Midwives’ attitudes toward participation of pregnant individuals in a preventive vaccine hypothetical clinical trial

Gagneux‐Brunon, Amandine; Guyot, Emilie; Detoc, M.; Botelho-Nevers, Élisabeth; Raia-Barjat, Tiphaïne

doi:10.1016/j.vaccine.2022.07.049

Cited by 3 publications

(11 citation statements)

References 15 publications

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“…Thirty-nine papers used qualitative methodologies [ 39 , 40 , 42 – 48 , 53 , 54 , 56 – 66 , 69 , 70 , 72 – 74 , 78 , 81 , 82 , 84 – 87 , 89 – 92 , 96 ], 18 papers used quantitative methodologies [ 38 , 41 , 50 – 52 , 67 , 68 , 71 , 75 – 77 , 79 , 80 , 88 , 93 – 95 , 97 ], and 3 papers used mixed-methods study designs [ 49 , 55 , 83 ].…”

Section: Resultsmentioning

confidence: 99%

“…The 60 papers present data from 27 countries and 4 geographic regions: 13 countries in Africa [ 44 – 47 , 65 , 73 , 78 , 84 , 85 ], 8 countries in Europe [ 38 , 39 , 41 , 48 – 50 , 53 – 56 , 58 , 59 , 61 , 62 , 64 , 67 – 69 , 72 , 74 , 80 – 83 , 86 , 89 , 90 , 92 , 94 , 96 ], 3 countries in the Americas [ 42 , 43 , 51 , 52 , 57 , 60 , 63 , 66 , 70 , 71 , 75 , 77 , 79 , 85 , 88 , 91 , 93 , 95 ], and 3 countries in the Western Pacific [ 40 , 76 , 87 , 97 ].…”

Section: Resultsmentioning

confidence: 99%

“…Fifty-one papers focused on pregnant women only [ 38 – 41 , 44 , 47 – 50 , 52 , 53 , 55 – 70 , 72 – 94 , 97 ], 2 papers focused on lactating women only [ 46 , 96 ], and 7 papers focused on pregnant and lactating women [ 42 , 43 , 45 , 51 , 54 , 71 , 95 ]. Thirty-seven papers addressed a therapeutic drug-related intervention [ 38 , 40 , 41 , 44 – 49 , 53 , 56 , 59 – 62 , 66 , 69 , 70 , 72 , 73 , 77 , 79 – 90 , 92 , 93 , 96 , 97 ], 11 papers focused on a vaccine-related intervention [ 50 , 51 , 55 , 57 , 58 , 63 , 64 , 67 , 68 , 78 , 94 ...…”

Section: Resultsmentioning

confidence: 99%

“…Twenty-five papers included perspectives of pregnant women [ 38 , 45 , 47 , 48 , 51 , 57 , 58 , 60 , 61 , 64 , 65 , 67 , 71 – 75 , 77 , 85 , 89 – 91 , 94 , 95 , 97 ], 28 papers included perspectives of postpartum women [ 39 – 41 , 44 – 46 , 49 , 51 , 56 , 57 , 59 , 62 , 63 , 69 – 71 , 74 , 79 – 87 , 92 , 95 ], and 14 papers included health workers’ perspectives [ 44 , 47 , 50 , 52 – 54 , 61 , 64 , 65 , 67 , 87 , 88 , 91 , 94 ]. For other stakeholder groups, please refer to Table 1 .…”

Section: Resultsmentioning

confidence: 99%

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Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review

