Chelsie Derman

Discussion between 3 subject matter experts on the impact of stigmatization on outcomes of alcohol-related liver disease.

HCPLive Alcohol Stigma Discussion Part 2

Shame derived from structural or self-stigma may inhibit patients from obtaining treatment for their 

. This could be because patients might downplay their drinking problems. By internalizing cultural norms surrounding 

, those with alcohol-related liver disease might fear being labeled as an “alcoholic.” 

The healthcare system was designed to separate addiction and hepatology care. Patients would see their alcohol or addiction specialist for alcohol-related issues and would see their hepatology specialist for liver problems. This contributes to patients feeling like they are the ones to be blamed—that their alcohol use was the sole reason they had developed liver disease.

However, this is not true. Although alcohol can lead to liver problems, other causes such as genetics or obesity can lead to liver issues, too.

Research suggests work needs to be done on de-stigmatizing alcohol-related liver disease. A 

 revealed limited usage of non-stigmatization language for AUD and alcohol-related liver disease, underscoring the need for more patient-centered language in transplant centers.

 special report, Hersh Shroff, MD, MPA, moderated a conversation between hepatology specialist Jay Luther, MD, and addiction specialist Chris Kahler, PhD, to discuss the stigmatization of AUD and how hepatologists and addiction specialists can work to collaborate to give patients improved care.

The first part of the report focused on the different types of stigma and how the stigma around AUD may contribute to delays in seeking care for liver disease. The second half of the discussion pivoted to how the collaboration between hepatology and addiction specialists may reduce the stigma surrounding alcohol-associated liver disease.

“To expect that the individual necessarily will have full control over their capacity to say, ‘I can stop drinking tomorrow’ is not realistic for many people,” Kahler said. “It involves not just the involvement of psychiatrists, but social workers, or psychologists, other people who can think about the social determinants of health because those are often driving factors both in alcohol use, but also in delays in seeking care.”

He added the importance of peer support or recovery coaches to share experiences with to reduce the stigma. He also said screening for unhealthy alcohol use is important, rather than a doctor telling their patient, “I think you need to quit drinking.” Kahler stressed the importance of referring the patient to a liver specialist so they can examine actual negative impacts instead of making assumptions.

“Catching patients early or getting patients in who are at high risk for developing disease, so they never develop disease… are critical pieces to the puzzle that…need more attention,” Luther said.

Check out the first half of the discussion: 

https://www.hcplive.com/view/recognizing-stigma-impact-care-alcohol-related-liver-disease

 a transplant hepatologist and an assistant professor of medicine at the University of North Carolina School of Medicine

 an assistant professor of medicine at Harvard Medical School and director of the Massachusetts General Hospital Alcohol Liver Center

 a professor of behavioral and social sciences, a professor of psychiatry and human behavior, and the director of the Center for Alcohol and Addiction Studies at Brown University

Shroff, Luther, and Kahler have no relevant disclosures.

Schomerus G, Leonhard A, Manthey J, et al. The stigma of alcohol-related liver disease and its impact on healthcare. 

. 2022;77(2):516-524. doi:10.1016/j.jhep.2022.04.026

Mahle R, Okanlawon A, Luther J, Louissaint J, Zhang W. Stigmatizing Language for Alcohol Use Disorder and Liver Disease on Liver Transplant Center Websites. 

. 2024;7(2):e2355320. Published 2024 Feb 5. doi:10.1001/jamanetworkopen.2023.55320

Brooks, A. The Power of Words: Liver Transplant Centers Continue to Use Stigmatizing Language. 

https://www.hcplive.com/view/the-power-words-liver-transplant-centers-continue-use-stigmatizing-language

Videos

The second segment of a special report stresses the importance of cross-specialty collaboration with hepatology and psychiatry when treating alcohol-related liver disease.

Addressing Stigma to Improve Outcomes in Alcohol-Related Liver Disease

Credit: University of Kentucky, College of Nursing

A new study on patients with rheumatoid arthritis (RA) underscores the critical role of psychosocial, clinical, and demographic factors and patient-provider relationships in medication adherence and satisfaction.

“This study contributes to the understanding of factors likely contributing to health disparities,” wrote investigators, led by Elizabeth Salt, PhD, from the University of Kentucky.

RA affects 18 million people worldwide, and it is recommended to begin disease-modifying anti-rheumatic drugs within 3 months of diagnosis to prevent joint destruction, loss of joint function, and pain, all of which can happen with untreated synovitis. Unfortunately, only 40% of patients do not have medication adherence.

Factors such as age, gender, comorbidities, medication use, and disease status affect medication adherence in RA patients. Studies also suggest other factors that may affect medication adherence include trust in the provider, knowledge about RA and RA medications, medication adverse events, and the quality of patient-provider communication.

The observational study assessed the relationship between psychosocial, clinical, and demographic factors with medication adherence, patient satisfaction, and medication intolerance.

