Underrepresentation of Racial and Ethnic Minorities in High-Impact Cirrhosis Clinical Trials

Diaz, Paige McLean; Venkatesh, Ananya; Nephew, Lauren; Jones, Patricia D.; Kochar, Bharati; Ufere, Nneka N.

doi:10.1016/j.cgh.2022.11.020

Cited by 2 publications

(2 citation statements)

References 7 publications

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“…Efforts should be made to ensure appropriate representation of the target population with respect to age, sex, race, ethnicity, and socioeconomic status. 104 , 105 Inclusion criteria should specify a minimum symptom burden (using a consistent rating system) to standardize the study sample. The selection of comparators should ensure comparison to the highest standard of “usual care,” and “usual care” should be pre-specified at the study outset.…”

Section: Resultsmentioning

confidence: 99%

Targets and study design for symptom-focused trials aimed at patients with cirrhosis: An expert consensus

Patel

Tapper

Kanwal

et al. 2023

Hepatology Communications

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Background: Symptom-focused trials are critically needed for patients with cirrhosis. However, this work would benefit from standard processes and validated measures. Methods: A writing group was formed among hepatologists, nurses, palliative care providers, pharmacists, and clinical trial experts focused on symptom management in patients with cirrhosis to define the key (1) components of trial design, (2) symptom targets, (3) measurement, and (4) outcomes for each target. From July 2022 to January 2023, panelists participated in an iterative process of developing and arriving at a consensus for each component. The goal was to provide consensus definitions that can be operationalized in future clinical trials, including for patients with cirrhosis. Results: The panel reached a consensus on key reporting features for clinical trials, along with considerations for study design. Nine key symptom targets (muscle cramps, pruritus, pain, fatigue, sexual dysfunction, sleep disorders, depression and anxiety, nausea/vomiting, and dyspnea/breathlessness) were identified. The panel selected instruments that can be considered for clinical trials based on psychometric validation and previous experience. The panel identified ongoing needs, including instrument validation, safety data, evidence about non-pharmacologic interventions, and comparative effectiveness studies. Conclusion: This expert panel identified key design, reporting, and measurement elements to standardize processes and measures in future symptom-focused clinical trials in the context of cirrhosis.

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Section: Resultsmentioning

confidence: 99%

Targets and study design for symptom-focused trials aimed at patients with cirrhosis: An expert consensus

Patel

Tapper

Kanwal

et al. 2023

Hepatology Communications

View full text Add to dashboard Cite

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“…The study participants were also predominantly White (9/11, 82%). Although the study participants reflected the demographics of the geographic area served by the clinic, the inclusion of ethnic and racial minority individuals in research is important to ensure that tools that meet the needs of diverse populations and promote health equity are developed [ 64 ]. In addition, participants were recruited from 1 hepatology clinic, which brings about 2 other limitations: other clinics in other health care systems may be set up differently and people without access to health care were not considered for the study.…”

Section: Discussionmentioning

confidence: 99%

Testing a Digital Health App for Patients With Alcohol-Associated Liver Disease: Mixed Methods Usability Study

Park,

Kornfield,

Yezihalem

et al. 2023

JMIR Form Res

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Background Alcohol-associated liver disease (ALD) is increasingly common and associated with serious and costly health consequences. Cessation of drinking can improve ALD morbidity and mortality; however, support for cessation is not routinely offered to those diagnosed with ALD, and continued drinking or resumption of drinking after diagnosis is common. Mobile health (mHealth) has the potential to offer convenient and scalable support for alcohol cessation to those diagnosed with ALD, but mHealth interventions for alcohol cessation have not been designed for or evaluated in a population with ALD. Objective This study aims to understand how individuals with ALD would perceive and use an mHealth tool for alcohol cessation and to gather their perspectives on potential refinements to the tool that would allow it to better meet their needs. Methods We interviewed 11 individuals who attended clinic visits related to their ALD to elicit their needs related to support for alcohol cessation and views on how mHealth could be applied. After completing initial interviews (pre), participants were provided with access to an mHealth app designed for alcohol cessation, which they used for 1 month. Afterward, they were interviewed again (post) to give feedback on their experiences, including aspects of the app that met their needs and potential refinements. We applied a mixed methods approach, including a qualitative analysis to identify major themes from the interview transcripts and descriptive analyses of use of the app over 1 month. Results First, we found that a diagnosis of ALD is perceived as a motivator to quit drinking but that patients had difficulty processing the overwhelming amount of information about ALD they received and finding resources for cessation of alcohol use. Second, we found that the app was perceived as usable and useful for supporting drinking recovery, with patients responding favorably to the self-tracking and motivational components of the app. Finally, patients identified areas in which the app could be adapted to meet the needs of patients with ALD, such as providing information on the medical implications of an ALD diagnosis and how to care for their liver as well as connecting individuals with ALD to one another via a peer-to-peer support forum. Rates of app use were high and sustained across the entire study, with participants using the app a little more than half the days during the study on average and with 100% (11/11) of participants logging in each week. Conclusions Our results highlight the need for convenient access to resources for alcohol cessation after ALD diagnosis and support the potential of an mHealth approach to integrate recovery support into care for ALD. Our findings also highlight the ways the alcohol cessation app should be modified to address ALD-specific concerns.

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Underrepresentation of Racial and Ethnic Minorities in High-Impact Cirrhosis Clinical Trials

Cited by 2 publications

References 7 publications

Targets and study design for symptom-focused trials aimed at patients with cirrhosis: An expert consensus

Targets and study design for symptom-focused trials aimed at patients with cirrhosis: An expert consensus

Testing a Digital Health App for Patients With Alcohol-Associated Liver Disease: Mixed Methods Usability Study

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