Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Medical Sociology and Rehabilitation Science, Charitéplatz 1, 10117, Berlin, Germany.
Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Biometry and Clinical Epidemiology, Charitéplatz 1, 10117, Berlin, Germany.
BMC Cancer. 2022 May 18;22(1):560. doi: 10.1186/s12885-022-09646-6.
Given the psychosocial burdens patients in advanced stages of cancer face, innovative care concepts are needed. At the same time, such vulnerable patient groups are difficult to reach for participation in intervention studies and randomized patient inclusion may not be feasible. This article aims to identify systematic biases respectively selection effects occurring during the recruitment phase and to discuss their potential causes based on a non-randomized, multicenter intervention study with patients in advanced stages of cancer.
Patients diagnosed with at least one of 16 predefined cancers were recruited at four hospitals in three German cities. The effect of social care nurses' continuous involvement in acute oncology wards was measured by health-related quality of life (EORTC QLQ-C30), information and participation preferences, decisional conflicts, doctor-patient communication, health literacy and symptom perception. Absolute standardized mean difference was calculated as a standardized effect size to test baseline characteristics balance between the intervention and control groups.
The study enrolled 362 patients, 150 in the intervention and 212 in the control group. Except for gender, both groups differed in relevant socio-demographic characteristics, e.g. regarding age and educational background. With respect to the distribution of diagnoses, the intervention group showed a higher symptom burden than the control group. Moreover, the control group reported better quality of life at baseline compared to the intervention group (52.6 points (SD 21.7); 47.8 points (SD 22.0), ASMD = 0.218, p = 0.044).
Overall, the intervention group showed more social and health vulnerability than the control group. Among other factors, the wide range of diagnoses included and structural variation between the recruiting clinics increased the risk for bias. We recommend a close, continuous monitoring of relevant social and health-related characteristics during the recruitment phase as well as the use of appropriate statistical analysis strategies for adjustment, such as propensity score methods.
German Clinical Trials Register (DRKS-ID: DRKS00013640 ); registered on 29th December 2017.
鉴于晚期癌症患者面临的心理社会负担，需要创新的护理理念。与此同时，这些弱势群体患者群体很难参与干预研究，随机患者纳入可能不可行。本文旨在确定在招募阶段发生的系统偏差和选择效应，并基于一项非随机、多中心的晚期癌症患者干预研究，讨论其潜在原因。
在德国三个城市的四家医院招募了至少被诊断患有 16 种预定癌症之一的患者。通过健康相关生活质量（EORTC QLQ-C30）、信息和参与偏好、决策冲突、医患沟通、健康素养和症状感知，来衡量社会护理护士在急性肿瘤病房持续参与的效果。绝对标准化均数差被计算为标准化效应大小，以检验干预组和对照组之间的基线特征平衡。
该研究共纳入 362 名患者，其中 150 名患者接受干预，212 名患者接受对照组。除了性别，两组在相关社会人口统计学特征上存在差异，例如年龄和教育背景。在诊断分布方面，干预组的症状负担高于对照组。此外，与干预组相比，对照组在基线时报告的生活质量更好（52.6 分（SD 21.7）；47.8 分（SD 22.0），ASMD=0.218，p=0.044）。
总体而言，干预组比对照组表现出更多的社会和健康脆弱性。除其他因素外，纳入的诊断范围广泛以及招募诊所之间的结构差异增加了偏倚的风险。我们建议在招募阶段密切、持续监测相关的社会和健康特征，并使用适当的统计分析策略进行调整，例如倾向评分方法。
德国临床试验注册处（DRKS-ID：DRKS00013640）；注册于 2017 年 12 月 29 日。
