Introduction: Continuous monitoring is the hallmark of managing chronic disease. Multiple sclerosis (MS), in particular, requires patients to visit their treating neurologists typically twice a year, at least. In that respect, the COVID-19 pandemic made us rethink our communication strategies. This study determined satisfaction with remote visits for people with MS (pwMS) by comparing non-inferiority to conventional visits. Methods: TELE MS was a randomized controlled trial that was open to any person with MS. We randomized a volunteer sample of 45 patients. We compared satisfaction with remote visits (via phone or via videochat) with conventional outpatient visits. The primary endpoint was patient satisfaction determined by the Telemedicine Perception Questionnaire (TMPQ, min: 17 and max: 85 points) with the hypothesis of non-inferiority of televisits to conventional visits. Physician satisfaction measured on the PPSM score (Patient and Physician Satisfaction with Monitoring, min: 5 and max: 25 points) was the secondary endpoint. Results: The trial met both endpoints. Mean (SD) TMPQ scores in the individual groups were 58 (6.7) points for conventional visits, 65 (7.5) points for phone visits, and 62 (5.5) points for video visits. Physician satisfaction over the whole cohort was similarly high. Median (range) PPSM scores were 23 (16-25) for the whole cohort, 19 (16-25) for conventional visits, 25 (17-25) for phone visits, and 25 (16-25) for video visits. Conclusions: Televisits in multiple sclerosis yield a high level of satisfaction for both patients and treating physicians. This concept for remote patient monitoring adopted during the current pandemic may be communicable to other chronic diseases as well. ClinicalTrials.gov identifier: NCT04838990.
Introduction: Continuous monitoring is the hallmark of managing chronic disease. Multiple sclerosis (MS), in particular, requires patients to visit their treating neurologists typically twice a year, at least. In that respect, the COVID-19 pandemic made us rethink our communication strategies. This study determined satisfaction with remote visits for people with MS (pwMS) by comparing non-inferiority to conventional visits. Methods: TELE MS was a randomized controlled trial that was open to any person with MS. We randomized a volunteer sample of 45 patients. We compared satisfaction with remote visits (via phone or via videochat) with conventional outpatient visits. The primary endpoint was patient satisfaction determined by the Telemedicine Perception Questionnaire (TMPQ, min: 17 and max: 85 points) with the hypothesis of non-inferiority of televisits to conventional visits. Physician satisfaction measured on the PPSM score (Patient and Physician Satisfaction with Monitoring, min: 5 and max: 25 points) was the secondary endpoint. Results: The trial met both endpoints. Mean (SD) TMPQ scores in the individual groups were 58 (6.7) points for conventional visits, 65 (7.5) points for phone visits, and 62 (5.5) points for video visits. Physician satisfaction over the whole cohort was similarly high. Median (range) PPSM scores were 23 (16-25) for the whole cohort, 19 (16-25) for conventional visits, 25 (17-25) for phone visits, and 25 (16-25) for video visits. Conclusions: Televisits in multiple sclerosis yield a high level of satisfaction for both patients and treating physicians. This concept for remote patient monitoring adopted during the current pandemic may be communicable to other chronic diseases as well. ClinicalTrials.gov identifier: NCT04838990.
Multiple sclerosis (MS) is a chronic disease that requires regular care. It affects
about 2.5 million people worldwide and is the most frequent cause of disability in
young adults, aside from trauma.
.
Monitoring the health status of people with MS (pwMS) encompasses periodic
visits to their treating neurologists in order to review the most recent patient
history, receive a clinical assessment and discuss the latest paraclinical exams.
In light of the current pandemic, we have faced an interruption to
face-to-face care. Beyond doubt, this exemplifies an imperative need to develop,
offer and implement strategies to maintain consistent monitoring and create an
opportunity for the exchange of health information.The hallmark of telehealth is the provision of remote healthcare as it can sustain
disease management without the physical co-presence of the patient and
physician.[5-7] The majority of
recent telehealth applications in the field of MS centered on telerehabilitation and
biosensors. These studies illustrated, among others, attenuated adherence and
improved quality of life as palpable benefits.[8-11] In contrast, only a handful
of investigations focused on remote visits per se. One randomized crossover trial
reported feasibility of remote monitoring demonstrated by the percentage of
completed televisits compared to conventional outpatient appointments.
