Expert consensus on the management of infusion-related reactions (IRRs) in patients with sickle cell disease (SCD) receiving crizanlizumab: a RAND/UCLA modified Delphi panel.

Crizanlizumab, a monoclonal antibody against P-selectin, has been shown to reduce vaso-occlusive crises (VOCs) compared to placebo in patients ≥ 16 years with sickle cell disease (SCD). However, there have been rare reports of patients experiencing severe pain and subsequent complications within 24 hours of crizanlizumab infusions. These events are defined as infusion-related reactions (IRRs). Informed by current literature and clinical experience, a group of content experts developed clinical guidelines for the management of IRRs in patients with SCD. We used the RAND/University of California, Los Angeles (UCLA) modified Delphi panel method, a valid, reproducible technique for achieving consensus. We present our recommendations for managing IRRs, which depend on patient characteristics including: prior history of IRRs to other monoclonal antibodies or medications, changes to crizanlizumab infusion rate and patient monitoring, pain severity relative to patient's typical SCD crises, and severe allergic symptoms. These recommendations outline how to evaluate and manage IRRs in patients receiving crizanlizumab. Future research should validate this guidance using clinical data and identify patients at risk for these IRRs.

Modified Delphi Panel Consensus Recommendations for Management of Severe Aplastic Anemia.

Severe aplastic anemia (SAA) is a rare hematologic condition for which there is no clear management algorithm. A panel of 11 adult and pediatric experts on aplastic anemia was assembled and, using the RAND/UCLA modified Delphi panel method, evaluated >600 varying patient care scenarios to develop clinical recommendations for the initial and subsequent management of patients of all ages with SAA. Here we present the panel's recommendations to rule out inherited bone marrow failure (IBMF) syndromes, on supportive care prior to and during first-line therapy, and on first-line (initial management) and second-line (subsequent management) therapy of acquired SAA, focusing on when transplant versus medical therapy is most appropriate. These recommendations represent the consensus of 11 experts informed by published literature and experience. They are intended only as general guidance for experienced clinicians who treat patients with SAA and are in no way intended to supersede individual physician and patient decision-making. Current and future research should validate this consensus using clinical data. Once validated, we hope these expert panel recommendations will improve outcomes for patients with SAA.

Using a Modified Delphi Panel to Estimate Health Service Utilization for Patients with Advanced and Non-Advanced Systemic Light Chain Amyloidosis.

Purpose: Patients with diagnosed with systemic light chain (AL) amyloidosis at advanced Mayo stages have greater morbidity and mortality than those diagnosed at non-advanced stages. Estimating service use by severity is difficult because Mayo stage is not available in many secondary databases. We used an expert panel to estimate healthcare utilization among advanced and non-advanced AL amyloidosis patients. Patients and Methods: Using the RAND/UCLA modified Delphi method, expert panelists completed 180 healthcare utilization estimates, consisting of inpatient and outpatient visits, testing, chemotherapy, and procedures by disease severity and organ involvement during two treatment phases (the 1 year after starting first line [1L] therapy and 1 year following treatment [post-1L]). Estimates were also provided for post-1L by hematologic treatment response (complete or very good partial response [CR/VGPR], partial, no response or relapse [PR/NR/R]). Areas of disagreement were discussed during a meeting, after which ratings were completed a second time. Results: During 1L therapy, 55% of advanced patients had ≥1 hospitalization and 38% had ≥2 admissions. Rates of hematopoietic stem cell transplant (HSCT) in advanced patients were 5%, while pacemaker or implantable cardioverter defibrillator (ICD) placement were 15%. During post-1L therapy, rates of hospitalization in advanced patients remained high (≥1 hospitalization: 20-43%, ≥2 hospitalizations: 10-20%), and up to 10% of advanced patients had a HSCT. Ten percent of these patients underwent pacemaker/ICD placement. Conclusion: Experts estimated advanced patients, who would not be good candidates for HSCT, would have high rates of hospitalization (traditionally the most expensive type of healthcare utilization) and other health service use. The development of new treatment options that can facilitate organ recovery and improve function may lead to decreased utilization.

