Keywords
decision support techniques - drug therapy - computer-assisted - online systems -
knowledge bases - pediatric dosages
Background and Significance
Background and Significance
Drug therapy in pediatric patients is a complex process. Children are not simply small
adults, but are subject to continuous growth and variation in drug-metabolizing enzyme
activity, which requires continuous adaption of dosages. Extrapolation of adult data
to guide drug dosing in children requires great diligence and cannot replace clinical
trials on efficacy, safety, and pharmacokinetics in pediatric patients.[1]
[2] For most drugs, the costs of specific clinical trials and the development of an
age-appropriate formulation (e.g., a liquid with good palatability, dosing accuracy
for low doses, and without inappropriate preservatives) exceed the possible revenue,
especially for conditions that seldom occur in minors. Both the U.S. and the European
Union have introduced legislation for the development of pediatric medicines. Pharmaceutical
companies are granted an additional 6 months' patent extension as an incentive for
pediatric trials on newly developed drugs. According to the pediatric regulation,
since 2007 for all new drugs early in the developmental stage, a pediatric investigation
plan has to be delivered, that will be assessed and agreed by the pediatric committee
of the European Medicine Agency.[3] This is mandatory for drug licensing.
Nonetheless, there is still a substantial number of medicines on the market that are
not licensed for pediatric populations. Thus, off-label use is common in both ambulatory
and hospital settings.[4]
[5]
[6] The Study of Health of Childs and Youth in Germany (KiGGS study) found that nearly
one-third of medicines used in pediatric outpatients were not licensed for their age.[4] The younger the patient, the higher the prevalence of off-label uses.[4]
[7] This prevalence is higher in the inpatient setting—and especially in intensive care
units.[8] In Germany, there is currently no database that provides publicly accessible evidence-based
information on drug dosages in children and adolescents. However, worldwide there
are very few formularies providing evidence-based dosing recommendations and transparency
on sources used.[9] Therefore, the information provided may not correspond to the best available evidence.
Especially for the widespread off-label use, these details are essential to find a
rational, best evidence-based therapy for a patient and at the same time minimize
the risks during drug application. In other countries, such as the United Kingdom,
the Netherlands, and Switzerland, a national database for pediatric medicines has
brought significant progress in pediatric pharmacotherapy.[9]
With the implementation of an electronic prescribing system at the Department of Pediatrics
and Adolescent Medicine at the University Hospital Erlangen, Germany, in 2012, dosing
recommendations based on a systematic research of clinical pharmacological evidence
were established for internal use.[10] To expand access to this comprehensive information to a wider audience of pediatricians
in Germany, initial funding was granted from the German Ministry of Health for the
development of a Web-based online platform, termed Pediatric Dosing Recommendations
(PaedDos). PaedDos is intended to serve as a German reference database for evidence-based
dosing recommendations as well as pharmacological and pharmaceutical drug information
in pediatrics. A separate journal article focusing on the pharmaceutical content of
the platform is currently being finalized.
To achieve a high level of acceptance among medical experts, the development of PaedDos
was based on a user-centered design (UCD) approach with its iterative steps.[11] In a UCD approach, the end user—in this case the resident doctors, clinicians, and
pharmacists—is highly involved in all steps of the development process and the user
interface design. Functional scope and operation are tailored to the feedback of the
test users. Through cyclic evaluations using various methods (e.g., pluralistic walkthroughs,
user tests, thinking-aloud tests[12]
[13]
[14]
[15]), the system is constantly evaluated in terms of its usability and acceptability
by the end users. Standardized scoring systems, for example, System Usability Scale
(SUS),[16]
[17]
[18] can be used for objective usability assessment. Research shows that a UCD process
increases the usability of applications in health care and thus can improve the productivity
of systems, their accessibility, and reduces the risk of harm.[19]
[20]
[21]
This article describes for the first time the development of Web-based online platform
for pediatric dosing recommendation in Germany. The specific purpose of this article
is: (1) to survey the demand of physicians for an evidence-based knowledge base, to
check to what extend the requirements are fulfilled, and which new requirements arise,
and (2) to assess a prototype of an online platform with end users in terms of usability
and functionality.