Another study concluded that pwMS highly appreciate scheduled
teleconsultations, which may even enhance access to specialized care.
However, these investigations lack an association between mere acceptance of
telehealth on one side and MS-related patient reported outcomes or standardized
clinical outcome measures on the other (such as the Expanded Disability Status Scale (EDSS)
or quality of life). Furthermore, these observations did not account for
physician satisfaction. It remains unknown how satisfaction with remote visits
compares to regular visits in the view of the patient and physician.Therefore, in this randomized controlled trial, we aimed to demonstrate
non-inferiority of remote visits in pwMS based on satisfaction expressed by both
patients and physicians. We used standardized and validated outcome measures to test
our hypotheses. Additionally, we performed ancillary analyses to identify patients
particularly pleased with this alternative form of healthcare delivery.
Methods
Ethics review, consent and trial registration
The ethics review board at the Medical University of Vienna approved this study
(EK2157/2020). We obtained informed written consent from all study participants
and followed guidelines set by the Declaration of Helsinki. We adhered to
CONSORT guidelines when writing this report.
This study is registered with ClinicalTrials.gov (identifier:
NCT04838990).
Trial design and participants
TELE MS was a single center parallel assignment unblinded randomized controlled
trial designed to demonstrate non-inferiority of remote visits (video visits or
phone visits) compared to conventional visits (control group). We enrolled 45
patients and randomized them 1:1:1 into three study groups (one control group
and two intervention groups). The three groups differed in their type of follow
up visits. Patients treated at the MS outpatient clinic at the Department of
Neurology at the Medical University of Vienna, Austria, and fulfilling current
McDonald diagnostic criteria for MS were eligible to participate in this study.
Study inclusion was irrespective of parameters such as age, gender,
disease phenotype, disease duration or current treatment. Exclusion criteria
were obvious language barriers or technical obstacles (no smart device that
would enable video chatting, no phone or no internet connection). There was no
change in protocol or re-allocation of study participants once the first patient
was enrolled. Treating neurologists documented, in a structured format, clinical
characteristics of participating patients including age and gender, disease
duration in years, disease phenotype (relapsing MS, progressive MS,
) neurological disability on the EDSS,
number of relapses over the past 12 months, and disease-modifying
treatment (DMT, categorized as moderately effective [dimethyl fumarate,
glatiramer acetate, interferons, teriflunomide], highly effective treatment
[cladribine, fingolimod, natalizumab, ocrelizumab, rituximab]) or no
treatment.For interpreting our data, it is important to discuss our national COVID-related
restrictions concerning patient care. As stated later, our study was open from
November 2020 through April 2021, a time when Austria experienced a nationwide
lockdown. For our tertiary care center, we were encouraged to limit patient
contact to a tolerable and safe minimum as to not expose our patients to a risk
of contracting COVID-19. These measures, however, had no influence on patient
recruitment as our study participants were recruited on site during a regular
visit and the subsequent study visits were randomized.
Interventions and outcomes
Figure 1 illustrates the
overview of the trial design. We informed patients about the study protocol,
which consisted of five steps. First, the regular (baseline) visit at the MS
outpatient clinic at which study participation was offered and baseline disease
characteristics were assessed (age, gender, disease phenotype, disease duration,
number of relapses in the past year, EDSS, and Multiple Sclerosis Impact Scale [MSIS].
