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Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paediatric clinical settings: Results of a multicentre observational study
YJPDN-02113; No of Pages 5 Journal of Pediatric Nursing xxx (xxxx) xxx
Contents lists available at ScienceDirect
Journal of Pediatric Nursing journal homepage: www.pediatricnursing.org
Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paediatric clinical settings: Results of a multicentre observational study Angelo Dante a, Ilaria Franconi b, Anna Rita Marucci c, Celeste M. Alfes d,a, Loreto Lancia a,⁎ a
University of L'Aquila, Department of Health, Life and Environmental Sciences, Edificio Rita Levi Montalcini - Via G. Petrini, 67010 L'Aquila, Italy AOU Ospedali Riuniti Ancona, Obstetrics, Gynaecology, and Paediatric Operating Room, Salesi Children's Hospital, via Conca 71, 60030 Ancona, Italy c AO San Camillo Forlanini Hospital, Emergency Department, Unit Care and Paediatric Emergency, Ring Road Gianicolense, 87-00152 Rome, Italy d Case Western Reserve University, Frances Payne Bolton School of Nursing, 1905 Euclid Avenue, Cleveland 44106 – 4904, OH, USA b
a r t i c l e
i n f o
Article history: Received 24 September 2019 Revised 25 November 2019 Accepted 26 November 2019 Available online xxxx Keywords: Body temperature Forehead thermometer Tympanic thermometer Axillary thermometer Children Bland-Altman
a b s t r a c t Purpose: This study was conducted to investigate the interchangeability of infrared forehead, digital axillary, and infrared tympanic thermometers while identifying the most reliable non-invasive body temperature measurement method in paediatric settings. Design and methods: A multicentre observational study was conducted enrolling all children less than or equal to 14 years of age requiring a temperature measurement and after obtaining their parent's informed consent. Sociodemographic characteristics and temperature values in Celsius (°C) were simultaneously collected using forehead, axillary, and tympanic thermometers. Results: A total of 433 children were enrolled, 57.5% were male and the mean age was 5.3 ± 3.9 years. The average value of tympanic temperature (37.05 °C) was higher than forehead (36.87 °C) and axillary (36.8 °C). The mean difference between axillary and forehead temperatures (−0.06 °C) was not statistically significant (p = 0.158). Comparing the measurements of each type of thermometer with the overall average of the three measurements recorded as the virtual gold standard, Bland Altman analysis highlighted tympanic with narrower 95% limits of agreement (+0.96 °C to −0.68 °C). The tympanic thermometer also had the highest percentage (81.6%) of differences falling within the maximum clinically acceptable difference (±0.5 °C). Conclusions: Differences between paired measurements of the three investigated devices demonstrated the devices are not interchangeable. Measurements using the tympanic thermometer more closely resembled the reference temperature indicating its preferential use in paediatric clinical practice. Practice implications: To safely and consistently measure body temperature, nurses should not assume peripheral thermometers are interchangeable. It is essential to clinically validate all temperature values with clinical observations. © 2019 Published by Elsevier Inc.
Introduction Body temperature (BT) measurement is an important aspect of paediatric health care since BT values contribute to orient diagnoses and therapies in children (Chiappini et al., 2017; Green et al., 2013; NICE, 2017; Nursing, 2017). Unreliable measurements of patient's BTs may lead to misdiagnosis, omittance or delay of necessary treatments, and the prescribing of unnecessary therapies or exams (NICE, 2017; RCN, 2017). BT measurement devices should be accurate, non-invasive, time-efficient, inexpensive, safe, and technique-independent (ElRadhi, 2014). Historically, the mercury thermometer has been recognised as the standard tool for non-invasive BT measurements; ⁎ Corresponding author. E-mail address: [email protected] (L. Lancia).
however, such device is increasingly banned worldwide as part of a global treaty aimed to protect the human health and environment from the adverse effects of mercury (UNEP, 2017). Consequently, for the non-invasive BT measurement in children, current guidelines recommend the use of devices alternative to mercury, such as digital and infrared thermometers. Among them, digital axillary and infrared tympanic thermometers are considered as the best choices in children, since these devices seem to satisfy the above-mentioned characteristics and do not generate risk of infections and injuries (Chiappini et al., 2017; Green et al., 2013; NICE, 2017; RCN, 2017). Despite the recommendations provided by guidelines for clinical practice, nurses continue to utilize a wide variety of BT measurement devices with the paediatric population. For example, the infrared forehead thermometer is increasingly being used since it meets the clinical requirements for a non-invasive, rapid,
https://doi.org/10.1016/j.pedn.2019.11.014 0882-5963/© 2019 Published by Elsevier Inc.
