Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection - a qualitative study

doi:10.1186/s12884-021-03541-x

. 2021 Jan 20;21(1):67.

doi: 10.1186/s12884-021-03541-x.

Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection - a qualitative study

Dominick J Lemas^{1

2

3}, Lauren Wright⁴, Elizabeth Flood-Grady^{5

6}, Magda Francois^{4

5}, Lynn Chen⁴, Austen Hentschel⁴, Xinsong Du⁴, Chu J Hsiao^{7

8

9}, Huan Chen¹⁰, Josef Neu¹¹, Ryan P Theis⁴, Elizabeth Shenkman^{4

5}, Janice Krieger^{5

6

11}

Affiliations

¹ Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, USA. djlemas@ufl.edu.
² Department of Obstetrics & Gynecology, College of Medicine, University of Florida, Gainesville, USA. djlemas@ufl.edu.
³ Clinical Translational Science Institute, University of Florida, Gainesville, USA. djlemas@ufl.edu.
⁴ Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, USA.
⁵ Clinical Translational Science Institute, University of Florida, Gainesville, USA.
⁶ STEM Translational Communication Center, College of Journalism and Communications, University of Florida, Gainesville, USA.
⁷ MD-PhD Training Program University of Florida, Gainesville, USA.
⁸ Genetics Institute, University of Florida, Gainesville, USA.
⁹ Department of Anthropology, University of Florida, Gainesville, USA.
¹⁰ Department of Advertising, College of Journalism and Communications, University of Florida, Gainesville, USA.
¹¹ Department of Pediatrics, College of Medicine, University of Florida, Gainesville, USA.

PMID: 33472584
PMCID: PMC7816422
DOI: 10.1186/s12884-021-03541-x

Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection - a qualitative study

Dominick J Lemas et al. BMC Pregnancy Childbirth. 2021.

. 2021 Jan 20;21(1):67.

doi: 10.1186/s12884-021-03541-x.

Authors

Affiliations

¹ Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, USA. djlemas@ufl.edu.
² Department of Obstetrics & Gynecology, College of Medicine, University of Florida, Gainesville, USA. djlemas@ufl.edu.
³ Clinical Translational Science Institute, University of Florida, Gainesville, USA. djlemas@ufl.edu.
⁴ Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, USA.
⁵ Clinical Translational Science Institute, University of Florida, Gainesville, USA.
⁶ STEM Translational Communication Center, College of Journalism and Communications, University of Florida, Gainesville, USA.
⁷ MD-PhD Training Program University of Florida, Gainesville, USA.
⁸ Genetics Institute, University of Florida, Gainesville, USA.
⁹ Department of Anthropology, University of Florida, Gainesville, USA.
¹⁰ Department of Advertising, College of Journalism and Communications, University of Florida, Gainesville, USA.
¹¹ Department of Pediatrics, College of Medicine, University of Florida, Gainesville, USA.

PMID: 33472584
PMCID: PMC7816422
DOI: 10.1186/s12884-021-03541-x

Abstract

Background: Investigation of the microbiome during early life has stimulated an increasing number of cohort studies in pregnant and breastfeeding women that require non-invasive biospecimen collection. The objective of this study was to explore pregnant and breastfeeding women's perspectives on longitudinal clinical studies that require non-invasive biospecimen collection and how they relate to study logistics and research participation.

Methods: We completed in-depth semi-structured interviews with 40 women who were either pregnant (n = 20) or breastfeeding (n = 20) to identify their understanding of longitudinal clinical research, the motivations and barriers to their participation in such research, and their preferences for providing non-invasive biospecimen samples.

Results: Perspectives on research participation were focused on breastfeeding and perinatal education. Participants cited direct benefits of research participation that included flexible childcare, lactation support, and incentives and compensation. Healthcare providers, physician offices, and social media were cited as credible sources and channels for recruitment. Participants viewed lengthy study visits and child protection as the primary barriers to research participation. The barriers to biospecimen collection were centered on stool sampling, inadequate instructions, and drop-off convenience.

