Care Clinical Trials Research Articles

Patient feasibility as a novel approach for integrating IRT and LCA statistical models into patient-centric qualitative data-a pilot study.

Clinical research increasingly recognizes the role and value of patient-centric data incorporation in trial design, aiming for more relevant, feasible, and engaging studies for participating patients. Despite recognition, research on analytical models regarding qualitative patient data analysis has been insufficient. This pilot study aims to explore and demonstrate the analytical framework of the "patient feasibility" concept-a novel approach for integrating patient-centric data into clinical trial design using psychometric latent class analysis (LCA) and interval response theory (IRT) models. A qualitative survey was designed to capture the diverse experiences and attitudes of patients in an oncological indication. Results were subjected to content analysis and categorization as a preparatory phase of the study. The analytical phase further employed LCA and hybrid IRT models to discern distinct patient subgroups and characteristics related to patient feasibility. LCA identified three latent classes each with distinct characteristics pertaining to a latent trait defined as patient feasibility. Covariate analyses further highlighted subgroup behaviors. In addition, IRT analyses using the two-parameter logistic model, generalized partial credit model, and nominal response model highlighted further distinct characteristics of the studied group. The results provided insights into perceived treatment challenges, logistic challenges, and limiting factors regarding the standard of care therapy and clinical trial attitudes.

Longitudinal evaluation of individuals with severe alpha-1 antitrypsin deficiency (Pi*ZZ genotype)

Homozygous Pi∗Z mutation in alpha-1 antitrypsin (Pi∗ZZ genotype) predisposes to pulmonary loss-of-function and hepatic gain-of-function injury. To facilitate selection into clinical trials typically targeting only 1 organ, we systematically evaluated an international, multicenter, longitudinal, Pi∗ZZ cohort to uncover natural disease course and surrogates for future liver- and lung-related endpoints. Cohort 1 recruited 737 Pi∗ZZ individuals from 25 different centers without known liver comorbidities who received a baseline clinical and laboratory assessment as well as liver stiffness measurement (LSM). A follow-up interview was performed after at least 6 months. Cohort 2 consisted of 135 Pi∗ZZ subjects without significant liver fibrosis, who received a standardized baseline and follow-up examination at least 2 years later, both including LSM. During 2634 patient-years of follow-up, 39 individuals died, with liver and lung being responsible for 46% and 36% of deaths, respectively. Forty-one Pi∗ZZ subjects who developed a hepatic endpoint presented with significantly higher baseline liver fibrosis surrogates, that is, LSM (24 vs 5 kPa, P < .001) and aspartate aminotransferase-to-platelet ratio index (1.1 vs 0.3 units, P < .001). Liver-related endpoints within 5 years were most accurately predicted by LSM (area under the curve 0.95) followed by aspartate aminotransferase-to-platelet ratio index (0.92). Baseline lung parameters displayed only a moderate predictive utility for lung-related endpoints within 5 years (forced expiratory volume in the first second area under the curve 0.76). Fibrosis progression in those with no/mild fibrosis at baseline was rare and primarily seen in those with preexisting risk factors. Noninvasive liver fibrosis surrogates accurately stratify liver-related risks in Pi∗ZZ individuals. Our findings have direct implications for routine care and future clinical trials of Pi∗ZZ patients.

Exploring Racial Disparities in Awareness and Perceptions of Oncology Clinical Trials: Cross-Sectional Analysis of Baseline Data From the mychoice Study.

Black/African American adults are underrepresented in oncology clinical trials in the United States, despite efforts at narrowing this disparity. This study aims to explore differences in how Black/African American oncology patients perceive clinical trials to improve support for the clinical trial participation decision-making process. As part of a larger randomized controlled trial, a total of 244 adult oncology patients receiving active treatment or follow-up care completed a cross-sectional baseline survey on sociodemographic characteristics, clinical trial knowledge, health literacy, perceptions of cancer clinical trials, patient activation, patient advocacy, health care self-efficacy, decisional conflict, and clinical trial intentions. Self-reported race was dichotomized into Black/African American and non-Black/African American. As appropriate, 2-tailed t tests and chi-square tests of independence were used to examine differences between groups. Black/African American participants had lower clinical trial knowledge (P=.006), lower health literacy (P<.001), and more medical mistrust (all P values <.05) than non-Black/African American participants. While intentions to participate in a clinical trial, if offered, did not vary between Black/African American and non-Black/African American participants, Black/African American participants indicated lower awareness of clinical trials, fewer benefits of clinical trials, and more uncertainty around clinical trial decision-making (all P values <.05). There were no differences for other variables. Despite no significant differences in intent to participate in a clinical trial if offered and high overall trust in individual health care providers among both groups, beliefs persist about barriers to and benefits of clinical trial participation among Black/African American patients. Findings highlight specific ways that education and resources about clinical trials could be tailored to better suit the informational and decision-making needs and preferences of Black/African American oncology patients.

