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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↗

Absence of leukaemic fusion gene transcripts in preterm infants exposed to diagnostic x rays.

BACKGROUND: Childhood leukaemias express novel, clonotypic fusion genes that may already be present at birth before the clinical manifestation of leukaemia. Exposure of the fetus to diagnostic x rays is reported to increase the risk of childhood leukaemia, and may do so by generating leukaemic fusion genes. Advances in neonatal medicine in the past decade that have extended the limits of viability of preterm babies down to 23 weeks of gestation have resulted in the increased use of diagnostic x rays to monitor neonatal progress. AIM: To investigate whether exposure of very preterm infants to diagnostic x rays in the neonatal period leads to the development of leukaemic fusion genes. METHODS: Peripheral blood samples were collected at birth from very preterm infants (23-30 weeks gestation) and following exposure to diagnostic x rays at intervals of two weeks, until discharge. Cord blood samples from normal full term infants served as controls. Total RNA was extracted from the blood and the expression of the fusion genes TEL-AML1, MLL-AF4, and BCR-ABL, characteristic of three subtypes of childhood leukaemia, was investigated in the preterm and full term infant samples using a nested reverse transcriptase polymerase chain reaction method. Serial pre- and post-x ray samples from 42 preterm babies, pre-x ray samples from an additional 46 preterm infants, and cord blood samples from 100 normal full term infants were screened for fusion gene transcripts. RESULTS: No leukaemic fusion gene transcripts were detected in preterm infants following exposure to diagnostic x rays. A BCR-ABL transcript was identified in a single preterm infant prior to x ray exposure. TEL-AML1 transcripts were detected in cord blood samples from two full term infants. MLL-AF4 transcripts were not detected in any of the pre- or full term infants tested. CONCLUSIONS: Exposure of the preterm infants to x rays in this small series and at the doses used for diagnostic purposes did not induce leukaemic fusion gene expression, but we cannot exclude the possibility that a small proportion of preterm infants may be unusually sensitive to x rays.

Cell Line↗

Diagnostic accuracy of B type natriuretic peptide and amino terminal proBNP in the emergency diagnosis of heart failure.

OBJECTIVE: To compare head to head the diagnostic accuracy of B type natriuretic peptide (BNP) and the amino terminal fragment of its precursor hormone (NT-proBNP) for congestive heart failure (CHF) in an emergency setting. METHODS: 251 consecutive patients presenting to the emergency department with dyspnoea as a chief complaint were prospectively studied. Patients with acute coronary syndromes were excluded. The diagnosis of CHF was based on the Framingham score for CHF plus echocardiographic evidence of systolic or diastolic dysfunction. Blood concentrations of BNP and NT-proBNP were measured by two commercially available assays (Abbott and Roche methods). The diagnostic accuracies of BNP and NT-proBNP were assessed by receiver operating characteristic curve analysis. RESULTS: Areas under the curve for BNP and NT-proBNP in patients with dyspnoea caused by CHF (n = 137) and in patients with dyspnoea attributable to other reasons (n = 114) did not differ significantly (area under the curve 0.916 v 0.903, p = 0.277, statistical power 94%). Cut off concentrations with the highest diagnostic accuracy were 295 ng/l for BNP (sensitivity 80%, specificity 86%, diagnostic accuracy 83%) and 825 ng/l for NT-proBNP (sensitivity 87%, specificity 81%, diagnostic accuracy 84%). Evaluation of discordant false classifications at these cut off concentrations showed no advantage for either BNP nor NT-proBNP in the biochemical diagnosis of CHF (17 misclassifications by BNP and 14 by NT-proBNP, p = 0.720). In the population studied, age, sex, and renal function had no impact on the diagnostic utility of both tests when compared by logistic regression models. CONCLUSIONS: BNP and NT-proBNP may be equally useful as an aid in the diagnosis of CHF in short of breath patients presenting to the emergency department.

Aged↗

Effect of one or more co-morbid conditions on diagnostic accuracy of coronary flow velocity reserve for detecting significant left anterior descending coronary stenosis.

