Value-Based, Cost-Effective Care: The Role of the Allergist-Immunologist.

Asthma and allergic disease impact millions of patients and are associated with high costs. Up to 30% of all medical care involves wasted spending. Across the spectrum of care provided by the allergist-immunologist, there are opportunities to improve value and reduce medical waste. Several examples highlight this reality. Evidence suggests that most patients may receive cost-effective care in the management of chronic spontaneous urticaria without the need for laboratory testing. For patients with asthma, although a single maintenance and reliever therapy approach may be cost-effective, insurance-mandated therapy changes are not, and may harm patients. Biologics may be very effective in improving asthma control but are too expensive for this indication-as demonstrated by cost-effectiveness analyses and highlighted by the Institute of Clinical and Economic Review, which concluded that the value-based price for asthma biologics ranges between $6500 and 14,3000 per year. Early introduction may prevent food allergy, but screening before first introduction is neither necessary nor cost-effective, although early salvage food oral immunotherapy may result in improved quality of life and cost savings. Evidence does not support the presence of allergic disease as a risk factor for anaphylaxis to coronavirus disease 2019 vaccination, and risk-stratified vaccination approaches do not appear cost-effective. Allergen immunotherapy is a very cost-effective treatment option. The practice of allergy-immunology has continued to evolve in recent years and can provide a leading example of high-value practice.

Socioeconomic status associates with worse asthma morbidity among Black and Latinx adults.

BACKGROUND: Asthma disproportionately affects African American/Black (AA/B) and Hispanic/Latinx (H/L) patients and individuals with low socioeconomic status (SES), but the relationship between SES and asthma morbidity within these racial/ethnic groups is inadequately understood. OBJECTIVE: To determine the relationship between SES and asthma morbidity among AA/B and H/L adults with moderate to severe asthma using multidomain SES frameworks and mediation analyses. METHODS: We analyzed enrollment data from the PeRson EmPowered Asthma RElief randomized trial, evaluating inhaled corticosteroid supplementation to rescue therapy. We tested for direct and indirect relationships between SES and asthma morbidity using structural equation models. For SES, we used a latent variable defined by poverty, education, and unemployment. For asthma morbidity, we used self-reported asthma exacerbations in the year before enrollment (corticosteroid bursts, emergency room/urgent care visits, or hospitalizations), and Asthma Control Test scores. We tested for mediation via health literacy, perceived stress, and self-reported discrimination. All models adjusted for age, sex, body mass index, ethnicity, and comorbidities. RESULTS: Among 990 AA/B and H/L adults, low SES (latent variable) was directly associated with hospitalizations (ß = 0.24) and worse Asthma Control Test scores (ß = 0.20). Stress partially mediated the relationship between SES and increased emergency room/urgent care visits and worse asthma control (ß = 0.03 and = 0.05, respectively). Individual SES domains were directly associated with asthma morbidity. Stress mediated indirect associations between low educational attainment and unemployment with worse asthma control (ß = 0.05 and = 0.06, respectively). CONCLUSIONS: Lower SES is directly, and indirectly through stress, associated with asthma morbidity among AA/B and H/L adults. Identification of stressors and relevant management strategies may lessen asthma-related morbidity among these populations.

Building eConsult (Electronic Consults) Capability at an Academic Medical Center to Improve Efficiencies in Delivering Specialty Care.

As the COVID-19 health crisis continues to reshape healthcare, systems across the country face increasing pressure to adapt their models of care to expand access to care, while also improving efficiency and quality in the face of limited resources. Consequently, many have shown a growing interest and receptivity to the expansion of telehealth models to help meet these demands. Electronic consultations (eConsults) are a telehealth modality that allow for a non-face-to-face asynchronous consultation between a primary care provider (PCP) and a specialist aimed at facilitating specialist input without the need for a patient visit. The aim of this case study is to describe eConsults, how they differ from traditional in person models of care and other models of telemedicine and to review the evidence related to the effectiveness of eConsults by PCPs and clinicians from multiple specialties at the University of Colorado School of Medicine. We have worked to develop an infrastructure, delivery system integration, and care model adaptations that aim to improve delivery system performance by ensuring proper care in appropriate settings and lowering costs through reduced utilization. Lastly, we have increased care coordination, improved collaboration and better care transitions through strengthening of relationships between community-based PCPs and academic medical center-based specialists. This work has resulted in cost savings to patients and positive provider satisfaction.

