Graft-versus-host disease (GVHD) is a major cause of morbidity and mortality after allogeneic stem cell transplantation. These patients face a unique challenge due to the complexity of GVHD and the toxicity of treatments received. GVHD has significant impact on quality of life (QOL), but this is not routinely evaluated formally. Despite the availability of patient-reported outcome measures (PROMs) to assess QOL, there is currently no consensus regarding the optimal PROMs that should be used to evaluate the impact of GVHD. We undertook a systematic review to determine the current evidence for the use of PROMs in assessment of QOL, symptom burden, and disease severity of patients with GVHD. A comprehensive systematic review based on the COSMIN guidelines was conducted to identify studies using PROMs (including those for QOL and symptom burden) in acute and chronic GVHD (cGVHD) patients. The following databases were searched: OVID Medline, AMED, CINAHL, Embase, PROQOLID, ProQuest, PsychINFO, and Social Sciences Citation Index from inception to May 2018. Hand searches updated the search to December 2018. Articles were screened by 2 independent reviewers, with discrepancies resolved by a third independent reviewer. Included articles were critically appraised using the COSMIN Risk of Bias tool, and relevant data on measurement properties for the included PROMs were extracted from within the target population. A total of 4545 articles were identified, and 64 articles reporting on 27 PROMs were included in this review. PROMs were separated into 5 groups; generic patient-reported measures (n = 7), cancer-specific measures (n = 4), bone marrow transplant-specific measures (n = 2), cGVHD-specific measures (n = 4), and dimension-specific measures (n = 10). Three PROMs (Human Activity Profile, Lee Symptom Scale, National Institutes of Health Eleven Point Scale) had evidence to support strong reliability (including internal consistency), responsiveness, and aspects of validity within the cGVHD population. Only 5 included PROMs were used in patients with acute GVHD. This review summarizes the current evidence regarding the use of 27 included PROMs in the context of GVHD. The choice of the most optimal PROM depends on the clinical or research context of use. Future research should comprehensively validate these tools in the GVHD population, including the testing and possible development of a PROM for use in acute GVHD, which remains a current critical gap in the existing literature.

中文翻译：

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对患者报告的移植物抗宿主病结果指标的系统评价。

异体干细胞移植后，移植物抗宿主病（GVHD）是发病和死亡的主要原因。由于GVHD的复杂性和所接受治疗的毒性，这些患者面临独特的挑战。GVHD对生活质量（QOL）产生重大影响，但这不是常规的正式评估。尽管可以使用患者报告的结局指标（PROM）来评估QOL，但目前尚无关于应用于评估GVHD影响的最佳PROM的共识。我们进行了系统的审查，以确定使用PROM评估GVHD患者的QOL，症状负担和疾病严重程度的当前证据。基于COSMIN指南进行了全面的系统评价，以鉴定在急性和慢性GVHD（cGVHD）患者中使用PROM（包括QOL和症状负担的研究）进行的研究。搜索了以下数据库：从开始到2018年5月，OVID Medline，AMED，CINAHL，Embase，PROQOLID，ProQuest，PsychINFO和Social Sciences Citation Index。手工搜索将搜索更新到2018年12月。文章由2名独立审阅者进行了筛选，包括由第三位独立审核者解决的差异。使用COSMIN偏见风险工具对包括的文章进行严格评估，并从目标人群中提取有关包含的PROM的测量属性的相关数据。总共鉴定了4545篇文章，其中64篇报道了27个PROM的文章被纳入了该评价。PROM分为5组；患者报告的一般措施（n = 7），癌症特异性措施（n = 4），骨髓移植特异性措施（n = 2），cGVHD特异性措施（n = 4）和尺寸特异性措施（n = 10）。三个PROM（人类活动档案，李氏症状量表，美国国立卫生研究院十一点量表）有证据支持cGVHD人群中的强可靠性（包括内部一致性），反应性和有效性方面。急性GVHD患者仅使用5个PROM。这篇综述总结了有关在GVHD中使用27种PROM的当前证据。最佳PROM的选择取决于使用的临床或研究环境。未来的研究应在GVHD人群中全面验证这些工具，