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Evaluation of Noninvasive Thermometers in an Endoscopy Setting

Blake, Stacie, BSN, RN, CGRN; Fries, Kellie, MSN, FNP-C, RN, PCCN; Higginbotham, Lauren, BSN, RN, PCCN; Lorei, Carol, RN, ADN, CEN; McGee, Michael, RN, ADN, CEN; Murray, Robert, RN, ADN; Priest, Melissa, BSN, RN, CGRN; Rangel, Julie, BSN, RN, CGRN; Remick-Erickson, Kara, BSN, RN, MS; Schneider, Lise, MSN, RN, PCCN; Vodopest, Barbara, RN, ADN; Moore, Aline, MSN, RN, CGRN

doi: 10.1097/SGA.0000000000000367
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The measurement of body temperature is an important aspect of assessment prior to invasive procedures. The purpose of the study was to determine the level of agreement between temporal artery, noncontact infrared, and disposable oral electronic thermometers to a clinical reference device (nondisposable oral electronic thermometer) in outpatients prior to an endoscopic procedure. A descriptive, method-comparison study design was used to compare 3 noninvasive thermometers with a clinical reference device. Four noninvasive temperatures were measured with 3 test devices (temporal artery with ear tap; temporal artery without ear tap; disposable oral electronic; and noncontact infrared), followed by measurement with the clinical reference device (nondisposable, oral electronic). Differences (bias) and limits of agreement (±1.96 SD) were calculated for the test devices and graphed using Bland–Altman method. Clinically acceptable levels of agreement were set at a bias of 0.54 °F or less and precision of 0.90 °F or less. A total of 25 endoscopy patients (N = 14 female; N = 11 male) were studied, with temperatures ranging from 97.5 to 98.9, averaging 98.1 ± 0.3 °F. All thermometers, with the exception of the noncontact infrared (0.66 °F), had acceptable ranges for use in clinical practices. Findings from this study support the use of both temporal artery and disposable oral electronic thermometers in afebrile outpatients but not the noncontact infrared thermometer.

Stacie Blake, BSN, RN, CGRN, is Registered Nurse, North Kansas City Hospital, North Kansas City, Missouri.

Kellie Fries, MSN, FNP-C, RN, PCCN, is Registered Nurse, Endoscopic Lab, North Kansas City Hospital, North Kansas City, Missouri.

Lauren Higginbotham, BSN, RN, PCCN, is Registered Nurse, Endoscopic Lab, North Kansas City Hospital, North Kansas City, Missouri.

Carol Lorei, RN, ADN, CEN, is Registered Nurse, Endoscopic Lab, North Kansas City Hospital, North Kansas City, Missouri.

Michael McGee, RN, ADN, CEN, is Registered Nurse, North Kansas City Hospital, North Kansas City, Missouri.

Robert Murray, RN, ADN, is Registered Nurse, North Kansas City Hospital, North Kansas City, Missouri.

Melissa Priest, BSN, RN, CGRN, is Registered Nurse, Endoscopic Lab, North Kansas City Hospital, North Kansas City, Missouri.

Julie Rangel, BSN, RN, CGRN, is Registered Nurse.

Kara Remick-Erickson, BSN, RN, MS, is Registered Nurse, Endoscopic Lab, North Kansas City Hospital, North Kansas City, Missouri.

Lise Schneider, MSN, RN, PCCN, is Registered Nurse, CenterPoint Medical Center, South Independence, Missouri.

Barbara Vodopest, RN, ADN, is Registered Nurse, Endoscopic Lab, North Kansas City Hospital, North Kansas City, Missouri.

Aline Moore, MSN, RN, CGRN, is Registered Nurse, Endoscopic Lab, North Kansas City Hospital, North Kansas City, Missouri.

Correspondence to: Michael McGee, RN, ADN, CEN, North Kansas City Hospital, Endoscopy Lab, 2790 Clay Edwards Dr, North Kansas City, MO 64116 (michael.mcgee@nkch.org).

