Surfing the MASH Tsunami

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SurfingNASH is offering something different for Season 4, Episode 37 while the co-hosts are off enjoying a well-deserved holiday amid a busy year. Rather than leaving a gap in the podcast's program, this week we are revisiting an episode From the Vault that, now more than ever, maintains its relevance. As the field grapples with new nomenclature for liver disease and the imminence of therapeutic approvals, education and educational resources are critically needed. This session, led by Louise Campbell, focuses on the roles that allied health can play in prevention, early stage management and clinical trial recruitment for NAFLD/NASH. Allied health is our primary interface for the education and support within the clinical setting of patients with any disease. Allied health professionals are a vastly experienced resource supporting both physicians and patients in the delivery of care and efficacy. Stephen Harrison also joins Louise and guest panelists (Kathryn Jack, Michele Clayton, Pam O’Donoghue and Patrizia Kunzler) to consider the many ways that liver nurses and advanced nursing practitioners can do more to support NASH education and patient management and where they should fit into the paradigm. In this conversation, we meet the four key nursing opinion leaders who have joined Louise and Stephen and learn about the broad sets of skills and experiences each brings to the table. At the start of the episode, Stephen responds to a question that a patient e-mailed to SurfingNASH.com during the previous week.

If you have questions or comments around our From the Vault series, allied health, education or any other ideas addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

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SurfingNASH is offering something different for Season 4, Episode 37 while the co-hosts are off enjoying a well-deserved holiday amid a busy year. Rather than leaving a gap in the podcast's program, this week we are revisiting an episode From the Vault that, now more than ever, maintains its relevance. As the field grapples with new nomenclature for liver disease and the imminence of therapeutic approvals, education and educational resources are critically needed. This session, led by Louise Campbell, focuses on the roles that allied health can play in prevention, early stage management and clinical trial recruitment for NAFLD/NASH. Allied health is our primary interface for the education and support within the clinical setting of patients with any disease. Allied health are a vastly experienced resource supporting both physicians and patients in the delivery of care and efficacy. Stephen Harrison also joins Louise and guest panelists (Kathryn Jack, Michele Clayton, Pam O’Donoghue and Patrizia Kunzler) to consider the many ways that liver nurses and advanced nursing practitioners can do more to support NASH education and patient management and where they should fit into the paradigm. Listen on to learn more about how the Fatty Liver community can make the best use of these talented and knowledgeable resources.

If you have questions or comments around our From the Vault series, allied health, education or any other ideas addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected]. 

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One of the most important challenges facing Fatty Liver stakeholders involves improving early diagnosis for patients with clinically relevant or advanced fibrosis (F2/3). Today, a significant percentage of patients learn they are living with cirrhosis in the Emergency Department during a decompensating event. Four in ten of these patients in the UK do not leave the hospital. Episode 39 reviewed a model that Ian Rowe and Richard Parker developed to determine the most cost-effective strategy for F2/3 diagnosis.

This conversation From the Vault centers around challenges related to early diagnosis and NASH Patient Management. As Roger Green notes, listeners to NASH Tsunami might recall a significant number of conversations in which patients and advocates complain about doctors telling them “not to worry” about their Fatty Livers for years until the condition progresses to cirrhosis. Louise Campbell focuses on a different challenge: that of NASH patient management when patients are dealing with other metabolic diseases that are better known or where approved treatments exist.

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Co-hosts Louise Campbell and Roger Green are joined by friend of the podcast, Naim Alkhouri, and new guest, Professor James O’Beirne, to discuss learning from liver disease in Australia and developing improved models for patient identification and risk stratification.

This final conversation starts with Roger discussing the idea that upscaling training is very important. Louise follows up with a comment that we must remember these are complicated technologies to use and that dedication to training is pivotal in optimizing their potential. After a digression to consider the size of the indigenous candidates in the study, the group moves onto a final question. James shares what comes next in the study and the other panelists comment on what can be taken away from this discussion in terms of improving screening or cost effectiveness.

If you have questions or comments around the LOCATE-NAFLD study or any other ideas addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

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Co-hosts Louise Campbell and Roger Green are joined by friend of the podcast, Naim Alkhouri, and new guest, Professor James O’Beirne, to discuss learning from liver disease in Australia and developing improved models for patient identification and risk stratification.

