Development of CARRA/PReS-endorsed consensus Core and Expanded Datasets in childhood-onset systemic lupus erythematosus for international registry-based research.

OBJECTIVES: Childhood-onset systemic lupus erythematosus (cSLE), representing 15%-20% of individuals with SLE, has been difficult to study globally due to differences between registries. This initiative, supported by Childhood Arthritis Rheumatology Research Alliance (CARRA) and Paediatric Rheumatology European Society (PReS), aims to create Core and Expanded cSLE Datasets to standardise and enhance research worldwide. METHODS: 21 international cSLE experts and 4 patients participated in a Delphi process (questionnaires, 2 topic-specific focus groups and 3 virtual consensus meetings) to create 2 standardised cSLE datasets. The Core cSLE Dataset was designed to include data essential to meaningful clinical research across many settings. The Expanded cSLE Dataset was designed for centres able to consistently collect data to address broader research questions. Final data items for the Core and Expanded datasets were determined by consensus defined as >80% agreement) using an adapted nominal group technique and voting. RESULTS: The resulting Core cSLE Dataset contains 46 items, including demographics, clinical features, laboratory results, medications and significant adverse events. The Expanded cSLE Dataset adds 26 additional items and includes patient-reported outcomes. Consensus was also achieved regarding the frequency and time points for data collection: baseline, quarterly follow-up visits, annually and flare visits. CONCLUSION: Standardised Core and Expanded cSLE Datasets for registry-based international cSLE research were defined through the consensus of global experts and patient/caregiver representatives, endorsed by CARRA and PReS. These datasets incorporate disease-specific and patient-specific features, optimised for diverse settings to facilitate international collaborative research for children and adolescents with SLE worldwide.

Effects of Social Vulnerability and Environmental Burden on Care Fragmentation and Social Needs Among Individuals With Rheumatic Conditions.

OBJECTIVE: Environmental hazards and heightened neighborhood social vulnerability coexist and disproportionately affect minoritized populations. We investigated associations between exposure to adverse environmental burden concentrated in areas with high social vulnerability and care fragmentation (missed appointments, emergency department visits, and hospitalizations) and social needs (eg, food and housing insecurity) among individuals with rheumatic conditions. METHODS: We identified adults receiving care in a Massachusetts multihospital system with at least two rheumatic disease codes and complete street addresses. Geocoded addresses were linked to the Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry Social-Environmental Ranking (SER), which combines census-tract social vulnerability variables (eg, socioeconomic status) with environmental hazards (eg, air and water pollution). Social needs were obtained from self-reported surveys. Multilevel, multinomial regression models estimated associations between SER quartiles and care fragmentation and social need burden, accounting for demographics and comorbidities. RESULTS: Among 16,856 individuals with rheumatic conditions, 70% were female, 6% were Black, 82% were White, and 7% resided in the highest combined social vulnerability and environmental burden (SER quartile 4) areas. Among 7,083 with social needs data, 19% experienced more than one challenge. Individuals in SER quartile 4 areas (vs quartile 1) had 2.02 (95% confidence interval [CI] 1.67-2.46) times greater odds of at least four care fragmentation occurrences (vs 0) and 2.37 (95% CI 1.73-3.25) times greater odds of at least two social needs (vs 0). CONCLUSION: Residence in areas of high combined adverse environmental burden and social vulnerability was associated with significantly greater odds of care fragmentation and social needs. Addressing structural factors and emerging environmental threats contributing to these adverse exposures is essential to reduce rheumatic disease care inequities.

Cost-Related Medication Behaviors for Patients With and Without Systemic Autoimmune Rheumatic Diseases.

