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Evidence-based Practice

 
Evidence-based PracticeThe Duke Evidence-based Practice Center brings together the expertise necessary to develop state of the art systematic reviews and meta-analyses.  The EPC advances understanding of clinical topics through 1) a thorough ascertainmment of available scientific research, 2) a scientifically-driven process for evaluating available evidence, and 3) a methodologically sophisticated analysis designed to demonstrate and estimate bias.  The goal of such projects is to aid in the development of clinical practice guidelines or practice improvement projects.  The center is one of 13 Evidence-based Practice Centers (EPCs) nationwide designated and funded by the Agency for Healthcare Research and Quality (AHRQ).
 
 
 
 

 Cardiac Spectral Analysis

Dates: Nov. 1, 2008-Nov. 30, 2009
 
PI: John W. Williams Jr., MD, MHS
 
Project Type: Technology Assessment
 
Funders/Sponsors: Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS)
Aims/objectives:
The Agency for Healthcare Research and Quality (AHRQ) commissioned a technology assessment to summarize the available clinical and scientific evidence on signal averaging technologies (e.g., ecg signal averaging), also known as spectral analysis, for evaluating patients with suspected coronary artery disease.  In addition, a horizon scan will be performed to identify emerging technologies using this approach.  Signal averaging technologies are used in radiological and non-radiological devices.  This report will focus only on non-radiological devices.  The objective is to inform AHRQ and CMS about the diagnostic utility of this emerging technology. 
Key Questions:
1.  What devices are available for cardiac signal averaging? What is the FDA status of these devices?
2. What is the evidence on the use of this technology for diagnosis of coronary artery disease?  This question will be addressed as follows:
a) What is the evidence for inter-rater, intra-rater, and intra-patient variability?
b) What is the evidence for diagnostic test performance compared to a criterion standard?
c) What is the evidence that signal-averaging technologies impact diagnostic decision-making?
d) What is the evidence that signal-averaging technologies impact patient outcomes?

 Analysis of data from the National Oncologic PET Registry

Dates: June 30, 2008 – March 31, 2009
 
PI:  Gregory Samsa, PhD
 
Project Type:  Technology Assessment
 
Funders/Sponsors: Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS)
Aims/objectives:
Positron emission tomography (PET) with flurodeoxyglucose (FDG) is, among others, used to provide information about glucose metabolism.  Most malignancies have greater glucose utilization than do normal tissues and thus exhibit greater FDG uptake.  Thus, it is believed that PET can help to diagnose and stage cancers.
 
As of 2007, CMS has extended national coverage for PET-FDG to the following: characterization of an indeterminate solitary pulmonary nodule (1998), initial staging of suspected metastatic non-small cell lung cancer (1998), restaging of suspected recurrent colorectal cancer (1999), staging and restaging of lymphoma when used as an alternative to gallium scintigraphy (1999), evaluating the recurrence of melanoma before surgery when used as an alternative to gallium scintigraphy (1999), diagnosis, staging and restaging of melanoma, lymphoma, non-small cell lung, esophageal, colorectal, and head and neck cancers (2001), certain breast cancer indications (2002), a specific thyroid cancer indication (2003), and a specific cervical cancer indication (2007).
 
We will perform an independent re-analysis of the NOPR data.  The most comprehensive such analysis would begin with an assessment of registry design and data integrity.  We understand that neither of these features are desired, and that all of our results will be conditional on making the stipulation that the data in the NOPR are an acceptably accurate representation of physician intentions before and after PET-FDG.

 Percutaneous Heart Valve Replacement – Technical Brief

Dates: June 1, 2008 – December 31, 2008
 
PI: John W. Williams, MD, MHS
 
Project Type: Technology Brief
 
Funders/Sponsors: Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS)
Aims/objectives:
The Centers for Medicare and Medicaid (CMS) is commissioning a Technical Brief from the Agency for Healthcare Research and Quality (AHRQ) to summarize the available clinical and scientific evidence on Percutaneous Heart Valves (PHV) for aortic and mitral valve disease relative to traditional surgical heart valve replacement.  The objective is to inform Medicare about this emerging technology. 
 
Although CMS is interested in the general issue of the comparative effectiveness of heart valve replacement, the immediate focus of this assessment is on PHV.   To that end, the report will consider PHVs in the context of valve replacement in general as well as offer a framework for assessing valve replacement technologies.

