Accuracy Of Index Test Research Articles

Diagnostic accuracy of chest X-ray and CT using artificial intelligence for osteoporosis: systematic review and meta-analysis.

Artificial intelligence (AI)-based systems using chest images are potentially reliable for diagnosing osteoporosis. We performed a systematic review and meta-analysis to assess the diagnostic accuracy of chest X-ray and computed tomography (CT) scans using AI for osteoporosis in accordance with the diagnostic test accuracy guidelines. We included any type of study investigating the diagnostic accuracy of index test for osteoporosis. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and IEEE Xplore Digital Library on November 8, 2023. The main outcome measures were the sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for osteoporosis and osteopenia. We described forest plots for sensitivity, specificity, and AUC. The summary points were estimated from the bivariate random-effects models. We summarized the overall quality of evidence using the Grades of Recommendation, Assessment, Development, and Evaluation approach. Nine studies with 11,369 participants were included in this review. The pooled sensitivity, specificity, and AUC of chest X-rays for the diagnosis of osteoporosis were 0.83 (95% confidence interval [CI] 0.75, 0.89), 0.76 (95% CI 0.71, 0.80), and 0.86 (95% CI 0.83, 0.89), respectively (certainty of the evidence, low). The pooled sensitivity and specificity of chest CT for the diagnosis of osteoporosis and osteopenia were 0.83 (95% CI 0.69, 0.92) and 0.70 (95% CI 0.61, 0.77), respectively (certainty of the evidence, low and very low). This review suggests that chest X-ray with AI has a high sensitivity for the diagnosis of osteoporosis, highlighting its potential for opportunistic screening. However, the risk of bias of patient selection in most studies were high. More research with adequate participants' selection criteria for screening tool will be needed in the future.

Xpert MTB/XDR assay: rapid TB drug resistance detection.

To assess the Xpert MTB/XDR assay's efficiency in promptly detecting resistance to isoniazid, fluoroquinolones, ethionamide, and second-line injectable drugs among tuberculosis (TB) patients. From August 2020 to July 2021, TB suspected patient samples were enrolled at a tertiary care center for our study. We conducted mycobacterial culture, phenotypic DST using proportion method in liquid culture at WHO-recommended concentrations, and the line probe assay (LPA). Simultaneously, the Index test, Xpert MTB/XDR, was performed following the manufacturer's instructions. Among 360 samples, 107 were excluded due to incomplete information. Resistance to isoniazid, levofloxacin and moxifloxacin was found in 45/251, 21/251 and 20/251 samples, respectively by phenotypic DST. The diagnostic accuracy of Index test, taking phenotypic DST as a reference standard, was 95.8%, 99.04%, and 99.05% for isoniazid, levofloxacin, and moxifloxacin, respectively. The Index test assay demonstrated a specificity of 99.1% for detecting SLID resistance, yielding a diagnostic accuracy of 99.2. Comparing the Index test with LPA revealed a significant enhancement in sensitivity for detecting isoniazid resistance (86.7% vs. 82.2%). The Index test exhibited promising outcomes in identifying resistance to isoniazid and fluoroquinolones, surpassing the performance of the LPA. This could be valuable for promptly initiating treatment in cases of drug-resistant tuberculosis.

Accuracy of Diagnostic Tests for Detecting Schistosoma mansoni and S. haematobium in Sub-Saharan Africa: A Systematic Review and Meta-Analysis.

