Quality Of Diagnostic Accuracy Studies Research Articles

Systematic review on Vitamin D supplement on hypercholesterolemia and coronary artery disease outcomes

ABSTRACT Globally, Vitamin D insufficiency is a problem that has a considerable impact on people’s health. According to recent studies, Vitamin D may potentially have positive impacts on serum lipid profiles, enhancing coronary condition. Therefore, the main aim of the present review is to examine Vitamin D supplement on hypercholesterolemia and coronary artery disease (CAD). We conducted a comprehensive literature search from 2012 to 2023, comprising Medline, Web of Science, PubMed, Cochrane Library, and additional sources such as Google Scholar and clinicaltrials.gov. We reviewed a wide range of study types, including studies, trials, commentaries, and editorials. To assess bias, we used a recommended methodology, utilizing a two-part tool to address five specific domains: Selection bias, performance bias, attrition bias, selective reporting, and other biases. We also employed a quality assessment tool for evaluating the quality of diagnostic accuracy studies. In this review, we incorporated 11 studies. The mean age of the cases was 60.11 years. The Vitamin D supplement mean dose was 8772.42 IU/day. The Vitamin D supplement group showed mean variations in high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TAG) cholesterol, and total cholesterol levels of 3.3 mg/dl, 8.6 mg/dl, 10.625 mg/dl, and 9.45 mg/dl, correspondingly. Whereas, the mean variation in HDL-C, LDL-C, TAG as well as total cholesterol levels in the placebo group was 4.185714 mg/dl, 2.60825 mg/dl, 6.50625 mg/dl, and 6.2875 mg/dl, respectively. Vitamin D supplementation demonstrated enhancements in serum levels of total cholesterol, LDL-C, HDL-C, and TAGs. Clinical tests for hypercholesterolemia should be implemented on patients at risk for heart illness and CAD, and Vitamin D supplements are beneficial. For individuals who are Vitamin D deficient, doctors may think about supplementing their routine cholesterol therapies with Vitamin D.

Predictive value of the Ranson and BISAP scoring systems for the severity and prognosis of acute pancreatitis: A systematic review and meta-analysis.

To systematically assess and compare the predictive value of the Ranson and Bedside Index of Severity in Acute Pancreatitis (BISAP) scoring systems for the severity and prognosis of acute pancreatitis (AP). PubMed, Embase, Cochrane Library, and Web of Science were systematically searched until February 15, 2023. Outcomes in this analysis included severity and prognosis [mortality, organ failure, pancreatic necrosis, and intensive care unit (ICU) admission]. The revised Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool was used to evaluate the quality of diagnostic accuracy studies. The threshold effect was evaluated for each outcome. The sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and the area under the summary receiver operating characteristic (SROC) curve (AUC) as well as 95% confidence intervals (CI) were calculated. The DeLong test was used for AUC comparisons. For the outcome evaluated by over 9 studies, publication bias was assessed using the Deeks' funnel plot asymmetry test. Totally 17 studies of 5476 AP patients were included. For severity, the pooled sensitivity of the Ranson and BISAP was 0.95 (95%CI: 0.87, 0.98) and 0.67 (95%CI: 0.27, 0.92); the pooled specificity of the Ranson and BISAP was 0.74 (0.52, 0.88) and 0.95 (95%CI: 0.85, 0.98); the pooled AUC of the Ranson and BISAP was 0.95 (95%CI: 0.93, 0.97) and 0.94 (95%CI: 0.92, 0.96) (P = 0.480). For mortality, the pooled sensitivity of the Ranson and BISAP was 0.89 (95%CI: 0.73, 0.96) and 0.77 (95%CI: 0.58, 0.89); the pooled specificity of the Ranson and BISAP was 0.79 (95%CI: 0.68, 0.87) and 0.90 (95%CI: 0.86, 0.93); the pooled AUC of the Ranson and BISAP was 0.91 (95%CI: 0.88, 0.93) and 0.92 (95%CI: 0.90, 0.94) (P = 0.480). For organ failure, the pooled sensitivity of the Ranson and BISAP was 0.84 (95%CI: 0.76, 0.90) and 0.78 (95%CI: 0.60, 0.90); the pooled specificity of the Ranson and BISAP was 0.84 (95%CI: 0.63, 0.94) and 0.90 (95%CI: 0.72, 0.97); the pooled AUC of the Ranson and BISAP was 0.86 (95%CI: 0.82, 0.88) and 0.90 (95%CI: 0.87, 0.93) (P = 0.110). For pancreatic necrosis, the pooled sensitivity of the Ranson and BISAP was 0.63 (95%CI: 0.35, 0.84) and 0.63 (95%CI: 0.23, 0.90); the pooled specificity of the Ranson and BISAP was 0.90 (95%CI: 0.77, 0.96) and 0.93 (95%CI: 0.89, 0.96); the pooled AUC of the Ranson and BISAP was 0.87 (95%CI: 0.84, 0.90) and 0.93 (95%CI: 0.91, 0.95) (P = 0.001). For ICU admission, the pooled sensitivity of the Ranson and BISAP was 0.86 (95%CI: 0.77, 0.92) and 0.63 (95%CI: 0.52, 0.73); the pooled specificity of the Ranson and BISAP was 0.58 (95%CI: 0.55, 0.61) and 0.84 (95%CI: 0.81, 0.86); the pooled AUC of the Ranson and BISAP was 0.92 (95%CI: 0.81, 1.00) and 0.86 (95%CI: 0.67, 1.00) (P = 0.592). The Ranson score was an applicable tool for predicting severity and prognosis of AP patients with reliable diagnostic accuracy in resource and time-limited settings. Future large-scale studies are needed to verify the findings.

