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2016 IEEE 29th International Symposium on Computer-Based Medical Systems

Quality Evaluation of Poison Control Information


Systems: A Case Study of the DATATOX System
João M. Alves, Christiane G. von Wangenheim, Aldo von Wangenheim Alexandre Savaris
Postgraduate Program in Computer Science Telemedicine Laboratory
Federal University of Santa Catarina – UFSC Brazilian Institute for Digital Convergence – INCoD
Florianópolis, Brazil Florianópolis, Brazil
joao@telemedicina.ufsc.br, gresse@inf.ufsc.br, aldo.vw@ufsc.br savaris@telemedicina.ufsc.br

Marlene Zannin Danielle B. L. Albino, Marisete C. Resener


Pathology Department Santa Catarina Toxicology Information Centre – CIT/SC
Universidade Federal de Santa Catarina – UFSC Brazilian Association of Toxicology Information and
Florianópolis, Brazil Assistance Centres – ABRACIT
marlenezannin@gmail.com Florianópolis, Brazil
danialb@terra.com.br, mcresener@yahoo.com.br

Abstract—Poison Control Centres (PCCs) provide information Sul [4]) shows that the number of reported intoxications has
and advise about poisoning, poisoning case management, and risen 46% from 2005 to 2013, with over 147,000 cases of
toxicovigilance activities. They are supported by information intoxication by drugs or venomous animals being registered
systems that help physicians and toxicologists to attend cases of
patient exposure to poisonous agents. Still, there is no consensus
during that period. From the registered cases 0.31% ended in
on how to evaluate software quality of such systems. This death, and 0.59% resulted in sequelae for the patients.
work performs a case study applying a customized software Poison Control Centres (PCCs) have the responsibility to
quality evaluation model – the AdEQUATE model – in order provide toxicological information and advice, management of
to assess the software quality of a poison control information poisoning cases, provision of laboratory analytical services,
system widely used in Brazil – the DATATOX information
system. Analysing the specificities of DATATOX we customized
surveillance activities, research, education, and training in the
AdEQUATE, a model for evaluating the quality of telemedicine prevention of poisoning [5]. Countries such as the United
systems based on the ISO/IEC 25010 standard through the use of States [6] and the British Isles [7] maintain poisoning infor-
a questionnaire. The questionnaire has been answered by 49 end mation centres that provide toxicological advisory services 24
users, and the acquired data were analysed employing descriptive hours a day. Most of those services rely on telephone inter-
statistics. Overall, the DATATOX information system has been
perceived as having a good quality, specifically for characteristics
action, but some PCCs have on-line interaction systems, such
like effectiveness, efficiency, and satisfaction. Nevertheless, few as the Web Poison Control website [8], allowing information
characteristics have been considered of low quality, including requesters to get help using the Internet.
reliability, compatibility, and age. As a complement, the work In this context, Teletoxicology is a specialization of
attest the feasibility on using AdEQUATE’s questionnaires as an telemedicine that provides toxicology services at a distance,
evaluation tool for software quality evaluation.
which can be used in the absence of immediately available
Keywords— software quality evaluation; poison control centres
information systems; case study; toxicology specialists [9]. Although easily defined, there is no
consensus in the literature about the objectives to be achieved
and the main functionalities to be provided by teletoxicology
I. I NTRODUCTION
systems: TOXBASE [10] and the American National Poison
Poisoning has caused anguish and adversities throughout Data System [11], for instance, act respectively as a poison
history. The literature points out that from the ergot epidemics information database for health care professionals and as a
of the Middle Ages up to contemporary industrial disasters, record of cases reporting the exposure of patients to poisonous
these plagues have had great political, economical, social, and agents. Despite its final aims, such systems manage informa-
environmental implications – particularly within the past 100 tion that has a direct impact on patient’s health; therefore, it
years – as the number of toxins and potential toxins handled is important to maintain a minimal level of quality to prevent
in everyday situations has risen dramatically [1]. Yearly, errors that could impose risks to patients.
poisoning accounts for about 170,000 hospital admissions in There exist quality guidelines that could be applied to
the NHS (National Health Service) of the United Kingdom, a teletoxicology systems, as the guideline for poison control
considerable workload for the health service staff, especially in centres of the World Health Organization [5], and the Practice
hospital emergency departments and medical admission units Guidelines for Live, on Demand Primary and Urgent Care of
[2]. Information about poisoning in Brazil (based on reports the American Telemedicine Association [12]. However, these
from the States of Santa Catarina [3] and Rio Grande do guidelines usually do not consider software quality as a whole,