Schistosomiasis is causing high morbidity and significant mortality in endemic areas. Kato-Katz stool examination and urine filtration techniques are the conventional methods for the detection of intestinal and urinary schistosomiasis. The most appropriate diagnostic tools for the detection of schistosomiasis especially in low-prevalence settings should be used. Therefore, this study is aimed at investigating the diagnostic accuracy of S. mansoni and S. haematobium diagnostic tools in sub-Saharan Africa. Electronic databases such as PubMed, PubMed Central/Medline, HINARI, Scopus, EMBASE, Science Direct, Google Scholar, and Cochrane Library were reviewed. The pooled estimates and heterogeneity were determined using Midas in Stata 14.0. The diagnostic accuracy of index tests was compared using the hierarchical summary of the receiver operating characteristic (HSROC) curve in Stata 14.0. Twenty-four studies consisting of 12,370 individuals were tested to evaluate the accuracy of antigen, antibody, and molecular test methods for the detection of S. mansoni and S. haematobium. The pooled estimate of sensitivity and specificity of CCA was 88% (95% CI: 83-92) and 72 (95% CI: 62-80), respectively, when it is compared with parasitological stool examination for S. mansoni detection. On the other hand, ELISA showed a pooled estimate of sensitivity and specificity of 95% (95% CI: 93-96) and 35% (95% CI: 21-52), respectively, for the examination of S. mansoni using stool examination as a reference test. With regard to S. haematobium, the pooled estimate of sensitivity and specificity of polymerase chain reaction was 97% (95% CI: 78-100) and 94% (95% CI: 74-99), respectively. Moreover, the sensitivity and specificity of urine CCA vary between 41-80% and 55-91%, respectively, compared to urine microscopy. The effort of schistosomiasis elimination requires accurate case identification especially in low-intensity infections. This study showed that CCA had the highest sensitivity and moderate specificity for the diagnosis of S. mansoni. Similarly, the sensitivity of ELISA was excellent, but its specificity was low. The diagnostic accuracy of PCR for the detection of S. haematobium was excellent compared to urine microscopic examination.

Identifying eating disorders in adolescents and adults with overweight or obesity: A systematic review of screening questionnaires.

ObjectiveThis review aimed to examine the validity of self‐report screening questionnaires for identifying eating disorder (ED) risk in adults and adolescents with overweight/obesity.MethodFive databases were searched from inception to September 2020 for studies assessing validation of self‐report ED screening questionnaires against diagnostic interviews in adolescents and adults with overweight/obesity. The review was registered with PROSPERO (https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=220013).ResultsTwenty‐seven papers examining 15 questionnaires were included. Most studies validated questionnaires for adults (22 of 27 studies), and most questionnaires (12 of 15) screened for binge eating or binge‐eating disorder (BED). The Eating Disorder Examination Questionnaire (sensitivity = .16–.88, specificity = .62–1.0) and Questionnaire on Eating and Weight Patterns (sensitivity = .07–1.0, specificity = .0–1.0) were most frequently validated (six studies each). Five studies of three questionnaires were in adolescents, with the Adolescent Binge‐Eating Disorder Questionnaire having highest sensitivity (1.0) but lower specificity (.27). Questionnaires designed to screen for BED generally had higher diagnostic accuracy than those screening for EDs in general.DiscussionQuestionnaires have been well validated to identify BED in adults with overweight/obesity. Validated screening tools to identify other EDs in adults and any ED in adolescents with overweight/obesity are lacking. Thus, clinical assessment should inform the identification of patients with co‐morbid EDs and overweight/obesity.Public SignificanceIndividuals with overweight/obesity are at increased risk of EDs. This review highlights literature gaps regarding screening for ED risk in this vulnerable group. This work presents possibilities for improving care of individuals with overweight/obesity by reinventing ED screening tools to be better suited to diverse populations.

Are there diagnostic alternatives to histopathology in detecting oral cancer?

