Optimising informed consent for participants in a randomised controlled trial in rural Uganda: a comparative prospective cohort mixed-methods study

Background Poor participant understanding of research information can be a problem in community interventional studies with rural African women, whose levels of illiteracy are high. This study aimed to improve the informed consent process for women living in rural eastern Uganda. We assessed the impact of alternative consent models on participants’ understanding of clinical trial information and their contribution to the informed consent process in rural Uganda. Methods The study applied a parallel mixed-methods design for a prospective comparative cohort, nested within a pilot study on the community distribution of an alcohol-based hand rub to prevent neonatal sepsis (BabyGel pilot trial). Women of at least 34 weeks’ pregnancy, suitable for inclusion in the BabyGel pilot trial, were recruited into this study from their homes in 13 villages in Mbale District. As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information, a slide show using illustrated text on a flip chart or a video showing the patient information being read as if by a newsreader in either English or the local language. In addition, all women received the patient information sheet in their preferred language. Each information-giving method was used in recruitment for 1 week. Two days after recruitment, women’s understanding of the clinical trial was evaluated using the modified Quality of Informed Consent (QuIC) tool. They were also shown the other two methods and their preference assessed using a 5-point Likert scale. Semi-structured interviews were administered to each participant. The interviews were audio-recorded, transcribed and translated verbatim, and thematically analysed. Results A total of 30 pregnant women in their homes participated in this study. Their recall of the trial information within the planned 48 h was assessed for the majority (90%, 27/30). For all three consent models, women demonstrated a high understanding of the study. There was no statistically significant difference between the slide-show message (mean 4.7; standard deviation, SD 0.47; range 4–5), video message (mean 4.9; SD 0.33; range 4–5) and standard method (mean 4.5; SD 0.53; range 4–5; all one-way ANOVA, p = 0.190). The slide-show message resulted in the most objective understanding of question items with the highest average QuIC score of 100 points. For women who had been recruited using any of the three models, the slide show was the most popular method, with a mean score for all items of not less than 4.2 (mean 4.8; SD 0.6; range 4–5). Most women (63%, 19/30) preferred the slide-show message, compared with 17% (5/30) and 20% (6/30) for the standard and video messages, respectively. The reasons given included the benefits of having pictures to aid understanding and the logical progression of the information. Conclusion Our results from this small study suggest that slide-show messages may be an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom have little or no literacy

LYVE1+ Macrophages Regulate Collagen Content in the Mitral Valve

Poster reporting findings on LYVE1 macrophages in the mitral valve. LYVE1 macrophages were shown to significantly regulate collagen content.Regulation of cardiac extracellular matrix (ECM) is crucial to an organism’s overall health. Valvular ECM composition is important because valves maintain blood pressure and direction of flow. If the mitral valve becomes inflexible, it decreases blood flow in the body. Valvular stability and flexibility necessitate ECM proteins such as collagen, which must be regulated. Without regulation, a buildup of ECM proteins can occur. Many essential cardiovalvular regulatory mechanisms are poorly understood. However, regulation of collagen by specialized resident macrophages has been seen in arteries. Hyaluronan receptors (LYVE1) are present on specialized macrophages that, when bound, release matrix metalloproteinases (MMPs) that proteolyse collagen. To further our understanding on valvular flexibility, we used cross-sections of mitral valves from Lyve1-cre x Csf1r-floxed mouse models to compare mice with LYVE1+ macrophages to mice with depletion of LYVE1+ macrophages. We hypothesized that when LYVE1+ macrophages are depleted, there will be increased collagen content in the mitral valve. We found through picrosirius red staining and analysis that mice with LYVE1+ macrophages contain less collagen in the mitral valve when compared to mice where LYVE1+ macrophages were depleted. This indicates that LYVE1+ macrophages assist in the maintenance of ECM composition.Peck, Alyssa L; Binstadt, Bryce; Osinski, Victoria; Auger, Jennifer; Farager, Jessica. (2022). LYVE1+ Macrophages Regulate Collagen Content in the Mitral Valve. Retrieved from the University Digital Conservancy, https://hdl.handle.net/11299/241667