Measuring What Matters: A Qualitative Study of the Relevance and Clinical Utility of PROMIS Surveys in Systemic Lupus Erythematosus.

OBJECTIVE: To evaluate the relevance and clinical utility of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys in patients with systemic lupus erythematosus (SLE). METHODS: Adults with SLE receiving routine outpatient care at a tertiary care academic medical center participated in a qualitative study. Patients completed PROMIS computerized adaptive tests (CATs) in 12 selected domains and rated the relevance of each domain to their experience with SLE. Focus groups and interviews were conducted to elucidate the relevance of the PROMIS surveys, identify additional domains of importance, and explore the utility of the surveys in clinical care. Focus group and interview transcripts were coded, and a thematic analysis was performed using an iterative inductive process. RESULTS: Twenty-eight women and 4 men participated in 4 focus groups and 4 interviews, respectively. Participants endorsed the relevance and comprehensiveness of the selected PROMIS domains in capturing the effect of SLE on their lives. They ranked fatigue, pain interference, sleep disturbance, physical function, and applied cognition abilities as the most salient health-related quality of life (HRQOL) domains. They suggested that the disease-agnostic PROMIS questions holistically captured their lived experience of SLE and its common comorbidities. Participants were enthusiastic about using PROMIS surveys in clinical care and described potential benefits in enabling disease monitoring and management, facilitating communication, and empowering patients. CONCLUSION: PROMIS includes the HRQOL domains that are of most importance to individuals with SLE. Patients suggest that these universal tools can holistically capture the impact of SLE and enhance routine clinical care.

Listening to Patients With Lupus: Why Not Proactively Integrate the Internet as a Resource to Drive Improved Care?

Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease. It is characterized by a broad spectrum of manifestations, depending on the affected organs and the severity of the inflammation at the time of presentation. Despite improvements in management, treatments are required on a chronic, cyclical basis; have high potential for unpleasant side effects; and deliver variable efficacy. Patients require care from multiple specialists, which can be delivered simultaneously and sporadically. Our fragmented health care system further exacerbates the disconnect between intermittent medical care and the lived experiences of patients with SLE. The goals of this research are to (1) assess the current standard of care for patients with SLE through the review of medical literature, including clinical consensus guidelines and systematic reviews; (2) assess the lived experiences of patients with lupus through the review of peer-reviewed literature on social listening, structured interviews, and data available from the open-access digital health platform PatientsLikeMe; and (3) present the perspective that the medical community has an opportunity to acknowledge and review the use of digital health interventions (DHIs) with their patients. The results of this research indicate that patients are incorporating DHIs, such as the internet and social media platforms, as critical components of their care for even the most basic of support. Although patients with SLE are depending on this support to shape their care, it is not considered a primary source of care by clinicians. Integrating the voices of patients brings valuable dimension to understanding the lived experiences of patients with SLE and the impacts of mutually dependent patient needs as patients navigate the disease in daily life. The medical community has a meaningful opportunity to leverage and recommend existing DHIs, such as web-based community platforms and web-based patient registries, at every stage of the patient journey to help patients better manage their condition. This has the potential to proactively build patient trust and well-being, reduce the underreporting of symptoms, increase shared decision-making, inform and shape clinical guidelines and future research, and improve patient outcomes.

Clinical integration of patient-reported outcome measures to enhance the care of patients with SLE: a multi-centre prospective cohort study.

OBJECTIVE: To assess the feasibility and impact of integrating electronic patient-reported outcome measures (PROMs) into the routine outpatient care of patients with SLE. METHODS: We conducted a prospective cohort study, utilizing a mixed-methods sequential explanatory design, of SLE outpatients receiving rheumatology care at two academic medical centres. Participants completed electronic PROMs at enrolment and then prior to their next two routine rheumatology visits. PROM score reports were shared with patients and rheumatologists before visits. Patients and rheumatologists completed post-visit surveys evaluating the utility of PROMs in the clinical encounters. Focus groups of patients and interviews with treating rheumatologists were conducted to further explore their experience utilizing PROMs. RESULTS: A total of 105 SLE patients and 17 rheumatologists participated in the study. Patients completed PROMs in 159 of 184 encounters (86%), with 93% of surveys completed remotely. Patients reported that PROMs were 'quite a bit' or 'very' useful (55% of encounters) and beneficial to communication (55% of encounters). In contrast, physicians found PROMs useful (20%) and beneficial to communication (17%) less frequently. There was no significant change in visit length, health-related quality of life or disease activity after implementation of PROMs; however, patient satisfaction improved slightly. Qualitative analyses revealed that patients felt PROMs provided utility primarily by facilitating communication, particularly when physicians discussed the surveys. CONCLUSION: The remote capture and integration of electronic PROMs into clinical care was feasible in a diverse cohort of SLE outpatients. PROMs were useful to patients and enhanced their clinical experience primarily by facilitating communication.

