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ORIGINAL ARTICLE

Evaluating the accuracy of the VitalWellness

device
Nicole Polanco1,2*, Sharon Odametey1,2,3, Seyyedeh Neda Derakhshani1,2, Mark Khachaturian4,
Connor Devoe1,2, Kamal Jethwani1,2,3, Sujay Kakarmath1,2,3
1
Connected Health Innovation, Partners HealthCare, 2Department of Dermatology, Massachusetts General Hospital, 3Harvard Medical
School, 4Vital USA, USA

ABSTRACT
Background and Objective: Portable and readily accessible wellness devices can aid vital sign measuring for those interested
in tracking their health. In this diagnostic accuracy study, we evaluated the performance of the VitalWellness device (VW), a
wireless, compact, noninvasive device that measures four vital signs (VS) – blood pressure (BP), heart rate (HR), respiratory
rate (RR), and body temperature (BT) – using the index finger and forehead. Methods: Adult volunteers with VS that fell both
within and outside of the normal physiological range were enrolled to provide BP, HR, RR, and BT measurements using both
the VW and Food and Drug Administration-approved reference devices. A subgroup of participants underwent an additional
test to analyze the VW’s performance on HR and RR outside of normal physiological ranges. Statistical measurements were
plotted on scatter and Bland–Altman plots. Sensitivity analyses to evaluate the VW’s performance by gender, skin color, finger
size, and auxiliary activities were performed. Results: A total of 263 participants completed the study. On an average, systolic
BP measured using the VW was 10 mmHg lower than that of the reference device (correlation coefficient r = 0.7), whereas
diastolic BP was 3 mmHg lower (r = 0.6), and RR was 2 bpm lower (r = 0.7). VW HR and BT measurements were, on average,
1 bpm and 0.3°F higher than the corresponding reference measurements (r = 0.9 and r = 0.3), respectively. Conclusion: The
VW device is well-suited for home-based, nonmedical monitoring of HR, RR, and BP. Further improvement in measurement
accuracy is required to enable applications for medical use.
Keywords: Cuff-less blood pressure monitor, monitoring, vital signs, Wellness device

INTRODUCTION trend is growing, driven largely by the availability of a

Wellness devices for remote health tracking and
monitoring have been reported to help up to 56% of the
United States population living with chronic conditions
to actively manage their disease(s).[1] In the US, patients
living with chronic conditions account for about 75%
of all healthcare expenditures per year: over $1 trillion
dollars annually.[2] Even among healthy individuals this
*Address for correspondence:
Nicole Polanco, BA,
Partners Healthcare, 25 New Chardon St., 3rd Floor,
Suite 300, Boston, 02114, Massachusetts, USA.
E-mail: nvpolanco@partners.org
Access this article online
Quick Response Code
Website:
www.digitmedicine.com
variety of health tracking tools and mobile devices such as
smartphones and smartwatches. National data provided
by the Pew Research Center indicates that “69% of U.S.
adults keep track of at least one health indicator.”[1] Access
to tracking and monitoring tools may help individuals
become more aware of their own health status and may
facilitate change toward healthy behaviors.[3-5]
When monitoring patient health, health-care providers
(HCP) depend on vital signs (VSs) – including height,
weight, blood pressure (BP), heart rate (HR), respiratory
This is an open access journal, and articles are distributed under the terms of
the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License,
which allows others to remix, tweak, and build upon the work non-commercially,
as long as appropriate credit is given and the new creations are licensed
under the identical terms.
For reprints contact: reprints@medknow.com

DOI:
How to cite this article: Polanco N, Odametey S, Derakhshani SN,
10.4103/digm.digm_22_19 Khachaturian M, Devoe C, Jethwani K, et al. Evaluating the accuracy of the
VitalWellness device. Digit Med 2019;5:109-18.

