Search

IntroductionConsensus is lacking on the optimal management of asymptomatic congenital pulmonary airway malformation (CPAM). For future studies, the CONNECT consortium (the COllaborative Neonatal Network for the first European CPAM Trial)—an international collaboration of specialised caregivers—has established consensus on a core outcome set of outcome parameters concerning respiratory insufficiency, surgical complications, mass effect and multifocal disease. These outcome parameters have been incorporated in the CONNECT trial, a randomised controlled trial which, in order to develop evidence-based practice, aims to compare conservative and surgical management of patients with an asymptomatic CPAM.Methods and analysisChildren are eligible for inclusion after the CPAM diagnosis has been confirmed on postnatal chest CT scan and they remain asymptomatic. On inclusion, children are randomised to receive either conservative or surgical management. Subsequently, children in both groups are enrolled into a standardised, 5-year follow-up programme with three visits, including a repeat chest CT scan at 2.5 years and a standardised exercise tolerance test at 5 years.The primary outcome is exercise tolerance at age 5 years, measured according to the Bruce treadmill protocol. Secondary outcome measures are molecular genetic diagnostics, validated questionnaires—on parental anxiety, quality of life and healthcare consumption—, repeated imaging and pulmonary morbidity during follow-up, as well as surgical complications and histopathology. This trial aims to end the continuous debate surrounding the optimal management of asymptomatic CPAM.Ethics and disseminationThis study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol (MEC-2022–0441). Results will be disseminated through peer-reviewed scientific journals and conference presentations.Trial registration numberNCT05701514.

IntroductionSevere neonatal hyperbilirubinaemia can place a neonate at risk for acute bilirubin encephalopathy and kernicterus spectrum disorder. Early diagnosis is essential to prevent these deleterious sequelae. Currently, screening by visual inspection followed by laboratory-based bilirubin (LBB) quantification is used to identify hyperbilirubinaemia in neonates cared for at home in the Netherlands. However, the reliability of visual inspection is limited. We aim to evaluate the effectiveness of universal transcutaneous bilirubin (TcB) screening as compared with visual inspection to: (1) increase the detection of hyperbilirubinaemia necessitating treatment, and (2) reduce the need for heel pricks to quantify bilirubin levels. In parallel, we will evaluate a smartphone app (Picterus), and a point-of-care device for quantifying total bilirubin (Bilistick) as compared with LBB.Methods and analysisWe will undertake a multicentre prospective cohort study in nine midwifery practices across the Netherlands. Neonates born at a gestational age of 35 weeks or more are eligible if they: (1) are at home at any time between days 2 and 8 of life; (2) have their first midwife visit prior to postnatal day 6 and (3) did not previously receive phototherapy. TcB and the Picterus app will be used after visual inspection. When LBB is deemed necessary based on visual inspection and/or TcB reading, Bilistick will be used in parallel. The coprimary endpoints of the study are: (1) hyperbilirubinaemia necessitating treatment; (2) the number of heel pricks performed to quantify LBB. We aim to include 2310 neonates in a 2-year period. Using a decision tree model, a cost-effectiveness analysis will be performed.Ethics and disseminationThis study has been approved by the Medical Research Ethical Committee of the Erasmus MC Rotterdam, Netherlands (MEC-2020-0618). Parents will provide written informed consent. The results of this study will be published in peer-reviewed journals.Trial registration numberDutch Trial Register (NL9545).

Background Children with pharmacoresistant epilepsy usually receive ketogenic diet (KD) as an inpatient, which makes it an expensive treatment. Objective To compare the effectiveness, safety, and costs of outpatient versus inpatient initiated KD. Design Retrospective observational non-inferiority study. Patients/setting Patients (1–18 years of age) who started KD either inpatient or outpatient. Main outcome measures Effectiveness was defined as ≥50% seizure reduction. Safety was measured by the numbers of emergency visits and complications. Economic impact was analyzed by calculating total costs of treatment. Statistical analyses Non-inferiority of outpatient initiation was tested using 95% confidence intervals of the differences in effectiveness and safety endpoints between groups with non-inferiority margins of 10%. Nonparametric bootstrap techniques were used to derive a 95% confidence interval for the mean difference in total costs between the groups. Results Hundred and five patients started KD in the period 2001 to 2017: 43 inpatient and 62 outpatient. At three months, the KD was effective in 61% of outpatients versus 63% of inpatients. The KD was considered safe in 36% of the outpatients, as compared to 29% in the inpatients. Outpatient initiation was shown to be non-inferior to inpatient initiation in terms of safety. Total health care costs of outpatient initiation were € 2901, as compared to € 8195 of inpatient initiation per patient (mean difference € 5294, 95% CI; -€ 7653 to -€ 2935). Conclusions Our study suggests that outpatient KD initiation is no worse than inpatient initiation in terms of effectiveness and safety, while carrying lower health care costs.

Purpose The quality of resuscitation and effective leadership are decisive for the outcome of a resuscitation. Nurses are usually the first responders upon cardiac arrest. Therefore, we started the “proficiency check” project, which aims to improve nurses' resuscitation and teamwork skills. This article describes the effectiveness of the proficiency check and nurses' experiences with it. Design and methods This study was done among intensive care nurses working on a pediatric ICU (PICU) in the Netherlands. It was designed as a mixed-methods study combining a quantitative and a qualitative approach. Quantitative data were obtained through a pre-posttest comparison of nurses' resuscitation and teamwork skills, in a simulation setting. Qualitative data on nurses' experiences were collected through semi-structured individual interviews. Results Both resuscitation and teamwork skills improved significantly. In 39 nurses (32%), the improvement of both resuscitation and teamwork skills after the intervention was large (effect size >0.8). The experiences of nurses regarding the proficiency check were diverse: on the positive side, increased knowledge and confidence were reported, whereas negative experiences related, among other things, to stress and anxiety. Conclusions Resuscitation and teamwork skills of PICU nurses can be enhanced by the ‘proficiency check’ studied here. This simulation-based training can be further improved by incorporating the nurses' experiences. Practice implications A simulation-based assessment for resuscitation may play an important role in a PICU, and possibly for other skills and in other settings as well. Particular attention should be paid to the stress that many nurses experience due to skills assessment.

IntroductionPectus excavatum repair is associated with substantial postoperative pain, despite the use of epidural analgesia and other analgesic regimens. Perioperative recorded music interventions have been shown to alleviate pain and anxiety in adults, but evidence for children and adolescents is still lacking. This study protocol describes a randomised controlled trial that evaluates the effects of recorded music interventions on postoperative pain relief in children and adolescents after pectus excavatum repair.MethodsA multicentre randomised controlled trial was set up comparing the effects of perioperative recorded music interventions in addition to standard care with those of standard care only in patients undergoing a Nuss procedure for pectus excavatum repair. One hundred and seventy subjects (12–18 years of age) will be included in three centres in the Netherlands. Patient inclusion has started in November 2018, and is ongoing. The primary outcome is self-reported perceived pain measured on the visual analogue scale. Secondary outcomes are anxiety level, analgesics consumption, vital parameters such as heart rate, blood pressure and respiratory rate, length of hospital stay, postoperative complications, quality of life and cost-effectiveness.Ethics and disseminationThis study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Centre Rotterdam, The Netherlands, has approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.Trial registration numberNL6863

Objective: To evaluate the feasibility of infants’ weaning of opioids and sedatives at home. Design: Retrospective observational study. Setting: Level 3 pediatric intensive care unit. Patients: Neonates treated for congenital diaphragmatic hernia (CDH) with extra corporeal membrane oxygenation (ECMO). Intervention: Eligible infants were discharged early and further weaned of analgesics and/or sedatives at home. Results: Of the 30 neonates treated for CDH with ECMO from 2003 to 2005, 15 survived. Five of these were weaned at home, on the guidance of telephone contact once a week. The mean infusion rates of morphine and midazolam for these children were significantly higher than those for other infants. Weaning at home took 11, 42, 107, 173, and 180 days, respectively, in the resultant mean savings on hospitalization costs per patient amounted to €150,000. Conclusions: The results indicate that home weaning reduced the length of hospital stay by a median of 107 days for the five infants in this study, and thereby considerably reduced healthcare costs. Parents need to be informed clearly about possible withdrawal symptoms and should consent in this strategy. The strategy of final weaning with the aid of weekly telephone consultations with a consultant pediatric intensivist was feasible for these parents.