Background Oral potentially malignant disorders (OPMDs) include erythroplakia, erosive lichen planus, non-homogenous leukoplakia and many others. These lesions may revert to healthy tissues, remain unchanged, or undergo malignant change to oral squamous cell carcinoma (OSCC). Early detection allows early management, which subsequently improves survival rates for OSCC. Current diagnostic practice involves a tissue biopsy with histology. This can be uncomfortable for patients and delays diagnosis. Other, less invasive diagnostic tests are available which can provide immediate results.Objectives Primary objective: to evaluate the diagnostic accuracy of index tests in detecting OSCC and OPMDs. Secondary objective: to determine the relative accuracy of alternative diagnostic tests.Search methods Four online databases including Medline (OVID), Embase (OVID), the US National Institute of Health Ongoing Trials Register (clinicaltrials.gov) and the World Health Organisation International Clinical Trials Registry Platform were searched for ongoing trials to 20 October 2020. Citation searches were conducted, with no language restrictions, and reference lists were reviewed for any additional references.Selection criteria Studies reporting the diagnostic test accuracy of the following index tests were included if used in conjunction with oral examination in determining OPMDs or OSCC: oral spectroscopy, light-based detection, vital staining, saliva and/or blood analysis and oral cytology.Data collection and analysis Titles and abstracts were screened by two designated review authors to determine relevance. A minimum of two authors, both independently and together, assessed the eligibility of the papers and undertook the quality assessment and data extraction. The methodological quality was determined using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Results of each index test in various studies were amalgamated using meta-analysis following the bivariate approach to determine sensitivity and specificity.Results Seventy-nine datasets were included, spanning from 1980 to 2020. A total of 7,942 lesions were examined. These studies assessed diagnostic sensitivity and specificity of tissue biopsy and histology in comparison to oral cytology (24 datasets), oral spectroscopy/light-based detection (24 datasets) and vital staining (22 datasets). Nine datasets evaluated two combined index tests. No eligible diagnostic accuracy studies assessing salivary or blood sample analysis were identified. Two studies were deemed low risk of bias in all categories (patient selection, index tests, reference standards and flow and timing) with 33 studies being low concern for applicability across three sectors. Patient selection, demographics, the index test and reference standard used were appropriate to a secondary care setting. Meta-analysis of eligible index tests showed the following results. Cytological sensitivity was 0.90 (CI 0.82-0.94) and specificity 0.94 (CI 0.88-0.97) from 24 datasets. For oral spectroscopy, sensitivity was 0.87 (CI 0.78-0.93) and specificity 0.50 (CI 0.32-0.68) from 24 datasets. For vital staining, sensitivity was 0.86 (CI 0.79-0.90) and specificity 0.68 (CI 0.58-0.77) from 22 datasets. For combined tests, sensitivity was 0.78 (CI 0.45-0.94) and specificity 0.71 (CI 0.53-0.84) from nine datasets.Conclusion None of the adjunctive tests can presently be recommended in lieu of tissue biopsy and histological assessment. Of the modalities, oral cytology showed the greatest potential based on the high summary estimate values for sensitivity and specificity. Further research is needed into the utility of these alternative diagnostic tests.

Protocol for a systematic review of the diagnostic test accuracy of tests for IgE‐mediated food allergy

The European Academy of Allergy and Clinical Immunology (EAACI) is in the process of updating the guidelines on the diagnosis and management of food allergy. The existing guidelines are based on a systematic review of the literature until 30 September 2012. Therefore, a new systematic review must be undertaken to inform the new guidelines. This systematic review aims to assess the accuracy of index tests to support the diagnosis of IgE-mediated food allergy. The databases Cochrane CENTRAL (Trials), MEDLINE (OVID) and Embase (OVID) will be searched for diagnostic test accuracy studies from 1 October 2012 to 30June 2021. Inclusion and exclusion criteria will be used to select appropriate studies. Data from these studies will be extracted and tabulated, and then reviewed for risk of bias and applicability using the QUADAS-2 tool. All evaluations will be done in duplicate. Studies with a high risk of bias and low applicability will be excluded. Meta-analysis will be performed if there are three or more studies of the same index test and food. A protocol for the systematic review and meta-analyses is presented and was registered using Prospero prior to commencing the literature search. Oral food challenges are the reference standard for diagnosis but involve considerable risks and resources. This protocol for systematic review aims to assess the accuracy of various tests to diagnose food allergy, which can be useful in both clinical and research settings.

Evaluation of TB-LAMP assay for detection of Mycobacterium tuberculosis in children

