Standards For Reporting Of Diagnostic Accuracy Studies Research Articles

Protocol for Conducting a Systematic Review on Diagnostic Accuracy in Clinical Research

In the landscape of modern medicine, the ability to accurately diagnose various clinical conditions is paramount. As new diagnostic tools continue to emerge, their accuracy must be rigorously assessed before clinical implementation. This paper introduces a systematic review protocol tailored for diagnostic accuracy studies, drawing inspiration from a review on dysphagia screening in post-stroke patients. The protocol, designed with precision and transparency at its core, facilitates a thorough synthesis of evidence, employing tools such as the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) and the Standards for Reporting of Diagnostic Accuracy Studies (STARD) checklist for robust evaluation. The protocol emphasizes registration with the PROSPERO database and adherence to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The systematic search approach encompasses a comprehensive exploration of databases and precise keyword combinations. Distinctive inclusion and exclusion criteria, coupled with a dual-reviewer methodology, ensure the selection of high-quality studies. This framework has the potential to serve as a benchmark for systematic reviews in diagnostic accuracy, highlighting the importance of standardization, transparency, and adaptability in clinical research. This approach paves the way for a research methodology that delves deeper into diagnostic tools across various clinical scenarios, promoting evidence-based advancements in patient care.

Multicenter evaluation of the diagnostic efficacy of jaundice color card for neonatal hyperbilirubinemia

Objective: To evaluate the diagnostic efficacy and practicality of the Jaundice color card (JCard) as a screening tool for neonatal jaundice. Methods: Following the standards for reporting of diagnostic accuracy studies (STARD) statement, a multicenter prospective study was conducted in 9 hospitals in China from October 2019 to September 2021. A total of 845 newborns who were admitted to the hospital or outpatient department for liver function testing due to their own diseases. The inclusion criteria were a gestational age of ≥35 weeks, a birth weight of ≥2 000 g, and an age of ≤28 days. The neonate's parents used the JCard to measure jaundice at the neonate's cheek. Within 2 hours of the JCard measurement, transcutaneous bilirubin (TcB) was measured with a JH20-1B device and total serum bilirubin (TSB) was detected. The Pearson's correlation analysis, Bland-Altman plots and the receiver operating characteristic (ROC) curve were used for statistic analysis. Results: Out of the 854 newborns, 445 were male and 409 were female; 46 were born at 35-36 weeks of gestational age and 808 were born at ≥37 weeks of gestational age. Additionally, 432 cases were aged 0-3 days, 236 cases were aged 4-7 days, and 186 cases were aged 8-28 days. The TSB level was (227.4±89.6) μmol/L, with a range of 23.7-717.0 μmol/L. The JCard level was (221.4±77.0) μmol/L and the TcB level was (252.5±76.0) μmol/L. Both the JCard and TcB values showed good correlation (r=0.77 and 0.80, respectively) and agreements (96.0% (820/854) and 95.2% (813/854) of samples fell within the 95% limits of agreement, respectively) with TSB. The JCard value of 12 had a sensitivity of 0.93 and specificity of 0.75 for identifying a TSB ≥205.2 μmol/L, and a sensitivity of 1.00 and specificity of 0.35 for identifying a TSB ≥342.0 μmol/L. The TcB value of 205.2 μmol/L had a sensitivity of 0.97 and specificity of 0.60 for identifying TSB levels of 205.2 μmol/L, and a sensitivity of 1.00 and specificity of 0.26 for identifying TSB levels of 342.0 μmol/L. The areas under the ROC curve (AUC) of JCard for identifying TSB levels of 153.9, 205.2, 256.5, and 342.0 μmol/L were 0.96, 0.92, 0.83, and 0.83, respectively. The AUC of TcB were 0.94, 0.91, 0.86, and 0.87, respectively. There were both no significant differences between the AUC of JCard and TcB in identifying TSB levels of 153.9 and 205.2 μmol/L (both P>0.05). However, the AUC of JCard were both lower than those of TcB in identifying TSB levels of 256.5 and 342.0 μmol/L (both P<0.05). Conclusion: JCard can be used to classify different levels of bilirubin, but its diagnostic efficacy decreases with increasing bilirubin levels. When TSB level are ≤205.2 μmol/L, its diagnostic efficacy is equivalent to that of the JH20-1B. To prevent the misdiagnosis of severe jaundice, it is recommended that parents use a low JCard score, such as 12, to identify severe hyperbilirubinemia (TSB ≥342.0 μmol/L).