Comprehensive Review on the Clinical Impact of Next-Generation Sequencing Tests for the Management of Advanced Cancer.

PURPOSE: This review summarizes the published evidence on the clinical impact of using next-generation sequencing (NGS) tests to guide management of patients with cancer in the United States. METHODS: We performed a comprehensive literature review to identify recent English language publications that presented progression-free survival (PFS) and overall survival (OS) of patients with advanced cancer receiving NGS testing. RESULTS: Among 6,475 publications identified, 31 evaluated PFS and OS among subgroups of patients who received NGS-informed cancer management. PFS and OS were significantly longer among patients who were matched to targeted treatment in 11 and 16 publications across tumor types, respectively. CONCLUSION: Our review indicates that NGS-informed treatment can have an impact on survival across tumor types.

Impact of early detection on cancer curability: A modified Delphi panel study.

Expert consensus on the potential benefits of early cancer detection does not exist for most cancer types. We convened 10 practicing oncologists using a RAND/UCLA modified Delphi panel to evaluate which of 20 solid tumors, representing >40 American Joint Committee on Cancer (AJCC)-identified cancer types and 80% of total cancer incidence, would receive potential clinical benefits from early detection. Pre-meeting, experts estimated how long cancers take to progress and rated the current curability and benefit (improvement in curability) of an annual hypothetical multi-cancer screening blood test. Post-meeting, experts rerated all questions. Cancers had varying estimates of the potential benefit of early cancer detection depending on estimates of their curability and progression by stage. Cancers rated as progressing quickly and being curable in earlier stages (stomach, esophagus, lung, urothelial tract, melanoma, ovary, sarcoma, bladder, cervix, breast, colon/rectum, kidney, uterus, anus, head and neck) were estimated to be most likely to benefit from a hypothetical screening blood test. Cancer types rated as progressing quickly but having comparatively lower cure rates in earlier stages (liver/intrahepatic bile duct, gallbladder, pancreas) were estimated to have medium likelihood of benefit from a hypothetical screening blood test. Cancer types rated as progressing more slowly and having higher curability regardless of stage (prostate, thyroid) were estimated to have limited likelihood of benefit from a hypothetical screening blood test. The panel concluded most solid tumors have a likelihood of benefit from early detection. Even among difficult-to-treat cancers (e.g., pancreas, liver/intrahepatic bile duct, gallbladder), early-stage detection was believed to be beneficial. Based on the panel consensus, broad coverage of cancers by screening blood tests would deliver the greatest potential benefits to patients.

The Economic and Humanistic Burden of Pediatric-Onset Multiple Sclerosis.

Background: Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system. Pediatric-onset MS (POMS), defined as onset of MS before 18 years of age, is estimated to account for 2% to 5% of the MS population worldwide. Objectives: To conduct a literature review focused on the healthcare resource utilization and cost as well as quality-of-life (QOL) outcomes among patients with POMS. Methods: We conducted a systematic literature review of English-language studies published after September 2010 in MEDLINE and Embase to describe the global economic healthcare resource utilization and costs and humanistic (QOL) burden in patients with POMS. Results: We found 11 studies that reported on healthcare resource utilization, cost, or insurance coverage and 36 studies that reported on QOL outcomes in patients with POMS. Patients with POMS had higher rates of primary care visits (1.41 [1.29-1.54]), hospital visits (10.74 [8.95-12.90]), and admissions (rate ratio, 4.27 [2.92-6.25];OR, 15.2 [12.0-19.1]) compared with healthy controls. Mean per-patient costs in the United States were $5907 across all settings per year of follow-up between 2002 and 2012; mean costs per hospital stay were $38 543 (in 2015 USD) between 2004 and 2013. Three studies reported psychosocial scores between 71.59 and 79.7, and 8 studies reported physical health scores between 74.62 to 82.75 using the Pediatric Quality of Life Measurement Model (PedsQLTM). Twelve studies used the PedsQL™ Multidimensional Fatigue Scale. Mean scores on the self-reported general fatigue scale ranged from 63.15 to 78.5. Quality-of-life scores were lower than those of healthy controls. Discussion: Our review presents a uniquely broad and recent overview of the global economic and humanistic burden of patients with POMS. Additional research on healthcare resource utilization and cost would provide a more robust understanding of the economic burden in this population. Conclusions: Healthcare resource utilization and costs are high in this population, and patients report reduced QOL and significant fatigue compared with healthy children and adolescents.