Background Paediatric tuberculosis remains a major public health problem in developing countries. The diagnosis of tuberculosis in children is challenging because of the paucibacillary nature of the disease, due to which more sensitive nucleic acid amplification tests are needed. In this study, we determined the accuracy of WHO endorsed TB-LAMP assay for detection of Mycobacterium tuberculosis in children. Methods This was a prospective study conducted between March to July, 2018. A total of 177 samples from consecutive suspected TB children were received for microbiological diagnosis of TB. All tests for Mycobacterium tuberculosis detection were performed in parallel (smear microscopy, mycobacterial culture, Xpert MTB/RIF and TB-LAMP). The diagnostic accuracy of index test i.e. TB LAMP were determined using mycobacterial culture as a reference standard. Results Of the 177 samples, 2 (1.1%) were excluded from the study. Among 175 samples, TB-LAMP and Xpert MTB/RIF were positive in 27 (15.4%) and 25 (14.3%) samples, respectively. The sensitivity of both Xpert MTB/RIF and TB-LAMP was same, i.e. 84% (95%CI: 63.9–95.5%), when culture was considered as the reference standard. The specificity, positive predictive value and negative predictive value of TB-LAMP assay was 96% (95%CI: 91.5–98.5%), 77.8% (95%CI: 61.1–88.6%) and 97.3% (95%CI: 93.6–98.9%), respectively. Conclusion For the detection of M. tuberculosis in paediatric samples, TB-LAMP showed a sensitivity and specificity comparable to Xpert MTB/RIF.

Diagnostic tests for oral cancer and potentially malignant disorders in patients presenting with clinically evident lesions.

Squamous cell carcinoma is the most common form of malignancy of the oral cavity, and is often proceeded by oral potentially malignant disorders (OPMD). Early detection of oral cavity squamous cell carcinoma (oral cancer) can improve survival rates. The current diagnostic standard of surgical biopsy with histology is painful for patients and involves a delay in order to process the tissue and render a histological diagnosis; other diagnostic tests are available that are less invasive and some are able to provide immediate results. This is an update of a Cochrane Review first published in 2015. Primary objective: to estimate the diagnostic accuracy of index tests for the detection of oral cancer and OPMD, in people presenting with clinically evident suspicious and innocuous lesions. to estimate the relative accuracy of the different index tests. Cochrane Oral Health's Information Specialist searched the following databases: MEDLINE Ovid (1946 to 20 October 2020), and Embase Ovid (1980 to 20 October 2020). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were also searched for ongoing trials to 20 October 2020. No restrictions were placed on the language or date of publication when searching the electronic databases. We conducted citation searches, and screened reference lists of included studies for additional references. We selected studies that reported the diagnostic test accuracy of the following index tests when used as an adjunct to conventional oral examination in detecting OPMD or oral cavity squamous cell carcinoma: vital staining (a dye to stain oral mucosa tissues), oral cytology, light-based detection and oral spectroscopy, blood or saliva analysis (which test for the presence of biomarkers in blood or saliva). Two review authors independently screened titles and abstracts for relevance. Eligibility, data extraction and quality assessment were carried out by at least two authors, independently and in duplicate. Studies were assessed for methodological quality using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). Meta-analysis was used to combine the results of studies for each index test using the bivariate approach to estimate the expected values of sensitivity and specificity. This update included 63 studies (79 datasets) published between 1980 and 2020 evaluating 7942 lesions for the quantitative meta-analysis. These studies evaluated the diagnostic accuracy of conventional oral examination with: vital staining (22 datasets), oral cytology (24 datasets), light-based detection or oral spectroscopy (24 datasets). Nine datasets assessed two combined index tests. There were no eligible diagnostic accuracy studies evaluating blood or salivary sample analysis. Two studies were classed as being at low risk of bias across all domains, and 33 studies were at low concern for applicability across the three domains, where patient selection, the index test, and the reference standard used were generalisable across the population attending secondary care. The summary estimates obtained from the meta-analysis were: - vital staining: sensitivity 0.86 (95% confidence interval (CI) 0.79 to 0.90) specificity 0.68 (95% CI 0.58 to 0.77), 20 studies, sensitivity low-certainty evidence, specificity very low-certainty evidence; - oral cytology: sensitivity 0.90 (95% CI 0.82 to 0.94) specificity 0.94 (95% CI 0.88 to 0.97), 20 studies, sensitivity moderate-certainty evidence, specificity moderate-certainty evidence; - light-based: sensitivity 0.87 (95% CI 0.78 to 0.93) specificity 0.50 (95% CI 0.32 to 0.68), 23 studies, sensitivity low-certainty evidence, specificity very low-certainty evidence; and - combined tests: sensitivity 0.78 (95% CI 0.45 to 0.94) specificity 0.71 (95% CI 0.53 to 0.84), 9 studies, sensitivity very low-certainty evidence, specificity very low-certainty evidence. At present none of the adjunctive tests can be recommended as a replacement for the currently used standard of a surgical biopsy and histological assessment. Given the relatively high values of the summary estimates of sensitivity and specificity for oral cytology, this would appear to offer the most potential. Combined adjunctive tests involving cytology warrant further investigation. Potentially eligible studies of blood and salivary biomarkers were excluded from the review as they were of a case-control design and therefore ineligible. In the absence of substantial improvement in the tests evaluated in this updated review, further research into biomarkers may be warranted.