The authors declare no conflicts of interest.

The measurement of body temperature is an important aspect of assessment prior to invasive procedures such as endoscopy (Collins et al., 2013). An elevation in body temperature is often an indicator of an ongoing infection and can be a contraindication to performing elective endoscopic procedures. Use of an accurate temperature device is essential to screen for temperature elevations in clinical situations (Bridges & Thomas, 2009).

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Background

Accuracy of temperature devices is determined by calculating the bias and precision of each test device when compared with an acceptable clinical reference device (Szaflarski & Slaughter, 1996). If bias and precision values are small enough, the test device is deemed to be clinically equivalent to the existing clinical reference device. Bias is the average difference in temperatures between a test and clinical reference device. Precision is the standard deviation value for bias. Experts have determined that the level of agreement for temperature devices is clinically acceptable for acute care use of test thermometers when the bias is ±0.54 °F or less and precision is ±0.90 °F or less (Bridges & Thomas, 2009; Forbes, 2009; Lawson et al., 2007; Sessler, 2008).

The most accurate methods for determining core body temperature are with invasive thermometers such as the thermistor on a pulmonary artery catheter, an esophageal probe, or a rectal thermometer (Bridges & Thomas, 2009; Smith, 2004). Because these invasive temperature devices are associated with significant risks (Marschall et al., 2008) and/or cannot be used during an endoscopic procedure, indirect methods for temperature measurement are used. Prior studies have found that indirect temperature measurement with a nondisposable, oral electronic thermometer closely approximates core body temperatures (bias of ≤0.54 °F; precision of ≤0.90 °F) (Calonder et al., 2010; Giuliano, Scott, Elliot, & Giuliano, 1999; Lawson et al., 2007; Niven et al., 2015; Smith, 2004).

Until recently, the nondisposable oral electronic thermometer has been used to obtain temperatures in most healthcare settings. Some institutions are using disposable, oral electronic thermometers (Figure 1A) as one of the many strategies to decrease hospital-acquired infections (Marschall et al., 2008; Yokoe, 2008). The recent development of a noncontact infrared thermometer (Figure 1B) provides healthcare workers with another option to limit exposure and cross contamination.

FIGURE 1

FIGURE 1

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Disposable Oral Electronic Thermometer

Despite their widespread use in healthcare settings, evaluation of disposable oral electronic thermometers has been limited. In one clinical study, the disposable oral electronic thermometer evaluated had bias and precision values within the acceptable range when tested in 48 afebrile, critically ill patients (Counts et al., 2014). Clinicians have accepted these devices as equivalent to the oral, nondisposable electronic digital thermometers with limited research to support that judgment. Additional research is needed on device accuracy of the disposable oral electronic digital thermometer before widespread clinical use is recommended.

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Infrared Sensor Thermometers

A variety of clinical circumstances preclude the safe use of an oral thermometer (i.e., uncooperative or unconscious patients; oral/facial trauma or surgery; mucositis or other oral lesions) (Bridges & Thomas, 2009). Several indirect noninvasive temperature devices are available for nonoral body temperature measurement. Thermometers using infrared sensor technology were developed for temperature measurement first in the ear (tympanic thermometer), later by sliding the device across the forehead area (temporal artery thermometer) (Figure 1C), and most recently by pointing the device at the forehead skin without touching it (noncontact infrared thermometer) (Figure 1B).

Tympanic thermometers are no longer recommended for routine temperature monitoring because of large bias and precision values related to user error (both within and between users) (Bridges & Thomas, 2009; Dew, 2010; Dodd, Lancaster, Craig, Smyth, & Williamson, 2006; Giuliano et al., 1999; Hooper & Andrews, 2006). Experts believe that the user error associated with the tympanic thermometer is likely related to the anatomy of the ear canal and not the infrared technology itself (Bridges & Thomas, 2009; Dodd et al., 2006).