An Adaptation of the RAND/UCLA Modified Delphi Panel Method in the Time of COVID-19.

The RAND/UCLA modified Delphi panel method is a formal group consensus process that systematically and quantitatively combines expert opinion and evidence by asking panelists to rate, discuss, then re-rate items. The method has been used to develop medical society guidelines, other clinical practice guidelines, disease classification systems, research agendas, and quality improvement interventions. Traditionally, a group of experts meet in person to discuss results of a first-round survey. After the meeting, experts complete a second-round survey used to develop areas of consensus. During the COVID-19 pandemic, this aspect of the method was not possible. As such, we have adapted the method to conduct virtual RAND/UCLA modified Delphi panels. In this study, we present a targeted literature review to describe and summarize the existing evidence on the RAND/UCLA modified Delphi panel method and outline our adaptation for conducting these panels virtually. Transitioning from in-person to virtual meetings was not without challenges, but there have also been unexpected advantages. The method we describe here can be a cost-effective and efficient alternative for researchers and clinicians.

Developing an emergency department order set to treat acute pain in sickle cell disease.

STUDY OBJECTIVE: Patients with sickle cell disease (SCD) have many emergency department visits because of painful vaso-occlusive episodes (VOE). Guidelines recommend treatment within 30 minutes of triage, but this is rarely achieved in clinical practice. Our goal was to develop an order set that is being implemented in the ED to facilitate and standardize emergency care for SCD patients in acute pain from VOEs presenting to the emergency department (ED) in New York City (NYC). METHODS: Using a RAND/University of California, Los Angeles modified Delphi panel, we convened a multidisciplinary panel and reviewed evidence on how to best manage SCD pain in the ED. Panelists collaboratively developed then rated 202 items that could be included in an ED order set. RESULTS: A consensus order set, a practical how-to guide for managing SCD pain in the ED, was developed based on items that received high median ratings. CONCLUSIONS: The management of acute pain experienced during VOEs is critical to patients with SCD; ED order sets, such as this one, can help standardize pain management, including at triage, evaluation, discharge, and follow-up care. After implementation in NYC EDs, studies to examine changes in quality care metrics (eg, wait times, readmissions) are planned.

Persistence with Early-Line Abatacept versus Tumor Necrosis Factor-Inhibitors for Rheumatoid Arthritis Complicated by Poor Prognostic Factors.

Background: Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling and destruction that leads to severe disability. There are no clear guidelines regarding the order of therapies. Gathering data on treatment patterns outside of a clinical trial setting can provide useful context for clinicians. Objectives: To assess real-world treatment persistence in early-line abatacept versus tumor necrosis factor-inhibitors (TNFi) treated patients with RA complicated by poor prognostic factors (including anti-cyclic citrullinated peptide antibodies [ACPA] and rheumatoid factor [RF] seropositivity). Methods: We performed a multi-center retrospective medical record review. Adult patients with RA complicated by poor prognostic factors were treated with either abatacept or TNFis as the first biologic treatment at the clinic. Poor prognostic factors included ACPA+, RF+, increased C-reactive protein levels, elevated erythrocyte sedimentation rate levels, or presence of joint erosions. We report 12-month treatment persistence, time to discontinuation, reasons for discontinuation, and risk of discontinuation between patients on abatacept versus TNFi. Select results among the subgroup of ACPA+ and/or RF+ patients are presented. Results: Data on 265 patients (100 abatacept, 165 TNFis) were collected. At 12 months, 83% of abatacept patients were persistent versus 66.1% of TNFi patients (P=0.003). Median time to discontinuation was 1423 days for abatacept versus 690 days for TNFis (P=0.014). In adjusted analyses, abatacept patients had a lower risk of discontinuing index treatment due to disease progression (0.3 [95% confidence interval (CI): 0.1-0.6], P=0.001). Among the subgroup of ACPA+ and/or RF+ patients (55 abatacept, 108 TNFis), unadjusted 12-month treatment persistence was greater (83.6% versus 64.8%, P=0.012) and median time to discontinuation was longer (961 days versus 581 days, P=0.048) in abatacept versus TNFi patients. Discussion: Patients with RA complicated by poor prognostic factors taking abatacept, including the subgroup of patients with ACPA and RF seropositivity, had statistically significantly higher 12-month treatment persistence and a longer time to discontinuation than patients on TNFis. Conclusions: In a real-world setting, RA patients treated with abatacept were more likely to stay on treatment longer and had a lower risk of discontinuation than patients treated with TNFis.

