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PubMed1996

Accurate detection of coronary artery disease by integrated analysis of the ST-segment depression/heart rate patterns during the exercise and recovery phases of the exercise electrocardiography test.

In this comparative cross-sectional study, we evaluated whether a novel computerized diagnostic variable, ST-segment depression/heart rate ST/HR analysis during both the exercise and postexercise recovery phases of the exercise electrocardiography (ECG) test, can detect coronary artery disease more accurately than methods using either exercise or recovery phase alone. The study population comprised 347 clinical patients referred for a routine bicycle exercise ECG test at Tampere University Hospital, Finland. Of these, 127 had angiographically proven coronary artery disease, whereas 13 had no coronary artery disease according to angiography, 18 had no perfusion defect according to technetium-99m sestamibi single-photon emission computed tomography, and 189 were clinically normal with respect to cardiac diseases. For each patient, the maximum values of the ST/HR hysteresis, ST/HR index, end-exercise ST depression, and recovery ST depression were determined from the Mason-Likar modification of the standard 12-lead exercise electrocardiogram [aVL, aVR, and V1 excluded]. The diagnostic performance of these continuous diagnostic variables was compared by means of receiver-operating characteristic analysis. The area under the receiver-operating characteristic curve of the ST/HR hysteresis was 89%, which was significantly larger than that of the end-exercise ST depression (76%, p < or = 0.0001), recovery ST depression (84%, p = 0.0063), or ST/HR index (83%, p = 0.0023), indicating superior diagnostic performance of the ST/HR hysteresis independent of the partition value selection. In conclusion, computerized analysis of the HR-adjusted ST depression pattern during the exercise phase, integrated with the HR-adjusted ST depression pattern during the recovery phase after exercise, can significantly improve the diagnostic performance and clinical utility of the exercise ECG test for the detection of coronary artery disease.

Adult↗

PubMedDate not supplied

Solitary pulmonary nodules: a comparative study evaluated with contrast-enhanced dynamic MR imaging and CT.

OBJECTIVE: The aim of this prospective study was to compare the diagnostic performances of dynamic MR imaging and CT for the differentiation of benign and malignant solitary pulmonary nodules (SPNs). METHODS: Eighty-one patients with SPNs (32 malignant, 49 benign) underwent dynamic MR imaging (n=31), dynamic CT (n=27), or both (n=23). The degree of peak enhancement of benign and malignant SPNs was compared on both dynamic MR imaging and CT. Receiver operating characteristic (ROC) analysis was performed to compare the diagnostic performances of dynamic MR imaging and CT. RESULTS: The malignant SPNs revealed significantly greater degrees of peak enhancement on dynamic MR imaging (mean +/- SD [p%SI] 131.2 +/- 46.1 versus 54.2 +/- 45.3; range [p%SI] 82.6-260.0 versus -0.7-171.7; P <0.0001) and CT (mean +/- SD [DMI] 37.8 +/- 15.1 versus 17.9 +/- 21.8; range [DMI] 14.1-68.2 versus -5.4-107.6; P=0.0004). Although dynamic MR imaging was somewhat superior to dynamic CT, the diagnostic performances of the 2 modalities based on ROC analysis were not statistically significant. CONCLUSIONS: Dynamic MR imaging and CT seem to be equally well suited for the differentiation between benign and malignant SPNs.

Adolescent↗

PubMed2006

Development and validation of pheochromocytoma of the adrenal gland scaled score for predicting malignant pheochromocytomas.

OBJECTIVES: To evaluate the diagnostic performances of the pheochromocytoma of the adrenal gland scaled score (PASS) proposed in a previous report and that of a logistic model developed in this investigation. METHODS: In all 130 patients with malignant or assumed benign pheochromocytomas, 15 predictive variables were observed. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the diagnostic performance of PASS. The logistic model was developed using the 15 predictive variables. Its performance was evaluated by calculating the area under the ROC curve and comparing it with that of the PASS. RESULTS: The PASS had the area under the ROC curve of 0.899 (95% confidence interval 0.844 to 0.954). Of the 15 variables entered in the logistic regression analysis, 9 were retained in the model. The area under the ROC curve for the logistic model was 0.983 (95% confidence interval 0.967 to 0.998). CONCLUSIONS: ROC analysis indicated that the PASS could be used for the diagnosis of malignant pheochromocytomas. The logistic model was able to improve the diagnostic performance of the PASS using a different variable weighting method. We emphasize, however, that a clinical prospective evaluation is needed to confirm their actual value.