Publications on the diagnostic accuracy of dermatopathology tests: A cross-sectional quality analysis.

Ancillary diagnostic tests are frequent in dermatopathology practice. Publications on their accuracy influence their utilization. The transparency and completeness of these publications are unknown. We performed a cross-sectional study on diagnostic accuracy studies in dermatopathology published between 2020 and 2022 for compliance with Standards for Reporting of Diagnostic Accuracy Studies (STARD) and the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2). 14.67 ± 3.02 STARD items were reported in 62 publications (range, 9.5-23.5 out of the recommended total of 30). More items were reported in high-impact factor journals (16.01 vs. 13.32, p = 0.0002) and journals that endorsed STARD in their author instructions (17.22 vs. 14.11, p = 0.0039). Less than 10% of publications reported quantifiable hypotheses, sample size calculations, flow diagrams, or study registrations. The risk of bias by our analysis of QUADAS-2 criteria was high or uncertain for index test interpretation (36/62, 58%) and patient selection (44/62, 71%). Publications on dermatopathology tests are exploratory studies without prespecified hypotheses or study designs. They do not meet the criteria for transparent reporting. We suggest that medical journal leadership should consider updating their instructions with more explicit guidance on recommended manuscript elements.

Adherence to Complication Reporting for Randomized Controlled Trials Contained in Clinical Practice Guidelines for the Management of Carpal Tunnel Syndrome

Randomized controlled trials (RCTs) are frequently used in creating recommendations contained within clinical practice guidelines (CPGs). However, investigations outside of hand surgery have reported that RCTs within CPGs infrequently report complications and harms-related data. Our purpose was to assess adherence to complication reporting and harms-related outcomes contained in the Consolidated Standards for Reporting (CONSORT) Extension of Harms and Standards for Reporting of Diagnostic Accuracy Studies (STARD) reporting checklists for RCTs within the American Academy of Orthopaedic Surgery (AAOS) CPGs for carpal tunnel syndrome (CTS). We identified all RCTs within the AAOS CTS CPGs. All therapeutic RCTs and diagnostic studies were included. We used the CONSORT Harms Checklist criteria to assess adherence to the reporting of adverse events for therapeutic RCTs and the STARD criteria to assess the diagnostic accuracy of the articles. We defined adequate compliance as adherence to ≥50% of the checklist items. We identified 82 therapeutic RCTs and 90 diagnostic accuracy articles within the AAOS CTS CPG. For therapeutic RCTs, we found that the average compliance with the published checklists was 19%. For diagnostic studies, the average compliance with checklists was found to be 55%. Eleven therapeutic RCTs (13%) and 60 diagnostic studies (67%) were determined to have adequate compliance for the CONSORT and STARD checklists, respectively. Randomized controlled trials in the AAOS CPGs for CTS have low compliance with the CONSORT Extension for Harms Checklist. Although the overall adherence to the items published in the STARD statement for diagnostic accuracy evaluation remains higher, future efforts should be made to improve the adherence rates to both checklists. Improved standardization of complication reporting may aid in comparing outcomes across multiple clinical investigations of upper-extremity procedures.

Transparency and completeness of reporting of depression screening tool accuracy studies: A meta-research review of adherence to the Standards for Reporting of Diagnostic Accuracy Studies statement.

