Video-Assisted Informed Consent in a Clinical Trial of Resuscitation of Extremely Preterm Infants: Lessons Learned.

OBJECTIVE: Obtaining informed consent for clinical trials is challenging in acute clinical settings. For the VentFirst randomized clinical trial (assisting ventilation during delayed cord clamping for infants <29 weeks' gestation), we created an informational video that sites could choose to use to supplement the standard in-person verbal and written consent. Using a postconsent survey, we sought to describe the impact of the video on patient recruitment, satisfaction with the consent process, and knowledge about the study. STUDY DESIGN: This is a descriptive survey-based substudy. RESULTS: Of the sites participating in the VentFirst trial that obtained institutional review board (IRB) approval to allow use of the video to supplement the standard informed consent process, three elected to participate in the survey substudy. From February 2018 to January 2021, 82 women at these three sites were offered the video and completed the postconsent survey. Overall, 73 of these 82 women (89%) consented to participate in the primary study, 78 (95%) indicated the study was explained to them very well or extremely well, and the range of correct answers on five knowledge questions about the study was 63 to 98%. Forty-six (56%) of the 82 women offered the video chose to watch it. There were no major differences in study participation, satisfaction with the consent process, or knowledge about the study between the women who chose to watch or not watch the video. CONCLUSION: Watching an optional video to supplement the standard informed consent process did not have a major impact on outcomes in this small substudy. The ways in which audiovisual tools might modify the traditional informed consent process deserve further study. KEY POINTS: · Informed consent in acute clinical contexts is difficult.. · Videos offer an alternative communication tool.. · Continued research is necessary to optimize the consent process..

Prenatal consults with illustrated literature (PnCIL): a RCT studying visual aids during prenatal consults.

OBJECTIVE: We hypothesize that addition of illustrated handouts during prenatal consultations decreases maternal anxiety and improves maternal knowledge. STUDY DESIGN: Inpatient gravid women at 25 0/7-34 6/7 weeks gestation were randomized to Standard or Illustrated consults, verbal consults supplemented with a visual handout. Post consult surveys were administered assessing maternal anxiety and knowledge acquisition. RESULT: We enrolled 82 women; 54 to Standard Consult, 28 to Illustrated Consult. Consult duration was the same across arms. Anxiety and knowledge were not impacted by the intervention overall. We found higher mean knowledge by 17% for consults ≥31 min (P = 0.006; 95% CI 0.67-3.82), and 13% in primigravids (P = 0.032; 95% CI 0.15-3.21) in the intervention arm. CONCLUSIONS: Using illustrated handouts is feasible and does not increase duration of prenatal consults. It may improve knowledge acquisition in long consults and in primigravida women, although it does not impact anxiety and knowledge overall.

Respiratory failure secondary to congenital pulmonary arterial thrombus with lung dysplasia.

Respiratory failure requiring extracorporeal membranous oxygenation in the newborn is commonly seen secondary to severe pathology such as congenital diaphragmatic hernia, meconium aspiration syndrome, pulmonary hypertension and pulmonary hypoplasia. However, atypical causes of respiratory failure, such as pulmonary arterial thrombi, are often refractory to traditional management and require careful multidisciplinary evaluation. We report a case of respiratory failure secondary to congenital pulmonary arterial thrombosis of unknown aetiology in an otherwise healthy neonate. We discuss the abnormal anatomy and pathophysiology that presented in our patient secondary to this condition and discuss our diagnostic process, management and outcomes. Additionally, we review the literature for reported cases and discuss current hypotheses on the development of congenital pulmonary arterial thrombi. Given the rare occurrence of this event, we hope to contribute to the understanding of future similar cases and emphasise the importance of keeping pulmonary arterial thrombi in the clinical differential.