scholarly journals Overtreatment of Nonneoplastic Gallbladder Polyps due to Inadequate Routine Ultrasound Assessment

2020 ◽  
pp. 1-7
Author(s):  
Sarah Z. Wennmacker ◽  
Elise A.J. de Savornin Lohman ◽  
Nesar A. Hasami ◽  
Iris D. Nagtegaal ◽  
Marja A. Boermeester ◽  
...  

<b><i>Background:</i></b> The primary aim was to assess the diagnostic accuracy of routine ultrasound assessment for gallbladder polyps. The secondary aim was to identify the characteristics that differentiate neoplastic polyps from nonneoplastic polyps. <b><i>Methods:</i></b> A total of 156 patients with histopathologically proven gallbladder polyps in 4 Dutch hospitals between 2003 and 2013 were included. Sensitivity and specificity of ultrasound for polyp size, number of polyps, and polyp type were assessed using histopathological findings as a reference standard. In addition, diagnostic accuracy of sonographic size ≥1 cm for neoplasia was assessed. Subgroup analysis for patients with polyps as primary indication for cholecystectomy was performed. The sonographic polyp characteristics on preoperative routine ultrasound were described. <b><i>Results:</i></b> Fifty-six percent of gallbladder polyps were preoperatively identified on ultrasound, of which 31% were neoplastic. Sensitivity and specificity of ultrasound to estimate polyp size were 93 and 43% (subgroup; 92 and 33%). Sensitivity and specificity of sonographic polyp size ≥1 cm for neoplasia were 86 and 32% (subgroup; 94 and 26%). No specific sonographic characteristics for neoplastic polyps could be established due to lack of reporting. <b><i>Conclusion:</i></b> Routine ultrasound assessment of polyps is associated with overestimation of polyp size and low specificity of sonographic size ≥1 cm for neoplasia, which contributes to surgical overtreatment of nonneoplastic polyps.

2019 ◽  
Vol 57 (6) ◽  
Author(s):  
Emily MacLean ◽  
Giorgia Sulis ◽  
Claudia M. Denkinger ◽  
James C. Johnston ◽  
Madhukar Pai ◽  
...  

ABSTRACT Invasive collection methods are often required to obtain samples for the microbiological evaluation of children with presumptive pulmonary tuberculosis (PTB). Nucleic acid amplification testing of easier-to-collect stool samples could be a noninvasive method of diagnosing PTB. We conducted a systematic review and meta-analysis to evaluate the diagnostic accuracy of testing stool with the Xpert MTB/RIF assay (“stool Xpert”) for childhood PTB. Four databases were searched for publications from January 2008 to June 2018. Studies assessing the diagnostic accuracy among children of stool Xpert compared to a microbiological reference standard of conventional specimens tested by mycobacterial culture or Xpert were eligible. Bivariate random-effects meta-analyses were performed to calculate pooled sensitivity and specificity of stool Xpert against the reference standard. From 1,589 citations, 9 studies (n = 1,681) were included. Median participant ages ranged from 1.3 to 10.6 years. Protocols for stool processing and testing varied substantially, with differences in reagents and methods of homogenization and filtering. Against the microbiological reference standard, the pooled sensitivity and specificity of stool Xpert were 67% (95% confidence interval [CI], 52 to 79%) and 99% (95% CI, 98 to 99%), respectively. Sensitivity was higher among children with HIV (79% [95% CI, 68 to 87%] versus 60% [95% CI, 44 to 74%] among HIV-uninfected children). Heterogeneity was high. Data were insufficient for subgroup analyses among children under the age of 5 years, the most relevant target population. Stool Xpert could be a noninvasive method of ruling in PTB in children, particularly those with HIV. However, studies focused on children under 5 years of age are needed, and generalizability of the evidence is limited by the lack of standardized stool preparation and testing protocols.


