Browsing by Subject "Decision Support Techniques"
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Item Open Access A risk score for in-hospital death in patients admitted with ischemic or hemorrhagic stroke.(J Am Heart Assoc, 2013-01-28) Smith, Eric E; Shobha, Nandavar; Dai, David; Olson, DaiWai M; Reeves, Mathew J; Saver, Jeffrey L; Hernandez, Adrian F; Peterson, Eric D; Fonarow, Gregg C; Schwamm, Lee HBACKGROUND: We aimed to derive and validate a single risk score for predicting death from ischemic stroke (IS), intracerebral hemorrhage (ICH), and subarachnoid hemorrhage (SAH). METHODS AND RESULTS: Data from 333 865 stroke patients (IS, 82.4%; ICH, 11.2%; SAH, 2.6%; uncertain type, 3.8%) in the Get With The Guidelines-Stroke database were used. In-hospital mortality varied greatly according to stroke type (IS, 5.5%; ICH, 27.2%; SAH, 25.1%; unknown type, 6.0%; P<0.001). The patients were randomly divided into derivation (60%) and validation (40%) samples. Logistic regression was used to determine the independent predictors of mortality and to assign point scores for a prediction model in the overall population and in the subset with the National Institutes of Health Stroke Scale (NIHSS) recorded (37.1%). The c statistic, a measure of how well the models discriminate the risk of death, was 0.78 in the overall validation sample and 0.86 in the model including NIHSS. The model with NIHSS performed nearly as well in each stroke type as in the overall model including all types (c statistics for IS alone, 0.85; for ICH alone, 0.83; for SAH alone, 0.83; uncertain type alone, 0.86). The calibration of the model was excellent, as demonstrated by plots of observed versus predicted mortality. CONCLUSIONS: A single prediction score for all stroke types can be used to predict risk of in-hospital death following stroke admission. Incorporation of NIHSS information substantially improves this predictive accuracy.Item Open Access Comparative cost-effectiveness analysis of voriconazole and fluconazole for prevention of invasive fungal infection in patients receiving allogeneic hematopoietic cell transplants.(American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2013-09) Mauskopf, Josephine; Chirila, Costel; Graham, Jon; Gersten, Iris D; Leather, Helen; Maziarz, Richard T; Baden, Lindsey R; Bolaños-Meade, Javier; Brown, Janice MY; Walsh, Thomas J; Horowitz, Mary H; Kurtzberg, Joanne; Marr, Kieren A; Wingard, John RPurpose
The cost-effectiveness of voriconazole versus fluconazole prophylaxis against fungal infections in hematopoietic cell transplant (HCT) recipients is investigated.Methods
A decision-analytic model was developed to estimate the drug costs associated with planned or supplemental prophylaxis and empirical therapy and the costs of treating suspected or documented invasive fungal infections (IFIs) in HCT recipients. Published clinical trial data on 599 patients who received 100-180 days of prophylactic therapy with voriconazole or fluconazole were used to model specified IFI-prevention and mortality outcomes; 6-month, 12-month, and lifetime incremental cost-effectiveness ratios (ICERs) were estimated, with a bootstrap analysis performed to reffect the uncertainty of the clinical trial data.Results
Estimated mean total prophylaxis and IFI-related costs associated with voriconazole versus fluconazole prophylaxis over 12 months were higher in the entire study population and among patients receiving HCT for diagnoses other than acute myeloid leukemia (AML) but were not significantly different for patients with AML. The cost per IFI avoided ($66,919) and the cost per life-year gained ($5,453) were lower among patients with AML who received voriconazole relative to the full study population. ICERs were more favorable for voriconazole over a 6-month time frame and when modeling was conducted using generic price data. Assuming a threshold value of $50,000 for one year of life gained, the calculated probability of voriconazole being cost-effective was 33% for the full study population and 85% for the AML subgroup.Conclusion
The decision model indicated that voriconazole prophylaxis was cost-effective for patients undergoing allogeneic HCT for AML.Item Open Access Cost-effectiveness analysis of the diagnosis of meniscus tears.(Am J Sports Med, 2015-01) Mather, Richard C; Garrett, William E; Cole, Brian J; Hussey, Kristen; Bolognesi, Michael P; Lassiter, Tally; Orlando, Lori ABACKGROUND: Diagnostic imaging represents the fastest growing segment of costs in the US health system. This study investigated the cost-effectiveness of alternative diagnostic approaches to meniscus tears of the knee, a highly prevalent disease that traditionally relies on MRI as part of the diagnostic strategy. PURPOSE: To identify the most efficient strategy for the diagnosis of meniscus tears. STUDY DESIGN: Economic and decision analysis; Level of evidence, 1. METHODS: A simple-decision model run as a cost-utility analysis was constructed to assess the value added by MRI in various combinations with patient history and physical examination (H&P). The model examined traumatic and degenerative