Durham VA Medical Center

Although common, insomnia is often undertreated and underrecognized in primary care settings. Few studies have examined primary care provider (PCP) perspectives to better understand the context of insomnia assessment and treatment. The purpose of the current study was to examine Veterans Affairs (VA) provider knowledge and practice regarding the assessment and treatment of insomnia by utilizing qualitative inquiry. We recruited PCPs at a VA healthcare facility located in the southeastern United States to engage in a qualitative descriptive study of their perspectives on the management of insomnia in the primary care setting. Participants completed a demographic form and semi-structured interviews. Interview data were analyzed using a rapid qualitative analysis approach. 12 PCPs participated in semi-structured interviews. Themes were knowledge gaps in appropriate assessment, treatment, and documentation practices. Providers tended to focus on the event that precipitated insomnia rather than factors that perpetuate it and relied heavily on sleep hygiene recommendations. Systemic barriers, such as time constraints, also impeded the highest quality of care. PCPs may benefit from additional training on factors that maintain insomnia and on evidence-based treatments for insomnia. There may also be an opportunity to develop tools such as shared decision-making aids to increase referrals to evidence-based treatments. Development of strategies to facilitate assessment and treatment of insomnia disorder in the context of busy, fast-paced primary care settings may be beneficial to veterans and civilians with sleep disorders.

PGA less than 0.5, prednisone less than 5mg/day, and stable immunosuppressants).LLDAS was defined as SLEDAI-2K less than 4, no major organ activity, no new disease activity, PGA less than 1, and prednisone less than 7.5mg/day.Organ damage was measured with the SLICC/ACR Damage Index (SDI).Patient-reported outcomes (PROs) included HAQ and Lupus Impact Tracker (LIT).Associations between HAQ, SDI and remission status were analyzed.Results We studied 339 patients (89.1% female, mean age 53.2 14.6 years, median disease duration 127 months), 22.9% had lupus nephritis and 37.6% were receiving corticosteroids.Antimalarial use was common (80.6%).At evaluation, 57.9% fulfilled DORIS remission and 84.9% were in LLDAS.Nonetheless, 42.2% had SDI equal to 1 and 23.3% SDI equal to 2. Interestingly, 52.9% of patients not in remission or LLDAS had no damage (SDI=0).Among those in remission, 81% had HAQ scores between 0-1, compared to 60.7% of patients not achieving remission.Spearman's correlation showed a significant association between HAQ and SDI (r=0.42;p<0.001).Correlations between remission status and HAQ (r=-0.31)and remission status and SDI (r=-0.28)were weaker but significant.Conclusions A high proportion of patients achieved LLDAS (84.9%) and DORIS remission (57.9%).Still, 42.2% in remission had organ damage (SDI equal to 1), showing poor correlation between activity and damage.Thus, both indices should be assessed separately.HAQ correlated better with SDI, suggesting functional status reflects cumulative damage more reliably than activity alone.

Objectives LN increases the risk of end-stage kidney disease and mortality.Belimumab selectively inhibits B-lymphocyte stimulator, and has been shown to prevent organ damage progression in SLE and preserve kidney function in LN.We evaluated whether belimumab is associated with a lower risk of progression to LN among patients with SLE versus standard of care (SOC) in real-world practice.Methods A retrospective, longitudinal cohort study (GSK Study 217533) using claims linked with electronic health record data (Optum Market Clarity database).Index: date of initiation of belimumab or SOC (immunosuppressant [IS, except as LN initial therapy], intravenous glucocorticoids [GCs], or oral GC

The purpose of this study was to examine the association between diabetes-specific and overall medication regimen complexity and diabetes distress among adults with type 2 diabetes. This study examined data from 220 patients with type 2 diabetes and hypertension and persistently elevated A1C, who were recruited for a remote monitoring-enabled telehealth trial (Clinicaltrials.gov NCT05120544). Chart review was performed to obtain prescription data to determine medication regimen complexity using the validated medication regimen complexity index. Multiple regression models were used to investigate the link between regimen complexity and Diabetes Distress Scale and subscale scores, adjusting for sociodemographic variables and comorbidities. Study sample was 64% women, 68% Black, with a mean age of 54.5. The mean A1C was 9.8% (84 mmol/mol), and 63% reported moderate to high distress. The study population was prescribed a mean of 2.9 diabetes medications and 11.5 overall long-term medications. The mean diabetes-specific and overall Medication Regimen Complexity Index were 11.5 and 30.2, respectively. No statistically significant associations between diabetes-specific or overall medication regimen complexity and diabetes distress were identified. Overall medication regimen complexity was negatively associated with regimen-related diabetes distress. Medication regimen complexity did not significantly impact the association between diabetes distress and A1C. Participants with high overall medication regimen complexity had lower regimen-related diabetes distress. Further studies are needed to evaluate associations between medication regimen complexity and diabetes distress while ensuring sufficient statistical power.

