As shopper applied sciences like health trackers and cellphones turn into extra extensively used for health-related knowledge assortment, so does the alternative to leverage these knowledge pathways to check and advance our understanding of medical circumstances. We have beforehand touched upon how our work explores the use of this expertise inside the context of power illnesses, particularly a number of sclerosis (MS). This effort leverages the FDA MyStudies platform, an open-source platform used to create scientific research apps, that makes it simpler for anybody to run their very own studies and acquire good high quality healthcare knowledge, in a trusted and protected manner.
Today, we describe the setup that we developed by increasing the FDA MyStudies platform and display how it may be used to arrange a digital health research. We additionally current our exploratory research research created by means of this platform, known as MS Signals, which consists of a symptom monitoring app for MS sufferers. The aim 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 know how new knowledge assortment mechanisms can be utilized to revolutionize sufferers’ power illness administration and monitoring. We have open sourced our extension to the FDA MyStudies platform below the Apache 2.0 license to offer a useful resource for the community to construct their very own studies.
Extending the FDA MyStudies platform
The unique FDA MyStudies platform allowed folks 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 a variety of accessibility adjustments. Some of the major enhancements embody: cross-platform (iOS and Android) app era by means of the use of 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 rapidly (below a day normally); and, most significantly, an emphasis on accessibility in order that various affected person’s voices are heard. The accessibility enhancements embody adjustments to the underlying options of the platform and to the explicit research design of the MS Signals research app.
Multi-platform assist with speedy prototyping
We selected the use of Flutter as it might be a single level that might generate each iOS and Android apps in a single go, lowering the work required to assist a number of platforms. Flutter additionally supplies hot-reloading, which permits builders to construct & preview options rapidly. The design-system in the app takes benefit of this function to offer a central level from which the branding & theme of the app might be modified to match the tone of a brand new research and previewed immediately. The demo atmosphere in the app additionally makes use of this function 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 reside with clinicians.
System accessibility enhancements
To enhance the accessibility of the platform for extra customers, we made a number of usability enhancements:
- Light & darkish theme assist
- Bold textual content & variable font-sizes
- High-contrast mode
- Improving consumer consciousness of accessibility settings
Extended 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 often. Some small or mild text-elements are illegible to customers with imaginative and prescient impairments, so we added 1) bold-text and assist for bigger font-sizes and a couple of) high-contrast color-schemes. To be certain that accessibility settings are simple to seek out, we positioned an introductory one-time display that was introduced throughout the app’s first launch, which might instantly take customers to their system accessibility settings.
Study accessibility enhancements
To make the research itself simpler to work together with and scale back cognitive overload, we made the following adjustments:
- 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 with a purpose to scale back confusion and participant drop-off.
The unique questionnaire design in the app introduced every query in a card format, which makes use of a part of the display for shadows and depth results of the card. In many conditions, this can be a nice aesthetic, however in apps the place accessibility is precedence, these visible components prohibit the area accessible on the display. Thus, when extra accessible, bigger font-sizes are used there are extra frequent phrase breaks, which reduces readability. We mounted this just by eradicating the card design components and as an alternative utilizing the total display, permitting for higher visuals with bigger font-sizes.
The MS Signals prototype research
To check the usability of those adjustments, we used our redesigned platform to create a prototype research app known as MS Signals, which makes use of surveys to collect details about a participant’s MS-related signs.
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| MS Signals app screenshots. |
MS Studies app design
As a primary step, earlier than coming into any research info, members are requested to finish an eligibility and research comprehension questionnaire to make sure that they’ve learn by means of the probably prolonged phrases of research participation. This would possibly embody, for instance, questions like “In what nation is the research accessible?” or “Can you withdraw from the research?” A piece like that is widespread in most health studies, and it tends to be the first drop-off level for members.
To decrease research drop-off at this early stage, we stored the eligibility check temporary and mirrored appropriate solutions for the comprehension check again to the members. This helps decrease the variety of occasions a consumer might have to undergo the preliminary eligibility questionnaire and ensures that the essential facets of the research protocol are made clear to them.
After profitable enrollment, members are taken to the major app view, which consists of three pages:
- Activities:
This web page lists the questionnaires accessible to the participant and is the place the majority of their time is spent. The questionnaires range in frequency — some are one-time surveys created to collect 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 throughout the eligibility and comprehension step. - Dashboard:
To be certain that members get one thing again in return for the info they enter throughout a research, the Dashboard space presents a abstract of their responses in graph or pie chart kind. Participants might probably present this knowledge to their care supplier as a abstract of their situation over the final 6 months, an enchancment over the conventional pen and paper strategies that many make use of right now. - Resources:
A set of helpful hyperlinks, assist articles and customary questions associated to MS.
Questionnaire design
Since needing to often enter knowledge can result in cognitive overload, participant drop off, and dangerous 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 selection 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 info is available in the app, together with the time of the entry.
In designing the survey content material, we collaborated carefully with skilled clinicians and researchers to finalize the wording and format. While studies on this discipline sometimes use the Likert scale to collect symptom info, we outlined a extra intuitive verbose scale to offer higher expertise for members monitoring their illness and the clinicians or researchers viewing the illness historical past. For instance, in the case of imaginative and prescient points, quite than asking members to price their signs on a scale from 1 to 10, we as an alternative current a a number of selection query the place we element widespread imaginative and prescient issues that they could 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 strategy 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.
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| Side-by-side comparability with a Likert scale on the left, and a Verbose scale on the proper. |
Focusing on accessibility
Mobile-based studies can usually current extra challenges for members with power circumstances: the textual content might be arduous to learn, the colour distinction might make it tough to see sure bits of data, or it could be difficult to scroll by means of pages. This might lead to 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 offer knowledge.
In order to stop such points, we embody the following accessibility options:
- Throughout, we make use of colour blind accessible colour schemes. This consists of bettering the distinction between essential textual content and essential extra info, which could in any other case be introduced in a smaller font and a light textual content colour.
- We lowered the quantity of motion required to entry essential controls by inserting all buttons near the backside of the web page and making certain that pop-ups are controllable from the backside a part of the display.
To check the accessibility of MS Signals, we collaborated with the National MS Society to recruit members for a consumer expertise research. For this, a name for participation was despatched out by the Society to their members, and 9 respondents had been requested to check out the numerous app flows. The majority indicated that they want a greater manner than their present technique to trace their symptom knowledge, that they thought-about MS Signals to be a singular and priceless instrument that might improve the accuracy of their symptom monitoring, and that they might need to share the dashboard view with their healthcare suppliers.
Next steps
We need to encourage everybody to utilize the open supply platform to begin establishing and working their very own studies. We are engaged on making a set of normal research templates, which might incorporate what we discovered from above, and we hope to launch these quickly. For any points, feedback or questions please try our useful resource web page.