Real-world antiseizure medication treatment outcomes in drug-resistant focal epilepsy patients.

OBJECTIVE: To gather real-world evidence on antiseizure medications (ASMs) treatment patterns and related outcomes in patients with drug-resistant focal epilepsy. METHODS: Medical insurance claims from the start of 2014 till the end of 2019 were used. Patient selection criteria included International Classification of Diseases (ICD) codes followed by documented ASM use. Baseline patient demographics along with ASM and rescue medication use patterns and related patient outcome were documented for first (index) ASM regimen. Patients who failed the first regimen and then failed the second regimen were considered drug resistant. Multivariate analyses were performed to identify risks and other characteristics for positive or negative treatment outcomes. RESULTS: Study cohort consisted of 46 474 patients with a mean age of 47.23 (SD: 16.94). Levetiracetam was the most first-encountered ASM (37.94%). At baseline, 87.14% were treated with ASMs prior to having study-confirmed diagnoses. Mental comorbidities were present in 37.86% of patients. After first-year ASM treatment, 34.61% of patients persisted on their index regimen and 5.91% were seizure-free. Patients failing first ASM regimen numbered 12 868 (27.69%). Drug-resistant patients who failed first and then second ASM regimens numbered 6335 (49.23%). Percentages of patients who had successful second treatment and seizure-free were 21.32 and 3.65, respectively. Initiating patients on lamotrigine or carbamazepine (relative to levetiracetam), baseline use of index ASM, rescue medications, and older age or male gender all lowered the risk for treatment failure. Having higher comorbidity, comorbid mental illness, headache, or neoplasty increased such a risk. Baseline use of index ASM, depressive episode, or anxiety disorder all entailed higher risk of failing second ASM treatment. SIGNIFICANCE: Overall, reported findings indicated that patient history at baseline and the early selection of an ASM all influenced treatment outcomes. Findings pointed to the complex nature of ASM treatment in drug-resistant focal epilepsy patients calling for additional research to identify the optimal treatment to achieve beneficial patient outcomes.

Quantifying weight loss program preferences of men working in trade and labor occupations: A discrete choice experiment.

Objective: Men who work in skilled and unskilled trades and labor occupations (i.e., blue-collar occupations), have high rates of obesity and associated comorbidities but are underrepresented in weight loss programs. A first step in engaging this group is to better understand their preferences for weight loss programs. Methods: Respondents were men working in trade and labor occupations, with overweight/obesity, and an interest in losing weight. A discrete choice experiment was developed, and the data were analyzed using mixed logit model. Respondent characteristics were tested as effect modifiers. Results: Respondents (N = 221, age (M ± SD) 45.0 ± 12.6, BMI 33.3 ± 6.3, 77% non-Hispanic white) working in a variety of occupations (construction 31%, manufacturing 30%, transportation 25%, maintenance/repair 14%) participated in this study. Results indicate preferences for programs that encourage making smaller dietary changes, are delivered online, and do not incorporate competition. Results were consistent across sensitivity analyses and most respondent groups. Conclusions: The results suggest specific ways to make weight loss programs more appealing to men in trade and labor occupations. Using experimental methods to quantify preferences using larger, more representative samples would further assist in tailoring behavioral weight loss programs for under-reached populations.

Comparison of Preferences and Data Quality between Discrete Choice Experiments Conducted in Online and Face-to-Face Respondents.

