International Journal of Medical Informatics 116 (2018) 46–51

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International Journal of Medical Informatics

journal homepage: www.elsevier.com/locate/ijmedinf

A pilot study of daily telemonitoring to predict acute exacerbation in chronic T

obstructive pulmonary disease
Joanna Miłkowska-Dymanowskaa,b, Adam J. Białasa,b, Waldemar Obrębskia,b, Paweł Górskia,b,
⁎
Wojciech J. Piotrowskia,b,
a
Department of Pneumology and Allergy, Medical University of Łódź, Poland
b
Healthy Ageing Research Centre (HARC), Medical University of Łódź, Poland

A R T I C LE I N FO A B S T R A C T

Keywords: Background: Exacerbations of COPD (ECOPD) are important events in the course of COPD and they accelerate
Chronic obstructive pulmonary disease the rate of decline of lung function, and exacerbations requiring hospitalization are associated with significant
COPD mortality. Therefore, developing approaches of prevention and early treatment of ECOPDs are of special clinical
Telemonitoring interests. One of such approaches is telecare, including home telemonitoring.
Oxygen saturation
Material and methods: Daily telemonitoring of HR, BP, SpO2 and spirometry was performed. Variables were
compared using the bootstrap-boosted inference tests: the paired t-test or Wilcoxon signed rank test, depending
on data normality, and categorical variables were compared using exact McNemar's test.
Results: Nineteen patients were included to the study. We observed significant decrease in SpO2 7 days preceding
ECOPD (P = 0.007; Pbootstrap-boosted = 0.005) and increase in number of events of day-to-day decrease in
oxygen saturation > 4% in the period of 7 days preceding ECOPD versus reference period (P = 0.02).
Conclusions: Oxygen saturation telemonitoring would be successfully used in predicting ECOPD. Recording of
day-to-day decrease in oxygen saturation > 4% as alarming events would be effective approach which would be
easily implemented in telemonitoring devices, however this outcome should be further validated in larger size
samples.

1. Introduction prevent from ECOPDs and, as the effect, ameliorate prognoses.

Telemedicine is the use of telecommunication and information
Chronic Obstructive Pulmonary Disease (COPD) is one of the major technology to provide clinical health care from a distance. It has been
global health problems with more than 3 million people died in 2005, used to overcome distance barriers and to improve access to medical
and the estimations predict that it will become the third leading cause services that would often not be consistently available in distant com-
of death worldwide in 2030 [1]. COPD is characterized by persistent munities [7]. Telemedicine might be also one of the tool that help to
respiratory symptoms and airflow limitation that is due to airway and/ predict ECOPD, delayed hospitalizations and can fulfill an important
or alveolar abnormalities usually caused by significant exposure to role in enabling patients with COPD to better manage their condition
noxious particles or gases [2]. and remain out of hospital [8].
Exacerbations of COPD (ECOPD) are important events in the course The aim of the study was to assess the usefulness of pulse oximetry
of COPD and they accelerate the rate of decline of lung function [2–4]. (SpO2), heart rate (HR), blood pressure (BP), and spirometry in tele-
Exacerbations requiring hospitalization are associated with significant monitoring as the approach for early prevention of ECOPD.
mortality. Exacerbation, with hypercapnia (elevated level of carbon
dioxide in blood) is burdened with approximately 10% of in-hospital 2. Materials and methods
mortality [5]. Long-term prognosis following hospitalization for ECOPD
is also poor – according to metaanalysis by Hoogendoorn et al. the Patients with COPD in category D according to GOLD guidelines
average in-hospital mortality rate was 6.7%, the average mortality rates (the most severe category of COPD patients, those symptomatic and
at 3 and 6 months were 18% and 26%, respectively, and 51% at 5 years with high risk of death) were enrolled to the study form July 2014 to
[6]. This is why there is a strong need to elaborate approaches to August 2017. Patients were enrolled in the Outpatient Clinic and

⁎
Corresponding author at: Department of Pneumology and Allergy, 1st Chair of Internal Medicine, Medical University of Lodz, 22 Kopcinski Street, 90-153, Lodz, Poland.
E-mail address: [email protected] (W.J. Piotrowski).

https://doi.org/10.1016/j.ijmedinf.2018.04.013
Received 2 February 2018; Received in revised form 5 April 2018; Accepted 29 April 2018
1386-5056/ © 2018 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/BY-NC-ND/4.0/).
J. Miłkowska-Dymanowska et al. International Journal of Medical Informatics 116 (2018) 46–51

Fig. 1. Equipment used for telemonitoring: A. Mobile phone as a reporting device, B. sphygmomanometer, C. spirometer and pulse oximeter.

