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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 generalizability 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 health care.

Algorithms↗

Diagnostic accuracy of Tuned Aperture Computed Tomography (TACT).

The diagnostic accuracy of Tuned Aperture Computed Tomography (TACT) was evaluated for a variety of diagnostic tasks. Drawbacks of 2D radiography, lack of accessibility and high cost associated with advanced imaging modalities prompted these studies. Mechanically induced vertical/oblique radicular fractures (VRF) on unrestored and endodontically treated teeth were imaged using 2D radiography, unprocessed and TACT-IR images. The effect of iterative restoration on diagnostic accuracy was studied in association with detection tasks such as VRF and mandibular fractures, as also with quantification efforts associated with osseous healing studied in vivo. Iterative restoration deblurring of TACT produced consistently higher diagnostic quality than the other two image types. The effect of observer training and previous experience with viewing TACT indicated that observers with prior experience performed better. It was also noted that fractures extending beyond the middle third of the roots were more accurately detected. The effect of the number of basis images on diagnostic accuracy of TACT radiographs for mandibular fractures showed that reconstructions using 16 basis images that had been iteratively restored performed significantly better. In the in vivo study, quantitative evaluation of healing of osseous defects subjected to different types of grafts using TACT indicates that the most optimal healing occurred with osteoblast-polymer matrix combination. TACT-IR correlated most with histomorphometric data. Increases in gray values corresponding to bone formation were notable during the early period following surgery. These studies indicate that there is enough justification for TACT to find applications in many clinical situations where an ordinary dental x-ray source and a digital sensor/film are currently being used.

Alveolar Bone Loss↗

Diagnostic accuracy of CT-guided automated needle biopsy of lung nodules.

OBJECTIVE: The purpose of this study was to determine the factors influencing diagnostic accuracy in CT-guided automated needle biopsies of lung nodules. SUBJECTS AND METHODS: One hundred thirty-eight consecutive CT-guided automated needle biopsy procedures were performed in 123 patients (124 pulmonary nodules). Factors for diagnostic accuracy were evaluated through analysis of the procedures, which were classified into a success group (true-positive and true-negative) and a failure group (false-positive and false-negative). RESULTS: Final diagnoses were 81 malignant lesions (91 biopsies) and 43 benign lesions (47 biopsies). More than two CT-guided biopsies were performed for 13 lesions. Seventy lesions were true-positive, 44 were true-negative, three were false-positive, and 21 were false-negative. The overall diagnostic accuracy was 82.6%. The sensitivity for malignancy and specificity for benign lesions were 76.9% and 93.6%, respectively. Positive and negative predictive values were 95.9% and 67.7%, respectively. Lesion size was a significant factor contributing to diagnostic accuracy (p = 0.014). Mean diameters of lesions (+/-SD) in the success and failure groups were 24.1+/-12.4 mm and 17.6+/-7.8 mm, respectively. For lesions 6-10 mm in diameter, diagnostic accuracy was 66.7%; for lesions 11-20 mm in diameter, 78.9%; for lesions 21-30 mm in diameter, 86.7%; for lesions 31-50 mm in diameter, 93.3%; and for lesions 51-70 mm in diameter, 100%. CONCLUSION: Lesion size was a determining factor in diagnostic accuracy. Diagnostic accuracy decreased in proportion to the decrease in the lesion diameter.

Adult↗

A unification of models for meta-analysis of diagnostic accuracy studies.

Studies of diagnostic accuracy require more sophisticated methods for their meta-analysis than studies of therapeutic interventions. A number of different, and apparently divergent, methods for meta-analysis of diagnostic studies have been proposed, including two alternative approaches that are statistically rigorous and allow for between-study variability: the hierarchical summary receiver operating characteristic (ROC) model (Rutter and Gatsonis, 2001) and bivariate random-effects meta-analysis (van Houwelingen and others, 1993), (van Houwelingen and others, 2002), (Reitsma and others, 2005). We show that these two models are very closely related, and define the circumstances in which they are identical. We discuss the different forms of summary model output suggested by the two approaches, including summary ROC curves, summary points, confidence regions, and prediction regions.

