Higher Patient Activation Research Articles

Low Haemoglobin is Inversely Associated with Disease Activity in Rheumatoid Arthritis: A Cross-Sectional Study from a Tertiary Care Hospital.

Extra-articular manifestations especially haematological abnormalities are common in Rheumatoid arthritis (RA). The aim is to study the haematological parameters and its correlation with disease severity and gender. A cross-sectional study was conducted at a tertiary centre among 50 RA patients who attended the Rheumatology or General Medicine OPD from January 2020 to June 2021. The number of swollen joints, tender joints, the patient's global assessment, rheumatoid factor, and complete blood counts were recorded. Disease Activity Score (DAS-28) was calculated from these variables and data was analysed using SPSS version 29 with p<0.05 considered as statistically significant. Of the study subjects, forty (80%) were females; thirty (60%) belonged to the age group 41-50 years. Median age was 42.4(18, 50) years. 79 % (19 out of 24) of subjects with normal haemoglobin had moderate disease activity on DAS 28 score and 50% (13/26) of participants with low haemoglobin levels had high disease activity. Simple linear regression analysis showed low haemoglobin is inversely associated with DAS 28 score (R2 = 0.407, F= 32.888, p < 0.001). Compared to females, males had a higher haemoglobin level which was statistically significant. Female patients had statistically significant higher DAS 28 scores than males (p = 0.016). Low haemoglobin levels are associated with high disease activity in RA patients and males had less severe disease than females.

The impact of cognitive impairment on patient activation and their value in self-management among COPD patients

ObjectivesTo examine the impact of the interaction between cognitive function and patient activation on self-management behaviors among COPD patients. MethodsWe conducted a study of 331 COPD patients. Cognitive function and patient activation were evaluated at baseline, relevant information on social demography and diseases was collected simultaneously. The primary outcome was self-management behaviors. We performed a multiple logistic regression analysis to evaluate the interaction between cognitive function and patient activation. ResultsWe found the interaction between mild cognitive impairment (MCI) and low patient activation on poor self-management behaviors was multiplicative. The proportion of participants with high patient activation was lower than those with low patient activation among patients with MCI. The incidence of poor self-management behaviors in patients with normal cognition differed significantly between participants with different activation levels (90.2 % vs.31.3 % vs.9.7 %). However, the difference was small in those with MCI (94 % vs. 73.5 % vs. 84.5). Notably, poor self-management behaviors were high among patients with MCI, regardless of their activation level. ConclusionsPatients with COPD are more likely to have poor self-management behaviors when MCI and low patient activation coexist, and it was difficult to be activated for patients with MCI. Practice implicationsThe assessment of cognitive function is crucial for patients with COPD, especially those with low activation.

Factors associated with patient activation among patients with diabetes on hemodialysis: a multicenter cross-sectional study from a developing country

BackgroundDiabetes mellitus (DM) is a major public health concern with considerable morbidity and mortality. DM affects patients’ quality of life and can lead to multiple complications, including chronic kidney disease (CKD) and the need for dialysis. Higher patient activation can improve health outcomes in hemodialysis patients with DM. This study aimed to explore the factors associated with higher patient activation and health-related quality of life (HRQoL) among hemodialysis patients with DM.MethodsThis was a cross-sectional, questionnaire-based study conducted on hemodialysis patients with DM in Palestine. The quota sampling method was utilized to draw samples from six dialysis centers. The questionnaire consists of three sections. The first section includes demographic, socioeconomic and clinical questions. The second section utilizes the patient activation measure-13 (PAM-13) to measure patient activation, while the third section assesses HRQoL using the EQ-5D-5 L tool and the visual analog scale (VAS). Mann‒Whitney and Kruskal‒Wallis tests were employed to examine the relationships between variables at the bivariate level, and multiple regression analysis was employed at the multivariate level.ResultsOf the 200 patients who were approached, 158 were included. The median PAM, EQ-5D index, and VAS score were low at 51.0, 0.58, and 60.0, respectively. A higher PAM score was independently associated with a higher household income level and taking medications independently. A higher EQ-5D index was associated with taking more than eight medications, taking medications independently, living with fewer than three comorbid conditions, and having a higher PAM. A higher VAS score was associated with being married, and receiving less than 3.5 hours of hemodialysis.ConclusionsA higher patient activation level was associated with a higher income level and independence in taking medications. Interventions designed to improve patient activation, such as medication management programs, should address these factors among the target population. Longitudinal studies are needed to assess the time effect and direction of causation between health status and patient activation.

Deescalated 225Ac-PSMA-617 Versus 177Lu/225Ac-PSMA-617 Cocktail Therapy: A Single-Center Retrospective Analysis of 233 Patients.