Accurate and complete study reporting allows evidence users to critically appraise studies, evaluate possible bias, and assess generalizability and applicability. We evaluated the extent to which recent studies on depression screening accuracy were reported consistent with Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement requirements. MEDLINE was searched from January 1, 2018 through May 21, 2021 for depression screening accuracy studies. 106 studies were included. Of 34 STARD items or sub-items, the number of adequately reported items per study ranged from 7 to 18 (mean=11.5, standard deviation [SD]=2.5; median=11.5), and the number inadequately reported ranged from 3 to 17 (mean=10.1, SD=2.5; median=10.0). There were eight items adequately reported, seven partially reported, 11 inadequately reported, and four not applicable in ≥50% of studies; the remaining four items had mixed reporting. Items inadequately reported in ≥70% of studies related to the rationale for index test cut-offs examined, missing data management, analyses of variability in accuracy results, sample size determination, participant flow, study registration, and study protocol. Recently published depression screening accuracy studies are not optimally reported. Journals should endorse and implement STARD adherence.

P-318 Application of the Standards for Reporting of Diagnostic Accuracy studies (STARD) 2015 to research on blood biomarkers of endometriosis

Abstract Study question How completely reported are studies on blood biomarkers of endometriosis, according to their adherence to the STARD 2015 checklist? Summary answer Studies on blood biomarkers of endometriosis are often incompletely reported, with only an overall adherence rate of 28.5% to the STARD 2015 checklist. What is known already Laparoscopy, the gold standard diagnostic method for determining endometriosis, is invasive, expensive, requires anesthesia and is associated with risk of vascular/ visceral damage. Therefore, less invasive diagnostics are needed. Many studies have been published on blood biomarkers of endometriosis with variable methodological quality. To assess applicability and risk of bias of diagnostic accuracy studies, completeness of study reporting must first be ensured. STARD 2015 checklist was introduced to guide reporting of diagnostic accuracy studies. The degree of adherence in studies on blood biomarkers of endometriosis to this 30-item STARD 2015 checklist is not known. Study design, size, duration Our systematic review included 126 studies from the 2016 Cochrane review on blood biomarkers of endometriosis. We added 84 more studies after updating the search in Pubmed, CINHAL and Web of Science, for the period May 2015- July 2021, with the keywords: endometriosis and biomarkers/ non-invasive diagnosis/ laboratory tests/ blood test, using the same eligibility criteria as in the Cochrane review. Totally, 210 studies were assessed for adherence to STARD 2015 checklist. Participants/materials, setting, methods STARD 2015 items were scored 1 if reported, or 0 if unreported. Each study received an adherence rate (percent of reported STARD items). Every item received individual item’s reporting rate (percent of its reporting across studies). Effect of publication year on study adherence and item reporting rates was examined by linear and logistic regressions, respectively. Journal impact factors were classified to tertiles and their relation to study adherence rate examined with one-way ANOVA. Main results and the role of chance Adherence rate was 28.5%, with 8.8± 3.1 reported items per study (range 2-18). Study adherence to STARD 2015 significantly increased with advancing publication years [r = 0.344 (95% CI 0.219 – 0.458), p &amp;lt; 0.001]. Journal impact factor had no effect on adherence to STARD 2015 (P = 0.274). Items with reporting rates &amp;gt;50% included #1 (identification as diagnostic accuracy study), #5 (prospective or retrospective), #7 (participants identification), #10a (index test), #10b (reference standard), #14 (diagnostic accuracy measures), #21a (disease severity), #21b (alternate diagnosis), and #22 (time between index test and reference standard). Items with reporting rates 20 to 50% included #6 (eligibility criteria), #8 (when/ where participants identifies), #12a (test positivity cutoff), #20 (participant characteristics) and #26 (limitations). Reporting rate &amp;lt; 20% seen in items #3 (background), #4 (hypothesis), #9 (consecutive /random recruitment), #13a/b (blinding of index test/ reference standard performers), #15 (intermediate results), #16 (missing data), #17 (analysis of variability), #18 (sample size), #19 (flow diagram), #23 (cross tabulation), #24 (diagnostic accuracy precision), #25 (adverse events), #27 (implications), #28 (registration), #29 (protocol), #30 (funding). Reporting improved for items: #1, #8, #10a, #10b, #12a, #14, #17, #18, #19, #20 and #25 and declined for items #9, #21a and #27 over publication years. Limitations, reasons for caution As the consequence of our choice to adhere to the methodology of the original Cochrane review, a limitation of our study is that we excluded non-English language studies and limited the search to the previously chosen 3 databases only. Wider implications of the findings With inadequately reported diagnostic accuracy studies, the derived evidence can be misleading. Our findings represent a baseline evaluation of the reporting status of studies on blood biomarkers of endometriosis. Our results can guide researchers and editors about poorly reported STARD 2015 items, aiming to improve their future reporting quality. Trial registration number PROSPERO # CRD42021259990

