RKStudio – Frequently Asked Questions

General

How much experience with programming and/or database knowledge is required to use RKStudio?

No programming or database experience is needed to use RKStudio. The point and click study builder within RKStudio is all you need to create your studies and surveys.

How do participants complete surveys and interact with a study?

Participants complete surveys, active tasks, and manage device data directly on the mobile (iOS and Android) MyDataHelps app. In addition, participants can use the web to complete surveys, although active tasks (e.g., two finger tapping, memory test) and electronic consent functionality are not currently supported on the web.

How does RKStudio and the MyDataHelps participant app increase participant adherence?

Participants find it more convenient to complete surveys on their phone compared to the traditional research method of scheduling and completing a phone call with a study administrator or visiting a clinic. Additionally, participants can be reminded daily via a push notification to complete any outstanding surveys. You may nudge participants by sending targeted messages to only those that meet certain criteria.

Will I be able to change my research study after I start inviting participants?

Yes, you can continually update survey instruments, modify schedules, and deliver tasks during the course of a study.

Data Security, Legal and Compliance

How is participant’s data secured?

Participant data is maintained in the United States by us or our authorized partners. We use appropriate physical, organizational, and technical safeguards designed to protect the confidential, security, and integrity of the Data we collect. For example, data is encrypted both while it is stored and while it is transmitted using National Institutes of Standards and Technology (NIST) Federal Information Processing Standard (FIPS) Publication 140-2 recommended security standards for securing data. These are the standards recommended by the Department of Health and Human Services for securing health information. We strive to protect the privacy of the Personal Information we collect and hold but we cannot guarantee complete security. Unauthorized entry or use, hardware or software failure, and other factors, may compromise the security of data at any time.

Is RKStudio and MyDataHelps HIPAA compliant?

The RKStudio platform (including myDataHelps)is built on top of the CareEvolution HIEBus platform, which has been securely handling protected health information (PHI) for over 15 years for hospitals, insurance companies, and other organizations. HIEBus is HIPAA compliant and Meaningful Use Certified. Role-based access control ensures that participant data is only exposed to individuals with the appropriate permissions.

Account and Billing

What does the free account include? How many participants can I add with this free product? Is there a time limit?

You may currently create a free account and utilize all RKStudio functionality to send your study to up to 100 participants. There is no time limit in using the free version of the product.

A team at my institution already has an organization created in RKStudio. Do I need to create a new organization?

If you plan to utilize the same surveys and instruments as an existing organization you can request that organization administrator add you as a user, after you register and create your individual RKStudio account. You will then be able to create a new study within the existing organization and utilize the surveys and settings already created. If you intend to create a different study with a different set of surveys, you will need to create a second organization.

Consent Forms and Electronic Signatures

How do participants sign a study consent form before joining a research study?

Before joining a study in the MyDataHelps app, participants are prompted to complete the electronic consent form and provide their electronic signature.

Will my IRB allow me to launch an app using electronic consent through MyDataHelps?

While each IRB may vary in their policies and procedures, we have worked with several research institutions that allow electronic consents. Many of these institutions have found that the electronic consent process is much more efficient than traditional print, sign, and scan processes.

Survey Question and Answer Types

What types of survey questions are supported? What type of answer formats are supported?

Currently, RKStudio surveys include but are not limited to the following question or step types: instruction, question, form (multiple questions within one step), image capture, video capture, completion step, and countdown step. For a full list of current steps/questions, please create a free account and view the “Surveys” tab and explore the “Step” types in the right bar.

What type of answers are supported in RKStudio?

Supported answers include but are not limited to yes/no, numeric (integer and decimal), free text, continuous scale, discrete scale, complete scale, height, weight, date, time of day, and value picker. For a full list of current answer types, please create a free account and view the “Surveys” tab and explore the “Answer Format” types in the right bar. If you do not see what you are looking for, please contact us as we are continually adding new functionality.

What if I want to add a step type that isn’t supported? Is there a way to extend RKStudio surveys with additional functionality?

You may create customizable HTML-based web view steps in RKStudio. As an example, a “digital body map” was created to serve as a self-report measure that accurately assesses for the distribution of pain. Javascript can be utilized to create highly interactive and sophisticated survey steps.