INTRODUCTION: Discrete choice experiments (DCE) are increasingly being conducted using online panels. However, the comparability of such DCE-based preferences to traditional modes of data collection (e.g., in-person) is not well established. In this study, supervised, face-to-face DCE was compared with its unsupervised, online facsimile on face validity, respondent behavior, and modeled preferences. METHODS: Data from face-to-face and online EQ-5D-5L health state valuation studies were compared, in which each used the same experimental design and quota sampling procedure. Respondents completed 7 binary DCE tasks comparing 2 EQ-5D-5L health states presented side by side (health states A and B). Data face validity was assessed by comparing preference patterns as a function of the severity difference between 2 health states within a task. The prevalence of potentially suspicious choice patterns (i.e., all As, all Bs, and alternating As/Bs) was compared between studies. Preference data were modeled using multinomial logit regression and compared based on dimensional contribution to overall scale and importance ranking of dimension-levels. RESULTS: One thousand five Online respondents and 1,099 face-to-face screened (F2FS) respondents were included in the main comparison of DCE tasks. Online respondents reported more problems on all EQ-5D dimensions except for Mobility. The face validity of the data was similar between comparators. Online respondents had a greater prevalence of potentially suspicious DCE choice patterns ([Online]: 5.3% [F2FS] 2.9%, P = 0.005). When modeled, the relative contribution of each EQ-5D dimension differed between modes of administration. Online respondents weighed Mobility more importantly and Anxiety/Depression less importantly. DISCUSSION: Although assessments of face validity were similar between Online and F2FS, modeled preferences differed. Future analyses are needed to clarify whether differences are attributable to preference or data quality variation between modes of data collection.

Quantitative revenue estimates and qualitative assessments of innovative fundraising sources for treating rare diseases in Colombia.

Background: Like many developing countries, Colombia faces difficulties in financing health-care services as well as programs for health promotion and health education and there is evidence that its health-care system is underperforming. Objective: To provide evidence-based estimates of potential funding levels and assess the strengths, weaknesses, and viability of innovative funding mechanisms with a focus on treating rare diseases in Colombia. Methods: The strategy involved evidence-based projections of potential funding levels and a qualitative viability assessment using an expert panel. Results: Crowdfunding, corporate donation, and social impact bonds (SIBs) were deemed to be the most viable of numerous potential strategies. Expected funding levels over 10 years for rare diseases in Colombia from crowdfunding, corporate donations, and SIBs were roughly $7,200, $23,000, and $12,400, respectively. Conclusions: Based on the combination of projected funding potential along with expert consensus regarding viability and operability, crowdfunding, corporate donations, and SIBs, especially in combination, have the potential to substantially improve funding for vulnerable patient populations in Colombia.

The effectiveness and value of gene therapy for hemophilia: A Summary from the Institute for Clinical and Economic Review's California Technology Assessment Forum.

DISCLOSURES: Dr Tice and Mr Sarker received ICER grants during the conduct of the study. Dr Moradi, Ms Herce-Hagiwara, Dr Faghim, Dr Agboola, Dr Rind, and Dr Pearson reports grants from Arnold Ventures, grants from Blue Cross Blue Shield of MA, grants from California Healthcare Foundation, grants from The Commonwealth Fund, grants from The Peterson Center on Healthcare, during the conduct of the study; other from Aetna, other from America's Health Insurance Plans, other from Anthem, other from AbbVie, other from Alnylam, other from AstraZeneca, other from Biogen, other from Blue Shield of CA, other from Cambia Health Services, other from CVS, other from Editas, other from Express Scripts, other from Genentech/Roche, other from GlaxoSmithKline, other from Harvard Pilgrim, other from Health Care Service Corporation, other from Health Partners, other from Johnson & Johnson (Janssen), other from Kaiser Permanente, other from LEO Pharma, other from Mallinckrodt, other from Merck, other from Novartis, other from National Pharmaceutical Council, other from Premera, other from Prime Therapeutics, other from Regeneron, other from Sanofi, other from Spark Therapeutics, other from United Healthcare, other from HealthFirst, other from Pfizer, other from Boehringer-Ingelheim, other from uniQure, other from Evolve Pharmacy Solutions, other from Humana, other from Sun Life, outside the submitted work.

Time-Specific Differences in Stated Preferences for Health in the United States.

