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Objective: The aim of this study was to examine how calibration uncertainty affects the overall uncertainty of a mathematical model and to evaluate potential drivers of calibration uncertainty.Methods: A lifetime Markov model of the natural history of human papillomavirus (HPV) infection and cervical disease was developed to assess the cost effectiveness of a hypothetical HPV vaccine. Published data on cervical cancer incidence and mortality and prevalence of pre-cursor lesions were used as endpoints to calibrate the age- and HPV-type-specific transition probabilities between health states using the Nelder-Mead simplex method of calibration. A conventional probabilistic sensitivity analysis (PSA) was performed to assess uncertainty in vaccine efficacy, cost and utility estimates. To quantify the uncertainty around calibrated transition probabilities, a second PSA (calibration PSA) was performed using 25 distinct combinations of objective functions and starting simplexes.Results: The initial calibration produced an incremental cost-effectiveness ratio (ICER) of $US 4300 per QALY for vaccination compared with no vaccination, and the conventional PSA gave a 95% credible interval of dominant to $US 9800 around this estimate (2005 values). The 95% credible interval for the ICERs in the calibration PSA ranged from $US 1000 to $US 37,700.Conclusions: Compared with a conventional PSA, the calibration PSA results reveal a greater level of uncertainty in cost-effectiveness results. Sensitivity analyses around model calibration should be performed to account for uncertainty arising from the calibration process. [ABSTRACT FROM AUTHOR]

BACKGROUND: The Institute for Clinical and Economic Review (ICER) is a prominent health technology assessment (HTA) entity in the United States that considers costs and applies economic analyses to derive price-based recommendations. ICER continues to adjust its value framework, yet discussion persists regarding whether ICER methodologies align with established research standards. This work evaluates ICER assessments relative to those standards, providing a benchmark with the release of ICER's most recent value framework update. OBJECTIVES: To evaluate ICER economic assessments for trends, factors related to recommendations, and quality for use in U.S. decision making. METHODS: We evaluated all ICER final evidence reports published between 2006 and August 31, 2019, with regard to base-case result trends over time, pricing sources, comparator selection, analytic perspectives, model uncertainty, how modeling results aligned with ICER's determinations of value for money, and comparison of ICER methodological approaches with established modeling standards. Analyses were stratified by time period, where appropriate, to account for changes in ICER's framework over time. RESULTS: Of 58 ICER final evidence reports, 47 used the most commonly reported outcome (cost per quality-adjusted life-year [QALY]); ICER-developed models evaluated 131 interventions and comparators with 238 base-case results. Pricing sources for ICER reports became more standardized in 2017, although sources were not associated with the likelihood of falling below ICER's cost-effectiveness thresholds. In 30% of base-case analyses (n = 72), ICER did not use a clinical comparator, although reasonable treatments were available. In modified societal perspectives scenarios applied in later assessments, 75% of analyses (n = 76) included productivity but did not specify how it was quantified. Reports did not explain how sensitivity and scenario analyses were selected or implications of results. ICER value for money determinations generally aligned with cost-effectiveness results, although 2 of 33 (6%) interventions ranked as low value and 3 of 5 (60%) interventions ranked as low-moderate value, met a $150,000 per QALY threshold, and 14 of 37 (38%) moderate-value interventions exceeded this threshold; the most common rationale was related to national budget impact. CONCLUSIONS: While some progress has been made, further improvement is needed to ensure that ICER assessments address the most relevant questions for target audiences, adhere to established research standards, and are reported in a manner that can be readily interpreted and applied to policymaking. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose.

