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Factors affecting diagnostic accuracy of CT-guided coaxial cutting needle lung biopsy: retrospective analysis of 631 procedures.

PURPOSE: To analyze variables affecting diagnostic accuracy of computed tomography (CT)-guided percutaneous coaxial cutting needle biopsy of lung lesions. MATERIALS AND METHODS: A retrospective analysis of factors affecting diagnostic accuracy of CT-guided percutaneous coaxial cutting needle lung biopsy was performed in 631 consecutive procedures with confirmed final diagnoses. Benign and malignant needle biopsy results were cross-examined with correct and incorrect final outcomes to determine diagnostic accuracy. Factors affecting diagnostic accuracy were determined by multivariate logistic regression analysis of variables thought to affect diagnostic accuracy. A P value less than 0.05 was interpreted as statistically significant. RESULTS: The overall diagnostic accuracy of CT-guided percutaneous coaxial cutting needle biopsy of lung lesions was 95% (95% CI: 92.7%-96.2%). Sensitivity was 93%, specificity 98%, negative predictive value 6%, positive predictive value 99%, false-positive rate 0.7%, and false-negative rate 15%. The factors affecting diagnostic accuracy were final diagnoses (benign, 86%; malignant, 99%; chi(2) test, P < 0.001) and lesion size (lesions <1.5 cm, 84%; lesions 1.5-5.0 cm, 96%; lesions >5 cm, 93%; chi(2) test, P = 0.06). CONCLUSION: Benign lung lesions, lung lesions smaller than 1.5 cm (which pose technical difficulty), and lung lesions larger than 5 cm (which are associated with a higher necrosis rate) affect diagnostic accuracy of CT-guided percutaneous coaxial cutting needle biopsy of lung lesions.

Biopsy, Needle↗

Diagnostic accuracy evaluation using ROC curve analysis.

The diagnostic accuracy of a biochemical quantity is inversely related to the overlapping zone between the values of the population suffering from a disease and the population which does not. The ROC curves are an indirect measure of the overlapping zone between both populations. Specimens (plasma and urine) taken from 928 patients with symptoms of acute abdominal pain were used and the catalytic concentration of alpha-amylase, pancreatic alpha-amylase and triacylglycerol lipase (determined by two methods) were measured. Definitive diagnosis was obtained by following the directives of expert groups on the evaluation of diagnostic tests. Diagnostic accuracy was characterized by calculating the diagnostic sensitivity and specificity, by representing the ROC curves and by quantifying the areas under the ROC curves. The catalytic concentration of pancreatic alpha-amylase in plasma was the quantity with a greater area under the ROC curve (A = 0.9740) and then the one which had greatest diagnostic accuracy. If we considered the upper limit of the reference interval to be the cut-off value, the catalytic concentration of pancreatic alpha-amylase in plasma had a diagnostic sensitivity and specificity values of 0.96 and 0.88 respectively for the acute pancreatitis.

Acute Disease↗

Hemangiomas and vascular malformations: analysis of diagnostic accuracy.

OBJECTIVES: To evaluate the diagnostic accuracy and satisfaction of patient or family (or both) in the evaluation of hemangiomas and other vascular malformations. STUDY DESIGN: Prospective, relational database. METHODS: Ninety-eight patients participated in a prospective, Institutional Review Board-approved, relational database study in the Hemangioma and Vascular Birthmark Center at the Children's Hospital of Buffalo (Buffalo, NY) from July 1998 to April 2000. This included 68 patients with hemangiomas and 30 with vascular malformations. Data regarding presenting and final diagnosis and satisfaction of patient or family (or both) were obtained. RESULTS: Analysis of diagnostic accuracy revealed a concurrence between initial and final combined clinical and magnetic resonance imaging-based diagnosis in only 37% of cases. Analysis of patient and family satisfaction with the care received from previous consultants revealed only 26% "entirely" satisfied, 26% "somewhat" satisfied, and 37% "not at all" satisfied. On average, 2.5 (SD = 1.6; range, 1-9; median, 2) different physicians saw the patient before the patient or family (or both) was satisfied. CONCLUSIONS: Accurate diagnosis of hemangiomas and vascular malformations remains a challenge for physicians. Confusing terminology, lack of knowledge regarding lesion behavior, and poorly understood diagnostic criteria by physicians are some of the reasons for patient frustration. Education of primary care providers through improved communication helps to optimize a coordinated, interdisciplinary approach to patients and their families who present with vascular anomalies.

