Review Of Test Accuracy Studies Research Articles

Diagnostic Test Accuracy of Urine C-peptide Creatinine Ratio for the Correct Identification of the Type of Diabetes: A Systematic Review

Objective: To examine the accuracy of urine c-peptide creatinine ratio (UCPCR) for identifying the type of diabetes in appropriate clinical settings. Design: Systematic review of test accuracy studies on patients with different forms of diabetes. Data sources: Medline, Embase and Cochrane library databases from 1 January 2000 to 15 November 2020. Eligibility criteria: Studies reporting the use of UCPCR for diagnosing patients with type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) and monogenic forms of diabetes (categorized as maturity-onset diabetes of the young [MODY]). Study selection and data synthesis: Two reviewers independently assessed articles for inclusion and assessed the methodological quality of the studies using the Quality Assessment of Diagnostic Accuracy Studies-2 tool, with input from a third reviewer to reach consensus when there was a dispute. Meta-analysis was performed with the studies reporting complete data to derive the pooled sensitivity, specificity and diagnostic odds ratio (DOR), and narrative synthesis only for those with incomplete data. Results: Nine studies with 4,488 patients were included in the qualitative synthesis, while only four of these (915 patients) had complete data and were included in the quantitative synthesis. All the studies had moderate risk of bias and applicability concerns. Meta-analysis of three studies (n=130) revealed sensitivity, specificity and DOR of 84.4% (95% confidence interval [CI] 68.1–93.2%), 91.6% (82.8–96.1%) and 59.9 (32.8–106.0), respectively, for diagnosing T1DM using a UCPCR cut-off of <0.2 nmol/mmol. For participants with T2DM (three studies; n=739), UCPCR >0.2 nmol/mmol was associated with sensitivity, specificity and DOR of 92.8% (84.2–96.9%), 81.6% (61.3–92.5%) and 56.9 (31.3–103.5), respectively. For patients with MODY in the appropriate clinical setting, a UCPCR cut-off of >0.2 nmol/mmol showed sensitivity, specificity and DOR of 85.2% (73.1–92.4%), 98.0% (92.4–99.5%) and 281.8 (57.5–1,379.7), respectively. Conclusions: Based on studies with moderate risk of bias and applicability concerns, UCPCR confers moderate to high sensitivity, specificity, and DOR for correctly identifying T1DM, T2DM and monogenic diabetes in appropriate clinical settings. Large multinational studies with multi-ethnic participation among different age groups are necessary before this test can be routinely used in clinical practice. Study registration: Protocol was registered as PROSPERO CRD42017060633.

Informant-based screening tools for diagnosis of dementia, an overview of systematic reviews of test accuracy studies protocol

BackgroundRobust diagnosis of dementia requires an understanding of the accuracy of the available diagnostic tests. Informant questionnaires are frequently used to assess for dementia in clinical practice. Recent systematic reviews have sought to establish the diagnostic test accuracy of various dementia informant screening tools. However, most reviews to date have focused on a single diagnostic tool and this does not address which tool is ‘best’. A key aim of the overview of systematic reviews is to present a disparate evidence base in a single, easy to access platform.MethodsWe will conduct an overview of systematic reviews in which we ‘review the systematic reviews’ of diagnostic test accuracy studies evaluating informant questionnaires for dementia. As an overview of systematic reviews of test accuracy is a relatively novel approach, we will use this review to explore methods for visual representation of complex data, for highlighting evidence gaps and for indirect comparative analyses. We will create a list of informant tools by consulting with dementia experts. We will search 6 databases (EMBASE (OVID); Health and Psychosocial Instruments (OVID); Medline (OVID); CINAHL (EBSCO); PSYCHinfo (EBSCO) and the PROSPERO registry of review protocols) to identify systematic reviews that describe the diagnostic test accuracy of informant questionnaires for dementia. We will assess review quality using the AMSTAR-2 (Assessment of Multiple Systematic Reviews) and assess reporting quality using PRISMA-DTA (Preferred Reporting Items for Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies) checklists. We will collate the identified reviews to create an ‘evidence map’ that highlights where evidence does and does not exist in relation to informant questionnaires. We will pool sensitivity and specificity data via meta-analysis to generate a diagnostic test accuracy summary statistic for each informant questionnaire. If data allow, we will perform a statistical comparison of the diagnostic test accuracy of each informant questionnaire using a network approach.DiscussionOur overview of systematic reviews will provide a concise summary of the diagnostic test accuracy of informant tools and highlight areas where evidence is currently lacking in this regard. It will also apply network meta-analysis techniques to a new area.

