HOW TO EVALUATE HUMAN FACTORS AFFECTING

WIRELESS BIOMEDICAL SENSORS

Identifying Aspects of Patient Acceptance based on a Preliminary Clinical Trial

Rune Fensli

and Egil Boisen

Faculty of Engineering and Science, University of Agder, Grimstad, Norway

Department of Health Science and Technology, Aalborg University, Aalborg, Denmark

Keywords: Quality of life, Patient Acceptance of Health Care, Ambulatory Monitoring, Telehomecare, Usability.

Abstract: In this paper, we highlight some important aspects of how to evaluate patient acceptance with wearable

sensors recording vital signs information, used in a telehomecare environment. Questions of human factors

and patient satisfaction need to be addressed, where the patient is able to carry out daily life activities in his

own environment. We compare results from a preliminary clinical trial with patients using a wireless ECG

sensor for three days out-of-hospital service, to available published results from telehomecare projects, and

propose important aspects and plans for future investigations. It is important not only to observe the patient,

but also the possible changes in the family situation when a sick patient is transferred to his own home for

active treatment. At the same time, emotional barriers and stigmatisation are challenging factors where time

is needed to let the patient adopt this new situation. Therefore, measures should be on an on-going basis

with long-term use of the technological equipment in order for the patient to integrate this into his body

scheme as well as daily activities. Of special importance will be the evaluation of the communication be-

tween the patient and the health professionals, as quick feedback from the doctor to the patient on his or her

own measurements is of outmost importance.

1 INTRODUCTION

Several research projects have been focusing on

wearable biomedical sensors and their benefits for

ambient assisted living, where the patients are re-

motely monitored by different sensors placed on the

body for vital signs recording (Jones et al., 2006).

However, little efforts have been done investigating

how the patients experience and manage this new

technology.

Chronically ill patients experience a greater de-

gree of freedom and are more involved in the treat-

ment with daily monitoring of vital information

during hospitalization in their own home, than with

the traditional treatment procedures at hospital. In-

troducing advanced medical technology in the pa-

tient’s own home will influence the patient’s situa-

tion as it makes empowerment and self-management

possible (Barlow et al., 2002).

At the same time, coordinated follow-up and new

workflow procedures for the health-care services

need to be implemented in order to give the patient

satisfactory support by virtual visits in his home

(Wootton and Kvedar, 2006). However, this support

also must be integrated in the self-monitoring of

vital signs information performed by the patients,

with understandable interpretations of the results.

The primary goal of developing wireless ECG

sensors is to find ways of monitoring the everyday

life of the patient as closely as possible. In other

words, the rationale is to increase the quality of data

being collected by decreasing the impact on the

patient’s everyday life when he or she is being moni-

tored. When implementing such equipment it is

therefore necessary to allow the patient to integrate

it into his or her daily activities. Also, we argue that

this integration concerns a person’s body scheme,

being a dynamic, and typically unaware, representa-

tion of the positions of one’s body parts (Haggard

and Wolpert, 2005). To monitor this process, meas-

ures should therefore be based on long-term use of

the wireless equipment in an everyday life situation.

In this paper we will focus on how the technol-

ogy acceptance can be monitored in order to high-

light obstacles and possible improvements both in

Fensli R. and Boisen E. (2008).

HOW TO EVALUATE HUMAN FACTORS AFFECTING WIRELESS BIOMEDICAL SENSORS - Identifying Aspects of Patient Acceptance based on a

Preliminary Clinical Trial.

In Proceedings of the First International Conference on Health Informatics, pages 3-8

 SciTePress

the technology solutions and in coordination with

the health care services. Based on experiences from

a preliminary clinical trial, we try to identify some

important aspects of patient acceptance and present

plans for future projects involving observations of

user acceptance.

1.1 Usability and Telehomecare

Home telehealth is a growing field of patient treat-

ment and follow-up, but most research studies have

focused on the technology, and so questions of hu-

man factors and patient satisfaction need to be ad-

dressed. A systematic review of studies of patient

satisfaction with telemedicine was done by Mair and

Whitten, arguing that “available research fails to

provide satisfactory explanations of the underlying

reasons for patient satisfaction or dissatisfaction

with telemedicine”. They found that the studies

concerning patient satisfaction mainly used simple

survey instruments and that many of the studies had

only a few participants (Mair and Whitten, 2000).

