Procalcitonin-guided antibiotic therapy in patients with fever in a general emergency department population: a multicentre non-inferiority randomized clinical trial (HiTEMP study).

OBJECTIVES: 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. METHODS: 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 PCT <0.5 µg/L, and starting antibiotic regimens at PCT ≥0.5 µg/L. Exclusion criteria were immunocompromised conditions, pregnancy, moribund patients, patients <72 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%. RESULTS: 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). CONCLUSIONS: 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.

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 be taken into account in the debate on timing of inguinal hernia repair in premature infants.

Short term and long term health related quality of life after congenital anorectal malformations and congenital diaphragmatic hernia.

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.

The cost-effectiveness of neonatal surgery and subsequent treatment for congenital anorectal malformations.

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 Euro 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.