Arteriovenous Malformations↗

Reproducibility of the STARD checklist: an instrument to assess the quality of reporting of diagnostic accuracy studies.

BACKGROUND: In January 2003, STAndards for the Reporting of Diagnostic accuracy studies (STARD) were published in a number of journals, to improve the quality of reporting in diagnostic accuracy studies. We designed a study to investigate the inter-assessment reproducibility, and intra- and inter-observer reproducibility of the items in the STARD statement. METHODS: Thirty-two diagnostic accuracy studies published in 2000 in medical journals with an impact factor of at least 4 were included. Two reviewers independently evaluated the quality of reporting of these studies using the 25 items of the STARD statement. A consensus evaluation was obtained by discussing and resolving disagreements between reviewers. Almost two years later, the same studies were evaluated by the same reviewers. For each item, percentages agreement and Cohen's kappa between first and second consensus assessments (inter-assessment) were calculated. Intraclass Correlation coefficients (ICC) were calculated to evaluate its reliability. RESULTS: The overall inter-assessment agreement for all items of the STARD statement was 85% (Cohen's kappa 0.70) and varied from 63% to 100% for individual items. The largest differences between the two assessments were found for the reporting of the rationale of the reference standard (kappa 0.37), number of included participants that underwent tests (kappa 0.28), distribution of the severity of the disease (kappa 0.23), a cross tabulation of the results of the index test by the results of the reference standard (kappa 0.33) and how indeterminate results, missing data and outliers were handled (kappa 0.25). Within and between reviewers, also large differences were observed for these items. The inter-assessment reliability of the STARD checklist was satisfactory (ICC = 0.79 [95% CI: 0.62 to 0.89]). CONCLUSION: Although the overall reproducibility of the quality of reporting on diagnostic accuracy studies using the STARD statement was found to be good, substantial disagreements were found for specific items. These disagreements were not so much caused by differences in interpretation of the items by the reviewers but rather by difficulties in assessing the reporting of these items due to lack of clarity within the articles. Including a flow diagram in all reports on diagnostic accuracy studies would be very helpful in reducing confusion between readers and among reviewers.

Advisory Committees↗

Sources of variation and bias in studies of diagnostic accuracy: a systematic review.

BACKGROUND: Studies of diagnostic accuracy are subject to different sources of bias and variation than studies that evaluate the effectiveness of an intervention. Little is known about the effects of these sources of bias and variation. PURPOSE: To summarize the evidence on factors that can lead to bias or variation in the results of diagnostic accuracy studies. DATA SOURCES: MEDLINE, EMBASE, and BIOSIS, and the methodologic databases of the Centre for Reviews and Dissemination and the Cochrane Collaboration. Methodologic experts in diagnostic tests were contacted. STUDY SELECTION: Studies that investigated the effects of bias and variation on measures of test performance were eligible for inclusion, which was assessed by one reviewer and checked by a second reviewer. Discrepancies were resolved through discussion. DATA EXTRACTION: Data extraction was conducted by one reviewer and checked by a second reviewer. DATA SYNTHESIS: The best-documented effects of bias and variation were found for demographic features, disease prevalence and severity, partial verification bias, clinical review bias, and observer and instrument variation. For other sources, such as distorted selection of participants, absent or inappropriate reference standard, differential verification bias, and review bias, the amount of evidence was limited. Evidence was lacking for other features, including incorporation bias, treatment paradox, arbitrary choice of threshold value, and dropouts. CONCLUSIONS: Many issues in the design and conduct of diagnostic accuracy studies can lead to bias or variation; however, the empirical evidence about the size and effect of these issues is limited.

Bias↗

[Clinical relevance of computed tomography under emergency conditions--diagnostic accuracy, therapeutic consequences].

