STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration

The Lancet Oncology

BackgroundGuidelines are inconclusive on whether contrast-enhanced MRI using gadoxetic acid and diffusion-weighted imaging should be added routinely to CT in the investigation of patients with colorectal liver metastases who are scheduled for curative liver resection or thermal ablation, or both. Although contrast-enhanced MRI is reportedly superior than contrast-enhanced CT in the detection and characterisation of colorectal liver metastases, its effect on clinical patient management is unknown. We aimed to assess the clinical effect of an additional liver contrast-enhanced MRI on local treatment plan in patients with colorectal liver metastases amenable to local treatment, based on contrast-enhanced CT.MethodsWe did an international, multicentre, prospective, incremental diagnostic accuracy trial in 14 liver surgery centres in the Netherlands, Belgium, Norway, and Italy. Participants were aged 18 years or …

Evaluating the completeness of reporting of recently published DTA systematic reviews (and abstracts) to PRISMA-DTA (and PRISMA-DTA for abstracts) five years following the publication of the PRISMA-DTA.

Nederlands Tijdschrift voor Geneeskunde

OBJECTIVE: Test decisions depend on the context in which health care is delivered. We interviewed paediatricians about perceived societal developments and their influence on diagnostic testing.DESIGN: Qualitative interview study.METHODS: Semi-structured in-depth interviews with 20 practicing Dutch paediatricians.RESULTS: Paediatricians associated societal developments, such as decreased risk acceptance, with perceived pressure from parents to perform tests. They were motivated to restrict unnecessary tests to avoid harming the child.CONCLUSION: Besides motivation and effort of health care providers, appropriate testing requires system-level actions, such as counteracting a culture of blame and considering societal interests in guideline recommendations.

Nederlands tijdschrift voor geneeskunde

ObjectiveTest decisions depend on the context in which health care is delivered. We interviewed paediatricians about perceived societal developments and their influence on diagnostic testing.DesignQualitative interview study.MethodsSemi-structured in-depth interviews with 20 practicing Dutch paediatricians.ResultsPaediatricians associated societal developments, such as decreased risk acceptance, with perceived pressure from parents to perform tests. They were motivated to restrict unnecessary tests to avoid harming the child.ConclusionBesides motivation and effort of health care providers, appropriate testing requires system-level actions, such as counteracting a culture of blame and considering societal interests in guideline recommendations.

Liver international

Background & Aims There is a need to reduce the screen failure rate (SFR) in metabolic dysfunction‐associated steatohepatitis (MASH) clinical trials (MASH+F2‐3; MASH+F4) and identify people with high‐risk MASH (MASH+F2‐4) in clinical practice. We aimed to evaluate non‐invasive tests (NITs) screening approaches for these target conditions. Methods This was an individual participant data meta‐analysis for the performance of NITs against liver biopsy for MASH+F2‐4, MASH+F2‐3 and MASH+F4. Index tests were the FibroScan‐AST (FAST) score, liver stiffness measured using vibration‐controlled transient elastography (LSM‐VCTE), the fibrosis‐4 score (FIB‐4) and the NAFLD fibrosis score (NFS). Area under the receiver operating characteristics curve (AUROC) and thresholds including those that achieved 34% SFR were reported. Results We included 2281 unique cases. The prevalence of MASH+F2‐4 …

Journal of the College of Community Physicians of Sri Lanka

ImportanceMendelian randomization (MR) studies use genetic variation associated with modifiable exposures to assess their possible causal relationship with outcomes and aim to reduce potential bias from confounding and reverse causation.ObjectiveTo develop the STROBE-MR Statement as a stand-alone extension to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guideline for the reporting of MR studies.Design, Setting, and ParticipantsThe development of the STROBE-MR Statement followed the Enhancing the Quality and Transparency of Health Research (EQUATOR) framework guidance and used the STROBE Statement as a starting point to draft a checklist tailored to MR studies. The project was initiated in 2018 by reviewing the literature on the reporting of instrumental variable and MR studies. A group of 17 experts, including MR methodologists, MR study design …

(Dennis, Falah-Hassani, & Shiri, 2017): Systematic review of all studies of the prevalence of anxiety symptoms and anxiety disorders in pregnancy and postnatally. 15.2% of women have an anxiety disorder in pregnancy and 9.9% postnatally.(Fairbrother, Janssen, Antony, Tucker, & Young, 2016): This study highlighted a prevalence of 1% in pregnancy and 2.9% postnatally. In this study anxiety disorders were more common than depression and there was not much overlap.