OBJECTIVE: Medication nonadherence challenges the management of systemic autoimmune rheumatic diseases (SARDs). We investigated cost-related medication behaviors among patients with SARDs, and compared them to those of patients without SARDs, in a large diverse cohort across the United States. METHODS: As part of the All of Us (version 7), a nationwide diverse adult cohort with linked electronic health records begun in 2017, participants completed questionnaires concerning cost-related medication behaviors. Chi-square tests compared responses between patients with SARDs, by disease and medication type, and to those without SARDs. Logistic regression analyses were used to calculate odds ratios (95% confidence intervals [CIs]). RESULTS: We analyzed data from 3,997 patients with SARDs and 73,990 participants without SARDs. After adjustment, patients with versus without SARDs had 1.56 times increased odds of reporting unaffordability of prescription medicines (95% CI 1.43-1.70), 1.43 times increased odds of cost-related medication nonadherence (95% CI 1.31-1.56), and 1.23 times increased odds of using cost-reducing strategies (95% CI 1.14-1.32). Patients with SARDs who reported unaffordability were 16.5% less likely to receive a disease-modifying drug (95% CI 0.70-0.99) but 18.1% more likely to receive glucocorticoids (95% CI 0.99-1.42). In addition, unaffordability of prescription medicines was likely to have 1.27 times increased odds of one to two emergency room visits per year (95% CI 1.03-1.57) and 1.38-fold increased odds of three or more emergency room visits per year (95% CI 0.96-1.99). CONCLUSION: In this large diverse cohort, patients with versus without SARDs had more self-reported cost-related medication behaviors, and those who reported medication unaffordability received fewer disease-modifying drugs and had more emergency room visits.

Community-engaged randomised controlled trial to disseminate COVID-19 vaccine-related information and increase uptake among Black individuals in two US cities with rheumatic conditions.

INTRODUCTION: Inequities in COVID-19 infection and vaccine uptake among historically marginalised racial and ethnic groups in the USA persist. Individuals with rheumatic conditions, especially those who are immunocompromised, are especially vulnerable to severe infection, with significant racialised inequities in infection outcomes and in vaccine uptake. Structural racism, historical injustices and misinformation engender racial and ethnic inequities in vaccine uptake. The Popular Opinion Lleader (POL) model, a community-based intervention that trains trusted community leaders to disseminate health information to their social network members (eg, friends, family and neighbours), has been shown to reduce stigma and improve care-seeking behaviours. METHODS AND ANALYSIS: This is a community-based cluster randomised controlled trial led by a team of community and academic partners to compare the efficacy of training POLs with rheumatic or musculoskeletal conditions using a curriculum embedded with a racial justice vs a biomedical framework to increase COVID-19 vaccine uptake and reduce vaccine hesitancy. This trial began recruitment in February 2024 in Boston, Massachusetts and Chicago, Illinois, USA. Eligible POLs are English-speaking adults who identify as Black and/or of African descent, have a diagnosis of a rheumatic or musculoskeletal condition and have received >=1 COVID-19 vaccine after 31 August 2022. POLs will be randomised to a 6-module virtual educational training; the COVID-19 and vaccine-related content will be the same for both groups however the framing for arm 1 will be with a racial justice lens and for arm 2, a biomedical preventative care-focused lens. Following the training, POLs will disseminate the information they learned to 12-16 social network members who have not received the most recent COVID-19 vaccine, over 4 weeks. The trial's primary outcome is social network member COVID-19 vaccine uptake, which will be compared between intervention arms. ETHICS AND DISSEMINATION: This trial has ethical approval in the USA. This has been approved by the Mass General Brigham Institutional Review Board (IRB, 2023P000686), the Northwestern University IRB (STU00219053), the Boston University/Boston Medical Center IRB (H-43857) and the Boston Children's Hospital IRB (P00045404). Results will be published in a publicly accessible peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05822219.

Leveraging Habits to Improve Adherence to Gout Medications: A Qualitative Study.

OBJECTIVE: This study investigates patients' medication-taking routines and the feasibility of harnessing habit formation through context cues and rewards to improve medication adherence. METHODS: Semistructured qualitative interviews with patients with gout from an urban health care system were conducted to explore typical medication-taking behavior, experiences using electronic pill bottles, barriers to adherence, existing context cues, and potential cues and rewards for habit-forming behavior. Medication-taking patterns were recorded for six weeks using electronic pill bottles before interviews to inform discussion. Transcribed interviews were analyzed to generate themes using codes developed by the study team, with representative quotations selected as illustrations. RESULTS: We conducted interviews with 15 individuals (mean age 60.6 [SD 20.3] years, three women [20%], and nine White patients [60%]). Pill bottle-recorded adherence to urate-lowering therapy (ULT) was high (mean 0.91 [SD 0.10]), and one patient was experiencing an active gout flare. Five key themes emerged: (1) reasons for nonadherence, (2) internal and external motivations for adherence, (3) structured routines around taking medications, (4) rewards for good medication adherence, and (5) the role of pill cap technology in medication-taking. CONCLUSION: The importance of a predictable, structured routine in which participants could incorporate their medication-taking behavior emerged as a key factor that promoted consistent adherence. Further, identifying context cues and reminders seemed to promote incorporation of medication-taking into routines. Therefore, habit-based interventions that use context cues to establish routines around medication-taking may be a feasible strategy to improve adherence in patients with chronic conditions such as gout.

