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

Abstract

<div class="section"> <a class="named-anchor" id="S1"> <!-- named anchor --> </a> <h5 class="section-title" id="d7756227e216">Objective</h5> <p id="P3">To identify the reasons underlying women’s refusal to participate in a pregnancy trial and to identify ways of increasing recruitment. </p> </div><div class="section"> <a class="named-anchor" id="S2"> <!-- named anchor --> </a> <h5 class="section-title" id="d7756227e221">Design</h5> <p id="P4">Mixed methods study using a questionnaire and qualitative interviews.</p> </div><div class="section"> <a class="named-anchor" id="S3"> <!-- named anchor --> </a> <h5 class="section-title" id="d7756227e226">Sample</h5> <p id="P5">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. </p> </div><div class="section"> <a class="named-anchor" id="S4"> <!-- named anchor --> </a> <h5 class="section-title" id="d7756227e231">Results</h5> <p id="P6">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. </p> </div><div class="section"> <a class="named-anchor" id="S5"> <!-- named anchor --> </a> <h5 class="section-title" id="d7756227e236">Conclusions</h5> <p id="P7">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. </p> </div>