Background: Traumatic brain injury (TBI) is an increasingly diagnosed condition, but the trends in TBI visits and the cost of which have not been quantified from the hospital perspective. Objectives: To quantify the costs of TBI stratified by inpatient and outpatient visits and to examine trends in TBI incidence over time. Methods: This descriptive study utilized data for 2007-2012 from the Premier hospital database, which includes clinical and utilization information from hospitals across the United States. TBI was identified through International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes. Descriptive data were obtained to identify the TBI costs, visit costs, patient characteristics, and intertemporal trends in TBI rates. Results: TBI patients were treated on an outpatient basis 88% of the time. Nearly 45% (44.3%) of TBI patients requiring inpatient admissions were age 65 or over, and 20% of TBI patients treated as an outpatient were age 75 or over. Children aged 4 or younger accounted for nearly 14% of TBI cases treated on an outpatient basis. TBI patients treated in the inpatient setting incurred fairly long hospital visits (mean 4.8 days; median 3.0 days) and substantial hospital costs (mean $12,717; median $8,176). The rate of TBI visits have risen substantially over time, especially among children under age 18 years and patients in the Northeast US Census Region. Conclusion: TBI is a serious medical condition that appears to be on the rise. Large differences exist between the hospital costs associated with TBIs treated in the inpatient and outpatient settings. Further research to understand factors affecting the costs and clinical outcomes of TBI can help refine treatment strategies to enhance patient outcomes while providing cost effective care.

Background: Chronic stress affects many Americans. Stress management programs may be prohibitively expensive or have limited access., Purpose: This study aims to determine feasibility of an 8-week Internet-based stress management program (ISM) based on mindfulness principles in reducing stress in a 12-week, parallel, randomized, controlled trial., Methods: Participants were randomly allocated to ISM, ISM plus online message board (ISM+), or control groups. Perceived stress, mindfulness, self-transcendence, psychological well-being, vitality, and quality of life were measured at baseline, week 8, and week 12 using standard validated questionnaires., Results: ISM and ISM+ groups demonstrated statistically significant improvements compared with control on all measures except vitality and physical health., Conclusions: The ISM program effectively and sustainably reduced measures of stress. The magnitude of improvement is comparable to traditional mindfulness programs, although fewer participants were engaged. This feasibility study provides strong support for online stress management programs, which increase access at a fraction of cost of traditional programs.

Background and Purpose: An earlier study demonstrated significantly improved access, treatment, and outcomes after the implementation of a progressive, comprehensive stroke program at a tertiary care community hospital, Saint Luke's Neuroscience Institute (SLNI). This study evaluated the costs associated with implementing such a program., Methods: Retrospective analysis of total hospital costs and payments for treating patients with ischemic stroke at SLNI (n=1570) as program enhancement evolved over time (2005, 2007, and 2010) and compared with published national estimates. Analyses were stratified by patient demographic characteristics, patient outcomes, treatments, time, and comorbidities., Results: Controlling for inflation, there was no difference in SLNI total costs between 2005 and either 2007 or 2010, suggesting that while SLNI provided an increased level of services, any additional expenditures were offset by efficiencies. SLNI total costs were slightly lower than published benchmarks. Consistent with previous stroke care cost estimates, the median overall differential between total hospital costs and payments for all ischemic stroke cases was negative., Conclusions: SLNI total costs remained consistent over time and were slightly lower than previously published estimates, suggesting that a focused, streamlined stroke program can be implemented without a significant economic impact. This finding further demonstrates that providing comprehensive stroke care with improved access and treatment may be financially feasible for other hospitals.

Background: Overall and age-specific cervical cytological and histological abnormalities prevalence data across geographical regions, in conjunction with human papillomavirus vaccination status, will be important for the future evaluation of HPV prophylactic vaccine effectiveness., Methods: A systematic review was conducted to summarize worldwide data on the prevalence of high- and low-grade squamous intraepithelial lesions, and cervical intraepithelial neoplasia (CIN) 2/3 or 1., Results: More than 12,400,000 women were included in 103 studies. Most studies were from Europe and Middle East (40%) or North America (14%), 14% were from Asia, 17% from Central and South America, and 15% from Africa. Age-specific data were limited from Asia, Central and South America, and Africa. Screening techniques and study exclusion criteria varied, depending on region and population surveyed. Age trends of high-grade cervical lesions seemed to peak at a relatively younger age in North America (<30 years), compared with 25 to 40 years in Europe and Middle East, Africa, Asia, and Central and South America. Age patterns of low-grade lesions generally declined after a peak in the younger age groups (20-30 years). Age-specific CIN 1 and CIN 2/3 prevalence were lower compared with low- and high-grade squamous intraepithelial lesions from the same studies, respectively., Conclusions: Variation in the age patterns of high-grade lesions across regions is likely attributable to differences in age at screening initiation, frequency, coverage, and rates of follow-up of women with cervical abnormalities. Observed age patterns of low-grade lesions are generally consistent to those of human papillomavirus infection in women worldwide. Potential factors contributing to variations in the burden of cytological and histological abnormalities across studies include subjectivity in evaluating cytological slides and discrepancies in the processing, referral rates, and diagnostic interpretation of colposcopically directed biopsy.

