Department of Public Health and Primary Care, University of Leuven, Biomedical Quality Assurance Research Unit, Leuven, Belgium.
Laboratory of Pathological Anatomy, Antwerp University Hospital, Edegem, Belgium.
BMC Cancer. 2022 Jul 6;22(1):736. doi: 10.1186/s12885-022-09798-5.
For patients with non-small cell lung cancer (NSCLC), targeted therapies are becoming part of the standard treatment. It is of question which information the clinicians provide on test requests and how the laboratories adapt test conclusions to this knowledge and regulations.
This study consisted of two components; 1) checking the presence of pre-defined elements (administrative and key for therapy-choice) on completed requests and corresponding reports in Belgian laboratories, both for tissue- and liquid biopsy (LB)-testing and b) opinion analysis from Belgian pathologists/molecular biologists and clinicians during national pathology/oncology meetings.
Data from 4 out of 6 Belgian laboratories with ISO-accreditation for LB-testing were analyzed, of which 75% were university hospitals. On the scored requests (N = 4), 12 out of 19 ISO-required elements were present for tissue and 11 for LB-testing. Especially relevant patient history, such as line of therapy (for LB), tumor histology and the reason for testing were lacking. Similarly, 11 and 9 out of 18 elements were present in the reports (N = 4) for tissue and LB, respectively. Elements that pathologists/molecular biologists (N = 18) were missing on the request were the initial activating mutation, previous therapies, a clinical question and testing-related information. For reporting, an item considered important by both groups is the clinical interpretation of the test result. In addition, clinicians (N = 28) indicated that they also wish to read the percentage of neoplastic cells.
Communication flows between the laboratory and the clinician, together with possible pitfalls were identified. Based on the study results, templates for complete requesting and reporting were proposed.
对于非小细胞肺癌 (NSCLC) 患者，靶向治疗正在成为标准治疗的一部分。目前还不清楚临床医生在检测申请中提供了哪些信息，以及实验室如何根据这些知识和规定调整检测结论。
本研究由两部分组成；1）检查比利时实验室中组织和液体活检（LB）检测完成的申请和相应报告中是否存在预定义的元素（管理和治疗选择关键）；2）在全国病理/肿瘤学会议期间，对来自比利时病理学家/分子生物学家和临床医生的意见进行分析。
对具有 LB 检测 ISO 认证的 6 家比利时实验室中的 4 家的数据进行了分析，其中 75%是大学医院。在评分申请（N=4）中，组织和 LB 检测分别有 19 个 ISO 要求的元素中的 12 个和 11 个。特别重要的患者病史，如治疗线（对于 LB）、肿瘤组织学和检测原因，都没有提供。同样，组织和 LB 报告（N=4）中分别有 11 个和 9 个元素。病理学家/分子生物学家（N=18）在申请中遗漏的元素是初始激活突变、先前的治疗、临床问题和与检测相关的信息。对于报告，临床医生（N=28）表示他们还希望阅读检测结果的临床解释。此外，临床医生还希望阅读肿瘤细胞的百分比。
确定了实验室和临床医生之间的沟通流程以及可能存在的缺陷。基于研究结果，提出了完整申请和报告的模板。