Diagnostic and prognostic value of the HFA-PEFF score for heart failure with preserved ejection fraction: a systematic review and meta-analysis.

To assess the diagnostic and prognostic performances of the Heart Failure Association Pre-test Assessment, Echocardiography & Natriuretic Peptide, Functional Testing, Final Etiology (HFA-PEFF) score for heart failure with preserved ejection fraction (HFpEF) in a comprehensive manner. PubMed, Embase, Cochrane Library, and Web of Science were comprehensively searched from the inception to June 12, 2023. Studies using the "Rule-out" or "Rule-in" approach for diagnosis analysis or studies on cardiovascular events and all-cause death for prognosis analysis were included. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool was adopted to assess the quality of diagnostic accuracy studies. The sensitivity (SEN), specificity (SPE), positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratio (DOR), and area under the summary receiver operating characteristic (SROC) curve (AUC) were presented with 95% confidence intervals (CIs). For CVEs and all-cause death, the hazard ratio (HR) values were calculated. Fifteen studies involving 6420 subjects were included, with 9 for diagnosis analysis, and 7 for prognosis analysis. For the diagnostic performance of the HFA-PEFF score, with the "Rule-out" approach, the pooled SEN was 0.96 (95%CI: 0.94, 0.97), the pooled SPE was 0.39 (95%CI: 0.37, 0.42), and the pooled AUC was 0.85 (95%CI: 0.67, 1.00), and with the "Rule-in" approach, the pooled SEN was 0.59 (95%CI: 0.56, 0.61), the pooled SPE was 0.86 (95%CI: 0.84, 0.88), and the pooled AUC was 0.83 (95%CI: 0.79, 0.87). For the predictive performance of the HFA-PEFF score, regarding CVEs, the pooled SEN was 0.63 (95%CI: 0.58, 0.67), the pooled SPE was 0.53 (95%CI: 0.49, 0.58), and the pooled AUC was 0.65 (95%CI: 0.40, 0.90), and concerning All-cause death, the pooled SEN was 0.85 (95%CI: 0.81, 0.88), the pooled SPE was 0.48 (95%CI: 0.44, 0.52), and the pooled AUC was 0.65 (95%CI: 0.47, 0.83). A higher HFA-PEFF score was associated with a higher risk of all-cause death (HR 1.390, 95%CI 1.240, 1.558, P < 0.001). The HFA-PEFF score might be applied in HFpEF diagnosis and all-cause death prediction. More studies are required for finding validation.

A systematic review of screening diagnostic tools for trigeminal neuralgia.