 Compendia Conflict of Interest

Dates: April 1, 2008 – September 30, 2008
 
PI: Ross McKinney, PhD
 
Project Type: Technology Assessment
 
Funders/Sponsors: Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS)
Aims/objectives:
Commercial drug compendia exert a strong influence on drug policy and decision-making. Many payors, including the Centers for Medicare and Medicaid Services (CMS) and private insurers, base reimbursement policies on the evidence included in specified compendia.  A recent CMS/AHRQ-sponsored technology assessment found, however, that the evidence in those compendia specified for off-label indications of anticancer drugs was frequently out-of-date or of poor quality. Moreover, there was little transparency in these compendia’s decision-making processes regarding up-dating of information and inclusion of specific agents, and little consistency in the information provided across compendia.  These findings raise legitimate concerns about the factors driving compendia development, one of which might be potential conflicts of interest (COIs).
 
The purpose of this project is to identify potential COIs in the production of drug compendia, and to describe the ways in which drug compendia developers address this potential.

Use of Bayesian Techniques in Randomized Clinical Trials: A CMS Case Study

Dates: 4/2007-9/2008
 
PI: Gillian Sanders, PhD
 
Project Type: Technology Assessment
 
Funders/Sponsors: Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS)
Aims/objectives:
The overall goal of the proposed research will be to provide the Centers for Medicare and Medicaid (CMS) with a general approach for assessing the use of Bayesian techniques in its evidence-based policy processes.
 
To reach this goal we will have three specific aims:
 
1) To provide a synthesis of exisiting research regarding the advantages and disadvantages of Bayesian techniques in clinical trial design and analysis, focusing on how such techniques can modify inferences that affect policy-level decision making. 
2) To explore Bayesian techniques in the CMS context through the specific clinical domain of the prevention of sudden cardiac death (SCD) and trials to determine the effective use of the implantable cardioverter defibrillator (ICD).  Based on existing data, we will simulate alternative analysis strategies using Bayesian and frequentist approaches, examining how these approaches may change the perceived value of specific treatment strategies in general and for important patient subgroups. 
3) To use the findings of specific aim 1 and 2 to determine lessons learned specific to the CMS context and to provide for CMS general guidelines for the inclusion of studies that apply Bayesian techniques; the circumstances in which such techniques may or may not be particularly appropriate; and how such techniques can be used in conjunction with other data sources available to CMS, such as registries.

Technology Assessment on Spinal Fusion for Treatment of Degenerative Disease Affecting the Lumbar Spine

Dates: 8/2006-6/2008 
                                           
PI: Douglas McCrory, MD, MHS
 
Project Type: Technology Assessment
 
Sponsor/Funder: The Centers for Medicare and Medicaid Services (CMS)
Aims/objectives:
CMS has requested a technology assessment on spinal fusion for treatment of degenerative disease affecting the lumbar spine.  The objective is to address specific questions about indications and outcomes of spinal fusion.  The report will consist of a systematic review discussing the indications and outcomes of lumbar spinal fusion used for either degenerative disk disease (DDD) and/or facet degenerative disease (DJD), leading to sponyloisthesis, spinal stenosis, or both. 
 

Horizon Scan: To What Extent do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base? 

Dates: 5/2007-4/2008
                                            
PI: Amy Abernethy, MD
 
Project Type: Technology Assessment
 
Funders/Sponsors: Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS)
Aims/objectives:
The objective of this project is to develop a white paper that will assist the Center for Medicare and Medicaid Services (CMS) in its decisions regarding payment policy, especially the timing of initiating coverage, for new therapeutic agents.  Specifically, our aims are to: (a) assess the extent to which changes in third-party payment policies affect the conduct of clinical trials, particularly the accrual and retention of patients to participate in trials; (b) consider the impact of differing payment structures for interventions being studied on patients? participation in those studies; and (c) describe the impact of these payment factors on the quality of subsequently accumulated evidence.
 
The following key questions will be addressed:
 
1) How do payment policies by CMS and other third-party payors affect enrollment into clinical trials?
2) How do payment policies by CMS and other third-party payors affect randomization and blinding within clinical trials?
3) What is the summary impact of this effect?
4) Does the timing of third-party payment in the clinical trial process impact the development of better evidence?
5) Do differing payment structures within clinical trials affect the resulting evidence?

