International Journal of Medical Informatics 124 (2019) 31–36

Contents lists available at ScienceDirect

International Journal of Medical Informatics

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

Synchronous video telemedicine in lower extremities ulcers treatment: A T

real-world data study
Alexander Gamusa,b, , Elad Kerena,c, Hanna Kaufmana, Gabriel Chodicka,b
⁎

a
Maccabi Healthcare Services, HaMered 27, Tel Aviv, Israel
b
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
c
Orthopedic Department, Soroka Medical Center, Beer-Sheba, Israel

ARTICLE INFO ABSTRACT

Keywords: Introduction: With growing prevalence of lower extremity ulcers (LEU) and shortage of wound specialists, gaps
Telemedicine in access to care may occur, particularly in remote areas. This gap can be mitigated with high-quality tele-
Lower extremities ulcers medicine (TM). This study aims to explore the effectiveness of synchronous video TM compared to the con-
Wound therapy ventional face-to-face treatment (FTF).
Israel
Methods: The study was conducted at Maccabi Healthcare Services, a 2.2-million-member sick fund in Israel. We
reviewed all consecutive visits of LEU patients to wound care specialists between Jan 2013 and Jun 2017. Both
TM and FTF modalities were implemented using identical treatment settings with the same nurse at each lo-
cation. Study endpoint was ulcer healing as assessed by the treating specialist.
Results: The study population included 650 LEU cases (nTM = 277, nFTF = 373) and contained 5203 visits.
Comparable (P = 0.475) proportions of healed ulcers (52% in TM vs. 55% in FTF) were detected. Survival
analyses found a non-significant advantage of TM (0.887; 0.650–1.212) compared to FTF. The non-inferiority of
TM was demonstrated within the Δ = 0.15 range limits and 80% statistical power. Trial replication probability is
0.93.
Conclusions: Synchronous video-conferencing based telemedicine may be a feasible and efficient method of LEU
management.

1. Introduction Traditionally, TM aims to facilitate a virtual realization of a doctor-

Lower extremities ulcers (LEU) impose a heavy burden on in-
dividuals as well as on healthcare organizations [1–5]. The estimated
annual prevalence of the foot and leg ulcers in published studies varies
from 0.18% to 2.1%, reaching to 5% in patients over 65 years [6,8] In
Israel, where the prevalence of diabetes mellites (DM) is estimated at
8.4%, up to 15% of DM patients may develop diabetic foot ulcers [6,7].
In addition to DM, there are other morbidities associated with LEU,
such as the arterial/venous insufficiencies, resulting in a higher pre-
valence of LEU [6,8–12].
Providing medical services to LEU patients in geographically remote
regions is a growing concern in healthcare systems, due to a shortage of
specialists. In addition, chronic wounds often coincide with other
morbidities, adding physical and psychological strain, further limiting a
patient’s ability to make their way to a specialist, usually located in
urban centers. [2,4,5] Telemedicine (TM) has been suggested to be a
potential solution to this problem [13–17].
patient interaction from the comfort of one’s home or other preferred
location. The concept of TM has been around for 30 years, mostly in an
asynchronous (store-and-forward) mode of operation. Most studies
published in the last two decades focused on the use of asynchronous or
mobile, internet-based implementations (rather than stationary) high-
quality synchronous video TM technologies. [18–22] In this study we
aimed to focus on synchronous (real-time) video conferencing-based
TM technology that enables a high-resolution video for a clear wound
display with near-real color separation while providing an interactive,
"same-room like" intervention.
The purpose of this study was to compare a stationary synchronous
video-conferencing (VC) based TM to the standard face-to-face (FTF)
treatment of LEU in Israeli outpatient clinics: ulcers status, number of
interventions, and time to heal.

⁎
Corresponding author at: Maccabi Health Services, Sackler Faculty of Medicine, Tel-Aviv University, Israel.
E-mail address: gamus@mail.tau.ac.il (A. Gamus).

