Patient-reported outcome measures used in prophylactic dysphagia intervention for head and neck cancer patients undergoing radiation therapy: a systematic review

The primary objective of this systematic review was to identify and assess the Patient Reported Outcome Measures (PROMs) used in studies of prophylactic dysphagia intervention for patients with head and neck cancer undergoing non-surgical treatments. A secondary objective was to evaluate the quality of the PROMs used in these intervention studies and examine the articles related to their development.
Five databases (MEDLINE via PubMed, Web of Science, Pro-Quest, CINHAL, and SCOPUS) were searched for intervention studies on dysphagia in head and neck cancer patients, initiated before or during radiation/chemoradiation, with at least one PROM outcome. Studies on the psychometric development of identified PROMs were also analyzed separately.
Sixteen intervention studies met the inclusion criteria. Twenty studies on development of 17 PROMs were evaluated. The most used were: MD Anderson Dysphagia Inventory, European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Quality of Life Head and Neck Module (EORTC-QLQ-H&N35). PROMs varied in construct and developmental characteristics, and none met criteria for all measurement domains.
Although several studies on prophylactic dysphagia intervention during radiation therapy have reported significant improvements in the clinician-rated outcomes, the current systematic review revealed that patient-reported findings do not depict significant changes pre- and post- intervention, however a trend towards improved scores was noted that warrants further investigation. Including PROMs in research and clinical settings is important, but their growing number makes selecting the right one challenging. Users should exercise caution and understand a PROM’s developmental characteristics before use. t.

本系统综述的首要目标是识别并评估针对接受非手术治疗的头颈部癌症患者的预防性吞咽障碍干预研究中所使用的患者报告结局指标（Patient Reported Outcome Measures, PROMs）。次要目标为评估此类干预研究中所使用的PROMs的质量，并梳理与其开发相关的文献。
研究检索了5个数据库（PubMed收录的MEDLINE、Web of Science、ProQuest、CINAHL、SCOPUS），检索对象为在放疗/放化疗前或期间启动的、包含至少一项PROM结局指标的头颈部癌症患者吞咽障碍干预研究；同时还单独分析了经识别的PROMs的心理测量学开发相关研究。
最终有16项干预研究符合纳入标准。另有20项针对17种PROMs开发的研究被纳入评估。其中使用最为频繁的包括：MD安德森吞咽障碍问卷（MD Anderson Dysphagia Inventory）、欧洲癌症研究与治疗组织（European Organisation for Research and Treatment of Cancer, EORTC）生活质量问卷核心30项（EORTC QLQ-C30）以及EORTC头颈部生活质量模块（EORTC-QLQ-H&N35）。各类PROMs在构念与开发特征上存在差异，且无任何一款PROM能够覆盖所有测量维度。
尽管多项针对放疗期间预防性吞咽障碍干预的研究报告了临床医师评定结局的显著改善，但本系统综述结果显示，患者报告的结局并未体现出干预前后的显著变化，不过观察到评分存在改善趋势，这有待进一步研究验证。在研究与临床场景中纳入PROMs具有重要意义，但PROMs数量的不断增长使得合理选择指标颇具挑战。使用者在使用前应保持审慎，并充分了解某一PROM的开发特征。