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Use of OpenClinica's Participate in OCTOPUS

Daramola-Rose A1, Mahoro O1, Pugh C1, Maniatis C1, Sweeney H1, Rauchenberger M1, Mangion S2, Wade C2, Chataway J2 

  1. MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, WC1V 6LJ
  2. Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, WC1B 5EH

Background 

The Optimal Clinical Trials Platform for Progressive Multiple Sclerosis (OCTOPUS) has secondary patient reported outcome measures (PROMs) and measures of drug compliance, that requires participants to complete questionnaires either on paper or online, using the OpenClinica eDC trial database module called Participate. 

These are: 

  • Multiple Sclerosis Impact Scale v2 (MSIS29v2) 
  • Multiple Sclerosis Walking Scale v2 (MSWSv2)
  • Fatigue (MFIS-21 and CFQ)
  • Pain Assessment (Neuropathic Pain Scale and overall pain intensity) 
  • EQ-5D-5L Health Questionnaire
  • Drug compliance collected via Diary card summary

We wanted to examine the performance of Participate in OCTOPUS and investigate any operational trends highlighted by its use in comparison to paper questionnaires.

How does Participate work?

Participants consent to provide their email address and/or mobile number to the local research team (OCTOPUS trial team do not receive or have access to them). The participants then receive link via text or email to allow them to access each of the PROMs and Diary card. When selected, participants see the screen as seen in the image and can select each questionnaire individually.

Participants do not need to do all at the same time and can come back to complete later. The answers to the questionnaires are submitted when all are completed. Paper versions can be collected and entered on OpenClinica database by site teams. Comparison metrics of forms completed online versus paper were calculated using audit trial data from the eDC.

 

Results

PROMs

In August, the percentage of Week 0 questionnaires completed online increased to 44% (with 56% on paper).

As trial visits proceed, the percentage of PROMs being completed online has increased, with 95% of PROMs completed using Participate at Week 52 (51% of these completed during the visit).

Drug Diary Card

The majority of drug compliance entry has been completed by paper rather than electronically. Uncertainty on details and timing of collection has resulted in 48% of those entered online requiring correction.

Like the PROMs, an increase of completion on Participate can generally be seen as visits proceed.

Participants' and clinicians' thoughts on Participate

"It takes a bit of getting used to at the start, but it's great for clearing part of the visit early and from home"

"It's so much easier to fill out my questionnaires from home rather than having to go to the clinic."

"Really useful system - and less paper waste!“

Dr Charles Wade, Clinical Research fellow at UCLH says:

"Using the Participate platform streamlines our research by saving time during visits, eliminating manual data entry, and providing precise timestamps for data, simplifying data cleaning and improving efficiency."

 

Conclusions

Preliminary analysis and participant feedback show that the use of Participate is working well for questionnaire collection. Training and guidance for sites is showing to have helped.

The use of Participate at subsequent site visits has increased, which is felt to be due to reminders and checks by site teams, as well as increased familiarity and ease of use for participants.

For PROMs completed electronically, completion during the visit is the preferred method however, completion before the visit is showing an upward trend.

The OCTOPUS trial team have recently created participant guidance for circulation which is hoped to contribute further to the increasing trend of using Participate. However, drug compliance collection continues to be inconsistent and may be causing a burden to participants and research staff.

The team are aware that further training and guidance is needed for sites to improve the use of Participate, and completion of the data compliance fields.