Applying PEOP to Develop an Intervention Framework for Employment in Parkinson's Disease.

Employment intervention is essential for supporting people with Parkinson's disease (PwPD), who leave the workforce on average 5 years earlier than those without Parkinson's disease (PD). We developed a framework for occupational therapists (OTs) to address employment for PwPD. Our qualitative analysis employed data source triangulation of environmental scan of resources and publications, electronic medical records data, and focus groups with clinicians and PwPD. The framework underwent expert panel review by OTs and researchers who are knowledgeable of current evidence-based practices for PD. The framework is based on the Person-Environment-Occupation-Performance (PEOP) Model and PEOP Occupational Therapy Process and comprised of four parts: PEOP features of PD relevant to employment, performance changes experienced by PwPD, a process to evaluate and address employment, and intervention ideas. This framework serves as an impetus to explore evidence-based, scalable, proactive intervention approaches to address employment in PwPD.

Creating a framework to help occupational therapists support people with Parkinson's Disease to maintain employmentThis study aims to support people with Parkinson's disease (PwPD) in maintaining employment by developing a framework for occupational therapists (OTs). PwPD often leave their jobs 5 years earlier than others because they lack early employment support. OTs are well suited to address this need due to their expertise in task analysis, client-centered interventions, and enabling participation in meaningful activities.The researchers created a framework through an iterative process. They analyzed various sources, including occupational therapy resources and medical records, and reviewed data from focus groups with clinicians and PwPD. The framework aligns with the Person-Environment-Occupation-Performance (PEOP) Model and PEOP Occupational Therapy Process and consists of four main parts:Understanding how Parkinson's disease affects individuals, their work environment, and job-related aspects.Identifying the changes in employment performance experienced by PwPD.Outlining a process for OTs to evaluate and intervene in employment-related issues.Providing various intervention ideas categorized by therapeutic domain.The study also acknowledges the challenges clinicians face when addressing employment needs in PwPD. In conclusion, this framework serves as a foundation for clinicians and researchers to explore evidence-based, proactive intervention strategies for assisting PwPD in maintaining their employment.

Treatment of Refractory Vulvar Lichen Sclerosus With Methotrexate.

We report the successful treatment of severe vulvar lichen sclerosus refractory to topical corticosteroids in 3 adult female patients using low-dose oral methotrexate. All cases reported symptomatic and clinical improvement within 12 weeks.

Effects of economic interventions on pediatric and adolescent HIV care outcomes: a systematic review.

Economic insecurity and poverty present major barriers to HIV care for young people. We conducted a systematic review of the current evidence for the effect of economic interventions on HIV care outcomes among pediatric populations encompassing young children, adolescents, and youth (ages 0-24). We conducted a search of PubMed MEDLINE, Cochrane, Embase, Scopus, CINAHL, and Global Health databases on October 12, 2022 using a search strategy curated by a medical librarian. Studies included economic interventions targeting participants <25 years in age which measured clinical HIV outcomes. Study characteristics, care outcomes, and quality were independently assessed, and findings were synthesized. Title/abstract screening was performed for 1934 unique records. Thirteen studies met inclusion criteria, reporting on nine distinct interventions. Economic interventions included incentives (n = 5), savings and lending programs (n = 3), and government cash transfers (n = 1). Study designs included three randomized controlled trials, an observational cohort study, a matched retrospective cohort study, and pilot intervention studies. While evidence is very limited, some promising findings were observed supporting retention and viral suppression, particularly for those with suboptimal care engagement or with detectable viral load. There is a need to further study and optimize economic interventions for children and adolescents living with HIV.

A systematic review and meta-analysis of diet and nutrient intake in adults with irritable bowel syndrome.