Two new applications of infrared technology have been introduced to measure skin temperature on the forehead area. The first device, the temporal artery thermometer (Figure 1C), is a noninvasive probe that is lightly moved across the forehead to the hairline, followed by a light tap behind the ear. The temporal artery thermometer has been studied in adults (Barringer et al., 2011; Calonder et al., 2010; Counts et al., 2014; Fountain, Goins, Scoles, Hartman, & Hays, 2008; Frommelt, Ott, & Hays, 2008; Furlong et al., 2015; Lawson et al., 2007; Sessler, 2008; Suleman, Douufas, Akca, Ducharme, & Sessler, 2002; Winslow et al., 2012; Wolfson, Granstrom, Pomarico, & Reimanis, 2013) and pediatric patients (Callanan, 2003; Hebbar, Fortenberry, Rogers, Merritt, & Easley, 2005; Lee et al., 2011; Roy, Powell, & Gerson, 2003; Schuh et al., 2004; Sessler, 2008; Siberry, Diener-West, Schappell, & Karron, 2002; Suleman et al., 2002; Titus, Hulsey, Heckman, & Losek, 2009). Although the majority of the pediatric studies found acceptable agreement between the temporal artery thermometer and an appropriate reference thermometer (Lee et al., 2011; Roy et al., 2003; Siberry et al., 2002; Suleman et al., 2002; Titus et al., 2009), many of the adult studies found bias or precision values to slightly exceed the recommended range of acceptability (Barringer et al., 2011; Counts et al., 2014; Furlong et al., 2015; Sessler, 2008; Suleman et al., 2002; Wolfson et al., 2013). Unfortunately, some of the temporal artery studies had methodological problems, such as inappropriate statistical methods (Roy et al., 2003; Siberry et al., 2002; Suleman et al., 2002; Titus et al., 2009) and/or inadequate study details or incorrect device use (Calonder et al., 2010; Counts et al., 2014; Fountain et al., 2008; Frommelt et al., 2008; Furlong et al., 2015; Hebbar et al., 2005; Lee et al., 2011; Roy et al., 2003; Schuh et al., 2004; Sessler, 2008; Suleman et al., 2002; Winslow et al., 2012). This greatly limits the generalizability of their findings. A noted concern was the lack of detail in many studies on the scanning technique used and whether or not the ear tap step of the procedure (Figure 1D) was done.

Further studies are needed that use appropriate statistical methods and ensure inclusion of the ear tap step during temperature measurement. Because many clinicians do not include the ear tap despite the manufacturer's clear directions to do so, evaluating the accuracy of the device both with and without the ear tap step would be beneficial.

The second device is the noncontact infrared thermometer (Figure 1B) that uses the same type of technology as the temporal artery thermometer; however, the probe does not touch the skin. Limited studies have been published on the accuracy of the noncontact infrared thermometer (Apa et al., 2013; Chiappini et al., 2011; Fortuna et al., 2010; Kelechi, Michel, & Wiseman, 2006; Osio & Carnelli, 2007; Paes, Vermeulen, Brochet, van der Ploeg, & de Winter, 2010; Selent et al., 2013; Sener, Karcioglu, Eken, Yaylaci, & Ozsaqrac, 2012; Teran et al., 2012). None of these studies compared the device with an appropriate reference thermometer (i.e., direct core temperature or nondisposable, oral electronic thermometer) and all but one were conducted in children (Kelechi et al., 2006).

Studies are needed in a variety of clinical situations, especially in adults, using an appropriate reference thermometer for comparison. Because temperature is measured farther from the source (circulation under the skin of the forehead) with the noncontact infrared thermometer, there is concern that it may not be accurate enough for clinical use. If the device has acceptable levels of agreement with reference thermometers, the noncontact aspect of the device would be an advantage for infection control reasons, particularly in acute care hospitals.

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Clinical Question

Well designed and executed studies in adults are needed to determine whether the temporal artery, noncontact infrared, and disposable oral electronic digital thermometers have acceptable levels of bias and precision to allow routine use in adult care. If one or more of these devices have acceptable levels of bias and precision, they could expand the options available when oral temperature measurement is contraindicated or difficult to perform.

