Acute decompensation (AD) is defined as the development of complications related to portal hypertension and liver dysfunction that affect the progression of chronic liver disease (CLD) or liver cirrhosis (LC). Variations exist in patient demographics and prognostic outcomes of AD based on the aetiology of CLD, encompassing LC. However, limited research has been conducted to analyse these discrepancies across aetiologies.

The prospective Korean Acute-on-Chronic Liver Failure (KACLiF) cohort consisted of 1,501 patients who were hospitalized with AD of CLD from July 2015 to August 2018. In this study, we assess the clinical attributes and prognostic implications of AD with CLD/LC stratified by the aetiology.

Among 1,501 patients, the mean age was 54.7 years old and 1,118 patients (74.5%) were men. The common events of AD were GI bleeding (35.3%) and jaundice (35.0%). There was a median follow-up of 8.0 months (1.0-16.0 months). The most common aetiology of CLD was alcohol (n = 1021), followed by viral hepatitis (n = 206), viral hepatitis with alcohol-related (n = 129), cryptogenic (n = 108) and autoimmune (n = 37). Viral hepatitis with alcohol-related CLD showed a poor liver function profile and a high frequency of acute-on-chronic liver failure (ACLF) [22.1% vs. 19.6% (alcohol CLD), 8.1% (viral CLD), 5.6% (autoimmune related CLD and 16.0% (cryptogenic CLD)] with worse adverse outcomes (mortality or liver transplantation) than other aetiologies. The difference in aetiology was a significant factor for 28-day adverse outcomes in multivariate analysis even in a high MELD score (≥15), which indicated poor baseline liver function and prognosis (p < 0.001).

The aetiology of CLD constitutes a pivotal determinant influencing both short- and long-term adverse outcomes of AD in CLD, even among individuals presenting with elevated MELD scores. Notably, patients afflicted with viral hepatitis should exercise caution even in the consumption of modest quantities of alcohol that induced the exacerbations in the adverse outcomes associated with AD.

The risk of microbial infections is increased in cirrhosis and other forms of advanced liver disease such as alcohol-associated hepatitis. Such infections may precipitate new or further decompensation and death, especially in patients with clinical features of acute-on-chronic liver failure. The severe immune dysfunction or "immune paralysis" caused by advanced liver disease is associated with high short-term mortality. However, the pathogenic mechanisms underlying immune dysfunction and immunodeficiency are incompletely understood. Evidence to date suggests a complex, dynamic process that perturbs the physiological roles of the liver as a master regulator of systemic immunity and protector against noxious effects of exogenous molecules in the portal vein flowing from the gut. Thus, in cirrhosis and severe alcohol-associated hepatitis, the ability of hepatocytes and intrahepatic immune cells to balance normal context-dependent dichotomous responses of tolerance vs immune activation is lost. Contributing factors include loss of the gut barrier with translocation of microbial products through the portal vein, culminating in development of functional defects in innate and adaptive immune cells, and generation of immune-regulatory myeloid cells that permit microbial colonization and infection. This review addresses key evidence supporting the paradigm of immune dysfunction as a risk for microbial infections and identifies potential therapeutic targets for intervention. The primary focus is on cirrhosis-associated immune dysfunction and alcohol-associated liver disease, because the bulk of available data are from these 2 conditions.

Introduction Liver cirrhosis (LC) is a chronic disease with serious complications affecting adversely patients' quality of life (QoL), leading to a significant burden on the healthcare system. Effective management of LC involves both treating the underlying etiology to delay disease progression and addressing long-term complications. Insufficient adherence of patients to treatment recommendations is considered a major factor of ineffective disease management. Methods This is a controlled interventional prospective study, involving cirrhotic patients who were followed up at the outpatient hepatology department of a general hospital in Athens from January 2015 to September 2018. The educational intervention consisted of one session supported by a nurse along with a specific information leaflet. Data were collected at patients' initial evaluation and subsequently at thee and six months. Adherence was estimated by the A-14 scale and QoL by the Chronic Liver Disease Questionnaire (CLDQ). Statistical analysis was performed by the use of the SPSS 22.0 statistical program (IBM Corp., Armonk, NY, USA). The level of statistical significance was set at 0.05. Results A total of 125 patients participated in the study of whom 65 (52%) were included in the intervention group and 60 (48%) in the control group. Patients' mean ± standard deviation age was 66.5±11.8 and 64.2±13.7 years in the intervention and control group, respectively. The educational intervention led to a statistically significant improvement in adherence to treatment recommendations, and this effect was maintained during the 6-month follow-up period (p<0.001). Additionally, the educational intervention improved the overall QoL (p<0.001) and reduced the proportion of patients with at least one readmission as well as the total number of readmissions (p<0.001) during the 6-month follow-up period. Multivariate analysis showed that the effect of the educational intervention on patients' adherence to treatment recommendations and QoL, was independent of patients' demographic and clinical characteristics. Conclusions Ongoing education is an important nursing intervention for improving both LC patients' adherence to treatment recommendations and their QoL.

Objective: The prevalence and mortality of chronic liver disease has risen significantly. In end-stage liver disease (ESLD), the survival of patients is approximately 2 years. Despite the poor prognosis and high symptom burden, integration of palliative care in ESLD is reduced, and the majority of patients continue to die in inpatient care. We aim to assess predictors and outcomes of home palliative care, as well as factors associated with death at home in patients with ESLD. Methods: Retrospective cohort study of patients with ESLD, followed by a palliative care team between 2017 and 2022. Information regarding patient demographics, ESLD etiology, decompensations, and interventions was collected. Two-sided tests were used to identify factors associated with home palliative care. Results: We analyzed 75 patients: 44% had home palliative care and 33% died at home. ESLD patients with home palliative care were older (72.52 vs 64.45; p = 0.002), had a longer palliative care intervention time (149.97 ± 196.23 vs 43.69 ± 100.60 days; p = 0.007), higher rates of ascites or hepatic encephalopathy (χ2 = 11.024; p = 0.029), and hepatocarcinoma (90.9% vs 64.3%; p = 0.007). Patients with home palliative care had a reduction in-hospital admissions (2.61 vs 1.06; p = 0.000) and a greater probability of death at home (66.7% vs 33.3%; p = 0.000). Patients who died at home (33.3%) were older (72.20 vs 64.40; p = 0.000) and had longer palliative care intervention time (178.80 ± 211.78 vs 46.28 ± 99.67 days; p = 0.006). Conclusion: Home palliative care in ESLD differs based on demographics and disease complications, with a positive impact of homecare translated into a reduction in hospital admissions and an increased probability of death at home.

