Remission and low disease activity are associated with lower healthcare costs: results from the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort.

OBJECTIVES: This study aims to determine the independent impact of definitions of remission/low disease activity (LDA) on direct/indirect costs (DCs, ICs) in a multicentre inception cohort. METHODS: Patients from 31 centres in 10 countries were enrolled within 15 months of diagnosis and assessed annually. Five mutually exclusive disease activity states (DAS) were defined as (1) remission off-treatment: clinical (c) SLEDAI-2K=0, without prednisone/immunosuppressants; (2) remission on-treatment: cSLEDAI-2K=0, prednisone ≤5 mg/day and/or maintenance immunosuppressants; (3) LDA-Toronto Cohort (TC): cSLEDAI-2K≤2, without prednisone/immunosuppressants; (4) modified lupus LDA state (mLLDAS): SLEDAI-2K≤4, no activity in major organs/systems, no new activity, prednisone ≤7.5 mg/day and/or maintenance immunosuppressants and (5) active: all remaining assessments.At each assessment, patients were stratified into the most stringent DAS fulfilled and the proportion of time in a DAS since cohort entry was determined. Annual DCs/ICs (2021 Canadian dollars) were based on healthcare use and lost workforce/non-workforce productivity over the preceding year.The association between the proportion of time in a DAS and annual DC/IC was examined through multivariable random-effects linear regressions. RESULTS: 1692 patients were followed a mean of 9.7 years; 49.0% of assessments were active. Remission/LDA (per 25% increase in time in a remission/LDA state vs active) were associated with lower annual DC/IC: remission off-treatment (DC -$C1372; IC -$C2507), remission on-treatment (DC -$C973; IC -$C2604,) LDA-TC (DC -$C1158) and mLLDAS (DC -$C1040). There were no cost differences between remission/LDA states. CONCLUSIONS: Our data suggest that systemic lupus erythematosus patients who achieve remission, both off and on-therapy, and reductions in disease activity incur lower costs than those experiencing persistent disease activity.

Projecting the Clinical and Economic Impacts of Changes to HIV Care Among Adolescents and Young Adults in the United States: Lessons From the COVID-19 Pandemic.

BACKGROUND: During the COVID-19 pandemic, many US youth with HIV (YHIV) used telehealth services; others experienced disruptions in clinic and antiretroviral therapy (ART) access. METHODS: Using the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-Adolescent HIV microsimulation model, we evaluated 3 scenarios: 1) Clinic: in-person care; 2) Telehealth: virtual visits, without CD4 or viral load monitoring for 12 months, followed by return to usual care; and 3) Interruption: complete care interruption with no ART access or laboratory monitoring for 6 months (maximum clinic closure time), followed by return to usual care for 80%. We assigned higher 1-year retention (87% vs 80%) and lower cost/visit ($49 vs $56) for Telehealth vs Clinic. We modeled 2 YHIV cohorts with non-perinatal (YNPHIV) and perinatal (YPHIV) HIV, which differed by mean age (22 vs 16 years), sex at birth (85% vs 47% male), starting CD4 count (527/µL vs 635/µL), ART, mortality, and HIV-related costs. We projected life months (LMs) and costs/100 YHIV over 10 years. RESULTS: Over 10 years, LMs in Clinic and Telehealth would be similar (YNPHIV: 11 350 vs 11 360 LMs; YPHIV: 11 680 LMs for both strategies); costs would be $0.3M (YNPHIV) and $0.4M (YPHIV) more for Telehealth than Clinic. Interruption would be less effective (YNPHIV: 11 230 LMs; YPHIV: 11 620 LMs) and less costly (YNPHIV: $1.3M less; YPHIV: $0.2M less) than Clinic. Higher retention in Telehealth led to increased ART use and thus higher costs. CONCLUSIONS: Telehealth could be as effective as in-person care for some YHIV, at slightly increased cost. Short interruptions to ART and laboratory monitoring may have negative long-term clinical implications.

Are There Racial Disparities in Perioperative Pain? A Retrospective Study of a Gynecological Surgery Cohort.

