The patientsʼ perspective of important glucocorticoid effects: A nominal group study among patients with Systemic Lupus Erythematosus and Myositis

Background/Objective The objective of this cohort study was to understand the positive and negative effects of glucocorticoids (GCs) in patients with systemic lupus erythematosus and myositis from the patients' perspective with the aim of developing a patient-reported outcome measure. Methods Included patients were asked to participate in 1 of 5 nominal groups where demographic information and a quality-of-life questionnaire were collected. Patients were asked 2 open-ended questions on (1) benefits and (2) harms related to GC use. We used the Nominal Group Technique, a highly structured consensus method in which responses are generated, shared, and ranked. Descriptive statistics were used to summarize the results. Nominal group sessions took place from April to May 2019. Results Of 206 patients who were approached, 21 patients participated, 17 with systemic lupus erythematosus and 4 with myositis, predominantly women with more than 10 years of steroid use. The domains ranked highest for GC benefits were disease control (55 votes), fast onset of action (30 votes), increased energy (10 votes), and pain relief (10 votes). The highest-ranked negative effects were bone loss (38 votes) and weight gain (16 votes); psychological effects and damaged internal organs each received 12 votes. Conclusions The top-ranked GC effects - both benefits and harms - among patients with systemic rheumatic disease are consistent with the top domains associated with GC use reported with other inflammatory diseases. This study informs the development of a comprehensive patient-reported outcome measure that can be used across inflammatory diseases

Cardiovascular co-morbidity in patients with rheumatoid arthritis: a narrative review of risk factors, cardiovascular risk assessment and treatment

Abstract Cardiovascular disease (CVD) is markedly increased in patients with rheumatoid arthritis partly due to accelerated atherosclerosis from chronic inflammation. Traditional cardiovascular risk factors such as hypertension, hyperlipidemia, smoking, diabetes mellitus and physical inactivity are also highly prevalent among patients with rheumatoid arthritis (RA) and contribute to the CVD risk. The impact of traditional risk factors on the CVD risk appears to be different in the RA and non-RA population. However, hyperlipidemia, diabetes mellitus, body mass index and family history of CVD influence the CVD risk in RA patients the same way they do for the non-RA population. Despite that, screening and treatment of these risk factors is suboptimal among patients with RA. Recent guidelines from the European League Against Rheumatism (EULAR) recommend aggressive management of traditional risk factors in addition to RA disease activity control to decrease the CVD risk. Several CVD risk calculators are available for clinical use to stratify a patients’ risk of developing a CVD event. Most of these calculators do not account for RA as a risk factor; thus, a multiplication factor of 1.5 is recommended to predict the risk more accurately. In order to reduce CVD in the RA population, national guidelines for the prevention of CVD should be applied to manage traditional risk factors in addition to aggressive control of RA disease activity. While current data suggests a protective effect of non-biologic disease modifying anti-rheumatic drugs (DMARDs) and biologics on cardiovascular events among patients with RA, more data is needed to define this effect more accurately

Comparative Effectiveness of Etanercept and Adalimumab in Patient Reported Outcomes and Injection-Related Tolerability.

To describe patient preferences in selecting specific biologics and compare clinical response using patient reported outcomes (PROs) among patients with rheumatoid arthritis (RA) started on different anti-tumor necrosis factor (TNF) therapies.Participants were enrollees in Kaiser Permanente Northern California. Patients with RA who had at least two provider visits and started a new anti-TNF therapy from 10/2010-8/2011, were eligible for participation in this longitudinal study. Using a telephone survey, patient preferences in biologic selection and RAPID3, MDHAQ, and SF-12 scores were collected at baseline and at 6 months. Patient scores rating injection/infusion-site burning and stinging (ISBS) were collected at 6 months.In all, 267 patients with RA responded to the baseline survey, of whom 57% preferred an injectable biologic, 22% preferred an infused biologic, and 21% had no preference. Motivation for injectable biologics was convenience (92%) and for infusion therapy was dislike or lack of self-efficacy for self-injection (16%). After 6 months of treatment with anti-TNF, 70% of the 177 patients who answered the ISBS question reported ISBS with the last dose; on a scale of 1 (none) to 10 (worst), 41% of these reported a score of 2-5; and 29% reported a score of 6-10. Adalimumab users experienced 3.2 times (95% confidence interval 1.2-8.6) the level of ISBS that etanercept users experienced. There were no significant differences in RAPID3, MDHAQ, or SF-12 scores between etanercept or adalimumab initiators.Convenience and fear of self-injection were important considerations to patients selecting a biologic drug. Although more convenient, adalimumab associated with more ISBS than did etanercept, and this rate was higher than reported in clinical trials. At 6 months, PROs did not differ between etanercept and adalimumab users

A Novel Approach for Mixed‐Methods Research Using Large Language Models: A Report Using Patients’ Perspectives on Barriers to Arthroplasty

Objective Mixed‐methods research is valuable in health care to gain insights into patient perceptions. However, analyzing textual data from interviews can be time‐consuming and require multiple analysts for investigator triangulation. This study aims to explore a novel approach to investigator triangulation in mixed‐methods research by employing a large language model (LLM) for analyzing data from patient interviews. Methods This study compared the thematic analysis and survey generation performed by human investigators and ChatGPT‐4, which uses GPT‐4 as its backbone model, using data from an existing study that explored patient perceptions of barriers to arthroplasty. The human‐ and ChatGPT‐4–generated themes and surveys were compared and evaluated based on their representation of salient themes from a predetermined topic guide. Results ChatGPT‐4 generated analogous dominant themes and a comprehensive corresponding survey as the human investigators but in significantly less time. The survey questions generated by ChatGPT‐4 were less precise than those developed by human investigators. The mixed‐methods flowchart proposes integrating LLMs and human investigators as a supplementary tool for the preliminary thematic analysis of qualitative data and survey generation. Conclusion By utilizing a combination of LLMs and human investigators through investigator triangulation, researchers may be able to conduct more efficient mixed‐methods research to better understand patient perspectives. Ethical and qualitative implications of using LLMs should be considered

Flow diagram showing patient selection at baseline.