Cost-Effectiveness of Biologics for Allergic Diseases.

The introduction of specific humanized monoclonal antibodies over the past 20 years has dramatically changed the treatment of allergic diseases. At present, 5 mAbs are licensed for treating moderate to severe allergic and eosinophilic asthma, atopic dermatitis, chronic spontaneous urticaria, chronic sinusitis with nasal polyps, and eosinophilic granulomatosis with polyangiitis. Given the high costs of biologics, understanding their cost-effectiveness is critical. As new biologics are developed and new indications are approved for existing biologics, the use of biologics for allergic diseases will increase. Conducting cost-effectiveness evaluations in parallel to efficacy and effectiveness trials will help patients, providers, payers, and policymakers in decision making.

Quantitative computed tomography assessment of bronchiolitis obliterans syndrome after lung transplantation.

BACKGROUND: Bronchiolitis obliterans syndrome (BOS) is a clinical manifestation of chronic allograft rejection following lung transplantation. We examined the quantitative measurements of the proximal airway and vessels and pathologic correlations in subjects with BOS. METHODS: Patients who received a lung transplant at the Brigham and Women's Hospital between December 1, 2002 and December 31, 2010 were included in this study. We characterized the quantitative CT measures of proximal airways and vessels and pathological changes. RESULTS: Ninety-four (46.1%) of the 204 subjects were included in the study. There was a significant increase in the airway vessel ratio in subjects who developed progressive BOS compared to controls and non-progressors. There was a significant increase in airway lumen area and decrease in vessel cross-sectional area in patients with BOS compared to controls. Patients with BOS had a significant increase in proximal airway fibrosis compared to controls. CONCLUSIONS: BOS is characterized by central airway dilation and vascular remodeling, the degree of which is correlated to decrements in lung function. Our data suggest that progressive BOS is a pathologic process that affects both the central and distal airways.

Pharmacogenomic test that predicts response to inhaled corticosteroids in adults with asthma likely to be cost-saving.

AIM: To identify the clinical and economic circumstances under which a pharmacogenomic test that predicts response to inhaled corticosteroids might be a cost-effective option for individuals with asthma. MATERIALS & METHODS: We synthesized published data on clinical and economic outcomes to project 10-year costs, quality-adjusted life-years and cost-effectiveness of pharmacogenomic testing for inhaled corticosteroid response. We assumed the pharmacogenomic test cost was $500 with a sensitivity and specificity of 84 and 98%, respectively. These were varied in sensitivity analyses. RESULTS: Both strategies, pharmacogenomic testing for inhaled corticosteroid response and no testing conferred 7.1 quality-adjusted life-years. Compared with no testing, pharmacogenomic testing costs less. CONCLUSION: Pharmacogenomic testing for asthma is cost-saving and noninferior in improving health. Original submitted 19 November 2014; Revision submitted 23 February 2015.

Pharmacogenomic test that predicts response to ß2-agonists in adults with asthma is cost effective.

BACKGROUND: Pharmacogenomic tests that predict which asthma patients are likely to respond to ß2-agonists hold promise to improve care for asthma. OBJECTIVE: To identify the clinical and economic circumstances under which a pharmacogenomic test that predicts response to ß2-agonists might or might not be an appropriate, cost-effective option. METHODS: We synthesized published data on clinical and economic outcomes in adults 18-35 to project 10-year costs, quality-adjusted life years and cost-effectiveness of pharmacogenomic testing for ß2-agonist response. RESULTS: Pharmacogenomic testing for ß2-agonist response conferred a cost-effectiveness ratio of $13,700 per quality-adjusted life year gained compared with no testing. CONCLUSION: Pharmacogenomic testing for ß2-agonist response in individuals with asthma is potentially cost effective and should be pursued by test developers.

The development, implementation, and assessment of an innovative faculty mentoring leadership program.