Background: Use of combination vaccines has been associated with improved coverage rates, but their effect on timeliness remains to be explored. This study assessed the effect of diphtheria-tetanus-acellular pertussis/hepatitis B/inactivated polio vaccine (DTaP/HepB/IPV) on the timeliness of vaccine administration., Methods: This retrospective cohort study used administrative claims data from the Georgia Medicaid program. Children with 24 months of continuous enrollment and at least 4 vaccine-related office visits were stratified into 2 cohorts: those with at least 3 DTaP/HepB/IPV doses (DTaP/HepB/IPV cohort) and those with at least 3 doses of DTaP but no doses of DTaP/HepB/IPV (reference cohort). Children who received any dose of HepB/Hib were excluded to isolate the effect of the study vaccine. Timeliness was measured as the percentage of children who received their vaccines on time and the cumulative days undervaccinated., Results: There were 2880 children in the DTaP/HepB/IPV cohort and 2672 in the reference cohort. After controlling for covariates, receipt of DTaP/HepB/IPV was associated with significantly improved timeliness for 3 doses of DTaP (on-time rates: 66.3% vs. 60.8%, P < 0.0001; cumulative days undervaccinated: 29.5 vs. 70.4 days, P < 0.0001). Significantly improved timeliness was also observed in the DTaP/HepB/IPV cohort for IPV, HepB, Hib, 4 DTaPs, and the combination series assessed (P < 0.001 for all comparisons)., Conclusions: Use of DTaP/HepB/IPV in this Medicaid population was associated with improved on-time vaccination and fewer undervaccinated days. These findings, along with previous research associating combination vaccines with improved coverage rates, provide quantitative data to support the ACIP, AAP, and AAFP preference for combination vaccines.