Methods
Initial Prototype Development
Pediatricians from the Erlangen Children's Hospital and the project management created
a list of initial requirements for the online platform. One of these requirements
was to tailor the online platform to usage by three main user groups according to
the content, the presentation of the prepared information, as well as the functionality
and the design. The first group consists of pediatricians in private practice, including
general practitioners with a large proportion of pediatric patients, which later would
be the largest and most important user group; the second group comprises clinicians
from pediatric hospitals; and the third group are pharmacists, who also need information
on dosages of drugs for children and adolescents in their daily work. The initial
requirements led to paper mock-ups having a visual basis for discussions around the
platform, its design, and its functionalities. After an internal feedback round, the
platform and its content were divided into six modules:
-
Information (general information about the active substances).
-
Dosage (dosing recommendations).
-
Special dosage information (information about liver and kidney insufficiency).
-
Side effects and warnings (including overdosing and contraindications).
-
Drug–drug interactions.
-
Preparations (information about the available formulations like flavor).
Subsequently, a first interactive prototype was developed, based on common Web technologies
(HTML, CSS, JavaScript, PHP, and SQL) and frameworks (W3.CSS, Bootstrap, JQuery, AngularJS).
This prototype was evaluated in two rounds with external users previously not involved
in the project to analyze to what extent user requirements have already been considered
and to derive further requirements.
First Evaluation Round—Pluralistic Walkthrough
During a pluralistic walkthrough in July 2017, experts and future end users of the
system were invited to evaluate the initial prototype to draw attention to errors
and provide information on its acceptance at an early stage of development. A pluralistic
walkthrough is a collaborative usability evaluation method that involves both users
and members of the product team. In this method, the test moderator presents the participants
the system and invites discussion related to usability issues. At this development
state, the system contained information in all modules for seven active ingredients.
The active substances were selected from different groups (on-demand medication, antibiotics,
antiepileptics, etc.). About 100 active substances were listed with dosing recommendations
but not yet fully developed with all information in all modules.
Participants
In total, three participants, one representative of each of the main user groups,
and the development team took part in the pluralistic walkthrough.
Procedure
The pluralistic walkthrough was divided into two parts. For the first part, three
exemplary drug ordering scenarios with clindamycin, ibuprofen, and acetylsalicylic
acid were defined. Based on these scenarios, the online platform was presented to
the walkthrough participants. Next, the scope of search functions (search for active
substances, trade name, indication, and Anatomical Therapeutic Chemical [ATC] code)
and the live search functionality (search while typing) were demonstrated to the participants.
Finally, all participants had the opportunity to test the system themselves with open
scenarios and ask questions about the platform's user interface.
In the second part of the pluralistic walkthrough, the participants were asked to
write down both positive and negative aspects of the platform on cards. All cards
were collected by the moderator on the flipchart, categorized, and prioritized in
an open discussion with the participants. Participants were further encouraged to
evaluate the user interface in terms of color, terminology, redundancy, content, and
features. In addition, they were motivated to express wishes concerning the functionalities
which the current prototype version did not yet meet.
The complete walkthrough was recorded with the software Camtasia Studio (https://www.techsmith.de/camtasia.html) and later transcribed verbatim. The main statements, as well as the results of the
categorization and prioritization of recommendations and wishes, were summarized to
create an enhanced version of the requirements specification. The joint categorization
process led to three requirement priority levels, from “high need for action,” via
“medium need for action,” to “low need for action.” Feedback on issues that required
only minor adjustments was implemented into the platform immediately after the walkthrough.
Second Evaluation Round—Online User Test
Prior to the second evaluation round, some requirements defined and analyzed during
the pluralistic walkthrough were integrated into the development process to tailor
the online platform more to the end users' needs. The requirements defined under high
and medium need for action could not be integrated due to various problems explained
in the “Discussion” section. All other requirements were implemented. For the second
evaluation round, the number and content of active substances in the database was
expanded. For the online test, approximately 50 active substances with information
in all modules were available to the users, as well as a total of approximately 150
listed active substances with dosage recommendations.
Participants
For the user test, pediatricians, pediatric clinicians, and pharmacists from Bavaria,
Germany, were contacted by the authors. A total of 12 persons could be recruited who
were willing to participate in the online test: 6 resident doctors, 3 clinicians,
and 3 pharmacists. The chosen distribution reflects the intended distribution of end
users after the release of the online platform. None of the participants had previously
participated in the pluralistic walkthrough. The participants had no economic interest
and were not part of the project team.
