Palliative clinical trials in advanced chronic liver disease: Challenges and opportunities

Verma, Sumita; Hingwala, Jay; Low, Joseph; Patel, Arpan; Bremner, Stephen; Haddadin, Yazan; Shinall, Myrick C.; Komenda, Paul; Ufere, Nneka N.

doi:10.1016/j.jhep.2023.06.018

Cited by 11 publications

(5 citation statements)

References 100 publications

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“…The ESAS-r has a well-established MCID for both individual symptom scores and its total score and its validation in the population with DC supports its use in symptom management intervention trials. 3 5 6 Importantly, the ESAS-r can be used as a key outcome measure to capture the effect of interventions that have the potential to address multiple symptoms simultaneously, such as cognitive behavioral therapy, integrative medicine, and palliative care. Longitudinal symptom monitoring, particularly when associated with triggered alerts to clinicians, has been shown to improve symptoms and HRQOL, reduce acute care utilization, and even increase quality-adjusted survival among adults with cancer in multiple randomized controlled trials.…”

Section: Discussionmentioning

confidence: 99%

“… 26 27 For SF-LDQOL, we used an MCID cutoff of 8 based on an ongoing clinical trial on the treatment of ascites using SF-LDQOL as the primary outcome (REDUCe 2 Study). 6 …”

Section: Methodsmentioning

confidence: 99%

“… 3 4 However, a key barrier to achieving this goal is the lack of a simple and clinically relevant tool for assessing a diverse set of symptoms that is reliable, responsive to change, and validated among patients with DC. 3 5 6 Additionally, the relative contribution of symptom burden to HRQOL among patients with DC is not yet well understood.…”

Section: Introductionmentioning

confidence: 99%

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The Edmonton Symptom Assessment System is a valid, reliable, and responsive tool to assess symptom burden in decompensated cirrhosis

Donlan,

Zeng,

Indriolo

et al. 2024

Hepatology Communications

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Background: While there is a growing need for interventions addressing symptom burden in patients with decompensated cirrhosis (DC), the lack of validated symptom assessment tools is a critical barrier. We investigated the psychometric properties of the revised Edmonton Symptom Assessment System (ESAS-r) in a longitudinal cohort of patients with DC. Methods: Adult outpatients with DC were prospectively recruited from a liver transplant center and completed ESAS-r at baseline and week 12. We examined reliability, floor/ceiling effects, structural validity, and known-groups validity. We examined the convergent and predictive validity of ESAS-r with health-related quality of life using the Short Form Liver Disease Quality of Life (SF-LDQOL) and responsiveness to changes in anxiety and depression using the Hospital Anxiety and Depression Scale and Patient Health Questionnaire-9 from baseline to week 12. Results: From August 2018 to September 2022, 218 patients (9% Child-Pugh A, 59% Child-Pugh B, and 32% Child-Pugh C) were prospectively recruited and completed the ESAS-r, SF-LDQOL, Patient Health Questionnaire-9, and Hospital Anxiety and Depression Scale at baseline and week 12 (n = 135). ESAS-r had strong reliability (Cronbach’s alpha 0.86), structural validity (comparative fit index 0.95), known-groups validity (Child-Pugh A: 25.1 vs. B: 37.5 vs. C: 41.4, p = 0.006), and convergent validity (r = −0.67 with SF-LDQOL). Floor effects were 9% and ceiling effects were 0.5%. Changes in ESAS-r scores from baseline to week 12 significantly predicted changes in SF-LDQOL (β = −0.36, p < 0.001), accounting for 30% of the variation. ESAS-r was strongly responsive to clinically meaningful changes in SF-LDQOL, Patient Health Questionnaire-9, and Hospital Anxiety and Depression Scale. Conclusions: ESAS-r is a reliable, valid, and responsive tool for assessing symptom burden in patients with DC and can predict changes in health-related quality of life. Future directions include its implementation as a key outcome measure in cirrhosis care and clinical trials.

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Section: Discussionmentioning

confidence: 99%

“… 26 27 For SF-LDQOL, we used an MCID cutoff of 8 based on an ongoing clinical trial on the treatment of ascites using SF-LDQOL as the primary outcome (REDUCe 2 Study). 6 …”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The Edmonton Symptom Assessment System is a valid, reliable, and responsive tool to assess symptom burden in decompensated cirrhosis

Donlan,

Zeng,

Indriolo

et al. 2024

Hepatology Communications

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“…For end-stage liver disease, palliative treatment is not ideal and lacks of evidence-based medical evidence, so liver transplantation (LT) is often the only standard curative treatment 8 , 9 . However, the severe shortage of donors has greatly tethered the development of LT and remains a great challenge worldwide.…”

Section: Introductionmentioning

confidence: 99%

Prediction of early recovery of graft function after living donor liver transplantation in children

Tan,

Yang,

et al. 2024

Sci Rep

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For end-stage liver disease in children, living donor liver transplantation (LDLT) is often the important standard curative treatment. However, there is a lack of research on early recovery of graft function after pediatric LDLT. This is a single-center, ambispective cohort study. We collected the demographic and clinicopathological data of donors and recipients, and determined the risk factors of postoperative delayed recovery of hepatic function (DRHF) by univariate and multivariate Logistic analyses. 181 cases were included in the retrospective cohort and 50 cases in the prospective cohort. The incidence of DRHF after LDLT in children was 29.4%, and DRHF could well evaluate the early recovery of graft function after LDLT. Through Logistic analyses and AIC score, preoperative liver function of donors, ischemia duration level of the liver graft, Ln (Cr of recipients before operation) and Ln (TB of recipients on the 3rd day after operation) were predictive indicators for DRHF after LDLT in children. Using the above factors, we constructed a predictive model to evaluate the incidence of postoperative DRHF. Self-verification and prospective internal verification showed that this prediction model had good accuracy and clinical applicability. In conclusion, we pointed many risk factors for early delayed recovery of graft function after LDLT in children, and developed a visual and personalized predictive model for them, offering valuable insights for clinical management.

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“…More work is needed to develop novel PC delivery models in hepatology, including embedded PC clinics co-located within hepatology specialty care as well as telehealth-based and home-based PC for patients with AdvLD (Table 4). 19 Lastly, and most encouragingly, multiple large-scale studies are currently ongoing, which will provide the evidence base for optimal models of primary and specialty PC for patients with AdvLD 20 …”

Section: Introductionmentioning

confidence: 99%

Improving palliative care access for patients with cirrhosis

Manning,

Ufere

2024

Clinical Liver Disease

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Palliative clinical trials in advanced chronic liver disease: Challenges and opportunities

Cited by 11 publications

References 100 publications

The Edmonton Symptom Assessment System is a valid, reliable, and responsive tool to assess symptom burden in decompensated cirrhosis

The Edmonton Symptom Assessment System is a valid, reliable, and responsive tool to assess symptom burden in decompensated cirrhosis

Prediction of early recovery of graft function after living donor liver transplantation in children

Improving palliative care access for patients with cirrhosis

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