International teleproctoring in neurointerventional surgery and its potential impact on clinical trials in the era of COVID-19: legal and technical considerations.

BACKGROUND: Existing travel restrictions limit the mobility of proctors, significantly delaying clinical trials and the introduction of new neurointerventional devices. We aim to describe in detail technical and legal considerations regarding international teleproctoring, a tool that could waive the need for in-person supervision during procedures. METHODS: International teleproctoring was chosen to provide remote supervision during the first three intracranial aneurysm treatments with a new flow diverter (currently subject of a clinical trial) in the US. Real-time, high-resolution transmission software streamed audiovisual data to a proctor located in Canada. The software allowed the transmission of images in a de-identified, HIPAA-compliant manner. RESULTS: All three flow diverters were implanted as desired by operator and proctor and without complication. The proctor could swap between images from multiple sources and reported complete spatial and situational awareness, without any significant lag or delay in communication. Procedural times and radiologic dose were similar to those of uncomplicated, routine flow diversion cases at our institution. CONCLUSIONS: International teleproctoring was successfully implemented in our clinical practice. Its first use provided important insights for establishing this tool in our field. With no clear horizon for lifting the current travel restrictions, teleproctoring has the potential to remove the need for proctor presence in the angiography suite, thereby allowing the field to advance through the continuation of trials and the introduction of new devices in clinical practice. In order for this tool to be used safely and effectively, highly reliable connection and high-resolution equipment is necessary, and multiple legal nuances have to be considered.

The clinical significance of adaptation to changing health: a meta-analysis of response shift.

AIMS: When individuals experience changes in their health states, they may alter their internal standards, values, or conceptualization of quality of life (QOL). Such 'response shifts' can affect or distort QOL outcome measurement, which is of particular concern when evaluating medical or psychosocial interventions. Although clinicians and researchers acknowledge the occurrence of response shifts, little is known about the magnitude and clinical significance of those effects. To fill this gap in knowledge about response shift phenomena, we performed a meta-analysis on published QOL articles on response shift. METHODS: Extensive literature searches and multiple contacts with researchers yielded a collection of 494 articles for potential reviewing. We retained only published longitudinal studies that measured response shift, resulting in 26, of which 19 reported the requisite data for computing an effect size (ES). We calculated and compared the ESs for each study with regard to potential moderator variables: the QOL domains measured, disease group investigated, sample size, and response shift method used. We rated studies for quality to allow ES weighting. RESULTS: When we examined ES absolute values, we found that ES magnitude was small, with the largest ESs detected for fatigue, followed by global QOL, physical role limitation, psychological well-being, and pain (mean absolute value(ES(weighted)) = 0.32, 0.30, 0.24, 0.12, and 0.08, respectively). ESs varied considerably in direction. Aggregating raw ES scores over all studies led to positive and negative values canceling each other out (mean directional ES(weighted) = 0.17, 0.02, -0.01, 0.06, and 0.02, respectively). We found little evidence of an effect for the moderator variables examined. CONCLUSIONS: A definitive conclusion on the clinical significance of response shift cannot currently be drawn from existing studies. For a number of reasons, ES estimates were primarily based on then-test results, a method that is not without criticism, such as its susceptibility to recall bias. We recommend a standardized approach for reporting results of future response shift research to advance the field and to facilitate interpretation and comparisons across studies.