Please cite this article as: A. Dante, I. Franconi, A.R. Marucci, et al., Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014
2
A. Dante et al. / Journal of Pediatric Nursing xxx (xxxx) xxx
easy BT measurement and has been well received by nurses, families, and children (Hurwitz, Brown, & Altmiller, 2015). However, little evidence is available regarding the reliable interchangeability of forehead thermometers with digital axillary and infrared tympanic devices in the paediatric setting. Further, most research has been conducted in the paediatric critical care area and results are contradictory. In particular, some authors considered the forehead thermometer as a good alternative to the axillary device due to a small mean difference in BT measurements (Chiappini et al., 2011) or to their safety and quick use (Isler, Aydin, Tutar Guven, & Gunay, 2014). Conversely, other authors (Franconi, La Cerra, Marucci, Petrucci, & Lancia, 2018; Robertson-Smith, McCaffrey, Sayers, Williams, & Taylor, 2015; Sethi, Patel, Nimbalkar, Phatak, & Nimbalkar, 2013) did not consider the forehead thermometer as accurate as the axillary one reporting broad values in 95% limits of agreement (−1.18 °C to +1.99 °C, −0.87 °C to +1.16 °C, and −2.3 °C to +1.2 °C, respectively). Furthermore, Franconi et al. (2018) highlighted different magnitude of bias based on different BT values. Considering the importance of BT values in clinical decision-making, it is pivotal to investigate the interchangeability of the devices as an alternative to mercury thermometers historically used with hospitalized children. Therefore, in order to contribute to the efforts of the scientific community, this study aimed to investigate the interchangeability of infrared forehead, digital axillary, and infrared tympanic thermometers while identifying the most reliable non-invasive BT measurement method in Italian paediatric settings. The hypothesis of this study was that axillary, tympanic, and forehead thermometers, commonly used in paediatric clinical practice, were interchangeable in the routine care of hospitalized children up to 14 years of age.
Materials and methods Study design, setting, and participants A multicentre observational study was conducted during 2018 in the Paediatric Units of five Italian hospitals. All children 14 years of age and younger needing a BT measurement were consecutively enrolled after their parents provided informed consent. Children in critical condition or not able to tolerate multiple BT measurements were excluded. G* Power 3.1.9.2 software was used to estimate the sample size (n = 128) needed to detect a minimum BT difference of ±0.5 °C with an 80% power (1-β) and a 5% α error.
Variables, instruments, and data collection Data regarding age, gender, time of detection, and BT values in Celsius (°C) using forehead (FHD), axillary (AXL), and tympanic (TYM) sites were collected. The FHD BT was measured using the infrared Chicco® Easy Touch thermometer which provided BT measurements in b30 s (mean = 5–8 s) by scanning the infrared radiation from the temporal artery. The AXL BT was measured using the digital Chicco® Digi Baby thermometer which provided BT measurements in about 1 min by heat conduction. The infrared Chicco® Comfort Quick device was used to detect TYM body temperature values. To reach accurate measurements, on the basis of current guidelines, the ear was gently pulled backward in children up to two years, whereas in all others was pulled upward and backward. All the measurements were performed simultaneously on clean and dry skin, waiting at least 30 min after meals or baths, and making sure that the ear had not been in contact with pillow before the TYM measurement. To ensure accurate measurements, thermometers were calibrated according to the manufacturer standards. Data were collected by trained nurses and reported in a BT flowsheet.
Data analysis Categorical data were summarized through frequencies and percentages, whereas central tendency indexes (means and medians) with dispersion measures, i.e. standard deviation (±SD), interquartile range (IQR), and min-max were used in case of continuous variables. The simultaneous measurements collected through the three devices were examined by means of a two-step analysis. The first consisted of a comparative analysis of the three mean values by using a paired sample t-test. In the second step, Bland Altman scatterplots were used to visually compare first the mean differences between the paired measurements and then, in aggregate by comparing the measurements of each instrument with the overall average of the three measurements recorded as the virtual gold standard (VGS) BT value (AXL + FHD + TYM/3). Therefore, VGS, according to Bland and Altman (1999) recommendations, represented the best available estimate of patient BT since the true BT value was not known. For each pair of measurements, the scatterplot illustrates their difference and their mean on the vertical and horizontal axes, respectively (Bland & Altman, 1986; Martin Bland & Altman, 1999; Giavarina, 2015). Furthermore, it shows three superimposed horizontal lines: one marks the average difference among all the paired measurements, whereas the other two highlight the upper and lower 95% Limits of Agreement (LoA). A pre-established maximum LoA of ±0.5 °C was considered as clinically acceptable (19). Data were analyzed using IBM SPSS version 19.0 (IBM Corp., Armonk, New York, USA).
Ethics The study was approved by the Internal Review Board of the University of L'Aquila (No. 18/2017–10/10/2017). According to national laws (Public Law No. 196, 2003), the confidentiality of the data concerning participants has been guaranteed. Before the data collection, the aim of the study was explained to parents from whom the written informed consent was obtained. Despite the parental consent, all children had the opportunity to refuse the multiple BT measurements. No child was forced to participate in case of verbal or non-verbal refusal.
Results Participants A total of 433 children were enrolled, 57.5% were male and the mean age was 5.3 ± 3.9 years, median = 5.0, IQR = 7.0, min-max = 0–14 (Table 1). No significant differences emerged when comparing the gender distribution among the five centres; conversely, a heterogeneity in the mean age was detected (p b 0.001).
Table 1 Characteristics of participants (n = 433). Centre
Participants
Gender
Age
Female
A B C D E Overall p
Male
N
n
%
n
%
205 47 42 89 50 433
90 20 19 43 12 184 0.074⁎
43.9 42.6 45.2 48.3 24.0 42.5
115 27 23 46 38 249
56.1 57.4 54.8 51.7 76.0 57.5
Mean
SD
5.1 3.7 7.5 5.7 5.7 5.3 b0.001⁎⁎
3.7 3.8 3.8 4.3 4.1 3.9
⁎ χ2 test. ⁎⁎ ANOVA test.