Background: While much has been published on utilization of antidepressants and associated resource use, surprisingly little information is available on the relationship between a change in antidepressant agent and health care utilization. Given that many patients will not respond to initial therapy (and therefore would be candidates for switching treatment) and the array of antidepressant medications on the market, information on the impact of switching would be beneficial to both providers and policymakers., Objective: To explore patterns of antidepressant drug use and depression-related and all-cause medical costs for patients who switched therapy between 2 drug classes, selective serotonin reuptake inhibitors (SSRIs) and the selective norepinephrine reuptake inhibitor (SNRI) venlafaxine., Methods: Using an administrative claims database of 36 million members from 61 health plans, this retrospective cohort analysis examined patients who had (1) a diagnosis of major depressive disorder (MDD, International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 296.2x for MDD single episode, 296.3x for MDD recurrent episode, 300.4 for dysthymic disorder, and 311 for depressive disorder not elsewhere classified) and (2) a newly prescribed antidepressant during the year 2002. Costs were defined as amounts paid by health plans for all inpatient, outpatient, physician and pharmacy services (i.e., allowed charges after subtraction of member cost-share). Depression-related costs were defined using (1) medical claims with primary diagnosis of depression and (2) pharmacy claims for antidepressants. Using an index date of the first antidepressant claim, 12 months of pre-index and postindex data were available for all eligible patients. Switching was defined as occurring between the SSRIs and venlafaxine (i.e., patients who switched within the SSRI drug class across different SSRIs were treated as non-switchers until they switched to venlafaxine), and there was no minimum or maximum gap in therapy. The SSRIs included fluoxetine, citalopram, sertraline, and paroxetine; the only SNRI on the market at the time was venlafaxine. Multivariate regression analyses determined predictors of switching and factors influencing overall and depression-related costs, while controlling for confounding factors. For the 12-month period following the index date (fixed length of follow-up), the study compared per-patient per-year (PPPY) costs for (1) patients who switched versus those who did not switch and (2) patients with single versus multiple trials of SSRI for the subgroup of patients who switched from an SSRI to venlafaxine. For the time periods before versus after the switch (variable lengths of follow-up), per-patient means and medians of monthly cost averages (with follow-up periods <1 month set to 1 month for 16.5% [n=272] of SSRI-to-venlafaxine switchers and 14.1% [n=103] of venlafaxine-to-SSRI switchers) were calculated for the subgroup of patients who made a switch., Results: A total of 48,950 patients were included in the study, with 43,653 (89.2%) treated first with SSRIs and 5,297 (10.8%) treated first with venlafaxine. Of the initial SSRI users, 1,645 (3.8%) switched to venlafaxine, and of the initial venlafaxine users, 733 (13.8%) switched to an SSRI. Mean (standard deviation [SD]) 12-month total (medical plus pharmacy) depression-related costs in 2002-2003 dollars were 118.0% higher for SSRI switchers ($1,225 [$3,438] vs. $562 [$2,153], P<0.001) and 18.4% higher for venlafaxine switchers ($863 [$1,503] vs. $729 [$1,185], P=0.021) as compared with non-switchers. From the pre-switch to post-switch periods, depression-related mean monthly medical costs declined by 66.4% among switchers from SSRIs ($113 [$912] vs. $38 [$347], P=0.001) and by 61.1% among switchers from venlafaxine ($54 [$299] vs. $21 [$138], P=0.005). Monthly mean depression-related pharmacy costs increased by 62.2% following a switch from an SSRI to venlafaxine (from $45 [$38] to $73 [$62], P<0.001) and declined by 17.3% following a switch from venlafaxine to an SSRI (from $52 [$45] to $43 [$38], P<0.001). After adjustment for multiple covariates including demographic characteristics, 10 selected comorbidities, and physician specialty, general linear models with log-transformed costs as the dependent variables demonstrated significant associations between switching and total costs (both all-cause and depression-related) in both the SSRI and the venlafaxine cohorts., Conclusions: Although relatively few patients switched antidepressant drug classes, patients who made a switch had higher all-cause health care costs and higher depression-related costs than patients who did not switch. Switching drug classes was associated with lower mean monthly depression-related health care costs following the switch. For those patients switching from an SSRI to venlafaxine, mean medical cost reductions offset higher pharmacy costs; for patients switching from venlafaxine to an SSRI, mean medical and pharmacy costs declined.

Objective: To assess the comparative efficacy of fluticasone propionate (FP) and montelukast (MON), using administrative claims for pediatric asthma in a clinical setting., Study Design: This retrospective observational study used the PharMetrics Integrated-Outcomes Database. Children age 4 to 17 years with an ICD-9-CM 493.xx for asthma, therapy with an inhaled corticosteroid in the 12 months before the index medications, and an index claim for FP or MON between January 2001 and December 2003 were studied. FP- and MON-treated children were propensity-matched based on health care utilization. Asthma-related parameters studied included treatment failure, hospitalizations, and total cost of care., Results: The children treated with MON were more likely to experience treatment failure (odds ratio [OR] = 2.55; 95% confidence interval [CI] = 2.19 to 2.96) and to be admitted to the hospital for asthma-related care (OR = 1.99; 95% CI = 1.15 to 3.44) compared with those treated with FP. Furthermore, the children treated with MON incurred significantly higher asthma-related treatment costs compared with those treated with FP (parameter estimate = 0.418; P < .0001)., Conclusions: In children with asthma, treatment with FP is associated with better outcomes and lower cost than treatment with MON.

