Understanding Heterogeneity in Patients' Conceptualisation of Treatment for Rheumatoid Arthritis: A Cluster Analysis.

OBJECTIVE: Uptake of treat-to-target (TTT) strategies for rheumatoid arthritis (RA) management is low. Our objective was to understand the heterogeneity in patients' conceptualisation of RA treatment to inform interventions improving TTT uptake. DESIGN: Eligible participants recruited from an online research registry rated 56 items (on 5-point scales) reflecting concepts raised from patient interviews. Using items describing adhering to physician recommendations to create a binary criterion variable for medication adherence, we conducted a principal components analysis on the remaining items using Varimax rotation, describing how these factors predict adherence over and above demographic characteristics. We further use optimal sets in regression to identify the individual concepts that are most predictive of medication adherence. RESULTS: We found significant heterogeneity in patients' conceptualisation of RA treatment among 621 persons with RA. A scree plot revealed a four-factor solution explained 38.4% of the variance. The four factors expected to facilitate TTT uptake were (% variance explained): (1) Access to high quality care and support (11.3%); (2) low decisional conflict related to changing disease-modifying antirheumatic drugs (DMARDs) (10.1%); (3) endorsement of a favourable DMARD risk/benefit ratio (9.9%); and (4) confidence that testing reflects disease activity (7.2%). These factors account for 13.8% of the variance in full medication adherence, fully explaining the only significant demographic predictor, age of the patient. The individual items most predictive of poor adherence centre on the lack of effective patient-physician communication, specifically insufficient access to information from rheumatologists, along with the need to seek information elsewhere. CONCLUSION: Patients' conceptualisation of RA treatment varies; however, almost all patients have difficulty escalating DMARDs, even with access to quality information and an understanding of the benefits of TTT. Tailored interventions are needed to address patient hesitancy to escalate DMARDs.

Racial and Ethnic Distribution of Rheumatic Diseases in Health Systems of the National Patient-Centered Clinical Research Network.

OBJECTIVE: To evaluate the relative prevalence of 8 rheumatic and musculoskeletal diseases (RMDs) across racial and ethnic groups within the National Patient-Centered Clinical Research Network (PCORnet). METHODS: Electronic health records from participating PCORnet institutions and systems from January 1, 2013, to December 31, 2018, were used to identify adult patients with ≥ 2 diagnosis codes for rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), osteoporosis (OP), granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA), giant cell arteritis (GCA), and Takayasu arteritis (TAK). Among those with race and ethnicity data available, we compared prevalence of RMDs by race and ethnicity. RESULTS: Data from 28,059,546 patients were available for analysis. RA was more common in patients who were American Indian or Alaska Native vs White, with a prevalence of 11.57 vs 10.11/1000 (odds ratio [OR] 1.15, 95% CI 1.09-1.22). SLE was more common in patients who were Black or African American (6.73/1000), American Indian or Alaska Native (3.82/1000), and Asian (3.39/1000) vs White (2.80/1000; OR 2.43, 95% CI 2.39-2.46; OR 1.39, 95% CI 1.25-1.53; OR 1.26, 95% CI 1.21-1.31, respectively). SLE was more common in patients who were Hispanic vs non-Hispanic (prevalence 3.93 vs 3.45/1000, OR 1.14, 95% CI 1.12-1.16). TAK was more common in patients who were Asian vs White (prevalence 0.05 vs 0.04/1000, OR 1.43, 95% CI 1.00-2.03). OP, RA, and the vasculitides were all more common in patients who were White vs Black or African American. CONCLUSION: These data provide important information on the prevalence of RMDs by race and ethnicity in the United States. PCORnet can be used as a reliable data source to study RMDs within a large representative population.

Assessment of Real-World Patient-Reported Outcomes in Patients Initiating Biologic Agents for the Treatment of Autoimmune Diseases: An Observational Study in Four Patient-Powered Research Networks.

