Evaluation of atypical presentation of angina chest pain in emergency department is difficult. Hospitalization of this patient may impose additional costs and waste the time, early discharge may lead to miss the patients. The aim of this study was to determine volubility of Single Photon Emission Computed Tomography (SPECT) in management of patients admitted to emergency department with atypical manifestations of angina pain, un-diagnostic Electrocardiogram (ECG) and negative enzyme. Half of 100 patients admitted to emergency department with atypical chest pain and un-diagnostic ECG who were candidate for admission, underwent ECG gated resting SPECT. According to the results of SPECT, low risk patient discharged after negative stress SPECT. All discharged patients were followed up for major cardiac events (cardiac death, nonfatal myocardial infarction and repeat admission for congestive heart failure) for 12 months. According to rest SPECT Myocardial Perfusion Imaging (MPI), about 70% of patients in case group was low risk and 30% of them had moderate or high risk. Case group represented lower hospitalization rate and lower need for Coronary Artery Angiography (CAG) in comparison with control group. Mean cost in case group was significantly lower than control group (175.15$ vs. 391.33$, P < 0.001). In one year follow- up no cases of mortality or major cardiovascular events as cardiac infraction were found in discharged patients in case group. our study showed that rest SPECT fulfillment in admitted patients in emergency department was validated method for assessing patients' risk which avoids unnecessary hospitalizations and additional costs.

The last twenty years have seen an explosive growth in cardiovascular disease research. The purpose of our study was to evaluate the characteristics of published research in the field of non-invasive cardiovascular imaging research from 1991-2011. Our aims were to determine: (1) the origin of the studies (international or from the U.S.) (2) differences in funding sources for U.S. publications and (3) if there has been an evolving trend pertaining to the mode of imaging. We evaluated characteristics of original research articles from Circulation, Circulation cardiovascular imaging, Journal of the American College of Cardiology (JACC), Journal of the American College of Cardiology cardiovascular imaging, Journal of the American Medical Association and the New England Journal of Medicine for the years 1991-91, 2001-02 and 2010-11. To establish trends for contributions for U.S. based studies and proportions of U.S. based studies receiving NIH funding in the study period, data was compared using a chi-square test. A two sided p value of less than or equal to 0.05 was used as the threshold for significance. Differences in modes of imaging under study were made by comparing average number of publications between the data sets in the study period using a t-test analysis. A total of 5431 studies were reviewed; 594 studies were selected as per the standardized abstraction criteria. U.S. based publications outnumbered international publications; its' share declined from 77% in 1991-92 to 57% in 2010-2011 (p<0.0001). Funding for U.S. publications by the National Institutes of Health (NIH) remained static (1991-92: 40%; 2001-02: 49%; 2010-11: 42%). A decline was seen in the investigation of echocardiography (47%, p=0.44); cardiac computed tomography and cardiac magnetic resonance imaging studies grew 6.5 times (p=0.002) and 7-fold (p=0.01) respectively. Nuclear cardiology imaging fell by more than 50% (p=0.02). The last twenty years have seen a globalization of research in non-invasive cardiovascular imaging with a shift in focus towards investigation of cardiac magnetic resonance imaging. The decline in U.S. based publications coupled with a stasis in NIH funding may call for increased federal support for non-invasive imaging research.

To understand how people value information from diagnostic technologies, we reviewed and analyzed published willingness-to-pay (WTP) studies on the topic.

We searched PubMed for English-language articles related to WTP for diagnostic laboratory tests published from 1985 through 2011. We characterized methodological differences across studies, examined individual- and technology-level factors associated with WTP, and summarized median WTP values across different diagnostic tests.

We identified 66 relevant WTP studies. Half focused on oncology, while others analyzed infectious diseases (n = 11, 16.1%) and obstetric or gynecological conditions (n = 8, 11.7%), among others. Most laboratory tests included in studies were biological samples/genetic testing (n = 44, 61.1%) or imaging tests (n = 23, 31.9%). Approximately one third of the analyses (n = 20, 30.3%) used discrete-choice questions to elicit WTP values. Higher income, education, disease severity, perceived disease risk, family history, and more accurate tests were in general associated with higher WTP values for diagnostic information. Of the 44 studies with median WTP values available, most reported a median WTP value below $100. The median WTP value for colon or colorectal cancer screening ranged from below $100 to over $1000.

The contingent valuation literature in diagnostics has grown rapidly, and suggests that many respondents place considerable value on diagnostic information. There exists, however, great variation in studies with respect to the type of technologies and diseases assessed, respondent characteristics, and study methodology. The perceived value of diagnostic technologies is also influenced by the study design and elicitation methods.

Recent studies have demonstrated a superior diagnostic accuracy of cardiovascular magnetic resonance (CMR) for the detection of coronary artery disease (CAD). We aimed to determine the comparative cost-effectiveness of CMR versus single-photon emission computed tomography (SPECT).

Based on Bayes' theorem, a mathematical model was developed to compare the cost-effectiveness and utility of CMR with SPECT in patients with suspected CAD. Invasive coronary angiography served as the standard of reference. Effectiveness was defined as the accurate detection of CAD, and utility as the number of quality-adjusted life-years (QALYs) gained. Model input parameters were derived from the literature, and the cost analysis was conducted from a German health care payer's perspective. Extensive sensitivity analyses were performed.

Reimbursement fees represented only a minor fraction of the total costs incurred by a diagnostic strategy. Increases in the prevalence of CAD were generally associated with improved cost-effectiveness and decreased costs per utility unit (ΔQALY). By comparison, CMR was consistently more cost-effective than SPECT, and showed lower costs per QALY gained. Given a CAD prevalence of 0.50, CMR was associated with total costs of €6,120 for one patient correctly diagnosed as having CAD and with €2,246 per ΔQALY gained versus €7,065 and €2,931 for SPECT, respectively. Above a threshold value of CAD prevalence of 0.60, proceeding directly to invasive angiography was the most cost-effective approach.

