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PubMed1991

Utility of combining two diagnostic tests.

Methods for evaluating a single diagnostic test with reference to the disease prevalence in a given population include sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Patient disease status and, ultimately, the treatment course is determined by the outcome of these diagnostics. The advantage of ordering a single diagnostic test, or series of diagnostic tests is a concern of physicians. How much information is gained from using the results of two diagnostic tests, each designed to detect the same disease? Combining tests may be the optimal methodology for determining the disease status of the patient. We propose a systematic strategy for optimizing (minimizing alpha and/or beta errors) the combination of two diagnostic tests. This strategy is then illustrated by the use of data from Doppler ultrasound and ocular pneumoplethysmography in detecting carotid artery disease.

Carotid Artery Diseases↗
PubMed2006

A 96-well formatted method for exon and exon/intron boundary full sequencing of the CFTR gene.

Full genotypic characterization of subjects affected by cystic fibrosis (CF) is essential for the definition of the genotype-phenotype correlation as well as for the enhancement of the diagnostic and prognostic value of the genetic investigation. High-sensitivity diagnostic methods, capable of full scanning of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, are needed to enhance the significance of these genetic assays. A method for extensive sequencing of the CFTR gene was optimized. This method was applied to subjects clinically positive for CF and to controls from the general population of central Italy as well as to a single subject heterozygous for a mild mutation and with an uncertain diagnosis. Some points that are crucial for the optimization of the method emerged: a 96-well format, primer project and purification, and amplicon purification. The optimized method displayed a high degree of diagnostic sensitivity; we identified a subset of 13 CFTR mutations that greatly enhanced the diagnostic sensitivity of common methods of mutational analysis. A novel G1244R disease causing mutation, leading to a CF phenotype with pancreatic sufficiency but early onset of pulmonary involvement, was detected in the subject with an uncertain diagnosis. Some discrepancies between our results and previously published CFTR sequence were found.

Base Sequence↗
PubMedDate not supplied

Pain and the diagnostic process: conceptions and misconceptions.

Pain may be considered a diagnostic alarm that acknowledges but usually fails to determine the etiology of a particular clinical problem. Diagnosis thus involves the extraction of additional information from a patient in order to determine rational bases for treatment. The process is ill-defined and fraught with error unless the diagnostician is aware of all and only the relevant diagnostic alternatives. This list of alternatives plus an appreciation of the likelihood of each possible diagnostic outcome determines the fastest rate that diagnostic information can be processed by any system in the absence of unpredictable events called noise. Human diagnosticians must be fluent in the "language" used to convey the desired information if performance is to be optimized. In general this involves restructuring the diagnostic task into smaller pieces which are easier to digest perceptually. One way to accomplish this is to ignore or eliminate patterns which are either irrelevant or occur so rarely (or so commonly) that they usually have negligible impact on diagnostic performance. The utility of a diagnosis is determined ultimately by the degree to which it influences the health and well-being of both the patient and society at large. Hence, the consequence of a particular disease may offset the low diagnostic yield per examination resulting from a low or high prevalence of the disease. When diagnostic patterns are limited by ignorance to only signs and/or symptoms such as pain, the diagnostic process loses its meaning and treatment decisions are compromised necessarily by uncertainty.

Diagnosis, Differential↗
PubMed1985

[Principles of the postgraduate training of pathologists in the histological diagnosis of precancer and early forms of cancer].

The following general principles are necessary for achieving the maximum efficiency in the postgraduate training of pathologists in the histological diagnostics of various diseases particularly that of precancer and early forms of cancer: 1) specification of the optimal working classification clinically (prognostically) significant and corresponding to the methodological possibilities of pathologists; 2) use of the most informative diagnostical criteria; 3) formation of visual images of the diagnostical criteria including the stages of transition from the stereometric representation into the plane one, the differentiation between the feature and structural formations that imitate it, elaboration of criteria for the evaluation of the degree of semiquantitative signs; 4) placing the diagnostical criteria in the optimal order; 5) finding the criteria of the correctness of the diagnosis in question. The development of the above criteria is important in teaching, in working out methodological literature and in postgraduate selfeducation.

Cytodiagnosis↗
PubMed1986

Diagnostic approaches for deep vein thrombosis.