Scenarios
For the online user test, two different drug ordering scenarios were defined by the
development team for each of the three end-user groups ([Supplementary Appendix A], available in the online version). During the online user test, the participants
got access to the revised prototype and were asked to evaluate the prototype based
on their respective two scenarios. All scenarios were developed in collaboration with
a pediatrician and pharmacists.
Online Questionnaire
After testing the prototype, the participants were instructed to answer questions
about the content, functionality, and user-friendliness. The questions were based
on the SUS[16]
[17]
[18] and a set of self-developed questions ([Supplementary Appendix B] [available in the online version]: questions about the design and functionality),
focusing on the particular drug dosing information to capture an overall level of
usability.
All self-developed questions were designed by a usability expert at the Department
of Medical Informatics in Erlangen and pretested in terms of understandability. A
5-point Likert scale (ranging from “does not apply at all” [1] to “completely applies”
[5]) was used for numerical evaluation. If a question was answered in negative ([1],
[2], or [3]), an additional question was displayed to ask the participant for details
in free text.
In total, the online questionnaire comprised 90 questions, categorized as follow:
-
Demographic questions (n = 11).
-
SUS questionnaire (n = 10).
-
Questions about the technical devices used (n = 5).
-
Questions about the scenarios (n = 12).
-
Questions about the design and functionality of the online platform (n = 49).
-
Positive and negative aspects of the online platform (n = 2).
-
Free-text field for notes and wishes of any kind (n = 1).
The following demographic information was collected (with different answer options):
user group (physician in private practice, clinician, pharmacist), professional experience
in years (little: ≤ 10, medium: > 10 and ≤ 20, much: > 20 years), number of prescriptions
per day (less: ≤ 10, medium: > 10 and ≤ 25, many: > 25 medications per day), and computer
knowledge (subjective/own assessment: low, medium, high) to examine the dependencies
of the results according to these aspects.
System Usability Score
To ensure global comparability of the system's usability with similar international
developments and systems, the SUS was calculated. The SUS is a standardized questionnaire
with a 5-point scale (ranging from “does not apply at all” to “completely applies”),
whereby questions are alternately formulated positively and negatively. The statements
relate to a range of aspects of system use, such as complexity, ease-of-use, and learnability.
Overall SUS results range from 0 (poor) to 100 (very good).[17]
[18] As described by Brooke,[16] the threshold values are worst imaginable (25), poor (38.5), ok (52), good (73),
excellent (85), and best imaginable (100). To summarize SUS responses from participants,
mean, median, minimum, and maximum were calculated.
Procedure
The online questionnaire was created with the online tool SoSci Survey (https://www.soscisurvey.de/). The participants had 2 weeks in December 2017 to complete the questionnaire for
the two scenarios. In addition, each test user had the opportunity to explore the
knowledge base independently, to search for dosing recommendations and information
on active substances and to familiarize oneself with the functions, even during the
processing of the questionnaire. The test users had full access to the online platform
and its contents.
Data Analysis
Through the structure of the questions in 5-point Likert scales, a numerical evaluation
of the questions was possible; frequencies were analyzed and means were calculated.
With the exception of the SUS questionnaire, a rating of 5 was interpreted as positive
and a rating of 1 as negative. Mean differences were compared between the three user
groups and concerning a possible influence of information technology knowledge, years
of work experience, and the number of daily prescriptions. The text-based answers
were examined and scanned for significant statements, clustered, and also checked
for dependencies.
Results
Results of the Pluralistic Walkthrough—First Evaluation Round
Positive Aspects
Especially the clarity of the user interface and the structure were appreciated, so
that the users were able to quickly comprehend the user interface layout and system
navigation. The different search functions (by list of active substances, dropdown
list of live search, search options) turned out to be very user-friendly and were
well received by the participants.
Negative Aspects
Negative feedback (wishes, missing functions for a good workflow, and optimization
potential of the system regarding design and structure) was categorized as high need
for action, medium need for action, and low need for action.
High need for action:
-
Interaction check of the active substance with other active substances (e.g., interactions
with isoniazid).
-
Smart prioritization of active substances for the treatment of children (e.g., display
ibuprofen before acetylsalicylic acid in search results for indication fever) based
on the experts' definitions.
-
A calculator for dosages (age, weight based on active substance), glomerular filtration
rate according to Schwartz et al,[22]
[23] and body surface.
Medium need for action:
Low need for action:
-
Add application time (e.g., before/after a meal) to some active substances.
-
Applying a uniform font style and font size.