BACKGROUND: Anesthesia and surgery may influence toddlers' sensory processing and consequently postoperative adjustment and behavior. This is the first study to: 1) test pre- to postoperative changes in sensory processing after pediatric anesthesia using the validated Infant/Toddler-Sensory Profile for 7-36 months (ITSP7-36); 2) identify putative predictors of these changes.METHODS: This prospective cohort study included 70 healthy boys (ASA I & II), aged 18-30 months, who underwent circumcision for religious reasons. Exclusion: boys with prior surgery and known developmental delay. Primary outcome: changes in sensory processing from the day of admission to day 14 postoperatively. The accompanying parent completed the ITS P7-36. Putative predictors: 1) child' preoperative emotional/behavioral problems; 2) child' state anxiety at induction; 3) postoperative pain at home. All children received standardized anesthesia and pain management.RESULTS: For 45 boys, assessments were completed at both time points. Significant changes in sensory processing (mean ITSP7-36 scores) were found on: low registration (47.5 to 49.8; P=0.015), sensory sensitivity (45.2 to 48.0; P=0.011), sensation avoiding (48.2 to 51.3; P=0.010), low threshold (93.4 to 99.4; P=0.007), auditory processing (39.3 to 43.3; P=0.000) and tactile processing (53.9 to 58.4; P=0.002). Higher scores on emotional/behavioral problems predicted changes on sensory processing.CONCLUSIONS: Sensory processing of these toddlers had changed after anesthesia. Children with more pre-existent emotional/behavioral problems are more vulnerable to these changes.

Overuse of broad-spectrum antibiotics in emergency departments (EDs) results in antibiotic resistance. We determined whether procalcitonin (PCT) -guided therapy can be used to reduce antibiotic regimens in EDs by investigating efficacy, safety and accuracy.This was a non-inferiority multicentre randomized clinical trial, performed in two Dutch hospitals. Adult patients with fever ≥38.2°C (100.8°F) in triage were randomized between standard diagnostic workup (control group) and PCT-guided therapy, defined as standard workup with the addition of one single PCT measurement. The treatment algorithm encouraged withholding antibiotic regimens with PCT0.5 μg/L, and starting antibiotic regimens at PCT ≥0.5 μg/L. Exclusion criteria were immunocompromised conditions, pregnancy, moribund patients, patients72 h after surgery or requiring primary surgical intervention. Primary outcomes were efficacy, defined as number of prescribed antibiotic regimens; safety, defined as combined safety end point consisting of 30 days mortality, intensive-care unit admission, ED return visit within 2 weeks; accuracy, defined as sensitivity, specificity and area-under-the-curve (AUC) of PCT for bacterial infections. Non-inferiority margin for safety outcome was 7.5%.Between August 2014 and January 2017, 551 individuals were included. In the PCT-guided group (n = 275) 200 (73%) patients were prescribed antibiotic regimens, in the control group (n = 276) 212 (77%) patients were prescribed antibiotics (p 0.28). There was no significant difference in combined safety end point between the PCT-guided group, 29 (11%), and control group, 46 (16%) (p 0.16), with a non-inferiority margin of 0.46% (n = 526). AUC for confirmed bacterial infections for PCT was 0.681 (95% CI 0.633-0.730), and for CRP was 0.619 (95% CI 0.569-0.669).PCT-guided therapy was non-inferior in terms of safety, but did not reduce prescription of antibiotic regimens in an ED population with fever. In this heterogeneous population, the accuracy of PCT in diagnosing bacterial infections was poor. TRIAL REGISTRATION IN NETHERLANDS TRIAL REGISTER: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4949.

Background: Children with intestinal failure (IF) depend on parenteral nutrition (PN). The goal in the treatment of IF is to wean children off PN through intestinal rehabilitation (IR). Although the healthcare burden of IF is enormous, to our knowledge there has been no previous cost-effectiveness analysis in pediatric IF including IR.Objective: We sought to determine the cost-effectiveness of IR in terms of costs and life-years.Design: We simulated the treatment of IF in children in a discrete-event model. Data for this model were derived from patient records, the Dutch Registry of Intestinal Failure and Transplantation, the Intestinal Transplant Registry, and the literature. The time horizon of the model was 40 y. Simulated patients were enrolled at a rate of 40 patients/mo for 10 y. Actual costs were calculated for hospital admissions, surgical interventions, endoscopies, PN, and immunosuppressive medication. We evaluated the cost-effectiveness of IR by comparing 1 scenario with IR with 1 scenario without IR. In the scenario with IR, a proportion of patients who represented those with the ability to wean off PN were assigned to IR. In the scenario without IR, all patients progressed to. home PN (HPN). In both scenarios, a proportion of patients receiving HPN were eventually eligible for an intestinal transplantation.Results: IR prolonged survival; the mean number of life-years per patient was 19.4 in the scenario with IR compared with 18.2 in the scenario without IR. Average total costs per patient were 819,292 in the scenario with IR compared with 1,176,830 in the scenario without IR (equivalent to 1,129,230 US$ and 1,622,025 US$, respectively, in January 2014); costs mainly included hospital admissions and PN.Conclusions: On the basis of our simulations, we concluded that IR improved the survival of children with IF and was associated with cost savings. Therefore, we consider IR to be a cost-effective treatment for children with IF.

Health economics deals with issues about the use of scarce resources in healthcare. An important branch of health economics concerns economic evaluations, which consist of a comparison of the costs and effects of 2 or more treatments. The role and importance of economic evaluations in oral care are increasing but are not yet as evident as in other areas of healthcare (such as pharmacy). An economic evaluation provides a broad picture of the costs and health benefits of a particular diagnostic or treatment strategy, resulting in a cost-effectiveness ratio (expressed, for example, as costs per quality-adjusted life year gained). The results are intended for use in policy-making, such as decisions about in- or exclusion from the basic benefits package. To date, only a limited number of economic evaluations of oral care have been carried out, mainly focused on caries. It is important to be able to demonstrate that the treatment provided in oral care is cost-effective. Oral care may put itself in a vulnerable position in the distribution of scarce resources when the costeffectiveness of its treatments is uncertain.De gezondheidseconomie houdt zich bezig met vraagstukken over de besteding van schaarse middelen in de gezondheidszorg. Een belangrijk aspect hiervan betreft de economische evaluatie waarbij de kosten en effecten van 2 of meer behandelingen worden vergeleken. De rol en het belang van economische evaluaties in de mondzorg neemt toe, maar is nog niet zo evident als bijvoorbeeld in de farmacie. Een economische evaluatie geeft een beeld van de kosten en gezondheidsopbrengsten van een diagnostische of behandelstrategie.Dit resulteert in een kosteneffectiviteitsratio (bijvoorbeeld uitgedrukt in kosten per gewonnen quality-adjusted life year). De resultaten zijn bestemd voor gebruik bij beleidsvorming over bijvoorbeeld het basispakket. Tot op heden is slechts een beperkt aantal economische evaluaties (meestal gericht op cariës) van mondzorg gedaan.In de mondzorg is het van belang aan te kunnen tonen dat de geleverde zorg kosteneff ectief is. Wanneer dit ongewis is, brengt de mondzorg zichzelf mogelijk in een kwetsbare positie bij de verdeling van schaarse middelen.