Second, a randomized allocation to one of the three intervention groups
determining the type of follow-up visit (a conventional physical visit to our
outpatient department as a control group or a visit and clinical exam over the
phone or over a videochat application). The time of the study visit was
determined consensually between the patient and treating physician at baseline
and followed the usual frequency of appointments. Third, a self-assessment
filled out 3–7 days prior to the subsequent study visit by means of an online
tool, in which participants could enter a self-report on their health status in
their own words and fill out an MSIS questionnaire. The treating physician would
read these reports before the visit and document them in the patient record
along with the MSIS scores. Fourth, the actual study visit for which the
participating patient and treating neurologist would meet at the scheduled
appointment. Over the course of this visit, doctor and patient could discuss the
patients’ current condition and other relevant information (e.g. laboratory
reports, radiological reports, information on adherence to medication, etc.).
Furthermore, physicians assessed follow up scores on the EDSS either using the
conventional physical method (control group) or the phone EDSS (phone or video
group) which is a comparable and validated tool to assess EDSS scores remotely.
In addition, participating neurologists filled out the PPSM (Patient and
Physician Satisfaction with Monitoring) questionnaires, a five-question
validated survey to rate the respective study visit. This score has been
validated in German and each question counts up to five points, leading to a
maximum of 25 points with higher points indicating greater satisfaction. Fifth,
the day after the study visit, participating patients received an invitation for
an online tool where they could fill out the TMPQ (Telemedicine Perception
Questionnaire) and they were offered the opportunity to give open comments. The
TMPQ is a validated 17-item survey, through which patients can rate their
experience with a televisit
.
Similar to the PPSM, each question is worth up to five points and higher
scores demonstrate greater satisfaction.
Figure 1.
Study overview of the TELE MS RCT. MSIS-29 – Multiple Sclerosis Impact
Scale, MS – Multiple sclerosis, MSologist – Neurologist treating persons
with MS, PPSM – Patient and Physician Satisfaction with Monitoring, RCT
– Randomized Controlled Trial, TMPQ – Telemedicine Perception
Questionnaire.
Study overview of the TELE MS RCT. MSIS-29 – Multiple Sclerosis Impact
Scale, MS – Multiple sclerosis, MSologist – Neurologist treating persons
with MS, PPSM – Patient and Physician Satisfaction with Monitoring, RCT
– Randomized Controlled Trial, TMPQ – Telemedicine Perception
Questionnaire.The primary endpoint was patient satisfaction measured by the TMPQ to determine
non-inferiority of televisits compared to a conventional visit. We considered a
difference of 10% (≥9 points) to be clinically meaningful. The secondary
endpoint was physician satisfaction (with the hypothesis of non-inferiority)
measured by the PPSM. We considered a difference of 10% (≥3 points) as relevant.
Exploratory outcomes were determined with respect to identifying patients
particularly satisfied with their remote visits translating as high scores on
the TMPQ.
Sample size, randomization and implementation
Sample size was determined based on the hypothesis of non-inferiority defined as
a <10 point difference in the primary endpoint at 80% power and an
alpha-error of 5%. We performed randomization by preparing 45 concealed
envelopes that would determine the study group (15 for each of the three
groups). Upon enrollment, patients would randomly draw an envelope that would
irrevocably allocate them to their respective study group. After this process,
the envelope was discarded.All participating neurologists were board certified in neurology and were trained
and examined EDSS raters for both the conventional EDSS and phone EDSS.
Considerations of data protection and privacy
Our study protocol adhered to current and strict data protection guidelines set
by both the country of Austria and the Medical University of Vienna as of
December 1st, 2020. Patients were educated on these guidelines on the
informed consent form, which was approved by our local ethics review board.
Patients consented to having their relevant study information implemented into
their regular patient record (i.e. MSIS scores plus a copy of their
self-description). The provision of questionnaires through an online tool
(self-description and satisfaction) was enabled via an academic platform widely
used in German speaking countries (http://www.soscisurvey.de). Only one of the authors involved in this
study had access to the data on that platform. All information on the survey
portal was stored in a pseudo-anonymized manner through a study identification
number (study ID) which we assigned to participants upon enrollment. For the
video visit group we used an end-to-end encrypted video chat system that would
operate on personal computers, smartphones or tablets all the same (Webex by
Cisco, Milpitas, CA, USA).
Statistical analyses
Statistical analysis was performed using SPSS 26.0 (SPSS Inc, Chicago, IL, USA).