Background & Aims: The clinical impact of nonadherence to gastroprotective agents (GPAs) coprescribed with anti-inflammatory therapies has not been evaluated. In a large, commercial, managed-care database, we retrospectively characterized the use of GPAs among patients receiving nonselective nonsteroidal anti-inflammatory drugs (ns-NSAIDs) or cyclooxygenase-2-selective inhibitors (coxibs) and determined the impact of nonadherence on the likelihood of gastroduodenal ulcer complications., Methods: Analyses identified the populations of patients with concomitant histamine-2 receptor antagonist or proton pump inhibitor (PPI) therapy and determined adherence with the prescribed therapy with respect to the duration of anti-inflammatory treatment. Multivariate regression analyses modeled the association between adherence with concomitant protective therapy and the likelihood of upper gastrointestinal (GI) complications including peptic ulcer disease, ulcer, and/or upper-GI bleed., Results: Among 144,203 patients newly prescribed anti-inflammatory therapies, 1.8% received concomitant GPA treatment (ns-NSAIDs, 1.4% vs coxibs, 2.6%; P < .0001). The likelihood of GPA use increased with the presence of risk factors: age older than 65 years (odds ratio [OR], 1.40; 95% confidence interval [CI], 1.3-1.5) and prior history of peptic ulcer disease (OR, 2.5; 95% CI, 1.8-3.3), esophagitis/gastroesophageal reflux (OR, 3.8; 95% CI, 3.5-4.1), ulcer/upper-GI bleed (OR, 1.4; 95% CI, 1.2-1.5), or gastritis (OR, 2.5; 95% CI, 2.2-2.8). Of patients receiving concomitant PPI therapy, 68% had adherence rates of 80% or more. A significantly higher risk of upper-GI ulcers/complications was observed in ns-NSAID patients with adherence rates of less than 80% compared with adherence rates of 80% or more (OR, 2.4; 95% CI, 1.0-5.6), but no such relationship was observed among patients who took coxibs., Conclusions: Few patients receive concomitant GPA therapy when prescribed anti-inflammatory treatment, although use increased with the presence of risk factors. Adherence to concomitant therapy is paramount to reducing GI events among ns-NSAID users and educational efforts should be undertaken to promote use of and adherence to GPA therapy among these patients.

Objective: To characterize the diagnosis of anxiety and depression within a large managed care population and to measure the impact of having both of these conditions on treatment patterns, health care utilization, and cost. Further, to compare the impact of having both conditions with having neither or either condition alone., Method: A retrospective, cross-sectional analysis of population-level anxiety-related and depression-related utilization over a 12-month study period was conducted. Data were from the PharMetrics Patient-Centric database, which is composed of medical and pharmaceutical claims for approximately 36 million patients from 61 health plans across the United States. Patients 18 years and older were included as cases in the analysis if they had a diagnosis of depression or anxiety during 2002. Four groups were identified based on the presence of anxiety and/or depression diagnosis: anxiety only, depression only, anxiety and depression, and controls. Controls were matched to the anxiety and depression cohort using a 4:1 ratio, based on patient age, gender, and similarity of health coverage. Cohorts were compared with respect to patient demographics, comorbid diagnoses, medication use, specialist care, utilization of health care services, and treatment costs, using both univariate and multivariate statistics., Results: Significant differences in comorbid diagnoses, medication use, health care utilization, and treatment costs existed between the study groups. Specifically, patients with both anxiety and depression tended to have more somatic complaints such as abdominal pain, malaise, or chest pain than patients with either condition alone or the control group. Antidepressant use was highest among the anxiety and depression cohort, while anxiolytic use was as prevalent in the anxiety and depression cohort as in the anxiety only cohort. Patients in the anxiety only, depression only, or anxiety plus depression groups had a higher number of anxiety- and/or depression-related visits as well as visits not related to depression or anxiety than the control group, with the anxiety and depression cohort incurring the highest utilization of medical services. Similarly, in terms of cost, the disease cohorts incurred significantly higher cost than their control counterparts, with the anxiety and depression cohort incurring higher cost than those with either condition alone, even after accounting for differences in patient characteristics., Conclusions: Combination of anxiety and depression is fairly common in a managed care population as evidenced by diagnosis and treatment. The combination of both diagnoses appears to increase the complexity of these patients with respect to comorbid conditions as well as increases the economic cost to payers.