Tapering thrombopoietin receptor agonists in primary immune thrombocytopenia: Expert consensus based on the RAND/UCLA modified Delphi panel method.

BACKGROUND: Thrombopoietin receptor agonists (TPO-RAs) are used to treat primary immune thrombocytopenia (ITP). Some patients have discontinued treatment while maintaining a hemostatic platelet count. OBJECTIVES: To develop expert consensus on when it is appropriate to consider tapering TPO-RAs in ITP, how to taper patients off therapy, how to monitor patients after discontinuation, and how to restart therapy. METHODS: We used a RAND/UCLA modified Delphi panel method. Ratings were completed independently by each expert before and after a meeting. Second-round ratings were used to develop the panel's guidance. The panel was double-blinded: The sponsor and nonchair experts did not know each other's identities. RESULTS: Guidance on when it is appropriate to taper TPO-RAs in children and adults was developed based on patient platelet count, history of bleeding, intensification of treatment, trauma risk, and use of anticoagulants/platelet inhibitors. For example, it is appropriate to taper TPO-RAs in patients who have normal/above-normal platelet counts, have no history of major bleeding, and have not required an intensification of treatment in the past 6 months; it is inappropriate to taper TPO-RAs in patients with low platelet counts. Duration of ITP, months on TPO-RA, or timing of platelet response to TPO-RA did not have an impact on the panel's guidance on appropriateness to taper. Guidance on how to taper patients off therapy, how to monitor patients after discontinuation, and how to restart therapy is also provided. CONCLUSION: This guidance could support clinical decision making and the development of clinical trials that prospectively test the safety of tapering TPO-RAs.

Development of a Severity Classification System for Sickle Cell Disease.

PURPOSE: There is no well-accepted classification system of overall sickle cell disease (SCD) severity. We sought to develop a system that could be tested as a clinical outcome predictor. PATIENTS AND METHODS: Using validated methodology (RAND/UCLA modified Delphi panel), 10 multi-disciplinary expert clinicians collaboratively developed 180 simplified patient histories and rated each on multiple axes (estimated clinician follow-up frequency, risk of complications or death, quality of life, overall disease severity). Using ratings on overall disease severity, we developed a 3-level severity classification system ranging from Class I (least severe) to Class III (most severe). RESULTS: The system defines patients as Class I who are 8-40 years with no end organ damage, no chronic pain, and ≤4 unscheduled acute care visits due to vaso-occlusive crises (VOC) in the last year. Patients <8 or >40 years with no end organ damage, no chronic pain, and <2 unscheduled acute care visits are also considered Class I. Patients any age with ≥5 unscheduled acute care visits and/or with severe damage to bone, retina, heart, lung, kidney, or brain are classified as Class III (except patients ≥25 years with severe retinopathy, no chronic pain, and 0-1 unscheduled acute care visits, who are considered Class II). Patients not meeting these Class I or III definitions are classified as Class II. CONCLUSION: This system consolidates patient characteristics into homogenous groups with respect to disease state to support clinical decision-making. The system is consistent with existing literature that increased unscheduled acute care visits and organ damage translate into clinically significant patient morbidity. Studies to further validate this system are planned.

