Completion rate and time analysis
of electronic quality of life measures

P-02Authors	Reina Davis-Aoki, M.S., Ph.D., Clinical Science Associate, eCOA Clinical Science and Consulting
Kelly Dumais, Ph.D., Director, eCOA Clinical Science and Consulting

Introduction
Quality of life (QoL) measures are critical to assess patients’ health in clinical trials. There has been increased regulatory attention on1
designing more patient-centric clinical trials , with emphasis on reducing the burden on patients to participate. One way to reduceburden is providing more convenient methods for collecting QoL measures, such as the use of electronic patient-reported outcomes(ePROs). We aimed to understand how electronically administered QoL measures are utilized in studies, including their completion timeand rate using metadata.

Methods
Participants completed assessments electronically on Clario Tablet devices at clinical trial sites. Operational data were extracted andanalyzed for four commonly used patient-reported QoL measures: EQ-5D-5L (five levels of severity), EQ-5D-3L (three levels of severity),
SF-36v2 Standard and SF-36v2 Acute.

Results
The sample included 116 studies across different therapeutic areas and phases, with 120,565 instances of completion status analyzed
for the four QoL measures.

Figure 1: Percentage of studies using each QoL measure
Independently, EQ-5D-5L was the most frequently used QoL
measure (in 64 studies), followed by EQ-5D-3L (in 20 studies),
then SF-36v2 Acute (in 10 studies), and finally SF-36v2 Acute(in seven studies). Some studies used different combinations of
EQ-5D and SF-36v2 versions (EQ-5D-5L + SF-36v2 Standard inseven studies, EQ-5D-3L + SF-36v2 Standard in six studies, andEQ-5D-5L + SF-36v2 Acute in two studies).

Figure 2. QoL measures used across therapeutic areas
The QoL measures used in the studies varied according to thetherapeutic area. For instance, EQ-5D-5L was most frequently
used in Oncology and Central Nervous System studies, whereas
EQ-5D-3L was predominantly used in Dermatology studies. Both
SF-36 assessments were most commonly used in Immunology
studies.

Figure 3. Mean Completion Rates and Number of Questions
The mean completion rates were 96.5% (EQ-5D-3L), 95.2% (EQ5D-5L), 96.1% (SF-36v2 Standard) and 99.0% (SF-36v2 Acute).
The number of questions in assessments had no correlation withthe completion rates.

Figure 4. Median vs Estimated Completion Time
The study specific median time for form completion was 65s for
EQ-5D-3L (range 17-114s), 80s for EQ-5D-5L (range 43-157s),
354s for SF-36v2 Standard (range 129-455s) and 384s for SF36v2 Acute (range 256-7840s). All assessments took less time tocomplete than the estimates. *The estimated completion times
for SF-36v2 and EQ-5D were derived by taking the mid-pointsof the range provided by Mapi Research Trust2 and Jin, X et al.,3
respectively.

Conclusions
Among the four QoL measures, EQ-5D-5L was the most frequently used. Different versions of EQ-5D and SF-36v2 were employed in various
combinations, with the choice of QoL measure varying for each therapeutic area.
Completion compliance was high for all tablet QoL measures regardless of completion time or number of questions. This suggests thatlonger QoL measures may not negatively impact compliance at site, and that electronic measures have benefits of yielding high complianceand enhanced data quality.
The analysis of instances where the assessments were completed at home was not feasible due to the limited sample size. Additional analysisof home-based assessments will determine any potential impact of location on compliance.

References
1. Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments, Draft Guidance,FDA, June 2022
2. SF-36 Health Survey (SF-36® / SF-36v2®) ePROVIDETM by Mapi Research Trust
3. Jin, X., Al Sayah, F., Ohinmaa, A., Marshall, D. A., Smith, C., & Johnson, J. A. (2019). The EQ-5D-5L Is Superior to the -3L Version in
Measuring Health-related Quality of Life in Patients Awaiting THA or TKA. Clinical orthopaedics and related research, 477(7), 1632–1644.
Disclosures: Authors are employees of Clario.