ED Chest Pain Rules: Follow Your HEART?

ED Chest Pain Rules: Follow Your HEART?

Attention, arousal and other rapid bedside screening instruments for delirium in older patients: a systematic review of test accuracy studies.

delirium occurs frequently in frail patients but is easily missed. Screening with a rapid, easy-to-use and highly sensitive instrument might help improve recognition. The aim of this study was to review attention, arousal and other rapid bedside screening instruments for delirium in older patients. a literature search was performed in PubMed, PsycINFO and Embase. We scrutinized forward citations in Google Scholar, and references of included articles and prior reviews. We included studies among older patients that investigated the sensitivity and specificity of delirium screening instruments that could be administered in 3 min or less, and did not require surrogate information. We extracted study characteristics, risk of bias, sensitivity and specificity. we identified 27 studies among 4,766 patients in hospitals and nursing homes. They tested many different single and several combined screening instruments. Prevalence of delirium varied between 4% and 57%. Only one study scored a low risk of bias on all domains. Sensitivity varied between 17% and 100%, and specificity between 38% and 99%. Of the 22 tests with sensitivity ≥90%, seven also had specificity ≥80% in older patients in general. These results were approximately reproduced for the Observational Scale of Level of Arousal (OSLA) and Richmond Agitation and Sedation Scale (RASS): sensitivity and specificity were >80%. two arousal tests-OSLA and RASS-had reproduced high sensitivity and specificity in older patients. Nurses can administer these tests during daily interaction with patients. Test accuracy studies about rapid screening tools for delirium superimposed on dementia were scarce.

A systematic review of test accuracy studies evaluating molecular micro-satellite instability testing for the detection of individuals with lynch syndrome

BackgroundA systematic review was conducted to assess the diagnostic test accuracy of polymerase chain reaction (PCR)-based microsatellite instability (MSI) testing for identifying Lynch syndrome in patients with colorectal cancer (CRC). Unlike previous reviews, this was based on assessing MSI testing against best practice for the reference standard, and included CRC populations that were unselected, age-limited or high-risk for Lynch syndrome.MethodsSingle- and two-gate diagnostic test accuracy studies, or similar, were identified, assessed for inclusion, data extracted and quality appraised by two reviewers according to a pre-specified protocol. Sensitivity of MSI testing was estimated for all included studies. Specificity, likelihood ratios and predictive values were estimated for studies that were not based on high-risk samples. Narrative synthesis was conducted.ResultsNine study samples were included. When MSI-Low results were considered to be negative, sensitivity estimates ranged from 67% (95% CI 47, 83) to 100% (95% CI 94, 100). Three studies contributed to estimates of both sensitivity and specificity, with specificity ranging from 61% (95% CI 57, 65), to 93% (95% CI 89, 95). Good sensitivity was achieved at the expense of specificity. When MSI-L was considered to be positive (effectively lowering the threshold for a positive index test result) sensitivity increased and specificity decreased. Between-study heterogeneity in both the MSI and reference standard testing, combined with the low number of studies contributing to both sensitivity and specificity estimates, precluded pooling by meta-analysis.ConclusionsMSI testing is an effective screening test for Lynch syndrome. However, there is significant uncertainty surrounding what balance of sensitivity and specificity will be achieved in clinical practice and how this relates to specific characteristics of the test (such as the panel of markers used or the thresholds used to denote a positive test).

On-Site Test to Detect Syphilis in Pregnancy: A Systematic Review of Test Accuracy Studies

(Abstracted from BJOG 2017;124:734–741) Syphilis, an infection of the Treponema pallidum bacterium, can easily go undetected. This sexually transmitted infection can affect pregnant women and lead to adverse outcomes through vertical infection including congenital anomalies and neonatal death.

