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Improving recruitment to clinical trials during pregnancy: a mixed methods investigation

Improving recruitment to clinical trials during pregnancy: a mixed methods investigation
Improving recruitment to clinical trials during pregnancy: a mixed methods investigation
Objective: to identify the reasons underlying women’s refusal to participate in a pregnancy trial and to identify ways of increasing recruitment.

Design: mixed methods study using a questionnaire and qualitative interviews.

Sample: a questionnaire asking them to indicate reasons for their decision was completed by 296 pregnant women who declined to participate in one of two trials of nutritional supplementation in a large teaching hospital in the south of England. Qualitative interview data were collected from two samples of pregnant women: 1) 30 women who declined to participate in a trial but completed the questionnaire; and 2) 44 women who participated in a trial.

Results: most reported reasons in questionnaires by women who declined to participate in a trial were concerns about study requirements, such as not wanting to take study medication, have a bone scan or extra blood tests, or being too busy. Thematic analysis identified differences in self-efficacy and levels of trust in medical research between participants and decliners. Participants believed that the research would cause no harm, while decliners felt they or their unborn child would be at risk. When faced with potential obstacles, participants found ways around them while decliners felt they were insurmountable.

Conclusions: recruitment methods for pregnancy trials should focus on building women’s trust in the trial and research staff and on enhancing women’s self-efficacy so they feel able to meet trial requirements. Suggestions for building trust include improving visibility of the research team, testimonials from previous participants and advertising study safety and ethical conduct. Self-efficacy can be enhanced by training research staff in empowering styles of communication enabling women to feel heard and supporting them to overcome practical problems associated with participating. These strategies could be implemented relatively easily into pregnancy trial protocols, and their effectiveness tested through their impact on recruitment rates.
0277-9536
73-82
Strommer, Sofia
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Lawrence, Wendy
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Rose, Taylor
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Vogel, Christina
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Watson, Daniella
271f1bca-0bd0-47b3-95bc-79e39b283c50
Bottel, Joanne N
a559956e-901e-4973-a9e7-621d6932531a
Harvey, Nicholas
ce487fb4-d360-4aac-9d17-9466d6cba145
Cooper, Cyrus
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Inskip, Hazel
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Baird, Janis
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Barker, Mary
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Strommer, Sofia
a025047e-effa-4481-9bf4-48da1668649e
Lawrence, Wendy
e9babc0a-02c9-41df-a289-7b18f17bf7d8
Rose, Taylor
ad05dc29-02db-434e-8f06-e88bf09d5adb
Vogel, Christina
768f1dcd-2697-4aae-95cc-ee2f6d63dff5
Watson, Daniella
271f1bca-0bd0-47b3-95bc-79e39b283c50
Bottel, Joanne N
a559956e-901e-4973-a9e7-621d6932531a
Harvey, Nicholas
ce487fb4-d360-4aac-9d17-9466d6cba145
Cooper, Cyrus
e05f5612-b493-4273-9b71-9e0ce32bdad6
Inskip, Hazel
5fb4470a-9379-49b2-a533-9da8e61058b7
Baird, Janis
f4bf2039-6118-436f-ab69-df8b4d17f824
Barker, Mary
374310ad-d308-44af-b6da-515bf5d2d6d2

Strommer, Sofia, Lawrence, Wendy, Rose, Taylor, Vogel, Christina, Watson, Daniella, Bottel, Joanne N, Harvey, Nicholas, Cooper, Cyrus, Inskip, Hazel, Baird, Janis and Barker, Mary (2018) Improving recruitment to clinical trials during pregnancy: a mixed methods investigation. Social Science & Medicine, 200, 73-82. (doi:10.1016/j.socscimed.2018.01.014).

Record type: Article

Abstract

Objective: to identify the reasons underlying women’s refusal to participate in a pregnancy trial and to identify ways of increasing recruitment.

Design: mixed methods study using a questionnaire and qualitative interviews.

Sample: a questionnaire asking them to indicate reasons for their decision was completed by 296 pregnant women who declined to participate in one of two trials of nutritional supplementation in a large teaching hospital in the south of England. Qualitative interview data were collected from two samples of pregnant women: 1) 30 women who declined to participate in a trial but completed the questionnaire; and 2) 44 women who participated in a trial.

Results: most reported reasons in questionnaires by women who declined to participate in a trial were concerns about study requirements, such as not wanting to take study medication, have a bone scan or extra blood tests, or being too busy. Thematic analysis identified differences in self-efficacy and levels of trust in medical research between participants and decliners. Participants believed that the research would cause no harm, while decliners felt they or their unborn child would be at risk. When faced with potential obstacles, participants found ways around them while decliners felt they were insurmountable.

Conclusions: recruitment methods for pregnancy trials should focus on building women’s trust in the trial and research staff and on enhancing women’s self-efficacy so they feel able to meet trial requirements. Suggestions for building trust include improving visibility of the research team, testimonials from previous participants and advertising study safety and ethical conduct. Self-efficacy can be enhanced by training research staff in empowering styles of communication enabling women to feel heard and supporting them to overcome practical problems associated with participating. These strategies could be implemented relatively easily into pregnancy trial protocols, and their effectiveness tested through their impact on recruitment rates.

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How to improve recruitment in pregnancy trials FINAL - Accepted Manuscript
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More information

Accepted/In Press date: 12 January 2018
e-pub ahead of print date: 17 January 2018
Published date: March 2018

Identifiers

Local EPrints ID: 417570
URI: https://eprints.soton.ac.uk/id/eprint/417570
ISSN: 0277-9536
PURE UUID: 78b08cca-364f-4820-aa3e-4558392d13db
ORCID for Nicholas Harvey: ORCID iD orcid.org/0000-0002-8194-2512
ORCID for Cyrus Cooper: ORCID iD orcid.org/0000-0003-3510-0709
ORCID for Hazel Inskip: ORCID iD orcid.org/0000-0001-8897-1749
ORCID for Janis Baird: ORCID iD orcid.org/0000-0002-4039-4361
ORCID for Mary Barker: ORCID iD orcid.org/0000-0003-2976-0217

Catalogue record

Date deposited: 05 Feb 2018 17:30
Last modified: 10 Dec 2019 05:34

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