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Polanco, et al.: Evaluating the accuracy of the VitalWellness device
rate (RR), and body temperature (BT).[6] Regular VS
monitoring may allow HCP to detect issues early so
they can provide the care needed to mitigate negative
health outcomes and contain health-care costs.[7,8] VS
measurement can be a time- and people-intensive
process, requiring several sessions per day. Moreover,
hospital monitoring devices require staff to transfer
data to a patient’s electronic medical record, introducing
opportunities for human error.[9]
Advances in technology have provided multiple tools to
monitor VS remotely, thereby allowing HCPs to closely
monitor patients outside of the hospital.[10] However,
most commercially available VS remote monitoring
devices target a single VS measurement, and users may
need up to five different devices.[11] Using multiple devices
to transmit data to caregivers is cumbersome and may
cause delays in reporting.[12] Having a single device that
can perform multiple measurements, within a short span
of time may offer a better experience for users.
Vital USA has developed a wireless device – the
VitalWellness (VW) – to measure four VS using the index
finger and forehead. The device can transmit information
electronically and is part of the VW platform, which
also includes the Vital app. Using a single, small wireless
device that transmits data in real time through Bluetooth
to a smartphone application could enable individuals
to be more involved in managing their health.[13] The
device is intended to monitor VS outside of the medical
environment; can be used remotely, without trained
clinical staff; and reduces personnel and equipment
needed to measure VS.
METHODS
The primary aim of this study was to assess the accuracy
of the VW in measuring four VS (BP, HR, RR and BT)
in comparison with the Food and Drug Administration
(FDA)-approved reference devices typically used in a
hospital environment. The study protocol was approved
by the Partners Healthcare Institutional Review Board
and is registered on the NIH clinical trials website
(NCT03589716).
The VitalWellness device
The VW is a compact VS measurement device that uses
proprietary sensor technology to non-invasively measure
four VS [Figure 1]. BP, HR, and RR are measured from a
person’s left index finger and BT at the forehead. Results
are transmitted through Bluetooth to a smartphone which
displays the results via a mobile application. The app
110
Figure 1: VitalWellness device
collects and tracks data to show longitudinal trends, and it
also guides users on how to capture their VS measurements.
The VW is connected to a smartphone for storage and
has a USB interface for charging, thereby requiring no
electrical connection during use. Measurements are taken
with the device, independent of the phone.
BP is calculated with an inflatable finger cuff and
dynamic light scattering (DLS) sensor subsystem which
measures blood flow after occlusion to calculate systolic
BP (SBP) and diastolic BP (DBP). HR is calculated by
photoplethysmography (PPG)-based subsystem from
the ratio of 660 (nm) and 940 (nm) light absorption in
the finger. RR is evaluated through a combination of
DLS and PPG subsystems. BT is calculated through an
FDA-510(k)-approved infrared sensor and proprietary
BT algorithm.
Reference devices
The FDA-approved Welch Allyn 767 Mobile Aneroid
Sphygmomanometer and the 3M Littman Master
Classic II Teaching 40-inch Stethoscope, used together,
measured BP. The Welch Allyn Connex Spot VS Monitor
measured HR and BT. The Capnostream™ Portable
Bedside Capnograph obtained EtCO2 waveforms for RR
assessment, which were then read by a physician.
Sample size
Sample size was determined based on consensus guidelines
recommended by the International Standardization
Organization (ISO) for each VS [Table 1].[14,15] A total of up
to 80 participants with VS within the normal physiological
range and up to 190 participants with VS outside of the
normal physiological range were required to participate.
Assuming that up to 5% of the study participants who
attended the in-person enrollment visit might withdraw
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Polanco, et al.: Evaluating the accuracy of the VitalWellness device

Table 1: Sample size

VS Participants with VS within Participants with VS outside of Number of readings Total number Total number
the normal physiological range the normal physiological range per participant of participants of readings
BP 40 45 3 85 255
HR 80 40 3 120 360
RR 60 30 1 90 90
BT 70 35 1 105 105
Total 80a 190b - 270 -
a
All VS were measured in participants with VS outside of the normal physiological range; therefore, the total sample size is equal to the highest value in the
column. bParticipants underwent measurement only for the specific VS they were recruited for. Therefore, the total sample size is equal to the sum of all
values in the column. BP: Blood pressure, VS: Vital sign, HR: Heart rate, RR: Respiratory rate, BT: Body temperature