Endoscopy

Aims Colorectal polyp size is important for risk stratification and clinical decision-making regarding polypectomy technique and surveillance intervals. However, polyp size measurement is known to be prone to inter-observer variability and a standardized measurement method is lacking. Recently, a virtual scale (VS) function has been developed that facilitates polyp size measurement through the projection of a virtual measurement scale on the monitor screen during live endoscopy. This study aimed to compare VS measurements to other measurement methods in terms of variability and systematic differences. Moreover, clinical feasibility of the VS was evaluated in terms of measurement success rate and duration.Methods We conducted a prospective study comprising 120 polyps. Polyp size was measured in real-time during colonoscopy using three methods:(1) visual estimation (without aid of any tools),(2) 9-mm …

Clinical Infectious Diseases

Introduction The 2023 Duke-International Society of Cardiovascular Infectious Diseases (ISCVID) Criteria for IE were introduced to improve classification of infective endocarditis (IE) for research and clinical purposes. External validation studies are required. Methods We studied consecutive patients with suspected IE referred to the IE Team of Amsterdam University Medical Center (October 2016-March 2021). An international expert panel independently reviewed case summaries, and assigned a final diagnosis of “IE” or “Not IE” , which served as the reference standard, to which the “Definite” Duke-ISCVID classifications were compared. We also evaluated accuracy when excluding cardiac surgery and pathology data (“Clinical Criteria”). Lastly, we compared the 2023 Duke-ISCVID to the 2000 Modified Duke Criteria and the 2015 and 2023 European Society of Cardiology (ESC …

Endoscopy

Aims Gastric cancer is a more recently recognized challenge in the management of familial adenomatous polyposis (FAP). Proximal gastric adenomas are believed to be precursor lesions. This study aimed to describe the incidence of these gastric adenomas in patients with FAP and identify potential risk factors for their development.Methods Data was retrospectively collected from FAP patients who had undergone esophagogastroduodenoscopy (EGD) between 2015 and 2023 at our academic center. All diagnoses of gastric adenomas were histologically confirmed. A multivariable Cox proportional hazard regression analysis was performed to identify risk factors for proximal adenoma development.Results Among the 196 FAP patients who underwent EGD, 33 (17%) were diagnosed with proximal gastric adenomas. The median age at diagnosis was 48 years (range 19-80). A total of 105 proximal adenomas were …

Gastroenterology

Background and aimsIn more than half of the colorectal cancer (CRC) screening participants with a positive fecal immunochemical test (FIT) result, no advanced neoplasia (AN) is detected at colonoscopy. The positive FIT result could also be generated by cancers located proximal to the colon: upper gastrointestinal, oral cavity, nose and throat cancers. We evaluated screenees’ risk of being diagnosed with a cancer proximal to the colon within the three years and compared risks between those with a positive versus those with a negative FIT.MethodsData of Dutch CRC screening participants who underwent biennial FIT-based screening 2014-2018 were collected from the national screening database and linked to the National Cancer Registry. Screenees were classified into three groups: FIT-positives with AN (FIT+/AN+), FIT-positives without AN (FIT+/AN-) and FIT-negatives (FIT-). We compared the cumulative …

J. Perinat. Med

The Editors and Publisher thank the members of the Editorial Board and the following colleagues for their assistance in reviewing articles submitted to Clinical Chemistry and Laboratory Medicine in 2023.[1]