BACKGROUND: Numerous individual and environmental factors including diet may play an important role in the pathophysiology of irritable bowel syndrome (IBS). It is unclear to what degree dietary intake is affected in individuals with IBS. We aimed to perform a systematic review and meta-analysis to summarize dietary intake of adults with IBS and to compare dietary intake between adults with IBS and non-IBS controls. METHODS: Ovid MEDLINE, Embase, Cochrane, CINAHL, and Scopus were searched through February 2023 for clinical trials and observational studies measuring usual diet in adults with IBS. Pooled weighted averages were estimated for total energy, macronutrient, and micronutrient data. Mean differences (MD) in nutrient intake were estimated for adults with IBS versus non-IBS controls using a random effects model. Heterogeneity was assessed by the inconsistency index (I2). KEY RESULTS: Sixty-three full-text articles were included in the review of which 29 studies included both IBS and control subjects. Nutrients not meeting the recommended intake level for any dietary reference values in the IBS population were fiber and vitamin D. Meta-regression by female proportion was positively correlated with total fat intake and negatively correlated with carbohydrate intake. Comparisons between participants with IBS and controls showed significantly lower fiber intake in participants with IBS with high heterogeneity (MD: -1.8; 95% CI: -3.0, -0.6; I2 = 85%). CONCLUSIONS AND INFERENCES: This review suggests that fiber and vitamin D intake is suboptimal in IBS; however, overall dietary intake does not appear to be comprised. Causes and consequences of reduced fiber in IBS deserve further study. Results of this systematic review and meta-analysis suggest that fiber and vitamin D intake is suboptimal in IBS. However, overall intake of other macro- and micronutrients does not appear to be compromised. Causes and consequences of reduced fiber and Vitamin D intake in IBS deserve further study.

Feasibility and Implementation Determinants of a Structured Goal Setting and Goal Management System.

IMPORTANCE: There is no evidence-based system to guide occupational therapists in implementing theory-based, client-engaged goal setting and goal management. A new system is needed to support high-quality goal setting and goal management. OBJECTIVE: To determine the acceptability, appropriateness, feasibility, credibility, and expectancy of a new structured theory-based, client-engaged goal setting and goal management system, called MyGoals, for occupational therapists. We explored MyGoals' implementation determinants, potential positive outcomes, and comparative advantages. DESIGN: This was a mixed-methods feasibility study. SETTING: Community. PARTICIPANTS: Occupational therapists (N = 7). OUTCOMES AND MEASURES: Acceptability, appropriateness, and feasibility were assessed using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Credibility and expectancy were assessed with the Credibility and Expectancy Questionnaire (CEQ). Semistructured 1:1 interviews were conducted to explore occupational therapy perspectives on MyGoals and its implementation-related factors. RESULTS: MyGoals had high AIM (M = 18.1, SD = 1.9), IAM (M = 17.9, SD = 2.2), FIM (M = 17.3, SD = 2.1) scores and high CEQ Credibility (M = 22.1, SD = 5.0) and Expectancy (M = 20.6, SD = 4.3) scores. Interview data revealed suggestions to improve MyGoals, implementation determinants across the individuals involved, inner setting, and intervention characteristic domains, client- and clinician-related potential positive outcomes, and comparative advantages. CONCLUSIONS AND RELEVANCE: MyGoals is an acceptable, appropriate, feasible, credible, and promising system to guide occupational therapists in implementing theory-based, client-engaged goal setting and goal management for adults with chronic conditions in community-based rehabilitation. What This Article Adds: MyGoals is an easy-to-use, appealing, and helpful system to support occupational therapists in delivering theory-based goal setting and goal management components and to enable adults with chronic conditions to actively engage in their rehabilitation. This study supports the usefulness of MyGoals in community-based rehabilitation to improve goal setting and goal management quality and personally meaningful rehabilitation goal achievement in this population.

Cognitive Self-Efficacy in Parkinson's Disease.

Cognitive self-efficacy (CSE), one's belief in their ability to control their cognitive performance, is important for participation in daily activities and rehabilitation. This study aims to understand how Parkinson's disease (PD) affects CSE. The Cognitive Self-Efficacy Questionnaire (CSEQ) was administered to 47 non-demented PD and 52 healthy comparison (HC) participants. Groups were compared on their self-reported ability to recognize (Part 1) and manage (Part 2) cognitive symptoms and to perform cognitively complex functional activities (Part 4). Relationships between CSEQ scores and individual characteristics were assessed within PD. The PD group had lower CSEQ scores than the HC group for all Parts. Within PD, Part 2 scores were lower than Parts 1 and 4, and worse depressive symptoms and higher medication dosage correlated with lower CSE. People with PD may have low CSE, which can contribute to participation restrictions and reduced engagement in treatment. Occupational therapists should consider CSE with clients with PD.