Background: The most reliable and meaningful approach for inclusion of patient-reported outcomes (PROs) in the evaluation of real-world clinical effectiveness of biologics in the treatment of autoimmune diseases is u ncertain. This study aimed to assess and compare the proportions of patients who had abnormalities in PROs measuring important general health domains at the initiation of treatment with biologics, as well as the effects of baseline abnormalities on subsequent improvement. Methods: PROs were collected for patient participants with inflammatory arthritis, inflammatory bowel disease, and vasculitis using Patient-Reported Outcomes Measurement Information System instruments. Scores were reported as T-scores normalized to the general population in the United States. Baseline PROs scores were collected near the time of biologic initiation, and follow-up scores were collected 3 to 8 months later. In addition to summary statistics, the proportion of patients with PROs abnormalities (scores ≥5 units worse than the population norm) was determined. Baseline and follow-up scores were compared, and an improvement of ≥5 units was considered significant. Results: There was wide variation across autoimmune diseases in baseline PROs scores for all domains. For example, the proportion of participants with abnormal baseline pain interference scores ranged from 52% to 93%. When restricted to participants with baseline PROs abnormalities, the proportion of participants experiencing an improvement of ≥5 units was substantially higher. Conclusion: As expected, many patients experienced improvement in PROs following initiation of treatment with biologics for autoimmune diseases. Nevertheless, a substantial proportion of participants did not exhibit abnormalities in all PROs domains at baseline, and these participants appear less likely to experience improvement. For PROs to be reliably and meaningfully included in the evaluation of real-world medication effectiveness, more knowledge and careful consideration are needed to select the most appropriate patient populations and subgroups for inclusion and evaluation in studies measuring change in PROs.

Using pooled electronic health records data to conduct pharmacoepidemiology safety studies: Challenges and lessons learned.

PURPOSE: We assessed the suitability of pooled electronic health record (EHR) data from clinical research networks (CRNs) of the patient-centered outcomes research network to conduct studies of the association between tumor necrosis factor inhibitors (TNFi) and infections. METHODS: EHR data from patients with one of seven autoimmune diseases were obtained from three CRNs and pooled. Person-level linkage of CRN data and Centers for Medicare and Medicaid Services (CMS) fee-for-service claims data was performed where possible. Using filled prescriptions from CMS claims data as the gold standard, we assessed the misclassification of EHR-based new (incident) user definitions. Among new users of TNFi, we assessed subsequent rates of hospitalized infection in EHR and CMS data. RESULTS: The study included 45 483 new users of TNFi, of whom 1416 were successfully linked to their CMS claims. Overall, 44% of new EHR TNFi prescriptions were not associated with medication claims. Our most specific new user definition had a misclassification rate of 3.5%-16.4% for prevalent use, depending on the medication. Greater than 80% of CRN prescriptions had either zero refills or missing refill data. Compared to using EHR data alone, there was a 2- to 8-fold increase in hospitalized infection rates when CMS claims data were added to the analysis. CONCLUSIONS: EHR data substantially misclassified TNFi exposure and underestimated the incidence of hospitalized infections compared to claims data. EHR-based new user definitions were reasonably accurate. Overall, using CRN data for pharmacoepidemiology studies is challenging, especially for biologics, and would benefit from supplementation by other sources.

Rheumatologist and Patient Mental Models for Treatment of Rheumatoid Arthritis Help Explain Low Treat-to-Target Rates.

