Service de Pneumologie B et Transplantation Pulmonaire, APHP.Nord-Université de Paris, Hôpital Bichat-Claude Bernard, Paris, France; Physiopathology and Epidemiology of Respiratory Diseases, UMR1152 INSERM and Université de Paris, Paris, France.
INSERM CIC-EC1425, Hôpital Bichat, Paris, France; APHP, département Epidémiologie Biostatistiques et Recherche Clinique, Hôpital Bichat, Paris, France.
Respir Med Res. 2022 May;81:100896. doi: 10.1016/j.resmer.2022.100896. Epub 2022 Feb 26.
Patient-important outcomes (PIOs) have emerged in respiratory medicine, in order to place the patient at the center of research. Mortality is a debated PIO in lung transplantation (LTx). The use of PIO in this specific setting has never been studied. We aimed to systematically review the use of PIOs in LTx research.
MEDLINE, Cochrane Library and Embase databases were searched to include prospective studies published in 2019, involving adult LTx recipients. We excluded articles reporting non-prognostic studies, letters, reviews, commentaries, or case reports. PIOs considered were mortality, pain, physical function, pulmonary, gastrointestinal, neuropsychological, cardiac, sleep or sexual symptoms and quality of life. This systematic review was prospectively registered in the PROSPERO register (CRD42020163425).
Among 1048 references retrieved, 51 were finally included in the analysis. In total, 26 (51%) studies investigated at least one PIO, as a primary outcome in 12 (23.5%) and secondary outcome in 21 (41.2%). In 15 (29.4%) studies, mortality was the most frequently reported PIO; 11 (21.5%) studies evaluated at least one PIO other than mortality, quality of life being this PIO in 6.
PIOs were described in half of prospective articles dealing with adult LTx recipients published in 2019. Outcomes other than mortality were insufficiently considered. A core outcome set of PIOs in LTx should be developed with patient input to guide future research in LTx.
为了将患者置于研究的中心，患者重要结局（PIO）已在呼吸医学中出现。死亡率是肺移植（LTx）中备受争议的 PIO。在这种特定环境中使用 PIO 从未被研究过。我们旨在系统地回顾 LTx 研究中 PIO 的使用情况。
检索 MEDLINE、Cochrane 图书馆和 Embase 数据库，纳入 2019 年发表的涉及成人 LTx 受者的前瞻性研究。我们排除了报告非预后研究、信件、综述、评论或病例报告的文章。考虑的 PIO 包括死亡率、疼痛、身体功能、肺部、胃肠道、神经心理学、心脏、睡眠或性功能障碍以及生活质量。这项系统评价前瞻性地在 PROSPERO 登记处（CRD42020163425）进行了登记。
在检索到的 1048 篇参考文献中，最终有 51 篇被纳入分析。共有 26 项（51%）研究调查了至少一项 PIO，其中 12 项（23.5%）为主要结局，21 项（41.2%）为次要结局。在 15 项（29.4%）研究中，死亡率是最常报告的 PIO；11 项（21.5%）研究评估了除死亡率以外的至少一项 PIO，其中 6 项研究将生活质量作为 PIO。
2019 年发表的涉及成人 LTx 受者的前瞻性文章中，有一半描述了 PIO。其他结局，而非死亡率，未得到充分考虑。应在患者参与的情况下制定 LTx 中 PIO 的核心结局集，以指导未来的 LTx 研究。
