Big(ger) Data and Patient Safety in Paediatric Anaesthesia
Dr Barry Lyons
CAI Director of Patient Safety
Dept. of Anaesthesia and Critical Care Medicine, Children’s Health Ireland
While the use of large data sets in medicine to look at outcomes is not a new phenomenon in medicine, their use in respect of patient safety in paediatric anaesthesia is something of a more recent focus.1 In response to concerns about the neurodevelopmental impact of anaesthesia on the neonatal and infant brain, a large-scale database analysis of a Swedish nationwide cohort study comprising > 2 million children reported only a minimal effect of surgery in the first 4 years of life on subsequent academic performance. Social determinants, such as age at school entry, gender, and maternal education were reported to have a far greater influence.2 This finding was confirmed by some further large cohort studies, but questions were raised by others, including the risk of ADHD in children exposed to multiple surgeries at a young age.3 What it is probably reasonable to say at this point is that the cumulative evidence indicates that a single exposure to general anaesthesia in a child under the age of 3 years has very limited, if any, detrimental impact on cognitive outcomes.4 Of course what is of concern in these studies is the lifelong consequences of any early surgical/anaesthetic intervention. Globally, paediatric anaesthesia is a growing part of clinical practice, yet parents (and the paediatric patient) and anaesthesiologists often express unease about children undergoing anaesthesia because of perceptions of the risk of acute morbidity and mortality. Two large prospective observational pan-European studies have recently sought to quantify this risk.
The most recent of these (NECTARINE) recruited neonates and infants up to 60 weeks’ postmenstrual age undergoing anaesthesia for surgical or diagnostic procedures from 165 centres in 31 European countries. 5 Critical event(s), mainly hypotension and/or hypoxia, requiring intervention occurred in 35.2% of cases. The triad of anaemia, hypotension and hypoxia was significantly associated with a poor outcome at 90 days (morbidity RR 3.56; mortality RR 19.8). A secondary analysis of the data indicated that intubating neonates is not always straightforward. Difficult tracheal intubation, defined as two failed attempts of direct laryngoscopy, occurred in 5.8% of procedures and with a significant decrease in oxygen saturation reported in 40% of these. 6
Perhaps of more relevance to anaesthesiologists who do not specialise in paediatrics, APRICOT (Anaesthesia Practice In Children Observational Trial) prospectively gathered data on the incidence (and outcomes) of severe critical events in children from birth to 15 years of age undergoing elective or urgent anaesthesia for diagnostic or surgical procedures.7 There were 261 participating centres across 33 European countries, and data on 31,127 anaesthetics was recorded. The incidence of perioperative severe critical events was 5·2% (including respiratory=3.9%; cardiovascular instability 1·9%). The all-cause 30-day in-hospital mortality rate was 10 in 10 000. None of the reported deaths were anaesthesia-related. Of note,
What was notable in both the APRICOT and NECTARINE trials was the wide variability of practice in terms of triggers for response to events, and the response itself. The authors of APRICOT observed: “A considerable variation in the incidence and management of severe peri-operative critical events between European countries was reported and has raised concerns regarding current paediatric anaesthesia training, the experience of the teams managing sick children, workload, resources and infrastructure.” APRICOT also found that senior anaesthetists had 1% fewer critical respiratory events per year of experience, and that those centres with a higher caseload had a lower rate of serious critical events. This idea of an inverse relationship between experience and caseload on the one hand, and outcome on the other is postulated for many specialties, but interestingly when the UK patient cohort was independently assessed (the UK contributed 25% of the patients to APRICOT recruited from 41 centres) this inverse effect was not observed. The rates of critical events were also significantly lower in the UK cohort when compared with the rest of the pool. 8 APRICOT has invited a revisit to the discussion of the adequacy of training in paediatric anaesthesia in different jurisdictions, and the perennial debate on where and by whom children should be anaesthetised. In response, UK commentators, and some from Japan (obviously external to APRICOT but on review identifying the inadequacy of their paediatric anaesthesia training (25 cases < 6years old)), have pointed to the efficacy of simulation based educational courses for maintaining and enhancing relevant skills.8,9 One in particular, “Managing Emergencies in