This article briefly reviews the advantages and limitations of currently available methods for the diagnosis of deep vein thrombosis (DVT). Clinical evaluation alone is inadequate but still useful in assessing the need for further testing. The medical history, especially the detection of risk factors for DVT, is as important as the physical examination. Confirmation by objective diagnostic tests is essential. Venography has been the traditional standard for determining the optimal management of DVT, but has significant limitations which are not widely appreciated. Noninvasive diagnostic methods for DVT are essential for effective management, but the optimal method for a particular hospital depends on the personnel and resources available.

Humans↗
PubMed2005

Triple arterial phase dynamic MRI with sensitivity encoding for hypervascular hepatocellular carcinoma: comparison of the diagnostic accuracy among the early, middle, late, and whole triple arterial phase imaging.

OBJECTIVE: We assessed and compared the diagnostic accuracy of the early, middle, late, and whole triple arterial phase MRI with sensitivity encoding (SENSE) for the detection of hypervascular hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Thirty-one patients with 102 HCCs underwent dynamic MRI with SENSE. The findings of CT examinations, combined with those of visceral angiography or histopathologic examination, were used as the gold standard. After acquisition of T1- and T2-weighted images, gadolinium-enhanced triple arterial, portal, and delayed phase images were obtained. Acquisition of the triple arterial phase imaging was started at the timing of peak aortic enhancement and completed within a single breath-hold. Acquisition time for each phase was 8.4 sec. Four image sets including the early, middle, late, and whole triple arterial phase imaging were interpreted separately by four observers. The mean values of area under alternative-free-response receiver operating characteristic (AFROC) curve and of sensitivity were compared among the four image sets. RESULTS: The mean values of area under AFROC curve were 0.52, 0.66, 0.53, and 0.68 and of sensitivity were 45%, 64%, 48%, and 65% for the image sets with the early, middle, late, and whole triple arterial phase imaging, respectively. Both mean values were significantly higher for the image sets with the middle and whole triple arterial phase imaging than for those with the early and late arterial phase imaging. CONCLUSION: The middle arterial phase imaging with k-space centered at 12.6 sec after the peak aortic enhancement was optimal for detecting HCC and showed diagnostic accuracy equivalent to that of the whole triple arterial phase imaging.

Aged↗
PubMed2003

[Metastatic bone disease. Strategies for imaging].

Skeletal metastases represent the most common malignant bone tumor. They occur mainly in adults and even more frequently in the elderly. The most common metastases in men are from prostate cancer (60%) and in women from breast cancer (70%). Other primitive tumors responsible for bone metastases are: lung, kidney, thyroid, alimentary tract, bladder, and skin. The spine and pelvis are the most common metastatic sites, due to the presence of red (haematopoietic active) bone marrow in a high amount. As a general rule, the radiographic pattern was lytic type; other aspects were osteosclerotic, mixed, lytic vs mixed and osteosclerotic vs lytic patterns. The main symptom is pain, although many bone metastases are asymptomatic. The most severe consequences are pathologic fractures and cord compression. Clinical evaluation of patients with skeletal metastases needs multimodal diagnostic imaging, able to detect lesions, to assess their extension and localization, and eventually drive the biopsy (for histo-morphological diagnosis). These techniques give different performances in terms of sensitivity and specificity; but none of the modalities alone seems to be adequate to yield a reliable diagnostic outcome. Therefore multidisciplinary cooperation is required to optimize the screening, clinical management and follow-up of the patients. In other terms, what is the efficacy of these new diagnostic tests compared to the "older" diagnostic tests? Frequently the new procedures do not replace the older one, but it is added to the diagnostic workup, thereby increasing costs without impacting the "patient's condition". The aim of the present work is to propose an "algorithm" for the detection and diagnosis of skeletal metastases, which may be applied differently in symptomatic and asymptomatic oncologic patients. Bone scintigraphy remains the first choice technique in the evaluation of asymptomatic patients, in whom skeletal metastases are supposed. Although it has a high sensitivity, scintigraphy is unspecific. So that a negative scan response has to be re-evaluated with other methods: if clinical status remains "negative", the diagnostic route can stop. On the contrary, in patients with "positive" scan or with local symptoms and pain, the screening of metastatic lesions must be accomplished by a combination of radiography and CT: the result may be negative (for low sensitivity of conventional radiology), not conclusive (in this case bone biopsy is necessary) or symptoms are not due to metastatic lesions (i.e., osteoarthritis). CT represents an excellent mean of defining the extent of any metastatic lesions, especially those located at sites difficult to evaluate (vertebral column and pelvis). Before bone biopsy is carried out, MRI must be performed, because it is the only technique that makes it possible to distinguish between bone marrow components. It has been used most extensively in the evaluation of spine metastases. The limitation of MRI is the unspecificity of its findings, which may lead to an equivocal diagnosis, and because only part of the skeleton can be studied.

