Table_5_Defining a Standard Set of Health Outcomes for Patients With Squamous Cell Carcinoma of the Head and Neck in Spain.docx

PurposeA systematic, standardized collection of health outcomes during patient treatment and follow-up, relevant from the perspective of all stakeholders, is a crucial step toward effective and efficient disease management. This project aimed to define a standard set of health outcomes for patients with squamous cell carcinoma of the head and neck (SCCHN).
MethodsThe project was led and coordinated by a scientific committee (SC). It comprised: (1) a literature review (to identify variables used during SCCHN management); (2) 1st-SC meeting (to select the variables for presentation during nominal groups-NG); (3) five NG (n=42 experts) and four interviews with patients (to reach consensus on the variables for inclusion); and (4) final-SC meeting (to review the results of NG ensuring consensus on the variables where consensus was not reached).
ResultsExperts agreed to include the following variables in the standard set: treatment-related (treatment intent and type, response to treatment, treatment toxicity/complication, treatment completion), degree of health (performance status, patient-reported health status, pain, dysphonia, feeding and speech limitations, body image alteration, tracheotomy), survival (overall and progression-free survival, cause of death), nutritional (weight, nutritional intervention), other variables (smoking status, alcohol consumption, patient satisfaction with aftermath care, employment status), and case-mix variables (demographic, tumor-related, clinical and nutritional factors).
ConclusionsThis project may pave the way to standardizing the collection of health outcomes in SCCHN and promote the incorporation of patients’ perspective in its management. The information provided through the systematic compilation of this standard set may define strategies to achieve high-quality, patient-centered care.

研究背景与目的：系统性、标准化收集患者治疗及随访期间的健康结局，并兼顾所有利益相关方视角，是实现高效优质疾病管理的关键环节。本研究旨在为头颈部鳞状细胞癌（squamous cell carcinoma of the head and neck, SCCHN）患者制定一套标准化健康结局指标集。
研究方法：本项目由科学委员会（scientific committee, SC）牵头统筹，研究内容包括：（1）文献综述：梳理头颈部鳞状细胞癌临床管理中涉及的变量；（2）首次科学委员会会议：遴选将在名义小组法（nominal groups, NG）研讨环节展示的变量；（3）5次名义小组研讨（共纳入42名专家）与4次患者访谈：就纳入的变量达成共识；（4）最终科学委员会会议：审核名义小组研讨结果，针对未达成共识的变量进一步确认共识。
研究结果：专家共识将以下变量纳入标准化指标集：①治疗相关变量：治疗意图与方案类型、治疗应答情况、治疗毒性/并发症、治疗完成情况；②健康状况相关变量：体能状态（performance status）、患者自评健康状况、疼痛、发声困难（dysphonia）、进食与言语功能受限、体像改变、气管切开术（tracheotomy）；③生存相关变量：总生存期（overall survival）、无进展生存期（progression-free survival）、死亡原因；④营养相关变量：体重、营养干预措施；⑤其他变量：吸烟状态、饮酒情况、患者对后续护理的满意度、就业状况；⑥病例组合变量：人口学特征、肿瘤相关因素、临床与营养相关因素。
研究结论：本项目可为头颈部鳞状细胞癌患者健康结局的标准化收集奠定基础，并推动在临床管理中纳入患者视角。通过系统性汇编该标准化指标集所获得的信息，可为制定高质量、以患者为中心的诊疗策略提供依据。