The aim of this work is to evaluate our clinical real-world data obtained with 225Ac-PSMA-617 (AcPSMA), which were acquired under compassionate care regulations in patients with advanced-stage prostate cancer. The objective parameters that could be derived from this evaluation are compared with previous literature about AcPSMA and 177Lu-PSMA-617 (LuPSMA). Methods: The medical files of all patients who had received AcPSMA on an individual patient basis at the Heidelberg University Hospital since January 2014 were analyzed retrospectively. Previously published patients were excluded. The remaining patients were tailored into 2 subgroups with different treatment strategies: group 1 received AcPSMA as a deescalated monotherapy, and group 2 received LuPSMA plus AcPSMA as a cocktail regimen. Baseline characteristics, serum prostate-specific antigen (PSA) response, and overall survival were compared with the most appropriate historical controls. Results: Of 287 patients treated, 54 were excluded because of previous publication and 233 were evaluated, 104 of whom received AcPSMA monotherapy (median, 6 MBq). In this group, 55 patients (53%) presented with a best PSA response of at least 50%. The other 129 patients received a cocktail therapy of AcPSMA (median, 4 MBq) plus LuPSMA (4 GBq). In this group, a best PSA response of at least 50% was observed in 74 patients (57%). The median overall survival in the monogroup was 9 mo and in the cocktail group was 15 mo. If adjusted for prognostic baseline characteristics, the efficacy of both regimens was not significantly different. Conclusion: Deescalated treatment activities of AcPSMA or AcPSMA and LuPSMA cocktail regimens present better tolerability with regard to xerostomia than previous regimens of at least 100 kBq/kg while retaining high antitumor activity in poor-prognosis prostate cancer patients.

Patient activation and psychological coping strategies to manage challenging circumstances during the COVID-19 pandemic in people with kidney disease

BackgroundCoping with health problems requires some degree of self-management; however, an individual’s ability to self-manage can be threatened during challenging times, such as the COVID-19 pandemic. Exploring differences and changes in psychological well-being and coping strategies between those with low and high patient activation may inform appropriate interventions to support psychological coping.MethodsPeople with chronic kidney disease (CKD) (non-dialysis and transplant) were recruited from 11 hospital sites across England between August and December 2020. Participants responded to an online survey study, including the Brief Coping Orientation to Problem Experienced (COPE) Inventory, Depression, Anxiety and Stress Scale (DASS-21), Short Health Anxiety Index (SHAI), and Patient Activation Measure (PAM-13). A follow-up survey was conducted 6–9 months later. Paired t tests assessed within-group changes, and chi-squared tests compared coping strategies utilised by low- and high-activated participants. General linear modelling was performed to determine the relationship between patient activation and coping strategies, and covariates.ResultsTwo hundred and fourteen participants were recruited (mean age: 60.7, 51% male, mean eGFR: 38.9 ml/min/1.73 m2). Low-activated participants were significantly more anxious than high-activated participants (P = 0.045). Health anxiety significantly decreased (i.e., got better) for high-activated participants (P = 0.016). Higher patient activation scores were associated with greater use of problem-focused strategies (β = 0.288, P < 0.001). Age (β = − 0.174, P = 0.012), sex (β = 0.188, P = 0.004), and education level (β = 0.159, P = 0.019) significantly predicted use of problem-focused strategies.DiscussionThose with higher activation had lower levels of anxiety, and more frequently used adaptive coping strategies during the pandemic. Targeted support and interventions may be required for people with CKD to enhance patient activation, encourage more positive adaptive coping strategies, and mitigate maladaptive coping strategies.Graphical abstract

The impact of patient activation on the effectiveness of digital health remote post-discharge follow-up and same-day-discharge after elective colorectal surgery.

Low patient activation (PA) is associated with worse postoperative outcomes, however, its impact on the effectiveness of digital health interventions is unknown. We sought to determine the impact of PA on the effectiveness of digital health application for remote post-discharge follow-up for patients undergoing elective colectomy. Data analysis included a control cohort (CC) of patients undergoing elective colorectal surgery from 10/2017 to 04/2018 without the digital health intervention and a digital application cohort (DAC) that received a smart phone application for remote post-discharge follow-up from 03/2021 to 08/2022, including a subset of same-day discharge (SDD) patients. PA was measured using the Patient Activation Measure (PAM; score 0-100) and categorized into low (< 55.1) and high (≥ 55.1). The PAM was administered 4-6weeks before surgery in the DAC group and on postoperative day (POD) 1 in the CC group. The main outcome measure was 30-day emergency department (ED) visits. A total of 164 patients were included (89DAC with 50 SDD, 75CC), with no differences in patient characteristics other than more stoma closures in the DAC group. Overall, 77% of patients had high PA level, with no difference between CC and DAC (77% vs. 81%, p = 0.25). There was no difference in ED visits between CC and DAC (19% vs. 18%, p = 0.90). Overall, low PA was associated more ED visits (29% vs 14%, p = 0.04). In the SDD subgroup, low PA patients had more ED visits (38% vs. 7%, p = 0.015). PA level did not affect app usage metrics. On multiple regression, only low PA remained independently associated with ED visits (OR 3.42, 95%CI 1.27, 9.24). Low PA remains an important predictor of surgical outcomes after elective colorectal surgery regardless of the use of a digital health application for remote post-discharge follow-up. This suggests that improving PA levels may improve postoperative outcomes.