On-site test to detect syphilis in pregnancy: a systematic review of test accuracy studies.

Syphilis in pregnancy can lead to fetal and neonatal death or congenital anomalies. Accurate on-site tests are an essential part of effective prevention of mother-to-child transmission of the disease. This systematic review assessed the accuracy of on-site tests to detect infection with Treponema pallidum in pregnant women. Major databases were searched from inception to January 2016 using terms: 'pregnancy', 'antenatal', 'syphilis', 'Treponema pallidum' with their variations, and the search limit for the relevant study design. We included studies that used dual reference standard (non-treponemal and treponemal tests) to detected syphilis in pregnancy. Extracted accuracy data were tabulated and pooled using hierarchical, bivariate random effects model. Seven studies (combined sample 17546) reporting the accuracy of four on-site tests met the eligibility criteria. On average, Determine™ and SD BioLine Syphilis 3.0 had the highest sensitivity of all the evaluated tests: 0.83 (95% CI 0.58, 0.98) and 0.86 (95% CI 0.82, 0.89), respectively, with a high specificity 0.96 (95% CI 0.89, 1.00) and 0.99 (95% CI 0.94, 1.00), respectively. The Qualitative Rapid Plasma Reagin card commonly used in clinical practice had a pooled sensitivity of 0.70 (95% CI 0.54, 0.88) and specificity of 0.97 (95% CI 0.96, 0.99). Immunochromatographic tests such as Determine™ and SD BioLine Syphilis 3.0 seem to be acceptable options in antenatal testing for syphilis, especially in resource-limited settings. Future research should seek more evidence to strengthen this claim. On-site test to detect syphilis-options during antenatal care.

Colour Doppler analysis of ophthalmic vessels in the diagnosis of carotic artery and retinal vein occlusion, diabetic retinopathy and glaucoma: systematic review of test accuracy studies.

BackgroundColour Doppler analysis of ophthalmic vessels has been proposed as a promising tool in the diagnosis of various eye diseases, but the available diagnostic evidence has not yet been assessed systematically. We performed a comprehensive systematic review of the literature on the diagnostic properties of Colour Doppler imaging (CDI) assessing ophthalmic vessels and provide an inventory of the available evidence.MethodsEligible papers were searched electronically in (Pre) Medline, Embase and Scopus, and via cross-checking of reference lists. The minimum requirement to be included was the availability of original data and the possibility to construct a two-by-two table. Study selection, critical appraisal using the QUADAS II instrument and extraction of salient study characteristics was made in duplicate. Sensitivity and specificity was computed for each study.ResultsWe included 11 studies (15 two-by-two tables) of moderate methodological quality enrolling 820 participants (range 30 to 118). In 44.4% participants were female (range 37–59% in specific subgroups). CDI was assessed for internal carotid stenosis, diabetic retinopathy, glaucoma, and branch or central retinal vein occlusion diagnosis. There was insufficient data to pool the results for specific illnesses. For the assessments of ophthalmic arteries, mean sensitivity was 0.69 (range 0.27–0.96) with a corresponding mean specificity of 0.83 (range 0.70–0.96). Mean sensitivity of the central retinal artery assessments was 0.58 (range 0.31–0.84) and the corresponding mean specificity was 0.82 (range 0.63–0.94).ConclusionsRobust assessments of the diagnostic value of colour Doppler analysis remain uncommon, limiting the possibilities to extrapolate its true potential for clinical practice.PROSPERO 2014:CRD42014014027.

Incorporating quality assessments of primary studies in the conclusions of diagnostic accuracy reviews: a cross-sectional study

