Point of care laboratory testing is the most rapidly growing segment of the clinical laboratory market, with a projected increase in sales from $4.2 billion to $6.2 billion between 2002 and 2007, representing an 8.1% increase. The rising prevalence of this technology will present the Centers for Medicare and Medicaid Services (CMS) with a variety of issues surrounding the quality of care and cost effectiveness for Medicare beneficiaries. CMS has requested objective data in the form of technology assessments to better inform coverage and payment decisions that CMS will need to make in the future.

The present evaluation of quality of life for patients with age-related macular degeneration (AMD) was designed to respond to three specific questions posed by the Centers for Medicare and Medicaid Services (CMS): 1. What is the status of current methods of measuring quality of life of individuals with AMD?1.1. What QoL measurement methods have been used in the AMD population and in those with visual disabilities from AMD (e.g., self-reporting, proxy reporting, measuring performance, etc.)?1.2. Have these QoL measuring methods been used across other eye disease populations?1.3. What are the psychometric properties of these methods (e.g., reliability, validity, responsiveness, etc.)?2. What are other factors that may influence responses using these methods?3. How do these QoL measurement methods relate to traditional outcome measures (e.g., visual acuity, contrast, etc.)?In performing this assessment related to AMD and health-related quality of life, we chose to focus on those methods and instruments that have been used in AMD populations. Thus, the instruments considered under Question 1b are a subset of the instruments considered under Question 1a, not vice versa. In other words, while there are many instruments that have been used for eye diseases other than AMD, if they have not also been used for AMD they were not included in this report. Conversely, for those instruments that have been used in patients with AMD, applications to patients with other types of eye disease were also of interest. Accordingly, our search and inclusion strategies (described below) were first focused toward attempting to find and include all articles pertaining to patients with AMD, and then in finding applications of these instruments outside of AMD. In the following section, we describe the general methods of this assessment.

The Agency for Healthcare Research and Quality (AHRQ), on behalf of the Centers for Medicare and Medicaid Services (CMS), has requested a technology assessment on transmyocardial laser revascularization (TMR) and percutaneous myocardial laser revascularization (PMR) in preparation for a Medicare Coverage Advisory Committee meeting on this topic. The specific aims of this technology assessment are as follows: 1. Provide a summary and description of the technology.2. Review the peer-reviewed clinical literature on the outcomes associated with the use of: 1.1. TMR as a stand-alone procedure; 1.2. TMR used together with coronary artery bypass grafting (CABG);1.3. PMR.3. Review of available information on clinical trials underway as a horizon scan for this technology. In addition, studies on the mechanism of action and the specific lasers used for each of the procedures were reviewed, and a description of those findings is included in this report.

The use of Bayesian statistical approaches has gained broader acceptance within the clinical trial community. The impact of these methods on CMS decisional contexts and policy-level decisionmaking however was uncertain. Our analyses explore the main proclaimed advantages of Bayesian statistics (namely, the use of prior information, sample size determination, borrowing strength from different trials, and sequential monitoring of trials) and provide examples of decisionmaking situations where the findings reached using these approaches both agree with and differ from findings reached using frequentist statistical techniques. Our findings confirm that, like classical techniques, Bayesian approaches are affected by the problems of model specification (i.e., the relationship between various factors - patient, provider, intervention, and other contextual features - and the outcome of interest). In addition, Bayesian approaches can be substantially affected by the "Bayesian prior" - the representation of beliefs about the quantity of interest (e.g., relative risk of events when a new device is used vs. a conventional device). Thus, when considering using or interpreting Bayesian analyses, the focus of attention and thoughtful ex ante agreement are the specification of the model and specification of the Bayesian prior. The case study of the use of ICD therapy in the prevention of sudden cardiac death demonstrates the application of these techniques and highlights some of the practical challenges. The use of Bayesian statistical approaches, and incorporation of our findings concerning their strengths and limitations into the CMS decisionmaking process will enable policymakers to harness the power of the available sources of clinical evidence, explore subgroup effects within a trial and across trials in a methodologically rigorous manner, assess the uncertainty in clinical trial findings, and - ideally - improve health outcomes for Medicare beneficiaries.