Impact of the first wave of the COVID-19 pandemic on systemic lupus erythematosus patients: Results from a multi-center prospective cohort.

OBJECTIVE: The aim of this study was to evaluate the initial impact of the COVID-19 pandemic on individuals with systemic lupus erythematosus (SLE). METHODS: Patients with SLE participating in a multi-center longitudinal cohort study in New York and Boston were invited to complete a supplemental web-based questionnaire in the summer of 2020. Participants completed standardized patient-reported outcome (PRO) measures and a combination of Likert scale and open-ended questions exploring the impact of the COVID-19 pandemic on their health and access to health care. Changes in PROs were evaluated with paired t-tests and frequencies of worsened symptoms were calculated. A thematic qualitative analysis was conducted on free text responses. RESULTS: Of 97 patients invited, 63 (65%) completed a supplemental questionnaire. Nearly 50% of respondents exhibited increases in anxiety (47.5%) and depression (48.3%) and over 40% scored worse in measures of pain interference, fatigue, and cognitive abilities. Respondents with pre-existing diagnoses of anxiety did not differ from other participants in PRO scores, but were more than three times as likely to report worsened health status. Patients denied difficulties accessing medications (85%) or medical care (84%) and over 50% participated in telehealth visits. Anxiety and increased health risks due to immunosuppression were recurring themes in free text responses. CONCLUSIONS: SLE patients experienced a significant physical and emotional toll in the initial months of the COVID-19 pandemic. Comprehensive patient-centered care, including monitoring and addressing anxiety and health-related quality of life, is critical to improving health outcomes in this population during the ongoing health crisis.

Current Perspectives on Arthroplasty in Systemic Lupus Erythematosus: Rates, Outcomes, and Adverse Events.

Systemic lupus erythematosus (SLE) is a chronic debilitating condition with significant impact on the musculoskeletal system. Arthroplasty may be indicated for damage related to active lupus or its treatment. As therapies for SLE have advanced, morbidity and mortality have declined, while the rate of joint replacement has increased. The age of SLE patients undergoing arthroplasty is increasing, and the indication for surgery is evolving-while avascular necrosis was previously the predominant indication for arthroplasty, osteoarthritis now accounts for a larger proportion of surgeries. Pain and functional outcomes of arthroplasty in SLE patients are comparable to those of the general population with osteoarthritis, but lupus remains an independent risk factor for post-hip arthroplasty complications and mortality. Further research is needed to characterize the impact of lupus disease activity and severity on arthroplasty outcomes.

Comparison of the 1987 American College of Rheumatology and the 2010 American College of Rheumatology/European League against Rheumatism criteria for classification of rheumatoid arthritis in the Nurses' Health Study cohorts.