Delirium screening tools in the post-anaesthetic care unit: a systematic review and meta-analysis.

Delirium is a serious neurocognitive disorder among surgical patients in the post-anaesthetic care unit (PACU). Despite the development of screening tools to identify delirium, it is not clear which tool is the most accurate and reliable in assessing delirium in the PACU. To examine the diagnostic accuracy of delirium screening tools used in the PACU. A systematic literature search of CINAHL, MEDLINE, Embase, PsycINFO and Scopus was conducted, using MeSH terms and relevant keywords, from databases establishment to 23 April 2021. Studies were assessed for methodological quality using the Standards for Reporting of Diagnostic Accuracy Studies (STARD) tool. A total of 1503 studies were screened from the database search, four studies met the inclusion criteria for this review. Six delirium screening tools used in the PACU were identified in the selected studies. Three studies evaluated screening tools in adult surgical patients without cognitive impairment and dementia. Two studies evaluated screening tools among patients who were scheduled for elective surgery. Review results indicated that two tools, the 4A's test (4AT; sensitivity 96%; specificity 99%) and the 3min diagnostic interview for the Confusion Assessment Method (3D-CAM; sensitivity 100%; specificity 88%), had greatest validity and reliability as a screening tool for detecting delirium in the PACU. Results indicate the 4AT and the 3D-CAM are most accurate screening tools to detect delirium in the PACU. Further research is required to validate those tools among a broader surgical population, including patients with cognitive impairment, dementia and those undergoing emergency surgical procedures.

Artificial Intelligence for Computer Vision in Surgery: A Call for Developing Reporting Guidelines.

Artificial Intelligence for Computer Vision in Surgery: A Call for Developing Reporting Guidelines.

Developing Specific Reporting Standards in Artificial Intelligence Centred Research.

Developing Specific Reporting Standards in Artificial Intelligence Centred Research.

Prenatal Exome Sequencing in Recurrent Fetal Structural Anomalies: Systematic Review and Meta-Analysis.

To determine the diagnostic yield of exome sequencing (ES), a microarray analysis was carried out of fetuses with recurrent fetal structural anomalies (with similar anomalies in consecutive pregnancies). This is a systematic review conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. The selected studies describing ES in fetuses with recurrent fetal malformation were assessed using the Standards for Reporting of Diagnostic Accuracy Studies (STARD) criteria for risk of bias. Incidence was used as the pooled effect size by single-proportion analysis using random-effects modeling (weighted by inverse of variance). We identified nine studies on ES diagnostic yield that included 140 fetuses with recurrent structural anomalies. A pathogenic or likely pathogenic variant was found in 57 fetuses, resulting in a 40% (95%CI: 26% to 54%) incremental performance pool of ES. As expected, the vast majority (86%: 36/42) of the newly identified diseases had a recessive inheritance pattern, and among these, 42% (15/36) of variants were found in homozygosity. Meckel syndrome was the monogenic disease most frequently found, although the genes involved were diverse. The ES diagnostic yield in pregnancies with recurrent fetal structural anomalies was 40% (57/140). Homozygous disease-causing variants were found in 36% (15/57) of the newly identified monogenic disorders.

Recognition of Psychogenic Versus Epileptic Seizures Based on Videos.