Gel-ultraphonophoresis for patients with scarring on the skin: results of comparative prospective intervention study

INTRODUCTION. In modern realities of peace and military trauma there are an increasing number of scar skin defects, often accompanied by pronounced subjective sensations and tissue functional limitations. An urgent task is the scientific substantiation of effective methods of their correction.&#x0D; OBJECTIVE. To determine healing effects and safety of using ultraphonophoresis of enzyme gel with high transcutaneous and proteolytic activity in patients with scarring on the skin.&#x0D; MATERIALS AND METHODS. There was examination of 82 patients with emerging (N=21 study group, N=16 comparison group) and mature (N=25 study group, N=20 comparison group) scar skin of different localizations at the rehabilitation stage after various injuries, burns, removal of skin neoplasms. The study applied clinical and functional methods in the assessment of scar tissue, medical and sociological methods in evaluating patients’ quality of life and safety profile.&#x0D; RESULTS. There were improved clinical indicators and functional skin properties in the scar area, a significant regression of subjective sensations, an increased quality of life score, more pronounced in the study groups. Dynamics of clinical indicators is more expressed in group 1 and group 3. Vascularization values before and after treatment in the groups were: in group 1 and 3 before treatment - 6,4±0,93 and 5,8±0,25, after - 3,0±0,24 and 2,7±0,31, respectively; in group 2 the values before and after treatment were 5,6±0,26 и 4,2±0,62, respectively, in group 4 – before treatment 4,9±0,53, after - 4,1±0,48. As a result of dynamics of the quality of life indicators, a more significant improvement was found in the study groups with respect to the comparison groups. In the group with emerging scars the sum of points before treatment was 20,4±0,3, after treatment - 12,4±0,3; in the comparison group - 18,7±0,5 and 13,4±0,5 before and after treatment, respectively; in the group with mature scars: before treatment - 23,6±0,3, after - 13,7±0,4; in the comparison group - 21,3±0,4 и 16,2±0,5 before and after treatment, respectively. A favorable safety profile of treatment was defined: adverse events (tingling, burning) were transient and fully cupped after the procedure.&#x0D; DISCUSSION. Ultraphonophoresis, one of the man methods in the transdermal delivery, contributes to changing the epidermal barrier permeability for molecules of various drugs as well as potentiation for actions of anti-scarring agents at different stages of emerging and existing scar skin defects.&#x0D; CONCLUSION. Ultraphonophoresis of the enzyme gel with a high transcutaneous and proteolytic activity has fibromodulating and sedative curative effects in patients with scarring skin of different genesis and duration.

Does Patient-Reported Outcome Measures Use at New Foot and Ankle Patient Clinic Visits Improve Patient Activation, Experience, and Satisfaction?

Category: Other; Ankle Introduction/Purpose: Patient-reported outcome measures (PROMs) can help predict clinical outcomes and improve shared clinical decision-making discussions. There remains a paucity of research assessing how the use of PROMs may drive improved patient experience and patient activation. This randomized, controlled trial study objectives: 1) Determine if the active use and discussion of PROMs during new patient visits are associated with patient satisfaction and experience 2) Determine if the active use and discussion of PROMs during new patient clinic visits are associated with patient activation; and 3) To determine if the objectives (1) and (2) differ based on surgeon or sociodemographic factors. Methods: This Institutional Review Board (IRB) approved singled-blinded RCT was registered prior to data collection on ClinicalTrials.gov (NCT04654910). As a standard of care, new foot and ankle patients completed PROMIS Physical Function (PF), Pain Interference (PI), and Depression assessments. Patients were then randomized to viewing and discussing their PROMIS scores with their surgeon or not. Following the clinic visit, patients completed a series of Clinician &amp; Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) questions and the Patient Activation Measure (PAM). CG-CAHPS findings and PAM responses were compared between the two groups and after clustering on surgeon. Potential interaction effects by social deprivation were also explored. Results: After enrolling patients but removing those lost to follow-up or with missing data, 97 and 116 patients remained in the intervention control cohorts, respectively. No difference was found in CG-CAHPS responses, nor PAM scores between the two groups (p&gt;0.05). All surgeons were highly rated by all patients. When clustered by surgeon, intervention subjects were less likely to indicate “top box” scores for the understanding domain of the CG-CAHPS question (OR:0.51;p &lt; 0.001) and had decreased odds of high patient activation compared to control subjects (OR:0.67;p=0.005). Among the most socially disadvantaged patients, there was no difference in control and intervention subjects in their likelihood of having high patient activation (p=0.09). Conclusion: Well perceived foot and ankle surgeons who show and discuss PROMs results may not improve the patient experience or activation and may, in fact, decrease understanding or patient activation in select populations. Future work is needed to determine when PROMs discussions are most beneficial and how best to present PROMs data. Health literacy tools and/or communication training may better engage different patient groups regarding PROMs.

