The association of major adverse limb events and combination stent and atherectomy in patients undergoing revascularization for lower extremity peripheral artery disease.

BACKGROUND: The effectiveness of combined atherectomy and stenting relative to use of each procedure alone for the treatment of lower extremity peripheral artery disease has not been evaluated. AIMS: The objective of this study was to evaluate the short- and long-term major adverse limb event (MALE) following the receipt of stenting, atherectomy, and the combination of stent and atherectomy. METHODS: A retrospective cohort of patients undergoing atherectomy, stent, and combination stent atherectomy for lower extremity peripheral artery disease was derived from the Vascular Quality Initiative (VQI) data set. The primary outcome was MALE and was assessed in the short-term and long-term. Short-term MALE was assessed immediately following the procedure to discharge and estimated using logistic regression. Long-term MALE was assessed after discharge to end of follow-up and estimated using the Fine-Gray subdistribution hazard model. RESULTS: Among the 46,108 included patients, 6896 (14.95%) underwent atherectomy alone, 35,774 (77.59%) received a stent, and 3438 (7.5%) underwent a combination of stenting and atherectomy. The adjusted model indicated a significantly higher odds of short-term MALE in the atherectomy group (OR = 1.35; 95% confidence interval [CI]:1.16-1.57), and not significantly different odds (OR = 0.93; 95% CI:0.77-1.13) in the combination stent and atherectomy group when compared to stenting alone. With regard to long-term MALE, the model indicated that the likelihood of experiencing the outcome was slightly lower (HR = 0.90; 95% CI:0.82-0.98) in the atherectomy group, and not significantly different (HR = 0.92; 95% CI:0.82-1.04) in the combination stent and atherectomy group when compared to the stent group. CONCLUSIONS: Patients in the VQI data set who received combination stenting and atherectomy did not experience significantly different rates of MALE when compared with stenting alone. It is crucial to consider and further evaluate the influence of anatomical characteristics on treatment strategies and potential differential effects of comorbidities and other demographic factors on the short and long-term MALE risks.

Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: Updated reporting guidance for health economic evaluations.

Health economic evaluations are comparative analyses of alternative courses of action in terms of their costs and consequences. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement, published in 2013, was created to ensure health economic evaluations are identifiable, interpretable, and useful for decision making. It was intended as guidance to help authors report accurately which health interventions were being compared and in what context, how the evaluation was undertaken, what the findings were, and other details that may aid readers and reviewers in interpretation and use of the study. The new CHEERS 2022 statement replaces previous CHEERS reporting guidance. It reflects the need for guidance that can be more easily applied to all types of health economic evaluation, new methods and developments in the field, as well as the increased role of stakeholder involvement including patients and the public. It is also broadly applicable to any form of intervention intended to improve the health of individuals or the population, whether simple or complex, and without regard to context (such as health care, public health, education, social care, etc). This summary article presents the new CHEERS 2022 28-item checklist and recommendations for each item. The CHEERS 2022 statement is primarily intended for researchers reporting economic evaluations for peer reviewed journals as well as the peer reviewers and editors assessing them for publication. However, we anticipate familiarity with reporting requirements will be useful for analysts when planning studies. It may also be useful for health technology assessment bodies seeking guidance on reporting, as there is an increasing emphasis on transparency in decision making.

Safety of Antidepressant Classes Used Following Traumatic Brain Injury Among Medicare Beneficiaries: A Retrospective Cohort Study.