BACKGROUND: Changes over time in health state values from a societal perspective may be an important reason to consider updating societal value sets for preference-based measures of health. OBJECTIVE: The aim was to examine whether stated health preferences are different between 2002 and 2017, controlling for demographic changes in the United States. METHODS: Data from 2002 and 2017 US EQ-5D-3L valuation studies were combined. The primary analysis compared valuations of better-than-dead (BTD) states only, as both studies used the same time trade-off (TTO) method for these states. For worse-than-dead (WTD) states, the 2017 study used the lead-time TTO and the 2002 study used the conventional TTO, which necessitated transformation. Regression models were fitted to BTD values to estimate time-specific differences, adjusting for respondent characteristics. Secondary analyses examined models that fitted WTD values (using linear and nonlinear transformations of the 2002 data) and all values. RESULTS: The adjusted BTD-only model showed mean values were higher for 2017 compared with 2002 (ßY2017=0.05, P<0.001). WTD-only models showed negative changes over time but that were dependent on the transformation method (linear ßY2017=-0.72; nonlinear ßY2017=-0.35; both P<0.001). Using all values, 2017 mean valuations were lower using a linear transformation (ßY2017=-0.11; P<0.001) but did not differ with the nonlinear transformation. CONCLUSIONS: Individuals in 2017 are generally less willing to trade quantity for quality of life compared with 2002. This study provides evidence of time-specific differences in a society's preferences, suggesting that the era in which values were elicited may be an important reason to consider updating societal value sets.

Mavacamten for hypertrophic cardiomyopathy: effectiveness and value.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Sun Life Financial, uniQure, and United Healthcare. Beinfeld, Nhan, Rind, and Pearson are employed by ICER. Through their affiliated institutions, Wasfy, Walton, and Sarker received funding from ICER for the work described in this summary. Walton also reports consulting fees from Second City Outcomes Research. Wasfy reports personal fees from Biotronik and Pfizer; grants from National Institutes of Health, National Football League Players Association and American Heart Association; and travel support from American College of Cardiology. Sarker has nothing additional to disclose.

Community Health Worker Asthma Interventions for Children: Results From a Clinically Integrated Randomized Comparative Effectiveness Trial (2016‒2019).

Objectives. To compare asthma control for children receiving either community health worker (CHW) or certified asthma educator (AE-C) services. Methods. The Asthma Action at Erie Trial is a comparative effectiveness trial that ran from 2016 to 2019 in Cook County, Illinois. Participants (aged 5‒16 years with uncontrolled asthma) were randomized to 10 home visits from clinically integrated asthma CHWs or 2 in-clinic sessions from an AE-C. Results. Participants (n = 223) were mainly Hispanic (85%) and low-income. Both intervention groups showed significant improvement in asthma control scores over time. Asthma control was maintained after interventions ended. The CHW group experienced a greater improvement in asthma control scores. One year after intervention cessation, the CHW group had a 42% reduction in days of activity limitation relative to the AE-C group (b = 0.58; 95% confidence interval = 0.35, 0.96). Conclusions. Both interventions were associated with meaningful improvements in asthma control. Improvements continued for 1 year after intervention cessation and were stronger with the CHW intervention. Public Health Implications. Clinically integrated asthma CHW and AE-C services that do not provide home environmental remediation equipment may improve and sustain asthma control.

The effectiveness and value of emicizumab and valoctocogene roxaparvovec for the management of hemophilia A without inhibitors.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, California Health Care Foundation, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, Aetna, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, uniQure, and United Healthcare. Agboola, Rind, Herron-Smith, and Pearson are employed by ICER. Walton and Quach, through the University of Illinois at Chicago, received funding from ICER for development of the economic model described in this report.

Protocol for a randomized controlled trial of low-intensity physical activity for frail older adults: Promoting seniors' health with home care aides (Pro-Home).

Regular participation in physical activity benefits older adults physically and mentally. However, the availability and assessment of physical activity programs that are safe and appropriate for homebound older adults at risk for nursing home admission are limited. Here we describe the protocol for a randomized controlled trial that examines the effectiveness of a gentle physical activity program. Delivered by home care aides who regularly help hard-to-reach older home care clients with housekeeping and routine personal care services in the home, this program is implemented in a real-world context of caregiver-client dyads in a Medicaid-funded home care program. The trial uses a two-group repeated measures design (baseline, Month 4, and Month 8) with 300 pairs of eligible home care clients and their home care aides. The results from this trial could provide evidence and guidelines for a new model of home care, which would facilitate the working together of older home care clients and their home care aides to maintain or improve the functional status of nursing home-eligible older adults.