Please cite this article as: A. Dante, I. Franconi, A.R. Marucci, et al., Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014
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Fig. 1. Paired comparisons among BT values (°C) detected with the three devices (N = 495).
values were included in the above-mentioned LoA, followed by FHD (74.5%) and AXL (73.5%) (Fig. 4).
Comparisons among thermometers The first step of analysis highlighted the TYM BT mean value (37.05 °C) was higher than FHD and AXL BT mean values (36.87 °C and 36.81 °C, respectively) (Fig. 1) and showed only a mean value difference between the AXL and FHD (−0.06 °C) which was not statistically significant (p = 0.158). In the second step of analysis, measurements were compared through Bland Altman scatterplots using the mean differences between first the paired measurements and then the overall VGS. In the first case, the scatterplots (Fig. 2a, b, c) highlighted extreme BT values of the detected differences were within the 95% LoA, ranging from a minimum of (+1.22 °C to −1.70 °C) for AXL vs. TYM (Fig. 2a) to a maximum of (+1.79 °C to −1.67 °C) for FHD vs. AXL (Fig. 2c). When each measurement was plotted against the VGS, the Bland Altman analysis highlighted TYM (Fig. 3a) with narrower 95% LoA (+0.96 °C to −0.68 °C), while FHD (Fig. 3b) and AXL (Fig. 3c) both demonstrated broader limits (+0.94 °C to – 1.02 °C and +0.84 °C to −1.04 °C respectively) and a greater number of outlier values especially below the lower 95% LoA. Considering ±0.5 °C as the maximum clinically acceptable difference in BT, when comparing the three devices with VGS, 81.6% of TYM
Discussion In order to test the hypothesis, the three BT values were simultaneously obtained from 433 children in five Paediatric Units of Italian hospitals, representing the proper sample size to ensure the preestablished minimum power of 80%. Data were first analyzed to provide a descriptive analysis of the three groups of measurements and detect any possible significant differences of their paired mean values. In this step of analysis, statistically significant mean differences were found between FHD and TYM (−0.18 °C) and between AXL and TYM (−0.24 °C), but not between FHD and AXL (0.06 °C). However, these differences are not relevant from a clinical point of view (Geijer, Udumyan, Lohse, & Nilsagård, 2016; Niven et al., 2015). Although this first step of analysis could lead one to believe the hypothesis of the interchangeability of the three instruments, the Bland Altman scatterplots demonstrated that 95% of differences (mean ± SD*1.96) between the paired measurements fell within a too broad range (minimum +1.22 °C to −1.70 °C for AXL vs. TYM; maximum +1.79 °C to −1.67 °C for FHD vs. AXL). Therefore, the interchangeability hypothesis cannot be accepted for paediatric clinical
Fig. 2. Paired comparison between thermometers.
Please cite this article as: A. Dante, I. Franconi, A.R. Marucci, et al., Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014
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Fig. 3. BT values detected with each thermometer compared with VGS.
practice due to these broad differences. However, regarding mean difference between each thermometer and VGS, TYM demonstrated values closest to VGS (95% LoA +0.96 °C to −0.68 °C) with 81.6% of mean differences within the ±0.5 °C LoA. In the light of these results, the findings of this study seem to partially support the paediatric guidelines recommending either the use of TYM or AXL thermometers to detect BT in children (Chiappini et al., 2017; Green et al., 2013; NICE, 2017; RCN, 2017). Considering TYM and FHD sites more closely reflect the internal BT (Allegaert, Casteels, van Gorp, & Bogaert, 2014; Niven et al., 2015; Sollai et al., 2016); it is not anomalous that this study produced AXL values lower than TYM and FHD especially when mean BT is b36.5 °C. In order to guarantee accuracy, consistency, and patient safety when measuring BT in the paediatric population, it is essential for each patient nurses utilize the same thermometer device for all BT measurements. Variables such as the nurse's ability and compliance with the manufacturer guidelines, the clinical condition and compliance of the child, the device's technical limits, and the environmental temperature (Chiappini et al., 2009; El-Radhi, 2014; Sollai et al., 2016) may all affect the accuracy of BT measurement in the paediatric patient. Therefore, it is essential that nurses verify the instrumental BT measurements with the patient's clinical assessment, since acting on an incorrect BT value may delay necessary treatments or lead to misdiagnoses and incorrect therapies. In this regard, evaluating the skin (e.g. pallor, redness), respiratory dynamic function (e.g. tachypnoea, use of accessory muscles), cardio-circulatory condition (e.g. tachycardia, hypotension), as well as the child's activity (e.g. no response to social cues, cry) and symptoms (e.g. headache, shiver, nausea), all provide excellent criteria to confirm or doubt a BT value (NICE, 2017; RCN, 2017). Most importantly, if the clinical observation is in contrast with the BT values, it is advisable to repeat the measurement or obtain a rectal BT measurement (Chiappini et al., 2017; Green et al., 2013; NICE, 2017; RCN, 2017).
