380
Design and Technical Aspects
Systems need to be user-friendly and intuitive and should pose minimal burden on
the staff to reach successful integration and sustai ned use [ 41 , 90 ]. Electronic
PROMs questions can be depicted in different ways, for example, from one question
to various questions per screen at a time, allowance of the “not applicable/unknown
options,” ticks, or radiobuttons. Software applications can be programmed differ-
ently, for example, they require an item response, represent missed items, and/or
respect patients’ rights to leave questions unanswered. The resulting varying design
features may result in a different answering behavior and thus might affect ePROMs’
results [ 41 , 50 ]. Another biasing factor that needs to be considered is whether
patients answer the ePROMs on their own or are assisted by relatives or support
personnel; some PROMs offer even two different versions [ 91 ].
While most apps are developed without taking all stakeholders’ needs and require-
ments into account, Herschman et al. published a methodology for developing a
health app for patients with systemic lupus erythematosus to generate guidance to
mobile app developers [ 92 ]. Besides well-known issues for software development
(as easy navigation, informational content, etc.) aspects of gamifi cation and options
for customization were identifi ed as being relevant in the development process [ 92 ].
As patient groups may have different technology comfort levels (e.g., of the graphi-
cal user interface) design needs to be evaluated by patients and adapted [ 51 , 93 ]. In
addition, as discussed for Internet sites that provide information on diseases, apps
need to be fl agged as high quality when their intended use is to enhance the interac-
tions with the stakeholders [ 94 , 95 ].
Technical and Data Security Aspects
Systems might handle missing data differently. This given situation is complicated
by the fact that not all PROMs score algorithms comment on how to handle missing
data. Thus, there may be errors in the calculation of the scores and this may have an
effect on the clinical decision making. System validation studies are indispensible,
as the user must be able to rely on correct score calculations.
Assessments of ePROMs implicate a large amount of infrastructure-related
issues as data security , analytic, and practical issues. These issues may differ in the
systems but include from the following: given IT infrastructure and related logistic
issues at the clinic/private practice, link to patient health record or other data storage
systems, data storage issues (databases locations and interactions, time periods, and
copies), data access and user rights, pseudonymization issues, self-determinable
data storage/withdrawal policies, and standardized analytic and reporting methods
[ 93 , 96 ]. Systems need to consider security issues: If ePROMs are presented to the
patients on their own, secure log-ins need to be realized and levels of data encryp-
tion need to be determined as well as implemented [ 41 ]. Institutional support might
J. Richter et al.