Conclusion: Women in this study were interested in participating in clinical studies that require non-invasive biospecimen collection, and motivations to participate center on breastfeeding and the potential to make a scientific contribution that helps others. Effectively recruiting pregnant or breastfeeding participants for longitudinal microbiome studies requires protocols that account for participant interests and consideration for their time.

Keywords: Grounded theory; Mother-infant; NVivo; Qualitative research; Stool samples; Study visits; Thematic analysis.

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Conflict of interest statement

The authors declare that they have no competing interests.

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References

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1. Tamburini S, Shen N, Wu HC, Clemente JC. The microbiome in early life: implications for health outcomes. Nat Med 2016; 22:713–22. Available at: http://www.ncbi.nlm.nih.gov/pubmed/27387886. - PubMed
1. Abrahamson M, Hooker E, Ajami NJ, Petrosino JF, Orwoll ES. Successful collection of stool samples for microbiome analyses from a large community-based population of elderly men. Contemp Clin Trials Commun. 2017;7:158–162. doi: 10.1016/j.conctc.2017.07.002. - DOI - PMC - PubMed
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[1] Frew PM, Saint-Victor DS, Isaacs MB, et al. Recruitment and retention of pregnant women into clinical research trials: an overview of challenges, facilitators, and best practices. Clin Infect Dis 2014; 59:S400–S407. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4303058/pdf/ciu726.pdf. - PMC - PubMed

[2] Frew PM, Saint-Victor DS, Isaacs MB, et al. Recruitment and retention of pregnant women into clinical research trials: an overview of challenges, facilitators, and best practices. Clin Infect Dis 2014; 59:S400–S407. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4303058/pdf/ciu726.pdf. - PMC - PubMed

[3] Yan J, Liu L, Zhu Y, Huang G, Wang PP. The association between breastfeeding and childhood obesity: a meta-analysis. BMC Public Health. 2014;14:1267. doi: 10.1186/1471-2458-14-1267. - DOI - PMC - PubMed

[4] Yan J, Liu L, Zhu Y, Huang G, Wang PP. The association between breastfeeding and childhood obesity: a meta-analysis. BMC Public Health. 2014;14:1267. doi: 10.1186/1471-2458-14-1267. - DOI - PMC - PubMed

[5] Tamburini S, Shen N, Wu HC, Clemente JC. The microbiome in early life: implications for health outcomes. Nat Med 2016; 22:713–22. Available at: http://www.ncbi.nlm.nih.gov/pubmed/27387886. - PubMed

[6] Tamburini S, Shen N, Wu HC, Clemente JC. The microbiome in early life: implications for health outcomes. Nat Med 2016; 22:713–22. Available at: http://www.ncbi.nlm.nih.gov/pubmed/27387886. - PubMed

[7] Abrahamson M, Hooker E, Ajami NJ, Petrosino JF, Orwoll ES. Successful collection of stool samples for microbiome analyses from a large community-based population of elderly men. Contemp Clin Trials Commun. 2017;7:158–162. doi: 10.1016/j.conctc.2017.07.002. - DOI - PMC - PubMed

[8] Abrahamson M, Hooker E, Ajami NJ, Petrosino JF, Orwoll ES. Successful collection of stool samples for microbiome analyses from a large community-based population of elderly men. Contemp Clin Trials Commun. 2017;7:158–162. doi: 10.1016/j.conctc.2017.07.002. - DOI - PMC - PubMed

[9] Flint HJ, Scott KP, Louis P, Duncan SH. The role of the gut microbiota in nutrition and health. Nat Rev Gastroenterol Hepatol. 2012;9:577–589. doi: 10.1038/nrgastro.2012.156. - DOI - PubMed

[10] Flint HJ, Scott KP, Louis P, Duncan SH. The role of the gut microbiota in nutrition and health. Nat Rev Gastroenterol Hepatol. 2012;9:577–589. doi: 10.1038/nrgastro.2012.156. - DOI - PubMed

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Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection - a qualitative study

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Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection - a qualitative study

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