their consent during the study; we estimated the final
sample size at 284.
Recruitment
Study volunteers were recruited from the public and clinical
practices within the Partners HealthCare System (PHS).
The study was advertised on three online portals: The PHS
clinical trials website, Craigslist.com and the NIH clinical
trials website. Study investigators also sought patients from
the Wellesley Family Care Associates clinic, the Massachusetts
General Hospital Revere Health Center, and the Brigham and
Women’s Hospital Division of Renal Medicine. In addition,
study staff sent out letters and made recruitment phone calls
to study volunteers from previous studies at PHS who had
consented to being contacted for future research.
Eligibility criteria
Volunteers age ≥18  years with enough understanding
of the English language to understand and consent to
study procedures were eligible to participate. The study
participants with physical disabilities that precluded
safe and adequate testing, and those with implanted or
body-worn electronic medical devices were excluded. For
measurements using exercise or aerobic step testing, the
following study volunteers were excluded: VS outside of
normal physiological range during initial measurements;
age ≥65  years; self-report of food, alcohol or caffeine
consumption within 3 h of testing; pregnant; self-
reported history of fall or fracture in the past year; those
with arthritis, dizziness, neurological illness, chest pain,
myocardial infarction, heart disease, stroke, transient
ischemic attack; self-report of being under active treatment
for anemia, electrolyte imbalance or hyperthyroidism;
and mental impairment with limited ability to cooperate.
Participants with nail polish or artificial nail on the left
index finger were excluded from HR measurements. The
following exclusions applied for the paced breathing test:
VS outside of normal physiological range; history of
seizures or epilepsy; panic attacks; history of respiratory
or heart disease; hyperthyroidism; and/or pregnancy.
Study protocol
The study participants were instructed not to consume
food, alcohol, or caffeine in the 30-min period before the
study visit.
Participants were enrolled in a quiet, temperature-
controlled room. To enable the assessment of variability
in measurements due to differences in finger size, a
Mudder Ring Gauge was used to measure participants’
left index finger size. Skin color was assessed using
the NIS Skin Color Scale,[16] which required trained
study staff to make a subjective judgment of skin
color and assign a score based on the scale. VS were
measured first with the VW, then with the respective
reference device. Different staff members obtained
measurements using the VW and the reference devices,
respectively, and each was blinded to measurements
taken by the other.
Study staff recorded any VW device failure as a “failed
measurement” while collecting VS measurements. This
included connection loss between device and cellphone,
device freezing or turning off during testing, and errors in
participants’ finger position.
Blood pressure measurement
Participants placed their left index finger inside of
the VW finger cuff, held the device in their palm, and
placed it on their chest at heart level for 3 min. Two
consecutive measurements were taken. Thereafter, two
reference BP measurements were obtained by two staff
simultaneously. The ISO 2009 guidelines were followed
using the aforementioned sphygmomanometer and
stethoscope.[15]
Per VW user guidelines, if two consecutive VW
measurements for a given participant differed by
≥12  mmHg for SBP or by ≥8  mmHg for DBP,
the complete set of measurements (including the
reference device measurements) was discarded.
Otherwise, the first measurement was recorded as

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Polanco, et al.: Evaluating the accuracy of the VitalWellness device
the VW value for SBP and DBP, and the second
one was discarded. Similarly, if the two reference
measurements differed by ≥4  mmHg, the set of
measurements was discarded, and a fresh set was
obtained after a 10-min wait. [15]
Heart rate measurement
Using the VW and the Welch Allyn Connex Spot Monitor
one after the other, HR was administered three times on
the participant’s index finger for 1 min each.
To obtain HR values >130 beats/min, eligible participants
underwent either a cycle ergometer test or an aerobic step
test.
• Exercise physiologists used the Borg Scale to assess
the participant’s perceived exertion on a Scifit 100R
Cycle Ergometer every 3 min. The resistance level of
the ergometer was increased by 10 watts every 3 min
until the participant reached a perceived exertion level
of “somewhat hard”
• The Harvard step test protocol was used for aerobic
step testing.[17] The reference device was placed on the
participant’s finger to enable real-time monitoring of
HR. Participants were asked to step up and down in
synchrony with a metronome set at 96 beats/min. The
procedure lasted for 5 min, or until the participant’s
HR reached 140 beats/min.
Respiratory rate measurement
RR was measured using the Capnostream™ Monitor and
the VW simultaneously. The participant breathed into a
nasal prong capnography sensor that captured exhaled
air. The EtCO2 waveform was then printed and read by a
physician to confirm the RR value.
To obtain RR values >30 breaths/min, eligible study
participants underwent a paced breathing test. They
matched their breathing to a metronome set variably
between 60 and 80 beats/min (that is, 30–40 breaths/min)
for up to 100 s.
Temperature measurement
To measure temperature, study staff placed the VW 0.5–1”
away from a participant’s forehead and held the power
button for 1 s. Staff then placed the temperature probe
in the posterior pocket under the participant’s tongue to
obtain BT measurements.
Artifact testing
To test the variability of VS measurements, a sub-
sample of participants (n = 15) were asked to cough
(n = 5), drink water (n = 5) or talk (n = 5) while VS were
112 DIGITAL MEDICINE / VOLUME 5 / ISSUE 3 / JULY-SEPTEMBER 2019
measured in accordance with the procedures outlined
above.
Statistical analysis
We calculated correlation coefficients, mean, standard
deviation, mean difference, standard deviation of mean
difference, and standard error of the mean difference with
95% confidence intervals for measurements obtained by the
VW and respective reference devices. The measurements
were plotted on a scatter plot and a Bland–Altman plot.
We conducted exploratory data analysis and identified
data points that might bias the estimated correlation
between the VW and reference devices. For BT
measurements, implausible data points (<96°F
or >104°F) were identified and excluded. For BP
measurements, a complete set of measurements
was excluded if the reference device measurements
were ≥12  mmHg for SBP or ≥8  mmHg for DBP.[15]
Thereafter, data points having the greatest influence
on the correlation coefficient were identified using
Cook’s distance and excluded from the final set of
measurements, using a cutoff value of 0.05.
For sensitivity analyses, mean difference with 95%
confidence intervals was calculated for subgroups based
on gender, finger size, skin color, and the presence of
auxiliary activities. We compared the mean differences
between subgroups using an independent sample t-test.
RESULTS
Study population
The study enrolled 265 participants, with two withdrawing
before the study completion [Figure 2]. The total sample
Screened
(n = 375) Excluded
-Ineligible (n = 1)
-Decline (n = 6)
-Did not schedule appointment (n = 21)
-Canceled appointment (n = 73)
-No show (n = 9)
Eligible
(n = 265)
Enrolled
(n = 265)
Withdrew Consent
(n = 2)
Completed
(n = 265)
Figure 2: Recruitment and enrollment flow chart
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Polanco, et al.: Evaluating the accuracy of the VitalWellness device