tears in 2 distinct settings: primary care and orthopaedic sports medicine clinic. Strategies were compared using the incremental cost-effectiveness ratio (ICER). RESULTS: In both practice settings, H&P alone was widely preferred for degenerative meniscus tears. Performing MRI to confirm a positive H&P was preferred for traumatic tears in both practice settings, with a willingness to pay of less than US$50,000 per quality-adjusted life-year. Performing an MRI for all patients was not preferred in any reasonable clinical scenario. The prevalence of a meniscus tear in a clinician's patient population was influential. For traumatic tears, MRI to confirm a positive H&P was preferred when prevalence was less than 46.7%, with H&P preferred above that. For degenerative tears, H&P was preferred until the prevalence reaches 74.2%, and then MRI to confirm a negative was the preferred strategy. In both settings, MRI to confirm positive physical examination led to more than a 10-fold lower rate of unnecessary surgeries than did any other strategy, while MRI to confirm negative physical examination led to a 2.08 and 2.26 higher rate than H&P alone in primary care and orthopaedic clinics, respectively. CONCLUSION: For all practitioners, H&P is the preferred strategy for the suspected degenerative meniscus tear. An MRI to confirm a positive H&P is preferred for traumatic tears for all practitioners. Consideration should be given to implementing alternative diagnostic strategies as well as enhancing provider education in physical examination skills to improve the reliability of H&P as a diagnostic test. CLINICAL RELEVANCE: Alternative diagnostic strategies that do not include the use of MRI may result in decreased health care costs without harm to the patient and could possibly reduce unnecessary procedures.Item Open Access Decision analytic modeling in spinal surgery: a methodologic overview with review of current published literature.(The spine journal : official journal of the North American Spine Society, 2015-10) McAnany, Steven J; Anwar, Muhammad AF; Qureshi, Sheeraz ABackground context
In recent years, there has been an increase in the number of decision analysis studies in the spine literature. Although there are several published reviews on the different types of decision analysis (cost-effectiveness, cost-benefit, cost-utility), there is limited information in the spine literature regarding the mathematical models used in these studies (decision tree, Markov modeling, Monte Carlo simulation).Purpose
The purpose of this review was to provide an overview of the types of decision analytic models used in spine surgery. A secondary aim was to provide a systematic overview of the most cited studies in the spine literature.Study design/setting
This is a systematic review of the available information from all sources regarding decision analytics and economic modeling in spine surgery.Methods
A systematic search of PubMed, Embase, and Cochrane review was performed to identify the most relevant peer-reviewed literature of decision analysis/cost-effectiveness analysis (CEA) models including decisions trees, Markov models, and Monte Carlo simulations. Additionally, CEA models based on investigational drug exemption studies were reviewed in particular detail, as these studies are prime candidates for economic modeling.Results
The initial review of the literature resulted in 712 abstracts. After two reviewer-assessment of abstract relevance and methodologic quality, 19 studies were selected: 12 with decision tree constructs and 7 with Markov models. Each study was assessed for methodologic quality and a review of the overall results of the model. A generalized overview of the mathematical construction and methodology of each type of model was also performed. Limitations, strengths, and potential applications to spine research were further explored.Conclusions
Decision analytic modeling represents a powerful tool both in the assessment of competing treatment options and potentially in the formulation of policy and reimbursement. Our review provides a generalized overview and a conceptual framework to help spine physicians with the construction of these models.Item Open Access Development of a decision aid to inform patients' and families' renal replacement therapy selection decisions.(BMC Med Inform Decis Mak, 2012-12-01) Ameling, Jessica M; Auguste, Priscilla; Ephraim, Patti L; Lewis-Boyer, LaPricia; DePasquale, Nicole; Greer, Raquel C; Crews, Deidra C; Powe, Neil R; Rabb, Hamid; Boulware, L EbonyBACKGROUND: Few educational resources have been developed to inform patients' renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients' treatment and support patients' decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function. METHODS: We designed a decision aid comprising a complementary video and informational handbook. We based our development process on data previously obtained from qualitative focus groups and systematic literature reviews. We simultaneously developed the video and handbook in "stages." For the video, stages included (1) directed interviews with