Aged↗
PubMedDate not supplied

Cortisol level and perinatal outcome in pregnant women with posttraumatic stress disorder: a pilot study.

Posttraumatic stress disorder (PTSD) affects 12% of women in the United States and could affect childbearing via behavioral and neuroendocrine mechanisms. This pilot study collected preliminary data about the extent to which the low cortisol profile found in patients with PTSD also occurs in the hormonal context of pregnancy, as well as the association between PTSD and less optimal processes and outcomes of pregnancy. Standardized psychiatric diagnostic telephone interviews, salivary cortisol assays, and medical records review were evaluated in a community sample of 25 women pregnant with their first child. Higher PTSD symptom counts correlated with worse overall perinatal outcomes summarized by an Optimality Index Score (n = 22; r = -.725; P < .001). The women whose symptoms met diagnostic criteria for PTSD or partial PTSD had lower peak basal salivary cortisol concentrations (n = 14; mean = .4584 versus .8123; P = .010). Further research on the effects of PTSD on pregnancy processes and outcomes is warranted. Differences in cortisol levels were consistent with the pattern seen in nonpregnant women with PTSD. This finding suggests that salivary cortisol would be a useful biological measure to include in perinatal research on PTSD and childbearing.

Abortion, Spontaneous↗
PubMed2026

MET-Aberrant non-small cell lung cancer: from kinase dependence to cell-surface targetability-mechanistic basis and biomarker framework for bispecific antibodies and antibody-drug conjugates.

MET-aberrant non-small cell lung cancer (NSCLC) is not a uniform therapeutic entity. Its biology, diagnostic pathways, and treatment sensitivity differ across MET exon 14 skipping alteration (METex14), MET amplification, and MET overexpression. This heterogeneity cannot be fully explained by conventional event-based classification and is reflected in the distinct clinical activity of MET tyrosine kinase inhibitors (MET-TKIs), bispecific antibodies (BsAbs), and antibody-drug conjugates (ADCs). With the emergence of antibody-based therapies, MET has evolved from a signaling driver to a cell-surface target for receptor modulation and payload delivery. We therefore propose a clinically anchored two-dimensional framework for interpreting therapeutic relevance in MET-aberrant NSCLC: kinase dependence and cell-surface targetability. Neither dimension should be regarded as a directly measurable binary variable. Kinase dependence is inferred from genomic and treatment-contextual proxies, most strongly METex14 and, more conditionally, high-level focal MET amplification. Cell-surface targetability is approximated by drug-specific IHC assessment of assay-defined c-MET protein expression; however, receptor internalization, intracellular trafficking, and payload delivery capacity remain incompletely measurable in routine clinical practice. Within this framework, MET-TKIs have the most evidence-supported established role in tumors with evidence of MET-driven kinase dependence. EGFR &#xd7; MET BsAbs have demonstrated clinical activity in broad post-osimertinib EGFR-mutant NSCLC, while EGFR/MET co-dependence or MET-mediated bypass activation provides a mechanistic rationale for their use; MET-defined preferential benefit remains to be prospectively established. MET-directed antibody-drug conjugates (MET-ADCs) are supported in drug- and assay-defined populations with high c-MET protein overexpression, although the predictive relevance of delivery-related factors remains hypothesis-generating. Accordingly, MET testing should shift from single-event detection to platform-oriented stratification: next-generation sequencing (NGS) for driver alterations and resistance profiles, fluorescence in situ hybridization (FISH) for high-level focal amplification, and immunohistochemistry (IHC) for surface expression relevant to antibody-based therapies. This framework is intended to organize current biological and clinical evidence rather than to replace drug-specific companion diagnostics, regulatory indications, or prospectively validated treatment-selection algorithms. Precision treatment of MET-aberrant NSCLC is thus moving from event-based drug selection toward mechanism-based therapeutic matching. Future priorities include standardizing biomarkers, defining optimal target populations, and aligning biological subtypes, diagnostic strategies, and therapeutic platforms.