Hepatic encephalopathy (HE) is a common neurocognitive cirrhosis-related complication with a broad range of symptoms. Timely recognition and treatment of HE, including identifying precipitating factors, when possible, is critical for improving outcomes in patients with cirrhosis. Lactulose and rifaximin therapies, as appropriate, are recommended for patients with cirrhosis and a history of HE episode(s) to reduce risk of HE recurrence.

To provide clinical considerations for nurse practitioners and physician assistants (PAs) on the diagnosis and management of patients with cirrhosis.

A PubMed search of English-language articles published between January 1, 2008, and March 13, 2024, was performed to identify publications on the diagnosis and treatment of HE.

Important topics to address when discussing care with patients with cirrhosis and their caregivers include concomitant medication use, recent infection history, comorbid conditions (e.g., diabetes), fall and frailty risks, and sleep quality. In addition, ensuring treatment adherence is important for reducing the risk of future HE episodes and HE-related hospitalizations. Engaging and empowering caregivers helps reinforce the need for patient adherence to treatment and facilitates earlier identification of HE symptoms.

Early recognition of HE, treatment, and reduction in risk of recurrence are imperative to minimize patient morbidity and mortality.

Nurse practitioners and PAs play an important role in supporting patients with cirrhosis who are at risk for developing HE, as well as their caregivers. Understanding and recognizing precipitating factors and clinical symptoms of HE and treating and preventing HE recurrence can improve patient outcomes.

The Australian Liver FaIlurE (ALFIE) trial, a multicentre, randomised controlled trial, assessed the efficacy of a nurse-coordinated model of care to reduce liver-related emergency admissions (LREAs) in patients with decompensated cirrhosis. The model of care was delivered by a specialist nurse, including intensive postdischarge monitoring, linkage to multidisciplinary care, rapid access to care pathway, enhanced education and self-management support.

To examine the experiences of participants and practitioners in the ALFIE trial to understand its impact, barriers and areas for improvement.

A qualitative semistructured interview analysis nested within the ALFIE trial.

A purposeful sample of 15 patients, 14 controls and 12 staff.

Thematic analysis of interview transcripts.

Interventional participants and the nurses perceived the care provided as personalised, holistic and continuous. The intervention enabled the development of robust therapeutic relationships and trust that promoted participant engagement and risk factor modification. It helped intervention participants navigate the busy hospital system. The control participants desired more education and a personal contact to deal with emergencies. With respect to the intervention, nurses felt that their support helped reduce LREAs and improve care, but it was overwhelming. A number of barriers and systemic issues were identified. Suggestions for improvement of the intervention model included increased staffing, improved mental health support and communication pathways with primary care practitioners.

The ALFIE trial was well received by nurses and participants. It met the needs of intervention participants and the health system through easy-to-navigate, personalised, holistic and ongoing care. The study identified barriers and systemic improvement areas.

ACTRN12617001293358.

Liver disease remains a significant global health concern. In China, the number of patients with liver cirrhosis is estimated to reach 7 million. In addition to the high risk of death, cirrhosis leads to several severe complications. Patients with cirrhosis have significantly longer hospital stays and higher total hospital costs than those without cirrhosis. We aimed to investigate the predictors of readmission among patients with cirrhosis in China.

We conducted a retrospective study to evaluate adult patients with cirrhosis. Data on various sociodemographic, clinical, and hospitalization characteristics were collected. We defined the primary endpoint as the first liver-related readmission occurring within 30-90 days of initial hospitalization. Adult patients with cirrhosis admitted to our hospital between January 2009 and December 2022 were included. Differences between groups were analyzed using Student's t-test and chi-square test. Logistic and multiple linear regression analyses were performed to identify predictors associated with readmission and the length of the first hospitalization.

In total, 1,285 patients were diagnosed with cirrhosis. Among these patients, 767 (59.7%) were males, and the mean age was 58.9 ± 12.3 years. Seventy-two (5.6%) and 154 (12.0%) patients were readmitted within 30 and 90 days, respectively. Compared with those who were not readmitted, patients readmitted at 30-day and 90-day had a higher proportion of males, ascites, spontaneous bacterial peritonitis, electrolyte abnormalities, higher Child-Pugh-Turcotte scores, longer initial hospital stays, and higher initial hospitalization costs. Logistic regression analysis indicated that hepatic encephalopathy, spontaneous bacterial peritonitis, diabetes, and ascites were predictors of 30- and 90-day readmission. Hypertension and spontaneous bacterial peritonitis were significant predictors of the length of the first hospitalization.

Patients with cirrhosis presenting with hepatic encephalopathy, ascites, and spontaneous bacterial peritonitis may have a higher risk of rehospitalization.

There is a growing global burden of liver disease with the current management for complications of liver cirrhosis being reactive as opposed to proactive, affecting outcomes. Management can often be suboptimal in overburdened health-care systems with considerable socioeconomic and geographical disparity existing, which was exacerbated by the COVID-19 pandemic, highlighting the need for sustainable care pathways to be delivered remotely. To this end, digital health care could be the key and, in this Review, we highlight the principal studies that have explored the use of digital technology in the management of cirrhosis complications. While digital health care is a somewhat new field, considerable advances have been made in various domains, particularly in the development of remote monitoring and risk modelling. We aim to provide a balanced perspective of the opportunities for and barriers to the integration of digital technology into established liver-care pathways. Lastly, we reflect on the current acceptability of digital health care and the required future directions to ensure the digital transformation of hepatology is a success.

Improving the care of decompensated cirrhosis is a significant clinical challenge. The primary aim of this trial was to assess the efficacy of a chronic disease management (CDM) model to reduce liver-related emergency admissions (LREA). The secondary aims were to assess model effects on quality-of-care and patient-reported outcomes.

