Clinical Imaging Research: Higher Evidence, Global Collaboration, Improved Reporting, and Data Sharing Are the Grand Challenges.

The four grand challenges of imaging research­increasing evidence levels, enhancing global collaboration, improving research reporting quality, and sharing trial data­can be addressed, utilizing the tail wind of digital transformation, by consolidating actions of all stakeholders, with the ultimate goal of evidence-based, reproducible, generalizable, and broadly accepted results that will improve the quality and consistency of patient care.

Impact and perceived value of journal reporting guidelines among Radiology authors and reviewers.

OBJECTIVES: To analyse the author-perceived impact on the final manuscript and perceived value of journal reporting guidelines among Radiology authors and reviewers. METHODS: This survey was conducted among all corresponding authors of original research submissions to Radiology. Separately, we surveyed active Radiology reviewers. Results were analysed using logistic multivariate regression. RESULTS: Overall, 60% of authors (831/1391) completed the survey. Only 15% (120/821) had used the guideline and checklist when designing the study, significantly more so for PRISMA (55%, 16/29) compared with STARD and STROBE users (17%, 52/310; p < 0.001 and 10%, 46/443; p < 0.001). For 23% of the surveyed manuscripts (189/821), authors used the guidelines when writing the manuscript; these authors more often reported an impact on the final manuscript (i.e. changes in the content, 57%, 107/189) compared to those who used the guideline when submitting the manuscript (35%, 95/272; p < 0.001; OR 0.433, 95% confidence interval [CI] 0.288-0.648, p < 0.001) or when the checklist was requested by the editorial office (17%, 41/240; p < 0.001; OR 0.156, CI 0.097-0.247, p < 0.001). The perceived value of the reporting guideline was rated significantly higher the earlier the authors used the guideline in the research process (p < 0.001). The checklist was used by 77% of reviewers (200/259) some or all of the time; 60% (119/199) said it affected their reviews. CONCLUSION: Reporting guidelines had more author-perceived impact on the final manuscript and higher perceived value the earlier they were used, suggesting that there is a need for enhanced education on the use of these guidelines. KEY POINTS: • Only 15% of authors had used the respective reporting guideline and checklist when designing the study. • Almost 4 out of 5 Radiology authors and half of reviewers judged the guideline checklists to be useful or very useful. • Reporting guidelines had more author-perceived impact on manuscripts, i.e. changes that were made in the final manuscript, the earlier authors used them in the research process.

Gadolinium Retention: A Research Roadmap from the 2018 NIH/ACR/RSNA Workshop on Gadolinium Chelates.

Gadolinium-based contrast agents (GBCAs) have revolutionized MRI, enabling physicians to obtain crucial life-saving medical information that often cannot be obtained with other imaging modalities. Since initial approval in 1988, over 450 million intravenous GBCA doses have been administered worldwide, with an extremely favorable pharmacologic safety profile; however, recent information has raised new concerns over the safety of GBCAs. Mounting evidence has shown there is long-term retention of gadolinium in human tissues. Further, a small subset of patients have attributed a constellation of symptoms to GBCA exposure, although the association of these symptoms with GBCA administration or gadolinium retention has not been proven by scientific investigation. Despite evidence that macrocyclic GBCAs show less gadolinium retention than linear GBCAs, the safety implications of gadolinium retention are unknown. The mechanism and chemical forms of gadolinium retention, as well as the biologic activity and clinical importance of these retained gadolinium species, remain poorly understood and underscore the need for additional research. In February 2018, an international meeting was held in Bethesda, Md, at the National Institutes of Health to discuss the current literature and knowledge gaps about gadolinium retention, to prioritize future research initiatives to better understand this phenomenon, and to foster collaborative standardized studies. The greatest priorities are to determine (a) if gadolinium retention adversely affects the function of human tissues, (b) if retention is causally associated with short- or long-term clinical manifestations of disease, and (c) if vulnerable populations, such as children, are at greater risk for experiencing clinical disease. The purpose of the research roadmap is to highlight important information that is not known and to identify and prioritize needed research. ©RSNA, 2018 Online supplemental material is available for this article .

Connecting Technological Innovation in Artificial Intelligence to Real-world Medical Practice through Rigorous Clinical Validation: What Peer-reviewed Medical Journals Could Do.