OBJECTIVE: To determine the effect of one or multiple co-morbid conditions on the diagnostic accuracy of coronary flow velocity reserve (CFVR) in a heterogeneous patient population. METHODS: CFVR was measured in the left anterior descending coronary artery (LAD) by transthoracic Doppler echocardiography (TTDE) in 318 consecutive patients before elective coronary angiography. CFVR was calculated as the average peak diastolic velocity during intravenous ATP infusion divided by baseline flow velocity. All patients underwent coronary angiography within 48 hours. Significant LAD stenosis was defined as > 50% luminal narrowing. Diagnostic accuracy of CFVR was analysed according to the type and number of risk factors that may adversely affect microvascular function. RESULTS: CFVR was measured in 309 patients, of whom 105 were found to have significant LAD stenosis based on coronary angiography. CFVR < 2.0 had a sensitivity of 86% and a specificity of 77% for predicting significant LAD stenosis. Left ventricular hypertrophy (LVH) was the only factor that significantly lowered diagnostic accuracy (61% with LVH v 84% without LVH, p < 0.001). Diagnostic accuracy was not affected by increasing number of risk factors. CONCLUSIONS: The diagnostic accuracy of CFVR by TTDE for detecting significant LAD stenosis remains high in a more clinically relevant population with multiple cardiovascular co-morbidities. Only the presence of LVH adversely affected diagnostic accuracy.

Adult↗

Complications of diagnostic cardiac catheterisation: results from a confidential inquiry into cardiac catheter complications.

OBJECTIVES: To estimate the frequency and nature of complications in patients undergoing diagnostic cardiac catheterisation and to assess time trends in complications since the introduction of a voluntary cooperative audit. METHODS: Cardiac centres undertaking diagnostic cardiac catheterisation in England and Wales during the 10 years 1990-9 were invited to join the study. Each participating centre reported numbers of patients catheterised each month and details of complications and deaths as they occurred. Complication rates were calculated for the main diagnostic procedures and for each participating hospital and time trends in complications were examined. RESULTS: 41 cardiac centres contributed. 211 645 diagnostic procedures in adults and 7582 paediatric procedures were registered. The majority (87%) of diagnostic catheter studies in adults were left heart studies with coronary arteriography. The overall complication rate for adult procedures was 7.4/1000, with mortality at 0.7/1000; for paediatric procedures the complication rate was similar but mortality rather higher. Complication rates varied between centres but there was little association with caseload. Time trends across the decade showed both complication and mortality decreasing; from 9.5 to 5.8/1000 and from 1.4 to 0.4/1000, respectively. CONCLUSION: Complication rates of diagnostic catheterisation are low but neither negligible nor irreducible. While voluntary audit of cardiac catheter complications is useful and inexpensive, there is a clear need to establish a formal reporting system in all cardiac catheter laboratories, with clear definitions of reportable complications.

Adult↗

Medical diagnostic decision support systems--past, present, and future: a threaded bibliography and brief commentary.

Articles about medical diagnostic decision support (MDDS) systems often begin with a disclaimer such as, "despite many years of research and millions of dollars of expenditures on medical diagnostic systems, none is in widespread use at the present time." While this statement remains true in the sense that no single diagnostic system is in widespread use, it is misleading with regard to the state of the art of these systems. Diagnostic systems, many simple and some complex, are now ubiquitous, and research on MDDS systems is growing. The nature of MDDS systems has diversified over time. The prospects for adoption of large-scale diagnostic systems are better now than ever before, due to enthusiasm for implementation of the electronic medical record in academic, commercial, and primary care settings. Diagnostic decision support systems have become an established component of medical technology. This paper provides a review and a threaded bibliography for some of the important work on MDDS systems over the years from 1954 to 1993.

Computers↗

The problem of diagnostic variability in general practice.

