Why Do I Need to Care About STARD?
Increasingly, top U.S.-based medical journals, including Radiology, AJR, and AJNR, in accordance with the recommendation of the International Committee of Medical Journal Editors, require submissions to comply with applicable EQUATOR Network guidelines, such as the Statement for Reporting Studies of Diagnostic Accuracy (STARD.) Thus, researchers should ensure that they understand and fulfill all relevant criteria.What is STARD?
STARD exists because academicians and editors, perceiving the problem of incomplete reporting, produced in 2003 a checklist of essential items to include in studies of diagnostic accuracy. STARD’s creators aimed to bolster completeness and transparency in order to facilitate evaluation and replication of research. In addition, they hoped to illuminate potential sources of bias and consider generalisability, or applicability of findings from the sample population to the population at large.
STARD pertains to diagnostic accuracy studies, which evaluate a test against a clinical reference standard, sometimes designated as the “gold standard.” Results commonly include sensitivity (the proportion of correct positive identifications,) specificity, (the proportion of correct negative identifications,) predictive values (the probability that the positive or negative result is true,) and still other measures or representations of diagnostic accuracy. Other study designs necessitate different EQUATOR Network guidelines, such as STROBE, PRISMA, or CONSORT, rather than STARD.
According to the team responsible for the STARD the checklist addresses the endemic issue of insufficient or selective reporting, which could bias or decontextualize results. For instance, sometimes authors fail to include all patients in the final analysis, which critically undermines the assessment of test accuracy. Furthermore, the setting, selection of patients, and definition of reference standard affect outcomes such as sensitivity and specificity. Thus, authors must clearly and completely communicate this information.
What Should I Know About the Recent Update?
The process of updating STARD began in 2013 and culminated with the publication of the revised guidelines in 2015. The original members of the steering committee, joined by new, invited contributors, had two significant objectives, identified by the final report:
“[F]irst, to incorporate recent evidence about sources of bias, applicability concerns, and factors facilitating generous interpretation in test accuracy research, and, second, to make the list easier to use. In making modifications, we also considered harmonization with other reporting guidelines, such as Consolidated Standards of Reporting Trials (CONSORT) 2010.”
To this end, the group combined, split, reworded, and even added items. Below, find a table containing all of the new criteria:
| Number | Item | Rationale |
|---|---|---|
| 2 | Structured abstract | Abstracts are increasingly used to identify key elements of study design and results. |
| 3 | Intended use and clinical role of the test | Describing the targeted application of the test helps readers to interpret the implications of reported accuracy estimates. |
| 4 | Study hypotheses | Not having a specific study hypothesis may invite generous interpretation of the study results and “spin” in the conclusions. |
| 18 | Sample size | Readers want to appreciate the anticipated precision and power of the study and whether authors were successful in recruiting the targeted number of participants. |
| 26-27 | Structured discussion | To prevent jumping to unwarranted conclusions, authors are invited to discuss study limitations and draw conclusions keeping in mind the targeted application of the evaluated tests (see item 3). |
| 28 | Registration | Prospective test accuracy studies are trials, and, as such, they can be registered in clinical trial registries, such as ClinicalTrials.gov, before their initiation, facilitating identification of their existence and preventing selective reporting. |
| 29 | Protocal | The full study protocol, with more information about the predefined study methods, may be available elsewhere, to allow more fine grained critical appraisal. |
| 30 | Sources of funding | Awareness of the potentially compromising effects of conflicts of interest between researchers’ obligations to abide by scientific and ethical principles and other goals, such as financial ones; test accuracy studies are no exception. |
Source: BMJ 2015;351:h5527.
How Superior Medical Editing Can Help with STARD Requirements
Since STARD is both required by journals and a stellar resource for authors who strive for accurate and complete reporting of research, Superior Medical Editing returns to you an annotated STARD checklist. We indicate which guidelines you already met and suggest changes or insertions necessary for compliance. Read about this service on our Compliance and Formatting page.