IntroductionHigh morbidity and mortality rates of proven bacterial infection are the main reason for substantial use of intravenous antibiotics in neonates during the first week of life. In older children, intravenous-to-oral switch after 48 hours of intravenous therapy has been shown to have many advantages and is nowadays commonly practised. We, therefore, aim to evaluate the effectiveness, safety and cost-effectiveness of an early intravenous-to-oral switch in neonates with a probable bacterial infection.Methods and analysisWe present a protocol for a multicentre randomised controlled trial assessing the non-inferiority of an early intravenous-to-oral antibiotic switch compared with a full course of intravenous antibiotics in neonates (0–28 days of age) with a probable bacterial infection. Five hundred and fifty patients will be recruited in 17 hospitals in the Netherlands. After 48 hours of intravenous treatment, they will be assigned to either continue with intravenous therapy for another 5 days (control) or switch to amoxicillin/clavulanic acid suspension (intervention). Both groups will be treated for a total of 7 days. The primary outcome will be bacterial (re)infection within 28 days after treatment completion. Secondary outcomes are the pharmacokinetic profile of oral amoxicillin/clavulanic acid, the impact on quality of life, cost-effectiveness, impact on microbiome development and additional yield of molecular techniques in diagnosis of probable bacterial infection.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the Erasmus Medical Centre. Results will be presented in peer-reviewed journals and at international conferences.Trial registration numberNCT03247920

Purpose Inguinal hernia repair is frequently performed in premature infants. Evidence on optimal management and timing of repair, as well as related medical costs is still lacking. The objective of this study was to determine the direct medical costs of inguinal hernia, distinguishing between premature infants who had to undergo an emergency procedure and those who underwent elective inguinal hernia repair. Methods This cohort study based on medical records concerned premature infants with inguinal hernia who underwent surgical repair within 3 months after birth in a tertiary academic children’s hospital between January 2010 and December 2013. Two groups were distinguished: patients with incarcerated inguinal hernia requiring emergency repair and patients who underwent elective repair. Real medical costs were calculated by multiplying the volumes of healthcare use with corresponding unit prices. Nonparametric bootstrap techniques were used to derive a 95 % confidence interval (CI) for the difference in mean costs. Results A total of 132 premature infants were included in the analysis. Emergency surgery was performed in 29 %. Costs of hospitalization comprised 65 % of all costs. The total direct medical costs amounted to €7418 per premature infant in the emergency repair group versus €4693 in the elective repair group. Multivariate analysis showed a difference in costs of €1183 (95 % CI −1196; 3044) in favor of elective repair after correction for potential risk factors. Conclusion Emergency repair of inguinal hernia in premature infants is more expensive than elective repair, even after correction for multiple confounders. This deserves to be taken into account in the debate on timing of inguinal hernia repair in premature infants.

IntroductionAnastomotic stricture formation is the most common postoperative complication after oesophageal atresia (OA) repair. The standard of care is endoscopic dilatation. A possible adjuvant treatment is intralesional steroid injection, which is thought to inhibit scar tissue formation and thereby to prevent stricture recurrence. We hypothesise that this intervention could prevent refractory strictures and reduce the total number of dilatations needed in these children.Methods and analysisThis is an international multicentre randomised controlled trial. Children with OA type C (n=110) will be randomised into intralesional steroid injection followed by balloon dilatation or dilatation only. Randomisation and intervention will take place when a third dilatation is performed. The indication for dilatation will be confirmed with an oesophagram. One radiologist—blinded for randomisation—will review all oesophagrams. The primary outcome parameter is the total number of dilatations needed with 2 association test. Secondary outcome parameters include the level of dysphagia, the luminal oesophageal diameter and stricture length (measured on the oesophagrams), the influence of comedication on stricture formation, systemic effects of intralesional steroids (cortisol levels, length and weight) and the cost-effectiveness. Patients will undergo a second oesophagram; length and weight will be measured repeatedly; a scalp hair sample will be collected; and three questionnaires will be administered. The follow-up period will be 6 months, with evaluation at 2–3 weeks, 3 and 6 months after the intervention.Ethics and disseminationPatients will be included after written parental informed consent. The risks and burden associated with this trial are minimal. The institutional review board of the Erasmus Medical Centre approved this protocol (MEC-2018–1586/NL65364.078.18). The results of the trial will be published in a peer-reviewed scientific journal and will be presented at international conferences.Trial registration numbers2018-002863-24 and NTR7726/NL7484.

BackgroundChildren undergoing adenotonsillectomy are at risk of severe postoperative pain and sleep problems. Little is known about the specific child risk factors for these problems. AimsThe aim of this study was to assess the occurrence of postoperative pain, sleep problems, and medication adherence, and assess the influence of internalizing and externalizing problems on postoperative pain. MethodsThis prospective cohort study included 160 children, aged 1.5‐5 years undergoing day‐care adenotonsillectomy. Parents rated their child's pain with the Parents’ Postoperative Pain Measure and their child's sleep problems with Vernon's Post Hospital Behavioral Questionnaire during the first 3 days and at day 10 postoperatively. Emotional/behavioral problems (ie, internalizing and externalizing behaviors) during the past 2 months were assessed using the Child Behavior Checklist. Regression analysis was used to assess whether children's pain intensity at home was associated with internalizing/externalizing problems, after controlling for age, preoperative child state anxiety, parental state anxiety, parental need for information, and socioeconomic status. ResultsApplying a threshold of ≥6 on the Parents’ Postoperative Pain Measure, the incidence of moderate to severe pain was 57.6% at day 1, 53.5% at day 2, 35.4% at day 3, and 4.8% at day 10. During the first three postoperative nights, 37.1% of the children woke up. Internalizing problems (β = 0.343; P = 0.001) and parental need for information (β = 0.207; P = 0.011) were independently associated with higher pain scores at home during the first 3 days (R2 = 0.225). ConclusionFollowing adenotonsillectomy, children often experienced moderate to severe pain and sleep problems during the first 3 days at home. Preoperative internalizing problems and parental need for information were independently associated with increased pain at home. Screening for these problems can help to identify vulnerable children and adapt the perioperative analgesic strategy accordingly (which includes preparation, information, and prescription of pain analgesics).