This conversation focuses largely on funding, starting with Louise’s question about Medicare payment for patients in Australia. James notes that all care was free to patients, and that this might skew results. As the conversation continues, Louise notes the importance for Australians of having Australian data to use in valuing medicines, diagnostics and procedures, given that NICE analyses rely exclusively on UK data. She goes on to ask about the quality of referrals from primary care, which prompts James to note that some primary care practitioners provided better data and novel referrals, while others appeared overwhelmed by the data. Roger asks the group how geographic dispersion will affect referrals as hepatologists push into primary care relationships. James suggests that geography is a challenge, leading Naim to comment that an inexpensive, hand-held device will be pivotal to mass screenings and that blood tests should be part of the mass screening armamentarium. James, followed by Louise, replies that nurses and some practitioners see imaging as a therapeutic event and an opportunity to engage the patient in a discussion of their numbers and how to improve lifestyles. As the conversation winds down, James and Naim discuss concerns around consistency of reads, and Louise, then Naim, provide tips on how to get a more accurate measurement.

If you have questions or comments around the LOCATE-NAFLD study or any other ideas addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

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Co-hosts Louise Campbell and Roger Green are joined by friend of the podcast, Naim Alkhouri, and new guest, Professor James O’Beirne, to discuss learning from liver disease in Australia and developing improved models for patient identification and risk stratification.

This conversation starts with Louise discussing some of the improvements in patient motivation and compliance as a result of FibroScan when administered in specialty sites. From here Roger asks Louise and James how they envision practical implementation of this kind of study design in other countries. Louise speculates on how this might work in 3rd world countries where there are large distances between communities and concludes it is quite feasible when dieticians and other allied professionals are empowered and can conduct scans. Naim discusses the extensive free-scan program that Arizona Liver Health offers which is typically focused on patients with type 2 diabetes, obesity and other risk factors. James notes that one element of the design is that it can provide cost analysis to demonstrate cost effectiveness and generate public funding in single-payer countries. Naim identifies limitations in the design and ways these might be ameliorated over time. As the conversation closes, James suggests that one cost saving might come from reducing treatment for patients who do not have high risk of disease.

If you have questions or comments around the LOCATE-NAFLD study or any other ideas addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

Stay Safe and Surf On!

Send us Fan Mail

Co-hosts Louise Campbell and Roger Green are joined by friend of the podcast, Naim Alkhouri, and new guest, Professor James O’Beirne, to discuss learning from liver disease in Australia and developing improved models for patient identification and risk stratification.

This conversation proceeds from a high-level overview of the LOCATE-NAFLD study. Discussion opens to comments from the panelists, starting with Naim commending the basic idea of a randomized study and the sample size for this initiative. He goes on to ruminate on how effective this design will be at correctly assessing positive and negative predictive values. James describes some of the funding and regulatory issues that shaped the design. As the conversation continues, it becomes clear that the median times to referral in the intervention and control groups were dramatically different and that these differences will have real clinical impact in a world with approved NASH agents. Louise raises the point that this kind of model can speed access to trial tremendously. James shares ideas around what motivated patients to enroll in the study and explains that significant numbers of patients screened out, most often due to high levels of alcohol consumption. As the conversation winds down, James mentions two interesting pieces of data from early analysis: a significant and clinically meaningful differences between successful FibroScan reads in the two groups and, separately, the lack of separation between the groups in quality of life scores.

If you have questions or comments around the LOCATE-NAFLD study or any other ideas addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

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Co-hosts Louise Campbell and Roger Green are joined by friend of the podcast, Naim Alkhouri, and new guest, Professor James O’Beirne, to discuss learning from liver disease in Australia and developing improved models for patient identification and risk stratification.

This conversation starts with an introduction to James both personally and professionally. A Consultant Hepatologist at the Sunshine Coast University Hospital, James describes how he came to his work and interests around risk stratification in liver disease, particularly in NAFLD, hepatocellular carcinoma and portal hypertension. From here Louise shares a bit about why she feels the LOCATE-NAFLD study is compelling and well-worth an investigation on the podcast. Among her notes, Louise praises the study for its integration and comparison of different pathways and outcomes. At the bottom of the session, James provides a high-level overview of the study:

Rationale
NAFLD is the most common type of chronic liver disease in Australia. NAFLD is associated with a reduction in health-related quality of life, and as the number of NAFLD cases increase, the health system will incur increased costs associated with its diagnosis, management and disease progression. Currently, many patients who present to primary care with abnormal liver function tests or steatosis on liver ultrasound are referred for assessment in secondary care. Due to the large number of patients with NAFLD, this results in long waits for clinical and fibrosis assessment, placing unnecessary burden on the public hospital system. The study proposes to introduce better and faster assessment and stratification of patients in the community. As a result, the study aims to significantly reduce referrals for hospital-based appointments, and improve surveillance of high-risk disease, resulting in enhanced management of complications that result in avoidable, high cost admissions.

Study Design
The LOCATE-NAFLD study is a 1:1 parallel randomized trial to compare two alternative models of care for NAFLD (usual care versus LOCATE-NAFLD).

Usual care group

• Patients will attend a specialist hepatology clinic for their care.

