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Diagnostic accuracy in malignant melanoma.

The diagnostic accuracy and index of suspicion concerning malignant melanoma were calculated based on review of 5,538 histologically examined lesions (of which 99 were melanomas) that were recorded in the Oncology Section of the Skin and Cancer Unit from 1955 to 1967. The diagnostic accuracy of the physicians in the Section was determined to be 64.4%. Thus, in almost one of every three melanomas an error in clinical diagnosis was made. This "batting average" is, however, better than those of previously published reports. The index of suspicion in relation to malignant melanoma in our series was 96%. Thus, the physicians in the Oncology Section demonstrated an appropriate awareness of this tumor. However, coupled with a diagnostic accuracy of 64%, a problem nevertheless exists in the diagnosis of this serious cutaneous cancer. Our study emphasizes the importance of having histologic verification prior to definitive radical surgery on patients with malignant melanoma.

Biopsy

Diagnostic accuracy and perforation rate in appendicitis: association with age and sex of the patient and with appendicectomy rate.

OBJECTIVE: To see if diagnostic accuracy and perforation rate in acute appendicitis is associated with age and sex of the patients and with the appendicectomy rate. DESIGN: Retrospective study of consecutive patients from a defined population. Study of associations between diagnostic accuracy and perforation rate and appendicectomy rate in published reports. SETTING: Jönköping county, Sweden. SUBJECTS: 3,029 patients operated on for suspected acute appendicitis from 1984-1989. MAIN OUTCOME MEASURES: Findings at laparotomy for acute appendicitis, confirmed with histological examination in 83% of the cases. RESULTS: Diagnostic accuracy was low at the extremes of age and in women (60% compared with 79% in men, p less than 0.001). When all intra-abdominal conditions were considered the percentage of negative laparotomies among women (24%) was twice that among men (12%, p less than 0.001). This difference between the sexes was also seen in nonfertile ages. Perforation rate was higher among men (18% compared with 13%, p less than 0.01) and at extremes of age. According to correlation analysis of published reports the perforation rate is unrelated to either diagnostic accuracy or appendicectomy rate while diagnostic accuracy is inversely associated with the appendicectomy rate. CONCLUSION: A low diagnostic accuracy is a problem mainly at extremes of age and in females. A low appendicectomy rate is associated with a high diagnostic accuracy, while the perforation rate is unaffected. A conservative attitude to exploration therefore seems justified.

Adult

The effect of baseline electrocardiographic abnormalities on the diagnostic accuracy of exercise-induced ST segment changes.

Although exercise-induced ST segment depression is thought to be unreliable marker of myocardial ischemia in the presence of resting electrocardiographic changes, this conclusion is based on limited and disparate data from studies often lacking acceptable measures of ischemia. To determine the diagnostic accuracy of the ST segment response in a blinded prospective protocol, we compared ST deviation to thallium201 SPECT scintigraphy in 95 patients during exercise. Diagnostic accuracy was poor in the 95 patients with resting abnormalities: left bundle branch block (LBBB) = 70%, complete right bundle branch block (cRBBB) = 75%, incomplete right bundle branch block (incRBBB) = 79%, intraventricular conduction delay (IVCD) = 44%, left ventricular hypertrophy (LVH) = 59%, digitalis = 53%, compared with a diagnostic accuracy of 90% in 29 patients without resting changes. There were 20 false negative and 17 false positive ST segment responses. The extent and direction of resting ST deviation varied substantially and had no influence on diagnostic accuracy. The extent of change in ST deviation with exercise required for a positive response did not alter diagnostic accuracy: -1.0 mm = 61%, -1.5 mm = 63%, and -2.0 = 61%. While the location of regional ischemia did not influence the accuracy of ST segment analysis, a QRS duration less than 120 msec did improve diagnostic accuracy. Our data confirm that ST segment analysis with exercise testing is not reliable in patients with resting electrocardiographic abnormalities and demonstrates that accuracy is not improved by adjusting for either resting or exercise-induced ST segment changes or for location of the ischemic region.

Aged

Enhancing and evaluating diagnostic accuracy.