(n = 263) were aged 18–97, with a median of 38 years old. Table 2: Study population characteristics (n=263)
Nearly two-thirds of participants were female, most were Study population characteristics Subject population
Caucasian, and two-thirds self-reported their educational (n=263)
status as “college or post college.” More than half of the Age distribution, median (range) 38 (18-97)
participants self-reported their occupation as “employed,” Gender, n (%)
Female 164 (62)
followed by “student” (14%) and “unemployed” (14%). Race, n (%)
About three-fourths of the study participants were White 163 (63)
subjectively assigned an NIS skin color score of 1–3 by Black or African American 46 (18)
study staff, 20% of them were given skin color scores of Asian 26 (10)
Other or >1 race 23 (9)
4–6, and <4% were determined to have a skin color score
Unknown (excluded in calculations) 5
>6 [Table 2]. Max level of education, n (%)
Less than high school 8 (3)
Vital signs High school diploma or GED 29 (11)
Some college/vocational program/ 51 (19)
Statistical measurements were plotted on scatter and technology program
Bland–Altman plots to show correlation between VW and College graduate or professional degree 175 (67)
reference device measurements [Figures 3 and 4]. Table 3 Employment statusa, n (%)
and Figure 5 show which VS measurements were included Employed 155 (59)
Unemployed 38 (14)
in the final analysis. Table 4 shows the mean values and Homemaker 15 (6)
differences for VS measured by reference device and VW. Student 38 (14)
The sensitivity analysis did not suggest any differences in the Retired 28 (11)
performance of the VW by gender, skin color, or auxiliary Disabled 13 (5)
Ring sizeb, n (%)
activities [Tables 5 and 6]. However, the mean difference of
First tertile 79 (30)
the RR – but not the other VS – between the reference and Second tertile 88 (33)
VW was lower for larger finger sizes [Table 6]. Third tertile 96 (37)
NIS skin color scale, n (%)
1 54 (21)
DISCUSSION 2 105 (41)
3 40 (15)
Principal findings 4 28 (11)
We compared measurements for four VS from the VW 5 14 (5)
in comparison with the FDA-approved reference devices 6 10 (4)
and conclude that the measurements correlate well for 7 5 (2)
8 3 (1)
HR, RR, and BP. 9 0
10 0
HR obtained from the VW are similar in accuracy to those Unknown (excluded in calculations) 4
reported for commercially-available wrist-worn devices a
Study participants were allowed to self-report more than one employment.
Therefore, the totals in this section of the table are greater than the sample
and superior to those reported for smartphone-based size, and the percentages sum to greater than 100%, bSubgroups are
applications that use optical input from the phone’s adjusted for gender. The first tertile includes ring size <7.5 for women, and
<9.5 for men. The second tertile includes ring size 7.5-9 for women, and
camera to determine HR.[18] The accuracy of the VW for 9.5-11.5 for men. The third tertile includes ring size ≥9 for women, and
SBP and DBP is similar to that of smartphone-based ≥11.5 for men. NIS: New immigrant survey