Screening to understand pregnancy preferences and offer referrals and treatment (SUPPORT): Results of a pilot quality improvement initiative.

OBJECTIVE: To assess the feasibility of integrating a pregnancy intention assessment screening algorithm into the electronic medical record (EMR) at a multispecialty clinic focused on the health of women and people assigned female at birth (AFAB). STUDY DESIGN: This pilot quality improvement project implemented a series of clinician reminders, new data fields in the patient record, and templated clinical notes to prompt care providers across specialties to ask AFAB reproductive age individuals about their desire for future pregnancies. Investigators created a novel screening question based on prior literature and expert input. Prospective observational study of one year of during-intervention EMR data on screening uptake and documentation, contraceptive use, and referrals to obstetrics and gynecology (OBGYN) for preconception care, contraceptive care, and related services. RESULTS: SUPPORT launched in February 2020 and was paused for 6 months due to the COVID-19 pandemic. During the intervention period through July 2021, 18% of patients for whom the automated screening reminder was activated had a documented pregnancy intention. Patients were screened in OBGYN, internal medicine, and eight subspecialty medical clinics. Among those screened, individuals who reported they did not desire pregnancy in the next year were more likely to use contraception (aOR 1.8, 95% CI 1.1, 3.1). Individuals that did desire pregnancy in the next year were more likely to be subsequently referred to OBGYN (aOR 2.7, 95% CI 1.2, 6.0). CONCLUSIONS: Despite the competing demands of the COVID-19 pandemic, the SUPPORT intervention was utilized at higher rates than prior similar interventions and across multiple disease specialties. IMPLICATIONS: Results from the SUPPORT pilot suggest that pregnancy intention screening of reproductive age AFAB individuals with an EMR-based screening prompt is feasible at scale.

Classifying Individuals With Rheumatic Conditions as Financially Insecure Using Electronic Health Record Data and Natural Language Processing: Algorithm Derivation and Validation.

OBJECTIVE: We aimed to examine the feasibility of applying natural language processing (NLP) to unstructured electronic health record (EHR) documents to detect the presence of financial insecurity among patients with rheumatologic disease enrolled in an integrated care management program (iCMP). METHODS: We incorporated supervised, rule-based NLP and statistical methods to identify financial insecurity among patients with rheumatic conditions enrolled in an iCMP (n = 20,395) in a multihospital EHR system. We constructed a lexicon for financial insecurity using data from available knowledge sources and then reviewed EHR notes from 538 randomly selected individuals (training cohort n = 366, validation cohort n = 172). We manually categorized records as having "definite," "possible," or "no" mention of financial insecurity. All available notes were processed using Narrative Information Linear Extraction, a rule-based version of NLP. Models were trained using the NLP features for financial insecurity using logistic, least absolute shrinkage operator (LASSO), and random forest performance characteristic and were compared with the reference standard. RESULTS: A total of 245,142 notes were processed from 538 individual patient records. Financial insecurity was present among 100 (27%) individuals in the training cohort and 63 (37%) in the validation cohort. The LASSO and random forest models performed identically and slightly better than logistic regression, with positive predictive values of 0.90, sensitivities of 0.29, and specificities of 0.98. CONCLUSION: The development of a context-driven lexicon used with rule-based NLP to extract data that identify financial insecurity is feasible for use and improved the capture for presence of financial insecurity with high accuracy. In the absence of a standard lexicon and construct definition for financial insecurity status, additional studies are needed to optimize the sensitivity of algorithms to categorize financial insecurity with construct validity.

American College of Rheumatology White Paper: The Effects of Climate Change on Rheumatic Conditions-An Evolving Landscape and a Path Forward.

