Medically Tailored Meals for Patients With Cirrhosis and Hepatic Encephalopathy: The BRAINFOOD Proof-of-concept Trial.

Background and aims: Guidelines recommend that patients with hepatic encephalopathy (HE) receive a high-protein diet (roughly 1 g/kg actual body weight). Concommitant sodium restriction, low health literacy, and food insecurity limit patients' ability to meet this goal. We aimed to determine the feasibility of home-delivered high-protein medically tailored meals (MTMs) for patients with a recent episode of overt HE. Methods: We enrolled patients with prior overt HE on active HE therapy in a 6-month trial of MTM. All received 21 home-delivered meals/week with protein snacks (mid-day and bedtime) for 12 weeks. Patients completed follow-up at week 24. The primary outcome was feasibility. Additional outcomes included change in protein and micronutrient intake (measured using 24 h dietary recalls performed by dieticians), cognitive function (Animal Naming Test [ANT]; EncephalApp Stroop), physical function (Liver Frailty Index [LFI]), and quality of life (Short Form-8 Health Survey [SF-8]). Healthcare utilization was also assessed. Results: Ten patients competed the study with >90% of MTM consumed. Protein intake rose from 74.6 ± 25.1 g at baseline to 93.8 ± 24.3 g on MTM (P = 0.04). Branched-chain amino acids also increased-valine 3.73 ± 1.26 g to 5.17 ± 1.28 g, isoleucine 3.32 ± 1.18 to 4.69 ± 1.55, leucine 5.83 ± 2.00 to 7.49 ± 2.07, all P < 0.001. The LFI score improved from 4.42 ± 0.32 to 3.96 ± 0.82 by the end of the MTM phase (P = 0.03). SF-8 quality-of-life scores improved from 55.5 ± 15.5 at baseline to 64.7 ± 18.3 after the MTM phase, to 64.4 ± 19.1 at the end of the study (P = 0.1). EncephalApp Stroop time improved from 227 ± 94 to 194 ± 58s by the end of the MTM phase (P = 0.08). ANT scores were similarly non-significantly improved. Conclusion: Home-delivered MTMs are feasible, increase protein consumption, and may improve patient wellbeing. A randomized trial is needed.

CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis.

BACKGROUND: Patient caregivers experience burden and distress that negatively impacts health-related quality of life (HRQOL). Mindfulness may alleviate caregiver burden but randomized trials of mindfulness activities on caregiver burden and distress are lacking. METHODS: Caregivers for patients with advanced liver disease were recruited from the Universities of Michigan and Pennsylvania (12/2019-12/2021) and followed for 8 weeks. Participants were randomized 1:1:1 to: written emotional disclosure for 4 weeks, resilience training for 4 weeks, or control (no active intervention). All completed assessments at baseline, week 4 and 8. The primary outcome was change in the Zarit Caregiver Burden Index-12 (ZBI) at week 8. Secondary outcomes included changes at week 4 and 8 in the ZBI, distress thermometer (DT), HRQOL visual analog scale (VAS), and caregiver captivity index (CCI). RESULTS: Eighty seven caregivers were enrolled, 59(72%) completed the study. In unadjusted analyses at week 4, the burden measured by ZBI was not significantly different between arms, increasing by 0.6 ± 5.7 and 2.5 ± 5.2 points, for the written emotional disclosure and resilience training study arms, respectively, and by 2.9 ± 6.1 points in the control arm. At week 8, the non-significant ZBI change was - 1.0 ± 8.9, 2.8 ± 6.1, and 1.5 ± 7.4 for written emotional disclosure, resilience training, at week 8, respectively. The DT and VAS worsened in all arms, however, it worsened the least in the written emotional disclosure arm. In analyses adjusted for differences in baseline characteristics, the ZBI declined by - 4.21 ± 2.03(p = 0.04) in the emotional disclosure arm at week 4. This decrease was attenuated week 8, - 1.13 ± 2.6(p = 0.67). There were no significant differences in secondary outcomes save for resilience training reducing the CCI at week 4 by 1.36 ± 0.67(p = 0.04). CONCLUSION: Written emotional disclosure may reduce caregiver burden in the short term among caregivers for patients with cirrhosis. REGISTRATION: NCT04205396.

Predicting which patients with cirrhosis will develop overt hepatic encephalopathy: Beyond psychometric testing.

It remains challenging to identify covert hepatic encephalopathy and predict progression to overt hepatic encephalopathy. Psychometric testing is a widely used diagnostic modality, but it is often inaccurate and difficult to implement in diverse populations, making it a less than ideal assessment. Alternatively, by using easily accessible data from the electronic health record, simple clinical assessment tools, and patient-reported outcomes, we may be better able to predict hepatic encephalopathy across multiple populations. Furthermore, incorporation of patient-reported outcomes into our diagnostic toolset not only aids detection of covert hepatic encephalopathy and prediction of overt hepatic encephalopathy, but also allows us to target therapies and track their impact. Herein, we outline a potential algorithm based on these easily integrated tools to promote patient risk-stratification and early therapeutic intervention.

Falls are an underappreciated driver of morbidity and mortality in cirrhosis.

Content available: Author Interview and Audio Recording.

The emotional burden of caregiving for patients with cirrhosis.