We report categorical variables as frequencies and percentages, continuous
variables as mean and standard deviation or median and interquartile range or
range as appropriate. Continuous variables for normal distribution were tested
by the Kolmogorov-Smirnov test with Lilliefors correction. Group comparisons
were calculated by independent analyses of variance (ANOVA), Kruskal-Wallis-Test
or by chi-square test A value of p <0.05 was considered statistically
significant. All multiple analyses were corrected using Bonferroni method. We
performed our final analysis in a per-protocol manner.
Results
Patient characteristics
Figure 2 demonstrates
the patient flow. We screened 49 patients for eligibility. Four patients
declined participation upon informed consent stating the following reasons: (i)
no internet connection at home (n = 1), (ii) not wanting to be allocated to the
remote visit group (n = 1), (iii) not being interested without giving a reason
(n = 2). Three participants dropped out over the course of the observational
period due to (i) scheduling conflicts (n = 1) and (ii) incomplete or missing
satisfaction questionnaires (n = 2). Recruitment was open from November 2020
(first patient in) and lasted until April 2021 (last patient in). Study visits
took place from April 2021 (first patient out) through September 2021 (last
patient out). The trial ended with data analysis in October 2021. Table 1 lists
clinical information and patient reported outcome measures from 42 patients who
completed this study and were included in the final analysis. The mean age in
our cohort was 34 (SD 8) years, gender distribution was 2:1 (f:m) and 37
patients had relapsing MS (88%). Patient characteristics were distributed evenly
between all three intervention groups. Two patients experienced a disease
relapse over the course of the observation period (one on moderate and one on
highly active treatment).
Figure 2.
CONSORT flow diagram for the TELE MS trial. CONSORT
flow diagram showing participant flow through each stage of the
TELE MS randomized open controlled trial (enrollment, intervention
allocation, follow-up and final analysis).
Table 1.
Demographic and clinical characteristics for the whole cohort and each
intervention group.
Parameter
Category
Total cohort
Conventional visit
Phone visit
Video visit
Between-group difference
Participants analyzed1
number
42 (100%)
13 (31%)
15 (36%)
14 (33%)
n.s.
Age2
years
34 (8)
34 (7)
37 (9)
33 (9)
n.s.
Gender1
female
27 (64%)
8 (62%)
10 (67%)
9 (64%)
n.s.
male
15 (36%)
5 (38%)
5 (33%)
5 (36%)
n.s.
Disease phenotype1
relapsing MS
37 (88%)
13 (100%)
11 (73%)
13 (93%)
n.s.
progressive MS
5 (12%)
0 (0%)
4 27 (%)
1 (7%)
n.s.
Number of relapses2
last 12 months
0.52 (0.59)
0.46 (0.52)
0.47 (0,74)
0.64 (0.50)
n.s.
Disease duration3
years
4 (1-30)
4 (1-18)
4 (1-30)
3.5 (1-19)
n.s.
MS medication1
moderately effective
21 (50%)
8 (61%)
8 (53%)
5 (36%)
n.s.
highly active
18 (43%)
4 (31%)
6 (40%)
8 (57%)
n.s.
no treatment
3 (7%)
1 (8%)
1 (7%)
1 (7%)
n.s.
EDSS at baseline3
0 (0-6)
0 (0-4)
0 (0-6)
0.5 (0-4)
n.s.
EDSS at follow up3
0 (0-6)
0 (0-4)
0 (0-6)
1 (0-4)
n.s.
MSIS physical at baseline3
6 (0-71)
6 (0-25)
3 (0-11)
13 (0-71)
n.s.
MSIS physical at follow up3
6 (0-79)
4 (0-35)
4 (0-36)
11 (1-79)
n.s.
Δ MSIS physical3
1 (-15; 36)
1 (-13; 13)
0 (-5; 36)
3 (-15; 27)
n.s.
MSIS psychological at baseline3
8 (0-44)
8 (6-28)
8 (3-25)
8 (0-44)
n.s.
