Matthew D. F. McInnes

Introduction: This meta-review aims to evaluate meta-analyses on adherence of diagnostic test accuracy (DTA) studies to the STAndards for Reporting of Diagnostic Accuracy Studies (STARD) 2015 checklist. Methods: We searched MEDLINE and EMBASE and included reviews using STARD 2015 to evaluate completeness of reporting of primary DTA studies in humans in any field of research and presented their results quantitatively. We extracted data independently, in duplicate. Random-effects meta-analysis models using restricted maximum likelihood estimation were used to determine overall mean and 95% confidence intervals (CI) of adherence to STARD 2015, compare fields of research, and evaluate adherence over time. Subgroup analyses to compare adherence across fields of research (diagnostic imaging, lab/biomarker, and other), were performed with pairwise differences between subgroups tested using meta-regression models with field of research as a categorical moderator. Results: A total of 14 reviews evaluating 1115 primary DTA studies were included. The range of primary studies evaluated in each review was 6 to 158. Included reviews were from Canada (n = 6), Germany (n = 3), Australia (n = 1), USA (n = 2), Spain (n = 1), and South Korea (n = 1). Field of research of included reviews were diagnostic imaging (n = 7), lab/biomarker (n = 4), and other (n = 3). The overall mean STARD 2015 adherence was 53.2% (95% CI: 45.9-60.5). Mean adherence was higher among diagnostic imaging studies (61.7% [95% CI: 56.8-66.6]) compared to lab/biomarker studies (48.5% [95% CI: 33.5-63.4]; P = .02) and other fields of research (39.4% [95% CI: 23.9-54.9]; P < .001). Time trends analysis found that STARD adherence did not change over time ( P = .28). Conclusion: Adherence of primary DTA studies to STARD 2015 was evaluated to be incomplete.

Background: Hepatocellular carcinoma (HCC) has an uneven global distribution and a higher incidence in males. The Liver Imaging Reporting and Data System (LI-RADS) is a standardized imaging framework for HCC diagnosis. It is unclear whether the evidence used to inform LI-RADS reflects the global burden of HCC. Purpose: To determine whether the geographic and sex distribution of studies assessing LI-RADS and those included in the LI-RADS individual participant data (IPD) database reflect the global burden of HCC. Materials and Methods: We conducted a cross-sectional meta-research study comparing the country- and sex-specific HCC prevalence from GLOBOCAN 2022 with the distribution of studies eligible for and included in the LI-RADS IPD database. Studies were identified through a systematic search of 4 databases. Study Protocol: OSF page . Results: We identified 470 eligible studies including 98 014 patients; of these, 76 studies comprising 11 924 patients were included in the IPD database. Asian and African countries, excluding Republic of Korea, were underrepresented in both the eligible and the IPD dataset. North America was overrepresented. Female patients were under-represented in LI-RADS eligible studies ( Z = −21.95, P < .0001) and in studies included in the IPD ( Z = −9.02, P < .0001) compared to the global prevalence of HCC in females. Conclusion: LI-RADS research is disproportionately reported from some countries relative to HCC burden. Asia, Africa, and female patients remain underrepresented. This may affect the generalizability and diagnostic equity of the LI-RADS system and underscore the need for improved global inclusivity in LI-RADS research.

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Purpose The Liver Imaging Reporting and Data System (LI-RADS, LR) provides a framework for diagnosing hepatocellular carcinoma (HCC, LR-5). However, not all HCCs meet LR-5 criteria and are instead categorized as LR-M, probably or definitely malignant but not specific for HCC, necessitating biopsy for diagnosis. The purpose is to identify factors associated with HCC in LR-M observations. Methods This is an IRB-approved, retrospective analysis of participants from 8 institutions that had a LR-M observation on CT or MRI with corresponding histopathologic diagnosis. Demographics and biochemical data were examined. Central review using the LI-RADS v2018 algorithm was performed. Kappa statistics defined inter-reader agreement. Random forest and logistic regression analyses generated a model for HCC diagnosis. Results 162 participants with 162 LR-M observations were included. 46% of observations (74/162) were HCC and 37% were cholangiocarcinoma (60/162). Two of 34 imaging features– observation size and intra-lesion iron– showed moderate to strong inter-reader agreement (Kappa ≥ 0.60) while the remainder showed weak or no agreement (Kappa < 0.60). Random forest analysis showed biochemical features to be more predictive of HCC than imaging features. Logistic regression analysis of a model based on INR and AFP provided a 72% sensitivity and 61% specificity for HCC by Youden’s index and a 90% specificity threshold yielded 38% sensitivity, 75% positive predictive value, and 66% negative predictive value. Conclusions Our results show INR and AFP are associated with HCC in LR-M observations. A high-specificity threshold may assist in the non-invasive diagnosis of HCC in the appropriate setting. Summary statement In certain at-risk patients with a LR-M observation on diagnostic imaging, serum AFP and INR maybe useful tools for the non-invasive diagnosis of HCC.