Implications for nursing practice and research Results of this study indicate the infrared tympanic thermometer is the most reliable device for measuring BT in the paediatric clinical setting. To safely and consistently measure BT in the hospitalized paediatric population, nurses should not assume peripheral thermometers can be used interchangeably. It is vital that nurses clinically validate all BT values with clinical observations. Since the study aims did not include to assess the sensitivity and specificity of alternative devices in detecting fever, data collected on febrile children were used only for the evaluation of measurement differences among thermometers. Therefore, high-quality diagnostic accuracy studies are needed to confirm the validity and reliability of the three thermometers investigated. Strengths and limitations The strengths of this study were the multicentre approach, the involvement of a large sample of peadiatric patients, the measurement of BT in the real clinical setting, and the use of appropriate statistical methods. Limitations of the study included the inability to detect the environmental temperature making it difficult to assess its influence on the BT values provided by the devices, although such detection is not usually performed during clinical practice. Further, the diagnostic accuracy of the investigated thermometers was not calculated. Conclusions Differences between paired measurements of TYM, FHD, and AXL thermometers fell within broad 95% LoA and, therefore, demonstrated the three devices are not interchangeable.
Fig. 4. BT values detected with each thermometer compared with VGS: values within ±0.5 °C mean difference.
Please cite this article as: A. Dante, I. Franconi, A.R. Marucci, et al., Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014
A. Dante et al. / Journal of Pediatric Nursing xxx (xxxx) xxx
In this study, TYM measurements more closely resembled the VGS value, suggesting TYM as the preferred device for paediatric clinical practice. It is crucial for nurses to use the same thermometer device for each patient when measuring body temperature to ensure accuracy, consistency, and safety in the paediatric population. Funding This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors. Declaration of competing interest None. Acknowledgment The authors thank ARTSANA GROUP S.p.A. for the provision of thermometers used in this study. Also, all nurses working in ‘Pediatria d'Urgenza e Pronto Soccorso — IRCCS Istituto Giannina Gaslini, Genova’, ‘Pronto Soccorso Pediatrico Ospedale San Camillo Forlanini, Roma’, ‘Pronto Soccorso e Medicina e Chirurgia d'Accettazione e d'urgenza pediatrica - Ospedali Riuniti di Ancona presidio Salesi, Ancona’, ‘Pronto Soccorso pediatrico - Ospedale infantile Regina Margherita - Città della Salute e della Scienza, Torino’, and ‘Pediatria D.U. e Pronto Soccorso Pediatrico – ASL 1 Abruzzo, Ospedale San Salvatore, L'Aquila’ are thanked for their precious contribution in the data collection. References Allegaert, K., Casteels, K., van Gorp, I., & Bogaert, G. (2014). Tympanic, infrared skin, and temporal artery scan thermometers compared with rectal measurement in children: A real-life assessment. Current Therapeutic Research, Clinical and Experimental, 76, 34–38. https://doi.org/10.1016/j.curtheres.2013.11.005. Bland, J. M., & Altman, D. G. (1986). Statistical methods for assessing agreement between two methods of clinical measurement. Lancet, 1(8476), 307–310. Bland, J. M., & Altman, D. G. (1999). Measuring agreement in method comparison studies. Statistical Methods in Medical Research, 8(2), 135–160. Chiappini, E., Principi, N., Longhi, R., Tovo, P. A., Becherucci, P., Bonsignori, F., ... de Martino, M. (2009). Management of fever in children: Summary of the Italian pediatric society guidelines and other therapies as well as in pharmacoeconomics. Clinical Therapeutics, 31(8), 1826–1843. https://doi.org/10.1016/j.clinthera.2009.08.006.
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Chiappini, E., Sollai, S., Longhi, R., Morandini, L., Laghi, A., Osio, C. E., & de Martino, M. (2011). Performance of non-contact infrared thermometer for detecting febrile children in hospital and ambulatory settings. Journal of Clinical Nursing, 20(9–10), 1311–1318. https://doi.org/10.1111/j.1365-2702.2010.03565.x. Chiappini, E., Venturini, E., Remaschi, G., Principi, N., Longhi, R., Tovo, P. A., ... Festini, F. (2017). 2016 update of the Italian pediatric society guidelines for Management of Fever in children. The Journal of Pediatrics, 180(e171), 177–183. https://doi.org/10. 1016/j.jpeds.2016.09.043. El-Radhi, A. S. (2014). Determining fever in children: The search for an ideal thermometer. British Journal of Nursing, 23(2), 91–94. https://doi.org/10.12968/bjon.2014.23.2. 91. Franconi, I., La Cerra, C., Marucci, A. R., Petrucci, C., & Lancia, L. (2018). Digital axillary and non-contact infrared thermometers for children. Clinical Nursing Research, 27(2), 180–190. https://doi.org/10.1177/1054773816676538. Geijer, H., Udumyan, R., Lohse, G., & Nilsagård, Y. (2016). Temperature measurements with a temporal scanner: Systematic review and meta-analysis. BMJ Open, 6(3), e009509. https://doi.org/10.1136/bmjopen-2015-009509. Giavarina, D. (2015). Understanding Bland Altman analysis. Biochemia Medica, 25(2), 141–151. https://doi.org/10.11613/bm.2015.015. Green, R., Jeena, P., Kotze, S., Lewis, H., Webb, D., & Wells, M. (2013). Management of acute fever in children: Guideline for community healthcare providers and pharmacists. South African Medical Journal, 103(12), 948–954. https://doi.org/10.7196/samj. 7207. Hurwitz, B., Brown, J., & Altmiller, G. (2015). Improving pediatric temperature measurement in the ED. The American Journal of Nursing, 115(9), 48–55. https://doi.org/10. 