Title: Non-contact infrared thermometers for measuring body temperature in acutely ill children: a method comparison study
Funder: Department of Health and Social Care

Abstract: Design: Method Comparison Study Setting: In-hours and Out-of-Hours General Practice Population: Children aged 0-5 years who attend primary care with an acute illness Health Technologies Being Assessed: Non-contact thermometer for measuring body temperature in acutely ill children. NICE currently recommend an electronic axillary thermometer in children younger than four weeks; for children over the age of four weeks they recommend an electronic axillary thermometer, an infrared tympanic thermometer or a chemical dot disposable thermometer in the axilla (although the latter is not recommended when multiple measurements are needed). However, electronic axillary thermometers require parents or healthcare professionals to undress the child and hold the thermometer in the axilla for 30 seconds or longer. Infrared tympanic thermometers are easier to use, but can be inaccurate due to ear wax or insufficient straightening of the ear canal. Oral and rectal thermometers are no longer recommended for safety and hygienic reasons. More recently, non-contact infrared thermometers (NCIT) have been developed. Early evidence suggests that NCITs may provide a rapid, hygienic, and non-invasive means of measuring body temperature, with high sensitivity and specificity in detecting fever. However, these findings are mostly based on small studies conducted in hospital settings. A recent review recommended that further research is needed to determine the reliability of NCITs in primary care. Measurement of Costs and Outcomes: We aim to assess the agreement between NCITs and conventional thermometers currently recommended by NICE in children presenting to primary care, and explore both parents’ and children’s experiences of the different techniques. We will compare an NCIT (the Thermofocus 0800 which is the device for which there is most evidence) with an electronic axillary thermometer and a tympanic thermometer. In addition, we will compare the Thermofocus, which is a relatively expensive device, a factor which could prevent uptake by general practitioners, with a cheaper alternative, the selection of which will be based on price and availability in the UK at the time of the study. The primary outcome of the study will be agreement between the temperature measured using Thermofocus and the electronic axillary thermometer. Secondary outcomes include agreement between NCIT and infrared tympanic thermometers and between the two NCIT types, the ability of each thermometer to detect fever (38°C or higher), parental and where possible child acceptability of each type, and failure rates of each type. Each NCIT type will also be assessed for reproducibility. Sample Size: Assuming the 95% confidence interval of the limits of agreement should be a maximum of ±0.075°C, a minimum sample size of 533 children will be required to assess our primary outcome. Project timetables: The study will have a total duration of 18 months. Stage 1 (5 months): production of study materials, ethical review, recruitment of study sites; Stage 2 (9 months): recruitment of at least 14 children/week; Stage 3 (4 months): data analysis and reporting. Expertise in team: The team consists of academic GPs with a track record of leading trials recruiting paediatric populations from primary care and a biomedical engineer with expertise in diagnostic studies in unwell children.

Lay abstract: Fever in young children is very common, and doctors measure a child’s temperature to help them decide whether the child can be kept at home or needs to go in to hospital. National guidelines recommend measuring temperature whenever a child is ill using a digital thermometer in the armpit or an infrared thermometer in the ear. However, both of these types of thermometers can be difficult to use in unwell children who are not cooperating with the doctor. A new type of thermometer, the non-contact infrared thermometer, can measure temperature very quickly without touching the child. However, a recent review found that at present there is not enough research evidence to recommend their widespread use. In this study we aim to assess whether non-contact thermometers are as good at measuring temperature as digital armpit or infrared ear thermometers. We will also compare their ability to detect a fever and the number of times they fail to work (either because the child won’t cooperate or the device doesn’t work) with these standard types. We will ask parents and children what they think about the different types of thermometers, and interview some parents in more detail about this. We will see whether non-contact thermometers produce similar results when the measurement is repeated in the same child. Since some non-contact thermometers are much more expensive than others, we will assess two brands: the Thermofocus, which is relatively expensive (£125) but has been used in the majority of research on this topic, and a cheaper brand, which we will choose based on availability in the UK and price when the study is due to start. We will recruit 533 children who have come to see their GP because they have recently become unwell with a problem which was not an injury. Each child will have their temperature measured with 4 different devices. We will aim to do this before their GP appointment, so that the GP can make use of our temperature measurement when they assess the child. The findings of this study could change the practice of GPs who assess unwell children. We think our findings will also be of great interest to parents and providers of childcare to the under 5s. Our patient advisers will help us on deciding how to publicise our findings to these groups. We will publish the findings of this research in highly respected and widely read academic journals and present it at national conferences. To ensure that our results have a rapid impact we will discuss them with clinicians, health care commissioners who could fund new innovations in primary care, relevant industry partners and the groups responsible for developing new national guidance on how to assess children with fever. Professor Van den Bruel has led multiple projects exploring how best to diagnose serious infection in children and the team is experienced in delivering clinical trials and evaluations of diagnostics tests in children and adults in primary care.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: INFECTION