scholarly journals Digital Pathology Using Primary Case Sign-Out

2021 ◽  
Vol 1 (12) ◽  
Author(s):  
Rob Edge ◽  
Aleksandra Grobelna

The applicability of the identified findings and the potential impact on patient outcomes for any individual diagnostic setting was unclear. In the majority of the identified studies, the authors reported diagnostic accuracy and clinical utility outcomes that supported digital pathology systems as a valuable diagnostic modality, comparable to conventional microscopy. These studies lacked statistical power calculations, making the accuracy of these statements unclear. One systematic review and 1 diagnostic study reported clinical utility outcomes of digital pathology. This evidence supported digital pathology using primary case sign-out for accurate prognosis of patient outcomes; however, the clinical utility compared to conventional microscopy was unclear in the identified evidence. One systematic review and 13 diagnostic cohort studies reported on the diagnostic accuracy of whole slide image (WSI). The identified outcomes indicated that WSI is a valuable diagnostic modality; however, a large range of diagnostic accuracy in different settings, and a lack of clear statistical power in all studies make comparator conclusions to conventional microscopy unclear. One systematic review and 4 diagnostic cohort studies reported diagnostic areas that can present challenges for a digital pathology implementation, the most common being the interpretation and grading of dysplasia. One identified systematic review stressed the importance of whole-system validation to identify strengths and weaknesses of specific digital pathology implementations. The range of diagnostic accuracy across studies also indicated that implementation of digital pathology primary case sign-out systems is associated with unclear diagnostic accuracy until appropriately validated. No relevant cost-effectiveness evidence for digital pathology using primary case sign-out was identified.

2021 ◽  
pp. 1-8
Author(s):  
Akihiro Shiroshita ◽  
Yasuhiro Oda ◽  
Seiji Takenouchi ◽  
Noboru Hagino ◽  
Yuki Kataoka

<b><i>Background:</i></b> The sensitivity and specificity of anti-glomerular basement membrane (GBM) antibodies have not been systematically analyzed. In this systematic review, we aimed to evaluate the diagnostic accuracy of anti-GBM antibodies for anti-GBM disease. <b><i>Summary:</i></b> Potential studies were searched using MEDLINE, Embase, the Cochrane Library, and the International Clinical Trials Registry Platform based on the index test and target condition. The inclusion criteria were prospective or retrospective cohort studies or case-control studies assessing the sensitivity and specificity of anti-GBM antibodies, and the reference standard was clinical diagnosis including biopsy results. The exclusion criteria were review articles, case reports, animal studies, and in vitro studies. Quality assessment was conducted based on the Quality Assessment of Diagnostic Accuracy Studies-2. The pooled estimates of sensitivity and specificity were calculated using a bivariate random-effects model. The overall quality was evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation. Six studies (1,691 patients) and 11 index tests were included in our systematic review. A high risk of bias and concerns regarding the applicability of patient selection were noted because of the case-control design in 67% of the included studies. The pooled sensitivity and specificity were 93% (95% CI: 84–97%) and 97% (95% CI: 94–99%), respectively. The certainty of evidence was low because of the high risk of bias and indirectness. <b><i>Key Messages:</i></b> Anti-GBM antibodies may exhibit high sensitivity and specificity in the diagnosis of anti-GBM disease. Further cohort studies are needed to confirm their precise diagnostic accuracy and compare diagnostic accuracies among different immunoassays.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e22188-e22188 ◽  
Author(s):  
Christian Apfel ◽  
Kimberly Souza ◽  
Cyrill Hornuss ◽  
Larry Weisenthal ◽  
Robert Alan Nagourney

e22188 Background: Cytometric analysis, or in-vitro functional profiling, has been developed as a method to predict tumor response to different drugs with the premise to personalize chemotherapy and improve patient outcomes. Methods: We performed a systematic review and a meta-analysis a) of correlative studies using cytometric profiling that reported diagnostic accuracy (sensitivity and specificity) and b) of effectiveness studies comparing patient outcomes when allocated to treatment guided by a cytometric assay versus population-based standard of care. We used Meta-DiSc software to find pooled sensitivity and specificity and analyze the summary receiver operating characteristic (sROC) curve and used Review Manager 5.1 to generate forest plots on overall tumor response (50% or greater decrease in tumor diameter) and on 1-year overall survival. Results: We included 28 mostly retrospective trials (n=664) reporting accuracy data and 15 prospective trials (n=1917) reporting therapeutic efficacy data. The accuracy of correlative study revealed an overall sensitivity of 0.922 (95% confidence interval 0.888 to 0.948), specificity of 0.724 (95% CI 0.669 to 0.774) and an area under the sROC curve of 0.893 (SE=0.023, p<0.001). Studies comparing the clinical utility revealed a two-fold overall tumor response for an assay-guided therapy versus standard of care therapy (odds ratio 2.04, 95% CI 1.62 to 2.57, p<0.001). Similarly, patients who received assay-guided therapy compared to those who received standard of care or physician’s choice had a significantly higher 1-year survival rate (OR 1.44, 95% CI 1.06 to 1.95, p=0.02). Conclusions: Despite various limitations of individual studies, the aggregate and fairly consistent evidence of these data suggests cytometric profiling to be accurate, to improve overall tumor response, and to increase 1-year patient survival. Given the enormous potential for our society, a well-designed and sufficiently-powered randomized controlled trial is urgently needed to validate these results.


CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S43-S44 ◽  
Author(s):  
L. Richardson ◽  
O. Loubani ◽  
P. Atkinson

Introduction: Undifferentiated hypotension remains one of the most life-threatening presentations to emergency departments (ED) around the world. An accurate and rapid initial assessment is essential, as shock carries a high mortality with multiple unique etiologies and management plans. Point of care ultrasound (PoCUS) has emerged as a promising tool to improve these diagnostic and management challenges, yet its reliability in this setting remains unclear. Methods: We performed a systematic review of Medline, EMBASE, CINAHL, Cochrane, and clinicaltrials.gov databases from inception to June 8, 2018. Databases were reviewed by two independent researchers and all languages were included. The methodological quality of included studies were evaluated using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Our primary outcome was diagnostic accuracy of PoCUS in hypotension, with secondary outcomes including patient outcomes and changes to management. Results: Our literature search revealed 5345 articles after duplicates were removed, leaving 235 articles for full article review. Following full article review, 9 studies remained and were included in the systematic review. There were 2 randomized control trials, 6 prospective cohort trials, and 1 retrospective cohort trial. For our primary outcome of diagnostic accuracy, eight studies were included; we extracted Kappa values ranging from 0.70 to 0.971, pooled sensitivity ranging from 69% to 88%, and pooled specificity ranging from 88% to 96%. Four studies reported on management change including results reporting shorter time to disposition, change in diagnostic test ordering (18% to 31%), change in consultation (13.6%), change in admission location (12%) and change in management plan (25% to 40%). Only one study reported on patient outcomes, which revealed no survival or length of stay benefit. Conclusion: When assessing for the diagnostic accuracy of PoCUS in the setting of undifferentiated hypotension presenting to the emergency department, we found fair consistency between PoCUS and final diagnosis with high Kappa values, fair to good pooled sensitivities, and good to excellent specificities. There was no strong evidence indicating improved outcomes. However, the large amount of heterogeneity amongst studies has limited our ability to make a strong conclusion except that future research should focus on a uniform study design and patient focused outcomes.


2020 ◽  
Author(s):  
Yohei Okada ◽  
Norihiro Nishioka ◽  
Shigeru Ohtsuru ◽  
Yasushi Tsujimoto

Abstract Background: Pelvic fractures are common among blunt trauma patients, and timely and accurate diagnosis can improve patient outcomes. However, it remains unclear whether physical examinations are sufficient in this context. This study aims to perform a systematic review and meta-analysis of studies on the diagnostic accuracy and clinical utility of physical examination for pelvic fracture among blunt trauma patients.Methods: Studies were identified using the MEDLINE, EMBASE, and CENTRAL databases starting from the creation of the database to January 2020. A total of 20 studies (49,043 patients with 8,300 cases [16.9%] of pelvic fracture) were included in the quality assessment and meta-analysis. Two investigators extracted the data and evaluated the risk of bias in each study. The meta-analysis involved a hierarchical summary receiver operating curve (ROC) model to calculate the diagnostic accuracy of the physical exam. Subgroup analysis assessed the extent of between-study heterogeneity. Clinical utility was assessed using decision curve analysis.Results: The median prevalence of pelvic fracture was 10.5% (interquartile range: 5.1–16.5). The pooled sensitivity (and corresponding 95% confidence interval) of the hierarchical summary ROC parameters was 0.859 (0.761–0.952) at a given specificity of 0.920, which was the median value among the included studies. Subgroup analysis revealed that the pooled sensitivity among patients with a Glasgow Coma Scale score ≥ 13 was 0.933 (0.847–0.998) at a given specificity of 0.920. The corresponding value for patients with scores ≤ 13 was 0.761 (0.560–0.932). For threshold probability < 0.01 with 10%–15% prevalence, the net benefit of imaging tests was higher than that of physical examination. Conclusion: Imaging tests should be performed in all trauma patients regardless of findings from physical examination or patients’ levels of consciousness. However, the clinical role of physical examination should be considered given the prevalence and threshold probability in each setting.