The study design was a 2-year, multicenter, randomized controlled study with 1:1 allocation of a CDM model versus usual care. The study setting involved both tertiary and community care. Participants were randomly allocated following a decompensated cirrhosis admission. The intervention was a multifaceted CDM model coordinated by a liver nurse. A total of 147 participants (intervention=75, control=71) were recruited with a median Model for End-Stage Liver Disease score of 19. For the primary outcome, there was no difference in the overall LREA rate for the intervention group versus the control group (incident rate ratio 0.89; 95% CI: 0.53-1.50, p =0.666) or in actuarial survival (HR=1.14; 95% CI: 0.66-1.96, p =0.646). However, there was a reduced risk of LREA due to encephalopathy in the intervention versus control group (HR=1.87; 95% CI: 1.18-2.96, p =0.007). Significant improvement in quality-of-care measures was seen for the performance of bone density ( p <0.001), vitamin D testing ( p <0.001), and HCC surveillance adherence ( p =0.050). For assessable participants (44/74 intervention, 32/71 controls) significant improvements in patient-reported outcomes at 3 months were seen in self-management ability and quality of life as assessed by visual analog scale ( p =0.044).

This CDM intervention did not reduce overall LREA events and may not be effective in decompensated cirrhosis for this end point.

Variations in cirrhosis management practices and care quality affect patient prognoses and outcomes. We aimed to evaluate the number of successful cirrhosis care processes and the relationship between the quality statement implementation and clinical outcomes in patients with cirrhosis.

This retrospective cohort study included hospitalized patients with cirrhosis. Eighteen process-based methods were independently assessed. Measurement indices for each participant were selected per cirrhosis severity. Service quality was determined using standard settings for each process-based gap scale. The optimal care group comprised participants who adhered to all instruction quality indices. Kaplan-Meier survival analysis assessed the 90-day readmission and mortality rates relating to the optimal quality care.

Of the 205 patients (73.2% male; mean age, 62.7±11.8 years), the median Model for End-stage Liver Disease score was 15.35 (9.37-21.37), and the majority were Child-Pugh B/C. Previously set performance gaps were observed for 13/18 quality processes, and 5/13 clinical processes attained the final goal. Paracentesis in ascites patients, antibiotic administration within 12 hours of spontaneous bacterial peritonitis diagnosis, and precipitating factors identification with lactulose therapy were the top three quality index (QI) accomplishments. Out of 205 patients, 84 attained optimal care. Concerning optimal care, although the readmission rate remained same, patients with decompensated Child-Pugh C who received excellent complete QI care had significantly increased both 1-month (100% vs. 43.5%; p=0.022) and 3-month (100% vs. 26.1%; p=0.022) survival in comparison to those receiving incomplete QI care.

Using quality metrics for the appropriate stage of individual cirrhosis treatment is advocated as best practice. Adherence to standard practices improves clinical outcomes.

The transition from compensated to decompensated cirrhosis is crucial, drastically reducing prognosis from a median survival of over 10 years to 2 years. There is currently an unmet need to accurately predict decompensation. We systematically reviewed and meta-analysed data regarding biomarker use to predict decompensation in individuals with compensated cirrhosis.

PubMed and EMBASE database searches were conducted for all studies from inception until February 2024. The study was carried out according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The Quality of Prognosis Studies framework was used to assess the risk of bias. The meta-analysis was conducted with a random effects model using STATA software.

Of the 652 studies initially identified, 63 studies (n=31 438 patients) were included in the final review, examining 49 biomarkers. 25 studies (40%) were prospective with the majority of studies looking at all-cause decompensation (90%). The most well-studied biomarkers were platelets (n=17), Model for End-Stage Liver Disease (n=17) and albumin (n=16). A meta-analysis revealed elevated international normalised ratio was the strongest predictor of decompensation, followed by decreased albumin. However, high statistical heterogeneity was noted (l2 result of 96.3%). Furthermore, 21 studies were assessed as having a low risk of bias (34%), 26 (41%) moderate risk and 16 (25%) high risk.

This review highlights key biomarkers that should potentially be incorporated into future scoring systems to predict decompensation. However, future biomarker studies should be conducted with rigorous and standardised methodology to ensure robust and comparable data.

Hepatic encephalopathy is a common and serious complication of decompensated cirrhosis. It can considerably contribute to economic burden and impaired quality of life. However, its pathogenesis remains unclear.

In this study, we aimed to visually analyse the research status and development trends in hepatic encephalopathy pathogenesis using bibliometrics and knowledge mapping. Information regarding publications between 1978 and 2022 were obtained from the Web of Science Core Collection. CiteSpace was used to analyse and present data by year, author, institution, country, journal, reference, and keyword.

A total of 1578 publications on hepatic encephalopathy pathogenesis in patients with cirrhosis were retrieved from Web of Science Core Collection. A gradual increasing trend in annual publications has occurred. The collaborative network analysis results suggest the United States of America, the University of London, and Bajaj, Jasmohan S as the most influential country, institution, and author, respectively, in this research field. Notably, China appeariiuis to be the most promising country. Research on 'hepatology' garners the most significant papers in the field. Combined with reference co-citation and keyword co-occurrence analyses, we found that ammonia metabolism, gut microbiota, sarcopenia, and trace elements will become future research frontiers that are likely to be explored for a considerable length of time.

Future research directions in HE pathogenesis may target modulating the ammonia metabolism, the gut microbiota, sarcopenia, and trace elements.

Some evidence suggests an association between gut dysbiosis and cirrhosis progression. The authors investigated Gut Microbiome (GM) influence on 90-day mortality and hospitalization/rehospitalization rates in cirrhotic patients.

Compensated/decompensated outpatients and decompensated inpatients were prospectively included and compared to healthy controls. Clinical, laboratory, GM, and two ratios between phyla were evaluated. Patients were followed up for 90 days for hospitalization/rehospitalization and mortality.

165 individuals were included (50 compensated, 49 decompensated outpatients; 36 decompensated inpatients; 30 healthy), 48.5 % female, mean age was 61, main cirrhosis etiology was hepatitis C (27.3 %), and mostly Child-Pugh (CP) B patients, median MELD of 13. As liver disease progressed, microbiota diversity decreased between the groups (p = 0.05; p < 0.004). There were 9 deaths and 22 hospitalizations or rehospitalizations. GM composition had correlation with norfloxacin (p = 0.36, p = 0.04), encephalopathy (p = 0.31, p = 0.01), lactulose (p = 0.26, p = 0.01), 90-day mortality (p = 0.22, p = 0.04), CP (p = 0.17, p = 0.01), previous 6-month antibiotic use (p = 0.16, p = 0.01), MELD (p = 0.145, p = 0.01), ALBI (p = 0.1, p = 0.04) and 90-day hospitalization/rehospitalization (p = 0.08, p = 0.03). Firmicutes/Bacteroidetes (F/B) and Firmicutes/Proteobacteria (F/P) ratios were progressively lower and more significant and had an association with 90-day mortality (p < 0.001). Three MELD set-points (≥ 15, 18 and 20) were significantly associated with both ratios, with similar accuracies.

