Risk factors for severe COVID-19 among patients with systemic lupus erythematosus: a real-world analysis of a large representative US administrative claims database, 2020-2021.

OBJECTIVES: To identify risk factors for progression to severe COVID-19 and estimate the odds of severe COVID-19 associated with vaccination among patients with systemic lupus erythematosus (SLE). METHODS: This retrospective cohort study identified adults with SLE in the Merative™ MarketScan® Databases. Patients were continuously enrolled the year before 1 April 2020 (baseline) and had a COVID-19 diagnosis between 1 April 2020 and the earliest of death, enrolment end or 31 December 2021. Severe COVID-19 was defined as hospitalisation with a COVID-19 diagnosis. Demographics on 1 April 2020, baseline comorbidities, corticosteroid use ≤30 days before COVID-19 diagnosis and other SLE medication use ≤6 months before COVID-19 diagnosis were assessed. Vaccination was identified by claims for a COVID-19 vaccine or vaccine administration. Backward stepwise logistic regression estimated odds of progression to severe COVID-19 associated with patient characteristics and vaccination. RESULTS: Among 2890 patients with SLE with COVID-19, 500 (16.4%) had a COVID-19-related hospitalisation. Significant risk factors for progression to severe COVID-19 included rituximab (OR (95% CI) 2.92 (1.67 to 5.12)), renal failure (2.15 (95% CI 1.56 to 2.97)), Medicaid (vs Commercial; 2.01 (95% CI 1.58 to 2.57)), complicated hypertension (1.96 (95% CI 1.38 to 2.77)) and time of infection, among others. Vaccination had a significant protective effect (0.68(95% CI 0.54 to 0.87)) among all patients with SLE with COVID-19, but the effect was not significant among those with prior use of belimumab, rituximab or corticosteroids. CONCLUSIONS: Certain chronic comorbidities and SLE medications increase the odds of progression to severe COVID-19 among patients with SLE, but vaccination confers significant protection. Vaccine effectiveness may be attenuated by SLE treatments. Protective measures such as pre-exposure prophylaxis and booster vaccines should be encouraged among patients with SLE.

Untreated Sleep Apnea: An Analysis of Administrative Data to Identify Risk Factors for Early Nonadherence.

STUDY OBJECTIVES: Discontinuation of positive airway pressure (PAP) treatment for obstructive sleep apnea (OSA) is widely reported, but research has not adequately addressed nonadherence with diagnostic testing for sleep disorders and initiation of PAP. This study sought to identify drivers of nonadherence with diagnostic sleep testing and PAP treatment initiation among patients preauthorized for these services. METHODS: This observational cohort study used preauthorization records from a sleep management program and administrative medical claims from a large commercial health insurer. Participants included adults preauthorized for sleep testing and a subset in whom OSA was diagnosed and who were preauthorized for PAP treatment. Outcome measures were nonadherence with diagnostic sleep testing and PAP treatment initiation, identified as lack of a claim for a preauthorized service within 3 months of preauthorization of that service. Risk factors for nonadherence included patient demographics, prescribing factors, signs and symptoms of OSA, comorbidities, and prior health service utilization. RESULTS: Of 51,749 patients preauthorized for diagnostic testing, 23.5% did not undergo testing. Among 19,968 patients preauthorized for PAP treatment, 11.1% did not initiate treatment. Testing and treatment ordered by primary care providers, residence outside the Midwest region, and two or fewer office visits within 6 months before preauthorization were strong predictors of nonadherence. Apnea-hypopnea index score < 30 events/h was also a strong predictor of nonadherence with treatment initiation. CONCLUSIONS: This study adds to existing knowledge about risk factors for nonadherence with sleep testing and treatment initiation following preauthorization. Health plans and providers should develop strategies to better engage patients with higher risk of nonadherence.

Treatment Patterns of Newly Diagnosed Rheumatoid Arthritis Patients from a Commercially Insured Population.