Performance of rheumatoid arthritis (RA) classification by the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) criteria, compared to the 1987 ACR criteria, has not been assessed in population-based cohorts in which disease identification is by mailed questionnaire. Women followed in the Nurses' Health Study and Nurses' Health Study II cohorts self-reported new doctor-diagnosed RA on biennial questionnaires. Two RA experts reviewed medical records of 128 new RA self-reports to obtain individual 1987 and 2010 criteria and arrived at a consensus opinion. We compared agreement in classification by the two criteria sets (kappa), and calculated sensitivity and specificity, with reviewers' opinion as gold standard. Ninety-eight (77%) participants were classified as RA by reviewers' consensus opinion; 98 (77%) fulfilled 1987 criteria, while 79 (63%) fulfilled 2010 criteria. Seventy-two (56%) were classified as RA by both sets, 21 (16%) by neither, 26 (20%) by only 1987 criteria, and 9 (7%) by only 2010 criteria. Kappa for concordance was 0.36 (95% CI 0.20-0.53). Compared to reviewer's opinion, sensitivity and specificity were 0.93 and 0.77 for 1987 criteria, and 0.79 and 0.87 for 2010 criteria. Participants fulfilling 1987 criteria only were more likely to be seronegative. In these prospective population-based cohorts, significant discordance between 1987 ACR and 2010 ACR/EULAR criteria for classifying RA exists. Using the 2010 ACR/EULAR criteria alone had decreased sensitivity, and seronegative RA cases would be excluded in particular. Combined use of both will be necessary to maximize inclusion and allow sensitivity analyses.

Lay Health Worker Interventions in Rheumatology: A Scoping Review.

OBJECTIVE: To determine next steps for lay health worker (LHW) intervention research, specifically in patients with rheumatic musculoskeletal diseases (RMDs), there is a need to establish what strategies have been effective for chronic disease management thus far. The goal of this scoping review is to collate the literature of LHW interventions for adults with RMDs to inform next steps for LHW research. METHODS: A comprehensive literature search was performed in the following databases from inception to September 2021: Ovid Medline, Ovid Embase, CINAHL, PsycINFO, and The Cochrane Library. Studies retrieved were then screened for eligibility against predefined inclusion and exclusion criteria. RESULTS: Twenty-two articles were eligible and included in this review. The most common RMDs studied, not mutually exclusive, were osteoarthritis (n = 13), rheumatoid arthritis (n = 9), and unspecified or other RMD (n = 14). Most studies had a homogenous patient population, enrolling White, non-Hispanic, or Latina women over the age of 60 (n = 13). Eight studies observed statistically significant results in the intervention arm compared with the control. Only one of these studies exhibited sustained treatment effects past one year. CONCLUSION: There are not enough data to conclude if LHW interventions have a positive, null, or negative effect on patients with RMDs. Future LHW interventions should specify a priori hypotheses, be powered to detect statistical significance for primary outcomes, employ a theoretical framework, include an active control, describe training protocols for LHWs, and increase minority representation to establish the effectiveness of LHWs for patients with RMDs.

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.

"Unspoken Questions": A Qualitative Study of Rheumatologists' Perspectives on the Clinical Implementation of Patient-reported Outcome Measures.

OBJECTIVE: To identify rheumatologists' views on perceived barriers and facilitators to the clinical implementation of patient-reported outcome measures (PROM). METHODS: Semistructured interviews were conducted with academically affiliated clinical rheumatologists. Interviews were audio-recorded and transcribed. Deidentified transcripts were independently coded and analyzed for themes. RESULTS: Fifteen attending rheumatologists, 8 women (53%) and 7 men (47%) with a mean of 17.3 years in practice (range 5-43) at 2 urban academic medical centers, participated in interviews. Rheumatologists identified several barriers to integrating PROM in clinical care, highlighting physician buy-in and culture change as significant challenges beyond logistical considerations. They further underscored the lack of effective interventions and resources for addressing the domains of most interest to patients. Physicians also recognized significant benefits of PROM in clinical care, including contributing to the clinical impression by providing the patient perspective, and promoting agenda setting by uncovering "unspoken questions." They additionally noted that PROM could support treatment planning, build patient-physician relationships, and facilitate patient engagement. Participants suggested that technology, physician education, and team-based care could facilitate the effective implementation of PROM. CONCLUSION: Rheumatologists identified multiple mechanisms through which PROM could augment clinical care, but also noted several obstacles to implementation, questioning the added value of PROM and the limited availability of interventions to improve patient-centered outcomes. Programs seeking to successfully integrate PROM to enhance patient-centered care and meet quality benchmarks should prioritize physician buy-in and training, and provide resources to address the outcomes that are measured.

Responsiveness of the Patient-Reported Outcomes Measurement Information System Global Health Short Form in Outpatients With Systemic Lupus Erythematosus.