-
Addition of search function by trade name.
The following optimization suggestions were implemented immediately after the walkthrough:
-
Links to the referenced sources in the individual dosing recommendation for quick
and easy verification.
-
Prioritization of the drug monographs and dosing recommendations when the page is
opened (not showing disclaimer).
-
Disclaimer as menu item, but not as main page.
-
Link to official form for spontaneous reporting of adverse drug reactions.
Fig. 1 Excerpt from the table of dosing recommendation using ibuprofen as an example.
Results of the Online User Test—Second Evaluation Round
The results of the first evaluation round were implemented and a next prototype version
was created, which was evaluated by an online test with end users. In the following,
the results according to the different question sections are presented.
Technical Devices Used
Most participants (n = 10) responded that they would prefer to use PaedDos on a desktop personal computer.
Nevertheless, they also expressed demand to use the system on mobile devices (smartphones:
n = 8, tablets: n = 5; multiple answer selections were allowed). Therefore, a responsive design of
the user interface for future PaedDos versions is recommended. Problems with the use
of different browser types were not recorded.
Design and Functionality of the Online Platform
Almost all questions about the functions and design of the online platform received
positive or very positive feedback. Except for one question (GP07_04), all averages
and medians were above 3 and thus on the positive side of the answer scale ([Fig. 2]). All answers to questions about design and functionality can be seen in [Table 1].
Fig. 2 Mean values of questions concerning the design and functionality of PaedDos.
Table 1
Excerpt of questionnaire and answers with mean, median, maximum, and minimum about
the design and functions of the online platform
|
ID
|
Question
|
Mean
|
Median
|
Maximum
|
Minimum
|
|
GP02
|
If I had an automatic dosage calculator on the platform, I would use it
|
4.58
|
5
|
5
|
2
|
|
GP05
|
The possibility of searching according to the criteria “active substance,” “trade
name,” “indication,” and “ATC code” is sufficient for my work
|
4.64
|
5
|
5
|
3
|
|
GP15
|
The user interface of the online platform is visually attractive (colors, fonts, contrast)
|
3.83
|
4
|
5
|
2
|
|
GP16
|
The font size was easy for me to read
|
4.50
|
5
|
5
|
2
|
|
GP19
|
I believe that the online platform has the potential to improve the quality of the
medication prescription for children and adolescents
|
4.67
|
5
|
5
|
3
|
|
GP23
|
If I had access to this online platform, I would most likely use it in the next months
|
4.58
|
5
|
5
|
4
|
|
GP24
|
Please specify for each module how often you would use it in your clinical routine
|
|
|
GP24_01
|
Module 1: Information
|
3.33
|
3
|
5
|
2
|
|
GP24_02
|
Module 2: Dosage
|
4.50
|
4.5
|
5
|
4
|
|
GP24_03
|
Module 3: Special dosage information
|
3.92
|
4
|
5
|
3
|
|
GP24_04
|
Module 4: Side effects and warnings
|
4
|
4
|
5
|
3
|
|
GP24_05
|
Module 5: Interactions
|
3.83
|
4
|
5
|
2
|
|
GP24_06
|
Module 6: Preparations
|
4.08
|
4
|
5
|
3
|
Abbreviation: ATC, Anatomical Therapeutic Chemical.
Note: Full questionnaire available in [Supplementary Appendix B] (available in the online version).
The function for searching via ATC codes was perceived as unimportant.
As already expressed in the pluralistic walkthrough, there is a great demand for an
automatic online dosage calculator. The free-text responses confirmed this pattern,
insofar as four users explicitly mentioned a dosage calculator.
Strengths and Weaknesses of the Online Platform
The free-text answers to the pros and cons of the online platform were clustered.
The classified answers to the strengths of the online platform are shown in [Table 2]. Multiple answers of a participant that were categorized in the same category were
summed. The user-friendliness was perceived as positive by 8 out of 12 participants
(e.g., “Fast, clear, easy”).
Table 2
Clustered free-text answers (with examples) to the strengths of the online platform
|
Category
|
Frequency
|
|
Usability
“Easy, fast”, “Quick overview […]”, “[…] simple availability […]”
|
14
|
|
Dosing recommendations
“Therapy duration visible”, “Dosage available for various indications”
|
6
|
|
Indication
“Disease specific listing”, “Linking drugs with indications”
|
5
|
|
Preparations
|
4
|
|
Special dosage and application information
|
3
|
|
Search function
|
3
|
|
Active substance information
|
2
|
|
Approval status
|
1
|
|
Reference (transparency)
|
1
|
The presentation, the information content, and the quick availability of the dosing
recommendations have been explicitly named a total of 6 times as one of the great
strengths of the system (e.g., “Fast dosage finding”).