Background: Adherence of diagnostic accuracy imaging research to the STARD 2015 reporting guideline was assessed at baseline in 2016; on average, only 55% of 30 items were reported. Several knowledge translation strategies have since been implemented by the STARD group. Purpose: The purpose of this study was to evaluate the adherence of diagnostic accuracy studies recently published in imaging journals to STARD 2015, to assess for changes in the level of adherence relative to the baseline study. Methods: We performed an electronic search on MEDLINE for diagnostic accuracy studies, published between May and June of 2024, from a select group of imaging journals. The timespan was modulated to achieve a sample size of 100 to 150 included studies. Overall and item-specific adherence to STARD 2015 was evaluated, in addition to associations with journal of publication, imaging modality, study design, country of corresponding author, imaging subspecialty area, journal impact factor, and journal STARD adoption. Statistical comparison to the baseline study from 2016 was also performed. Poisson Regression and two-tailed student’s tests were used to compare STARD adherence relative to variables included in subgroup analysis. Results: In the 126 included studies, average adherence to STARD 2015 was 61% (18.3/30 items; SD = 3.1), improved compared to the baseline study (55%; 16.6/30 items; SD = 2.2; P < .0001). Studies published in higher impact factor journals reported more items than those in lower impact factor journals (20.6 vs 18.4 items, P -value <.0001). There was no significant association between reporting completeness and journal of publication ( P = .7), imaging modality ( P = .21), country of corresponding author ( P = .46), imaging subspecialty ( P = .31), and journal STARD adoption status ( P = .55). Conclusion: Recently published diagnostic accuracy studies reported more STARD 2015 items than studies published in 2016, but completeness of reporting is still not optimal.

Contrast media, including iodinated contrast media and gadolinium-based contrast agents, are commonly administered pharmaceuticals with excellent safety profiles. However, a minority of the population may experience a hypersensitivity reaction following intravenous administration. Hypersensitivity reactions can be immediate or delayed, and range from mild, such as urticaria, to severe, including anaphylaxis. There is emerging evidence that longstanding pretreatment protocols, such as diphenhydramine and corticosteroids, are ineffective and have the potential for side effects and other harms. Moreover, the evidence for efficacy on which this practice is based is weak and outdated. A joint collaborative working group of representatives from the Canadian Association of Radiologists and the Canadian Society of Allergy and Clinical Immunology was assembled to inform medical professionals and hospital policies regarding hypersensitivity reactions to contrast media. The objectives of the working group were to provide an overview of the epidemiology, physiology, risk factors, and types of hypersensitivity reactions; to synthesize the evidence for pretreatment strategies that minimize the risk of a breakthrough reaction for both iodinated contrast media and gadolinium-based contrast agents; to review the allergy investigations used to evaluate patients with a history of severe hypersensitivity reaction; and to provide an overview of existing guidelines. Following appraisal of the evidence, the working group established recommendations based on consensus in this practice guidance.

Background: We evaluated reporting of diagnostic test accuracy (DTA) systematic reviews using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-DTA and PRISMA-DTA for abstracts. Methods: We searched MEDLINE for recent DTA systematic reviews (September 2023–Mar 2024) to achieve a sample size of 100. Analyses evaluated adherence to PRISMA-DTA (and abstracts), on a per-item basis. Association of reporting with journal, country, impact factor (IF), index-test type, subspecialty area, use of supplemental material, PRISMA citation, word count, and PRISMA adoption was evaluated. Comparison to the baseline evaluation from 2019 was done. Protocol: https://doi.org/10.17605/OSF.IO/P25TE. Results: Overall adherence (n = 100) was 78% (20.3/26.0 items, SD = 2.0) for PRISMA-DTA and 52% (5.7/11.0 items, SD = 1.6) for abstracts. Infrequently reported items (<33% of studies): eligibility criteria, definitions for data extraction, synthesis of results, and characteristics of the included studies. Infrequently reported items in abstracts were characteristics of the included studies, strengths and limitations, and funding. Reporting completeness for full text was minimally higher in studies in higher IF journals [20.7 vs 19.8 items; 95% confidence interval (95%CI) (0.09; 1.77)], as well as studies that cited PRISMA [21.1 vs 20.1 items; 95%CI (0.04; 1.95)], or used supplemental material (20.7 vs 19.2 items; 95%CI (0.63; 2.35)]. Variability in reporting was not associated with author country, journal, abstract word count limitations, PRISMA adoption, structured abstracts, study design, subspecialty, open-access status, or index test. No association with word counts was observed among full text or abstracts. Compared to the baseline evaluation, reporting was improved for full texts [71% to 78%; 95%CI (1.18; 2.26)] but not for abstracts [50% to 52%; 95%CI (−0.20; 0.60)]. Conclusions: Compared to the baseline evaluation published in 2019, we observed modest improved adherence to PRISMA-DTA and no improvement in PRISMA-DTA for abstracts reporting.