Tests to detect and inform the diagnosis of root caries.

Root caries is a well-recognised disease, with increasing prevalence as populations age and retain more of their natural teeth into later life. Like coronal caries, root caries can be associated with pain, discomfort, tooth loss, and contribute significantly to poorer oral health-related quality of life in the elderly. Supplementing the visual-tactile examination could prove beneficial in improving the accuracy of early detection and diagnosis. The detection of root caries lesions at an early stage in the disease continuum can inform diagnosis and lead to targeted preventive therapies and lesion arrest. To assess the diagnostic test accuracy of index tests for the detection and diagnosis of root caries in adults, used alone or in combination with other tests. Cochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 31 December 2018); Embase Ovid (1980 to 31 December 2018); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 31 December 2018); and the World Health Organization International Clinical Trials Registry Platform (to 31 December 2018). We studied reference lists as well as published systematic review articles. We included diagnostic accuracy study designs that compared one or more index tests (laser fluorescence, radiographs, visual examination, electronic caries monitor (ECM), transillumination), either independently or in combination, with a reference standard. This included prospective studies that evaluated the diagnostic accuracy of single index tests and studies that directly compared two or more index tests. In vitro and in vivo studies were eligible for inclusion but studies that artificially created carious lesions were excluded. Two review authors extracted data independently and in duplicate using a standardised data extraction and quality assessment form based on the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) specific to the review context. Estimates of diagnostic test accuracy were expressed as sensitivity and specificity with 95% confidence intervals (CI) for each dataset. We planned to use hierarchical models for data synthesis and explore potential sources of heterogeneity through meta-regression. Four cross-sectional diagnostic test accuracy studies providing eight datasets with data from 4997 root surfaces were analysed. Two in vitro studies evaluated secondary root caries lesions on extracted teeth and two in vivo studies evaluated primary root caries lesions within the oral cavity. Four studies evaluated laser fluorescence and reported estimates of sensitivity ranging from 0.50 to 0.81 and specificity ranging from 0.40 to 0.80. Two studies evaluated radiographs and reported estimates of sensitivity ranging from 0.40 to 0.63 and specificity ranging from 0.31 to 0.80. One study evaluated visual examination and reported sensitivity of 0.75 (95% CI 0.48 to 0.93) and specificity of 0.38 (95% CI 0.14 to 0.68). One study evaluated the accuracy of radiograph and visual examination in combination and reported sensitivity of 0.81 (95% CI 0.54 to 0.96) and specificity of 0.54 (95% CI 0.25 to 0.81). Given the small number of studies and important differences in the clinical and methodological characteristics of the studies we were unable to pool the results. Consequently, we were unable to formally evaluate the comparative accuracy of the different tests considered in this review. Using QUADAS-2 we judged all four studies to be at overall high risk of bias, but only two to have applicability concerns (patient selection domain). Reasons included bias in the selection process, use of post hoc (data driven) positivity thresholds, use of an imperfect reference standard, and use of extracted teeth. We downgraded the certainty of the evidence due to study limitations and serious imprecision of the results (downgraded two levels), and judged the certainty of the evidence to be very low. Visual-tactile examination is the mainstay of root caries detection and diagnosis; however, due to the paucity of the evidence base and the very low certainty of the evidence we were unable to determine the additional benefit of adjunctive diagnostic tests for the detection and diagnosis of root caries.