https://doi.org/10.1016/j.ijmedinf.2019.01.009
Received 14 October 2018; Received in revised form 30 December 2018; Accepted 14 January 2019
1386-5056/ © 2019 Elsevier B.V. All rights reserved.
A. Gamus et al.
2. Methods
2.1. Settings
This historical cohort study was performed using the electronic
medical records (EMR) database of Maccabi Healthcare Services (MHS),
a 2.2-million-member sick fund in Israel. The study period was between
Jan 1 st, 2013 – Jun 31 st, 2017 and took place in eight MHS’s Northern
and Southern District clinics. TM cohort included patients from six
outpatient's clinics operating via identical telecommunications, in-
formation technologies, and video-conferencing infrastructures. The
same specialist supervised the treatment in both modalities (TM and
FTF) in each district, and at each location (central or remote clinics),
the same nurse treated all patients. Sessions appointments in MHS as-
signed by a dedicated central service according to patient’s request and
physician’s availability in TM or FTF treatment modalities. Only data on
LEU patients treated at the same clinic throughout the observation
period were included.
Inclusion criteria: Adult patients with a history of LEU for more than
six weeks.
Exclusion criteria: Patients with less than two treatment interven-
tions, or ulcerations above the knee level.
2.2. Infrastructures
The study employed a commercial video conferencing system
(Lifesize Inc, Austin, Texas, USA) operating through MHS' high-avail-
ability secure internal telecommunications network with at least 1
Mbps (Megabits per second) trunks capacity. The Quality of Service
(QoS) functionality was enabled, facilitating permanent communica-
tions bandwidth. We deployed the communications protocol H.232 and
the H.264 video compression technique. Two different video con-
ferencing setups were used: (a) for the specialist site at the central
clinic, and (b) for the remote outpatient clinic. At the specialist facility,
a high-definition 21″ screen with built-in communications and video
conferencing equipment was implemented. At the remote TM site, an
additional stationary Sony video camera (resolution of 1280 × 720)
was deployed. For the remote clinic's communications equipment, in-
cluding 21″ screen, microphone, and video cameras, a special purpose
ruggedized cart was designed and manufactured (Galil-S.L.G. Ltd.,
Israel).
Both TM and FTF modalities were implemented in an identical
treatment setting with the same nurse at each location, who was present
in all treatment sessions. During the first consultation stage (anamnesis)
the patient was sitting in front of a screen and a camera. Next, the
patients’ wound was monitored using an additional video camera in-
stalled on the adjustable arm, designed specifically for this purpose. A
patient could sit or lay down according to his or her medical condition
and the location of their wound. The camera was operated by a nurse,
as instructed by a physician. The medical records were available to the
specialist for viewing and updates throughout the session using
Maccabi patients' records application.
2.3. Study variables
Ulcer-related data including DM ulcers (DU), composite wounds,
arterial and venous insufficiency, and pressure ulcers, were dichot-
omized in two groups: (a) DU, and (b) non-diabetic ulcers (NDU).
Information was also obtained on the initial ulcers severity status –
ulcer type, area size, depth, and number of ulcers per patient at pre-
sentation. The study database records did not include a classification of
ulcers severity; ulcers depth in mm was used to estimate the severity
grade. [23]
The ulcer's size data, which appeared to be right skewed, were
consequently transformed to natural log values and dichotomized in
small (under 4cm2), and large (above 4 cm2) size categories. We
32
International Journal of Medical Informatics 124 (2019) 31–36
excluded five outliers (0.77%) with ulcers area above 150cm2 in TM
modality from the initial population analyses. [24]
The ulcers depth data distribution was also skewed to the right.
Consequently, the data was transposed into log values and dichot-
omized. The ulcer’s depth groups definition was (a) superficial, less
than 0.34 log value (geometric 1.5 mm), and (b) cavernous, larger than
0.34 log value. This value may correspond to the Stage2 in Curative
Health Services wound grade scale: superficial ulcers with full ulcer
thickness and subcutaneous tissues. [25] Cavernous ulcers group in-
cludes all ulcer conditions above Stage2 (exposed tendons, ligaments,
joints, necrotic tissues, and gangrene).
Other collected study variables were gender, age, and body mass
index (BMI).
2.4. Investigated endpoints
The main study outcome was ulcer status (healed or deteriorated) at
the last recorded intervention. Positive outcomes (POS) were defined as
at least 50% ulcer closure with granulation tissue appearance, as
compared to the first recorded measurement. Negative outcomes (NEG)
were defined as no improvement or less than 50% ulcer closure or
deterioration of ulcers in size. Secondary outcomes included duration of
treatment, the number of interventions, and mortality. We defined
healing duration as the period required to achieve a POS outcome.
2.5. Study power
An acquired sample size of n = 650 for both treatment modalities
satisfied a 90% statistical power value for adopted difference of 0.15.
[26,27]
2.6. Statistical analysis
Populations distribution in both modalities for age group, gender,
BMI, and initial severity was tested using a chi-square test (cross-ta-
bulation) and the non-parametric Mann-Whitney test according to the
data distribution pattern. Additional ulcers severity (size and depth)
distribution differences were assessed by Hedge’s g effect size for dif-
ferent size groups. [28] A pseudo-randomization of study cohorts was
conducted using the propensity score analysis [29,30]. Kaplan-Meyer
survival analyses and Cox proportional hazards regression were utilized
to assess outcomes. Hosmer-Lemeshow test demonstrated a good fit of
the model (p = 0.602).
The TM and FTF modalities equality assessment implied two one-
sided tests for each modality’ non-inferiority to the other. A non-in-
feriority margin of 0.15 in our trial was similar to the reported in the
published studies (0.15 to 0.20). [26,27,31]
Mortality comparison in an LEU population was assessed by the chi-
square test. Power and statistical analyses were performed using IBM
SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp., and
WinPepi version 11.65 [31].
3. Results
3.1. Population
The LEU and outpatient clinics data was filtered, leading to 650
records used for analyses. The final sample included n = 373 and
n = 277 records for FTF and TM modalities, respectively. An overall
number of visits was n = 5203.
The descriptive data of the sample population demographics and
clinical conditions are shown in Table 1. The initial ulcers size eva-
luation indicated right-skewed distribution across the modalities. The
probable higher severity of ulcers in TM cohort was found. The ex-
cluded outliers significantly deviate from a set of TM and FTF cohorts
data (150 cm2 to 3.7cm2 in mean values).
A. Gamus et al. International Journal of Medical Informatics 124 (2019) 31–36