Potassium competitive acid blockers (PCABs) are superior to proton pump inhibitors (PPIs) for healing of Los Angeles (LA) class C/D erosive esophagitis and are approved for nonerosive gastroesophageal reflux disease (GERD) given their efficacy measured by heartburn-free days. However, they are more expensive than PPIs. We estimated the cost-effectiveness of PCABs compared with PPIs for the management of GERD. A decision tree was constructed for the base case of a patient with GERD. We tested scenarios in which nonerosive reflux disease, LA A/B, or LA C/D esophagitis was present, comparing PCABs with PPIs as first-line therapy, including step up therapy and/or class switching if symptoms persisted. Using publicly available cost estimates, quality-adjusted life years (QALYs) were compared using a willingness-to-pay threshold of $100,000/QALY from a societal perspective at 6 months. The cost of PCABs for GERD was $3,240 more than PPIs, with an incremental cost-effectiveness ratio of $144,208/QALY. When evaluating GERD phenotypes separately, the incremental cost-effectiveness ratio was consistently over our willingness-to-pay threshold. One-way analyses showed the most influential parameters were PCAB cost and efficacy for heartburn-free days. Probabilistic sensitivity analysis favored PPIs 71.7% out of 100,000 iterations. Reducing one-week costs to below $91 would make PCABs a cost effective first-line strategy across all GERD phenotypes. Despite PCAB efficacy, PPIs are a cost-effective strategy for GERD treatment, and can be positioned ahead of PCAB escalation on this basis. Reducing PCAB costs or accepting a higher willingness-to-pay threshold would influence this finding, although PCABs may be favored in some current situations as evidenced by probabilistic sensitivity results.

In a well-designed clinical trial, time zero is when eligibility is determined, treatment is assigned, follow-up time begins, and each of these elements is aligned. Attaining this alignment can be challenging in observational studies, risking potential bias. We compared the impact of different time zero designations on the estimated effectiveness of nirmatrelvir-ritonavir for COVID-19. We identified US veterans who tested positive for SARS-CoV-2 from April 2022 to March 2023 and compared nirmatrelvir-ritonavir vs no treatment using 5 time zero approaches: (1a) test-date (treated) vs test-date (untreated) allowing treatment on days 0-5 with matching, (1b) day 0 only with matching, or (1c) days 0-5 with a clone-censor-weight method; (2) treatment date vs test-date with matching; or (3) treatment date vs matched index date. Thirty-day incidence of hospitalization or death was lower in the nirmatrelvir-ritonavir group than the no treatment group for all time zero approaches. Estimated risk differences (95% CI) were larger for approaches 1a (-2.10% [-2.35 to -1.86]), 1b (-2.03% [-2.40 to -1.84]), and 2 (-2.26% [-2.47 to -2.02]); -1.80% (-1.89 to -1.45) for approach 3; and lowest for approach 1c (-0.95% [-1.11 to -0.75]). Different time zero designations can influence effect estimates and should be carefully considered when designing pharmacoepidemiology studies.

Clinical remission (CR) is an emerging treatment goal in asthma. However, evidence showing whether CR is achievable with inhaled therapy is lacking. This post hoc analysis of CAPTAIN evaluated attainability of a composite CR endpoint with inhaled fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or FF/VI. CAPTAIN (GSK 205715) was a Phase IIIA, randomized, controlled, 24-52-week trial comparing once-daily single-inhaler FF/UMEC/VI versus FF/VI in adults with uncontrolled moderate-to-severe asthma despite ICS/LABA. CR was defined as a composite endpoint comprising no systemic corticosteroids, no severe exacerbations, ACQ-5 total score < 1.50, and either change from baseline in FEV1 ≥ 0ml (lung function stabilization) or ≥ 100ml (lung function optimization), assessed for patients meeting the CR endpoint at Week 24 (W24) and achieving CR at W52 with FF/UMEC/VI (100/62.5/25, 200/62.5/25μg) versus FF/VI (100/25, 200/25μg). Additional analyses assessed the CR endpoint at W24/W52 using ACQ-5 ≤ 0.75 and ≤ 1.00 thresholds. Adjusted odds/risk ratios for CR were calculated for W24. More patients met the CR endpoint (lung function stabilization/optimization) with FF/UMEC/VI versus FF/VI at W24 (stabilization: 42-47% vs 31-36%; optimization: 31-36% vs 19-26%) and W52 (stabilization: 43-47% vs 33-34%; optimization: 30-38% vs 21-24%). Using more stringent ACQ-5 thresholds, fewer patients met the CR endpoint with ACQ ≤ 0.75 versus < 1.50 across treatment arms and timepoints. The odds and probability of meeting the CR endpoint versus not meeting the CR endpoint at W24 were greater with FF/UMEC/VI versus FF/VI, regardless of FF dose. The results of this post hoc analysis demonstrate that CR is achievable with inhaled therapy in moderate-to-severe asthma and is more likely with FF/UMEC/VI than FF/VI. CR should be considered an attainable treatment goal for patients with asthma, irrespective of disease severity or treatment history. ClinialTrials.gov identifier, NCT02924688.

This Viewpoint discusses how real-world evidence studies could help the US Centers for Medicare &amp;amp;amp; Medicaid Services align spending with value in their drug price negotiations.