MSIS psychological at follow up3
14 (0-72)
11 (0-36)
11 (0-72)
29 (0-69)
n.s.
Δ MSIS psychological3
1 (-22; 64)
0 (-22; 28)
-3 (-11; 64)
6 (-8.3; 53)
n.s.
1 absolute number (percentage)
2 mean (standard deviation)
3 median (range)
4 median (interquartile range)
EDSS: Expanded Disability Status Scale, MS: multiple sclerosis, MSIS:
Multiple Sclerosis Impact Scale, N/A: not applicable or not
relevant, n.s.: statistically not significant, Δ: change in
value.
CONSORT flow diagram for the TELE MS trial. CONSORT
flow diagram showing participant flow through each stage of the
TELE MS randomized open controlled trial (enrollment, intervention
allocation, follow-up and final analysis).Demographic and clinical characteristics for the whole cohort and each
intervention group.EDSS: Expanded Disability Status Scale, MS: multiple sclerosis, MSIS:
Multiple Sclerosis Impact Scale, N/A: not applicable or not
relevant, n.s.: statistically not significant, Δ: change in
value.
Primary endpoint: Patient satisfaction
Figure 3 demonstrates
patient satisfaction with the study visits determined on the TMPQ and displayed
for the whole cohort and the three study groups. For the whole cohort, the mean
satisfaction measured on the TMPQ was 62 (SD 7) points. Mean scores in the
individual groups were: 58 (SD 6.7) points for conventional visits, 65 (SD 7.5)
points for phone visits, and 62 (SD 5.5) points for video visits. Mean scores
for the phone and video visits were slightly higher than in the control group.
However, as the lower border of the 95% confidence interval in both the phone
and video visit groups were less than 10 points below the mean score in the
conventional group, our results fall within the predetermined threshold for
non-inferiority (respective differences were 2.6 points [conventional vs. phone]
and 0.1 points [conventional vs. video]). We also asked patients to rate their
visit experience on a Likert scale. Percentages of answers are presented in
Table 2.
Figure 3.
Patient satisfaction with the study visit. This box and whiskers plot
shows scores on the TMPQ scale (y-axis, higher scores indicate greater
satisfaction) for the three study groups and the whole cohort (x-axis).
Boxes indicate the interquartile range and whiskers min-max. TMPQ –
Telemedicine perception questionnaire.
Table 2.
Patients rating their TELE MS study visit.
Whole cohort
favorable
39 (93%)
neutral
3 (7%)
unfavorable
0
Conventional visit
favorable
11 (85%)
neutral
2 (15%)
unfavorable
0
Phone visit
favorable
15 (100%)
neutral
0
unfavorable
0
Video visit
favorable
12 (92%)
neutral
1 (8%)
unfavorable
0
Pooled results for favorable (“very good” or “good”), neutral, and
unfavorable ratings (“very poor” or “poor”) on a Likert-scale.
Patient satisfaction with the study visit. This box and whiskers plot
shows scores on the TMPQ scale (y-axis, higher scores indicate greater
satisfaction) for the three study groups and the whole cohort (x-axis).
Boxes indicate the interquartile range and whiskers min-max. TMPQ –
Telemedicine perception questionnaire.Patients rating their TELE MS study visit.Pooled results for favorable (“very good” or “good”), neutral, and
unfavorable ratings (“very poor” or “poor”) on a Likert-scale.
Secondary endpoint: Physician satisfaction
Physician satisfaction over the whole cohort was high (Figure 4). Median PPSM scores were 23
(range: 16–25) for the whole cohort, 19 (range: 16–25) for conventional visits,
25 (range: 17–25) for phone visits, and 25 (range: 16–25) for video visits.
Physician satisfaction did not differ statistically significant between the
three groups (p = 0.175). The lower border of the 95% confidence interval in the
remote visit groups were less than 3 points below the mean score in the
conventional group, thus, the secondary endpoint of assumed non-inferiority was
met (respective differences were 0.6 points [conventional vs. phone] and 0.4
points [conventional vs. video]). Moreover, we asked physicians participating in
remote visits (n = 28) to state, whether they believe that individual visit had
resulted in a loss of information. 25 (89%) gave a favorable rating (Likert
scale, pooled for “strongly disagree” and “disagree”) and 3 (11%) an unfavorable
rating (pooled for “strongly agree” and “agree”).
