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Background Guidelines for follow-up after locoregional breast cancer treatment recommend imaging for distant metastases only in the presence of patient signs and/or symptoms. However, guidelines have not been updated to reflect advances in imaging, systemic therapy, or the understanding of biological subtype. We assessed the association between mode of distant recurrence detection and survival. Methods In this observational study, a stage-stratified random sample of women with stage II-III breast cancer in 2006-2007 and followed through 2016 was selected, including up to 10 women from each of 1217 Commission on Cancer facilities (n = 10 076). The explanatory variable was mode of recurrence detection (asymptomatic imaging vs signs and/or symptoms). The outcome was time from initial cancer diagnosis to death. Registrars abstracted scan type, intent (cancer-related vs not, asymptomatic surveillance vs not), and recurrence. Data were merged with each patient’s National Cancer Database record. Results Surveillance imaging detected 23.3% (284 of 1220) of distant recurrences (76.7%, 936 of 1220 by signs and/or symptoms). Based on propensity-weighted multivariable Cox proportional hazards models, patients with asymptomatic imaging compared with sign and/or symptom detected recurrences had a lower risk of death if estrogen receptor (ER) and progesterone receptor (PR) negative, HER2 negative (triple negative; hazard ratio [HR] = 0.73, 95% confidence interval [CI] = 0.54 to 0.99), or HER2 positive (HR = 0.51, 95% CI = 0.33 to 0.80). No association was observed for ER- or PR-positive, HER2-negative (HR = 1.14, 95% CI = 0.91 to 1.44) cancers. Conclusions Recurrence detection by asymptomatic imaging compared with signs and/or symptoms was associated with lower risk of death for triple-negative and HER2-positive, but not ER- or PR-positive, HER2-negative cancers. A randomized trial is warranted to evaluate imaging surveillance for metastases results in these subgroups.

Identifying factors associated with COVID-19 vaccination acceptance among vulnerable groups, including autistic individuals, can increase vaccination rates and support public health. The purpose of this study was to determine differences among autistic adults who reported COVID-19 vaccination acceptance from those who did not. In this study we describe COVID-19 vaccination status and self-reported preferences among autistic adults and identify related factors. Vaccine accepters were more likely to report increased loneliness during COVID-19, lived in more populous counties (p = 0.02), and lived in counties won by President Biden in the 2020 US presidential election (p 0.001). Positive correlations were found between desire to protect others, concern about contracting COVID-19, and trusting vaccine safety (p 0.001). Concern about vaccine safety was common among the vaccine hesitant, while lack of concern about COVID-19 overall was not. Identifying health promotion strategies based on self-reported, lived experiences about COVID-19 among vulnerable groups is key for public health impact.

Background: Patients receiving allogeneic hematopoietic cell transplantation (HCT) have high morbidity and mortality risk, but literature is limited on factors associated with end-of-life (EOL) car...

Background Provider orders for inappropriate advanced imaging, while rarely altering patient management, contribute enough to the strain on available health care resources, and therefore the United States Congress established the Appropriate Use Criteria Program. Objectives To examine whether co-designing clinical decision support (CDS) with referring providers will reduce barriers to adoption and facilitate more appropriate shoulder ultrasound (US) over magnetic resonance imaging (MRI) in diagnosing Veteran shoulder pain, given similar efficacies and only 5% MRI follow-up rate after shoulder US. Methods We used a theory-driven, convergent parallel mixed-methods approach to prospectively (1) determine medical providers' reasons for selecting MRI over US in diagnosing shoulder pain and identify barriers to ordering US, (2) co-design CDS, informed by provider interviews, to prompt appropriate US use, and (3) assess CDS impact on shoulder imaging use. CDS effectiveness in guiding appropriate shoulder imaging was evaluated through monthly monitoring of ordering data at our quaternary care Veterans Hospital. Key outcome measures were appropriate MRI/US use rates and transition to ordering US by both musculoskeletal specialist and generalist providers. We assessed differences in ordering using a generalized estimating equations logistic regression model. We compared continuous measures using mixed effects analysis of variance with log-transformed data. Results During December 2016 to March 2018, 569 (395 MRI, 174 US) shoulder advanced imaging examinations were ordered by 111 providers. CDS “co-designed” in collaboration with providers increased US from 17% (58/335) to 50% (116/234) of all orders (p Conclusion Partnering with medical providers to co-design CDS reduced barriers and prompted appropriate transition to US from MRI for shoulder pain diagnosis, promoting evidence-based practice. This approach can inform the development and implementation of other forms of CDS.

TPS12148 Background: Prior research has shown that monitoring symptoms in advanced cancer patients may provide a survival benefit. Monitoring is a labor-intensive process that requires nursing staff response and visiting a medical office. This may be more challenging in rural areas, given staffing challenges and distances traveled for care. Lower density of supportive care services has been documented in rural as compared to urban settings in Pennsylvania and West Virginia. We have developed a computer tablet-based supportive care program, called Nurse AMIE, and are investigating its use in symptom management among cancer survivors. Our hypothesis is that a tablet-based supportive care program can improve overall survival of advanced cancer patients in rural Pennsylvania and West Virginia. Methods: This randomized controlled trial will recruit 344 patients residing in a rural county or zip code (RUCC 4-9 or RUCA 4-10) in Pennsylvania or West Virginia, who receive treatment for stage III-IV cancer, are 18 years or older, ECOG 0-3, are fluent in written and spoken English, have sufficient vision/hearing to interact with a computer tablet and staff, and have a clinician-defined life expectancy of 6 months or more. Exclusion criteria: patients on active treatment or behavioral or supportive care trials, or with medical or psychiatric conditions that would impair ability to test study hypotheses. Patients will be randomized on a 1:1 basis to receive either Nurse AMIE or a binder with written supportive care materials. Intervention participants will be asked to log into Nurse AMIE daily, where they will interact with a nurse avatar and answer symptom questions (focusing on sleep, fatigue, pain, and distress). They will receive an empathic response to symptoms and be offered evidence based, guideline concordant self-care interventions to address symptoms (including exercise, nutrition, guided meditation, cognitive behavioral therapy videos, and soothing music). Once weekly, patients will answer 21 questions from the Pro-CTCAE survey. All symptom data will be loaded into a dashboard reviewed daily by study staff. Pain or distress scores of 7+ (out of 10) will be communicated to the care team through the EMR. The trial is powered to detect a 19% difference in overall survival at 2 years follow-up (based on Denis et al JAMA 2019). Secondary outcomes include incidence of chemotherapy toxicities, patient reported outcomes, and cost effectiveness. Enrollment is anticipated to start in March 2022. A community advisory board of 12 cancer patients and stakeholders meet on a quarterly basis to provide feedback on study activities (e.g., usability testing, adaptations, overall implementation) and ensure the project responds to the needs and preferences of rural cancer patients in Pennsylvania and West Virginia. NIH R01-CA254659. Clinical trial information: NCT05221606.