BACKGROUND: The modified Yale Preoperative Anxiety Scale is widely used to assess children's anxiety during induction of anesthesia, but requires training and its administration is time-consuming. A Visual Analog Scale, in contrast, requires no training, is easy-to-use and quickly completed. AIM: The aim of this study was to evaluate a Visual Analog Scale as a tool to assess anxiety during induction of anesthesia and to determine cut-offs to distinguish between anxious and nonanxious children. METHODS: Four hundred and one children (1.5-16 years) scheduled for daytime surgery were included. Children's anxiety during induction was rated by parents and anesthesiologists on a Visual Analog Scale and by a trained observer on the modified Yale Preoperative Anxiety Scale. Psychometric properties assessed were: (i) concurrent validity (correlations between parents' and anesthesiologists' Visual Analog Scale and modified Yale Preoperative Anxiety Scale scores); (ii) construct validity (differences between subgroups according to the children's age and the parents' anxiety as assessed by the State-Trait Anxiety Inventory); (iii) cross-informant agreement using Bland-Altman analysis; (iv) cut-offs to distinguish between anxious and nonanxious children (reference: modified Yale Preoperative Anxiety Scale ≥30). RESULTS: Correlations between parents' and anesthesiologists' Visual Analog Scale and modified Yale Preoperative Anxiety Scale scores were strong (0.68 and 0.73, respectively). Visual Analog Scale scores were higher for children ≤5 years compared to children aged ≥6. Visual Analog Scale scores of children of high-anxious parents were higher than those of low-anxious parents. The mean difference between parents' and anesthesiologists' Visual Analog Scale scores was 3.6, with 95% limits of agreement (-56.1 to 63.3). To classify anxious children, cut-offs for parents (≥37 mm) and anesthesiologists (≥30 mm) were established. CONCLUSIONS: The present data provide preliminary data for the validity of a Visual Analog Scale to assess children's anxiety during induction. ispartof: PEDIATRIC ANESTHESIA vol:27 issue:9 pages:955-961 ispartof: location:France status: published

Economic evaluations for medical nutrition, such as oral nutritional supplements (ONS), are relatively uncommon compared with other health technologies, and represent an area that has not been reviewed so far. In this systematic review, economic evaluations of enteral medical nutrition in the management of disease-related malnutrition (DRM) were reviewed and qualified to estimate the economic value. Initially, 481 studies were found, of which 37 full-text articles were assessed for eligibility and were rated on their quality using the Quality of Health Economic Studies (QHES) instrument. The final review focused on the high QHES quality economic evaluation studies. As both the studied medical nutrition intervention and the form of the economic evaluation varied, a quantitative synthesis (meta-analysis) was not attempted but a critical analysis and comparison of the individual study results were performed. ONS was the most studied intervention, covering several patient populations and different health care settings. Outcomes included cost savings (n = 3), no significant extra costs per unit of clinical and/or functional improvement (n = 1), or significantly higher costs per unit of clinical and/or functional improvement but still cost-effective for the used threshold (n = 4). This review shows that the use of enteral medical nutrition in the management of DRM can be efficient from a health economic perspective. Copyright (C) 2014 - American Medical Directors Association, Inc.

_Background:_ Congenital malformations are a significant component of the global burden of disease among children, accounting for 25 million disability-adjusted life years (DALYs) worldwide. Unfortunately, efforts to estimate the burden of pediatric surgical disease in Africa are limited by the absence of population-based data. The objective of this study was to estimate both the prevalence and the disease burden of several common congenital surgical malformations among children in Kenya. _Methods:_ Community volunteers randomly surveyed households at sites across Kenya. Caretakers were asked to identify on a photographic portfolio, several congenital malformations present among the children in their household, including club foot, hypospadias, hydrocephalus, spina bifida/encephalocele, cleft lip, bladder exstrophy and imperforate anus. DALYs were then calculated based on life expectancy tables and published and estimated disability weights for the conditions encountered. _Results:_ The caregivers of 5559 children (54% female) were surveyed in 1909 households, 56% of which were rural, 31% suburban and 12% urban. The overall prevalence of congenital malformations was 6.3 per 1000 children, amounting to 54-120 DALYs per 1000 children, depending on the life tables used. The most prevalent condition in the survey was club foot, whereas spina bifida had the highest burden of disease. _Discussion:_ This study is the first to document the prevalence of selected surgical congenital malformations among children in Kenya and the burden of disease associated with them. The results will serve to inform strategies aimed at reducing the unmet burden of surgical disease in resource-limited regions.

The relationship between nutrition and health-economic outcomes is important at both the individual and the societal level. While personal nutritional choices affect an individual's health condition, thus influencing productivity and economic contribution to society, nutrition interventions carried out by the state also have the potential to affect economic output in significant ways. This review summarizes studies of nutrition interventions in which health-related economic implications of the intervention have been addressed. Results of the search strategy have been categorized into three areas: economic studies of micronutrient deficiencies and malnutrition; economic studies of dietary improvements; and economic studies of functional foods. The findings show that a significant number of studies have calculated the health-economic impacts of nutrition interventions, but approaches and methodologies are sometimes ad hoc in nature and vary widely in quality. Development of an encompassing economic framework to evaluate costs and benefits from such interventions is a potentially fruitful area for future research.

Background Fever is a common symptom in the emergency department(ED). Fever can be caused by bacterial infections, which are treated with antibiotics. Often, bacterial infections cannot be ruled out in the ED using standard diagnostics, and empiric antibiotic treatment is started. Procalcitonin(PCT) is a biomarker for bacterial infections, but its role in an undifferentiated ED population remains unclear. We hypothesize that PCT-guided therapy may reduce antibiotics prescription in undifferentiated febrile ED patients. The primary objectives of this study are to determine a) the efficacy, b) the safety of PCT-guided therapy, and c) the accuracy of the biomarker PCT for bacterial infections. The secondary objective is to study the cost-effectiveness of PCT-guided therapy. Methods/design This is a multicenter noninferiority randomized controlled trial. All adult ED patients with fever(≥38.2 °C) are randomized between standard care with and without the addition of a PCT level, after written informed consent.For efficacy, the reduction of patients receiving antibiotics is calculated, using a superiority analysis: differences between the PCT-guided group and control group are assessed using a Fisher’s exact test, and a multivariable logistic regression analysis to account for the effects of demographic and medical variables on the percentage of febrile patients receiving antibiotics.Safety consists of a composite endpoint, defined as mortality, intensive care admission and ED return visit within 14 days. Noninferiority of PCT will be tested using a one-sided 95 % confidence interval for the difference in the composite safety endpoint between the PCT-guided and control groups using a noninferiority margin of 7.5 %.Accuracy of PCT and CRP for the diagnosis of bacterial infections will be reported, using the sensitivity, specificity, and the area under the receiver-operating-characteristic curve in the definitive diagnosis of bacterial infections. The sample size is 550 patients, which was calculated using a power analysis for all primary objectives. Enrollment of patients started in August 2014 and will last 2 years. Discussion PCT may offer a more tailor-made treatment to the individual ED patient with fever. Prospective costs analyses will reveal the economic consequences of implementing PCT-guided therapy in the ED. This trial is registered in the Dutch trial register NTR4949

Background: Surgeons prefer to close ostomies at least 6 weeks after the primary operation because of the anticipated postoperative abdominal adhesions. Limited data support this habit. Our aim was to evaluate adhesion formation-together with an analysis of resource consumption and costs-in patients with necrotizing enterocolitis who underwent early closure (EC), compared with a group of patients who underwent late closure (LC). Methods: Chart reviews and cost analyses were performed on all patients with necrotizing enterocolitis undergoing ostomy closure from 1997 to 2009. Operative reports were independently scored for adhesions by 2 surgeons. Results: Thirteen patients underwent EC (median, 39 days; range, 32-40), whereas 62 patients underwent LC (median, 94 days; range, 54-150). Adhesion formation in the EC group (10/13 patients, or 77%) was not significantly different (P = 1.000) from the LC group (47/59 patients, or 80%). No differences were found in the costs of hospital stay, surgical interventions, and outpatient clinic visits. Conclusions: Ostomy closure within 6 weeks of the initial procedure was not associated with more adhesions or with changes in direct medical costs. Therefore, after stabilization of the patient, ostomy closure can be considered within 6 weeks during the same admission as the initial laparotomy. (C) 2012 Elsevier Inc. All rights reserved.