The Humanistic and Economic Burden of Pediatric Focal Seizures in the United States.

OBJECTIVE: To better understand the humanistic and economic burden of focal seizures in children 2-12 years old. METHODS: We conducted a targeted literature review by searching MEDLINE for English-language publications reporting on children 2-12 years old with focal seizures published in the United States since 2008. RESULTS: Thirty-five publications were included. Incidence of focal seizures was 23.2 to 47.1 per 100,000 children per year; prevalence was 2.0 per 1,000 children, and ranged from 1.6 - 2.6 per 1,000 in patients of any age. Life expectancy was 47.3-61.8 years among children 3-12 years old. Patients took several antiepileptic drugs and experienced frequent seizures, sleep disorders, mood disorders, migraine, and seizure-related injuries (eg, bone fractures, sprains, open wounds). Children with focal seizures scored below average on cognitive assessments and up to 42%, 16%, and 19% had depression, anxiety, and attention-deficit disorder, respectively. Patients of any age had about 10 outpatient visits (2 epilepsy-related), 2 inpatient visits (less than 1 epilepsy-related), and 24 procedures (1 epilepsy-related) per year. Medication adherence was low: only half of pediatric patients maintained ≥90% adherence over 6 months. Annual total health care costs among patients of any age ranged from $18,369 - 38,549; first-year total health care costs for children were $19,883. CONCLUSIONS: Incidence and prevalence of focal seizures is high and the humanistic and economic burdens are significant. Future studies focused exclusively on children with focal seizures are needed to more precisely describe the burden. We also suggest further research and implementation of methods to improve medication adherence as an approach to lessen burden on these young patients.

Medication Adherence, Health Care Utilization, and Costs in Patients With Major Depressive Disorder Initiating Adjunctive Atypical Antipsychotic Treatment.

PURPOSE: The purpose of this study was to compare medication adherence, health care utilization, and cost among patients receiving adjunctive treatment for major depressive disorder (MDD) with brexpiprazole, quetiapine, or lurasidone. METHODS: Using Truven Health MarketScan® Commercial, Medicaid, and Medicare Supplemental Databases, we identified adults with MDD initiating adjunctive treatment with brexpiprazole, quetiapine, or lurasidone (index atypical antipsychotic [AAP]). We compared medication adherence and persistence measured by proportion of days covered (PDC) and treatment duration of index AAP, all-cause and psychiatric hospital care (hospitalization or emergency department visit), and medical costs during 6-month follow-up. Models performed included logistic regression for hospital care, linear regression for PDC and cost, and Cox proportional hazards regression for time to discontinuation, adjusting for demographic, clinical, and utilization differences during the 6 months before index AAP. FINDINGS: The total sample included 778 brexpiprazole, 626 lurasidone, and 3458 quetiapine therapy initiators. Adjusting for baseline differences, the risk of discontinuation of index AAP was statistically significantly higher for quetiapine than for brexpiprazole (hazard ratio [HR] = 1.13; 95% CI, 1.02-1.25; P = 0.023) and did not differ between lurasidone and brexipiprazole (HR = 1.14; 95% CI, 1.00-1.29; P = 0.054). The adjusted rate of all-cause hospitalization or emergency department visit in the postindex period was lowest for brexpiprazole at 27.4% (95% CI, 24.0%-31.0%), compared with 31.1% (95% CI, 27.3%-35.2%) for lurasidone and 35.3% (95% CI, 33.5%-37.1%) for quetiapine (P< 0.001 for all comparisons). Quetiapine users had increased all-cause costs compared with brexpiprazole users (estimate = $2309; 95% CI, $31-$4587; P = 0.047); all-cause medical costs did not differ between lurasidone and brexpiprazole (estimate = $913; 95% CI, $-2033 -$3859; P = 0.543). Adjusted psychiatric hospital care, psychiatric costs, and PDC did not differ significantly among the groups. IMPLICATIONS: In patients with MDD and a variety of insurance types, brexpiprazole use was associated with statistically significantly lower risks of discontinuation, risk of hospital care (hospitalization and ED visits), and all-cause medical costs compared with adjunctive quetiapine. Differences between brexpiprazole and lurasidone were not statistically significant. These findings suggest that drug choice is associated with subsequent health care utilization and costs.