Is conditional or branching logic supported?

Yes, you can create conditional/branching logic for every step within a survey to ensure participants only complete the applicable steps.

What types of Apple ResearchKit active tasks are supported?

We currently support the majority of Apple’s ResearchKit active tasks. We are continuously updating our library as additional active tasks become available.

Additional Features and Functionality

How much training is required to build a study in RKStudio?

No training is required. The RKStudio point and click WYSIWYG survey designer makes it easy to create a survey within hours with no coding required. Additionally, we maintain a user guide to ensure you have the support you need to build your study.

Can I send messages to participants? Is it possible to send messages to only the participants that match certain criteria?

Yes, this is possible utilizing our advanced rules engine. You may send push notifications or emails to participants that match certain criteria including but not limited to recent activity (e.g. adherence, survey answers, enrollment, device usage, surgery date), clinical outcomes (e.g. labs, medications), and participant phenotypes (e.g. age, sex, date of birth).

What are the different ways I can schedule surveys to be delivered to participants?

You may set a schedule to deliver surveys to participants anchored on enrollment, participant event, or a specific date. You may choose to deliver a survey on a set frequency anchored on that date (e.g. deliver a survey every two days, starting one week after enrollment). Additionally, you may manually deliver surveys to participants.

Can I schedule surveys to be delivered relative to some custom anchor date such as date of surgery or date of discharge?

Yes, you can set a custom date as a reference point to deliver surveys to participants.

What sensor or wearable device and 3rd party application data can participants share with my study via RKStudio/MyDataHelps?

MyDataHelps is able to collect data from the Apple Health or Google Fit ecosystems and therefore supports the devices and 3rd party applications that are supported by Apple Health or Google Fit. For example, with Apple Health, this includes but is not limited to Apple Watch sensor data (heart rate, steps, etc.), blood pressure devices, scales, and sleep apps. For a full list of current data integration, please create a free account and view the “Studies” tab and then click the “Sensor Data” tab. If you do not see what you are looking for, please contact us as we are continually adding new integrations as they become available.

Does RKStudio/MyDataHelps support collecting data from Apple’s Movement Disorder API for participants with an Apple Watch?

Yes, but this functionality is only available for studies involving people with Parkinson’s disease or other movement disorders. Contact the RKStudio support team if you are interested collecting this data for your study.

Is RKStudio able to integrate participant location data into studies?

Yes, participants can share location data with your study. This is currently available on iOS devices.

Can participants easily share their medical history with my study?

Yes, through MyDataHelps the participant can download their medical history data from supported systems that comply with the SMART on FHIR standards. Current institutions that support this standard include, but are not limited to, Cedars-Sinai, Cleveland Clinic, and Geisinger.

Is historical Medicare data available for participant’s to import into a study?

Yes, Medicare claims data is available under the CMS Blue Button 2.0 initiative, which includes four years of Medicare Part A, B and D data for 53 million Medicare beneficiaries. This data reveals a variety of information about a beneficiary’s health, including type of Medicare coverage, drug prescriptions, primary care treatment and cost. Blue Button 2.0 uses the HL7 FHIR standard for beneficiary data and the OAuth 2.0 standard for beneficiary authorization.

Does RKStudio support multi-site / multi-center studies?

Yes. A study can be utilized by researchers from multiple sites and institutions.

Is it possible to import my studies and surveys from other survey design and delivery solutions such as REDCap?

Yes, we support the ability to import your existing surveys and data from REDCap.

Exporting Data

What file formats does RKStudio support for exporting data for analysis?

Data from your study can be easily exported into CSV and JSON.

How often can I export my data?

You can set up RKStudio to automatically export your incremental data on a daily, weekly, or monthly schedule.

Can I export my study data manually?

Yes, this is possible by working with an RKStudio team support member. To ensure your have your data on demand, it is recommended that you set an automatic export frequency before going live with your study.

How do I export and view study data?

RKStudio allows you to set a daily, weekly, or monthly frequency to export your incremental study data.

Can I use an SFTP server to export?

Yes. In addition to or as an alternative to setting an automatic export frequency, you may set the RKStudio settings to export your data directly to an SFTP (SSH file transfer protocol) server site.