2015 ◽  
Vol 19 (43) ◽  
pp. 1-336 ◽  
Author(s):  
Mark Simmonds ◽  
Jane Burch ◽  
Alexis Llewellyn ◽  
Claire Griffiths ◽  
Huiqin Yang ◽  
...  

BackgroundIt is uncertain which simple measures of childhood obesity are best for predicting future obesity-related health problems and the persistence of obesity into adolescence and adulthood.ObjectivesTo investigate the ability of simple measures, such as body mass index (BMI), to predict the persistence of obesity from childhood into adulthood and to predict obesity-related adult morbidities. To investigate how accurately simple measures diagnose obesity in children, and how acceptable these measures are to children, carers and health professionals.Data sourcesMultiple sources including MEDLINE, EMBASE and The Cochrane Library were searched from 2008 to 2013.MethodsSystematic reviews and a meta-analysis were carried out of large cohort studies on the association between childhood obesity and adult obesity; the association between childhood obesity and obesity-related morbidities in adulthood; and the diagnostic accuracy of simple childhood obesity measures. Study quality was assessed using Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) and a modified version of the Quality in Prognosis Studies (QUIPS) tool. A systematic review and an elicitation exercise were conducted on the acceptability of the simple measures.ResultsThirty-seven studies (22 cohorts) were included in the review of prediction of adult morbidities. Twenty-three studies (16 cohorts) were included in the tracking review. All studies included BMI. There were very few studies of other measures. There was a strong positive association between high childhood BMI and adult obesity [odds ratio 5.21, 95% confidence interval (CI) 4.50 to 6.02]. A positive association was found between high childhood BMI and adult coronary heart disease, diabetes and a range of cancers, but not stroke or breast cancer. The predictive accuracy of childhood BMI to predict any adult morbidity was very low, with most morbidities occurring in adults who were of healthy weight in childhood. Predictive accuracy of childhood obesity was moderate for predicting adult obesity, with a sensitivity of 30% and a specificity of 98%. Persistence of obesity from adolescence to adulthood was high. Thirty-four studies were included in the diagnostic accuracy review. Most of the studies used the least reliable reference standard (dual-energy X-ray absorptiometry); only 24% of studies were of high quality. The sensitivity of BMI for diagnosing obesity and overweight varied considerably; specificity was less variable. Pooled sensitivity of BMI was 74% (95% CI 64.2% to 81.8%) and pooled specificity was 95% (95% CI 92.2% to 96.4%). The acceptability to children and their carers of BMI or other common simple measures was generally good.LimitationsLittle evidence was available regarding childhood measures other than BMI. No individual-level analysis could be performed.ConclusionsChildhood BMI is not a good predictor of adult obesity or adult disease; the majority of obese adults were not obese as children and most obesity-related adult morbidity occurs in adults who had a healthy childhood weight. However, obesity (as measured using BMI) was found to persist from childhood to adulthood, with most obese adolescents also being obese in adulthood. BMI was found to be reasonably good for diagnosing obesity during childhood. There is no convincing evidence suggesting that any simple measure is better than BMI for diagnosing obesity in childhood or predicting adult obesity and morbidity. Further research on obesity measures other than BMI is needed to determine which is the best tool for diagnosing childhood obesity, and new cohort studies are needed to investigate the impact of contemporary childhood obesity on adult obesity and obesity-related morbidities.Study registrationThis study is registered as PROSPERO CRD42013005711.FundingThe National Institute for Health Research Health Technology Assessment programme.


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Yohei Okada ◽  
Norihiro Nishioka ◽  
Shigeru Ohtsuru ◽  
Yasushi Tsujimoto

Abstract Background Pelvic fractures are common among blunt trauma patients, and timely and accurate diagnosis can improve patient outcomes. However, it remains unclear whether physical examinations are sufficient in this context. This study aims to perform a systematic review and meta-analysis of studies on the diagnostic accuracy and clinical utility of physical examination for pelvic fracture among blunt trauma patients. Methods Studies were identified using the MEDLINE, EMBASE, and CENTRAL databases starting from the creation of the database to January 2020. A total of 20 studies (49,043 patients with 8300 cases [16.9%] of pelvic fracture) were included in the quality assessment and meta-analysis. Two investigators extracted the data and evaluated the risk of bias in each study. The meta-analysis involved a hierarchical summary receiver operating curve (ROC) model to calculate the diagnostic accuracy of the physical exam. Subgroup analysis assessed the extent of between-study heterogeneity. Clinical utility was assessed using decision curve analysis. Results The median prevalence of pelvic fracture was 10.5% (interquartile range, 5.1–16.5). The pooled sensitivity (and corresponding 95% confidence interval) of the hierarchical summary ROC parameters was 0.859 (0.761–0.952) at a given specificity of 0.920, which was the median value among the included studies. Subgroup analysis revealed that the pooled sensitivity among patients with a Glasgow Coma Scale score ≥ 13 was 0.933 (0.847–0.998) at a given specificity of 0.920. The corresponding value for patients with scores ≤ 13 was 0.761 (0.560–0.932). For threshold probability < 0.01 with 10–15% prevalence, the net benefit of imaging tests was higher than that of physical examination. Conclusion Imaging tests should be performed in all trauma patients regardless of findings from physical examination or patients’ levels of consciousness. However, the clinical role of physical examination should be considered given the prevalence and threshold probability in each setting.


