Department of Ophthalmology, University Hospital Bonn, Bonn, Germany.
Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany.
BMC Med Res Methodol. 2021 Mar 17;21(1):54. doi: 10.1186/s12874-021-01243-8.
Recruiting asymptomatic participants with early disease stages into studies is challenging and only little is known about facilitators and barriers to screening and recruitment of study participants. Thus we assessed factors associated with screening rates in the MACUSTAR study, a multi-centre, low-interventional cohort study of early stages of age-related macular degeneration (AMD).
Screening rates per clinical site and per week were compiled and applicable recruitment factors were assigned to respective time periods. A generalized linear mixed-effects model including the most relevant recruitment factors identified via in-depth interviews with study personnel was fitted to the screening data. Only participants with intermediate AMD were considered.
A total of 766 individual screenings within 87 weeks were available for analysis. The mean screening rate was 0.6 ± 0.9 screenings per week among all sites. The participation at investigator teleconferences (relative risk increase 1.466, 95% CI [1.018-2.112]), public holidays (relative risk decrease 0.466, 95% CI [0.367-0.591]) and reaching 80% of the site's recruitment target (relative risk decrease 0.699, 95% CI [0.367-0.591]) were associated with the number of screenings at an individual site level.
Careful planning of screening activities is necessary when recruiting early disease stages in multi-centre observational or low-interventional studies. Conducting teleconferences with local investigators can increase screening rates. When planning recruitment, seasonal and saturation effects at clinical site level need to be taken into account.
ClinicalTrials.gov NCT03349801 . Registered on 22 November 2017.
招募处于疾病早期阶段且无症状的参与者参与研究具有挑战性，人们对筛查和招募研究参与者的促进因素和障碍知之甚少。因此，我们评估了 MACUSTAR 研究中与筛查率相关的因素，该研究是一项多中心、低干预性的年龄相关性黄斑变性（AMD）早期阶段的队列研究。
编译了每个临床站点和每周的筛查率，并将适用的招募因素分配到相应的时间段。通过对研究人员进行深入访谈，确定了最相关的招募因素，并将其纳入广义线性混合效应模型，对筛查数据进行拟合。仅考虑患有中间型 AMD 的参与者。
共有 766 例个体筛查在 87 周内可供分析。所有站点的平均筛查率为每周 0.6±0.9 次筛查。参加研究人员电话会议（相对风险增加 1.466，95%置信区间[1.018-2.112]）、公共假期（相对风险降低 0.466，95%置信区间[0.367-0.591]）和达到 80%的站点招募目标（相对风险降低 0.699，95%置信区间[0.367-0.591]）与个体站点水平的筛查次数相关。
在多中心观察性或低干预性研究中招募疾病早期阶段时，需要仔细规划筛查活动。与当地研究人员进行电话会议可以提高筛查率。在规划招募时，需要考虑临床站点水平的季节性和饱和效应。
ClinicalTrials.gov NCT03349801。于 2017 年 11 月 22 日注册。
