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ROC analysis of diagnostic performance in liver scintigraphy.

Studies on the accuracy of liver scintigraphy for the detection of metastases were assembled from 38 sources in the medical literature. An ROC curve was fitted to the observed values of sensitivity and specificity using an algorithm developed by Ogilvie and Creelman. This ROC curve fitted the data better than average sensitivity and specificity values in each of four subsets of the data. For the subset dealing with Tc-99m sulfur colloid scintigraphy, performed for detection of suspected metastases and containing data on 2800 scans from 17 independent series, it was not possible to reject the hypothesis that interobserver variation was entirely due to the use of different decision thresholds by the reporting clinicians. Thus the ROC curve obtained is a reasonable baseline estimate of the performance potentially achievable in today's clinical setting. Comparison of new reports with these data is possible, but is limited by the small sample sizes in most reported series.

Colloids↗

Diagnostic performance of United States Air Force cytology laboratories. An eight-year experience in central monitoring.

Based on experience obtained through review of historical case material, the cytology program of the United States Air Force was regionalized into ten cytocenters, which annually process approximately 375,000 gynecologic cases. In order to assure uniformity and quality of diagnosis to multiple supplying clinics, standardized diagnoses were developed with required central reporting of all abnormal recovery rates. Initial results showed a sign-out abnormal rate (class II or worse) ranging from 1% in two cytocenters to nearly 6% in two others--over a fivefold variation on a demographically similar population. Variation by diagnostic class and follow-up tissue biopsies are reported to validate the higher abnormal rates. Through an applied program over the last seven years of formal education of pathologists and cytotechnologists, consultative visits and sharing of comparative referred statistics, the subsequent abnormal rates were substantialy altered to a range of 3.5% to 7.0%. More recently, required reporting of abnormal rates per technologist appears to be another monitor of laboratory quality, in that a given cytocenter may have a total abnormal rate of 4.5%, but a range among cytotechnolgists of 1.3% to 8.7%. These and other presented statistics may prove valuable for external monitoring (including assessment of quality performance) of individual cytology laboratories.

Aerospace Medicine↗

A modified combination technique for performing diagnostic peritoneal lavage.

Existing open diagnostic peritoneal lavage techniques (DPL) use small bore catheters, through a small lower midline incision or infra-umbilical incision. This study evaluated a modified DPL technique using a 10 mm umbilical incision, with open insertion of a 20 French peritoneal lavage catheter. The catheter has 27 radial side holes in the terminal distal 13 cm, and a female Leur lock connector. Warmed saline is infused via a cystoscopy infusion set. The time required to perform a new technique was studied in 10 patients. The median time to catheter insertion was 2.4 +/- 3.8 min, infusion time 0.75 +/- 0.3 min, effusion time 0.3 +/- 1.7 min, and a median total time of 7.6 +/- 4.2 min (median +/- s.d.). There was no complications. This technique of DPL is cosmetically attractive, much quicker than existing techniques and we have found its initial use encouraging.

Abdominal Injuries↗

[Spontaneous closure of dural arteriovenous fistula after performing diagnostic angiography].

The pathogenesis and clinical treatment of dural arteriovenous fistulas (DAVF) has been well established. However, only 15 cases of spontaneous closure of DAVFs have been reported. We describe a case of spontaneous closure of a DAVF. A 60-year-old male presented with pulsatile tinnitus. Selective cerebral angiography revealed a left posterior DAVF fed by the left occipital artery and the middle meningeal artery, which drained into the left transverse sinus and sigmoid sinus. Following the initial angiography, the patient exhibited vomiting with transient disorientation and amnesia. These symptoms, along with the tinnitus, disappeared by the following day. Seven days after the initial angiography, a second angiography was performed that revealed the complete disappearance of the DAVF. Previous reports have described a long period of closure for DAVFs following initial diagnosis. Possible mechanisms for spontaneous closure of DAVFs include the development of scar tissue or a sinus thrombosis that leads to occlusion of the DAVF In this case, the DAVF closure may have been due to a sinus thrombosis induced by sinus stenosis, since occlusion of the draining sinuses coincided with the spontaneous closure of the DAVF. In cases of non-traumatic DAVF without cortical venous reflex that do not present severe symptoms, a prudent course of treatment is necessary since there is a chance of spontaneous closure of the DAVF occuring.

