目的:直肠癌治疗期间和之后的标准化患者报告结局(PRO)监测提供了对患者经历的治疗相关毒性的洞察,并改善了健康相关的生活质量以及总生存率。我们旨在选择PRO版本的不良事件通用术语标准(PRO-CTCAE)的子集,以标准化监测直肠癌中与治疗相关的症状毒性。
方法:我们使用了混合方法方法,包括文献综述,与参与直肠癌护理和直肠癌患者的医疗保健提供者(HCP)进行半结构化访谈。总结了文献和访谈的结果,并将其用于改良的Delphi程序中,以选择针对直肠癌的PRO-CTCAE子集。
结果:从文献中确定了26个PRO-CTCAE症状毒性。来自多个学科的15个HCP(医学,放射和外科肿瘤学),和一组由15名接受化疗和/或放疗和/或手术治疗的直肠癌患者组成的异质组,参加半结构化面试。10名HCP(67%)和9名患者(90%)参加了第一轮Delphi。最终选择的PRO-CTCAE核心子集包含16种症状毒性:\'腹泻\',\'大便失禁\',\'便秘\',\'腹部腹胀\',\'腹部疼痛\',\'呕吐\',\'性欲下降\',\'阴道性交时疼痛\',“实现和保持勃起的能力”,\'疲劳\',\'焦虑\',\'感觉没有什么能让你振作起来\',\'尿失禁\',\'排尿疼痛\',\'一般疼痛\',和“手足综合症”。
结论:基于综合混合方法研究,本研究确定了用于直肠癌标准化治疗相关症状毒性监测的PRO-CTCAE子集.建议使用该子集评估症状毒性监测的有效性和依从性。
OBJECTIVE: Standardized patient-reported outcomes (PRO) monitoring during and after rectal cancer treatment provides insight into treatment-related toxicities patients experience and improves health-related quality-of-life as well as overall survival. We aimed to select a subset of the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for standardized monitoring of treatment-related symptomatic toxicities in rectal cancer.
METHODS: We used a mixed methods approach including a literature review, and semi-structured interviews with health care providers (HCPs) involved in rectal cancer care and rectal cancer patients. Results from literature and interviews were summarized and used in a modified Delphi procedure to select a PRO-CTCAE subset specific for rectal cancer.
RESULTS: Twenty-six PRO-CTCAE symptomatic toxicities were identified from literature. Fifteen HCPs from multiple disciplines (medical, radiation and surgical oncology), and a heterogeneous group of fifteen rectal cancer patients treated with chemotherapy and/or radiotherapy and/or surgery, participated in semi-structured interviews. Ten HCPs (67%) and nine patients (90%) participated in the first Delphi round. The final selected PRO-CTCAE core-subset contained 16 symptomatic toxicities: \'diarrhea\', \'fecal incontinence\', \'constipation\',\'bloating of the abdomen\', \'pain in the abdomen\', \'vomiting\', \'decreased libido\', \'pain during vaginal sex\', \'ability to achieve and maintain erection\', \'fatigue\', \'anxiety\', \'feeling that nothing could cheer you up\', \'urinary incontinence\', \'painful urination\', \'general pain\', and \'hand-foot syndrome\'.
CONCLUSIONS: Based on a comprehensive mixed methods study, a PRO-CTCAE subset for standardized treatment-related symptomatic toxicity monitoring in rectal cancer was identified. Assessment of the effectiveness and compliance of symptomatic toxicity monitoring using this subset is recommended.