Ethics Approval Support Document

BACKGROUND:

Society of Vascular and Interventional Neurology (SVIN) is a non-profit organization with a mission to advance the field of neurointervention and the goal of improving clinical care and outcomes of patients with stroke and cerebrovascular diseases. Mission Thrombectomy (MT2020+) is a global campaign initiated by the SVIN with multiple stakeholders to increase regional thrombectomy procedure capacity and enable access to thrombectomy around the world. Global Thrombectomy Tracking (GTT) App is a data collection tool developed with a specific purpose of 1) tracking the mechanical thrombectomy procedures performed worldwide as an aggregate number by location, and 2) providing an opportunity to the local healthcare facility or the registered user of the GTT App to maintain a secure and readily accessible list of thrombectomy procedures performed at a given location.

GTT App:

GTT App is designed to function on a mobile electronic device platform such as the Android or the iOS. The application was developed by the SVIN and is available for download on Google Play Store or Apple App Store. There is no cost to download or use the GTT App, but a mobile-data plan or an internet connection will be required for download.  An internet-based platform of the GTT application is also available online at https://mt2020.org/.

HOSPITAL:

A participating healthcare facility, clinic or medical center where mechanical thrombectomy procedures can be performed will be universally referred to as “hospital” in this document. The Interventionalist (physician performing the thrombectomy procedure) and/or the designated Associate at a participating hospital will be identified as the key personnel providing data on mechanical thrombectomy procedures performed at that hospital.

ACCOUNT REGISTRATION:

The Interventionalist and/or Associate will initially register with MT2020 by creating a user account. This generates a username and password that provides secure access to enter the thrombectomy data on electronic devices (mobile phone, tablets or laptop/computer).

DATA COLLECTION:

Information collected using the GTT App is primarily limited to the name of the Interventionalist, name of the hospital where procedure is performed, clinical severity of the ischemic stroke, location of the occlusion in the pre-cerebral or cerebral blood vessel and the mechanical thrombectomy procedure.

Patient-related information collected is limited to age and gender. No protected health information (PHI) such as name, date of birth, address, contact information, etc. will be collected (please see below for details).

  1. Name of the Hospital (required)
  2. Gender (M / F)
  3. Age (in years)
  4. Occlusion site
  5. Date of thrombectomy procedure
  6. NIHSS score (0-42)
  7. Onset to ED arrival time (minutes)
  8. Door to puncture time (minutes) (optional)
  9. Due to recanalization time (minutes)
  10. Discharge mRS (0-5)
  11. 90-day mRS (0-5)
  12. TICI recanalization grade (required)
  13. Symptomatic hemorrhage (Yes / No)
  14. Other (case description) (optional)

NIHSS: National Institutes of Health Stroke Scale, ED Emergency Department, mRS modified Rankin Score, TICI Thrombolysis in Cerebral Infarction, MT Mechanical Thrombectomy

Approximate duration to enter all information for a patient / case is < 5 minutes.

DATA STORAGE:

All data entered using the GTT App is uploaded and stored on a highly secure cloud-based server (Amazon Web Services, Inc). No data is stored locally on the electronic devices used to enter the information. The Interventionalist and/or the Associate will have access only to the user-level data stored on the server (account-specific). All data will be stored for a period of 10 years. After 10 years, the data on the cloud-based central server will be permanently deleted.

DATA SECURITY:

The GTT App user information and the data is encrypted, protected and secured on the Amazon Web Server. Both the Web and the Mobile App communications use encrypted channels as well as secure protocols. Enhanced security tools to prevent unwanted and malicious intrusion into the application will be adapted. GTT application uses all necessary security standards including input validation and output filtering. Application has been tested for various malicious attacks like SQL Injection Attacks, Cross Site Request Forgery (CSRF) attacks, Cross Site Scripting (XSS) attacks. Industry standard Authentication and Authorization layers of security have been embedded in the system. Access Control Filter (ACF) and Role-Based Access Control (RBAC) has been incorporated. For password protection, best hashing algorithms were used.

CONFIDENTIALITY / PRIVACY:

The GTT App was designed maintain the privacy and confidentiality of the patient. All information entered into the GTT application will be devoid of patient identifiers and protected health information. Any additional case description will remain as an optional data entry field on the GTT App.

DATA RELEASE:

Data entered by the registered user using the GTT App will be available for download at all times. Available data download options would include both hospital-specific data and registered user-specific data. Any requests for download of regional or global data will require approval of the MT2020+ Core Executive Committee, and such requests may be directed to the SVIN MT2020+ Committee.

APPROVAL / CONSENT:

Data from all ischemic stroke patients undergoing mechanical thrombectomy procedure is eligible for entry on the GTT App. An informed consent from the patient or family member is not required prior to entry of data. However, approval for data sharing from the local institutional review board (IRB) or the institutional ethics committee is highly recommended.

RISKS AND BENEFITS:

There is no risk involved to the patient from sharing of the mechanical thrombectomy data. Similarly, there is no direct benefit to the patient. There is also no financial compensation or benefit to the Interventionalist and/or the Associate entering the data. There are conceivable benefits to the society. Use of data-driven initiatives may result in increased thrombectomy procedures in the region, and data strongly suggests that patient outcomes are better at higher volume centers.

QUESTIONS?

For questions and additional information, the registered user of the GTT App at the Hospital (Interventionalist and/or the designated Associate) or the Regional Committee of MT2020+ may be contacted.