Targeted Assessment on Targeted Therapies for Cancer 

Dates: 11/2006-4/2008
 
PI: Amy Abernethy, MD
                                            
Project Type: Systematic Review
 
Fundors/Sponsors: Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS)
Aims/objectives:
We proposed a systematic review aimed at assessing targeted anticancer chemotherapies.  The main focus of this work will be a systematic review of phase II or phase III clinical trials for the monoclonal antibody and small molecule anticancer therapies listed below used for indications other than their FDA-approved indications.  Given the rapid evolution of this literature, we will conduct a limited horizon scan on these agents and additional targeted monoclonal antibody and small molecule anticancer chemotherapies that have earlier clinical data (e.g. phase I trials only) or other prominent preclinical data.  The goal of this limited horizon scan is to put the current body of literature into context and to flag expected future directions.

Effectiveness and Efficiency of Assisted Reproductive Technology

Dates: 7/2005-2/2008
 
PI: Evan Myers, MD, MPH
 
Project Type: Systematic Review (Evidence Report)
                                            
Sponsor/Funder: Agency for Healthcare Research and Quality (AHRQ) and the National Institute of Health Office of Research on Women's Health 
Aims/objectives:
Reviews the evidence regarding short- and long-term outcomes of interventions used in ovulation induction, superovulation, and in vitro fertilization (IVF) for the treatment of infertility.
 
Key questions:
 
1) Among women of reproductive age, what are the benefits and risks of Clomid? and Pergonal? (or other injectable super-ovulatory drugs) and Glucophage?, and how do they vary in different patient populations?
2) Among women of reproductive age, which laboratory, clinical, and other practice approaches result in the highest successful singleton pregnancy (or live-born) rates, and what practices lead to high multiple rates?
3) What are the adverse outcomes of ovulatory drug-induced pregnancies and of pregnancies achieved with IVF?  Is there evidence to link these adverse outcomes with the treatments and not the underlying maternal health or gestational age problems?

Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Antagonists (ARBs) for Treating Essential Hypertension

Dates: 5/2006-5/2007
                                      
PI: David Matchar, MD, FACP, FAHA
 
Project Type: Systematic Review (Comparative Effectiveness Review)
 
Sponsor/Funder: Agency for Healthcare Research and Quality (AHRQ)
Aims/objectives:
Summarizes the evidence on the comparative long-term benefits and harms of ACEIs vs. ARBs, focusing on their use for treating essential hypertension in adults. Key questions:
 
1) For adult patients with essential hypertension, how do ACEIs and ARBs differ in blood pressure control, cardiovascular risk reduction, cardiovascular events, quality of life, and other outcomes?
2) For adult patients with essential hypertension, how do ACEIs and ARBs differ in safety, adverse events, tolerability, persistence, and adherence?
3) Are there subgroups of patients based on demographic characteristics (age, racial and ethnic groups, sex), use of other medications concurrently, or comorbidities for which ACEIs or ARBs are more effective, associated with fewer adverse events, or better tolerated?
 
Selected publications:
Comparative Effectiveness Review ? full report:  http://effectivehealthcare.ahrq.gov/repFiles/ACEI_ARBFullReport.pdf.
 
Comparative Effectiveness Review ? executive summary:  http://effectivehealthcare.ahrq.gov/repFiles/ACEI_ARBExecSummary.pdf.
 
Journal article: 
Matchar DB, McCrory DC, Orlando LA, Patel MR, Patel UD, Patwardhan MB, Powers B, Samsa GP, Gray RN. Systematic review: comparative effectiveness of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for treating essential hypertension. Annals of Internal Medicine 2008;148(1):16-29. (PMID: 17984484)

Compendia for Coverage of Off-label Uses of Drugs and Biologics in an Anticancer Chemotherapeutic Regimen 

Dates: 11/2006-4/2007
                                         
PI: Amy Abernethy, MD
 
Project Type: Technology Assessment
 
Funders/Sponsers: Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS)
Aims/objectives:
Describes the process by which anticancer drugs are added to published drug compendia of the sort used (by law) by CMS to inform coverage decisions; evaluates a selected set of compendia using pre-specified criteria to determine to what extent these compendia use evidence-based approaches in their collection, review, and reporting of the literature. Key questions:
 