GM dysbiosis was associated with higher CP, MELD, 90-day mortality and hospitalization/rehospitalization. F/B and F/P ratios were associated with 90-day mortality.

Remote patient monitoring (RPM) is an emerging focus in health care, and specialized programs may reduce medical costs, supplement in-office visits, and improve patient satisfaction. In this study, we describe the development, feasibility, and early outcomes of an RPM program for patients with decompensated cirrhosis.

Forty-six patients were offered enrollment at the time of hospital discharge in the cirrhosis RPM program (CiRPM), of which 41 completed at least 30 days of monitoring. Participants were mailed remote monitoring equipment and a tablet to be used for patient-reported outcomes. Alerts were continuously monitored by virtual nursing staff who could perform targeted interventions. A cohort of historical controls (n = 74) was created for comparison using inverse probability of treatment weighting.

Patients were enrolled in the program for a mean of 83.9 days, with 28 (68%) completing the full 90-day program. Participants uploaded vital signs and responded to symptom-based questionnaires on 93% of the monitored days. On end-of-program surveys, over 75% of patients expressed satisfaction with the program. Gender, age, and MELD-Na were similar between CiRPM and weighted control groups. The 90-day readmission rate was 34% in CiRPM and 47% in weighted controls. In the CiRPM group, 12% of subjects had 2 or more admissions, compared to 37% in the weighted control group.

This study demonstrates the feasibility of a cirrhosis-specific RPM program. Overall, patient satisfaction and utilization of the CiRPM was high. Future studies are needed to confirm the impact of RPM on the reduction of hospital readmissions in decompensated cirrhosis.

Patients with cirrhosis are prone to developing acute kidney injury (AKI), a complication associated with a markedly increased in-hospital morbidity and mortality, along with a risk of progression to chronic kidney disease. Whereas patients with cirrhosis are at increased risk of developing any phenotype of AKI, hepatorenal syndrome (HRS), a specific form of AKI (HRS-AKI) in patients with advanced cirrhosis and ascites, carries an especially high mortality risk. Early recognition of HRS-AKI is crucial since administration of splanchnic vasoconstrictors may reverse the AKI and serve as a bridge to liver transplantation, the only curative option. In 2023, a joint meeting of the International Club of Ascites (ICA) and the Acute Disease Quality Initiative (ADQI) was convened to develop new diagnostic criteria for HRS-AKI, to provide graded recommendations for the work-up, management and post-discharge follow-up of patients with cirrhosis and AKI, and to highlight priorities for further research.

Hepatic encephalopathy-a common and debilitating complication of cirrhosis-results in major health care burden on both patients and caregivers through direct and indirect costs. In addition to risk of falls, inability to work and drive, patients with hepatic encephalopathy often require hospital admission (and often readmission), and many require subacute care following hospitalization. The costs and psychological impact of liver transplantation often ensue. As the prevalence of chronic liver disease increases throughout the United States, the health care burden of hepatic encephalopathy will continue to grow.

Hepatic encephalopathy is a strong predictor of hospital readmissions in patients with advanced liver disease. The frequent recurrence of hepatic encephalopathy and subsequent readmissions may lead to nonreversible organ dysfunction, resulting in a significant decrease of patient quality of life and increase of health care burden costs for patients and facilities. Many of these readmissions for hepatic encephalopathy are preventable. Multidisciplinary patient-centered care throughout the continuum is essential in the management of hepatic encephalopathy. Understanding the patient's daily functions and limitations in the outpatient setting is key to correctly identifying the cause of hospital admission.

Hepatic encephalopathy (HE) can occur as a complication of chronic liver disease as well as acute liver failure. HE is associated with significantly increased morbidity and worse patient outcomes. The clinical manifestation of HE ranges from early less-severe presentations that may only be accurately detected on dedicated psychomotor diagnostic testing to overt alterations in cognition and mental status to the most severe form of coma. Greater awareness of the clinical manifestations of HE across the spectrum of symptom severity is critical for early identification and timely initiation of appropriate therapy to improve patient outcomes.

Hospital readmissions are common in patients with cirrhosis, but there are few studies describing readmission preventability. We aimed to describe the incidence, causes, and risk factors for preventable readmission in this population.

We performed a prospective cohort study of patients with cirrhosis hospitalized at a single center between June 2014 and March 2020 and followed up for 30 days postdischarge. Demographic, clinical, and socioeconomic data, functional status, and quality of life were collected. Readmission preventability was independently and systematically adjudicated by 3 reviewers. Multinomial logistic regression was used to compare those with (i) preventable readmission, (ii) nonpreventable readmission/death, and (iii) no readmission.

Of 654 patients, 246 (38%) were readmitted, and 29 (12%) were preventable readmissions. Reviewers agreed on preventability for 70% of readmissions. Twenty-two (including 2 with preventable readmission) died. The most common reasons for readmission were hepatic encephalopathy (22%), gastrointestinal bleeding (13%), acute kidney injury (13%), and ascites (6%), and these reasons were similar between preventable and nonpreventable readmissions. Preventable readmission was often related to paracentesis timeliness, diuretic adjustment monitoring, and hepatic encephalopathy treatment. Compared with nonreadmitted patients, preventable readmission was independently associated with racial and ethnic minoritized individuals (odds ratio [OR] 5.80; 95% CI, 1.96-17.13), nonmarried marital status (OR 2.88; 95% CI, 1.18-7.05), and admission in the prior 30 days (OR 3.45; 95% CI, 1.48-8.04).

For patients with cirrhosis, readmission is common, but most are not preventable. Preventable readmissions are often related to ascites and hepatic encephalopathy and are associated with racial and ethnic minorities, nonmarried status, and prior admissions.

Recurrent episodes of Portal Systemic Encephalopathy (PSE), poses a significant burden of illness on the patients and healthcare system. The objective of this study was to assess the recurrence of PSE in cirrhotic patients after index episode of PSE and to identify various risk factors associated with it.

A retrospective, single-centre study was conducted at Aga Khan University Hospital over a span of one year. Patients who were admitted first time with PSE and admitted within three months of index PSE were enrolled in the study. Variables assessed were demographic data, associated comorbid conditions, aetiology of cirrhosis, Child-Turcotte-Pugh (CTP) score, Model of End-Stage Liver Disease (MELD) score, PSE grade, laboratory tests, ascites with spontaneous bacterial peritonitis (SBP), variceal bleeding. Statistical analysis was done and variables of those who developed recurrence were compared with those who did not.