According to Friedman & Wyatt, usability stud-

ies can be useful in the evaluation of new biomedical

equipment, with the aim of observing speed of use,

user comments and completion of simple tasks

(Friedman and Wyatt, 2006). They describe field

function studies as useful in the validation of proto-

types or released versions of new biomedical equip-

ments, but the trials should be conducted in situa-

tions with real use of the equipment, and with the

aim of observing speed and quality of data collected

and accuracy of advice given from the devices.

The principles of user-centered design can be

useful when designing new telehomecare devices.

Adlam and colleagues describe how user evaluation

can be implemented in the design process (Adlam et

al., 2006). They start with discovering the “real

problem” and the users’ requirements, which can be

accomplished with a simple prototype demonstrating

the actual functionality of a device. However, inter-

acting with real users in their own environments will

be a challenging task, and protypes with limited

functionality can give restrictions on the use of the

new solution to be developed, resulting in prelimi-

nary tests, which do not reflect a more complicated

use situation, i.e. the daily activities of the patients.

Kaufmann and colleagues developed a system

design for both usability testing and usability inspec-

tion in the patient’s home for a diabetes telemedicine

system. First, they used a cognitive walkthrough to

identify goals and sequences of actions to anticipate

potential user problems. Second, a field usability

testing was performed as a series of tasks to be ac-

complished by the subjects in their home and closely

followed by semi-structured interviews to reveal

problems and barriers to efficient and safe use of the

system (Kaufmann et al., 2003). A similar approach

has been suggested by Kushniruk and Patel, who

have developed a low-cost portable usability testing

solution intended to be used by patients in their

homes (Kushniruk and Patel, 2004).

In a study of the patient’s perspectives on high-

tech homecare technology, Lehoux found that the

user-acceptance was shaped by different types of

anxiety, which mainly was related to the actual

equipment and the procedures. At the same time, the

patients complained of reductions in daily activities

as well as feelings of stigmatization, as they tended

to withdraw from social activities in order to hide

the medical equipment from the eyes of visitors. For

a patient wearing a permanent catheter, this will alter

the patient’s body image (Lehoux, 2004). Lehoux

found that good usability is dependant on compe-

tence, where lay people are supposed to use high-

tech medical devices, as well as on technical and

human dimensions, where the technology is inte-

grated into the patients’ private and social lives.

Hopp and colleagues measured the outcome for

patients receiving telehealth home-care and used a

questionnaire at baseline and after six months, where

they used a modified version of the SF-36 to meas-

ure Health Related Quality Of Life (HRQOL) (Hopp

et al., 2006). In addition they used separate questions

to ask about satisfaction with the telehealth equip-

ment for the intervention group, with questions from

the National Ambulatory Care Survey and modified

for use in evaluating telehealth services. They found

a high degree of satisfaction with the telemedicine

equipment, but few patients reported that their fam-

ily members had been taught how to use the equip-

ment installed in their homes.

2 OBJECTIVES

In this paper, we present some ideas of how to

evaluate human aspects of telehomecare solutions,

which are based on preliminary results from a clini-

cal study where patients have used wearable sensors

for a three day period of out-of-hospital service. We

focus on the impact on everyday life during the

patients’ use of the wireless ECG-sensor; the experi-

ences with daily behaviour as well as general patient

satisfaction. The important question is which factors

to include in future evaluations, and how to observe

the degree of the patients’ influence on new tele-

homecare services, together with their perception

HEALTHINF 2008 - International Conference on Health Informatics

and possible adoption of the new technology.

3 METHODS

Patients referred to long-term ambulatory “Holter”

arrhythmia procedures at the outpatient clinic at

Sørlandet Sykehus HF in Arendal, Norway, were

asked to participate in a study wearing our newly

developed wireless ECG-sensor (Fensli et al., 2005).

By signing the informed consent form, they partici-

pated in the study during their ordinary arrhythmia

investigation. The inclusion criteria was patients

with suspected arrhythmias, and the exclusion crite-

ria was patients with dementia who were anticipated

not being able to handle the equipment and contrib-

ute in filling out the required questionnaires.

After signing the informed consent form, the pa-

tients were given information of the research project

and they received several questionnaires to be filled

in during the time they used the wireless ECG-

system as a usability study. Because influences from

participating in a three day trial of the new recording

solutions can be a bias in the evaluation of patient

acceptance, a reference group with patients undergo-

ing a “normal” routine investigation at the hospital

using conventional “Holter” monitoring equipment

(Huntleigh Healthcare) was established.