1097/01.naj.0000471249.69068.73. Isler, A., Aydin, R., Tutar Guven, S., & Gunay, S. (2014). Comparison of temporal artery to mercury and digital temperature measurement in pediatrics. International Emergency Nursing, 22(3), 165–168. https://doi.org/10.1016/j.ienj.2013.09.003. Italian Parliament (2003). Public Law No. 196. Codice in materia di protezione dei dati personali. National Institute for Health and Care Excellence (2017). Fever in under 5s: Assessment and initial management. https://www.nice.org.uk/guidance/cg160. Niven, D. J., Gaudet, J. E., Laupland, K. B., Mrklas, K. J., Roberts, D. J., & Stelfox, H. T. (2015). Accuracy of peripheral thermometers for estimating temperature: A systematic review and meta-analysis. Annals of Internal Medicine, 163(10), 768–777. https://doi. org/10.7326/m15-1150. Robertson-Smith, J., McCaffrey, F. T., Sayers, R., Williams, S., & Taylor, B. J. (2015). A comparison of mid-forehead and axillary temperatures in newborn intensive care. Journal of Perinatology, 35(2), 120–122. https://doi.org/10.1038/jp.2014.148. Royal College of Nursing (2017). Standards for assessing, measuring and monitoring vital signs in infants, children and young people. https://www.rcn.org.uk/professionaldevelopment/publications/pub-005942, Accessed date: 27 June 2019. Sethi, A., Patel, D., Nimbalkar, A., Phatak, A., & Nimbalkar, S. (2013). Comparison of forehead infrared thermometry with axillary digital thermometry in neonates. Indian Pediatrics, 50(12), 1153–1154. Sollai, S., Dani, C., Berti, E., Fancelli, C., Galli, L., de Martino, M., & Chiappini, E. (2016). Performance of a non-contact infrared thermometer in healthy newborns. BMJ Open, 6 (3), e008695. https://doi.org/10.1136/bmjopen-2015-008695. United Nations Environment Programme (2017). Minamata convention on mercury. http://www.mercuryconvention.org/Portals/11/documents/Booklets/COP1% 20version/Minamata-Convention-booklet-eng-full.pdf, Accessed date: 30 June 2019.
Please cite this article as: A. Dante, I. Franconi, A.R. Marucci, et al., Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014
Contents lists available at ScienceDirect
Journal of Pediatric Nursing journal homepage: www.pediatricnursing.org
Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paediatric clinical settings: Results of a multicentre observational study Angelo Dante a, Ilaria Franconi b, Anna Rita Marucci c, Celeste M. Alfes d,a, Loreto Lancia a,⁎ a
University of L'Aquila, Department of Health, Life and Environmental Sciences, Edificio Rita Levi Montalcini - Via G. Petrini, 67010 L'Aquila, Italy AOU Ospedali Riuniti Ancona, Obstetrics, Gynaecology, and Paediatric Operating Room, Salesi Children's Hospital, via Conca 71, 60030 Ancona, Italy c AO San Camillo Forlanini Hospital, Emergency Department, Unit Care and Paediatric Emergency, Ring Road Gianicolense, 87-00152 Rome, Italy d Case Western Reserve University, Frances Payne Bolton School of Nursing, 1905 Euclid Avenue, Cleveland 44106 – 4904, OH, USA b
a r t i c l e
i n f o
Article history: Received 24 September 2019 Revised 25 November 2019 Accepted 26 November 2019 Available online xxxx Keywords: Body temperature Forehead thermometer Tympanic thermometer Axillary thermometer Children Bland-Altman
a b s t r a c t Purpose: This study was conducted to investigate the interchangeability of infrared forehead, digital axillary, and infrared tympanic thermometers while identifying the most reliable non-invasive body temperature measurement method in paediatric settings. Design and methods: A multicentre observational study was conducted enrolling all children less than or equal to 14 years of age requiring a temperature measurement and after obtaining their parent's informed consent. Sociodemographic characteristics and temperature values in Celsius (°C) were simultaneously collected using forehead, axillary, and tympanic thermometers. Results: A total of 433 children were enrolled, 57.5% were male and the mean age was 5.3 ± 3.9 years. The average value of tympanic temperature (37.05 °C) was higher than forehead (36.87 °C) and axillary (36.8 °C). The mean difference between axillary and forehead temperatures (−0.06 °C) was not statistically significant (p = 0.158). Comparing the measurements of each type of thermometer with the overall average of the three measurements recorded as the virtual gold standard, Bland Altman analysis highlighted tympanic with narrower 95% limits of agreement (+0.96 °C to −0.68 °C). The tympanic thermometer also had the highest percentage (81.6%) of differences falling within the maximum clinically acceptable difference (±0.5 °C). Conclusions: Differences between paired measurements of the three investigated devices demonstrated the devices are not interchangeable. Measurements using the tympanic thermometer more closely resembled the reference temperature indicating its preferential use in paediatric clinical practice. Practice implications: To safely and consistently measure body temperature, nurses should not assume peripheral thermometers are interchangeable. It is essential to clinically validate all temperature values with clinical observations. © 2019 Published by Elsevier Inc.