Trigeminal neuralgia (TN) is a rare chronic neuropathic pain condition of sudden and severe pain, often described as an electric shock. Diagnosis is challenging for non-expert clinicians, particularly in primary care settings. We wanted to identify and assess the diagnostic accuracy of existing screening tools for TN and orofacial pain that could be used to support the diagnosis of TN in primary care. We searched key databases (MEDLINE, ASSIA, Embase, and Web of Knowledge and PsycINFO) supplemented by citation tracking from January 1988 to 2021. We used an adapted version of the Quality of Diagnostic Accuracy Studies (QUADAS-2) to assess the methodological quality of each study. Searches identified five studies, from the UK, USA and Canada; three validated self-report questionnaires; and two artificial neural networks. All screened for multiple orofacial pain diagnoses, including dentoalveolar pain, musculoskeletal pain (temporomandibular disorders) and neurological pain (trigeminal neuralgia, headache, atypical facial pain and postherpetic neuralgia). The overall quality assessment was low for one study. Diagnosis of TN can be challenging for non-expert clinicians. Our review found few existing screening tools to diagnose TN, and none is currently suitable to be used in primary care settings. This evidence supports the need to adapt an existing tools or to create a new tool for this purpose. The development of an appropriate screening questionnaire could assist non-expert dental and medical clinicians to identify TN more effectively and empower them to manage or refer patients for treatment more effectively.

Meta-Analysis of Lung Ultrasound Scores for Early Prediction of Bronchopulmonary Dysplasia.

Rationale: Lung ultrasound scores (LUS) might be useful in monitoring neonates with chronic pulmonary insufficiency of prematurity and in predicting bronchopulmonary dysplasia (BPD). Given their ease of use, accuracy, and lack of invasiveness, LUS have been the subject of several recent studies. Objectives: We sought to clarify whether LUS provide an accurate and early (within the first 2 wk of life) prediction of BPD in preterm infants of gestational age ⩽32 weeks. Methods: This was a systematic review and diagnostic accuracy meta-analysis following PRISMA-P (Preferred Reporting Items for Systematic review and Meta-Analysis Protocols), PRISMA (Preferred Reporting Items for Systematic review and Meta-Analysis), and QUADAS (QUAlity of Diagnostic Accuracy Studies) guidelines. Studies designed to predict BPD in the first 2 weeks of life using LUS were selected. A classical LUS (calculated for 6 chest areas) and its extended version (eLUS, 10 chest areas) were tested. Results: Seven studies (1,027 neonates) were meta-analyzed. LUS and eLUS showed good diagnostic accuracy in predicting BPD at 7 and 14 days of life (area under the curve, 0.85-0.87; pooled sensitivity, 70-80%; pooled specificity, 80-87%). The diagnostic accuracy of LUS and eLUS did not differ at any time point (area under the curve difference always P > 0.05). Repeating the analyses without outliers or with moderate to severe BPD as the outcome yielded similar results. Meta-regressions showed that prenatal steroid prophylaxis and sex were not significant effect confounders. Conclusions: LUS are accurate for early prediction of BPD and moderate to severe BPD, in an average population of preterm infants ⩽32 weeks' gestation. The diagnostic accuracy is similar for LUS and eLUS, so the use of the simpler score should be advocated. Registration: PROSPERO CRD42021233010.

EEG Patterns and Outcomes After Hypoxic Brain Injury: A Systematic Review and Meta-analysis.

Electroencephalography (EEG) is used to prognosticate recovery in comatose patients with hypoxic ischemic brain injury (HIBI) secondary to cardiac arrest. We sought to determine the prognostic use of specific EEG patterns for predicting disability and death following HIBI secondary to cardiac arrest. This systematic review searched Medline, Embase, and Cochrane Central up to January 2020. We included original research involving prospective and retrospective cohort studies relating specific EEG patterns to disability and death in comatose adult patients suffering HIBI post cardiac arrest requiring admission to an intensive care setting. We evaluated study quality using the Quality of Diagnostic Accuracy Studies 2 tool. Descriptive statistics were used to summarize study, patient, and EEG characteristics. We pooled study-level estimates of sensitivity and specificity for EEG patterns defined a priori using a random effect bivariate and univariate meta-analysis when appropriate. Funnel plots were used to assess publication bias. Of 5191 abstracts, 333 were reviewed in full text, of which 57 were included in the systematic review and 32 in meta-analyses. No reported EEG pattern was found to be invariably associated with death or disability across all studies. Pooled specificities of status epilepticus, burst suppression, and electrocerebral silence were high (92-99%), but sensitivities were low (6-39%) when predicting a composite outcome of disability and death. Study quality varied depending on domain; patient flow and timing performed was well conducted in all, whereas EEG interpretation was retrospective in 17 of 39 studies. Accounting for variable study quality, EEG demonstrates high specificity with a low risk of false negative outcome attribution for disability and death when status epilepticus, burst suppression, or electrocerebral silence is detected. Increased use of standardized cross-study protocols and definitions of EEG patterns are required to better evaluate the prognostic use of EEG for comatose patients with HIBI following cardiac arrest.