Diagnostic Tests, Routine↗

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↗

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 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 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 clinicians, researchers, reviewers, journals, and the public.

Algorithms↗

Factors determining the diagnostic accuracy of digitized conventional intraoral radiographs.

A number of factors may determine the diagnostic accuracy of digitized intraoral radiographs. Conventional film radiographs were digitized with three different digitizers, a laser-scanner, a drum-scanner and a TV camera. Digital images, varying in pixel size, grey level and image processing, were displayed on three different video-monitors and assessed by 10 dentists. The detectability of incipient proximal surface caries was used as an index of the diagnostic accuracy and the effect of the different factors compared by means of receiver operating characteristic (ROC) analysis. Images digitized by the drum-scanner were found to have the best diagnostic accuracy. Sufficient diagnostic accuracy could be attained on the low-cost video monitor of a personal computer. Digital images with a pixel size of 100 microns and 32 grey levels were found to be acceptable for intraoral radiographs for diagnostic purposes. These results provide a practical guide for establishing a digital image acquiring system for any intraoral radiographs, reducing demands on data storage to a minimum.

Analysis of Variance↗

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

BACKGROUND: 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 generalizability 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 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. 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.

Diagnostic Errors↗

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

OBJECTIVE: Our aim was 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 generalizability 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 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. 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 and/or the reference standard. 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.

Bias↗

[Computerized tomography with lipiodol in hepatocarcinoma. Assessment of its diagnostic accuracy with anatomo-pathological control].

PURPOSE: To assess the diagnostic accuracy and predictive value of Lipiodol CT for hepatocellular carcinoma (HCC) before liver transplantation (OLT). MATERIAL AND METHODS: Seventy-eight cirrhotic patients awaiting OLT underwent Lipiodol CT to demonstrate the presence and extent of possible HCC. Radiologically, focal uptake areas with dense, homogeneous or "mosaic" iodized oil uptake were considered to be neoplastic nodules. All patients underwent OLT within 4 months of Lipiodol CT. Pathologic examination of the explanted livers was performed using the standard technique and, if necessary, with additional slices. Pathologic findings were compared with radiologic results to calculate the diagnostic accuracy and predictive value of Lipiodol CT in relation to both patients and lesions. RESULTS: Lipiodol CT depicted 61 focal areas of iodized oil uptake in 48 patients; pathologic examinations detected 57 HCC lesions in 42 patients (diameter .8 cm, mean 2.2 cm); agreement with radiologic diagnosis was found in 35 patients only. Patient by patient, Lipiodol CT had 83.3% sensitivity, 63.8% specificity, 74.3% diagnostic accuracy, 72.9% positive predictive value (PPV), and 76.6% negative predictive value. Lesion by lesion, Lipiodol CT showed overall sensitivity and PPV of 75.4-70.5%, 74-69.8% for "small" HCCs (diameter < or = 3 cm), and 72.9-71.1% for nodules < or = 2 cm in size. Eighteen uptake areas in 13 patients were diagnosed as HCC by Lipiodol CT but the finding was not confirmed at histology: 4 were hemangiomas and 14 corresponded to cirrhotic tissue without neoplastic foci. CONCLUSIONS: Our study, as the few others comparing radiologic results and pathologic findings of whole explanted liver, demonstrates that Lipiodol CT has relatively low diagnostic accuracy; particularly, specificity and PPV were limited by possible false positives, with HCC overstaging and mistakes in the indications/contraindications for OLT.

Adult↗

Lower diagnostic accuracy of thallium-201 SPECT myocardial perfusion imaging in women: an effect of smaller chamber size.