Fifty one patients were recruited. Thirty three (64.7%) were readmitted with PSE. On comparative analysis of both groups; infection, Meld score, low albumin, and raised total bilirubin showed significant P-value (<0.05).

Identification of risk factors during assessment can reduce the recurrence of PSE. We would recommend to validate result of our study on a large scale prospectively.

In this investigation, we aimed to explore risk factors for 90-day hospital readmission among patients with cirrhosis and ascites in an Asian population.

In this retrospective study, we included consecutive patients diagnosed with cirrhosis and ascites hospitalized in Renji Hospital between 2018 and 2022 to elucidate risk factors for 90-day readmission. We conducted multivariate logistic regression analysis to identify readmission risk factors.

We included 265 patients with cirrhosis and ascites. A 43% readmission rate was observed within 90 days. After adjustment for multiple covariates, we found that readmission within 90 days was independently linked to reduced levels of hemoglobin (odds ratio [OR] 0.96, 95% confidence interval [CI] 0.94-0.97) and serum albumin (OR 0.88, 95% CI 0.83-0.93), and higher Model for End-Stage Liver Disease and sodium (MELD-Na) scores (OR 1.04, 95% CI 1.01-1.07) at discharge.

Patients with cirrhosis who have ascites are frequently rehospitalized within 90 days after discharge. Lower hemoglobin or albumin and higher MELD-Na scores at discharge may be the main risk factors for hospital readmission.

Patient portals are a common electronic medical record tool that allow for the asynchronous exchange of health information between patients and their health care teams. Patients can leverage patient portals to perform tasks such as viewing test results, reviewing clinical notes, and messaging their health care team. The impact of patient portal use on clinical outcomes in cirrhosis is unknown.

In this study, we evaluated the relationship between patient portal use patterns and readmissions in cirrhosis.

We identified 131 patients with decompensated cirrhosis with an index cirrhosis-related admission between May 1, 2018, and May 1, 2019. We then examined patient portal enrollment and use data during the 6-month period preceding the study period. Portal functions evaluated included sending a message, reading a message, and reading a test result. Use was categorized as active (sending a message) and passive (reading a message or test result) and was further stratified as no, moderate, or frequent use based on the frequency of portal function use compared to the mean. The primary outcomes were 90-day and overall readmissions, adjusted for age, model for end-stage liver disease-sodium, alcohol-related cirrhosis etiology, ascites, and hepatic encephalopathy. Portal functions assessed included sending a message, reading a message, and reading a result; the total number of times a portal function was performed was divided by the number of months the patient was enrolled in the patient portal during the 6-month period.

The study population was 50.4% (66/131) female, with a mean age of 58 years. Enrollment in the patient portal was 63.4% (83/131), and there was no significant difference in enrollment based on clinical or demographic characteristics. For the entire cohort, 14.5% (19/131) and 22.1% (29/131) of patients were moderate and frequent active users, respectively. Of those enrolled in the patient portal, 97.6% (81/83) of patients were moderate or frequent passive users for both reading a message and reading a test result. Moderate active users had less 90-day readmissions (odds ratio 0.77, 95% CI 0.60-1.00) and overall readmissions (subdistribution hazard ratio 0.42, 95% CI 0.21-0.84), compared to nonactive users. There was no relationship between readmissions and passive use.

Passive use of the patient portal is very high but is not associated with the risk of readmissions in people with decompensated cirrhosis. However, moderately active use of the patient portal is associated with a reduced risk of readmissions. Further work is needed to identify possible confounders and refine key use behaviors that may be protective with regard to the risk of readmission in this population.

To describe the development of multimodal, web-based educational resources about cirrhosis alongside patients and caregivers.

We used an iterative process that was guided by the Strategy for Patient Oriented Research (SPOR) patient engagement framework in describing patient engagement activities to partner with a team of 16 patients and caregivers (Patient Advisory Team (PAT)). This process included five phases: a) Prioritize and gather content, b) design and build the website and videos, c) gather and integrate feedback, d) improve user accessibility, and e) assess usability and knowledge uptake for users.

This 2-year process resulted in a 55-page website and 78 animated and live-action videos on cirrhosis complications, procedures, nutrition, and exercise. We implemented usability testing through pre-defined tasks and a think-aloud method from individuals with no previous exposure to the website to assess navigation, appearance, and content issues. Following usability testing, we have been gathering quantitative data from each unique page about relevance and ease of use, as well as qualitative data on the value of the content itself.

Collaboration between clinicians, patients, and caregivers is key to developing high-quality digital educational resources. Lessons from our process may help other organizations looking to address disease-specific knowledge gaps. Next steps with www.cirrhosiscare.ca will be continued iterative refinement and structured impact evaluation.

This project used a patient-centered approach to develop a comprehensive online educational resource for patients with cirrhosis. By having patients with cirrhosis as a key part of our team, we ensured that the site met the needs of this unique population.

Background: Hepatic encephalopathy (HE) caused by cirrhosis has severe consequences on an individual's lifespan, leading to long-term liver complications and potentially life-threatening outcomes. Despite recent interest in this condition, the effectiveness of secondary prophylaxis involving rixafimin, lactulose, or L-ornithine L-aspartate (LOLA) may be hindered by the unique microbial profiles each patient possesses. Methods: Thus, in this manuscript, we aimed to search, identify, and gather all randomized controlled trials (RCTs) published between 2000-2023 (November) in four major academic databases such as PubMed, ISI Web of Science, Scopus, and ScienceDirect by using a controlled terminology and web strings that reunite six main keywords. We complementarily retrieved data on the ongoing RCTs. Results: Regardless of the relatively high number of results displayed (n = 75), 46.66% (n = 35) were initially deemed eligible after the first evaluation phase after removing duplicates, n = 40 (53.34%). At the second assessment stage, we eliminated 11.42% (n = 4) studies, of which n = 22 finally met the eligibility criteria to be included in the main body of the manuscript. In terms of RCTs, otherwise found in distinct stages of development, n = 3 target FMT and n = 1 probiotics. Conclusions: Although we benefit from the necessary information and technology to design novel strategies for microbiota, only probiotics and synbiotics have been extensively studied in the last decade compared to FMT.