Adrenal Gland Neoplasms↗

PubMedDate not supplied

Complication rates of diagnostic angiography performed by vascular surgeons.

The objective of this study was to compare the complication rates of diagnostic angiography performed by vascular surgeons to those previously published by interventional radiologists. From May 1999 through August 2000, 3 board-certified vascular surgeons performed 224 endovascular procedures in a modern endovascular suite. Of these 224 procedures, 144 were diagnostic angiographies. A retrospective chart review was conducted to identify periprocedural complications of these angiographies. The patients were classified into 3 groups according to the indication for angiography, and the major and overall complication rates were tabulated. The complication rates for the initial 25 and subsequent 119 arteriographies were compared to evaluate the presence of a learning curve. Thirty-eight percent of angiographies were performed to define aneurysmal anatomy (type I), 51% to define peripheral arterial stenosis or occlusion (type II), and 12% to assess symptomatic carotid artery disease or mesenteric ischemia (type III). The major complication rates for these 3 types were 0%, 2.7%, and 5.9%, respectively, and showed no statistical difference (Fischer's exact test) compared to published rates of 0.7%, 2.9%, and 9.1%. Major complications included an external iliac artery dissection, a cerebral air embolus, and a deep venous thrombosis. The overall major complication rate was 2.1%, which compares to published rates of 1.9-2.9%. The major complication rates for the initial 25 and final 119 were 8% and 0.8%, respectively. Vascular surgeons can perform diagnostic angiography with acceptable complication rates. The complication rate is reduced with angiographic experience.

Aged↗

PubMed2003

MR imaging of the menisci and cruciate ligaments: a systematic review.

PURPOSE: To systematically review and synthesize published data on the diagnostic performance of magnetic resonance (MR) imaging of the menisci and cruciate ligaments and to assess the effect of study design characteristics and magnetic field strength on diagnostic performance. MATERIALS AND METHODS: Articles published between 1991 and 2000 were included if at least 30 patients were studied, arthroscopy was the reference standard, the magnetic field strength was reported, positivity criteria were defined, and the absolute numbers of true-positive, false-negative, true-negative, and false-positive results were available or derivable. Pooled weighted and summary receiver operating characteristic (ROC) analyses were performed for tears of both menisci and both cruciate ligaments separately and for the four lesions combined, by using random effects models. Differences were assessed according to lesion type. RESULTS: Twenty-nine of 120 retrieved articles were included. Pooled weighted sensitivity was higher for medial meniscal tears than that for lateral meniscal tears. However, pooled weighted specificity for the medial meniscus was lower than that for the lateral meniscus. In summary ROC analyses performed per lesion, various study design characteristics were found to influence diagnostic performance. Higher magnetic field strength significantly improved discriminatory power only for anterior cruciate ligament tears. When all lesions were combined in one overall summary ROC analysis, magnetic field strength was a significant but modest predictor of diagnostic performance. CONCLUSION: Diagnostic performance of MR imaging of the knee is different according to lesion type and is influenced by various study design characteristics. Higher magnetic field strength modestly improves diagnostic performance, but a significant effect was demonstrated only for anterior cruciate ligament tears.

Anterior Cruciate Ligament Injuries↗

PubMed2005

[Measures for the performance of diagnostic tests].