OBJECTIVES: We attempted to formally compare the diagnostic accuracy of thallium-201 single-photon emission computed tomographic (SPECT) myocardial perfusion imaging in men and women and the effect of chamber size on accuracy. BACKGROUND: The diagnostic accuracy of conventional exercise testing has been shown to be lower in women. Less is known about the relative accuracy of perfusion imaging. Because of smaller body size, women have a smaller heart size than men, a factor that may reduce accuracy. METHODS: We identified 323 patients undergoing thallium-201 SPECT myocardial perfusion imaging who either had < 5% probability of coronary artery disease (CAD) by Bayesian analysis or who underwent cardiac catheterization within 60 days of stress testing. Patients with documented history of infarction, coronary artery bypass grafting, pathologic Q waves on the electrocardiogram, left bundle branch block or nonischemic cardiomyopathy were not included. We performed strict quantitative analysis, and receiver operating characteristic (ROC) curves were generated and the area under the curve was calculated for men and women. A size index was generated from the number of short-axis slices and average radius of each slice, and the group was classified as having a large or a small chamber size. The ROC areas of men and women with a large and a small chamber size were then compared. RESULTS: Diagnostic accuracy was lower in women than in men (ROC are 0.82 vs. 0.93, p < 0.05) despite similar values for peak heart rate and rate-pressure product and similar severity of CAD. There was a greater difference in accuracy between patients with a large versus a small chamber size (ROC area 0.94 vs. 0.73, p < 0.01) despite similar levels of exercise and severity of CAD. When we compared men and women in groups stratified by chamber size, we could not detect a significant difference between ROC area values of men and women (large: 0.94 men, 0.93 women, p = 0.77, power to detect difference in area of 0.15 = 91%; small: 0.79 men, 0.72 women, p = 0.58, power to detect difference in area of 0.15 = 35%). CONCLUSIONS: The diagnostic accuracy of thallium SPECT myocardial perfusion imaging is lower in women than in men. Most of the difference appears to be due to smaller left ventricular chamber size in women, although a small residual gender effect in smaller heart sizes cannot be entirely excluded. It is proposed that the most likely cause for this difference is the relatively greater effect of imaging blurring on smaller hearts.

Aged↗

Tests of equivalence and non-inferiority for diagnostic accuracy based on the paired areas under ROC curves.

Assessment of equivalence or non-inferiority in accuracy between two diagnostic procedures often involves comparisons of paired areas under the receiver operating characteristic (ROC) curves. With some pre-specified clinically meaningful limits, the current approach to evaluating equivalence is to perform the two one-sided tests (TOST) based on the difference in paired areas under ROC curves estimated by the non-parametric method. We propose to use the standardized difference for assessing equivalence or non-inferiority in diagnostic accuracy based on paired areas under ROC curves between two diagnostic procedures. The bootstrap technique is also suggested for both non-parametric method and the standardized difference approach. A simulation study was conducted empirically to investigate the size and power of the four methods for various combinations of distributions, data types, sample sizes, and different correlations. Simulation results demonstrate that the bootstrap procedure of the standardized difference approach not only can adequately control the type I error rate at the nominal level but also provides equivalent power under both symmetrical and skewed distributions. A numerical example using published data illustrates the proposed methods.

Computer Simulation↗

A randomized controlled trial of the diagnostic accuracy of internet-based telepathology compared with conventional microscopy.

AIMS: To compare the diagnostic accuracy of internet-based virtual microscopy with conventional light microscopy, in the context of renal biopsies assessed by participants in the UK National Renal Pathology External Quality Assessment (EQA) Scheme. METHODS AND RESULTS: 'Virtual slides' of current EQA cases were made available over the internet to participants in the scheme. The approach permitted what may reasonably be described as a randomized controlled trial of the diagnostic accuracy of this mode of telepathology, in the context of renal pathology. No significant difference in diagnostic accuracy could be detected between the diagnoses proffered on the basis of virtual slides and conventional slides; but using virtual slides took pathologists considerably longer. CONCLUSIONS: This result provides some encouragement for the implementation of such virtual slide-based telepathology systems. However, in failing to detect a difference, equivalence of diagnostic accuracy has not been proved; nor has the relevance of this result to other fields of histopathology been demonstrated. A decision to implement a diagnostic telepathology system requires consideration of numerous factors beyond diagnostic accuracy, including financial, legal, professional and ethical issues.

Diagnosis↗

Sample sizes of studies on diagnostic accuracy: literature survey.