Central Nervous System Vascular Malformations↗

Using a CompuCyte Pathfinder to evaluate cytotechnology student diagnostic performance.

OBJECTIVE: To determine whether the Pathfinder Cytology System facilitates comparison of initial student diagnoses to rescreener diagnoses; provides a platform for collection, storage and retrieval of data on student screening performance; and generates a student screening "score." STUDY DESIGN: Using two CompuCyte Pathfinder units networked to a PC server and printer, eight cytotechnology students prescreened 1,224 gynecologic cases and entered their results into the Pathfinder database. Five staff cytotechnologists rescreened the cases and entered their diagnoses. The database containing the initial and rescreen diagnoses were transferred to a modified scoring grid that computed a screening "score" for each of the students. RESULTS: Student diagnoses matched cytotechnologist target diagnoses in 1,107 to 1,224 total cases (90.4%). Of these 1,107 cases, 996 (81.3%) were reported as "within normal limits" (negative) by both student and cytotechnologist, and 111 (9.1%) were target diagnosed as abnormal (atypical squamous cells of undetermined significance [ASCUS] or above) by both student and cytotechnologist. Of 117 remaining cases, 112 (9.2%) were considered minor discrepancies (one-step discrepancy--e.g., benign cell change-reactive vs. ASCUS--favor reactive), and 5 (0.4%) were considered significant discrepancies (two or more diagnostic categories of difference between student and cytotechnologist-within normal limits vs. low grade squamous intraepithelial lesion). The modified scoring grid developed by CompuCyte for this study was able to compute a numerical score for each student. CONCLUSION: Our preliminary assessment indicated that Pathfinder will facilitate evaluation of student performance. The system shows potential for eliminating the "paper trail" and manual dotting required for traditional student evaluation and, with the addition of a scoring program, may be standardized for use in both educational and clinical settings.

Automation↗

Meta-analysis of comparative diagnostic performance of magnetic resonance imaging and multislice computed tomography for noninvasive coronary angiography.

BACKGROUND: Magnetic resonance imaging (MRI) and multislice computed tomography (MSCT) have emerged as potential noninvasive coronary imaging techniques. The objective of the present study was to clarify the current accuracy of both modalities in the detection of significant coronary artery lesions (compared to conventional angiography as the gold standard) by means of a comprehensive meta-analysis of the presently available literature. METHODS: A total of 51 studies on the detection of significant coronary artery stenoses (> or = 50% diameter stenosis) and comparing results with conventional angiography were identified by means of a MEDLINE search. Weighted sensitivities, specificities, and predictive values, all with 95% CIs, as well as summary odds ratios, were calculated for both techniques. In addition, the relationship between diagnostic specificity and disease prevalence was determined using metaregression analysis. RESULTS: A comparison of sensitivities and specificities revealed significantly higher values for MSCT (weighted average 85% [95% CI 86%-88%] and 95% [95% CI 95%]) as compared with MRI (weighted average 72%, 95% CI 69%-75% and 87%, 95% CI 86%-88%). A significantly higher odds ratio (16.9-fold) for the presence of significant stenosis was observed for MSCT as compared with MRI (6.4-fold) (P < .0001). Linear regression analysis revealed a better specificity for MSCT versus MRI in lower disease prevalence populations (P = .056). CONCLUSION: Meta-analysis of the available studies with MRI and MSCT for noninvasive coronary angiography indicates that MSCT has currently a significantly higher accuracy to detect or exclude significant coronary artery disease.

Coronary Angiography↗

Evaluation of the Roche Neisseria gonorrhoeae 16S rRNA PCR for confirmation of AMPLICOR PCR-positive samples and comparison of its diagnostic performance according to storage conditions and preparation of endocervical specimens.