culturally appropriate patients and families and preliminary script development, (2) video production, and (3) screening the video with patients and their families. For the handbook, stages comprised (1) preliminary content design, (2) a mixed-methods pilot study among diverse patients to assess comprehension of handbook material, and (3) screening the handbook with patients and their families. RESULTS: The video and handbook both addressed potential benefits and trade-offs of treatment selections. The 50-minute video consisted of demographically diverse patients and their families describing their positive and negative experiences with selecting a treatment option. The video also incorporated health professionals' testimonials regarding various considerations that might influence patients' and families' treatment selections. The handbook was comprised of written words, pictures of patients and health care providers, and diagrams describing the findings and quality of scientific studies comparing treatments. The handbook text was written at a 4th to 6th grade reading level. Pilot study results demonstrated that a majority of patients could understand information presented in the handbook. Patient and families screening the nearly completed video and handbook reviewed the materials favorably. CONCLUSIONS: This rigorously designed decision aid may help patients and families make informed decisions about their treatment options for RRT that are well aligned with their values.Item Open Access Economic analysis of a tailored behavioral intervention to improve blood pressure control for primary care patients.(American heart journal, 2010-08) Datta, Santanu K; Oddone, Eugene Z; Olsen, Maren K; Orr, Melinda; McCant, Felicia; Gentry, Pam; Bosworth, Hayden BBackground
Few telemedicine programs have undergone cost analyses, impeding their implementation into practice. We report on the economic analysis of a nurse-administered intervention designed to improve blood pressure control among hypertensive veterans.Methods
We randomized hypertensive patients at the Durham Veterans Affairs Medical Center primary care clinic to behavioral (n = 294) or nonbehavioral (n = 294) interventions. Behavioral intervention patients received tailored information bimonthly for 2 years via telephone. To calculate intervention cost, we microcosted the nurse's labor cost and computer hardware and software costs, applied a direct-to-indirect cost ratio, and distributed the costs over an estimated cohort of patients. We analyzed data from the Veterans Affairs Decision Support System to assess whether the intervention impacted overall health care utilization and costs. We used life expectancy estimates from the literature to develop decision models to calculate cost per life-year saved.Results
The mean annual intervention cost was $112 (range $61-$259). During 2 years of follow-up, patients in the intervention group incurred $7,800 in inpatient costs and $9,741 in outpatient costs; the nonintervention group incurred $6,866 in inpatient costs and $9,599 in outpatient costs. The total cost difference was not statistically significant (P = .56). Cost-effectiveness of the behavioral intervention ranged from $42,457 per life-year saved for normal-weight women to $87,300 per life-year saved for normal-weight men.Conclusions
The study results suggest that a nurse-administered, tailored behavioral intervention can be implemented at nominal cost and be cost-effective; however, there was no apparent lowering of health care utilization and costs during the 2 years of follow-up.Item Open Access Economic evaluation of access to musculoskeletal care: the case of waiting for total knee arthroplasty.(BMC Musculoskelet Disord, 2014-01-18) Mather, Richard C; Hug, Kevin T; Orlando, Lori A; Watters, Tyler Steven; Koenig, Lane; Nunley, Ryan M; Bolognesi, Michael PBACKGROUND: The projected demand for total knee arthroplasty is staggering. At its root, the solution involves increasing supply or decreasing demand. Other developed nations have used rationing and wait times to distribute this service. However, economic impact and cost-effectiveness of waiting for TKA is unknown. METHODS: A Markov decision model was constructed for a cost-utility analysis of three treatment strategies for end-stage knee osteoarthritis: 1) TKA without delay, 2) a waiting period with no non-operative treatment and 3) a non-operative treatment bridge during that waiting period in a cohort of 60 year-old patients. Outcome probabilities and effectiveness were derived from the literature. Costs were estimated from the societal perspective with national average Medicare reimbursement. Effectiveness was expressed in quality-adjusted life years (QALYs) gained. Principal outcome measures were average incremental costs, effectiveness, and quality-adjusted life years; and net health benefits. RESULTS: In the base case, a 2-year wait-time both with and without a non-operative treatment bridge resulted in a lower number of average QALYs gained (11.57 (no bridge) and 11.95 (bridge) vs. 12.14 (no delay). The average cost was $1,660 higher for TKA without delay