A Systematic Review of Clinical Vestibular Symptom Triage, Tools, and Algorithms.

The evaluation of peripheral vestibular disorders in clinical practice is an especially difficult endeavor, particularly for the inexperienced clinician. The goal of this systematic review is thus to evaluate the design, approaches, and outcomes for clinical vestibular symptom triage and decision support tools reported in contemporary published literature. A comprehensive search of existing literature in August 2020 was conducted using MEDLINE, CINAHL, and EMBASE using terms of desired diagnostic tools such as algorithm, protocol, and questionnaire as well as an exhaustive set of terms to encompass vestibular disorders. Study characteristics, tool metrics, and performance were extracted using a standardized form. Quality assessment was conducted using a modified version of the Quality of Diagnostic Accuracy Studies 2 (QUADAS-2) assessment tool. A total of 18 articles each reporting a novel tool for the evaluation of vestibular disorders were identified. Tools were organized into 3 discrete categories, including self-administered questionnaires, health care professional administered tools, and decision support systems. Most tools could differentiate between specific vestibular pathologies, with outcome measures including sensitivity, specificity, and accuracy. A multitude of tools have been published to aid with the evaluation of vertiginous patients. Our systematic review identified several low-evidence reports of triage and decision support tools for the evaluation of vestibular disorders.

How to diagnose and measure primary hyperhidrosis: a systematic review of the literature.

Hyperhidrosis (i.e. excessive sweating) is diagnosed from patient medical history and physical examination. In addition, focal sweat measurements can substantiate the hyperhidrosis diagnosis. Likewise, the impact of living with hyperhidrosis can be assessed with patient-reported outcome measures. However, no consensus exists on how to diagnose hyperhidrosis, how to quantify the disease, or how to measure the impact hyperhidrosis has on patients. Therefore, the objective of this review was to summarize the literature on diagnostic criteria, focal sweat measurement methods, and patient-reported outcome measures of hyperhidrosis. A literature search of Cochrane Library, Embase, and PubMed was conducted. Studies that included and aimed at developing or validating hyperhidrosis diagnostic criteria, focal sweat measurement methods, or patient-reported outcome measures for individuals with hyperhidrosis were eligible for inclusion. The methodological quality of diagnostic accuracy studies about focal sweat measurement methods was determined using the Quality Assessment of Diagnostic Accuracy Studies-2. Overall, 33 studies were included. We identified two sets of hyperhidrosis diagnostic criteria, one scale for assessment of severity of hyperhidrosis sweating, four focal sweat measurement methods, and 15 patient-reported outcome measures. The algorithm for diagnosing hyperhidrosis and focal sweat measurement methods needs validation in large cohorts. Most patient-reported outcome measures for hyperhidrosis are not adequately validated. A potential solution is to develop a core outcome set that can standardize outcomes reported in clinical trials.

Reporting and Assessing the Quality of Diagnostic Accuracy Studies for Cervical Cancer Screening and Management.