Human Reproduction

STUDY QUESTION What are the costs and effects of tubal patency testing by hysterosalpingo-foam sonography (HyFoSy) compared to hysterosalpingography (HSG) in infertile women during the fertility work-up? SUMMARY ANSWER During the fertility work-up, clinical management based on the test results of HyFoSy leads to slightly lower, though not statistically significant, live birth rates, at lower costs, compared to management based on HSG results. WHAT IS KNOWN ALREADY Traditionally, tubal patency testing during the fertility work-up is performed by HSG. The FOAM trial, formally a non-inferiority study, showed that management decisions based on the results of HyFoSy resulted in a comparable live birth rate at 12 months compared to HSG (46% versus 47%; difference −1.2%, 95% CI: −3.4% to 1.5%; P = 0.27). Compared to HSG, HyFoSy is …

medRxiv

Accurate assessments of symptoms and diagnoses are essential for health research and clinical practice but face many challenges. The absence of a single error-free measure is currently addressed by assessment methods involving experts reviewing several sources of information to achieve a more accurate or best-estimate assessment. Three bodies of work spanning medicine, psychiatry, and psychology propose similar assessment methods: The Expert Panel, the Best-Estimate Diagnosis, and the Longitudinal Expert All Data (LEAD). However, the quality of such best-estimate assessments is typically very difficult to evaluate due to poor reporting of the assessment methods and when it is reported, the reporting quality varies substantially. Here we tackle this gap by developing reporting guidelines for such studies, using a four-stage approach: 1) drafting reporting standards accompanied by rationales and empirical evidence, which were further developed with a patient organization for depression, 2) incorporating expert feedback through a two-round Delphi procedure, 3) refining the guideline based on an expert consensus meeting, and 4) testing the guideline by i) having two researchers test it and ii) using it to examine the extent previously published articles report the standards. The last step also demonstrates the need for the guideline: 18 to 58% (Mean = 33%) of the standards were not reported across fifteen randomly selected studies. The LEADING guideline comprises 20 reporting standards related to four groups: The Longitudinal design; the Appropriate data; the Evaluation – experts, materials, and procedures; and the Validity group …

Nederlands Tijdschrift voor Geneeskunde

Since the introduction of the Health Insurance Act, effectiveness has been one of the criteria for coverage decisions in the Netherlands. The Health Insurance Board, later succeeded by Zorginstituut Nederland, elaborated that criterion: when assessing whether care meets the" state of science and practice", it uses the principles of evidence-based medicine. In recent years, several organisations have called for the structural evaluation of health care interventions and the removal of non-effective care from the benefits package. This intention was also reflected in the Integral Care Agreement concluded last year.

Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy A guide to conducting systematic reviews of test accuracy In Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy, a team of distinguished researchers deliver the official guide to preparing and maintaining systematic reviews of test accuracy in healthcare. This first edition of the Handbook contains guidance on understanding test accuracy measures, search strategies and study selection, understanding meta-analysis and risk of bias and applicability assessments, presentation of findings, and drawing conclusions. Readers will also find: An introduction to test evaluation, including the purposes of medical testing, test accuracy and the impact of tests on patient outcomes Comprehensive explorations of the design of test accuracy studies, including discussions of reference standards and comparative test accuracy studies Considerations of the methods and presentation of systematic reviews of test accuracy Elaboration of study selection, data collection, and undertaking risk of bias and applicability assessments Perfect for medical practitioners and clinicians, Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy will also benefit professionals in epidemiology and students in related fields.

Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy

Before undertaking a test accuracy meta‐analysis, it is necessary to understand the distinct types of data, as well as the presentation and meaning of statistical summaries of test accuracy reported in the primary studies. The accuracy of a test can be presented using several individual measures or pairs of measures. This chapter explains and illustrates the most commonly encountered measures. It provides an overview of types of test data, followed by how to deal with inconclusive test results and a summary of issues in defining the target condition. The chapter then focuses on analysis, including the basic analysis of a primary test accuracy study, thresholds for defining test positivity and their relationship with estimates of test accuracy, generating and understanding receiver operating characteristic curves, and concluding with an analysis of comparative accuracy studies.