Figure 4.
Physician satisfaction with the study visit. This box and whiskers plot
shows scores on the PPMS scale (y-axis, higher scores indicate greater
satisfaction) for the three study groups and the whole cohort (x-axis).
Boxes indicate the interquartile range and whiskers min-max. PPSM –
Physician and Patient Satisfaction with Monitoring.
Physician satisfaction with the study visit. This box and whiskers plot
shows scores on the PPMS scale (y-axis, higher scores indicate greater
satisfaction) for the three study groups and the whole cohort (x-axis).
Boxes indicate the interquartile range and whiskers min-max. PPSM –
Physician and Patient Satisfaction with Monitoring.
Ancillary analyses
We investigated whether there was a certain group of patients inclined to be more
satisfied with remote visits (Figure 5(a)-(f)). A detailed description is included in the
supplement.
Figure 5a-d.
Patient characteristics in groups with satisfaction below and above this
study's median TMPQ score. This box and whiskers plots illustrates
patient characteristics (y-axis) along scores on the TMPQ scale
(x-axis). In case there were no ourliers, boxes indicate the
interquartile range and whiskers the min-max. Outliers, if existent, are
indicated by black dots and, in that case, whiskers indicate values
ranging from 1.5 times the IQR from the first and third quartile. TMPQ –
Telemedicine perception questionnaire. Figure 5e-f Satisfaction score
(TMPQ) in relation to change in the MSIS score. This box and whiskers
plots illustrates patient characteristics (y-axis) along scores on the
TMPQ scale (x-axis). Boxes indicate the interquartile range and whiskers
min-max. TMPQ – Telemedicine perception questionnaire, MSIS – Multiple
Sclerosis Impact Scale.
Patient characteristics in groups with satisfaction below and above this
study's median TMPQ score. This box and whiskers plots illustrates
patient characteristics (y-axis) along scores on the TMPQ scale
(x-axis). In case there were no ourliers, boxes indicate the
interquartile range and whiskers the min-max. Outliers, if existent, are
indicated by black dots and, in that case, whiskers indicate values
ranging from 1.5 times the IQR from the first and third quartile. TMPQ –
Telemedicine perception questionnaire. Figure 5e-f Satisfaction score
(TMPQ) in relation to change in the MSIS score. This box and whiskers
plots illustrates patient characteristics (y-axis) along scores on the
TMPQ scale (x-axis). Boxes indicate the interquartile range and whiskers
min-max. TMPQ – Telemedicine perception questionnaire, MSIS – Multiple
Sclerosis Impact Scale.
Open comments from patients
Table 3 lists all
open statements that participating patients made available. These statements
were collaborately translated by two authors without further interpretation.
Table 3.
Open statements from patients participating in the TELE MS trial.
I perceived the phone visit to be a great addition to my
care. If my health remains stable, I would like to do it
again. However, these phone visits should not replace a
physical appointment as this allows for a more accurate
evaluation [by my physician]. Thank you for this
effort.
I cannot have video-visits only as I need to come to the
hospital for my blood draws.
I think the video visit made scheduling easier for me.
Thank you for this nice opportunity. I would definitely like
to repeat this experience; however, I could not tell how I
would feel about it in case my health declines.
I think it is essential that my doctor's equipment
(microphone) works properly.
I enjoy not needing to drive to the hospital for my
appointments.
I was very happy with my video visit.
Thank you for this welcome addition to my care.
Open statements from patients participating in the TELE MS trial.
Harms or unintended effects
We defined harm beforehand as patients reporting significant clinical worsening
in their self-report, resulting in them expressing their wish to decline a
remote visit in order to have a conventional visit instead (“group switch”).
There were no such reports in this study, thus, we could not detect any harms or
unintended effects of our interventions.