OBJECTIVE: There is poor evidence supporting the use of any pharmacologic treatments for neuropsychiatric disorders following traumatic brain injury (TBI), especially among older adults. Informed by our recent characterization of psychotropic medication use among Medicare beneficiaries with TBI, the objective of this study was to compare the risk of several adverse events associated with use of the three most commonly used classes of antidepressants following TBI in this population. METHODS: We conducted a retrospective cohort study using administrative claims data from US Medicare beneficiaries hospitalized with TBI between 2006 and 2010 (n = 30,886). We assessed monthly selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), and tricyclic antidepressant (TCA) use. We identified adverse events associated with these drug classes that were available in administrative claims data from studies in TBI and non-TBI populations: seizures, hemorrhagic stroke, ischemic stroke, gastrointestinal bleed, hyponatremia, and fractures. We made comparisons between antidepressant classes to assess excess risk of each adverse event using discrete time analysis and controlling for potential confounders. RESULTS: SSRIs were the most commonly used of the antidepressant classes, followed by SNRIs and TCAs. We observed a total of 23,021 adverse events. Ischemic stroke was the most frequent (8296 events). Hemorrhagic stroke (1706 events) and seizures (1841) were least often observed. Compared with TCAs, SSRI use was associated with an increased risk of hemorrhagic stroke (risk ratio 2.47; 95% confidence interval 1.30-4.70). No other antidepressant class comparisons were associated with increased risk of adverse events. CONCLUSION: Compared with SSRIs, use of SNRIs and TCAs following hospitalization for TBI among Medicare beneficiaries was not associated with an increased risk of any of the studied adverse events. Compared to TCAs, SSRI use was associated with increased risk of hemorrhagic stroke. This information may help guide patients and prescribers in selecting antidepressants for older adults following TBI.

Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.

PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations. RESULTS: The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. CONCLUSION: The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.

Bridging the divide: building infrastructure to support community-academic partnerships and improve capacity to conduct patient-centered outcomes research.

For research to be useful, trustworthy, and ultimately lead to greater dissemination of findings to patients and communities, it is important to train and mentor academic researchers to meaningfully engage community members in patient-centered outcomes research (PCOR). Thus, it is necessary for research institutions to strengthen their underlying infrastructure to support PCOR. PATIENTS-PATient-centered Involvement in Evaluating effectiveNess of TreatmentS-at the University of Maryland, Baltimore, focuses on improving PCOR methods and addressing health disparities. It relies on evidence-based engagement methods to sustain and leverage innovative partnerships so patients, health care providers, and academic partners are motivated to participate in the conduct and dissemination of PCOR. Program components address training needs, bi-directional engagement, cultural competency, and dissemination and implementation. Activities (guided by community representatives, leadership from university schools, patient advocates, and PCOR experts) include providing resources, conducting PCOR projects, engaging community members, and disseminating PCOR findings. With its emphasis on the broad range of PCOR topics and methods, and through fostering sustainable relationships with community members and researchers, PATIENTS has successfully cultivated bi-directional partnerships and provided operational and scientific support for a new generation of skilled PCOR researchers. Early evidence of effectiveness includes progress in training and mentoring students and investigators, an increase in submission of PCOR proposals, and community-informed strategies for dissemination. Programs such as PATIENTS reinforce the value of bridging the traditional divide between academia and communities to support patient- and community-engaged dissemination and implementation research and foster sustainable PCOR infrastructure.

Health Ministry and Activities in African American Faith-Based Organizations: A Qualitative Examination of Facilitators, Barriers, and Use of Technology.

African American faith-based organizations (FBOs) play an important role in addressing health disparities. Increasingly, churches offer health fairs, screenings, or education through health ministries. However, little is known about linking these organizations with evidence-based interventions (EBIs) developed by research. This study explored 1) factors that facilitate or impede health ministry activities, including the adoption of EBIs, and 2) opportunities to use technology to support/enhance the capacity of FBOs to sustain health-related activities. We conducted 18 key informant interviews with African American pastors and FBO leaders and six focus groups with members. A popular health ministry strategy was distribution of print materials. There was limited awareness of EBIs and how to access them. Challenges included maintaining qualified volunteers, financial resources, and technical assistance needs. Participants used technology and social media but older adults did so less often. Findings have implications for dissemination/implementation research in FBOs, in relation to the translational continuum.

Risk of skeletal related events among elderly prostate cancer patients by site of metastasis at diagnosis.