Psychosocial, Clinical, and Demographic factors

 Anxiety, trust in the provider, quality of patient-provider communication, fatigue, RA knowledge, adverse medication events

 Disease activity, RA medications, RA duration

The team also aimed to identify the psychosocial, clinical, and demographic factors that could predict medication adherence, patient satisfaction, and medication intolerance among RA patients.

The study included a sample of 155 RA patients who were ≥ 18 years old. The mean age was 55.3 years, and most were female (84%). A large percentage of the sample were non-Hispanic White (86%). Less than half (45%) had been diagnosed with RA in the last 10 years.

They had an RA diagnosis based on the 2010 American College of Rheumatology Diagnostic Criteria. At baseline, they self-reported a questionnaire addressing 13 measures:

Medication Adherence: Medication Adherence Report Scale-9RA

Patient satisfaction: Client Satisfaction Questionnaire-8

Medication Intolerance (Patient-Perceived Methotrexate Intolerance Scale)

Patient knowledge about RA medications and care

Trust in the provider (Trust in the Physician Scale)

Quality of patient-provider communication (Patient-health Care Provider Communication Scale

Pain intensity (1 item on the 29-item PROMIS short form)

Pain interference (4 items of the 29-item PROMIS short form)

Anxiety (4 items of the 29-item PROMIS short form)

Fatigue (4 items of the 29-item PROMIS short form)

Disease activity (Routine Assessment of Patient Index Data 3)

Clinical and demographic data (self-reporting RA duration)

Salt and colleagues analyzed the relationships by using correlation analysis, linear regression, and cluster analysis to detect patient subgroups with determination decisions based on Schwartz’s Bayesian Criterion.

Investigators found non-Hispanic White participants have a greater medication adherence (

= .028) and greater trust in their healthcare provider. They were linked to lower disease activity and pain intensity.

Patients diagnosed more recently had greater patient satisfaction (

 = .050). The team saw patient satisfaction increased when lower disease activity, pain intensity, interference, fatigue, and anxiety decreased (each 

< .01). Conversely, patient satisfaction had a positive association with RA knowledge, trust in the provider, and quality of patient-provider communication (each 

Investigators found medication tolerance varied depending on the disease duration, and tolerance was positively associated with disease activity, pain interference, and fatigue.

Compared to Cluster 2, participants in Cluster 1 had greater medication adherence, patient satisfaction, lower medication intolerance, more knowledge about RA, greater trust in their provider, and perceived quality of patient-provider communication.

The team highlighted 3 limitations: the study was only conducted at 1 university health care system, PPMIS is a new measure needing further validation, and the study lacked consideration about beliefs regarding medication and how it may relate to medication adherence.

“This study identified a unique phenotype of patients disproportionately affected by social determinants of health and adversely affected by poor RA health outcomes,” investigators concluded. “It is imperative that multilevel interventions tailored for those most impacted by social determinants of health be developed to improve the identified disparities in RA outcomes.”

Salt E, Wiggins AT, Francis D, Lohr K, Rayens MK. Patient trust, quality communication, and medication adherence in rheumatoid arthritis patients highly affected by social determinants of health. 

Articles

Demographic, psychosocial, and clinical factors—along with patient-provider relationships—all impact medication adherence and patient satisfaction with RA treatment.

Demographic Factors Influence Medicine Adherence, Satisfaction for RA Treatment

PharmaTher announced on April 18 the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Priority Original Abbreviated New Drug Application (ANDA) for ketamine (KETARX).

The letter was comparable to the FDA review letter PharmaTher received on February 12, 2024, stating quality deficiencies.

“Although we will not receive approval on the GDUFA goal date of April 29, 2024, we are pleased that the FDA review of our ANDA has been completed and no additional deficiencies were mentioned from its original review letter,” said CEO of PharmaTher Fabio Chinaelli, in a press release.

The abbreviated new drug application had intended to help increase access to ketamine, a drug used to treat pain, 

, anesthesia, sedation, and neurological indications. Ketamine is essential for relieving pain. According to the WHO Essential Medicines List, it is used for anesthesia and analgesia.

Other than pain, Ketamine may help treat psychiatric disorders. A recent 2023 study found assessing the real-world effectiveness of ketamine intravenous therapy demonstrated significant improvement in depression, anxiety, and suicidal ideation.

Ketamine has been in short supply since February 2018, according to the FDA’s list of scarce drugs.

 A ketamine shortage also exists in Canada, classified as a Tier 3 drug shortage since February 2022.

This scarcity potentially prompted individuals to seek out compounded ketamine products. Although compounded ketamine products lack FDA approval for psychiatric disorders, these compounds are still used for mental health issues due to the shortage of the approved version.

However, compounded ketamine products can be dangerous for people using them for psychiatric disorders. On October 10, 2024, the FDA published a compounding risk alert stating the potential risks linked to compounded ketamine products for psychiatric disorders, particularly for telehealth providers that deliver in-home ketamine services.