Screening tests for active pulmonary tuberculosis in children

Objectives This is a protocol for a Cochrane Review (diagnostic). The objectives are as follows: To determine the sensitivity, specificity, and positive and negative predictive value of 1) the presence of one or more tuberculosis symptoms, or symptom combinations; 2) chest radiography; 3) Xpert MTB/RIF; 4) Xpert Ultra; and 5) combinations of the aforementioned tests as screening tests for detecting active pulmonary tuberculosis in children in the following groups. Household contacts of a person with active tuberculosis; School contacts of a person with active tuberculosis; Other close contacts of a person with active tuberculosis; Children living with HIV; Children with pneumonia; Other risk groups (e.g. children with a history of previous tuberculosis, malnourished children); Children in the general population in high burden settings Secondary objectives To compare the accuracy of the different index tests, including different applications of tests (e.g. CXR with any abnormality versus, more specifically, CXR with abnormality suggestive of tuberculosis); we are interested in the accuracy of the index tests in any setting (i.e. community, outpatient, and inpatient). To investigate potential sources of heterogeneity in accuracy estimates in relation to age group, HIV status, whether the study was conducted in a high tuberculosis burden country, and whether the child received a single screening or more than one screening.

Tests to detect and inform the diagnosis of caries

Background Root caries is a well-recognised disease, with increasing prevalence as populations age and retain more of their natural teeth into later life. Like coronal caries, root caries can be associated with pain, discomfort, tooth loss, and contribute significantly to poorer oral health-related quality of life in the elderly. Supplementing the visual-tactile examination could prove beneficial in improving the accuracy of early detection and diagnosis. The detection of root caries lesions at an early stage in the disease continuum can inform diagnosis and lead to targeted preventive therapies and lesion arrest. Objectives To assess the diagnostic test accuracy of index tests for the detection and diagnosis of root caries in adults, used alone or in combination with other tests. Search methods Cochrane Oral Health's Information Specialist undertook a search of the following databases: MEDLINE Ovid (1946 to 31 December 2018); Embase Ovid (1980 to 31 December 2018); US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov, to 31 December 2018); and the World Health Organization International Clinical Trials Registry Platform (to 31 December 2018). We studied reference lists as well as published systematic review articles. Selection criteria We included diagnostic accuracy study designs that compared one or more index tests (laser fluorescence, radiographs, visual examination, electronic caries monitor (ECM), transillumination), either independently or in combination, with a reference standard. This included prospective studies that evaluated the diagnostic accuracy of single index tests and studies that directly compared two or more index tests. In vitro and in vivo studies were eligible for inclusion but studies that artificially created carious lesions were excluded. Data collection and analysis Two review authors extracted data independently and in duplicate using a standardised data extraction and quality assessment form based on the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) specific to the review context. Estimates of diagnostic test accuracy were expressed as sensitivity and specificity with 95% confidence intervals (CI) for each dataset. We planned to use hierarchical models for data synthesis and explore potential sources of heterogeneity through meta-regression. Main results Four cross-sectional diagnostic test accuracy studies providing eight datasets with data from 4997 root surfaces were analysed. Two in vitro studies evaluated secondary root caries lesions on extracted teeth and two in vivo studies evaluated primary root caries lesions within the oral cavity. Four studies evaluated laser fluorescence and reported estimates of sensitivity ranging from 0.50 to 0.81 and specificity ranging from 0.40 to 0.80. Two studies evaluated radiographs and reported estimates of sensitivity ranging from 0.40 to 0.63 and specificity ranging from 0.31 to 0.80. One study evaluated visual examination and reported sensitivity of 0.75 (95% CI 0.48 to 0.93) and specificity of 0.38 (95% CI 0.14 to 0.68). One study evaluated the accuracy of radiograph and visual examination in combination and reported sensitivity of 0.81 (95% CI 0.54 to 0.96) and specificity of 0.54 (95% CI 0.25 to 0.81). Given the small number of studies and important differences in the clinical and methodological characteristics of the studies we were unable to pool the results. Consequently, we were unable to formally evaluate the comparative accuracy of the different tests considered in this review. Using QUADAS-2 we judged all four studies to be at overall high risk of bias, but only two to have applicability concerns (patient selection domain). Reasons included bias in the selection process, use of post hoc (data driven) positivity thresholds, use of an imperfect reference standard, and use of extracted teeth. We downgraded the certainty of the evidence due to study limitations and serious imprecision of the results (downgraded two levels), and judged the certainty of the evidence to be very low. Authors' conclusions Visual-tactile examination is the mainstay of root caries detection and diagnosis; however, due to the paucity of the evidence base and the very low certainty of the evidence we were unable to determine the additional benefit of adjunctive diagnostic tests for the detection and diagnosis of root caries.