OBJECTIVES: To determine sample sizes in studies on diagnostic accuracy and the proportion of studies that report calculations of sample size. DESIGN: Literature survey. DATA SOURCES: All issues of eight leading journals published in 2002. METHODS: Sample sizes, number of subgroup analyses, and how often studies reported calculations of sample size were extracted. RESULTS: 43 of 8999 articles were non-screening studies on diagnostic accuracy. The median sample size was 118 (interquartile range 71-350) and the median prevalence of the target condition was 43% (27-61%). The median number of patients with the target condition--needed to calculate a test's sensitivity--was 49 (28-91). The median number of patients without the target condition--needed to determine a test's specificity--was 76 (27-209). Two of the 43 studies (5%) reported a priori calculations of sample size. Twenty articles (47%) reported results for patient subgroups. The number of subgroups ranged from two to 19 (median four). No studies reported that sample size was calculated on the basis of preplanned analyses of subgroups. CONCLUSION: Few studies on diagnostic accuracy report considerations of sample size. The number of participants in most studies on diagnostic accuracy is probably too small to analyse variability of measures of accuracy across patient subgroups.

Confidence Intervals↗

Diagnostic accuracy and short-term surgical outcomes in cases of suspected acute appendicitis.

OBJECTIVE: To test the hypothesis that, with modern diagnostic methods and antibiotics, more conservative use of surgery in cases of suspected appendicitis would not result in increased rates of short-term complications in confirmed cases. DESIGN: Population-based observational study using administrative data. SETTING: All Ontario hospitals in which primary appendectomy was performed from Apr. 1, 1981, to Mar. 31, 1992. PATIENTS: All 126,815 patients admitted to hospital for a primary appendectomy during the study period. OUTCOME MEASURES: Diagnostic accuracy rate (acute appendicitis as the primary diagnosis), perforation rate, in-hospital death rate and length of stay. RESULTS: The diagnostic accuracy rate among the male patients was stable throughout the decade; among the female patients it rose significantly, from 71.7% in 1981 to 75.3% in 1991 (p < 0.01). The perforation rates increased significantly among both the female and male patients (p < 0.01), whereas the mean length of stay decreased (p < 0.05). Despite sex-related differences in the accuracy rates, the male and female patients had similar in-hospital death rates and mean lengths of stay. The institutional diagnostic accuracy rates, as determined from data for 1989-90 to 1991-92, ranged from 50.0% to 96.7%. Multivariate analyses of 27,189 confirmed cases of appendicitis at 175 hospitals revealed that perforation was a strong predictor of in-hospital death (odds ratio [OR] 2.46, 95% confidence interval [CI] 1.24 to 4.88), but comorbidity was the strongest predictor (OR 11.50, 95% CI 5.96 to 22.10). For each 10% increase in the diagnostic accuracy rate, the perforation rate increased 14% (OR 1.14, 95% CI 1.10 to 1.19), but the accuracy rate was not significantly related to the in-hospital death rate or the length of stay. CONCLUSION: A higher diagnostic accuracy rate is associated with more perforated appendixes. Although perforation itself leads to adverse outcomes, a higher accuracy rate does not. This suggests that hospitals with higher accuracy rates incur more perforations, but, with close observation, timely laparotomy and the use of modern antibiotics, these patients have favourable outcomes. This contrasts with adverse effects of perforation among patients at high risk for perforation (especially very young children and elderly people) in centres at all accuracy levels. The variation in hospitals' diagnostic accuracy rates suggests that some proportion of appendectomies could be safely avoided.

Abdominal Pain↗

Anti-Saccharomyces cerevisiae antibodies in Japanese patients with inflammatory bowel disease: diagnostic accuracy and clinical value.

BACKGROUND: The diagnostic accuracy of the determination of anti- Saccharomyces cerevisiae antibodies (ASCA) and its clinical significance in Crohn's disease (CD) have been reported in Western countries, but scarcely reported in Japan, where the dietary habits of people differ markedly from those of Western countries. Th present study was undertaken to examine the diagnostic accuracy and clinical significance of ASCA determination in Japanese patients with CD or ulcerative colitis (UC). METHODS: Seventy-five serum samples obtained from 68 patients with CD, 34 serum samples obtained from 30 patients with UC, 35 serum samples from 35 patients with liver cirrhosis, and 31 serum samples from 31 healthy controls were examined. The optical density of each sample was measured by an enzyme-linked immunosorbent assay (ELISA) method to quantify ASCA IgA and IgG. RESULTS: The cutoff level, as determined by discriminant analysis of the data, was 0.1502 for ASCA IgA and 0.156 for ASCA IgG. Of the 68 patients with CD, 31 (45.6%) were ASCA-positive, and of the 30 patients with UC, 4 (13.3%) were ASCA-positive according to these cutoff levels. The sensitivity and specificity of ASCA determination for the differential diagnosis of CD from UC were 45.6% and 86.7%, respectively. When the relationship between ASCA and the clinical features of CD was analyzed, ASCA positivity was found to be correlated with duration of illness. CONCLUSIONS: The specificity of ASCA was high; however, the sensitivity was not. ASCA titers were generally low in the Japanese population examined. It would be desirable to determine cutoff levels for ASCA tailored to the Japanese people for the diagnosis of inflammatory bowel disease.