PURPOSE: The purpose of this study was to examine whether racial disparities exist in immediate postoperative pain scores and intraoperative analgesic regimens in a single surgical cohort. DESIGN: A single-center, retrospective analysis. METHODS: This retrospective study of a single surgical cohort was conducted via chart review of the existing electronic health record. A total of 203 patients who underwent minimally invasive hysterectomy were included in the analysis. Three initially reviewed patient records were excluded from the final analysis due to the small size of their racial cohorts (two Asian or Pacific Islander and one Native American). The White patients (n = 103) and Black patients (n = 100) were compared for differences in pain scores in the postanesthesia care unit (PACU). The patients' intraoperative analgesic regimens were also compared. FINDINGS: There were no significant differences between races in the postoperative pain scores in the PACU or in the analgesia administered by the anesthesia provider intraoperatively. CONCLUSIONS: In this specific population, there was no evidence of racial disparities in postoperative pain or intraoperative analgesia administration. Further research is needed to understand the unique factors of the perioperative period, to see if the absence of disparities in this study is repeated in other cohorts, and to mitigate any disparities that are found.

Assessing the Costs of Neuropsychiatric Disease in the Systemic Lupus International Collaborating Clinics Cohort Using Multistate Modeling.

OBJECTIVE: To estimate direct and indirect costs associated with neuropsychiatric (NP) events in the Systemic Lupus International Collaborating Clinics inception cohort. METHODS: NP events were documented annually using American College of Rheumatology definitions for NP events and attributed to systemic lupus erythematosus (SLE) or non-SLE causes. Patients were stratified into 1 of 3 NP states (no, resolved, or new/ongoing NP event). Change in NP status was characterized by interstate transition rates using multistate modeling. Annual direct costs and indirect costs were based on health care use and impaired productivity over the preceding year. Annual costs associated with NP states and NP events were calculated by averaging all observations in each state and adjusted through random-effects regressions. Five- and 10-year costs for NP states were predicted by multiplying adjusted annual costs per state by expected state duration, forecasted using multistate modeling. RESULTS: A total of 1,697 patients (49% White race/ethnicity) were followed for a mean of 9.6 years. NP events (n = 1,971) occurred in 956 patients, 32% attributed to SLE. For SLE and non-SLE NP events, predicted annual, 5-, and 10-year direct costs and indirect costs were higher in new/ongoing versus no events. Direct costs were 1.5-fold higher and indirect costs 1.3-fold higher in new/ongoing versus no events. Indirect costs exceeded direct costs 3.0 to 5.2 fold. Among frequent SLE NP events, new/ongoing seizure disorder and cerebrovascular disease accounted for the largest increases in annual direct costs. For non-SLE NP events, new/ongoing polyneuropathy accounted for the largest increase in annual direct costs, and new/ongoing headache and mood disorder for the largest increases in indirect costs. CONCLUSION: Patients with new/ongoing SLE or non-SLE NP events incurred higher direct and indirect costs.

Implementation and Evaluation of a Wraparound Virtual Care Program for Children with Medical Complexity.

Objectives: Children and adolescents with medical complexity benefit from care coordination and specialized pediatric care, but many access barriers exist. We implemented a virtual wraparound model to support patients with medical complexity and their families and used an economic framework to measure outcomes. Methods: Children with medical complexity were identified and enrolled in a virtual complex care program with a dedicated multidisciplinary team, which provided care coordination, education, parental support, acute care triage, and virtual visits. A retrospective pre- and postanalysis of data obtained from the Hospital Industry Data Institute (HIDI) database measured inpatient, outpatient, and emergency department (ED) utilization and charges before implementation and during the 2-year program. Results: Eighty (n = 80) children were included in the economic evaluation, and 75 had sufficient data for analysis. Compared to the 12 months before enrollment, patients had a 35.3% reduction in hospitalizations (p = 0.0268), a 43.9% reduction in emergency visits (p = 0.0005), and a 16.9% reduction in overall charges (p = 0.1449). Parents expressed a high degree of satisfaction, with a 70% response rate and 90% satisfaction rate. Conclusions: We implemented a virtual care model to provide in-home support and care coordination for medically complex children and adolescents and used an economic framework to assess changes in utilization and cost. The program had high engagement rates and parent satisfaction, and a pre/postanalysis demonstrated statistically significant reduction in hospitalizations and ED visits for this high-cost population. Further economic evaluation is needed to determine sustainability of this model in a value-based payment system.

A Modification of Time-Driven Activity-Based Costing for Comparing Cost of Telehealth and In-Person Visits.

