Engineering

Researcher's Guide to Building a Research App

What is ResearchKit?

Research studies provide a key input into medical research, but conducting effective studies has proven to be both financially and logistically challenging.

It is difficult to recruit patients, particularly in the numbers necessary to be statistically meaningful. Requiring patients to keep numerous appointments at a clinic can prove burdensome, leading to incomplete engagement. Reading long consent documents and filling out hand-written surveys is time-consuming for both the patient and the researcher, and can cause the patient to lose interest.

Apple has sought to transform the world of medical research by bringing research studies to the device in everyone’s pocket - their mobile phone. To this end, they have built ResearchKit, a set of tools that, in Apple’s own words: “makes it easy for researchers and developers to create apps that could revolutionize medical studies, potentially transforming medicine forever.”

ResearchKit is a toolkit: a software framework that has been developed with the help of leading medical institutions to simplify the process of creating different parts of a mobile phone-based research app.

Iain Sanderson, the Vice Dean for Research Informatics at the Duke University School of Medicine, has described the development of ResearchKit as a “defining event” in his field, comparing it to the adoption of Epic and Electronic Health Records (EHR).

Why would I want to have a mobile app for research?

iPhones are in the hands and pockets of hundreds of millions of people around the world. The phones can monitor health and fitness data, record audio and video, take measurements, and ask for timely input, which make them a valuable tool to meet the needs of medical studies.

Game-changing benefits include:

  • Research can now take place outside of a lab or clinic.
  • The phone is always with the patient, so the data gathered is more objective.
  • Data can be easily gathered much more often, even daily or hourly - as often as necessary.
  • A study can now be available to people all over the world - potentially everyone who has an iPhone.
  • The study participant can easily fill out necessary information or take surveys right on their phone, without the need for an appointment or a visit.
  • Collecting data becomes much more cost-effective for organizations. Data is no longer gathered using lengthy forms or on paper surveys in a lab. This frees up the researcher’s valuable time to actually do research.
  • Data no longer has to be entered by hand into a computer system - it moves straight from the phone into the researcher database where it is available for large-scale analysis.
How does ResearchKit make developing apps easier?

There are several tasks which are often part of a research study. ResearchKit provides modules to cover these main needs within the context of a research app.

Research studies generally involve sharing a long document with the user to fully inform them about the study. ResearchKit provides tools to present this document in small, visual, understandable sections, followed by an opportunity for the user to review the full official document and then digitally sign.

Surveys

Qualitative and quantitative information can be collected from the patient through surveys. ResearchKit provides a variety of supplied survey question types.

Active Tasks

Research often involves collecting data and real-time measurements of the patient as they perform different tasks. A ResearchKit app can invite users to perform activities under semi-controlled conditions, using iPhone sensors to collect data.

Charts and Graphs

ResearchKit provides tools for displaying data to the user on different types of charts and graphs. These can be used in the traditional sense to present data points, or they can be used to provide visual feedback such as presenting the user’s progress through a list of daily tasks that are part of the study.

ResearchKit breaks down the consent flow into a visual procession of small, understandable sections. The framework provides predefined sections that are commonly included in consent documents. These each come with default graphics, and they include:

  • Overview
  • Data Gathering
  • Privacy
  • Data use
  • Time commitment
  • Surveys
  • Tasks
  • Withdrawal

If you choose to present them in this predefined order, the graphics will even animate from one screen to the next, for a more polished workflow.

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Since not all consent processes will use only these predefined sections, there are mechanisms provided to add custom sections to the process. Surveys can also be included within the consent flow to determine eligibility and to provide a quick test for the user to make sure they understand what they have read.

Once the visual flow is complete, you can use the tools to provide full official consent for approval, then have the user digitally sign the consent document using their finger on the screen.

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There are also tools to allow your app to create a PDF document of signed consent to store for study records and to email to the user, so they can always refer to what they signed.

What kinds of SURVEY questions does ResearchKit provide?

ResearchKit provides numerous question types for easily presenting surveys to the user. Available types currently include:

  • Text entry
  • Numeric entry
  • Email entry
  • Time of day selection
  • Date selection
  • Selection along a scale (horizontal or vertical)
  • Selection of one (or more) items from a predefined list
  • Selection from list of pictures / images

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What types of ACTIVE TASKS are available to use in a research app?

