Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.
J Patient Rep Outcomes. 2024 Jul 9;8(1):68. doi: 10.1186/s41687-024-00752-6.
The NFLymSI-18 is a patient-reported outcome measure comprised of the highest priority symptoms, emotional concerns, treatment side effects, and other concerns identified by lymphoma patients and oncologists. This study assessed the content validity of the NFLymSI-18 for patients with indolent B-cell non-Hodgkin's lymphoma (iNHL), with a focus on the Disease-Related Symptoms Physical (DRS-P) subscale.
Patients with a confirmed iNHL diagnosis who had received one or more lines of treatment were recruited during clinic visits. Patients described their symptoms, treatment side effects, and emotional concerns related to iNHL in a semi-structured interview. Qualitative data were analyzed using NVivo10.
Data saturation was obtained by the 18th interview. Most participants (67%) had follicular lymphoma. 28% of participants had marginal zone lymphoma, and one participant had lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia. Mean age of the 18 participants was 67 years. 56% of the sample was male. Most participants (67%) had a college or advanced degree. When asked to describe their iNHL symptoms, patients most often discussed swelling (n = 14), fatigue (n = 11), and pain (n = 8). The following symptoms were mentioned by three patients each: anxiety, appetite loss, rash, sleep disruption, trouble breathing, and malaise. Mapping of NFLymSI-18 content to these concerns showed the instrument includes all those most frequently mentioned symptoms.
This study supports the content validity of the NFLymSI-18, including its DRS-P Subscale, for patients with iNHL. The instrument shows strong validity for the most referenced symptoms of swelling, fatigue, and pain. The diversity of additional symptoms reported by patients is consistent with the heterogeneous symptomology of iNHL.
NFLymSI-18 是一种患者报告的结局测量工具,由淋巴瘤患者和肿瘤学家确定的最高优先级症状、情绪问题、治疗副作用和其他关注点组成。本研究评估了 NFLymSI-18 对惰性 B 细胞非霍奇金淋巴瘤(iNHL)患者的内容效度,重点是疾病相关症状身体(DRS-P)子量表。
在就诊期间招募了已确诊 iNHL 并接受过一次或多次治疗的患者。患者在半结构化访谈中描述了他们与 iNHL 相关的症状、治疗副作用和情绪问题。使用 NVivo10 对定性数据进行分析。
第 18 次访谈获得了数据饱和。大多数参与者(67%)患有滤泡性淋巴瘤。28%的参与者患有边缘区淋巴瘤,1 名参与者患有淋巴浆细胞样淋巴瘤/华氏巨球蛋白血症。18 名参与者的平均年龄为 67 岁。样本中 56%为男性。大多数参与者(67%)具有大学或高等学历。当被要求描述他们的 iNHL 症状时,患者最常讨论肿胀(n=14)、疲劳(n=11)和疼痛(n=8)。以下症状有 3 名患者提到:焦虑、食欲减退、皮疹、睡眠中断、呼吸困难和不适。NFLymSI-18 内容与这些问题的映射表明,该工具包含了最常提到的症状。
这项研究支持 NFLymSI-18 的内容效度,包括其 DRS-P 子量表,适用于 iNHL 患者。该工具对肿胀、疲劳和疼痛等最常提及的症状具有很强的有效性。患者报告的其他额外症状的多样性与 iNHL 的异质性症状一致。