123I-MIBG scintigraphy and 18F-FDG-PET imaging for diagnosing neuroblastoma.

123I-MIBG scintigraphy and 18F-FDG-PET imaging for diagnosing neuroblastoma.

Diagnostic tests for oral cancer and potentially malignant disorders in patients presenting with clinically evident lesions.

Oral squamous cell carcinoma is the most common form of malignancy of the lip and oral cavity, often being proceeded by potentially malignant disorders (PMD). Early detection can reduce the malignant transformation of PMD and can improve the survival rate for oral cancer. The current standard of scalpel biopsy with histology is painful for patients and involves a delay whilst histology is completed; other tests are available that are unobtrusive and provide immediate results. To estimate the diagnostic accuracy of index tests for the detection of oral cancer and PMD of the lip and oral cavity, in people presenting with clinically evident lesions. To estimate the relative accuracy of the different index tests. The electronic databases were searched on 30 April 2013. We searched MEDLINE (OVID) (1946 to April 2013) and four other electronic databases (the Cochrane Diagnostic Test Accuracy Studies Register, the Cochrane Oral Health Group's Trials Register, EMBASE (OVID) and MEDION (Ovid)). There were no restrictions on language in the searches of the electronic databases. We conducted citation searches and screened reference lists of included studies for additional references. We selected studies that reported the diagnostic test accuracy of the following index tests when used as an adjunct to conventional oral examination in detecting PMD or oral squamous cell carcinoma of the lip or oral cavity: vital staining, oral cytology, light-based detection and oral spectroscopy, blood or saliva analysis (which test for the presence of biomarkers in blood or saliva). Two review authors independently screened titles and abstracts for relevance. Eligibility, data extraction and quality assessment were carried out by at least two authors, independently and in duplicate. Studies were assessed for methodological quality using QUADAS-2. Meta-analysis was used to combine the results of studies for each index test using the bivariate approach to estimate the expected values of sensitivity and specificity. We included 41 studies, recruiting 4002 participants, in this review. These studies evaluated the diagnostic accuracy of conventional oral examination with: vital staining (14 studies), oral cytology (13 studies), light-based detection or oral spectroscopy (13 studies). Six studies assessed two combined index tests. There were no eligible diagnostic accuracy studies evaluating blood or salivary sample analysis.The summary estimates for vital staining obtained from the meta-analysis were sensitivity of 0.84 (95% CI 0.74 to 0.90) with specificity of 0.70 (0.59 to 0.79), with 14 studies were included in the meta-analysis. For cytology, sensitivity was 0.91 (0.81 to 0.96) and specificity was 0.91 (0.81 to 0.95) with 12 studies included in the meta-analysis. For light-based detection, sensitivity was 0.91 (0.77 to 0.97) and specificity was 0.58 (0.22 to 0.87) with 11 studies included in the meta-analysis. The relative test accuracy was assessed by adding covariates to the bivariate analysis, no difference in model fit was observed. The overall quality of the included studies was poor. None of the adjunctive tests can be recommended as a replacement for the currently used standard of a scalpel biopsy and histological assessment. Given the relatively high values of the summary estimates of sensitivity and specificity for cytology, this would appear to offer the most potential. Combined adjunctive tests involving cytology warrant further investigation.

Evaluating PET‐CT in the detection and management of recurrent cervical cancer: systematic reviews of diagnostic accuracy and subjective elicitation