Atypical antipsychotic adherence is associated with lower inpatient utilization and cost in bipolar I disorder.

AIMS: This study explored the association between medication adherence to oral atypical antipsychotics (AAP) and both psychiatric hospitalization and associated costs in bipolar I disorder (BD-I) in a real-world setting. MATERIALS AND METHODS: This retrospective study used the Truven Health MarketScan Medicaid, Commercial, and Medicare Supplemental Claims Databases. Adults were identified if they had BD-I and initiated an AAP treatment during the study identification period (July 1, 2015-June 30, 2016 for Medicaid, July 1, 2015-March 31, 2016 for Commercial and Medicare Supplemental) and had ≥6-month continuous enrollment before (baseline) and after (follow-up) the first day of treatment. Medication adherence was measured by the proportion of days covered (PDC) and grouped as: fully-adherent (PDC ≥80%), partially-adherent (40% ≤ PDC <80%), and non-adherent (PDC <40%). Logistic and linear regression models were conducted to estimate the risk of psychiatric hospitalization and costs during the 6-month follow-up period. RESULTS: The final sample consisted of 5,892 (32.0%) fully-adherent, 4,246 (23.1%) partially-adherent, and 8,250 (44.9%) non-adherent patients. The adjusted rate of psychiatric hospitalization during the follow-up period was lower in the fully-adherent (6.0%) vs partially- (8.3%) or non-adherent (8.8%) groups (p < 0.001). Using the fully-adherent cohort as the reference group, the odds of psychiatric hospitalization were significantly higher for the partially-adherent (OR = 1.42; 95% CI = 1.23-1.64) and non-adherent (1.51; 1.33-1.71) cohorts. The mean adjusted psychiatric hospitalization cost over 6 months among hospitalized patients was lower for the fully-adherent cohort ($11,748), than the partially-adherent ($15,051 p = 0.002) or non-adherent cohorts ($13,170, not statistically significant). LIMITATIONS: The medication adherence measures relied on prescription claims data, not actual use. CONCLUSIONS: In the treatment of BD-I, better medication adherence to AAP was associated with fewer psychiatric hospitalizations. Among hospitalized patients, fully-adherent patients had statistically significantly lower psychiatric costs than partially-adherent ones. These findings suggest that improving adherence to AAP in BD-I may be a valuable goal from both clinical and economic perspectives.

Earlier Versus Later Augmentation with an Antipsychotic Medication in Patients with Major Depressive Disorder Demonstrating Inadequate Efficacy in Response to Antidepressants: A Retrospective Analysis of US Claims Data.

INTRODUCTION: There is little evidence regarding the most effective timing of augmentation of antidepressants (AD) with antipsychotics (AP) in patients with major depressive disorder (MDD) who inadequately respond to first-line AD (inadequate responders). The study's objective was to understand the association between timing of augmentation of AD with AP and overall healthcare costs in inadequate responders. METHODS: Using the Truven Health MarketScan® Medicaid, Commercial, and Medicare Supplemental databases (7/1/09-12/31/16), we identified adult inadequate responders if they had one of the following indicating incomplete response to initial AD: psychiatric hospitalization or emergency department (ED) visit, initiating psychotherapy, or switching to or adding on a different AD. Two mutually exclusive cohorts were identified on the basis of time from first qualifying event date to first date of augmentation with an AP (index date): 0-6 months (early add-on) and 7-12 months (late add-on). Patients were further required to be continuously enrolled 1 year before (baseline) and 1 year after (follow-up) index date. Patients with schizophrenia or bipolar disorder diagnoses were excluded. General linear regression was used to estimate adjusted healthcare costs in the early versus late add-on cohort, controlling for baseline demographic and clinical characteristics, insurance type, medications, and ED visits or hospitalizations. RESULTS: Of the 6935 identified inadequate responders, 68.7% started an AP early and 31.3% late. At baseline, before AP augmentation, patients in the early add-on cohort had higher psychiatric comorbid disease burden (47.3% vs. 42.5%; p < 0.001) and higher inpatient utilization [mean (SD) 0.41 (0.72) vs. 0.27 (0.67); p < 0.001] than in late add-on cohort. During follow-up, the adjusted total all-cause healthcare cost was significantly lower in the early vs. late add-on cohort ($18,864 vs. $20,452; p = 0.046). CONCLUSION: Findings of this real-world study suggest that, in patients with MDD who inadequately responded to first-line AD treatment, adding an AP earlier reduces overall healthcare costs. FUNDING: Otsuka Pharmaceutical Development and Commercialization, Inc. and Lundbeck.

