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

Motivations et différences démographiques parmi les personnes enceintes quant à leur décision de participer à la recherche

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Abstract

Purpose

Although 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.

Methods

We 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.

Results

The 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.

Conclusions

These findings can help identify areas for improvement of participation of pregnant individuals in research studies. Demographic associations may influence participation and reasons for participation.

Résumé

Objectif

Bien que bon nombre de patient·es acceptent de participer à des études de recherche, beaucoup déclinent. La décision de participer ou non est particulièrement complexe chez les personnes enceintes, car elles peuvent être inquiètes pour elles-mêmes et pour le fœtus. Nous avons cherché à comprendre le raisonnement des patient·es et les associations démographiques concernant la participation à une étude portant sur l’utilité de la morphine péridurale sans agent de conservation après un accouchement vaginal réussi.

Méthode

Nous avons mené une étude basée sur des questionnaires dans laquelle les personnes parturientes ont été approchées dans les 36 heures suivant l’accouchement afin de compléter un questionnaire évaluant les raisons pour lesquelles elles avaient participé ou non à l’étude initiale. Le questionnaire comprenait également des données démographiques autodéclarées. Les réponses au questionnaire ont été classées comme suit : participation active, participation passive, ambivalence, aversion, mauvaise communication, difficulté clinique, refus de recevoir un placebo et échecs au dépistage.

Résultats

Le taux de réponse était de 47 %. Le fait d’avoir un baccalauréat ou plus était associé à la participation à l’étude (rapport de cotes [RC], 1,97; intervalle de confiance [IC] à 95 %, 1,07 à 3,64; P = 0,03). La race et l’origine ethnique n’étaient pas prédictives de la participation. Les participant·es qui se sont identifié·es comme Noir·es étaient plus susceptibles de choisir des raisons d’aversion pour expliquer leur non-participation à l’étude (RC, 2,6; IC 95 %, 1,00 à 6,75; P = 0,05). Soixante-treize pour cent des participant·es qui se sont identifié·es comme Noir·es et ont refusé de participer ont choisi l’aversion, comparativement à 31 % des personnes qui se sont identifié·es comme non Noir·es. De plus, 71 % des participant·es qui se sont identifié·es comme d’origine hispanique et ont refusé de participer ont choisi l’aversion, comparativement à 32 % des personnes qui se sont identifié·es comme non Hispaniques.

Conclusion

Ces résultats peuvent aider à identifier les domaines dans lesquels la participation des personnes enceintes aux études de recherche peut être améliorée. Les associations démographiques peuvent influencer la participation et les raisons de la participation.

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Authors and Affiliations

  1. Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA

    Cynthia R. Mercedes MS, BA, Hung-Mo Lin ScD & Daniel Katz MD

  2. Department of Anesthesiology, Perioperative and Pain Medicine, Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, Box 1010, New York, NY, 10029, USA

    Talia A. Scott MD

Authors
  1. Talia A. Scott MD
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  2. Cynthia R. Mercedes MS, BA
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  3. Hung-Mo Lin ScD
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Contributions

Talia A. Scott contributed to data curation, formal analysis, and writing (original draft). Cynthia R. Mercedes contributed to investigation, project administration, data curation, and writing (review and editing). Hung-Mo Lin contributed to formal analysis and writing (review and editing). Daniel Katz contributed to conceptualization, supervision, and writing (review and editing).

Corresponding author

Correspondence to Talia A. Scott MD.

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Prior conference presentations

These data were presented at the 2023 Society for Obstetric Anesthesia and Perinatology Annual Meeting in a Research & Case-Report Session (3–7 May, New Orleans, LA, USA).

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This submission was handled by Dr. Ronald B. George, Associate Editor, Canadian Journal of Anesthesia/Journal canadien d’anesthésie.

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Scott, T.A., Mercedes, C.R., Lin, HM. et al. Motivations and demographic differences in pregnant individuals in the decision to participate in research. Can J Anesth/J Can Anesth 71, 87–94 (2024). https://doi.org/10.1007/s12630-023-02635-8

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  • DOI: https://doi.org/10.1007/s12630-023-02635-8

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