The purpose of this study was to estimate the risk of developing skeletal-related events (SREs) based on site of metastasis at diagnosis and identify other predictors of developing SREs among metastatic prostate cancer patients. We conducted a retrospective cohort study using linked SEER (Surveillance, Epidemiology, and End Results) and Medicare data and identified men over the age of 65 with incident metastatic prostate cancer diagnosed during 2005-2009. SREs included radiation (RAD), pathological fractures (PF), bone surgery (BS), and spinal cord compression (SCC). The association between site of metastasis at diagnosis and SRE was examined using a Cox proportional hazards model that accounts for death as a competing risk. Among 4404 men (median age: 79 years) with incident metastatic prostate cancer, 44% experienced SREs at a median of 9.6 months post diagnosis. Compared to bone metastasis only, our model showed that patients were significantly less likely to develop SREs if they had LN-only metastasis at diagnosis (Sub-Hazard Ratio [SHR] 0.56; 95% Confidence Interval [CI]: 0.43-0.72) or unknown site of metastasis (SHR: 0.79; CI: 0.64-0.97). Other predictors of reduced SRE risk were age 80+ years (SHR: 0.83; CI: 0.75-0.91), non-Hispanic Black (SHR: 0.77; CI: 0.65-0.90), or being diagnosed in year 2009 (SHR: 0.85; CI: 0.72-0.99). Patients were significantly more likely to develop SREs if they received androgen deprivation therapy (SHR: 1.73; CI: 1.48-2.02) or had Gleason score 8-10 disease (SHR: 0.79; CI: 0.64-0.97). Compared to patients who present with bone metastasis only at diagnosis, patients presenting with other metastatic sites have similar risk of developing SREs, with the exception of those presenting with lymph node only metastasis who have a significantly reduced risk of SREs.

Cardiovascular event-free survival after adjuvant radiation therapy in breast cancer patients stratified by cardiovascular risk.

The objective of this study was to estimate the risk of a cardiovascular event or death associated with modern radiation in a population of elderly female breast cancer patients with varying baseline cardiovascular risk. The data used for this analysis are from the linked Surveillance, Epidemiology, and End-Results (SEER)-Medicare database. The retrospective cohort study included women aged 66 years and older with stage 0-III breast cancer diagnosed between 2000 and 2005. Women were grouped as low, intermediate, or high cardiovascular risk based on the presence of certain clinical diagnoses. The risk for the combined outcome of a hospitalization for a cardiovascular event or death within 6 months and 24 months of diagnosis was estimated using a multivariable Cox model. The median follow-up time was 24 months. Among the 91,612 women with American Joint Committee on Cancer (AJCC) stage 0-III breast cancer: 39,555 (43.2%) were treated with radiation therapy and 52,057 (56.8%) were not. The receipt of radiation therapy in the first 6 months was associated with a statistically significant increased risk for the combined outcome in women categorized as high risk (HR = 1.510; 95% CI, 1.396-1.634) or intermediate risk (HR = 1.415; 95% CI, 1.188-1.686) but not low risk (HR = 1.027; 95% CI, 0.798-1.321). Women with a prior medical history of cardiovascular disease treated with radiation therapy are at increased risk for an event and should be monitored for at least 6 months following treatment with radiation therapy.

Guidance Document: Global Pharmacoeconomic Model Adaption Strategies.

OBJECTIVE: The purpose of this guidance was to assist in the adaptation of pharmacoeconomic models originally developed in one country and intended for use in another. The intent was to produce user-friendly recommendations and a checklist for adapting a global model to treat a specific disease state. This guidance will allow model developers to tailor existing models so that they are "locally applicable," while maintaining the scientific integrity of the original pharmacoeconomic model and will benefit formulary decision makers and other stakeholders involved in evaluating pharmacoeconomic studies. METHODS: A working group of experts from various countries participated in the Global Pharmacoeconomic Model Guidance development to discuss the adaptation of pharmacoeconomic models. A systematic review of studies adapting pharmacoeconomic models and translation across countries was conducted and recommendations were made for adaptation. The working group interviewed internal and external stakeholders to solicit best practices for model adaptation and developed a draft set of key principles and general recommendations for global adaptation. RESULTS: The working group provided a set of 16 recommendations for adapting pharmacoeconomic models for local decision makers. The recommendations span various aspects of estimating or modeling both the costs and effectiveness of pharmacoeconomic models as well as guidance for ensuring local acceptability. CONCLUSIONS: These recommendations and the related principles not only will provide pharmacoeconomic models that are meaningful to local decision makers but also will improve the consistency and credibility of pharmacoeconomic model adaptations. The guidance may also help those who will build the original models to design them with the flexibility to allow pharmacoeconomic model adaptations as described in this document.

Transarterial chemoembolization treatment: association between multiple treatments, cumulative expenditures, and survival.

