dysfunction and cirrhosis.1 At pres

dysfunction and cirrhosis.1 At present, there are no licencedpharmacological therapies for NASH and so managementfocusses on lifestyle modification to achieve weight loss by dietand exercise. Although prior to hepatic decompensation, NAFLD/NASH is generally considered asymptomatic, this dogma isincreasingly being brought into question.69,70 A holistic approachto patient care implies a need for clinicians to appreciate thewider consequences of a NASH diagnosis, including how itspsychosocial and symptom burden impacts on HRQoL and theability of patients to make substantive lifestyle changes, evenprior to hepatic decompensation. Such knowledge, objectivelymeasured, not only informs our understanding of the livedexperience of the disease but allows the impact of novel therapies on HRQoL to be measured; addressing the first tenant of theFDA’s patient-focussed drug development, that treatment mustbenefit how patients “feel, function and survive”.11 The aim ofthis review was firstly, to identify humanistic burden of diseasein patients with diagnosed NASH and compensated cirrhosis, andsecondly, to identify which instruments, generic or diseasespecific PROMs have been used to assess the impact of NASHcirrhosis and have sufficient evidence to render them suitablefor use in support of regulatory label claims