Department of Pneumology and Allergy of Medical University of Lodz. day-to-day variations and which leads to a change in medication. All
The main criterion was ≥1 exacerbation requiring hospitalization the events were confirmed by physician. Each patient was monitored
within last 12 months and/or ≥2 exacerbations not requiring hospi- until the first recorded exacerbation. The telemonitoring was termi-
talization with the need for systemic steroid therapy and/or antibiotic nated 19th December 2017.
therapy. All patients had to obtain positive result in Mini Mental Test Continuous data was presented as the mean with standard deviation
and training with the use of telemedicine equipments. Informed consent (SD) or median with interquartile range (IQR), depending of distribu-
was obtained from all subjects. Study was approved by the Institutional tion of data. Data were stratified using two periods: reference period
Ethical Committee and informed consent was obtained from all pa- (7 days within stable period of COPD) and period of 7 days preceding
tients. ECOPD. These time periods were based on previous evidence, which
Daily telemonitoring of following parameters was performed: HR, has suggested that symptoms tend to worsen during the 7 days im-
BP, SpO2 and spirometry (Spirotel®, MIR Company, Rome, Italy), using mediately before an exacerbation episode [9,10]. The “stable” period
equipment presented in Fig. 1. Measurements should have been made was defined as a next time window of 7 days before this time.
every day, in siting position, after 5-min rest. Those subjects who re- Variables were compared using the bootstrap-boosted inference
quired long term oxygen therapy (LTOT) were asked to use it during the tests: the paired t-test or Wilcoxon signed rank test, depending on data
measurements. The results were reported using telemetric system en- normality. Categorical variables were compared using exact McNemar's
tirely designed and produced for the purpose of this study (Mediguard test. P-value < 0.05 was considered as statistically significant.
®
) – Fig. 2. This software enables clinical data storage and analysis in Statistical analyses were performed using R software for MacOS.
real time. Monitoring staff have access to the data via protected internet
website, compatibile with all types of browsers, 24 h a day. 3. Results
As the exacerbation we recognized an event characterized by a
worsening of the patient’s respiratory symptoms that is beyond normal 29 patients were enrolled in the study, of whom 22 had ECOPD.

®
Fig. 2. Mediguard software interface, presenting day-to-day SpO2 in one of the patients (from 5 days of observation).

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J. Miłkowska-Dymanowska et al. International Journal of Medical Informatics 116 (2018) 46–51

