Lisembard Gabrielle, Rochoy Michaël, Quersin François, Deken Valérie, Duhamel Alain, Descamps Axel, Berkhout Christophe, Serman Fanny
Department of General Medicine, School of Medicine, Lille University, Lille, France.
ULR 2694 - METRICS, University Hospital Lille, Lille University, Lille, France.
BMC Res Notes. 2025 Mar 24;18(1):123. doi: 10.1186/s13104-025-07186-3.
The PaCUDAHL randomized clinical trial evaluated an HPV self-sampling device provided by the family doctor to female patients not participating in the usual opportunistic cervical screening program from 2016 to 2019. Reliable data on the Hawthorne (observer) effect (HE) in clinical trials were lacking. This nested study aimed to verify whether there was a significant difference between participating and non-participating general practitioners (GPs) in the trial, and to measure whether there was an HE in the female patients of participating GPs.
We carried out an analytical retrospective cohort study involving 332 GPs and their 70,983 female patients, aged 25-65, registered with the Health Insurance Fund of Flanders, using claims database for the three-year periods 2012-2015 and 2016-2019. Statistical analyses were performed using a linear generalized hierarchical mixed model with geographic level as a random effect. The patients of the 24 participating GPs did not have a cervical cancer screening rate different from that of the non-participating GPs, either before recruitment (p = 0.24) or during the PaCUDAHL trial period (p = 0.15). There were significant increases in cervical cancer screening rates over four years regardless of the group considered (p < 0.0001). In conclusion there was no observer effect but a significant cohort effect.
帕库达尔随机临床试验评估了家庭医生向2016年至2019年未参加常规机会性宫颈筛查项目的女性患者提供的一种人乳头瘤病毒（HPV）自检装置。临床试验中缺乏关于霍桑（观察者）效应（HE）的可靠数据。这项嵌套研究旨在验证参与试验和未参与试验的全科医生（GP）之间是否存在显著差异，并衡量参与试验的全科医生的女性患者中是否存在霍桑效应。
我们进行了一项分析性回顾性队列研究，涉及332名全科医生及其在弗拉芒健康保险基金注册的70983名年龄在25至65岁之间的女性患者，使用了2012 - 2015年和2016 - 2019年这两个三年期的理赔数据库。使用以地理区域为随机效应的线性广义分层混合模型进行统计分析。在招募前（p = 0.24）或帕库达尔试验期间（p = 0.15），24名参与试验的全科医生的患者宫颈癌筛查率与未参与试验的全科医生的患者相比没有差异。无论考虑哪个组，四年内宫颈癌筛查率都有显著提高（p < 0.0001）。总之，不存在观察者效应，但存在显著的队列效应。