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DOI 10.1109/CBMS.2016.53
limiting themselves to proposals on how a specific quality toxicology environment, gathering references from three sets
characteristic should be addressed by systems. On the other of repositories:
hand, over the years a number of software quality evaluation Set #1: Sagepub1 , IEEEXplore2 , Springer Link3 , ACM
models and standards have been proposed to support quality Digital Library4 , and MEDLINE5 . The search was
control of software systems [13]. Yet, models like ISO/IEC performed using the following well-formed string:
25010 [14] are generic and, thus, may not fully address the "((toxicology AND information system) OR
specific needs of teletoxicology systems. In order to ensure (teletoxicology AND information system))";
that a specific product meets user and customer needs, it is Set #2: Journal of Telemedicine and e-Health6 , International
necessary to customize the quality evaluation model to the Journal of Telemedicine and Applications7 , International
context at hand [15]. Journal of Telemedicine and Clinical Practices8 , and
A customization approach based on the ISO/IEC 25010 International Journal of E-Health and Medical Commu-
standard is AdEQUATE (questionnAire for Evaluation of nications9 . The search included all references related to
QUAlity in TElemedicine systems) [16]. AdEQUATE is toxicology;
an evaluation model built considering the specificities of Set #3: Journal of Medical Toxicology10 , Toxicology11 , and
telemedicine systems, decomposing an evaluation goal repres- Trends in Pharmacological Sciences12 . The search in-
ented as a set of analysis questions into metrics, being exerted cluded all references related to information systems.
by a questionnaire in order to allow data analysis from the We considered all state-of-the-art references that met the
end user’s perception. following criteria: a) Publication in English; b) focus on
In this work we focus on evaluating the software quality information systems for toxicology; and c) publication date
of DATATOX, a teletoxicology information system supported between January, 2011 and December, 2015 . References that
by the Brazilian Association of Toxicology Information and do not describe an information system or quality aspects of
Assistance Centres (ABRACIT) used in nine States by toxico- an information system were excluded from the result set. The
logy experts to aid poisoned victims, manage poisoning cases, initial search executed in November, 2015 resulted in a total
and provide statistics to the Brazilian National Health Sur- of 848 references. By analysing the title and keywords and
veillance Agency. The evaluation is made from the viewpoint applying the inclusion and exclusion criteria, we identified 38
of end users – on-duty toxicologists, medical students, and potentially relevant articles. After a careful reading of its full
physicians – employing the AdEQUATE model. We aim, also, content, we considered that 11 articles match all criteria. Table
to attest the feasibility of systematically generate customized, I summarizes the SLR result.
ISO/IEC 25010-based software quality models able to evaluate According to the classification, three references have focus
in detail teletoxicology systems, addressing its specificities on teleconsultation (i.e. the telemonitoring intervention includ-
while maintaining the generality and software-quality-as-a- ing patient–caregiver asynchronous or synchronous commu-
whole approach of the referred standard. nication to connect caregivers and one or more patients simul-
In Section II we provide a background on teletoxicology taneously [20]). Information databases, in turn, correspond to
systems and software quality evaluation. In Section III we the most common type of teletoxicology system, addressing
describe the customization process performed on AdEQUATE the toxic effects of medications and hazardous chemicals –
and its application through questionnaires. The collected data including household products – providing information about
is analysed and discussed in Sections IV and V, guiding the general and environmental health issues [21].
conclusions about the feasibility of the evaluation approach, Software tools supporting the toxicology practice are cited
which is presented in Section VI. by one reference, and poisoning control systems – focus of the
current work – are present in two references. None of those
II. BACKGROUND AND R ELATED W ORKS works focused on the evaluation of its software quality.
A. Toxicology and Poison Information Systems Although not explicitly defined, [25], [28], [8], [32], [33],
[34], [35] list three categories of stakeholders for teletoxi-
Clinical toxicology concerns the investigation, diagnosis and
cology systems: Requesters, attendants, and physicians. Re-
management of suspected poisoning cases [17], contributing
for the reduction of rates related to drug abuse [18] and in 1 http://online.sagepub.com/

helping victims of poisoning by several agents, such as drugs, 2 http://ieeexplore.ieee.org/Xplore/home.jsp