In patients with low to intermediate CAD probabilities, CMR is more cost-effective than SPECT. Moreover, lower costs per utility unit indicate a superior clinical utility of CMR.

The detection and quantification of coronary artery calcification (CAC) significantly improves cardiovascular risk prediction in asymptomatic patients. Many have advocated for expanded CAC testing in symptomatic patients based on data demonstrating that the absence of quantifiable CAC in patients with possible angina makes obstructive coronary artery disease (CAD) and subsequent adverse events highly unlikely. However, the widespread use of CAC testing in symptomatic patients may be limited by the high background prevalence of CAC and its low specificity for obstructive CAD, necessitating additional testing ('test layering') in a large percentage of eligible patients. Further, adequately powered prospective studies validating the comparative effectiveness of a 'CAC first' approach with regards to cost, safety, accuracy and clinical outcomes are lacking. Due to marked reductions in patient radiation exposure and higher comparative accuracy and prognostic value make coronary computed tomographic angiography the preferred CT-based test for appropriately selected symptomatic patients.

The aim of this study was to systematically review the reporting of the value of imaging unrelated to treatment consequences and test characteristics in all imaging-related published cost-utility analyses (CUAs) in the medical literature.

All CUAs published between 1976 and 2008 evaluating diagnostic imaging technologies contained in the CEA Registry, a publicly available comprehensive database of health related CUAs, were screened. Publication characteristics, imaging modality, and the inclusion of test characteristics including accuracy, costs, risks, and the potential value unrelated to treatment consequences (eg, reassurance or anxiety) were assessed.

Ninety-six published CUAs evaluating 155 different imaging technologies were included in the final sample; 27 studies were published in imaging-specialized journals. Fifty-two studies (54%) evaluated the performance of a single imaging modality, while 44 studies (46%) compared two or more different imaging modalities. The most common areas of interest were cardiovascular (45%) and neuroradiology (17%). Forty-two technologies (27%) concerned ultrasound, while 34 (22%) concerned magnetic resonance. Seventy-nine (51%) technologies used ionizing radiation. Test accuracy was reported or calculated for 90% (n = 133 and n = 5, respectively) and assumed perfect (reference test or gold-standard test without alternative testing strategy to capture false-negatives and false-positives) for 8% (n = 12) of technologies. Only 22 studies (23%) assessing 40 imaging technologies (26%) considered inconclusive or indeterminate results. The risk of testing was reported for 32 imaging technologies (21%). Fifteen studies (16%) considered the value of diagnostic imaging unrelated to treatment. Four studies incorporated it as quality-of-life adjustments, while 10 studies mentioned it only in their discussions or as a limitation.

The intrinsic value of imaging (the value of imaging unrelated to treatment) has not been appropriately defined or incorporated in the existing cost-utility literature, which could be due to a lack of evidence on the issue. Thus, more research is needed on metrics for a more comprehensive evaluation of diagnostic imaging. Similarly, the incorporation of variations in imaging tests accuracy, inconclusive results and associated risks has lacked uniformity in the cost-utility literature. Acknowledgment of these characteristics in future cost-utility publications will enhance their value and provide results that more closely resemble routine clinical practice.

This report summarizes the Joint FDA-MIPS Workshop on Methods for the Evaluation of Imaging and Computer-Assist Devices. The purpose of the workshop was to gather information on the current state of the science and facilitate consensus development on statistical methods and study designs for the evaluation of imaging devices to support US Food and Drug Administration submissions. Additionally, participants expected to identify gaps in knowledge and unmet needs that should be addressed in future research. This summary is intended to document the topics that were discussed at the meeting and disseminate the lessons that have been learned through past studies of imaging and computer-aided detection and diagnosis device performance.

To review and evaluate the literature of cost-utility analyses (CUAs) regarding diagnostic laboratory testing.

We reviewed all articles related to diagnostic laboratory testing in the Tufts Medical Center Cost-Effectiveness Analysis Registry (www.cearegistry.org), which contains detailed information on over 2000 published CUAs through 2008. We analyzed the extent to which the studies adhered to recommended practices for conducting and reporting cost-effectiveness analyses. We also recorded whether the studies contained information on diagnostic test accuracy and costs, and whether any account was taken of potential benefits or harms of testing that are unrelated to subsequent treatment, such as the reassurance value of testing.

We identified 141 published CUAs pertaining to diagnostic laboratory testing published through 2008 which contained 433 separate incremental cost-effectiveness ratios. Prior to 2000, there were only 20 CUAs published, but the number averaged 13.4 annually thereafter. Most studies focused on hematology/oncology (n = 42, 30%) and obstetrics/gynecology (n = 36, 26%) applications. Approximately 63% (n = 89) of studies clearly reported information about the accuracy of the test, but only 10% (n = 14) mentioned test safety or possible risks. A small number (n = 10, 7%) mentioned or considered the potential value or harm of testing unrelated to treatment consequences. Over 55% of the reported incremental cost-effectiveness ratios (ICERs) were either dominant (more quality-adjusted life years for less cost), or below $50,000 per quality-adjusted life years gained (in 2008 US dollars).

The number of CUAs investigating laboratory diagnostic testing has increased substantially with applications to diverse clinical areas. The literature reveals many areas in which testing represents good value for money. The vast majority of studies have not considered preferences for test information unrelated to treatment consequences.