Getting Started with ResearchKit

THREAD Research and Aptible give an overview of ResearchKit. Learn what's possible, and key considerations for study design, deployment, and security.

View the talk at: https://youtu.be/zgQVi71TyGI

Transcript

1. SEE WHAT’S POSSIBLE. GETTING STARTED WITH RESEARCHKIT
2. TODAY’S SPEAKERS ▸ AJ Triano, VP, THREAD Research ▸ Chas Ballew, Co-Founder, Aptible Introduction to ResearchKit
3. Introduction to ResearchKit ‣ ResearchKit Overview ‣ Example Academic Study: EpiWatch ‣ Regulatory, Security, & IRB Considerations ‣ Translating clinical studies to digital UI/UX ‣ High-level cost considerations TOPICS COVERED
4. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit iPhone
5. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit Sensors Devices Apps iPhone
6. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit Sensors Devices Apps iPhone
7. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit Sensors Devices Apps iPhone
8. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit Sensors Devices Apps Consent Surveys Dashboard Active Tasks iPhone
9. TEXT WHAT IS RESEARCHKIT? HealthKit Health App ResearchKit Sensors Devices Apps Consent Surveys Dashboard Active Tasks Your Database iPhone
10. IN-CLINIC +HOMEWORK
11. WELCOME TO THE CLINIC SIR
15. Introduction to ResearchKit EXAMPLE STUDY: EPIWATCH
16. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM
17. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical Need
18. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical Need • Limitation of current EEG measurement capabilities
19. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical Need • Limitation of current EEG measurement capabilities • Researching the physiology of eight 
 seizure types
20. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical Need • Limitation of current EEG measurement capabilities • Researching the physiology of eight 
 seizure types • Capturing contextual data
21. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical Need • Limitation of current EEG measurement capabilities • Researching the physiology of eight 
 seizure types • Capturing contextual data - Seizure event: Type, duration, frequency, responsiveness and cognition
22. Introduction to ResearchKit EPIWATCH STUDY Adrianna Williams/Corbis http://bit.do/bS7DM Challenging Clinical Need • Limitation of current EEG measurement capabilities • Researching the physiology of eight 
 seizure types • Capturing contextual data - Seizure event: Type, duration, frequency, responsiveness and cognition - Correlation factors: Triggers, medication adherence and side effects
23. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection http://bit.do/epiwatch
24. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Clinical Manifestations http://bit.do/epiwatch
25. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Clinical Manifestations Convulsions, Shaking Accelerometer Accelerometer http://bit.do/epiwatch
26. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Clinical Manifestations Convulsions, Shaking Falls Accelerometer Accelerometer Gyroscope http://bit.do/epiwatch
27. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Clinical Manifestations Convulsions, Shaking Falls Heart Rate Increase (80%) Accelerometer Accelerometer Gyroscope Heart Rate http://bit.do/epiwatch
28. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Clinical Manifestations Convulsions, Shaking Falls Heart Rate Increase (80%) Unresponsiveness Accelerometer Accelerometer Gyroscope Heart Rate UI http://bit.do/epiwatch
29. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection http://bit.do/epiwatch
30. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering http://bit.do/epiwatch
31. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Type, Duration and Frequency Seizure Event http://bit.do/epiwatch
32. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Type, Duration and Frequency Seizure Event http://bit.do/epiwatch
33. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Type, Duration and Frequency Responsiveness and cognition Seizure Event http://bit.do/epiwatch
34. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Type, Duration and Frequency Responsiveness and cognition Seizure Event http://bit.do/epiwatch
35. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Type, Duration and Frequency Responsiveness and cognition Seizure Event http://bit.do/epiwatch
36. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Type, Duration and Frequency Responsiveness and cognition Seizure Event http://bit.do/epiwatch
37. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Correlation Factors Type, Duration and Frequency Responsiveness and cognition Triggers Seizure Event http://bit.do/epiwatch
38. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Correlation Factors Type, Duration and Frequency Responsiveness and cognition Triggers Seizure Event http://bit.do/epiwatch
39. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Correlation Factors Type, Duration and Frequency Responsiveness and cognition Triggers Triggers Seizure Event http://bit.do/epiwatch
40. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Correlation Factors Type, Duration and Frequency Responsiveness and cognition Triggers Triggers Medication Adherence Seizure Event http://bit.do/epiwatch
41. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Contextual Data Gathering Correlation Factors Type, Duration and Frequency Responsiveness and cognition Triggers Triggers Medication Adherence Emergency Care Delivery* SMS Alert Seizure Event http://bit.do/epiwatch
42. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection http://bit.do/epiwatch
43. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Study Goals http://bit.do/epiwatch
44. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Study Goals Clinical Research (now) http://bit.do/epiwatch
45. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Study Goals Patient & Caregiver Engagement Clinical Research (now) http://bit.do/epiwatch
46. Introduction to ResearchKit EPIWATCH STUDY Possibilities of Non-EEG Seizure Detection Study Goals Algorithmic Detection Patient & Caregiver Engagement Clinical Research (now) http://bit.do/epiwatch
47. Introduction to ResearchKit EPIWATCH STUDY Design Process
48. Introduction to ResearchKit EPIWATCH STUDY Design Process
49. Introduction to ResearchKit EPIWATCH STUDY Design Process
50. Introduction to ResearchKit EPIWATCH STUDY Design Process
51. Introduction to ResearchKit EPIWATCH STUDY Design Process
52. Introduction to ResearchKit REGULATORY, SECURITY, & IRB CONSIDERATIONS ▸ Apps may be regulated ▸ Data may be regulated ▸ IRB will look for compliance + security + privacy
53. Introduction to ResearchKit REGULATORY CONSIDERATIONS ▸ FDA regulates “mobile medical devices” ▸ HHS —> HIPAA regulates “protected health information” ▸ FTC + state agencies regulate personally identifiable information, financial information, children’s privacy, and more
54. Introduction to ResearchKit REGULATORY CONSIDERATIONS: FDA Strategy 1: Avoid classification as a “mobile medical application” • Avoid “diagnosis, cure, mitigation, treatment, or prevention” • Leverage user-initiated activities only (disease tracking) http://bit.do/FDA
55. Introduction to ResearchKit REGULATORY CONSIDERATIONS: FDA Strategy 1: Avoid classification as a “mobile medical application” • Avoid “diagnosis, cure, mitigation, treatment, or prevention” • Leverage user-initiated activities only (disease tracking) Medical Device Any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar or related article, including any component, part, or accessory intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease http://bit.do/FDA
56. Introduction to ResearchKit REGULATORY CONSIDERATIONS: FDA Strategy 1: Avoid classification as a “mobile medical application” • Avoid “diagnosis, cure, mitigation, treatment, or prevention” • Leverage user-initiated activities only (disease tracking) Medical Device Any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar or related article, including any component, part, or accessory intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease Mobile Medical Application Is a medical device when it is intended: • to be used as an accessory to a regulated medical device; or • to transform a mobile platform (smartphone, tablet, etc.) into a regulated medical device http://bit.do/FDA
57. Introduction to ResearchKit REGULATORY CONSIDERATIONS: FDA Strategy 2: Qualify for enforcement discretion as a “low risk” device • Avoid medical intervention - do not diagnose or treat • Do not replace an existing medical device (e.g., electronic stethoscope) • Do not control an existing medical device (e.g. iPhone infusion pump settings app) http://bit.do/FDA
58. Introduction to ResearchKit REGULATORY CONSIDERATIONS: FDA Strategy 2: Qualify for enforcement discretion as a “low risk” device • Avoid medical intervention - do not diagnose or treat • Do not replace an existing medical device (e.g., electronic stethoscope) • Do not control an existing medical device (e.g. iPhone infusion pump settings app) http://bit.do/FDA
59. Introduction to ResearchKit REGULATORY CONSIDERATIONS: FDA Strategy 2: Qualify for enforcement discretion as a “low risk” device • Avoid medical intervention - do not diagnose or treat • Do not replace an existing medical device (e.g., electronic stethoscope) • Do not control an existing medical device (e.g. iPhone infusion pump settings app) Enforcement Discretion Apps that are medical devices, but pose lower risk to the public, and are therefore not subject to FDA regulation “at this time”: • Apps that help asthmatics track inhaler usage, asthma episodes experienced, location of user at the time of an attack, or environmental triggers of asthma attacks • Apps that use a checklist of common signs and symptoms to provide a list of possible medical conditions and advice on when to consult a health care provider • Apps that allow a user to collect, log, track and create trend data, such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a health care provider, or upload it to an online (cloud) database, personal or electronic health record http://bit.do/FDA
60. Introduction to ResearchKit REGULATORY CONSIDERATIONS: HIPAA http://bit.do/regulatory
61. Introduction to ResearchKit REGULATORY CONSIDERATIONS: HIPAA http://bit.do/regulatory ▸ HIPAA only regulates certain data ▸ “Protected health information” - has to touch an insurance transaction in its lifecycle ▸ Academic studies often not regulated; ResearchKit can be used for private studies or products
62. Introduction to ResearchKit REGULATORY CONSIDERATIONS: HIPAA http://bit.do/regulatory ▸ HIPAA requires privacy, security, & breach notification controls ▸ Vendors must be approved and sign special BAA contracts ▸ Vendors must be secure and compliant
63. Introduction to ResearchKit REGULATORY CONSIDERATIONS: OTHER LAWS http://bit.do/regulatory http://bit.do/regulatory
64. Introduction to ResearchKit REGULATORY CONSIDERATIONS: OTHER LAWS http://bit.do/regulatory http://bit.do/regulatory
65. Introduction to ResearchKit REGULATORY CONSIDERATIONS: OTHER LAWS http://bit.do/regulatory http://bit.do/regulatory
66. Introduction to ResearchKit REGULATORY CONSIDERATIONS: OTHER LAWS http://bit.do/regulatory http://bit.do/regulatory
67. Introduction to ResearchKit SECURITY CONSIDERATIONS ‣ Authentication ‣ How do users log in? ‣ Access Controls ‣ Is there an admin dashboard? ‣ Do researchers have different levels of access? ‣ Audit Controls ‣ Integrity + Business Continuity ‣ Data backup ‣ Storage encryption ‣ Transmission Security ‣ Encryption
68. Introduction to ResearchKit SECURITY CONSIDERATIONS ‣ Security Management ‣ Who will document the security controls applied? ‣ Who will approve them? ‣ Who will maintain them? ‣ How and how often will you verify them?