Techniques that may enhance diagnostic accuracy in clinical settings were tested in the context of mammography. Statistical information about the relevant features among those visible in a mammogram and about their relative importances in the diagnosis of breast cancer was the basis of two decision aids for radiologists: a checklist that guides the radiologist in assigning a scale value to each significant feature of the images of a particular case, and a computer program that merges those scale values optimally to estimate a probability of malignancy. A test set of approximately 150 proven cases (including normals and benign and malignant lesions) was interpreted by six radiologists, first in their usual manner and later with the decision aids. The enhancing effect of these feature-analytic techniques was analyzed across subsets of cases that were restricted progressively to more and more difficult cases, where difficulty was defined in terms of the radiologists' judgements in the standard reading condition. Accuracy in both standard and enhanced conditions decreased regularly and substantially as case difficulty increased, but differentially, such that the enhancement effect grew regularly and substantially. For the most difficult case sets, the observed increases in accuracy translated into an increase of about 0.15 in sensitivity (true-positive proportion) for a selected specificity (true-negative proportion) of 0.85 or a similar increase in specificity for a selected sensitivity of 0.85. That measured accuracy can depend on case-set difficulty to different degrees for two diagnostic approaches has general implications for evaluation in clinical medicine. Comparative, as well as absolute, assessments of diagnostic performances--for example, of alternative imaging techniques--may be distorted by inadequate treatments of this experimental variable. Subset analysis, as defined and illustrated here, can be useful in alleviating the problem.

Breast Neoplasms

The diagnostic accuracy and complications of closed lung biopsies.

The diagnostic yields and complication rates of closed lung biopsies were determined by responses to a questionnaire. Of 5,255 procedures reported, 30% were aspiration biopsies (AB), 7% tissue core biopsies (CB), 2% trephine biopsies (TR), 37% bronchial brush biopsies (BB), and 23% transbronchial biopsies (TB). Of these biopsies, 70% were done for suspected neoplasms. The diagnostic accuracy rates were: AB=82%, CB=84%, TR=86%, BB=61%, and TB=56%. Mortality rates were: AB=0.1%, CB=0.3%, TR=2.9%, BB=0.0%, and TB=0.3%. Transthoracic needle biopsies (AB, CB) had the highest overall diagnostic accuracy, with an associated low mortality and moderate morbidity.

Biopsy

Coronary arteriography in a district general hospital: feasibility, safety, and diagnostic accuracy.

OBJECTIVE: To determine the feasibility, safety, and diagnostic accuracy of coronary arteriography in the radiology department of a district general hospital using conventional fluoroscopy and videotape recording. DESIGN: Observational study of the feasibility and safety of coronary arteriography in a district general hospital and analysis of its diagnostic accuracy by prospective within patient comparison of the video recordings with cinearteriograms obtained in a catheter laboratory. SETTING: Radiology department of a district general hospital and the catheter laboratory of a cardiological referral centre. SUBJECTS: 50 Patients with acute myocardial infarction treated with streptokinase who underwent coronary arteriography in a district general hospital three (two to five) days after admission. 45 Of these patients had repeat coronary arteriography after four (three to seven) days in the catheter laboratory of a cardiological referral centre. MAIN OUTCOME MEASURES: Incidence of complications associated with catheterisation and the sensitivity and specificity of video recordings in the district general hospital (judged by two experienced observers) for identifying the location and severity of coronary stenoses. RESULTS: Coronary arteriograms recorded on videotape in the district general hospital were obtained in 47 cases and apart from one episode of ventricular fibrilation (treated successfully by cardioversion) there were no complications of the procedure. 45 Patients were transferred for investigation in the catheter laboratory, providing 45 paired coronary arteriograms recorded on videotape and cine film. The specificity of the video recordings for identifying the location and severity of coronary stenoses was over 90%. Sensitivity, however, was lower and for one observer fell below 40% for lesions in the circumflex artery. A cardiothoracic surgeon judged that only nine of the 47 video recordings were adequate for assessing revascularisation requirements. CONCLUSIONS: Coronary arteriography in the radiology department of a district general hospital is safe and feasible. Nevertheless, the quality of image with conventional fluoroscopy and video film is inadequate and will need to be improved before coronary arteriography in this setting can be recommended.

Aged

Diagnostic accuracy of sialic acid in the diagnosis of malignant ascites.

The authors evaluated the diagnostic accuracy of sialic acid and its lipid-bound fraction in ascites and compared these tests with others (fibronectin, cholesterol) recently claimed as valuable in the differential diagnosis of ascites. Fibronectin yielded the best diagnostic accuracy (85%) with no false-positive and 37% of false-negative (10/27). The authors also found higher concentration of sialic acid in malignant ascites than in nonmalignant ascites (P less than 0.001) and, taking 300 mg/l as the cutoff value, the false-positive rate was 10% (four of 40), the false-negative rate 30% (eight of 27), and the overall diagnostic accuracy 82%, comparable to that of the fibronectin. The authors conclude that both fibronectin and sialic acid determinations in ascites may be regarded as accurate markers of neoplastic involvement of the peritoneum, although no test is useful in the ascites with hepatocellular carcinoma and cirrhosis of the liver.