LOCATE-NAFLD group

• Patients will be assessed by a specialist study nurse in the primary care setting, such as local general practice clinic.
• The specialist nurse will assess patients using mobile transient elastography, using a FibroScan machine.
• Scan results will be reviewed by the specialist nurse and hepatologist
• Patients with low levels of liver scarring will be referred back to their GP for care
• Patients with high levels of liver scarring will be followed up in secondary care hepatology clinics

Quality of life will be assessed for all patients at baseline and at 12-month follow-up via a questionnaire. The study will analyse intervention costs, hospital outpatient clinic utilization, hospital admissions, hospital costs and patient death data.

If you have questions or comments around the LOCATE-NAFLD study or any other ideas addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

Stay Safe and Surf On!

Send us Fan Mail

Co-hosts Louise Campbell and Roger Green are joined by friend of the podcast, Naim Alkhouri, and new guest, Professor James O’Beirne, to discuss liver disease in Australia and developing improved models for patient identification and risk stratification.

James , a Consultant Hepatologist at the Sunshine Coast University Hospital, shares his professional background and introduces events which lead to the LOCATE-NAFLD study. After Australia became the first country to allow access to direct-acting antiviral agents for HCV in 2016, there was the strong need to determine which patients were cirrhotic. With relatively unprepared primary care providers, specialist and hospital care were inundated with referrals. In response, James contributed to the inception of a mobile FibroScan program to deliver scans, assessments and treatment recommendations to community health clinics and GP practices. The program was very successful and it was decided that data should be published followed by an economic analysis to demonstrate how this was an effective model of democratizing access to risk stratification. As it was later sought to be applied to different disease areas, the LOCATE-NAFLD project was born. James outlines the parameters which can be read in a succinct overview here:

The LOCATE-NAFLD study is a 1:1 parallel randomized trial to compare two alternative models of care for NAFLD (usual care versus LOCATE-NAFLD).

Usual care group

• Patients will attend a specialist hepatology clinic for their care.

LOCATE-NAFLD group

• Patients will be assessed by a specialist study nurse in the primary care setting, such as local general practice clinic.
• The specialist nurse will assess patients using mobile transient elastography, using a FibroScan machine.
• Scan results will be reviewed by the specialist nurse and hepatologist
• Patients with low levels of liver scarring will be referred back to their GP for care
• Patients with high levels of liver scarring will be followed up in secondary care hepatology clinics

Quality of life will be assessed for all patients at baseline and at 12-month follow-up via a questionnaire. The study will analyse intervention costs, hospital outpatient clinic utilization, hospital admissions, hospital costs and patient death data.

From here the conversation opens to comments from the other panelists and Naim commends that this effort is being studied in a randomized trial and goes on to ask questions around protocol. Louise discusses the impact conducting FibroScan has on mediating patient behavior and the potential reach this sort of model has as she considers empowering the likes of dieticians and other skilled practitioners. Roger introduces ideas around extrapolating these insights for use in countries outside of Australia and goes on to discuss clinical care pathways and what motivating frontline treaters looks like both in the absence and presence of approved medications. Naim shares his experiences venturing into Arizona with mobile FibroScan consultations, mostly focused on patients with type 2 diabetes, obesity and other risk factors. The second half of the conversation touches more on economic analysis and the impact of improving technology on delivering more consistent results for scans. For final question, Roger prods James for what's next in this story and asks Louise and Naim what about this conversation influences their work and respective locations today.

If you have questions or comments around the LOCATE-NAFLD study or any other ideas addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

Stay Safe and Surf On

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The wider community of liver stakeholders witnessed an exciting July as new compelling data and presentations were revealed across two major meetings, EASL Congress and the American Diabetes Association Scientific Sessions. Throughout that month, SurfingNASH provided real-time coverage and review of the emerging stories spanning topics like drug development, new nomenclature, omics and AI, NITs and more. For this episode the trio of co-hosts, Jörn Schattenberg, Louise Campbell and Roger Green, embark on their first exclusive discussion together in a while without any guest panelists. The overarching theme of the program observes what has made 2023 interesting and exciting thus far before offering a look into what the audience can expect to learn more about in the imminent months.

This conversation focuses largely on the episodes we have planned for the next couple of months. It starts with Louise discussing episodes she will be potentially leading in August while Jörn and then Roger go off on holiday. The group goes on to offer a glimpse into other items expected to be covered later in the year. If you want to learn more about what you can soon expect from this podcast, listen on.

Reviewing this episode and the various conversations is a strong reminder of how much information has already become available this year and what it portends in terms of future episodes and an ever-increasing explosion of new information about liver disease, drugs, testing, and so much more. If you have questions or comments around the EASL Congress or ADA meetings, the discussed therapeutics, new nomenclature, or any other topic addressed in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at [email protected].

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