2020 ◽  
Vol 35 (2) ◽  
pp. 199-212 ◽  
Author(s):  
Gijs H. J. de Smet ◽  
Daniël P. V. Lambrichts ◽  
Sjoerd van den Hoek ◽  
Leonard F. Kroese ◽  
Stefan Buettner ◽  
...  

Abstract Purpose Parastomal hernia (PSH) is a common complication following stoma formation. The incidence of PSH varies widely due to several factors including differences in diagnostic modality, observer, definition, and classification used for diagnosing PSH. The aim of this systematic review was to evaluate the diagnostic accuracy of the modalities used to identify PSH. Methods Embase, MEDLINE, Cochrane, Web of Science, and Google Scholar databases were searched. Studies reporting PSH incidence rates detected by two or more different diagnostic modalities or inter-observer variation on one diagnostic modality were included. Article selection and assessment of study quality were conducted independently by two researchers using Cochrane Collaboration’s tool for assessing risk of bias. PROSPERO registration: CRD42018112732. Results Twenty-nine studies (n = 2514 patients) were included. Nineteen studies compared CT to clinical examination with relative difference in incidence rates ranging from 0.64 to 3.0 (n = 1369). Overall, 79% of studies found an increase in incidence rate when using CT. Disagreement between CT and clinical examination ranged between 0 and 37.3% with pooled inter-modality agreement Kappa value of 0.64 (95% CI 0.52–0.77). Four studies investigated the diagnostic accuracy of ultrasonography (n = 103). Compared with peroperative diagnosis, CT and ultrasonography both seemed accurate imaging modalities with a sensitivity of 83%. Conclusion CT is an accurate diagnostic modality for PSH diagnosis and increases PSH detection rates, as compared with clinical examination. Studies that specially focus on the diagnostic accuracy are needed and should aim to take patient-reported outcomes into account. A detailed description of the diagnostic approach, modality, definition, and involved observers is prerequisite for future PSH research.


2020 ◽  
Author(s):  
Yohei Okada ◽  
Norihiro Nishioka ◽  
Shigeru Ohtsuru ◽  
Yasushi Tsujimoto

Abstract Background: Pelvic fractures are common among blunt trauma patients, and timely and accurate diagnosis can improve patient outcomes. However, it remains unclear whether physical examinations are sufficient in this context. This study aims to perform a systematic review and meta-analysis of studies on the diagnostic accuracy and clinical utility of physical examination for pelvic fracture among blunt trauma patients. Methods: Studies were identified using the MEDLINE, EMBASE, and CENTRAL databases starting from the creation of the database to January 2020. A total of 20 studies (49,043 patients with 8,300 cases [16.9%] of pelvic fracture) were included in the quality assessment and meta-analysis. Two investigators extracted the data and evaluated the risk of bias in each study. The meta-analysis involved a hierarchical summary receiver operating curve (ROC) model to calculate the diagnostic accuracy of the physical exam. Subgroup analysis assessed the extent of between-study heterogeneity. Clinical utility was assessed using decision curve analysis. Results: The median prevalence of pelvic fracture was 10.5% (interquartile range: 5.1–16.5). The pooled sensitivity (and corresponding 95% confidence interval) of the hierarchical summary ROC parameters was 0.859 (0.761–0.952) at a given specificity of 0.920, which was the median value among the included studies. Subgroup analysis revealed that the pooled sensitivity among patients with a Glasgow Coma Scale score ≥ 13 was 0.933 (0.847–0.998) at a given specificity of 0.920. The corresponding value for patients with scores ≤ 13 was 0.761 (0.560–0.932). For threshold probability < 0.01 with 10%–15% prevalence, the net benefit of imaging tests was higher than that of physical examination. Conclusion: Imaging tests should be performed in all trauma patients regardless of findings from physical examination or patients’ levels of consciousness. However, the clinical role of physical examination should be considered given the prevalence and threshold probability in each setting.


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