Cognitive deficits are common in people with Parkinson's disease (PD) and affect their quality of life. In this study, the researchers looked at cognitive self-efficacy (CSE) or the belief in one's cognitive abilities and compared the CSE of healthy individuals with individuals with PD without dementia. The findings of the study suggest that non-demented individuals with PD have lower CSE as compared with healthy individuals. Furthermore, individuals with PD may have difficulty recognizing and managing their cognitive deficits such as memory deficits or distractibility. This may affect their ability to participate in everyday tasks that require complex cognition such as managing finances or shopping or engaging in therapy interventions focused on cognition. The study also found that greater depressive symptoms and higher dose of dopamine medications in non-demented individuals with PD lowered their CSE. This study recommends that rehabilitation professionals include assessments and interventions on CSE during treatment sessions.

Subjective Memory Complaints Predict Decline in Memory, Instrumental Activities of Daily Living, and Social Participation in Older Adults: A Fixed-Effects Model.

IMPORTANCE: Although subjective memory complaints (SMCs) have been suggested to be associated with future memory impairment, limitations in instrumental activities of daily living (IADLs), and social participation restriction, these associations are still inconclusive. OBJECTIVE: To determine whether changes in SMCs over time predict decline in memory, IADLs, and social participation in older adults. DESIGN: Longitudinal study. SETTING: Community. PARTICIPANTS: Sample 1 included 2,493 community-dwelling older adults drawn from the Health and Retirement Study (HRS) data collected between 2004 and 2018. Sample 2 included 1,644 community-dwelling older adults drawn from the HRS data collected between 2008 and 2018. OUTCOMES AND MEASURES: Self-reported SMCs, memory function, self-reported IADL performance, and self-reported social participation. RESULTS: The mean age of Sample 1 at baseline was 70.16 yr; 1,468 (58.88%) were female. In Sample 1, immediate and delayed memory (all ps < .001) and IADL performance (p < .01) declined over time. Increases in SMCs over time significantly predicted future immediate and delayed memory declines (p < .01 and p < .001, respectively) and future IADL performance decline (p < .001), after controlling for depressive symptoms. The mean age of Sample 2 at baseline was 71.52 yr; 928 (56.45%) were female. In Sample 2, social participation declined over time (all ps < .001). Increases in SMCs over time significantly predicted future social participation decline (p < .05), after controlling for depressive symptoms. CONCLUSIONS AND RELEVANCE: Increases in SMCs predict future decline in memory, IADL performance, and social participation after accounting for depressive symptoms. What This Article Adds: SMCs can be used as an early indicator of future memory impairment, IADL limitations, and social participation restrictions in older adults. Furthermore, interventions that minimize SMCs may help older adults achieve successful aging.

Feasibility, Client Engagement, and Person-Centeredness of Telehealth Goal Setting and Goal Management Intervention.

Telehealth-delivered goal setting and goal management may guide occupational therapists (OTs) to form a strong foundation of active client engagement and personally meaningful goals on which to base effective telehealth intervention. The objective was to determine the feasibility of a goal setting and goal management system, called MyGoals, delivered through telehealth and hybrid formats for adults with chronic conditions. This was a mixed-method feasibility study. The Credibility and Expectancy Questionnaire and Client Satisfaction Questionnaire-8 measured credibility, expectancy, and satisfaction. The Goals and Participation subscales of the Client-Centredness of Goal Setting Scale measured engagement and person-centeredness. Targeted self-ratings measured change objective achievement. Individuals' perspectives on MyGoals' feasibility were further explored in semi-structured interviews. In telehealth (N = 8) and hybrid (N = 9) groups, MyGoals had good credibility (M = 25.5, SD = 1.9), expectancy (M = 23.4, SD = 3.3), satisfaction (M = 31.3, SD = 0.9), client engagement (M = 29.4, SD = 1.5), person-centeredness (M = 19.5, SD = 1.2), and change objective achievement (M = 9.6, SD = 0.2). The interview data suggested improvements for MyGoals. In conclusion, telehealth delivery of MyGoals is feasible to support goal setting and goal management for adults with chronic conditions.