STUDY OBJECTIVE: The aim was to examine the scale, source, and relevance of variation between general practices in respect of the rates with which patients consulted with illnesses falling in each of several diagnostic groups. DESIGN: This study involved a general practice morbidity survey conducted over two years, 1970-72. All patients who consulted their general practitioners were identified and the number of these who consulted with diagnoses attributable to each of the 18 main chapters of the International classification of diseases were counted. Patients who consulted for more than one diagnosis within a chapter were counted once only; those who consulted for one or more diagnoses in each of several chapters were counted once for each chapter. SETTING: This was a national survey involving general practitioners in England and Wales. SUBJECTS: The study involved 214,524 patients from 53 selected general practices (115 doctors) who were registered with their general practitioners for the whole of the year 1970-71 and for whom their morbidity data had been linked with their social data from the 1971 census. MEASUREMENTS AND MAIN RESULTS: Using the numbers of patients on the practice lists as denominators, practice patient consulting rates (PPCR) were calculated for each practice and for each ICD chapter. Variability in chapter PPCR was examined by calculating coefficients of variation and, after allowance for random variation, coefficients of residual variation. There were large interpractice (doctor) variations in all chapter rates. These variations were only marginally attributable to: chance; different age, sex and social class mixes of practice populations; geographical locations; and practice organisation. The rates were, however, consistent from one year to the next for any one practice. Approximately half of the interpractice (doctor) diagnostic variability was associated with overall patient consulting behaviour. When the effects of this behaviour were discounted, any major residual diagnostic variability was confined largely to ICD chapters I-V, XVI, and XVII, ie, those chapters where aetiology forms the basis of classification. CONCLUSION: Variations in recorded diagnostic rates are mainly due to the consistent but idiosyncratic and selective exclusion by practitioners of some components from the total set which often coexist in a new diagnosis. Because of the scale of interpractice diagnostic variability, the use of algorithms and information technology is largely precluded from outcome studies, auditing procedures, and studies of practice work loads in general. However, (1) the consistency of any individual doctor's pattern of diagnostic recording from one year to another permits studies of trends; and (2) given a reasonable number of recording practices, the population mean practice consulting rates can be estimated with sufficient accuracy for many epidemiological research and administrative uses.

Age Factors↗

Diagnostic and counselling difficulties using a fully comprehensive screening protocol for families at risk for tuberous sclerosis.

Tuberous sclerosis (TS) results from an autosomal dominant gene which exhibits variable expression and reduced penetrance. Although there are well established diagnostic criteria for TS, examination of first degree relatives can cause diagnostic criteria for TS, examination of first degree relatives can cause diagnostic problems with consequent difficulties in genetic counselling. Using an extensive, non-invasive protocol consisting of skin examination with Wood's lamp, cranial CT scan, specialist ophthalmological and dental examination, skeletal survey, and echocardiography, we have examined 56 first degree relatives of persons with TS. These consisted of 40 parents and seven sibs from 25 sporadically affected families and nine persons from seven multigeneration families. In seven of the apparently sporadically affected families, three mothers had echocardiographical findings consistent with one or more rhabdomyoma. In another, the mother's renal ultrasound showed evidence of single cysts in both kidneys. In a fifth family, the father had suggestive but not diagnostic features of TS on the cranial CT scan and skeletal survey. In the sixth family, the mother was found to have atypical calcification on CT scan. In a seventh instance a sib from a two generation family had echocardiographical evidence of a rhabdomyoma. Even though the proband in three of the sporadically affected families presented with fits, developmental delay, and depigmented patches, and therefore did not strictly fulfil the diagnostic criteria for TS, two mothers were found to have evidence of rhabdomyomata on echocardiography and the brother of the third had typical depigmented patches. Although the presently accepted diagnostic criteria for TS may not allow one to make a definitive diagnosis of TS in these relatives, we recommend that an extensive screening protocol be used to examine first degree relatives and that caution be used in counselling apparently unaffected members of families at risk for TS.

Bone and Bones↗

Stereotactic 11-gauge vacuum-assisted breast biopsy: influence of number of specimens on diagnostic accuracy.

PURPOSE: To determine whether number of specimens obtained at stereotactic 11-gauge vacuum-assisted breast biopsy with the patient prone influences diagnostic accuracy and to determine whether this number varies depending on mammographic appearance of lesions as masses or microcalcifications. MATERIALS AND METHODS: Biopsy was prospectively performed in 100 patients (median age, 55 years; range, 31-81 years) with 100 lesions that were mammographically evident as masses (n = 50) and microcalcifications (n = 50) with standardized protocol to acquire 20 specimens per lesion in three 360 degrees probe rotations at one skin entry site. Specimens were histologically evaluated sequentially, and findings were compared with results of surgical excision or of mammographic follow-up for at least 24 months. Differences in diagnostic yield after each probe rotation and differences in diagnostic yield between masses and microcalcifications were determined with chi(2) test. RESULTS: Up to 12 specimens harvested within two 360 degrees probe rotations were necessary to yield correct diagnosis in 96% of patients with masses and 92% of patients with microcalcifications. Diagnostic yield was not improved with more than 12 specimens for masses or microcalcifications. In two (4%) of 47 patients with lesions that were eventually diagnosed as cancer, results at stereotactic biopsy indicated they were benign. Underestimation of diagnosis of lesions as atypical ductal hyperplasia and ductal carcinoma in situ occurred in two (50%) of four and two (17%) of 12 lesions, respectively. With 20 specimens harvested during three probe rotations, there was no statistically significant difference in diagnostic yield between patients with masses and those with microcalcifications (P =.68). CONCLUSION: At 11-gauge vacuum-assisted biopsy, highest diagnostic yield was achieved with 12 specimens per lesion, independent of mammographic appearance of the lesion. Even with standardized retrieval of 20 specimens per lesion, underestimation of disease still occurs.