Introduction: Cost studies of telehealth (TH) and virtual visits are few and report mixed results of the economic impact of virtual care and TH. Largely missing from the literature are studies that identify the cost of delivering TH versus in-person care. The objective was to demonstrate a modified time-driven activity-based costing (TDABC) approach to compare weighted labor cost of an in-person pediatric clinic sick visit before COVID-19 to the same virtual and in-person sick-visit during COVID-19. Methods: We examined visits before and during COVID-19 using: (1) recorded structured interviews with providers; (2) iterative workflow mapping; (3) electronic health records time stamps for validation; (4) standard cost weights for wages; and (5) clinic CPT billing code mix for complexity weighs. We examined the variability in estimated time using a decision tree model and Monte Carlo simulations. Results: Workflow charts were created for the clinic before COVID-19 and during COVID-19. Using TDABC and simulations for varying time, the weighted cost of clinic labor for sick visit before COVID-19 was $54.47 versus $51.55 during COVID-19. Discussion: The estimated mean labor cost for care during the pandemic has not changed from the pre-COVID period; however, this lack of a difference is largely because of the increased use of TH. Conclusions: Our TDABC approach is feasible to use under virtual working conditions; requires minimal provider time for execution; and generates detailed cost estimates that have "face validity" with providers and are relevant for economic evaluation.

Minimally important difference in cost savings: Is it possible to identify an MID for cost savings?

As healthcare costs continue to increase, studies assessing costs are becoming increasingly common, but researchers planning for studies that measure costs differences (savings) encounter a lack of literature or consensus among researchers on what constitutes "small" or "large" cost savings for common measures of resource use.  Other fields of research have developed approaches to solve this type of problem. Researchers measuring improvement in quality of life or clinical assessments have defined minimally important differences (MID) which are then used to define magnitudes when planning studies. Also, studies that measure cost effectiveness use benchmarks, such as cost/QALY, but do not provide benchmarks for cost differences. In a review of the literature, we found no publications identifying indicators of magnitude for costs. However, the literature describes three approaches used to identify minimally important outcome differences: (1) anchor-based, (2) distribution-based, and (3) a consensus-based Delphi methods. In this exploratory study, we used these three approaches to derive MID for two types of resource measures common in costing studies for: (1) hospital admissions (high cost); and (2) clinic visits (low cost). We used data from two (unpublished) studies to implement the MID estimation. Because the distributional characteristics of cost measures may require substantial samples, we performed power analyses on all our estimates to illustrate the effect that the definitions of "small" and "large" costs may be expected to have on power and sample size requirements for studies. The anchor-based method, while logical and simple to implement, may be of limited value in cases where it is difficult to identify appropriate anchors. We observed some commonalities and differences for the distribution and consensus-based approaches, which require further examination. We recommend that in cases where acceptable anchors are not available, both the Delphi and the distribution-method of MID for costs be explored for convergence.

Economic Evaluation of Damage Accrual in an International Systemic Lupus Erythematosus Inception Cohort Using a Multistate Model Approach.

OBJECTIVE: There is a paucity of data regarding health care costs associated with damage accrual in systemic lupus erythematosus. The present study was undertaken to describe costs associated with damage states across the disease course using multistate modeling. METHODS: Patients from 33 centers in 11 countries were enrolled in the Systemic Lupus International Collaborating Clinics (SLICC) inception cohort within 15 months of diagnosis. Annual data on demographics, disease activity, damage (SLICC/American College of Rheumatology Damage Index [SDI]), hospitalizations, medications, dialysis, and selected procedures were collected. Ten-year cumulative costs (Canadian dollars) were estimated by multiplying annual costs associated with each SDI state by the expected state duration using a multistate model. RESULTS: A total of 1,687 patients participated; 88.7% were female, 49.0% were white, mean ± SD age at diagnosis was 34.6 ± 13.3 years, and mean time to follow-up was 8.9 years (range 0.6-18.5 years). Mean annual costs were higher for those with higher SDI scores as follows: $22,006 (Canadian) (95% confidence interval [95% CI] $16,662, $27,350) for SDI scores ≥5 versus $1,833 (95% CI $1,134, $2,532) for SDI scores of 0. Similarly, 10-year cumulative costs were higher for those with higher SDI scores at the beginning of the 10-year interval as follows: $189,073 (Canadian) (95% CI $142,318, $235,827) for SDI scores ≥5 versus $21,713 (95% CI $13,639, $29,788) for SDI scores of 0. CONCLUSION: Patients with the highest SDI scores incur 10-year cumulative costs that are ~9-fold higher than those with the lowest SDI scores. By estimating the damage trajectory and incorporating annual costs, data on damage can be used to estimate future costs, which is critical knowledge for evaluating the cost-effectiveness of novel therapies.

