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Background and Aims: Nonalcoholic steatohepatitis (NASH) is a progressive form of fatty liver disease characterized by excessive liver fat accumulation, inflammation, cell injury and fibrosis. The aim was to explore the impact of NASH from the patients’ perspective and to determine the availability of suitable patient-reported outcome (PRO) scales for NASH adults. Methods: Searches conducted using PubMed (from 2006 to 2015) and grey literature identified key articles and patient-reported narratives occurring in social media/patient support forums. Areas of NASH-impact identified by the process were summarised and reviewed by medical experts and patient support group representatives (US/UK). Results: Published studies on patient-perceived NASH impact are scarce. Early stage NASH is often considered asymptomatic but chronic fatigue, malaise and right upper-quadrant abdominal discomfort related to hepatomegaly are reported; symptom impact increases with progressing fibrosis. Psychiatric assessments reveal significantly increased major depression disorder (MDD) and generalised anxiety disorder (GAD) for confirmed NASH patients compared to matched controls (MDD: p = 0.018; GAD p = 0.005). Confirmed NASH patients also have worse health-related quality of life (HRQOL) compared to fatty liver disease patients with no NASH on the Short Form–36 (SF-36) (physical health component scores: 44.5 NASH, 47.1 no-NASH p = 0.018; vitality scores: 44.4 NASH, 46.6 no-NASH, p = 0.043; bodily pain: 47.7 NASH, 50.0 no-NASH, p = 0.043; general health: 41.8 NASH, 44.2 no-NASH, p = 0.023); however, the SF-36 is a generic instrument not validated for NASH and is unlikely to address all issues relevant to NASH patients. No NASH-specific PRO instrument was identified by the current search. The social media review identified patient narratives presented on support group websites which reinforce the observation that NASH profoundly impacts many aspects of patients’ lives, including; ability to conduct day-to-day activities, personal and social relationships, and HRQOL. Clinical experts and patient representatives agreed that the review findings matched their views of the patient experience but noted that further qualitative work was needed with NASH patients. Conclusions: While NASH clearly impacts patients’ HRQOL, no PRO instrument has been developed based on patient insights. Clinical experts and patient representatives confirmed the need to develop a NASH-specific PRO measure based on patient and expert insights and FDA guidance.