We adapted the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool for studies of cervical cancer screening and management and used the adapted tool to evaluate the quality of studies included in a systematic review supporting the 2019 Risk-Based Management Consensus Guidelines. We evaluated the quality of all studies included in our systematic review for postcolposcopy (n = 5) and posttreatment (n = 23) surveillance using QUADAS-2 criteria. Subsequently, we adapted signaling questions to indications of cervical cancer screening and management. An iterative process was carried out to evaluate interrater agreement between 2 study authors (M.A.C. and N.W.). Discrepant ratings were discussed, and criteria were adapted accordingly. We also evaluated the influence of study quality on risk estimates and between study variation using stratified subgroup meta-analyses. Twelve signaling questions for bias assessment that were adapted to or newly developed for cervical cancer screening and management are described here. Interrater agreement on bias assessment increased from 70% to 83% during the adaptation process. Detailed assessment of bias and applicability showed that all studies on postcolposcopy management and 90% of studies on posttreatment management had high risk of bias in at least 1 domain. Most commonly, high risk of bias was observed for the patient selection domain, indicating the heterogeneity of study designs and clinical practice in reported studies. The adapted QUADAS-2 will have broad application for researchers, evidence evaluators, and journals who are interested in designing, conducting, evaluating, and publishing studies for cervical cancer screening and management.

Reporting Quality of Diagnostic Accuracy Studies in Laboratory Medicine: Adherence to Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015.

BackgroundPoor reporting quality in diagnostic accuracy studies hampers an adequate judgment of the validity of the study. The Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was published to improve the reporting quality of diagnostic accuracy studies. This study aimed to evaluate the adherence of diagnostic accuracy studies published in Annals of Laboratory Medicine (ALM) to STARD 2015 and to identify directions for improvement in the reporting quality of these studies.MethodsTwo independent authors assessed articles published in ALM between 2012–2018 for compliance with 30 STARD 2015 checklist items to identify all eligible diagnostic accuracy studies published during this period. We included 66 diagnostic accuracy studies. A total of the fulfilled STARD items were calculated, and adherence was analyzed on an individual-item basis.ResultsThe overall mean±SD number of STARD items reported for the included studies was 11.2±2.7. Only five (7.6%) studies adhered to more than 50% of the 30 items. No study satisfied more than 80% of the items. Large variability in adherence to reporting standards was detected across items, ranging from 0% to 100%.ConclusionsAdherence to STARD 2015 is suboptimal among diagnostic accuracy studies published in ALM. Our study emphasizes the necessity of adherence to STARD to improve the reporting quality of future diagnostic accuracy studies to be published in ALM.

Bedside tests for predicting difficult airways: an abridged Cochrane diagnostic test accuracy systematic review.

Although bedside screening tests are routinely used to identify people at high risk of having a difficult airway, their clinical utility is unclear. We estimated the diagnostic accuracy of commonly used bedside examination tests for assessing the airway in adult patients without apparent anatomical abnormalities scheduled to undergo general anaesthesia. We searched for studies that reported our pre-specified bedside index screening tests against a reference standard, published in any language, from date of inception to 16 December 2016, in seven bibliographic databases. We included 133 studies (127 cohort type and 6 case-control) involving 844,206 participants. Overall, their methodological quality (according to QUADAS-2, a standard tool for assessing quality of diagnostic accuracy studies) was moderate to high. Our pre-specified tests were: the Mallampati test (6 studies); modified Mallampati test (105 studies); Wilson risk score (6 studies); thyromental distance (52 studies); sternomental distance (18 studies); mouth opening test (34 studies); and the upper lip bite test (30 studies). Difficult facemask ventilation, difficult laryngoscopy, difficult intubation and failed intubation were the reference standards in seven, 92, 50 and two studies, respectively. Across all reference standards, we found all index tests had relatively low sensitivities, with high variability, but specificities were consistently and markedly higher than sensitivities. For difficult laryngoscopy, the sensitivity and specificity (95%CI) of the upper lip bite test were 0.67 (0.45-0.83) and 0.92 (0.86-0.95), respectively; upper lip bite test sensitivity (95%CI) was significantly higher than that for the mouth opening test (0.22, 0.13-0.33; p<0.001). For difficult tracheal intubation, the modified Mallampati test had a significantly higher sensitivity (95%CI) at 0.51 (0.40-0.61) compared with mouth opening (0.27, 0.16-0.41; p<0.001) and thyromental distance (0.24, 0.12-0.43; p<0.001). Although the upper lip bite test showed the most favourable diagnostic test accuracy properties, none of the common bedside screening tests is well suited for detecting unanticipated difficult airways, as many of them are missed.