BackgroundDrawing conclusions from systematic reviews of test accuracy studies without considering the methodological quality (risk of bias) of included studies may lead to unwarranted optimism about the value of the test(s) under study. We sought to identify to what extent the results of quality assessment of included studies are incorporated in the conclusions of diagnostic accuracy reviews.MethodsWe searched MEDLINE and EMBASE for test accuracy reviews published between May and September 2012. We examined the abstracts and main texts of these reviews to see whether and how the results of quality assessment were linked to the accuracy estimates when drawing conclusions.ResultsWe included 65 reviews of which 53 contained a meta-analysis. Sixty articles (92%) had formally assessed the methodological quality of included studies, most often using the original QUADAS tool (n = 44, 68%). Quality assessment was mentioned in 28 abstracts (43%); with a majority (n = 21) mentioning it in the methods section. In only 5 abstracts (8%) were results of quality assessment incorporated in the conclusions. Thirteen reviews (20%) presented results of quality assessment in the main text only, without further discussion. Forty-seven reviews (72%) discussed results of quality assessment; the most frequent form was as limitations in assessing quality (n = 28). Only 6 reviews (9%) further linked the results of quality assessment to their conclusions, 3 of which did not conduct a meta-analysis due to limitations in the quality of included studies. In the reviews with a meta-analysis, 19 (36%) incorporated quality in the analysis. Eight reported significant effects of quality on the pooled estimates; in none of them these effects were factored in the conclusions.ConclusionWhile almost all recent diagnostic accuracy reviews evaluate the quality of included studies, very few consider results of quality assessment when drawing conclusions. The practice of reporting systematic reviews of test accuracy should improve if readers not only want to be informed about the limitations in the available evidence, but also on the associated implications for the performance of the evaluated tests.

What is the accuracy of blood pressure in predicting complications in pre-eclampsia?

BackgroundBlood pressure is considered to be the most predictive of complications in women with pre-eclampsia compared to the other tests.MethodsWe performed systematic quantitative review of test accuracy studies. We conducted...

Cardiac Testing for Coronary Artery Disease in Potential Kidney Transplant Recipients: A Systematic Review of Test Accuracy Studies

Cardiovascular disease is the leading cause of death after kidney transplant. Screening for coronary artery disease is integral to pretransplant evaluation, although the relative performance of different tests is uncertain. Systematic review of diagnostic test accuracy studies using hierarchical summary receiver operating characteristic analysis. Kidney transplant candidates undergoing pretransplant assessment. SELECTION CRITERIA OF STUDIES: Studies evaluating the accuracy of screening tests for detecting coronary artery disease. Any non- or minimally invasive test used to diagnose coronary artery disease. Coronary angiography. 11 studies (690 participants) evaluated dobutamine stress echocardiography; 7 (317 participants), myocardial perfusion scintigraphy; 2 (129 participants), exercise stress electrocardiography; and 2 (121 participants), other tests. Dobutamine stress echocardiography had pooled sensitivity of 0.80 (95% CI, 0.64-0.90) and specificity of 0.89 (95% CI, 0.79-0.94). Myocardial perfusion scintigraphy had pooled sensitivity of 0.69 (95% CI, 0.48-0.85) and specificity of 0.77 (95% CI, 0.59-0.89). Head-to-head comparison of dobutamine stress echocardiography and myocardial perfusion scintigraphy (2 studies; 116 participants) showed that dobutamine stress echocardiography had higher specificity and at least equivalent or higher sensitivity. Indirect comparison suggested dobutamine stress echocardiography may have improved accuracy over myocardial perfusion scintigraphy (P = 0.07). Power to detect differences in accuracy between tests is limited due to sparse data. Absence of significant coronary artery disease may not necessarily correlate with cardiac event-free survival after transplant. Dobutamine stress echocardiography may perform better than myocardial perfusion scintigraphy; however, additional studies directly comparing dobutamine stress echocardiography and myocardial perfusion scintigraphy are needed. Further research should focus on assessing the ability of functional tests to predict postoperative outcome.

Evidence-based diagnosis

Making an accurate diagnosis is essential to ensure that a patient receives appropriate treatment and correct information regarding their prognosis. Characteristics of diagnostic tests are quantified in test accuracy studies, but many such studies have methodological flaws. The HSRC evidence-based diagnosis programme has focused on methods for systematic reviews of test accuracy studies, and the wider context in which tests are ordered and interpreted. We carried out a range of projects relating to literature searching, quality assessment, meta-analysis, presentation of results, and interactions between doctors and patients during the diagnostic process. We have shown that systematic reviews of test accuracy studies should search a range of databases and that current diagnostic filters do not have sufficient accuracy to be used in test accuracy reviews. Summary quality scores should not be used in test accuracy reviews; the Quality Assessment of Studies of Diagnostic Accuracy included in Systematic Reviews (QUADAS) tool for assessing test accuracy studies is acceptable for quality assessment. We have shown that the hierarchical summary receiver operating characteristic (HSROC) and bivariate models for meta-analysis of test accuracy are statistically equivalent in many circumstances, and have developed an add-on module for the statistical software package Stata that enables these statistically rigorous models to be fitted by those without expert statistical knowledge. Three areas that would benefit from further research are literature searching, synthesis of results from individual patient data and presentation of results.

