YJPDN-02113; No of Pages 5

Journal of Pediatric Nursing xxx (xxxx) xxx

Contents lists available at ScienceDirect

Journal of Pediatric Nursing

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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
b
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

a r t i c l e i n f o a b s t r a c t

Article history: Purpose: This study was conducted to investigate the interchangeability of infrared forehead, digital axillary, and
Received 24 September 2019 infrared tympanic thermometers while identifying the most reliable non-invasive body temperature measure-
Revised 25 November 2019 ment method in paediatric settings.
Accepted 26 November 2019 Design and methods: A multicentre observational study was conducted enrolling all children less than or equal to
Available online xxxx
14 years of age requiring a temperature measurement and after obtaining their parent's informed consent. Socio-
demographic characteristics and temperature values in Celsius (°C) were simultaneously collected using fore-
Keywords:
Body temperature
head, axillary, and tympanic thermometers.
Forehead thermometer Results: A total of 433 children were enrolled, 57.5% were male and the mean age was 5.3 ± 3.9 years. The average
Tympanic thermometer value of tympanic temperature (37.05 °C) was higher than forehead (36.87 °C) and axillary (36.8 °C). The mean
Axillary thermometer difference between axillary and forehead temperatures (−0.06 °C) was not statistically significant (p = 0.158).
Children Comparing the measurements of each type of thermometer with the overall average of the three measurements
Bland-Altman 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 differ-
ences falling within the maximum clinically acceptable difference (±0.5 °C).
Conclusions: Differences between paired measurements of the three investigated devices demonstrated the de-
vices are not interchangeable. Measurements using the tympanic thermometer more closely resembled the ref-
erence 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 however, such device is increasingly banned worldwide as part of a

Body temperature (BT) measurement is an important aspect of pae-
diatric 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 (El-
Radhi, 2014). Historically, the mercury thermometer has been
recognised as the standard tool for non-invasive BT measurements;
⁎ Corresponding author.
E-mail address: loreto.lancia@cc.univaq.it (L. Lancia).
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 rec-
ommend the use of devices alternative to mercury, such as digital and
infrared thermometers. Among them, digital axillary and infrared tym-
panic 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 clini-
cal practice, nurses continue to utilize a wide variety of BT mea-
surement 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, fam-
ilies, and children (Hurwitz, Brown, & Altmiller, 2015). However,
little evidence is available regarding the reliable interchangeability
of forehead thermometers with digital axillary and infrared tym-
panic 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 al-
ternative 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 in-
frared 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.
Data analysis
Categorical data were summarized through frequencies and per-
centages, 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 sam-
ple t-test. In the second step, Bland Altman scatterplots were used to vi-
sually 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 esti-
mate of patient BT since the true BT value was not known.
For each pair of measurements, the scatterplot illustrates their dif-
ference 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

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.
The study was approved by the Internal Review Board of the Univer-
sity 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
Variables, instruments, and data collection 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 gen-
Data regarding age, gender, time of detection, and BT values in Cel- der distribution among the five centres; conversely, a heterogeneity in
sius (°C) using forehead (FHD), axillary (AXL), and tympanic (TYM) the mean age was detected (p b 0.001).
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 Table 1
temporal artery. The AXL BT was measured using the digital Chicco® Characteristics of participants (n = 433).
Digi Baby thermometer which provided BT measurements in about Centre Participants Gender Age
1 min by heat conduction. The infrared Chicco® Comfort Quick device
Female Male Mean SD
was used to detect TYM body temperature values. To reach accurate
measurements, on the basis of current guidelines, the ear was gently N n % n %

pulled backward in children up to two years, whereas in all others A 205 90 43.9 115 56.1 5.1 3.7
was pulled upward and backward. All the measurements were per- B 47 20 42.6 27 57.4 3.7 3.8
C 42 19 45.2 23 54.8 7.5 3.8
formed simultaneously on clean and dry skin, waiting at least 30 min
D 89 43 48.3 46 51.7 5.7 4.3
after meals or baths, and making sure that the ear had not been in con- E 50 12 24.0 38 76.0 5.7 4.1
tact with pillow before the TYM measurement. To ensure accurate mea- Overall 433 184 42.5 249 57.5 5.3 3.9
surements, thermometers were calibrated according to the p 0.074⁎ b0.001⁎⁎
manufacturer standards. Data were collected by trained nurses and re- ⁎ χ2 test.
ported in a BT flowsheet. ⁎⁎ 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
 A. Dante et al. / Journal of Pediatric Nursing xxx (xxxx) xxx 3

Fig. 1. Paired comparisons among BT values (°C) detected with the three devices (N = 495).

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 be-
tween the AXL and FHD (−0.06 °C) which was not statistically signifi-
cant (p = 0.158).
In the second step of analysis, measurements were compared
through Bland Altman scatterplots using the mean differences be-
tween 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 dem-
onstrated 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 differ-
ence in BT, when comparing the three devices with VGS, 81.6% of TYM
values were included in the above-mentioned LoA, followed by FHD
(74.5%) and AXL (73.5%) (Fig. 4).
Discussion
In order to test the hypothesis, the three BT values were simulta-
neously obtained from 433 children in five Paediatric Units of Italian
hospitals, representing the proper sample size to ensure the pre-
established 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 signifi-
cant 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; maxi-
mum +1.79 °C to −1.67 °C for FHD vs. AXL). Therefore, the inter-
changeability 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
4 A. Dante et al. / Journal of Pediatric Nursing xxx (xxxx) xxx

Fig. 3. BT values detected with each thermometer compared with VGS.

practice due to these broad differences. However, regarding mean dif-
ference 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 dif-
ferences 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 in-
ternal 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 compli-
ance 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 paediat-
ric patient. Therefore, it is essential that nurses verify the instrumen-
tal 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, evaluat-
ing 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 observa-
tion 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 set-
ting. To safely and consistently measure BT in the hospitalized paediat-
ric 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 fe-
brile children were used only for the evaluation of measurement differ-
ences 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 in-
volvement 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 en-
vironmental 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 accu-
racy 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, consis-
tency, and safety in the paediatric population.
Funding
This research did not receive any specific grant from funding agen-
cies 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 ther-
mometers 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 An-
cona presidio Salesi, Ancona’, ‘Pronto Soccorso pediatrico - Ospedale in-
fantile 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.
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thermometers in Italian paedia..., Journal of Pediatric Nursing, https://doi.org/10.1016/j.pedn.2019.11.014
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