Ictal semiology interpretation for differentiating psychogenic nonepileptic seizures (PNESs) and epileptic seizures (ESs) is important for the institution of appropriate treatment. Our objective was to assess the ability of different health care professionals (HCPs) or students to distinguish PNES from ES based on video-recorded seizure semiology. This study was designed following the Standards for Reporting of Diagnostic Accuracy Studies (STARD) guidelines. We showed in a random mix 36 videos of PNES or ES (18 each) and asked 558 participants to classify each seizure. The diagnostic accuracy of various groups of HCPs or students for PNES versus ES was assessed, as well as the effect of patient age and sex. Measures of diagnostic accuracy included sensitivity, specificity, and area under the curve (AUC). The descending order of diagnostic accuracy (AUC) was the following (p ≤ 0.001): (1) neurologists and epileptologists; (2) neurology residents; (3) other specialists and nurses with experience in epilepsy; and (4) undergraduate medical students. Although there was a strong trend toward statistical difference, with AUC 95% confidence intervals (CIs) that were not overlapping, between epileptologists (95% CI 93, 97) compared to neurologists (95% CI 88, 91), and neurologists compared to electroencephalography technicians (95% CI 82, 87), multiple pairwise comparisons with the conservative Tukey-Kramer honest significant difference test revealed no statistical difference (p = 0.25 and 0.1, respectively). Patient age and sex did not have an effect on diagnostic accuracy in neurology specialists. Visual recognition of PNES by HCPs or students varies overall proportionately with the level of expertise in the field of neurology/epilepsy.

Adherence to the Standards for Reporting of Diagnostic Accuracy Studies (STARD): a survey of four journals in laboratory medicine

BackgroundThe Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement has been updated in 2015. Many diagnostic test accuracy (DTA) studies have been published in medical laboratory journals, but their adherence to the updated STARD statement remains unknown.MethodsWe searched the PubMed database to verify studies published in 4 laboratory journals, including Clinical Chemistry, Clinical Chemistry and Laboratory Medicine, Clinica Chimica Acta, and Clinical Biochemistry, in 2019. DTA studies were identified and their adherence to the STARD statement was assessed.ResultsA total of 45 studies were included in this analysis. Overall, 18 out of 34 STARD items were reported. The items (adherence rate) of sample size estimation (4%), adverse events (9%), protocol (9%), registration (16%), missing value (22%), indeterminate results (18%), and cross-tabulation (22%) were the most frequently unreported items.ConclusionsAdherence to the STARD statement in DTA articles published in laboratory medicine seems as yet unsatisfactory. Our study emphasizes the necessity to improve the reporting quality of DTA studies published in medical laboratory journals.

Preferred Reporting Items for Diagnostic Accuracy Studies in Endodontics (PRIDASE) guidelines: a development protocol.

Diagnostic accuracy studies play an important role in informing clinical practice and patient management, by evaluating the ability of diagnostic testing and imaging to identify the presence or absence of a disease or condition. These studies compare the relative diagnostic strength of the test or device with a reference standard, therefore, guiding clinical decisions on the reliability of the test, the need for further tests, and whether to monitor or treat a particular condition. Inadequate and incomplete reporting of diagnostic accuracy studies can disguise methodological deficiencies and ultimately result in study bias and the inability to translate research findings into daily clinical practice. The Preferred Reporting Items for Diagnostic Accuracy Studies in Endodontics (PRIDASE) guidelines are being developed in order to improve the accuracy, transparency, completeness and reproducibility of diagnostic accuracy studies in the speciality of Endodontology. The aim of this paper is to report the process used to develop the PRIDASE guidelines based on a well-established consensus process. The project leaders (PD, VN) formed a steering committee of nine members (PD, VN, PA, AF, DR, SP, CK, MP, HD) to oversee and manage the project. The PRIDASE steering committee will develop the initial draft of the PRIDASE guidelines by adapting and modifying the Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015 guidelines, adding new items related specifically to the nature of Endodontics and incorporate the Clinical and Laboratory Images in Publication (CLIP) principles. The initial guidelines will consist of a series of domains and individual items and will be validated by the members of a PRIDASE Delphi Group (PDG) consisting of a minimum of 30 individuals who will evaluate independently the individual items based on two parameters: 'clarity' using a dichotomous scoring (yes/no) and 'suitability' for inclusion using a 9-point Likert Scale. The scores awarded by each member and any suggestions for improvement will be shared with the PDG to inform an iterative process that will result in a series of items that are clear and suitable for inclusion in the new PRIDASE guidelines. Once the PDG has completed its work, the steering committee will create a PRIDASE Meeting Group (PMG) of 20 individuals from around the world. Members of the PDG will be eligible to be the part of PMG. The draft guidelines and flowchart approved by the PDG will then be presented for further validation and agreement by the PMG. As a result of these discussions, the PRIDASE guidelines will be finalized and then disseminated to relevant stakeholders through publications and via the Preferred Reporting Items for study Designs in Endodontology (PRIDE) website (http://pride-endodonticguidelines.org). Periodic updates to the PRIDASE guidelines will be made based on feedback from stakeholders and end-users.