OBJECTIVE: Increases in global temperatures and extreme weather events associated with climate change have complex yet poorly understood detrimental impacts on human health. We reviewed the current published literature on climate change-related effects and rheumatic conditions. METHODS: To summarize our current understanding of the likely effects of climate change, including increased air pollution, on rheumatic disease, we searched the published, peer-reviewed English-language literature from January 2000 to December 2022. Articles were reviewed by a team of rheumatologists and clinical and translational science researchers. Systematic review articles were not included but informed additional literature searches. RESULTS: After extensive examination and adjudication, 88 articles met inclusion criteria and were selected for review. Much of the epidemiologic investigations assessed associations between air pollution and increased risk of development of rheumatoid arthritis, anti-citrullinated protein antibodies, flares of gout, and hospitalizations for systemic lupus erythematosus. Increased heat vulnerability was associated with higher odds of recurrent hospitalizations across rheumatic conditions. Mechanisms for observed associations are poorly understood but could include the effects of epigenetic changes, oxidative stress, and inflammatory cytokines. Studies had limitations, including restricted geography and populations studied without focus on historically marginalized communities at highest risk for adverse effects from pollution and climate change, the relative lack of mechanistic evaluations, and most with only indirect links to climate change. CONCLUSION: To date, the published literature lacks studies that directly examine effects of climate change on rheumatic diseases. Collaborative translational and epidemiologic research is needed to enhance our understanding and awareness in this area.

Barriers, Facilitators, and Preferences for Mental Health Services Among Patients With Systemic Lupus Erythematosus: A Qualitative Study.

OBJECTIVE: Although patients with systemic lupus erythematosus (SLE) experience high levels of depression and anxiety disorders, evidence concerning patient perceptions of facilitators and barriers to effective uptake of mental health services (eg, referral to therapists and psychiatrists, psychoeducational interventions, or support groups) is limited. METHODS: We conducted semistructured qualitative interviews with 15 adults with SLE to explore patient experiences and perceptions of mental health services to identify facilitators and barriers to accessing mental health care among patients with SLE. Qualitative interviews were conducted via telephone and audio recorded for transcription and directed content analysis using NVivo software by two coders. RESULTS: The median age of the 15 participants was 48 years, 87% were female, 33% identified as Black or African American, and 33% identified as Hispanic or Latino. Qualitative themes were organized into three domains: barriers, facilitators, and preferences for mental health services. Barriers to the use of mental health services include mental health stigma, sociodemographic factors, lack of autonomy, and time commitment. Facilitators to the use of mental health services included strong relationships with their rheumatologists and mental health care clinician experience with patients with SLE. Preferences for mental health services included education-based formats, mental health providers who work with patients with SLE, peer group formats, demographically and disease-matched psychological resources, and an emphasis on non-disease-related activities. CONCLUSION: In the setting of persistent unmet psychosocial needs of patients living with SLE, data from this qualitative study will inform the development and refinement of mental health interventions that bolster psychological wellbeing in the SLE population.

A community-engaged approach to translate a Vaccine Hesitancy Scale into Haitian Creole.

OBJECTIVE: Accurately translated health materials are needed to achieve equity in vaccine uptake among U.S. individuals with non-English language preferences. Verbatim translations may not capture the cultural and linguistic vernacular required to understand vaccine hesitancy. We leveraged a community-engaged approach to translate the Vaccine Hesitancy Scale (VHS) into Haitian Creole. METHODS: Following the "WHO Guidelines on Translation and Adaptation of Instruments" and a community-engaged framework, a validated 10-question Vaccine Hesitancy Scale (VHS) underwent forward translation, expert panel review, back translation, and focus group pilot testing. RESULTS: Haitian Creole-speaking translators included two community leaders, one community partner, one study team member, and 13 Haitian, greater Boston-based community members who participated in a focus group to pretest the survey. After four iterations, a linguistic and cultural translation of the VHS was created. CONCLUSION: A community-engaged framework strengthened community partnerships and resulted in a culturally relevant Haitian Creole vaccine hesitancy scale.

Factors Associated With COVID-19 Vaccine Hesitancy in Rheumatology Outpatients in New York City.

