目标:鉴于癌症晚期患者面临的心理社会负担,需要创新的护理理念。同时,这些脆弱的患者群体很难参与干预研究,随机纳入患者可能不可行.本文旨在确定在招募阶段发生的系统性偏见,分别选择效应,并基于非随机,晚期癌症患者的多中心干预研究。
方法:在德国三个城市的四家医院招募了被诊断患有16种预定义癌症中至少一种的患者。通过健康相关生活质量(EORTCQLQ-C30)衡量社会护理护士持续参与急性肿瘤科病房的效果,信息和参与偏好,决策冲突,医患沟通,健康素养和症状感知。将绝对标准化平均差异计算为标准化效应大小,以测试干预组和对照组之间的基线特征平衡。
结果:该研究招募了362名患者,干预组150人,对照组212人。除了性别,两组在相关的社会人口统计学特征上有所不同,例如关于年龄和教育背景。关于诊断的分布,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了更好的生活质量(52.6分(SD21.7);47.8分(SD22.0),ASMD=0.218,p=0.044)。
结论: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,包括的诊断范围广泛,以及招募诊所之间的结构差异增加了偏倚的风险.我们建议关闭,在招聘阶段持续监测相关的社会和健康相关特征,并使用适当的统计分析策略进行调整,如倾向评分法。
背景:德国临床试验注册(DRKS-ID:DRKS00013640);注册于2017年12月29日。
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
BACKGROUND: German Clinical Trials Register (DRKS-ID: DRKS00013640 ); registered on 29th December 2017.