Improving health through better nutrition of the population may contribute to enhanced efficiency and sustainability of healthcare systems. A recent expert meeting investigated in detail a number of methodological aspects related to the discipline of nutrition economics. The role of nutrition in health maintenance and in the prevention of non-communicable diseases is now generally recognised. However, the main scope of those seeking to contain healthcare expenditures tends to focus on the management of existing chronic diseases. Identifying additional relevant dimensions to measure and the context of use will become increasingly important in selecting and developing outcome measurements for nutrition interventions. The translation of nutrition-related research data into public health guidance raises the challenging issue of carrying out more pragmatic trials in many areas where these would generate the most useful evidence for health policy decision-making. Nutrition exemplifies all the types of interventions and policy which need evaluating across the health field. There is a need to start actively engaging key stakeholders in order to collect data and to widen health technology assessment approaches for achieving a policy shift from evidence-based medicine to evidence-based decision-making in the field of nutrition. Refereed/Peer-reviewed

Purpose Relatively few attempts to measure the effects on the health-related quality of life (HRQoL) of informal caregivers within the context of economic evaluations have been reported. This paper is an exploratory attempt to find suitable methods to assess caregivers’ HRQoL, using a population of parents of children with major congenital anomalies. Methods A total of 306 parents of children born with either congenital anorectal malformations (ARM) or congenital diaphragmatic hernia were surveyed. They rated their current HRQoL on the EQ-VAS. After that, they rated their HRQoL again on the assumption that someone would take over their caregiving activities completely and free of charge. Finally, the parents classified their HRQoL on the EQ-5D. The caregivers’ scores on the EQ-VAS and the EQ-5D were compared with scores elicited in the general population. Results Most parents indicated that their HRQoL would not change if someone else took on their caregiving activities. Some methodological issues may have influenced this outcome, such as difficulties in self-assessing HRQoL changes due to caregiving, process utility, protest answers, and difficulties in understanding the hypothetical question. The HRQoL of the parents was relatively low compared with population statistics, especially in the parents of children with ARM and in mothers. This can be illustrated by the difference between the mean EQ-5D score of the mothers aged 25–34 years of the children with ARM and that of the general population (0.83 vs. 0.93; P = 0.002). Conclusions Significant HRQoL differences exist between parents caring for children with congenital anomalies and the general population. It would be useful to further improve our understanding of the HRQoL impact of informal caregiving, separating ‘caregiving effects’ from ‘family effects’, and distinguishing parent–child relationships from other caregiving situations. This study underlines the importance of considering caregivers, also in the context of economic evaluations. It indicates that general HRQoL measures, as used in patients, may be able to detect HRQoL effects in caregivers, which facilitates the incorporation in common economic evaluations of HRQoL effects in carers. Analysts and policy makers should be aware that if HRQoL improvement is an important aim, they should register HRQoL changes not only in patients but also in their caregivers.

Nowadays, the belief is widespread that a safety culture is crucial to achieving patient safety, yet there has been virtually no analysis of the safety culture in pediatric hospital settings so far. Our aim was to measure the safety climate in our unit, compare it with benchmarking data, and identify potential deficiencies.Prospective longitudinal survey study at two points in time.Pediatric surgical intensive care unit at a Dutch university hospital.All unit personnel.To measure the safety climate, the Safety Attitudes Questionnaire was administered to physicians, nurses, nursing assistants, pharmacists, technicians, and ward clerks in both May 2006 and May 2007. This questionnaire assesses caregiver attitudes through use of the six following scales: teamwork climate, job satisfaction, perceptions of management, safety climate, working conditions, and stress recognition. Earlier research showed that the Safety Attitudes Questionnaire has good psychometric properties and produced benchmarking data that can be used to evaluate strengths and weaknesses in a given clinical unit against peers.The response rates for the Safety Attitudes Questionnaire were 85% (May 2006) and 74% (May 2007). There were mixed findings regarding the difference between physicians and nurses: on three scales (i.e., teamwork climate, safety climate, and stress recognition), physicians scored better than nurses at both points in time. On another two scales (i.e., perceptions of management and working conditions), nurses consistently had higher mean scale scores. Probably due to the small number of physicians, only some of these differences between physicians and nurses reached the level of statistical significance. Compared to benchmarking data, scores on perceptions of management were higher than expected (p.01), whereas scores on stress recognition were low (p.001). The scores on the other scales were somewhat above (job satisfaction), close to (teamwork climate, safety climate), or somewhat below (working conditions) what was expected on the basis of benchmarking data, but no persistent significant differences were observed on these scales.Although on most domains the safety culture in our unit was good when compared to benchmark data, there is still room for improvement. This requires us to continue working on interventions intended to improve the safety culture, including crew resource management training, safety briefings, and senior executive walk rounds. More research is needed into the impact of creating a safety culture on patient outcomes.

Background: Since 1999 a multidisciplinary follow-up programme for parents and children with major anatomical congenital anomalies is in place in our hospital, run by a dedicated team. The aim of the present study was to evaluate the services of this team from a parental perspective. Methods: Parents completed a questionnaire including open and closed questions about satisfaction with the various professional disciplines involved in the follow-up, statements on usefulness of the follow-up services and suggestions for improvement. Results: Four hundred and sixty-nine surveys were sent out, of which 71% were returned. Non-responding parents included significantly more parents of non-Dutch origin (P = 0.038) and parents who never responded to invitations for follow-up examinations (P < 0.001). Parental satisfaction differed for the various disciplines. Eighty per cent of the parents were (very) satisfied with the social worker, compared with 92% with nurses. More than half of the parents agreed that the follow-up services give peace of mind. Almost a quarter of parents, however, considered the follow-up services as redundant. The children of these parents had significantly shorter intensive care unit stay (P = 0.02), were older at the time of the questionnaire (P = 0.04), of higher socio-economic status (P = 0.001) and less likely to be of non-Dutch origin (P = 0.008). Sixty-one per cent of the parents had contacted the 24-h helpline. Ninety per cent of the parents were satisfied with the intensive care unit, almost 80% with the general ward. Conclusion: Overall, parents were satisfied with the services of the follow-up team. Some parents, however, saw room for improvement related to better communication, recognizability of the team and better planning and organization. © 2009 The Authors. Journal compilation

Title. Telephone helpline for parents of children with congenital anomalies. Aim. This paper is a report of a study to evaluate how often and for what reason parents of children born with severe anatomical congenital anomalies use a 24-hour telephone helpline, and to identify differences between callers and non-callers. Background. Children born with severe congenital anomalies often remain dependent on medical care and technology after discharge. Adequate medical consultation in the home situation may lower parental burden. Method. Observational study of telephone contacts from 2000 to 2006 with parents of congenital anomaly patients discharged home after neonatal intensive care admission. Frequency of telephone calls was categorized per type of anomaly. Resulting interventions in terms of consultation and hospital admission were recorded. Finally, costs of personnel needed to provide 24-hour telephone helpline availability were calculated. Findings. A total of 670 calls occurred outside office hours, from 34·4% of all parents; 23·7% of these calls concerned feeding problems. Parents of children with oesophageal atresia, urogenital malformation and congenital diaphragmatic hernia called most frequently (44·3–50·6%). Non-callers were more often first-time parents, divorced/separated or immigrants. Nurses handled 24·5% of calls by themselves and 20·2% of calls led to emergency room consultations resulting in 4·9% admissions. First contact took place at median age 3 months, last contact at median age 8 months. Total personnel costs amounted to €27,191 per year. Conclusion. A 24-hour telephone helpline provides easy access to medical and supportive care for parents of children with congenital anomalies at relatively low cost. Nurses can effectively run this telephone helpline with paediatrician back-up.