Effective mentoring is an important component of academic success. Few programs exist to both improve the effectiveness of established mentors and cultivate a multispecialty mentoring community. In 2008, in response to a faculty survey on mentoring, leaders at Brigham and Women's Hospital developed the Faculty Mentoring Leadership Program as a peer learning experience for midcareer and senior faculty physician and scientist mentors to enhance their skills and leadership in mentoring and create a supportive community of mentors. A planning group representing key administrative, educational, clinical, and research mentorship constituencies designed the nine-month course.Participants met monthly for an hour and a half during lunchtime. Two cofacilitators engaged the diverse group of 16 participants in interactive discussions about cases based on the participants' experiences. While the cofacilitators discussed with the participants the dyadic mentor-mentee relationship, they specifically emphasized the value of engaging multiple mentors and establishing mentoring networks. In response to postsession and postcourse (both immediately and after six months) self-assessments, participants reported substantive gains in their mentoring confidence and effectiveness, experienced a renewed sense of enthusiasm for mentoring, and took initial steps to build a diverse network of mentoring relationships.In this article, the authors describe the rationale, design, implementation, assessment, and ongoing impact of this innovative faculty mentoring leadership program. They also share lessons learned for other institutions that are contemplating developing a similar faculty mentoring program.

Modeling asthma exacerbations through lung function in children.

BACKGROUND: Formal economic evaluation using a model-based approach is playing an increasingly important role in health care decision making. OBJECTIVE: To develop a model by using an objective measure of lung function-- prebronchodilator FEV(1) as a percent of predicted (FEV(1)% predicted)--as the primary independent factor to predict the frequency of adverse events related to the exacerbation of asthma on a population level. METHODS: We developed a Markov simulation model of childhood asthma by using data from the Childhood Asthma Management Program. The primary outcomes were the result of asthma exacerbations defined as hospitalizations, emergency department (ED) visits, and the need for oral corticosteroid therapy. Predicted monthly frequencies for each acute event were based on negative binomial regression equations estimated from the placebo arm of the Childhood Asthma Management Program with covariates of age, prebronchodilator FEV(1)% predicted, time in study, prior hospitalizations, and prior nocturnal awakenings. RESULTS: Simulated versus observed mean number of acute events were similar within the placebo and treatment groups. While the trial demonstrated treatment effects of 48% reduction in hospitalizations, 46% reduction in ED visits, and 44% reduction in the need for oral corticosteroid therapy at 48 months, the model simulated similar reductions of 49% in hospitalizations, 41% in ED visits, and 46% in the need for oral corticosteroid therapy. CONCLUSIONS: Our findings suggest that longitudinal intervention effects may be modeled through FEV(1)% predicted to estimate hospitalizations, ED visits, and need for oral corticosteroid therapy in childhood asthma for planning and evaluation purposes.

Effect of combination fluticasone propionate and salmeterol or inhaled corticosteroids on asthma-related outcomes in a Medicare-eligible population.

BACKGROUND: National asthma treatment guidelines recommend either the use of inhaled corticosteroids (ICS) or ICS in combination with a long-acting bronchodilator for the treatment of moderate to severe asthma. Even though asthma is common among older adults, few studies have assessed the differences in effectiveness between these two recommended therapies in patients over 65 years of age. OBJECTIVE: The aim of this study was to assess the association of the fluticasone-salmeterol combination (FSC) or ICS initiation on asthma-related events in Medicare-eligible asthma patients. METHODS: This was a retrospective observational study using a large health claims database (July 1, 2001 to June 30, 2008). Subjects 65 to 79 years of age with 12-month preindex and 3- to 12-month postindex eligibility, an asthma diagnosis (ICD-493.xx), and with 1 or more FSC or ICS claims at index were included. Subjects with an FSC or ICS claim in the preindex and any claim for chronic obstructive pulmonary disease were excluded. Subjects were observed until they had an event (emergency department [ED] inpatient hospitalization [IP], combined IP/ED or oral corticosteroid [OCS] use) or were no longer eligible in the database, whichever came first. Cox proportional hazards regression was used to assess risk of an asthma-related event (IP, ED, or IP/ED). Baseline characteristics (age, sex, region, index season, comorbidities, preindex use of short-acting ß-agonists, OCS, other asthma controllers, and asthma-related ED/IP visits) were independent covariates in the model. RESULTS: A total of 10,837 met the criteria (4843 ICS and 5994 FSC). Age (70.4 and 70.5 years, respectively) and the percentage of female subjects (65.5% and 64.8%, respectively) were similar. Asthma-related events were also similar at baseline. Postindex unadjusted rates occurring after >30 days were ED (1.8% vs 1.5%, P = 0.18), IP (2.7% vs 1.7%, P < 0.001), and ED/IP (4.1% vs 2.8%, P < 0.001) for ICS and FSC, respectively. Subjects who received FSC were associated with a 32% (adjusted HR = 0.68; 95% CI, 0.51-0.91) lower risk of experiencing an IP visit and a 22% (HR = 0.78; 95% CI, 0.62-0.98) lower risk of experiencing an ED/IP visit. No differences were observed for ED visits (HR = 0.94; 95% CI, 0.68-1.29). CONCLUSIONS: In Medicare-eligible asthma patients, FSC use was associated with lower rates of asthma-related serious exacerbations compared with ICS.