Background Cost-effectiveness analysis is an important tool for informing treatment coverage and pricing decisions, yet no consensus exists about what threshold for the incremental cost-effectiveness ratio (ICER) in dollars per quality-adjusted life-year (QALY) gained indicates whether treatments are likely to be cost-effective in the United States. Objective To estimate a U.S. cost-effectiveness threshold based on health opportunity costs. Design Simulation of short-term mortality and morbidity attributable to persons dropping health insurance due to increased health care expenditures passed though as premium increases. Model inputs came from demographic data and the literature; 95% uncertainty intervals (UIs) were constructed. Setting Population-based. Participants Simulated cohort of 100 000 individuals from the U.S. population with direct-purchase private health insurance. Measurements Number of persons dropping insurance coverage, number of additional deaths, and QALYs lost from increased mortality and morbidity, all per increase of $10 000 000 (2019 U.S. dollars) in population treatment cost. Results Per $10 000 000 increase in health care expenditures, 1860 persons (95% UI, 1080 to 2840 persons) were simulated to become uninsured, causing 5 deaths (UI, 3 to 11 deaths), 81 QALYs (UI, 40 to 170 QALYs) lost due to death, and 15 QALYs (UI, 6 to 32 QALYs) lost due to illness; this implies a cost-effectiveness threshold of $104 000 per QALY (UI, $51 000 to $209 000 per QALY) in 2019 U.S. dollars. Given available evidence, there is about 14% probability that the threshold exceeds $150 000 per QALY and about 48% probability that it lies below $100 000 per QALY. Limitations Estimates were sensitive to inputs, most notably the effects of losing insurance on mortality and of premium increases on becoming uninsured. Health opportunity costs may vary by population. Nonhealth opportunity costs were excluded. Conclusion Given current evidence, treatments with ICERs above the range $100 000 to $150 000 per QALY are unlikely to be cost-effective in the United States. Primary funding source None.

Many epidemiological models of the COVID-19 pandemic have focused on preventing deaths. Questions have been raised as to the frailty of those succumbing to the COVID-19 infection. In this paper we employ standard life table methods to illustrate how the potential quality-adjusted life-year (QALY) losses associated with COVID-19 fatalities could be estimated, while adjusting for comorbidities in terms of impact on both mortality and quality of life. Contrary to some suggestions in the media, we find that even relatively elderly patients with high levels of comorbidity can still lose substantial life years and QALYs. The simplicity of the method facilitates straightforward international comparisons as the pandemic evolves. In particular, we compare five different countries and show that differences in the average QALY losses for each COVID-19 fatality is driven mainly by differing age distributions for those dying of the disease.

The primary objective of this study was to predict healthcare cost trajectories for patients with newly diagnosed acute myeloid leukemia (AML) receiving allogeneic hematopoietic cell transplantation (alloHCT), as a function of days since chemotherapy initiation, days relative to alloHCT, and days before death or last date of insurance eligibility (LDE). An exploratory objective examined patients with AML receiving chemotherapy only. We used Optum’s de-identified Clinformatics® Data Mart Database to construct cumulative cost trajectories from chemotherapy initiation to death or LDE (through 31 December 2014) for US patients aged 20–74 years diagnosed between 1 March 2004 and 31 December 2013 (n = 187 alloHCT; n = 253 chemotherapy only). We used generalized additive modeling (GAM) to predict expected trajectories and bootstrapped confidence intervals (CIs) at user-specified intervals conditional on dates of alloHCT and death or LDE relative to chemotherapy initiation. Expected costs (in 2017 values) for a hypothetical patient receiving alloHCT 60 days after chemotherapy initiation and followed for 5 years were $US572,000 (95% CI 517,000–633,000); $US119,000 (95% CI 51,000–192,000); $US102,000 (95% CI 0–285,000); $US79,000 (95% CI 0–233,000), for years 1–4, respectively, and either $US494,000 (95% CI 212,000–799,000) or $US108,000 (95% CI 0–230,000) in year 5, whether the patient died or was lost to follow-up on day 1825, respectively. Rates of cost accrual varied over time since chemotherapy initiation, with accelerations around the time of alloHCT and death. GAM is a potentially useful approach for imputing longitudinal costs relative to treatment initiation and one or more intercurrent, clinical, or terminal events in randomized controlled trials or registries with unrecorded costs or for dynamic decision–analytic models.

PURPOSE: Higher mortality after a breast cancer diagnosis has been observed among women who are obese. We investigated the relationships between body mass index (BMI) and all-cause or breast cancer-specific mortality after a diagnosis of locoregional breast cancer. METHODS: Women diagnosed in 2004 with AJCC Stage I, II, or III breast cancer (n = 5394) were identified from a population-based National Program of Cancer Registries (NPCR) patterns of care study (POC-BP) drawing from registries in seven U.S. states. Differences in overall and breast cancer-specific mortality were investigated using Cox proportional hazards regression models adjusting for demographic and clinical covariates, including age- and stage-based subgroup analyses. RESULTS: In women 70 or older, higher BMI was associated with lower overall mortality (HR for a 5 kg/m(2) difference in BMI = 0.85, 95% CI 0.75–0.95). There was no significant association between BMI and overall mortality for women under 70. BMI was not associated with breast cancer death in the full sample, but among women with Stage I disease; those in the highest BMI category had significantly higher breast cancer mortality (HR for BMI ≥ 35 kg/m(2) vs. 18.5–24.9 kg/m(2) = 4.74, 95% CI 1.78–12.59). CONCLUSIONS: Contrary to our hypothesis, greater BMI was not associated with higher overall mortality. Among older women, BMI was inversely related to overall mortality, with a null association among younger women. Higher BMI was associated with breast cancer mortality among women with Stage I disease, but not among women with more advanced disease.

Background We investigated whether variation in post-acute care (PAC) services could be explained by surgeons discharging clinically similar patients to different PAC destinations, including home health (HH), skilled nursing facilities (SNF), and inpatient rehabilitation (IR). Methods We studied patients having colectomy, pancreatectomy or hepatectomy in the 2008–2011 Nationwide Inpatient Sample. We used propensity matching to determine: 1. Proportion of patients discharged to SNF/IR who could be matched to clinically similar patients discharged with HH. 2. Potential cost savings from greater use of HH. Results 30,843 patients were discharged with HH and 23,172 to SNF or IR. 14,163 (61%) SNF/IR patients could be matched to similar patients discharged with HH. Potential cost savings from increasing use of HH as an alternative to SNF/IR ranged from $2.5-$438 million annually. Conclusions There is considerable potential for reducing variation in PAC use and costs by better understanding how surgeons make decisions about PAC placement. Summary Many surgical patients discharged to inpatient rehabilitation or skilled nursing facilities have similar pre- and postoperative characteristics as individuals discharged home with home health. In order to reduce variation and deliver cost-effective care after discharge, it is important to understand how surgeons make decisions about post-acute care, and to develop processes to identify which type of post-acute care is best for each patient.