1) How do the methods used to develop compendia listings compare to methods used to develop published guidelines, systematic reviews, and narrative reviews, and to the publication criteria used by journals? 
2) Describe the process by which anticancer drugs/biologics are added to the compendia, focusing on pre-specified topics (including criteria for weighing evidence, transparency, and conflict of interest).  
3) For selected off-label anticancer drugs/biologics, evaluate the compendia for level of detail in the evidence reviewed, explicit recommendations, silence (i.e., no listing), and possible bias.  
4) Is an analysis of potential harms and potential benefits included?  If yes, what components are used, and how are they quantified? 
5) For selected drugs/biologics, how do each compendium?s listings compare with its stated methods and with an independent review of the evidence?  
6) Do the compendia currently used by Medicare adhere to their stated criteria and processes in making recommendations?
 
Selected publications:
Technology Assessment:  http://www.cms.hhs.gov/determinationprocess/downloads/id46TA.pdf

Genomics Tests for Ovarian Cancer Detection and Management 

Dates: 9/2005-10/2006
                                         
PI: Evan Myers, MD, MPH
 
Project Type: Systematic Review (Evidence Report)
 
Sponsor/Funder: Agency for Healthcare Research and Quality (AHRQ) and the Centers for Disease Control and Prevention
Aims/objectives:
Summarizes the evidence for the diagnostic accuracy, benefits, and harms of genomic tests in screening and management of ovarian cancer in the clinical and public health settings. Key questions:
 
1) What is the evidence that ovarian cancer genomic tests performed in a typical clinical laboratory actually measure what they are purported to measure? 
2) What is the sensitivity and specificity of genomic tests in detecting ovarian cancer in asymptomatic and symptomatic women, including high-risk women?
3) What is the evidence that genomic testing to detect ovarian cancer in asymptomatic women, including high-risk women, changes clinical management and leads to improved health outcomes?
4) What is the evidence that genomic testing in women with clinical suspicion of ovarian cancer or with already-diagnosed ovarian cancer changes clinical management and leads to improved health outcomes?
5) What are the harms of using genomic tests for ovarian cancer prevention and management?
6) Has direct-to-consumer and direct-to-physician marketing of genomic tests on ovarian cancer increased the ?appropriate? use (as defined by study investigators) of these tests?
 
Selected publications:
 
Evidence Report ? structured abstract:  http://www.ahrq.gov/clinic/tp/genovctp.htm#Report.

Testing for Cytochrome P450 Polymorphisms in Adults with Non-Psychotic Depression Treated with Selective Serotonin Reuptake Inhibitors (SSRIs) 

Dates: 11/2005-9/2006
                                     
PI: David Matchar, MD, FACP, FAHA; Mugdha Thakur, MD
 
Project Type: Systematic Review (Evidence Report)
 
Sponsor/Funder: Agency for Healthcare Research and Quality (AHRQ) and the Centers for Disease Control and Prevention
Aims/objectives: 
Summarizes the evidence on testing for CYP450 polymorphisms in adults with non-psychotic depression initiating treatment with SSRIs, and ? where research is now insufficient for policy decision making ? proposes a list of rational research priorities. Key questions:  

1) Overarching question:  Does testing for cytochrome P450 (CYP450) polymorphisms in adults entering selective serotonin reuptake inhibitor (SSRI) treatment for non-psychotic depression lead to improvement in outcomes, or are testing results useful in medical, personal, or public health decision making?
2) What is the analytic validity of tests that identify key CYP450 polymorphisms?
3) How well do particular CYP450 genotypes predict metabolism of particular SSRIs?  Do factors such as race/ethnicity, diet, or other medications, affect this association?
4) How well does CYP450 testing predict drug efficacy?  Do factors such as race/ethnicity, diet, or other medications, affect this association?
5) How well does CYP450 testing predict adverse drug reactions?  Do factors such as race/ethnicity, diet, or other medications, affect this association?
6) Does CYP450 testing influence depression management decisions by patients and providers in ways that could improve or worsen outcomes?
7) Does the identification of the CYP450 genotypes in adults entering SSRI treatment for non-psychotic depression lead to improved clinical outcomes compared to not testing?
8) Are the testing results useful in medical, personal or public health decision making?
9) What are the harms associated with testing for CYP450 polymorphisms and subsequent management options?
 