Mortality rates in neonatal surgery have dropped markedly, illustrating the enormous progress made. Yet, new questions have arisen. To mention one, health care budgets have tightened. It follows that the effects of medical interventions should be weighted against their costs. As evidence was particularly sparse, we set out to analyse cost-effectiveness of neonatal surgery. The purpose of this article is to summarise our findings and to review recent studies. Moreover, this article explains the relevance of cost-effectiveness analysis and explores how cost-effectiveness interacts with other determinants of health care priority setting. Our research revealed that treatments for two common diagnostic categories in neonatal surgery (congenital anorectal malformations and congenital diaphragmatic hernia) produce good cost-effectiveness. Other groups also published cost-effectiveness studies in the field of neonatal surgery, although their number is still small. Contemporaneously, the economic aspects of health care have captured the interest of policy makers. Importantly, this is not to say that there are no other factors playing a role in priority setting, foremost among which are ethical questions and arguments of equity. This article concludes that, according to present evidence, neonatal surgery yields good value for money and contributes to equity in health.

Background: The economic consequences of interventions to promote rational, evidence-based use of laboratory tests by physicians are not yet fully understood. We evaluated the cost consequences of a computer-based, guideline-driven decision-support system (CDSS) for ordering blood tests in primary care. Methods: We installed the CDSS in 118 practices [159 general practitioners (GPs)] throughout The Netherlands and calculated the costs of the intervention in this group. During a period of 6 months before and 6 months after installation of the CDSS, the test-ordering behavior of 87 (109 GPs) of these 118 study practices was studied and the results were compared with those of a nonhistorical control group that did not receive the CDSS. In addition the costs of laboratory requests were calculated for both groups. Results: Total intervention costs, comprising development costs and installation costs, amounted to €79 000 (€670 per practice). Whereas the introduction of the CDSS did not affect the number of order forms submitted to the laboratories, it did reduce the number of blood tests per order form. As a result, the CDSS yielded mean savings on the costs of laboratory requests of €847 per practice per 6 months. Conclusions: This study demonstrates that providing electronic decision support for ordering blood tests in primary care represents an economically promising concept. Savings on laboratory costs are achievable and not offset by disproportionally high intervention costs.

There is a growing recognition that nutrition may have a positive impact on public health and that it may reduce medical expenditures. Yet, such claims need to be substantiated by evidence. This evidence could be delivered by health technology assessment (HTA), which can be thought of as the evaluation of technologies for clinical effectiveness, cost-effectiveness, and ethical, legal, and social impacts. The application of HTA to the field of "nutrition interventions" is recent. So far, HTA and nutrition have represented two worlds far apart in many respects. This contribution, roughly, addresses the following issues: is there a need for HTAs in the field of nutrition, what would such HTAs look like, and how can the results coming from these HTAs optimally aid policy making? In essence, HTAs of nutrition have much of the same basic principles and structure as HTAs of "classical" health care treatments. Nevertheless, there are challenges to rigorous HTAs of nutrition interventions, for various reasons. To mention a few: the evidence base for nutrition interventions is less well developed than that for many health care treatments. Furthermore, it is a matter of debate which outcome measures should be used in HTAs of nutrition. For example, one may argue that nutrition not only has health effects, but also effects that are not captured by traditional health-related quality of life measures (e.g., the pleasure of eating, effects relating to ease of use, or effects on well-being). HTAs in the field of nutrition may deliver information valuable to a wide range of stakeholders, including consumers/patients, health professionals, hospital administrators, insurers, and decision makers. The results of HTAs are typically used in making treatment guidelines, in informing decisions about reimbursement or about public health campaigns, etc. Yet, it is uncertain how the results of HTAs of nutrition can be used optimally. For example, would it be possible to summarize the results of a HTA in a single ratio (such as costs per quality-adjusted life-year gained) and then to either approve or reject the intervention based on this ratio, compared to a certain threshold? Apart from that, in the field of nutrition, it is typically not about reimbursement of a technology. Related to this, it is important that the message from HTAs of nutrition is brought to a range of stakeholders including the general population and that these HTAs are tailored to the decision-making context. To conclude, a growing need is felt for HTA-type evaluations of nutrition, which are sparse these days. Little thought has been given to developing an optimal methodology for HTAs of nutrition and to how its results should be integrated into policy making. Further work in these areas would stimulate the development of nutrition interventions that yield a gain in societal welfare. To achieve this, the two worlds of HTA and nutrition need to be brought together.

The criterion of medical need figures prominently in the Dutch model for reimbursement decisions as well as in many international models for health care priority setting. Nevertheless the conception of need remains too vague and general to be applied successfully in priority decisions. This contribution explores what is wrong with the proposed definitions of medical need and identifies features in the decision-making process that inhibit implementation and usefulness of this criterion. In contrast to what is commonly assumed, the problem is not so much a failure to understand the nature of the medical need criterion and the value judgments involved. Instead the problem seems to be a mismatch between the information regarding medical need and the way in which these concerns are incorporated into policy models. Criteria--medical need, as well as other criteria such as effectiveness and cost-effectiveness--are usually perceived as "hurdles," and each intervention can pass or fail assessment on the basis of each criterion and therefore be included or excluded from public funding. These models fail to understand that choices are not so much between effective and ineffective treatments, or necessary and unnecessary ones. Rather, choices are often between interventions that are somewhat effective and/or needed. Evaluation of such services requires a holistic approach and not a sequence of fail or pass judgments. To improve applicability of criteria that pertain to medical need we therefore suggest further development of these criteria beyond their original binary meaning and propose meaningful ways in which these criteria can be integrated into policy decisions.

Background: In the Sophia Children's Hospital, both a ward stock system and a decentralized, patient-orientated, ready-to-use drug distribution system (a 'satellite pharmacy system') exist. Hospital management considered expanding the concept of the satellite pharmacies. Little was known, however, about the efficiency of this drug distribution system, whereas there is increasing pressure to demonstrate the cost-effectiveness of pharmacy services. Objective: To analyze the efficiency of satellite pharmacies compared with other medication distribution systems. Methods: All medication orders and prepared doses were counted. The workload of the two current distribution systems was calculated using the direct time study method. Furthermore, the consequences of altering the distribution system were calculated by formulating nine variants in which certain activities surrounding the medication distribution were moved between nurses and pharmacy technicians. Moreover, we varied the degree of computerization of the medication order registration. Results: The required working hours are the largest in the variants in which nurses do the preparation of the drugs. Moving the distribution of some drug categories, such as ready-to-use drugs, prepared oral drugs, and prepared inhalation drugs, from pharmacy technicians to nurses appeared not to produce noticeable benefits compared with the current distribution system. Expanding the concept of the satellite pharmacies involves a small rise in total working hours compared with the current situation, but does not raise personnel costs. The largest cost savings can be achieved by introducing an on-line computerized physician order-entry system. Conclusions: The concept of satellite pharmacies offers an efficient distribution system for the Sophia Children's Hospital.