Background Assessment of drug costs for cost-effectiveness analyses (CEAs) in the United States is not straightforward because the prices paid for drugs are not publicly available and differ between payers. CEAs have relied on list prices that do not reflect the rebates and discounts known to be associated with these purchases. Objectives To review available cost measures and propose a novel strategy that is transparent, consistent, and applicable to all CEAs taking a US health care sector perspective or a societal payer's perspective. Methods We propose using the National Average Drug Acquisition Cost (NADAC), the Veterans Affairs Federal Supply Schedule (VAFSS), and their midpoint as the upper bound, lower bound, and base case, respectively, to estimate net drug prices for various payers. We compare this approach with wholesale acquisition cost (WAC), the most common measure observed in our literature review. The minimum WAC is used to provide the most conservative comparison. Results Our sample consists of 1436 brand drugs and 1599 generic drugs. On average, the upper bound (NADAC) is 1% and 9.8% lower than the WAC for brand and generic drugs respectively, whereas the lower bound (VAFSS) is 48.3% and 54.2% lower than the WAC. The NADAC is less than the WAC in 89.6% of drug groups. The distributions of these relationships do not show a clear mode and have wide variation. Conclusions Our study suggests that the WAC may be an overestimate for the base case because the minimum WAC is higher than the NADAC for most drugs. Our approach balances uncertainty and lack of data for the cost of pharmaceuticals with the need for a transparent and consistent approach for valid CEAs.

Although not guideline recommended, studies suggest 50% of locoregional breast cancer patients undergo systemic imaging during follow-up, prompting its inclusion as a Choosing Wisely measure of potential overuse. Most studies rely on administrative data that cannot delineate scan intent (prompted by signs/symptoms vs. asymptomatic surveillance). This is a critical gap as intent is the only way to distinguish overuse from appropriate care. Our aim was to assess surveillance systemic imaging post-breast cancer treatment in a national sample accounting for scan intent. A stage-stratified random sample of 10 women with stage II–III breast cancer in 2006–2007 was selected from each of 1217 Commission on Cancer-accredited facilities, for a total of 10,838 patients. Registrars abstracted scan type (computed tomography [CT], non-breast magnetic resonance imaging, bone scan, positron emission tomography/CT) and intent (cancer-related vs. not, asymptomatic surveillance vs. not) from medical records for 5 years post-diagnosis. Data were merged with each patient’s corresponding National Cancer Database record, containing sociodemographic and tumor/treatment information. Of 10,838 women, 30% had one or more, and 12% had two or more, systemic surveillance scans during a 4-year follow-up period. Patients were more likely to receive surveillance imaging in the first follow-up year (lower proportions during subsequent years) and if they had estrogen receptor/progesterone receptor-negative tumors. Locoregional breast cancer patients undergo asymptomatic systemic imaging during follow-up despite guidelines recommending against it, but at lower rates than previously reported. Providers appear to use factors that confer increased recurrence risk to tailor decisions about systemic surveillance imaging, perhaps reflecting limitations of data on which current guidelines are based. ClinicalTrials.gov Identifier: NCT02171078.

Endoscopic ultrasound (EUS) is used for pancreatic adenocarcinoma staging and obtaining a tissue diagnosis. The objective was to determine patterns of preoperative EUS and the impact on downstream treatment.The Surveillance, Epidemiology, and End Results (SEER) Medicare-linked database was used to identify patients with pancreatic adenocarcinoma. The staging period was the first staging procedure within 6 months of surgery until surgery. Logistic regression was used to determine factors associated with preoperative EUS. The main outcome was EUS in the staging period, with secondary outcomes including number of staging tests and time to surgery.2782 patients were included, 56% were treated at an academic hospital (n = 1563). 1204 patients underwent EUS (43.3%). The factors most associated with receipt of EUS were: earlier year of diagnosis, SEER area, and a NCI or academic hospital (all p 0.0001). EUS was associated with a longer time to surgery (17.8 days; p 0.0001), and a higher number of staging tests (40 tests/100 patients; p 0.0001).Factors most associated with receipt of EUS are geographic, temporal, and institutional, rather than clinical/disease factors. EUS is associated with a longer time to surgery and more preoperative testing, and additional study is needed to determine if EUS is overused.

The American College of Cardiology/American Heart Association recommends statins for adults aged 40-75 years with a cardiovascular disease risk factor and a 10-year risk of cardiovascular events of 7.5%-19.9%.To examine the association of county-level social determinant measures of health and composition of health services with use of statin prescriptions under Medicare Part D.We used 2013 Medicare Part D prescriber county-level data to construct 2 measures of statin use: (1) statin beneficiaries ÷ total beneficiaries (prevalence [βA 1 standard deviation (SD) increase in the proportion of African Americans living in a county is associated with a 0.096 SD decrease in adequacy of supply (βRace and ethnicity, income, and distribution of provider types were significantly associated with county-level variation in statin use, despite being unlikely to measure differences in actual medical need. Such variation more likely reflects predisposing and enabling factors potentially affected by social, economic, and public health policy. Tracking variation in county-level statin use associated with these factors could help policymakers assess progress in reducing health care disparities and better target program resources.No funding was received for this work. Karpinski reports employment by Aetna, Anthem, and Ingenio-Rx. Vanness reports unrelated consulting fees from CHEORS, Evidera, BMS, Novartis, and Merck. Look has nothing to disclose.

This letter to the editor comments on the recently published article by Flynn et al. about shared decision making as related to discontinuation of tyrosine kinase inhibitors for chronic myeloid leukemia.

Background The economics of allogeneic hematopoietic cell transplantation (alloHCT) for older patients with acute myeloid leukemia (AML) affects clinical practice and public policy. To assess reimbursement, utilization, and overall survival (OS) up to 1 year post-alloHCT for Medicare beneficiaries aged 65 years or older with AML, a unique merged dataset of Medicare claims and national alloHCT registry data was analyzed. Methods Patients diagnosed with AML undergoing alloHCT from 2010 to 2011 were included for a retrospective cohort analysis with generalized linear model adjustment. One-year post-alloHCT reimbursement included Medicare, secondary payer, and beneficiary copayments (no coinsurance) (inflation adjusted to 2017 dollars). Cost-to-charge ratios were applied to estimate department-specific inpatient costs. Cox proportional hazards regression models were utilized to identify risk factors of 1-year OS post-alloHCT. Results A total of 250 patients met inclusion criteria. Mean total reimbursement was $230 815 (95% confidence interval [CI] = $214 381 to $247 249) 1 year after alloHCT. Pharmacy was the most- costly inpatient service category. Adjusted mean total reimbursement was statistically higher for patients who received cord blood grafts (P = .01), myeloablative conditioning (P Conclusions This merged dataset allowed adjustment for a richer set of patient- and HCT-related characteristics than claims data alone. The finding that nonmyeloablative conditioning was associated with lower reimbursement and improved OS 1 year post-alloHCT warrants further investigation.