Antibody-drug conjugate↗
PubMed2003

Diagnostic laparoscopy in abdominal stab wounds: a prospective, randomized study.

BACKGROUND: The optimal strategy for identifying patients with abdominal stab wounds requiring surgical repair has not been defined. The potential benefits of diagnostic laparoscopy by incorporating it into the routine diagnostic workup of patients with anterior abdominal stab wounds was evaluated in a two-layer, randomized study. METHODS: From May 1997 through January 2002, stable patients without peritonitis but with demonstrated peritoneal violation were randomized (A) to exploratory laparotomy (AEL) (n = 23) or diagnostic laparoscopy (ADL) (n = 20). Simultaneously, patients with equivocal peritoneal violation on local wound exploration were randomized (B) to diagnostic laparoscopy (BDL) (n = 28) or expectant nonoperative management (BNOM) (n = 31). Hospital morbidity, length of stay, and costs were primary endpoints, with postdischarge disability being a secondary endpoint. RESULTS: In patients with peritoneal penetration (AEL vs. ADL), there were minimal differences in the therapeutic operation rate (8 of 23 [AEL] vs. 8 of 20 [ADL], p = 0.761), mortality (none), morbidity (3 of 23 vs. 2 of 20, p = 0.999), hospital stay (mean +/- SD) (5.7 +/- 2.5 vs. 5.1 +/- 4.0 days, p = 0.049), hospital costs (4.6 +/- 1.3 vs. 4.8 +/- 1.9 x 1,000 EUR, p = 0.576), and length of sick leave (34 +/- 12 vs. 29 +/- 11 days, p = 0.305). In patients with equivocal peritoneal penetration (BDL vs. BNOM), laparoscopy found more mostly minor organ injuries (7 of 28 [BDL] vs. 1 of 31 [BNOM], p = 0.022) with no significant difference in therapeutic operations (3 of 28 vs. 1 of 31, p = 0.337) or morbidity (3 of 28 vs. 0 of 31, p = 0.101), but was associated with increased length of stay (2.6 +/- 2.1 vs. 1.9 +/- 1.8 days, p = 0.022), hospital costs (4.2 +/- 1.3 vs. 1.5 +/- 1.1 x 1,000 EUR, p = 0.000), and sick leave requirements (18 of 23 vs. 8 of 28 of eligible patients, p = 0.001). CONCLUSION: In patients with demonstrated peritoneal violation, laparoscopy offers little benefit over exploratory laparotomy. In patients with equivocal peritoneal penetration on local wound exploration, laparoscopy detects more mostly minor organ injuries than expectant nonoperative management but is associated with increased hospital stay, costs, and sick leave requirements. Overall, diagnostic laparoscopy cannot be recommended as a routine diagnostic tool in anterolateral abdominal and thoracoabdominal stab wounds.

Abdominal Injuries↗
PubMed2003

Optimal fecal assessment.

Fecal testing is a common component of most gastrointestinal work-ups. A multitude of diagnostic techniques are available for identifying parasites and pathogens, or showing abnormalities of flora. Optimal fecal assessment involves careful formulation of a differential list based on signalment, history, and clinical signs. Tests should be selected and interpreted based on their relative sensitivity and specificity for specific conditions. It is essential to use effective testing methods for the etiologies of concern. This article reviews the plethora of diagnostic techniques available for fecal assessment. Indications, limitations, and issues of specimen handling for each technique are discussed. The optimal approach to the diagnosis of some common parasites, pathogens, abnormalities of flora, and metabolic conditions are covered.

Animals↗
PubMed2000

Quality control and optimized procedure of hybridization capture-PCR for the identification of Mycobacterium avium subsp. paratuberculosis in faeces.