BAFF system expression in double negative 2, activated naïve and activated memory B cells in systemic lupus erythematosus.

B cell activating factor (BAFF) has an important role in normal B cell development. The aberrant expression of BAFF is related with the autoimmune diseases development like Systemic Lupus Erythematosus (SLE) for promoting self-reactive B cells survival. BAFF functions are exerted through its receptors BAFF-R (BR3), transmembrane activator calcium modulator and cyclophilin ligand interactor (TACI) and B cell maturation antigen (BCMA) that are reported to have differential expression on B cells in SLE. Recently, atypical B cells that express CD11c have been associated with SLE because they are prone to develop into antibody-secreting cells, however the relationship with BAFF remains unclear. This study aims to analyze the BAFF system expression on CXCR5- CD11c+ atypical B cell subsets double negative 2 (DN2), activated naïve (aNAV), switched memory (SWM) and unswitched memory (USM) B cells. Forty-five SLE patients and 15 healthy subjects (HS) were included. Flow cytometry was used to evaluate the expression of the receptors in the B cell subpopulations. Enzyme-linked immunosorbent assay (ELISA) was performed to quantify the soluble levels of BAFF (sBAFF) and IL-21. We found increased frequency of CXCR5- CD11c+ atypical B cell subpopulations DN2, aNAV, SWM and USM B cells in SLE patients compared to HS. SLE patients had increased expression of membrane BAFF (mBAFF) and BCMA receptor in classic B cell subsets (DN, NAV, SWM and USM). Also, the CXCR5+ CD11c- DN1, resting naïve (rNAV), SWM and USM B cell subsets showed higher mBAFF expression in SLE. CXCR5- CD11c+ atypical B cell subpopulations DN2, SWM and USM B cells showed strong correlations with the expression of BAFF receptors. The atypical B cells DN2 in SLE showed significant decreased expression of TACI, which correlated with higher IL-21 levels. Also, lower expression of TACI in atypical B cell DN2 was associated with high disease activity. These results suggest a participation of the BAFF system in CXCR5- CD11c+ atypical B cell subsets in SLE patients. Decreased TACI expression on atypical B cells DN2 correlated with high disease activity in SLE patients supporting the immunoregulatory role of TACI in autoimmunity.

Stimulation of the vagus nerve as atherapeutic principle.

Modulation of the parasympathetic tone leads to extensive physiological reactions at several levels, including the decreased production of proinflammatory cytokines. Many studies have demonstrated that chronic inflammatory diseases are associated with reduced parasympathetic and increased sympathetic activities. Moreover, it was demonstrated that a low parasympathetic and a high sympathetic activity in patients with rheumatoid arthritis (RA) predicts apoor therapeutic response to anti-tumor necrosis factor (TNF) treatment compared to RA patients with amore balanced autonomic nervous system. The autonomic equilibrium could be restored by electrical stimulation of the vagus nerve. Considering the patients who do not sufficiently respond to the available drugs, patients for whom the effectiveness of the drugs wanes over time, or have drug-related adverse events, anonpharmacological approach such as bioelectronics might be auseful supplement as an instrument in the successful extension of the therapeutic armamentarium for rheumatic diseases; however, there is a great need for further studies and the development of novel therapeutic strategies in the field of neuroimmunology.

Efficacy of ultraphonophoresis with an enzyme gel with high transcutaneous and proteolytic activity in patients with atrophic skin scars: a prospective interventional cohort comparative study

Introduction. The trend towards an increase in peacetime and wartime injuries and the frequent formation of severe cicatricial dysplasia dictate the need to develop an effective, universal, and widely available method for the prevention and correction of fibrotic skin deformities applied by doctors of various specialties: dermatocosmetologists, physiotherapists, and rehabilitologists. In addition to persistent irreversible structural damage and a visible skin defect, patients are concerned about itching and other subjective sensations in the scar area. Physical methods of correction using transdermal deliveries of enzyme fibromodulatory drugs are scientifically substantiated and are widely used in the rehabilitation period of patients with scars of various origins. Meanwhile, the therapeutic possibilities of influencing the subjective sensations of this group of patients remain only partially studied up to date. Materials and methods. A prospective interventional cohort comparative study of the efficacy and safety of using the ultraphonophoresis technique with an enzyme gel with a high transcutaneous and proteolytic ability in patients with atrophic skin scars was carried out. The study included 56 patients with a diagnosis of «atrophic scars» (ICD-10 Chapter XII: Diseases of the skin and subcutaneous tissue, L90). The entire sample was divided into groups with developing (n=27) and mature (n=29) scars. As a result of random distribution, the study subgroups (groups 1, 3 n=14 and n=15) and comparison subgroups (groups 2, 4 n=13 and n=14), in which the patients were prescribed topical therapy with traditionally used anti-scar drugs, were formed. During the study, clinical, instrumental, and medico-sociological research methods were used. Results. In the study groups, a high safety profile of gel ultraphonophoresis procedures and more significant changes in the macro-relief of the scar, instrumental indicators, and quality of life indicators have been established. Conclusion. The method of ultraphonophoresis with an enzyme gel with high transcutaneous and proteolytic activity in patients with atrophic skin scars has been scientifically substantiated and tested. The effectiveness of the treatment complex is 84–88 %.

