Ethical Barriers to Perinatal Mental Health Research and Evidence-Based Treatment: An Empirical Study

Brandon, Anna R.

doi:10.1080/21507716.2011.561517

Cited by 7 publications

(15 citation statements)

References 44 publications

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“…66 Our reliance on observational studies and registries 67,68 may propagate biases, as they have methodological limitations; thus, we keenly await new studies for replication and to confirm previous results. One of the strengths of our analysis was our attention to study quality.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Antidepressant Exposure During Pregnancy and Congenital Malformations: Is There an Association?

Grigoriadis¹,

VonderPorten²,

Mamisashvili³

et al. 2013

J. Clin. Psychiatry

152

117

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Objective: Depression is often not optimally treated during pregnancy, partially because of conflicting data regarding antidepressant medication risk. This meta-analysis was conducted to determine whether antenatal antidepressant exposure is associated with congenital malformations and to assess the effect of known methodological limitations. Data Sources: EMBASE, CINAHL, PsycINFO, and MEDLINE were searched from their start dates to June 2010. Keywords of various combinations were used, including, but not limited to depressive/mood disorder, pregnancy, antidepressant drug/agent, congenital malformation, and cardiac malformation. Study Selection: English language studies reporting congenital malformations associated with antidepressants were included. Of 3,074 abstracts reviewed, 735 studies were retrieved and 27 studies were included. Data Extraction: Two reviewers working independently assessed article quality. Data on use of any antidepressant, including fluoxetine and paroxetine specifically, were extracted. Outcomes included congenital malformations, major congenital malformations, cardiovascular defects, septal heart defects (ventral septal defects and atrial septal defects), and ventral septal defects only. Results: Nineteen studies were above quality threshold and make up the primary meta-analyses. Pooled relative risks (RRs) were derived by using random-effects methods. Antidepressant exposure was not associated with congenital malformations (RR = 0.93; 95% CI, 0.85-1.02; P = .113) or major malformations (RR = 1.07; 95% CI, 0.99-1.17; P = .095). However, increased risk for cardiovascular malformations (RR = 1.36; 95% CI, 1.08-1.71; P = .008) and septal heart defects (RR = 1.40; 95% CI, 1.10-1.77; P = .005) were found; the RR for ventral septal defects was similar to septal defects, although not significant (RR = 1.54; 95% CI, 0.71-3.33; P = .274). Pooled effects were significant for paroxetine and cardiovascular malformations (RR = 1.43; 95% CI, 1.08-1.88; P = .012). These results are contrasted with those addressing methodological limitations but are typically consistent. Conclusions: Overall, antidepressants do not appear to be associated with an increased risk of congenital malformations, but statistical significance was found for cardiovascular malformations. Results were robust in several sensitivity analyses. Given that the RRs are marginal, they may be the result of uncontrolled confounders. Although the RRs were statistically significant, none reached clinically significant levels.

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Section: Strengths and Limitationsmentioning

confidence: 99%

Antidepressant Exposure During Pregnancy and Congenital Malformations: Is There an Association?

Grigoriadis¹,

VonderPorten²,

Mamisashvili³

et al. 2013

J. Clin. Psychiatry

152

117

View full text Add to dashboard Cite

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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%

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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“…14,15 Moreover, recruiting pregnant women poses an even greater challenge, not only because of reluctance from the women themselves, 16 but also due to specific external regulatory barriers to the recruitment of pregnant women into clinical research studies. 17,18 Regulatory barriers on pregnant women's participation in research have ethical implications for women's equitable access to safe and effective treatments for both physical and mental health diagnoses. 19 Ethical issues pertaining to perinatal mental health research have also received commentary in the literature, specifically with regards to the exclusion of pregnant women from research, the arguably paternalistic Proximity searching was used due to the complexity of concepts one and two.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Systematic review of ethical issues in perinatal mental health research

Wet

Hannon

et al. 2023

Nurs Ethics

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Background Maternal mental health during the peripartum period is critically important to the wellbeing of mothers and their infants. Numerous studies and clinical trials have focused on various aspects of interventions and treatments for perinatal mental health from the perspective of researchers and medical health professionals. However, less is known about women’s experiences of participating in perinatal mental health research, and the ethical issues that arise. Aim To systematically review the literature on the ethical issues that emerge from pregnant and/or postpartum women’s experiences of taking part in perinatal mental health-related research. Methods Systematic review of nine bibliographic databases, from inception to July 2021. Qualitative, quantitative and mixed method studies were included if they reported on ethical issues experienced by perinatal women. Research ethical issues encompassed any issue relating to women’s experiences of being offered study information, recruitment, consent, retention and respect for autonomy. Titles, abstracts and full text screening, appraisal of the methodological quality of included studies, and data extraction, were conducted independently by two reviewers. Ethical considerations Ethical approval was not required for this systematic review. Findings A total of 9830 unique citations was retrieved. Six studies met the inclusion criteria. Studies were clinically and methodologically heterogenous, and only one was purposively designed to explore women’s experiences. The key finding was the establishment of trust between the researcher and participant in all stages of the research process. Findings are presented according to recruitment and consent processes, participation and retention, and study follow-up and completion. Conclusion The establishment of trust between the researcher and perinatal women leads to a dynamic with research ethical implications relevant to all stages of perinatal mental health-related research. Further research on the research ethical issues experienced by perinatal women is required because of the limited literature.

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Ethical Barriers to Perinatal Mental Health Research and Evidence-Based Treatment: An Empirical Study

Cited by 7 publications

References 44 publications

Antidepressant Exposure During Pregnancy and Congenital Malformations: Is There an Association?

Antidepressant Exposure During Pregnancy and Congenital Malformations: Is There an Association?

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

Systematic review of ethical issues in perinatal mental health research

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