MON-701 - Outcomes Inventory for Self-Reported Symptoms at Enrollment in Severe Hypertriglyceridemia (Shtg) Populations in A Mobile App-Based Observational Study

Background/Synopsis – sHTG, defined by severely elevated triglycerides (TG; ≥500 mg/dL) , affects approximately 1-2% of US adults, with 0.3% of US adults having TG ≥880 mg/dL. Individuals with sHTG are at high risk for complications (e.g., acute pancreatitis) especially those with TG ≥880 mg/dL- and all may experience symptoms that impact their daily lives and emotional well-being; however, evidence on the latter is sparse. The meTriG study explores the impact of sHTG on day-to-day symptom burden and health-related quality of life (HRQoL), alongside real-world treatment utilization.
Objective/Purpose – To comprehensively examine the self-reporting of symptoms and symptom severity of individuals with elevated TG, stratified by TG level in a real-world setting (i.e., meTriG study), and the degree of coverage with domains captured in patient-reported outcomes (PROs).
Methods – This 6-month, prospective observational study enrolled 183 US-based adults with sHTG. Study activities are conducted remotely in the Folia Health® app through self-tracking of home-reported outcomes (HROs; i.e., participants’ self-identified symptoms). HROs responses were ranked on a Likert-like scale (0 “did not experience”, to 5 “severe”). At enrollment, participants report baseline health, select symptoms for routine tracking, and complete a survey to collect additional HRQoL data using electronic PROs (e.g., EQ-5D-5L, PROMIS®). PROs collectively measured 13 domains (EQ-5D-5L: mobility, self-care, usual activities, pain/discomfort, anxiety/depression; PROMIS: fatigue, depression, anxiety, sleep disturbance, cognitive function, physical function, pain interference, pain intensity, and social function). Study participants are categorized into two groups based on TG level at enrollment (A: 500-879 mg/dL, B: ≥880 mg/dL).
Results – Participants selected 63 symptoms across 17 domains at baseline. Group A (n= 124) selected 58 symptoms (17 domains), with an average severity of 2.83 (SD= 0.96). Group B (n= 59) selected 24 symptoms (11 domains), with an average severity of 2.87 (1.04). The proportion of participants reporting symptom-free was 19% in Group A, and 12% in Group B. Cognitive symptoms (i.e., difficulty remembering things), anxiety, and fatigue were the most tracked symptom domains across both groups.
All PRO domains were reflected in HRO tracking data. Participants' HRO tracking captured an additional 8 domains (including gastrointestinal, dermatological, ophthalmologic, urinary, neurological, endocrine/metabolic, cardiovascular, musculoskeletal).
Conclusion – Integrating HROs with PRO administration allows for a comprehensive, patient-centered evaluation of disease burden and highlights additional symptoms and quality of life impacts, otherwise not measured that are experienced by individuals with sHTG.

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