OBJECTIVE: Despite proven benefits, less than half of patients with rheumatoid arthritis (RA) are treated using a treat-to-target (TTT) strategy. Our objective was to identify critical discrepancies between rheumatologist and patient mental models related to the treatment of RA to inform interventions designed to increase implementation of TTT. METHODS: We developed rheumatologist and patient mental models using the Mental Models Approach to Risk Communication. We conducted semistructured interviews to elicit views related to RA treatment decisions with 14 rheumatologists and 30 patients with RA. We also included responses (n = 284) to an open-ended question on a survey fielded to augment qualitative descriptions from the interviews. Interviews were transcribed and coded independently by two members of the research team. RESULTS: Rheumatologist and patient mental models for RA treatment are significantly more complex than the TTT model. Both consider domains (system factors and patient readiness) outside of disease activity measurement, target setting, and risk versus benefit assessment in their decision-making. Furthermore, specific factors were found to be unique to each model. For example, the physician model stresses the importance of evaluating disease activity over time and patient adherence. In contrast, patients discussed the impact of chronic disease weariness, medication-related fatigue, the importance of feeling adequately informed, and stress associated with changing medications. CONCLUSION: We found several discrepancies primarily related to information gaps and differences in how patients and physicians value trade-offs that can serve as specific targets to improve patient-physician communication and ultimately inform interventions to improve uptake of TTT.

Protocol for the pilot randomized trial of the CArdiovascular Risk assEssment for Rheumatoid Arthritis (CARE RA) intervention: a peer coach behavioral intervention.

BACKGROUND: Cardiovascular disease (CVD) is the most common cause of death among people with rheumatoid arthritis (RA), with an estimated increased risk of 50-60% compared to the general population. Lipid-lowering strategies have been shown to lower CVD risk significantly in people with RA and hyperlipidemia. Thus, CVD risk assessment has an important role to play in reducing CVD among people with RA. Yet currently only 37 to 45% of this population are receiving primary lipids screening. This paper describes the CArdiovascular Risk assEssment for RA (CARE RA) intervention, which is designed to address this issue. CARE RA is a peer coach intervention, that is, an intervention in which a person with RA coaches another person with RA, which is designed to educate people with RA about the relation between RA and CVD risk and to help them obtain evidence-based CVD risk assessment and treatment. METHODS: This is an open-label pilot study that will test if the participants assigned to complete the CARE RA curriculum with a peer coach will receive a cardiovascular risk assessment more frequently compared to those that complete the CARE RA curriculum by themselves. The CARE RA intervention is guided by Social Cognitive Theory. Participants in the peer coach intervention arm will receive the assistance of a peer coach who will call the participants once a week for 5 weeks to go over the CARE RA curriculum and train them on how to obtain CVD risk assessment. The control arm will complete the CARE RA curriculum without any assistance. Participants will be randomized 1:1 either to the control arm or to the peer coach intervention arm. The primary outcome is a participant's having a CVD risk assessment or initiating a statin, if indicated. Secondary outcomes include patient activation and RA medication adherence. The RE-AIM implementation framework guides the implementation and evaluation of the intervention. DISCUSSION: This pilot study will test the feasibility of the peer coach intervention in anticipation of a larger trial. CARE RA pioneers the use of peer coaches to facilitate the implementation of evidence-based treatment guidelines among people with RA. TRIAL REGISTRATION: ClinicalTrials.gov NCT04488497 . Registered on July 28, 2020.

Cannabis for Rheumatic Disease Pain: a Review of Current Literature.

PURPOSE OF REVIEW: Changing attitudes about marijuana have led to an increase in use of medicinal marijuana, especially for painful chronic conditions. Patients ask rheumatologists for guidance on this topic. This review provides up-to-date information on the safety and efficacy of medicinal cannabis for rheumatic disease pain. RECENT FINDINGS: The number of publications related to rheumatic disease and cannabis has increased, but recent literature skews heavily toward reviews vs primary research. Data supporting a role for cannabinoids in rheumatic disease continue to grow. Observational and survey studies show increased use of medicinal cannabis, both by people with rheumatic disease and the general population, and suggest that patients find these treatments beneficial. Prospective studies, however, including randomized controlled clinical trials, are rare and sorely needed. As medicinal cannabis use for rheumatic diseases rises, despite lack of evidence, we review the sparse data available and provide tips for conversations about medicinal cannabis for rheumatologists.

Treatment Satisfaction and Decision-making from the Patient Perspective in Axial Spondyloarthritis: Real-World Data from a Descriptive Cross-sectional Survey Study from the ArthritisPower Registry.

