Motivations and demographic differences in pregnant individuals in the decision to participate in research

PurposeAlthough many patients agree to participate in research studies, many decline. The decision of whether or not to participate is especially complex in pregnant individuals as they may be concerned about both themselves and the fetus. We sought to understand patient reasoning for and demographic associations with participation in a trial surrounding the utility of epidural preservative-free morphine after successful vaginal delivery.MethodsWe conducted a survey-based study in which parturients were approached within 36 hr after delivery to complete a survey assessing reasons for why they participated or not in the original trial. The survey also included self-reported demographics. Survey responses were categorized as follows: active participation, passive participation, ambivalence, aversion, miscommunication, clinical difficulty, unwilling to receive placebo, and screening failures.ResultsThe survey response rate was 47%. Having a bachelor's degree or higher was associated with participating in the study (odds ratio [OR], 1.97; 95% confidence interval [CI], 1.07 to 3.64; P = 0.03). Race and ethnicity were not predictive of participation. Participants who self-identified as Black were more likely to select reasons of aversion for why they did not participate in the trial (OR, 2.6; 95% CI, 1.00 to 6.75; P = 0.05). Seventy-three percent of participants who self-identified as Black and declined to participate selected aversion, compared with 31% of those who self-identified as non-Black. Additionally, 71% of participants who self-identified as Hispanic and declined to participate selected aversion, compared with 32% of those who self-identified as non-Hispanic.ConclusionsThese findings can help identify areas for improvement of participation of pregnant individuals in research studies. Demographic associations may influence participation and reasons for participation. ObjectifBien que bon nombre de patient center dot es acceptent de participer a des etudes de recherche, beaucoup declinent. La decision de participer ou non est particulierement complexe chez les personnes enceintes, car elles peuvent etre inquietes pour elles-memes et pour le f oe tus. Nous avons cherche a comprendre le raisonnement des patient center dot es et les associations demographiques concernant la participation a une etude portant sur l'utilite de la morphine peridurale sans agent de conservation apres un accouchement vaginal reussi.MethodeNous avons mene une etude basee sur des questionnaires dans laquelle les personnes parturientes ont ete approchees dans les 36 heures suivant l'accouchement afin de completer un questionnaire evaluant les raisons pour lesquelles elles avaient participe ou non a l'etude initiale. Le questionnaire comprenait egalement des donnees demographiques autodeclarees. Les reponses au questionnaire ont ete classees comme suit : participation active, participation passive, ambivalence, aversion, mauvaise communication, difficulte clinique, refus de recevoir un placebo et echecs au depistage.ResultatsLe taux de reponse etait de 47 %. Le fait d'avoir un baccalaureat ou plus etait associe a la participation a l'etude (rapport de cotes [RC], 1,97; intervalle de confiance [IC] a 95 %, 1,07 a 3,64; P = 0,03). La race et l'origine ethnique n'etaient pas predictives de la participation. Les participant center dot es qui se sont identifie center dot es comme Noir center dot es etaient plus susceptibles de choisir des raisons d'aversion pour expliquer leur non-participation a l'etude (RC, 2,6; IC 95 %, 1,00 a 6,75; P = 0,05). Soixante-treize pour cent des participant center dot es qui se sont identifie center dot es comme Noir center dot es et ont refuse de participer ont choisi l'aversion, comparativement a 31 % des personnes qui se sont identifie center dot es comme non Noir center dot es. De plus, 71 % des participant center dot es qui se sont identifie center dot es comme d'origine hispanique et ont refuse de participer ont choisi l'aversion, comparativement a 32 % des personnes qui se sont identifie center dot es comme non Hispaniques.ConclusionCes resultats peuvent aider a identifier les domaines dans lesquels la participation des personnes enceintes aux etudes de recherche peut etre amelioree. Les associations demographiques peuvent influencer la participation et les raisons de la participation.

Automated summary

This study aims to understand the reasons and demographic factors associated with patient participation in a trial on the utility of epidural preservative-free morphine after successful vaginal delivery. The findings reveal that higher education level is positively associated with participation, while race and ethnicity are not predictive of participation.