than wait-time with no bridge, but $1,810 less than wait-time with non-operative bridge. The incremental cost-effectiveness ratio comparing wait-time with no bridge to TKA without delay was $2,901/QALY. When comparing TKA without delay to waiting with non-operative bridge, TKA without delay produced greater utility at a lower cost to society. CONCLUSIONS: TKA without delay is the preferred cost-effective treatment strategy when compared to a waiting for TKA without non-operative bridge. TKA without delay is cost saving when a non-operative bridge is used during the waiting period. As it is unlikely that patients waiting for TKA would not receive non-operative treatment, TKA without delay may be an overall cost-saving health care delivery strategy. Policies aimed at increasing the supply of TKA should be considered as savings exist that could indirectly fund those strategies.Item Open Access Empiric antibiotic treatment of erythema migrans-like skin lesions as a function of geography: a clinical and cost effectiveness modeling study.(Vector Borne Zoonotic Dis, 2013-12) Lantos, Paul M; Brinkerhoff, R Jory; Wormser, Gary P; Clemen, RobertThe skin lesion of early Lyme disease, erythema migrans (EM), is so characteristic that routine practice is to treat all such patients with antibiotics. Because other skin lesions may resemble EM, it is not known whether presumptive treatment of EM is appropriate in regions where Lyme disease is rare. We constructed a decision model to compare the cost and clinical effectiveness of three strategies for the management of EM: Treat All, Observe, and Serology as a function of the probability that an EM-like lesion is Lyme disease. Treat All was found to be the preferred strategy in regions that are endemic for Lyme disease. Where Lyme disease is rare, Observe is the preferred strategy, as presumptive treatment would be expected to produce excessive harm and increased costs. Where Lyme disease is rare, clinicians and public health officials should consider observing patients with EM-like lesions who lack travel to Lyme disease-endemic areas.Item Open Access Estimation and validation of a multiattribute model of Alzheimer disease progression.(Med Decis Making, 2010-11) Stallard, Eric; Kinosian, Bruce; Zbrozek, Arthur S; Yashin, Anatoliy I; Glick, Henry A; Stern, YaakovOBJECTIVES: To estimate and validate a multiattribute model of the clinical course of Alzheimer disease (AD) from mild AD to death in a high-quality prospective cohort study, and to estimate the impact of hypothetical modifications to AD progression rates on costs associated with Medicare and Medicaid services. DATA AND METHODS: The authors estimated sex-specific longitudinal Grade of Membership (GoM) models for AD patients (103 men, 149 women) in the initial cohort of the Predictors Study (1989-2001) based on 80 individual measures obtained every 6 mo for 10 y. These models were replicated for AD patients (106 men, 148 women) in the 2nd Predictors Study cohort (1997-2007). Model validation required that the disease-specific transition parameters be identical for both Predictors Study cohorts. Medicare costs were estimated from the National Long Term Care Survey. RESULTS: Sex-specific models were validated using the 2nd Predictors Study cohort with the GoM transition parameters constrained to the values estimated for the 1st Predictors Study cohort; 57 to 61 of the 80 individual measures contributed significantly to the GoM models. Simulated, cost-free interventions in the rate of progression of AD indicated that large potential cost offsets could occur for patients at the earliest stages of AD. CONCLUSIONS: AD progression is characterized by a small number of parameters governing changes in large numbers of correlated indicators of AD severity. The analysis confirmed that the progression of AD represents a complex multidimensional physiological process that is similar across different study cohorts. The estimates suggested that there could be large cost offsets to Medicare and Medicaid from the slowing of AD progression among patients with mild AD. The methodology appears generally applicable in AD modeling.Item Open Access Factors influencing malaria control policy-making in Kenya, Uganda and Tanzania.(Malar J, 2014-08-08) Mutero, CM; Kramer, RA; Paul, C.; Lesser, A; Miranda, ML; Mboera, LEG; Kiptui, R; Kabatereine, N; Ameneshewa, BBACKGROUND: Policy decisions for malaria control are often difficult to make as decision-makers have to carefully consider an array of options and respond to the needs of a large number of stakeholders. This study assessed the factors and specific objectives that influence malaria control policy decisions, as a crucial first step towards developing an inclusive malaria decision analysis support tool (MDAST). METHODS: Country-specific stakeholder engagement activities using structured questionnaires were carried out in Kenya, Uganda and Tanzania. The survey respondents were drawn from a non-random purposeful sample of stakeholders, targeting individuals in ministries and non-governmental organizations whose policy decisions and actions are