As client applied sciences like health trackers and cell phones turn out to be extra extensively used for health-related knowledge assortment, so does the chance to leverage these knowledge pathways to review and advance our understanding of medical circumstances. We have now beforehand touched upon how our work explores using this know-how throughout the context of persistent illnesses, specifically a number of sclerosis (MS). This effort leverages the FDA MyStudies platform, an open-source platform used to create medical research apps, that makes it simpler for anybody to run their very own research and gather good high quality healthcare knowledge, in a trusted and protected approach.
As we speak, we describe the setup that we developed by increasing the FDA MyStudies platform and show how it may be used to arrange a digital well being research. We additionally current our exploratory analysis research created by means of this platform, referred to as MS Alerts, which consists of a symptom monitoring app for MS sufferers. The purpose for this app is twofold: 1) to make sure that the enhancements to the FDA MyStudies platform made for a extra streamlined research creation expertise; and a couple of) to grasp how new knowledge assortment mechanisms can be utilized to revolutionize sufferers’ persistent illness administration and monitoring. We have now open sourced our extension to the FDA MyStudies platform beneath the Apache 2.0 license to supply a useful resource for the group to construct their very own research.
Extending the FDA MyStudies platform
The unique FDA MyStudies platform allowed individuals to configure their very own research apps, handle members, and create separate iOS and Android apps. To simplify the research creation course of and guarantee elevated research engagement, we made various accessibility modifications. Among the most important enhancements embrace: cross-platform (iOS and Android) app era by means of using Flutter, an open supply framework by Google for constructing multi-platform purposes from a single codebase; a simplified setup, in order that customers can prototype their research shortly (beneath a day generally); and, most significantly, an emphasis on accessibility in order that numerous affected person’s voices are heard. The accessibility enhancements embrace modifications to the underlying options of the platform and to the actual research design of the MS Alerts research app.
Multi-platform help with speedy prototyping
We selected using Flutter as it might be a single level that will generate each iOS and Android apps in a single go, decreasing the work required to help a number of platforms. Flutter additionally gives hot-reloading, which permits builders to construct & preview options shortly. The design-system within the app takes benefit of this characteristic to supply a central level from which the branding & theme of the app could be modified to match the tone of a brand new research and previewed immediately. The demo setting within the app additionally makes use of this characteristic to permit builders to mock and preview questionnaires regionally on their machines. In our expertise this has been an enormous time-saver in A/B testing the UX and the format and wording of questions stay with clinicians.
System accessibility enhancements
To enhance the accessibility of the platform for extra customers, we made a number of usability enhancements:
Gentle & darkish theme help
Daring textual content & variable font-sizes
Excessive-contrast mode
Enhancing person consciousness of accessibility settings
Prolonged publicity to vivid mild themes can pressure the eyes, so supporting darkish theme options was essential to make it simpler to make use of the research app regularly. Some small or mild text-elements are illegible to customers with imaginative and prescient impairments, so we added 1) bold-text and help for bigger font-sizes and a couple of) high-contrast color-schemes. To make sure that accessibility settings are straightforward to search out, we positioned an introductory one-time display screen that was offered in the course of the app’s first launch, which might straight take customers to their system accessibility settings.
Research accessibility enhancements
To make the research itself simpler to work together with and scale back cognitive overload, we made the next modifications:
Clarified the onboarding course of
Improved design for questionnaires
First, we clarified the on-boarding course of by presenting customers with a listing of required steps once they first open the app in an effort to scale back confusion and participant drop-off.
The unique questionnaire design within the app offered every query in a card format, which makes use of a part of the display screen for shadows and depth results of the cardboard. In lots of conditions, this can be a nice aesthetic, however in apps the place accessibility is precedence, these visible parts limit the area obtainable on the display screen. Thus, when extra accessible, bigger font-sizes are used there are extra frequent phrase breaks, which reduces readability. We fastened this just by eradicating the cardboard design parts and as a substitute utilizing the whole display screen, permitting for higher visuals with bigger font-sizes.
The MS Alerts prototype research
To check the usability of those modifications, we used our redesigned platform to create a prototype research app referred to as MS Alerts, which makes use of surveys to assemble details about a participant’s MS-related signs.
MS Alerts app screenshots.