BP monitoring through the oscillometric finger-pressing

method, but lower than FDA-approved home BP Table 3: Vital signs included in analysis
monitoring devices.[19-21] VS Total Discarded Discarded Included in
readings outliers (%)# other (%)# analysis#
BP 615 2 (0.3) SBP 517 (84) 96 (16) SBP
The accuracy of the VW for RR measurements is lower
5 (0.8) DBP 93 (15) DBP
than that reported for continuous RR monitors designed for HR 454 6 (1) 0 448 (99)
hospital use as well as that reported for human observers by RR 97 1 (1) 0 96 (99)
counting for a full minute or counting for 15 s and quadrupling Temperature 148 1 (1) 3a (2) 145 (98)
the value.[22-25] We did not find any peer-reviewed validation Data point outside of plausible range (96°-104°F). BP: Blood pressure,
a

SBP: Systolic BP, DBP: Diastolic BP, VS: Vital sign, HR: Heart rate,
reports on wellness devices that measure RR. RR: Respiratory rate

The estimated correlation of the VW for BT was the mean difference in temperature measurements
lower than that observed for other VS. However, is quite low compared to the reference device and

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Polanco, et al.: Evaluating the accuracy of the VitalWellness device

Figure 3: Correlation between vital sign measured using the reference device and that measured with VitalWellness. r = Pearson’s correlation
coefficient

Table 4: Mean values and difference for vital signs measured by reference device and VitalWellness
VS Reference, VW, mean Mean differencea SD of SEM Correlation
mean (SD) (SD) (95% CI) difference difference coefficient (95% CI)
SBP (n=96) 111 (15) 101 (13) 10 (8-12) 11 1 0.7 (0.6-0.8)
DBP (n=93) 69 (11) 66 (8) 3 (1-5) 9 0.9 0.6 (0.4-0.7)
HR (n=448) 73 (13) 74 (13) −1 (−2-−0.6) 6 0.3 0.9 (0.88-0.92)
Temperature (n=144) 98 (0.3) 99 (0.6) −0.3 (−0.4-−0.2) 0.6 0.1 0.3 (0.1-0.4)
RR (n=97) 21 (8) 19 (4) 2 (0.3-3) 6 0.6 0.7 (0.6-0.8)
a
Difference has been calculated as reference minus VW. VW: VitalWellness, VS: Vital sign, CI: Confidence interval, SBP: Systolic blood pressure, DBP: Diastolic
blood pressur, HR: Heart rate, RR: Respiratory rate, SD: Standard deviation, SEM: Standard error of the mean

Table 5: Differences in vital sign measurements between the reference device and VitalWellness in the
study participant subgroups
VS Gender Skin color (NIS Scale)
Male Female 1-2 3-4 ≥5
n Mean difference n Mean difference n Mean difference n Mean difference n Mean difference
(95% CI) (95% CI) (95% CI) (95% CI) (95% CI)
SBP 33 9 (6-13) 63 10 (7-13) 56 11 (8-14) 28 8 (3-12) 11 10 (1-19)
DBP 31 3 (−0.6-6) 62 3 (1-5) 52 3 (0.9-6) 29 3 (−0.1-6) 11 4 (−3-11)
HR 156 −0.7 (−2-0.1) 292 −1 (−2-−0.7) 267 −0.9 (−2-−0.3) 120 −1 (−3-−0.2) 55 −1 (−3-−0.1)
Temperature 49 −0.4 (−0.5-−0.2) 95 −0.3 (−0.4-−0.1) 83 −0.3 (−0.4-−0.1) 39 −0.5 (−0.7-−0.3) 20 −0.1 (−0.4-0.2)
RR 48 2 (−0.2-3) 49 2 (−0.2-3) 65 2 (0.3-3) 18 0.4 (−2-3) 10 2 (−4-9)
CI: Confidence interval, SBP: Systolic blood pressure, DBP: Diastolic blood pressure, VS: Vital sign, HR: Heart rate, RR: Respiratory rate, NIS: New
immigrant survey

suggests that the correlation coefficient may have measurement devices is higher than that of the VW.[27]
been impacted by low variability within obtained However, the mean difference in temperature for
temperature measurements.[26] The reported accuracy the VW is substantially lower than that reported for
of commercially-available wireless dermal temperature temporal artery thermometers.[28]

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Figure 4: Bland-Altman plots of the difference in vital sign measurements between the reference device and VitalWellness. Solid lines indicate
mean difference and dotted lines indicate limits of agreement