likely to have an impact on the status of malaria. Summary statistics across the three countries are presented in aggregate. RESULTS: Important findings aggregated across countries included a belief that donor preferences and agendas were exerting too much influence on malaria policies in the countries. Respondents on average also thought that some relevant objectives such as engaging members of parliament by the agency responsible for malaria control in a particular country were not being given enough consideration in malaria decision-making. Factors found to influence decisions regarding specific malaria control strategies included donor agendas, costs, effectiveness of interventions, health and environmental impacts, compliance and/acceptance, financial sustainability, and vector resistance to insecticides. CONCLUSION: Malaria control decision-makers in Kenya, Uganda and Tanzania take into account health and environmental impacts as well as cost implications of different intervention strategies. Further engagement of government legislators and other policy makers is needed in order to increase funding from domestic sources, reduce donor dependence, sustain interventions and consolidate current gains in malaria.Item Open Access Hardware Removal in Craniomaxillofacial Trauma: A Systematic Review of the Literature and Management Algorithm.(Annals of plastic surgery, 2015-11) Cahill, Thomas J; Gandhi, Rikesh; Allori, Alexander C; Marcus, Jeffrey R; Powers, David; Erdmann, Detlev; Hollenbeck, Scott T; Levinson, HowardBackground
Craniomaxillofacial (CMF) fractures are typically treated with open reduction and internal fixation. Open reduction and internal fixation can be complicated by hardware exposure or infection. The literature often does not differentiate between these 2 entities; so for this study, we have considered all hardware exposures as hardware infections. Approximately 5% of adults with CMF trauma are thought to develop hardware infections. Management consists of either removing the hardware versus leaving it in situ. The optimal approach has not been investigated. Thus, a systematic review of the literature was undertaken and a resultant evidence-based approach to the treatment and management of CMF hardware infections was devised.Materials and methods
A comprehensive search of journal articles was performed in parallel using MEDLINE, Web of Science, and ScienceDirect electronic databases. Keywords and phrases used were maxillofacial injuries; facial bones; wounds and injuries; fracture fixation, internal; wound infection; and infection. Our search yielded 529 articles. To focus on CMF fractures with hardware infections, the full text of English-language articles was reviewed to identify articles focusing on the evaluation and management of infected hardware in CMF trauma. Each article's reference list was manually reviewed and citation analysis performed to identify articles missed by the search strategy. There were 259 articles that met the full inclusion criteria and form the basis of this systematic review. The articles were rated based on the level of evidence. There were 81 grade II articles included in the meta-analysis.Result
Our meta-analysis revealed that 7503 patients were treated with hardware for CMF fractures in the 81 grade II articles. Hardware infection occurred in 510 (6.8%) of these patients. Of those infections, hardware removal occurred in 264 (51.8%) patients; hardware was left in place in 166 (32.6%) patients; and in 80 (15.6%) cases, there was no report as to hardware management. Finally, our review revealed that there were no reported differences in outcomes between groups.Conclusions
Management of CMF hardware infections should be performed in a sequential and consistent manner to optimize outcome. An evidence-based algorithm for management of CMF hardware infections based on this critical review of the literature is presented and discussed.Item Open Access Optimal management of Riata leads with no known electrical abnormalities or externalization: a decision analysis.(Journal of cardiovascular electrophysiology, 2015-02) Pokorney, Sean D; Zhou, Ke; Matchar, David B; Love, Sean; Zeitler, Emily P; Lewis, Robert; Piccini, Jonathan PIntroduction
Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA) can develop conductor cable externalization and/or electrical failure. Optimal management of these leads remains unknown.Methods and results
A Markov model compared 4 lead management strategies: (1) routine device interrogation for electrical failure, (2) systematic yearly fluoroscopic screening and routine device interrogation, (3) implantation of new ICD lead with capping of the in situ lead, and (4) implantation of new ICD lead with extraction of the in situ lead. The base case was a 64-year-old primary prevention ICD patient. Modeling demonstrated average life expectancies as follows: capping with new lead implanted at 134.5 months, extraction with new lead implanted at 134.0 months, fluoroscopy with routine interrogation at 133.9 months, and routine interrogation at 133.5 months. One-way sensitivity analyses identified capping as the preferred strategy with only one parameter having a threshold value: when risk of nonarrhythmic death associated with lead abandonment is greater than 0.05% per year, lead extraction is preferred over capping. A second-order Monte Carlo simulation (n = 10,000), as a probabilistic sensitivity analysis, found that lead revision was favored with 100% certainty (extraction 76% and capping 24%).Conclusions