Systematic reviews have revealed that the methodological quality of studies on diagnostic accuracy is mediocre. In addition, clinicians may experience difficulties in interpreting and using measures describing the accuracy of a test. Using the Ottawa Ankle Rule as an example, we review the measures commonly used to describe the accuracy of diagnostic tests. The performance of tests is often given in terms of sensitivity and specificity. However, these measures have no relevance to clinicians unless they can be converted into predictive values. We describe how to calculate the predictive values and how they can be determined using likelihood ratios and Fagan's nomogram. The reader is introduced to the critical appraisal of results based on studies of the accuracy of tests. We describe how both the clinical spectrum and the methodological quality can influence estimates of diagnostic accuracy and stress the inevitable uncertainty involved in extrapolating results from the literature to clinical practice. Methods of calculating the confidence intervals for estimates of accuracy are presented.

Ankle Injuries↗

PubMedDate not supplied

Realities of diagnosing Helicobacter pylori infection in clinical practice: a case for non-invasive indirect methodologies.

BACKGROUND: The current, arbitrarily defined gold standard for the diagnosis of H. pylori infection requires histologic examination of two specially stained antral biopsy specimens. However, routine histology is potentially limited in general clinical practice by both sampling and observer error. The current study was designed to examine the diagnostic performance of invasive and non-invasive H. pylori detection methods that would likely be available in general clinical practice. METHODS: The diagnostic performance of rotating clinical pathology faculty using thiazine staining was compared with that of an expert gastrointestinal pathologist in 38 patients. In situ hybridization stains of adjacent biopsy cuts were also examined by the expert pathologist for further comparison. Receiver operator characteristic (ROC) analysis was performed to evaluate whether the diagnostic performance of the expert pathologist differed depending upon the histologic method employed. A similar analysis was made to evaluate the diagnostic performance of pathology trainees relative to the expert. In the absence of an established invasive gold standard, non-invasive testing methods (rapid serum antibodies, formal Elisa antibodies and carbon-14 urea breath testing) were evaluated in 74 patients by comparison with a gold standard defined using a combination of diagnostic tests. RESULTS: Using either rapid urease testing of biopsy specimens or urea breath testing as the gold standard for comparison, the diagnostic performance of the rotating clinical pathology faculty was inferior to that of the expert gastrointestinal pathologist especially with regard to specificity (e.g., 69 percent for the former versus 88 percent, with the latter relative to rapid urease testing). Although interpretation of in situ hybridization staining by the expert appeared to have an even higher specificity, ROC analysis failed to show a difference. The mean ROC areas for thiazine and in situ hybridization staining for trainee pathologists relative to the expert were 0.88 and 0.94, respectively. In untreated patients, urea breath testing had a sensitivity and specificity of 100 percent as compared with thiazine staining with a sensitivity of 83 percent and a specificity of 97 percent. Post-therapy, breath testing had a sensitivity of 100 percent but a specificity of only 86 percent as compared with invasive testing with a sensitivity and specificity of 100 percent. Rapid serum antibody testing and formal Elisa antibody testing agreed in 93 percent of cases (Kappa 0.78) with the rapid test being correct in three of the four disagreements. CONCLUSIONS: The current study illustrates a number of realities regarding H. pylori diagnosis. There is no diagnostic gold standard in general clinical practice. Accurate interpretation of specially stained slides is a learned activity with a tendency towards overdiagnosis early on. Urea breath testing is likely to be the diagnostic method of choice for untreated patients in general clinical practice although antibody testing is almost as accurate. Rapid antibody tests are at least as accurate as formal Elisa antibody tests. Urea breath testing is useful for confirming cure after therapy, but false-positive results may occur in some patients.

Biopsy↗

PubMed2002

Performance of diagnostic mammography for women with signs or symptoms of breast cancer.