Table 1 Table 3
Baseline population data. Abbreviations: IQR – interquartile range, GERD – Numbers of events with particular levels of day-to-day decrease in oxygen sa-
gastro-esophageal reflux, BMI – body mass index, LTOT – long term oxygen turation observed in analyzed periods. P-value and 1-β are given for exact
therapy, BODE – acronym for “Body-mass index, airflow Obstruction, Dyspnea, McNemar’s tests.
and Exercise”, MMSE – Mini–Mental State Examination, CAT – COPD
Desaturation Reference period n 7 days preceding ECOPD n P-value 1-β
Assessment Test, mMRC – Modified Medical Research Council, FVC – forced
(%) (%)
vital capacity, FEV1 – forced expiratory volume in 1 s.
1% 6 (31.58) 12 (63.16) 0.11 0.45
Parameter Result
2% 12 (63.16) 9 (47.37) 0.51 0.17
Age, years (SD) 68.37 (5.81) 3% 5 (26.32) 6 (31.58) 1.0 0.06
Female, n (%) 14 (73.68) 4% 5 (26.32) 1 (5.26) 0.22 0.37
History of COPD, years (IQR) 8 (3.5–11) > 4% 3 (15.79) 10 (52.63) 0.02 0.81
History of smoking, n (%) 18 (94.74)
Ex-smoker, n (%) 15 (78.95)
Active-smoker, n (%) 3 (15.79) 4. Discussion
Never-smoker, n (%) 1 (5.26)
Pack-years (SD) 34.33 (14.08)
Our study aimed to analyze the usefulness of oxygen saturation
FEV1, L (SD) 0.99 (0.51)
FEV1, % (SD) 41.21 (17.68) telemonitoring in predicting ECOPD. We detected significantly de-
FVC, L (IQR) 2.05 (1.3–2.47) creased saturation in the period of 7 days preceding ECOPD. However,
FVC, % (SD) 66.62 (24.37) any way of summarizing data, such as mean, median and their deri-
FEV1/FVC (SD) 0.48 (0.14) vatives are clinically impractical. This is why we assessed recording of
mMRC, stage (IQR) 3 (3–4)
CAT, points (SD) 23.94 (6.63)
day-to-day decrease in oxygen saturation > 4% as alarming events, and
MMSE, points (IQR) 28 (27–30) our results suggest its usefulness. This approach would be easily im-
BODE index (IQR) 7 (5–8.5) plemented in telemonitoring devices and alarming telemedic staff
History of exacerbations, n/24 months (IQR) 2 (2–3) against possibly upcoming exacerbation. It would enable contact with
Exacerbations requiring hospitalization, n (IQR) 1 (0–1)
the patient and early medical intervention, contributing potentially to
LTOT, n (%) 13 (68.42)
BMI, kg/m2 (SD) 27 (5.66) prevent from exacerbation development or decrease the risk of hospital
admission. To our knowledge, this is a first study which report such
Comorbidities:
Ischemic heart disease, n (%) 7 (36.84) approach to oxygen saturation telemonitoring. Telemedicine in COPD is
Acute myocardial infarction in history, n (%) 6 (31.58) still under development, however increasing number of studies analyze
Congestive heart failure, n (%) 9 (47.37) the usefulness of this approach to care patients with this disease. On the
Arterial hypertension, n (%) 14 (73.68) other hand, a variety of approaches, methodologies, study groups and
History of pulmonary embolism, n (%) 1 (5.26)
devices were used, impeding their unequivocal comparison [10–28].
Stomach ulceration, n (%) 4 (21.05)
GERD, n (%) 6 (31.58) The same discussion is lead in other medical fields. Authors of the
Osteoporosis, n (%) 9 (47.37) cardiac telemedicine study suggest that cost-efficient care models could
Obesity, n (%) 9 (47.37) be implemented in standard care in [29].
Others, n (%) 7 (36.84)
Bashshur et al. performed a comprehensive systematic review, in
which analyzed the impact of telemonitoring on chronic diseases being
three of the leading causes of death in the The United States: CHF,
Data from 3 patients were incomplete and were excluded from the
stroke, and COPD [30]. Authors found that the capacity for early in-
analysis. Finally, 19 patients were included to the study. Baseline po-
tervention and rapid response associated with telemedicine may have
pulation data are presented in Table 1.
beneficial effects, including reductions in use of service: hospital ad-
A majority of the patients (68.42%) were treated LTOT at least 15 h
missions/re-admissions, length of hospital stay, and emergency de-
per day. Patients were monitored for 366.6 (240.8) days. We observed
partment visits typically declined. On the other hand, INSPIRE-II study
significant decrease in SpO2 7 days preceding ECOPD, however with
indicated that a telehealth coping skills training intervention produced
low power of the test. Differences in the rest of analyzed parameters did
clinically meaningful improvements in quality of life and functional
non achieve statistical significance, both in classical and in bootstrap-
capacity, but no overall improvement in risk of COPD-related hospita-
boosted inference (Table 2).
lization and all-cause mortality [31].
However, mean or median oxygen saturation would be unservice-
Pinnock et al. performed randomized controlled trial of 256 patients
able parameter according to alarming algorithm in telemonitoring.
using device for receiving daily patient responses to questions about
Therefore, we tried to find a specific event of day-to-day decrease in
symptoms and use of treatment and oxygen saturation. The primary
oxygen saturation. Exact McNemar’s test revealed significant increase
outcome was time to hospital admission due to COPD exacerbation up
in number of events of day-to-day decrease in oxygen saturation > 4%
to one year after randomization. Other outcomes included number and
in the period of 7 days preceding AECOPD versus reference period
duration of admissions, and validated questionnaire assessments of
(P = .02, 1-β = 0.81) Table 3.
health-related quality of life. Authors concluded, that in participants
Due to incomplete data (long periods in lack of reporting), spiro-
with a history of admission for ECOPD, telemonitoring was not effective
metry results were not analyzed.
in postponing admissions and did not improve quality of life. [18].