<p>Flow diagram showing patient selection at baseline.</p

The association of patient and disease factors with ISBS^*.

<p>The association of patient and disease factors with ISBS^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0149781#t002fn001" target="_blank">*</a>}.</p

Etanercept and adalimumab patient characteristics at the time of the baseline survey^*.

<p>Etanercept and adalimumab patient characteristics at the time of the baseline survey^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0149781#t001fn001" target="_blank">*</a>}.</p

Virtual training of rheumatoid arthritis peer coaches in motivational interviewing skills and concepts of cardiovascular disease

Background: Peer coaching interventions are effective in helping individuals with chronic conditions understand their disease. Most peer coach training programs occur in person, which has become an obstacle during the COVID pandemic. We describe our experiences with virtual training for future peer coach interventions. Methods: Individuals with rheumatoid arthritis (RA) between 40 and 75 years of age were recruited and interviewed by the research team. We conducted seven virtual training sessions focused on four main points: Listen, Discuss, Practice, and Certify. The peer coaches provided feedback throughout the program, which was used to refine the training and intervention. A post-training focus group assessed satisfaction with the training program and intervention development process. Results: Four peer coaches (3 women, 1 man) were trained, including 2 Black and 2 White individuals with advanced degrees. Their ages ranged from 52 to 57, and their RA duration ranged from 5 to 15 years. An iterative process with the coaches and researchers resulted in a nine-week training program. Peer coaches reported satisfaction, confidence, and a preference for the virtual training format. Conclusion: This virtual peer coach training program was feasible and acceptable for coaches with advanced degrees during the global COVID-19 pandemic. Our approach represents an opportunity to adapt training that has been traditionally done in person. By doing so, our approach facilitates the recruitment and training of a diverse group of coaches and promotes sustainability

Patients and surgeons provide endorsement of core domains for total joint replacement clinical trials

Abstract Background Our objective in this study was to examine whether stakeholders further endorse the core domain set proposed by the Outcome Measures in Rheumatology Trials (OMERACT) total joint replacement (TJR) working group. Methods We emailed a survey to 3810 hip/knee arthroplasty patients and 49 arthroplasty surgeons at a high-volume arthroplasty center to rate the importance of each core domain (i.e., pain, function, patient satisfaction, revision surgery, adverse events, and death) and two additional domains (i.e., cost and participation). Ratings were on a 1–9 scale, with 1–3 indicating limited or no importance for patients, 4–6 being important but not critical, and 7–9 being critical. We calculated median (IQR) values and compared ratings by sex, age, and participant type using the Wilcoxon rank-sum test. Results The questionnaire was completed by 1295 patients (34%) and 21 surgeons (43%). Patient nonresponders were similar to responders in age (≥55 years, 85.7% vs. 88.6%), sex (female, 57.5% vs. 57.3%), and joint procedure (total hip replacement, 56.9% vs. 63.2%). Overall, all core domains and one noncore domain (i.e., participation) were confirmed as “critical” by both stakeholder groups. Cost was rated as only “important” but not “critical” by surgeons. A completed consensus for all the core domains persisted even when we stratified by sex, age, arthritis type, and the affected joint (knee vs. hip). We received suggestions for additional critical domains from 217 patients and 5 surgeons, prompting the inclusion of 2 research agenda items. Conclusions Our study confirmed a consensus rating of the OMERACT TJR core domain set as critical for patients. This broad endorsement should encourage the identification of candidate outcome instruments to further develop a TJR core measurement set that can harmonize reporting in TJR clinical trials

A single-center, open-label, randomized, parallel-group trial to pilot the effectiveness of a peer coach behavioral intervention versus an active control in reducing anxiety and depression in patients scheduled for total knee replacement

Abstract Background Moving Well is a behavioral intervention for patients with knee osteoarthritis (KOA) scheduled for a total knee replacement (TKR). The objective of this intervention is to help patients with KOA mentally and physically prepare for and recover from TKR. Methods This is an open-label pilot randomized clinical trial that will test the feasibility and effectiveness of the Moving Well intervention compared to an attention control group, Staying Well, to reduce symptoms of anxiety and depression in patients with KOA undergoing TKR. The Moving Well intervention is guided by Social Cognitive Theory. During this 12-week intervention, participants will receive 7 weekly calls before surgery and 5 weekly calls after surgery from a peer coach. During these calls, participants will be coached to use principles of cognitive behavioral therapy (CBT), stress reduction techniques, and will be assigned an online exercise program, and self-monitoring activities to complete on their own time throughout the program. Staying Well participants will receive weekly calls of similar duration from research staff to discuss a variety of health topics unrelated to TKR, CBT, or exercise. The primary outcome is the difference in levels of anxiety and/or depression between participants in the Moving Well and Staying Well groups 6 months after TKR. Discussion This study will pilot test the feasibility and effectiveness of Moving Well, a peer coach intervention, alongside principles of CBT and home exercise, to help patients with KOA mentally and physically prepare for and recover from TKR. Trial registration Clinicaltrials.gov. NCT05217420; Registered: January 31, 2022