An initial evaluation of expanded hemodialysis on hospitalizations, drug utilization, costs, and patient utility in Colombia.

To examine new evidence linking expanded hemodialysis (HDx) using a medium cut-off (MCO) membrane with hospitalizations, hospital days, medication use, costs, and patient utility. This retrospective study utilized data from Renal Care Services medical records database in Colombia from 2017 to 2019. Clinics included had switched all patients from high flux hemodialysis (HD HF) to HDx and had at least a year of data on HD HF and HDx. Data included demographic characteristics, comorbidities, years on dialysis, hospitalizations, medication use, and quality of life measured by the 36 item and Short Form versions of the Kidney Disease Quality of Life survey at the start of HDx, and 1 year after HDx, which were mapped to EQ-5D utilities. Generalized linear models were run on the outcomes of interest with an indicator for being on HDx. Annual cost estimates were also constructed. The study included 81 patients. HDx was significantly associated with lower dosing of erythropoietin stimulating agents, iron, hypertension medications, and insulin. HDx was also significantly associated with lower hospital days per year (5.94 on HD vs. 4.41 on HDx) although not with the number of hospitalizations. Estimates of annual hospitalization costs were 23.9% lower using HDx and patient utilities did not appear to decline. HDx was statistically significantly associated with reduced hospitalization days and lower medication dosages. Furthermore, this preliminary analysis suggested potential for HDx being a dominant strategy in terms of costs and utility and should motivate future work with larger samples and better controls.

Comparison of online and face-to-face valuation of the EQ-5D-5L using composite time trade-off.

OBJECTIVE: The aim of this study was to compare online, unsupervised and face-to-face (F2F), supervised valuation of EQ-5D-5L health states using composite time trade-off (cTTO) tasks. METHODS: The official EuroQol experimental design and valuation protocol for the EQ-5D-5L of 86 health states were implemented in interviewer-assisted, F2F and unsupervised, online studies. Validity of preferences was assessed using prevalence of inconsistent valuations and expected patterns of TTO values. Respondent task engagement was measured using number of trade-offs and time per task. Trading patterns such as better-than-dead only was compared between modes. Value sets were generated using linear regression with a random intercept (RILR). Value set characteristics such as range of scale and dimension ranking were evaluated between modes. RESULTS: Five hundred one online and 1,134 F2F respondents completed the surveys. Mean elicited TTO values were higher online than F2F when compared by health state severity. Compared to F2F, a larger proportion of online respondents did not assign the poorest EQ-5D-5L health state (i.e., 55555) the lowest TTO value ([Online] 41.3% [F2F] 12.2%) (p < 0.001). A higher percentage of online cTTO tasks were completed in 3 trade-offs or fewer ([Online] 15.8% [F2F] 3.7%), (p < 0.001). When modeled using the RILR, the F2F range of scale was larger than online ([Online] 0.600 [F2F] 1.307) and the respective dimension rankings differed. CONCLUSIONS: Compared to F2F data, TTO tasks conducted online had more inconsistencies and decreased engagement, which contributed to compromised data quality. This study illustrates the challenges of conducting online valuation studies using the TTO approach.

Increasing respondent engagement in composite time trade-off tasks by imposing three minimum trade-offs to improve data quality.