Methylation profiling in the contemporary management of meningioma.

The last decade has seen major international research efforts focus on better understanding disease heterogeneity in meningioma. Multiple molecular platforms have generated significant biological and clinical utility, and there is a need to translate these findings into routine clinical practice. Here we review the role of DNA methylation profiling in meningioma and advocate for its widespread adoption. We review modern DNA methylation-based classification and outcome prediction tools in meningioma. Biological classifiers, which were constructed agnostic to outcome using unsupervised approaches, outcome predictors, and liquid biopsy models are discussed in detail. DNA methylation has been used for biological classification and outcome in meningioma with considerable success. Several groups have proposed novel molecular classification systems which share similar features with one another and outperform WHO grade in their ability to predict outcome and explain subgroup-specific biological processes. In addition, recent studies have suggested a role for methylation-based liquid-biopsy in meningioma, which represents an exciting avenue for further exploration. DNA methylation profiling has been revolutionary in meningioma. There is a need for widespread adoption of these approaches to personalize care and inform clinical trial design.

Abstract B136: Health related social needs of people with cancer underrepresented in clinical trials: Early experience of the Cancer Research Equity and Advocacy through Engagement Initiative (CREATE) clinical trial patient navigation program

Abstract Background: Black and African Americans (AA) remain severely underrepresented in therapeutic oncology clinical trials (TOCTs) and have the highest cancer mortality rates compared to all other groups. Racially biased clinical trial offers, poor physician-patient communication, and social determinants of health largely contribute to these racial inequities. The UNC Lineberger CREATE Clinical Trial Patient Navigation (CTPN) program was established to advance racial equity in TOCT participation. The CTPN program entails clinical trial education, facilitating communication between patients and their medical/research team, identifying barriers to clinical trial participation and connecting patients to resources to address those barriers. Here we describe the health-related social needs and referrals made to address those needs. Methods: The CTPN program employed a targeted proactive approach to reach patients with a new cancer diagnosis who self-identified as Black/African American (AA) or were insured by Medicaid. The patient navigator used the electronic medical record (EMR) to review the oncologist's schedule to identify patients meeting the above criteria. Identified patients received a letter in the mail describing the CTPN program and were offered an in-person clinic visit and/or telephone call with the patient navigator. During these encounters, the patient navigator assessed clinical trial barriers including health-related social needs and made referrals to resources to help address these needs. The CTPN program was initially launched in the thoracic oncology clinic but later became available for direct referrals from all oncology groups. Results: In the first 18 months of the CTPN program, there were 292 patient encounters among183 unique patients who received navigation services. Most patients (83%) were identified through the EMR, 79% identify as Black or AA, 64% have Medicaid. Patients had a diagnosis of lung (62%), head and neck (18%), gynecological (9%), and breast (2%) cancers. Clinical trial related barriers and health-related social needs included lack of clinical trial knowledge (68%), housing (9%), transportation (26%), financial support (18%), and family/caregiver support (14%). CTPN program materials were provided to address clinical trial informational needs (78%), and referrals were made to assist with emotional (13%), logistical (20%), and financial (21%) needs. On average, 2 referrals were made per patient encounter. Conclusion: CTPN can engage Black/AA patients with cancer using a proactive EMR approach to identify patients and may help address health-related social needs to facilitate cancer care and potential clinical trial participation. Future work will evaluate the impact of CTPN on enrollment of Black/AAs in therapeutic cancer clinical trials. Citation Format: Ashley Rankin Collins, Hayley N. Morris, Lauren N. Matthews, Omar N. Buenaventura Gomez, Marjory Charlot. Health related social needs of people with cancer underrepresented in clinical trials: Early experience of the Cancer Research Equity and Advocacy through Engagement Initiative (CREATE) clinical trial patient navigation program [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B136.

Exploration of alive-and-ventilator free days as an outcome measure for clinical trials of Resuscitative interventions.