BACKGROUND: The performance of diagnostic mammography for women with signs or symptoms of breast cancer has not been well studied. We evaluated whether age, breast density, self-reported breast lump, and previous mammography influence the performance of diagnostic mammography. METHODS: From January 1996 through March 1998, prospective diagnostic mammography data from women aged 25-89 years with no previous breast cancer were linked to cancer outcomes data in six mammography registries participating in the Breast Cancer Surveillance Consortium. We used the final mammographic assessment at the end of the imaging work-up to determine abnormal mammographic examination rate, positive predictive value (PPV), sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve. We used age, breast density, prior mammogram, and self-reported breast lump jointly as predictors of performance. All statistical tests were two-sided. RESULTS: Of 41 427 diagnostic mammograms, 6279 (15.2%) were judged abnormal. The overall PPV was 21.8%, sensitivity was 85.8%, and specificity was 87.7%. Multivariate analysis showed that sensitivity and specificity generally declined as breast density increased (P =.007 and P<.001, respectively), that previous mammography decreased sensitivity (odds ratio [OR] = 0.52, 95% confidence interval [CI] = 0.36 to 0.74; P<.001) but increased specificity (OR = 1.43, 95% CI = 1.31 to 1.57; P<.001), and that a self-reported breast lump increased sensitivity (OR = 1.64, 95% CI = 1.13 to 2.38; P =.013) but decreased specificity (OR = 0.54, 95% CI = 0.49 to 0.59; P<.001). ROC analysis showed that higher breast density and previous mammography were negatively related to accuracy (P<.001 for both). CONCLUSIONS: Diagnostic mammography in women with signs or symptoms of breast cancer shows higher sensitivity and lower specificity than screening mammography does. Higher breast density and previous mammographic examination appear to impair performance.

Adult↗

PubMed2003

Detection of subtle undisplaced rib fractures in a porcine model: radiation dose requirement--digital flat-panel versus screen-film and storage-phosphor systems.

PURPOSE: To compare a large-area direct read-out flat-panel detector radiography system with screen-film and storage-phosphor systems with regard to detection of subtle undisplaced rib fractures and to assess the diagnostic performance of the flat-panel system with decreasing exposure level. MATERIALS AND METHODS: Subtle fractures were created artificially in 100 of 200 porcine rib specimens. Specimens were enclosed in containers of water to generate absorption and scatter radiation conditions similar to those of a human chest wall. Imaging was performed with flat-panel, screen-film, and storage-phosphor systems with conditions that were exactly matched. Different exposure levels equivalent to speed classes (S) of 400, 800, 1,600, and 6,400 were used. All images were independently assessed for the presence of fracture by three radiologists with a five-level confidence scale. Receiver operating characteristic (ROC) analysis was performed for a total of 4,200 observations (600 for each imaging system and exposure level). Diagnostic performance was estimated with area under the ROC curve (Az). Significance of differences in diagnostic performance was tested with analysis of variance. RESULTS: ROC analysis yielded mean Az values for the flat-panel system of 0.879 (S = 400), 0.833 (S = 800), 0.765 (S = 1,600), and 0.576 (S = 6,400). Az values were 0.834 (S = 400) for the screen-film system and 0.789 (S = 400) and 0.729 (S = 800) for the storage-phosphor system. Analysis of variance revealed significant differences in diagnostic performance between various combinations of imaging system and exposure levels (P <.05). CONCLUSION: The flat-panel system is superior to the screen-film and storage-phosphor systems for detection of subtle undisplaced rib fractures at clinical exposure settings (eg, S = 400). With the flat-panel system, radiation dose can be reduced by 50% to achieve diagnostic performance comparable to that of a speed class 400 screen-film system.

Animals↗

PubMed2004

Types of procedures performed by diagnostic radiology practices: past patterns and future directions.

OBJECTIVE: The purpose of our study was to determine the types of imaging procedures performed by diagnostic radiology practices and the patterns and differences related to practice characteristics. MATERIALS AND METHODS: The American College of Radiology (ACR) surveyed 970 practices by mail, using a 65-item questionnaire, in 1999. A response rate of 66% was achieved. Weighting was used to make responses representative of all radiology practices in the United States. Trends were explored by making comparisons with data from a 1991-1992 ACR study. RESULTS: Among the types of procedures studied, the highest percentage of multiradiologist diagnostic-radiology-only practices performed mammography (95%) and sonography (94%). (General conventional radiography and fluoroscopy were not studied.) The lowest percentage of these practices performed interventional procedures (69%) and MRI (77%). Solo practices showed less diversity in types of procedures performed than did multiradiologist practices and were a good deal less likely to perform each type of procedure except mammography and sonography. Generally, higher percentages of practices in nonmetropolitan cities or towns and rural practices performed various types of procedures than practices in metropolitan areas. Practice size, types of settings served (hospital or nonhospital), and practice type also influenced the number of types of procedures performed by a practice. The fraction of practices performing CT decreased from 91% to 83% between 1991-1992 and 1999. Percentages for other types of procedures were generally stable over time. CONCLUSION: Certain practice characteristics play a role in determining the types of imaging procedures a diagnostic radiology practice performs. The decline in the percentage of practices providing CT and the failure during the 1990s of percentages for MRI and interventional radiology to increase from a relatively low base is worrisome. Future analyses based on a subsequent ACR survey will provide further insights into trends.

