eCOA across age groups: enhancing clinical trials from pediatrics to geriatrics

Author: Jill V. Platko PhD, Vice President, Scientific Services 

Snapshot:

• Commonality Among Age Groups: From pediatrics to geriatrics, study participants benefit from well-designed user interfaces and comprehensive eCOA training. 

• Reliable Reporting is Crucial: While eCOA can be tailored for younger participants, sponsors must consider response validity when deciding who will report outcomes. 

• Adolescents often Less Compliant: Adolescents are often the least compliant group, requiring age specific questionnaires and compliance monitoring. 

• Older Adults Adapt Well: Older adults often experience no significant technical difficulties while reporting through eCOA, but may benefit from extended training.

Electronic Clinical Outcome Assessments (eCOA) have enhanced clinical trials, delivering improved accuracy and efficiency in data collection. Although the characteristics of great eCOA systems–that is, usability, simplicity, and accuracy--are important across demographic groups and therapeutic areas, there are some special considerations for how to implement eCOA systems when serving different populations.

This blog post delves into how eCOA can be used effectively to address the unique challenges of clinical trials involving pediatric, adolescent, and older adult participants.

eCOA in pediatric trials: Capturing young voices 

Pediatric clinical trials present unique challenges, particularly when it comes to capturing accurate and meaningful data from young participants. eCOA systems have proven valuable in this context, offering innovative data collection solutions to meet the needs of the trial.
 

Key considerations for pediatric COA use and eCOA implementations include: 

1. Who reports outcomes data?
   The first step in any pediatric study is to assess who should be responding to outcomes data collection assessments. And while we (mostly) love our children’s point of view, it’s not always appropriate to put them in the driver’s seat on outcomes reporting. As kids get older, their self-reported data generally becomes more reliable with higher validity, with potentially some exceptions for adolescent compliance (more on that below).
   
   ISPOR provides important guidance around developmental differences in children's ability to self-report health status across various age groups:¹
   
   
   
   
2. How to capture data from those populations?
   Once the determination of who should report outcomes data has been made, eCOA systems should incorporate age-specific questionnaires designed for children. For example, the Pediatric Quality of Life Inventory (PedsQL) provides different questionnaire versions tailored for different age groups, specifically designed so that the questions and data collection approach are developmentally appropriate
   
   This means that while the core concepts being assessed remain consistent, the specific wording, the actual questions, and who completes a questionnaire can differ across age brackets.²  This approach helps to deliver accurate data collection.
   
   
3. When is it recommended to involve parents?
   For very young children (ages 0-4), eCOA systems usually include what's known as caregiver functionality. This feature of eCOA systems allows for multiple observers to complete an Observer-Reported Outcomes (ObsRO) and facilitates attribution of that ObsRO.
   
   It's essential that the eCOA system can capture who is actually recording the data in these cases, because more than one parent or caregiver may report data on behalf of their children.³

One area of exploration in pediatric studies is the use of video-based assessments for capturing pediatric outcomes.⁴ These visual records may provide a less stressful and more objective account of a child's performance, potentially reducing biases associated with a clinic visit, and may expand access to studies by offering home-based assessments.

eCOA for adolescents: Navigating compliance challenges 

Adolescence is a critical period of development, but far from an easy one. In adolescent clinical trials, eCOA systems have shown potential in strengthening outcomes data collection, particularly in sensitive areas such as mental health. 

However, in what will be no surprise to any parent of a teenager, adolescents traditionally have the lowest eCOA compliance among all clinical trial populations. That’s where a strong eCOA system can be particularly useful, especially if the system includes: 

1. Compliance monitoring 
   Because adolescents often struggle to consistently complete their questionnaires and diaries, eCOA systems can provide a check for sites to monitor and follow-up on compliance, such as alerts when a questionnaire is missed.
   
   
2. Age-specific questionnaires
   There has been increasing effort to develop questionnaires that accurately measure outcomes from the patient (adolescent) perspective. One example of this is adolescent suicidality. Traditionally, adolescent suicidality has been assessed by a clinician or the adolescent’s parent. While this approach may yield higher compliance, it can create problems such as false positives, poor predictive validity, and an inability to capture symptom changes over time. 
   