During the period from November 2006 to May

2007, 11 patients were enrolled in the study, and 25

patients were included in the reference group. The

questionnaires focused on several topics, among

them questions defining the Dimensions: Hygienic

Aspects (3 items), Physical Activity (6 items), Skin

Reactions (2 items), Anxiety (3 items), and Equip-

ment (5 items) (Fensli et al., 2008). After a three day

period of arrhythmia investigation with the use of

the wireless sensor, 4 patients in the intervention

group were followed-up with qualitative interviews,

in order to discover more general experience with

regard to the use of a wearable sensor.

4 EXPLORATORY RESULTS

In the questionnaire, the patients are asked about

their experiences with the use of the equipment,

where we have used an 11-point semantic differen-

tial scale. The patients should evaluate their experi-

ence of using the wireless equipment in terms of

their agreement to the statements describing actual

situations of the equipment usage. For some of the

questions the scale was ranging from “0 – Extremely

problematic” to “10 – Without any problems”. Some

items described a statement with scale values rang-

ing from “0 – I completely disagree” to “10 – I com-

pletely agree”. In addition, they filled in some gen-

eral characteristics, such as gender and age. The

results are given in Table 1.

Table 1: Patients’ general characteristics and results from

the calculated dimensions based on the questionnaires,

Mean (SD). Calculations of Cronbach’s alpha for the

dimension Hygienic Aspects was 0.83, for Physical Activ-

ity 0.88, for Skin Reactions 0.65, for Anxiety 0.80 and for

Equipment 0.86.

General characteristics

and Dimensions

Wireless

sensor

(n=11)

Reference

group

(n=25)

Gender: Man/woman 6 / 5 7 / 18

Age 40.2 (19.4) 56.4 (13.2)

SAI 8.2 (1.0) 7.6 (1.9)

Hygienic Aspects 8.6 (1.6) 6.6 (2.9)

Physical Activity 9.2 (0.8) 8.0 (2.8)

Skin Reactions 6.3 (2.5) 8.6 (2.4)

Anxiety 9.0 (1.3) 7.3 (3.5)

Equipment 8.0 (1.7) 7.5 (2.8)

* significant difference p<.05

The internal consistency, as calculated by Cron-

bach’s alpha, showed acceptable levels. The con-

struct validity was evaluated by confirmatory factor

analysis, giving reasonable factor loading according

to our expectations. Calculations of a Sensor Accep-

tance Index (SAI) as an aggregated score showed a

tendency towards a higher score for the wireless

group compared to the reference group; however this

difference was not at a significant level. For the

dimension Hygienic Aspects regression analyses

showed a significant difference between the two

groups (F (1,34)=4.51; p<0.05), with a higher score

for the wireless group. The dimension Skin Reac-

tions showed a significantly higher score for the

reference group (F (1,31)=5.95; p<0.05). With re-

gard to the dimensions Anxiety and Physical Activ-

ity, the wireless sensor showed higher scores; how-

ever, this was not a significant difference.

In the interviews with four of the patients in the

intervention group, we tried to discover some gen-

eral experiences from the patients’ use of the wire-

less recording equipment. All patients reported some

anxiety because of what they found to be a degree of

uncertainty, as they did not receive any feedback

from the recording system of the measurements

made. They expected a quick feedback from the

hospital, and two of the patients expressed the need

for patient influence, while one of the respondents

HOW TO EVALUATE HUMAN FACTORS AFFECTING WIRELESS BIOMEDICAL SENSORS - Identifying Aspects

of Patient Acceptance based on a Preliminary Clinical Trial

said that he was not concerned with influence.

The hygienic factor focused on actual tasks re-

lated to the patient’s ability to perform body wash

and use of the equipment during the night while

asleep, in order to obtain information about any

problems relating to the wearable recording sensor.

The survey showed a significant difference for the

hygienic aspects, and the wireless solution obviously

was preferable, since it is easy to wear and does not

involve any hindrances like cables. This was con-

firmed both by responses to the open questions in

the questionnaire and by statements in the inter-

views, as the patients generally expressed high satis-

faction with the wireless solution compared to the

existing “Holter” system. They felt free to carry out

daily activities without any hindrance.

With respect to the equipment used, one patient

complained about the “Holter” recorder, and said

that he had “a feeling of being a living medical in-

strument”, because of all the cables he had to wear.

With regard to the wireless sensor, he said: “The

wireless sensor was comfortable to wear, and most

of the time I just forgot I was wearing this system”.