The purpose of this study was to determine the level of agreement (accuracy; bias and precision values) between three noninvasive test thermometers (temporal artery; noncontact infrared; and disposable oral electronic digital) and the clinical reference device (nondisposable oral electronic thermometer) in outpatients prior to invasive endoscopic procedures. In addition, the study was designed to determine whether the inclusion of the ear tap step when using the temporal artery thermometer improves device accuracy.

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Materials and Methods

This study was conducted in a 451-bed community-based hospital in the Midwest region of the United States. The setting was a 36-bed endoscopy laboratory. Study approval was obtained from the institution's investigational review committee prior to data collection. Data collection was completed over a 2-week period.

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Study Design

A descriptive, method-comparison study design was used to compare three different noninvasive thermometers (temporal artery; disposable oral electronic; and noncontact infrared) with the clinical reference device (nondisposable, oral electronic). Each subject served as his or her own control. The dependent variable in the study was the level of agreement (bias; precision) between the test thermometers and the clinical reference device. Order of temperature measurement was assigned by a computer-generated random number scheme, with the clinical reference temperature always measured last. Investigators were blinded from device order until just before temperature measurement.

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Sample Selection

Subjects for this study included outpatients admitted to the endoscopy laboratory for elective gastrointestinal procedures. Exclusion criteria included less than 18 years of age; nasal or oral oxygen use; isolation precautions; altered mental status; the presence of any impediment or contraindication to oral or forehead temperature measurement; and/or the ingestion of cold or hot liquids within the previous 15 minutes (Quatrara et al., 2007).

A minimum of 19 subjects were required for the purpose of data analysis. Determination of sample size was based on power analysis for the Student t test (paired data) with α = .05, power = 0.80, and effect size = 0.61 (medium) (Faul, Erdfelder, Buchner, & Lang, 2009). Effect size was calculated to identify a bias of greater than 0.54 °F and precision of greater than 0.90 °F (Bridges & Thomas, 2009; Forbes, 2009; Lawson et al., 2007; Sessler, 2008).

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Instruments

All nondisposable temperature devices used in this study were calibrated by biomedical engineering staff according to manufacturer instructions prior to data collection and dedicated for study use.

  1. Nondisposable oral electronic thermometer (clinical reference device): SureSigns VS3 Vital Signs Monitor (Release A.03, Philips Medical Systems, Andover, MA). Manufacturer's specifications include a clinical accuracy of ±0.2 °F for temperatures from 90.0 °F to 109.9 °F.
  2. Disposable oral electronic thermometer (test thermometer): Adtemp II 412 (American Diagnostic Corporation, Hauppauge, NY) (Figure 1A). Manufacturer's specifications include a clinical accuracy 0.2 °F for temperatures between 96.0 °F to 107.0 °F at a room temperature.
  3. Temporal artery thermometer (test thermometer): TAT-5000 (Exergen Corp., Watertown, MA) (Figure 1C). Manufacturer's specifications include a clinical accuracy of ±0.2 °F for temperatures from 61 °F to 110 °F.
  4. Noncontact infrared thermometer (test thermometer): Thermofocus (Technimed SRI, Verese, Italy) (Figure 1B). Manufacturer's specifications include a clinical accuracy of ±0.2 °C for temperatures from 36.0 °C to 39.0 °C and ±0.3 °C for temperatures from 34.0 °C to 35.9 °C.
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Study Procedure

Investigators were trained in study methods and proper use of the four temperature devices before beginning data collection. Interrater and intrarater reliability testing during the training session for all devices was found to be r > .97 (p > .001) for all four temperature devices.

Consent was obtained during the admission process to the endoscopy laboratory by a study investigator not assigned to care for the patient. Before obtaining an admission temperature, a sealed envelope containing the random assignment of temperature device order was opened by the study investigator. Four temperatures were then measured with the three test devices (temporal artery with ear tap step; temporal artery without ear tap step; disposable oral electronic; and noncontact infrared), followed by measurement with the clinical reference device (nondisposable, oral electronic). The same body position was maintained throughout temperature monitoring.

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Data Analysis

Data were summarized using descriptive statistics. Differences and limits of agreement were calculated for the test devices and graphed using the Bland–Altman method (Bland & Altman, 1996; Szaflarski & Slaughter, 1996). Clinically acceptable levels of agreement were a bias of 0.54 °F or less and a precision of 0.90 °F or less (Bridges & Thomas, 2009; Forbes, 2009; Lawson et al., 2007; Sessler, 2008). Analysis of variance was used to determine whether the order of the temperature device testing contributed to temperature differences between devices. The level of significance for all statistical tests was p < .05.

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Results

A total of 25 endoscopic patients (N = 14 female; N = 11 male) were studied over a period of 2 weeks by 7 study investigators. Ages ranged from 31 to 75 years, averaging 57.4 ± 11.1 years. Temperatures measured with the clinical reference device ranged from 97.5 °F to 98.9 °F, averaging 98.1 ± 0.3 °F, and no participants were diaphoretic at the time of temperature measurement. The order of temperature device use was not found to affect temperature difference (p > .05).

Differences and limits of agreement between each of the test devices and the clinical reference device are summarized in Table 1 and graphed in Figure 2. All but one of the devices had bias and precision values within an acceptable range for use in clinical practice (differences/bias ≤0.54 °F; limits of agreement/precision ≤0.9 °F) (Bridges & Thomas, 2009; Forbes, 2009; Lawson et al., 2007; Sessler, 2008). The noncontact infrared device had a bias value outside the acceptable range (bias = 0.66 °F).

TABLE 1

TABLE 1

FIGURE 2

FIGURE 2

Of the test temperatures measured, 40% of those taken with the noncontact thermometer and 32% taken with the temporal artery with tap were greater than 1.0 °F from the clinical reference device (Table 1). Test temperatures measured with the temporal artery thermometer without a tap had greater than 1.0 °F difference from the clinical reference device 8% of the time, with the disposable oral electronic thermometer being greater than 1.0 °F difference 4% of the time.

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Discussion

The temporal artery and disposable oral electronic temperature devices had bias and precision values that were within the acceptable range for clinical equivalency (bias ≤0.54 °F; precision ≤0.90 °F). The bias value for the noncontact infrared thermometer was 0.66 °F, exceeding the acceptable range for clinical use recommended by experts. Temperatures with the disposable oral electronic thermometer were almost always less than 1.0 °F different from temperatures with the reference thermometer (N = 24 of 25; 96%). The temporal artery and noncontact infrared temperature devices had 32% (N = 8 of 25) and 40% (N = 10 of 25), respectively, of temperatures that were more than 1.0 °F different from the nondisposable oral thermometer. Temperature differences of more than 2 °F occurred only once with the disposable oral electronic thermometer and nondisposable thermometer (4%). Lower bias and precision values were found when the ear tap was not done during temperature measurement, compared with its inclusion.

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Temporal Artery Thermometer

Of the 11 prior adult studies of the temporal artery thermometer, only four found bias and precision values within the recommended range (Calonder et al., 2010; Frommelt et al., 2008; Lawson et al., 2007; Winslow et al., 2012). The other seven studies had bias and/or precision values that slightly exceeded the upper range of acceptability (Barringer et al., 2011; Counts et al., 2014; Fountain et al., 2008; Furlong et al., 2015; Sessler, 2008; Suleman et al., 2002; Wolfson et al., 2013). Because the procedure used for the temporal artery measurement was clearly described in only three of the 11 studies (Barringer et al., 2011; Lawson et al., 2007; Wolfson et al., 2013), it is possible that the disparity in study results could be related to procedural differences between studies. Although our bias and precision values with and without the ear tap step were both within the acceptable range, better agreement was found when the ear tap step was not included.