Ascites

Direct measurement of the effect of film miniaturization on diagnostic accuracy.

A method for directly measuring the reduction in diagnostic accuracy incurred by altering original radiographs was applied to evaluate a 35 mm film system. A total of 4,290 readings of 2,145 proved cases were collected. Analysis of the results indicate that the 35 mm system reduced diagnostic accuracy by about 2.3% +/- 2.4% at a 95% confidence level. The same method can be used to evaluate other photographic reduction systems, television displays, enhancement schemes, or even the importance of clinical data in roentgenographic interpretation.

Diagnostic Errors

An evaluation of the diagnostic accuracy of Pathfinder.

We present an evaluation of the diagnostic accuracy of Pathfinder, an expert system that assists pathologists with the diagnosis of lymph node diseases. We evaluate two versions of the system using both informal and decision-theoretic metrics of performance. In one version of Pathfinder, we assume incorrectly that all observations are conditionally independent. In the other version, we use a belief network to represent accurately the probabilistic dependencies among the observations. In both versions, we make the assumption--reasonable for this domain--that diseases are mutually exclusive and exhaustive. The results of the study show that (1) it is cost effective to represent probabilistic dependencies among observations in the lymph node domain, and (2) the diagnostic accuracy of the more complex version of Pathfinder is at least as good as that of the Pathfinder expert. In addition, the study illustrates how informal and decision-theoretic metrics for performance complement one another.

Diagnosis, Computer-Assisted

MIC-based tuberculosis drug susceptibility testing using Sensititre MYCOTB: a diagnostic accuracy meta-analysis.

Accurate drug susceptibility testing (DST) is crucial for designing effective regimens for multidrug-resistant (MDR) and pre-extensively drug-resistant tuberculosis (pre-XDR TB). Sensititre MYCOTB enables simultaneous determination of minimum inhibitory concentrations (MICs) for multiple drugs, but its diagnostic performance varies across studies. This meta-analysis evaluated the diagnostic performance of Sensititre MYCOTB for key MDR and pre-XDR TB drugs. The protocol was registered in PROSPERO (CRD420251230599). PubMed, Cochrane, Google Scholar, Scopus, ONOS, Web of Science, ScienceDirect, and registries were systematically searched for studies published between 2010 and 2025. Studies comparing the Sensititre MYCOTB with reference DST for Mycobacterium tuberculosis complex (MTBC) were included. Bias assessment and pooled diagnostic accuracy estimates were generated. Fourteen studies, including 1,728 isolates, were analyzed. Rifampicin and isoniazid demonstrated high sensitivity (0.976 [95% CI: 0.94-0.99] and 0.977 [95% CI: 0.95-0.99]) and specificity (0.958 [95% CI: 0.84-0.98] and 0.957 [95% CI: 0.83-0.99], respectively) with low heterogeneity. Amikacin, kanamycin, and ofloxacin demonstrate good diagnostic accuracy, with high specificity (>0.98 [95% CI]). Moderate diagnostic accuracy was observed for ethambutol, streptomycin, ethionamide, and rifabutin. Cycloserine, moxifloxacin, and para-aminosalicylic acid showed inconsistent performance despite excellent specificity (>0.97 [95% CI]). Sensitivity analysis partially improved pooled sensitivity for moxifloxacin 0.801 (95% CI: 0.585-0.924) and para-aminosalicylic acid 0.76 (95% CI: 0.518-0.894), whereas cycloserine remained at 0.436 (95% CI: 0.190-0.725), although heterogeneity persisted. Sensititre MYCOTB DST demonstrates high diagnostic accuracy for MDR-TB and pre-XDR-TB drugs, while caution is required with cycloserine, moxifloxacin, and para-aminosalicylic acid. These findings support the integration of MIC-based testing into clinical decision-making.

Microbial Sensitivity Tests

Logistic discriminant analysis improves diagnostic accuracy of exercise testing for coronary artery disease in women.

