Tamar Krishnamurti

A Randomized Trial Testing US Food and Drug Administration “Breakthrough” Language

patients with atrial fibrillation with high global cardiovascular risk, the yield for detecting ischemia was 5.2%, and ischemia was not associated with increased mortality in this population. These findings suggest that these asymptomatic patients do not benefit from MPI. Harms of MPI include increased cancer risk from the high radiation burden (6-37 mSv depending on protocol, which is equivalent to hundreds or thousands of chest radiographs). These findings support a change in the AUC rating to the rarely appropriate category for this indication, and because MPI has definite harms without benefits for asymptomatic patients with atrial fibrillation this Research Letter merits the Less is More designation.

A Patient-Centered Approach to Informed Consent Results From a Survey and Randomized Trial

Purpose. Traditional informed consent documents tend to be too lengthy and technical to facilitate proper patient engagement. Patient-centered, short informed consent content could be equally informative, while minimizing patient burden and producing greater patient engagement. This study aimed to develop and evaluate patient-centered, patient-designed paper and video informed consent formats. Methods. Two studies were conducted. In study 1, 118 self-identifying asthma patients recruited from a national, online pool completed survey tasks from their personal computers. Participants in study 1 were randomly assigned to examine sections of a standard informed consent document for an asthma trial and to select information they deemed critical to their decision making. In study 2, a sample of 83 self-identifying asthma patients completed experimental tasks in a university laboratory. Participants in study 2 were randomly assigned to a full informed consent document; a shortened, patient-designed informed consent document created from study 1; or a video with content matched to the shortened paper form. Results. Study 1 yielded a more readable, concise version of a standard informed consent document (5 v. 17 pages). This shortened, patient-designed form closely met normative criteria for good clinical practice. In study 2, participants who viewed either the shortened paper consent or video reported greater engagement than those viewing the standard paper consent, without lowered performance on any other decision-relevant variables (i.e., comprehension, judged risk/benefit, feelings of trust). The video consent format did not cause increased enrollment. Conclusions. Results suggest that providing concise informed consent content, systematically developed from patients’ self-reported information needs, may be more effective at engaging and informing clinical trial participants than the traditional consent approach, without detriment to trial comprehension, risk assessment, or enrollment.