Artificial intelligence (AI) is projected to substantially influence clinical practice in the foreseeable future. However, despite the excitement around the technologies, it is yet rare to see examples of robust clinical validation of the technologies and, as a result, very few are currently in clinical use. A thorough, systematic validation of AI technologies using adequately designed clinical research studies before their integration into clinical practice is critical to ensure patient benefit and safety while avoiding any inadvertent harms. We would like to suggest several specific points regarding the role that peer-reviewed medical journals can play, in terms of study design, registration, and reporting, to help achieve proper and meaningful clinical validation of AI technologies designed to make medical diagnosis and prediction, focusing on the evaluation of diagnostic accuracy efficacy. Peer-reviewed medical journals can encourage investigators who wish to validate the performance of AI systems for medical diagnosis and prediction to pay closer attention to the factors listed in this article by emphasizing their importance. Thereby, peer-reviewed medical journals can ultimately facilitate translating the technological innovations into real-world practice while securing patient safety and benefit.

Are Study and Journal Characteristics Reliable Indicators of "Truth" in Imaging Research?

Purpose To evaluate whether journal-level variables (impact factor, cited half-life, and Standards for Reporting of Diagnostic Accuracy Studies [STARD] endorsement) and study-level variables (citation rate, timing of publication, and order of publication) are associated with the distance between primary study results and summary estimates from meta-analyses. Materials and Methods MEDLINE was searched for meta-analyses of imaging diagnostic accuracy studies, published from January 2005 to April 2016. Data on journal-level and primary-study variables were extracted for each meta-analysis. Primary studies were dichotomized by variable as first versus subsequent publication, publication before versus after STARD introduction, STARD endorsement, or by median split. The mean absolute deviation of primary study estimates from the corresponding summary estimates for sensitivity and specificity was compared between groups. Means and confidence intervals were obtained by using bootstrap resampling; P values were calculated by using a t test. Results Ninety-eight meta-analyses summarizing 1458 primary studies met the inclusion criteria. There was substantial variability, but no significant differences, in deviations from the summary estimate between paired groups (P > .0041 in all comparisons). The largest difference found was in mean deviation for sensitivity, which was observed for publication timing, where studies published first on a topic demonstrated a mean deviation that was 2.5 percentage points smaller than subsequently published studies (P = .005). For journal-level factors, the greatest difference found (1.8 percentage points; P = .088) was in mean deviation for sensitivity in journals with impact factors above the median compared with those below the median. Conclusion Journal- and study-level variables considered important when evaluating diagnostic accuracy information to guide clinical decisions are not systematically associated with distance from the truth; critical appraisal of individual articles is recommended. © RSNA, 2017 Online supplemental material is available for this article.

External Factors That Influence the Practice of Radiology: Proceedings of the International Society for Strategic Studies in Radiology Meeting.

In both the United States and Europe, efforts to reduce soaring health care costs have led to intense scrutiny of both standard and innovative uses of imaging. Given that the United States spends a larger share of its gross domestic product on health care than any other nation and also has the most varied health care financing and delivery systems in the world, it has become an especially fertile environment for developing and testing approaches to controlling health care costs and value. This report focuses on recent reforms that have had a dampening effect on imaging use in the United States and provides a glimpse of obstacles that imaging practices may soon face or are already facing in other countries. On the basis of material presented at the 2015 meeting of the International Society for Strategic Studies in Radiology, this report outlines the effects of reforms aimed at (a) controlling imaging use, (b) controlling payer expense through changes in benefit design, and (c) controlling both costs and quality through "value-based" payment schemes. Reasons are considered for radiology practices on both sides of the Atlantic about why the emphasis needs to shift from providing a large volume of imaging services to increasing the value of imaging as manifested in clinical outcomes, patient satisfaction, and overall system savings. Options for facilitating the shift from volume to value are discussed, from the use of advanced management strategies that improve workflow to the creation of programs for patient engagement, the development of new clinical decision-making support tools, and the validation of clinically relevant imaging biomarkers. Radiologists in collaboration with industry must enhance their efforts to expand the performance of comparative effectiveness research to establish the value of these initiatives, while being mindful of the importance of minimizing conflicts of interest. © RSNA, 2017.

2016: Reviewing for Radiology-Reporting Guidelines and Why We Use Them.

It is our hope that increased use and awareness of guideline criteria will allow for the manuscripts, at the time of submission, to be more complete and aid our reviewers in better understanding, and thus critiquing, the methodology and results of submissions they receive. Online supplemental material is available for this article.

STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies.

Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.

STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies.

Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.