Introduction Body temperature (BT) measurement is an important aspect of paediatric health care since BT values contribute to orient diagnoses and therapies in children (Chiappini et al., 2017; Green et al., 2013; NICE, 2017; Nursing, 2017). Unreliable measurements of patient's BTs may lead to misdiagnosis, omittance or delay of necessary treatments, and the prescribing of unnecessary therapies or exams (NICE, 2017; RCN, 2017). BT measurement devices should be accurate, non-invasive, time-efficient, inexpensive, safe, and technique-independent (ElRadhi, 2014). Historically, the mercury thermometer has been recognised as the standard tool for non-invasive BT measurements; ⁎ Corresponding author. E-mail address: [email protected] (L. Lancia).
however, such device is increasingly banned worldwide as part of a global treaty aimed to protect the human health and environment from the adverse effects of mercury (UNEP, 2017). Consequently, for the non-invasive BT measurement in children, current guidelines recommend the use of devices alternative to mercury, such as digital and infrared thermometers. Among them, digital axillary and infrared tympanic thermometers are considered as the best choices in children, since these devices seem to satisfy the above-mentioned characteristics and do not generate risk of infections and injuries (Chiappini et al., 2017; Green et al., 2013; NICE, 2017; RCN, 2017). Despite the recommendations provided by guidelines for clinical practice, nurses continue to utilize a wide variety of BT measurement devices with the paediatric population. For example, the infrared forehead thermometer is increasingly being used since it meets the clinical requirements for a non-invasive, rapid,
https://doi.org/10.1016/j.pedn.2019.11.014 0882-5963/© 2019 Published by Elsevier Inc.
Please cite this article as: A. Dante, I. Franconi, A.R. Marucci, et al., Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014
2
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easy BT measurement and has been well received by nurses, families, and children (Hurwitz, Brown, & Altmiller, 2015). However, little evidence is available regarding the reliable interchangeability of forehead thermometers with digital axillary and infrared tympanic devices in the paediatric setting. Further, most research has been conducted in the paediatric critical care area and results are contradictory. In particular, some authors considered the forehead thermometer as a good alternative to the axillary device due to a small mean difference in BT measurements (Chiappini et al., 2011) or to their safety and quick use (Isler, Aydin, Tutar Guven, & Gunay, 2014). Conversely, other authors (Franconi, La Cerra, Marucci, Petrucci, & Lancia, 2018; Robertson-Smith, McCaffrey, Sayers, Williams, & Taylor, 2015; Sethi, Patel, Nimbalkar, Phatak, & Nimbalkar, 2013) did not consider the forehead thermometer as accurate as the axillary one reporting broad values in 95% limits of agreement (−1.18 °C to +1.99 °C, −0.87 °C to +1.16 °C, and −2.3 °C to +1.2 °C, respectively). Furthermore, Franconi et al. (2018) highlighted different magnitude of bias based on different BT values. Considering the importance of BT values in clinical decision-making, it is pivotal to investigate the interchangeability of the devices as an alternative to mercury thermometers historically used with hospitalized children. Therefore, in order to contribute to the efforts of the scientific community, this study aimed to investigate the interchangeability of infrared forehead, digital axillary, and infrared tympanic thermometers while identifying the most reliable non-invasive BT measurement method in Italian paediatric settings. The hypothesis of this study was that axillary, tympanic, and forehead thermometers, commonly used in paediatric clinical practice, were interchangeable in the routine care of hospitalized children up to 14 years of age.
Materials and methods Study design, setting, and participants A multicentre observational study was conducted during 2018 in the Paediatric Units of five Italian hospitals. All children 14 years of age and younger needing a BT measurement were consecutively enrolled after their parents provided informed consent. Children in critical condition or not able to tolerate multiple BT measurements were excluded. G* Power 3.1.9.2 software was used to estimate the sample size (n = 128) needed to detect a minimum BT difference of ±0.5 °C with an 80% power (1-β) and a 5% α error.
Variables, instruments, and data collection Data regarding age, gender, time of detection, and BT values in Celsius (°C) using forehead (FHD), axillary (AXL), and tympanic (TYM) sites were collected. The FHD BT was measured using the infrared Chicco® Easy Touch thermometer which provided BT measurements in b30 s (mean = 5–8 s) by scanning the infrared radiation from the temporal artery. The AXL BT was measured using the digital Chicco® Digi Baby thermometer which provided BT measurements in about 1 min by heat conduction. The infrared Chicco® Comfort Quick device was used to detect TYM body temperature values. To reach accurate measurements, on the basis of current guidelines, the ear was gently pulled backward in children up to two years, whereas in all others was pulled upward and backward. All the measurements were performed simultaneously on clean and dry skin, waiting at least 30 min after meals or baths, and making sure that the ear had not been in contact with pillow before the TYM measurement. To ensure accurate measurements, thermometers were calibrated according to the manufacturer standards. Data were collected by trained nurses and reported in a BT flowsheet.