 Paracentesis is currently performed by interventional radiologists (IR) rather than gastroenterologists/hepatologists or internists. In this model of care, there is usually no evaluation of patients' renal function or adjustment of their medications at the time of paracentesis. The objectives of this study were to analyze hospital utilization and cirrhosis complications within six months of index outpatient paracentesis by IR and to identify potential areas of improvement in care.

This is a retrospective study of patients with cirrhosis and ascites who underwent outpatient paracentesis by IR between October 15, 2015, and October 15, 2018, at a tertiary academic medical center. We collected demographics, data on cirrhosis etiology/complications, laboratory tests, provider notes, outpatient paracentesis dates, emergency department (ED) visits, hospitalizations, and ICU admissions within the following six months post index paracentesis. Associations between categorical predictors and clinical outcomes were analyzed using the chi-square test. Associations between quantitative predictors and clinical outcomes were analyzed using the Wilcoxon rank sum test.

Our study included 69 unique patients who had at least one outpatient encounter for paracentesis by IR in the study period. Most patients were men (71%), had alcohol-related cirrhosis as primary etiology (53.6%), an average age of 60 years, and an average Model for End-Stage Liver Disease-sodium (MELDNa) score at baseline of 16. Within six months from index paracentesis, 44 patients (64.7%) underwent repeat IR outpatient paracentesis (total 187 paracenteses, 4.25 paracenteses/patient), 43 patients (62.3%) had ER visits (total 118 ER visits, 2.8/patient), 41 patients (59.4%) had hospital admissions (total 88 admissions, 2.2/patient), and 11 patients required ICU admission. Complications of cirrhosis noted during follow-up included hepatic encephalopathy (40.5%), acute kidney injury (38.2%), upper gastrointestinal (UGI) bleeding (16%), and spontaneous bacterial peritonitis (SBP) in 15%. The mortality rate at six months was 20%. On multivariate analysis, the predictive factors for mortality were older age (p = 0.03) and MELDNa score (p = 0.02). Baseline MELDNa was predictive of acute kidney injury (p = 0.02), UGI bleed (p < 0.01), and ICU admission (p < 0.01), but not of SBP, encephalopathy, ED visit, or hospital admissions. Among patients with more than one paracentesis (64%),six patients underwent transjugular portosystemic shunt (TIPS), but there was no documentation of TIPS consideration in 31 patients (70.4%). A total of 20 patients (29%) were waitlisted for liver transplantation.

In this contemporary cohort of patients with cirrhosis undergoing outpatient IR paracentesis, we found a high rate of short-term cirrhosis complications and hospital utilization, while TIPS consideration was very low. Further data are needed to identify specific gaps in care, but IR paracentesis should be integrated within a multidisciplinary management model, with emphasis on early TIPS in eligible patients, as recommended by the current practice guidelines.

The human gastrointestinal tract houses a diverse array of probiotic and pathogenic bacteria and any alterations in this microbial composition can exert a significant influence on an individual's well-being. It is well-established that imbalances in the gut microbiota play a pivotal role in the development of liver diseases. In light of this, a new adjuvant therapy for liver diseases could be regulating the intestinal microbiota. Through fecal microbiota transplantation, patients whose microbiomes are compromised are treated with stool from healthy donors in an attempt to restore a normal microbiome and alleviate their symptoms. A review of cross-sectional studies and case reports suggests that fecal microbiota transplants may offer effective treatment for chronic liver diseases. Adding to the potential of this emerging therapy, recent research has indicated that fecal microbiota transplantation holds promise as a therapeutic approach specifically for liver cirrhosis. By introducing a diverse range of beneficial microorganisms into the gut, this innovative treatment aims to address the microbial imbalances often observed in cirrhotic patients. While further validation is still required, these preliminary findings highlight the potential impact of fecal microbiota transplantation as a novel and targeted method for managing liver cirrhosis. We aimed to summarize the current state of understanding regarding this procedure, as a new therapeutic method for liver cirrhosis, as well as to explain its clinical application and future potential.

Delivering effective secondary preventive and integrated care has the potential to break the revolving-door phenomenon of frequent readmissions in patients with advanced chronic liver disease. To address this, we launched the Care Coordination of Liver Disease (CCoLD) pilot, a novel nurse-led cirrhosis clinic in Western Sydney.

Following an index presentation to Blacktown or Mount Druitt hospitals (BMDH), patients (n = 89, matched by age, sex, and MELD-NA) were consecutively either followed up by the CCoLD clinical nurse consultant (intervention cohort) or received standard care (control cohort). Controlled evaluation of the impact of the nurse-led clinic was carried out for a 3-month period including readmission rates, survival, and cost effectiveness.

The inaugural nurse-led clinic led to improvement in patient-level outcomes including a reduction in unplanned liver-related readmissions (2.08% for intervention cohort vs 12.2% for control cohort, p < 0.01), and mortality at 30 days (0% for intervention cohort vs 7.3% for control cohort, p = 0.03). Similar trends were observed at 90 days from index discharge. No deaths were observed in the intervention cohort as compared to the control cohort at 90 days (0% versus 7.3%, p = 0.03), while unplanned liver-related readmissions were 10.41% for the intervention cohort vs 19.5% for the control cohort (p = 0.115). Moreover, time to readmission was significantly longer in the intervention cohort, resulting in an overall cost-effective intervention.

These findings highlight the significant impact of optimised care-coordination. A nurse-led clinic can deliver patient-centred, goal-directed, and cost-effective secondary prevention and care. A multicentre randomised trial for wider evaluation of these findings is warranted.

Hospital admissions for patients with cirrhosis continue to increase. In New York City, 25% to 30% of hospitalized cirrhotics are readmitted within 30 days. Rehospitalization is associated with increased mortality, poor quality of life, and financial burden to patients, hospitals, and payers. Preventable readmissions are partially accounted for by a well-documented quality gap between evidence-based guidelines for cirrhosis management and real-world adherence to these recommendations.

We performed a prospective cohort study that compared outcomes among cirrhotic patients admitted to 4 internal medicine teams over a 6-month period. An electronic medical record (EMR) note template that outlined best-practice measures for cirrhotics was developed. Inpatient providers on 2 teams were instructed to include it in daily progress notes and discharge summaries. The recommended practices included diagnostic paracentesis and diuretics for ascites, rifaximin, and lactulose for hepatic encephalopathy, beta blockers for esophageal varices, and antibiotic prophylaxis for spontaneous bacterial peritonitis. The remaining 2 teams continued the standard of care for cirrhotic patients. The primary outcome was 30-day readmissions. Secondary outcomes included in-hospital mortality, 30-day mortality, length of stay, and adherence to best-practice guidelines.