Adult↗

Not so rapid progression of peripheral vascular disease after diagnostic angiography.

It was recently reported that peripheral vascular disease may progress so rapidly after diagnostic angiography that most likely the diagnostic procedure is in some way responsible. Because flow-limiting arterial stenoses often become complete occlusions within hours or days of the diagnostic procedure, it was recommended that angioplasty be performed immediately after diagnostic angiography to avoid this complication. The authors attempted to confirm these findings before implementing this recommendation. In fact, they did not confirm the findings. Among 96 flow-limiting stenoses considered for angioplasty, the procedure was performed in 31 on the same day. Among the remaining 65 cases, in 64 the stenosis did not occlude and angioplasty was successfully performed. Only one stenosis was discovered to have thrombosed, and this occurred 3 weeks after diagnostic angiography. These results indicate that there is not such rapid progression of peripheral vascular disease after diagnostic angiography. It is not necessary to perform angioplasty of stenotic lesions emergently, and treatment is not impaired by electively scheduling the patient for the next available day.

Angiography↗

The solitary pulmonary nodule--is it malignant or benign? Diagnostic performance of Tc-depreotide SPECT.

BACKGROUND: The diagnosis of malignancy may be difficult to establish in solitary pulmonary nodules (SPNs). OBJECTIVES: It was the aim of this study to assess diagnostic performances of technetium-99m ((99m)Tc)-depreotide in differentiating benign from malignant SPNs and compare its diagnostic accuracy with fluor-18-fluoro-deoxyglucose positron emission tomography (FDG-PET) in a subgroup of patients. METHODS: One hundred and eighteen patients presenting with an SPN < or =3 cm suspected of malignancy on CT were included in a prospective, open-label, European multicentre trial. Single photon emission computed tomography (SPECT) images were acquired 1.1-4.5 h after injection of 459-770 MBq of (99m)Tc-depreotide. A subset of 29 patients also underwent FDG-PET imaging. Images were interpreted blindly and correlated with histopathology. RESULTS: (99m)Tc-depreotide was positive in 65 of 73 patients with a malignant lesion and negative in 30 of 45 patients with a benign lesion, resulting in a sensitivity, specificity and diagnostic accuracy of 89, 67 and 81%, respectively. In 40 patients with SPN < or =1.5 cm, diagnostic accuracy was 88, sensitivity 75 and specificity 96%. In the subset of 29 patients who underwent both (99m)Tc-depreotide SPECT and FDG-PET imaging, sensitivity, specificity and diagnostic accuracy were identical for both modalities, i.e. 90, 67 and 83%, respectively. CONCLUSIONS: The diagnostic accuracy of (99m)Tc-depreotide SPECT is good and comparable with FDG-PET imaging in SPN of indeterminate origin.

Adolescent↗

Computerized screening devices and performance assessment: development of a policy towards automation. International Academy of Cytology Task Force summary. Diagnostic Cytology Towards the 21st Century: An International Expert Conference and Tutorial.