Barriers to reporting guideline adherence in point-of-care ultrasound research: a cross-sectional survey of authors and journal editors

ObjectiveAlthough the literature supporting the use of point-of-care ultrasound (POCUS) continues to grow, incomplete reporting of primary diagnostic accuracy studies has previously been identified as a barrier to translating research...

Diagnostic Accuracy of Intracochlear Test Electrode for Acoustic Nerve Monitoring in Vestibular Schwannoma Surgery.

Cochlear implants (CIs) are a well-known hearing restoration option for patients with vestibular schwannoma (VS) in cases of neurofibromatosis type-2 and, more recently, for patients with sporadic VS. One of the main limitations when performing CI during VS surgery is the capability to preserve the acoustic nerve (AN) anatomically and functionally. Significant efforts have been directed toward developing an intraoperative testing method for monitoring the AN function to determine if, after tumor removal, it is suitable for conducting stimuli delivered by a CI. However, all these methods have significant limitations, and none of them have documented diagnostic efficacy. To overcome these limitations and to obtain reliable information before CI insertion, a minimally invasive intracochlear test electrode (TE) has been recently developed. This TE has demonstrated to be suitable to test the integrity of the AN before CI in patients without any residual hearing by recording electrically evoked auditory brainstem responses (EABR). The present study constitutes the next phase of this research, which was to determine the usefulness of EABR obtained intraoperatively with the intracochlear TE after the resection of a VS and to calculate its diagnostic accuracy to assess the functionality of the AN for CI. This was a prospective, multicenter study of diagnostic accuracy. It was conducted in three tertiary referral centers between January 2015 and 2018. This study was designed following the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement guidelines. The STARD statement are guidelines to improve the completeness and transparency of reports of diagnostic accuracy studies. The diagnostic accuracy of the EABR evoked with the intracochlear TE after tumor removal was studied. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value were calculated. Patients eligible for the study were consecutive adults undergoing surgery for VS with simultaneous CI. The test under evaluation (index test) was the EABR obtained with the intracochlear TE after resection of the tumor. The reference test (gold standard) was the presence of auditory perception with the CI, defined as the presence of sound detection on an audiogram at 500, 1000, 2000, and 4000 Hz of no greater than 50 dB. In all the cases, auditory perception was verified by the presence of a positive EABR evoked with the CI. Twenty-one patients were included during the study period; seven patients were excluded from the diagnostic efficacy analysis due to inconclusive EABR results or absence of the gold standard to compare (they did not finally receive the CI). Thus, the outcome of the gold standard was assessed in 14 cases: 9 cases had positive EABR, all of them obtained auditory perception with the CI, and 5 cases had negative EABR, only one case had auditory perception with the CI, which constitutes the only false negative of this study. Accuracy of the TE was 93% (95% confidence interval, 66 to 100%), sensitivity 90% (95% confidence interval, 71 to 100%), specificity 100% (95% confidence interval, 100 to 100%), positive predictive value 100% (95% confidence interval, 100 to 100%), and negative predictive value 80% (95% confidence interval, 45 to 100%). EABR elicited with the intracochlear TE had a diagnostic accuracy of 93% for predicting auditory perception with CIs after VS removal. These results suggest that the intracochlear TE can be used intraoperatively after tumor removal to test the integrity of the AN as a useful tool to complement the surgeon's perception for decision-making regarding implantation.