Locating systematic reviews of test accuracy studies: How five specialist review databases measure up

The aim of this study was to examine location of systematic reviews of test accuracy in five specialist review databases: York CRD's DARE and HTA databases, Medion (University of Maastricht), C-EBLM (International Federation of Clinical Chemistry), and the ARIF in-house database (University of Birmingham). Searches were limited to the period 1996-2006. Test accuracy reviews were located using in-house diagnostic search filters and with help from database producers where databases were not confined to test accuracy reviews. References were coded according to disease area, review purpose, and test application. Ease of use, volume, overlap, and content of databases was noted. A large degree of overlap existed between databases. Medion contained the largest number (n = 672) and the largest number of unique (n = 328) test accuracy references. A combination of three databases identified only 76% of test reviews. All databases were rated as easy to search but varied with respect to timeliness and compatibility with reference management software. Most reviews evaluated test accuracy (85%) but the HTA database had a larger proportion of cost-effectiveness and screening reviews and C-EBLM more reviews addressing early test development. Most reviews were conducted in secondary care settings. Specialist review databases offer an essential addition to general bibliographic databases where application of diagnostic method filters can compromise search sensitivity. Important differences exist between databases in terms of ease of use and content. Our findings raise the question whether the current balance of research setting, in particular the predominance of research on tests used in secondary care, matches the needs of decision makers.

Accuracy of B-type natriuretic peptide tests to exclude congestive heart failure: systematic review of test accuracy studies

Accuracy of B-type natriuretic peptide tests to exclude congestive heart failure: systematic review of test accuracy studies

Systematic reviews of test accuracy should search a range of databases to identify primary studies

Objective To estimate the yield from searching a range of bibliographic databases and additional sources to identify test accuracy studies for systematic reviews. Study Design and Setting We examined eight systematic reviews and their database searches: MEDLINE, EMBASE, BIOSIS, Science Citation Index, LILACS, Pascal, and CENTRAL. We used studies included in each systematic review as the “gold standard,” against which yield was estimated. For each database, we classified studies in each gold standard set as being (1) included in the database and identified by searches, (2) included and not identified, and (3) not included in the database. Results No search identified all studies in any gold standard set. EMBASE, Science Citation Index, and BIOSIS contained studies that were not on MEDLINE. Over 20% of studies in the gold standard sets were not identified by searching MEDLINE. Six studies on LILACS were not on any other database. Eight gold standard studies were not included in any of the databases, and a further 22 were not identified by the electronic search strategies. Conclusions Systematic reviews of test accuracy studies should search a range of databases. Even searches designed to be very sensitive, that do not use study design filters, can fail to identify relevant studies.

Accuracy of serum uric acid in predicting complications of pre‐eclampsia: a systematic review