E05 Is subchondral bone marrow edema predictive of bone mineral density loss in juvenile idiopathic arthritis?

Abstract Introduction Inflammation plays a crucial role in impaired bone metabolism [1]. Subchondral bone marrow oedema (BME) in Magnetic Resonance Imaging (MRI) was associated to bone mineral density (BMD) loss in adult spondyloarthritis [1]. BME was less studied in juvenile idiopathic arthritis (JIA). Objectives We aimed to study the link between MRI BME and BMD in JIA patients. Methods We conducted a retrospective study of 44 patients with JIA who fulfilled the International League of Associations for Rheumatology (ILAR) 2001 criteria. For each patient we collected the following data: age, age at the onset of JIA, JIA subtype, disease duration, C-reactive protein (CRP) and Erythrocyte sedimentation rate (ERS) levels, BMD assessed using bone densitometry and MRI. Disease activity was assessed using the JADAS score. Statistical analysis was performed using SPSS software. Results We included 28 boys and 16 girls. The mean age was 13.65 ± 4.62 years. The mean age at the onset of the disease 9.57 ± 3.97 years. The mean disease duration was 4.34 ± 3.09 years. There was enthesitis-related arthritis in 61% of the cases (n = 27), oligoarticular JIA in 14% of the cases (n = 6), polyarticular JIA in 11% of the cases (n = 5), and psoriatic arthritis in 7% of the cases (n = 3). JIA was undifferentiated in 7% of the cases (n = 3). The mean CRP and ESR were 14.42 ± 19.67 mg/l and 26.56 ± 20.87 mm, respectively. The mean JADAS was 6.6 ± 4.7. Bone densitometry was performed in 17 patients. The mean BMD and the mean Z-score were 0.961 ± 0.128 g/cm2 and -0.4 ± 1.16 standard deviation, respectively. Magnetic resonance imaging (MRI) showed BME in 52% of the patients (n = 23). Bone marrow oedema was present in the sacroiliac joints in 43% of the cases (n = 19), in the coxofemoral joints in 27% of the cases (n = 12), and in the spine in 9% of the cases (n = 4). The presence of BME was associated with a higher ESR (32.71 ± 25.71 vs 18.94 ± 10.72 mm, P = 0.032), higher JADAS (8.01 ± 5.36 vs 4.75 ± 3.29, P = 0.023), and a lower Z-score (-1.3 ± 0.77 vs 0.4 ± 0.8 standard deviation, P = 0.001). Conclusion Our study showed that MRI BME was associated with high disease activity and BMD loss in JIA patients. This result is consistent with those of Akgöl et al. [2]. Bone marrow oedema seems to predict BMD loss in JIA and should lead to optimizing the treatment.

Stimulation of the vagus nerve as a therapeutic principle. German Version

Modulation of the parasympathetic tone leads to extensive physiological reactions at several levels, including the decreased production of proinflammatory cytokines. Many studies have demonstrated that chronic inflammatory diseases are associated with reduced parasympathetic and increased sympathetic activities. Moreover, it was demonstrated that a low parasympathetic and a high sympathetic activity in patients with rheumatoid arthritis (RA) predicts apoor therapeutic response to anti-tumor necrosis factor (TNF) treatment compared to RA patients with amore balanced autonomic nervous system. The autonomic equilibrium could be restored by electrical stimulation of the vagus nerve. Considering the patients who do not sufficiently respond to the available drugs, patients for whom the effectiveness of the drugs wanes over time, or have drug-related adverse events, anonpharmacological approach such as bioelectronics might be auseful supplement as an instrument in the successful extension of the therapeutic armamentarium for rheumatic diseases; however, there is a great need for further studies and the development of novel therapeutic strategies in the field of neuroimmunology.

A phase 1 study evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of Bcl-2 inhibitor BGB-11417 in adult patients with mature B-cell malignancies.