3 http://link.springer.com/
pesticides, bites and envenomations, plants, and chemicals [6].
4 http://dl.acm.org/
In this context, teletoxicology systems are information sys- 5 http://www.ncbi.nlm.nih.gov/pubmed
tems that support the referred practice over distance. Despite 6 http://online.liebertpub.com/loi/TMJ
its importance, there are few works available describing its 7 http://www.hindawi.com/journals/ijta/
8 http://www.inderscience.com/jhome.php?jcode=ijtmcp
architecture, workflow, and common functionalities. In order
9 http://www.igi-global.com/journal/international-journal-health-medical-
to provide a consistent background in teletoxicology systems,
communications
we conducted a systematic literature review (SLR) following 10 http://link.springer.com/journal/13181
the procedures defined by Kitchenham [19]. The scope of our 11 http://www.journals.elsevier.com/toxicology/

SLR is limited on literature about information systems in a 12 http://www.cell.com/trends/pharmacological-sciences/home

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Table I 1) The DATATOX information system: DATATOX is an
R ELATED TELETOXICOLOGY WORKS
example of a teletoxicology information system; deployed in
2013, it is currently in use by 11 PCCs from 9 States in Brazil,
Tele- Poisoning Information Computational
Reference and is available 24/7.
consultation Control Database Toxicology
[22] X
Since its adoption, DATATOX has managed over 81,000
[23] X occurrences of poisoning caused by drugs, pesticides (both do-
[21] X mestic and industrial), rat poison, household cleaning products,
[24] X
[25] X
cosmetics and toiletries, industrial products, metals, abuse
[26] X drugs, plants and fungi, food, venomous, and poisonous anim-
[27] X als. Medical doctors are the most common requesters, followed
[28] X X
[29] X
by relatives and nurses. Undergraduate medical students, in
[30] X turn, coordinated by a medical doctor, are the most common
[31] X attendants.
DATATOX offers 3 main functionalities to its users: case
registry, case review, and case follow-up. The case registry
questers provide information about the poisoning occurrence. is used by attendants to register a poisoning or informative
A requester can be a patient, a person responsible for a patient, case, that may be corrected or improved by a physician using
a health care professional looking for educative material, or the case review functionality. The case follow-up allows the
a common person looking for information. Attendants are re- attendants to further improve the information about the case,
sponsible for the record of information provided by requesters, getting in touch with requesters if needed. The DATATOX in-
evaluating the severity of the reported case and eventually formation system does not have a toxicology database module,
conducting requesters to a course of action. Physicians, in turn, so on-duty attendants or physicians rely on external databases
advise and supervise groups of attendants, being responsible such as TOXBASE[36] c and Micromedex Solutions[37].
c
for the management and organization of toxicology database A common scenario involving DATATOX is as follows: the
resources. PCC receives a telephone call made by a requester. The call
Fig. 1 depicts the workflow of a teletoxicology information is answered by an attendant, who registers all information
system, including its stakeholders. regarding the poisoning case within the information system
As can be seen in Fig. 1, the requester contacts the PCC and proceeds to assess the current situation of the patient. In
providing all information available for the case (1) (e.g. patient order to support its assessment, the attendant might search
age, patient weight, intoxication pathway). In cases involving external toxicology databases or ask directly to a supervising
drugs, it is important to report what kind of drug was used physician for information. After its assessment, the attendant
and/or the quantity consumed. The attendant interacts with the gives the proper feedback to the requester, and the call is
poison control information system (2), assessing the severity ended. If necessary, the attendant schedules a follow-up in the
of the case. If necessary, the attendant can search for comple- DATATOX information system with the requester, that might
mentary information in toxicology databases (either in hard occur when a laboratory analysis arrives, or just to check the
copies or in electronic form) (3.a); alternatively, the attendant patient’s evolution. The case is closed only after a careful
may ask for the opinion of a physician (3.b). The physician, in analysis performed by a physician.
turn, may also consult toxicology databases giving feedback
B. Software quality
(5) to the attendant. Finally, the attendant gives feedback to
the requester (6) with the appropriate recommendations (e.g. Software quality is defined as the degree to which a system
first aid to be applied, medication to be prescribed). satisfies the stated and implied needs of its various stakehold-
ers [14]. Being an abstract concept, it is difficult to measure or
evaluate software quality [38]; therefore, quality models and
standards are proposed defining a set of characteristics and
relationships between characteristics as a basis for specifying
quality requirements and quality evaluation [39].
Several quality models were proposed since 1970, which
recently have been integrated into the industry quality standard
ISO/IEC 25010. This standard is divided into two models:
the quality in use model that defines five quality character-
istics related to the user interaction (effectiveness, efficiency,
satisfaction, freedom from risk, and context coverage) and
the product quality model, which defines eight characteristics
related to static software properties (functional suitability,
performance efficiency, compatibility, usability, reliability, se-
Figure 1. A common workflow supported by teletoxicology information
systems. curity, maintainability, and portability). These characteristics