Identification of Undiagnosed Hyperlipidemia: Do Work Site Screening Programs Work?

PURPOSE: We evaluated the rate of hyperlipidemia identified during workplace screening in previously undiagnosed individuals, the association between workplace hyperlipidemia screening and use of medical care during follow-up, and changes in lipid profile among individuals with hyperlipidemia at screening. DESIGN: Nonexperimental longitudinal study. SETTING: Employees who participated in a workplace health screening. PARTICIPANTS: A total of 18 993 individuals from 39 self-insured employers in the United States. MEASURES: Total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides were measured during screening. A claims-based algorithm was used to identify hyperlipidemia cases. ANALYSIS: Discrete-time survival analysis was used to estimate monthly rates of new hyperlipidemia diagnoses or prescriptions. Paired t tests were used to evaluate 1-year changes in lipid profile. RESULTS: A total of 1872 (9.9%) individuals had hyperlipidemia at screening. Among all individuals, a significantly greater rate of new hyperlipidemia diagnoses was observed during the first month after screening, compared to the 3 months before screening (odds ratio [95% CI]: 2.99 [2.66-3.36]). Among the 987 individuals who were followed up 1 year later, significant improvements were observed in total cholesterol (-8.5% ± 13.6%) and LDL levels (-10.2% ± 19.3%). CONCLUSION: Workplace health screenings in an insured population were associated with a subsequent increase in physician visits and prescriptions for hyperlipidemia. After 1 year, significant improvements in total cholesterol and LDL levels were observed among individuals who screened positive for hyperlipidemia.

Novel screening metric for the identification of at-risk peripheral artery disease patients using administrative claims data.

Despite high morbidity and mortality associated with peripheral artery disease (PAD), it remains under-diagnosed and under-treated. The objective of this study was to develop a screening metric to identify undiagnosed patients at high risk of developing PAD using administrative data. Commercial claims data from 2010 to 2012 were utilized to develop and internally validate a PAD screening metric. Medicare data were used for external validation. The study population included adults, aged 30 years or older, with new cases of PAD identified using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis/procedure codes or the Healthcare Common Procedure Coding System (HCPCS) codes. Multivariate logistic regression was conducted to determine PAD risk factors used in the development of the screening metric for the identification of at-risk PAD patients. The cumulative incidence of PAD was 6.6%. Sex, age, congestive heart failure, hypertension, chronic renal insufficiency, stroke, diabetes, acute myocardial infarction, transient ischemic attack, hyperlipidemia, and angina were significant risk factors for PAD. A cut-off score of ⩾20 yielded sensitivity, specificity, positive predictive value, negative predictive value, and c-statistics of 83.5%, 60.0%, 12.8%, 98.1%, and 0.78, respectively. By identifying patients at high risk for developing PAD using only administrative data, the use of the current pre-screening metric could reduce the number of diagnostic tests, while still capturing those patients with undiagnosed PAD.

New bundled world: quality of care and readmission in diabetes patients.