INTRODUCTION: To describe treatment patterns in newly diagnosed rheumatoid arthritis (RA) patients in a large, nationally representative managed-care database. METHODS: Newly diagnosed RA patients were identified from 07/01/2006-08/31/2014. Patients had ≥ 1 RA diagnosis by a rheumatologist, or ≥ 2 non-rheumatologist RA diagnoses ≥ 30 days apart, or RA diagnosis followed by a disease-modifying antirheumatic drug (DMARD) prescription fill within 1 year. Patients were ≥ 18 years old at index (earliest date fulfilling diagnostic criteria) and had ≥ 6 and 12 months of pre- and post-index health plan enrollment, respectively. Patterns of DMARD treatment, including conventional synthetic DMARDs (csDMARD), tumor necrosis factor inhibitors (TNFi), non-TNFi, and Janus kinase inhibitors (JAKi), were captured during follow-up. RESULTS: Of the 63,101 RA patients identified, 73% were female; mean age was 57 years. During an average of 3.5 ± 2.1 years of follow-up, 45% of patients never received a DMARD, 52% received a csDMARD (94 ± 298 mean ± SD days from index), 16% a TNFi (315 ± 448 days), 4% a non-TNFi (757 ± 660 days), and < 1% a JAKi. Among DMARD recipients, the most common treatment patterns were: receiving csDMARDs only (68%), adding a TNFi as second-line therapy after initiation of a csDMARD (12%), and receiving only a TNFi (6%) during follow-up. Among those not on DMARDs, the all-cause usage of an opioid was 56% and 19% had chronic opioid use (≥ 180 days supplied). CONCLUSIONS: Despite American College of Rheumatology recommendations for DMARD treatment of RA, nearly half of newly diagnosed RA patients received no DMARD therapy during follow-up. These data identify a treatment gap in RA management. FUNDING: Eli Lilly & Company.

Offering A Price Transparency Tool Did Not Reduce Overall Spending Among California Public Employees And Retirees.

Insurers, employers, and states increasingly encourage price transparency so that patients can compare health care prices across providers. However, the evidence on whether price transparency tools encourage patients to receive lower-cost care and reduce overall spending remains limited and mixed. We examined the experience of a large insured population that was offered a price transparency tool, focusing on a set of "shoppable" services (lab tests, office visits, and advanced imaging services). Overall, offering the tool was not associated with lower shoppable services spending. Only 12 percent of employees who were offered the tool used it in the first fifteen months after it was introduced, and use of the tool was not associated with lower prices for lab tests or office visits. The average price paid for imaging services preceded by a price search was 14 percent lower than that paid for imaging services not preceded by a price search. However, only 1 percent of those who received advanced imaging conducted a price search. Simply offering a price transparency tool is not sufficient to meaningfully decrease health care prices or spending.

Treatment of Chronic Hepatitis C Infection with Sofosbuvir-Based Regimens in a Commercially Insured Patient Population.

BACKGROUND: The response to treatment with direct-acting antiviral agents in patients with chronic hepatitis C virus (HCV) is not well-characterized in the real-world setting. OBJECTIVE: To describe patients' response to 3 sofosbuvir-based treatment regimens among commercially insured patients with chronic HCV. METHODS: In this observational study, we identified patients with HCV who started sofosbuvir treatment with 1 of 3 sofosbuvir-based regimens between December 1, 2013, and April 30, 2014, in the HealthCore Integrated Research Database, a large managed care repository. All patients were aged ≥18 years and had ≥1 RNA viral load tests after starting treatment. Pharmacy and medical claims, laboratory results, and patient medical records were integrated for information on HCV genotype, treatment regimen, RNA viral load, and other clinical and demographic characteristics. The primary outcome was the response to HCV treatment during and after treatment completion, which was defined as an HCV RNA viral load of <25 IU/mL. The 3 HCV treatment regimens included sofosbuvir plus peginterferon alfa and ribavirin; sofosbuvir plus ribavirin; and sofosbuvir plus simeprevir, with or without ribavirin in patients with HCV genotypes 1 to 3. The secondary outcome was the number of patients who had a treatment response in the first 4, 6, and 8 weeks of therapy to determine whether a lack of early response to treatment is suggestive of a posttreatment lack of response. Relapse was defined as regression from response during treatment, with a detectable viral load of ≥25 IU/mL in the most recent test after treatment completion. RESULTS: Among 249 patients with ≥1 documented viral load tests after treatment initiation, 200 (80%) patients had ≥1 tests after the end of treatment. The posttreatment response rate for all 3 regimens was 88% (95% confidence interval, 84%-93%), ranging from 81% to 93%. In the largest category-patients with genotype 1 HCV (N = 130)-the response rate was between 83% and 92% across the 3 regimens. During treatment, 34% of the patients with any viral load test results by week 4 did not respond; however, 81% of those patients had a response after week 12. Of the patients who responded during treatment, 8% had relapsed disease after the end of treatment. CONCLUSION: The response rate to the sofosbuvir-based regimens included in this study was similar to those seen in published randomized clinical trials. Although 34% of the patients with any viral load test result by week 4 of treatment had viral loads of ≥25 IU/mL, persistent treatment was associated with response in the majority of those patients. This supports the effectiveness of sofosbuvir treatment and the need for treatment persistence. The rapid emergence of new treatments in this field presents exciting opportunities for additional research, and holds important clinical and economic implications for patients and their families, healthcare providers, and critically, for payers, who have to accommodate the new pricing models associated with these treatments.