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are then decomposed into subcharacteristics, and finally into more than six months but less than a year, and only 14% of
measures. In order to be widely adopted, the ISO/IEC 25010 respondents used the system for less than six months.
standard is defined in a generic manner applicable to any kind
IV. DATA A NALYSIS AND I NTERPRETATION
of software system; however, it must be customized to the
evaluation of specific types of software systems in order to Data collected during the case study execution are analysed
ensure that particular product functionalities meet the user using two metrics, applied to every AdEQUATE characteristic
needs [15]. computing the distribution of each response option available
1) The AdEQUATE Model: AdEQUATE is a quality model to respondents.
developed based on the ISO/IEC 25010 standard, whose Metric #1: For every questionnaire item, the percentage of the
objective is to evaluate the software quality of telemedicine sum of response options chosen by respondents.
and telehealth systems from the perspective of its end users The chart in Fig. 2 shows the distribution of each response
[16]. The model systematically decomposes the quality charac- option grouped by ISO/IEC 25010 quality characteristics
teristics into measures, and pre-defines a questionnaire to op- within AdEQUATE. It is observed that for the majority of
erationalize data collection. The questionnaire13 is composed characteristics, the answers “totally agree” or “agree” (light
of 70 items: green and dark green bars) correspond to more than 50% of
• 2 demographic items, discriminating the role of the the responses; exceptions are “compatibility”, “reliability”, and
respondents within the system and its experience in using “context coverage”. Since the “don’t understand” option was
the system; chosen in a maximum of 2% of responses, it is considered that
• 68 systematically derived items from the quality char- all characteristics were well understood by the respondents.
acteristics and subcharacteristics found in the referred To further comprehend the quality degree of each character-
standard. istic, we calculated a score value according to (1). In the equa-
The response format for the questionnaire items is a 4- tion, R̃i corresponds to the median of responses given on the
point Likert scale, including three additional options: “not questionnaire for the subcharacteristic n by respondent i, and
applicable”, “do not know”, and “did not understand the item”. W (R̃i ) corresponds to a weight function based on a response
All items are accompanied by counterexamples, formulated as option assuming the following values: 3 for “totally agree”, 2
positive assertions. for “agree”, 1 for “disagree”, and 0 for “totally disagree”. The
response options “don’t know”, “non applicable”, and “don’t
III. M ETHODOLOGY understand the item” are ignored. The last component in (1)
In order to assess the software quality of the DATATOX guarantees that Sn varies from 0 (poorest degree of quality
information system in the context of ABRACIT’s poison – i.e. all 49 respondents choose “totally disagree”) to 100
control centres, we defined and executed a case study. This (exceptional degree of quality – i.e. all 49 respondents choose
Section characterizes the case study, and section IV presents “totally agree”).
the analysis of the acquired data.  
49
100
Sn = ∑ W (R̃i ) ∗ (1)
A. Case study definition i=1 147
Based on our SLR and experience with the DATATOX infor- Using (1), the second metric is defined as follows:
mation system, we considered all software quality characterist- Metric #2: The median of the scores for every questionnaire
ics and subcharacteristics proposed by the AdEQUATE model item and characteristic.
as relevant13 . In order to operationalize data collection, we
We adopted the scoring system defined by the System
revised the questionnaire items and exemplified each item with
Usability Scale (SUS) [40], because it is related to software
a counterexample extracted from the context of teletoxicology
quality and it is a well established evaluation tool in the
systems and the routine of poison control centres.
14 https://www.limesurvey.org/
B. Case study execution
From November, 2015 to December, 2015 we collected
data using on-line questionnaires available via LimeSurvey14
answered by DATATOX users from multiple work shifts in all
available facilities. In the main facility users were personally
invited to answer the questionnaire; in other facilities, users
were invited by telephone. A total of 49 users were invited
and answered the questionnaire. From respondents, 65% were
attendants and 35% were physicians. Also, 55% of them used
the system for more than a year, 31% used the system for
13 The full range of AdEQUATE characteristics, subcharacteristics and
questionnaire items can be accessed in https://arquivos.ufsc.br/f/61d4095f6a/ Figure 2. Distribution of questionnaire answers between characteristics.

