Multimedia in the informed consent process for endoscopic sinus surgery: A randomized control trial

2015 ◽  
Vol 126 (6) ◽  
pp. 1273-1278 ◽  
Author(s):  
Jennifer M. Siu ◽  
Brian W. Rotenberg ◽  
Jason H. Franklin ◽  
Leigh J Sowerby
Keyword(s):  
Informed Consent ◽  
Endoscopic Sinus Surgery ◽  
Randomized Control Trial ◽  
Informed Consent Process ◽  
Sinus Surgery ◽  
Consent Process ◽  
Randomized Control

Facilitators, barriers, and recommendations related to the informed consent of Marshallese in a randomized control trial

2020 ◽  
Vol 15 (2) ◽  
pp. 75-83
Author(s):  
Rachel S Purvis ◽  
Leah R Eisenberg ◽  
Christopher R Trudeau ◽  
Christopher R Long ◽  
Pearl A McElfish
Keyword(s):  
Informed Consent ◽  
Randomized Control Trial ◽  
Diabetes Management ◽  
Community Based Participatory Research ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Approach ◽  
Community Based ◽  
Randomized Control ◽  
Participatory Research Approach

Background The Pacific Islander population is the second fasting growing population in the United States and Arkansas is home to the largest Marshallese population in the continental US. The Marshallese community have significant health disparities with high prevalence of diabetes, heart disease, and obesity compared to the general US population. Using a community-based participatory research approach, researchers and Marshallese community stakeholders identified diabetes as the top health issue for research. Methods From 2014 to 2018, a randomized control trial was conducted comparing standard diabetes management education with a culturally adapted family model of standard diabetes management education delivered in participants’ homes by Marshallese community health workers and certified diabetes educators. Interviews were held with Marshallese participants to document their experiences with and perceptions of the informed consent process for this randomized control trial. Results Participants provided feedback on the process of enrolling in the study, describing barriers and facilitators to giving informed consent from their perspective, and offering recommendations for improving the informed consent process. Conclusion Findings suggest that informed consent with underserved communities, including immigrant and migrant populations who do not speak English or have limited English proficiency, is possible, and that using a community-based participatory research approach can help facilitate the informed consent process.

Comparing a Multimedia Digital Informed Consent Tool to Traditional Paper-based Methods Among GenEx Trial Participants: Randomized Control Trial (Preprint)

2020 ◽  
Author(s):  
Fuad Abujarad ◽  
Peter Peduzzi ◽  
Sophia Mun ◽  
Kristina Carlson ◽  
Siyuan Ma ◽  
...  
Keyword(s):  
Informed Consent ◽  
Randomized Control Trial ◽  
Cognitive Theory ◽  
Digital Health ◽  
Informed Consent Process ◽  
Ease Of Use ◽  
Consent Process ◽  
New Haven ◽  
Randomized Control ◽  
The Impact

BACKGROUND The traditional informed consent process rarely emphasizes research participants’ comprehension of medical information, leaving them vulnerable to unknown risks and consequences associated with procedures or studies. OBJECTIVE This paper explores how we evaluated the feasibility of a digital health tool called ‘VIC’ for advancing the informed consent process and compared the results to traditional paper-based methods of informed consent. METHODS By utilizing Digital Health and virtual coaching, we developed the ‘Virtual multimedia interactive Informed Consent’ (VIC) tool that uses multimedia and other interactive digital features to improve the current informed consent process. Development of the tool was based on the user-centered design (UCD) process and on Mayer’s cognitive theory of multimedia learning. In a randomized control trial, we compared VIC’s feasibility against standard paper consent to understand the impact of interactive digital consent. Participants were recruited from the Winchester Chest Clinic (WCC) at Yale New Haven Hospital in New haven, CT, as well as from the community using fliers. The trial was coordinator-assisted, and participants were randomized to complete the informed consent process using VIC on the iPad or with traditional paper consent. The study was conducted at WCC and the outcomes were self-assessed through coordinator-administrated questionnaires. RESULTS Overall 50 participants were recruited in the study (VIC: n=25; Paper: n=25). Participant comprehension was high in both groups. VIC participants reported higher satisfaction, higher perceived ease of use, higher ability to complete the consent independently, and a shorter perceived time for completing the consent process. CONCLUSIONS The use of dynamic, interactive audiovisual elements in VIC may improve participants satisfaction and facilitate the informed consent process. We believe that using VIC in an ongoing, real-world study rather than a hypothetical study improved the reliability of our findings which demonstrate VIC’s potential to improve research participant’s comprehension as well as the overall process of the informed consent. CLINICALTRIAL ClinicalTrials.gov NCT02537886; https://clinicaltrials.gov/ct2/show/NCT02537886.

scholarly journals The Effect of Pterygopalatine Fossa Block (PPFB) during Endoscopic Sinus Surgery (ESS) on Intraoperative Bleeding: A Randomized Control Trial

2018 ◽  
Vol 1 (2) ◽  
pp. 35-41
Author(s):  
Deepak Paudel ◽  
S.T. Chettri ◽  
S.P. Shah ◽  
B.P. Shah ◽  
S. Manandhar ◽  
...  
Keyword(s):  
Blood Loss ◽  
Endoscopic Sinus Surgery ◽  
Randomized Control Trial ◽  
Pterygopalatine Fossa ◽  
Sinus Surgery ◽  
Block Group ◽  
Double Blind ◽  
Intraoperative Complication ◽  
Intraoperative Bleeding ◽  
Randomized Control

Background: Bleeding is the frequent intraoperative complication in most of the surgeries and remains a challenge for the surgeons and anesthesiologists. Major blood loss during FESS is rare but even a small amount of bleeding disturbs the endoscopic surgery field, increases the likelihood of complications, lengthens the time of surgery and results in incomplete surgery. The greater palatine canal (GPC) local injection is used to limit posterior bleeding during sinus surgery. Objective: To study the effect of pterygopalatine fossa block on intraoperative bleeding and operative field optimization during endoscopic sinus surgery. Methods: Prospective double blind randomized control trial. Thirty six patients were recruited in the study who also acted as their own control. PPFB was done only on one side of the nostril and the side was randomized by the lottery; neither the patient nor the operating surgeons were aware of the laterality. Boezaart score was used to quantify the intra-operative blood loss. Results: Blood loss between block group and non-block group was compared. Patients in block group had more stable hemodynamics with no fluctuations, better visibility of the surgical field and decreased blood loss as compared with non-block group. Conclusion: Greater palatine fossa block is a useful adjunct in patients undergoing endoscopic sinus surgery. It provided more stable hemodynamics, good operative conditions by lowering blood loss.

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