Pre-eclampsia is one of the largest causes of maternal and fetal mortality and morbidity. Hyperuricemia is often associated with pre-eclampsia. To determine the accuracy with which serum uric acid predicts maternal and fetal complications in women with pre-eclampsia. Systematic quantitative review of test accuracy studies. We conducted electronic searches in MEDLINE (1951-2004), EMBASE (1980-2004), the Cochrane Library (2004:4) and the MEDION database to identify relevant articles. A hand-search of selected specialist journals and reference lists of articles obtained was then carried out. There were no language restrictions for any of these searches. Two reviewers independently selected the articles in which the accuracy of serum uric acid was evaluated to predict maternal and fetal complications of pre-eclampsia. Data were extracted on study characteristics, quality and accuracy to construct 2 x 2 tables with maternal and fetal complications as reference standard. Summary likelihood ratios for positive (LR+) and negative LR(-) test results are generated for various threshold levels of uric acid. There were 18 primary articles that met the selection criteria, including a total of 3913 women and forty-one 2 x 2 tables. In women with pre-eclampsia, a positive test result of uric acid greater than or equal to a 350-micromol/l threshold predicted eclampsia with a pooled likelihood ratio (LR) of 2.1 (95% CI 1.4-3.5), while a negative test result had a pooled LR of 0.38 (95% CI 0.18-0.81). For severe hypertension as the outcome measure, the LRs were 1.7 (95% CI 1.3-2.2) and 0.49 (95% CI 0.38-0.64) for positive and negative test results, respectively, and for caesarean section the LRs were 2.4 (95% CI 1.3-4.7) and 0.39 (95% CI 0.20-0.76). For stillbirths and neonatal deaths the respective LRs were 1.5 (95% CI 0.91-2.6) and 0.51 (95% CI 0.20-1.3). For the prediction of small-for-gestational-age fetus, the pooled LRs were 1.3 (95% CI 1.1-1.7) and 0.60 (95% CI 0.43-0.83) for positive and negative results, respectively. AUTHOR'S CONCLUSION: Serum uric acid is a poor predictor of maternal and fetal complications in women with pre-eclampsia.

Accuracy of sperm-cervical mucus penetration tests in evaluating sperm motility in semen: a systematic quantitative review.

Our objective was to determine the accuracy of in-vitro sperm penetration into cervical mucus or substitutes in evaluating sperm motility in semen. This was a systematic quantitative review of test accuracy studies. The Cochrane library (2000:4), Medline (1966-2001), Embase (1988-2001) and SciSearch (1981-2001) were searched, in addition to manual searches of conference papers and bibliographies of known primary and review articles. Primary studies measuring in-vitro sperm penetration into cervical mucus, or substitutes (i.e. sperm-mucus penetration test, SMPT) and comparing results with sperm motility in semen were included. There were 18 primary diagnostic studies published in 17 papers, involving a total of 2580 samples. Fourteen primary diagnostic tests used vanguard distance as diagnostic criteria (SMPT(vd)) and the pooled likelihood ratio (LR) for positive (LR+) and negative (LR-) tests were 2.29 (1.82-2.87) and 0.52 (0.44-0.63) respectively. Four studies used diagnostic criteria based directly or indirectly on swim-up sperm count per high power field (SMPT(sc)) instead. Their pooled LR+ and LR- were 5.24 (3.36-8.18) and 0.15 (0.06-0.39) respectively. SMPT(vd) has a low accuracy in the evaluation of sperm motility in semen. However, SMPT(sc) was found to be more accurate. This method of using sperm concentration, instead of vanguard distance, as diagnostic criteria of in-vitro SMPT has potential as a useful laboratory-based sperm function test.

Accuracy of cervico-vaginal fetal fibronectin test in predicting the risk of spontaneous preterm birth—a systematic review

We studied the accuracy with which the cervico-vaginal fetal fibronectin test predicts spontaneous preterm birth in asymptomatic and symptomatic pregnant women. This was a systematic quantitative review of test accuracy studies. Two reviewers selected and extracted data on study characteristics, quality and accuracy independently. Accuracy data were used to form 2 × 2 contingency tables with spontaneous preterm birth before 34 and 37 weeks’ gestation and birth within 7–10 days of testing (only for symptomatic pregnant women) as reference standards. Data were pooled to produce summary receiver operating characteristic (ROC) curves and summary likelihood ratios for positive (LR+) and negative (LR−) test results. There were 64 primary articles consisting of 28 accuracy studies in asymptomatic women and 40 accuracy studies in symptomatic women, including a total of 22 390 women. Among asymptomatic women, the best summary LR+ was 4.01 (95% confidence interval 2.93–5.49) for predicting birth before 34 weeks’ gestation, with corresponding summary LR− of 0.78 (0.72–0.84). Among symptomatic women, the best summary LR+ was 5.42 (4.36–6.74) for predicting birth within 7–10 days of testing, with corresponding summary LR− of 0.25 (0.20–0.31).