Faculty of Education, Health and Human Sciences, School of Human Sciences, University of Greenwich, Park Row, London, SE10 9LS, UK.
Nutritional Epidemiology Observatory, Department of Social and Applied Nutrition, Institute of Nutrition Josué de Castro, Rio de Janeiro Federal University, Rio de Janeiro, Brazil.
Trials. 2020 Mar 5;21(1):244. doi: 10.1186/s13063-020-4142-5.
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.
A mixed-method sequential exploratory design was applied. Qualitative and quantitative data on recruitment to a 2 × 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.
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.
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.
ClinicalTrials.gov, NCT03148483. Registered on 11 May 2017.
在低收入城市社区开展研究存在困难，但有关如何应对这些挑战的方法学挑战和建议往往没有记录。本研究的目的是描述招募和纳入患有牙周炎的低收入孕妇参加维生素 D/钙强化牛奶和牙周治疗的临床试验的挑战，并描述与女性不合格和拒绝参与研究相关的患者、研究方案和环境因素。
采用混合方法序贯探索性设计。使用关于 2×2 因子可行性临床试验招募的定性和定量数据。18 名在巴西里约热内卢杜奎德卡西亚斯（Duque de Caxias）低收入地区保健中心就诊的妇女参加了焦点小组讨论，对数据进行了主题分析。使用适当的描述性统计方法（包括绝对和相对频率）对定量数据进行了分析。
在所有转介（767 人）中，548 人（78.5%）不符合最初的入选标准。排除的主要原因（58%）是首次产前预约时的孕龄较大（>20 周）。在牙周检查（牙齿筛查）中，排除的主要原因是广泛的龋齿（127 例排除中 64 例）。牙周检查合格但未参与的人数约为 24%（92 名合格妇女中的 22 名），主要与患者相关的障碍有关（例如交通障碍、家庭责任、患者不响应电话和电话断线）。该研究在 53 周内招募了 70 名患有牙周炎的妇女，未能在 36 周内达到 120 名妇女的基准（原始目标的 58.3%）。由于总罢工，保健中心关闭严重阻碍了招募工作。招募的产率为首次产前就诊时接触的所有女性的 9.1%（70/767），以及筛查合格并纳入试验的女性的 76.1%（70/92）。女性没有报告对随机分配的担忧，并认为强化牛奶是一种有益于孕妇健康和安全的食物。一些女性报告说，经济限制（例如交通费用）可能会阻碍参与研究。
研究团队与保健中心工作人员（例如护士）之间的合作促进了转介和招募，但一些孕妇未能参与研究，主要是由于与患者相关的重大社会人口学障碍和环境因素。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。
ClinicalTrials.gov，NCT03148483。于 2017 年 5 月 11 日注册。