Gut

ObjectiveNew screening tests for colorectal cancer (CRC) are rapidly emerging. Conducting trials with mortality reduction as the end point supporting their adoption is challenging. We re-examined the principles underlying evaluation of new non-invasive tests in view of technological developments and identification of new biomarkers.DesignA formal consensus approach involving a multidisciplinary expert panel revised eight previously established principles.ResultsTwelve newly stated principles emerged. Effectiveness of a new test can be evaluated by comparison with a proven comparator non-invasive test. The faecal immunochemical test is now considered the appropriate comparator, while colonoscopy remains the diagnostic standard. For a new test to be able to meet differing screening goals and regulatory requirements, flexibility to adjust its positivity threshold is desirable. A rigorous and efficient four …

The Lancet Gastroenterology & Hepatology

BackgroundHistologically assessed liver fibrosis stage has prognostic significance in patients with non-alcoholic fatty liver disease (NAFLD) and is accepted as a surrogate endpoint in clinical trials for non-cirrhotic NAFLD. Our aim was to compare the prognostic performance of non-invasive tests with liver histology in patients with NAFLD.MethodsThis was an individual participant data meta-analysis of the prognostic performance of histologically assessed fibrosis stage (F0–4), liver stiffness measured by vibration-controlled transient elastography (LSM-VCTE), fibrosis-4 index (FIB-4), and NAFLD fibrosis score (NFS) in patients with NAFLD. The literature was searched for a previously published systematic review on the diagnostic accuracy of imaging and simple non-invasive tests and updated to Jan 12, 2022 for this study. Studies were identified through PubMed/MEDLINE, EMBASE, and CENTRAL, and authors …

Endoscopy international open

Background and study aims In patients with familial adenomatous polyposis (FAP), endoscopic resection of duodenal adenomas is commonly performed to prevent cancer and prevent or defer duodenal surgery. However, based on studies using different resection techniques, adverse events (AEs) of polypectomy in the duodenum can be significant. We hypothesized that cold snare polypectomy (CSP) is a safe technique for duodenal adenomas in FAP and evaluated its outcomes in our centers. Patients and methods We performed a prospective international cohort study including FAP patients who underwent CSP for one or more superficial non-ampullary duodenal adenomas of any size between 2020 and 2022. At that time, this technique was common practice in our centers for superficial duodenal adenomas. The primary outcome was the occurrence of intraprocedural and post …

Current Pediatrics

Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www. equator-network. org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports. Present article is Russian-language translation of the original manuscript edited by Doctor of Medicine RT Saygitov.

Current Pediatrics

Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www. equator-network. org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports. Present article is Russian-language translation of the original manuscript edited by Doctor of Medicine RT Saygitov.

Current Pediatrics

Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www. equator-network. org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports. Present article is Russian-language translation of the original manuscript edited by Doctor of Medicine RT Saygitov.

Current Pediatrics

Diagnostic accuracy studies are, like other clinical studies, at risk of bias due to shortcomings in design and conduct, and the results of a diagnostic accuracy study may not apply to other patient groups and settings. Readers of study reports need to be informed about study design and conduct, in sufficient detail to judge the trustworthiness and applicability of the study findings. The STARD statement (Standards for Reporting of Diagnostic Accuracy Studies) was developed to improve the completeness and transparency of reports of diagnostic accuracy studies. STARD contains a list of essential items that can be used as a checklist, by authors, reviewers and other readers, to ensure that a report of a diagnostic accuracy study contains the necessary information. STARD was recently updated. All updated STARD materials, including the checklist, are available at http://www. equator-network. org/reporting-guidelines/stard. Here, we present the STARD 2015 explanation and elaboration document. Through commented examples of appropriate reporting, we clarify the rationale for each of the 30 items on the STARD 2015 checklist, and describe what is expected from authors in developing sufficiently informative study reports. Present article is Russian-language translation of the original manuscript edited by Doctor of Medicine RT Saygitov.

Current Pediatrics

The first three years are of vital importance for children's neurodevelopment; however, this is notusually assessed at an individual level on a preventive basis. Our aim was to assess the dimensions ofmuscle tone, motor response, perception, rhythm-inhibition and adaptation-relationship in 209children from 13 to 36 months of age and to identify those that did not show a level in accordance withtheir chronological age. Experts in child neuropsychology and educators applied the NDS 0-3 Scale,for neurodevelopmental disorders from 0 to 3 years of age. The results showed the assessment of fivesubjects with scores below the minimum levels corresponding to their age who needed a more in-depthdiagnosis. Elements were identified in which the scores were below the minimum levels in alldimensions while, on average, the level of overall neurofunctional development was equal to or greaterthan the chronological …