studies

926A AASLD ABSTRACTS HEPATOLOGY, October, 2015
included. 132 (85%) underwent additional HVPG measurements.
Hepatic decompensation (ascites, HE, jaundice) and
mortality was recorded during follow-up. Results: Baseline
characteristics: age: 52±11years, 73% male, main etiologies:
47.7% viral, 31% ALD, 21.3% others. Median TE values were
29.1kPa (11.3-75). Mean HVPG was:15±6.5mmHg. Median
follow up was 967 days(89.2-1609.2). In total 56/155
patients decompensated or died during follow up. Hepatic
decompensation or death occurred significantly more often in
patients with TE>20kPa: 49/106 (46.2%) than in patients with
TE20kPa is an independent risk factor
for decompensation or mortality in ACLD patients. Considering
that numbers of ACLD patients with TE150G/L are low, still around 50% showed varices – not
supporting the Baveno VI recommendation to avoid screening
endoscopy in this constellation. The 20kPa stratification strategy
should be prospectively evaluated in larger cohorts.
Disclosures:
Thomas Reiberger - Consulting: Xtuit; Grant/Research Support: Roche, Gilead,
MSD, Phenex; Speaking and Teaching: Roche, Gilead, MSD
Mattias Mandorfer - Consulting: Janssen; Speaking and Teaching: AbbVie, Gilead,
Janssen, Boehringer Ingelheim, Bristol-Myers Squibb, Roche
Michael Trauner - Advisory Committees or Review Panels: MSD, Janssen, Gilead,
Abbvie; Consulting: Phenex; Grant/Research Support: Intercept, Falk Pharma,
Albireo; Patent Held/Filed: Med Uni Graz (norUDCA); Speaking and Teaching:
Falk Foundation, Roche, Gilead
Markus Peck-Radosavljevic - Advisory Committees or Review Panels: Bayer, Gilead,
Janssen, BMS, AbbVie; Consulting: Bayer, Boehringer-Ingelheim, Jennerex,
Eli Lilly, AbbVie; Grant/Research Support: Bayer, Roche, Gilead, MSD, AbbVie;
Speaking and Teaching: Bayer, Roche, Gilead, MSD, Eli Lilly, AbbVie, Bayer
The following authors have nothing to disclose: Rafael Paternostro, Monika Ferlitsch,
Alexandra Etschmaier, Remy Schwarzer, Arnulf Ferlitsch
1467
Development of an Electronic Diary (E-Diary) for Caregivers
(CG) of Patients with Overt Hepatic Encephalopathy
(OHE)
R Todd Frederick 1 , Marwan Ghabril 2 , Karin Coyne 3 , Mary Kay
Margolis 3,4 , Michael Santoro 5 , Dion F. Coakley 5 , Masoud Mokhtarani
5 , Bruce F. Scharschmidt 5 , Marzena Jurek 5 ; 1 California Pacific
Medical Center, San Francisco, CA; 2 Indiana University, Indianapolis,
IN; 3 Evidera, Bethesda, MD; 4 Patient-Centered Outcomes
Research Institute (PCORI), Washington, DC; 5 Horizon Therapeutics
(formerly Hyperion Therapeutics, Inc.), Brisbane, CA
Care of patients with OHE requires education and involvement
of the CG, as most episodes occur outside of the hospital or
clinic. However, some CG may try to manage the episodes
without informing or receiving input from the medical provider.
Moreover, lack of systematic patient evaluation and/or communication
with the provider by CG may hinder identification of
OHE episodes in clinical practice and represents a challenge
in the design and interpretation of OHE endpoints in clinical
trials. Study Design: A 3 part approach was used to develop a
daily e-diary for CG of OHE patients. Part 1 was conducted at
2 clinical sites and included concept elicitation, i.e. interviews
with 12 CG who had cared for a patient with OHE within the
last three months, to determine the signs and symptoms CG use
to identify OHE. In Part 2, a daily e-diary for CG was developed
that included questions with branching logic and skip
patterns for standardized feedback, automatic reminders for
completion, and real time alerts sent to the site if CG answers
were suggestive of OHE. This e-diary was evaluated for comprehensiveness
and understandability by 10 CG in semi-structured
interviews. Part 3 was a 3-day field test among 10 CG
to assess real-world usability on their own devices. The final
e-diary was translated and culturally adapted with CG input
into 16 languages. Results: Part 1 CG collectively described
33 different HE-related symptoms experienced by the patients
they cared for. Forgetfulness/confusion and sleep difficulties
(e.g., day-night inversion) were reported by all CG; most also
described speech problems (difficulty finding words [92%] or
repeating words or phrases [50%]). No one symptom emerged
as most important and most CG (83%) reported that they did
not contact a physician unless there was progression or non-resolution
of OHE symptoms. Part 2 interviews identified 7 items
(speech difficulties, unusual behavior, forgetfulness/confusion,
orientation, and level of consciousness), which adequately and
comprehensively captured what CG observe and monitor at
home and that the e-format was user friendly. Part 3 confirmed
the usability of the e-diary on the CG’ personal devices, including
web-enabled smart phones (iPhone, Android), laptop, and
desktop computers. Conclusion: A comprehensive, easy to
use CG e-diary was developed for use in clinical trials of OHE
and in clinical practice. Real time communication with health
care providers and standardized evaluation of manifestations
of OHE by CG will improve documentation of endpoints in
trials of OHE and may lead to earlier medical intervention and
improved patient outcomes in clinical practice.
Disclosures:
R Todd Frederick - Advisory Committees or Review Panels: Gilead, Bristol Myers
Squibb, Salix, Vital Therapies, Hyperion, AbbVie
Marwan Ghabril - Grant/Research Support: Salix
Karin Coyne - Consulting: Evidera
Michael Santoro - Employment: Horizon Therapeutics, Inc.
Dion F. Coakley - Employment: Horizon Therapeutics
Masoud Mokhtarani - Employment: Hyperion; Stock Shareholder: Hyperion
Marzena Jurek - Employment: Horizon Therapeutics, Inc.
The following authors have nothing to disclose: Mary Kay Margolis, Bruce F.
Scharschmidt
1468
Muscle mass in liver transplant candidates: From the Fitness,
Life Enhancement, and Exercise in Transplantation
(FLEXIT) Consortium
Jennifer C. Lai 1 , Elizabeth J. Carey 2 , Connie W. Wang 1 , Srinivasan
Dasarathy 3 , Michael A. Dunn 4 ; 1 UCSF, San Francisco, CA;
2 Mayo Clinic Arizona, Scottsdale, AZ; 3 Cleveland Clinic, Cleveland,
OH; 4 University of Pittsburgh, Pittsburgh, PA
Background: Sarcopenia, frailty, and deconditioning are distinct
terms for anatomic and functional disturbances related to
muscle wasting, a frequent and often lethal manifestation of
advanced cirrhosis. We hypothesized that sarcopenia measured
on cross sectional imaging as an indicator of muscle
wasting could be consistently evaluated as a common parameter,
and that its clinical significance in liver transplant candidates
from multiple centers would confirm earlier single-center