2015 ◽  
Vol 53 (12) ◽  
pp. 3738-3749 ◽  
Author(s):  
Caroline Chartrand ◽  
Nicolas Tremblay ◽  
Christian Renaud ◽  
Jesse Papenburg

Respiratory syncytial virus (RSV) rapid antigen detection tests (RADT) are extensively used in clinical laboratories. We performed a systematic review and meta-analysis to evaluate the accuracy of RADTs for diagnosis of RSV infection and to determine factors associated with accuracy estimates. We searched EMBASE and PubMed for diagnostic-accuracy studies of commercialized RSV RADTs. Studies reporting sensitivity and specificity data compared to a reference standard (reverse transcriptase PCR [RT-PCR], immunofluorescence, or viral culture) were considered. Two reviewers independently extracted data on study characteristics, diagnostic-accuracy estimates, and study quality. Accuracy estimates were pooled using bivariate random-effects regression models. Heterogeneity was investigated with prespecified subgroup analyses. Seventy-one articles met inclusion criteria. Overall, RSV RADT pooled sensitivity and specificity were 80% (95% confidence interval [CI], 76% to 83%) and 97% (95% CI, 96% to 98%), respectively. Positive- and negative-likelihood ratios were 25.5 (95% CI, 18.3 to 35.5) and 0.21 (95% CI, 0.18 to 0.24), respectively. Sensitivity was higher in children (81% [95% CI, 78%, 84%]) than in adults (29% [95% CI, 11% to 48%]). Because of this disparity, further subgroup analyses were restricted to pediatric data (63 studies). Test sensitivity was poorest using RT-PCR as a reference standard and highest using immunofluorescence (74% versus 88%;P< 0.001). Industry-sponsored studies reported significantly higher sensitivity (87% versus 78%;P= 0.01). Our results suggest that the poor sensitivity of RSV RADTs in adults may preclude their use in this population. Furthermore, industry-sponsored studies and those that did not use RT-PCR as a reference standard likely overestimated test sensitivity.


2019 ◽  
Author(s):  
Choon Han Tan ◽  
Bhone Myint Kyaw ◽  
Helen Smith ◽  
Colin S Tan ◽  
Lorainne Tudor Car

BACKGROUND Diabetic retinopathy (DR), a common complication of diabetes mellitus, is the leading cause of impaired vision in adults worldwide. Smartphone ophthalmoscopy involves using a smartphone camera for digital retinal imaging. Utilizing smartphones to detect DR is potentially more affordable, accessible, and easier to use than conventional methods. OBJECTIVE This study aimed to determine the diagnostic accuracy of various smartphone ophthalmoscopy approaches for detecting DR in diabetic patients. METHODS We performed an electronic search on the Medical Literature Analysis and Retrieval System Online (MEDLINE), EMBASE, and Cochrane Library for literature published from January 2000 to November 2018. We included studies involving diabetic patients, which compared the diagnostic accuracy of smartphone ophthalmoscopy for detecting DR to an accurate or commonly employed reference standard, such as indirect ophthalmoscopy, slit-lamp biomicroscopy, and tabletop fundus photography. Two reviewers independently screened studies against the inclusion criteria, extracted data, and assessed the quality of included studies using the Quality Assessment of Diagnostic Accuracy Studies–2 tool, with disagreements resolved via consensus. Sensitivity and specificity were pooled using the random effects model. A summary receiver operating characteristic (SROC) curve was constructed. This review is reported in line with the Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies guidelines. RESULTS In all, nine studies involving 1430 participants were included. Most studies were of high quality, except one study with limited applicability because of its reference standard. The pooled sensitivity and specificity for detecting any DR was 87% (95% CI 74%-94%) and 94% (95% CI 81%-98%); mild nonproliferative DR (NPDR) was 39% (95% CI 10%-79%) and 95% (95% CI 91%-98%); moderate NPDR was 71% (95% CI 57%-81%) and 95% (95% CI 88%-98%); severe NPDR was 80% (95% CI 49%-94%) and 97% (95% CI 88%-99%); proliferative DR (PDR) was 92% (95% CI 79%-97%) and 99% (95% CI 96%-99%); diabetic macular edema was 79% (95% CI 63%-89%) and 93% (95% CI 82%-97%); and referral-warranted DR was 91% (95% CI 86%-94%) and 89% (95% CI 56%-98%). The area under SROC curve ranged from 0.879 to 0.979. The diagnostic odds ratio ranged from 11.3 to 1225. CONCLUSIONS We found heterogeneous evidence showing that smartphone ophthalmoscopy performs well in detecting DR. The diagnostic accuracy for PDR was highest. Future studies should standardize reference criteria and classification criteria and evaluate other available forms of smartphone ophthalmoscopy in primary care settings.