OBJECTIVE: The aim of this study was to measure COVID-19 vaccine hesitancy among rheumatology outpatients from an early COVID-19 "hotspot" during the initial period of vaccine availability. METHODS: In March 2021, a Web-based survey was sent to 7505 adults seen at a Rheumatology Division in New York City. We evaluated characteristics associated with 3 categories of COVID-19 vaccination status: declined, undecided, and willing/already received. We used multinomial logistic regression models to calculate relative risk ratios assessing predictors of vaccination status. RESULTS: Among 2384 (32%) respondents (80% female, 87% White, 59% with systemic rheumatic disease), 2240 (94.0%) were willing/already received COVID-19 vaccination, 88 (3.7%) were undecided, and 56 (2.3%) declined. Compared with those willing/already vaccinated, those declining or undecided were younger, more likely identified as Black or Hispanic/Latinx, and had lower household income and educational attainment. Immunosuppressive medication use did not differ among groups. After multivariable adjustment, every 1-year increase in age was associated with a 0.96 lower relative risk of declining or being undecided versus willing/already vaccinated. Respondents identifying as Black versus White had a higher relative risk ratio of being undecided (4.29 [95% confidence interval, 1.96-9.36]), as did those identifying as Hispanic/Latinx versus non-Hispanic/non-Latinx (2.81 [95% confidence interval, 1.29-6.09]). Those declining vaccination were least likely to believe in general vaccine importance or the safety and efficacy of the COVID-19 vaccine. CONCLUSIONS: Among rheumatology patients in New York City with and without systemic rheumatic disease, COVID-19 vaccine uptake was high after its initial availability. Sociodemographic but not medication-related factors were associated with vaccine hesitancy; these findings can inform future rheumatology vaccination programs.

Evaluation and management of pericarditis in rheumatic diseases.

ABSTRACT: This review summarizes the evaluation for underlying rheumatic conditions in patients presenting with acute pericarditis, treatment considerations for specific rheumatic conditions, and the role of imaging in diagnosis and monitoring. Pericarditis may be one of the initial presentations of a rheumatic disease or identified in a patient with known rheumatic disease. There is also growing evidence for using anti-inflammatory and immunosuppressive agents for treating recurrent pericarditis, which can overlap with the treatment of rheumatic diseases.

Public Insurance and Single-Guardian Households Are Associated with Diagnostic Delay in Slipped Capital Femoral Epiphysis.

BACKGROUND: Extensive literature documents the adverse sequelae of delayed diagnosis of slipped capital femoral epiphysis (SCFE), including worsening deformity and surgical complications. Less is known about predictors of delayed diagnosis of SCFE, particularly the effects of social determinants of health. The purpose of this study was to evaluate the impact of insurance type, family structure, and neighborhood-level socioeconomic vulnerability on the delay of SCFE diagnosis. METHODS: We reviewed medical records of patients who underwent surgical fixation for stable SCFE at a tertiary pediatric hospital from 2002 to 2021. We abstracted data on demographic characteristics, insurance status, family structure, home address, and symptom duration. We measured diagnostic delay in weeks from the date of symptom onset to diagnosis. We then geocoded patient addresses to determine their Census tract-level U.S. Centers for Disease Control and Prevention (CDC) and Agency for Toxic Substances and Disease Registry (ATSDR) Social Vulnerability Index (SVI), using U.S. Census and American Community Survey data. We performed 3 separate logistic regression models to examine the effects of (1) insurance status, (2) family structure, and (3) SVI on a delay of ≥12 weeks (reference, <12 weeks). We adjusted for age, sex, weight status, number of siblings, and calendar year. RESULTS: We identified 351 patients with SCFE; 37% (129) had a diagnostic delay of ≥12 weeks. In multivariable logistic regression models, patients with public insurance were more likely to have a delay of ≥12 weeks than patients with private insurance (adjusted odds ratio [OR], 1.83 [95% confidence interval (CI), 1.12 to 2.97]; p = 0.015) and patients from single-guardian households were more likely to have a delay of ≥12 weeks than patients from multiguardian households (adjusted OR, 1.95 [95% CI, 1.11 to 3.45]; p = 0.021). We did not observe a significant increase in the odds of delay among patients in the highest quartile of overall SVI compared with patients from the lower 3 quartiles, in both the U.S. comparison (adjusted OR, 1.43 [95% CI, 0.79 to 2.58]; p = 0.24) and the Massachusetts comparison (adjusted OR, 1.45 [95% CI, 0.79 to 2.66]; p = 0.23). CONCLUSIONS: The delay in diagnosis of SCFE remains a concern, with 37% of patients with SCFE presenting with delay of ≥12 weeks. Public insurance and single-guardian households emerged as independent risk factors for diagnostic delay. Interventions to reduce delay may consider focusing on publicly insured patients and those from single-guardian households. LEVEL OF EVIDENCE: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.