G-CSF and IL-8 for early diagnosis of sepsis in neonates and critically ill children - safety and cost effectiveness of a new laboratory prediction model: study protocol of a randomized controlled trial [ISRCTN91123847].

INTRODUCTION: Bacterial infection represents a serious risk in neonates and critically ill paediatric patients. Current clinical practice is characterized by frequent antibiotic treatment despite low incidence of true infection. However, some patients escape early diagnosis and progress to septic shock. Many new markers, including cytokines, have been suggested to improve decision making, but the clinical efficacy of these techniques remains uncertain. Therefore, we will test the clinical efficacy of a previously validated diagnostic strategy to reduce antibiotic usage and nosocomial infection related morbidity. METHODS: All patients admitted to the multidisciplinary neonatal and paediatric intensive care unit of a university children's hospital will be included. Patients will be allocated either to routine sepsis work up or to the intervention strategy with additional cytokine measurements. Physicians will be requested to estimate the pre-test probability of sepsis and pneumonia at initial suspicion. In the treatment arm, physicians will receive raw cytokine results, the likelihood ratio and the updated post-test probability. A high post-test probability will suggest that immediate initiation of antibiotic treatment is appropriate, whereas a low post-test probability will be supportive of watchful waiting or discontinuing prophylactic empirical therapy. Physicians may overrule the suggestions resulting from the post-test probability. CONCLUSION: This trial will ascertain the clinical efficacy of introducing new diagnostic strategies consisting of pre-test probability estimate, novel laboratory markers, and computer-generated post-test probability in infectious disease work up in critically ill newborns and children.

Does critical incident reporting contribute to medication error prevention?

UNLABELLED: Medication-related critical incidents (CIs) comprise harmful and potentially harmful events. The aim of CI monitoring is quality improvement through system changes. In a prospective survey, we analysed our drug-related CIs of the year 2001 with an emphasis on how they contributed to system changes. A voluntary, anonymous, non-punitive CI reporting was used. The study was performed in a multidisciplinary, 23-bed, neonatal-paediatric intensive care unit (ICU). CI severity was graded: minor (no interventions required), moderate (requiring routine therapy, available outside the ICU), major (need for therapeutic interventions specific to the ICU). There were 284 drug-related CIs, 76% (95% confidence interval 71%-81%) of minor, 19% of moderate and 5% of major severity. A total of 24 CIs were potentially life threatening (if not detected). Some 27% of CIs were intercepted, 17% before preparation and 10% before administration of the drug to the patient. There was a negative correlation between median delay (from CI to detection) and mean severity of the different drug classes involved (P = 0.027). As to the impact on quality, 46 CIs were followed by system changes and 63% (95% confidence interval 49%-77%) of these CIs were of minor severity. Examples of system changes are: double checking for potentially harmful drugs, standardised prescription form and contact to the national drug control agency regarding misleading drug labels. CONCLUSION: most of the system changes were based on minor critical incidents which were often detected only after a longer period of time. This shows the value of our "low-threshold" critical incident monitoring. Repeated checks along the drug delivery process (prescription, preparation, administration) are an important means to reduce adverse drug events.