BACKGROUND: Diagnostic accuracy of the exercise electrocardiogram in women has been shown to be limited for the detection of coronary artery disease. New diagnostic methods based on computer analysis of the exercise electrocardiogram and multivariate analysis have improved the diagnostic value of exercise testing in male subjects. The aim of the present study was to assess whether the diagnostic value of exercise testing can be enhanced in women by using multivariate analysis of exercise data. METHODS AND RESULTS: Between 1978 and 1984, 135 infarct-free women underwent exercise testing and coronary angiography. Significant coronary artery disease was present in 41% of the patients. In this first group, maximal exercise variables were submitted to a stepwise logistic analysis. Work load, heart rate, and ST60X were selected to build a diagnostic model. The model was tested in a second group of 115 catheterized women (significant coronary artery disease in 47%) and of 76 volunteers. We compared the present model with conventional analysis of the exercise electrocardiogram, with ST changes adjusted for heart rate, and with a previously described analysis. In both groups, sensitivity was better with the present model (66% and 70%) than by conventional (68% and 59%) and by the previously described analysis (57% and 44%) without a loss of specificity (85% and 93%). Receiver-operator characteristic curves showed also a better diagnostic accuracy with the present model. CONCLUSIONS: In women, logistic analysis of exercise variables improves the diagnostic value of exercise testing. It yields a significantly better sensitivity without a loss of specificity.

Coronary Disease

Diagnostic accuracy and clinical utility of thermography for lumbar radiculopathy. A meta-analysis.

The role of thermography for diagnosing lumbar radiculopathy was evaluated by literature review and meta-analysis. From 81 relevant citations, 28 studies could be analyzed for diagnostic-accuracy data (sensitivity and specificity) and method. Diagnostic-accuracy data varied significantly between studies; therefore meaningful pooled summary statistics could not be reported. Twenty-seven studies had major methodologic flaws including biased test interpretations, faulty cohort assembly, poor clinical descriptions, and small sample size. The only study of reasonably high quality found no discriminant value for liquid-crystal thermography. The role of thermography remains unclear. Rigorous clinical research is required to establish its diagnostic accuracy and clinical utility. Thermography cannot be recommended currently for routine clinical use in evaluating low-back pain.

Back Pain

Diagnostic accuracy of fibronectin in the differential diagnosis of ascites.

To evaluate the diagnostic accuracy of fibronectin levels in ascites to differentiate malignant from non-malignant ascites, the authors studied 30 patients with sterile uncomplicated ascites in chronic liver disease, 18 patients with malignant ascites and four patients with spontaneous bacterial peritonitis. Fibronectin concentration was significantly higher in malignant ascites than in sterile ascites (P less than 0.001). High values (greater than 85 mg/l) were found in four of six cases of hepatocellular carcinoma in liver cirrhosis with negative cytologic examination, and in six of seven peritoneal carcinomatoses. Low values (less than 85 mg/l) were found in four patients with liver metastases and in one patient with intrahepatic biliary duct carcinoma in cirrhosis. In four patients with infected ascites, the fibronectin level was low. Among all other parameters (total protein concentration, lactate dehydrogenase, gamma-glutamyl-transpeptidase, pH, amylase, triglycerides, leukocyte count, and cytologic examination), fibronectin yielded the best degree of discrimination (diagnostic accuracy, 79%).

Adult

Radiosialometry. II. The diagnostic accuracy of different evaluation parameters.

The temporal course of 99TcmO4 accumulation in the parotid gland after fast intravenous injection of the radionuclide was measured quantitatively by radiosialometry in 32 patients suffering from inflammatory or neoplastic diseases of the parotid glands. The diagnostic accuracy of five different evaluation parameters was compared. It was found that without reducing diagnostic accuracy, the method used could be simplified by omitting three of the five evaluation parameters. This implies a shortening of the measuring time from 18 to 10 minutes. The diagnostic accuracy of radiosialometry in 14 cases with a general engagement of the parotid parenchyma (irradiation damage, collagen sialosis and chronic recurrent parotitis) was high. Thus, all these 14 cases had abnormal radiosialometric values. Parotid tumours not causing extensive destruction of the parotid parenchyma were not detected by this method.

Collagen Diseases

Diagnosis of squamous-cell carcinoma of the lung by sputum cytology: with special reference to correlation of diagnostic accuracy with size and proximal extent of resected tumor.

Sputum cytology was performed in 179 cases of squamous-cell carcinoma of the lung; 134 cases were diagnosed as positive. There were no significant differences in diagnostic accuracy of sputum cytology between tumors sizes. In cases with tumors extending proximally into the main, lobar, or segmental bronchi, the diagnostic accuracy of sputum cytology was significantly higher than in cases where the proximal invasion of tumor was limited to the peripheral bronchi. In cases with tumors 3 cm or less in diameter, when tumors extended proximally into main, lobar, or segmental bronchi, the diagnostic accuracy of sputum cytology was significantly higher than in cases with tumors extending proximally into subsegmental or subsubsegmental bronchi. In peripherally located squamous-cell carcinoma, in cases in which the tumor arose in subsegmental or subsubsegmental bronchi, carcinoma could be detected by sputum cytology even when it was roentgenographically occult.