Asthma Severity in patients initiating controller monotherapy versus combination therapy.

BACKGROUND: Asthma treatment guidelines recommend medications based on the level of asthma control. OBJECTIVE: To evaluate differences in asthma control between patients who initiated asthma controller monotherapy versus combination therapy. PATIENTS AND METHODS: Children (5-16 years; n = 488) and adults (17-80 years; n = 530) with asthma and no controller therapy in the prior 6 months were included. Telephone surveys were conducted within 5 days of filling a new asthma controller prescription with either the caregiver of children or the adult patient. Demographics, asthma control before therapy, and asthma-related resource use were assessed for patients initiating monotherapy (filling one asthma controller prescription) and combination therapy (filling more than one controller medication or a fixed-dose combination). RESULTS: Mean pediatric age was 10 years; 53% were male. Mean adult age was 47 years; 25% were male. There were no significant differences in asthma control score between patients receiving monotherapy and combination therapy. Children on combination therapy did not have more nighttime awakening or short-acting ß-agonist use but were more likely to have been hospitalized due to asthma attack (p = .05) and have more unscheduled (p = .0374) and scheduled (p = .009) physician visits. Adults on combination therapy were more likely to have been hospitalized due to asthma attack (p < .05) and have regular doctor visits for asthma (p < .01). CONCLUSIONS: Assessment of asthma control scores in the 4 weeks before index medication suggests that asthma severity during a treatment-free period did not differ significantly for patients initiating controller monotherapy versus combination therapy. From these findings, it appears that although physicians may not focus on asthma control when choosing the intensity of initial controller therapy, the intensity of health-care encounters may be an influence.

Patterns of inhaled corticosteroid use and asthma control in the Childhood Asthma Management Program Continuation Study.

BACKGROUND: Daily controller medication use is recommended for children with persistent asthma to achieve asthma control. OBJECTIVE: To examine patterns of inhaled corticosteroid (ICS) use and asthma control in an observational study of children and adolescents with mild-to-moderate asthma (the Childhood Asthma Management Program Continuation Study). METHODS: We assessed patterns of ICS use during a 12-month period (consistent, intermittent, and none) and asthma control (well controlled vs poorly controlled). Multivariate logistic regression examined the association between pattern of ICS use and asthma control. RESULTS: Of 914 patients enrolled, 425 were recommended to continue receiving ICS therapy in the Childhood Asthma Management Program Continuation Study. Of these patients, 46% reported consistent ICS use and 20% reported no ICS use during year 1. By year 4, consistent ICS use decreased to 20%, whereas no ICS use increased to 57%; poorly controlled asthma was reported in 18% of encounters. In multivariate models controlling for age, sex, forced expiratory volume in 1 second, and asthma severity assessment, patients reporting consistent ICS use during a 12-month period were more likely to report poor asthma control (odds ratio, 1.6; 95% confidence interval, 1.2-2.1) compared with those reporting no ICS use. CONCLUSIONS: In this observational study of children and adolescents with mild-to-moderate asthma, most did not report continued use of ICS. Patients recommended to continue receiving ICS therapy and reporting consistent ICS use were less likely to report well-controlled asthma even after controlling for markers of asthma severity. Although residual confounding by severity cannot be ruled out, many children and adolescents may not achieve well-controlled asthma despite consistent use of ICS.

Modeling the potential impact of a prescription drug copayment increase on the adult asthmatic medicaid population.