Risk of Neutropenia-Related Hospitalization in Patients Who Received Colony-Stimulating Factors With Chemotherapy for Breast Cancer.

Purpose To describe outcomes after granulocyte colony-stimulating factor (G-CSF) prophylaxis in patients with breast cancer who received chemotherapy regimens with low-to-intermediate risk of induction of neutropenia-related hospitalization. Patients and Methods We identified 8,745 patients age ≥ 18 years from a medical and pharmacy claims database for 14 commercial US health plans. This retrospective analysis included patients with breast cancer who began first-cycle chemotherapy from 2008 to 2013 using docetaxel and cyclophosphamide (TC); docetaxel, carboplatin, and trastuzumab (TCH); or doxorubicin and cyclophosphamide (conventional-dose AC) regimens. Primary prophylaxis (PP) was defined as G-CSF administration within 5 days of beginning chemotherapy. Outcome was neutropenia, fever, or infection-related hospitalization within 21 days of initiating chemotherapy. Multivariable regressions and number-needed-to-treat analyses were used. Results A total of 4,815 patients received TC (2,849 PP; 1,966 no PP); 2,292 patients received TCH (1,444 PP; 848 no PP); and 1,638 patients received AC (857 PP; 781 no PP) regimen. PP was associated with reduced risk of neutropenia-related hospitalization for TC (2.0% PP; 7.1% no PP; adjusted odds ratio [AOR], 0.29; 95% CI, 0.22 to 0.39) and TCH (1.3% PP; 7.1% no PP; AOR, 0.19; 95% CI, 0.12 to 0.30), but not AC (4.7% PP; 3.8% no PP; AOR, 1.21; 95% CI, 0.75 to 1.93) regimens. For the TC regimen, 20 patients (95% CI, 16 to 26) would have to be treated for 21 days to avoid one neutropenia-related hospitalization; with the TCH regimen, 18 patients (95% CI, 13 to 25) would have to be treated. Conclusion Primary G-CSF prophylaxis was associated with low-to-modest benefit in lowering neutropenia-related hospitalization in patients with breast cancer who received TC and TCH regimens. Further evaluation is needed to better understand which patients benefit most from G-CSF prophylaxis in this setting.

Finding the Value in 'Value' Designation: Evidence and Opportunity in the United States.

PURPOSE: Centers of Excellence (COE) designations have been used to distinguish high-quality facilities. Originally based on quality metrics alone, published evidence failed to consistently show improvements in measurable quality markers. COE development has since shifted to a value-based framework incorporating cost of care, providing greater transparency. This study evaluated the patient outcomes of such value-designated facilities certified under one of the larger U.S. commercial provider networks. DESIGN: Retrospective, observational study using 2009-2013 commercial administrative claims data. METHODOLOGY: Analysis included 33,827 adults (≥18 years) who received spine surgery at value-designated (n=6,141, 22%) vs. other facilities (n=27,686, 78%). Multivariate regression models were used to compare 90-day episodic costs and quality outcomes, adjusted for patient characteristics and comorbidities. RESULTS: Adjusted episodic cost per surgery was lower in value-designated facilities by $3,157 (16%) for lumbar discectomy/decompression, $6,784 (19%) for cervical simple fusion, and $11,134 (18%) for lumbar simple fusion (all P<.05). Adjusted complication rate was lower (1.5% vs. 2.0%; P<.05) at value-designated facilities, while other quality measures were similar. Value-designated facilities tended to be large, in metropolitan areas, affiliated with medical schools, and performed more surgical procedures and provided more nursing hours. CONCLUSIONS: To our knowledge, this is the first large-scale study evaluating value-designated COE. Value-designated COE programs represent an advance over a cost- or quality-alone designation in the ability to identify facilities with lower costs and equal or better quality outcomes. Value designation offers patients transparency for selecting care providers. Future efforts should continue to refine quality criteria used in designations to distinguish patient outcomes.