The AMPLICOR PCR was used to detect Neisseria gonorrhoeae in endocervical specimens. A 16S rRNA PCR performed on N. gonorrhoeae-positive samples showed sensitivities of 73.2, 64.3, and 94.4% for samples treated directly with AMPLICOR lysis buffer, samples suspended in 2-sucrose phosphate, and samples suspended in diluted phosphate-buffered saline, respectively.

Cervix Uteri↗

Diagnostic performance of urinary resveratrol metabolites as a biomarker of moderate wine consumption.

BACKGROUND: Nutritional biomarkers may be better measures of dietary exposure than self-reported dietary data. We evaluated resveratrol metabolites, potential biomarkers of wine consumption, in humans after moderate consumption of sparkling, white, or red wines. METHODS: We performed 2 randomized, crossover trials and a cohort study. In the first study, 10 healthy men consumed 30 g of ethanol/day as sparkling wine or gin for 28 days. In the second trial, 10 healthy women consumed 20 g of ethanol/day as white or red wine for 28 days. We also evaluated 52 participants in a study on the effects of a Mediterranean diet on primary prevention of cardiovascular disease (the PREDIMED Study). We used liquid chromatography-tandem mass spectrometry to analyze urinary total resveratrol metabolites (TRMs) and predictive values and ROC curve analyses to assess the diagnostic accuracy. RESULTS: We observed significant increases in TRMs [72.4 (95% confidence interval, 48.5-96.2; P = 0.005), 211.5 (166.6-256.3; P = 0.005), and 560.5 nmol/g creatinine (244.9-876.1; P = 0.005)] after consumption of sparkling, white, or red wine, respectively, but no changes after the washout or gin periods. In the cohort study, the reported daily dose of wine consumption correlated directly with TRMs (r = 0.654; P < 0.001). Using a cutoff of 90 nmol/g, we were able to use TRMs to differentiate wine consumers from abstainers with a sensitivity of 72% (60%-84%); and a specificity of 94% (87%-100%). CONCLUSIONS: Resveratrol metabolites in urine may be useful biomarkers of wine intake in epidemiologic and intervention studies.

Adult↗

Diagnostic performance of digital versus film mammography for breast-cancer screening.

BACKGROUND: Film mammography has limited sensitivity for the detection of breast cancer in women with radiographically dense breasts. We assessed whether the use of digital mammography would avoid some of these limitations. METHODS: A total of 49,528 asymptomatic women presenting for screening mammography at 33 sites in the United States and Canada underwent both digital and film mammography. All relevant information was available for 42,760 of these women (86.3 percent). Mammograms were interpreted independently by two radiologists. Breast-cancer status was ascertained on the basis of a breast biopsy done within 15 months after study entry or a follow-up mammogram obtained at least 10 months after study entry. Receiver-operating-characteristic (ROC) analysis was used to evaluate the results. RESULTS: In the entire population, the diagnostic accuracy of digital and film mammography was similar (difference between methods in the area under the ROC curve, 0.03; 95 percent confidence interval, -0.02 to 0.08; P=0.18). However, the accuracy of digital mammography was significantly higher than that of film mammography among women under the age of 50 years (difference in the area under the curve, 0.15; 95 percent confidence interval, 0.05 to 0.25; P=0.002), women with heterogeneously dense or extremely dense breasts on mammography (difference, 0.11; 95 percent confidence interval, 0.04 to 0.18; P=0.003), and premenopausal or perimenopausal women (difference, 0.15; 95 percent confidence interval, 0.05 to 0.24; P=0.002). CONCLUSIONS: The overall diagnostic accuracy of digital and film mammography as a means of screening for breast cancer is similar, but digital mammography is more accurate in women under the age of 50 years, women with radiographically dense breasts, and premenopausal or perimenopausal women. (ClinicalTrials.gov number, NCT00008346.)

Adult↗

Multicenter comparison of the diagnostic performance of free prostate-specific antigen.