OBJECTIVE: Aims were to 1) to characterize patient decision-making with treatment for axial spondyloarthritis (axSpA) and 2) to explore relationships among decision-making, treatment satisfaction, and biologic disease modifying antirheumatic drugs (bDMARDs). METHODS: ArthritisPower participants with physician-diagnosed axSpA were invited to complete an online survey about their treatment and their most recent physician visit. Analysis compared treatment decision by satisfaction and bDMARD status. RESULTS: Among the 274 participants, 87.2% were female, and the mean age was 50 years. Of participants, 79.5% had researched treatment before their most recent physician visit, and 56.9% discussed treatment change at their most recent physician visit. Of treatment-change discussions, 69.2% of them were related to escalation, compared with deescalation (27.6%) and/or switching (39.1%). Among those participants who discussed a change, 73.7% agreed to it because they felt that their disease was not being controlled (54.9%) or felt that it could be better controlled on new treatment (20.3%). Top symptoms prompting change were back/buttock pain (63.3%), other joint pain (55.1%), and fatigue (54.1%). Among bDMARD-treated participants (n = 128), important factors for treatment decisions were prevention of long-term axSpA consequences (92.9%) and doctor's advice (87.5%). Among 43.4% of participants reporting treatment dissatisfaction, 37% did not discuss treatment change. Current bDMARD use was more common in satisfied (61.9%) than dissatisfied participants (26.9%). CONCLUSION: In this cross-sectional study of a predominantly female axSpA population, patients frequently researched treatment options and discussed escalation with their providers. Under two-thirds of participants who were dissatisfied with treatment discussed changes at their most recent visit. Current bDMARD use was associated with higher satisfaction, and bDMARD users considered prevention of long-term consequences and doctor's advice to be very important for decision-making.

Social Distancing, Health Care Disruptions, Telemedicine Use, and Treatment Interruption During the COVID-19 Pandemic in Patients With or Without Autoimmune Rheumatic Disease.

BACKGROUND: We aimed to compare concerns, social distancing, health care disruptions, and telemedicine use in patients with autoimmune rheumatic disease (ARD) and non-ARD and to evaluate factors associated with immunomodulatory medication interruptions. METHODS: Patients in a multistate community rheumatology practice network completed surveys from April 2020 to May 2020. Adults with common ARD (rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus) or non-ARD (gout, osteoarthritis, osteoporosis) were evaluated. Concerns about coronavirus disease 2019 (COVID-19), social distancing, health care disruptions, and telemedicine use were compared in patients with ARD versus non-ARD, adjusting for demographics, rural residence, and zipcode-based measures of socioeconomic status and COVID-19 activity. Factors associated with medication interruptions were assessed in patients with ARD. RESULTS: Surveys were completed by 2319/36 193 (6.4%) patients with non-ARD and 6885/64 303 (10.7%) with ARD. Concerns about COVID-19 and social distancing behaviors were similar in both groups, although patients receiving a biologic or Janus kinase (JAK) inhibitor reported greater concerns and were more likely to avoid friends/family, stores, or leaving the house. Patients with ARD were less likely to avoid office visits (45.2% vs. 51.0%, odds ratio [OR] 0.79 [0.70-0.89]) with similar telemedicine use. Immunomodulatory medications were stopped in 9.7% of patients with ARD, usually (86.9%) without a physician recommendation. Compared with patients with an office visit, the likelihood of stopping medication was higher for patients with a telemedicine visit (OR 1.54 [1.19-1.99]) but highest for patients with no visits (OR 2.26 [1.79-2.86]). CONCLUSION: Patients with ARD and non-ARD reported similar concerns about COVID-19 and similar social distancing behaviors. Missed office visits were strongly associated with interruptions in immunomodulatory medication.

Identifying patient decisions and related information needs during decision making related to total knee arthroplasty.