OBJECTIVES: The Commonwealth of Massachusetts increased the copayment for prescription drugs by $1.50 for Medicaid (MassHealth) beneficiaries in 2003. We sought to determine the likely health outcomes and cost shifts attributable to this copayment increase using the example of inhaled corticosteroids (ICS) use among adult asthmatic Medicaid beneficiaries. METHOD: We compared the predicted costs and health outcomes projected over a 1-year time horizon with and without the increase in copayment from the perspective of MassHealth, providers, pharmacies, and MassHealth beneficiaries by employing decision analysis simulation model. RESULTS: In a target population of 17,500 adult asthmatics, increased copayments from 50 cent to $2.00 would result in an additional 646 acute events per year, caused by increased drug nonadherence. Annual combined net savings for the state and federal governments would be $2.10 million. Projected MassHealth savings are attributable to both decreased drug utilization and lower pharmacy reimbursement rates; these more than offset the additional costs of more frequent acute exacerbations. Pharmacies would lose $1.98 million in net revenues, MassHealth beneficiaries would pay an additional $0.28 million, and providers would receive additional $0.16 million. CONCLUSION: Over its first year of implementation, increase in the prescription drug copayment is expected to produce more frequent acute exacerbations among asthmatic MassHealth beneficiaries who use ICS and to shift the financial burden from government to other stakeholders.

Cost-effectiveness of omalizumab in adults with severe asthma: results from the Asthma Policy Model.

BACKGROUND: Omalizumab (trade name Xolair) is approved by the US Food and Drug Administration for treatment of moderate-to-severe allergic asthma. Given the high acquisition cost of omalizumab, its role and cost-effectiveness in disease management require definition. OBJECTIVE: We sought to identify the clinical and economic circumstances under which omalizumab might or might not be a cost-effective option by using a mathematic model. METHODS: We merged published data on clinical and economic outcomes (including acute event incidence, frequency/severity of hospitalizations, and health-related quality of life) to project 10-year costs, quality-adjusted life years (QALYs), and cost-effectiveness of treatment with omalizumab in addition to inhaled corticosteroids. Sensitivity analyses were conducted by using input data ranges from a variety of sources (published clinical trials and observational databases). RESULTS: For patients with baseline acute event rates, omalizumab conferred an additional 1.7 quality-adjusted months at an incremental cost of $131,000 over a 10-year planning horizon, implying a cost-effectiveness ratio of $821,000 per QALY gained. For patients with 5 times the baseline acute event rate, the cost-effectiveness ratio was $491,000 per QALY gained. The projected cost-effectiveness ratio could fall within a range of other programs that are widely considered to be cost-effective if the cost of omalizumab decreases to less than $200. CONCLUSION: Omalizumab is not cost-effective for most patients with severe asthma. The projected cost-effectiveness ratios could fall within a favorable range if the cost of omalizumab decreases significantly. CLINICAL IMPLICATIONS: Based on the high cost of omalizumab, it is especially important that clinicians explore alternative medications for asthma before initiating omalizumab.

Agreement between caregiver reported healthcare utilization and administrative data for children with asthma.

In asthma, healthcare utilization is frequently an outcome measure and can come from several sources. Asthma-related hospitalizations, emergency department (ED) visits, oral steroid bursts, and outpatient visits were compared between caregiver report and administrative data over 2 years. The difference between sources (caregiver minus administrative) was as follows: hospitalizations = -0.02 (95% limits of agreement, -0.66 to 0.61), ED visits = 0.18 (-1.16 to 1.52), steroid bursts = 0.26 (-3.98 to 4.49), and outpatient visits = 0.29 (-6.10 to 6.64). The percent of individuals with disagreement between sources was hospitalizations = 6.1%; ED visits = 20.2%; steroid bursts = 34.3%; and outpatient visits = 83.6%. The data sources resulted in similar estimates on the population level; however, there were pronounced differences for outpatient visits on an individual level. Importantly, the individual level disagreement between the data sources could negatively affect the perceived quality of care provided by a physician and reduce their compensation in a pay-for-performance system when physicians are rated using administrative data, yet they provide treatment based on patient-reported information.

The influence of variation in type and pattern of symptoms on assessment in pediatric asthma.