Objective: To describe the cost-effectiveness of pembrolizumab plus chemotherapy (carboplatin and paclitaxel or nab-paclitaxel; P + C) in metastatic, squamous, non-small-cell lung cancer (NSCLC) patients in the US. Methods: A model comparing P + C versus C alone is developed utilizing partitioned survival analysis. Primary clinical efficacy, treatment utilization, health utility and safety data are derived from the KEYNOTE-407 trial and projected over 20 years. Costs for drugs and non-drug disease management are also incorporated. Additionally, the cost-effectiveness of P + C vs. pembrolizumab monotherapy (P) is evaluated via an indirect treatment comparison, for patient subgroups with PD-L1 Tumor Proportion Score (TPS) ≥ 50% and 1–49%. Results: Overall, P + C is projected to increase life expectancy by 1.95 years vs. C (3.86 versus 1.91). The resultant ICER is $86,293/QALY. In patients with PD-L1 ≥ 50%, 1–49% and Conclusions: Across all eligible patients, the addition of pembrolizumab to chemotherapy is projected to approximately double life expectancy, yielding an extension to a point not previously seen in metastatic squamous NSCLC. Overall, and within all relevant PD-L1 subgroups, use of P + C yields an ICER below $100,000/QALY, and can be a cost-effective first-line treatment for eligible metastatic squamous NSCLC patients for whom chemotherapy is currently administered. In the PD-L1 ≥ 50% subgroup, additional follow-up within trials of pembrolizumab plus chemotherapy and pembrolizumab monotherapy are needed to better define cost-effectiveness between these comparators.

Every year, as many as 31 million Americans sustain traumatic injuries, leaving survivors with risks of disabilities and health settings with staggering medical costs. Little is known on the societal burden of injuries in terms of medical and out-of-pocket expenditures. Therefore, we used a nationally representative sample to evaluate the association between injuries and health expenditures among a nationally representative US sample.This study used years 2006 to 2010 (Panels 11-14; n = 53,065) of the Medical Expenditure Panel Survey. Each panel was followed up for 2 years. Total expenditures included insurance payments and out-of-pocket costs. Two-part models were constructed to examine differences in annual medical expenditures between injured and noninjured populations controlling for confounding effects.A total of 4,210 individuals (7.9%) reported injuries representing 21.5 million individuals. Injured individuals were more likely to be males, to be white, and to report higher medical expenditures in the second year than the reference population (p0.01). Adjusted analyses showed that reporting any injury was associated with $2,577 (95% confidence interval [CI], $2,049-$3,103) and $186 (95% CI, $142-$230) increase in total and out-of-pocket costs, respectively. While a moderate or severe injury was associated with $4,779 (95% CI, $3,947-$5,610) increase in the average of medical expenditures and $256 (95% CI, $190-$322) increase in out-of-pocket costs adjusting for covariates. Our adjusted national medical cost of injuries was estimated at $56 billion and out-of-pocket cost to be approximately $4 billion.Injuries pose a substantial burden on medical expenditures in the United States. Investment in injury prevention can facilitate reducing medical expenditures and save resources. Prevention programs may use the out-of-pocket findings to highlight injury burden on individual's prosperity and thus facilitate engagement of the public in prevention.Economic and evaluation study, level III.

Purpose To perform a systematic review and meta-analysis of all published studies since 2005 that evaluate the accuracy of magnetic resonance imaging (MRI) for the diagnosis of acute appendicitis in the general population presenting to emergency departments. Materials and Methods All retrospective and prospective studies evaluating the accuracy of MRI to diagnose appendicitis published in English and listed in PubMed, Web of Science, Cinahl Plus, and the Cochrane Library since 2005 were included. Excluded studies were those without an explicitly stated reference standard, with insufficient data to calculate the study outcomes, or if the population enrolled was limited to pregnant women or children. Data were abstracted by one investigator and confirmed by another. Data included the number of true positives, true negatives, false positives, false negatives, number of equivocal cases, type of MRI scanner, type of MRI sequence, and demographic data including study setting and gender distribution. Summary test characteristics were calculated. Forest plots and a summary receiver operator characteristic plot were generated. Results Ten studies met eligibility criteria, representing patients from seven countries. Nine were prospective and two were multicenter studies. A total of 838 subjects were enrolled; 406 (48%) were women. All studies routinely used unenhanced MR images, although two used intravenous contrast-enhancement and three used diffusion-weighted imaging. Using a bivariate random-effects model the summary sensitivity was 96.6% (95% confidence interval [CI]: 92.3%–98.5%) and summary specificity was 95.9% (95% CI: 89.4%–98.4%). Conclusion MRI has a high sensitivity and specificity for the diagnosis of appendicitis, similar to that reported previously for computed tomography. J. Magn. Reson. Imaging 2016;43:1346–1354.

To determine the diagnostic accuracy of an abbreviated, two-sequence MRI protocol using limited pulse sequences for the detection of radiographically occult hip and pelvis fractures in the elderly compared to the complete MRI examination. One hundred and eleven consecutive emergency department patients age 65 or older who had undergone MRI to evaluate for clinically suspected hip fracture after negative radiographs were included in the study. The large field-of-view coronal T1 and STIR sequences were isolated from the complete six-sequence MRI protocol and reviewed independently in a blinded fashion by two musculoskeletal fellowship-trained radiologists who recorded presence or absence of fractures of the proximal femora or pelvis, fracture type, and presence or absence of soft tissue injury. Test accuracy was calculated with 95% confidence intervals and accuracy of fracture classification for the abbreviated protocol was compared to that made on the basis of the full exam. For proximal femoral fractures, the abbreviated protocol had a pooled sensitivity and specificity for the two readers of 100 and 97%, respectively. For pelvic fractures, sensitivity was 92% and specificity was 98%. The kappa coefficient for fracture classification was 0.90 for reader 1 and 0.88 for reader 2, indicating excellent agreement for both readers in fracture classification compared to the classification made based on the complete MRI protocol. An abbreviated MRI protocol that includes only coronal T1 and STIR sequences maintains high sensitivity and specificity for hip and pelvis fracture detection and fracture classification.

The goal of patient-centered outcomes research (PCOR) is to help patients and those who care for them make informed decisions about healthcare. However, the clinical research enterprise has not involved patients, caregivers, and other non-providers routinely in the process of prioritizing, designing and conducting research in hematopoietic cell transplantation (HCT). To address this need, the National Marrow Donor Program (NMDP)/Be The Match® engaged patients, caregivers, researchers and other key stakeholders in a two-year project with the goal of setting a PCOR agenda for the HCT community. Through a collaborative process, we identified six major areas of interest: 1) Patient, Caregiver and Family Education and Support; 2) Emotional, Cognitive and Social Health; 3) Physical Health and Fatigue; 4) Sexual Health and Relationships; 5) Financial Burden; and 6) Models of Survivorship Care Delivery. We then organized into multi-stakeholder Working Groups to identify gaps in knowledge and make priority recommendations for critical research to fill those gaps. Gaps varied by Working Group, but all noted that a historical lack of consistency in measures utilized and patient populations made it difficult to compare outcomes across studies and urged investigators to incorporate uniform measures and homogenous patient groups in future research. Some groups advised that additional pre-emptory work is needed before conducting prospective interventional trials, whereas others felt ready to proceed with comparative clinical effectiveness research studies. This report presents the results of this major initiative, and makes recommendations by Working Group on priority questions for PCOR in HCT.