Caregivers for patients with cirrhosis face immense physical and psychological strain that negatively impact quality of life and ability to care for oneself. The aim is to explore the caregiver experience for patients with cirrhosis, identify prominent stressors, and understand the multidimensional contributors to caregiver burden, to help tailor effective interventions. The caregivers of 25 patients with decompensated cirrhosis underwent semistructured in-person interviews and completed written exercises targeting emotional disclosure or resilience training that were analyzed for dominant emotions and themes. Burden was quantified using the Zarit Burden Interview-12 (ZBI, range 0-48), Distress Thermometer (0-10), and Caregiver Captivity Index (0-4). Quality of life was assessed with a visual analog scale (0-100). Median ZBI was moderate (14 [10-19]), as was distress (5 [2-7]), and captivity (2 [1-4]). Quality of life was fair (80 [70-85]). Dominant emotions included anxiety, guilt, fear, frustration, captivity, and resentment. Prominent themes included lack of time for self-care, hierarchy of caregiver role, support from versus frustration with medical professionals, social support, spirituality and religion, and disease-related restrictions. Hepatic encephalopathy, and need to follow strict nutrition and diet recommendations, are frequent sources of disease-related caregiver burden. The health care system confers some degree of burden, especially when doubts arise regarding physician competence. Conclusion: Caregiver burden is significant. The impact of interventions to alleviate caregiver burden should be explored, so that their appreciated efforts do not have such detrimental effects on their quality of life.

The incidence and outcome of postoperative hepatic encephalopathy in patients with cirrhosis.

BACKGROUND: Cirrhosis is associated with increased perioperative risks related to hepatic decompensation. However, data are lacking regarding the incidence and outcomes of postoperative hepatic encephalopathy (HE). OBJECTIVE: To determine the incidence of HE postoperatively, factors associated with its development, and its association with in-hospital mortality. METHODS: Retrospective cohort study of 583 patients with cirrhosis undergoing non-hepatic surgery over a 10-year period. Outcomes included postoperative HE and in-hospital mortality and were, respectively, evaluated using multi-state modeling and Fine-Gray competing risk regression (with postoperative HE as a time-varying covariate). RESULTS: Overall, the median Model for End-Stage Liver Disease Sodium was 10, 61.7% had a history of ascites, 49.9% esophageal varices, and 34.6% HE. The most common surgeries including abdominal/non-bowel (33.3%), orthopedic (18.0%), and bowel (12.2%). A total of 42 (7.2%) patients developed HE postoperatively during admission. The cumulative risk of HE was 7.2%, which was most associated with a history of HE, ASA class, postoperative AKI, and postoperative infection. In-hospital mortality occurred in 34 (5.8%) individuals. Only ASA class was independently associated (HR 2.46, 95%CI 1.21-5.02), but there was a trend for postoperative HE (HR 1.71, 95%CI 0.73-3.98). DISCUSSION: HE is an uncommon but not rare postoperative complication that increases the risk of patient harm. This study implies its development is predictable. Consequently, at-risk patients should have consultation with a hepatologist before undergoing elective surgery.

How Do Patients With Cirrhosis and Their Caregivers Learn About and Manage Their Health? A Review and Qualitative Study.

The complexity of cirrhosis requires patients and their caregivers to be well educated to improve outcomes. Data are lacking regarding how to best educate patients and their caregivers in the setting of cirrhosis. Our aim is to understand (both through existing literature and by asking patients and their caregivers) how patients learn about their disease, barriers in their education and disease management, and self-management strategies. We performed a structured search of published articles in PubMed (1973 to 2020) using keywords "cirrhosis" plus "barriers", "education", "self-management", or "self-care". Additionally, we conducted a focus group of a representative sample of patients and their caregivers to understand how knowledge about cirrhosis is found and incorporated into self-management. Of 504 returned manuscripts, 11 pertained to barriers in cirrhosis, interventions, or educational management. Barriers are well documented and include disease complexity, medication challenges, comorbid conditions, and lack of effective education. However, data regarding addressing these barriers, especially effective educational interventions, are scarce. Current strategies include booklets and videos, patient empowerment, and in-person lectures. Without widespread use of these interventions, patients are left with suboptimal knowledge about their disease, a sentiment unanimously echoed by our focus group. Despite linkage to subspecialty care and consistent follow-up, patients remain uncertain about their disease origin, prognosis, and therapies to manage symptoms. It is clear that more data are needed to assess effective strategies to address unmet educational needs. Existing strategies need to be blended and improved, their effectiveness evaluated, and the results distributed widely.

Prevalence and Effect of Intestinal Infections Detected by a PCR-Based Stool Test in Patients with Inflammatory Bowel Disease.

BACKGROUND: The advent of PCR-based stool testing has identified a greatly increased number of infectious agents in IBD, but their clinical significance is unknown. AIMS: To determine the infectious agent prevalence and the clinical significance of these infectious agents in IBD patients. METHODS: This cross-sectional study compared the prevalence of GI infections among IBD patients with active and quiescent disease versus healthy controls. Among actively inflamed patients, we compared clinical characteristics, medication use, and disease course between those with positive and negative tests. RESULTS: Three hundred and thirty-three IBD patients and 52 healthy volunteers were included. The IBD group was divided into active Crohn's disease (CD, n = 113), inactive CD (n = 53), active ulcerative colitis (UC, n = 128), and inactive UC (n = 39). A significantly higher percentage of actively inflamed patients had positive stool tests (31.1%) compared to those with quiescent disease (7.6%, P = < 0.001) and healthy controls (13.5%, P = 0.01). In actively inflamed patients, shorter symptom duration and the use of multiple immunosuppressive agents were significantly associated with positive stool tests. Escalation of immunosuppressive therapy was less frequent in those with positive (61.3%) than with negative tests (77.7%, P = < 0.01). However, the need for surgery (13.3% vs. 18.7%, respectively, P = 0.31) and hospitalization (14.7% vs. 17.5%, respectively, P = 0.57) in 90 days was not significantly different. CONCLUSION: GI infections are common in IBD patients with active disease. Evaluating patients for infection may help avoid unnecessary escalation of immunosuppressants, especially during an acute flare or combination immunosuppression.