Particular emphasis was placed on the combination of indications and diseases for
active substances. This was also named as one of the strengths by the participants
(e.g., “Dosage can be viewed for different indications”).
Participants' free-text responses to existing weaknesses, suggestions for improvement,
and wishes were classified into four categories ([Table 3]). Multiple answers of one participant that were categorized in the same category
were summed.
Table 3
Clustered free-text answers (with examples) to the weaknesses of the online platform
|
Answer
|
Frequency
|
|
Content and further information
“Further drugs”, “[…] side effects according to clinical relevance”
|
17
|
|
Design
“Graphical representation”, “standardized dose display”
|
10
|
|
Functions
“List therapy alternatives”, “Alternative drugs references […]”
|
9
|
|
(Dosage-) Online-Calculator
“Automatic calculation […] after entering the weight”
|
5
|
SUS Results
Of the total of 12 participants, 2 had to be dropped from the SUS calculation because
of partly missing answers, thus invalidating their results for the SUS.
With an average value of 79.5 and a median of 81.25, the prototype of the online platform
is classified between “good” and “excellent” and is thus regarded as an “acceptable
system.”[16] Every participant rated the system as “accepted” (minimum: 52.5; maximum: 97.5).
Physicians in private practice tend to rate the system slightly lower, while pharmacists
rate it slightly higher. Further, SUS results did not show any significant deviations
according to the respective parameters ([Table 4]).
Table 4
SUS mean and median according to the dependencies of the analyzed parameters
|
Dependency on…
|
Resident doctors
|
Clinicians
|
Pharmacists
|
|
User group
|
Average: 74
|
Average: 81.25
|
Average: 87.5
|
|
Median: 75
|
Median: 81.25
|
Median: 85
|
|
Less
|
Medium
|
Much/Many
|
|
Experience in the profession
|
Average: 80
|
Average: 78.5
|
Average: 81.25
|
|
Median: 82.5
|
Median: 80
|
Median: 81.25
|
|
Number of prescriptions per day
|
Average: 78.75
|
Average: 85.625
|
Average: 80.83
|
|
Median: 78.75
|
Median: 86.25
|
Median: 80
|
|
Low
|
Medium
|
High
|
|
Computer knowledge
|
Average: -
|
Average: 76.68
|
Average: 83.75
|
|
Median: -
|
Median: 77.5
|
Median: 83.75
|
Abbreviation: SUS, System Usability Scale.
In summary, the possible end users have expressed themselves very positively about
the online platform and are already describing it as practical.
Discussion
Principal Findings
The results of the study clearly show the added value that such a platform would provide
for pediatric and adolescent medicine. Nine participants agreed completely that the
platform has the potential to increase the quality of the medication prescription
for children and adolescents. All participants stated that they would most likely
use the online platform if they had access to this page. This confirms that the health
care professionals in pediatrics and adolescent medicine want and need such an online
platform and consider it to be useful.
A serious problem in pediatrics is the extensive off-label use, where the summary
of product characteristics rarely provides sufficient information for dosing of drugs
in children and adolescents. Health care professionals, such as physicians and pharmacists,
need to retrieve information from various sources, which often do not provide the
evidence required to the intended uses. This is time-consuming, incompatible with
the stressful daily routine, and entail an increased risk for the patients. PaedDos
aims to provide children and adolescents with comprehensive, evidence-based dosing
information and thus significantly supports pediatricians in the prescribing and pharmacists
in the dispensing and verification process.
During the pluralistic walkthrough, the use of varying fonts was criticized, leading
to redesign and font standardization prior to the online user test. With the exception
of 3 participants, everyone was completely satisfied with the font size of the system.
This illustrates that the close user involvement and early system adaption were positively
accepted. The positive feedback from the participants of the user test indicates that
the UCD approach provides an effective way of structuring and simplifying the development
process. Moreover, it might make the development comprehensible to end users. UCD
facilitates the identification of requirements for design, function, and content,
both on a general level and with respect to specific details. The implemented functionality
related to those requirements that resulted from the pluralistic walkthrough in the
first round (e.g., to link the source information) received a positive feedback when
they were evaluated in the second round. This might serve as another example for the
advantages of a UCD approach.