Introduction Allogeneic hematopoietic cell transplant (HCT) recipients are at a high risk for morbidity and mortality. The literature on quality and intensity of end of life (EOL) care and its association with advance directives and palliative involvement in this population is sparse. Objectives We sought to describe the EOL care in a cohort of allogeneic HCT patients who died and examine its association with advance directives, palliative care involvement, and patient characteristics. Methods A retrospective review of the medical record of patients who had received their allogeneic HCT (n=368) at our institution between 2013 and 2017 and died (n=129) was performed to collect information on place of death, hospital length of stay, number of admissions, intensity of care and palliative/ chaplain referrals. High intensity EOL care was defined as >1 of the following: death in the hospital, invasive procedure in the last week of life, use of mechanical ventilation in the last week of life, change to ‘no resuscitation’ code status in the last 3 days of life, length of stay >14 days in the last hospitalization, and >50% of last hospitalization in ICU. Association between baseline characteristics (age, gender, disease, disease risk, education, race/ ethnicity), presence of a living will and palliative medicine consult with intensity of EOL care was examined by a multivariable logistical model. Results Out of 129 deaths, 83(64%) had received EOL care at our institution and were included in the analysis. Median age of the patients in the cohort was 60 (range 21 to 76) years, 64% were male, 89% were white, 32% had received college or higher education and 66% had private insurance. 59% patients died in hospice (36% in inpatient hospice, and 23% in home hospice) and 40% in the hospital (23% in ICU and 17% on the floor). Figure shows indicators of intense EOL care in patients who died in hospital vs. hospice. Median duration of hospice was 3 (range 1-41) days. 72% had an advance directive on record and 37% were seen by palliative medicine. There was a higher rate of mechanical ventilation (p 1 intensive care indicators. Conclusions There is a high utilization of intensive care and procedures in the last days of life for patients dying in the hospital. Patients with advance directives were more likely to experience a value based EOL care including avoidance of intensive, and ultimately futile, medical care.

INTRODUCTION: More than 60,000 women are diagnosed with ductal carcinoma in situ (DCIS) annually and offered the option of breast conserving surgery (BCS), often including radiation (RT) to reduce local recurrence. Although the incidence of radiation-associated sarcoma (RAS) is low (0.05-0.25% at 10 years), the low mortality associated with DCIS and large number of DCIS diagnoses means that an increasingly large number of women are at risk of RAS. This study sought to weigh the risk of RAS with the benefits of BCS+RT for DCIS. METHODS: A second-order Monte Carlo micro-simulation model of women ages 35 and older with DCIS was constructed. The decision analysis compared harm-benefit ratios of sarcoma-related deaths per breast cancer deaths averted within 20 years of treatment with BCS+RT versus BCS alone. Stratified analyses were performed by age group to account for differential life expectancy. To generate parameter estimates for model inputs, Bayesian network meta-analysis was used to synthesize rates of DCIS and invasive recurrence from clinical trials of BCS+RT and BCS alone using a Weibull specification. Sarcoma incidence was estimated non-parametrically using SEER. Constant hazard rates for breast cancer mortality after invasive recurrence and RAS mortality were estimated from clinical trials. To account for uncertainty, probabilistic sensitivity analysis was conducted using 10,000 Monte Carlo samples and 95% credible intervals (CrI) were constructed for event rates and harm-benefit ratios. RESULTS: The micro-simulation model of an age-distributed cohort demonstrated that 1 in 840 women with DCIS (95%CrI 1:648 to 1:3522) would develop RAS within 20 years after treatment with BCS+RT. Overall, there would be 1 RAS-related death for every 12 breast cancer deaths averted (95%CrI 1:7 to 1:19) by the addition of RT to BCS. Stratified analysis demonstrated that the harm-benefit ratio was higher in women CONCLUSIONS: The risk of developing a RAS following BCS+RT for DCIS should not be overlooked. This may be especially true for women at low risk of recurrence and younger women ( Age-Stratified Incremental Harm-Benefit Ratios for BCS+RT versus BCS AloneAge GroupRAS Deaths: Breast Cancer Deaths Averted* Posterior Median Ratio (95% CrI)Overall1:12 (1:7 to 1:19)35 to 541:10 (1:6 to 1:14 )55 to 741:11 (1:7 to 1:15)75+1:17 (1:9 to 1:24)*Probabilistic sensitivity analysis using 10,000 second-order parameter samples with a 20 year time horizon Citation Format: Marquita R Decker, Joseph F Levy, Lee G Wilke, David J Vanness, Heather B Neuman. Balancing the harms and benefits of radiation therapy for DCIS: A decision analysis examining the risk of radiation-associated sarcoma [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P6-09-06.

The primary aim of this study was to describe healthcare costs and utilization during the first year after a diagnosis of acute myeloid leukemia (AML) for privately insured non-Medicare patients in the United States (US) aged 50-64 years who were treated with either chemotherapy or chemotherapy and allogeneic hematopoietic cell transplantation (alloHCT). MarketScan (Truven Health Analytics) adjudicated total payments for inpatient, outpatient and prescription drug claims from 2007-2011 were used to estimate costs from the health system perspective. Stabilized inverse propensity score weights were constructed using logistic regression to account for differential selection of alloHCT over chemotherapy. Weighted generalized linear models (GLM) adjusted costs and utilization (hospitalizations, inpatient days and outpatient visit-days) for differences in age, sex, diagnosis year, region, insurance plan type, Elixhauser Comorbidity Index (ECI) and 60-day pre-diagnosis costs. Because mortality data were not available, models could not be adjusted for survival times. Among 29,915 patients with a primary diagnosis of AML, a total of 985 patients met inclusion criteria (774 [79%] receiving chemotherapy alone and 211 [21%] alloHCT). Adjusted mean one-year costs were $280,788 for chemotherapy and $544,178 for alloHCT. Patients receiving chemotherapy alone had a mean of 4 hospitalizations, 52.9 inpatient days and 52.4 outpatient visits in the year following AML diagnosis; patients receiving alloHCT had 5 hospitalizations, 92.5 inpatient days and 74.5 outpatient visits. Treating AML in the first year after diagnosis incurs substantial health care costs and utilization with chemotherapy alone and with alloHCT. Our analysis informs health care providers, policy makers and payers so they can better understand treatment costs and utilization for privately-insured patients age 50-64 with AML.