Design, statistical analysis and reporting standards for test accuracy studies for infectious diseases in animals: Progress, challenges and recommendations

The quality of diagnostic accuracy studies (DAS) for infectious diseases of animals has improved over the last 20 years because of international educational efforts, use of design and reporting standards to guide researchers and test developers, and acceptance of the use of latent class models to account for imperfect reference tests. In this review, we focus on measurement of diagnostic sensitivity and specificity as a measure of clinical validity, describe the leadership role of the World Organisation of Animal Health (OIE) in setting standards for test validation in the context of fitness-for-purpose, and describe how design and reporting quality have facilitated the increased use of systematic reviews and meta-analysis of DAS. Ongoing challenges for design, conduct, analysis and reporting of DAS are identified; and we make recommendations for improvements in these areas for OIE-listed and non-listed infectious diseases.

Moving Beyond Diagnostic Accuracy With Systematic Reviews and Meta-analyses.

Moving Beyond Diagnostic Accuracy With Systematic Reviews and Meta-analyses.

Diagnostic and classification tools for chronic headache disorders: A systematic review.

Background or aimDespite guidelines and the International Classification of Headache Disorders (ICHD-III beta) criteria, the diagnosis of common chronic headache disorders can be challenging for non-expert clinicians. The aim of the review was to identify headache classification tools that could be used by a non-expert clinician to classify common chronic disorders in primary care.MethodsWe conducted a systematic literature review of studies validating diagnostic and classification headache tools published between Jan 1988 and June 2016 from key databases: MEDLINE, ASSIA, Embase, Web of Knowledge and PsycINFO. Quality assessment was assessed using items of the Quality of Diagnostic Accuracy Studies (QUADAS-2).ResultsThe search identified 38 papers reporting the validation of 30 tools designed to diagnose, classify or screen for headache disorders; nine for multiple headache types, and 21 for one headache type only. We did not identify a tool validated in a primary care that can be used by a non-expert clinician to classify common chronic headache disorders and screen for primary headaches other than migraine and tension-type headache in primary care.ConclusionsDespite the availability of many headache classification tools we propose the need for a tool that could support primary care clinicians in diagnosing and managing chronic headache disorders within primary care, and allow more targeted referral to headache specialists.

ACCURACY OF THE LEVER SIGN TO DIAGNOSE ANTERIOR CRUCIATE LIGAMENT TEAR: A SYSTEMATIC REVIEW WITH META-ANALYSIS

The Lever sign has gained recent notoriety for its purported anterior cruciate ligament (ACL) diagnostics and simplicity of performance. The purpose of this systematic review with meta-analysis is to summarize the diagnostic accuracy of the Lever sign for use during assessment of the knee for an ACL tear in subjects with suspected acute and chronic knee injury. Systematic review with meta-analysis. A computer-assisted literature search of MEDLINE, CINAHL, and EMBASE databases using keywords related to diagnostic accuracy of the knee joint. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used for the search and reporting phases of the study. Quality assessment of bias and applicability was conducted using the Quality of Diagnostic Accuracy Studies (QUADAS). Mixed effects models were used to summarize accuracy. Eight articles, with only two demonstrating high quality, were included. Six of the articles were included in a meta-analysis. Diagnostic values, utilizing arthroscopy as a gold standard, were: pooled SN 0.55 (95% CI 0.22 to 0.84), pooled SP 0.89 (95% CI 0.44 to 0.99), positive likelihood ratio (+LR) 9.2 (95% CI 0.70 to 46.1), negative likelihood ratio (-LR) 0.58 (95% CI 0.18 to 1.28). Post-test probability with a positive finding (57% sampling prevalence) reached 92% (95% CI 83 to 97%). Post-test probability with a negative finding (57% sampling prevalence) reached 43% (95% CI 39 to 47%). Based on limited evidence of heterogeneous methodological quality, the Lever sign can moderately change post-test probability to rule in an ACL tear. These results should be interpreted cautiously due to a limited number of studies, with small sample sizes and study quality affecting test accuracy. Future investigation should be expanded to include additional high-quality studies examining diverse clinical contexts, as they become available, to enable a more comprehensive clinical examination of this test. 3aPROSPERO Registration # CRD42018084954.

Design standards for experimental and field studies to evaluate diagnostic accuracy of tests for infectious diseases in aquatic animals.