BACKGROUND: Web-based surveys are increasingly utilized for health valuation studies but may be more prone to lack of engagement and, therefore, poor data validity. The objective of this study was to evaluate the effect of imposed engagement (i.e., at least three trade-offs) in the composite time trade-off (cTTO) task. METHODS: The EQ-5D-5L valuation study protocol and study design were adapted for online, unsupervised completion in two arms: base case and engagement. Validity of preferences was assessed using the prevalence of inconsistent valuations and expected patterns of TTO values. Respondent task engagement was measured using time per task. Value sets were generated using linear regression with a random intercept (RILR). RESULTS: The base case (n = 501) and engagement arms (n = 504) clustered at different TTO values: [base case] 0, 1; [engagement] -0.5, 0.45, 0.6. Mean TTO values were lower for the engagement arm. Engagement respondents did not spend more time per TTO task: [base case] 63.3 s (SD 77.9 s); [engagement] 64.7 s (SD 73.3 s); p = 0.36. No significant difference was found between arms for prevalence of respondents with at least one inconsistent TTO value: [base case] 61.1%; [engagement] 63.5%; p = 0.43. Both value sets had significant intercepts far from 1: [base case] 0.846; [engagement] 0.783. The relative importance of the EQ-5D dimensions also differed between arms. CONCLUSIONS: Both online arms had poor quality data. A minimum trade-off threshold did not improve engagement nor face validity of the data, indicating that modifications to the number of iterations are insufficient alone to improve data quality/validity of online TTO studies.

Understanding Student Preferences in the Selection of a Graduate Allied Health Program: A Conjoint Analysis Study.

ISSUE: As the healthcare landscape rapidly changes, graduate allied health programs must position themselves to educate the next generation of healthcare professionals in a highly competitive landscape. No studies have directly measured the relative importance of attributes in program selection by prospective healthcare students. METHODS: We surveyed graduate healthcare management program applicants in the 2018 admissions cycle (n=512) to determine which attributes were most important in program choice. We utilized conjoint analysis to estimate utilities and importance scores of six attributes: program ranking, cost, work experience, geography, distance to home, and salary. We then conducted a market simulation to predict relative market share of academic programs. OUTCOMES: The most important attribute to prospective students was the projected starting salary, with US News and World Report ranking and tuition cost the second and third most important attributes, respectively. Each attribute was relatively inelastic respective to tuition cost. CONCLUSION: While future leaders placed the most value on earnings when selecting a program, they also valued rankings and cost. By focusing on these factors, programs can target their marketing efforts to recruit the best potential future healthcare leaders, while this method can be replicated to gauge the most important relative attributes for a variety of healthcare professions.

Being Precise About Precision Medicine: What Should Value Frameworks Incorporate to Address Precision Medicine? A Report of the Personalized Precision Medicine Special Interest Group.

Precision medicine is a dynamic area embracing a diverse and increasing type of approaches that allow the targeting of new medicines, screening programs or preventive healthcare strategies, which include the use of biologic markers or complex tests driven by algorithms also potentially taking account of patient preferences. The International Society for Pharmacoeconomics and Outcome Research expanded its current work around precision medicine to (1) describe the evolving paradigm of precision medicine with examples of current and evolving applications, (2) describe key stakeholders perspectives on the value of precision medicine in their respective domains, and (3) define the core factors that should be considered in a value assessment framework for precision medicine. With the ultimate goal of improving health of well-defined patient groups, precision medicine will affect all stakeholders in the healthcare system at multiple levels spanning the individual perspective to the societal perspective. For an efficient, timely and practical precision medicine value assessment framework, it will be important to address these multiple perspectives through building consensus among the stakeholders for robust procedures and measures of value aspects, including performance of precision mechanism; aligned reimbursement processes of precision mechanism and subsequent treatment; transparent expectations for evidence requirements and study designs adequately matched to the intended use of the precision mechanism and to the smaller target patient populations; recognizing the potential range of value-generation such as ruling-in and ruling-out decisions.

The Effectiveness and Value of Deflazacort and Exon-Skipping Therapies for the Management of Duchenne Muscular Dystrophy.