OBJECTIVES: This study examined the multicenter clinical performance of noncomplexed (free) prostate-specific antigen (PSA) in men presenting with total PSA values between 2.5 to 20 ng/mL. METHODS: Prebiopsy serum samples were obtained from 1,081 consecutively accrued, histologically diagnosed men between the ages of 40 and 75 years with total PSA values falling between 2.5 and 20 ng/mL. Total PSA was determined by either the Tosoh AIA-1200 or Hybritech method. Free PSA values were determined using the Dianon PSA II immunoradiometric method. Free PSA was expressed as a percentage of total PSA. Immunochemistry was performed at each accrual site. RESULTS: Among men diagnosed with prostate cancer (CaP), only 4% (21/520) had proportions of free to total PSA values > 25%. Conversely, among men with benign prostatic disease, only 2% (13/561) had proportions of free to total PSA values < 7%. These results confirm those of previous research. Differences among sites were found in age and prostate volume. CONCLUSIONS: These data confirm that free PSA values < 7% are highly suspicious for CaP whereas free PSA values > 25% suggest absence of malignancy. The data also suggest that age and/or prostate volume influences the serum level of free PSA but does not affect the diagnostic cutoff points of 7% and 25%. Future analysis is needed to confirm that younger men with small prostates are at higher risk for CaP.

Adult↗

Comparison of the diagnostic performance of three soluble fibrin monomer tests and a D-dimer assay in patients with clinically suspected deep vein thrombosis of the lower limbs.

We assessed three soluble fibrin monomer (SFM) assays in 231 in and out-patients with clinically suspected deep-vein thrombosis. Thrombosis was confirmed or excluded by complete lower-limb ultrasound. SFM assay were less accurate than VIDAS D-dimer and in patients with small thrombosis or under anticoagulation. Specificity was lower for a similar sensitivity.

Diagnostic Techniques, Cardiovascular↗

Screening and diagnostic performance of enzyme immunoassay for antibody to lymphadenopathy-associated virus.

In a multicenter cooperative study, an enzyme immunoassay (EIA) using purified antigen of lymphadenopathy-associated virus was compared with radioimmune precipitation (RIP) for detection of antibody to human immunodeficiency virus (HIV) in 634 patients with acquired immunodeficiency syndrome or related conditions, 687 apparently healthy persons at risk for HIV infection, 93 controls with cancer or autoimmune diseases, and 10,038 blood or plasma donors. Excluding the donors, the EIA was reactive in 875 (61.9%) of 1,414 subjects; compared with RIP, the sensitivity and specificity of EIA both were 99.8%. There was one false-positive EIA among 148 intravenous drug abusers and two false-negative EIAs among 472 apparently healthy homosexual men; no other discordant results between EIA and RIP occurred in these subjects. The EIA was repeatably reactive in 20 donors (0.2%), among whom 13 (65%) were positive by RIP; none of 529 randomly selected EIA-negative donors was RIP positive. In addition to its utility as a screening test in low-risk populations, the EIA for antibody to lymphadenopathy-associated virus is useful as a diagnostic test in persons with clinical evidence of or at risk for HIV infection.

Acquired Immunodeficiency Syndrome↗

Performance diagnostics in handbiking during competition.

STUDY DESIGN: Case study in handbiking under competition conditions. OBJECTIVE: To investigate exercise-induced, metabolic, pulmonary, cardiovascular and energetic reactions of a paraplegic athlete during a city marathon. SETTING: City marathon Cologne, Germany. SUBJECT: We tested a 27-year-old male athlete from the German national team. The handicap of the athlete was a complete traumatic spinal cord injury ASIA/IMSOP Grade A at the level of the fourth thoratic vertebra (Th4). METHOD: In the competition, the athlete used his own race handbike whose crank system had been exchanged for a power measurement system with registering option. For measuring ventilatory gas parameters during exercise, a portable spirometric system was used. The athlete managed to finish the marathon race in 1:48:54 h. RESULTS: The mean oxygen uptake (VO2) during the marathon was 1580 ml/min, with a maximum value of 2535 ml/min. The mean heart frequency was 137 bpm with a maximum of 157 bpm. During the race the mean energy consumption was 463 kcal/h with a maximum of 758 kcal/h. Prior to the race, the blood lactate value was 2.9 mmol/l; after 10 km 4.4 mmol/l; after 20 km 2.9 mmol/l, and after 30 km 2.9 mmol/l. CONCLUSION: Competition-oriented handbikers should concentrate on exercise units of long duration at low intensities--like marathon runners or cyclists--in order to improve their aerobic performance capacity. However, it has to be pointed out that paraplegic athletes develop relatively high metabolic intensities in competition and that the variability of their physiological parameters is considerably high.

