Barriers and facilitators of adherence to low-dose aspirin during pregnancy: A co-produced systematic review and COM-B framework synthesis of qualitative evidence.

INTRODUCTION: Women at increased risk of developing pre-eclampsia are advised to take a daily low-dose of aspirin from 12 weeks of pregnancy to reduce their risks. Despite the well-established prophylactic effect of aspirin, adherence to this therapy is low. This systematic review aimed to summarise evidence on the barriers and facilitators of adherence to low-dose aspirin to inform intervention development to support decision making and persistence with aspirin use for pre-eclampsia prevention. MATERIALS AND METHODS: A systematic review and meta-synthesis of qualitative research was co-produced by representatives from charities, and public, clinical and academic members. Eight electronic databases (MEDLINE, PsycINFO, CINAHL, Web of Science, Scopus, EMBASE, Prospero, OpenGrey), archives of charities and professional organisations were searched (between October and November 2023 and re-run in August 2023) using predefined search terms. Studies containing qualitative components related to barriers and facilitators of adherence to low-dose aspirin during pregnancy were included. Quality assessment was performed using the Critical Appraisal Skills Programme checklist for qualitative research. A combination of the COM-B framework with phases of adherence process as defined by international taxonomy was used as the coding framework. Co-production activities were facilitated by use of 'Zoom' and 'Linoit'. RESULTS: From a total of 3377 papers identified through our searches, five published studies and one dissertation met our inclusion criteria. Studies were published from 2019 to 2022 covering research conducted in the USA, Canada, UK, Netherlands and Australia. Barriers and facilitators to adherence were mapped to six categories of the COM-B for three phases of adherence: initiation, implementation, and discontinuation. The discontinuation phase of adherence was only mentioned by one author. Four key themes were identified relating to pregnancy: 'Insufficient knowledge', 'Necessity concerns balance', 'Access to medicine', 'Social influences', and 'Lack of Habit'. CONCLUSIONS: The COM-B framework allowed for detailed mapping of key factors shaping different phases of adherence in behavioural change terms and now provides a solid foundation for the development of a behavioural intervention. Although potential intervention elements could be suggested based on the results of this synthesis, additional co-production work is needed to define elements and plan for the delivery of the future intervention. TRIAL REGISTRATION: PROSPERO CRD42022359718. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022359718.

Let's talk aspirin: A survey of barriers and facilitators faced by midwives when engaging in conversations about aspirin with women at risk of pre-eclampsia.

OBJECTIVE: Adherence to low-dose aspirin is key in preventing pre-eclampsia. Midwives are well positioned to support women to take aspirin as prescribed. This study aimed to understand the barriers and facilitators that midwives face during consultations with pregnant women about prophylactic aspirin. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional, UK-wide, quantitative and qualitative study of midwives was conducted between November 2020 and April 2021 using social media platforms. The survey was designed using the Theoretical Domains Framework by a team of researchers experienced in using it. An open-ended question was embedded in the survey to allow midwives to expand on matters related to the study subject. FINDINGS: Out of 160 responders, 37.5 % indicated inadequate engagement in conversations with women about aspirin prophylaxis. Domains 'Knowledge' (OR 13.7, 95 %CI 5.7-32.7, p < 0.001), 'Professional role and Identity' (OR 15.3, 95 %CI 6.4-36.7, p < 0.001) and 'Beliefs about capabilities' (OR 13.6, 95 %CI 6.1-30.6, p < 0.001) were most prominently associated with effective engagement. Best fit model was comprised of 'Beliefs about Capabilities', 'Social/professional role and identity', and 'Knowledge'. Midwives' comments focused on barriers within 'environmental context' related to 'conflicting views' and 'deficit in resources' that compromise positive reinforcement of aspirin use. Responders also provided helpful 'Top tips' that streamline their daily practice. CONCLUSION AND IMPLICATIONS FOR PRACTICE: Beliefs about Capabilities, Social/professional role and identity, Knowledge, and Environmental Context and resources are key domains related to midwives' engagement in conversations about aspirin in pregnancy. Clear, up-to date information for midwives and the public should be available in an easy access format to allow provision of unequivocal advice related to the use of aspirin in pregnancy.

Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): protocol for a prospective cohort study.

INTRODUCTION: Maternal obesity increases the risk of multiple maternal and infant pregnancy complications, such as gestational diabetes and pre-eclampsia. Current UK guidelines use body mass index (BMI) to identify which women require additional care due to increased risk of complications. However, BMI may not accurately predict which women will develop complications during pregnancy as it does not determine amount and distribution of adipose tissue. Some adiposity measures (eg, waist circumference, ultrasound measures of abdominal visceral fat) can better identify where body fat is stored, which may be useful in predicting those women who need additional care. METHODS AND ANALYSIS: This prospective cohort study (SHAPES, Study of How Adiposity in Pregnancy has an Effect on outcomeS) aims to evaluate the prognostic performance of adiposity measures (either alone or in combination with other adiposity, sociodemographic or clinical measures) to estimate risk of adverse pregnancy outcomes. Pregnant women (n=1400) will be recruited at their first trimester ultrasound scan (11+2-14+1 weeks') at Newcastle upon Tyne National Health Service Foundation Trust, UK. Early pregnancy adiposity measures and clinical and sociodemographic data will be collected. Routine data on maternal and infant pregnancy outcomes will be collected from routine hospital records. Regression methods will be used to compare the different adiposity measures with BMI in terms of their ability to predict pregnancy complications. If no individual measure performs better than BMI, multivariable models will be developed and evaluated to identify the most parsimonious model. The apparent performance of the developed model will be summarised using calibration, discrimination and internal validation analyses. ETHICS AND DISSEMINATION: Ethical favourable opinion has been obtained from the North East: Newcastle & North Tyneside 1 Research Ethics Committee (REC reference: 22/NE/0035). All participants provide informed consent to take part in SHAPES. Planned dissemination includes peer-reviewed publications and additional dissemination appropriate to target audiences, including policy briefs for policymakers, media/social-media coverage for public and conferences for research TRIAL REGISTRATION NUMBER: ISRCTN82185177.

