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The British Journal of Radiology Dec 2019To evaluate the diagnostic accuracy of multiparametric MRI (mpMRI) for detecting extracapsular extension (ECE) in patients with prostate cancer (PCa). (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the diagnostic accuracy of multiparametric MRI (mpMRI) for detecting extracapsular extension (ECE) in patients with prostate cancer (PCa).
METHODS AND MATERIALS
We searched MEDLINE, PubMed, Embase and the Cochrane library up to December 2018. We included studies that used mpMRI to differentiate ECE from organ-confined PCa with a combination of weighted imaging (WI), diffusion-weighted imaging, and dynamic contrast-enhanced MRI. All studies included had pathological diagnosis with radical prostatectomy. Two reviewers independently assessed the methodological quality of included studies by using Quality Assessment of Diagnostic Accuracy Studies 2 tool. We calculated pooled sensitivity, specificity, positive and negative predictive values, diagnostic odds ratios and receiver operating characteristic curve for mpMRI from 2 × 2 tables.
RESULTS
A total of 17 studies that comprised 3374 participants were included. The pooled data showed a sensitivity of 0.55 (95% confidence interval 0.43, 0.66]) and specificity of 0.87 (95% confidence interval 0.82, 0.91) for extracapsular extension detection in PCa.
CONCLUSION
First, our meta-analysis shows moderate sensitivity and high specificity for mpMRI to differentiate ECE from organ-confined prostate cancer before surgery. Second, our meta-analysis shows that mpMRI had no significant differences in performance compared with the former meta-analysis with use of WI alone or with additional functional MRI.
ADVANCES IN KNOWLEDGE
It is the first meta-analysis to evaluate the accuracy of mpMRI in combination of WI, diffusion-weightedimaging and dynamiccontrast-enhanced-MRI for extracapsular extension detection.
Topics: Confidence Intervals; Contrast Media; Diffusion Magnetic Resonance Imaging; Humans; Magnetic Resonance Imaging; Male; Preoperative Care; Prostate; Prostatectomy; Prostatic Neoplasms; ROC Curve; Sensitivity and Specificity
PubMed: 31596123
DOI: 10.1259/bjr.20190480 -
The Cochrane Database of Systematic... Jul 2019Intrahepatic cholestasis of pregnancy is a pregnancy-specific liver disorder, possibly associated with an increased risk of severe fetal adverse events. Total serum bile...
BACKGROUND
Intrahepatic cholestasis of pregnancy is a pregnancy-specific liver disorder, possibly associated with an increased risk of severe fetal adverse events. Total serum bile acids (TSBA) concentration, alone or in combination with serum aminotransferases, have been the most often used biomarkers for the diagnosis of intrahepatic cholestasis of pregnancy in clinical practice. Serum bile acid profile, composed of primary or secondary, conjugated or non-conjugated bile acids, may provide more specific disease information.
OBJECTIVES
To assess and compare, independently or in combination, the diagnostic accuracy of total serum bile acids or serum bile acids profile, or both, for the diagnosis of intrahepatic cholestasis of pregnancy in pregnant women, presenting with pruritus. To define the optimal cut-off values for components of serum bile acid profile; to investigate possible sources of heterogeneity.
SEARCH METHODS
We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Hepato-Biliary Group Diagnostic Test Accuracy Studies Register, the Cochrane Library, MEDLINE Ovid, Embase Ovid, Science Citation Index Expanded, Conference Proceedings Citation Index - Science, BIOSIS, CINAHL, two Chinese databases (CKNI, VIP), Latin American and Caribbean Health Sciences Literature (LILACS), Scientific Electronic Library Online (SciELO), Evidence Search: Health and Social Care by the National Institute for Health and Care Excellence (NICE), the World Health Organization (WHO) Reproductive Health Library (RHL), and the Turning Research into Practice database (TRIP). The most recent date of search was 6 May 2019. We identified additional references by handsearching the references of articles, meta-analyses, and evidence-based guidelines retrieved from the computerised databases, on-line trial registries, and grey literature through OpenSIGLE, National Technical Information Service (NTIS), ProQuest Dissertations & Thesis Database, and Index to Theses in Great Britain and Ireland.
