birthweight, age of attaining diurnal continence, soiling and, for girls, menstruation, were statistically significant variables and thus contributed to predicting the probability of bedwetting, confirming the findings of previous studies. There was a large difference in prevalence using the two DSM definitions; a high percentage of DSM III enuretic children had more than two wet nights per week. Conclusion It is important that a consensus about the ‘working definitions’ of enuresis is reached to avoid bias in the recruitment step, to carry out comparable epidemiological studies and to obtain adequate therapeutic responses.