Background We evaluated whether diagnostic thyroidectomy for indeterminate thyroid nodules would be more cost-effective than genetic testing after including the costs of long-term surveillance. Methods We used a Markov decision model to estimate the cost-effectiveness of thyroid lobectomy versus genetic testing (Afirma®) for evaluation of indeterminate (Bethesda 3–4) thyroid nodules. The base case was a 40-year-old woman with a 1-cm indeterminate nodule. Probabilities and estimates of utilities were obtained from the literature. Cost estimates were based on Medicare reimbursements with a 3% discount rate for costs and quality-adjusted life-years. Results During a 5-year period after the diagnosis of indeterminate thyroid nodules, lobectomy was less costly and more effective than Afirma® (lobectomy: $6,100; 4.50 quality-adjusted life- years vs Afirma®: $9,400; 4.47 quality-adjusted life-years). Only in 253 of 10,000 simulations (2.5%) did Afirma® show a net benefit at a cost-effectiveness threshold of $100,000 per quality- adjusted life-years. There was only a 0.3% probability of Afirma® being cost saving and a 14.9% probability of improving quality-adjusted life-years. Conclusions Our base case estimate suggests that diagnostic lobectomy dominates genetic testing as a strategy for ruling out malignancy of indeterminate thyroid nodules. These results, however, were highly sensitive to estimates of utilities after lobectomy and living under surveillance after Afirma®.

Background Randomized clinical trials, particularly for comparative effectiveness research (CER), are frequently criticized for being overly restrictive or untimely for health-care decision making. Purpose Our prospectively designed REsearch in ADAptive methods for Pragmatic Trials (RE-ADAPT) study is a ‘proof of concept’ to stimulate investment in Bayesian adaptive designs for future CER trials. Methods We will assess whether Bayesian adaptive designs offer potential efficiencies in CER by simulating a re-execution of the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study using actual data from ALLHAT. Results We prospectively define seven alternate designs consisting of various combinations of arm dropping, adaptive randomization, and early stopping and describe how these designs will be compared to the original ALLHAT design. We identify the one particular design that would have been executed, which incorporates early stopping and information-based adaptive randomization. Limitations While the simulation realistically emulates patient enrollment, interim analyses, and adaptive changes to design, it cannot incorporate key features like the involvement of data monitoring committee in making decisions about adaptive changes. Conclusion This article describes our analytic approach for RE-ADAPT. The next stage of the project is to conduct the re-execution analyses using the seven prespecified designs and the original ALLHAT data.

Although breast cancer follow-up guidelines emphasize the importance of clinical examinations, prior studies suggest a small fraction of local–regional events occurring after breast conservation are detected by examination alone. Our objective was to examine how local–regional events are detected in a contemporary, national cohort of high-risk breast cancer survivors. A stage-stratified sample of stage II/III breast cancer patients diagnosed in 2006–2007 (n = 11,099) were identified from 1217 facilities within the National Cancer Data Base. Additional data on local–regional and distant breast events, method of event detection, imaging received, and mortality were collected. We further limited the cohort to patients with breast conservation (n = 4854). Summary statistics describe local–regional event rates and detection method. Local–regional events were detected in 5.5 % (n = 265) of patients. Eighty-three percent were ipsilateral or contralateral in-breast events, and 17 % occurred within ipsilateral lymph nodes. Forty-eight percent of local–regional events were detected on asymptomatic breast imaging, 29 % by patients, and 10 % on clinical examination. Overall, 0.5 % of the 4854 patients had a local–regional event detected on examination. Examinations detected a higher proportion of lymph node events (8/45) compared with in-breast events (18/220). No factors were associated with method of event detection. Clinical examinations, as an adjunct to screening mammography, have a modest effect on local–regional event detection. This contradicts current belief that examinations are a critical adjunct to mammographic screening. These findings can help to streamline follow-up care, potentially improving follow-up efficiency and quality.

Purpose MRI is frequently overused. The aim of this study was to analyze shoulder MRI ordering practices within a capitated health care system and explore the potential effects of shoulder ultrasound substitution. Methods We reviewed medical records of 237 consecutive shoulder MRI examinations performed in 2013 at a Department of Veterans Affairs tertiary care hospital. Using advanced imaging guidelines, we assessed ordering appropriateness of shoulder MRI and estimated the proportion of examinations for which musculoskeletal ultrasound could have been an acceptable substitute, had it been available. We then reviewed MRI findings and assessed if ultrasound with preceding radiograph would have been adequate for diagnosis, based on literature reports of shoulder ultrasound diagnostic performance. Results Of the 237 examinations reviewed, 106 (45%) were deemed to be inappropriately ordered, most commonly because of an absent preceding radiograph (n = 98; 92%). Nonorthopedic providers had a higher frequency of inappropriate ordering (44%) relative to orthopedic specialists (17%) ( P = .016; odds ratio = 3.15, 95% confidence interval = 1.24-8.01). In the 237 examinations, ultrasound could have been the indicated advanced imaging modality for 157 (66%), and most of these (133/157; 85%) could have had all relevant pathologies characterized when combined with radiographs. Regardless of indicated modality, ultrasound could have characterized 80% of all cases ordered by nonorthopedic providers and 50% of cases ordered by orthopedic specialists ( P = .007). Conclusions Advanced shoulder imaging is often not ordered according to published appropriateness criteria. While nonorthopedic provider orders were more likely to be inappropriate, inappropriateness persisted among orthopedic providers. A combined ultrasound and radiograph evaluation strategy could accurately characterize shoulder pathologies for most cases.

Background Air leaks after lobectomy are associated with increased length of stay (LOS) and protracted resource utilization. Portable drainage systems (PDS) allow for outpatient management of air leaks in patients otherwise meeting discharge criteria. We evaluated the safety and cost efficiency of a protocol for outpatient management of air leaks with a PDS. Methods We retrospectively assessed patients who underwent lobectomy for non–small-cell lung cancer at our institution between 2004 and 2014. All patients discharged with a PDS for air leak were included in the analysis. The study group was compared to an internally matched cohort of patients undergoing lobectomy for non–small-cell lung cancer managed without the need for outpatient PDS. Study end points included resource utilization, postoperative complications, and readmission. Results A total of 739 lobectomies were performed during the study period, 73 (10%) patients with air leaks were discharged with a PDS after fulfilling postoperative milestones. Shorter LOS was observed in the study group (3.88 ± 2.4 versus 5.68 ± 5.7 d, P = 0.014) without significant differences in 30-d readmission (11.7% versus 9.0%, P = 0.615). PDS-related complications occurred in 6.8% of study patients (5/73), and 2.7% (2/73) required overnight readmission. PDSs were used for 8.30 ± 4.5 outpatient days. A CMS-based cost analysis predicted an overall savings of $686.72/patient (4.9% of Medicare reimbursement for a major thoracic procedure), associated with significantly fewer hospital days and resources used. Conclusions In patients otherwise meeting discharge criteria, outpatient management of air leaks is safe and effective. This strategy is associated with improved efficiency of postoperative care and a modest reduction in hospital costs. This model may be applicable to other thoracic procedures associated with protracted LOS.