Table 6: Differences in vital sign measurements between the reference device and the VitalWellness in
the study participant subgroup
VS Finger size Presence of artifactsa
First tertile Second tertile Third tertile
n Mean difference n Mean difference n Mean difference n Mean difference
(95% CI) (95% CI) (95% CI) (95% CI)
SBP 27 9 (5-14) 36 8 (4-12) 33 12 (9-16) 14 5 (−5-15)
DBP 24 4 (0.8-7) 35 1 (−2-4) 34 5 (2-8) 13 5 (−2-12)
HR 168 −1 (−2-−0.2) 131 −0.5 (−1-0.4) 149 −2 (−3-−0.8) 14 1 (−3-5)
Temperature 48 −0.3 (−0.5-−0.2) 44 −0.4 (−0.6-−0.2) 52 −0.2 (−0.4-0.01) 14 0.04 (−1-1)
RR 28 4 (2-6) 40 2 (−0.6-4) 29 −0.6** (−3-1) 13 2 (−0.2-4)
**P<0.01. aIncluding coughing, drinking water, or talking. CI: Confidence interval, SBP: Systolic blood pressure, DBP: Diastolic blood pressure, VS: Vital
sign, HR: Heart rate, RR: Respiratory rate

Previous clinic-based studies have found accuracy wrist-worn sensors can vary based on skin tone.[18]
(difference of >5 mmHg) of SBP measured using The accuracy of the VW for all VS did not seem to
home BP devices to differ systematically by age, be influenced by gender, skin tone, finger size, or
gender, and size of cuff used.[19] Similarly, HR with auxiliary activities.

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Polanco, et al.: Evaluating the accuracy of the VitalWellness device

app guides the user at home, this is unlikely to affect the

Total BP readings Excluded:
(n = 615)
accuracy of the device.
Probable Observer error: Reference
device readings
≥4 mmHg between observers To provide a greater number of usable BP readings
(n = 184)
in future studies, a reassessment of study procedures
Readings after could be undertaken, including rest time before taking
observer error
removed Excluded:
BP measurements. In addition, obtaining more than
(n = 431) Device use guideline: VW SBP three BP readings per participant may be considered.
readings ≥ 12mmHg or DBP
readings ≥ 8mmHg
RR measurements outside of the physiological range
(n = 226) included in the analysis were obtained through
Readings after device
use guideline applied voluntary efforts by the participant in this study.
(n = 205) Future studies should consider recruiting participants
who naturally have RR outside of the physiological
Excluded:
Probable Reference device error: range.
measurement ≥ 12mmHg for SBP
Readings after or ≥ 8mmHg for DBP
reference device (n = 107)
There are two key strengths to this study. First, as far as
error we know, this is the first large-scale demonstration of
removed
(n = 98) successful BP measurement from the finger. Previous
studies have tested mobile applications and devices for
Excluded: BP but have enrolled a substantially smaller sample size,
Data points with high influence: 35–85 subjects compared to 263 in this study. One study
(Cook’s distance > 0.05) on
Readings correlation tested a BP app that required participants to use their
included in
final analysis
coefficient fingers to press on the smartphone’s screen and camera.
SBP (n = 2); DBP (n = 5)
SBP (n = 96) This method unlike the VW, required participant’s
DBP (n = 93) date of birth, sex, height, and weight.[30] Users may not
always have this information available to accurately use
Figure 5: Blood pressure readings included in the analysis
the app. Another study tested a small sensor attached
to a smartphone to collect BP via the user’s finger.
Strengths and limitations
Although the study compared the device’s performance
The study has several limitations. First, 75% of readings to an FDA approved BP measuring device, they did not
collected for BP were not included in the final analysis follow rigorous recruitment guidelines to make sure
to mitigate bias from observer error, within-person that they were accounting for a wide range of possible
variability in BP, and statistical outliers, as well as to BP measurements. Furthermore, this oscillometric
comply with VW device usage guidelines, and hence, we method does not provide nighttime BP measurements,
may have overestimated the magnitude of the correlation limiting the access to BP information. Another study
coefficient.[26] Second, RR measurements outside of that validated a cuffless device to collect BP showed
normal physiological ranges were obtained artificially promising results when tested against validated
by instructing study participants to synchronize their oscillometric BP monitors. However, the device does
breathing to a metronome. This artificially reduced the not provide DBP measurements, limiting the amount
variability in the data and possibly, underestimated the of information accessible to users. BP cuffless devices
RR correlation coefficient. Similarly, the range of values have mixed results, but like the VW, cuffless BP devices
obtained from temperature measurements was narrow may provide a compact and efficient way for patients
and may have underestimated the correlation coefficient. to measure their BP. Measurement of BP using the
Fourth, the race and ethnicity of participants do not arm is procedurally complex, has low reliability and is
represent the general population of the United States.[29] associated with poor patient adherence.[30] Furthermore,
However, results from the sensitivity testing by gender, the performance of the device for BP and other VS is
skin color, and finger size suggest that the device may likely to improve substantially once it is commercially
perform with similar accuracy in a more diverse sample available and data from a larger user pool is available to
of participants. Finally, the laboratory environment, in improve the algorithm underlying the measurements.
which the measurements were conducted by trained staff Finally, the study methods used for data collection and
is unlike a person’s home. However, as the companion analysis, were rigorous and followed protocols and