Aim: Research regarding decisions patients make about total knee arthroplasty, apart from having the procedure or not, are limited. Understanding patient decision making and related information needs is essential for shared decision making. Methods: Focus groups with an online community-based sample identified decisions about total knee arthroplasty beyond the decision to have the surgery itself. An online survey was used to determine relative importance of five major decisions and evaluate related information available. Results: Patients did not feel they have enough information to make important decisions of surgeon, device type, surgical approach, facility, or timing, for their total knee arthroplasty. Conclusion: Although further research is needed to generalize these findings, physicians should consider these questions during shared decision making with patients considering total knee arthroplasty.

Digital Tracking of Rheumatoid Arthritis Longitudinally (DIGITAL) Using Biosensor and Patient-Reported Outcome Data: Protocol for a Real-World Study.

BACKGROUND: Rheumatoid arthritis (RA) is a condition with symptoms that vary over time. The typical 3- to 6-month interval between physician visits may lead to patients failing to recall or underreporting symptoms experienced during the interim. Wearable digital technology enables the regular passive collection of patients' biometric and activity data. If it is shown to be strongly related to data captured by patient-reported outcome (PRO) measures, information collected passively from wearable digital technology could serve as an objective proxy or be complementary to patients' subjective experience of RA symptoms. OBJECTIVE: The goal of this study is to characterize the extent to which digital measures collected from a consumer-grade smartwatch agree with measures of RA disease activity and other PROs collected via a smartphone app. METHODS: This observational study will last 6 months for each participant. We aim to recruit 250 members of the ArthritisPower registry with an RA diagnosis who will receive a smartwatch to wear for the period of the study. From the ArthritisPower mobile app on their own smartphone device, participants will be prompted to answer daily and weekly electronic PRO (ePRO) measures for the first 3 months. RESULTS: The study was launched in December 2018 and will require up to 18 months to complete. Study results are expected to be published by the end of 2021. CONCLUSIONS: The completion of this study will provide important data regarding the following: (1) the relationship between passively collected digital measures related to activity, heart rate, and sleep collected from a smartwatch with ePROs related to pain, fatigue, physical function, and RA flare entered via smartphone app; (2) determine predictors of adherence with smartwatch and smartphone app technology; and (3) assess the effect of study-specific reminders on adherence with the smartwatch. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14665.

Digital Interventions to Build a Patient Registry for Rheumatology Research.

This article aims to describe key issues, processes, and outcomes related to development of a patient registry for rheumatology research using a digital platform where patients track useful data about their condition for their own use while contributing to research. Digital interventions are effective to build a patient research registry for people with rheumatoid arthritis and other rheumatic and musculoskeletal diseases. ArthritisPower provides evidence of the value of digital interventions to build community support for research and to transform patient engagement and patient-generated data capture.

Trends in use of antidepressants, lithium, and anticonvulsants in Kaiser Permanente-insured youths, 1994-2003.

In view of the current controversy regarding the use of antidepressants in children and adolescents, we examined trends from 1994 to 2003 in the use of antidepressants, lithium, and anticonvulsants by enrollees, aged 5-17 years, of Kaiser Permanente in Northern California. We found that the use of antidepressants more than doubled from 9.4 per 1000 enrollees to 21.3 per 1000. Most of this increase is associated with selective serotonin reuptake inhibitors (SSRIs), which increased from 4.6 to 14.5 per 1000. The use of tricyclic antidepressants (TCAs) decreased markedly, while the increase of other newer antidepressants rose from 1.3 to 6.5 per 1000. The use of anticonvulsants nearly doubled, from 3.5 to 6.9 per 1000, while lithium use was relatively stable at a rate of nearly 1 per 1000. Use of SSRIs, newer antidepressants, and anticonvulsants increased in boys as well as girls in each of three age groups: 5-9, 10-14, and 15-17 years. An increasing percentage of the antidepressant users had a diagnosis of depression, and an increasing percentage of anticonvulsant users had a diagnosis of bipolar disorder. Although the safety and efficacy of antidepressants in youths needs to be more firmly established, these findings may reflect progress in the diagnosis and treatment of mental illness.