SELECTION CRITERIA
Prospective or retrospective diagnostic case-control or cross-sectional studies, irrespective of publication date, format, and language, which evaluated the diagnostic accuracy of total serum bile acids (TSBA) or components of serum bile acid profile for the diagnosis of intrahepatic cholestasis of pregnancy in pregnant women of any age or ethnicity, in any clinical setting, symptomatic for pruritus.
DATA COLLECTION AND ANALYSIS
We selected studies by reading titles, abstracts, or full texts, and assessing their fulfilment of our inclusion criteria. We emailed primary authors to request missing data or individual participant data. Having extracted data from each included study, we built the two-by-two tables for each primary study and for all the index tests considered. We estimated sensitivity and specificity with their 95% confidence intervals (CI). We presented data in coupled forest plots, showing sensitivities and specificities of each study, and we plotted the studies in the Receiver Operating Characteristic (ROC) space. We performed meta-analyses adopting the hierarchical summary ROC model (HSROC) or the bivariate model to meta-analyse the data. We made indirect comparisons of the considered index tests by adding the index tests as covariates to the bivariate or HSROC models. We performed heterogeneity analysis and sensitivity analysis on studies assessing TSBA accuracy. We used Review Manager 5 (RevMan 5) and SAS statistical software, release 9.4 (SAS Institute Inc., Cary, NC, USA), to perform all statistical analyses. We used QUADAS-2 domains to assess the risk of bias of the included studies.
MAIN RESULTS
Our search yielded 5073 references, but at the end of our selection process, only 16 studies fulfilled the review inclusion criteria. Nine of these provided individual participant data. We analysed only data concerning TSBA, cholic acid (CA), glycocholic acid (GCA), chenodeoxycholic acid (CDCA), and CA/CDCA because the remaining planned index tests were assessed in few studies. Only one study had low risk of bias in all four QUADAS-2 domains. The most biased domains were the patient sampling and the reference standard domains. When considering all studies with a cut-off of 10 μmol/L, TSBA overall sensitivity ranged from 0.72 to 0.98 and specificity ranged from 0.81 to 0.97. After a sensitivity analysis excluding case-control studies, TSBA sensitivity ranged from 0.48 to 0.66 and specificity from 0.52 to 0.99. After a sensitivity analysis excluding studies in which TSBA was part of the reference standard, TSBA sensitivity ranged from 0.49 to 0.65 and specificity from 0.53 to 0.99. We found the estimates of the overall accuracy for some serum bile acid components (CA, GCA, CDCA, and CA/CDCA) to be imprecise, with the CI for sensitivity and specificity very wide or impossible to calculate. Indirect comparisons between serum bile acid profile components and TSBA were not statistically significant. None of the heterogeneity analysis performed was statistically significant, except for the timing of assessment of TSBA (onset of symptoms, peak value among multiple assessments, delivery) but without clinically relevant results. We could not analyse the diagnostic accuracy of combinations of index tests because none of the included studies carried them out, and because of the small number of included studies.
AUTHORS' CONCLUSIONS
The overall high risk of bias, the existing concern regarding applicability of the results in clinical practice, and the great heterogeneity of the results in the included studies prevents us from making recommendations and reaching definitive conclusions at the present time. Thus, we do not find any compelling evidence to recommend or refute the routine use of any of these tests in clinical practice. So far, the diagnostic accuracy of TSBA for intrahepatic cholestasis of pregnancy might have been overestimated. There were too few studies to permit a precise estimate of the accuracy of serum bile acid profile components. Further primary clinical research is mandatory. We need both further phase II and phase III diagnostic studies.
Topics: Bile Acids and Salts; Biomarkers; Cholestasis, Intrahepatic; Diagnostic Tests, Routine; Female; Humans; Pregnancy; Pregnancy Complications; Randomized Controlled Trials as Topic
PubMed: 31283001
DOI: 10.1002/14651858.CD012546.pub2