PURPOSE: To evaluate the diagnostic accuracy and therapeutic consequences of computed tomography performed on an emergency basis in a primary care hospital. MATERIAL AND METHODS: In 418 patients, 463 computed tomographies (thorax, abdomen, pelvis, spine, aorta, neck and extremities) were performed with-in 12 months, providing 999 diagnoses. The computed tomography diagnoses were retrospectively evaluated and correlated to surgery and discharge diagnoses. Therapeutical consequences were analyzed and allocated to a time period < 36 h (urgent) and > or = 36 - 72 h (elective). Average age was 49 (1 - 94) years (41% female and 59% male). Discharge diagnosis was defined as gold standard, provided that it was supported by clinical, blood chemical, diagnostic and possible surgical data. RESULTS: In 176 of 999 diagnoses (18%), the diagnoses were classified as "non-correlatable". Of the 823 correlated diagnoses, 431 were true positive, 14 false positive, 66 false negative and 312 true negative. Sensitivity, specificity and diagnostic accuracy of computed tomography was 87, 96 and 90%. Computed tomography had therapeutic consequences (surgery, drainage, puncture, reposition, thrombolytic therapy, chemotherapy, bronchoscopy, endoscopy, percutaneous transluminal angioplasty, coiling etc.) in 57% and no direct therapeutic interventions in 43%. Computed tomography excluded the suspected diagnosis in 36% and resulted in a conservative therapeutic regiment in 7%. Surgery was performed on 134 of the 418 patients (32%) who underwent computed tomography, with the surgery urgent in 71 (17%) and elective in 63 (15%) of the 418 patients. CONCLUSION: The high diagnostic accuracy and consecutive therapeutic consequences of computed tomography in establishing a precise, timely and reproducible diagnosis confirm its important role as primary diagnostic method on an emergency basis.

Adolescent↗

Image-guided automated needle biopsy of 106 thoracic lesions: a retrospective review of diagnostic accuracy and complication rates.

We reviewed the diagnostic accuracy and complication rates of transthoracic needle biopsy (TNB) with an automated 18-gauge core biopsy needle and gun, using either fluoroscopic or CT guidance. One hundred six lesions were biopsied in 103 patients between 1992 and 1998. Hard-copy images, imaging reports, pathology reports and clinical notes were reviewed. In 3 patients it was not possible to establish the lesion as either malignant or benign from the available follow-up, so these were removed from the analysis of diagnostic accuracy. Adequate samples for histological diagnosis were obtained in 104 of 106 (98%) biopsies. There were 75 of 85 (88%) true-positive core biopsies for malignant lesions and a specific cell type was identified in 70 of 85 (82%) cases. A specific histological diagnosis was obtained in 12 of 18 (66%) biopsies. There was a 19% rate of pneumothorax with only 2.4% requiring drainage. Minor haemoptysis occurred in 3.8% of procedures. The TNB technique with an automated core biopsy needle provides a high level of diagnostic accuracy, effectively distinguishes cell type in malignancy and provides a definite diagnosis in benign disease more frequently than fine needle aspiration (FNA). There is no increased complication rate compared with FNA.

Adult↗

Diagnostic accuracy of dementia with Lewy bodies.

BACKGROUND: Diagnostic criteria for dementia with Lewy bodies (DLB) are still evolving. No data exist on prospective differentiation of DLB and Alzheimer disease (AD). OBJECTIVE: To examine the clinician's diagnostic accuracy for DLB and analyze factors contributing to false-positive DLB diagnoses. METHODS: A prospective series of 10 patients with clinically diagnosed DLB who came to autopsy was compared with 32 autopsy-confirmed cases of DLB (27 Lewy body variant, 5 diffuse Lewy body disease) and 20 autopsy-confirmed cases of AD (matched on age, sex, education, and initial Mini-Mental State Examination score) with regard to distinguishing and/or confounding clinical features. RESULTS: The clinical diagnostic accuracy for DLB was 50%, with 5 of the 10 patients clinically presumed to have DLB confirmed at autopsy. Of the 5 misdiagnosed cases, 4 had AD and 1 had progressive supranuclear palsy. The misdiagnosed DLB cases who had pure AD had fewer hallucinations (25%) than those with Lewy body variant (63%) or diffuse Lewy body disease (100%) (P = .048); however, an equal amount of spontaneous (in the absence of neuroleptics) extrapyramidal signs was found. There were no differences among groups with regard to daily fluctuations in cognition or falls. Compared with the AD control group, the misdiagnosed DLB cases with pure AD showed significantly more spontaneous extrapyramidal signs (P< or =.02). CONCLUSIONS: The clinician's diagnostic accuracy for DLB was poor. Early spontaneous extrapyramidal signs in AD were associated with false-positive clinical diagnoses of DLB. The distinction between DLB and AD may be improved by greater emphasis on hallucinations.

Aged↗

Toward complete and accurate reporting of studies of diagnostic accuracy. The STARD initiative.

Our objective was to improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in the study, and to evaluate its generalizability. The Standards for Reporting of Diagnostic Accuracy Steering Committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organizations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, using evidence whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation, the reference standard, or both. Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve, to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

Attenuation correction and gating synergistically improve the diagnostic accuracy of myocardial perfusion SPECT.