Carcinoma, Squamous Cell

Diagnostic accuracy of combination of assays for immunosuppressive acidic protein and carcinoembryonic antigen in detection of recurrence of gastric cancer.

Two tumour markers, immunosuppressive acidic protein (IAP) and carcinoembryonic antigen (CEA), were assayed in gastric cancer patients. Levels of IAP and CEA were measured simultaneously in the preoperative and postoperative periods. The usefulness of the combined assay of these markers for detection of recurrence of cancer was investigated in terms of sensitivity, specificity and diagnostic accuracy. Sensitivity was not high (69.2%), but specificity and diagnostic accuracy were 96.7% and 86.9%, respectively. In cases with metastases in the liver, sensitivity (100.0%), specificity (100.0%) and diagnostic accuracy were high. In cases of peritoneal dissemination, these indices were low. The combination assay of IAP and CEA appears to be useful for detection of recurrence of gastric cancer, especially in patients with liver metastases.

Biomarkers, Tumor

Diagnostic Accuracy of a CRISPR-Based Assay in Smear- and Culture-Negative Fungal Keratitis.

IMPORTANCE: Diagnosing fungal keratitis (FK) in patients with negative smear and culture results remains clinically challenging, highlighting the need for alternative diagnostic approaches. OBJECTIVE: To determine the diagnostic accuracy of the clustered regularly interspaced short palindromic repeats (CRISPR)-based Rapid Identification of Mycoses using CRISPR (RID-MyC) assay for detecting FK in patients with negative smear and culture results using in vivo confocal microscopy (IVCM) as the reference standard. DESIGN, SETTING, AND PARTICIPANTS: This prospective diagnostic accuracy study was conducted from December 2024 to March 2025 at Aravind Eye Hospital, a tertiary ophthalmology referral hospital in Coimbatore, India. Consecutive patients clinically suspected to have microbial keratitis with negative smear and culture results were eligible for inclusion. Data were analyzed from March 2025 to June 2025. INTERVENTIONS: All included participants underwent corneal scraping for RID-MyC assay and imaging by IVCM. MAIN OUTCOMES AND MEASURES: The primary outcomes were sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic concordance of the RID-MyC assay compared with IVCM results. RESULTS: Of 245 consecutive patients clinically suspected to have microbial keratitis, 82 were smear negative. After exclusions due to contraindications or positive subsequent cultures, 41 patients with smear- and culture-negative results were ultimately included in the final analysis. Of these 41 patients (mean [SD] age, 51.0 [14.6] years; 21 [51.2%] women), RID-MyC demonstrated sensitivity of 82.1% (95% CI, 63%-94%) and specificity of 76.9% (95% CI, 46%-95%). Positive predictive value was 88.5% (95% CI, 74%-95%) and negative predictive value was 66.7% (95% CI, 46%-82%). Concordance between RID-MyC and IVCM was observed in 33 cases (80.5%). Notably, prior antifungal treatment was most frequent (4 of 5 [80%]) among patients with positive IVCM but negative RID-MyC results. Conversely, all patients (3 of 3 [100%]) with negative IVCM but positive RID-MyC findings had smaller, peripheral, or paracentral lesions. CONCLUSIONS AND RELEVANCE: In this diagnostic study, in patients with smear- and culture-negative FK, the RID-MyC assay showed good diagnostic accuracy comparable with IVCM and was feasible in all cases, including those in whom imaging was not possible. With its rapid turnaround and minimal equipment needs, RID-MyC may serve as a practical adjunct to conventional diagnostics, particularly in high-burden, resource-limited settings where IVCM is unavailable or contraindicated.

Humans

Diagnostic accuracy of transtracheal aspiration bacteriologic studies.

The diagnostic accuracy of transtracheal aspiration bacteriologic studies was examined in 488 patients. Twenty-three patients had bacteremic pneumonia, and in each instance the blood culture isolate was also recovered from the transtracheal aspirate. Clinical correlations in 119 patients with negative cultures of transtracheal aspirate indicated that 71 had an alternative diagnosis to explain an abnormal chest radiograph, and 44 appeared to have a bacterial infection but had received antimicrobial drugs before specimen collection. According to clinical parameters and final diagnosis, the incidence of false-negative cultures was 1 per cent among patients sampled before administration of antimicrobial drugs, and the incidence of false-positive cultures was 21 per cent.

Anti-Bacterial Agents