He said that the sensor after a while became “a part

of me”.

Another patient said the wireless system made it

possible for her to participate in physical exercise. It

was much easier to wear, especially during the night,

and it did not prevent her from being able to take a

shower. The Holter equipment was troublesome with

all the cables, and made the hygienic activities more

problematic. In her view, the differences in use be-

tween those two systems were huge, and they can

not be compared at all.

One of the patients expressed some dissatisfac-

tion with wearing this equipment, and she wanted to

hide the equipment from other people. Similar ex-

pressions of embarrassment were also found in re-

sponses to the open questions in the questionnaire,

and even if the calculated difference was not at a

significant level, it showed a trend toward more

anxiety regarding the use of the Holter equipment.

5 DISCUSSION

The results presented above are of interest in the

evaluation of patient experience with wearable sen-

sors attached to the chest for three days of continu-

ous monitoring. Even though this clinical trial was

limited both in terms of time and the number of

patients, some interesting aspects have been discov-

ered in relation to integration into the patients’ eve-

ryday life. By comparing results and experiences

from the clinical trial with available published re-

sults from other telehomecare projects, it has been

possible to discover some general aspects and point

out ideas for future investigations.

First, our findings point to the issue of stigmati-

zation, as some patients wish to hide the wireless

recorder from the eyes of other people. This was

similar to the findings by Myers et al., who studied

the impact of home-based monitoring on patients

with congestive heart failure, and followed up pa-

tients for a 2 month period. They found it necessary

to train patients in telemonitoring procedures on an

ongoing basis (Myers et al., 2006). During their

study, 13.5% of patients withdrew due to anxiety or

because they did not “like” the telemonitoring pro-

cedures or equipment. Their experiences of patient

perception and ability to learn how to use the

equipment indicate that the emotional barriers and

stigmatization were a challenging factor and time

was needed to allow the patients to adapt to this new

situation. Our findings, however, also showed that

when patients feel like the sensor is becoming “a

part of me”, as expressed by one of the patients, the

stigmatization factor does not seem to represent any

problems for the patient during daily activities, and

can be adopted within his or her body scheme.

Second, our findings point to a need of constant

feedback from the system or the health professionals

to the patients. In this study we did not implement a

daily reporting schema between the patient and the

hospital, which was probably the reason why the

patients expressed some worries about what the

technology was measuring in terms of irregularities

in their heart beats. Even though they trusted the

equipment, they would like to see the results and the

doctor’s evaluation of the results when they felt

irregular heart beats. These findings were in line

with our experiences from an earlier study where

patients underwent a 24-hour Holter recording pro-

cedure (Fensli et al., 2004), and quick feedback from

the doctor was evaluated to be of utmost importance.

However, although the patients appreciated good

information during the research project, they ex-

pressed some uncertainty with respect to from whom

they would receive an answer concerning arrhythmia

findings. Their misperception of the health care

sector as a “clear and strictly coordinated service”,

capable of giving them the desired follow-up, shows

that organizational issues will be of utmost impor-

tance when introducing new telemedical solutions. If

the co-ordination within the health care sector is not

clearly defined, questions from the patients will not

be correctly addressed and there will easily be situa-

tions where patients will suffer from not having

HEALTHINF 2008 - International Conference on Health Informatics

received the required feedback to the situation at

hand.

Third, during the interviews the patients ex-

pressed overall good confidence with using the

wearable sensor, mostly because of the ease of use

during daily activities, which was confirmed by the

significant difference calculated for the Hygienic

Aspects. As a general measure of satisfaction (SAI),

we found a relatively high score at 8.2 for the inter-

vention group and 7.6 for the reference group. Ac-

cording to the intentions of home-based health care

as expressed by Barlow and colleagues, those ex-

pressions of satisfaction were somewhat as expected

(Barlow et al., 2002). This has also been confirmed

by Whitten and Mickus in their study of patients

with congestive heart failure in addition to chronic

pulmonary disease, finding that the patients were

satisfied with the technology (Whitten and Mickus,

2007). Wootton and Kvedar have also pointed to the

importance of changes in the health care services

(Wootton and Kvedar, 2006), and their findings are

also in line with what was reported by Scalvini and

colleagues in their study of chronic heart patients

and the effects of home-based telecardiololgy (Scal-

vini et al., 2005). In our study, the scores for Anxi-

ety were relatively high indicating a low degree of

anxiety, with 9.0 in the intervention group and 7.3 in

the reference group. The age of patients in the refer-

ence group was slightly higher and consisted of

more female patients, which may represent a bias.