OBJECTIVES: To examine cumulative survival and Medicaid-paid expenses associated with multiple courses of transarterial chemoembolization (TACE) as primary treatment for hepatocellular carcinoma (HCC). METHODS: Medicare enrollees diagnosed with primary HCC from 2000 to 2007, ever treated with TACE, but not transplant/resection, followed through 2009 by using the Surveillance, Epidemiology and End-Results Program and linked Medicare databases. Cumulative all-cause/HCC-related survival was estimated by using multivariate Cox proportional hazards models stratified by the total number of TACE treatments. Multivariate weighted Cox regressions estimated the average risk of mortality faced with nonproportional hazards. Lin's inverse probability-weighted least squares regression method estimated cumulative Medicare expenditures adjusted for censoring and covariates. RESULTS: Of 1228 patients, 34% were stage 1, 16% stage 2, 19% stage 3, 6% stage 4, and 26% unstaged. About 44% were aged 65 to 75 years, 69% were men, and 72% were Caucasian. Over half (57%) of the patients received one course, 24% two, 11% three, and 8% four courses of TACE. One-course patients incurred an average $74,788 (95% confidence interval [CI] $71,890-$77,686), two-course patients $101,126 (95% CI $94,395-$107,856), three-course patients $111,776 (95% CI $101,931-$121,621), and four-plus-course patients $148,878 (95% CI $136,346-$161,409). One-course patients lived (all-cause) an average 1.86 (95% CI 1.82-1.90), two-course patients 2.09 (95% CI 2.05-2.13), three-course patients 2.81 (95% CI 2.66-2.97), and four-plus-course patients 3.06 (95% CI 2.95-3.18) years after diagnosis. Average risk of all-cause mortality was not significantly different between one/two courses or three/four-plus courses. CONCLUSIONS: Cumulative Medicare expenditures nearly doubled from one-course to four-plus-course patients. On average, four-plus-course patients lived over one more year than did one-course patients. Physician/patient decisions should be balanced with consideration of efficient use of limited resources, but payer's intervention in physician discretion may not be important in this setting.

Social networks help control hypertension.

Cardiovascular health disparities continue to pose a major public health problem. The authors evaluated the effect of education administered within social networks on the improvement of hypertension in 248 African Americans compared with historical controls. Patients formed clusters with peers and attended monthly hypertension education sessions. The authors assessed the likelihood of reaching goal below predefined systolic blood pressure (SBP) and diastolic blood pressure (DBP) thresholds as well as the absolute reduction in SBP and DBP, controlling for diabetes, smoking, baseline hypertension, and demographics. The intervention group was more likely to have ever reached treatment goal at 12-month follow-up (odds ratio, 1.72; P=.11). At 18-month follow-up, the Maryland Cardiovascular Disease Promotion Program group had a statistically significant larger drop in SBP (-4.82 mm Hg, P<.0001) and DBP (-3.37 mm Hg, P=.01) than the control group. The clustering of patients in social networks around hypertension education has a positive impact on the management of hypertension in minority populations and may help address cardiovascular health disparities.

Cost-effectiveness of cytochrome P450 2C19 genotype screening for selection of antiplatelet therapy with clopidogrel or prasugrel.

STUDY OBJECTIVE: To estimate the cost-effectiveness of genotype-guided selection of antiplatelet therapy compared with selecting clopidogrel or prasugrel irrespective of genotype. DESIGN: Decision model based on event occurrence in the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction (TRITON-TIMI) 38. PATIENTS: Simulated cohort of patients with acute coronary syndrome scheduled to undergo percutaneous coronary intervention (PCI), consisting of three arms: those receiving genotype-guided antiplatelet therapy with clopidogrel or prasugrel, those receiving clopidogrel regardless of genotype, and those receiving prasugrel regardless of genotype. MEASUREMENTS AND MAIN RESULTS: All three arms of the model incorporated the probability that patients would experience a cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke), a bleeding event (major or minor bleeding), or no event while receiving antiplatelet therapy during the 15 months after the scheduled PCI. The cytochrome P450 (CYP) 2C19 genotype determined antiplatelet drug selection in the genotyping group. Cost-effectiveness was expressed as the incremental cost-effectiveness ratio (ICER) for each event avoided in the genotype-guided therapy arm versus the other two arms. Genotype-guided antiplatelet therapy was dominant, or more effective and less costly, when compared with the selection of clopidogrel (ICER -$6760 [95% confidence interval (CI) -$6720 to -$6790]) or prasugrel (ICER -$11,710 [95% CI -$11,480 to -$11,950]) for all patients without regard to genotype. Genotype-guided therapy that included generic clopidogrel was dominant to prasugrel for all patients (ICER -$27,160 [95% CI -$27,890 to -$26,420]). Cost savings were not evident when genotype-guided therapy that included generic clopidogrel was compared with generic clopidogrel for all patients (ICER $2300 [95% CI $2290 to $2320]). [Correction added after online publication 12-Mar-2012: In the previous sentence -$2300 has been corrected as $2300.]. CONCLUSION: Genotype-guided antiplatelet therapy selection may be more cost-effective and may provide more clinical value due to fewer adverse outcomes.

