Challenges in Presenting Engagement Statistics in Real-World Digital Studies

Author(s)

Day L1, Lau J2, Quinn C2
1Vitaccess Ltd, SOUTHAMPTON, HAM, UK, 2Vitaccess Ltd, Oxford, UK

OBJECTIVES:

Missing or incomplete data present a common challenge for patient-reported outcome measures (PROMs) in real-world evidence (RWE), as well as an opportunity to better understand the data’s complexity. This review describes the challenges found in digital real-world studies, together with examples.

METHODS:

Descriptive statistics were used across four patient registries (in melanoma, Charcot-Marie-Tooth disease, myasthenia gravis, and cystic fibrosis) to parse and summarize attrition (leaving the study) and completion (remaining in the study but not providing complete data).

The different drivers of attrition and low completion rates are used to better understand missing data across registries. A detailed analysis is made of the Melanoma UK study as an example, and good-practice recommendations are provided for reporting on patient engagement and study performance with digital RWE.

RESULTS:

Across the four registries, profile surveys, which are presented at registration, generally have the highest completion rates. In the Melanoma UK study, the profile survey completion rate was 45%; completion rates for PROMs ranged from 40% to 57% at registration. Longitudinally, notional PROM completion rates at 6 and 12 months ranged from 14% to 16% and 8% to 10%, respectively.

Completion rates over time are heavily dependent on the chosen denominator. When only “active” participants – those who have completed data in the previous two months – are retained for analysis, adjusted PROM completion rates at 6 and 12 months ranged from 38% to 43% and 25% to 28%, respectively. This represents a 283% performance increase by capturing a 90% drop in the number of active participants.

CONCLUSIONS:

Missing data can be an issue across all RWE, particularly for patient-reported data; the data must be correctly interpreted to track participants’ retention and engagement, ensuring they continue to share high-quality data. The concepts of attrition and completion should be separated to better manage digital real-world studies.

Conference/Value in Health Info

2022-11, ISPOR Europe 2022, Vienna, Austria

Value in Health, Volume 25, Issue 12S (December 2022)

Code

MSR69

Topic

Methodological & Statistical Research, Patient-Centered Research

Topic Subcategory

Adherence, Persistence, & Compliance, Missing Data, Patient Engagement

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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