Cost Effectiveness of Neonatal Surgery: a matter of balance

This thesis addresses the cost-effectiveness of neonatal surgery. Beginning after the Second World War, neonatal surgery has been making enormous progress. Mortality rates for the majority of anomalies belonging to the field fell from almost 100% to less than 10%. Contemporaneously with these medical advancements came new and pressing dilemmas. First, survival is of course an important measure of success, but improved survival might come at the price of poor health-related quality of life (HRQoL) in later life. Second, the economic consequences of health care have become larger, in an era where budgetary restrictions are becoming tighter. As in other branches of medicine, medical advancements contributed to increasing costs in neonatal surgery as well. It is against this background of concerns about the HRQoL of the surviving infant and the increasing costs associated with neonatal surgery that the need for information about the cost and effects of neonatal surgery was recognized. This thesis directly emerges from these concerns, as explained in Chapter 1. This chapter, which introduces and motivates this thesis, also explains why costs should be considered in health care, and clarifies that we will not be able to offer certain medical practices that are known to have favorable effects, but whose effects are too small to justify the cost. It highlights the relevance of costeffectiveness analyses of health care, which aim at establishing whether the effects of a given treatment are worth the budget needed, compared to an alternative treatment. For the case of neonatal surgery, results from costeffectiveness analyses would make it possible to counteract critiques leveled against the discipline. Neonatal surgery has been criticized with arguments of cost-effectiveness: the high costs of an operation have been feared to come with low HRQoL after survival. Clearly, the current lack of evidence on the costeffectiveness of neonatal surgery is a main problem worth tackling. It threatens to give the discipline a weaker position in health care allocation deci

Nutrition and health technology assessment

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 cos

Herziening van de geneesmiddelendistributie in het Sophia Kinderziekenhuis (Academisch Ziekenhuis Rotterdam)

Doelstelling: In het Sophia Kinderziekenhuis is onderzoek verricht ter optimalisering van het geneesmiddelendistributiesysteem. De geneesmiddelendistributie verloopt momenteel op sommige afdelingen via verpleegkundigen en op andere via apothekersassistenten in depotheken. Methoden: De beoordeling van beide distributiesystemen vond plaats aan de hand van de kwaliteitsindicatoren klantgerichtheid, effectiviteit en doelmatigheid. De klantgerichtheid is in kaart gebracht met behulp van interviews. Het vóórkomen van distributiefouten en microbiologische contaminatie zijn beschouwd als effectiviteitsmaten. De doelmatigheid is bepaald met een rekenmodel waarbij het geneesmiddelengebruik is gemeten en tijdmetingen en kostenberekeningen zijn uitgevoerd. Met behulp van het rekenmodel is een aantal alternatieve distributievormen doorgerekend. Resultaten: De geneesmiddeldistributie via depotheken is de meest optimale distributievorm binnen het kinderziekenhuis. De geneesmiddelenbereiding door apothekersassistenten komt tegemoet aan de toenemende complexiteit van medicatiebehoeften in een academisch kinderziekenhuis. Bij het bereiden treedt minder contaminatie op. Bovendien blijkt de depotheek het doelmatigste distributiesysteem te zijn. De nadelen van het systeem van depotheken in de huidige vorm betreffen voornamelijk de inefficiëntie van het registratiesysteem. Daarnaast vindt te weinig sturing plaats op integratie met het primaire proces. Discussie: Automatisering zal de inefficiëntie van het administratieve deel binnen het distributietraject via depotheken grotendeels wegnemen. Daarnaast wordt het management geadviseerd om aandacht te besteden aan meer afstemming met het primaire proces. Op langere termijn verdient uitbreiding van het depotheeksysteem de voorkeur, waarbij rekening zal moeten worden gehouden met zekere randvoorwaarden (bijvoorbeeld omtrent ruimten en ARBO-eisen). Het rekenmodel is onder bepaalde voorwaarden geschikt om ook buiten het Sophia te worden toegepast

The hospital costs associated with acute paediatric burn injuries

__Background__ Ongoing rationing of healthcare threatens services that are well established, and cripples others that desperately require investment. Burn, for one, remains a neglected epidemic in South Africa (SA), despite the magnitude of the problem. __Objective__ To identify the prominent components contributing to the cost of hospital admission with paediatric burn injury. Determining the true costs of specialist services is important, so that resources can be allocated appropriately to achieve the greatest possible impact. __Methods__ A retrospective study was undertaken over 1 year to determine patient demographics and injury details of 987 patients admitted with burn injuries to Red Cross War Memorial Children’s Hospital, Cape Town, SA. The in-hospital financial records of 80 randomly selected patients were examined. This was followed by a prospective study to determine the financial implications of four cost drivers, i.e. bed cost per day, costs of medications received, costs of dressings for wound care, and costs of surgical intervention. A random selection of 37 dressing changes (in 31 p

Dairy foods and osteoporosis: an example of assessing the health-economic impact of food products

__Abstract__ 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

Music to prevent deliriUm during neuroSurgerY (MUSYC) Clinical trial:A study protocol for a randomised controlled trial

INTRODUCTION: Delirium is a neurocognitive disorder characterised by an acute and temporary decline of mental status affecting attention, awareness, cognition, language and visuospatial ability. The underlying pathophysiology is driven by neuroinflammation and cellular oxidative stress. Delirium is a serious complication following neurosurgical procedures with a reported incidence varying between 4% and 44% and has been associated with increased length of hospital stay, increased amount of reoperations, increased costs and mortality. Perioperative music has been reported to reduce preoperative anxiety, postoperative pain and opioid usage, and attenuates stress response caused by surgery. We hypothesize that this beneficial effect of music on a combination of delirium eliciting factors might reduce delirium incidence following neurosurgery and subsequently improve clinical outcomes. METHODS: This protocol concerns a single-centred prospective randomised controlled trial with 6 months follow-up. All adult patients undergoing a craniotomy at the Erasmus Medical Center in Rotterdam are eligible. The music group will receive recorded music through an overear headphone before, during and after surgery until postoperative day 3. Patients can choose from music playlists, offered based on music importance questionnaires administered at baseline. The control group will receive standard of clinical care Delirium is assessed by the Delirium Observation Scale and confirmed by a delirium-expert psychiatrist according to the DSM-5 criteria. Risk factors correlated with the onset of delirium, such as cognitive function at baseline, preoperative anxiety, perioperative medication use, depth of anaesthesia and postoperative pain, and delirium-related health outcomes such as length of stay, daily function, quality of life (ie, EQ-5D, EORTC questionnaires), costs and cost-effectiveness are collected. ETHICS AND DISSEMINATION: This study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Center Rotterdam, The Netherlands, approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations. TRIAL REGISTRATION NUMBERS: NL8503 and NCT04649450

Implementation of a children's hospital-wide central venous catheter insertion and maintenance bundle

Background: 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 healthc

Emergency repair of inguinal hernia in the premature infant is associated with high direct medical costs

_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 b

Higher diagnostic accuracy and cost-effectiveness using procalcitonin in the treatment of emergency medicine patients with fever (The HiTEMP study)

__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. a) 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. b) 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 %. c) 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

Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia

INTRODUCTION: Anastomotic 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 ANALYSIS: This 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 <28 days' interval, which will be analysed with a linear-by-linear χ2 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 le