Poster: eCOA Best Practices in Diabetes Clinical Trials
1
INTEGRATING TECHNOLOGY INTO DIABETES CLINICAL TRIALS BEST PRACTICES FOR CAPTURING ELECTRONIC CLINICAL OUTCOME ASSESSMENTS Jessica Thilaganathan, Karl McEvoy, Juha Matero, Olli Kotiranta, Katie Garner and Paul O’Donohoe. CRF Health, 229-243 Shepherds Bush Road, Hammersmith, London, W6 7AN, England It is expected that by 2030 diabetes will be the 7th leading cause of death globally. For the 347 million people living with the disease, managing their condition can involve a variety of demanding tasks including taking regular measurements of blood glucose, monitoring the nutritional value of meals and tracking insulin usage. Diabetes clinical trials typically seek to capture this data, as well as expecting participants to complete a variety of additional patient reported outcomes, often while having to alter their normal, established routine to align with the study protocol. This increased complexity can lead to higher patient burden and risks lower compliance within the study. Our aim was to develop a robust and intuitive system for use in diabetes clinical trials to capture clinically relevant data, while documenting best practices for electronic data capture which would decrease patient burden while increasing compliance and improving data quality. CRF Health created a diabetes solution that not only catered to the clinical team and sponsors’ needs for accurate data collection but was also designed to be relevant to patient’s symptoms and typical daily routine, while limiting any additional burden to the patient. Objectives With an increasing amount of data being collected in diabetes trials, an intuitive electronic diary can significantly reduce patient burden and improve patient engagement and compliance. This in turn leads to improved data quality and study efficiency, meeting the needs of patients and of all of the stakeholders involved. When the CRF Health diary solution was tested by patients they expressed a preference for this integrated electronic diary over traditional paper and electronic reporting methods as they found it to be less burdensome, and given the option they would choose to use it in a clinical trial setting. Feedback received during the creation of this solution demonstrated the benefit of patient engagement in product design. The design of the TrialMax ® diary allows for the tailoring of the solution to meet specific study requirements. With integrated alarms and text message alerts to remind patients to fill in patient reported outcomes, the solution enhances engagement and compliance and with the removal of paper a reduction in errors and a higher data quality can be achieved. Conclusions Feedback from sponsors and previous studies identified the specific challenges associated with capturing patient data in diabetes populations. These included: An online survey was used to assess aspects of diabetes patients daily routines. The survey was completed by patients from a diabetes support group, with a wide mix of ages, sexes and type I and type II diabetes. This feedback was used to inform the design and layout of the initial diary in CRF Health‘s TrialMax Touch ® software for handheld devices. This alpha version of the solution was then tested in focus groups formed of members of a diabetes support group, providing hands-on user testing data. This feedback was used to update the content, design and layout of the diary. Once the diary had been refined it was sent to an independent third party for usability testing with diabetes patients. This feedback was analysed to test how suitable the tailored electronic diary was and to ensure it fit in with the daily routines of diabetic patients. The feedback was used to further refine the diary and a final round of testing was done to gather evidence that the intended population deemed the product intuitive and easy to use. CRF Health then used the lessons learned to generate best practices for capturing electronic Clinical Outcome Assessments (eCOA) in diabetes clinical trials. Methods Monitoring hypoglycaemic events Getting glucose readings from the glucometer into the diary Matching glucometer readings to meal times 1 2 3 USER EXPERIENCE "Actual data transfer process between the meter and the diary was very fast and easy" "The user interface flow was easy to navigate" 2 a b Figure 2. Reporting screens for blood glucose values in first iteration of diary design (2.a) and in the final product (2.b) 12 glucose readings transferred. Press ‘Next’ to report the bolded reading. Next Date/Time Blood glucose mmol/L 12:44 pm 7.3 20 May 13 11:56 am 4.8 02:59 pm 5.1 03:14 pm 6.1 06:03 pm 4.7 06:54 pm 9.3 Page 2/2 Report blood glucose values 2 new readings transferred. Press (>) to indicate your ‘before lunch’ reading. Transfer new readings Back No reading 2:47 PM 5.7 1:38 PM 4.2 12:31 PM 5.0 11:44 PM 4.0 9:15 AM 5.6 > > > > > Time New New mmol/L myglucohealth ™ Figure 1. Data transfer from MyGlucoHealth meter to the diabetes diary 1 Please wait for the glucose readings to be transferred. © 2015 CRF Health. All rights reserved. www.crfhealth.com Results Feedback from focus groups involving patients aged between 30-80 and usability studies with eight patients aged between 11-67 revealed the following key points: The importance of flexibility in the eDiary design when monitoring blood glucose (figure 1) Including batch and individual reporting, reporting hypoglycaemic events as part of a meal event or as a unique event Edit checks to identify if multiple low measurements relate to the same event 1 2 3 Testing also highlighted some key features and activities related to planning, design, testing and delivery that are important for successful integration of blood glucose measurements with eCOA data including: Providing clear guidance to patients on how to transfer measurements to the eDiary A method for managing control test measurements should be incorporated Handling and re-use of eDiaries previously used by patients doing fingerstick tests poses a low and acceptable risk 1 2 3 As a result of these findings the diary was redesigned from blood glucose measurement driven reporting to meal time/event driven reporting (figure 2). Following refinement of the solution usability tested by patients confirmed that “The user interface flow was easy to navigate”; and, “Actual data transfer process between the meter and the diary was very fast and easy”.