This is the first study to evaluate the impact of the ear tap step on bias and precision. Although the manufacturer's directions (Exergen Corporation, 2007; M. Pompei, personal communication, September 1, 2016) stress the need for this step to improve accuracy in clinical situations in which forehead temperatures may differ from core temperatures (i.e., diaphoresis; fever), data from this study found better bias and precision values without the ear tap step. Additional studies are needed to verify these results, particularly in adults with and without diaphoresis and a range of body temperatures (hypothermia; normothermia; and hyperthermia). If the ear tap step is not found to improve accuracy of temporal artery temperatures, the manufacturer should consider removing the step from the device procedural directions.

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Disposable Oral Electronic Thermometer

Despite the growing use of disposable equipment in patient care today, limited research on device accuracy has been conducted on many of these devices. This is especially true of the disposable oral electronic thermometer that is used in many outpatient and inpatient units today. In the only published study of a disposable oral electronic thermometer, acceptable bias but not precision values were found in 49 critically ill patients (Counts et al., 2014). In that study, 21% of temperatures obtained with the MediChoice thermometer were more than 1.0 °F different from the nondisposable oral electronic thermometer, compared with only 4% in our study. One explanation for the different results found in our study may be related to the different models of the disposable oral electronic thermometer used in the two studies. Additional studies are needed to confirm the results of our study in a variety of different body temperatures and also to evaluate different models of the disposable oral electronic thermometers.

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Noncontact Infrared Thermometer

Our finding of bias values outside the acceptable range for the noncontact infrared thermometer is different from prior studies of this relatively new device (Apa et al., 2013; Chiappini et al., 2011; Fortuna et al., 2010; Kelechi et al., 2006; Osio & Carnelli, 2007; Paes et al., 2010; Selent et al., 2013; Sener et al., 2012; Teran et al., 2007). Several possible reasons for the difference could be related to anatomical variations in the adult and child forehead blood flow, the appropriateness of the reference thermometer, site of measurement, and/or different models of the thermometer used in the studies. Because infants and children have more superficial blood flow to the forehead and less skin thickness than adults, body heat may be easier to detect with the noncontact thermometer.

Another possible reason for the difference in our results and prior studies is that none of the prior studies used an appropriate comparison temperature (reference temperature). Additional studies of the noncontact infrared thermometer are needed in both children and adults before these devices should be used for clinical temperature assessment. Studies need to use an acceptable clinical reference thermometer for comparison with the noncontact thermometer and be done in patients with a range of different body temperatures.

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Study Limitations

This study was limited to outpatients with temperatures in the normal range. Different results may occur with febrile and/or hypothermic patients. Future studies should especially focus on testing the oral disposable and noncontact infrared thermometers in febrile and hypothermic patients, because there are no other clinical studies that have evaluated these devices in those temperature ranges. This study also evaluated only one type of oral disposable and noncontact infrared thermometer. Different results may occur with other models or manufacturers' devices. Future studies should evaluate other models of these devices.

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Clinical Implications

The findings of this study support the use of several different types of noninvasive thermometers in afebrile outpatients. Because the disposable oral thermometer had only one temperature difference of more than 1.0 °F, compared with noncontact infrared thermometer that had 40% higher than 1.0°, it may be a better alternative than the noncontact infrared thermometer when working with isolation patients. Although this study found improved bias and precision when the ear tap step was omitted when using the temporal artery thermometer, additional confirmatory studies are needed before changes are made in the directions for device use.

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Conclusions

Findings of this study support the use of both the temporal artery and disposable electronic thermometers in afebrile outpatients. Based on our results, the noncontact infrared thermometer is not recommended for clinical use at this time. Additional studies are needed to confirm the bias and precision values of the noncontact infrared thermometer in patient care situations.

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ACKNOWLEDGMENT

Special thanks to Marianne Chulay, PhD, RN, FAAN, for assistance with study design, data analysis, and manuscript preparations.

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