Nucleic acid sequence capture techniques are used to improve both the sensitivity and specificity of PCR for the diagnosis of plant, animal and human diseases. Hybridization capture-PCR (HC-PCR) was first reported as a method for the detection of Mycobacterium avium subsp. paratuberculosis in 1995 and was successfully trialed on a small number of faecal samples from cattle with Johne's disease. A locally optimized HC-PCR method was evaluated on faeces from infected and non-infected animals. However, sample to sample cross contamination during the DNA purification step highlighted that the original format of the test was unsuitable for routine diagnostic use. Here, we report modifications and optimization of HC-PCR, particularly with respect to DNA purification from faeces, hybridization and capture steps. We also identified procedurally sensitive critical points in the test during capture and washing of magnetic beads. Southern blotting was omitted from the protocol to preserve specificity but this resulted in analytical sensitivity of 5000 organisms per 200 mg faecal sample. Nevertheless, HC-PCR detected M.paratuberculosis in pellets from infected sheep diluted at rates of up to 1 in 100 in normal faeces, suggesting that the technique should be evaluated further for low-cost diagnosis in flocks/herds using pooled samples.

Animals↗
PubMed1982

Radiation treatment of carcinoma of the cervix.

To give the optimal treatment to each individual with cancer of the cervix, there must be very close cooperation and professional rapport between the radiation oncologist and gynecologic oncologist. Patients should be evaluated together with a review of the pertinent pathology and diagnostic roentgenograms in order to determine the optimal, individualized treatment plan for each patient. In the radiotherapeutic management of patients with cervical cancer, meticulous care must be taken in the treatment setups for external radiotherapy and the intracavitary radium applications. External fields should be carefully shaped to minimize the amount of normal tissue treated. Radium applications must be carefully reviewed with attention to and correction of minor deviations in the radium geometry, which could give rise to "hot" or "cold" spots in the radium dosage. With attention paid to the above factors, radiotherapy in the treatment of cervical cancer can be extremely rewarding. The majority of the patients treated will be cured and will be able to return to normal, functional lives. Most of the patients seen with cervical cancer do not have other major medical illnesses that will limit their lifespan, and as a result, 10-, 20-, and 30-yr survivals after treatment are being reported.

Carcinoma, Squamous Cell↗
PubMed1989

[Ultrasonic diagnosis of gallstone diseases].

In the past decade the sonography has effected radical changes in the diagnostics of gallstone troubles and their complications. Today it is the method of choice in search for gallstones. Taking into consideration all advantages connected with the method and a sensitivity of more than 95% with an approximately 99 per cent specificity at present no other diagnostic method can compete with it. The reliability in the gallstone diagnostics above all depends on the experience of the investigator and the size of the concrement. Data in modern literature indicate a sensitivity of 70-90%, among our own patients it is in 376 cases nearly 86% (specificity 92%). In optimal technical and personal prerequisites the ultrasound diagnostics it is the initial method of choice also in the diagnostics of the bile ducts. The intravenous cholegraphy and ERC as complementary methods are used only in the second place.

Cholecystitis↗
PubMedDate not supplied

The continuing value of electron microscopy in surgical pathology.

For decades, transmission electron microscopy has played a valuable diagnostic role in surgical pathology. The continuing importance of electron microscopy, however, can be debated, given the major advances that have occurred in immunohistochemistry and other techniques. Electron microscopy retains excellent educational potential and broad research applicability, and it continues to be a necessity for the evaluation of a small subset of surgical pathology cases, such as renal biopsies and cilia specimens. The real controversy, then, centers on the contribution of electron microscopy in the evaluation of neoplasms. The opinion of many experts indicates that electron microscopy is still vital in the diagnostic assessment of some neoplasms, and that both electron microscopy and immunohistochemistry are more powerful when viewed as complementary rather than competitive techniques. For electron microscopy to be used to its potential, however, electron microscopists must function effectively as consultants. When optimally applied, electron microscopy remains an essential diagnostic tool.

Costs and Cost Analysis↗
PubMed1998

Evaluation of the CytoRich technique for cervical smears.

