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 <i>via</i> 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&amp;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为识别并评估针对接受非手术治疗的头颈部癌症患者，其预防性吞咽障碍干预研究中所使用的患者报告结局量表（Patient Reported Outcome Measures，PROMs）。其次要目标为评估上述干预研究中所使用的PROMs质量，并梳理与其开发相关的文献。本研究检索了5个数据库：通过PubMed检索的MEDLINE、Web of Science、ProQuest、CINHAL以及SCOPUS，检索主题为头颈部癌症患者的吞咽障碍干预研究，且干预需启动于放疗或放化疗期间/之前，研究需包含至少一项PROM结局指标。此外，本研究还单独对已识别的PROMs的心理测量学开发相关研究进行了分析。最终有16项干预研究符合纳入标准，另有针对17种PROMs开发的20项研究被纳入评估。使用频次最高的量表包括：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）生活质量核心问卷30（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，且尚无任何一款量表能够覆盖所有测量领域。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干预前后存在显著变化，不过研究观察到评分存在改善的趋势，该趋势有待进一步探究。在研究与临床场景中纳入PROMs具有重要意义，但量表数量的不断增长使得合理选型颇具挑战。使用者应谨慎选择，并在使用前充分了解PROMs的开发特征。