Design and reporting quality of diagnostic accuracy studies (DAS) are important metrics for assessing utility of tests used in animal and human health. Following standards for designing DAS will assist in appropriate test selection for specific testing purposes and minimize the risk of reporting biased sensitivity and specificity estimates. To examine the benefits of recommending standards, design information from published DAS literature was assessed for 10 finfish, seven mollusc, nine crustacean and two amphibian diseases listed in the 2017 OIE Manual of Diagnostic Tests for Aquatic Animals. Of the 56 DAS identified, 41 were based on field testing, eight on experimental challenge studies and seven on both. Also, we adapted human and terrestrial-animal standards and guidelines for DAS structure for use in aquatic animal diagnostic research. Through this process, we identified and addressed important metrics for consideration at the design phase: study purpose, targeted disease state, selection of appropriate samples and specimens, laboratory analytical methods, statistical methods and data interpretation. These recommended design standards for DAS are presented as a checklist including risk-of-failure points and actions to mitigate bias at each critical step. Adherence to standards when designing DAS will also facilitate future systematic review and meta-analyses of DAS research literature.

A Systematic Review of the Methods of Diagnostic Accuracy Studies of the Afirma Gene Expression Classifier.

The Afirma® Gene Expression Classifier (GEC) risk stratifies The Bethesda System for the Reporting of Thyroid Cytopathology class III/IV (indeterminate) thyroid nodules (ITNs) as suspicious for malignancy or benign. Several authors have published studies describing the diagnostic accuracy of the GEC. However, the quality of these methods has not been rigorously examined. In this study, MEDLINE and EMBASE were searched for studies published between January 1, 2010, and June 30, 2016, examining the sensitivity, specificity, negative predictive value, and positive predictive value of the GEC. The Quality of Diagnostic Accuracy Studies 2 was customized to evaluate the methods of included studies in each of four domains: nodule selection, index test execution, reference standard assignment, and flow and timing. Signaling questions were used to identify sources of potential bias in calculation of diagnostic accuracy, and issues of applicability were assessed. Three panelists applied the Quality of Diagnostic Accuracy Studies 2 tool to each study included, and divergence was resolved in conference. In 12 studies evaluated, the most common methodologic flaw was lack of reference standard diagnosis assignment to un-excised GEC-benign ITNs. Exclusion of these ITNs from the analyses resulted in unreliable estimates of specificity and negative predictive value. Other flaws identified included restriction to ITNs that had already been selected for referral for thyroidectomy or lobectomy. Future studies should define and assign a "true negative" label to GEC-benign nodules that do not develop malignant signs or symptoms during a pre-specified period of follow-up, and these nodules should be included in calculations of diagnostic accuracy.

Assessment of Adherence to the STARD Statement for the Quality of Reports on Diagnostic Studies Published on the Iranian Journal of Radiology

Background: Standards for the Reporting of diagnostic accuracy studies (STARD) statement was developed to improve the accuracy and completeness of reporting of studies of diagnostic accuracy. It allows readers evaluate the internal and external validity and enable readers to assess the potential for bias in the study and the generalizability of the results. Objectives: Up to date, few data exist about the quality of diagnostic accuracy studies in Iran. Therefore, we evaluated the extent of adherence to the STARD for the quality of reports on diagnostic accuracy studies in the Iranian journal of radiology. Methods: In this cross-sectional descriptive study, we searched Iranian journal of radiology and retrieved all diagnostic accuracy studies for recent 3 years and evaluated their adherence to STARD. We used STARD checklist (version January 2003) available at www.stard-statement.org Results: We identified about 14 potential diagnostic accuracy studies meeting our inclusion criteria. In this preliminary study 50% identified the article as diagnostic accuracy study in the title or abstract (MeSH heading sensitivity and specificity). 4% reported details of blinding. 3% had a flow diagram. 38% described the number, training and expertise of the persons reading the index tests and the reference standard. 25% reported definition of cutoffs and/or categories of the results of the index tests and the reference standard. Only 40% of the reports of diagnostic evaluations reported precision for the estimates of diagnostic accuracy. The occurrence of uninterpretable, indeterminate and intermediate test results were 30%. The report time interval from the index tests to the reference standard was 40%. Only 40% of articles reported on more than 50% of STARD items, while no articles reported on more than 85%. A flow chart was presented in 3 articles. Assessment of reporting on individual items of the STARD statement revealed wide variation, with some items described in 15% of articles and others in 100%. Mean STARD score (0 - 25 points available) was 14.8 (range, 5.5 19.5). Conclusions: These findings show non-adherence to the STARD. The authors, reviewers, and editors should pay more attention to reporting by checking STARD statement items and including a flow diagram to represent study design and patient flow.