Effect of an Evidence-based Inpatient Tobacco Dependence Treatment Service on 1-Year Postdischarge Health Care Costs.

BACKGROUND: In 2014, the Medical University of South Carolina (MUSC) implemented a Tobacco Dependence Treatment Service (TDTS) consistent with the Joint Commission (JC) standards recommending that hospitals screen patients for smoking, provide cessation support, and follow-up contact for relapse prevention within 1 month of discharge. We previously demonstrated that patients exposed to the MUSC TDTS were approximately half as likely to be smoking one month after discharge and 23% less likely to have a 30-day hospital readmission. This paper examines whether exposure to the TDTS influenced downstream health care charges 12 months after patients were discharged from the hospital. METHODS: Data from MUSC's electronic health records, the TDTS, and statewide health care utilization datasets (eg, hospitalization, emergency department, and ambulatory surgery visits) were linked to assess how exposure to the MUSC TDTS impacted health care charges. Total health care charges were compared for patients with and without TDTS exposure. To reduce potential TDTS exposure selection bias, propensity score weighting was used to balance baseline characteristics between groups. The cost of delivering the MUSC TDTS intervention was calculated, along with cost per smoker. RESULTS: The overall adjusted mean health care charges for smokers exposed to the TDTS were $7299 lower than for those who did not receive TDTS services (P=0.047). The TDTS cost per smoker was modest by comparison at $34.21 per smoker eligible for the service. DISCUSSION: Results suggest that implementation of a TDTS consistent with JC standards for smoking cessation can be affordably implemented and yield substantial health care savings that would benefit patients, hospitals, and insurers.

Study of Flare Assessment in Systemic Lupus Erythematosus Based on Paper Patients.

OBJECTIVE: To determine the level of agreement of disease flare severity (distinguishing severe, moderate, and mild flare and persistent disease activity) in a large paper-patient exercise involving 988 individual cases of systemic lupus erythematosus. METHODS: A total of 988 individual lupus case histories were assessed by 3 individual physicians. Complete agreement about the degree of flare (or persistent disease activity) was obtained in 451 cases (46%), and these provided the reference standard for the second part of the study. This component used 3 flare activity instruments (the British Isles Lupus Assessment Group [BILAG] 2004, Safety of Estrogens in Lupus Erythematosus National Assessment [SELENA] flare index [SFI] and the revised SELENA flare index [rSFI]). The 451 patient case histories were distributed to 18 pairs of physicians, carefully randomized in a manner designed to ensure a fair case mix and equal distribution of flare according to severity. RESULTS: The 3-physician assessment of flare matched the level of flare using the 3 indices, with 67% for BILAG 2004, 72% for SFI, and 70% for rSFI. The corresponding weighted kappa coefficients for each instrument were 0.82, 0.59, and 0.74, respectively. We undertook a detailed analysis of the discrepant cases and several factors emerged, including a tendency to score moderate flares as severe and persistent activity as flare, especially when the SFI and rSFI instruments were used. Overscoring was also driven by scoring treatment change as flare, even if there were no new or worsening clinical features. CONCLUSION: Given the complexity of assessing lupus flare, we were encouraged by the overall results reported. However, the problem of capturing lupus flare accurately is not completely solved.

Effect of a smoking cessation intervention for women in subsidized neighborhoods: A randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of a community based participatory research (CBPR) developed, multi-level smoking cessation intervention among women in subsidized housing neighborhoods in the Southeastern US. METHODS: A total of n=409 women in 14 subsidized housing neighborhoods in Georgia and South Carolina participated in this group randomized controlled trial conducted from 2009 to 2013. Intervention neighborhoods received a 24-week intervention with 1:1 community health worker contact, behavioral peer group sessions, and nicotine replacement. Control neighborhoods received written cessation materials at weeks 1, 6, 12, 18. Random coefficient models were used to compare smoking abstinence outcomes at 6 and 12months. Significance was set a p<0.05. RESULTS: The majority of participants (91.2%) were retained during the 12-month intervention period. Smoking abstinence rates at 12months for intervention vs. control were 9% vs. 4.3%, p=0.05. Additional analyses accounting for passive smoke exposure in these multi-unit housing settings demonstrated 12month abstinence rates of 12% vs. 5.3%, p=0.016. However, in the multivariate regression analyses, there was no significant effect of the intervention on the odds of being a non-smoker (OR=0.44, 95% CI: 0.18-1.07). Intervention participants who kept coach visits, attended group sessions, and used patches were more likely to remain abstinent. CONCLUSIONS: This CBPR developed intervention showed potential to engage smokers and reduce smoking among women in these high-poverty neighborhoods. Effectiveness in promoting cessation in communities burdened with fiscal, environmental and social inequities remains a public health priority.