Overall there were minimal differences in survival with monitoring versus active lead management approaches. There is no evidence to support fluoroscopic screening for externalization of Riata or Riata ST leads.Item Open Access Performance of Novel High-Sensitivity Cardiac Troponin I Assays for 0/1-Hour and 0/2- to 3-Hour Evaluations for Acute Myocardial Infarction: Results From the HIGH-US Study.(Annals of emergency medicine, 2020-07) Nowak, Richard M; Christenson, Robert H; Jacobsen, Gordon; McCord, James; Apple, Fred S; Singer, Adam J; Limkakeng, Alexander; Peacock, William F; deFilippi, Christopher RSTUDY OBJECTIVE:We determine the accuracy of high-sensitivity cardiac troponin I (hs-cTnI), European-derived, rapid, acute myocardial infarction, rule-out/rule-in algorithms applied to a US emergency department (ED) population. METHODS:Adults presenting to the ED with suspected acute myocardial infarction were included. Plasma samples collected at baseline and between 40 and 90 minutes and 2 and 3 hours later were analyzed in core laboratories using the Siemens Healthineers hs-cTnI assays. Acute myocardial infarction diagnosis was independently adjudicated. The sensitivity, specificity, and negative and positive predictive values for rapid acute myocardial infarction rule-out/rule-in using European algorithms and 30-day outcomes are reported. RESULTS:From 29 US medical centers, 2,113 subjects had complete data for the 0/1-hour algorithm analyses. With the Siemens Atellica Immunoassay hs-cTnI values, 1,065 patients (50.4%) were ruled out, with a negative predictive value of 99.7% and sensitivity of 98.7% (95% confidence interval 99.2% to 99.9% and 96.3% to 99.6%, respectively), whereas 265 patients (12.6%) were ruled in, having a positive predictive value of 69.4% and specificity of 95.7% (95% confidence interval 63.6% to 74.7% and 94.7% to 96.5%, respectively). The remaining 783 patients (37.1%) were classified as having continued evaluations, with an acute myocardial infarction incidence of 5.6% (95% confidence interval 4.2% to 7.5%). The overall 30-day risk of death or postdischarge acute myocardial infarction was very low in the ruled-out patients but was incrementally increased in the other groups (rule-out 0.2%; continued evaluations 2.1%; rule-in 4.8%). Equivalent results were observed in the 0/2- to 3-hour analyses and when both algorithms were applied to the hs-cTnI ADVIA Centaur measurements. CONCLUSION:The European rapid rule-out/rule-in acute myocardial infarction algorithm hs-cTnI cut points can be harmonized with a demographically and risk-factor diverse US ED population.Item Open Access Potential Cost-effectiveness of Early Identification of Hospital-acquired Infection in Critically Ill Patients.(Ann Am Thorac Soc, 2016-03) Tsalik, Ephraim L; Li, Yanhong; Hudson, Lori L; Chu, Vivian H; Himmel, Tiffany; Limkakeng, Alex T; Katz, Jason N; Glickman, Seth W; McClain, Micah T; Welty-Wolf, Karen E; Fowler, Vance G; Ginsburg, Geoffrey S; Woods, Christopher W; Reed, Shelby DRATIONALE: Limitations in methods for the rapid diagnosis of hospital-acquired infections often delay initiation of effective antimicrobial therapy. New diagnostic approaches offer potential clinical and cost-related improvements in the management of these infections. OBJECTIVES: We developed a decision modeling framework to assess the potential cost-effectiveness of a rapid biomarker assay to identify hospital-acquired infection in high-risk patients earlier than standard diagnostic testing. METHODS: The framework includes parameters representing rates of infection, rates of delayed appropriate therapy, and impact of delayed therapy on mortality, along with assumptions about diagnostic test characteristics and their impact on delayed therapy and length of stay. Parameter estimates were based on contemporary, published studies and supplemented with data from a four-site, observational, clinical study. Extensive sensitivity analyses were performed. The base-case analysis assumed 17.6% of ventilated patients and 11.2% of nonventilated patients develop hospital-acquired infection and that 28.7% of patients with hospital-acquired infection experience delays in appropriate antibiotic therapy with standard care. We assumed this percentage decreased by 50% (to 14.4%) among patients with true-positive results and increased by 50% (to 43.1%) among patients with false-negative results using a hypothetical biomarker assay. Cost of testing was set at $110/d. MEASUREMENTS AND MAIN RESULTS: In the base-case analysis, among ventilated patients, daily diagnostic testing starting on admission reduced inpatient mortality from 12.3 to 11.9% and increased mean costs by $1,640 per patient, resulting