Diagnostic Accuracy of Imaging Modalities and Injection Techniques for the Diagnosis of Femoroacetabular Impingement/Labral Tear: A Systematic Review With Meta-analysis

Background: Diagnosing femoroacetabular impingement/acetabular labral tear (FAI/ALT) and subsequently making a decision regarding surgery are based primarily on diagnostic imaging and intra-articular hip joint injection techniques of unknown accuracy. Purpose: Summarize and evaluate the diagnostic accuracy and clinical utility of various imaging modalities and injection techniques relevant to hip FAI/ALT. Study Design: Systematic review with meta-analysis. Methods: A computer-assisted literature search was conducted of MEDLINE, CINAHL, and EMBASE databases using keywords related to diagnostic accuracy of hip joint pathologic changes. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for the search and reporting phases of the study. Quality assessment of bias and applicability was conducted using the Quality of Diagnostic Accuracy Studies (QUADAS) tool. Random effects models were used to summarize sensitivities (SN), specificities (SP), likelihood ratios (+LR and –LR), diagnostic odds ratios (DOR), and respective confidence intervals (CI). Results: The search strategy and assessment for risk of bias revealed 25 articles scoring above 10/14 on the items of the QUADAS. Four studies investigated FAI, and the data were not pooled. Twenty articles on ALT qualified for meta-analysis. Pretest probability of ALT in the studies in this review was 81% (72%-88%), while the pretest probability of FAI diagnosis was 74% (95% CI, 51%-91%). The meta-analysis showed that computed tomography arthrography (CTA) demonstrated the strongest overall diagnostic accuracy: pooled SN 0.91 (95% CI, 0.83-0.96); SP 0.89 (95% CI, 0.74-0.97); +LR 6.28 (95% CI, 2.78-14.21); –LR 0.11 (95% CI, 0.06-0.21); and DOR 64.38 (95% CI, 19.17-216.21). Conclusion: High pretest probability of disease was demonstrated. Positive imaging findings increased the probability that a labral tear existed by a minimal to small degree with the use of magnetic resonance imaging/magnetic resonance angiogram (MRI/MRA) and ultrasound (US) and by a moderate degree for CTA. Negative imaging findings decreased the probability that a labral tear existed by a minimal degree with the use of MRI and US, a small to moderate degree with MRA, and a moderate degree with CTA. Clinical Relevance: Although findings of the included studies suggested potentially favorable use of these modalities for the diagnosis of ALT and FAI, our results suggest that these findings have limited generalizability and clinical utility given very high pretest prevalence, large confidence intervals, and selection criteria of the studies. Registration: PROSPERO Registration #CRD42015027745.

Methodology and reporting of diagnostic accuracy studies of automated perimetry in glaucoma: evaluation using a standardised approach.

To evaluate methodological and reporting quality of diagnostic accuracy studies of perimetry in glaucoma and to determine whether there had been any improvement since the publication of the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines. A systematic review of English language articles published between 1993 and 2013 reporting the diagnostic accuracy of perimetry in glaucoma. Articles were appraised for methodological quality using the 14-item Quality assessment tool for diagnostic accuracy studies (QUADAS) and evaluated for quality of reporting by applying the STARD checklist. Fifty-eight articles were appraised. Overall methodological quality of these studies was moderate with a median number of QUADAS items rated as 'yes' equal to nine (out of a maximum of 14) (IQR 7-10). The studies were often poorly reported; median score of STARD items fully reported was 11 out of 25 (IQR 10-14). A comparison of the studies published in 10-year periods before and after the publication of the STARD checklist in 2003 found quality of reporting had not substantially improved. Methodological and reporting quality of diagnostic accuracy studies of perimetry is sub-optimal and appears not to have improved substantially following the development of the STARD reporting guidance. This observation is consistent with previous studies in ophthalmology and in other medical specialities.