Data Collection↗

PubMed1996

A receiver operating characteristic partial area index for highly sensitive diagnostic tests.

PURPOSE: Area under a receiver operating characteristic (ROC) curve (Az) is widely used as an index of diagnostic performance. However, Az is not a meaningful summary of clinical diagnostic performance when high sensitivity must be maintained clinically. The authors developed a new ROC partial area index, which measures clinical diagnostic performance more meaningfully in such situations, to summarize an ROC curve in only a high-sensitivity region. MATERIALS AND METHODS: The mathematical formation of the partial area index was derived from the conventional binormal model. Statistical tests of apparent differences in this index were formulated analogous to that of Az. One common statistical test involving the partial area index was validated by computer simulations under realistic conditions. RESULTS: An example in mammography illustrates a situation in which the partial area index is more meaningful than Az in measuring clinical diagnostic performance. CONCLUSION: The partial area index can be used as a more meaningful alternative to the conventional Az index for highly sensitive diagnostic tests.

ROC Curve↗

PubMed1998

Exercise echocardiography or exercise SPECT imaging? A meta-analysis of diagnostic test performance.

CONTEXT: Cardiac imaging has advanced rapidly, providing clinicians with several choices for evaluating patients with suspected coronary artery disease, but few studies compare modalities directly. OBJECTIVES: To review the contemporary literature and to compare the diagnostic performance of exercise echocardiography (ECHO) and exercise single-photon emission computed tomography (SPECT) imaging in the diagnosis of coronary artery disease. DATA SOURCES: Studies published between January 1990 and October 1997 identified from MEDLINE search; bibliographies of reviews and original articles; and suggestions from experts in each area. STUDY SELECTION: Articles were included if they discussed exercise ECHO and/or exercise SPECT imaging with thallous chloride TI 201 (thallium) or technetium Tc 99m sestamibi for detection and/or evaluation of coronary artery disease, if data on coronary angiography were presented as the reference test, and if the absolute numbers of true-positive, false-negative, true-negative, and false-positive observations were available or derivable from the data presented. Studies performed exclusively in patients after myocardial infarction, after percutaneous transluminal coronary angioplasty, after coronary artery bypass grafting, or with recent unstable coronary syndromes were excluded. DATA EXTRACTION: Clinical variables, technical factors, and test performance were independently extracted by 2 reviewers on a standardized spreadsheet. Discrepancies were resolved by consensus. RESULTS: Forty-four articles met inclusion criteria. In pooled data weighted by the sample size of each study, exercise ECHO had a sensitivity of 85% (95% confidence interval [CI], 83%-87%) with a specificity of 77% (95% CI, 74%-80%). Exercise SPECT yielded a similar sensitivity of 87% (95% CI, 86%-88%) but a lower specificity of 64% (95% CI, 60%-68%). In a summary receiver operating characteristic model comparing exercise ECHO performance to exercise SPECT, exercise ECHO was associated with significantly better discriminatory power (parameter estimate, 1.18; 95% CI, 0.71-1.65), when adjusted for age, publication year, and a setting including known coronary artery disease for SPECT studies. In models comparing the discriminatory abilities of exercise ECHO and exercise SPECT vs exercise testing without imaging, both ECHO and SPECT performed significantly better than exercise testing. The incremental improvement in performance was greater for ECHO (3.43; 95% CI, 2.74-4.11) than for SPECT (1.49; 95% CI, 0.91-2.08). CONCLUSIONS: Exercise ECHO and exercise SPECT have similar sensitivities for the detection of coronary artery disease, but exercise ECHO has better specificity and, therefore, higher overall discriminatory capabilities as used in contemporary practice.