In December of 2001, the Duke Evidence Practice Center (EPC) completed a technology assessment to review the existing scientific evidence with regard to the role of 2-Fluoro 2-deoxy D-glucose Positron Emission Tomography (FDG-PET) in assisting with the diagnosis of early dementia in elderly patients for whom the differential diagnosis included one or more kinds of neurodegenerative disease. There were two main conclusions 1) PET improves the overall accuracy of diagnosis compared to accuracy of an examination based on American Academy of Neurology (AAN) guidelines and 2) treatment based on a standard AAN-recommended examination leads to better health outcomes than treatment based on PET results. This result was robust to a broad range of assumptions. Based on the assumption that new data may have been published since 2000 that may impact these original findings, CMS requested an update of the technology assessment. In order to identify literature that would clarify the role of FDG-PET for use in these patients, a revised review was conducted to address three separate areas in which PET might be useful: diagnosis, prognosis and response to therapy. Twenty-two studies were initially identified for abstract review. Based on a review of these studies, including references and input from experts, four studies were identified for full text review. One examined the use of PET in distinguishing Parkinsonian dementia from AD (Bohnen, 2003). Three other studies described the ability of FDG-PET to predict progression to AD in patients with mild cognitive impairment (Chetelat, 2003; Arnaiz 2001; Silverman 2003). Of the four studies identified for full text review, one examined the use of PET in distinguishing Parkinsonian dementia from AD (Bohnen, 2003). The three other studies described the ability of FDG-PET to predict progression to AD in patients with mild cognitive impairment (Chetelat, 2003; Arnaiz 2001; Silverman 2003). Based on a review of these articles, there are two conclusions. 1) Publications since the prior TA do not provide evidence supporting revised estimates of the operating characteristics of PET for discriminating AD from other competing diagnoses. 2) Three studies suggest FDG-PET could be valuable for distinguishing patients with MCI who rapidly convert to frank AD. Two were relatively small studies that require validation and assessment of incremental value above conventional clinical measures. A third, larger study of FDG PET for prediction of progression for patients with MCI also suggests a potential role for PET in predicting clinical course for patients with dementia. However, this study did not comment on findings for patients with AD only, and results for PET, while suggestive of higher sensitivity and specificity, did not differ in a statistically significant manner from clinical findings. In addition, CMS requested that the Duke EPC review and summarize in the form of an annotated bibliography, the existing scientific evidence with regard to the role of single-photon emission CT (SPECT), volumetric assessment by computed tomography or magnetic resonance imaging (Volumetric CT/MRI), functional magnetic resonance imaging (fMRI), and magnetic resonance spectroscopy (MRS) in the diagnosis, prognosis and estimates of responsiveness to treatment for patients with cognitive abnormalities. Of 472 articles initially identified for abstract review, 12 articles for SPECT, 9 for Volumetric CT/MRI, 2 for fMRI, and 4 for MRS eventually met all inclusion criteria and are summarized as an annotated bibliography.

This report describes an evaluation of the available scientific evidence on direct non-invasive imaging tests (NITs) for coronary artery disease. In particular, we focus on six key questions provided by the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Medicare and Medicaid Services (CMS). The objective of this report is to provide background information to the Medicare Coverage Advisory Committee (MCAC) in their review of these questions during their May 2006 meeting. The six key questions examine the degree to which current evidence supports confident judgments about the use of NITs in the assessment of coronary anatomy in clinical practice. The two NITs that are examined in detail in this report are computed tomographic angiography (CTA) and magnetic resonance angiography (MRA) for evaluating native coronary arteries. In addition, we consider technologies on the horizon, as well as the general issue of establishing the value of NITs in specific clinical contexts in which coronary disease is being considered.

The Centers for Medicare & Medicaid Services (CMS) requested a technology assessment by the Agency for Health Care Research and Quality (AHRQ) to evaluate the performance of 2-Fluro 2-deoxy D-glucose positron emission tomography (FDG-PET) when compared to conventional imaging (such as computed tomography (CT) and magnetic resonance imaging (MRI)) and when used as an adjunct to conventional imaging for patient management of six different cancers (brain, cervical, ovarian, pancreatic, small cell lung, and testicular). The Duke Evidence-based Practice Center was asked to conduct an assessment of this technology.