Background/Purpose: The cost-effectiveness of medical interventions is becoming an important issue for decision makers. Until recently, evidence of the cost-effectiveness of neonatal surgery was largely lacking. The authors analyzed the cost-effectiveness of neonatal surgery and subsequent treatment for congenital diaphragmatic hernia (CDH). Methods: Both costs incurred inside and outside the health care sector (eg, out-of-pocket expenses and productivity losses) were included. Quality-adjusted life years (QALYs) were measured using the EuroQol EQ-5D questionnaire. Descriptive quality-of-life data were collected using a disease-specific questionnaire. Both costs and effects basically were measured in a life-time setting. Results: Total costs of treatment average €42,658, mainly consisting of costs of the initial hospitalization. Productivity losses in both the patients and their caregivers appear to be minor. Treated CDH patients, even adults, suffer from respiratory difficulties and stomach aches. According to the EQ-5D, however, their quality of life does not differ from the general population, suggesting that these symptoms barely affect overall quality of life. Treatment results in a gain of 17.5 QALYs. Costs per QALY amount to €2,434. Conclusions: Treatment for CDH has favorable cost-effectiveness. Considering the growing importance of cost-effective medicine, these are important and encouraging results. Health economics outlines the inevitability of making choices that directly affect patient care and places relative values on different health care programs. The results of this study provide convincing evidence that treatment for CDH is indeed cost effective. J Pediatr Surg 37:1245-1252. Copyright 2002, Elsevier Science (USA). All rights reserved.

Central venous catheter-associated bloodstream infections in children are an increasingly recognized serious safety problem worldwide, but are often preventable. Central venous catheter bundles have proved effective to prevent such infections. Successful implementation requires changes in the hospital system as well as in healthcare professionals’ behaviour. The aim of the study is to evaluate process and outcome of implementation of a state-of-the-art central venous catheter insertion and maintenance bundle in a large university children’s hospital. An interrupted time series design will be used; the study will encompass all children who need a central venous catheter. New state-of-the-art central venous catheter bundles will be developed. The Pronovost-model will guide the implementation process. We developed a tailored multifaceted implementation strategy consisting of reminders, feedback, management support, local opinion leaders, and education. Primary outcome measure is the number of catheter-associated infections per 1000 line-days. The process outcome is degree of adherence to use of these central venous catheter bundles is the secondary outcome. A cost-effectiveness analysis is part of the study. Outcomes will be monitored during three periods: baseline, pre-intervention, and post-intervention for over 48 months. This model-based implementation strategy will reveal the challenges of implementing a hospital-wide safety program. This work will add to the body of knowledge in the field of implementation. We postulate that healthcare workers’ willingness to shift from providing habitual care to state-of-the-art care may reflect the need for consistent care improvement. Trial registration: Dutch trials registry, trial # 3635. Dutch trials registry ( http://www.trialregister.nl ), trial # 3635

Summary Osteoporosis has become a major health concern, carrying a substantial burden in terms of health outcomes and costs. We constructed a model to quantify the potential effect of an additional intake of calcium from dairy foods on the risk of osteoporotic fracture, taking a health economics perspective. Introduction This study seeks, first, to estimate the impact of an increased dairy consumption on reducing the burden of osteoporosis in terms of health outcomes and costs, and, second, to contribute to a generic methodology for assessing the health-economic outcomes of food products. Methods We constructed a model that generated the number of hip fractures that potentially can be prevented with dairy foods intakes, and then calculated costs avoided, considering the healthcare costs of hip fractures and the costs of additional dairy foods, as well as the number of disability-adjusted life years (DALYs) lost due to hip fractures associated with low nutritional calcium intake. Separate analyses were done for The Netherlands, France, and Sweden, three countries with different levels of dairy products consumption. Results The number of hip fractures that may potentially be prevented each year with additional dairy products was highest in France (2,023), followed by Sweden (455) and The Netherlands (132). The yearly number of DALYs lost was 6,263 for France, 1,246 for Sweden, and 374 for The Netherlands. The corresponding total costs that might potentially be avoided are about 129 million, 34 million, and 6 million Euros, in these countries, respectively. Conclusions This study quantified the potential nutrition economic impact of increased dairy consumption on osteoporotic fractures, building connections between the fields of nutrition and health economics. Future research should further collect longitudinal population data for documenting the net benefits of increasing dairy consumption on bone health and on the related utilization of healthcare resources.

Objective: To evaluate compliance and costs of referral of nonurgent children, who present at the emergency department, to the general practitioner cooperative (GPC). Materials and methods: In a prospective observational before-after study, during 6 months in 2008, the triage nurse discussed referral to the GPC with parents, when self-referred children with a nontraumatic problem, aged 3 months-16 years were triaged as nonurgent (levels 4 and 5) according to the Manchester Triage System. A telephone follow-up was performed 2-4 days after referral. Real costs were calculated for emergency department consultation (preintervention period) and GPC referral (postintervention period). Compliance of referral was studied for 4 days a week. Results: One hundred and forty patients were referred to the GPC, of which 101 out of 140 patients (72%) attended a follow-up. After discharge seven patients (7%) had an unscheduled revisit. No patients were subsequently hospitalized. In total 275 patients were included to study compliance, with 28 (10%) reported missing. Ninety-five out of 247 (38%) patients were referred to the general practitioner and 46 out of 247 parents (19%) refused referral. For 106 out of 247 patients (43%) referral was not initiated by the nurse mainly because of comorbidity. Mean costs per patient were O 106 for the preintervention period and O 101 for the postintervention period. Conclusion: Compliance of referring low urgent patients is low, mainly because it was difficult for nursing staff to refer. Total overall cost benefit is minimal. Cost savings may be achieved in different settings, where general practitioner services are colocated and where large numbers can be referred.

There is a new merging of health economics and nutrition disciplines to assess the impact of diet on health and disease prevention and to characterise the health and economic aspects of specific changes in nutritional behaviour and nutrition recommendations. A rationale exists for developing the field of nutrition economics which could offer a better understanding of both nutrition, in the context of having a significant influence on health outcomes, and economics, in order to estimate the absolute and relative monetary impact of health measures. For this purpose, an expert meeting assessed questions aimed at clarifying the scope and identifying the key issues that should be taken into consideration in developing nutrition economics as a discipline that could potentially address important questions. We propose a first multidisciplinary outline for understanding the principles and particular characteristics of this emerging field. We summarise here the concepts and the observations of workshop participants and propose a basic setting for nutrition economics and health outcomes research as a novel discipline to support nutrition, health economics and health policy development in an evidence and health-benefit-based manner. © 2010 The Authors.

Background/Purpose To date, there are hardly any data on the treatment costs of infantile short bowel syndrome (SBS), despite growing interest in evidence-based and cost-effective medicine. Therefore, the aim of the study was to evaluate resource consumption and costs, next to studying nutritional and growth outcomes, in children with SBS who were treated by an interdisciplinary short bowel team. Methods Data were collected for 10 children with infantile SBS (≤1 year of age) born between 2002 and 2007. Data included demographic and medical data of the first admission and data on resource consumption, growth, and type of nutrition for the total follow-up period. Real economic costs were calculated in Euro (€) and US dollar ($). Results Seven of the 10 patients were discharged with home parenteral nutrition. Total follow-up varied between 9 months and 5.5 years (median, 1.5 years). Six patients could be weaned off parenteral nutrition and 5 patients off enteral tube feeding, resulting in full oral intake. Seven patients had normal growth. Median duration of initial hospital admission was 174 days, and average costs of initial admission amounted to €166,045 ($218,681). Average total costs were €269,700 ($355,195), reaching to a maximum of €455,400 ($599,762). These costs mainly comprised hospital admissions (82%), followed by nutrition (12%), surgical interventions (5%), and outpatient visits (1%). Conclusions This study is among the first to describe resource consumption and costs in infants with SBS, examining real economic costs and extending beyond the initial hospitalization. Treatment of SBS requires considerable resource consumption, especially when patients depend on parenteral nutrition. Because the costs mainly comprise those of hospital admissions, early home parenteral nutrition could contribute to costs reduction. Interdisciplinary teams have the potential to facilitate early home parenteral nutrition and thus may reduce health care costs.