Background Methicillin-resistant Staphylococcus aureus (MRSA) complicated skin and skin structure infection (cSSSI) is a prominent infection encountered in hospital and outpatient settings that is associated with high resource use for the health-care system. Objective A decision analytic (DA) model was developed to evaluate the cost-effectiveness analysis (CEA) of linezolid, daptomycin, and vancomycin in MRSA cSSSI. Methods Bayesian methods for evidence synthesis were used to generate efficacy and safety parameters for a DA model using published clinical trials. CEA was done from the US health-care perspective. Efficacy was defined as a successfully treated patient at the test of cure without any adverse reaction. Primary outcome was the incremental cost-effectiveness ratio between linezolid and vancomycin, daptomycin and vancomycin, and linezolid and daptomycin in MRSA cSSSI. Univariate and probabilistic sensitivity analyses were performed to test the robustness of the model. Results The total direct costs of linezolid, daptomycin, and vancomycin were $18,057, $20,698, and $23,671, respectively. The cost-effectiveness ratios for linezolid, daptomycin, and vancomycin were $37,604, $44,086, and $52,663 per successfully treated patient, respectively. Linezolid and daptomycin were dominant strategies compared to vancomycin. However, linezolid was dominant when compared to daptomycin. The model was sensitive to the duration of daptomycin and linezolid treatment. Conclusion Linezolid and daptomycin are potentially cost-effective based on the assumptions of the DA model; however, linezolid appears to be more cost-effective compared to daptomycin and vancomycin for MRSA cSSSIs.

Objectives Compare three commonly used methods to combine the impacts of multiple health conditions on SF-6D health utility scores. Study Design and Setting We used data from the 1998–2004 Medicare Health Outcomes Survey to compare three commonly suggested models of multiple health conditions' impacts on health-related quality of life: additive, minimum, and multiplicative. We modeled SF-6D scores using information about 15 health conditions, both unadjusted and adjusted for age, sex, education, and income. Model performance was assessed using mean squared error, mean predictive error by number of health conditions, and mean predictive error for groups with specific combinations of health conditions. Results Ninety-five thousand one hundred ninety-five observations were used for model estimation, and 94,794 observations were used for model testing. The adjusted models always had better performance than the unadjusted models. The multiplicative model showed smaller mean predictive error than the other models in both those younger than 65 years and those 65 years and older. Mean predictive error for the multiplicative model was generally within the minimally important difference of the SF-6D. Conclusion All tested models are imperfect in these Medicare data, but the multiplicative model performed best.

This study asked whether latent class modeling methods and multiple ratings of the same cases might permit quantification of the accuracy of forensic assessments. Five evaluators examined 156 redacted court reports concerning criminal defendants who had undergone hospitalization for evaluation or restoration of their adjudicative competence. Evaluators rated each defendant's Dusky-defined competence to stand trial on a five-point scale as well as each defendant's understanding of, appreciation of, and reasoning about criminal proceedings. Having multiple ratings per defendant made it possible to estimate accuracy parameters using maximum likelihood and Bayesian approaches, despite the absence of any "gold standard" for the defendants' true competence status. Evaluators appeared to be very accurate, though this finding should be viewed with caution.

Purpose: To evaluate the frequency and estimated costs of additional diagnostic workup for extracolonic findings detected at computed tomographic (CT) colonography in a large screening cohort. Materials and Methods: This retrospective HIPAA-compliant study, which had institutional review board approval, evaluated extracolonic findings in 2195 consecutive asymptomatic adults (1199 women, 996 men; age range, 40–90 years; mean age, 58.0 years ± 8.1 [standard deviation]) undergoing low-dose CT colonographic screening performed without contrast material at a single institution over a 20-month period. All diagnostic workups generated because of extracolonic findings were reviewed. Associated costs were estimated by using 2006 Medicare average reimbursement. Testing for statistical significance was performed by using the χ2 and t tests. Results: Further diagnostic workup for unsuspected extracolonic findings was performed in 133 (6.1%) of 2195 patients, including 18 patients in whom additional workup was not rec...

Background The aim of this study was to estimate the cost-effectiveness of injectable extended-release naltrexone (XR-NTX) compared with methadone maintenance and buprenorphine maintenance treatment (MMT and BMT, respectively) for adult males enrolled in treatment for opioid dependence in the United States from the perspective of state-level addiction treatment payers. Methods A Markov model with daily time cycles was used to estimate the incremental cost per opioid-free day in a simulated cohort of adult males aged 18–65 over a 6-month period from the state health program perspective. Results XR-NTX is predicted to be more effective and more costly than methadone or buprenorphine in our target population, with an incremental cost per opioid-free day gained relative to the next-most effective treatment (MMT) of $72. The cost-effectiveness of XR-NTX relative to MMT was driven by its effectiveness in deterring opioid use while receiving treatment. Conclusions XR-NTX is a cost-effective medication for treating opioid dependence if state addiction treatment payers are willing to pay at least $72 per opioid-free day.

There is a concern regarding the risk of occult leiomyosarcomas found at surgery for presumed benign fibroids. We sought to produce a comprehensive review of published data addressing this issue and provide high-quality prevalence estimates for clinical practice and future research. A comprehensive literature search using the PubMed/MEDLINE database and the Cochrane Library was performed. Inclusion criteria were human studies, peer-reviewed, with original data, involving cases for surgery in which fibroid-related indications were the primary reason for surgery, and histopathology was provided. Candidate studies (4864) were found; 3844 were excluded after review of the abstract. The remaining 1020 manuscripts were reviewed in their entirety, and 133 were included in the Bayesian binomial random effect meta-analysis. The estimated rate of leiomyosarcoma was 0.51 per 1000 procedures (95 % credible interval (CrI) 0.16–0.98) or approximately 1 in 2000. Restricting the meta-analysis to the 64 prospective studies resulted in a substantially lower estimate of 0.12 leiomyosarcomas per 1000 procedures (95 % CrI

PURPOSE We wanted to identify risk factors for persistently high use of primary care. METHODS We analyzed outpatient office visits to practitioners in family medicine, general internal medicine, general pediatrics, and obstetrics for 1997–1999 among patients in a small Midwestern city covered by a fee-for-service insurance plan with no co-payments for physician visits and no requirement for referral to specialty care. Logistic regression was used to predict which patients with 10 or more primary care visits in 1997 would repeat high use in 1998 based on demographic and diagnostic categories (adjusted clinical groups [ACGs]). A confirmatory data set (high primary care use in 1998 persistent into 1999) was used to evaluate the model. RESULTS Two percent of the 54,074 patients had 10 or more primary care visits in 1997, and of these, almost 19% had 10 or more visits in the next year. Among adults, 4 ambulatory diagnosis groups (ADGs) were simultaneously positive predictors of repeated high primary care visits: unstable chronic medical conditions, see and reassure conditions, minor time-limited psychosocial conditions, and minor signs and symptoms. Meanwhile, pregnancy was negatively associated. The area under the receiver operating characteristic (ROC) curve was 0.794 for adults in the developmental data set and 0.752 in the confirmatory data set, indicating a moderately accurate assessment. A satisfactory model was not developed for pediatric patients. CONCLUSIONS Many persistently high primary care users appear to be overserviced but underserved, with underlying problems not addressed by a medical approach. Some may benefit from psychosocial support, whereas others may be good candidates for disease management interventions.