The aim of the study was to assess the ability of the CytoRich System to prepare optimal gynaecological smears for diagnosis. The diagnostic results obtained from evaluating 1,325 matched slide-pairs, prepared using conventional methods and thin-layer technology, were compared. Cytological material for study was obtained using the combined spatula-cytobrush sampling technique. An assessment of the pitfalls associated with the interpretation of these smears was also undertaken. Diagnostic agreement was achieved in 1,272 of the 1,325 matched slide-pairs (96.0%), and these included 1,172 negative, 50 atypical, 24 low-grade squamous intraepithelial lesion (LSIL), 24 high-grade SIL (HSIL), and two malignancies. A total of 1,309 cases showed the same diagnosis within one diagnostic grade for an agreement of 98.8%. Evaluation of the 53 discordant diagnoses revealed that the conventional smear identified a significantly greater number of abnormal smears than the CytoRich technique (P < .001). It is suspected that the use of the combined spatula-cytobrush sampling technique did not provide adequate residual specimen for CytoRich after conventional smear preparation. This limitation is evidenced by the fact that the CytoRich preparations showed a lower yield of endocervical cells (P < .001) and infectious organisms (P < .001) than was demonstrated on conventional smears. Despite a number of diagnostic pitfalls associated with the interpretation of thin-layer smears, these preparations were easier and faster to screen and showed well-preserved and evenly distributed cells. Thin-layer smears were also characterised by a marked reduction in thick cell groups, air drying artifact, and obscuring inflammation and blood. The results confirm the limitation of the combined spatula-cytobrush technique in these types of comparative studies.

Carcinoma in Situ↗
PubMed1993

Evaluation of amniotic fluid cell filtration: an experimental approach to early amniocentesis.

Prior to a prospective application of amniotic fluid (AF) cell filtration to early amniocentesis, we tested the technique on a surplus from mid-trimester samples. By using the same sample size of 5 ml in experiments with a filter and in routine diagnostic procedures (control), we evaluated an optimal filter system. The prolonged culture time of filtered cells and the reduced number of clones are most probably due to mechanical stress (filtration pressure), whereas loss of the cells by adhesion to the filter system, and an AF-free culture medium (growth factors) are suggested to be less important. The AF cells are very sensitive to mechanical stress. Slow filtration (< or = ml AF/min) through filters with a high porosity and the largest possible pore size should be preferred. A mixed cellulose ester filter membrane with a pore size of 5.0 microns proved to be the most efficient, allowing harvest of the filtered cells after only a slight prolongation of the culture time (+2.4 days) compared with unfiltered aliquots. A filter set with a bypass connected by three-way taps allows cell filtration during either aspiration or reinjection of the AF. Cell filtration after amniocentesis and consecutive reverse flushing of the membrane with the appropriate amount of culture medium proved to be the best with regard to easy handling and reducing the risk of bacterial contamination.

Amniocentesis↗
PubMed1998

Concordance between symptom screening and diagnostic procedure: the Hopkins Symptom Checklist-25 and the Composite International Diagnostic Interview I.

The definition of case is a core issue in psychiatric epidemiology. Psychiatric symptom screening scales have been extensively used in population studies for many decades. Structured diagnostic interviews have become available during recent years to give exact diagnoses through carefully undertaken procedures. The aim of this article was to assess how well the Hopkins Symptom Checklist-25 (HSCL-25) predicted cases by the Composite International Diagnostic Interview (CIDI), and find the optimal cut-offs on the HSCL-25 for each diagnosis and gender. Characteristics of concordant and discordant cases were explored. In a Norwegian two-stage survey mental health problems were measured by the HSCL-25 and the CIDI. Only 46% of the present CIDI diagnoses were predicted by the HSCL-25. Comorbidity between CIDI diagnoses was found more than four times as often in the concordant cases (case agreed upon by both instruments) than in the discordant CIDI cases. Concordant cases had more depression and panic/generalized anxiety disorders. Neither the anxiety nor the depression subscales improved the prediction of anxiety or depression. The receiver operating characteristic (ROC) curves confirmed that the HSCL-25 gave best information about depression. Except for phobia it predicted best for men. Optimal HSCL-25 cut-off was 1.67 for men and 1.75 for women. Of the discordant HSCL-25 cases, one-third reported no symptoms in the CIDI, one-third reported symptoms in the CIDI anxiety module, and the rest had symptoms spread across the modules. With the exception of depression, the HSCL-25 was insufficient to select individuals for further investigation of diagnosis. The two instruments to a large extent identified different cases. Either the HSCL-25 is a very imperfect indicator of the chosen CIDI diagnoses, or the dimensions of mental illness measured by each of the instruments are different and clearly only partly overlapping.

Adult↗