Patient Use of Cost and Quality Data When Choosing a Joint Replacement Provider in the Context of Reference Pricing.

Health plans are encouraging consumerism among joint replacement patients by reporting information on hospital costs and quality. Little is known about how the proliferation of such initiatives impacts patients' selection of a surgeon and hospital. We performed a qualitative analysis of semistructured interviews with 13 patients who recently received a hip or knee replacement surgery. Patients focused on the choice of a surgeon as opposed to a hospital, and the surgeon choice was primarily made based on reputation. Most patients had long-standing relationships with an orthopedic surgeon and tended to stay with that surgeon for their replacement. Despite growing availability of cost and quality information, patients almost never used such information to make a decision.

Price transparency for MRIs increased use of less costly providers and triggered provider competition.

To encourage patients to select high-value providers, an insurer-initiated price transparency program that focused on elective advanced imaging procedures was implemented. Patients having at least one outpatient magnetic resonance imaging (MRI) scan in 2010 or 2012 were divided according to their membership in commercial health plans participating in the program (the intervention group) or in nonparticipating commercial health plans (the reference group) in similar US geographic regions. Patients in the intervention group were informed of price differences among available MRI facilities and given the option of selecting different providers. For those patients, the program resulted in a $220 cost reduction (18.7 percent) per test and a decrease in use of hospital-based facilities from 53 percent in 2010 to 45 percent in 2012. Price variation between hospital and nonhospital facilities for the intervention group was reduced by 30 percent after implementation. Nonparticipating members residing in intervention areas also observed price reductions, which indicates increased price competition among providers. The program significantly reduced imaging costs. This suggests that patients select lower-price facilities when informed about available alternatives.

Impact of clinical reminder redesign on physicians' priority decisions.

OBJECTIVE: Computerized clinical reminder (CCR) systems can improve preventive service delivery by providing patient-specific reminders at the point of care. However, adherence varies between individual CCRs and is correlated to resolution time amongst other factors. This study aimed to evaluate how a proposed CCR redesign providing information explaining why the CCRs occurred would impact providers' prioritization of individual CCRs. DESIGN: Two CCR designs were prototyped to represent the original and the new design, respectively. The new CCR design incorporated a knowledge-based risk factor repository, a prioritization mechanism, and a role-based filter. Sixteen physicians participated in a controlled experiment to compare the use of the original and the new CCR systems. The subjects individually simulated a scenario-based patient encounter, followed by a semi-structured interview and survey. MEASUREMENTS: We collected and analyzed the order in which the CCRs were prioritized, the perceived usefulness of each design feature, and semi-structured interview data. RESULTS: We elicited the prioritization heuristics used by the physicians, and found a CCR system needed to be relevant, easy to resolve, and integrated with workflow. The redesign impacted 80% of physicians and 44% of prioritization decisions. Decisions were no longer correlated to resolution time given the new design. The proposed design features were rated useful or very useful. CONCLUSION: This study demonstrated that the redesign of a CCR system using a knowledge-based risk factor repository, a prioritization mechanism, and a role-based filter can impact clinicians' decision making. These features are expected to ultimately improve the quality of care and patient safety.

Relationship of estimated resolution time and computerized clinical reminder adherence.

Electronic decision support systems are an important tool for improving performance and improving quality of care. We investigated the relationship between physicians' estimated resolution times for computerized clinical reminders and adherence rates in VA outpatient settings. We surveyed 10 expert physician users to assess the resolution times of four targeted CCRs for three cases: pessimistic (worst case), expected (average), and optimistic times (best case). ANOVA test shows that physicians' adherence rates for the four CCRs differed significantly (p = 0.01). CCR adherence rate and resolution time were highly linearly correlated (R-square= 0.876 for the best case, R-square= 0.997 for the average case, and R-square= 0.670 for the worst case). This study suggested that future efforts in designing CCRs need to take resolution time into consideration during design, usability testing and implementation phases.