Implementation strategies for occupational therapists to advance goal setting and goal management.

Background: There is a need for an effective evidence-based system to support high-quality goal setting and goal management implementation. We developed a new system for community-based rehabilitation, MyGoals, along with implementation strategies to support occupational therapists (OTs) in its administration. This study evaluates the acceptability, appropriateness, and feasibility of the implementation strategies, Clinician Education and Audit & Feedback. It also explores whether OTs achieve the change objectives of the MyGoals implementation strategies and MyGoals intervention fidelity. Methods: This mixed-methods case series study evaluated the MyGoals implementation strategies developed using Implementation Mapping (IM), specifically IM Task 5 - Implementation Outcome Evaluation. Seven OTs and 13 adults with chronic conditions participated in this study. OTs participated in two Clinician Education sessions, delivered two MyGoals interventions, and participated in two Audit & Feedback sessions. We evaluated the implementation strategies using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM), and semi-structured interviews and explored the OTs' self-rated MyGoals change objectives achievement and the intervention fidelity using quantitative MyGoals intervention fidelity measures and interviews. Quantitative data were analyzed using descriptive statistics. Qualitative data were analyzed by two independent coders using content analysis. Results: Seven OTs participated in this study (mean years of professional experience = 9.3, SD = 5.9). Clinician Education and Audit & Feedback had high AIM (M = 17.9, SD = 2.7), IAM (M = 17.3, SD = 3.60), and FIM scores (M = 17.3, SD = 3). The OTs also had high mean scores on self-perceived achievement of change objectives and intervention fidelity. Qualitative interviews suggested that the time commitment for Clinician Education is a key barrier to its acceptability, appropriateness, and feasibility. Participants also provided suggestions on how to improve the strategies (e.g., providing recorded Clinician Education, etc.). Conclusions: The MyGoals implementation strategies are acceptable, appropriate, and feasible to OTs working in community-based rehabilitation. They support OTs in achieving the change objectives necessary to deliver MyGoals completely and competently. Thus, the MyGoals implementation strategies may support clinicians in implementing a theory-based, client-engaged goal setting and goal management for adults with chronic conditions in community-based rehabilitation. This can ultimately help improve the integration of evidence-based interventions into practice.

Fatigue as an Understudied Barrier to Participation in Life Roles.

Fatigue is one of the most burdensome and disabling symptoms in numerous acute and chronic conditions and is associated with reduced participation in all aspects of daily life, for example, parenting, employment, and socialization. Historically, occupational practitioners played key roles in fatigue management by creating and implementing interventions. The American Occupational Therapy Foundation convened a Planning Grant Collective workshop with the goal to develop collaborative research ideas and proposals to advance the understanding and management of fatigue. Participants from occupational therapy and other disciplines, with expertise with fatigue or who were conducting research on fatigue, participated in a 3-day virtual workshop. Four main topics emerged: implementation science, treatment taxonomy, trial design and comparative effectiveness, and phenotyping. This white paper describes the proceedings, summarizes the discussions, and outlines recommendations from the PGC workshop on fatigue.

Factors facilitating shared decision making in eczema: Met and unmet needs from the patient perspective.

Background: Research has shown that eczema patients prefer some degree of shared control over treatment decisions, but little is known about factors perceived to be important to facilitate shared decision making (SDM). Objective: To determine factors eczema patients and caregivers consider to be important for SDM, and how often they experience them with their eczema healthcare provider (HCP). Methods: A cross-sectional survey study (64 questions) was conducted, which included factors related to SDM rated by respondents on a Likert scale for importance, and how often these factors were true with their current eczema HCP. Results: Respondents (840, response rate 62.4%) most frequently rated their health literacy and communication skills as important for SDM. Factors which indicated a strong provider-patient relationship, and HCPs who initiate treatment conversations were also deemed beneficial. Low importance was placed on concordant HCP race/ethnicity, however, of those who did rate it as important, 53/91 identified as Black (half of all Black respondents). Limitations: A high proportion of respondents were aware of the term SDM prior to the survey. Conclusions: SDM is more likely to be facilitated when patient education and empowerment are coupled with HCPs who initiate treatment discussions, maintain compassion resilience, and listen to patient perspectives.