7558 Background: BGB-11417 is a potent and highly selective Bcl-2 inhibitor. Phase 1 study results showing high activity and good tolerability in patients (pts) with mature B-cell malignancies were previously reported (Abstract 2989, ASH 2022). We present here results of BGB-11417 monotherapy in B-cell malignancies with a longer follow up. Methods: BGB-11417-102 (NCT04883957) is an ongoing, multicenter, phase 1, open-label, dose-finding study in China. Primary objectives: safety, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of BGB-11417 monotherapy for selected cohorts. Pts with relapsed/refractory (R/R) B-cell malignancies received escalating doses (80, 160, 320, or 640 mg once daily) with weekly or daily ramp-up to intended target dose. Dose-limiting toxicity (DLT) for each cohort was evaluated during ramp-up through day 21 at the intended dose. AEs were reported per CTCAE v5.0 (or Grading Scale for Hematologic Toxicity in chronic lymphocytic leukemia [CLL] Studies). Results: As of 1 Oct 2022, 54 pts (34 R/R non-Hodgkin lymphoma [NHL; 20 diffuse large B-cell lymphoma, 7 follicular lymphoma, 4 marginal zone lymphoma, 3 transformed NHL], and 20 R/R CLL/small lymphocytic lymphoma [SLL]) received ≤640 mg/d. 640mg was the highest dose pre-defined in the study and MTD was not reached. Median (range) values: age, 61 y (31-84); prior lines of systemic therapy, 2 (1-7); follow-up duration, 6.6 m (0.2-13.0). Study discontinuation: 23 pts (22 NHL; 1 CLL/SLL); reasons: 18 progressive disease, 4 withdrew, 1 investigator decision. Tx-emergent AEs (TEAEs): all grades, 92.6%; grade ≥3, 53.7%. Most common TEAE: all grades, white blood cell count decreased (48.1%); grade ≥3, neutropenia (25.9%). DLTs occurred in 3 patients at 80 mg/d or 160 mg/d; 14.8% had serious TEAEs and 14.8% had TEAEs leading to drug interruption. No pts had TEAEs leading to death/tx discontinuation or clinical tumor-lysis syndrome events. Of 39 pts available for tumor assessment (27 NHL; 12 CLL/SLL), 5 with NHL and 9 with CLL/SLL achieved responses (NHL: 3 partial responses [PR] at 160 mg/d, 1 PR at 320 mg/d, 1 complete response [CR] at 640 mg/d; CLL/SLL: 2 CR and 2 PR at 80 mg/d, 3 PR at 160 mg/d, 2 PR at 320 mg/d). Nine pts with R/R CLL/SLL (5 at 80mg/d, 4 at 160 mg/d) had minimum residual disease (MRD) assessment; 3 had undetectable MRD with CLL cell/total nucleated cells &lt; 10-4 (uMRD4; 1 pt achieved blood and bone marrow aspirate uMRD4 after 4.5 months at 80 mg/d; 2 pts had blood uMRD4 after 7.1 months at 160 mg/d). The monotherapy RP2D for R/R CLL/SLL was 320 mg/d. Conclusions: These results demonstrated that BGB-11417 monotherapy was well tolerated at all tested doses up to 640 mg/d, with no dose-dependent toxicity increase. BGB-11417 monotherapy showed promising initial efficacy results in R/R CLL/SLL, with pts achieving responses at lower dose levels. Clinical trial information: NCT04883957 .

E054 Rheumatic autoimmune diseases following COVID-19 infection: an observational study in Iraqi Kurdistan Region

Abstract Background/Aims In December 2019, a new type of novel coronavirus (COVID-19) was identified in Wuhan, China. The likelihood of developing an autoimmune and/or rheumatic diseases in COVID-19 survivors is high and a serious matter. The acute SARS-CoV-2 infection may unmask previously undiagnosed rheumatic conditions. We aimed to study rheumatic autoimmune disease manifestations diseases following COVID-19 infection survival. Methods The study was an observational case series study. The data collection was carried out in Iraqi Kurdistan region between the 1st of July 2021 and 20th of March 2022. Seventy-five patients were included: the patients who previously had confirmed COVID-19 infection who developed symptoms of rheumatic autoimmune diseases post COVID-19 cure. The study was conducted via a rigorous evaluation by two rheumatologists. Patients were investigated by (ESR (mm/h) and CRP (mg/L), some autoimmune screen panel for suspecting rheumatological disease patients were sent for ANA, anti-CCP (U/ML) and rheumatoid factor (IU/M) L. Then, patients were diagnosed according to the classification criteria for suspected autoimmune diseases and those with exacerbation were evaluated clinically and by laboratory; rheumatoid arthritis by DAS28, systemic lupus erythematosus by C3, C4. Results A total of seventy-five participants post-COVID-19 infection were enrolled in this study. Age of the participants was 47.15 ±16.18 SD, more of the participants were female (69) out of 75. For most of the patients the ESR were high with p value of 0.012, which was statistically significant. ANA was high titre in SLE patients which was (3.05±2.4) and in antiphospholipid syndrome p-value was significant at 0.042, Anti-CCP were positive in RA patients and in those with exacerbation of RA (44±10, 31.7±5.7 respectively), DAS28 was (4.95±0.59) moderate and high disease activity in patients with exacerbations. C3, C4 were low in patients with exacerbation of SLE (0.47±0.22, 0.03±0.01, respectively). Most of the patients developed symptoms post-COVID-19 between 4-10 weeks (37 participants). Conclusion Rheumatic autoimmune diseases presenting post-COVID-19 survival most commonly were systemic lupus erythematous followed by rheumatoid arthritis. and previous autoimmune diseases presented with exacerbation. Disclosure A.M. Jalal: None. N. Albarzinji: None.

Does Patient-Reported Outcome Measures Use at New Foot and Ankle Patient Clinic Visits Improve Patient Activation, Experience, and Satisfaction?