Cost-effectiveness analysis of linezolid compared with vancomycin for the treatment of nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus.

OBJECTIVE: This study compared the cost-effectiveness of linezolid and vancomycin in the treatment of patients with nosocomial pneumonia (NP) caused by methicillin-resistant Staphylococcus aureus (MRSA). METHODS: A retrospective decision-analytic model was applied to pooled data from 2 prospective, randomized, controlled, double-blind studies, and claims data from a large health plan (3.3 million members) located in the Mid-Atlantic region. Using hospital claims for patients in the health plan with suspected NP, we then determined their daily billed (submitted) hospital charges for 4 mutually exclusive potential health outcomes of linezolid or vancomycin treatment: survival with bacteremia, survival without bacteremia, nonsurvival with bacteremia, and nonsurvival without bacteremia. To generate the expected total daily billed hospital charge for each drug-treatment group, we weighted the determined daily billed hospital charges by the probabilities of each outcome developing in each treatment arm, as derived from the clinical-trial data. Drug acquisition costs were then incorporated, and the difference in expected total costs relative to the difference in rates of survival between the linezolid and vancomycin arms was used to calculate the incremental cost-effectiveness ratio (ICER) for linezolid. RESULTS: Costs were higher for nonsurviving patients compared with surviving patients. Estimated median daily billed treatment charges were $2888 for linezolid and $2993 for vancomycin. Based on Monte Carlo simulations, the respective 95% CIs were $2671 to $3106 and $2615 to $3372. Using mean treatment durations of 11.3 and 10.7 days, respectively, we obtained expected total hospitalization charges of $32,636 for linezolid treatment (95% CI, $30,182-$35,098), compared with $32,024 for vancomycin treatment (95% CI, $27,978-$36,078). The ICER for linezolid per life saved was $3600. CONCLUSIONS: The higher acquisition cost of linezolid was almost completely offset by improved survival and a reduction in health care costs associated with improved survival. As a result, linezolid was almost cost-neutral compared with vancomycin in the treatment of NP caused by MRSA.

Recruitment and participation in clinical trials: socio-demographic, rural/urban, and health care access predictors.

BACKGROUND: Recruitment and participation in clinical trials by minorities, particularly African Americans and rural underserved populations, are low. This report examines predictors of clinical trial recruitment and participation for adult Marylanders. METHODS: A cross-sectional design was used to survey 5154 adults (18 years and older) residing in 13 of the 24 jurisdictions in Maryland, including urban Baltimore City, and the rural regions of Western Maryland and the Eastern Shore. The survey, conducted between December 2001 and March 2003, used Computer-Assisted Telephone Interviewing and random-digit dialing procedures. Primary dependent variables included "ever asked to participate" (i.e., recruited) and "participated" in clinical trials. RESULTS: 11.1% of the respondents had been recruited to clinical trials. In addition, 59.4% of the respondents recruited to clinical trials actually participated in a clinical trial. Among respondents recruited to clinical trials, black and middle income respondents were significantly less likely to actually participate in clinical trials; whereas, respondents who received information about clinical trials from their health care provider, who were knowledgeable about clinical trials, and those who had the time commitment were significantly more likely to participate in clinical trials. CONCLUSIONS: These results suggest serious gaps in efforts to recruit racial/ethnic minorities and residents of rural regions into clinical trials. The findings provide the basis for the development and implementation of community-based educational programs for both the general public and health care professionals, and to enhance availability of community-based clinical trials, especially in the rural areas of the state.