As shopper applied sciences like health trackers and cell phones turn out to be extra broadly used for health-related information assortment, so does the chance to leverage these information pathways to check and advance our understanding of medical situations. We’ve got beforehand touched upon how our work explores the usage of this know-how throughout 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 medical research apps, that makes it simpler for anybody to run their very own research and acquire good high quality healthcare information, in a trusted and protected approach.
Right this moment, we describe the setup that we developed by increasing the FDA MyStudies platform and display how it may be used to arrange a digital well being research. We additionally current our exploratory analysis research created via this platform, referred to as MS Alerts, 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 grasp how new information assortment mechanisms can be utilized to revolutionize sufferers’ power illness administration and monitoring. We’ve got open sourced our extension to the FDA MyStudies platform below 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 plenty of accessibility modifications. Among the most important enhancements embrace: cross-platform (iOS and Android) app era via the usage 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 shortly (below a day generally); and, most significantly, an emphasis on accessibility in order that various 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 fast prototyping
We selected the usage of Flutter as it could be a single level that might generate each iOS and Android apps in a single go, decreasing the work required to help a number of platforms. Flutter additionally offers hot-reloading, which permits builders to construct & preview options shortly. The design-system within the app takes benefit of this function to supply a central level from which the branding & theme of the app will be modified to match the tone of a brand new research and previewed immediately. The demo surroundings within 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 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
- Bettering consumer consciousness of accessibility settings
Prolonged publicity to brilliant mild themes can pressure the eyes, so supporting darkish theme options was essential to make it simpler to make use of the research app ceaselessly. 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 simple to search out, we positioned an introductory one-time display that was offered through the app’s first launch, which might immediately take customers to their system accessibility settings.
Examine accessibility enhancements
To make the research itself simpler to work together with and cut 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 as a way to cut 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 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 components prohibit the house out there on the display. 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 components and as an alternative utilizing the whole display, 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 via the doubtless prolonged phrases of research participation. This would possibly embrace, for instance, questions like “In what nation is the research out there?” or “Are you able to withdraw from the research?” A piece like that is widespread 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 appropriate solutions for the comprehension take a look at again to the members. This helps reduce the variety of instances a consumer might must 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 primary app view, which consists of three pages:
- Actions:
This web page lists the questionnaires out there to the participant and is the place the vast majority of their time is spent. The questionnaires fluctuate 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 through 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. Individuals might doubtlessly present this information to their care supplier as a abstract of their situation over the past 6 months, an enchancment over the normal pen and paper strategies that many make use of right this moment. - Assets:
A set of helpful hyperlinks, assist articles and customary questions associated to MS.
Questionnaire design
Since needing to ceaselessly enter information can result in cognitive overload, participant drop off, and dangerous information high quality, we decreased 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 technique 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 subject sometimes 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, fairly than asking members to fee their signs on a scale from 1 to 10, we as an alternative current a a number of alternative query the place we element widespread imaginative and prescient issues that they might be experiencing.
This verbose scale helps sufferers observe 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, information collected utilizing the verbose scale would divulge to researchers whether or not nystagmus is extra outstanding in sufferers with MS in comparison with double imaginative and prescient.
Facet-by-side comparability with a Likert scale on the left, and a Verbose scale on the fitting. |
Specializing in accessibility
Cellular-based research can usually current further challenges for members with power situations: the textual content will be onerous to learn, the colour distinction might make it troublesome to see sure bits of knowledge, or it might be difficult to scroll via pages. This will likely 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 supply information.
As a way to stop such points, we embrace the next accessibility options:
- All through, we make use of shade blind accessible shade schemes. This consists of bettering 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 shade.
- We decreased the quantity of motion required to entry essential controls by inserting all buttons near the underside of the web page and guaranteeing that pop-ups are controllable from the underside a part of the display.
To check the accessibility of MS Alerts, we collaborated with the Nationwide MS Society to recruit members for a consumer expertise research. For this, an invitation was despatched out by the Society to their members, and 9 respondents have been requested to check out the varied app flows. The bulk indicated that they want a greater approach than their present methodology to trace their symptom information, that they thought of MS Alerts to be a novel and priceless software that might 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 begin establishing and operating 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 take a look at our useful resource web page.