Effect of a High-Fat Meal on Single-Dose Rencofilstat (CRV431) Oral Bioavailability in Healthy Human Subjects.

Rencofilstat (RCF) is a novel cyclophilin inhibitor under development for the treatment of nonalcoholic steatohepatitis and hepatocellular carcinoma. This phase 1, randomized, open-label study in healthy participants assessed the relative bioavailability of a single dose of RCF 225-mg soft gelatin capsules in both fasted and high-fat conditions. Forty-four participants were enrolled to either the fasted (n = 24) or the high-fat fed (n = 20) arm. Noncompartmental pharmacokinetics were evaluated following a single 225-mg oral dose. Administration of RCF with a high-fat meal led to increases in maximum concentration, area under the concentration-time curve (AUC) from time 0 to 24 hours, and AUC from time 0 to infinity fed-to-fasted geometric mean ratios of 102.2%, 114.5%, and 132.9%, respectively. All AUC geometric mean ratios were outside of the 80% to 125% range, suggesting that a high-fat meal can increase the extent of RCF exposure. Time to maximum concentration increased from 1.5 to 1.8 hours in the fasted and high-fat groups, respectively, suggesting slightly delayed absorption. High fat intake may delay gastric emptying while increasing the absorption and bioavailability of RCF. No treatment-emergent adverse events were observed in the fasted group, and 1 treatment-emergent adverse event occurred in the high-fat meal group. The differences in observed whole-blood concentrations are unlikely to have clinically relevant effects given the wide therapeutic index of RCF demonstrated in previous phase 1 studies.

Person-centered goal setting is feasible in people with Parkinson's disease who have subjective cognitive decline: a mixed methods study.

PURPOSE: Evaluate the feasibility of person-centered goal setting in people with Parkinson's disease (PD) who have subjective cognitive decline and explore characteristics of the formulated goals. MATERIALS AND METHODS: Participants completed person-centered goal setting as a part of two cognitive intervention studies. Participants were guided to develop at least three goals and rate the importance of each goal using a 10-point scale (1: not at all important - 10: extremely important). To evaluate the feasibility of person-centered goal setting, we calculated the mean number of formulated goals per person and the importance level of all goals. To explore goal characteristics, two independent authors coded all goals and synthesized them using deductive content analysis in consultation with the senior author. RESULTS: Thirty participants formulated a total of 166 goals. The mean number of formulated goals per participant was 5.53 (SD = 2.22, range = 3 - 10). The mean importance level of all formulated goals was 8.3 (SD = 1.49, range = 4 - 10). Formulated goals ranged across diverse domains and categories. CONCLUSIONS: Person-centered goal setting is feasible to guide people with PD to formulate personally meaningful goals. Findings highlight the diverse cognitive rehabilitation needs of people with PD, potential cognitive rehabilitation priorities, and future goal setting research directions.Implications for rehabilitationRehabilitation clinicians and researchers should not assume that people with PD who have subjective cognitive decline are not capable of engaging in their goal setting.Rehabilitation clinicians and researchers should acknowledge and act on our responsibility to enable people with PD who have subjective cognitive decline to engage in goal setting.Rehabilitation clinicians and researchers are encouraged to explore diverse goal domains to optimize goal setting and rehabilitation care among people with PD who have subjective cognitive decline.

Development of a goal setting and goal management system: Intervention Mapping.

