Shaunfield Sara, Yount Susan E, Boyken Lara, Agulnik Mark, Samant Sandeep, Cella David
Department of Medical Social Sciences Northwestern University Feinberg School of Medicine Chicago Illinois USA.
Buehler Center on Aging, Health and Society Northwestern University Feinberg School of Medicine Chicago Illinois USA.
Health Sci Rep. 2021 Oct 19;4(4):e401. doi: 10.1002/hsr2.401. eCollection 2021 Dec.
Patients with recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) experience vast disease and treatment burdens. Brief, focused instruments are needed to assess patient-reported priority symptoms and concerns as targeted outcome assessments for use in clinical research. Although the instrument was developed based on expert and patient input and is psychometrically valid, the Functional Assessment of Cancer Therapy (FACT)/National Comprehensive Cancer Network (NCCN) Head and Neck Symptom Index-10 (FHNSI-10) has yet to undergo content validation from the perspective of R/M SCCHN patients to evaluate its use as a brief symptom-focused targeted endpoint assessment for use in clinical research.
Interviews conducted with R/M SCCHN patients explored priority symptoms and concerns, followed by cognitive debriefing of the FHNSI-10 to evaluate face validity. Transcripts were analyzed, and results were mapped to the FHNSI-10. In accordance with published recommendations, expert input from the original development and published literature was considered for content validity assessment.
A total of 18 patients participated in a concept elicitation interview; saturation was obtained at interview 17. Most (83%) were undergoing active treatment, male (94%), white (72%), and did not have a college degree (67%). The most commonly mentioned symptoms were lumps/swelling, pain, sore throat, difficulty swallowing, and voice changes. For all items, ≥75% reported each question was relevant to their R/M SCCHN experience and 94% reported the instrument captured their experiences with R/M SCCHN.
Results provide support for the content validity of the FHNSI-10, inasmuch as all 10 items were spontaneously reported and considered relevant to R/M SCCHN. Content validity might be enhanced by adding cough and hearing impairment items; however, the existing FHNSI-10 covers the majority of symptoms uncovered in interviews with a small sample of R/M SCCHN patients.
复发性和/或转移性头颈部鳞状细胞癌（R/M SCCHN）患者承受着巨大的疾病和治疗负担。需要简短、有针对性的工具来评估患者报告的优先症状和担忧，作为临床研究中使用的靶向结局评估。尽管该工具是基于专家和患者的意见开发的，并且在心理测量学上是有效的，但癌症治疗功能评估（FACT）/美国国立综合癌症网络（NCCN）头颈部症状指数-10（FHNSI-10）尚未从R/M SCCHN患者的角度进行内容验证，以评估其作为临床研究中简短的以症状为重点的靶向终点评估的用途。
对R/M SCCHN患者进行访谈，探讨优先症状和担忧，随后对FHNSI-10进行认知反馈，以评估表面效度。对访谈记录进行分析，并将结果映射到FHNSI-10。根据已发表的建议，考虑原始开发和已发表文献中的专家意见进行内容效度评估。
共有18名患者参与了概念引出访谈；在第17次访谈时达到饱和。大多数（83%）患者正在接受积极治疗，男性（94%），白人（72%），且没有大学学历（67%）。最常提到的症状是肿块/肿胀、疼痛、喉咙痛、吞咽困难和声音变化。对于所有项目，≥75%的患者报告每个问题与他们的R/M SCCHN经历相关，94%的患者报告该工具能够体现他们的R/M SCCHN经历。
结果为FHNSI-10的内容效度提供了支持，因为所有10个项目都是患者自发报告的，并且被认为与R/M SCCHN相关。通过增加咳嗽和听力障碍项目可能会提高内容效度；然而，现有的FHNSI-10涵盖了对一小部分R/M SCCHN患者访谈中发现的大多数症状。