MS Research app design
As a primary step, earlier than coming into any research data, members are requested to finish an eligibility and research comprehension questionnaire to make sure that they’ve learn by means of the possibly prolonged phrases of research participation. This may embrace, for instance, questions like “In what nation is the research obtainable?” or “Are you able to withdraw from the research?” A bit like that is frequent in most well being research, and it tends to be the primary drop-off level for members.
To reduce research drop-off at this early stage, we stored the eligibility take a look at temporary and mirrored right solutions for the comprehension take a look at again to the members. This helps reduce the variety of instances a person might have to undergo the preliminary eligibility questionnaire and ensures that the essential points of the research protocol are made clear to them.
After profitable enrollment, members are taken to the principle app view, which consists of three pages:
Actions: This web page lists the questionnaires obtainable to the participant and is the place nearly all of their time is spent. The questionnaires range in frequency — some are one-time surveys created to assemble medical historical past, whereas others are repeated day by day, weekly or month-to-month, relying on the symptom or space they’re exploring. For the one-time survey we offer a counter above every query to sign to customers how far they’ve come and what number of questions are left, just like the questionnaire in the course of the eligibility and comprehension step.
Dashboard: To make sure that members get one thing again in return for the data they enter throughout a research, the Dashboard space presents a abstract of their responses in graph or pie chart type. Members might probably present this knowledge to their care supplier as a abstract of their situation over the past 6 months, an enchancment over the standard pen and paper strategies that many make use of at the moment.
Sources: A set of helpful hyperlinks, assist articles and customary questions associated to MS.
Questionnaire design
Since needing to regularly enter knowledge can result in cognitive overload, participant drop off, and unhealthy knowledge high quality, we lowered the burden in two methods:
We break down giant questionnaires into smaller ones, leading to 6 day by day surveys, containing 3–5 questions every, the place every query is a number of alternative and associated to a single symptom. This manner we cowl a complete of 20 main signs, and current them in the same option to how a clinician would ask these questions in an in-clinic setting.
We guarantee beforehand entered data is available within the app, together with the time of the entry.
In designing the survey content material, we collaborated intently with skilled clinicians and researchers to finalize the wording and structure. Whereas research on this discipline usually use the Likert scale to assemble symptom data, we outlined a extra intuitive verbose scale to supply higher expertise for members monitoring their illness and the clinicians or researchers viewing the illness historical past. For instance, within the case of imaginative and prescient points, quite than asking members to charge their signs on a scale from 1 to 10, we as a substitute current a a number of alternative query the place we element frequent imaginative and prescient issues that they might be experiencing.
This verbose scale helps sufferers monitor their signs extra precisely by together with context that helps them extra clearly outline their signs. This method additionally permits researchers to reply questions that transcend symptom correlation. For instance, for imaginative and prescient points, knowledge collected utilizing the verbose scale would divulge to researchers whether or not nystagmus is extra distinguished in sufferers with MS in comparison with double imaginative and prescient.
Aspect-by-side comparability with a Likert scale on the left, and a Verbose scale on the correct.
Specializing in accessibility
Cellular-based research can typically current further challenges for members with persistent circumstances: the textual content could be exhausting to learn, the colour distinction might make it tough to see sure bits of knowledge, or it could be difficult to scroll by means of pages. This may occasionally end in participant drop off, which, in flip, might yield a biased dataset if the people who find themselves experiencing extra superior types of a illness are unable to supply knowledge.
With a purpose to forestall such points, we embrace the next accessibility options:
All through, we make use of colour blind accessible colour schemes. This contains enhancing the distinction between essential textual content and essential further data, which could in any other case be offered in a smaller font and a pale textual content colour.
We lowered the quantity of motion required to entry essential controls by inserting all buttons near the underside of the web page and making certain that pop-ups are controllable from the underside a part of the display screen.
To check the accessibility of MS Alerts, we collaborated with the Nationwide MS Society to recruit members for a person expertise research. For this, an invitation was despatched out by the Society to their members, and 9 respondents had been requested to check out the assorted app flows. The bulk indicated that they want a greater approach than their present methodology to trace their symptom knowledge, that they thought-about MS Alerts to be a singular and invaluable instrument that will improve the accuracy of their symptom monitoring, and that they might need to share the dashboard view with their healthcare suppliers.
Subsequent steps
We need to encourage everybody to utilize the open supply platform to start out organising and working their very own research. We’re engaged on making a set of ordinary research templates, which might incorporate what we realized from above, and we hope to launch these quickly. For any points, feedback or questions please try our useful resource web page.