Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial
Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial
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DOI：
10.1186/s13063-020-4142-5
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发表时间：
2020-03-05
期刊：
影响因子：
2.5
通讯作者：
Heitmann, Berit L.
中科院分区：
文献类型：
--
作者：
Adegboye, Amanda Rodrigues Amorim;Cocate, Paula G.;Heitmann, Berit L.
背景在低收入城市社区开展研究存在困难，但方法上的挑战和如何应对这些挑战的建议往往没有记录。本研究的目的是描述招募和登记低收入孕妇牙周炎的维生素D/钙奶强化和牙周治疗的临床试验的挑战，并描述患者，研究方案和设置相关的因素，妇女的不合格和拒绝参加研究。方法采用混合方法序贯探索性设计。使用了2x2析因可行性临床试验招募的定性和定量数据。在Duque de卡希亚斯（巴西里约热内卢）低收入地区的保健中心就诊的18名妇女参加了重点小组讨论，并对数据进行了专题分析。使用适当的描述性统计分析定量数据，包括绝对和相对频率。结果767例患者中，548例（78.5%）不符合初始入选标准。排除的主要原因（58%）是第一次产前预约时的孕龄（> 20周）。在牙周检查（牙科筛查）中，排除的主要原因是存在广泛的龋齿（127例排除中有64例）。在牙周检查后，约有24%（92名符合条件的女性中有22名）的患者不参加，主要与患者相关的障碍有关（例如交通障碍，家庭义务，患者对电话无反应和电话断线）。该研究在53周内招募了70名患有牙周炎的女性，但没有达到36周内招募120名女性的基准（最初目标的58.3%）。由于总罢工，保健中心关闭，招募工作受到严重阻碍。招募率为9.1%（70/767）的所有妇女在第一次产前访视和76.1%（70/92）的筛选合格和参加试验。妇女没有报告对随机分配的担忧，并认为强化牛奶是孕妇健康和安全的食品。一些妇女报告说，财政限制（如交通费）可能会阻碍她们参与研究。结论研究团队和健康中心工作人员（如护士）之间的接触促进了转诊和招聘，但一些孕妇未能参加这项研究，主要是由于显着的患者相关的社会人口学障碍和设置相关因素。我们的数据说明了在资源有限的环境中克服临床试验招募和入组挑战的复杂性。
Background There are difficulties in carrying out research in low-income urban communities, but the methodological challenges and suggestions on how to deal with them are often undocumented. The aims of this study are to describe the challenges of recruiting and enrolling low-income pregnant women with periodontitis to a clinical trial on vitamin D/calcium milk fortification and periodontal therapy and also to describe the patient-, study protocol- and setting-related factors related to women's ineligibility and refusal to participate in the study. Methods A mixed-method sequential exploratory design was applied. Qualitative and quantitative data on recruitment to a 2 x 2 factorial feasibility clinical trial were used. Eighteen women attending the health centre in a low-income area in Duque de Caxias (Rio de Janeiro, Brazil) took part in focus group discussions, and the data were thematically analysed. Quantitative data were analysed using appropriate descriptive statistics, including absolute and relative frequencies. Results Of all referrals (767), 548 (78.5%) did not meet the initial eligibility criteria. The main reason for exclusion (58%) was advanced gestational age (> 20 weeks) at first prenatal appointment. In the periodontal examination (dental screen), the main reason for exclusion was the presence of extensive caries (64 out of 127 exclusions). Non-participation of those eligible after the periodontal examination was approximately 24% (22 out 92 eligible women) and predominantly associated with patient-related barriers (e.g. transportation barriers, family obligations, patients being unresponsive to phone calls and disconnected telephones). The study recruited 70 women with periodontitis in 53 weeks and did not reach the benchmark of 120 women in 36 weeks (58.3% of the original target). Recruitment was severely hindered by health centre closures due to general strikes. The recruitment yields were 9.1% (70/767) of all women contacted at first prenatal visit and 76.1% (70/92) of those screened eligible and enrolled in the trial. Women did not report concerns regarding random allocation and considered fortified milk as a healthful and safe food for pregnant women. Some women reported that financial constraints (e.g. transportation costs) could hinder participation in the study. Conclusion Engagement between the research team and health centre staff (e.g. nurses) facilitated referral and recruitment, yet some pregnant women failed to participate in the study largely due to significant patient-related sociodemographic barriers and setting-related factors. Our data illustrate the complexity of overcoming recruitment and enrolment challenges for clinical trials in resource-limited settings.