OBJECTIVE: We conducted a national, population-based survey to examine the asthma-related health burden of US children. METHODS: A telephone-based survey was conducted in 2004 of children 4 to 18 years of age with current asthma in the United States. In 41,433 households screened, 1089 children reported current asthma; 801 interviews were completed by parents of children aged 4 to 15 years and by children themselves aged 16 to 18 years. The survey included questions about symptoms, perceived level of control, activity limitations, health care use, medicines, disease management, and knowledge. Global asthma symptom burden, derived from the National Asthma Education and Prevention Program guidelines, was composed of 3 components: short-term symptom burden (4-week recall), long-term symptom burden (past year), and functional impact (activity limitation). RESULTS: The majority of children were classified with mild intermittent disease on the basis of recent daytime symptoms alone (80%); yet, when report of nighttime symptoms was included, the proportion of children classified as having mild intermittent symptoms decreased (74%). When asthma burden was assessed on the basis of the global symptom burden construct, only a minority (13%) of individuals was classified as having an asthma symptom burden consistent with mild intermittent disease; the majority (62%) was classified as having moderate/severe disease. In addition, the impact of asthma on the daily activities is substantial; avoiding exertion (47%) and staying inside (34%) are common approaches to improve control of asthma symptoms. CONCLUSIONS: The goals of therapy for asthma, based on the National Asthma Education and Prevention Program guidelines, have not been achieved for the majority of children. In addition, parents and children overestimate the child's asthma control and commonly restrict activities to control asthma symptoms. Deficiencies in the control of asthma may be related to the underestimation of the burden of disease.

Cost-effectiveness of inhaled steroids in asthma: impact of effect on bone mineral density.

BACKGROUND: The effects of inhaled corticosteroid (ICS) preparations on bone health have been debated. Multiple analyses have been published examining the question, with mixed results. OBJECTIVES: We examined how assumptions about the effect of ICS on bone mineral density (BMD) influence the cost-effectiveness of ICS in asthma. METHODS: We developed a mathematical simulation model to estimate clinical outcomes and costs for a cohort with mild/moderate asthma. The analysis conformed to reference case recommendations of the US Panel on Cost-Effectiveness in Health and Medicine. Sensitivity analysis evaluated the stability of our results to uncertainty in treatment duration, age at treatment, and ICS dose. RESULTS: Assuming a dose of 200 microg twice per day of ICS, a literature-based average effect of ICS on BMD and a 10-year time horizon, we observed a minimal increase in the costs attributed to hip fracture and incremental cost effectiveness ratio of $26,000 per quality-adjusted life-year and $14.00 per symptom-free day gained. Over an extended the time horizon (lifetime), the incremental cost effectiveness ratio increased to $42,000/quality-adjusted life-year. Only under a scenario of high-dose ICS, a lifetime horizon, and a large effect of ICS on BMD did the potential impact of ICS on BMD dramatically affect the economic attractiveness of therapy. CONCLUSION: To minimize any potential impact, use of the lowest effective dose of ICS and measures to target and intervene in high-risk individuals are warranted. However, ICS therapy in mild/moderate asthma compares favorably with commonly accepted interventions over a wide range of assumptions regarding this treatment and its effects on BMD.

A multisite randomized trial of the effects of physician education and organizational change in chronic asthma care: cost-effectiveness analysis of the Pediatric Asthma Care Patient Outcomes Research Team II (PAC-PORT II).

BACKGROUND: A decision to implement innovative disease management interventions in health plans often requires evidence of clinical benefit and financial impact. The Pediatric Asthma Care Patient Outcomes Research Team II trial evaluated 2 asthma care strategies: a peer leader-based physician behavior change intervention (PLE) and a practice-based redesign called the planned asthma care intervention (PACI). OBJECTIVE: To estimate the cost-effectiveness of the interventions. METHODS: This was a 3-arm, cluster randomized trial conducted in 42 primary care practices. A total of 638 children (age range, 3-17 years) with mild to moderate persistent asthma were followed up for 2 years. Practices were randomized to PLE (n = 226), PACI (n = 213), or usual care (n = 199). The primary outcome was symptom-free days (SFDs). Costs included asthma-related health care utilization and intervention costs. RESULTS: Annual costs per patient were as follows: PACI, USD 1292; PLE, USD 504; and usual care, USD 385. The difference in annual SFDs was 6.5 days (95% confidence interval [CI], -3.6 to 16.9 days) for PLE vs usual care and 13.3 days (95% CI, 2.1-24.7 days) for PACI vs usual care. Compared with usual care, the incremental cost-effectiveness ratio was USD 18 per SFD gained for PLE (95% CI, USD 5.21-dominated) and USD 68 per SFD gained for PACI (95% CI, USD 37.36-361.16). CONCLUSIONS: Results of this study show that it is possible to increase SFDs in children and move organizations toward guideline recommendations on asthma control in settings where most children are receiving controller medications at baseline. However, the improvements were realized with an increase in the costs associated with asthma care.