Outcome selection is a critically important aspect of clinical trial design. Alive-and-ventilator free days is an outcome measure commonly used in critical care clinical trials, but has not been fully explored in resuscitation science. A simulation study was performed to explore approaches to the definition and analysis of alive-and-ventilator free days in cardiac arrest populations. Data from an in-hospital cardiac arrest observational cohort and from the Pragmatic Airway Resuscitation Trial were used to inform and conduct the simulations and validate approaches to alive-and-ventilator free days measurement and analysis. Alive-and-ventilator-free days is a flexible outcome measure in cardiac arrest populations. An approach to alive-and-ventilator free days that assigns -1 days when return of spontaneous circulation is not achieved provides a wider distribution of the outcome and improves statistical power. The optimal approach to the analysis of alive-and-ventilator free days varies based on the expected impact of the intervention under study on rates of return of spontaneous circulation, survival, and ventilator-free survival. Alive-and-ventilator free days adds to the armamentarium of clinical trialists in the field of resuscitation science.

FOUND Trial: randomised controlled trial study protocol for case finding of obstructive sleep apnoea in primary care using a novel device

IntroductionObstructive sleep apnoea (OSA) is a common, but underdiagnosed, sleep disorder. If untreated, it leads to poor health outcomes, including Alzheimer’s disease, cancer, cardiovascular disease and all-cause mortality. Our aim...

A Health Care Clinical Data Platform for Rapid Deployment of Artificial Intelligence and Machine Learning Algorithms for Cancer Care and Oncology Clinical Trials.

The xCures platform aggregates, organizes, structures, and normalizes clinical EMR data across care sites, utilizing advanced technologies for near real-time access. The platform generates data in a format to support clinical care, accelerate research, and promote artificial intelligence/ machine learning algorithm development, highlighted by a clinical decision support algorithm for precision oncology.

Barriers, Solutions, and Opportunities for Adapting Critical Care Clinical Trials in the COVID-19 Pandemic

The COVID-19 pandemic created unprecedented challenges for clinical trials worldwide, threatening premature closure and trial integrity. Every phase of research operations was affected, often requiring modifications to protocol design and implementation. To identify the barriers, solutions, and opportunities associated with continuing critical care trials that were interrupted during the pandemic, and to generate suggestions for future trials. This mixed-methods study performed an explanatory sequential analysis involving a self-administered electronic survey and focus groups of principal investigators (PIs) and project coordinators (PCs) conducting adult and pediatric individual-patient randomized trials of the Canadian Critical Care Trials Group during the COVID-19 pandemic. Eligible trials were actively enrolling patients on March 11, 2020. Data were analyzed between September 2023 and January 2024. Importance ratings of barriers to trial conduct and completion, solutions employed, opportunities arising, and suggested strategies for future trials. Quantitative data examining barriers were analyzed using descriptive statistics. Data addressing solutions, opportunities, and suggestions were analyzed by qualitative content analysis. Integration involved triangulation of data sources and perspectives about 13 trials, synthesized by an interprofessional team incorporating reflexivity and member-checking. A total of 13 trials run by 29 PIs and PCs (100% participation rate) were included. The highest-rated barriers (on a 5-point scale) to ongoing conduct during the pandemic were decisions to pause all clinical research (mean [SD] score, 4.7 [0.8]), focus on COVID-19 studies (mean [SD] score, 4.6 [0.8]), and restricted family presence in hospitals (mean [SD] score, 4.1 [0.8]). Suggestions to enable trial progress and completion included providing scientific leadership, implementing technology for communication and data management, facilitating the informed consent process, adapting the protocol as necessary, fostering site engagement, initiating new sites, streamlining ethics and contract review, and designing nested studies. The pandemic necessitated new funding opportunities to sustain trial enrollment. It increased public awareness of critical illness and the importance of randomized trial evidence. While underscoring the vital role of research in society and drawing the scientific community together with a common purpose, the pandemic signaled the need for innovation to ensure the rigor and completion of ongoing trials. Lessons learned to optimize research procedures will help to ensure a vibrant clinical trials enterprise in the future.

Palliative care interventional research in general practice: a narrative review of factors affecting research conduct.