in an incremental cost-effectiveness ratio of $21,389 per life-year saved. Among nonventilated patients, inpatient mortality decreased from 7.3 to 7.1% and costs increased by $1,381 with diagnostic testing. The resulting incremental cost-effectiveness ratio was $42,325 per life-year saved. Threshold analyses revealed the probabilities of developing hospital-acquired infection in ventilated and nonventilated patients could be as low as 8.4 and 9.8%, respectively, to maintain incremental cost-effectiveness ratios less than $50,000 per life-year saved. CONCLUSIONS: Development and use of serial diagnostic testing that reduces the proportion of patients with delays in appropriate antibiotic therapy for hospital-acquired infections could reduce inpatient mortality. The model presented here offers a cost-effectiveness framework for future test development.Item Open Access Predicting risk of pelvic floor disorders 12 and 20 years after delivery.(American journal of obstetrics and gynecology, 2018-02) Jelovsek, J Eric; Chagin, Kevin; Gyhagen, Maria; Hagen, Suzanne; Wilson, Don; Kattan, Michael W; Elders, Andrew; Barber, Matthew D; Areskoug, Björn; MacArthur, Christine; Milsom, IanLittle progress has been made in the prevention of pelvic floor disorders, despite their significant health and economic impact. The identification of women who are at risk remains a key element in targeting prevention and planning health resource allocation strategies. Although events around the time of childbirth are recognized clinically as important predictors, it is difficult to counsel women and to intervene around the time of childbirth because of an inability to convey a patient's risk accurately in the presence of multiple risk factors and the long time lapse, which is often decades, between obstetric events and the onset of pelvic floor disorders later in life. Prediction models and scoring systems have been used in other areas of medicine to identify patients who are at risk for chronic diseases. Models have been developed for use before delivery that predict short-term risk of pelvic floor disorders after childbirth, but no models that predict long-term risk exist.The purpose of this study was to use variables that are known before and during childbirth to develop and validate prognostic models that will estimate the risks of these disorders 12 and 20 years after delivery.Obstetric variables were collected from 2 cohorts: (1) women who gave birth in the United Kingdom and New Zealand (n=3763) and (2) women from the Swedish Medical Birth Register (n=4991). Pelvic floor disorders were self-reported 12 years after childbirth in the United Kingdom/New Zealand cohort and 20 years after childbirth in the Swedish Register. The cohorts were split so that data during the first half of the cohort's time period were used to fit prediction models, and validation was performed from the second half (temporal validation). Because there is currently no consensus on how to best define pelvic floor disorders from a patient's perspective, we chose to fit the data for each model using multiple outcome definitions for prolapse, urinary incontinence, fecal incontinence, ≥1 pelvic floor disorder, and ≥2 pelvic floor disorders. Model accuracy was measured in the following manner: (1) by ranking an individual's risk among all subjects in the cohort (discrimination) with the use of a concordance index and (2) by observing whether the predicted probability was too high or low (calibration) at a range of predicted probabilities with the use of visual plots.Models were able to discriminate between women who experienced bothersome symptoms or received treatment at 12 and 20 years, respectively, for pelvic organ prolapse (concordance indices, 0.570, 0.627), urinary incontinence (concordance indices, 0.653, 0.689), fecal incontinence (concordance indices, 0.618, 0.676), ≥1 pelvic floor disorders (concordance indices, 0.639, 0.675), and ≥2 pelvic floor disorders (concordance indices, 0.635, 0.619). Route of delivery and family history of each pelvic floor disorder were strong predictors in most models. Urinary incontinence before and during the index pregnancy was a strong predictor for the development of all pelvic floor disorders in most models 12 years after delivery. The 12- and 20-year bothersome symptoms or treatment for prolapse models were accurate when predictions were provided for risk from 0% to approximately 15%. The 12- and 20-year primiparous model began to over predict when risk rates reached 20%. When we predicted bothersome symptoms or treatment for urinary incontinence, the 12-year models were accurate when predictions ranged from approximately 5-60%; the 20-year primiparous models were accurate from 5% and 80%. For bothersome symptoms or treatment for fecal incontinence, the 12- and 20-year models were accurate from 1-15% risk and began to over predict at rates at >15% and 20%, respectively.Models may provide an opportunity before birth to identify women who are at low risk of the development of pelvic floor disorders and may provide institute prevention strategies such as pelvic floor muscle training, weight control, or elective cesarean section for women who are at higher risk. Models are provided at http://riskcalc.org/UR_CHOICE/.Item Open Access Simplified Predictive Instrument to Rule Out Acute Coronary Syndromes in a High-Risk Population.