Patient Safety in Pediatrics: a Developing Discipline

__Abstract__ The publication of the breakthrough report “To Err is Human” by the Institute of Medicine was the launch of patient safety initiatives all over the world. In the intensive care unit (ICU) of the Erasmus MC-Sophia Children’s Hospital this resulted in the institution of a multimodal patient safety management system under the name Safety First in 2005. This system now includes nine major elements, representing monitoring and intervention activities. In this thesis we report on the results and the implementation of the patient safety management system called Safety First. __Outline of this thesis:__ In part I the concept of patient safety and the Safety First project are introduced. The rationale for selecting the elements of the patient safety management system is explained. As preventable mortality and morbidity are the public focus as outcome parameters for quality and safety of care, we have studied very long stay patients in our ICU (chapter 2). The goal of this study was to determine characteristics and mortality in these patients as well as modes of death. Chapter 3 presents an evaluation of potentially preventable deaths in our ICU. An important question was whether five years of patient safety efforts had resulted in fewer potentially preventable deaths. Part II reflects on the difficulties in monitoring adverse events. In chapter 4 we present numbers and types of adverse events identified with real time physicians’ registration during a 3-month period in general pediatric practice. The next chapter is a study into adverse events in the surgical pediatric ICU in a 2-year period. We combined the physicians’ registration with the Trigger Tool methodology as developed by the Institute for Healthcare, Boston, USA. The goals were to determine the rate and nature of the adverse events and to compare the two methods. In part III a number of elements of Safety First are described, as well as other studies into patient safety issues relevant to bedside ICU care. Chapter 6 brings the results of critical incident analysis with a focus on the factors contributing to the incident and the resultant recommendations. The next study evaluated the availability and reliability of drug formularies used in our ICU, which are crucial in safe drug prescription. In chapter 8 we discuss the safety of routine MRI scans in preterm infants at 30 weeks gestational age, as reflected by safety incidents and adverse events. In the next chapter, safety focused Mortality and Morbidity conference reports were scrutinized for numbers and types of recommendations stemming from these meetings. Chapter 10 is a study about nursing protocol violations established with the Critical Nursing Situation Index. Part IV describes a study of safety culture in the ICU, as it emerged from a safety attitude questionnaire administered to all staff. We aimed to compare findings to benchmark data and explore any deficiencies. In the general discussion in part V the results of the studies are commented on and future directions are given, including guidelines for optimal implementation of a patient safety management system and future benchmarking

Clinical Requirements of Future Patient Monitoring in the Intensive Care Unit: Qualitative Study

BACKGROUND: In the intensive care unit (ICU), continuous patient monitoring is essential to detect critical changes in patients' health statuses and to guide therapy. The implementation of digital health technologies for patient monitoring may further improve patient safety. However, most monitoring devices today are still based on technologies from the 1970s. OBJECTIVE: The aim of this study was to evaluate statements by ICU staff on the current patient monitoring systems and their expectations for future technological developments in order to investigate clinical requirements and barriers to the implementation of future patient monitoring. METHODS: This prospective study was conducted at three intensive care units of a German university hospital. Guideline-based interviews with ICU staff-5 physicians, 6 nurses, and 4 respiratory therapists-were recorded, transcribed, and analyzed using the grounded theory approach. RESULTS: Evaluating the current monitoring system, ICU staff put high emphasis on usability factors such as intuitiveness and visualization. Trend analysis was rarely used; inadequate alarm management as well as the entanglement of monitoring cables were rated as potential patient safety issues. For a future system, the importance of high usability was again emphasized; wireless, noninvasive, and interoperable monitoring sensors were desired; mobile phones for remote patient monitoring and alarm management optimization were needed; and clinical decision support systems based on artificial intelligence were considered useful. Among perceived barriers to implementation of novel technology were lack of trust, fear of losing clinical skills, fear of increasing workload, and lack of awareness of available digital technologies. CONCLUSIONS: This qualitative study on patient monitoring involves core statements from ICU staff. To promote a rapid and sustainable implementation of digital health solutions in the ICU, all health care stakeholders must focus more on user-derived findings. Results on alarm management or mobile devices may be used to prepare ICU staff to use novel technology, to reduce alarm fatigue, to improve medical device usability, and to advance interoperability standards in intensive care medicine. For digital transformation in health care, increasing the trust and awareness of ICU staff in digital health technology may be an essential prerequisite

The effect of duration of antimicrobial treatment for bacteremia in critically ill patients on in-hospital mortality - Retrospective double center analysis.

PURPOSE Excessive duration of antibiotic treatment is a major factor for inappropriate antibiotic consumption. Although in some instances shorter antibiotic courses are as efficient as longer ones, no specific recommendations as to the duration of antimicrobial treatment for bloodstream infections currently exist. In the present study, we investigated the effect of antibiotic treatment duration on in-hospital mortality using retrospective data from two cohorts that included patients with bacteremia at two Swiss tertiary Intensive Care Units (ICUs). MATERIALS AND METHODS Overall 8227 consecutive patients requiring ICU admission were screened for bacteremia between 01/2012-12/2013 in Lausanne and between 07/2016-05/2017 in Bern. Patients with an infection known to require prolonged treatment or having single positive blood culture with common contaminant pathogens were excluded. The primary outcome of interest was the time from start of antimicrobial treatment to in-hospital death or hospital discharge, whichever comes first. The predictor of interest was adequate antimicrobial treatment duration, further divided into shorter (≤10 days) and longer (>10 days) durations. A time-dependent Cox model and a cloning approach were used to address immortality bias. The secondary outcomes were the median duration of antimicrobial treatment for patients with bacteremia overall and stratified by underlying infectious syndrome and pathogens in the case of secondary bacteremia. RESULTS Out of the 707 patients with positive blood cultures, 382 were included into the primary analysis. Median duration of antibiotic therapy was 14 days (IQR, 7-20). Most bacteremia (84%) were monomicrobial; 18% of all episodes were primary bacteremia. Respiratory (28%), intra-abdominal (23%) and catheter infections (17%) were the most common sources of secondary bacteremia. Using methods to mitigate the risk of confounding associated with antibiotic treatment durations, shorter versus longer treatment groups showed no differences in in-hospital survival (time-dependent Cox-model: HR 1.5, 95% CI (0.8, 2.7), p = 0.20; Cloning approach: HR 1.0, 95% CI (0.7,1.5) p = 0.83). Sensitivity analyses showed that the interpretation did not change when using a 7 days cut-off. CONCLUSIONS In this restrospective study, we found no evidence for a survival benefit of longer (>10 days) versus shorter treatment course in ICU patients with bacteremia. TRIAL REGISTRATION The study was retrospectively registered on clinicatrials.gov (NCT05236283), 11 February 2022. The respective cantonal ethics commission (KEK Bern # 2021-02302) has approved the study

Evaluating ICT Applications in Health Care

This thesis is about evaluation of ICT applications in health care. How can information systems for patients and health care professionals best be evaluated? How to take into account that one - in practice - is often confronted with limited resources? The author describes the difficulties in designing information systems that are supposed to replace and add surplus value to existing forms of information exchange. For information systems to become and remain successful, one needs to have a thorough understanding of the needs of the users and the practical, social and political context in which these systems are used