The results of the user test indicate that the implemented search functions are sufficient
for users to obtain information. The division of the contents into 6 modules made
it possible to individually assess the added value of each module. The participants
stated that the extent of use of dosing information (module 2) in clinical routine
is expected to be “often to always.” On average, users would often use information
on specific dosage information (module 3), side effects and interactions (module 4
and module 5), and information on existing formulations in everyday clinical practice
(module 6). Such a knowledge base should therefore not only contain information on
the dosing recommendations and make them available to users, but should also provide
further knowledge and evidence. General information on active substances, as offered
in module 1 on the online platform, would be used occasionally by participants. Even
if this demand is lower than for the other modules, it is nonetheless present, and
it is therefore reasonable to integrate this information into the online platform.
Two main points of criticism were expressed by the participants with the scope of
the evaluations, which need to be discussed in detail. First, the presentation of
the dosing recommendations was criticized, in particular the table width. Second,
the demand for an online calculator was stated several times.
The variety of information (single dose, daily dose, maximum daily dose, frequency,
and standard dose) increases the width of the table of dosing recommendations, thereby
forcing the user to scroll sideways, especially on screens of normal or small size.
Nevertheless, it is necessary to present each of the different contents, since for
some drugs the description of a single dose is important, while for others the description
of the standard dose and frequency is important. As a result, some table cells are
empty ([Fig. 1]). It would be possible to hide them, but at the cost of fast information extraction,
since the user would be forced to check the information twice. Therefore, it is important
to always provide the information in the same place, or alternatively to apply an
unambiguous label. Labeling options could be colors or symbols that would need to
be checked in a further evaluation round.
The pluralistic walkthrough and the online test have shown a strong demand for an
online dosage calculator to facilitate daily work with pediatric medication and to
improve the quality of care. The implementation of a dosage calculator would be especially
helpful if PaedDos would be integrated in a providers' electronic health record (EHR)
system and input parameters for such formula (e.g., patient age, weight, and body
surface) would be directly drawn from the patients' medical record. Actually such
a feature would be a core functionality of a pediatric EHR[24] and would be a future extension of our platform. However, such an integrated decision
support functionality could fall under the regulations of the Medical Device Act (German:
Medizinproduktegesetz[25]) as well as Directive 95/46/EC,[26] and was thus not yet in the focus of our current research.
To the question “What would be your reasons for nonuse” of an integrated calculator,
a physician in private practice answered “False safety,” which is an important point
to consider. Doctors and others are using devices and systems that are not transparent
from the user's point of view, which means that they have to rely on the system if
they intend to use it. In a proven system, doctors could blindly accept dosing recommendations,
which in the worst case could have serious consequences for the patient. It should
therefore be noted that neither a dosage calculator nor an online platform for dosing
recommendations can replace doctors' decisions and knowledge, but can only support
them. The doctor is still responsible for the medication, which makes the transparency
of dosage calculations so important.
The results showed a demand for advanced functions related to drug safety, such as
an interaction check, or information about potential therapeutic alternatives. Such
functions require that the necessary knowledge is made available to the platform.
However, such extended functions make the validation procedure of the system and its
contents more complex. The current PaedDos prototype can be seen as a starting point
and might be extended in the future.
Comparison with Other Online Platforms
In the search for comparable systems, two systems were examined in more detail. The
“kinderformularium” from the Netherlands[27] is a freely accessible platform for dosing recommendations in pediatrics published
in 2008. Like PaedDos, this platform contains information on the level of evidence
of dosage recommendations, systematic primary literature research, license status,
national trade names, side effects and warning for use in children, contraindications,
interactions, and adjustments in renal insufficiency. The information on dosages is
not displayed in tabular form, but as a bullet list of text elements. The “kinderformularium”
provides an implemented and CE certified calculator, which supports to combine the
dosing recommendations with patient–individual variables, thus enabling the calculation
of a patient–individual recommendation.[9] The University Children's Hospital Zurich has a Web site “kinderdosierung.ch” with
information on dosing recommendations for pediatrics[28] only, but without warnings, side effects, interactions, etc. This platform focuses
on inpatient drugs and is in German language like PaedDos. The system provides a calculator,
which highlights the appropriate age group in the information list, copies it to the
top of the site for easier reading, and calculates the dosing to the manually inserted
patient parameters. The page is only accessible to qualified personnel and requires
a login.