Over a 6-month period, 108 cirrhotic patients were admitted, 83 in the interventional group and 25 in the control group. MELD-Na scores on admission did not differ between the groups (20.1 vs. 21.1, P =0.56). Thirty-day readmissions were not significantly different between the interventional and control groups (19.3% vs. 24%, P =0.61). However, 30-day mortality was significantly lower in the interventional group (8.4% vs. 28%, P =0.01). There was no difference between the 2 groups in in-hospital mortality (4.8% vs. 0%, P =0.27), 90-day mortality (15.7% vs. 28.0%, P =0.17) or length of stay (10.2 vs. 12.6 d, P =0.34). Adherence to best-practice metrics was similar between the groups, except for rates of diagnostic paracentesis, which were higher in the interventional group (98% vs. 80%, P =0.01).

Implementation of an EMR note template with cirrhosis best practices was associated with lower 30-day mortality and higher rates of diagnostic paracentesis among admitted patients with cirrhosis. These findings suggest that the integration of best-practice measures into the EMR may improve outcomes in hospitalized cirrhotic patients. Larger studies are required to validate these findings.

Cirrhosis is associated with sarcopaenia and fat wasting, which drive decompensation and mortality. Currently, nutritional status, through body composition assessment, is not routinely monitored in outpatients. Given the deleterious outcomes associated with poor nutrition in decompensated cirrhosis, there is a need for remotely monitoring this to optimise community care.

A retrospective analysis was conducted on patients monitored remotely with digital sensors post hospital discharge, to assess outcomes and indicators of new cirrhosis complications. 15 patients had daily fat mass measurements as part of monitoring over a median 10 weeks, using a Withing's bioimpedance scale. The Clinical Frailty Score (CFS) was used to assess frailty and several liver disease severity scores were assessed.

73.3% (11/15) patients were male with a median age of 63 (52-68). There was a trend towards more severe liver disease based on CLIF-Consortium Acute Decompensation (CLIF-C AD) scores in frail patients vs. those not frail (53 vs 46, p = 0.072). When the cohort was split into patients who gained fat mass over 8 weeks vs. those that lost fat mass, the baseline CLIF-C AD scores and WBC were significantly higher in those that lost fat (58 vs 48, p = 0.048 and 11.2 × 109 vs 4.7 × 109, p = 0.031).

This proof-of-principle study shows feasibility for remote monitoring of fat mass and nutritional reserve in decompensated cirrhosis. Our results suggest fat mass is associated with greater severity of acute decompensation and may serve as an indicator of systemic inflammatory response. Further prospective studies are required to validate this digital biomarker.

Hospitalizations are a sentinel event in cirrhosis; however, the changing demographics in patients with cirrhosis require updated hospitalization prediction models. Periodontitis is a risk factor for liver disease and potentially progression. The aim of this study was to determine factors, including poor oral health, associated with 3-month hospitalizations in a multi-center cohort of outpatients with cirrhosis.

North American Consortium for Study of End-stage Liver Disease (NACSELD-3), a new study cohort, recruits outpatients with cirrhosis. Cirrhosis details, demographics, minimal hepatic encephalopathy (MHE), frailty, and comorbid conditions including oral health were collected. All patients were followed for 3 months for nonelective hospitalizations. Multi-variable models were created for this outcome using demographics, cirrhosis details, oral health, MHE, frailty, and comorbid conditions with K-fold internal validation using 25%/75% split.

A total of 442 outpatients (70% men; 37% compensated; Model for End-stage Liver Disease-Sodium, 12; 42% ascites; and 33% prior HE) were included. MHE was found in 70%, frailty in 10%; and both in 8%. In terms of oral health, 15% were edentulous and 10% had prior periodontitis. Regarding 3-month hospitalizations, 14% were admitted for mostly liver-related reasons. These patients were more likely to be decompensated with higher cirrhosis complications, MHE, frailty and periodontitis history. Multi-variable analysis showed prior periodontitis (P = .026), composite MHE + frailty score (P = .0016), ascites (P = .004), prior HE (P = .008), and hydrothorax (P = .004) were associated with admissions using the training and validation subsets.

In a contemporaneous, prospective, multi-center cohort study in outpatients with cirrhosis, poor oral health is significantly associated with 3-month hospitalizations independent of portal hypertensive complications, MHE, and frailty. Potential strategies to reduce hospitalizations should consider oral evaluation in addition to MHE and frailty assessment in practice pathways.

Standardized order sets are a means of increasing adherence to clinical practice guidelines and improving the quality of patient care. Implementation of novel quality improvement initiatives like order sets can be challenging. Before the COVID-19 pandemic, we conducted a formative evaluation to understand healthcare providers' perspectives on implementing clinical changes and the individual, collective and organizational contextual factors that might impact implementation at eight hospital sites in Alberta, Canada.

We utilized concepts from the Consolidated Framework for Implementation Research (CFIR) and Normalisation Process Theory (NPT) to understand the context, past implementation experiences, and perceptions of the cirrhosis order set. Eight focus groups were held with healthcare professionals caring for patients with cirrhosis. Data were coded deductively using relevant constructs of NPT and CFIR. A total of 54 healthcare professionals, including physicians, nurses, nurse practitioners, social workers and pharmacists and a physiotherapist, participated in the focus groups.

Key findings revealed that participants recognized the value of the cirrhosis order set and its potential to improve the quality of care. Participants highlighted potential implementation challenges, including multiple competing quality improvement initiatives, feelings of burnout, lack of communication between healthcare provider groups, and a lack of dedicated resources to support implementation.

Implementing a complex improvement initiative across clinician groups and acute care sites presents challenges. This work yielded insights into the significant influence of past implementation of similar interventions and highlighted the importance of communication between clinician groups and resources to support implementation. However, by using multiple theoretical lenses to illuminate what and how contextual and social processes will influence uptake, we can better anticipate challenges during the implementation process.

There is lack of 30-day hospital readmission prediction score in patients with liver cirrhosis and SBP. The aim of this study is to recognize factors capable of predicting 30-day readmission and to develop a readmission risk score in patients with SBP.

This study prospectively examined the 30-day hospital readmission for patients previously discharged with a diagnosis of SBP. Based on index hospitalization variables, a multivariable logistic regression model was implemented to recognize predictors of patient hospital readmission within 30 days. Consequently, Mousa readmission risk score was established to predict 30-day hospital readmission.