   New research in medication-related suicide is developing and testing eCOA tools that can be completed by adolescent patients as well as clinicians. A study of the new tool, STOP-Medication-Related Suicidality Side Effects Scale (STOP-MS³), found acceptable inter-rater reliability between clinicians and adolescents using these tools.⁵ This suggests that well-designed eCOA tools can effectively capture accurate data on adolescent mental health.
    

eCOA in older adults: Surprising success and best practices 

Although the adolescents in our lives may not believe it, older adults generally demonstrate good compliance with eCOA and don't struggle significantly with technical proficiency. Anecdotally, older adults often show the second-highest level of eCOA compliance among age groups, surpassed only by new parents. 

eCOA systems themselves do not actually need to be designed differently for older adults. What older adults often do need is extended training time. Sites can allocate extra time for walking older participants through the system slowly and providing additional support, which could include in-person tutorials and an easily accessible helpdesk.⁶ 

Good practices for eCOA across age groups 

While each age presents unique challenges, there are common threads in eCOA implementation that span population groups: 

1. Training and technical support
   Regardless of age, all participants benefit from comprehensive training, which the FDA recommends and reviews for all trials.⁷ And, training participants to capture outcomes data is one of the most common experiences practitioners have with eCOA; in a recent Critical Path Institute survey, 82.1% of clinical trial site staff reported having experience training participants to capture eCOA data on provisioned devices.⁸
   
   
2. User experience and design
   Ensuring a positive user experience is crucial for all age groups, including clear and accessible navigation, visual design, and clear and concise instructions. For example, Suvoda's eCOA solution received high scores in usability testing with patients across ages and therapeutic areas.⁹  

Success in eCOA hinges on the ability to adapt and innovate while consistently prioritizing user experience. By embracing the challenges and opportunities presented by eCOA implementation across diverse age groups, we may be able to increase efficiency in clinical trial data collection, collect better data, and ultimately contribute to the development of better medications for patients who need them. 

Author

Jill V. Platko PhD
Vice President,
Scientific Services
Suvoda

CASE STUDY

Resources

1. Matza, Louis S., et al. “Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of the ISPOR pro Good Research Practices for the Assessment of Children and Adolescents Task Force.” Value in Health, vol. 16, no. 4, June 2013, pp. 461–479, https://doi.org/10.1016/j.jval.2013.04.004. 
   
   
2.  “Paediatric Quality of Life (PedsQL).”. Child Outcomes Research Consortium. https://www.corc.uk.net/outcome-experience-measures/paediatric-quality-of-life-pedsql/.
   
   
3. Matza, Louis S., et al. “Pediatric Patient-Reported Outcome Instruments for Research to Support Medical Product Labeling: Report of the ISPOR pro Good Research Practices for the Assessment of Children and Adolescents Task Force.” Value in Health, vol. 16, no. 4, June 2013, pp. 461–479, https://doi.org/10.1016/j.jval.2013.04.004. 
   
   
4.  Elisa Ferrer-Mallol et al., “Video-based Assessments of Activities of Daily Living: Generating Real-world Evidence in Pediatric Rare Diseases,” Expert Review of Pharmacoeconomics & Outcomes Research 24, no. 6 (June 7, 2024): 713–21, https://doi.org/10.1080/14737167.2024.2360201. 
   
   
5.  Paramala Santosh et al., "Suicidality Treatment Occurring in Paediatrics (STOP) Medication Suicidality Side Effects Scale in Young People in Two Cohorts Across Europe," BMJ Open 12, no. 5 (2022): e068140, https://doi.org/10.1136/bmjopen-2022-068140. 
   
   
6. Katie Garner and Bill Byrom, “Attitudes of Older People/Seniors to Completion of Electronic Patient-reported Outcome Measures and Use of Mobile Applications in Clinical Trials: Results of a Qualitative Research Study,” Journal of Comparative Effectiveness Research 9, no. 4 (March 1, 2020): 307–15, https://doi.org/10.2217/cer-2019-0155.  
   
   
7. Center for Drug Evaluation and Research, “Patient-Reported Outcome Measures: Use in Medical Product Development,” U.S. Food and Drug Administration, December 2009, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims. 
   
   
8.  Estelle Haenel et al., “Flexible Approaches to eCOA Administration in Clinical Trials: The Site Perspective,” Contemporary Clinical Trials Communications 37 (February 1, 2024): 101241, https://doi.org/10.1016/j.conctc.2023.101241. 
   
   
9.  "Suvoda Ecoa Earns High Marks in Patient Usability Study." PR Newswire, September 17, 2024. https://www.prnewswire.co.uk/news-releases/suvoda-ecoa-earns-high-marks-in-patient-usability-study-301980610.html.