- Test for advancing but undiagnosed Fibrotic Liver Disease in a co-morbid population.
- Educate at risk patients about liver disease and lifestyle as a way to be healthier.
Introduce patients with active disease to clinical trial information and provide contact tools if requested
SUNN STUDY: Screening for Undiagnosed NAFLD and NASH
The official guideline for screening at risk patients for liver disease it not to screen absent symptoms.
Excerpts from the AASLD Practice Guidelines 2017:
- It can be argued that there should be systematic screening for NAFLD, at least among higher-risk individuals attending diabetes and obesity clinics.
- Screening for NAFLD in adults attending primary care clinics or high-risk groups attending diabetes or obesity clinics is not advised at this time due to uncertainties surrounding diagnostic tests and treatment options, along with lack of knowledge related to the long-term benefits and cost-effectiveness of screening.
Develop data to test the argument that the practice guidelines should be changed to support fibrosis screening in patients suffering from co-morbid conditions such as type 2 diabetes. Longer term, the objective is to deploy 400 screening centers nationwide seeking to identify asymptomatic fibrosis patients before symptoms manifest.
Liver stiffness will be tested with FibroScan on a low cost private pay to free basis and offered to at risk but undiagnosed people. Participants will be offered education about the test, liver disease, lifestyle, diet, and other useful information as part of the intake process and then will receive a FibroScan test. Upon completion of the test the patient will be given a copy of their test results with additional information about liver disease. They will be connected via telemedicine or through a personal visit with a medically qualified contact for a discussion of their results and will be counseled on appropriate follow-up.
The goals of the study will be to develop population incidence data, operational characteristics and barriers, and a cost analysis to guide the design of screening centers to be deployed nationally. These will be the basis for the education of the at risk population and the recruitment of clinical trial candidates who are found to have advancing but undiagnosed disease.