Adult↗

[Optimized diagnostic performance of brain magnetic resonance imaging in children with idiopathic growth hormone deficiency].

PURPOSE: The aim of this study was to search for correlations between anatomic changes in the pituitary gland and hormonal disturbances in children with short stature. MATERIAL AND METHODS: Children with short stature were enrolled when criteria of pituitary growth hormone deficiency were partly or completely met. Magnetic resonance imaging was performed in 87 children and particular attention was given to the pituitary gland. Measurements were compared with pituitary dimensions accepted as normal in the literature. Contrast with GdDTPA was used to visualize the pituitary gland and associated structures (stalk, infundibulum). T1-weighted images in the sagittal and coronal planes were obtained. The results were statistically analyzed with non-parametric tests. CONCLUSIONS: 1. Magnetic resonance imaging is a very sensitive method for detecting changes in the pituitary gland and may well be recommended as a method of choice even though the percentage of changes detected with it is rather small. 2. The use of contrast agent may be abandoned to limit costs when searching for cause of growth deficit in children with idiopathic growth hormone deficiency, save for the following cases: hypoplasia or aplasia of the pituitary gland, transection of the stalk, empty sella syndrome or tumor in the central nervous system. 3. Pituitary volume and height appear to be of greatest diagnostic significance, while width (which varies little) can serve as an auxiliary parameter.

Adolescent↗

In search of an unknown primary tumour presenting with extracervical metastases: the diagnostic performance of FDG-PET.

A retrospective study was carried out to determine the performance of 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) in patients with unknown primary tumours presenting with metastases external to the neck. All patients referred to an academic PET centre (July, 1997 to December, 2000) presenting with an extracervical metastasis and no prior systemic therapy were eligible. The minimum follow-up period was 11 months. From 63 eligible cases, known metastases were FDG avid in all but one neuroendocrine process. PET scans were retrospectively classified as positive for a primary tumour (n=29), i.e. revealing at least one anatomical site suspected to be the primary tumour. This was confirmed in 16, either by histology (n=10) or radiological and clinical follow-up (n=6). There were four false positive cases. In nine patients, the primary tumour was never confirmed. Of the remaining 33 negative PET scans the primary tumour was clinically not found in 18. Follow-up and additional pathology investigations demonstrated the primary tumour in 15. A survey on clinical usefulness of PET (response rate 83%) suggested that PET positively contributed to diagnostic understanding in 29 of 52 evaluable cases. Applied late in the diagnostic trajectory, approximately four patients need to be scanned by PET in order to find one primary tumour. However, in addition to direct demonstration of unknown primaries, there appears to be a positive effect on the diagnostic work-up of these patients of a similar magnitude.

Adult↗

Diagnostic performance of stress perfusion and delayed-enhancement MR imaging in patients with coronary artery disease.

PURPOSE: To prospectively determine the accuracy of a combined magnetic resonance (MR) imaging approach (stress first-pass perfusion imaging followed by delayed-enhancement imaging) for depicting clinically significant coronary artery stenosis (> or = 70% stenosis) in patients suspected of having or known to have coronary artery disease (CAD), with coronary angiography serving as the reference standard. MATERIALS AND METHODS: The committee on human research approved the study protocol, and all participants gave written informed consent. This study was HIPAA compliant. Forty-seven patients (38 men and nine women; mean age, 63 years +/- 5.3 [standard deviation]) scheduled for coronary angiography were prospectively enrolled: 33 were suspected of having CAD (group A) and 14 had experienced a previous myocardial infarction and were suspected of having new lesions (group B). The MR imaging protocol included cine function, gadolinium-enhanced stress and rest first-pass perfusion MR imaging, and delayed-enhancement MR imaging. Myocardial ischemia was defined as a segment with perfusion deficit at stress first-pass perfusion MR imaging and no hyperenhancement at delayed-enhancement imaging. Myocardial infarction was defined as an area with hyperenhancement at delayed-enhancement imaging. RESULTS: One patient was excluded from analysis because of poor-quality MR images. Coronary angiography depicted significant stenosis in 30 of 46 patients (65%). In a per-vessel analysis (n = 138), stress first-pass perfusion MR imaging and delayed-enhancement imaging yielded sensitivity of 0.87, specificity of 0.89, and accuracy of 0.88, when compared with coronary angiography. The diagnostic accuracy of stress first-pass perfusion MR imaging and delayed-enhancement imaging was slightly better than that of stress and rest first-pass perfusion MR imaging in the entire population (0.88 vs 0.85), in group A (0.86 vs 0.82), and in group B (0.93 vs 0.90). CONCLUSION: Stress first-pass perfusion MR imaging followed by delayed-enhancement imaging is an accurate method to depict significant coronary stenosis in patients suspected of having or known to have CAD.