ISSUES: The extension of automation to the diagnostic assessment of clinical materials raises issues of professional responsibility, on the part of both the medical professional and designer of the device. The International Academy of Cytology (IAC) and other professional cytology societies should develop a policy towards automation in the diagnostic assessment of clinical cytologic materials. CONSENSUS POSITION: The following summarizes the discussion of the initial position statement at the International Expert Conference on Diagnostic Cytology Towards the 21st Century, Hawaii, June 1997. 1. The professional in charge of a clinical cytopathology laboratory continues to bear the ultimate medical responsibility for diagnostic decisions made at the facility, whether automated devices are involved or not. 2. The introduction of automated procedures into clinical cytology should under no circumstances lead to a lowering of standards of performance. A prime objective of any guidelines should be to ensure that an automated procedure, in principle, does not expose any patient to new risks, nor should it increase already-existing, inherent risks. 3. Automated devices should provide capabilities for the medical professional to conduct periodic tests of the appropriate performance of the device. 4. Supervisory personnel should continue visual quality control screening of a certain percentage of slides dismissed at primary screening as within normal limits (WNL), even when automated procedures are employed in the laboratory. 5. Specifications for the design of primary screening devices for the detection of cervical cancer issued by the IAC in 1984 were reaffirmed. 6. The setting of numeric performance criteria is the proper charge of regulatory agencies, which also have the power of enforcement. 7. Human expert verification of results represents the "gold standard" at this time. Performance characteristics of computerized cytology devices should be determined by adherence to defined and well-considered protocols. Manufacturers should not claim a new standard of care; this is the responsibility of the medical community and professional groups. 8. Cytology professionals should support the development of procedures that bring about an improvement in diagnostic decision making. Advances in technology should be adopted if they can help solve problems in clinical cytology. The introduction of automated procedures into diagnostic decision making should take place strictly under the supervision and with the active participation and critical evaluation by the professional cytology community. ONGOING ISSUES: Guidelines should be developed for the communication of technical information about the performance of automated screening devices by the IAC to governmental agencies and national societies. Also, guidelines are necessary for the official communication of IAC concerns to industry, medicolegal entities and the media. Procedures and guidelines for the evaluation of studies pertaining to the performance of automated devices, performance metrics and definitions for evaluation criteria should be established.

Automation↗

Ruling out deep venous thrombosis in primary care. A simple diagnostic algorithm including D-dimer testing.

In primary care, the physician has to decide which patients have to be referred for further diagnostic work-up. At present, only in 20% to 30% of the referred patients the diagnosis DVT is confirmed. This puts a burden on both patients and health care budgets. The question arises whether the diagnostic work-up and referral of patients suspected of DVT in primary care could be more efficient. A simple diagnostic decision rule developed in primary care is required to safely exclude the presence of DVT in patients suspected of DVT, without the need for referral. In a cross-sectional study, we investigated the data of 1295 consecutive patients consulting their primary care physician with symptoms suggestive of DVT, to develop and validate a simple diagnostic decision rule to safely exclude the presence of DVT. Independent diagnostic indicators of the presence of DVT were male gender, oral contraceptive use, presence of malignancy, recent surgery, absence of leg trauma, vein distension, calf difference and D-dimer test result. Application of this rule could reduce the number of referrals by at least 23% while only 0.7% of the patients with a DVT would not be referred. We conclude that by using eight simple diagnostic indicators from patient history, physical examination and the result of D-dimer testing, it is possible to safely rule out DVT in a large number of patients in primary care, reducing unnecessary patient burden and health care costs.

Adult↗

Spurious precision: procedural validity of diagnostic assessment in psychotic disorders.

OBJECTIVE: Very few studies have quantified the level of agreement among alternative diagnostic procedures that use a common set of fixed operational criteria. The authors examined the procedural validity of four independent methods of assigning DSM-III-R diagnoses of psychotic disorders. METHOD: The research was conducted as a satellite study to the DSM-IV Field Trial for Schizophrenia and Related Psychotic Disorders. The setting was the National Health and Medical Research Council Schizophrenia Research Unit's Early Psychosis Prevention and Intervention Centre, which focuses on first-episode psychosis. Consecutively admitted patients (N = 50) were assessed by independent raters who used four different procedures to determine a DSM-III-R diagnosis. These procedures were 1) the diagnostic instrument developed for the DSM-IV field trial, 2) the Royal Park Multidiagnostic Instrument for Psychosis, 3) the Munich Diagnostic Checklists, and 4) a consensus DSM-III-R diagnosis assigned by a team of clinician researchers who were expert in the use of diagnostic criteria. RESULTS: Concordance between pairs of diagnostic procedures was only moderate. Corresponding levels of percent agreement, however, ranged from 66% to 76%, with converse misclassification rates of 24%-34% (assuming one procedure to be "correct"). CONCLUSIONS: These findings have significant research and clinical implications. Despite the introduction of operationally defined diagnoses, there remained an appreciable level of differential classification or misclassification arising from variability in the method of assigning the diagnostic criteria rather than the criteria themselves. Such misclassification may impede neurobiological research and have harmful clinical effects on patients with first-episode psychosis.

Adolescent↗

Methods to improve diagnostic accuracy in a community mental health setting.