The majority of palliative care provision occurs in general practice, yet only 9% of palliative care clinical trials were conducted in this setting. Evidence from hospital and specialist settings is not readily transferable to general practice, as the population, context and care processes are vastly different. Conducting interventional palliative care research in general practice settings is subject to many challenges and barriers. This narrative review aims to describe the factors influencing the conduct of interventional research in general practice settings for patients with palliative care needs. A narrative review was performed to identify factors affecting the conduct of palliative care interventional studies in general practice. A literature search of MEDLINE was conducted on 26 September 2023, and data were synthesised utilising a narrative approach. Sixteen articles were identified. Five thematic groupings were identified from the literature that affected the interventions: factors related to health care professionals (HCPs), patients and carers, general practices, health systems, and research design. HCPs and practices were focused on providing clinical care and struggled to incorporate research into their workload. Staff and patients often had negative perceptions in palliative care combined with limited research experience, often resulting in unwillingness to engage in interventions and gatekeeping. Engaging with general practice staff to design, participate and champion research were key facilitators of successful interventions. Palliative care interventions in general practice are invariably complex and challenging, yet acutely needed to address the care needs of patients in the community setting. Working together with patients, carers and clinicians to design and implement interventions appropriate for general practice settings is fundamental to their success.

Collaborative discussions between GPs and pharmacists to optimise patient medication: a qualitative study within a UK primary care clinical trial.

There has been significant investment in pharmacists working in UK general practice to improve the effective and safe use of medicines. However, evidence of how to optimise collaboration between GPs and pharmacists in the context of polypharmacy (multiple medication) is lacking. To explore GP and pharmacist views and experiences of in-person, interprofessional collaborative discussions (IPCDs) as part of a complex intervention to optimise medication use for patients with polypharmacy in general practice. A mixed-method process evaluation embedded within the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial conducted in Bristol and the West Midlands, between February 2021 and September 2023. Audio-recordings of IPCDs between GPs and pharmacists, along with individual semi-structured interviews to explore their reflections on these discussions, were used. All recordings were transcribed verbatim and analysed thematically. A total of 14 practices took part in the process evaluation from February 2022 to September 2023; 17 IPCD meetings were audio-recorded, discussing 30 patients (range 1-6 patients per meeting). In all, six GPs and 13 pharmacists were interviewed. The IPCD was highly valued by GPs and pharmacists who described benefits, including: strengthening their working relationship; gaining in confidence to manage more complex patients; and learning from each other. It was often challenging, however, to find time for the IPCDs. The model of IPCD used in this study provided protected time for GPs and pharmacists to work together to deliver whole-patient care, with both professions finding this beneficial. Protected time for interprofessional liaison and collaboration, and structured interventions may facilitate improved patient care.

Equipping Scientists to Conduct Palliative Care Clinical Trials: The Clinical Trials Intensive (CTI) (RP307)

Equipping Scientists to Conduct Palliative Care Clinical Trials: The Clinical Trials Intensive (CTI) (RP307)

Gender Disparity in Leading Authorship of Critical Care Clinical Trials: A Systematic Review and Meta-Analysis.

In critical care medicine, research trials serve as crucial avenues for disseminating knowledge, influencing clinical practices, and fostering innovation. Notably, a significant gender imbalance exists within this field, potentially mirrored in the authorship of critical care research. This study aimed to investigate an exploration to ascertain the presence and extent of female representation in first and senior authorship roles within critical care literature. To this end, a systematic search was conducted across PubMed, Google Scholar, and Web of Science databases for original articles published up to February 2024, coupled with a methodological quality assessment via the Newcastle-Ottawa Scale (NOS) and statistical analyses through Review Manager software (RevMan, version 5.4.1, The Cochrane Collaboration, 2020). The study's findings, distilled from seven studies included in the final analysis, reveal a pronounced gender disparity. Specifically, in critical care literature examining mixed populations, female first authors were significantly less common than their male counterparts, with an odds ratio (OR) of 4.25 (95% confidence interval (CI): 3.18-5.68; p < 0.00001). Conversely, pediatric critical care studies did not show a significant difference in gender distribution among first authors (OR: 1.37; 95% CI: 0.31-6.10; p = 0.68). The investigation also highlighted a stark underrepresentation of female senior authors in critical care research across both mixed (OR: 11.67; 95% CI: 7.76-17.56; p < 0.00001) and pediatric populations (OR: 5.41; 95% CI: 1.88-15.56; p = 0.002). These findings underscore the persistent underrepresentation of women in critical care literature authorship and their slow progression into leadership roles, as evidenced by the disproportionately low number of female senior authors.

Point-of-Care Clinical Trials in Nephrology.

Point-of-Care Clinical Trials in Nephrology.