Coronary Disease↗

PubMed1997

Effects of dependent errors in the assessment of diagnostic test performance.

Latent class models can be used to assess diagnostic test performance when there is no perfectly accurate gold standard test available for comparison. These models usually assume independent errors between the tests, conditional on the true disease state of the subject. Maximum likelihood estimates of the prevalence of the disease and the error rates of diagnostic tests are then obtained. This paper examines the impact of error dependencies between binary diagnostic tests on the parameter estimates obtained from the latent class models. The independence model often gives parameter estimates having relatively small bias, but in some situations (for example, when disease prevalence is low and the tests have low specificity, such as in population screening) the bias may be more serious.

Bias↗

PubMed1994

Prospective assessment of the value of a chest radiograph in the performance of diagnostic cardiac catheterisation in adults.

OBJECTIVE: To assess the value of a chest radiograph in the performance of diagnostic cardiac catheterisation in adults. PATIENTS AND METHODS: 340 consecutive diagnostic cardiac catheter procedures in adults at one institution. It is normal practice for primary operators to report the results of catheterisation using a graphical user interface database system. Data entry screens were modified to present a study questionnaire to assess the use made of the chest radiograph in the performance of the catheter procedure. SETTING: Tertiary referral cardiac centre. RESULTS: The chest radiograph was judged of value in only 12/340 procedures (4%). The radiograph influenced catheter selection in six procedures, the volume of injected radiographic contrast medium in five, and showed an abnormality important to the planning or conduct of the procedure in six procedures. A dual benefit was reported in five procedures. Utility of the radiograph was related to the pre-catheter diagnosis. It proved of value in only 2/283 (0.7%) procedures with a working diagnosis of ischaemic heart disease, influencing only catheter selection. Its utility was greater in congenital heart disease, contributing in 3/4 (75%) procedures, dilated cardiomyopathy in 2/6 (33%) procedures, and valvar heart disease in 4/35 (11.5%) procedures. CONCLUSIONS: In the performance of diagnostic cardiac catheterisation in adults access to a recent chest radiograph contributes little to the conduct of investigations performed for suspected ischaemic heart disease, but may be of greater value in congenital disease, valve abnormalities, and dilated cardiomyopathy.

Adolescent↗

PubMed2001

A survival analysis of trypanosomosis diagnostic-test performance under natural infection challenge.

Little is known about the time-to-first detection and the time difference (TD) between first parasitological and first serological diagnosis of Trypanosoma spp. infections under natural infection challenge in cattle. The objective of our study was to estimate these measures of "longitudinal aspects" of diagnostic performance and to investigate potential biological factors. Emphasis was on diagnosis at the genus level (Trypanosoma spp.). Twelve N'Dama, 12 Gobra zebu and 12N'DamaxGobra (F1) crossbred cattle (all animals non-infected at the start of the experiment, six male and six female animals in each cohort) were exposed to natural high tsetse challenge in the Niamina East area in The Gambia [Acta Trop. 71 (1998) 57]. The animals were investigated parasitologically (detection of trypanosomes by buffy-coat technique), serologically (detection of T. brucei, T. congolense and T. vivax antigen by enzyme-linked immunosorbent assay (ELISA)) and clinically (packed-cell volume, PCV) over a period of 180 days. The time-to-first detection of trypanosomes, trypanosomal antigen (cut-off as suggested by test supplier) and drop in PCV (subject-based cut-off values) were recorded as outcomes of interest. Thus, incidence was both parasitologically (I(p)), serologically (I(s)) and clinically (I(c)). Recurrent events were not considered. The TD between first parasitological and first serological detection was established as I(s) time minus I(p) time. The effect of breed and sex on the time-to-first detection and on TD was investigated using Cox (proportional hazard) regression and ANOVA, respectively. We found that time-to-first parasitological detection of trypanosomosis in N'Dama animals was significantly longer than in the two other breeds (Cox regression, P=0.002). A similar but less-strong (P=0.063) effect of breed on time-to-first detection of trypanosomal antigen was found, whereas no breed effect was observed for clinical detection (P=0.432). Sex had no effect in all detection systems. The TD varied between -56 and 115 (mean 28). Marked differences among breeds and between sexes were not observed (ANOVA, P=0.8). We suggest that incidence studies are more suitable for detecting risk factors for animal trypanosomosis than prevalence-based (cross-sectional) studies because the latter often result in misinterpretation of factors that increase the survival time with infection as risk factors.