(J Am Heart Assoc, 2015-12-14) Fanaroff, Alexander C; Schulteis, Ryan D; Pieper, Karen S; Rao, Sunil V; Newby, L KristinBACKGROUND: It is unclear whether diagnostic protocols based on cardiac markers to identify low-risk chest pain patients suitable for early release from the emergency department can be applied to patients older than 65 years or with traditional cardiac risk factors. METHODS AND RESULTS: In a single-center retrospective study of 231 consecutive patients with high-risk factor burden in which a first cardiac troponin (cTn) level was measured in the emergency department and a second cTn sample was drawn 4 to 14 hours later, we compared the performance of a modified 2-Hour Accelerated Diagnostic Protocol to Assess Patients with Chest Pain Using Contemporary Troponins as the Only Biomarker (ADAPT) rule to a new risk classification scheme that identifies patients as low risk if they have no known coronary artery disease, a nonischemic electrocardiogram, and 2 cTn levels below the assay's limit of detection. Demographic and outcome data were abstracted through chart review. The median age of our population was 64 years, and 75% had Thrombosis In Myocardial Infarction risk score ≥2. Using our risk classification rule, 53 (23%) patients were low risk with a negative predictive value for 30-day cardiac events of 98%. Applying a modified ADAPT rule to our cohort, 18 (8%) patients were identified as low risk with a negative predictive value of 100%. In a sensitivity analysis, the negative predictive value of our risk algorithm did not change when we relied only on undetectable baseline cTn and eliminated the second cTn assessment. CONCLUSIONS: If confirmed in prospective studies, this less-restrictive risk classification strategy could be used to safely identify chest pain patients with more traditional cardiac risk factors for early emergency department release.Item Open Access Strategies for treating latent multiple-drug resistant tuberculosis: a decision analysis.(PLoS One, 2012) Holland, David P; Sanders, Gillian D; Hamilton, Carol D; Stout, Jason EBACKGROUND: The optimal treatment for latent multiple-drug resistant tuberculosis infection remains unclear. In anticipation of future clinical trials, we modeled the expected performance of six potential regimens for treatment of latent multiple-drug resistant tuberculosis. METHODS: A computerized Markov model to analyze the total cost of treatment for six different regimens: Pyrazinamide/ethambutol, moxifloxacin monotherapy, moxifloxacin/pyrazinamide, moxifloxacin/ethambutol, moxifloxacin/ethionamide, and moxifloxacin/PA-824. Efficacy estimates were extrapolated from mouse models and examined over a wide range of assumptions. RESULTS: In the base-case, moxifloxacin monotherapy was the lowest cost strategy, but moxifloxacin/ethambutol was cost-effective at an incremental cost-effectiveness ratio of $21,252 per quality-adjusted life-year. Both pyrazinamide-containing regimens were dominated due to their toxicity. A hypothetical regimen of low toxicity and even modest efficacy was cost-effective compared to "no treatment." CONCLUSION: In our model, moxifloxacin/ethambutol was the preferred treatment strategy under a wide range of assumptions; pyrazinamide-containing regimens fared poorly because of high rates of toxicity. Although more data are needed on efficacy of treatments for latent MDR-TB infection, data on toxicity and treatment discontinuation, which are easier to obtain, could have a substantial impact on public health practice.Item Open Access Using decision analysis to improve malaria control policy making.(Health Policy, 2009-10) Kramer, R; Dickinson, K; Anderson, R; Fowler, VG; Miranda, ML; Mutero, CB; Saterson, K; Wiener, JMalaria and other vector-borne diseases represent a significant and growing burden in many tropical countries. Successfully addressing these threats will require policies that expand access to and use of existing control methods, such as insecticide-treated bed nets (ITNs) and artemesinin combination therapies (ACTs) for malaria, while weighing the costs and benefits of alternative approaches over time. This paper argues that decision analysis provides a valuable framework for formulating such policies and combating the emergence and re-emergence of malaria and other diseases. We outline five challenges that policy makers and practitioners face in the struggle against malaria, and demonstrate how decision analysis can help to address and overcome these challenges. A prototype decision analysis framework for malaria control in Tanzania is presented, highlighting the key components that a decision support tool should include. Developing and applying such a framework can promote stronger and more effective linkages between research and policy, ultimately helping to reduce the burden of malaria and other vector-borne diseases.