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Polanco, et al.: Evaluating the accuracy of the VitalWellness device
guidelines recommended by the FDA for evaluation of
medical devices.
CONCLUSION
Current methods of measuring VS require multiple
devices and clinical staff to record these measurements. In
contrast, the VW allows for fast and accurate measurement
of key VS with minimal app-guided training. It can serve
as a convenient tool for users who monitor and track their
VS measurements remotely.
The VW device is well-suited for home-based, nonmedical
monitoring of HR, RR, and BP. Further studies with
more data variability are needed to conclusively assess
the accuracy of BT readings from the device, as well as
to evaluate usability and acceptability of the device by
end-users.
Acknowledgments
We would like to thank the following staff for helping
recruit and enroll participants into the study: Stephen
Agboola, M. D, M. P. H, Mursal Atif, Amanda J. Centi,
P. h. D, Odeta Dyrmishi, Felicia Estrada, Harriett
Gabbidon, Margaret Gorini, R. N, Saafia Masoom, Jessica
Odotei, R. N, Ramya Palacholla, M. D, M. P. H. Emily
de Redon and Nina Schussler. The following staff
provided financial and material support by tracking
and requesting sponsor payments: Colin Gorman. The
following staff provided support during the editing phase
of the manuscript draft: Julie R. Brown. The following
staff provided their clinics and patients for enrollment in
the study: Mallika L. Mendu, M. D, M. B. A, Jeffrey W.
Phillips, M. D, Sushrut S. Waikar, M. D and Amy Wheeler,
M. D. The following department and staff provided the
equipment and their expertise necessary to administer
the exercise test for the study: The MGH Cardiovascular
Disease Prevention Center.
Financial support and sponsorship
Vital USA financially supported this research study.
Conflicts of interest
The only conflict of interest to declare within the
manuscript is that the author, Mark Khachaturian, Ph.D.,
is employed by Vital USA, the company who financially
sponsored the study.
REFERENCES
1. Report Tracking. Washington, D.C: Pew Research Center; 2013.
Available from: https://www.pewinternet.org/2013/01/28/tracking-
for-health/. [Last accessed on 2019 Sep 23].
DIGITAL MEDICINE / VOLUME 5 / ISSUE 3 / JULY-SEPTEMBER 2019
2. Centers for Disease Control and Prevention. Chronic Disease
Prevention and Health Promotion. Available from: http://www.
cdc.gov/fmo/topic/budget%20information/factsheets/CHRONIC_
Factsheet.pdf. [Last accessed on 2019 Sep 23].
3. Kutz D, Shankar K, Connelly K. Making sense of mobile – And web-
based wellness information technology: Cross-generational study.
J Med Internet Res 2013;15:e83.
4. Paré G, Jaana M, Sicotte C. Systematic review of home telemonitoring
for chronic diseases: The evidence base. J  Am Med Inform Assoc
2007;14:269-77.
5. Yilmaz T, Foster R, Hao Y. Detecting vital signs with wearable
wireless sensors. Sensors (Basel) 2010;10:10837-62.
6. Kellett J, Sebat F. Make vital signs great again – A call for action. Eur
J Intern Med 2017;45:13-9.
7. Appelboom G, Camacho E, Abraham ME, Bruce SS, Dumont EL,
Zacharia BE, et al. Smart wearable body sensors for patient self-
assessment and monitoring. Arch Public Health 2014;72:28.
8. Weenk M, van Goor H, Frietman B, Engelen LJ, van Laarhoven CJ,
Smit J, et al. continuous monitoring of vital signs using wearable
devices on the general ward: Pilot study. JMIR Mhealth Uhealth
2017;5:e91.
9. Ludikhuize J, Smorenburg SM, de Rooij SE, de Jonge E. Identification
of deteriorating patients on general wards; measurement of vital
parameters and potential effectiveness of the modified early warning
score. J Crit Care 2012;27:424.e7-13.
10. Fanucci L, Saponara S, Bacchillone T, Donati M, Barba P, Sanchez-
Tato I, et al. Sensing devices and sensor signal processing for remote
monitoring of vital signs in CHF patients. EEE Trans Instrum Meas
2013,62:553-69.
11. Dias D, Paulo Silva Cunha J. Wearable health devices-vital sign
monitoring, systems and technologies. Sensors (Basel) 2018;18:2414.
12. Kaur A, Student ME. A review of remote patient monitoring system:
Potentials, challenges and current issues. International Journal of
Trend in Research and Development 2016;3:2394-933.352.
13. George J, MacDonald T. Home blood pressure monitoring. Eur
Cardiol 2015;10:95-101. [Doi: 10.15420/ecr.2015.10.2.95].
14. International Organization for Standardization. Medical Electrical
Equipment-Particular Requirements for Basic Safety and Essential
Performance of Clinical Thermometers for body Temperature
Measurement. (ISO 80601-2-56). International Organization for
Standardization; 2017.
15. International Organization for Standardization. Non-Invasive
Sphygmomanometers – Part 2: Clinical Investigation of Automated
Measurement Type (ISO 81060-2:2013). Geneva: International
Organization for Standardization; 2013.
16. Massey DS, Martin JA. 2003. The NIS Skin Color Scale. Switzerland:
International Organization for Standardization; 2013.
17. Harvey S. The No Sweat Exercise Plan: Lose Weight, Get Health, and
Live Longer (Harvard Medical School Guides). Blacklick: McGraw-
Hill; 2006.
18. Chandrasekhar A, Kim CS, Naji M, Natarajan K, Hahn JO,
Mukkamala R. Smartphone-based blood pressure monitoring via the
oscillometric fi nger-pressing method. Sci Transl Med 2018;10:431.
19. Ruzicka M, Akbari A, Bruketa E, Kayibanda JF, Baril C,
Hiremath S. How accurate are home blood pressure devices in use?
A cross-sectional study. PLoS One 2016;11:e0155677.
20. Hodgkinson JA, Sheppard JP, Heneghan C, Martin U, Mant J,
Roberts N, et al. Accuracy of ambulatory blood pressure monitors:
A systematic review of validation studies. J Hypertens 2013;31:239-50.
21. Shcherbina A, Mattsson CM, Waggott D, Salisbury H, Christle JW,
Hastie T, et al. Accuracy in wrist-worn, sensor-based measurements
of heart rate and energy expenditure in a diverse cohort. J Pers Med
2017; 7:7-9.
22. Subbe CP, Kinsella S. Continuous monitoring of respiratory rate in
117
[Downloaded free from http://www.digitmedicine.com on Monday, May 9, 2022, IP: 41.141.147.155]