Animals↗

PubMed2005

Use of prostate-specific antigen (PSA) isoforms for the detection of prostate cancer in men with a PSA level of 2-10 ng/ml: systematic review and meta-analysis.

OBJECTIVE: Measurement of serum prostate-specific antigen (PSA) for the detection of prostate cancer has poor specificity in men with PSA levels between 2 and 10 ng/ml. It has been suggested that measurement of the ratio of free to total PSA (f/tPSA) or complexed PSA (cPSA) might offer an improvement. We performed a systematic review and meta-analysis to evaluate the diagnostic performance of these tests among men with PSA levels between 2 and 10 ng/ml. METHODS: Data on sensitivity and specificity were extracted from 66 eligible studies. Likelihood ratios and summary receiver operating characteristic curves were estimated and possible sources of heterogeneity between studies examined. RESULTS: Use of the f/tPSA or the cPSA test improved diagnostic performance among men with a total PSA (tPSA) of 2-4 or 4-10 ng/ml compared to tPSA alone. The diagnostic performance of the f/tPSA test was significantly higher in the tPSA range of 4-10 ng/ml compared to a tPSA range of 2-4 ng/ml (p < 0.01); at a sensitivity of 95%, the specificity was 18% in the 4-10 ng/ml tPSA range and 6% in the 2-4 ng/ml tPSA range. Among studies that measured both isoforms, the diagnostic performance of the f/tPSA test and the cPSA was equivalent in both PSA ranges. CONCLUSIONS: The use of the f/tPSA or cPSA test among men with PSA levels between 2 and 10 ng/ml can reduce the number of unnecessary biopsies whilst maintaining a high cancer detection rate.

Humans↗

PubMedDate not supplied

Combined reflectance and fluorescence spectroscopy for in vivo detection of cervical pre-cancer.

Optical technologies, such as reflectance and fluorescence spectroscopy, have shown the potential to provide improved point-of-care detection methods for cervical neoplasia that are sensitive, specific, and cost-effective. Our specific goals are to analyze the diagnostic potential of reflectance and fluorescence spectra, alone and in combination, to discriminate normal and precancerous cervical tissue in vivo and to identify which classification features contain significant diagnostic information. Reflectance spectra are measured at four source-detector separations and fluorescence emission spectra are measured at 16 excitation wavelengths, from 324 sites in 161 patients. These 20 spectral features are permuted in all possible combinations of one, two, and three; and classification algorithms are developed to evaluate the diagnostic performance of each combination. Algorithms based on fluorescence spectra alone yield better diagnostic performance than those based on reflectance spectra alone. The combination of fluorescence and reflectance do not significantly improve diagnostic performance compared to fluorescence alone, except in the case of discriminating high-grade precancers from columnar normal tissue. In general, fluorescence emission spectra at 330- to 360-nm and 460- to 470-nm excitation provide the best diagnostic performance for separating all pairs of tissue categories.

Algorithms↗

PubMed2006

Measurement of the clinical and cost-effectiveness of non-invasive diagnostic testing strategies for deep vein thrombosis.