American College of Rheumatology criteria at inception, and accrual over 5 years in the SLICC inception cohort.

OBJECTIVE: To determine the frequency of each American College of Rheumatology (ACR) criterion met at time of enrollment, and the increase in each of the criteria over 5 years. METHODS: In 2000 the Systemic Lupus International Collaborating Clinics (SLICC) recruited an international inception cohort of patients with systemic lupus erythematosus (SLE; ≥ 4 ACR criteria) who were followed at yearly intervals according to a standard protocol. Descriptive statistics were used to assess the total and cumulative number of ACR criteria met at each visit. Regression models were done to compare the increase of individual and cumulative criteria as a function of race/ethnicity group, and sex. RESULTS: In all, 768 patients have been followed for a minimum of 5 years. Overall, 59.1% of the patients had an increase in the number of ACR criteria they met over the 5-year period. The mean number of ACR criteria met at enrollment was 5.04 ± 1.13 and at year 5 was 6.03 ± 1.42. At enrollment, nonwhite patients had a higher number of ACR criteria (5.19 ± 1.23) than white patients. The total number of criteria increased in both white and nonwhite ethnicities, but increased more among whites. Males had a slightly lower number of criteria at enrollment compared to females and males accrued fewer criteria at 5 years. CONCLUSION: In this international inception cohort of SLE patients with at least 4 ACR criteria at entry, there was an accumulation of ACR criteria over the following 5 years. The distribution of criteria both at inception and over 5 years is affected by sex and ethnicity.

Development and validation of the Lupus Impact Tracker: a patient-completed tool for clinical practice to assess and monitor the impact of systemic lupus erythematosus.

OBJECTIVE: To derive and validate a brief patient-completed instrument, the Lupus Impact Tracker (LIT), to assess and monitor the impact of systemic lupus erythematosus (SLE). METHODS: Items for the LIT were selected from the LupusPRO, a validated patient-reported outcomes measure, using 3 approaches: confirmatory factor analysis (CFA), stepwise regression, and patient focus groups. CFA was conducted to find items from the LupusPRO that fit a unidimensional structure to allow scoring as a single index. Stepwise regression methods identified items with the strongest relationship (convergent validity) with disease activity measures and patient health rating. Focus groups (n = 26 patients) identified the most important items describing SLE impact. Selected items were evaluated for reliability and validity. RESULTS: CFA found 21 items that fit a unidimensional structure. Stepwise regressions identified 15 of 21 items having good convergent validity with clinical measures. Patient focus groups identified 9 of 15 items as best capturing the impact of SLE. Overall, 7 items were selected across all 3 approaches (CFA, stepwise regression, and focus groups). Another 15 items were selected across 2 approaches. Through consensus with rheumatology clinician experts, a final set of 10 items was selected for the LIT. The LIT items showed good internal consistency (0.89) and test-retest reliabilities (0.87). Mean LIT scores differed significantly (P < 0.05) across criterion groups in the hypothesized direction, providing evidence of discriminant validity and responsiveness. CONCLUSION: The LIT is reliable and valid in SLE patients and offers a practical way for physicians and patients to assess and monitor the impact of SLE.

Sociodemographic associations with early disease damage in patients with systemic lupus erythematosus.

OBJECTIVE: To examine the extent of organ damage among recently diagnosed patients with systemic lupus erythematosus (SLE), and to assess the association between sociodemographic variables and total damage and organ-specific damage scores. METHODS: We evaluated damage in 132 patients with SLE (70 African Americans and 62 whites), 2-6 years (median 4 years) after diagnosis, using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index. The associations between demographic characteristics and total damage and organ-specific damage measures were evaluated using logistic regression, adjusting for age, income, and ethnicity. RESULTS: A total of 61% of patients scored >or=1 point on the damage index. Damage was most prevalent in the musculoskeletal (28%), skin (20%), neuropsychiatric (16%), and renal (12%) subscales. African American ethnicity and lower household income were independently associated with total damage scores (score >or=2: adjusted odds ratio [95% confidence interval] 6.0 [2.3-16.2] in African Americans and 2.7 [1.1-6.7] in patients with an annual household income