Aspirin non-adherence in pregnant women at risk of preeclampsia (ANA): a qualitative study.

BACKGROUND: Antenatal adherence to aspirin prophylaxis is key to reducing the occurrence of a major pregnancy complication: pre-eclampsia (PE). Up to 75% of pregnant women at increased risk of pre-eclampsia do not take aspirin as prescribed. Little research has been done to understand the psychological determinants of aspirin adherence in pregnancy. This qualitative study aimed to explore barriers and facilitators to aspirin adherence in women at increased risk of PE using version 2 of Theoretical Domains Framework (TDF). METHODS: Fourteen women from the North-East of England who declared various levels of non-adherence to aspirin (0-5 of 7 prescribed tablets/week) were interviewed 4-18 months after delivery, using the TDF as a guide. Semi-structured interviews were digitally recorded and transcribed verbatim. A thematic framework analysis was used. RESULTS: Women exhibited both intentional and unintentional non-adherence and faced multiple barriers at a personal and environmental level. They struggled to initiate, implement and persist in taking medication as prescribed. Women expressed inadequate knowledge about PE and aspirin; they struggled to identify as 'medication takers' and relate to the risk factors for PE as identified by the midwife. Significant barriers within the health-care environment were identified; women had difficulties obtaining medication and perceived conflict amongst health care professionals regarding medication safety. CONCLUSION: A combination of inadequate knowledge, lack of identification with the risk factors and beliefs about consequences of taking medication were interlinked with other domains, such as environmental context and resonate with the Necessity-Concerns Framework.

Informational needs related to aspirin prophylactic therapy amongst pregnant women at risk of preeclampsia - A qualitative study.

OBJECTIVE: Despite being key to reducing the occurrence of pre-eclampsia in high-risk women, adherence to aspirin prophylaxis is low, reflecting multifactorial challenges faced by pregnant women. It is therefore important to understand the barriers and facilitators of aspirin adherence in pregnancy. This sub-analysis of a qualitative study conducted to better understand barriers and facilitators of aspirin adherence was set to describe informational needs related to aspirin use in pregnancy. STUDY DESIGN: A qualitative study was conducted with 14 postnatal women from North-East of England, who declared various levels of non-adherence to aspirin (0-5/7 prescribed). A thematic framework analysis of semi-structured interviews was used. OUTCOME MEASURES: Emerging themes associated with informational needs about aspirin use in pregnancy. RESULTS: Main themes identified a) Informational needs, b) Nature of the information seeking behaviour (active vs passive), c) Sources of information, d) Preferred format of information, e) Partners seeking knowledge. Not all women actively seek information; some choose not to pursue it as they find thinking of hypothetical risks disturbing. When information is accessed, women use a wide range of informational resources from scientific articles and National Health Services website to social media sources and word-of-mouth. Women admit that reading leaflets can be difficult, preferring to receive information in interactive ways. Although partners seek information about risks and risk reduction strategies, they are often not included in conversations with health care professionals. CONCLUSION: New interactive and accessible informational resources are needed to engage pregnant women and their partners in aspirin prophylactic therapy.

Aspirin non-response in pregnant women at increased risk of pre-eclampsia.

OBJECTIVES: Low dose aspirin (LDA) is recommended for women at increased risk of preeclampsia (PE), however it is not always effective. The study sought to determine the prevalence of non-response to LDA and to ascertain the effect of increasing aspirin dose in non-responders. STUDY DESIGN: Single centre, cohort study of 166 women at increased risk of PE was conducted in a large maternity unit in the UK between 2013 and 2016. All women were prescribed 75 mg of aspirin and invited to attend study visits at 18-24 weeks' and 32-36 weeks' gestation. Non-response was defined as a serum thromboxane B2 (TXB2) ≤10 ng/mL. Aspirin dose was increased to 150 mg if a bedside VerifyNow test suggested non-response (test value ≥ 550 arachidonic acid reactive units [ARU]) at 18-24 weeks. Adherence was assessed by self-report. RESULTS: Based on serum TXB2, response rates were 85.3 % at 18-24 weeks and 79.3 % at 32-36 weeks' gestation. Compared to serum TXB2, the VerifyNow test demonstrated moderate test performance (AUC 0.79 95 % CI 0.71-0.88, p < 0.0001) to detect non-response. High prevalence of non-adherence (6/10) was evident in persistent non-response group. Dose change from 75 to 150 mg of aspirin in adherent participants improved response (VerifyNow: 598 [95 % CI 550-665] ARU at 18-24 weeks on 75 mg aspirin, 509 [95 % CI 350-667] at 32-36 weeks on 150 mg of aspirin, [p < 0.0001]). CONCLUSIONS: Non-response to LDA is common in pregnancy but appears to be largely attributable to non-adherence. Dose change could be useful to improve response to LDA in this cohort.