OBJECTIVES: To estimate the diagnostic accuracy of non-invasive tests for proximal deep vein thrombosis (DVT) and isolated calf DVT, in patients with clinically suspected DVT or high-risk asymptomatic patients, and identify factors associated with variation in diagnostic performance. Also to identify practical diagnostic algorithms for DVT, and estimate the diagnostic accuracy, clinical effectiveness and cost-effectiveness of each. DATA SOURCES: Electronic databases (to April 2004). A postal survey of hospitals in the UK. REVIEW METHODS: Selected studies were assessed against validated criteria. A postal survey of hospitals in the UK was undertaken to describe current practice and availability of tests, and identify additional diagnostic algorithms. Pooled estimates of sensitivity, specificity and likelihood ratios were obtained for each test using random effects meta-analysis. The effect of study-level covariates was explored using random effects metaregression. A decision-analytic model was used to combine estimates from the meta-analysis and estimate the diagnostic performance of each algorithm in a theoretical population of outpatients with suspected DVT. The net benefit of using each algorithm was estimated from a health service perspective, using cost--utility analysis, assuming thresholds of willingness to pay of pound 20,000 and pound 30,000 per quality-adjusted life-year (QALY). The model was analysed probabilistically and cost-effectiveness acceptability curves were generated to reflect uncertainty in estimated cost-effectiveness. RESULTS: Individual clinical features are of limited diagnostic value, with most likelihood ratios being close to 1. Wells clinical probability score stratifies proximal, but not distal, DVT into high-, intermediate- and low-risk categories. Unstructured clinical assessment by experienced clinicians may have similar performance to Wells score. In patients with clinically suspected DVT, D-dimer has 91% sensitivity and 55% specificity for DVT, although performance varies substantially between assays and populations. D-dimer specificity is dependent on pretest clinical probability, being higher in patients with a low clinical probability of DVT. Plethysmography and rheography techniques have modest sensitivity for proximal DVT, poor sensitivity for distal DVT, and modest specificity. Ultrasound has 94% sensitivity for proximal DVT, 64% sensitivity for distal DVT and 94% specificity. Computed tomography scanning has 95% sensitivity for all DVT (proximal and distal combined) and 97% specificity. Magnetic resonance imaging has 92% sensitivity for all DVT and 95% specificity. The diagnostic performance of all tests is worse in asymptomatic patients. The most cost-effective algorithm discharged patients with a low Wells score and negative D-dimer without further testing, and then used plethysmography alongside ultrasound, with venography in selected cases, to diagnose the remaining patients. However, the cost-effectiveness of this algorithm was dependent on assumptions of test independence being met and the ability to provide plethysmography at relatively low cost. Availability of plethysmography and venography is currently limited at most UK hospitals, so implementation would involve considerable reorganisation of services. Two algorithms were identified that offered high net benefit and would be feasible in most hospitals without substantial reorganisation of services. Both involved using a combination of Wells score, D-dimer and above-knee ultrasound. For thresholds of willingness to pay of pound 10,000 or pound 20,000 per QALY the optimal strategy involved discharging patients with a low or intermediate Wells score and negative D-dimer, ultrasound for those with a high score or positive D-dimer, and repeat scanning for those with positive D-dimer and a high Wells score, but negative initial scan. For thresholds of pound 30,000 or more a similar strategy, but involving repeat ultrasound for all those with a negative initial scan, was optimal. CONCLUSIONS: Diagnostic algorithms based on a combination of Wells score, D-dimer and ultrasound (with repeat if negative) are feasible at most UK hospitals and are among the most cost-effective. Use of repeat scanning depends on the threshold for willingness to pay for health gain. Further diagnostic testing for patients with a low Wells score and negative D-dimer is unlikely to represent a cost-effective use of resources. Recommendations for research include the evaluation of the costs and outcomes of using the optimal diagnostic algorithms in routine practice, the development and evaluation of algorithms appropriate for specific groups of patients with suspected DVT, such as intravenous drug abusers, pregnant patients and those with previous DVT, the evaluation of the role of plethysmography: interaction with other diagnostic tests, outcome of low-risk patients with negative plethysmography and measurement of the costs of providing plethysmography, and methodological research into the incorporation of meta-analytic data into decision-analytic modelling.

Adult↗