Positron emission tomography-computed tomography (PET-CT) is recommended to triage women for exenterative surgery and surveillance after treatment for advanced cervical cancer. To evaluate diagnostic accuracy of additional whole body PET-CT compared with CT/magnetic resonance imaging (MRI) alone in women with suspected recurrent/persistent cervical cancer and in asymptomatic women as surveillance. Systematic reviews. Subjective elicitation to supplement diagnostic information. Searches of electronic databases were performed to June 2013. Studies in women with suspected recurrent/persistent cervical cancer and in asymptomatic women undergoing follow up with sufficient numeric data were included. We calculated sensitivity, specificity and corresponding 95% confidence intervals. Meta-analyses employed a bivariate model that included a random-effects term for between-study variations (CT studies) and univariate random effects meta-analyses (PET-CT studies) for sensitivity and specificity separately. Prevalence of recurrence and the accuracy of imaging elicited using the allocation of points technique. Coherence of elicited subjective probabilities with estimates in the literature examined. We identified 15 relevant studies; none directly compared additional PET-CT with MRI or CT separately. Most CT and MRI studies used older protocols and the majority did not distinguish between asymptomatic and symptomatic women. Meta-analysis of nine PET-CT studies in mostly symptomatic women showed sensitivity of 94.8 (95% CI 91.2-96.9), and specificity of 86.9% (95% CI 82.2-90.5). The summary estimate of the sensitivity of CT for detection of recurrence was 89.64% (95% CI 81.59-94.41) and specificity was 76% (95% CI 43.68-92.82). Meta-analysis for MRI test accuracy studies was not possible because of clinical heterogeneity. The sensitivity and specificity of MRI in pelvic recurrence varied between 82 and 100% and between 78 and 100%, respectively. Formal statistical comparisons of the accuracy of index tests were not possible. Subjective elicitation provided estimates comparable to the literature. Subjective estimates of the increase in accuracy from the addition of PET-CT were less than elicited increases required to justify the use in PET-CT for surveillance. Evidence to support additional PET-CT is scarce, of average quality and does not distinguish between application for surveillance and diagnosis. Guidelines recommending PET-CT in recurrent cervical cancer need to be reconsidered in the light of the existing evidence base.

Serum Isoform [−2]proPSA Derivatives Significantly Improve Prediction of Prostate Cancer at Initial Biopsy in a Total PSA Range of 2–10 ng/ml: A Multicentric European Study

BackgroundStrategies to reduce prostate-specific antigen (PSA)–driven prostate cancer (PCa) overdiagnosis and overtreatment seem to be necessary. ObjectiveTo test the accuracy of serum isoform [−2]proPSA (p2PSA) and its derivatives, percentage of p2PSA to free PSA (fPSA; %p2PSA) and the Prostate Health Index (PHI)—called index tests—in discriminating between patients with and without PCa. Design, setting, and participantsThis was an observational, prospective cohort study of patients from five European urologic centers with a total PSA (tPSA) range of 2–10 ng/ml who were subjected to initial prostate biopsy for suspected PCa. Outcome measurements and statistical analysisThe primary end point was to evaluate the specificity, sensitivity, and diagnostic accuracy of index tests in determining the presence of PCa at prostate biopsy in comparison to tPSA, fPSA, and percentage of fPSA to tPSA (%fPSA) (standard tests) and the number of prostate biopsies that could be spared using these tests. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision curve analysis. Results and limitationsOf >646 patients, PCa was diagnosed in 264 (40.1%). Median tPSA (5.7 vs 5.8 ng/ml; p=0.942) and p2PSA (15.0 vs 14.7 pg/ml) did not differ between groups; conversely, median fPSA (0.7 vs 1 ng/ml; p<0.001), %fPSA (0.14 vs 0.17; p<0.001), %p2PSA (2.1 vs 1.6; p<0.001), and PHI (48.2 vs 38; p<0.001) did differ significantly between men with and without PCa. In multivariable logistic regression models, p2PSA, %p2PSA, and PHI significantly increased the accuracy of the base multivariable model by 6.4%, 5.6%, and 6.4%, respectively (all p<0.001). At a PHI cut-off of 27.6, a total of 100 (15.5%) biopsies could have been avoided. The main limitation is that cases were selected on the basis of their initial tPSA values. ConclusionsIn patients with a tPSA range of 2–10 ng/ml, %p2PSA and PHI are the strongest predictors of PCa at initial biopsy and are significantly more accurate than tPSA and %fPSA. Trial registrationThe study is registered at http://www.controlled-trials.com, ref. ISRCTN04707454.

P3-S5.03 Conflict of interest and point of care tests: an exploration of accuracy in Hepatitis C infection

BackgroundThe WHO estimates that 170 million people worldwide are infected with Hepatitis C. In the context of HIV co-infection, rapid point-of-care tests gain importance in both the developing and developed...