Table 1 P = 0.93 (based on Wald chi-square test) [31].

Patients' characteristics and population distribution in TM and FTF treatment
modalities. 4. Discussion
Samples Data at N (%) Risk Assessment
Presentation Our study results suggest that synchronous video TM has compar-
TM FTF OR 95% CI p-value able effectiveness to FTF in the treatment of LEU. The results are con-
sistent with previously published reports on TM comparison to FTF
Total Sample 277 (43) 373 (57)
Age Group: < 60 82 (29.5) 110 (29.6) 0.995 0.707 - 1.000 [14,16,19–21,32–35]. The similarity in all study endpoints (length of
> 60 195 (70.5) 263 (70.4) 1.398 time, number of consultations, and mortality) between the groups may
Gender: Female 92 (33.2) 135 (36.2) 1.141 0.822 – 0.455 endorse the synchronous video TM as a non-inferior method of LEU
Male 185 (66.8) 238 (63.8) 1.582
management.
BMI < 25 46 (16.6) 57 (15.3) 0.906 0.593 – 0.665
> 25 231 (83.4) 316 (84.7) 1.384
Three modes of treatment are relevant to LEU management in the
Ulcer Type: DU 59 (21.3) 89 (23.9) 1.158 0.797 - 0.451 Israeli healthcare environment: a) usual FTF care performed in out-
NDU 218(78.7) 284 (76.4) 1.682 patient clinics, b) remote TM care performed in remote outpatient
Number of Ulcers 94 (33.9) 134 (35.9) 1.092 0.787 – 0.619 clinics and c) visits at LEU patients homes. The home treatment requires
Single 1.513
extensive use of mobile devices, internet infrastructures, and informa-
Multiple 183 (66.1) 239 (64.1)
tion security technologies. A need to transfer information between the
TM-Telemedicine; FTF-Face-to-Face; DU-Diabetes ulcers, NDU-other than external internet and the secured provider’ IT environment may require
Diabetes Mellitus; OR – Odds Ratio. a considerable investment to purchase, install and maintain the cy-
bersecurity gateways, while technologies used in our study, may not
need it. Most previously reported studies on TM in LEU management
used an internet communications infrastructure and mobile devices,
The Mann-Whitney test of ulcers size distribution of two groups in while the still wound images were transmitted asynchronously
treatment modalities demonstrated a similarity with mean log values of [5,9,13–16,18–20,34]. Conversely, being centered on real-time syn-
0.569 (SD ± 0.373), p = 0.582 and 2.344 (SD ± 0.0.752), p = 0.159 chronous video treatment modalities, rather than asynchronous treat-
in small and large ulcers groups, respectively. The proportion of large ment modes, our study deployed a permanent wide-band communica-
ulcers in TM was higher than in FTF, 0.52 and 0.48 respectively. A tions channels and high-quality technology in a secure MHS networking
higher proportion (0.66) of small size ulcers was found in FTF group. setting. The quality and stability of permanent communications chan-
The Hedge’s g effect size for small and large ulcers groups in both nels are usually higher than those in a mobile environment. The tech-
treatment modalities was 0.045 and 0.210 respectively [28]. nical parameters of TM, such as the resolution of the image, color
Relatively similar mean log values of 0.099 (SD ± 0.100), depth, and data compression might have a significant effect on the
P = 0.111 and 0.581(SD ± 0.260), P = 0.762 were observed in su- results of LEU management [15,20–22].
perficial and cavernous ulcers groups respectively. The Hedge’s g effect In contrast with the NDU population, our analysis of DU indicated a
size for the superficial group was 0.158, and 0.232 for cavernous groups significantly higher proportion of healed ulcers in FTF group. A possible
in both treatment modalities.28 clinical reason could stem from a necessity for manual procedures in the
Logistic regression, adjusted for propensity score, demonstrated the treatment of these ulcers, which by Israeli regulations, may only be