“We have completed the necessary tests and are confirming to ensure our responses accurately reflect the FDA’s comments. We will submit them to address the CRL and obtain a revised GDUFA goal date,” Chinaelli said. “I believe that our goal to receive FDA approval for ketamine is closer.”

PharmaTher Provides Update of its Priority Original Abbreviated New Drug Application for Ketamine. 

https://www.pharmather.com/news/pharmather-provides-update-of-its-priority-original-abbreviated-new-drug-application-for-ketamine6168232

Hietamies TM, McInnes LA, Klise AJ, et al. The effects of ketamine on symptoms of depression and anxiety in real-world care settings: A retrospective controlled analysis. 

. 2023;335:484-492. doi:10.1016/j.jad.2023.04.141

FDA issued a CRL the abbreviated new drug application of ketamine, which had sought to enhance accessibility to the limited drug supply.


FDA Issues a CRL for Ketamine’s Abbreviated New Drug Application

A brief 2-week mindfulness-based intervention in patients with 

only helps enhance awareness but not improve skin status, a study found.

“Results of the short-term PP analysis indicated a significant large effect on self-reported mindfulness and a tendency to a significant moderate effect on self-reported self-compassion,” wrote investigators led by Markus Eckardt, from the Institute of Medical Psychology at the University of Gießen in Germany. “Results of the medium-term PP analysis also yielded a tendency to a significant moderate effect on mindfulness.”

According to the World Psoriasis Day consortium, 125 million people have psoriasis worldwide—2 to 3 percent of the total population.2 The chronic inflammatory skin condition is linked to an itch, depression, and anxiety.1 Mindfulness-based interventions have been demonstrated to help people with psoriasis, but it was not known whether a short, 2-week intervention would be just as effective.3

Eckardt and colleagues conducted a randomized controlled trial to see if a 2-week mindfulness intervention would influence mindfulness and self-compassion among people with psoriasis.1 The team broke participants (n = 59) into the experimental group (treatment-as-usual and mindfulness-based intervention; n = 28) and the control group (only treatment-as-usual; n = 31).

The primary outcome was self-reported mindfulness and self-compassion. Secondary outcomes included itch catastrophizing, social anxiety, stress, and skin status. The variables were assessed before, during the intervention, and 3 months after.

The team conducted a repeated-measures analysis of variance (ANOA) to evaluate the effects of mindfulness-based intervention. They recruited patients with psoriasis who participated in a special tertiary prevention program for dermatology patients from Clinic Borkum Riff in Germany. The programs are intended to help patients cope with their disease more functionally so they can return to work.

The mindfulness-based intervention consisted of 8 sessions, 45 – 60 minutes each. The intervention focused on different aspects of mindfulness and included exercises such as body scan or mindful breathing. A psychologist with ≥ 5 years in mindfulness meditation conducted the training.

The short-term and medium-term effects analyses had a smaller sample due to dropouts and missing data (39 and 32 participants, respectively). The mean age of the short-term effects analysis was 49.8 years.

The short-term analysis showed a significant interaction effect on self-reported mindfulness (P = .010) and self-compassion (

.090). Investigators did not observe any other significant effects, although most of the data favored the experimental group over the control group.

The control group was more favorable in 1 variable—skin status. The control group demonstrated greater improvement in skin health than the experimental group, showing the intervention only helped the mind but not the actual psoriasis.

However, the medium-term analysis saw a significant interaction with mindfulness (

 = .558). Additionally, they saw a significant interaction in the severity of psoriasis (

= .023), with a t-test showing a reduction in the severity of psoriasis (

 = .035). The team observed no interaction effects for itch catastrophizing (

Investigators wrote the study was limited by the delivery of the intervention limiting generalizability, the large age range, a possible too-short follow-up period, a lack of an active control group, and the pandemic preventing the planned sample size of 60.

“The effects of such a short intervention should be investigated further in a larger sample and different setting, possibly also using a group receiving a less comprehensive,” investigators concluded.

Eckardt, M., Stadtmueller, L., Zick, C., Kupfer, J., & Schut, C. (2024). Effects of a Brief Mindfulness-based Intervention in Patients with Psoriasis: A Randomized Controlled Trial. 

https://doi.org/10.2340/actadv.v104.18277

https://www.psoriasis.org/psoriasis-statistics/#:~:text=Prevalence&text=125%20million%20people%20worldwide%20%E2%80%94%202,the%20World%20Psoriasis%20Day%20consortium

Bartholomew E, Chung M, Yeroushalmi S, Hakimi M, Bhutani T, Liao W. Mindfulness and Meditation for Psoriasis: A Systematic Review. 

. 2022;12(10):2273-2283. doi:10.1007/s13555-022-00802-1


A new study found a 2-week mindfulness-based intervention for patients with psoriasis does not improve skin status—it only helps the mind.