Compliance With Standards for STARD 2015 Reporting Recommendations in Pathology.

Lack of experimental reproducibility has led to growing interest in guidelines to enhance completeness and transparency in research reporting. This retrospective survey sought to determine compliance with Standards for Reporting of Diagnostic Accuracy Studies (STARD) 2015 statement in the recent pathology scientific literature. Two raters independently scored 171 pathology diagnostic accuracy studies for compliance with 34 STARD items and subcomponents. Overall adherence was calculated as a proportion after excluding nonapplicable items. After excluding nonapplicable items, there was 50% overall adherence to STARD reporting recommendations. In total, 15.44 ± 3.59 items were reported per article (range, 4-28 out of maximum possible of 34). There was substantial heterogeneity in individual item reporting, with greater than 75% reporting in eight of 34 items and less than 25% reporting in 11 of 34 items. Less than 10% of articles reported hypotheses, subgroup analyses for confounding, sample size calculations, subject flow diagrams, study registrations, and links to full study protocols. Significantly more items were reported in articles from journals that endorsed STARD (16.14 vs 14.84, P = .0175). These findings demonstrate incomplete reporting of essential items in pathology diagnostic accuracy studies. More vigorous enforcement of reporting checklists might improve adherence to minimum reporting standards.

Suboptimal Quality and High Risk of Bias in Diagnostic Test Accuracy Studies at Chest Radiography and CT in the Acute Setting of the COVID-19 Pandemic: A Systematic Review.

PurposeTo synthesize the literature on diagnostic test accuracy of chest radiography, CT, and US for the diagnosis of coronavirus disease 2019 (COVID-19) in patients suspected of having COVID-19 in a hospital setting and evaluate the extent of suboptimal reporting and risk of bias.Materials and MethodsA systematic search was performed (April 26, 2020) in EMBASE, PubMed, and Cochrane to identify chest radiographic, CT, or US studies in adult patients suspected of having COVID-19, using reverse-transcription polymerase chain reaction test or clinical consensus as the standard of reference. Two × two contingency tables were reconstructed, and test sensitivity, specificity, positive predictive values, and negative predictive values were recalculated. Reporting quality was evaluated by adherence to the Standards for Reporting of Diagnostic Accuracy Studies (STARD), and risk of bias was evaluated by adherence to the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2).ResultsThirteen studies were eligible (CT = 12; chest radiography = 1; US = 0). Recalculated CT sensitivity and specificity ranged between 0.57 and 0.97, and 0.37 and 0.94, respectively, and positive predictive values and negative predictive values ranged between 0.59 and 0.92 and 0.57 and 0.96, respectively. On average, studies complied with only 35% of the STARD-guideline items. No study scored low risk of bias for all QUADAS-2 domains (patient selection, index test, reference test, and flow and timing). High risk of bias in more than one domain was scored in 10 of 13 studies (77%).ConclusionReported CT test accuracy for COVID-19 diagnosis varies substantially. The validity and generalizability of these findings is complicated by poor adherence to reporting guidelines and high risk of bias, which are most likely due to the need for urgent publication of findings in the first months of the COVID-19 pandemic.Supplemental material is available for this article.© RSNA, 2020

Systematic Review and STARD Scoring of Renal Cell Carcinoma Circulating Diagnostic Biomarker Manuscripts.