randomization effect in both TM and FTF populations. performed by a physician, meaning an introduction of artificial bias
towards a higher healing effect in FTF cohort. Consequently, a treat-
3.2. Outcomes ment by TM of DU type of ulcers in a given regulatory environment may
be further investigated.
Results of Kaplan-Meier survival analysis is presented in Fig. 1. The Similarly to the previously published studies, shorter healing time
results demonstrated no significant correlation of POS outcomes in TM and reduced number of visits were demonstrated in TM cohort, com-
and FTF modalities to the size (area) of the ulcers in both ulcers groups pared to FTF care, while the reason for this recurring effect is not clear
(DU and NDU). However, ulcers initial depth demonstrated a somewhat [5,13–17,19,20,22,32–34]. It might be speculated that in comparable
borderline significance in association with the POS outcome: TM and FTF treatments settings, this TM phenomenon may occur due to
rs = 0.151, P = 0.077 and rs = 0.126, P = 0.072 for TM and FTF re- a psychosocial factor, rather than statistical variance [35]. Further
spectively. A number of visits indicated a significant positive correla- longitudinal study of TM follow-up in LEU treatment could clarify this
tion with the treatment duration: rs = 0.679 and p < 0.001 in TM and effect.
rs = 0.509 and p < 0.001 in FTF modality. The mean number of visits We found a non-significant difference in the mortality rate between
in the POS outcomes group was 9.18 ± 11.05 for FTF and the treatment cohorts; however, a tendency for higher mortality rate
7.74 ± 6.79 for TM, however not significantly different (P = 0.842 within TM cohort was shown in our study as well as in previously
and P = 0.203 for FTF and TM respectively). Fully adjusted compar- published trials [36,38]. In addition to chance alone this may have
isons of the two treatment modalities are given in Table 2. resulted in by differences in prevalence of chronic diseases rather than
The mortality rate assessment demonstrated an increased risk in the by a treatment method, while no association between mortality and
TM group (odds ratio OR = 1.822 95% CI:0.766, 4.008), with a bor- type of treatment was demonstrated [34,36]. Since MHS database does
derline significance of P = 0.078. not have data on causes of death, our ability to further analyze these
Equality of TM and FTF methods was assessed using two one-sided associations are limited.
non-inferiority tests (WinPepi, Westlake-Schuirmann method). The Chronic conditions, such as LEU, are associated with significant
null-hypotheses of both tests stated that each modality is inferior to morbidity, financial burden and reduced quality of life [1,2,4]. The
another by adopted Δ = 0.15: FTF exceeds TM by 0.15 or more (z=- implementation of TM, in addition to FTF care, may have some benefits
4.53, P = 0.000), TM exceeds FTF by 0.15 or more (z = 3.02, to these patients as well as to the medical care provider, and contribute
P = 0.001). Both tests were significant indicating equality of TM and to a better distribution of health services and equality of health care.
FTF methods. The 99% confidence interval for the difference (-0.133 to [4,5,10,11] Patients travel costs savings combined with a better treat-
0.074) falls completely within the interval -0.15 to 0.15. The calculated ment availability may enrich their quality of life. Healthcare organi-
Cohen’s w effect size is 0.029. [31] Trial replication probability is zation may benefit from a room space saving on locations and more

33
A. Gamus et al. International Journal of Medical Informatics 124 (2019) 31–36

Fig. 1. Treatment duration until POS by Ulcers Size and Severity (Kaplan-Meier survival test). TM-Telemedicine; FTF-Face-to-Face; POS – positive outcome; DU-
Diabetic ulcers, NDU- None-diabetic ulcers.