Patient-reported outcome measures (PROMs) can help predict clinical outcomes and improve shared clinical decision-making discussions. There remains a paucity of research assessing how the use of PROMs may drive improved patient experience and patient activation. New foot and ankle patients completed PROMIS physical function (PF), pain interference (PI), and depression assessments. Patients were then randomized to viewing and discussing their PROMIS scores with their surgeon or not. Following the clinic visit, patients completed a series of Clinician & Group Survey-Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) questions and the Patient Activation Measure (PAM). Responses to the CG-CAHPS questions and PAM were compared between the 2 groups and after clustering on surgeon. Potential interaction effects by social deprivation were also explored. After enrolling patients but removing those lost to follow-up or with missing data, 97 and 116 patients remained in the intervention control cohorts, respectively. No difference was found in CG-CAHPS responses nor PAM scores between the 2 groups (P > .05). All surgeons were highly rated by all patients. When clustered by surgeon, intervention subjects were less likely to indicate "top box" scores for the understanding domain of the CG-CAHPS question (OR 0.51, P < .001) and had decreased odds of high patient activation compared to control subjects (OR 0.67; P = .005). Among the most socially disadvantaged patients, there was no difference in control and intervention subjects in their likelihood of having high patient activation (P = .09). Highly rated foot and ankle surgeons who show and discuss PROM results may not improve patient experience or activation and may, in fact, decrease understanding or patient activation in select populations. Future work is needed to determine when PROM discussions are most beneficial and how best to present PROMs data, as we suspect that how the information was presented-and not the use of PROMs-resulted in our findings. Health literacy tools and/or communication training may better engage different patient groups regarding PROMs. Level I, randomized controlled trial.

Association between xanthinoxidase activity andparameters of glucose homeostasis in patients with type 2 diabetes mellitus

Background. The purpose of the study is to determine the associations between clinical and anthropometric parameters, glucose homeostasis and serum xanthinoxidase (XO) activity in patients with type 2 diabetes mellitus (T2DM) taking into account gender, glycemic control and serum XO activity. Materials and methods. One hundred and twenty-five T2DM patients aged 34 to 81 years were examined, with an average age of 58.9±9.4 years, disease duration from 1 month to 29 years (average of 8.9±6.6 years). The age of patients at the time of the disease manifestation in the general sample was from 29 to 71 years, on average 50.6±9.1 years. Results. The authors have found a nonlinear dependence of serum XO activity on fasting insulin concentration in patients with T2DM in the total sample, described by the multiplicative model (r=0.45; p=0.001). Serum XO activity in patients with T2DM in the general sample increases with adaptive increase in secretory activity of β-cells on an empty stomach according to the HOMA_β%. Serum ХO activity was highest in T2DM patients with low fasting insulin sensitivity (HOMA_S% &lt; 50%). In addition, it has been determined that the serum ХО activity in the subjects is nonlinearly associated with the QUICKI (r=–0.35; p=0.016) and Caro indices (r=–0.40; p=0.007). We have found a nonlinear dependence of serum XO activity on fasting insulin (r=0.50; p=0.08), HOMA_β% (r=–0.53; p=0.06), HOMA_S% (r=–0.48; p=0.09), HOMA-IR (r=–0.48; p=0.09) in men with optimal glycemic control (HbA1c &lt; 7.5%) at the trend level and Caro (r=–0.64; p=0.02). In women of this group, there was a nonlinear dependence of serum XO activity on fasting insulin (r=0.56; p=0.004), HOMA_β% (r=0.56; p=0.003), HOMA_S% (r=–0.54; p=0.005), HOMA-IR (r=0.54; p=0.005), QUICKI (r=–0.50; p=0.01) and Caro (r=–0.61; p=0.003). Conclusions. In patients with T2DM, the serum uric acid is linearly associated with the level of serum XO activity, which determines 34% of its variability. In patients with T2DM, regardless of the state of glycemic control, serum XO activity is nonlinearly associated with parameters characterizing the state of glucose homeostasis (fasting insulin, HOMA_S%, HOMA_β%, QUICKI and Caro indices). Predictors of high serum XO activity in patients with T2DM are the level of postprandial blood glucose (t=–3.53; p=0.004) and serum uric acid (t=4.73; p=0.0005).

Functional estrogen receptor signal transduction pathway activity and antihormonal therapy response in low-grade ovarian carcinoma.

