We identified that there was a lack of patient information around the risks and benefits of thromboprophylaxis in VTE during pregnancy and the puerperium. This influenced how women perceived future trial participation. Due to lack of understanding of risks associated with thromboprophylaxis, participants perceived entering a trial could result in them receiving placebo which they perceived as having treatment withheld, having previously assumed their clinician had provided an effective treatment. Patients with VTE risk factors other than previous VTE, were often unaware of why they had been given thromboprophylaxis but still perceived receiving a placebo as an inferior option. Both groups reported lack of information about the risks and benefits of pharmacological thromboprophylaxis.
Women described having their concerns minimised and ignored by healthcare professionals, particularly their concerns about side-effects of injecting. These poor care experiences motivated women to participate in future trials to receive a higher standard of monitoring and care, as well as providing an opportunity to improve future care for others. Adherence to treatment may be affected by negative experiences of injecting and limited understanding of reasons why they had been offered thromboprophylaxis.
Other studies have focused on barriers and enablers to trial participation within women who were pregnant and post-partum and identified similar barriers. Van der Zande et al (2018) undertook a systematic review of women’s reasons for participating in research and identified a reluctance to take placebos as part of an RCT and disbelief in equipoise, wanting reassurance that they would receive the intervention (18). This suggests that the limited understanding of evidence-base and risk/benefit profiles of treatments applies to wider contexts. They similarly identified that indirect benefits, including additional monitoring or receiving better treatment were incentives to taking part in trials, particularly for more invasive interventions, which reflects our findings that women were motivated to participate in future trials to receive a higher standard of care. They also highlighted discomfort due to tests such as needle pricks as being a barrier to participation.
Stromner et al identified that women who were likely to take part in clinical trials during pregnancy had prior knowledge of the importance of the study topic, with women who declined participation having limited previous knowledge (19). This supports our finding that limited knowledge about the risks and benefits of VTE thromboprophylaxis may limit adherence or participation in trials.
Smyth identified that pregnant women were more likely to take part in trials when they had high levels of trust in clinicians, suggesting that clinicians have a key role to play in providing appropriate information and influencing women’s decisions to take part. (20) Hanrahan et al reported a ‘recruiter knows best’ attitude of healthcare professionals in recruiting pregnant women to trials, and paternalistic language suggesting a power imbalance between healthcare professionals and pregnant women. Indeed, much of the qualitative evidence of barriers to trial recruitment currently focusses on healthcare professional views of barriers to recruitment. (20–24) Improved provision of evidence-based information on the risks and benefits of treatment may help to address this imbalance of power.
Strengths and limitations
These focus groups asked women with previous, often recent, experience of being offered thromboprophylaxis during pregnancy for their views of trial recruitment in an area where they had experience. The focus groups offered opportunities for interaction which enabled participants to focus on areas that were important to them (e.g. side-effects of injecting) which helped to reveal important aspects of patient experience that were previously under-estimated or disregarded. However, this focus did mean that less time was dedicated to exploring individual perspectives about involvement in clinical trials than may have been possible had we used semi-structured interviews.
Although we aimed to recruit a diverse group of participants, the participants recruited were predominately white and highly educated, which reduces the transferability of findings to other groups. Recruitment via user groups may mean our sample had a higher level of health literacy and engagement with research than the general population. Despite attempts to recruit from non-dominant ethnic groups, none of our respondents who provided demographic details identified themselves as black or mixed/multiple ethnic groups, two identified as Asian/Asian British and 20 as White/Caucasian. Due to the Covid-19 pandemic our recruitment approaches were impersonal (i.e. social media, email), focus groups were conducted in English and materials were not made available in other languages which may have been potential barriers for recruitment from non-dominant ethnic groups. (Ref Rooney). However, given that improved communication has been highlighted as key to improving trial recruitment, it is likely that the biased sample may under-represent some of the concerns that would be held within a more diverse population.
Most participants had recent experience of childbirth and/or thromboprophylaxis and were able to provide their theoretical perspective of what would be important to them when being recruited to a trial. Inclusion of nulliparous women or those with no prior experience of being offered thromboprophylaxis would have enabled a more naïve stance that reflects likely future trial participants. However, perspectives of nulliparous women may have over-estimated likelihood of trial engagement due to lack of awareness of the realities of childbirth or post-partum experiences.
Although we aimed to focus on future trial participation, women focussed on their past experiences which shaped their motivations to be involved in future trials. Future trials attempting to recruit nulliparous participants may be more successful, as women may be more open to understanding equipoise, particularly for those without prior VTE. Although we asked for participants who had been offered thromboprophylaxis, we had few respondents who had been offered but refused thromboprophylaxis, which limits transferability of findings to this group.
Implications
Pregnant women receive limited information about VTE or risks and benefits of thromboprophylaxis during pregnancy or post-partum and those without prior VTE often do not understand why they have been given the treatment. Clearer information about the risks and benefits of thromboprophylaxis and an increased understanding of the rationale behind treatment may improve treatment adherence and recruitment and adherence to trials. Improved communication may also improve the experience and treatment adherence for women currently being offered thromboprophylaxis.
Negative experiences associated with injections were important to the women in this study yet minimised by healthcare professionals. In order to maximise participation in trials and reduce attrition these concerns need to recognised and addressed, not dismissed. Provision of honest information about potential side-effects of injections, an understanding of what is ‘normal’ as well as advice about how to decrease potential side-effects (e.g. use of ice) may help women make informed choices about taking part in clinical trials, and complying with treatment.
Discussion of VTE during pregnancy as well as consideration of why thromboprophylaxis may be required is needed during pregnancy when women are more able to consider treatment options rationally, and discuss with partners, family and friends.