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Objective. This report responds to a request from a deputy editor of the Journal of Ultrasound in Medicine (SUM) for guidelines for measurement and reporting of acoustic output and exposure. The request was addressed to the American Institute of Ultrasound in Medicine's Technical Standards and Bioeffects Committees, which appointed a task group to draft a response. A basic premise of scientific reporting is the expectation that another investigator will wish to replicate a reported study. Therefore, it is essential that all pertinent information available or accessible to an investigator be reported. Methods and Guidelines. Rationales and checklists are presented to draw authors' attention to aspects of experimental design and exposimetry that require consideration in project planning, execution, and reporting. Checklists are presented for use in 2 distinct categories of activity: (1) clinical settings in which a biophysical end point (bioeffect) is observed incidentally during another procedure; and (2) research projects specifically planned to investigate biophysical end points (bioeffects). Reportable parameters for the former are limited to essentials, whereas those for the latter are presented in detail. Certain basic information is recommended as mandatory for reports in both categories; certain additional parameters are designated as expected (at 3 levels of importance) when results of research are reported. Clinical investigators should comply with the short, first table (Table 1) and the last (Table 5) if applicable, but are encouraged to include additional data specified in other tables, as appropriate. Bioeffects experimenters should comply with Table 2 and such supplementary tables as are applicable to their study design. Table 3 is applicable if the study involved animal or human subjects. Table 4 is applicable if the study was on cells or in vitro. Table 5 is applicable if contrast agents were used in the study. Conclusions. We recommend that principal authors be required to certify to the JUM editors that they have reviewed the appropriate checklists and complied with indicated expectations. We recommend to reviewers that they consider individually adopting a mandatory requirement for reporting a basic set of parameters and/or descriptors of the equipment that are readily ascertainable by, or should be known to, a clinical user. |
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