Shankar,

Hazfiarini,

Zahroh

et al. 2024

PLoS Med

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Background Poor representation of pregnant and lactating women and people in clinical trials has marginalised their health concerns and denied the maternal–fetal/infant dyad benefits of innovation in therapeutic research and development. This mixed-methods systematic review synthesised factors affecting the participation of pregnant and lactating women in clinical trials, across all levels of the research ecosystem. Methods and findings We searched 8 databases from inception to 14 February 2024 to identify qualitative, quantitative, and mixed-methods studies that described factors affecting participation of pregnant and lactating women in vaccine and therapeutic clinical trials in any setting. We used thematic synthesis to analyse the qualitative literature and assessed confidence in each qualitative review finding using the GRADE-CERQual approach. We compared quantitative data against the thematic synthesis findings to assess areas of convergence or divergence. We mapped review findings to the Theoretical Domains Framework (TDF) and Capability, Opportunity, and Motivation Model of Behaviour (COM-B) to inform future development of behaviour change strategies. We included 60 papers from 27 countries. We grouped 24 review findings under 5 overarching themes: (a) interplay between perceived risks and benefits of participation in women’s decision-making; (b) engagement between women and the medical and research ecosystems; (c) gender norms and decision-making autonomy; (d) factors affecting clinical trial recruitment; and (e) upstream factors in the research ecosystem. Women’s willingness to participate in trials was affected by: perceived risk of the health condition weighed against an intervention’s risks and benefits, therapeutic optimism, intervention acceptability, expectations of receiving higher quality care in a trial, altruistic motivations, intimate relationship dynamics, and power and trust in medicine and research. Health workers supported women’s participation in trials when they perceived clinical equipoise, had hope for novel therapeutic applications, and were convinced an intervention was safe. For research staff, developing reciprocal relationships with health workers, having access to resources for trial implementation, ensuring the trial was visible to potential participants and health workers, implementing a woman-centred approach when communicating with potential participants, and emotional orientations towards the trial were factors perceived to affect recruitment. For study investigators and ethics committees, the complexities and subjectivities in risk assessments and trial design, and limited funding of such trials contributed to their reluctance in leading and approving such trials. All included studies focused on factors affecting participation of cisgender pregnant women in clinical trials; future research should consider other pregnancy-capable populations, including transgender and nonbinary people. Conclusions This systematic review highlights diverse factors across multiple levels and stakeholders affecting the participation of pregnant and lactating women in clinical trials. By linking identified factors to frameworks of behaviour change, we have developed theoretically informed strategies that can help optimise pregnant and lactating women’s engagement, participation, and trust in such trials.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review

Shankar,

Hazfiarini,

Zahroh

et al. 2024

PLoS Med

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“…In addition, vaccines should be provided at a reasonable cost to reduce financial burden [ 96 ]. In line with the aim of this narrative review, healthcare providers also need to be educated on RSV vaccination to improve the former’s awareness and support for routine vaccination [ 97 , 98 ].…”

Section: Discussionmentioning

confidence: 99%

Vaccination for Respiratory Syncytial Virus: A Narrative Review and Primer for Clinicians

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2023

Vaccines

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Respiratory syncytial virus (RSV) poses a significant burden on public health, causing lower respiratory tract infections in infants, young children, older adults, and immunocompromised individuals. Recent development and licensure of effective RSV vaccines provide a promising approach to lessening the associated morbidity and mortality of severe infections. This narrative review aims to empower clinicians with the necessary knowledge to make informed decisions regarding RSV vaccination, focusing on the prevention and control of RSV infections, especially among vulnerable populations. The paper explores the available RSV vaccines and existing evidence regarding their efficacy and safety in diverse populations. Synthesizing this information for clinicians can help the latter understand the benefits and considerations associated with RSV vaccination, contributing to improved patient care and public health outcomes.

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Characterizing Attitudes Toward Maternal RSV Vaccines Among Pregnant and Lactating Persons in Kenya: Key Considerations for Demand Generation Efforts for Vaccine Acceptance

Limaye,

Sauer,

Njogu

et al. 2023

Journal of the Pediatric Infectious Diseases Society

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Midwives’ attitudes toward participation of pregnant individuals in a preventive vaccine hypothetical clinical trial

Cited by 3 publications

References 15 publications

Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review

Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review

Vaccination for Respiratory Syncytial Virus: A Narrative Review and Primer for Clinicians

Characterizing Attitudes Toward Maternal RSV Vaccines Among Pregnant and Lactating Persons in Kenya: Key Considerations for Demand Generation Efforts for Vaccine Acceptance

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