Polanco, et al.: Evaluating the accuracy of the VitalWellness device

emergency admissions: Evaluation of the RespiraSense™ sensor in
acute care compared to the industry standard and gold standard.
Sensors (Basel) 2018;18. pii: E2700.
23. Donnelly N, Hunniford T, Harper R, Flynn A, Kennedy A, Branagh D,
et al. Demonstrating the accuracy of an in-hospital ambulatory patient
monitoring solution in measuring respiratory rate. Conf Proc IEEE
Eng Med Biol Soc 2013;2013:6711-5.
24. Takayama A, Takeshima T, Nakashima Y, Yoshidomi T, Nagamine T,
Kotani K. A  comparison of methods to count breathing frequency.
Respir Care 2019;64:555-63.
25. Rimbi M, Dunsmuir D, Ansermino JM, Nakitende I,
Namujwiga T, Kellett J. Respiratory rates observed over 15 and 30
s compared with rates measured over 60 s: Practice-based evidence
from an observational study of acutely ill adult medical patients
during hospital admission. QJM 2019;112:513-7.
26. Goodwin L, Leech N. Understanding correlation: Factors that affect
the size of r. J Exp Educ 2006;74:249-66.
27. Zsuzsanna Balla H, Theodorsson E, Ström J. Evaluation of commercial
wireless dermal thermometers for surrogate measurements of core
temperature. Scand J Clin Lab Invest 2019;79:1-6.
28. Geijer H, Udumyan R, Lohse G, Nilsagård Y. Temperature
measurements with a temporal scanner: Systematic review and
meta-analysis. BMJ Open 2016;6:e009509.
29. Available from: https://www.census.gov/quickfacts/fact/table/US/
PST045218. [Last accessed on 2019 Sep 23].
30. Milot JP, Birnbaum L, Larochelle P, Wistaff R, Laskine M, Van Nguyen P,
et al. Unreliability of home blood pressure measurement and the effect
of a patient-oriented intervention. Can J Cardiol 2015;31:658-63.

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