Data analysis Categorical data were summarized through frequencies and percentages, whereas central tendency indexes (means and medians) with dispersion measures, i.e. standard deviation (±SD), interquartile range (IQR), and min-max were used in case of continuous variables. The simultaneous measurements collected through the three devices were examined by means of a two-step analysis. The first consisted of a comparative analysis of the three mean values by using a paired sample t-test. In the second step, Bland Altman scatterplots were used to visually compare first the mean differences between the paired measurements and then, in aggregate by comparing the measurements of each instrument with the overall average of the three measurements recorded as the virtual gold standard (VGS) BT value (AXL + FHD + TYM/3). Therefore, VGS, according to Bland and Altman (1999) recommendations, represented the best available estimate of patient BT since the true BT value was not known. For each pair of measurements, the scatterplot illustrates their difference and their mean on the vertical and horizontal axes, respectively (Bland & Altman, 1986; Martin Bland & Altman, 1999; Giavarina, 2015). Furthermore, it shows three superimposed horizontal lines: one marks the average difference among all the paired measurements, whereas the other two highlight the upper and lower 95% Limits of Agreement (LoA). A pre-established maximum LoA of ±0.5 °C was considered as clinically acceptable (19). Data were analyzed using IBM SPSS version 19.0 (IBM Corp., Armonk, New York, USA).
Ethics The study was approved by the Internal Review Board of the University of L'Aquila (No. 18/2017–10/10/2017). According to national laws (Public Law No. 196, 2003), the confidentiality of the data concerning participants has been guaranteed. Before the data collection, the aim of the study was explained to parents from whom the written informed consent was obtained. Despite the parental consent, all children had the opportunity to refuse the multiple BT measurements. No child was forced to participate in case of verbal or non-verbal refusal.
Results Participants A total of 433 children were enrolled, 57.5% were male and the mean age was 5.3 ± 3.9 years, median = 5.0, IQR = 7.0, min-max = 0–14 (Table 1). No significant differences emerged when comparing the gender distribution among the five centres; conversely, a heterogeneity in the mean age was detected (p b 0.001).
Table 1 Characteristics of participants (n = 433). Centre
Participants
Gender
Age
Female
A B C D E Overall p
Male
N
n
%
n
%
205 47 42 89 50 433
90 20 19 43 12 184 0.074⁎
43.9 42.6 45.2 48.3 24.0 42.5
115 27 23 46 38 249
56.1 57.4 54.8 51.7 76.0 57.5
Mean
SD
5.1 3.7 7.5 5.7 5.7 5.3 b0.001⁎⁎
3.7 3.8 3.8 4.3 4.1 3.9
⁎ χ2 test. ⁎⁎ ANOVA test.
Please cite this article as: A. Dante, I. Franconi, A.R. Marucci, et al., Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014
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Fig. 1. Paired comparisons among BT values (°C) detected with the three devices (N = 495).
values were included in the above-mentioned LoA, followed by FHD (74.5%) and AXL (73.5%) (Fig. 4).
Comparisons among thermometers The first step of analysis highlighted the TYM BT mean value (37.05 °C) was higher than FHD and AXL BT mean values (36.87 °C and 36.81 °C, respectively) (Fig. 1) and showed only a mean value difference between the AXL and FHD (−0.06 °C) which was not statistically significant (p = 0.158). In the second step of analysis, measurements were compared through Bland Altman scatterplots using the mean differences between first the paired measurements and then the overall VGS. In the first case, the scatterplots (Fig. 2a, b, c) highlighted extreme BT values of the detected differences were within the 95% LoA, ranging from a minimum of (+1.22 °C to −1.70 °C) for AXL vs. TYM (Fig. 2a) to a maximum of (+1.79 °C to −1.67 °C) for FHD vs. AXL (Fig. 2c). When each measurement was plotted against the VGS, the Bland Altman analysis highlighted TYM (Fig. 3a) with narrower 95% LoA (+0.96 °C to −0.68 °C), while FHD (Fig. 3b) and AXL (Fig. 3c) both demonstrated broader limits (+0.94 °C to – 1.02 °C and +0.84 °C to −1.04 °C respectively) and a greater number of outlier values especially below the lower 95% LoA. Considering ±0.5 °C as the maximum clinically acceptable difference in BT, when comparing the three devices with VGS, 81.6% of TYM
Discussion In order to test the hypothesis, the three BT values were simultaneously obtained from 433 children in five Paediatric Units of Italian hospitals, representing the proper sample size to ensure the preestablished minimum power of 80%. Data were first analyzed to provide a descriptive analysis of the three groups of measurements and detect any possible significant differences of their paired mean values. In this step of analysis, statistically significant mean differences were found between FHD and TYM (−0.18 °C) and between AXL and TYM (−0.24 °C), but not between FHD and AXL (0.06 °C). However, these differences are not relevant from a clinical point of view (Geijer, Udumyan, Lohse, & Nilsagård, 2016; Niven et al., 2015). Although this first step of analysis could lead one to believe the hypothesis of the interchangeability of the three instruments, the Bland Altman scatterplots demonstrated that 95% of differences (mean ± SD*1.96) between the paired measurements fell within a too broad range (minimum +1.22 °C to −1.70 °C for AXL vs. TYM; maximum +1.79 °C to −1.67 °C for FHD vs. AXL). Therefore, the interchangeability hypothesis cannot be accepted for paediatric clinical
Fig. 2. Paired comparison between thermometers.