BackgroundNo validated molecular biomarkers exist to help guide diagnosis of renal cell carcinoma (RCC) patients. We seek to evaluate the quality of published RCC circulating diagnostic biomarker manuscripts using the Standards for Reporting of Diagnostic Accuracy Studies (STARD) guidelines.MethodsThe phrase “(renal cell carcinoma OR renal cancer OR kidney cancer OR kidney carcinoma) AND circulating AND (biomarkers OR cell free DNA OR tumor DNA OR methylated cell free DNA OR methylated tumor DNA)” was searched in Embase, MEDLINE, and PubMed in March 2018. Relevant manuscripts were scored using 41 STARD subcriteria for a maximal score of 26 points. All tests of statistical significance were 2 sided.ResultsThe search identified 535 publications: 27 manuscripts of primary research were analyzed. The median STARD score was 11.5 (range = 7-16.75). All manuscripts had appropriate abstracts, introductions, and distribution of alternative diagnoses. None of the manuscripts stated how indeterminant data were handled or if adverse events occurred from performing the index test or reference standard. Statistically significantly higher STARD scores were present in manuscripts reporting receiver operator characteristic curves (P < .001), larger sample sizes (P = .007), and after release of the original STARD statement (P = .005).ConclusionsMost RCC circulating diagnostic biomarker manuscripts poorly adhere to the STARD guidelines. Future studies adhering to STARD guidelines may address this unmet need.

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.

Detecting Hydroxychloroquine Retinal Toxicity using a Novel Multifocal Electroretinography Stimulus

AbstractPurposeTo evaluate a novel 5‐ring multifocal electroretinogram (mfERG) stimulus as a screening test for detecting hydroxychloroquine (HCQ) retinopathy.Study DesignA stratified case‐control study conducted in accordance to the Standards for Reporting of Diagnostic Accuracy Studies (STARD).MethodsConsecutive patients referred to the University of Ottawa for HCQ retinopathy screening from July 2018 to September 2018 underwent testing using a novel 5‐ring mfERG stimulus and the standard 61‐hexagon mfERG stimulus. Patients with amblyopia, high myopia or hyperopia, coexisting retinal disease, and prior retinal surgery were excluded. mfERG parameters were compared between protocols and against cumulative dose (CD), dose by real body weight (RBW), and duration of HCQ therapy. Ring amplitudes (R1‐R5) and ring ratios (R1‐R4/R5) were collected for each stimulus protocol. mfERG data was collected from an additional group of controls with no previous exposure to HCQ. Stata 15.1 software was used to perform the regression analyses, and to compute Spearman correlation coefficients between variables.Results24 eyes (10 patients, 2 controls) were included in the final analysis. The novel R2 and R3 P1 amplitudes and R2/R5 were moderately correlated with the respective R2 (r = 0.434, p = 0.034) and R3 (r = 0.429, p = 0.036) P1 amplitudes and R2/R5 (r = 0.422, p = 0.040) of the 61‐hexagon stimulus. The novel R2 P1 amplitude was highly correlated with CD (r = −0.687, p &lt; 0.001), treatment duration (r = −0.687, p &lt; 0.001), and dose by RBW (r = −0.763, p &lt; 0.001). Similarly, novel R2/R5 was highly correlated with CD (r = −0.743, p &lt; 0.001), treatment duration (r = −0.743, p &lt; 0.001), and dose by RBW (r = −0.567, p = 0.004). The correlations between the 61‐hexagon stimulus R2/R5 and HCQ risk factors also reached significance but were not as robust. Linear regression analysis showed that CD may account for almost half of the variance in the novel R2/R5. (r2 = 0.486, R2/R5 = 9.68063 + cumulative dose ‐0.00286)ConclusionsThe 2016 AAO guidelines focused primarily on the use of subjective functional testing and objective structural testing and relegated mfERG based on a lack of accessibility. This pilot study describes a new 5‐ring mfERG protocol specific for HCQ retinopathy screening and suggests equivalence to the 61‐hexagon protocol at characterizing parafoveal function. This novel 5‐ring stimulus has a significantly shorter acquisition period and the ring design may be more sensitive to HCQ induced electrophysiologic change in the parafoveal region. R2 P1 amplitude and R2/R5 ring ratios acquired using this novel mfERG stimulus are strongly correlated to treatment duration and HCQ dosing. Additional prospective cohort studies are needed to validate this novel stimulus which may decrease the resource burden associated with objective functional testing.