All three platforms are Web-based, evidence-based, independent of the pharmaceutical
industry, and structured according to drug, indication, route of application, age,
and weight. However, no scientific publications were found describing technical details
and evaluating the development process for “kinderformularium” and “kinderdosierung.ch.”
No studies could be found which address the usability aspects with the SUS of online
platforms for dosing recommendations in pediatrics.
Limitations
Three limitations of the study have to be considered. First, the pluralistic walkthrough
was conducted with only one representative from every end-user group. Actually, according
to Bias, 6 to 10 participants are recommended,[29] but due to immense recruiting difficulties in this project phase (nonavailability
of the physicians for the pluralistic walkthrough in addition to their professional
activity) and time constraints of the project, this was not possible. For this reason,
a sample size of three users representatives of the target audience was chosen, which
according to Riihiaho[30] is also sufficient for this method. However, this limitation was compensated by
subsequent system iterations and evaluations.
Second, a total of 12 participants of the online test does not represent the entire
PaedDos end-user group. Nevertheless, it is assumed that approximately 5 participants
are sufficient to identify at least 80% of the major usability problems.[31]
[32]
[33]
[34] In Brooke's retrospective study on SUS,[16] Tullis and Stetson[35] are referenced as having shown that it is possible to get reliable results with
samples of 8 to 12 users. In addition, further iterations and evaluations are planned
within the UCD, which will later include a larger sample.
Third, the user test has been performed in a test setting and not in a real-world
environment. Thus, the extent to which the actual end users are willing or able to
use the system in their daily work cannot be anticipated with certainty. The need
for an Internet connection or problems with the interoperability of the respective
information system of the doctor's practice, pharmacy, or clinic could lead to nonuse
of the online platform. This has to be examined in future field tests.
Conclusion
There is a strong demand for an evidence-based pediatric dosage information system
among resident doctors, clinicians, and pharmacists, which motivated the development
of the PaedDos prototype. Applying an UCD approach during system development resulted
in a rating between “good” and “excellent” (mean: 79.5, median: 81.25). Thus, the
PaedDos prototype is regarded as an “acceptable system.” The implemented search variants,
such as live search, to get quickly to the desired information in different ways,
received excellent feedback. The UCD approach proved to be a beneficial tool for optimizing
usability. There is a strong demand for patient–individual support functions, in particular
a dosage calculator. It has to be investigated in a field trial, similar to the studies
described in Ateya et al[36] and Kim et al,[37] whether and to what extent the developed platform prevents dosing errors and in
which ways it can support physicians.
Future work will focus on the integration of additional drug information for pediatrics,
the development of the responsive design, the creation of an app version for the user
interface, and the integration of an online calculator.
Clinical Relevance Statement
Clinical Relevance Statement
As of now, no system providing evidence-based dosing information for children in Germany
is publicly available for pediatricians in private practice, clinicians from pediatric
hospitals, and pharmacists, who need information on dosages of drugs for children
and adolescents. The aim of the PaedDos project was to establish a national Web platform
for pediatric drug information. The platform presented in this study is a first prototype
that was iteratively evaluated by real end users to provide such information for doctors
and pharmacists in their daily work.
Multiple Choice Questions
Multiple Choice Questions
-
Which is the most explicitly mentioned additional feature for an online platform about
dosing recommendations in pediatrics?
Correct Answer: The correct answer is option b. In the scope of this study, interaction check and
listing of alternative therapies was less named than a dosage calculator. A possible
connection between the platform and an internal system or the electronic patient records
(EPRs) was mentioned in a conversation with only one participant after the survey.
-
What is the problem with such a state-certified recommendation system?
-
Parents of patients could complain in case of complications.
-
If the system crashes, prescribing is not possible.
-
Doctors could trust the implemented system too much.
-
The doctor will be replaced by an electronic system.
Correct Answer: The correct answer is option c. Information on this platform is aligned for health
care professionals. To avoid misunderstandings of parents with regard to the dosing,
the database should be restricted to health care professionals only. In case of a
system crash, the doctor can still prescribe medication. A technical tool will never
be able to replace a doctor, but is always there to support him. Like a stethoscope,
an online reference book could also become a tool in the daily work of a doctor. Doctors
still need to keep themselves informed.