Please cite this article as: A. Dante, I. Franconi, A.R. Marucci, et al., Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014
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Fig. 3. BT values detected with each thermometer compared with VGS.
practice due to these broad differences. However, regarding mean difference between each thermometer and VGS, TYM demonstrated values closest to VGS (95% LoA +0.96 °C to −0.68 °C) with 81.6% of mean differences within the ±0.5 °C LoA. In the light of these results, the findings of this study seem to partially support the paediatric guidelines recommending either the use of TYM or AXL thermometers to detect BT in children (Chiappini et al., 2017; Green et al., 2013; NICE, 2017; RCN, 2017). Considering TYM and FHD sites more closely reflect the internal BT (Allegaert, Casteels, van Gorp, & Bogaert, 2014; Niven et al., 2015; Sollai et al., 2016); it is not anomalous that this study produced AXL values lower than TYM and FHD especially when mean BT is b36.5 °C. In order to guarantee accuracy, consistency, and patient safety when measuring BT in the paediatric population, it is essential for each patient nurses utilize the same thermometer device for all BT measurements. Variables such as the nurse's ability and compliance with the manufacturer guidelines, the clinical condition and compliance of the child, the device's technical limits, and the environmental temperature (Chiappini et al., 2009; El-Radhi, 2014; Sollai et al., 2016) may all affect the accuracy of BT measurement in the paediatric patient. Therefore, it is essential that nurses verify the instrumental BT measurements with the patient's clinical assessment, since acting on an incorrect BT value may delay necessary treatments or lead to misdiagnoses and incorrect therapies. In this regard, evaluating the skin (e.g. pallor, redness), respiratory dynamic function (e.g. tachypnoea, use of accessory muscles), cardio-circulatory condition (e.g. tachycardia, hypotension), as well as the child's activity (e.g. no response to social cues, cry) and symptoms (e.g. headache, shiver, nausea), all provide excellent criteria to confirm or doubt a BT value (NICE, 2017; RCN, 2017). Most importantly, if the clinical observation is in contrast with the BT values, it is advisable to repeat the measurement or obtain a rectal BT measurement (Chiappini et al., 2017; Green et al., 2013; NICE, 2017; RCN, 2017).
Implications for nursing practice and research Results of this study indicate the infrared tympanic thermometer is the most reliable device for measuring BT in the paediatric clinical setting. To safely and consistently measure BT in the hospitalized paediatric population, nurses should not assume peripheral thermometers can be used interchangeably. It is vital that nurses clinically validate all BT values with clinical observations. Since the study aims did not include to assess the sensitivity and specificity of alternative devices in detecting fever, data collected on febrile children were used only for the evaluation of measurement differences among thermometers. Therefore, high-quality diagnostic accuracy studies are needed to confirm the validity and reliability of the three thermometers investigated. Strengths and limitations The strengths of this study were the multicentre approach, the involvement of a large sample of peadiatric patients, the measurement of BT in the real clinical setting, and the use of appropriate statistical methods. Limitations of the study included the inability to detect the environmental temperature making it difficult to assess its influence on the BT values provided by the devices, although such detection is not usually performed during clinical practice. Further, the diagnostic accuracy of the investigated thermometers was not calculated. Conclusions Differences between paired measurements of TYM, FHD, and AXL thermometers fell within broad 95% LoA and, therefore, demonstrated the three devices are not interchangeable.
Fig. 4. BT values detected with each thermometer compared with VGS: values within ±0.5 °C mean difference.
Please cite this article as: A. Dante, I. Franconi, A.R. Marucci, et al., Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014
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In this study, TYM measurements more closely resembled the VGS value, suggesting TYM as the preferred device for paediatric clinical practice. It is crucial for nurses to use the same thermometer device for each patient when measuring body temperature to ensure accuracy, consistency, and safety in the paediatric population. Funding This research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors. Declaration of competing interest None. Acknowledgment The authors thank ARTSANA GROUP S.p.A. for the provision of thermometers used in this study. Also, all nurses working in ‘Pediatria d'Urgenza e Pronto Soccorso — IRCCS Istituto Giannina Gaslini, Genova’, ‘Pronto Soccorso Pediatrico Ospedale San Camillo Forlanini, Roma’, ‘Pronto Soccorso e Medicina e Chirurgia d'Accettazione e d'urgenza pediatrica - Ospedali Riuniti di Ancona presidio Salesi, Ancona’, ‘Pronto Soccorso pediatrico - Ospedale infantile Regina Margherita - Città della Salute e della Scienza, Torino’, and ‘Pediatria D.U. e Pronto Soccorso Pediatrico – ASL 1 Abruzzo, Ospedale San Salvatore, L'Aquila’ are thanked for their precious contribution in the data collection. References Allegaert, K., Casteels, K., van Gorp, I., & Bogaert, G. (2014). Tympanic, infrared skin, and temporal artery scan thermometers compared with rectal measurement in children: A real-life assessment. Current Therapeutic Research, Clinical and Experimental, 76, 34–38. https://doi.org/10.1016/j.curtheres.2013.11.005. Bland, J. M., & Altman, D. G. (1986). Statistical methods for assessing agreement between two methods of clinical measurement. Lancet, 1(8476), 307–310. Bland, J. M., & Altman, D. G. (1999). Measuring agreement in method comparison studies. Statistical Methods in Medical Research, 8(2), 135–160. Chiappini, E., Principi, N., Longhi, R., Tovo, P. A., Becherucci, P., Bonsignori, F., ... de Martino, M. (2009). Management of fever in children: Summary of the Italian pediatric society guidelines and other therapies as well as in pharmacoeconomics. Clinical Therapeutics, 31(8), 1826–1843. https://doi.org/10.1016/j.clinthera.2009.08.006.
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Please cite this article as: A. Dante, I. Franconi, A.R. Marucci, et al., Evaluating the interchangeability of forehead, tympanic, and axillary thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014