Advanced low-grade ovarian carcinoma (LGOC) is difficult to treat. In several studies, high estrogen receptor (ER) protein expression was observed in patients with LGOC, which suggests that antihormonal therapy (AHT) is a treatment option. However, only a subgroup of patients respond to AHT, and this response cannot be adequately predicted by currently used immunohistochemistry (IHC). A possible explanation is that IHC only takes the ligand, but not the activity, of the whole signal transduction pathway (STP) into account. Therefore, in this study, the authors assessed whether functional STP activity can be an alternative tool to predict response to AHT in LGOC. Tumor tissue samples were obtained from patients with primary or recurrent LGOC who subsequently received AHT. Histoscores of ER and progesterone receptor (PR) were determined. In addition, STP activity of the ER STP and of six other STPs known to play a role in ovarian cancer was assessed and compared with the STP activity of healthy postmenopausal fallopian tube epithelium. Patients who had normal ER STP activity had a progression-free survival (PFS) of 16.1months. This was significantly shorter in patients who had low and very high ER STP activity, with a median PFS of 6.0 and 2.1months, respectively (p<.001). Unlike ER histoscores, PR histoscores were strongly correlated to the ER STP activity and thus to PFS. Aberrant low and very high functional ER STP activity and low PR histoscores in patients with LGOC indicate decreased response to AHT. ER IHC is not representative of functional ER STP activity and is not related to PFS.

Evaluating the relationship between patient activation and health-related quality of life (HRQOL) in patients with pancreatic cancer (PwPC).

Advanced pancreatic cancer is synonymous with a high mortality rate, debilitating symptom profile, and minimal prolongation in overall survival. Therefore, health-related quality of life (HRQOL) is important in patients with pancreatic cancer (PwPC). In chronic conditions, patient activation is positively associated and higher HRQOL. However, no known study has evaluated patient activation, HRQOL, and their association in PwPC. A 43-item cross-sectional survey assessed patient activation and HRQOL of patients with locally advanced and metastatic pancreatic cancer undergoing chemotherapy. Variables were analyzed descriptively, and relationships were assessed using bivariate statistics (sig p < 0.05). Fifty-six patients participating in the study had an average age of 69.5 ± 11.1years, and the majority were females (51.8%), Caucasians (61.8%), married/partnered (64.3%), and had at least a college degree (59%). Almost half were at stage 4 (48.2%), and most were newly diagnosed (66.1%). Mean patient activation score was 63.5 ± 17.2 (scale range: 0-100), with most at higher activation levels of 3 or 4 (66.7%). Mean HRQOL score of 41.0 ± 12.7 (scale range: 0-72) was low. Patient activation levels, age, education level, and gender explained 21% of variation in overall HRQOL scores. Patients at activation level 4 had significantly higher overall HRQOL versus those at lower activation (level 1 or 2). Higher patient activation was significantly associated with having either private insurance only or multiple insurances and being partnered. Patient activation significantly predicted HRQOL in PwPC despite the low sample size. Initiatives to increase patient activation should focus on patients of low socioeconomic status and those without partner support.

Self-reported efficacy in patient-physician interaction in relation to anxiety, patient activation, and health-related quality of life among stroke survivors

Background Early detection of AF is critical for stroke prevention. Several commercially available smartwatches are FDA cleared for AF detection. However, little is known about how patient-physician relationships affect patients’ anxiety, activation, and health-related quality of life when prescribed smartwatch for AF detection. Methods Data were used from the Pulsewatch study (NCT03761394), which randomized adults (>50 years) with no contraindication to anticoagulation and a CHA2DS2-VASc risk score ≥2 to receive a smartwatch-smartphone app dyad for AF monitoring vs. conventional monitoring with an ECG patch (Cardea SoloTM) and monitored participants for up to 45 days. The Perceived Efficacy in Patient-Physician Interactions survey was used to assess patient confidence in physician interaction at baseline with scores ≥45 indicating high perceived efficacy in patient-provider interactions. Generalized Anxiety Disorder-7 Scale, Consumer Health Activation Index, and Short-Form Health Survey were utilized to examine anxiety, patient activation, and physical and mental health status, at baseline, 14, and 44 days, respectively. We used mixed-effects repeated measures linear regression models to assess changes in psychosocial outcomes among smartwatch users in relation to self-reported efficacy in physician interaction over the study period. Results A total of 93 participants (average age 64.1 ± 8.9 years; 43.0% female; 88.2% non-Hispanic white) were included in this analysis. At baseline, fifty-six (60%) participants reported high perceived efficacy in patient-physician interaction. In the fully adjusted models, high perceived efficacy (vs. low) at baseline was associated with greater patient activation and perceived mental health (β 12.0, p-value <0.001; β 3.39, p-value <0.05, respectively). High perceived self-efficacy was not associated with anxiety or physical health status (β − 0.61, p-value 0.46; β 0.64, p-value 0.77) among study participants. Conclusions Higher self-efficacy in patient-physician interaction was associated with higher patient activation and mental health status among stroke survivors using smartwatches. Furthermore, we found no association between anxiety and smartwatch prescription for AF in participants with high self-efficacy in patient-physician interaction. Efforts to improve self-efficacy in patient-physician interaction may improve patient activation and self-rated health and subsequently may lead to better clinical outcomes. KEY MESSAGES Higher self-efficacy in patient-physician interaction was associated with higher patient activation and mental health status among stroke survivors using smartwatches. No association between anxiety and smartwatch prescription for AF in participants with high self-efficacy in patient-physician interaction. Efforts to improve self-efficacy in patient-physician interaction may improve patient activation and self-rated health and subsequently may lead to better clinical outcomes.