Paediatric Anaesthesia” (MEPA, www.mepa.org.uk) has been validated and the curriculum covers many of the severe critical event scenarios described in APRICOT. One MEPA course has been run in the College, with a proposal to run more in response to demand, particularly for consultants who are not specialist paediatric anaesthesiologists but encounter children in their practice and who wish to update their skills. Unlike high resource jurisdictions, the paediatric surgical load in low- and middle-income countries (LMIC) is growing substantially; in many cases more than 50% of the population are children with a high need for surgery. However, surgical capacity in parts of the world such as Sub-Saharan Africa is well below what is required, resulting in much preventable morbidity and mortality. Children are often the most marginalized group in already marginalized societies, and their medical needs often neglected. For those that do get to an operating theatre, undergoing surgery and anaesthesia carries significant risk. In keeping with similar studies, recent data from 24 Kenyan hospitals acquired over a 3 year period found cumulative mortality rates of 0.8% at 24 h, 1.1% at 48 h, and 1.7% at 7 days postoperatively. 10 This is more than 100 times higher than occurs in high-resource settings. Factors particularly associated with poor outcomes were
Newton et al set out the general issues that arise in LMIC affecting safety:
stating that “each degrade the safety of the paediatric surgery ecosystem while making access extremely difficult, or not affordable”.10 There are efforts to improve the standards of paediatric anaesthesia in LMIC. 11 In addition to a variety of charitable endeavours, the World Federation of Societies of Anesthesiologists has instigated a number of initiatives including:
In addition, the Safe Anaesthesia From Education (SAFE) program has developed an effective short 3-day paediatric anaesthesia course for both physician and nonphysician anaesthesia providers. 13 Notwithstanding all of these valuable programmes, the gap between high and low resource countries in terms of children’s essential and safe access to surgery and anaesthesia remains appallingly wide. We can and must do better.
References
1. Graaff JC, Engelhardt T. How big data shape paediatric anaesthesia. British Journal of Anaesthesia 2017;119 (3): 448–51. doi:10.1093/bja/aex158 2. Glatz P, Sandin RH, Pedersen NL, Bonamy AK, Eriksson LI, Granath F. Association of anesthesia and surgery during childhood with long-term academic performance. JAMA Pediatr 2017; 171: e163470 3. Hu D, et al. Association between Exposure of Young Children to Procedures Requiring General Anesthesia and Learning and Behavioral Outcomes in a Population-based Birth Cohort. Anesthesiology. 2017;127(2):227-240. doi: 10.1097/ALN.0000000000001735. 4. Warner D et al. Association Between Behavioral and Learning Outcomes and Single Exposures to Procedures Requiring General Anesthesia Before Age 3: Secondary Analysis of Data From Olmsted County, MN, Anesthesia & Analgesia 2021:133(1):160-167. doi: 10.1213/ANE.0000000000005180. 5. Disma N et al. Morbidity and mortality after anaesthesia in early life: results of the European prospective multicentre observational study, neonate and children audit of anaesthesia practice in Europe (NECTARINE). British Journal of Anaesthesia 2021;126 (6): 1157-1172. doi:10.1016/j.bja.2021.02.016 6. Disma N et al. Difficult tracheal intubation in neonates and infants. NEonate andChildren audiT of Anaesthesia pRactice IN Europe (NECTARINE): a prospective European multicentre observational study. British Journal of Anaesthesia 2021;126 (6): 1173-1181. doi:10.1016/j.bja.2021.02.021. 7. Habre W, Disma N, Virag K, et al. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017;5(5):412-425. 8. Engelhardt T et al. Incidence of severe critical events in paediatric anaesthesia in the United Kingdom: secondary analysis of the Anaesthesia Practice In Children Observational Trial (APRICOT). Anaesthesia 2019;74(3):300-311. doi: 10.1111/anae.14520. 9. Obara S, Kuratani N. Training in pediatric anesthesia in Japan: how should we come along? J Anesth 2021;35:471–474. https://doi.org/10.1007/s00540-020-02859-8 10. Newton MW et al. Pediatric Perioperative Mortality in Kenya. A Prospective Cohort Study from 24 Hospitals. Anesthesiology 2020; 132:452–60 11. Cooper MG. Global Safe Pediatric Anesthesia Care. Anesthesiology 2020;132:413–5. DOI:10.1097/ALN.0000000000003028. 12. Gelb AW et al. International Standards for a Safe Practice of Anesthesia Workgroup: World Health Organization-World Federation of Societies of Anaesthesiologists (WHO- WFSA) International Standards for a Safe Practice of Anesthesia. Can J Anaesth 2018; 65:698–708. 13. Boyd N et al. The Safer Anaesthesia from Education (SAFE)® paediatric anaesthesia course: Educational impact in five countries in East and Central Africa. Anaesthesia 2019;74:1290–7.