Adult↗

The quality of diagnostic accuracy studies since the STARD statement: has it improved?

OBJECTIVE: To assess whether the quality of reporting of diagnostic accuracy studies has improved since the publication of the Standards for the Reporting of Diagnostic Accuracy studies (STARD statement). METHODS: The quality of reporting of diagnostic accuracy studies published in 12 medical journals in 2000 (pre-STARD) and 2004 (post-STARD) was evaluated by two reviewers independently. For each article, the number of reported STARD items was counted (range 0 to 25). Differences in completeness of reporting between articles published in 2000 and 2004 were analyzed, using multilevel analyses. RESULTS: We included 124 articles published in 2000 and 141 articles published in 2004. Mean number of reported STARD items was 11.9 (range 3.5 to 19.5) in 2000 and 13.6 (range 4.0 to 21.0) in 2004, an increase of 1.81 items (95% CI: 0.61 to 3.01). Articles published in 2004 reported the following significantly more often: methods for calculating test reproducibility of the index test (16% vs 35%); distribution of the severity of disease and other diagnoses (23% vs 53%); estimates of variability of diagnostic accuracy between subgroups (39% vs 60%); and a flow diagram (2% vs 12%). CONCLUSIONS: The quality of reporting of diagnostic accuracy studies has improved slightly over time, without a more pronounced effect in journals that adopted the STARD statement. As there is still room for improvement, editors should mention the use of the STARD statement as a requirement in their guidelines for authors, and instruct reviewers to check the STARD items. Authors should include a flow diagram in their manuscript.

Diagnostic Techniques and Procedures↗

Influence of Alzheimer pathology on clinical diagnostic accuracy in dementia with Lewy bodies.

OBJECTIVE: To determine whether AD neurofibrillary pathology influences clinical diagnostic accuracy in dementia with Lewy bodies (DLB). BACKGROUND: Pathologic diagnosis of DLB mandates Lewy bodies but also allows for AD pathology in the form of plaques and tangles. Because clinical diagnostic accuracy of DLB remains low, the authors questioned whether the severity of AD pathology in the form of tangles might affect the clinician's ability to correctly diagnose DLB in life. DESIGN/METHODS: Ninety-eight subjects with autopsy-proven DLB who had been evaluated annually at the University of California San Diego AD Research Center were identified. The clinical diagnosis used was the last diagnosis before death. Pathologic diagnosis of DLB was made according to Consensus guidelines, and Braak staging was used to assess the degree of neurofibrillary AD pathology. The clinical characteristics of subjects with DLB with low vs high Braak stages were compared and the clinical diagnostic accuracy for subjects stratified according to Braak stage was determined. RESULTS: Only 27% of the subjects with DLB demonstrated both visual hallucinations and spontaneous extrapyramidal signs (EPS). The low Braak stage (0 to 2, n = 24) subjects had a higher frequency of visual hallucinations (65%) than did subjects with DLB with higher (3 to 6, n = 66) Braak stages (33%, p = 0.008), and showed a slightly greater but not significant degree of EPS. Although clinical diagnostic accuracy for DLB was relatively low (49%), it was higher for subjects with low (75%) compared to high (39%) Braak stages (p = 0.0039). CONCLUSIONS: The degree of concomitant AD tangle pathology has an important influence on the clinical characteristics and, therefore, the clinical diagnostic accuracy of DLB.

Aged↗