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Transcript of Poster: eCOA Best Practices in Diabetes Clinical Trials
INTEGRATING TECHNOLOGY INTO DIABETES CLINICAL TRIALSBEST PRACTICES FOR CAPTURING ELECTRONIC CLINICAL OUTCOME ASSESSMENTS
Jessica Thilaganathan, Karl McEvoy, Juha Matero, Olli Kotiranta, Katie Garner and Paul O’Donohoe. CRF Health, 229-243 Shepherds Bush Road, Hammersmith, London, W6 7AN, England
It is expected that by 2030 diabetes will be the 7th leading cause of death globally. For the 347 million people living with the disease, managing their condition can involve a variety of demanding tasks including taking regular measurements of blood glucose, monitoring the nutritional value of meals and tracking insulin usage. Diabetes clinical trials typically seek to capture this data, as well as expecting participants to complete a variety of additional patient reported outcomes, often while having to alter their normal, established routine to align with the study protocol. This increased complexity can lead to higher patient burden and risks lower compliance within the study. Our aim was to develop a robust and intuitive system for use in diabetes clinical trials to capture clinically relevant data, while documenting best practices for electronic data capture which would decrease patient burden while increasing compliance and improving data quality. CRF Health created a diabetes solution that not only catered to the clinical team and sponsors’ needs for accurate data collection but was also designed to be relevant to patient’s symptoms and typical daily routine, while limiting any additional burden to the patient.
Objectives
With an increasing amount of data being collected in diabetes trials, an intuitive electronic diary can significantly reduce patient burden and improve patient engagement and compliance. This in turn leads to improved data quality and study efficiency, meeting the needs of patients and of all of the stakeholders involved. When the CRF Health diary solution was tested by patients they expressed a preference for this integrated electronic diary over traditional paper and electronic reporting methods as they found it to be less burdensome, and given the option they would choose to use it in a clinical trial setting. Feedback received during the creation of this solution demonstrated the benefit of patient engagement in product design. The design of the TrialMax® diary allows for the tailoring of the solution to meet specific study requirements. With integrated alarms and text message alerts to remind patients to fill in patient reported outcomes, the solution enhances engagement and compliance and with the removal of paper a reduction in errors and a higher data quality can be achieved.
Conclusions
Feedback from sponsors and previous studies identified the specific challenges associated with capturing patient data in diabetes populations. These included:
An online survey was used to assess aspects of diabetes patients daily routines. The survey was completed by patients from a diabetes support group, with a wide mix of ages, sexes and type I and type II diabetes.
This feedback was used to inform the design and layout of the initial diary in CRF Health‘s TrialMax Touch® software for handheld devices. This alpha version of the solution was then tested in focus groups formed of members of a diabetes support group, providing hands-on user testing data. This feedback was used to update the content, design and layout of the diary.
Once the diary had been refined it was sent to an independent third party for usability testing with diabetes patients. This feedback was analysed to test how suitable the tailored electronic diary was and to ensure it fit in with the daily routines of diabetic patients. The feedback was used to further refine the diary and a final round of testing was done to gather evidence that the intended population deemed the product intuitive and easy to use. CRF Health then used the lessons learned to generate best practices for capturing electronic Clinical Outcome Assessments (eCOA) in diabetes clinical trials.
Methods
Monitoring hypoglycaemic events
Getting glucose readings from the glucometer into the diary
Matching glucometer readings to meal times
1
2
3
USER EXPERIENCE
"Actual datatransfer process
between the meter and the diary was very fast and easy"
"The user interface flow was easy to navigate"
2
a b
Figure 2. Reporting screens for blood glucose values in first iteration of
diary design (2.a) and in the final product (2.b)
12 glucose readings transferred. Press ‘Next’ to report the bolded reading.
Next
Date/TimeBlood glucose
mmol/L
12:44 pm 7.3
20 May 13
11:56 am 4.8
02:59 pm 5.103:14 pm 6.106:03 pm 4.706:54 pm 9.3
Page 2/2
Report blood glucose values
2 new readings transferred. Press (>) to indicate your ‘before
lunch’ reading.
Transfer new readings
Back No reading
2:47 PM 5.7
1:38 PM 4.2
12:31 PM 5.0
11:44 PM 4.0
9:15 AM 5.6
>
>
>
>
>
Time
New
New
mmol/L
myglucohealth™
Figure 1. Data transfer from
MyGlucoHealth meter to the
diabetes diary
1
Please wait for the glucose readings to
be transferred.
© 2015 CRF Health. All rights reserved. www.crfhealth.com
ResultsFeedback from focus groups involving patients aged between 30-80 and usability studies with eight patients aged between 11-67 revealed the following key points:
The importance of flexibility in the eDiary design when monitoring blood glucose (figure 1)
Including batch and individual reporting, reporting hypoglycaemic events as part of a meal event or as a unique event
Edit checks to identify if multiple low measurements relate to the same event
1
2
3
Testing also highlighted some key features and activities related to planning, design, testing and delivery that are important for successful integration of blood glucose measurements with eCOA data including:
Providing clear guidance to patients on how to transfer measurements to the eDiary
A method for managing control test measurements should be incorporated
Handling and re-use of eDiaries previously used by patients doing fingerstick tests poses a low and acceptable risk
1
2
3
As a result of these findings the diary was redesigned from blood glucose measurement driven reporting to meal time/event driven reporting (figure 2). Following refinement of the solution usability tested by patients confirmed that “The user interface flow was easy to navigate”; and, “Actual data transfer process between the meter and the diary was very fast and easy”.
