Item 2.    State the research questions or study aims, such as estimating diagnostic accuracy or comparing accuracy between tests or across participant groups.

Example

Invasive x-ray coronary angiography remains the gold standard for the identification of clinically significant coronary artery disease. (…) A noninvasive test would be desirable. Coronary magnetic resonance angiography performed while the patient is breathing freely has reached sufficient technical maturity to allow more widespread application with a standardized protocol. Therefore, we conducted a study to determine the [accuracy] of coronary magnetic resonance angiography in the diagnosis of native-vessel coronary artery disease.[1]

The Helsinki Declaration states that biomedical research involving people should be based on a thorough knowledge of the scientific literature.[2] In the introduction of scientific reports authors describe the scientific background, previous work on the subject, the remaining uncertainty, and, hence, the rationale for their study.

Clearly specified research questions help the readers to judge the appropriateness of the study design and data analysis. A single general description, such as “diagnostic value” or “clinical usefulness”, is usually not very helpful to the readers.

In the example, the authors use the introduction section of their paper to describe the potential of coronary magnetic resonance angiography as a non-invasive alternative to conventional x-ray angiography in the diagnosis of clinically significant coronary stenosis. This description helps the reader to judge the appropriateness of the selection criteria, the choice of the reference standard, and the statistical methods used to summarize and analyze the data.

References