Aminophylline↗

Diagnostic performance of coronary magnetic resonance angiography as compared against conventional X-ray angiography: a meta-analysis.

OBJECTIVES: This study was designed to define the current role of coronary magnetic resonance angiography (CMRA) for the diagnosis of coronary artery disease (CAD). BACKGROUND: Coronary magnetic resonance angiography has been proposed as a promising noninvasive method for diagnosis of CAD, but individual studies evaluating its clinical value have been of limited sample size. METHODS: We identified all studies (MEDLINE and EMBASE) that evaluated CAD by both CMRA and conventional angiography in >/=10 subjects during the period 1991 to January 2004. We recorded true and false positive and true and false negative CMRA assessments for detection of CAD using X-ray angiography as the reference standard. Analysis was done at segment, vessel, and subject level. RESULTS: We analyzed 39 studies (41 separate comparisons). Across 25 studies (27 comparisons) with data on 4,620 segments (993 subjects), sensitivity and specificity for detection of CAD were 73% and 86%, respectively. Vessel-level analyses (16 studies, 2,041 vessels) showed sensitivity 75% and specificity 85%. Subject-level analyses (13 studies, 607 subjects) showed sensitivity 88% and specificity 56%. At the segment level, sensitivity was 69% to 79% for all but the left circumflex (61%) coronary artery; specificity was 82% to 91%. There was considerable between-study heterogeneity, but weighted summary receiver-operating characteristic curves agreed with these estimates. There were no major differences between subgroups based on technical or population characteristics, year of publication, reported blinding, or sample size. CONCLUSIONS: In evaluable segments of the native coronary arteries, CMRA has moderately high sensitivity for detecting significant proximal stenoses and may have value for exclusion of significant multivessel CAD in selected subjects considered for diagnostic catheterization.

Coronary Angiography↗

Laboratory and diagnostic performance of a coated well immunoradiometric assay for serum thyrotrophin.

A new, coated well immunoradiometric assay (IRMA) for thyrotrophin (TSH) in serum has been evaluated with a view to its use as a first-line test of thyroid function. The Amerwell TSH IRMA is simple, rapid to perform (2.5 h) and the assay sensitivity was 0.07 mU/L with a working range (intra-assay CV less than 10%) of 0.3-100 mU/L. The mean inter-assay CV was 6.6% for TSH concentrations of 0.30-30.7 mU/L. The method compared favourably with an in-house TSH radioimmunoassay and an alternative commercial IRMA. In consecutive referrals to a thyroid clinic all patients with overt hyperthyroidism (n = 103) had undetectable TSH concentrations and in those with subclinical hyperthyroidism (n = 14). TSH was undetectable in 10 and below the reference range in four. The 95% confidence interval for 63 euthyroid serum samples was 0.36-4.3 mU/L. All hypothyroid patients (n = 20) had increased TSH concentrations. TSH concentrations in pregnancy did not differ significantly from euthyroid TSH values. From 1916 routine tests, 13 undetectable TSH values were found in which thyroid hormone levels were normal and the patients had no known thyroid disorder. The assay appears suitable as a first-line test of thyroid function, but further assessment in a routine laboratory setting is required.

Humans↗