OBJECTIVE: This study determined the extent to which adding structured procedures improved diagnostic accuracy for outpatients with severe mental illness in a community mental health setting. METHOD: The Structured Clinical Interview for DSM-III-R (SCID) was used to interview 200 psychiatric outpatients. A research nurse reviewed medical records and amended the SCID diagnoses accordingly. A research psychiatrist or psychologist reviewed the diagnostic data and interviewed each patient to verify or further modify the previous findings. Diagnostic outcomes at each step of the procedure were compared to determine whether adding additional data improved diagnostic accuracy. The additional time required for each element of the diagnostic procedure was also assessed. RESULTS: Kappa comparisons of the different diagnostic levels showed that adding additional data significantly improved accuracy. Diagnoses rendered by combining the SCID and review of the medical record were the most accurate, followed by the SCID alone, and then diagnoses made by psychiatrists during routine care. In addition, the SCID alone identified five times as many current and past secondary diagnoses as were documented routinely in patients' charts. CONCLUSIONS: Combining structured interviewing with a review of the medical record appears to produce more accurate primary diagnoses and to identify more secondary diagnoses than routine clinical methods. The patients' knowledge of their diagnoses was limited, suggesting a need for patient education in this setting. Whether use of structured interviewing in routine practice improves patient outcomes deserves further study.

Adolescent↗

The diagnostic value of scoring models for organic and non-organic gastrointestinal disease, including the irritable-bowel syndrome.

Scoring models based on history and physical examination have been developed to discriminate patients with non-organic gastrointestinal disease from those who have organic disease. The application of these models may lead to more efficient diagnosis and prevent somatization. Although the models have high diagnostic accuracy in the population in which they have been developed, their value in other populations has not been established. In this study previously developed models were tested in validation populations defined by the original selection criteria from the studies in which the models were developed and in unselected general practice and outpatient populations. The diagnostic performance of the models are expressed in terms of odds ratio and sensitivity and specificity for the classification of patients as having organic and non-organic disease. The diagnostic performance of all the models were rather low in the validation populations. Relatively few elements of the models had independent diagnostic value. In addition, the correlation between the scoring models, expressed in Cohen's kappa, was extremely low. The diagnostic values of the scoring models were not reproduced in comparable and unselected populations. Therefore, it is concluded that the diagnostic value of such a model has little external validity.

Adolescent↗

Diagnostic delay in breast cancer: correlation with disease stage and prognosis.

Diagnostic delay in a group of 189 women with breast cancer was studied and correlated with first symptom, stage of disease, histologic grade and prognosis. Diagnostic delay was divided into patient delay (time from the patient's discovery of a symptom to the first medical consultation) and system delay (time from medical diagnosis to treatment). Patients were divided into five groups by patient-delay time: 0 to 30 days; 31 to 90 days; 91 to 180 days; 181 to 365 days; and greater than 365 days. The median diagnostic delay was 60 days (range, 4-980) and was not influenced by patient age, marital status or nature of first symptom. A consistent and direct relationship was found between delay and tumor size, nodal involvement, presence of metastases, and histologic grade of disease at diagnosis. No correlation was found between diagnostic delay and histologic type distribution. The three-year survival rate after treatment was significantly lower for patients with a longer delay. Our data indicate that diagnostic delay appears to be an important determinant of stage at diagnosis in women with breast cancer and that it has an important influence on survival. In most cases, delay was mainly patient dependent (60 days); the median system-dependent delay was 15 days (range, 4-47). Since early treatment is generally accepted to be one of the most important determinants of prognosis in breast cancer patients, a reduction in diagnostic delay may lengthen survival time.

Adult↗

The interpretation of diagnostic tests.

Laboratory diagnostic tests are central in the practice of modern medicine. Common uses include screening a specific population for evidence of disease and confirming or ruling out a tentative diagnosis in an individual patient. The interpretation of a diagnostic test result depends on both the ability of the test to distinguish diseased from nondiseased subjects and the particular characteristics of the patient and setting in which the test is being used. This article reviews statistical methodology for assessing laboratory diagnostic test accuracy and interpreting individual test results, with an emphasis on diagnostic tests that yield a continuous measurement. The article begins with a summary of basic concepts and terminology, then briefly discusses study design and reviews methods for assessing the accuracy of a single diagnostic test, comparing the accuracy of two or more diagnostic tests and interpreting individual test results.

Clinical Laboratory Techniques↗