However, being confident with using the wearable

equipment combined with a feeling of safety is im-

portant to the patients.

Patient acceptance of home hospitalization

equipment on a long-term basis does not seem to

have been given the necessary attention in previous

studies of telehomecare. Following a systematic

study of observed effects in home telemonitoring of

patients with diabetes, Jaana and colleagues found

that studies should be extended in time and involve

larger samples of patients in order to generalize the

findings and obtain sufficient validity (Jaana and

Pare, 2007). Long-term evaluation may probably

also discover some underlying reasons for the feel-

ings of anxiety as reported by Lehoux.

We therefore propose future studies to follow the

patients’ use of wearable sensors and telehomecare

equipment for a relatively long time in order for the

patient to adopt the technology into his/her daily

activities and body scheme. Attention should be paid

to the patients’ ability to carry out hygienic activities

such as body wash or even taking a shower, and it

should be possible to participate in physical sports

activities while using wearable sensor recorders.

Also, not only the patient but also his/her spouse

or partner should be taken into account and given the

necessary information about how the treatment

should be performed and how to interact with the

health care services in a coordinated manner using

tele-medical equipment. As proposed by Kushniruk

and Patel, multi-method evaluations can be impor-

tant, and even the use of video-recording can be

performed in the patients’ home (Kushniruk and

Patel, 2004). Hence, a multi-method approach can

be employed, where questionnaires can provide

some background information about the patients,

their behaviour, and acceptance of the technology. In

addition, interviews in the patient’s home can be

combined with video recordings and, later on, analy-

sis of the process data to obtain a more thorough

understanding of obstacles and barriers to the use of

such solutions. Evaluating the communication be-

tween the patient and health care services will also

be of special importance, and new e-health-based

forms of communication should be investigated. As

quick responses are required by the patients, quality

factors in the communication between the patient

and the health care service should be observed.

6 CONCLUSIONS

Implementation of wireless sensors for vital signs

recording for the use in home hospitalization can be

a great benefit for the patient, as this gives a feeling

of freedom compared to ordinary hospital stay. Dur-

ing the use of wireless ECG-sensors, the patients in

this study were satisfied with the ease of use in a

daily life situation, and gave a higher score in the

factor Hygienic Aspects than patients in the refer-

ence group. With respect to the factor Anxiety no

significant differences were discovered. However,

the use of wearable medical equipment can also

affect the patients’ everyday life situation in a nega-

tive manner, where they tended to hide the equip-

ment from the eyes of other people, and they ex-

pressed anxiousness for not using the telemedical

equipment in a correct manner. But at the same time,

the patients also expressed confidence with the sys-

tem and tended to adopt its use into their daily life.

During the interviews, the patients, however, ex-

pressed worries of not having immediate feedback

and responses to irregular heart beats, and their ex-

pectations of instant follow-up by the health care

sector were revealed. This can be a great challenge

where necessary coordinated routines and workflow

within the health care sector should be defined and

established before implementing new telemedical

HOW TO EVALUATE HUMAN FACTORS AFFECTING WIRELESS BIOMEDICAL SENSORS - Identifying Aspects

of Patient Acceptance based on a Preliminary Clinical Trial

services. The feedback channels to the patients’

questions and recordings should be timely defined

and validated. In order to investigate the use of

telemedical technology in everyday life situations,

research studies should be performed in a relatively

long-term manner. Also, by employing a multi-

method approach, such studies should focus on ob-

serving to which degree the patient adopts this new

technology into his or her everyday life as well as

body scheme or body image. Additionally, such

studies should take into account the interaction be-

tween the patient and the system, as well as the in-

teraction between the patient and the health care

professionals. Finally, it seems necessary to also

investigate how the patient’s partner or spouse ex-

periences the technology in daily use.

ACKNOWLEDGEMENTS

The study is supported by the Research Council of

Norway. The clinical trials are done in close co-

operation with Sørlandet Sykehus HF, Arendal and

the company WPR Medical AS. The authors thank

Torstein Gundersen, Ellen Ytrehus and Åse Løs-

nesløkken at Sørlandet Sykehus, and Eirik Aanonsen

at WPR Medical for good assistance with the pa-

tients during clinical trials. We also thank Kjersti

Nag, Hjørdis Løvdal Gulseth and Hedda Løvland for

their assistance with interviewing the patients.

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