In many countries of the Western world, the role of health technology assessment (HTA) in funding decisions of medical technologies is increasing. HTAs are expected to support decision-makers in delineating the collectively funded benefits package. To maximize their potential, it is essential that assessments are valid, reliable and timely, and that it is transparent how information provided in assessments is used in decision-making. Against this background, this article aims to review the current state of affairs regarding the use of HTA in the area of medical specialist care in The Netherlands and to evaluate strengths and weaknesses of the HTA-based system for priority setting. The reason to do so was the introduction of a new hospital financing system in The Netherlands, which allowed for expansion of the HTA system that already existed for pharmaceuticals to medical specialist care. A comprehensive account of the HTA system for medical specialist care was created using the so-called Hutton framework, followed by an exploration of its strengths and weaknesses. An important lesson to be learned from the early Dutch experiences with HTA in the area of medical specialist care is that the nature and complexity of health technologies in this area create practical problems regarding the amount and quality of available data needed to make the HTA-based system work. This hampers an unambiguous interpretation of assessment data and thus calls for stronger requirements regarding transparency and stakeholder participation. Future work focusing on the role of HTA in funding decisions is needed to provide insights in best practices for HTA systems in circumstances where a delicate balance needs to be achieved between promoting innovation, supporting effective and timely decision-making and preventing the coverage of technologies that represent a waste of resources.

Aims: To examine short term and long term health related quality of life (HRQoL) of survivors of congenital anorectal malformations (ARM) and congenital diaphragmatic hernia (CDH), and to compare these patients' HRQoL with that of the general population. Methods: HRQoL was measured in 286 ARM patients and 111 CDH patients. All patients were administered a symptom checklist and a generic HRQoL measure. For the youngest children (aged 1-4) the TAIQOL (a preliminary version of the TAPQOL) was used, for the other children (aged 5-15) the TACQOL questionnaire, and for adults (aged >16) the SF-36. Results: As appeared from the symptom checklists, many patients remained symptomatic into adulthood. In the youngest ARM patients (aged 1-4 years), generic HRQoL was severely affected, but the older ARM patients showed better HRQoL. In the CDH patients, the influence of symptoms on HRQoL seemed less profound. The instruments we used revealed little difference between adults treated for ARM or CDH and the general population. Conclusions: These results show that for two neonatal surgical procedures, improved survival does not come at the expense of poor HRQoL in adults. Even though there is considerable suffering in terms of both morbidity and mortality in the youngest group, the ultimate prognosis of survivors of the two studied congenital malformations is favourable. This finding can be used to reassure parents of patients in need of neonatal surgery for one of these conditions about the prospects for their child.

Background/Purpose: The progress made in all fields of medicine, including neonatal surgery, has contributed to the rise in healthcare costs. Although neonatal surgery may provide survival gains, these could be at the expense of worse quality of life caused by impairment after surgery. For example, congenital anorectal malformations (CAM) are complex anomalies, and the surgical techniques available have their limitations in achieving continence. It therefore seems justifiable to consider what the effects of treatment are in relation to the costs. Evidence of the cost-effectiveness of neonatal surgery, however, is lacking. Methods: The authors analyzed both direct and indirect, medical and nonmedical costs in patients who had undergone treatment for CAM. Quality-adjusted life years (QALYs) were measured using the EuroQol EQ-5D questionnaire. Descriptive quality-of-life data were collected using a disease-specific questionnaire and a medical consumption questionnaire. Results: Mean costs of treatment are calculated at Euro €31,593. Treated CAM patients suffer stool difficulties and their medical consumption is relatively high. The EQ-5D, however, shows that the quality of life of CAM patients is only slightly lower than that of the general population (0.88 v 0.93). Treatment results in a gain of 12.7 QALYs. Costs per QALY of treatment for CAM amount to €2,482. Conclusions: Treatment for CAM has a favorable cost-effectiveness ratio compared with other evaluated healthcare programs. Bearing in mind the increasing political interest in evidence-based and cost-effective medicine, the results are encouraging. J Pediatr Surg 36:1471-1478. Copyright © 2001 by W.B. Saunders Company.

Abstract 2110 Poster Board II-87 The management of massive blood loss in children during trauma or major surgery is still an unsolved problem in pediatric surgery and anesthesia. Primary operative repair of craniosynostosis in infants and young children can serve as a model for excessive acute blood loss. The introduction of thromboelastography (TEG) has led to a significant decrease in transfusion of packed red blood cells (pRBC), fresh frozen plasma (FFP) and platelets in adult surgery, thereby diminishing the risks of infections and immunosuppression. Moreover a significant decrease in accompanying costs has been reported. However, no studies have evaluated the effect of TEG-guided treatment on the amount of transfused blood products in children. The primary objective of this pilot study is to obtain reference TEG-values in children during surgical repair of primary craniosynostosis. We performed a single-center pilot study on TEG-monitoring in children during craniofacial surgery. Methods: The study includes 21 children with craniosynostosis undergoing elective craniofacial repair at the Sophia Children's Hospital, Erasmus Medical Center, Rotterdam, The Netherlands. Blood samples (5 ml blood taken from an arterial line) for TEG (Haemoscope®) measurement were obtained after induction of anesthesia (T1), after the application of Ringer's lactated solution (RLS) 10 ml × kg-1 body weight (T2), after the application of hetastarch 130/0.4 6% (Venofundin®, Fresenius Kabi) (T3), after transfusion of pRBC (T4), and eventually after the application of FFP (T5). Results: 21 children, less than 20 months of age, with a mean body weight of 8.5 kg underwent surgical repair of craniosynostosis. They were treated according to the local protocol on massive blood loss in children during surgery. Nine children were suffering from scaphocephalie, 4 from trigonocephalie, 3 from plagiocephalie, one from brachycephalie and 4 children had a mixed or complex form of craniosynostosis such as Crouzon disease. After the induction of anaesthesia (T1) and after the administration of RLS (T2) no changes in clot strength were seen, MA remained mean 62 mm. However, between T2 and T3 all children demonstrated a significant decline in hemoglobine from mean 6.5 to 3.8 mmol/L (p Discussion: The administration of hetastarch 130/0.4 6% at T3 resulted in a dilutional coagulopathy. This is due to blood loss, consumption of coagulation factors and platelets, and intravascular volume replacement. During blood loss fibrinogen synthesis will be limited. Additionally, the decreasing functional fibrinogen levels (MA-FF) point to reduced strength of the clot. Administering cryoprecipitate or concentrates of fibrinogen in an early phase might maintain clot firmness and thereby decrease blood loss and reduce the number of transfused blood products. Conclusion: In an attempt to decrease the amount of transfused blood products TEG will allow tailored interventions during pediatric surgery with specific medications like antifibrinolytic agents, concentrates of fibrinogen, or activated recombinant factor VII. Finally, TEG tailored therapy may decrease blood transfusions and transfusion related complications in children. These data strongly support the evaluation of TEG-guided interventions in children during massive blood loss. Disclosures: No relevant conflicts of interest to declare.