Of 475 patients hospitalized with SBP, 400 patients were included in this study. The 30-day readmission rate was 26.5%, with 16.03% of patients readmitted with SBP. Age ≥ 60, MELD > 15, serum bilirubin > 1.5 mg/dL, creatinine > 1.2 mg/dL, INR > 1.4, albumin < 2.5 g/dL, platelets count ≤ 74 (103/dL) were found to be independent predictors of 30-day readmission. Incorporating these predictors, Mousa readmission score was established to predict 30-day patient readmissions. ROC curve analysis demonstrated that at a cutoff value ≥ 4, Mousa score had optimum discriminative power for predicting the readmission in SBP with sensitivity 90.6% and specificity 92.9%. However, at cutoff value ≥ 6 the sensitivity and specificity were 77.4% and 99.7%, respectively, while a cutoff value ≥ 2 had sensitivity of 99.1% and specificity of 31.6%.

The 30-day readmission rate of SBP was 25.6%. With the suggested simple risk assessment Mousa score, patients at high risk for early readmission can be easily identified so as to possibly prevent poorer outcomes.

Patients with decompensated cirrhosis present frequent hospitalisations with a relevant clinical and socio-economic impact. This study aims to characterise unscheduled readmissions up to 1-year follow-up and identify predictors of 30-day readmission after an index hospitalisation for acute decompensation (AD).

We performed a secondary analysis of a prospectively collected cohort of patients admitted for AD. Laboratory and clinical data at admission and at discharge were collected. Timing and causes of unscheduled readmissions and mortality were recorded up to 1 year.

A total of 329 patients with AD were included in the analysis. Acute-on-chronic liver failure was diagnosed in 19% of patients at admission or developed in an additional 9% of patients during the index hospitalisation. During the 1-year follow-up, 182 patients (55%) were rehospitalised and 98 (30%) more than once. The most frequent causes of readmission were hepatic encephalopathy (36%), ascites (22%), and infection (21%). Cumulative incidence of readmission was 20% at 30 days, 39% at 90 days, and 63% at 1 year. Fifty-four patients were readmitted for emergent liver-related causes within 30 days. Early readmission was associated with a higher 1-year mortality (47 vs. 32%, p = 0.037). Multivariable Cox regression analysis showed that haemoglobin (Hb) ≤8.7 g/dl (hazard ratio 2.63 [95% CI 1.38-5.02], p = 0.003) and model for end-stage liver disease-sodium score (MELD-Na) >16 at discharge (hazard ratio 2.23 [95% CI 1.27-3.93], p = 0.005), were independent predictors of early readmission. In patients with MELD-Na >16 at discharge, the presence of Hb ≤8.7 g/dl doubles the risk of early rehospitalisation (44% vs. 22%, p = 0.02).

Besides MELD-Na, a low Hb level (Hb ≤8.7 g/dl) at discharge emerged as a new risk factor for early readmission, contributing to identification of patients who require closer surveillance after discharge.

Patients with decompensated cirrhosis face frequent hospitalisations. In the present study, type and causes of readmissions were analysed during 1-year follow-up in patients discharged after the index hospitalisation for an acute decompensation of the disease. Early (30-day) liver-related readmission was associated with higher 1-year mortality. The model for end-stage liver disease-sodium score and low haemoglobin at discharge were identified as independent risk factors for early readmissions. Haemoglobin emerged as a new easy-to-use parameter associated with early readmission warranting further investigation.

Although hyponatremia and hepatic encephalopathy (HE) are known independent predictors of mortality, their combined effect is unknown. We investigated whether the inpatient mortality differed among patients with both hyponatremia and HE compared to those with either hyponatremia or HE alone.

In this retrospective study, data were extracted from the National Inpatient Sample (NIS) to identify US adults (aged ≥18 years) with cirrhosis between January 1st, 2016, and December 31st, 2017. We analyzed the effects of hyponatremia, HE, or a combination of hyponatremia and HE on inpatient mortality using logistic regression.

Among 309,841 cirrhosis-related admissions, 22,870 (7%) patients died during hospitalization. Those with a combination of hyponatremia and HE had higher mortality (14%) than those with HE only (11%), hyponatremia only (9%), and neither hyponatremia nor HE (6%) (p<0.001). When compared to patients without hyponatremia or HE, patients with both hyponatremia and HE had the highest odds (adjusted odds ratio or aOR) of inpatient mortality (aOR 1.90, 95% CI: 1.79 - 2.01) followed by patients with HE only (aOR 1.75, 95% CI: 1.69 - 1.82) and patients with hyponatremia only (aOR 1.17, 95% CI: 1.12 - 1.22). Patients with HE only had 50% higher odds of inpatient mortality when compared to those with hyponatremia only (aOR: 1.50, 95% CI: 1.43 - 1.57).

In this nationwide study, the presence of both hyponatremia and HE was associated with higher inpatient mortality than either hyponatremia or HE alone.

App-based technologies could enhance patient and caregiver communication and provide alerts that potentially reducing readmissions. However, the burden of App alerts needs to be optimized to reduce provider burnout.

The purpose of this study was to determine subjective and objective burden of using the Patient Buddy App, a health information technology (HIT) on providers in a randomized multicenter trial, who completed a semi-quantitative Likert scale survey regarding training procedures, data and privacy concerns, follow-up details, and technical support. This randomized multicenter trial recruits cirrhosis inpatients and their caregivers, and randomizes them into standard-of-care, HIT (communication only via App) and HIT+visits (App+phone calls/visits) for 30 days after discharge. The alerts are monitored by providers through a central iPad. The reason(s) and number of alerts were recorded as the objective burden. A total of 1442 messages were sent as alerts from the 103 dyads (patient + caregiver) (n=206) randomized to HIT arms. The most common messages related to Hepatic Encephalopathy (HE) (high or low bowel movement=50% or orientation tests=37%). Twelve providers completed the surveys reflecting the following themes-92% and 100%, felt adequately trained and confident about educating the patients and caregivers before roll out of App and had no concerns related to data and privacy; 70%, felt that appropriate time was spent on pursuing reason for data not being logged; 60% each, had issues with availability of adequate technical support and connectivity.

The Patient Buddy App randomized multicenter trial till date shows an overall favorable rating regarding training procedures/education, privacy concerns, and ease of message follow-up, from providers. However, it is important to gauge and address subjective and objective burdens of monitoring human resources in current and future HIT studies to avoid burnout and to ensure successful study completion.