DISCLOSURES: Funding for this summary was contributed by Arnold Ventures, Commonwealth Fund, California Health Care Foundation, National Institute for Health Care Management (NIHCM), New England States Consortium Systems Organization, Blue Cross Blue Shield of Massachusetts, Harvard Pilgrim Health Care, Kaiser Foundation Health Plan, and Partners HealthCare to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from Aetna, America's Health Insurance Plans, Anthem, Allergan, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Cambia Health Services, CVS, Editas, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, Health Partners, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Premera, Prime Therapeutics, Regeneron, Sanofi, Spark Therapeutics, and United Healthcare. Agboola, Fluetsch, Rind, and Pearson are employed by ICER. Lin reports support from ICER during work on this economic model and grants from Mount Zion Health Fund, National Institutes of Health (National Cancer Institute and National Heart, Lung, and Blood Institute), and the Tobacco-Related Diseases Research Program, unrelated to this work. Walton reports support from ICER for work on this economic model and unrelated consulting fees from Baxter.

Estimating the Impact of Food and Drug Administration's Unapproved Drug Initiative on Drug Prices and Sales.

BACKGROUND: The 2006 FDA's Unapproved Drug Initiative (UDI) aimed to improve safety and public health by decreasing the availability of drug products that never obtained FDA approval (unapproved drug products) in the market and incentivizing manufacturers to emphasize that these products must obtain FDA approval. The objective of this study was to measure changes in the prices, sales, and quantities sold of drug products approved under the FDA-UDI. METHODS: Drug products that obtained voluntary approval under FDA-UDI from 2006 to 2015 were identified and trends in prices, sales, and units sold were analyzed using the IQVIA National Sales Perspective database. RESULTS: Eleven drug products were included in the final analysis. Relative to baseline levels 2 years before approval, a steep increase in price and sales was observed 2 years postapproval for all except 2 of the drug categories-with median percent change of 245% (range: -37% to 9618%) for price and 238% (range: -4% to 6707%) for sales. Substantial variance was observed in the changes in units sold. CONCLUSION: A marked increase was seen in postapproval prices and sales for the vast majority of drug products approved in the FDA-UDI with mixed results in changes in units sold. In addition to increased information on safety, the policy's impact on postapproval drug prices and associated effects on units sold should be considered in assessing the policy, especially when substantial price increases and decreases in units sold may negatively impact health.

Evaluating a remote patient monitoring program for automated peritoneal dialysis.

BACKGROUND: The benefits of automated peritoneal dialysis (APD) have been established, but patient adherence to treatment remains a concern. Remote patient monitoring (RPM) programs are a potential solution; however, the cost implications are not well established. This study modeled, from the payer perspective, expected net costs and clinical consequences of a novel RPM program in Colombia. METHODS: Amarkov model was used to project costs and clinical outcomes for APD patients with and without RPM. Clinical inputs were directly estimated from Renal Care Services data or taken from the literature. Dialysis costs were estimated from national fees. Inpatient costs were obtained from a recent Colombian study. The model projected overall direct costs and several clinical outcomes. Deterministic and probabilistic sensitivity analyses (DSA and PSA) were also conducted to characterize uncertainty in the results. RESULTS: The model projected that the implementation of an RPM program costing US$35 per month in a cohort of 100 APD patients over 1 year would save US$121,233. The model also projected 31 additional months free of complications, 27 fewer hospitalizations, 518 fewer hospitalization days, and 6 fewer peritonitis episodes. In the DSA, results were most sensitive to hospitalization rates and days of hospitalization, but cost savings were robust. The PSA found there was a 91% chance for the RPM program to be cost saving. CONCLUSION: The results of the model suggest that RPM is cost-effective in APD patients which should be verified by a rigorous prospective cost analysis.

Implementation Lessons From a Randomized Trial Integrating Community Asthma Education for Children.

This study characterized and compared the implementation of clinically integrated community health workers (CHWs) to a certified asthma educator (AE-C) for low-income children with asthma. In the AE-C arm (N = 115), 51.3% completed at least one in-clinic education session. In the CHW arm (N = 108), 722 home visits were completed. The median number of visits was 7 (range, 0-17). Scheduled in-clinic asthma education may not be the optimal intervention for this patient population. CHW visit completion rates suggest that the schedule, location, and content of CHW asthma services better met patients' needs. Seven to 10 visits seemed to be the preferred CHW dose.