OBJECTIVE: To evaluate the longitudinal responsiveness (sensitivity to change) of the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (PROMIS10) in outpatients with systemic lupus erythematosus (SLE). METHODS: Outpatients with SLE who were receiving care at an academic medical center completed the PROMIS10 at 2 visits that were a minimum of 1 month apart. Responsiveness of the PROMIS10 global physical and mental health domains to Patient-Reported improvement or deterioration of health status was evaluated, as measured by standard validated instruments. Effect sizes of changes in PROMIS10 scores between visits were evaluated using Kruskal-Wallis testing. RESULTS: A total of 223 SLE patients enrolled and completed baseline surveys, with 186 (83.4%) completing a second set of questionnaires. The PROMIS10 demonstrated mild-to-moderate responsiveness to Patient-Reported improvement (effect size 0.29) and worsening (effect sizes -0.27 and -0.54) of health status for both global physical health and global mental health. Changes in the PROMIS10 correlated poorly with changes in physician-reported measures of disease activity. CONCLUSION: The PROMIS10 showed responsiveness over time to Patient-Reported changes in SLE health status, but not physician-assessed changes. These data suggest that the PROMIS10 can be used to efficiently measure and monitor important aspects of the SLE patient experience that are not captured by standard physician-derived metrics. Further studies are needed to evaluate the role of the PROMIS10 in optimizing longitudinal disease management in SLE and to determine its responsiveness in other chronic health conditions.

Feasibility, Validity, and Reliability of the 10-item Patient Reported Outcomes Measurement Information System Global Health Short Form in Outpatients with Systemic Lupus Erythematosus.

OBJECTIVE: To assess the feasibility, validity, and reliability of the Patient Reported Outcomes Measurement Information System Global Health Short Form (PROMIS10) in outpatients with systemic lupus erythematosus (SLE). METHODS: SLE outpatients completed PROMIS10, Medical Outcomes Study Short Form-36 (SF-36), LupusQoL-US, and selected PROMIS computerized adaptive tests (CAT) at routine visits at an SLE Center of Excellence. Construct validity was evaluated by correlating PROMIS10 physical and mental health scores with PROMIS CAT, legacy instruments, and physician-derived measures of disease activity and damage. Test-retest reliability was determined among subjects reporting stable SLE activity at 2 assessments 1 week apart using intraclass correlation coefficients (ICC). RESULTS: A diverse cohort of 204 out of 238 patients with SLE (86%) completed survey instruments. PROMIS10 physical health scores strongly correlated with physical function, pain, and social health domains in PROMIS CAT, SF-36, and LupusQoL, while mental health scores strongly correlated with PROMIS depression CAT, SF-36, and LupusQoL mental health domains (Spearman correlations ≥ 0.70). Active arthritis, comorbid fibromyalgia (FM), and anxiety were associated with worse PROMIS10 scores, but sociodemographic factors and physician-assessed flare status were not. Test-retest reliability for PROMIS10 physical and mental health scores was high (ICC ≥ 0.85). PROMIS10 required < 2 minutes to complete. CONCLUSION: PROMIS10 is valid and reliable, and can efficiently screen for impaired physical function, pain, and emotional distress in outpatients with SLE. With strong correlations to LupusQoL and SF-36 but significantly reduced responder burden, PROMIS10 is a promising tool for measuring patient-reported outcomes in routine SLE clinical care and value-based healthcare initiatives.

Validity and Reliability of Patient Reported Outcomes Measurement Information System Computerized Adaptive Tests in Systemic Lupus Erythematosus.