Validity of the HEDIS criteria to identify children with persistent asthma and sustained high utilization.

BACKGROUND: The most widely used performance measure for asthma, the Health Plan Employer Data and Information Set (HEDIS), has been criticized because the delay between classification (year 1) and assessment of medication dispensing (year 2) may produce a "misalignment" and weaken the validity of the measure. OBJECTIVE: To examine whether a previously observed association between the HEDIS performance measure and asthma-related emergency department visits is robust when the period between the classification and outcome assessment is evaluated during a 2-year period as defined. METHODS: Children (N = 2766) aged 3 to 15 years enrolled in 1 of 3 managed care organizations with at least 1 asthma diagnosis listed for a hospitalization, an emergency department visit, or an ambulatory encounter and at least 2 consecutive years of data for analysis from July 1996 through June 1999 were identified. RESULTS: Children did not consistently meet the HEDIS criteria for persistent asthma, and 24% to 28% of children did not requalify in year 2 of observation. Multivariate regression models showed that a protective relationship between controller medication dispensing and asthma-related emergency department visits was no longer seen among children meeting the HEDIS criteria for persistent asthma when the total period of observation is extended to 2 years (odds ratio, 0.7; 95% confidence interval, 0.4-1.2). CONCLUSIONS: Our results suggest that the variable nature of asthma may affect how the HEDIS performance measure should be used for assessing quality of care. The period between identification of the target population and performance assessment should be closely related in time.

A multisite randomized trial of the effects of physician education and organizational change in chronic-asthma care: health outcomes of the Pediatric Asthma Care Patient Outcomes Research Team II Study.

BACKGROUND: Traditional primary care practice change approaches have not led to full implementation of national asthma guidelines. OBJECTIVE: To evaluate the effectiveness of 2 asthma care improvement strategies in primary care. DESIGN: Two-year randomized controlled clinical trial. SETTING: Forty-two primary care pediatric practices affiliated with 4 managed care organizations. PARTICIPANTS: Children aged 3 to 17 years with mild to moderate persistent asthma enrolled in primary care practices affiliated with managed care organizations. INTERVENTIONS: Peer leader education consisted of training 1 physician per practice in asthma guidelines and peer teaching methods. Planned care combined the peer leader program with nurse-mediated organizational change through planned visits with assessments, care planning, and self-management support, in collaboration with physicians. Analyses compared each intervention with usual care. MAIN OUTCOME MEASURES: Annualized asthma symptom days, asthma-specific functional health status (Children's Health Survey for Asthma), and frequency of brief oral steroid courses (bursts). RESULTS: Six hundred thirty-eight children completed baseline evaluations, representing 64% of those screened and eligible. Mean +/- SD age was 9.4 +/- 3.5 years; 60% were boys. Three hundred fifty (55%) were taking controller medication. Mean +/- SD annualized asthma symptom days was 107.4 +/- 122 days. Children in the peer leader arm had 6.5 fewer symptom days per year (95% confidence interval [CI], - 16.9 to 3.6), a nonsignificant difference, but had a 36% (95% CI, 11% to 54%) lower oral steroid burst rate per year compared with children receiving usual care. Children in the planned care arm had 13.3 (95% CI, - 24.7 to -2.1) fewer symptom days annually (-12% from baseline; P =.02) and a 39% (95% CI, 11% to 58%) lower oral steroid burst rate per year relative to usual care. Both interventions showed small, statistically significant effects for 2 of 5 Children's Health Survey for Asthma scales. Planned care subjects had greater controller adherence (parent report) compared with usual care subjects (rate ratio, 1.05 [95% CI, 1.00 to 1.09]). CONCLUSIONS: Planned care (nurse-mediated organizational change plus peer leader education) is an effective model for improving asthma care in the primary care setting. Peer leader education on its own may also serve as a useful model for improving asthma care, although it is less comprehensive and the treatment effect less pronounced.