BACKGROUND: The diagnostic accuracy of myocardial perfusion single photon emission computed tomography is limited by soft tissue attenuation. Artifacts may be reduced by attenuation correction (AC) or compensated for by assessment of wall motion in gated images. We studied the benefit of gating and AC, both separately and combined, in improving accuracy. METHODS AND RESULTS: Sixty-six subjects (27 with > or =50% angiographic stenosis, 5 with <50% stenosis, and 34 Bayesian normal volunteers) underwent gated AC single photon emission computed tomography. Images were reconstructed and independently viewed in 4 ways: static with motion correction (MC) only, gated with MC only, static with MC plus blur correction plus AC (referred to as combined corrections [CC]), and gated with CC. Images were interpreted by 2 blinded observers for overall presence of coronary disease and for vascular territory (left anterior descending [LAD], left circumflex [LCx], and right coronary artery [RCA]). Statistical analysis of sensitivity and normalcy was done by means of the Cochran Q test. Overall diagnostic accuracy showed statistically significant improvement (P =.05 for sensitivity, P <.001 for normalcy), progressing from static MC to gated MC to static CC to gated CC (sensitivity/normalcy = 85%/54%, 78%/62%, 93%/77%, and 96%/85%, respectively, for the 4 reconstruction and viewing approaches). Sensitivity was highest in all 3 vascular territories for the combination of gating and CC; normalcy was also highest with the same combination for the LAD and RCA territories; sensitivity/normalcy with this combination was 85%/87% for the LAD, 69%/87% for the LCx, and 89%/87% for the RCA territory. CONCLUSIONS: The combination of gating and CC provides the highest diagnostic accuracy, and gating and AC should thus be considered complementary and synergistic.

Artifacts↗

Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in the study and to evaluate its generalisability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering group searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, using evidence, whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy, to allow readers to assess the potential for bias in a study, and to evaluate a study's generalisability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a two day consensus meeting, with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25 item checklist, by using evidence, whenever available. A prototype of a flow diagram provides information about the method of patient recruitment, the order of test execution, and the numbers of patients undergoing the test under evaluation and the reference standard, or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the STARD checklist and flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in the study and to evaluate its generalisability. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organizations shortened this list during a two-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines regarding diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to 25 items, using evidence on bias whenever available. A prototypical flow diagram provides information about the method of patient recruitment, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of the clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

OBJECTIVE: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the generalisability of its results. METHODS: The Standards for Reporting of Diagnostic Accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a 2-day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, by using evidence whenever available. A prototype of a flow diagram provides information about the method of recruitment of patients, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard, or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative.

AIM: To improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the general isability of its results. METHODS: The standards for reporting of diagnostic accuracy (STARD) steering committee searched the literature to identify publications on the appropriate conduct and reporting of diagnostic studies and extracted potential items into an extensive list. Researchers, editors, and members of professional organisations shortened this list during a 2 day consensus meeting with the goal of developing a checklist and a generic flow diagram for studies of diagnostic accuracy. RESULTS: The search for published guidelines about diagnostic research yielded 33 previously published checklists, from which we extracted a list of 75 potential items. At the consensus meeting, participants shortened the list to a 25-item checklist, by using evidence whenever available. A prototype of a flow diagram provides information about the method of recruitment of patients, the order of test execution and the numbers of patients undergoing the test under evaluation, the reference standard, or both. CONCLUSIONS: Evaluation of research depends on complete and accurate reporting. If medical journals adopt the checklist and the flow diagram, the quality of reporting of studies of diagnostic accuracy should improve to the advantage of clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration.

The quality of reporting of studies of diagnostic accuracy is less than optimal. Complete and accurate reporting is necessary to enable readers to assess the potential for bias in the study and to evaluate the generalisability of the results. A group of scientists and editors has developed the STARD (Standards for Reporting of Diagnostic Accuracy) statement to improve the reporting the quality of reporting of studies of diagnostic accuracy. The statement consists of a checklist of 25 items and flow diagram that authors can use to ensure that all relevant information is present. This explanatory document aims to facilitate the use, understanding and dissemination of the checklist. The document contains a clarification of the meaning, rationale and optimal use of each item on the checklist, as well as a short summary of the available evidence on bias and applicability. The STARD statement, checklist, flowchart and this explanation and elaboration document should be useful resources to improve reporting of diagnostic accuracy studies. Complete and informative reporting can only lead to better decisions in healthcare.

Algorithms↗