Barriers and Facilitators of Surrogates Providing Consent for Critically Ill Patients in Clinical Trials: A Qualitative Study

BackgroundEnrollment into critical care clinical trials is often hampered by the need to rely on surrogate decision-makers. To identify potential interventions facilitating enrollment into critical care clinical trials, a better understanding of surrogate decision-making for critical care clinical trial enrollment is needed. Research QuestionWhat are the barriers and facilitators of critical care trial enrollment? What are surrogate decision makers’ perspectives on proposed interventions to facilitate trial enrollment? Study Design and MethodsThe authors conducted semi-structured interviews with 20 surrogate decision-makers of critically ill patients receiving mechanical ventilation. The interviews were recorded and transcribed verbatim, and analyzed for themes using an inductive approach. ResultsTwenty surrogate decision-makers of critically ill patients participated in the semi-structured interviews. Thematic analysis confirmed previous research showing that trust in the system, assessing the risks and benefits of trial participation, the desire to help others, and building medical knowledge as important motivating factors for trial enrollment. Two previously undescribed concerns among surrogate decision makers of critically ill patients were identified, including the potential to interfere with clinical treatment decisions and negative sentiment about placebos. Surrogates viewed public recognition and charitable donations for participation as favorable potential interventions to encourage trial enrollment. However, participants viewed direct financial incentives and prioritizing research participants during medical rounds negatively. InterpretationThis study confirms and extends previous findings that health system trust, study risks and benefits, altruism, knowledge generation, interference with clinical care and placebos are key concerns and barriers for surrogate decision-makers to enroll patients in critical care trials. Future studies are needed to evaluate if charitable giving on the patient's behalf and public recognition are effective strategies to promote enrollment into critical care trials.

Palliative Care Interventions for Persons With Neurodegenerative Disease: A Scoping Review of Clinical Trial Study Design Features.

Background: Within palliative care research, best practice guidelines to conduct scientifically rigorous clinical trials for neurodegenerative diseases are underexplored. This patient population experiences unique challenges, including fluctuations in cognitive capacity, care partner (CP) and proxy involvement, and high adverse events (AEs), that necessitate special consideration when designing clinical trials. Objective: The objective of this study was to describe and identify clinical trial design features that have been documented in studies involving a neuropalliative intervention for persons with neurodegenerative diseases, highlighting features that have been adapted for this unique patient population. Design: We conducted a scoping review of clinical trials with a neuropalliative intervention for persons with neurodegenerative disease. We searched Cochrane, Web of Science, EMBASE, Scopus, and PubMed (MEDLINE) databases for articles published in English between 1950 and 2023. Two reviewers screened, extracted, and synthesized data from the included articles. A third reviewer adjudicated instances of conflict. The data were analyzed using a thematic framework approach. Results: Of 1025 texts, 44 articles were included. Seven study design features were analyzed: (1) consent, (2) proxies and CPs, (3) recruitment strategies, (4) retention strategies, (5) choice of comparator, (6) AEs, and (7) internal validity. This scoping review found disparities in study design features around structured consent, proxies and CPs, comparators, and AEs. Conclusions: To date, neuropalliative care clinical trials have had varied study designs and the majority of research has focused on dementia. Research guideline development for high-quality neuropalliative care clinical trials is greatly needed across the range of neurodegenerative diseases. To increase the scientific rigor of clinical trials and neuropalliative care, we recommend a standardized capacity assessment for consent, defining conditions for the CP, proxy, and AEs, systematizing appropriate comparators, and outlining preemptive recruitment and retention strategies to address the broader unpredictable challenges of palliative care research.

Are Published Cancer Care Trial Protocols With Traditional Chinese Medicine Interventions Concordant With SPIRIT-TCM Extension 2018? A Scoping Review on Published Trial Protocols Between 2019 and 2022.

The SPIRIT-TCM Extension 2018 was created to guide the design and reporting of Traditional Chinese Medicine (TCM) clinical trial protocols. This study aims to investigate the extent of concordance with this guideline in the relevant field of cancer care research. A scoping review of TCM cancer trial protocols published in English and Chinese since January 2019 was conducted. Five major academic databases (MEDLINE, EMBASE, CINAHL, CENTRAL, and China National Knowledge Infrastructure) were searched. Concordance with the SPIRIT-TCM Extension 2018 was assessed by descriptive analysis. Fifty-three TCM cancer care trial protocols were identified, comprising 23 acupuncture, 26 Chinese herbal medicine (CHM), and 4 Tai Chi/Qigong (TCQ) interventions. The majority of the checklist items had a low rate of concordance, especially in the reporting of quality control and safety, dosage, TCM diagnostic patterns, possible interactions between Western Medicine and TCM interventions, and TCM-related outcome assessments. Although the SPIRIT-TCM Extension 2018 guideline was established through extensive Delphi consultation, there are low rates of concordance between published TCM cancer care clinical trial protocols with the guideline. Further research is necessary to understand the low rate of concordance and how scientific rigors of reporting can be improved in TCM cancer care research.