Selected publications:
 
Evidence Report ? structured abstract:  http://www.ahrq.gov/clinic/tp/cyp450tp.htm#Report

Cancer Care Quality Measures: Diagnosis and Treatment of Colorectal Cancer

Dates: 12/2004-12/2005
                                    
PI: Meenal Patwardhan, MD, MHSA
 
Project Type: Systematic Review (Evidence Report)
 
Fundors/Sponsors: Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), and the National Cancer Institute (NCI)
Aims/objectives:
Identifies measures currently available to assess the quality of care provided to patients with colorectal cancer and assesses the extent to which these measures have been developed and tested. Key questions:
 
1) What quality-of-care measures are available and what evidence is available for these measures to assess the quality of diagnosis of colorectal cancer, including: (a) appropriate use of colon imaging, endoscopic visualization, and biopsy; and (b) availability and accuracy of pathologic staging?
2) As appropriate to specific stages of colorectal cancer, what quality-of-care measures are available and what evidence is available for measures of quality of care of treatment of colorectal cancer, including: (a) polypectomy for malignant polyps, including evaluation of surgical margins; (b) surgical therapy for colon and rectal cancers; (c) appropriate use of adjuvant chemotherapy and adjuvant radiation therapy, including for patients with metastatic but potentially curable (hepatic/pulmonary-resectable) disease; and (d) appropriate use of radiation therapy for either curative or palliative therapy, specifically for rectal cancers?
3) What quality-of-care measures are available and what evidence is available for measures of colonoscopic surveillance for colorectal cancer?
4) What measures are available and what evidence is available for measures to assess the adequacy and completeness of documentation of pathology, operative, and chemotherapy reports?
5) For questions 1-4 above: (a) in what patient populations and for what purposes have these quality-of-care measures been used; and (b) does evidence support the use of any of these measures to assess differences in quality of care across patients? age, race/ethnicity, and/or socioeconomic status?
 
Selected publications:
 
Evidence Report ? structured abstract:  http://www.ahrq.gov/clinic/tp/colcanqmtp.htm

Management of Adnexal Mass 

Dates: 9/2004-9/2005
 
PI: Evan Myers, MD, MPH
 
Project Type: Systematic Review (Evidence Report)
 
Sponsor/Funder: Agency for Healthcare Research and Quality (AHRQ) and the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention (CDC)
Aims/objectives:
Summarizes the evidence on diagnostic strategies for distinguishing benign from malignant adnexal masses in peri- and post-menopausal women. Key questions:
 
1) What is the prevalence of various tumor types among women with an adnexal mass, stratified by cancer status (malignant vs. benign), age, menopausal status, and size of tumor?
2) What are the sensitivity, specificity, and reproducibility of the bimanual pelvic examination?
3) Among women with a palpable adnexal mass on exam or a mass identified by ultrasound/imaging, what is the sensitivity/specificity of various evaluation modalities including ultrasound (transvaginal ultrasound, transabdominal ultrasound, color Doppler, two-dimensional vs. three-dimensional ultrasound), computer tomography (CT) scan, magnetic resonance imaging (MRI) scan, and cancer antigen 125 (CA-125) levels for diagnosing malignant masses? 
4) What is the accuracy of explicit scoring systems which incorporate various combinations of imaging findings, patient risk factors, and/or CA-125 levels for detecting malignancy?  Have these scoring systems been applied to a population of women before laparoscopy or laparotomy?
5) Among women with suspected benign masses on initial investigation, what are the sensitivity and specificity of monitoring with periodic CA-125 and/or interval ultrasound examinations for detecting malignant masses?  How does the interval of testing/definition of change affect sensitivity and predictive value? 
6) Among women with adnexal masses, what are the morbidity and mortality from diagnostic surgery (laparoscopy or laparotomy)?  At what point does the risk of surgery outweigh the risk of detecting malignancy?   
7) What are the estimated trade-offs resulting from various strategies for evaluation of the adnexal mass?

Selected publications:
 
Evidence Report ? structured abstract:  http://www.ahrq.gov/clinic/tp/adnextp.htm#Report                               

 

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