Discussion
The design of the neurological reflex hammer in the late nineteenth century arguably
hailed the advent of the neurological exam
.
Although this neurological exam, along with radiological investigations,
remains the mainstay of disease monitoring in pwMS, advancing patient care to a new
era through the use of telemedicine may certainly be warranted
.
The COVID-19 pandemic has undoubtedly set a new tone in terms of
communication strategies. In current literature, the availability of telehealth
strategies has demonstrated a substantial benefit in terms of retaining an affinity
with patient outcomes in MS.[8-13] Studies have shown how
telerehabilitation can improve physical functioning and enhance quality of life.
,
,
This development is facilitated by the availability of validated tools that
can remotely monitor MS-related disability, for instance via a structured virtual
neurological exam, the assessment of health-related quality of life or cognitive functions
.
There is emerging evidence that pwMS appreciate attempts in remote monitoring
as they foster adherence and save time. Our present investigation emphasizes the
importance of promoting telehealth concepts in pwMS as we provide evidence from a
randomized controlled trial illustrating non-inferior satisfaction with remote
visits over the phone or via videochat compared to conventional visits for both pwMS
and their treating neurologists.The majority of patients rated their study visit as satisfying (90%) with a trend
towards greater satisfaction with phone visits. It was somewhat surprising that
patients seemed to prefer to stay “invisible” during their consultation. While this
observation could certainly be random, it definitely warrants further exploration as
our study was not designed to determine reasons for divergent satisfaction. In
follow-up visits outside the scope of this study, some patients mentioned that they
would prefer phone visits to videochat, as they would not want their treating
physician to judge their home situation. Moreover, they would feel less restricted
in terms of where the remote visit would take place. Physicians conducting the study
visits predominantly stated that remote visits did not result in a poor exchange of
health information (in 89% of cases) and they did not per se favor conventional
appointments over virtual ones. We would have expected to gain deeper insights into
our patients’ preferences by performing subgroup analyses. Surprisingly, there were
no significant differences identifying a specific population of patients more
satisfied with their corresponding visit type. However, our study was not conceived
to detect such nuances. We anticipated patients with more advanced or progressive
disease to favor remote visits. There was statistical significance with respect to
patients with progressive disease being more frequently satisfied with their remote
visit. However, this hypothesis cannot be fully supported, as this group of patients
was fairly underrepresented in our study (only 5 patients in the remote visit group
had progressive MS). This is a common observation in studies with unselected
recruiting of pwMS with disregard of their disease phenotype.Our results should be discussed with regard to strengths and limitations. This
randomized controlled trial depicts a real-life cohort with patient satisfaction as
the primary endpoint. Patient satisfaction with an intervention is rarely a main
endpoint in a clinical trial, yet we believe it is paramount when addressing a
particular patient need
.
We decided to choose a non-inferiority study design as we did not aim to
undermine the relevance of a conventional physical appointment. We selected both
patient and physician satisfaction as the core of this trial as we wanted to convey
the context of an equal doctor-patient relationship. Our study was sufficiently
powered with respect to our primary endpoint, yet our sample size was small and,
thus, limiting a potential benefit from subgroup analyses. Even so, the results from
our investigation may be useful when designing similar studies. Additionally,
patients hoping for a personal benefit from a remote visit were potentially more
inclined to participate in this study, which could have introduced selection bias
and, thus, possibly inflate satisfaction. However, only 4 out of 49 patients asked
to participate declined participation, rendering a selection bias unlikely. The fact
that we excluded persons with obvious language barriers may be considered a bias. We
chose this mainly for safety and feasibility reasons. The main tool to determine our
study endpoints (satisfaction questionnaires, MSIS, self-description of health
status) required a certain level of ability to communicate in written language. We
did not want to risk missing important information beneath this virtual setting.