Data can be collected using many of the advanced features of the phone including the GPS, gyroscope, accelerometer, multi-touch display, and microphone.

The framework includes predefined tasks in several different categories:

Motor Activities

  • Gait and balance
  • Tapping speed

Fitness

  • Fitness task
  • Timed walk

Cognition

  • Spatial memory
  • Paced auditory and/or visual serial addition test (PSAT)
  • Tower of Hanoi
  • Reaction time

Voice

  • Sustained phonation

Audio

  • Tone audiometry

A sample flow for the “Spatial memory” active task is shown below:

Reseachersguide4 ResearchKit is open-source, and there are mechanisms in place for you to develop your own tasks. Anything that can be collected using the phone’s tools could become part of a ResearchKit task. Developers are encouraged to contribute to the ResearchKit codebase.

Yes! During many of the ResearchKit Active Tasks, results can include health information from the user’s HealthKit database.

The app must first obtain the user’s permission to read each type of measurement from HealthKit. Once that permission is obtained, the app can access health data such as heart rate during a fitness exercise, or step count during a walking exercise.

Will my IRB or ethics committee approve of a mobile app?

Feedback from review committees has been very positive, for the following reasons:

  • ResearchKit allows the Informed consent to be presented in several different ways, which works well with users’ different learning styles. Screens are presented visually using images and animations. Content is displayed in small sections to digest individually. The consent is also shown in complete form for the user to read in detail at their own pace, without someone sitting and waiting for them to finish.
  • ResearchKit “standardizes” the research app. All of the ResearchKit apps have a similar look and feel because they are built with the same tools. The informed consent process even has standard, predefined sections. This helps the IRB review process because each new ResearchKit app in an organization will not involve a lot of new learning for the review board or for the study participants.
Do I need a professional app developer?

Yes! ResearchKit does not generate apps - it is a set of building blocks and tools that an app developer can use to more quickly and easily create a research app.

One way to look at it is to compare your project to building a house. The ResearchKit tools are some of the building blocks, similar to the cabinetry and the light fixtures. Unless you are a professional builder, you will want to hire someone with expertise to first design your house to meet your needs and then to put all of the fixtures in place.

Beyond that, the iPhone provides many other capabilities that can be used to gather information for your medical study. ResearchKit does provide pre-built access to several different tasks and features, but a professional app developer can add in measuring tools customized to your needs, including access to further health information from Apple’s HealthKit database.

What parts of the app does ResearchKit not provide?

The ResearchKit framework does not include a data management solution. You and your app developer will need to select and connect to a data management solution which takes into account the privacy and security needs of your data.

How can I access my research data?

Part of the development process for a research app is to develop a “back-end” data management solution. Results from the iPhone app need to be communicated securely to this back-end. From there you will need to build a way to organize and access these results so you can analyze your collected data.

Does ResearchKit guarantee the security of the research data?

Data security must be designed into each of the following: your research app, the transmission of the data to the server, and the back-end server itself. ResearchKit does not provide any tools specifically related to securing the data.

A typical approach would include the following:

  • Secure account creation and login to the app
  • Data stored in an encrypted format in the app
  • Secure transmission of data from the app to the server
  • Data stored in an encrypted database on the server
  • Secure access to the data on the server
Can I use ResearchKit to create an app that is not for medical research?

Yes! Many different apps need to ask the user a series of questions. The ResearchKit building blocks can certainly be used to quickly add surveys to your app.

Customization of how the predefined survey questions look is limited, which is by design, to keep all ResearchKit apps with a similar look and feel. If your survey questions map well into the predefined question types and you like the fonts, sizes and other “look and feel” items that you get with ResearchKit, it does provide a significant amount of ready-made code for presenting surveys and providing (and even presenting) results.

Does ResearchKit work on Android?

Apple’s ResearchKit does not work directly on Android, but Apple has made the source code open source and publicly available in the hopes that another group might be able to port to other platforms. The most promising effort to date is ResearchStack. Little Green Software is participating in an early private beta of this project. An Android version would expand the reach of research applications to other countries where Android usage is much higher than iOS, as well as within the United States to increase the breadth and diversity of reach within a wider range of socio-economic populations.