THE NIH STAGE MODEL AND STUDY EXAMPLES OF EARLY STAGES IN DEMENTIA CARE INTERVENTION DEVELOPMENT RESEARCH

Abstract The NIH’s Stage Model provides a common language to facilitate discussion of intervention development research. According to NIH Stage Model (2022), “an examination of the mechanisms of behavior change or the principles underlying an intervention is encouraged by the NIH Stage Model in every Stage of behavioral intervention development.” The five papers in this symposium focus on early-stage intervention development by refinement, adaptation and pilot testing (Stage 1) related to dementia and palliative care (PC) clinical trials. The first paper is a cluster trial of a PC education program for nurses (N=23) in 10 assisted living communities that tested the mechanism of staff self-efficacy in increases in advance care planning discussions with family members of residents living with dementia. The second paper is a clinical trial that tested the feasibility of Companion Robots in live-alone Korean-American older adults (N=30) to determine which features help improve health behaviors (e.g. medication adherence, daily exercises). The third paper is a single-site clinical trial pilot study developed with stakeholders which tested the feasibility of a palliative care community health worker support program for hospitalized minoritized persons living with dementia and their caregivers. The fourth paper adapts an evidence-based e-PainSupport intervention for use with dementia caregivers to report patient pain and administration of analgesics. The fifth paper is a protocol to test the feasibility and acceptability of a culturally sensitive caregiver peer support program (Pair2Care) in current (n=15) and trained former (n=15) African-American dementia caregivers. The discussant will highlight ways to improve clinical trial mechanisms.

Palliative Care Clinical Trials in Underrepresented Ethnic and Racial Minorities: A Narrative Review.

Introduction: A growing number of patients with serious illness who would benefit from palliative care are part of ethnoracial minority groups. Nevertheless, large disparities in provision of palliative services exist for minoritized populations. Furthermore, there is a relative dearth of palliative care research focused on minority groups and how best to provide high-quality, culturally tailored palliative care. The aim of this narrative review is to summarize the existing literature regarding palliative care clinical trials in underrepresented minority populations, describe methodological approaches, and provide guidance on future palliative care-focused clinical trials. Methods: We used the Scale for the Assessment of Narrative Review Articles (SANRA) and Cochrane's guidelines on conducting reviews. We used PubMed and Clinicaltrials.gov to review published, full-text articles or protocols (1950-2022), and limited to palliative care interventions focused on ethnoracial minority populations. We included randomized clinical trials (RCTs), including pilot and feasibility trials, protocols of RCTs, and studies that report RCT methodology. Two reviewers independently assessed eligibility. Results: Our search yielded 585 publications; of these, 30 met the full-text review criteria and 16 studies met our criteria for inclusion. We deemed nine articles as having low risk of bias and four as having high risk of bias. Discussion: Commonly used methodologic approaches for clinical trials in underrepresented minority populations included the following: the use of written and visual materials that were no higher than a sixth-grade reading level, the use of patient and lay health navigators, bilingual and multicultural study staff and study materials, race-concordant staff, the option of in-person and virtual visits that accommodated the patient and family's schedule, recruitment from faith communities, and the use of community-engaged research principles. Future palliative care clinical trials should expand on the strategies described in this article, adopt effective strategies currently used in nonpalliative care interventions, and innovate around the principles of community-engaged research.

Methods for assessing portal hypertension

Many researchers and clinicians have taken the value of hepatic venous pressure gradient (HVPG) as an essential prognostic factor in subjects with chronic liver diseases. HVPG ≥ 10 mmHg indicates the presence of clinically significant portal hypertension, the main predictor of the risk of variceal bleeding, hepatic decompensation, and mortality. However, HVPG measurement is invasive and requires high expertise, so its routine use outside tertiary care centers or clinical trials is limited. Clinically significant portal hypertension also might be detected using non-invasive options such as ultrasonography, elastography, magnetic resonance imaging, and indices derived from laboratory parameters. Our review aims to present the feasibility and applicability of HVPG in modern clinical practice in patients with liver cirrhosis, including invasive and non-invasive methods, based on literary sources from the MEDLINE database.