Simulations play an increasingly important role in the evaluation of osteoporosis interventions. Existing evaluations have been based on "reduced-form" cohort simulations that do not reflect the complexity and heterogeneity of osteoporosis and its outcomes. Such simplified models offer parsimony and ease of use, but they also are limited in their ability to explain and extrapolate outcomes in a way that is most useful for both clinical and health policy decision makers. Alternatively, evaluations could be based on "structural" microsimulations, which explicitly model the underlying biology of osteoporosis at the individual level. The structural approach presents technical challenges, including the need to obtain more-detailed data and the requirement that underlying biological models be validated. However, evaluations based on structural microsimulation may ultimately provide substantially more useful information, resulting in improved decision making.

Objective To determine factors that influence clinicians' decisions to treat subclinical hypothyroidism. Patients and Methods We studied patients living within 120 miles of our institution in Rochester, Minn, whose serum thyrotropin value was between 5.1 and 10.0 mIU/L from January 1, 1995, through December 31, 1996. Exclusion criteria were history of thyroid disease or prior abnormal thyrotropin level and fewer than 5 follow-up visits or fewer than 2 follow-up thyrotropin measurements. Of the 2655 patients in this cohort, only 55% (1466) had measurement of thyroid microsomal antibodies (TMAb). From this group, records of 539 patients were selected randomly according to antibody status (238 with positive, 199 with negative, and 102 with no TMAb measurement). After exclusion of patients receiving thyroxine replacement and other medications affecting thyroid function, patients with postpartum thyroiditis, and patients in the intensive care unit, data from 450 patients were analyzed. Results Thyroxine therapy was prescribed for 39% of the patients with thyrotropin levels between 5.1 and 10.0 mIU/L. In multivariate analysis, TMAb status (P P 4 ) (P=.03) were the strongest predictors for the decision to treat. Fifty-nine percent of the patients with positive TMAb were treated compared with 24% of those with negative TMAb and 30% of those who did not have a TMAb test. The mean thyrotropin level in the treated group was 7.1 mIU/L compared with 6.3 mIU/L in the untreated group. The mean FT 4 level was 1.08 ng/dL in the treated group who had this measured compared with 1.16 ng/dL in the untreated group. Treated patients were younger than untreated patients (56.5 years vs 60.6 years), and the proportion of female patients was higher in the treated group compared with the untreated group (75.8% vs 65.2%); however, neither of these differences was significant after correction for the multiple comparisons. In multivariate analysis neither age nor sex was a significant predictor of treatment, but in the subgroup comparison, patients aged 31 to 50 years were twice as likely to be treated compared with those aged 61 to 80 years. Conclusion Among patients with serum thyrotropin levels of 5.1 to 10.0 mIU/L, those with positive TMAb values, those with higher thyrotropin values, and those with lower FT 4 values were more likely to receive thyroxine therapy. Younger patients were more likely to be treated than older patients.

Background & Aims: To assess the prevalence and spectrum of extracolonic findings in a screening population undergoing computed tomography colonography (CTC), and to evaluate the short-term direct medical costs incurred from subsequent radiologic follow-up evaluation. Methods: Six hundred and eighty-one asymptomatic patients undergoing colonoscopy screening consented to a CTC examination. Extracolonic CT findings were classified into high, medium, and low importance. Clinical and radiologic follow-up, missed lesions, and outcomes were assessed by chart review (time interval, 410-1513 days; median, 913 days). Short-term direct medical costs of radiologic follow-up were determined based on Medicare 2002 reimbursement rates. Results: Extracolonic findings were found commonly. These were categorized as high clinical importance in 71 (10%) individuals, as medium importance in 183 individuals (27%), and as low importance in 341 individuals (50%). Subsequent medical or surgical interventions resulted from these findings in 9 of the 681 patients (1.3%). Costs of subsequent radiologic follow-up studies were calculated as $23,380.59 (average added costs per CTC examination $34.33). Conclusions: CTC commonly detects extracolonic findings that can be considered clinically important when applied to an asymptomatic screening population. Although such incidental findings add benefit to the screening intervention, moderate incremental costs are incurred based on additional radiologic procedures generated during short-term follow-up.

The objective of this study was to conduct an economic evaluation of rofecoxib and celecoxib compared with high-dose acetaminophen or ibuprofen with and without misoprostol for patients with symptomatic knee osteoarthritis (OA).A decision analysis model was designed over 6 months using two measures of effectiveness: 1) number of upper gastrointestinal (GI) adverse events averted; and 2) number of patients who achieved perceptible pain relief. Separate analyses were conducted for all patients and for those who did not respond to acetaminophen. Outcome probabilities were obtained from a comprehensive review of randomized controlled trials and observational studies. Costs were derived from actual resource utilization of OA patients.In terms of averting GI events, acetaminophen dominates the other options for an average risk patient population. For patients who did not respond to acetaminophen, rofecoxib had the lowest incremental cost-effectiveness ratio (ICER) per GI event avoided (32,000 US dollars) relative to ibuprofen. In terms of pain control, ibuprofen had an ICER of 610.77 US dollars per additional patient achieving minimal perceptible clinical improvement (MPCI) relative to acetaminophen, while rofecoxib had an ICER of 12,000 US dollars relative to ibuprofen. For patients who did not respond to acetaminophen and who are at high risk of developing an adverse GI event, rofecoxib dominates ibuprofen as the preferred alternative for both measures of effectiveness. One-way, two-way, and probabilistic sensitivity analyses established that these results were generally robust.Our results suggest that for average-risk knee OA patients, acetaminophen dominates the other therapies in terms of cost per GI event averted. In terms of pain relief, cost-effectiveness acceptability curves indicate that if one values pain relief below 275 US dollars per patient achieving MPCI, acetaminophen is the therapy most likely to be optimal; between 275 US dollars and 14,150 US dollars, ibuprofen is most likely to be optimal; and above 14,150 US dollars, rofecoxib is most likely to be optimal.

This paper demonstrates the usefulness of combining simulation with Bayesian estimation methods in analysis of cost-effectiveness data collected alongside a clinical trial. Specifically, we use Markov Chain Monte Carlo (MCMC) to estimate a system of generalized linear models relating costs and outcomes to a disease process affected by treatment under alternative therapies. The MCMC draws are used as parameters in simulations which yield inference about the relative cost-effectiveness of the novel therapy under a variety of scenarios. Total parametric uncertainty is assessed directly by examining the joint distribution of simulated average incremental cost and effectiveness. The approach allows flexibility in assessing treatment in various counterfactual premises and quantifies the global effect of parametric uncertainty on a decision-maker's confidence in adopting one therapy over the other.