2021 ◽  
pp. 2101116
Author(s):  
Patrick Orikiriza ◽  
Julianna Smith ◽  
Bob Ssekyanzi ◽  
Dan Nyehangane ◽  
Ivan Mugisha Taremwa ◽  
...  

BackgroundNon-sputum based diagnostic approaches are crucial in children at high risk of disseminated tuberculosis [TB] who cannot expectorate sputum. We evaluated the diagnostic accuracy of Xpert MTB/RIF from stool and urine AlereLipoarabinomannan [LAM] test in this group of children.MethodsHospitalised children with presumptive TB and either age <2 years, HIV-positive or severe malnutrition were enrolled in a diagnostic cohort. At enrolment, we attempted to collect two urine, two stool and two respiratory samples. Urine and stool were tested with AlereLAM and Xpert MTB/RIF, respectively. Respiratory samples were tested with Xpert MTB/RIF and mycobacterial culture. Both a microbiological and a composite clinical reference standard were used.ResultsThe study enrolled 219 children; median age 16.4 months, 72 (32.9%) HIV-positive and 184 (84.4%) severely malnourished. Twelve (5.5%) and 58 (28.5%) children had confirmed and unconfirmed TB respectively. Stool and urine were collected in 219 (100%) and 216 (98.6%) children. Against the microbiological reference standard the sensitivity and specificity (n/N, 95% confidence intervals) of stool Xpert MTB/RIF was 50.0% (6/12, 21.1–78.9) and 99.1% (198/200 96.4–99.9), while that of urine AlereLAM was 50.0% (6/12, 21.1–78.9) and 74.6% (147/197, 67.9–80.5) respectively. Against the composite reference standard sensitivity was reduced to 11.4% (8/70) for stool and 26.2% (17/68) for urine, with no major difference by age group (<2 and >2 years) or HIV status.ConclusionThe Xpert MTB/RIF assay has excellent specificity on stool, but sensitivity is suboptimal. Urine AlereLAM is compromised by poor sensitivity and specificity in children.


2020 ◽  
Vol 2020 ◽  
pp. 1-11 ◽  
Author(s):  
T. Indrielle-Kelly ◽  
F. Frühauf ◽  
M. Fanta ◽  
A. Burgetova ◽  
D. Lavu ◽  
...  

Objectives. The primary aim was to investigate the diagnostic accuracy of transvaginal ultrasound (TVS) and magnetic resonance imaging (MRI) in the mapping of deep pelvic endometriosis (DE) in a diseased population. The secondary aim was to offer first insights into the clinical applicability of the new International Deep Endometriosis Analysis group (IDEA) consensus for sonographic evaluation, which was also adapted for MRI and surgical reporting in this study. Methods. The study was a prospective observational cohort study. In this study, consecutive women planned for surgical treatment for DE underwent preoperative mapping of pelvic disease using TVS and MRI (index tests). The results were compared against the intraoperative findings with histopathological confirmation (reference standard). In case of disagreement between intraoperative and pathology findings, the latter was prioritised. Index tests and surgical findings were reported using a standardised protocol based on the IDEA consensus. Results. The study ran from 07/2016 to 02/2018. One-hundred and eleven women were approached, but 60 declined participation. Out of the 51 initially recruited women, two were excluded due to the missing reference standard. Both methods (TVS and MRI) had the same sensitivity and specificity in the detection of DE in the upper rectum (UpR) and rectosigmoid (RS) (UpR TVS and MRI sensitivity and specificity 100%; RS TVS and MRI sensitivity 94%; TVS and MRI specificity 84%). In the assessment of DE in the bladder (Bl), uterosacral ligaments (USL), vagina (V), rectovaginal septum (RVS), and overall pelvis (P), TVS had marginally higher specificity but lower sensitivity than MRI (Bl TVS sensitivity 89%, specificity 100%, MRI sensitivity 100%, specificity 95%; USL TVS sensitivity 74%, specificity 67%, MRI sensitivity 94%, specificity 60%; V TVS sensitivity 55%, specificity 100%, MRI sensitivity 73%, specificity 95%; RVS TVS sensitivity 67%, specificity 100%, MRI sensitivity 83%, specificity 93%; P TVS sensitivity 78%, specificity 97%, MRI sensitivity 91%, specificity 91%). No significant differences in diagnostic accuracy between TVS and MRI were observed except USL assessment (p=0.04) where MRI was significantly better and pouch of Douglas obliteration (p=0.04) where TVS was significantly better. Overall, there was a good agreement between reference standards and both index tests (TVS kappa value (κ) = 0.727 [p≤0.001), MRI κ = 0.755 [p=p≤0.001]). Conclusion. We found that both imaging techniques had overall good agreement with the reference standard in the detection of deep pelvic endometriosis. This is the first study to date involving the IDEA consensus for ultrasound, its modified version for MRI, and intraoperative reporting of deep pelvic endometriosis in clinical practice.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chinyereugo M. Umemneku Chikere ◽  
Kevin J. Wilson ◽  
A. Joy Allen ◽  
Luke Vale

Abstract Background Staquet et al. and Brenner both developed correction methods to estimate the sensitivity and specificity of a binary-response index test when the reference standard is imperfect and its sensitivity and specificity are known. However, to our knowledge, no study has compared the statistical properties of these methods, despite their long application in diagnostic accuracy studies. Aim To compare the correction methods developed by Staquet et al. and Brenner. Methods Simulations techniques were employed to compare the methods under assumptions that the new test and the reference standard are conditionally independent or dependent given the true disease status of an individual. Three clinical datasets were analysed to understand the impact of using each method to inform clinical decision-making. Results Under the assumption of conditional independence, the Staquet et al. correction method outperforms the Brenner correction method irrespective of the prevalence of disease and whether the performance of the reference standard is better or worse than the index test. However, when the prevalence of the disease is high (> 0.9) or low (< 0.1), the Staquet et al. correction method can produce illogical results (i.e. results outside [0,1]). Under the assumption of conditional dependence; both methods failed to estimate the sensitivity and specificity of the index test especially when the covariance terms between the index test and the reference standard is not close to zero. Conclusion When the new test and the imperfect reference standard are conditionally independent, and the sensitivity and specificity of the imperfect reference standard are known, the Staquet et al. correction method outperforms the Brenner method. However, where the prevalence of the target condition is very high or low or the two tests are conditionally dependent, other statistical methods such as latent class approaches should be considered.


2018 ◽  
Vol 29 (02) ◽  
pp. 106-117
Author(s):  
Venkatesh Aithal ◽  
Joseph Kei ◽  
Carlie Driscoll ◽  
Michio Murakoshi ◽  
Hiroshi Wada

AbstractDiagnosing conductive conditions in newborns is challenging for both audiologists and otolaryngologists. Although high-frequency tympanometry (HFT), acoustic stapedial reflex tests, and wideband absorbance measures are useful diagnostic tools, there is performance measure variability in their detection of middle ear conditions. Additional diagnostic sensitivity and specificity measures gained through new technology such as sweep frequency impedance (SFI) measures may assist in the diagnosis of middle ear dysfunction in newborns.The purpose of this study was to determine the test performance of SFI to predict the status of the outer and middle ear in newborns against commonly used reference standards.Automated auditory brainstem response (AABR), HFT (1000 Hz), transient evoked otoacoustic emission (TEOAE), distortion product otoacoustic emission (DPOAE), and SFI tests were administered to the study sample.A total of 188 neonates (98 males and 90 females) with a mean gestational age of 39.4 weeks were included in the sample. Mean age at the time of testing was 44.4 hr.Diagnostic accuracy of SFI was assessed in terms of its ability to identify conductive conditions in neonates when compared with nine different reference standards (including four single tests [AABR, HFT, TEOAE, and DPOAE] and five test batteries [HFT + DPOAE, HFT + TEOAE, DPOAE + TEOAE, DPOAE + AABR, and TEOAE + AABR]), using receiver operating characteristic (ROC) analysis and traditional test performance measures such as sensitivity and specificity.The test performance of SFI against the test battery reference standard of HFT + DPOAE and single reference standard of HFT was high with an area under the ROC curve (AROC) of 0.87 and 0.82, respectively. Although the HFT + DPOAE test battery reference standard performed better than the HFT reference standard in predicting middle ear conductive conditions in neonates, the difference in AROC was not significant. Further analysis revealed that the highest sensitivity and specificity for SFI (86% and 88%, respectively) was obtained when compared with the reference standard of HFT + DPOAE. Among the four single reference standards, SFI had the highest sensitivity and specificity (76% and 88%, respectively) when compared against the HFT reference standard.The high test performance of SFI against the HFT and HFT + DPOAE reference standards indicates that the SFI measure has appropriate diagnostic accuracy in detection of conductive conditions in newborns. Hence, the SFI test could be used as adjunct tool to identify conductive conditions in universal newborn hearing screening programs, and can also be used in diagnostic follow-up assessments.


Neurology ◽  
2020 ◽  
Vol 95 (12) ◽  
pp. e1745-e1753
Author(s):  
Ingrid J.T. Herraets ◽  
H. Stephan Goedee ◽  
Johan A. Telleman ◽  
Ruben P.A. van Eijk ◽  
Camiel Verhamme ◽  
...  

ObjectiveTo validate the diagnostic accuracy of a previously described short sonographic protocol to identify chronic inflammatory neuropathy (CIN), including chronic inflammatory demyelinating polyneuropathy (CIDP), Lewis Sumner syndrome, and multifocal motor neuropathy (MMN), and to determine the added value of nerve ultrasound to detect treatment-responsive patients compared to nerve conduction studies (NCS) in a prospective multicenter study.MethodsWe included 100 consecutive patients clinically suspected of CIN in 3 centers. The study protocol consisted of neurologic examination, laboratory tests, NCS, and nerve ultrasound. We validated a short sonographic protocol (median nerve at forearm, upper arm, and C5 nerve root) and determined its diagnostic accuracy using the European Federation of Neurological Societies/Peripheral Nerve Society criteria of CIDP/MMN (reference standard). In addition, to determine the added value of nerve ultrasound in detecting treatment-responsive patients, we used previously published diagnostic criteria based on clinical, NCS, and sonographic findings and treatment response (alternative reference standard).ResultsSensitivity and specificity of the sonographic protocol for CIN according to the reference standard were 87.4% and 67.3%, respectively. Sensitivity and specificity of this protocol according to the alternative reference standard were 84.6% and 72.8%, respectively, and of NCS 76.1% and 93.4%. With addition of nerve ultrasound, 44 diagnoses of CIN were established compared to 33 diagnoses with NCS alone.ConclusionsA short sonographic protocol shows high diagnostic accuracy for detecting CIN. Nerve ultrasound is able to detect up to 25% more patients who respond to treatment.Classification of evidenceThis multicenter study provides Class IV evidence that nerve ultrasound improves diagnosis of CIN.


10.2196/16658 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e16658
Author(s):  
Choon Han Tan ◽  
Bhone Myint Kyaw ◽  
Helen Smith ◽  
Colin S Tan ◽  
Lorainne Tudor Car

Background Diabetic retinopathy (DR), a common complication of diabetes mellitus, is the leading cause of impaired vision in adults worldwide. Smartphone ophthalmoscopy involves using a smartphone camera for digital retinal imaging. Utilizing smartphones to detect DR is potentially more affordable, accessible, and easier to use than conventional methods. Objective This study aimed to determine the diagnostic accuracy of various smartphone ophthalmoscopy approaches for detecting DR in diabetic patients. Methods We performed an electronic search on the Medical Literature Analysis and Retrieval System Online (MEDLINE), EMBASE, and Cochrane Library for literature published from January 2000 to November 2018. We included studies involving diabetic patients, which compared the diagnostic accuracy of smartphone ophthalmoscopy for detecting DR to an accurate or commonly employed reference standard, such as indirect ophthalmoscopy, slit-lamp biomicroscopy, and tabletop fundus photography. Two reviewers independently screened studies against the inclusion criteria, extracted data, and assessed the quality of included studies using the Quality Assessment of Diagnostic Accuracy Studies–2 tool, with disagreements resolved via consensus. Sensitivity and specificity were pooled using the random effects model. A summary receiver operating characteristic (SROC) curve was constructed. This review is reported in line with the Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies guidelines. Results In all, nine studies involving 1430 participants were included. Most studies were of high quality, except one study with limited applicability because of its reference standard. The pooled sensitivity and specificity for detecting any DR was 87% (95% CI 74%-94%) and 94% (95% CI 81%-98%); mild nonproliferative DR (NPDR) was 39% (95% CI 10%-79%) and 95% (95% CI 91%-98%); moderate NPDR was 71% (95% CI 57%-81%) and 95% (95% CI 88%-98%); severe NPDR was 80% (95% CI 49%-94%) and 97% (95% CI 88%-99%); proliferative DR (PDR) was 92% (95% CI 79%-97%) and 99% (95% CI 96%-99%); diabetic macular edema was 79% (95% CI 63%-89%) and 93% (95% CI 82%-97%); and referral-warranted DR was 91% (95% CI 86%-94%) and 89% (95% CI 56%-98%). The area under SROC curve ranged from 0.879 to 0.979. The diagnostic odds ratio ranged from 11.3 to 1225. Conclusions We found heterogeneous evidence showing that smartphone ophthalmoscopy performs well in detecting DR. The diagnostic accuracy for PDR was highest. Future studies should standardize reference criteria and classification criteria and evaluate other available forms of smartphone ophthalmoscopy in primary care settings.


2021 ◽  
Vol 108 (Supplement_9) ◽  
Author(s):  
Sharib Ziya Khan ◽  
Sita Kotecha ◽  
Sakshi Rajain ◽  
Krish Ravi

Abstract Background Gallbladder polyps are encountered in 5% of ultrasound scans and continue to remain a dilemma in terms of management. Very few polyps progress to cancer. However, most cancerous polyps are usually found at an advanced stage. It is therefore important to identify the premalignant polyps. There is a lack of national consensus in UK for surveillance of gallbladder polyps. Many trusts in the UK either adopt the European guidelines or formulate local protocols.  We aim to present our findings based on our local surveillance policy existent during the study period with a view to recommending new local guidelines. Methods A search from our radiology database being coded to gallbladder polyp identified patients. We identified 431 patients from 2017 – 2019 who had a total of 1014 scans. The data was collected from local hospital IT databases in terms of variables such as number of scans, polyp size, number of polyps, progression to surgery or discharge from surveillance and histology. The data was analysed on excel platform. Results Patient demographics revealed an incidence of 54% in females (males 46%) with an average age of 59.7 years. Pain was the dominant symptom prompting the first scan (48%). An average of 2.3 scans were performed per patient. 45% of the polyps were less than 5mm. Overall, 22% polyps demonstrated interval growth. Only 15% of polyps less than 5mm demonstrated interval growth and none required cholecystectomy.  6% patients proceeded to surgery mainly for symptoms (46%) compared to polyp progression (1.5%). No malignancy was identified in this study. 43% of patients with polyp diagnosis in primary care had no identified surveillance plan. Conclusions Our study demonstrates a low incidence of polyp progression. We would recommend stopping annual surveillance after 2 years from the index scan for multiple small (&lt;5mm) polyps with little or no progression but continue with annual surveillance for polyps greater than 5mm. We would recommend reserving cholecystectomy for symptomatic polyps and polyps greater than 10mm. There is wide variation in surveillance practice particularly in primary care.  We would recommend sharing the guideline widely with primary care for optimal surveillance.  


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