Background: Although goal setting and goal management (GSGM) is a key component of chronic disease management and rehabilitation practice, there is currently no widely used evidence-based intervention system available. This paper describes the theoretical underpinnings and development of a new intervention called MyGoals. MyGoals is designed to guide occupational therapy (OT) practitioners to implement theory-based, client-engaged GSGM for adults with chronic conditions in community-based OT rehabilitation settings. Methods: We first developed a planning team with two adults with chronic conditions, two clinicians, and two researchers. As a collaborative team, we co-developed MyGoals by following Intervention Mapping (IM) steps 1-4 and incorporating community-based participatory research principles to ensure equitable, ecologically valid, and effective intervention development. In the first step, the planning team conducted a discussion-based needs assessment and a systematic review of current GSGM practice to develop a logic model of the problem. In the second step, the planning team identified performance objectives, intervention target personal determinants, and change objectives, and created a logic model of change and matrics of change objectives. In the third step, the planning team designed MyGoals. Lastly, in the fourth step, the planning team produced, pilot-tested, and refined MyGoals. Results: The ultimate goal of the MyGoals intervention is to enable clients to achieve personally meaningful rehabilitation goals. The planning team identified four target determinants (e.g., self-efficacy), six intervention activities (e.g., Education, Reflection, Find My Goals, Make My Goals, Make My Plans, My Progress), eight performance objectives (e.g., List potential goals), and 26 change objectives (e.g., Understand the importance of GSGM). Two pilot tests indicated that MyGoals is feasible for clients and identified areas for improvement. Based on the feedback, minor refinements were made to the MyGoals intervention materials. Conclusions: We completed rigorous and collaborative IM to develop MyGoals. Establishing the theoretical and developmental foundation for MyGoals sets the groundwork for high-quality, evidence-based GSGM. Future studies on effectiveness and implementation are necessary to refine, translate, and scale MyGoals in rehabilitation practice.

Effects of Mindfulness Training and Exercise on Cognitive Function in Older Adults: A Randomized Clinical Trial.

Importance: Episodic memory and executive function are essential aspects of cognitive functioning that decline with aging. This decline may be ameliorable with lifestyle interventions. Objective: To determine whether mindfulness-based stress reduction (MBSR), exercise, or a combination of both improve cognitive function in older adults. Design, Setting, and Participants: This 2 × 2 factorial randomized clinical trial was conducted at 2 US sites (Washington University in St Louis and University of California, San Diego). A total of 585 older adults (aged 65-84 y) with subjective cognitive concerns, but not dementia, were randomized (enrollment from November 19, 2015, to January 23, 2019; final follow-up on March 16, 2020). Interventions: Participants were randomized to undergo the following interventions: MBSR with a target of 60 minutes daily of meditation (n = 150); exercise with aerobic, strength, and functional components with a target of at least 300 minutes weekly (n = 138); combined MBSR and exercise (n = 144); or a health education control group (n = 153). Interventions lasted 18 months and consisted of group-based classes and home practice. Main Outcomes and Measures: The 2 primary outcomes were composites of episodic memory and executive function (standardized to a mean [SD] of 0 [1]; higher composite scores indicate better cognitive performance) from neuropsychological testing; the primary end point was 6 months and the secondary end point was 18 months. There were 5 reported secondary outcomes: hippocampal volume and dorsolateral prefrontal cortex thickness and surface area from structural magnetic resonance imaging and functional cognitive capacity and self-reported cognitive concerns. Results: Among 585 randomized participants (mean age, 71.5 years; 424 [72.5%] women), 568 (97.1%) completed 6 months in the trial and 475 (81.2%) completed 18 months. At 6 months, there was no significant effect of mindfulness training or exercise on episodic memory (MBSR vs no MBSR: 0.44 vs 0.48; mean difference, -0.04 points [95% CI, -0.15 to 0.07]; P = .50; exercise vs no exercise: 0.49 vs 0.42; difference, 0.07 [95% CI, -0.04 to 0.17]; P = .23) or executive function (MBSR vs no MBSR: 0.39 vs 0.31; mean difference, 0.08 points [95% CI, -0.02 to 0.19]; P = .12; exercise vs no exercise: 0.39 vs 0.32; difference, 0.07 [95% CI, -0.03 to 0.18]; P = .17) and there were no intervention effects at the secondary end point of 18 months. There was no significant interaction between mindfulness training and exercise (P = .93 for memory and P = .29 for executive function) at 6 months. Of the 5 prespecified secondary outcomes, none showed a significant improvement with either intervention compared with those not receiving the intervention. Conclusions and Relevance: Among older adults with subjective cognitive concerns, mindfulness training, exercise, or both did not result in significant differences in improvement in episodic memory or executive function at 6 months. The findings do not support the use of these interventions for improving cognition in older adults with subjective cognitive concerns. Trial Registration: ClinicalTrials.gov Identifier: NCT02665481.

Rencofilstat, a cyclophilin inhibitor: A phase 2a, multicenter, single-blind, placebo-controlled study in F2/F3 NASH.

