ECTRIMS eLearning

Clinical electronic consent for the UK MS Register
Author(s): ,
R.M Middleton
Affiliations:
Medicine, Swansea University
,
D.V Ford
Affiliations:
Medicine, Swansea University
,
H Lockhart-Jones
Affiliations:
Medicine, Swansea University
,
D Naeh
Affiliations:
Medicine, Swansea University
,
A Akbari
Affiliations:
Medicine, Swansea University
O Pearson
Affiliations:
Neurology, ABMU, Swansea, United Kingdom
ECTRIMS Learn. Middleton R. 09/15/16; 146151; P310
Rod Middleton
Rod Middleton
Contributions
Abstract

Abstract: P310

Type: Poster

Abstract Category: Clinical aspects of MS - Epidemiology

Objectives: The UK MS Register is an observational research study capturing data from People with MS(PwMS), the NHS and carries out linkage with routine data

There are 14,000 PwMS submitting Patient Reported outcome Measures (PRoMS) and over 3500 patients consenting at NHS sites

A goal of the UK MS Register from the outset was that it be paperless. However, the process of informed consent requires signatures from patient and clinician. Clinical participants are consented using a triplicate consent form.

Electronic consent has a number of benefits:

  • Tablet computers are already in use at sites
  • Printing costs reduced
  • Participant expectations
  • Improved content and user experience, ie improved feedback, or multimedia elements
  • Ever increasing familiarity with tablet devices
Approach: Changing consent methodology is complex, all documentation, processes and changes are reviewed by an ethics committee. A privacy protecting, secure software package (iConsent) was developed by modifying an existing package from the Welsh Cancer Bank.

The software is server based, running on a Secured MS SQLServer 2014 and developed in .net to iOS/Android tablets.

The practitioner taking consent explains the process, hands the potential participant the tablet. They then work through the package, page by page. Lastly, they fill in some demographics, and are presented with the consent form, they then use a stylus to sign. The practitioner then countersigns.

Once completed a digitally signed, secure pdf is generated. Links are sent by email to the participant, the Register and unit administrator. The pdf is functionally identical to paper.

Results: The South West Central Bristol ethics committee approved the software following guidance on security and documentation design. Staff were trained in system usage.

A number patients were successfully e-consented, of note was a potential issue with some patients and how MS impacts their ability to sign without resting a hand on the screen.

Conclusion: Patients who have been e-consented have expressed satisfaction in ease of use and experience. Patients being unable to rest their hands on the screen is being examined. Newer devices can ignore inputs other than the stylus. e-Consent will not be appropriate for all MS patients.

The MS Register intends to use the software in more site for patient consent, the final paper will incorporate more results as the platform is rolled out.

Disclosure: The authors have nothing to disclose

Abstract: P310

Type: Poster

Abstract Category: Clinical aspects of MS - Epidemiology

Objectives: The UK MS Register is an observational research study capturing data from People with MS(PwMS), the NHS and carries out linkage with routine data

There are 14,000 PwMS submitting Patient Reported outcome Measures (PRoMS) and over 3500 patients consenting at NHS sites

A goal of the UK MS Register from the outset was that it be paperless. However, the process of informed consent requires signatures from patient and clinician. Clinical participants are consented using a triplicate consent form.

Electronic consent has a number of benefits:

  • Tablet computers are already in use at sites
  • Printing costs reduced
  • Participant expectations
  • Improved content and user experience, ie improved feedback, or multimedia elements
  • Ever increasing familiarity with tablet devices
Approach: Changing consent methodology is complex, all documentation, processes and changes are reviewed by an ethics committee. A privacy protecting, secure software package (iConsent) was developed by modifying an existing package from the Welsh Cancer Bank.

The software is server based, running on a Secured MS SQLServer 2014 and developed in .net to iOS/Android tablets.

The practitioner taking consent explains the process, hands the potential participant the tablet. They then work through the package, page by page. Lastly, they fill in some demographics, and are presented with the consent form, they then use a stylus to sign. The practitioner then countersigns.

Once completed a digitally signed, secure pdf is generated. Links are sent by email to the participant, the Register and unit administrator. The pdf is functionally identical to paper.

Results: The South West Central Bristol ethics committee approved the software following guidance on security and documentation design. Staff were trained in system usage.

A number patients were successfully e-consented, of note was a potential issue with some patients and how MS impacts their ability to sign without resting a hand on the screen.

Conclusion: Patients who have been e-consented have expressed satisfaction in ease of use and experience. Patients being unable to rest their hands on the screen is being examined. Newer devices can ignore inputs other than the stylus. e-Consent will not be appropriate for all MS patients.

The MS Register intends to use the software in more site for patient consent, the final paper will incorporate more results as the platform is rolled out.

Disclosure: The authors have nothing to disclose

By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies