Quality Assessment Of Diagnostic Studies Research Articles

Effectiveness of contrast-enhanced duplex ultrasound for detecting renal artery stenosis: A systematic review.

Contrast-enhanced duplex ultrasound (CEUS) might be a useful tool to diagnosing renal artery stenosis (RAS). We amalgamated and reviewed the evidence assessing the diagnostic accuracy of CEUS on detecting RAS compared to angiography. This preregistered systematic review included studies that compared the presence of RAS via CEUS with angiography. Sources were searched in November 2022 and included Scopus, EMBASE, MEDLINE, CINAHL, and Academic Search Premier (n = 1717). The Quality Assessment of Diagnostic Studies 2 tool assessed study quality. Results are presented narratively. The studies included (n = 11) had a total of 447 unique participants (193 females) and average age of 56 ± 9 years. Five of eleven studies investigated CEUS using SonoVue contrast agent and reported an average accuracy (91% ± 2%), sensitivity (91% ± 3%), specificity (90% ± 5%), negative predictive value (86% ± 6%), and positive predictive value (94% ± 1%) with all values >80%. The accuracy of CEUS using other types of contrast agent (n = 6), including Levovsit (n = 3/6), Definity (n = 1/6), perfienapent emulsion (n = 1/6), and perfluorocarbon-exposed sonicated dextrose albumin (n = 1/6) was mixed. These studies detected an average accuracy of 91 ± 11% (n = 2/3% > 80%), sensitivity of 98% ± 4%, (n = 3/3% > 80%), and specificity of 86% ± 10% (n = 2/3% > 80%). Included studies had generally low risk of bias and applicability concerns except for unclear flow and timing (n = 7/11) and applicability of patient selection (n = 4/11). Despite being limited by the heterogeneity of included studies, our review indicates a high overall diagnostic accuracy for CEUS to detect RAS compared to angiography, with the largest evidence-base for SonoVue contrast. Radiologists and hospital decision makers should consider CEUS as an acceptable alternative to angiography.

Accuracy of Duplex Ultrasound for Detecting Renal Artery Stenosis: A Systematic Review

Background: Duplex ultrasound (DUS) is a well-tolerated, noninvasive imaging technique. Renal artery stenosis (RAS)—a narrowing of the arteries that supply the kidney—is involved in the cause of renal failure, and its gold-standard method of detection is digital subtraction angiography (DSA). Whether DUS is a suitable alternative to DSA or other angiographic modalities has only been reviewed up to 2005, producing mixed results with studies based on older ultrasound technology without a measurement of study quality. Purpose: To provide an up-to-date review of the diagnostic accuracy of DUS for the diagnosis of RAS in comparison with angiography. Methods: Our registered systematic review (DOI: 10.17605/OSF.IO/SE9VN) examined articles post-2005. Studies must have compared RAS diagnosis between DUS and angiography. Sources were searched in November 2022 and included Scopus, EMBASE, MEDLINE, CINAHL, and Academic Search Premier (1749 citations; final: n = 34; DSA only: n = 9). Study quality was assessed using the Quality Assessment of Diagnostic Studies 2 tool and results are presented narratively. A total of 2968 (1281 females) patients were included. Duplex ultrasound exhibited moderately high agreement with DSA and other well-established angiographic criteria with the existing literature having low risk of bias and low concern for patient applicability. Studies exhibiting low agreement were generally in smaller samples or used unique definitions of stenosis. Conclusions: Improved study reporting, consistent definitions of stenosis, and a common statistical battery are needed.

Diffusion-weighted imaging for determining response to neoadjuvant therapy in pancreatic cancer: a systematic review and meta-analysis

ObjectivesTo determine the role of diffusion-weighted imaging (DWI) for predicting response to neoadjuvant therapy (NAT) in pancreatic cancer.Materials and methodsMEDLINE, EMBASE, and Cochrane Library databases were searched for studies evaluating the performance of apparent diffusion coefficient (ADC) to assess response to NAT. Data extracted included ADC pre- and post-NAT, for predicting response as defined by imaging, histopathology, or clinical reference standards. ADC values were compared with standardized mean differences. Risk of bias was assessed using the Quality Assessment of Diagnostic Studies (QUADAS-2).ResultsOf 337 studies, 7 were included in the analysis (161 patients). ADC values reported for the pre- and post-NAT assessments overlapped between responders and non-responders. One study reported inability of ADC increase after NAT for distinguishing responders and non-responders. A correlation with histopathological response was reported for pre- and post-NAT ADC in 4 studies. DWI’s diagnostic performance was reported to be high in three studies, with a 91.6–100% sensitivity and 62.5–94.7% specificity. Finally, heterogeneity and high risk of bias were identified across studies, affecting the domains of patient selection, index test, reference standard, and flow and timing.ConclusionDWI might be useful for determining response to NAT in pancreatic cancer. However, there are still too few studies on this matter, which are also heterogeneous and at high risk for bias. Further studies with standardized procedures for data acquisition and accurate reference standards are needed.Clinical relevance statementDiffusion-weighted MRI might be useful for assessing response to neoadjuvant therapy in pancreatic cancer. However, further studies with robust data are needed to provide specific recommendations for clinical practice.Key Points•The role of DWI with ADC measurements for assessing response to neoadjuvant therapy in pancreatic cancer is still unclear.•Pre- and post-neoadjuvant therapy ADC values overlap between responders and non-responders.•DWI has a reported high diagnostic performance for determining response when using histopathological or clinical reference standards; however, studies are still few and at high risk for bias.

The accuracy of artificial intelligence used for non-melanoma skin cancer diagnoses: a meta-analysis

BackgroundWith rising incidence of skin cancer and relatively increased mortality rates, an improved diagnosis of such a potentially fatal disease is of vital importance. Although frequently curable, it nevertheless places a considerable burden upon healthcare systems. Among the various types of skin cancers, non-melanoma skin cancer is most prevalent. Despite such prevalence and its associated cost, scant proof concerning the diagnostic accuracy via Artificial Intelligence (AI) for non-melanoma skin cancer exists. This study meta-analyzes the diagnostic test accuracy of AI used to diagnose non-melanoma forms of skin cancer, and it identifies potential covariates that account for heterogeneity between extant studies.MethodsVarious electronic databases (Scopus, PubMed, ScienceDirect, SpringerLink, and Dimensions) were examined to discern eligible studies beginning from March 2022. Those AI studies predictive of non-melanoma skin cancer were included. Summary estimates of sensitivity, specificity, and area under receiver operating characteristic curves were used to evaluate diagnostic accuracy. The revised Quality Assessment of Diagnostic Studies served to assess any risk of bias.ResultsA literature search produced 39 eligible articles for meta-analysis. The summary sensitivity, specificity, and area under receiver operating characteristic curve of AI for diagnosing non-melanoma skin cancer was 0.78, 0.98, & 0.97, respectively. Skin cancer typology, data sources, cross validation, ensemble models, types of techniques, pre-trained models, and image augmentation became significant covariates accounting for heterogeneity in terms of both sensitivity and/or specificity.ConclusionsMeta-analysis results revealed that AI is predictive of non-melanoma with an acceptable performance, but sensitivity may become improved. Further, ensemble models and pre-trained models are employable to improve true positive rating.

Routine and sleep EEG: Minimum recording standards of the International Federation of Clinical Neurophysiology and the International League Against Epilepsy.

This article provides recommendations on the minimum standards for recording routine ("standard") and sleep electroencephalography (EEG). The joint working group of the International Federation of Clinical Neurophysiology (IFCN) and the International League Against Epilepsy (ILAE) developed the standards according to the methodology suggested for epilepsy-related clinical practice guidelines by the Epilepsy Guidelines Working Group. We reviewed the published evidence using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement. The quality of evidence for sleep induction methods was assessed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) method. A tool for Quality Assessment of Diagnostic Studies (QUADAS-2) was used to assess the risk of bias in technical and methodological studies. Where high-quality published evidence was lacking, we used modified Delphi technique to reach expert consensus. The GRADE system was used to formulate the recommendations. The quality of evidence was low or moderate. We formulated 16 consensus-based recommendations for minimum standards for recording routine and sleep EEG. The recommendations comprise the following aspects: indications, technical standards, recording duration, sleep induction, and provocative methods.

Apparent diffusion coefficient for assessing Crohn’s disease activity: a meta-analysis

PurposeTo analyze relationships betweenapparent diffusion coefficient (ADC) and activity parameters of Crohn’s disease, e.g., length and wall thickness, CRP, FCP, MaRIA, CDAI, SES-CD, histologic inflammatory activity score, and the histological fibrotic score, based upon published data.Materials and methodsMEDLINE library, Scopus, and Embase databases were screened for association between ADC and activity parameters of Crohn’s disease in patients with Crohn’s disease up to Mai 2021. Overall, 21 studies with 1053 patients were identified. The following data were extracted from the literature: number of patients, correlation coefficients between ADC and length as well as wall thickness, CRP, FCP, MaRIA, CDAI, and SES-CD, inflammatory activity score, and fibrotic score. Associations between ADC and activity parameters were analyzed by Spearman’s correlation coefficient. The studies’ methodologic quality was evaluated by using the Quality Assessment of Diagnostic Studies (QUADAS 2) instrument, revealing a low risk of bias.ResultsIn the overall sample, the pooled correlation coefficient between ADC and CDAI was −0.8 (95% CI = [−0.94; −0.65]), between ADC and MaRIA −0.66 (95% CI = [−0.79; −0.53]). A strong association was observed between ADC and SES-CD with a pooled correlation of −0.66 (95% CI = [−0.87; −0.46]). The pooled sensitivity to discriminate between involved and non-involved bowel segments was 0.89, with an area under the curve of 0.89ConclusionsADC showed strong inverse correlations with CDAI, MaRIA, and SES-CD scores. However, the role of ADC in assessing fibrotic changes in the bowel wall is limited. ADC can reflect acute inflammatory reactions but not systemic inflammation.Key Points• ADC value can reflect acute inflammatory reactions but not systemic inflammation.• ADC is inversely correlated with CDAI, MaRIA, and SES-CD.• The role of ADC in assessing fibrotic changes in the bowel wall is limited.

The utility of erythrocyte sedimentation rate, C-reactive protein, and procalcitonin in detecting infections in patients with systemic lupus erythematosus: A systematic review

We conducted a systematic review with metanalysis to investigate the utility of erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and procalcitonin (PCT) in diagnosing infections in hospitalized patients with SLE. We searched Medline, Embase, Web of Science, ClinicalTrials.gov, and Cochrane Central Register of Controlled Trials (CENTRAL) with a search strategy developed by a medical librarian. We included retrospective, cross-sectional, case-control, and prospective studies in our analysis. We used the Quality Assessment of Diagnostic Studies (QUADAS-2) to assess for bias and applicability. We obtained mean differences, sensitivities, and specificities in our analysis. We included 26 studies in our analysis. Most studies had an unclear or high risk of bias and our results were widely heterogenous. For the diagnosis of infections, the CRP had a pooled sensitivity of 0.75 (95%CI 0.57-0.94) and specificity of 0.72 (0.59-0.85), PCT had a pooled sensitivity of 0.68 (95% CI 0.0.59-0.77) and specificity of 0.75 (0.59-0.90), and for ESR pooled estimates were not calculated but sensitivity ranged from 50 to 69.8 and specificity from 38.5 to 55.6. Modifying cut-offs improved sensitivities and specificities. The ESR, CRP, and PCT mean differences were all greater in infection groups versus non-infection (10.1, 95% CI 3.2-17.0; 46.8, 95% CI 36.5-57.0; 0.53, 95% CI 0.26-0.80; respectively). Poor sensitivities and specificities were observed for the evaluated biomarkers with substantial heterogeneity in the cut-offs used to determine infection. Although mean biomarker values were increased in the infection group compared with the non-infection, our findings do not support the widespread use of ESR, CRP, or PCT in diagnosing infection in hospitalized patients with SLE due to increased heterogeneity and risk of bias. Further investigation is needed.

The diagnostic value of contrast-enhanced ultrasound and superb microvascular imaging in differentiating benign from malignant solid breast lesions: A systematic review and meta-analysis.

To investigate the added value of contrast-enhanced ultrasound (CEUS) and superb microvascular imaging (SMI) to the conventional ultrasound (US) in the diagnosis of breast lesions. PubMed, EMBASE, Web of Science, Chinese national knowledge infrastructure databases, Chinese biomedical literature databases, and Wanfang were searched for relevant studies from November 2015 to November 2021. The quality of the included studies was evaluated using the Quality Assessment of Diagnostic Studies (QUADAS) tool. Meta-Disc version 1.4 was used to calculate sensitivity (SEN), specificity (SPE), positive likelihood ratio (LR+), negative likelihood ratio (LR-), area under curve (AUC), and diagnostic odds ratio (DOR). Meta-regression analysis was performed using STATA 16.0 software to compare the diagnostic accuracy of the two techniques. In the five studies included, 530 patients were eligible for this meta-analysis. For SMI, the pooled SEN and SPE were 0.75 (95% confidence interval [CI]: 0.69-0.91) and 0.88 (95% CI: 0.83-0.91), respectively, LR+ was 5.75 (95% CI: 4.26-7.78), LR- was 0.29 (95% CI: 0.23-0.36), DOR was 21.42 (95% CI, 13.61-33.73), and AUC was 0.8871. For CEUS, the pooled SEN and SPE were 0.87 (95% CI: 0.82-0.91) and 0.86 (95% CI: 0.82-0.89), respectively, LR+ was 5.92 (95% CI: 4.21-8.33), LR- was 0.16 (95% CI: 0.11-0.25), DOR was 38.27 (95% CI: 18.73-78.17), and AUC was 0.9210. Adding CEUS and (or) SMI to conventional US could improve its diagnostic performance in differentiating benign from malignant solid breast lesions.

Breast Cancer Subtypes and Quantitative Magnetic Resonance Imaging: A Systemic Review.

Magnetic resonance imaging (MRI) is the most sensitive imaging modality for breast cancer detection. This systematic review investigated the role of quantitative MRI features in classifying molecular subtypes of breast cancer. We performed a literature search of articles published on the application of quantitative MRI features in invasive breast cancer molecular subtype classification in PubMed from 1 January 2002 to 30 September 2021. Of the 1275 studies identified, 106 studies with a total of 12,989 patients fulfilled the inclusion criteria. Bias was assessed based using the Quality Assessment of Diagnostic Studies. All studies were case-controlled and research-based. Most studies assessed quantitative MRI features using dynamic contrast-enhanced (DCE) kinetic features and apparent diffusion coefficient (ADC) values. We present a summary of the quantitative MRI features and their correlations with breast cancer subtypes. In DCE studies, conflicting results have been reported; therefore, we performed a meta-analysis. Significant differences in the time intensity curve patterns were observed between receptor statuses. In 10 studies, including a total of 1276 lesions, the pooled difference in proportions of type Ⅲ curves (wash-out) between oestrogen receptor-positive and -negative cancers was not significant (95% confidence interval (CI): [−0.10, 0.03]). In nine studies, including a total of 1070 lesions, the pooled difference in proportions of type 3 curves between human epidermal growth factor receptor 2-positive and -negative cancers was significant (95% CI: [0.01, 0.14]). In six studies including a total of 622 lesions, the pooled difference in proportions of type 3 curves between the high and low Ki-67 groups was significant (95% CI: [0.17, 0.44]). However, the type 3 curve itself is a nonspecific finding in breast cancer. Many studies have examined the relationship between mean ADC and breast cancer subtypes; however, the ADC values overlapped significantly between subtypes. The heterogeneity of ADC using kurtosis or difference, diffusion tensor imaging parameters, and relaxation time was reported recently with promising results; however, current evidence is limited, and further studies are required to explore these potential applications.

The diagnostic accuracy of prehospital triage tools in identifying patients with traumatic brain injury: A systematic review

IntroductionPrehospital care providers are usually the first responders for patients with traumatic brain injury (TBI). Early identification of patients with TBI enables them to receive trauma centre care, which improves outcomes. Two recent systematic reviews concluded that prehospital triage tools for undifferentiated major trauma have low accuracy. However, neither review focused specifically on patients with suspected TBI. Therefore, we aimed to systematically review the existing evidence on the diagnostic performance of prehospital triage tools for patients with suspected TBI. MethodsA comprehensive search of the current literature was conducted using Medline, EMBASE, CINAHL Plus and the Cochrane library (inception to 1st June 2021). We also searched Google Scholar, OpenGrey, pre-prints (MedRxiv) and dissertation databases. We included all studies published in English language evaluating the accuracy of prehospital triage tools for TBI. We assessed methodological quality and risk of bias using a modified Quality Assessment of Diagnostic Studies (QUADAS-2) tool. Two reviewers independently performed searches, screened titles and abstracts and undertook methodological quality assessments. Due to the heterogeneity in the population of interest and prehospital triage tools used, a narrative synthesis was undertaken. ResultsThe initial search identified 1787 articles, of which 8 unique eligible studies met the inclusion criteria (5 retrospective, 2 prospective, 1 mixed). Overall, sensitivity of triage tools studied ranged from 19.8% to 87.9% for TBI identification. Specificity ranged from 41.4% to 94.4%. Two decision tools have been validated more than once: HITS-NS (2 studies, sensitivity 28.3–32.6%, specificity 89.1–94.4%) and the Field Triage Decision Scheme (4 studies, sensitivity 19.8–64.5%, specificity 77.4%-93.1%). Existing tools appear to systematically under-triage older patients. ConclusionFurther efforts are needed to improve and optimise prehospital triage tools. Consideration of additional predictors (e.g., biomarkers, clinical decision aids and paramedic judgement) may be required to improve diagnostic accuracy.

Apparent Diffusion Coefficient Can Predict Therapy Response of Hepatocellular Carcinoma to Transcatheter Arterial Chemoembolization

Aim: The goal of this meta-analysis was to assess the apparent diffusion coefficient (ADC) as a pre- and posttreatment (ADC value changes [ΔADC]) predictive imaging biomarker of response to transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC). Methods: Scopus database, Embase database, and MEDLINE library were scanned for connections between pre- and posttreatment ADC values of HCC and response to TACE. Six studies qualified for inclusion. The following parameters were collected: authors, publication year, study design, number of patients, drugs for TACE, mean ADC value, standard deviation, measure method, b values, and Tesla strength. The Quality Assessment of Diagnostic Studies 2 instrument was employed to check the methodological quality of each study. The meta-analysis was performed by utilizing RevMan 5.3 software. DerSimonian and Laird random-effects models with inverse-variance were used to regard heterogeneity. The mean ADC values and 95% confidence intervals were computed. Results: Six studies (n = 271 patients with 293 HCC nodules) were included. The pretreatment mean ADC in the responder group was 1.20 × 10⁻³ mm²/s (0.98, 1.42) and 1.14 × 10⁻³ mm²/s (0.89, 1.39) in the nonresponder group. The analysis of post-TACE ΔADC revealed a threshold of ≥20% to identify treatment responders. No suitable pretreatment ADC threshold to predict therapy response or discriminate between responders and nonresponders before therapy could be discovered. Conclusion: ΔADC can facilitate early objective response evaluation through post-therapeutic ADC alterations ≥20%. Pretreatment ADC cannot predict response to TACE.

Serum inhibin B for differentiating between congenital hypogonadotropic hypogonadism and constitutional delay of growth and puberty: a systematic review and meta-analysis

PurposeThe distinction between congenital hypogonadotropic hypogonadism (CHH) and constitutional delay of growth and puberty (CDGP) in patients with delayed puberty is difficult to distinguish, but important for timely treatment. The aim of this study is to perform a systematic review and meta-analysis to determine the diagnostic performance of serum inhibin B (INHB) levels for differentiating CHH and CDGP.MethodsPubMed, EMBASE, and Cochrane Library databases were systematically searched from the date of database inception to November 10, 2019 for studies examining the use of serum INHB to discriminate between CHH and CDGP. Pooled odds ratios (OR), sensitivity, specificity, and 95% confidence intervals (CI) were calculated. The Quality Assessment of Diagnostic Studies-2 (QUADAS-2) was used to assess the quality of the included studies. Sub-analyses were performed including that based on testicular volume (TV) and study design.ResultsSeven studies, comprising of 349 patients (96 CHH and 253 CDGP), were included in the meta-analysis. For differentiating between CHH and CDGP, INHB level exhibited good diagnostic accuracy with a pooled sensitivity of 92% (95% confidence interval [CI]: 0.86–0.96, I2 = 0.4%, p = 0.4343), specificity of 92% (95% CI: 0.88–0.94, I2 = 68.1%, p = 0.0009), and pooled area under the receiver operating characteristic curve (AUC) of 0.9619. The cut-off values of INHB for boys were 56, 66, 80, 96, 94.7, 111, and 113 pg/ml (assay method standardized to Gen II ELISA). Sub-analyses showed that testicular volume and study design could be a source of statistically significant heterogeneity in specificity. In boys with a testicular volume of ≤3 ml, INHB performed well with a sensitivity of 92%, specificity of 98%, and AUC of 0.9956.ConclusionINHB exhibits excellent diagnostic efficiency in distinguishing CHH from CDGP, especially in boys with severe puberty deficiency (TV ≤ 3 ml).

Accuracy of single molecular biomarkers in saliva for the diagnosis of periodontitis: A systematic review and meta-analysis.

To analyse, using a meta-analytical approach, the diagnostic accuracy of singlemolecular biomarkers in saliva for the detection of periodontitis in systemically healthy subjects. Articles on molecular biomarkers in saliva providing a binary contingency table (or sensitivity and specificity values and group sample sizes) in individuals with clinically diagnosed periodontitis were considered eligible. Searches for candidate articles were conducted in six electronic databases. The methodological quality was assessed through the tool Quality Assessment of Diagnostic Studies. Meta-analyses were performed using the Hierarchical Summary Receiver Operating Characteristic model. Meta-analysis was possible for 5 of the 32 biomarkers studied. The highest values of sensitivity for the diagnosis of periodontitis were obtained for IL1beta (78.7%), followed by MMP8 (72.5%), IL6 and haemoglobin (72.0% for both molecules); the lowest sensitivity value was for MMP9 (70.3%). In terms of specificity estimates, MMP9 had the best result (81.5%), followed by IL1beta (78.0%) and haemoglobin (75.2%); MMP8 had the lowest specificity (70.5%). MMP8, MMP9, IL1beta, IL6 and Hb were salivary biomarkers with good capability to detect periodontitis in systemically healthy subjects. MMP8 and IL1beta are the most researched biomarkers in the field, both showing clinically fair effectiveness for the diagnosis of periodontitis.

Accuracy of single molecular biomarkers in gingival crevicular fluid for the diagnosis of periodontitis: A systematic review and meta-analysis.

To analyse, by means of a meta-analytical approach, the diagnostic accuracy of molecular biomarkers in gingival crevicular fluid (GCF) for the detection of periodontitis in systemically healthy subjects. Studies on GCF molecular biomarkers providing a binary classification table (or sensitivity and specificity values and group sample sizes) in individuals with clinically diagnosed periodontitis were considered eligible. The search was performed using six electronic databases. The methodological quality of studies was assessed through the tool Quality Assessment of Diagnostic Studies. Meta-analyses were performed using the Hierarchical Summary Receiver Operating Characteristic, which adjusts classification data using random effects logistic regression. The included papers identified 36 potential biomarkers for the detection of periodontitis and for four of them meta-analyses were performed. The median sensitivity and specificity were for MMP8, 76.7% and 92.0%; for elastase, 74.6% and 81.1%; for cathepsin, 72.8% and 67.3%, respectively. The worst estimates of sensitivity and specificity were for trypsin (71.3% and 66.1%, respectively). MMP8 showed good sensitivity and excellent specificity, which resulted in this biomarker being clinically the most useful or effective for the diagnosis of periodontitis in systemically healthy subjects, regardless of smoking condition.

Diagnostic performance of image technique based transurethral resection for non-muscle invasive bladder cancer: systematic review and diagnostic meta-analysis

ObjectiveTo explore the diagnostic performance of image technique based transurethral resection for bladder cancer, with white light-guided cystoscopy (WLC) as the reference standard.DesignSystematic review and meta-analysis.Data sourcesPubMed/MEDLINE, Web of Science,...

Systematic review of the diagnostic accuracy, reliability, and safety of the sharp-purser test

ABSTRACTIntroduction: The Sharp-Purser Test (SPT) is used to assess for atlantoaxial instability (AI) in patients with rheumatoid arthritis (RA). The test is commonly used by clinicians; however, many experts argue it lacks reliability and validity along with concerns of safety. The primary purpose of this review is to determine the diagnostic accuracy of the SPT to detect AI.Methods: A search of five databases was performed from inception to 19 December 2018 using search terms related to the SPT. Studies were eligible for inclusion if the SPT was used on a patient/participant. Methodological quality assessment of diagnostic studies was performed with the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) for studies that reported data to calculate sensitivity (SN), specificity (SP), positive likelihood ratio (+LR), and negative likelihood ratio (-LR).Results: The search yielded 1009 articles, and 32 studies met the inclusion criteria for analysis. Meta-analysis on diagnostic accuracy studies assessing the SPT was not possible due to statistical heterogeneity. Six diagnostic accuracy studies assessed the SN of the SPT ranging from 0.19 to 1.00. Four of the studies assessed SP of the SPT ranging from 0.71 to 0.98. The +LR was identified in 4 studies was 0.655, 1.73, 22, and 17.25. The -LR was 1.14, 0.799, 0.571, and 0.323. Seven RCTs utilized the SPT to screen for AI, and the SPT was used in 18 case reports.Conclusion: The SPT may be inappropriate to use due to inconsistent validity, poor inter-rater reliability, and potential to cause harm.Level of evidence: 1

Meta-analysis of intravoxel incoherent motion magnetic resonance imaging in differentiating focal lesions of the liver.

Introduction:Accurate detection and characterization of focal liver lesions, including differentiation between malignant and benign lesions, are particularly important. The objective of this meta-analysis was to evaluate the parameters of intravoxel incoherent motion (IVIM), including apparent diffusion coefficient (ADC), pure molecular diffusion coefficient (D), perfusion-related diffusion coefficient (D∗), and perfusion fraction (f) in differentiating focal liver lesions.Methods:IVIM method employed for focal liver lesion and the quality assessment of diagnostic studies were evaluated. Standardized mean differences and 95% confidence intervals were calculated. The heterogeneity was quantified with the I2 statistic.Results:The difference between groups was analyzed according to the I2 values from 6 different studies using fixed effects or random effects models. Significant differences in ADC (P < .001) and D (P < .001) were observed between benign and malignant lesions. Moreover, significant differences in ADC (P < .001), D (P < .001), and f (P = .01) were found between hemangioma and hepatocellular carcinoma (HCC). In addition, no significant difference was observed between the metastases and HCC.Conclusions:D and ADC values were useful for the differentiation between benignity and malignancy; higher values of ADC, D, and f were observed in hemangioma compared to HCC. Nevertheless, IVIM did not result as the optimal approach for differentiation between the metastases and HCC.

The added value of contrast-enhanced ultrasound to conventional ultrasound in differentiating benign and malignant solid breast lesions: a systematic review and meta-analysis

To investigate the added value of contrast-enhanced ultrasound (CEUS) to the conventional ultrasound (US) in the diagnosis of breast lesions. PubMed, EMBASE, and Web of Science were searched for relevant studies published between 24 May 2005, and 29 October 2017. Studies incorporating CEUS into the conventional US were included. The reference standard was set by means of histopathological findings. The quality assessment of diagnostic studies (QUADAS) instrument was used to assess the quality of the included studies. Meta-Disc version 1.4. was used to calculate the sensitivity, specificity, summary receiver-operating characteristic (sROC) curves, and area under the curve (AUC). Meta-regression with Stata 12.0 was used to compare the diagnostic accuracy of the two techniques. Five studies, comprising 992 patients, were eligible for this meta-analysis. For conventional US, the pooled sensitivity and specificity for were 0.87 (95% confidence interval [CI]: 0.84-0.91) and 0.80 (95% CI: 0.76-0.84), respectively, the AUC was 0.9049. For CEUS-rerated US, the pooled sensitivity and specificity were 0.93 (95% CI: 0.90-0.95) and 0.87 (95% CI: 0.84-0.90). The AUC was 0.9482. Meta-regression showed the sensitivity of CEUS-rerated US did not differ from conventional US (p=0.29), while specificity showed significant difference (p<0.01). There was evidence of between-study heterogeneity regarding sensitivity and specificity for both assessments. Adding CEUS to conventional US could improve the diagnostic performance in differentiating benign from malignant solid breast lesions, whilst retaining high sensitivity, especially in Breast Imaging-Reporting and Data System (BI-RADS) 3-5 lesions. A uniform standard to distinguish benign from malignant lesions might be needed for further clinical application.

The Diagnostic Accuracy of Bleeding Assessment Tools for the Identification of Patients with Mild Bleeding Disorders: A Systematic Review

IntroductionA study of diagnostic test accuracy compares a single index test to a gold standard to determine status of disease. The observed accuracy of a test varies among patient subgroups and is sensitive to bias. To achieve reliable estimates of diagnostic accuracy, an appropriate study design in a clinically relevant population is warranted. Recently a review was published about the evolution of the bleeding assessment tool (BAT) in diagnosing patients with mild bleeding disorders (MBD) (Rydz et al. J Thromb Haemost 2012). Many validation studies have been done. However, a critical appraisal addressing the quality of these validation studies is lacking.ObjectiveWe performed a systematic review to determine the quality and applicability of studies assessing the diagnostic utility of the BAT for MBD among clinic based cohorts.MethodsThe literature search was conducted using the electronic database PubMed. The final search date was March 2, 2015. The search terms: 'bleeding disorder OR bleeding tendency' AND 'bleeding questionnaire' were used. All studies assessing the diagnostic accuracy of bleeding questionnaires in identifying adults (age > 18 years) with MBD were considered eligible, irrespective of study design or used reference standard. The methodological quality and applicability of each included study was assessed using a Quality Assessment of Diagnostic studies-2 (QUADAS-2) tool. This tool consists of four domains specific for patient selection, index test, reference standard and participant flow. For each domain bias was assessed using signaling questions, for the first three domains applicability was assessed.ResultsThe search yielded 530 citations, from which 35 possible relevant full-text studies were identified. Twenty-two studies were excluded, reasons for exclusion were: letter to the editor, validation of questionnaire combined with laboratory results and primary care population. Table 1 shows the 13 included studies, the assessed BAT and the targeted bleeding condition. Risk of bias and applicability concerns are summarized in figure 1. In 77% of the studies there was a high risk of bias for patient selection and applicability concerns. Many studies used a case control design, comparing patients with a known bleeding disorder with healthy controls. This leads to spectrum bias and might generate higher estimates of sensitivity and specificity (Rutjes et al. Clin Chem 2005). In 46% there was a high risk of bias for index test due to the use of a self-administered questionnaire or because the person conducting the questionnaire was aware of the diagnosis. This leads to observer bias caused by better awareness and over-reporting of bleeding symptoms. Finally, there was high risk of bias in study flow in 38% of the studies. These studies included symptoms after diagnosis of the bleeding disorder. Since bleeding disorders are managed by interventions to prevent bleeding, underestimation of the bleeding symptoms may occur.ConclusionThis review highlights the difficulties and advantages of the BAT validation studies. It provides the ability for medical practitioners to apply the BAT with full awareness of its restrictions and benefits. With the evaluation of the risks of bias in the included studies we highlighted limitations, especially in method of patient selection and use of index test, that future studies preferably should try to avoid. [Display omitted] [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Diagnostic Performance of Diffusion-weighted Magnetic Resonance Imaging in Bone Malignancy

Current state-of-the-art nuclear medicine imaging methods (such as PET/CT or bone scintigraphy) may have insufficient sensitivity for predicting bone tumor, and substantial exposure to ionizing radiation is associated with the risk of secondary cancer development. Diffusion-weighted MRI (DW-MRI) is radiation free and requires no intravenous contrast media, and hence is more suitable for population groups that are vulnerable to ionizing radiation and/or impaired renal functions. This meta-analysis was conducted to investigate whether whole-body DW-MRI is a viable means in differentiating bone malignancy. Medline and Embase databases were searched from their inception to May 2015 without language restriction for studies evaluating DW-MRI for detection of bone lesions. Methodological quality was assessed by the quality assessment of diagnostic studies (QUADAS-2) instrument. Sensitivities, specificities, diagnostic odds ratio (DOR), and areas under the curve (AUC) were used as measures of the diagnostic accuracy. We combined the effects by using the random-effects mode. Potential threshold effects and publication bias were investigated. We included data from 32 studies with 1507 patients. The pooled sensitivity, specificity, and AUC were 0.95 (95% CI, 0.90-0.97), 0.92 (95% CI, 0.88-0.95), and 0.98 on a per-patient basis, and they were 0.91 (95% CI, 0.87-0.94), 0.94 (95% CI, 0.90-0.96), and 0.97 on a per-lesion basis. In subgroup analysis, there is no statistical significance found in the sensitivity and specificity of using DWI only and DWI combined with other morphological or functional imaging sequence in both basis (P > 0.05). A b value of 750 to 1000 s/mm enables higher AUC and DOR for whole-body imaging purpose when compared with other values in both basis either (P < 0.01). The ROC space did not show a curvilinear trend of points and a threshold effect was not observed. According to the Deek's plots, there was no publication bias on both basis. Our results support the use of DWI as an effective means for distinguishing malignant bone lesions; however, various imaging parameters need to be standardized prior to its broad use in clinical practice.