Rencofilstat (RCF) demonstrated antifibrotic effects in preclinical models and was safe and well tolerated in Phase 1 studies. The aim of this Phase 2a study was safety, tolerability, pharmacokinetics, and exploration of efficacy biomarkers in subjects with nonalcoholic steatohepatitis (NASH). This Phase 2a, multicenter, single-blind, placebo-controlled study randomized 49 presumed F2/F3 subjects to RCF 75 mg once daily (QD), RCF 225 mg QD, or placebo for 28 days. Primary safety and tolerability endpoints were explored using descriptive statistics with post hoc analyses comparing active to placebo groups. Pharmacokinetics were evaluated using population pharmacokinetics methods. Efficacy was explored using biomarkers, transcriptomics, and lipidomics. RCF was safe and well tolerated, with no safety signals identified. The most frequently reported treatment-emergent adverse events were constipation, diarrhea, back pain, dizziness, and headache. No clinically significant changes in laboratory parameters were observed, and RCF pharmacokinetics were unchanged in subjects with NASH. Alanine transaminase (ALT) reduction was greater in active subjects than in placebo groups. Nonparametric analysis suggested that ALT reductions were statistically different in the 225-mg cohort compared with matching placebo: -16.3 ± 25.5% versus -0.7 ± 13.4%, respectively. ProC3 and C6M reduction was statistically significant in groups having baseline ProC3 > 15.0 ng/ml. RCF was safe and well tolerated after 28 days in subjects with presumed F2/F3 NASH. Presence of NASH did not alter its pharmacokinetics. Reductions in ALT, ProC3, and C6M suggest direct antifibrotic effects with longer treatment duration. Reductions in key collagen genes support a mechanism of action via suppression and/or regression of collagen deposition. Conclusion: These results support advancement of rencofilstat into a larger and longer Phase 2b study.

Past, Present, and Future Shared Decision-making Behavior Among Patients With Eczema and Caregivers.

Importance: Engaging in shared decision-making (SDM) can help patients understand and choose treatments according to their values and has been shown to improve patient satisfaction and adherence with treatment. It is well suited for conditions like eczema for which several medically appropriate treatment options exist. However, little is known about the use and experience of SDM in eczema. Objective: To understand experiences, preferences, and expectations for SDM in eczema care settings from the patient and caregiver perspective. Design, Setting, and Participants: The National Eczema Association conducted an online survey in January 2021 among self-selected patients and caregivers. Inclusion criteria (US resident, patient with eczema or caregiver of a patient with eczema aged ≤17 years, respondent age ≥18 years) were met by 1313 of 1387 respondents (94.7%). Data analysis was performed from May 2021 to November 2021. Main Outcomes and Measures: Outcomes were past SDM (using a 9-item SDM questionnaire [SDMQ9]; score ranges transformed to 0-100), present SDM (Control Preferences Scale), and future SDM (self-reported confidence and motivation to engage in SDM) behavior. Results: Among the 1313 respondents included in the study, most were female (1046 of 1313 [79.7%]) adult (1086 of 1313 [82.7%]) patients with a mean (SD) patient Recap of Atopic Eczema score of 11.7 (7.2), mean (SD) patient age of 39.5 (22.2) years, and mean (SD) SDMQ9 score of 65.1 (27.4). For present SDM, 479 of 966 (49.6%) reported "I prefer to make the final decision after seriously considering my doctor's opinion," and 655 of 955 (69.4%) reported being very or extremely confident to engage in SDM in the future. Those who reported feeling "very well informed" about the causes of eczema had a 14.7-point higher (95% CI, 9.2-20.2; P < .001, multiple linear regression) SDMQ9 score than those "not adequately informed" and were 3.4 times more likely (95% CI, 2.1-5.7; P < .001, multiple logistic regression) to be confident to engage in future SDM. Respondents reported that they would be motivated to engage in SDM if the clinician initiated SDM, valued input from the patient, and acknowledged that patients are experts on their own bodies or if a treatment is no longer working. Conclusions and Relevance: Results of this survey study suggest that a majority of patients with eczema and caregivers prefer a large role in decision-making for their care and that clinicians can initiate and facilitate SDM to improve patient satisfaction with care.