BACKGROUND: Hospital readmissions among patients with diabetes are substantial and costly. Although prior studies have shown that receipt of outpatient quality of care significantly reduces the risk of hospitalization among patients with diabetes, little is known about its impact on hospital readmission. The objective of this study is to assess the impact of outpatient quality of care on 30-day readmission among patients with diabetes. METHODS: We used deidentified administrative claims data from the IMS LifeLink and included commercially insured diabetes patients ≥ 19 years old discharged from hospitals in the United States in 2009 and 2010 (n = 30,139). The outcome was readmission within 2-30 days of discharge. The main independent variables were receipt of outpatient quality-of-care measures (i.e., two hemoglobin A1c tests, low-density lipoprotein (LDL) test, 90-day supply of statin, and 90-day supply of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers). Multivariate logistic regression was used to examine the impact of outpatient quality of care on hospital readmission while controlling for demographics, clinical characteristics, health care utilization, and insurance type in the year prior to admission. RESULTS: Overall 30-day readmission rates among patients with diabetes were 18.9%. Patients who received at least one LDL test [odds ratio (OR) = 0.918, 95% confidence interval (CI; 0.852 0.989), p < .025] and ≥90-day supply of statins (OR = 0.91, 95% CI [0.85 0.97], p < .01) were less likely to be readmitted to the hospital. CONCLUSIONS: Receipt of LDL testing and adherence to statin medications were effective in decreasing the likelihood of 30-day hospital readmission and may be considered as elements of a quality focused incentive-based health care delivery package for diabetes patients.

Preoperative predictors of weight loss following bariatric surgery: systematic review.

BACKGROUND: Obesity affects 32% of adults in the USA. Surgery generates substantial weight loss, but 20-30% fails to achieve successful weight loss. Our objective was to identify preoperative psychosocial factors associated with weight loss following bariatric surgery. METHODS: We performed a literature search of PubMed® and the Cochrane Database of Reviews of Effectiveness between 1988 and April 2010. Articles were screened for bariatric surgery and weight loss if they included a preoperative predictor of weight loss: body mass index (BMI), preoperative weight loss, eating disorders, or psychiatric disorder/substance abuse. One thousand seven titles were reviewed, 534 articles screened, and 115 included in the review. RESULTS: Factors that may be positively associated with weight loss after surgery include mandatory preoperative weight loss (7 of 14 studies with positive association). Factors that may be negatively associated with weight loss include preoperative BMI (37 out of 62 studies with negative association), super-obesity (24 out of 33 studies), and personality disorders (7 out of 14 studies). Meta-analysis revealed a decrease of 10.1% excess weight loss (EWL) for super-obese patients (95% confidence interval (CI) [3.7-16.5%]), though there was significant heterogeneity in the meta-analysis, and an increase of 5.9% EWL for patients with binge eating at 12 months after surgery (95% CI [1.9-9.8%]). CONCLUSIONS: Further studies are necessary to investigate whether preoperative factors can predict a clinically meaningful difference in weight loss after bariatric surgery. The identification of predictive factors may improve patient selection and help develop interventions targeting specific needs of patients.

Heart failure patients receiving ACEIs/ARBs were less likely to be hospitalized or to use emergency care in the following year.

Angiotensin-converting enzyme inhibitors (ACEIs) have been shown to decrease morbidity and mortality in heart failure (HF) patients in randomized-controlled trials; observational studies have confirmed this benefit among patients discharged with HF. Investigating the benefit of ACEIs or angiotensin receptor blockers (ARBs) among general HF patients has important implications for quality-of-care measurement and quality initiatives. The objective of this study is to assess the impact of receipt of ACEIs/ARBs among patients with HF on hospitalization, emergency care, and healthcare cost during the following year. Using administrative data, we identified HF patients between 2000 and 2005 in a large health plan (n=2,396 patients). We conducted multivariate analysis to assess the impact of receipt of an ACEI/ARB on likelihood of hospitalization and emergency care, and on total healthcare cost. We found that patients who received ACEIs/ARBs were less likely to be hospitalized (odds ratio [OR]=0.82, p<.05) or use emergency care (OR=0.82, p<.05) in the following year. Receipt of ACEIs/ARBs was not associated with significantly increased cost. Incentivizing the receipt of ACEIs/ARBs in a general population with HF may be a suitable target for pay-for-performance programs, disease management programs, or newer complementary frameworks, such as value-based insurance design.