James Ditai|J. Kanyago|M. Nambozo|N. Odeke|Julian Abeso|John Dusabe-Richards|Peter Olupot?Olupot|Enitan D. Carrol|Antonieta Medina-Lara|Melissa Gladstone|Julie Storr|Brian Faragher|Andrew Weeks
Optimising informed consent for participants in a randomised controlled trial in rural Uganda: a comparative prospective cohort mixed-methods study
Sanyu Africa Research Institute|Mbale Hospital|Sanyu Africa Research Institute|Mbale Hospital|Sanyu Africa Research Institute|Mbale Hospital|Sanyu Africa Research Institute|Mbale Hospital|Sanyu Africa Research Institute|Mbale Hospital|Liverpool School of Tropical Medicine|Busitema University|University of Liverpool|University of Exeter|Liverpool Women's Hospital|University of Liverpool|Liverpool School of Tropical Medicine|Liverpool Women's Hospital|University of Liverpool
poor participant understanding research information problem community interventional studies rural african women whose levels illiteracy high study aimed improve informed consent process women living rural eastern uganda assessed impact alternative consent models participants understanding clinical trial information contribution informed consent process rural uganda study applied parallel mixedmethods design prospective comparative cohort nested within pilot study community distribution alcoholbased hand rub prevent neonatal sepsis babygel pilot trial women least 34 weeks pregnancy suitable inclusion babygel pilot trial recruited study homes 13 villages mbale district part informed consent process information trial presented using one three consent methods standard researcherread information slide show using illustrated text flip chart video showing patient information read newsreader either english local language addition women received patient information sheet preferred language informationgiving method used recruitment 1 week two days recruitment womens understanding clinical trial evaluated using modified quality informed consent quic tool also shown two methods preference assessed using 5point likert scale semistructured interviews administered participant interviews audiorecorded transcribed translated verbatim thematically analysed total 30 pregnant women homes participated study recall trial information within planned 48 h assessed majority 90 2730 three consent models women demonstrated high understanding study statistically significant difference slideshow message mean 47 standard deviation sd 047 range 45 video message mean 49 sd 033 range 45 standard method mean 45 sd 053 range 45 oneway anova p 0190 slideshow message resulted objective understanding question items highest average quic score 100 points women recruited using three models slide show popular method mean score items less 42 mean 48 sd 06 range 45 women 63 1930 preferred slideshow message compared 17 530 20 630 standard video messages respectively reasons given included benefits pictures aid understanding logical progression information results small study suggest slideshow messages may effective popular alternative way presenting trial information women rural uganda many little literacy isrctn isrctn67852437 registered 18 march 2018