OBJECTIVE: The aims of this study were to assess the construct validity and the test-retest reliability of Patient Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests (CAT) in patients with systemic lupus erythematosus (SLE). METHODS: Adults with SLE completed the Medical Outcomes Study Short Form-36, LupusQoL-US version ("legacy instruments"), and 14 selected PROMIS CAT. Using Spearman correlations, PROMIS CAT were compared with similar domains measured with legacy instruments. CAT were also correlated with the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) disease activity and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) scores. Test-retest reliability was evaluated using ICC. RESULTS: There were 204 outpatients with SLE enrolled in the study and 162 completed a retest. PROMIS CAT showed good performance characteristics and moderate to strong correlations with similar domains in the 2 legacy instruments (r = -0.49 to 0.86, p < 0.001). However, correlations between PROMIS CAT and the SELENA-SLEDAI disease activity and SDI were generally weak and statistically insignificant. PROMIS CAT test-retest ICC were good to excellent, ranging from 0.72 to 0.88. CONCLUSION: To our knowledge, these data are the first to show that PROMIS CAT are valid and reliable for many SLE-relevant domains. Importantly, PROMIS scores did not correlate well with physician-derived measures. This disconnect between objective signs and symptoms and the subjective patient disease experience underscores the crucial need to integrate patient-reported outcomes into clinical care to ensure optimal disease management.

Pilot study of a multidisciplinary gout patient education and monitoring program.

OBJECTIVE: Gout patient self-management knowledge and adherence to treatment regimens are poor. Our objective was to assess the feasibility and acceptability of a multidisciplinary team-based pilot program for the education and monitoring of gout patients. METHODS: Subjects completed a gout self-management knowledge exam, along with gout flare history and compliance questionnaires, at enrollment and at 6 and 12 months. Each exam was followed by a nursing educational intervention via a structured gout curriculum. Structured monthly follow-up calls from pharmacists emphasized adherence to management programs. Primary outcomes were subject and provider program evaluation questionnaires at 6 and 12 months, program retention rate and success in reaching patients via monthly calls. RESULTS: Overall, 40/45 subjects remained in the study at 12 months. At 12 months, on a scale of 1 (most) to 5 (least), ratings of 3 or better were given by 84.6% of subjects evaluating the usefulness of the overall program in understanding and managing their gout, 81.0% of subjects evaluating the helpfulness of the nursing education program, and 50.0% of subjects evaluating the helpfulness of the calls from the pharmacists. Knowledge exam questions that were most frequently answered incorrectly on repeat testing concerned bridge therapy, the possibility of being flare-free, and the genetic component of gout. CONCLUSIONS: Our multidisciplinary program of gout patient education and monitoring demonstrates feasibility and acceptability. We identified variability in patient preference for components of the program and persistent patient knowledge gaps.

Corticosteroids in Lupus.

Corticosteroids are the mainstay of treatment of systemic lupus erythematosus, with most patients receiving them at some point in the course of their disease. Corticosteroid use is associated with significant side effects, including infections, hypertension, hyperglycemia, osteoporosis, avascular necrosis, myopathy, cataracts, and glaucoma. Dosing regimens are based on limited data, with the goal of adequately controlling inflammatory symptoms while minimizing steroid exposure in order to reduce adverse effects.

The epidemiology of atherosclerotic cardiovascular disease among patients with SLE: a systematic review.

OBJECTIVE: To perform a systematic review of the literature regarding the epidemiology of the association between systemic lupus erythematosus (SLE) and atherosclerotic cardiovascular disease (CVD), including the increased risk for CVD, as well as the risk factors responsible for development of CVD in patients with SLE. METHODS: We followed the PRISMA guidelines to systematically search the PubMed database from inception to June 2012. Studies were selected using predefined eligibility criteria, and 2 authors independently extracted data. The risk of bias was measured for each study using a domain-based assessment. RESULTS: We report on 28 studies that met criteria for inclusion in our analysis. We found strong epidemiologic evidence that SLE patients have an increased relative risk of CVD compared to controls. There is limited information regarding relative CVD mortality risks among SLE patients. Traditional CVD risk factors, including age, male sex, hyperlipidemia, smoking, hypertension, and CRP, are associated with CVD risk among SLE patients. Several SLE-specific factors, including disease activity and duration, and possibly specific manifestations and therapies, further increase risk. Several risk factors, such as disease activity and glucocorticoid use, are closely associated, making it difficult to disentangle their effects. CONCLUSIONS: CVD risk among SLE patients compared to the general population is at least doubled. While older SLE patients appear to have the highest absolute risks of CVD, young women have alarmingly high relative risks, given the rarity of CVD in the comparison general population. Both traditional and SLE-specific risk factors are important, although there are discrepancies within the literature.