Table 2
POS outcomes proportions and Proportional Hazard for POS outcomes in TM and FTF modalities.
POS outcomes group POS outcomes proportions and risk assessment Cox HR assessment for POS outcomes in TM vs. FTF **

N (%)* Odds Ratio Unadjusted Hazard Adjusted Hazard

TM FTF OR 95% CI p-value HR 95% CI p-value HR 95% CI p-value

1 2 3 4 5 6 7 8 9 10 11 12

Overall POS outcomes 144 (52.0) 205 (55.0) 0.89 0.65-1.21 0.475
Age Group: < 60 40 (48.8) 59 (53.6) 0.82 0.46-1.46 0.560 0.85 0.67 -1.07 0.171 0.82 0.65 -1.05 0.117
> 60 104 (53.3) 146 (55.5) 0.92 0.63-1.33 0.704
Gender: Female 46 (50.0) 70 (51.9) 0.92 0.55-1.58 0.789 0.83 0.66 -1.04 0.098 0.81 0.65 -1.02 0.077
Male 98 (53.0) 135 (56.7) 0.86 0.58-1.26 0.491
BMI < 25 25 (54.3) 35 (61.4) 0.75 0.34-1.65 0.548 0.86 0.65 -1.14 0.296 0.88 0.66 -1.17 0.374
> 25 119 (51.5) 170 (53.8) 0.91 0.65-1.28 0.604
Ulcer Type: DU 25 (42.4) 54 (60.7) 0.48 0.24-0.93 0.043 0.89 0.69 -1.15 0.359 1.04 0.79 -1.36 0.771
NDU 119 (54.6) 151 (53.2) 1.06 0.74-1.51 0.783
Number Of Ulcers Single 49 (52.1) 58 (43.3) 1.43 0.84-2.42 0.225 0.49 0.38 -0.63 < 0.001 0.49 0.38 -0.63 < 0.001
Multiple 95 (51.9) 147 (61.5) 0.68 0.46-0.99 0.059
Ulcer Depth Superficial 123 (51.9) 180 (55.2) 0.88 0.63-1.22 0.449 1.28 0.93 -1.75 0.134 1.32 0.96 -1.84 0.092
Cavernous 21 (52.5) 25 (53.2) 0.97 0.42-2.26 1.000
Ulcer Size (area) Small 52 (43.3) 109 (46.8) 0.87 0.56-1.36 0.574 0.76 0.61 -0.94 0.011 0.76 0.62 -0.95 0.017
Large 92 (58.6) 96 (68.6) 0.65 0.40-1.05 0.094

TM-Telemedicine; FTF-Face-to-Face; DU-Diabetic ulcers, NDU-other than diabetic ulcers; OR – Odds Ratio; SD- Standard Deviation; HR-Hazard ratio; * - proportions
relative to quantities in modality (POS + NEG);** -Cox HR stratified by modality.

34
A. Gamus et al.
efficient use of the specialist's services.
Strengths of our study include (a) a relatively large sample size,
possibly facilitating an external validity, (b) a relatively long observa-
tion period, and (c) the use of high-quality and secure infrastructures.
Nonetheless, some limitations should be addressed. While a similar
clinical knowledge applied to both cohorts, the generalizability of the
two investigated specialist's level of expertise and acquaintance with
TM technology is unclear and should be investigated in future studies.
However, the published TM acceptability by medical staff findings
proves that high-quality video technologies may serve as an effective
disease management method. [15,17,19–22,33,37] The external va-
lidity of our study results may be limited to applications with similar
settings, hence the TM feasibility studies in other morbidities and set-
tings are warranted.
TM may limit care by the specialist's inability to sense the wound
physically. This potential limitation compensated by the setting used in
our study and wound treatment practice in MHS, with a specialist-nurse
interactive communication at all sessions, FTF and TM. Our study, as
well as other published trials, support the appropriateness of TM for the
assisted remote LEU care [4,5,9,14–17,19,21–33,34].
5. Conclusions
Our study demonstrated that TM is not inferior to the existing FTF
practices in outcomes measures of LEU treatment. Video-based tech-
nologies may prove to be a valuable tool in foot and leg ulcer treatment
for both patients and healthcare organizations. Synchronous video-
based TM modalities thus could be considered to be a prime candidate
for wound therapy in remote areas. Further studies of TM im-
plementation in the LEU treatment, patients’ quality of life follow-up,
medical staff and patients satisfaction, as well as hospitalization and
mortality causes, are warranted.
Funding information
No funding provided for the research.
Conflict of interest
Authors declare that they have no conflict of interest.
Ethical approval
Maccabi Health Services ethical committee approved the study ac-
cording to the 1964 Helsinki declaration, permission number 42/2015.
Summary Points
What was known:
• With growing prevalence of LEU and shortage of wound spe-
cialists, gaps in access to medical care may occur, particu-
larly in remote areas.
•
This gap in access to the medical care can be mitigated with
high-quality TM.
What this study added:
• Synchronous video telemedicine based on a high-reliability
secure medical informatics network may be a feasible and
efficient method of LEU management.
• TM in LEU care may facilitate a shorter healing time, reduced
number of visits.
35
International Journal of Medical Informatics 124 (2019) 31–36
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