69. Introduction to ResearchKit IRB CONSIDERATIONS Gain early buy-in from IRB for electronic consent process • ResearchKit framework for e-consent has achieved significant review and support ‣ Guided by Sage Bionetworks review http://sagebase.org/e-consent/ ‣ HHS support in developing electronic research consenting process
70. Introduction to ResearchKit IRB CONSIDERATIONS Gain early buy-in from IRB for electronic consent process • ResearchKit framework for e-consent has achieved significant review and support ‣ Guided by Sage Bionetworks review http://sagebase.org/e-consent/ ‣ HHS support in developing electronic research consenting process Seek expedited IRB review for minimal risk research • Try to establish an “early and often” informal check-in throughout design/development • Prepare supporting documentation ‣ Full description of the app, it’s functionality and potential risks • App copy manuscript, technical flows, designs and diagrams, scientific literature ‣ Full description of the consent process ‣ Fully-developed data security plan that has been approved by appropriate institutional officials
71. Introduction to ResearchKit BONUS CONSIDERATION: IP PROTECTION Disclose conflicts of interest, commercial interests to IRB up front • Many research efforts have algorithm aspirations ‣ Are you validating/refining your algorithm hypothesis with the intention to make money?
72. Introduction to ResearchKit BONUS CONSIDERATION: IP PROTECTION Disclose conflicts of interest, commercial interests to IRB up front • Many research efforts have algorithm aspirations ‣ Are you validating/refining your algorithm hypothesis with the intention to make money? Consider patent, copyright, and trademark protection • Patent protection requires innovation: can’t be just “X + computers” • Limited protection for apps • You can’t simply implement an existing concept in software Do a search to make sure you don’t infringe on someone else’s patent
73. INTO DIGITAL UI/UX TRANSLATING CLINICAL EXPERIENCES
74. BREVITY RULES: ADAPT TO THE SMALL SCREEN
75. BREVITY RULES: ADAPT TO THE SMALL SCREEN Copy Density (Use Video)
76. BREVITY RULES: ADAPT TO THE SMALL SCREEN Copy Density (Use Video) Text Input (Use Touchscreen & Sensors)
77. BREVITY RULES: ADAPT TO THE SMALL SCREEN Copy Density (Use Video) Text Input (Use Touchscreen & Sensors) Dic1on (Users aren’t scien6sts/researchers)
78. THINK “FRESH”
79. RECRUITMENT & RETENTION GOING DIGITAL CHANGES
80. Introduction to ResearchKit LAUNCH KIT DIGITAL RECRUITING BRANDING & APP ICON DIGITAL RECRUITING App Icon Brand Mark RESPONSIVE SUPPORT MICROSITE SOCIAL MEDIA ACTIVATION DOWNLOADABLE WALL CLINGS
81. COST COMPARISON TRADITIONAL RESEARCH ▸ Medical Personnel ▸ Office Staff ▸ Clinic Space ▸ Office Space ▸ Survey Printing Postage & Data Processing ▸ Participant Recruitment
82. COST COMPARISON TRADITIONAL RESEARCH ▸ Medical Personnel ▸ Office Staff ▸ Clinic Space ▸ Office Space ▸ Survey Printing Postage & Data Processing ▸ Participant Recruitment ▸ Cost Per Patient???
83. COST COMPARISON MOBILE RESEARCH
84. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore Model for Organizations
85. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore Model for Organizations ▸ Digital Recruitment
86. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore Model for Organizations ▸ Digital Recruitment ▸ Secure Data Hosting
87. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore Model for Organizations ▸ Digital Recruitment ▸ Secure Data Hosting ▸ Analytics Software
88. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore Model for Organizations ▸ Digital Recruitment ▸ Secure Data Hosting ▸ Analytics Software
89. COST COMPARISON MOBILE RESEARCH ▸ App Development: Independent App UCore Model for Organizations ▸ Digital Recruitment ▸ Secure Data Hosting ▸ Analytics Software ▸ Cost Per Patient???
90. MORE THAN JUST CHEAPER
91. MORE THAN JUST CHEAPER • NEW TYPES OF DATA • CONTINUOUS DATA (NO MORE SNAPSHOTS) • HIGH-SPEED INSIGHTS (WEEKS NOT YEARS)
93. Have questions? Time to discuss . . . Q & A www.threadresearch.com https://www.aptible.com
94. www.threadresearch.com https://www.aptible.com
95. Want to discuss further? Get in touch! aj@threadresearch.com chas@aptible.com www.threadresearch.com https://www.aptible.com THANK YOU