Furthermore, our study design did not include a qualitative survey regarding
individual preferences of participants. Nonetheless, we used validated outcome
measures throughout this study.In terms of providing care to pwMS during the current pandemic, strategies for remote
patient monitoring acquired greater importance and urgency. Our study provides
insight into satisfaction with remote visits, which warrants further investigations
in a real-world setting. It is tempting to speculate that, for some patients,
recurring remote visits may be attractive. We learned from
another study that pwMS appreciate remote visits in terms of them being
cost-effective and timesaving.
This effect increased the farther participants resided from their clinic or
hospital. In the future, it may be useful to conduct a single remote visit and
determine, upon bilateral consent, the type of subsequent visit a few weeks before
the next appointment. This setting would certainly complement a recent initiative
adopted from follow up programs for people with gynecological malignancies:
patient-initiated follow-up (PIFU).
In short, PIFU provides a framework to individualize patient care with
particular interest in holistic needs and optimizing resources. Our present study
suggests that perhaps it is not only the pace but also the medium that the patient
should manage. That being said, we should appreciate that, currently, we lack
guidelines on how to identify patients particularly suitable for remote monitoring.
Fortunately, there is an increasing body of evidence supporting the relevance
of this topic. To our knowledge, there is no study reporting possible harms
resulting from a remote visit. However, reliable follow up data, that would allow
detecting potentially adverse effects from a one-time remote visit have not been
communicated. Up to now, we do not know how patients with highly active disease
(i.e. a high relapse rate) or particular needs (such as affective disorders, poor
adherence) would respond to a virtual appointment setting. In our study, the relapse
rate prior to entering this study was rather low at 0.5/year and only two patients
experienced a relapse over the course of our observation period. In this context,
open statements from this trial raised some interesting themes that warrant further
exploration. Some comments suggested that satisfaction with remote visits may be
context dependent, particularly considering that remote monitoring may not be
considered satisfactory if presented as the sole option for care. We believe that no
matter what the concept for teleconsultations may be, the patients perception on
their health status should factor in these kinds of decisions. Furthermore, we
should mention paraclinical exams for pwMS and how to address them in possible
teleconsultations. Important paraclinical exams for treatment monitoring include
repeated MRI scans and blood tests to monitor drug safety. In Austria, the majority
of patients do these tests in outsourced facilities, e.g. specialized facilities for
radiology or laboratory medicine. Thus, the running of these tests per se remains
unaffected by televisits as their results can be discussed all the same. In
addition, we should bear in mind that our study concerned primarily the interaction
between patient and neurologist. Multidisciplinary consultations, e.g. with a team
of physical therapists, occupational therapists etc., may require a different
approach.At last, we want to make a point to embrace new technology that has the potential to
improve individualized patient care. With technology emerging and innovative methods
of monitoring (disease) activity in pwMS becoming more and more accessible, we
should beware not to inadvertently transform our doctor patient relationship into an
exchange of health information between two avatars. Yet, we can use this knowledge
to pursue a new narrative when it comes to holistic disease monitoring. The matter
of reimbursement of televisits may certainly constitute a barrier to telehealth in
general. In Austria, this has been a matter of debate, although there is general
consent that televisits are reimbursable. As far as our study is concerned,
participating physicians offered their consultations on their own time. It will
certainly be interesting to observe how the dynamic imposed on modern patient care
will evolve beyond the COVID-19 pandemic.In summary, this randomized controlled trial demonstrates multifaceted aspects of
satisfaction concerning remote visits in a sample of pwMS. Patients and treating
physicians reported high levels of satisfaction with their virtual visit comparing
favorably with regular physical visits. We provide solid evidence that concepts for
remote visits in MS are feasible and worth exploring. The conclusions from our
investigation may be communicable to other chronic diseases as well, bearing in mind
individual patient needs and preferences.Click here for additional data file.Supplemental material, sj-docx-1-dhj-10.1177_20552076221112154 for Remote visits
for people with multiple sclerosis during the COVID-19 pandemic in Austria: The
TELE MS randomized controlled trial by Patrick Altmann, Fritz Leutmezer, Markus
Ponleitner, Dominik Ivkic, Nik Krajnc, Paulus Stefan Rommer, Thomas Berger and
Gabriel Bsteh in Digital Health
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