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industry [41]. It considers four response options (“Totally tolerance”, perceived by analysing data from the case study.
agree”, “agree”, “disagree”, and “totally disagree”), resulting DATATOX, also, does not have any integrated toxicology
in the chart depicted in Fig. 3. database, forcing its users to rely on external data sources
Differences between Fig. 2 and Fig. 3 show the influence and contributing to its low degree of “interoperability”.
of weighting a response option in the final result. While Fig.
2 shows “efficiency” and “effectiveness” roughly as having A. Threats to validity
the same quality degree, Fig. 3 shows that “efficiency” has To enhance the internal validity and avoid selection bias in
been better evaluated because it had more “totally agreed” our case study we invited DATATOX users from all available
responses. This difference is more evident in the case of facilities, from multiple working shifts, personally or via
“reliability” and “compatibility”. “Compatibility” had more telephone calls. To minimize bias in the research design,
“totally agree” responses, but also had more “totally disagree” we adopted the AdEQUATE model. Although the model has
responses; the result is that “reliability” could be perceived not yet been validated by a larger study, we assume that its
with a better quality degree than “compatibility”. On the other systematic derivation from a largely accepted international
hand, other characteristics were not affected by the change quality standard – the ISO/IEC 25010 standard – reduces
of metrics: “Satisfaction” and “context coverage” are still construction validity threats.
perceived as having, respectively, the highest and the lowest
Due to our focus be on a specific teletoxicology system –
quality degree. Finally, since every characteristic had a score
the DATATOX system – results of this study have a limited
that was over two interquartile ranges (IQR) away from the
external validity. Also, although it is not common to evaluate
median, we did not identify outliers for the metric #2.
quality through the use of questionnaires, the annex C in
V. D ISCUSSION the ISO/IEC 25010 standard states that all subcharacteristics
can be evaluated by external measures – degree to which a
Data acquired during the case study execution attest an software product enables the behaviour of a system to satisfy
overall good quality for the DATATOX information system. stated and implied needs for the system, including the software
The division of Fig. 3 into quartiles shows how end users to be used under specified conditions [14]. Furthermore, the
perceive the system related to its quality characteristics: “Sat- ISO/IEC 25022 standard proposes the use of questionnaires as
isfaction”, “efficiency”, and “effectiveness” have the highest a method to assess quality [42].
quality degrees, followed by “risk mitigation”, “security”, and
“functional suitability”; “performance efficiency” and “usabil- VI. C ONCLUSION
ity” were perceived as having a slightly lower quality degree,
and “reliability”, “compatibility”, and “context coverage” were Poison control information systems help toxicologists to
perceived as having a low quality degree. The low quality manage poisoning cases, handling data regarding the poi-
degree perceived for “context coverage” is due to a low degree soning agent, the victim, and controlling the follow-up for
of flexibility: The system can be used only on Mozilla Firefox, the cases as needed. Some systems can help toxicologists
only on desktop and laptop computers, and cannot be accessed even further by offering a specialized toxicology database. In
by requesters. Furthermore, end users consider the system as this context, software quality is an issue because there is no
being not optimal to be used in the toxicology context. specific standard guiding the development of such systems,
DATATOX is a web-based teletoxicology system, being neither a software quality evaluation model. While ISO/IEC
susceptible to fluctuations in the quality of the Internet con- 25010 presents characteristics and subcharacteristics allowing
nection. Such instabilities contribute to a low degree of “fault software engineers to evaluate general software quality, the
standard misses the specificities of the health care domain.
In this work we analysed DATATOX, a teletoxicology infor-
mation system used by a number of PCCs in Brazil, through
a case study based on the AdEQUATE evaluation model. The
performed analysis shows that the DATATOX system is per-
ceived as having a good overall quality degree; its strong points
are related to satisfaction, efficiency and effectiveness, reveal-
ing a system that satisfies users and allows them to execute
tasks with accuracy and completeness, spending few resources.
On the other hand, DATATOX was considered to have low
reliability, compatibility and context coverage, meaning that
the system does not always perform some functions, does not
exchange information with other systems, and is not flexible
enough to cover all contexts of use. Additionally, this work
shows the feasibility on evaluating software quality from the
perspective of end users of poison control information systems
Figure 3. Scores computed for each characteristic. using AdEQUATE’s systematically derived questionnaires.

34
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