Table 2
Comparison of telemonitored parameters. Abbreviations: DBP – diastolic blood pressure, HR – heart rate, SpO2–percutaneous oxygen saturation, SBP – systolic blood
pressure. **-for 10000 iterations.
parameter Reference period 7 days preceding ECOPD P-value 1-β Bootstrap-boosted P-value** 95%CI

SpO2, %, median (IQR) 92.57(87.83–93.9) 90.8 (86.4–92.71) 0.007 0.18 0.005 0.003; 0.007
SBP, mmHg, mean (SD) 120.66 (15.61) 124.66 (12.97) 0.14 0.21 0.15 0.141; 0.159
DBP, mmHg, mean (SD) 70.6 (6.56) 71.09 (6.89) 0.71 0.06 0.69 0.68; 0.71
HR, beats per minute, median (IQR) 82.29 (76.63–86.93) 84.5 (81–92.1) 0.19 0.06 0.18 0.17; 0.19

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These results are contrary to that of Wilkinson et al., who reported that 5. Study limitations
earlier treatment was associated with a faster recovery. Authors sug-
gested that patient recognition of exacerbation symptoms and prompt Several limitations of the current study demand comments. First, small
treatment improved exacerbation recovery, reduced risks of hospitali- sample size determines the character of the report as pilot study. The
zation, and was associated with a better health-related quality of life reason of small number of patients is caused by low agreement for this
[32]. Shany et al. used home telemonitoring of oximetry, temperature, method of care among patients, e.g. fears associated with daily mon-
pulse, electrocardiogram, blood pressure, spirometry, and weight with itoring. Additionally, we experienced low compliance in performing pro-
telephone support and home visits. Authors reported results suggesting cedures and reporting data. Incomplete data precluded analysis of spiro-
that telemonitoring had an impact on reduction in COPD-related ad- metric data. Finally, such studies are long lasting, time-consuming, and
missions, emergency department presentations, and hospital bed days. involving deep cooperation with physicians, IT-specialists, technicians and
Telemonitoring also seemed to increase the interval between ECOPDs other staff, additionally contributing to small size sample. On the other
requiring a hospital visit and prolonged the time to the first admission hand the use of ECOPD as a statistical unit would potentially obviate this
[33]. problem. However, in our opinion such proceeding is a violation of as-
Shah et al. reported lower mean value of oxygen saturation, and sumption of independence of analytical units and, as the effect, is bur-
increased both the pulse rate and respiratory rate before an impending dened by high bias, which potentially would influence the results. To
exacerbation episode, compared with stable periods. Authors reported mitigate small size sample limitation, we performed bootstrap-boosted
prediction of COPD exacerbation episodes with 60%–80% sensitivity inference. Additionally, our group consisted mainly of female subjects,
will result in 68%–36% specificity. Authors indicated SpO2 as sug- what does not reflect overall COPD population. The female patients pre-
gesting to be the most predictive vital sign [10]. Our results are par- sented better agreement with the possibility of 24-h monitoring and more
tially in line with this report, because we did not measure respiratory frequently expressed their consent for this method of care. However, there
rate and our results did not achieved significance according to the pulse is an evidence that female COPD patients might be more prone to have
rate, potentially due to small sample size. severe exacerbations, might have a long period of symptoms before being
It is worth to underline that the events of day-to-day decrease in admitted to the hospital, have higher number of hospitalizations, and
oxygen saturation > 4% were observed also in LTOT group of subjects. prolonged length of hospital stay. Above mentioned issues may be con-
68.42% of our patient were treated with LTOT. In that group of patients sidered as beneficial in a context of evaluating telemonitoring methods
ECOPD is most difficult to diagnose and therefore increased the prob- [31]. Besides this, lack of control group would be considered as a major
ability of poor outcome after admission for ECOPD [34]. Szafrański at limitation. However, in our opinion it was impossible to gather the same
al. observed exacerbation was the most frequent cause of death in pa- comparable group. We considered to observe the same group in different
tients receiving LTOT treatment [35]. part of time but according to Suissa et al., every ECOPD progress the
Further perspectives of our research will be focused on repro- disease and we can not compare two different exacerbation episodes [36].
gramming the software according to obtained results (Fig. 3) and
evaluate the usefulness of use the day-to-day criterion decrease in
oxygen saturation > 4% as an alarming event in prediction ECOPD and 6. Conclusion
possible consequences – reduce exacerbations requiring hospitalization,
and as the effect improvement of health-related quality of life, slower Oxygen saturation telemonitoring would be successfully used in
decline in lung function and, finally, mortality in COPD patient with predicting ECOPD. Recording of day-to-day decrease in oxygen sa-
GOLD “D” category. turation > 4% as alarming events would be effective approach which
would be easily implemented in telemonitoring devices, however this
outcome should be further validated in larger size samples.

Fig. 3. Proposition of the algorithm for telemonitoring in COPD for prevention of exacerbations.

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