Department of Palliative Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
Department of Palliative Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
BMJ Open. 2022 Sep 1;12(9):e059598. doi: 10.1136/bmjopen-2021-059598.
A range of referral criteria and scores have been developed in recent years to help with screening for the need of specialist palliative care (SPC) in advanced, incurable cancer patients. However, referral criteria have not yet been widely implemented in oncology, as they usually need to be revised by physicians or nurses with limited time resources. To develop an easily applicable screening for the need for SPC in incurable cancer inpatients, we aim to (a) test inter-rater reliability of multiprofessional expert opinion as reference standard for SPC need (phase I) and (b) explore the diagnostic validity of selected patient-reported outcome measures (PROMs) and routine data for the need of SPC (phase II).
Inclusion criteria for patients are metastatic or locally advanced, incurable cancer, ≥18 years of age and informed consent by patient or proxy. (Exclusion criteria: malignant haematological disease as main diagnosis). In phase I, three palliative care consultation teams (PCTs) of three German university hospitals assess the SPC need of 20 patient cases. Fleiss' Kappa will be calculated for inter-rater reliability. In phase II, 208 patients are consecutively recruited in four inpatient oncology wards of Freiburg University Hospital. The PCT will provide assessment of SPC need. As potential referral criteria, patients complete PROMs and a selection of routine data on person, disease and treatment is documented. Logistic regression models and ROC analyses are employed to test their utility in screening for SPC need.
Our findings will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the Ethics Committee of Albert-Ludwigs-University Freiburg, Germany (approval no. 20-1103).
German Clinical Trials Register, DRKS00021686, registered on 17 December 2020.
近年来，已经开发出一系列转诊标准和评分，以帮助筛选需要接受晚期不可治愈癌症患者的专科姑息治疗（SPC）。然而，转诊标准尚未在肿瘤学中广泛实施，因为它们通常需要由时间资源有限的医生或护士进行修订。为了开发一种易于应用的筛选方法，以确定不可治愈的癌症住院患者是否需要 SPC，我们旨在：（a）测试多专业专家意见的组内一致性，作为 SPC 需求的参考标准（第 I 阶段）；（b）探索选定的患者报告结局测量（PROMs）和常规数据对 SPC 需求的诊断有效性（第 II 阶段）。
患者纳入标准为转移性或局部晚期、不可治愈的癌症，年龄≥18 岁，并获得患者或代理人的知情同意。（排除标准：恶性血液病作为主要诊断）。在第 I 阶段，三家德国大学医院的三个姑息治疗咨询团队（PCT）评估 20 例患者的 SPC 需求。将计算 Fleiss' Kappa 以评估组内一致性。在第 II 阶段，弗赖堡大学医院的四个住院肿瘤科病房连续招募 208 例患者。PCT 将提供 SPC 需求评估。作为潜在的转诊标准，患者完成 PROMs，并记录人员、疾病和治疗的选择常规数据。将使用逻辑回归模型和 ROC 分析来测试其在筛选 SPC 需求方面的效用。
我们的研究结果将发表在同行评议的期刊上，并在国家和国际科学会议和大会上展示。德国阿尔伯特-路德维希-弗莱堡大学伦理委员会批准了本研究（批准号：20-1103）。
德国临床试验注册中心，DRKS00021686，于 2020 年 12 月 17 日注册。
