School of Public Health, University of Adelaide, Adelaide, Australia.
Centre for Health Economics, Monash Business School, Monash University, Clayton, Australia.
Qual Life Res. 2019 Mar;28(3):567-592. doi: 10.1007/s11136-018-2016-z. Epub 2018 Oct 3.
Patient-reported outcome measures (PROMs) could play an important role in identifying patients' needs and goals in clinical encounters, improving communication and decision-making with clinicians, while making care more patient-centred. Comprehensive evidence that PROMS are an effective intervention is lacking in single randomised controlled trials (RCTs).
A systematic search was performed using controlled vocabulary related to the terms: clinical care setting and patient-reported outcome. English language studies were included if they were a RCT with a PROM as an intervention in a patient population. Included studies were analysed and their methodologic quality was appraised using the Cochrane Risk of Bias tool. The protocol was registered with PROSPERO (CRD42016034182).
Of 4302 articles initially identified, 115 underwent full-text review resulting in 22 studies reporting on 25 comparisons. The majority of included studies were conducted in USA (11), among cancer patients (11), with adult participants only (20). Statistically significant and robust improvements were reported in the pre-specified outcomes of the process of care (2) and health care (3). Additionally, five, eight and three statistically significant but possibly non-robust findings were reported in the process of care, health and patient satisfaction outcomes, respectively.
Overall, studies that compared PROM to standard care either reported a positive effect or were not powered to find pre-specified differences. There is justification for the use of a PROM as part of standard care, but further adequately powered studies on their use in different contexts are necessary for a more comprehensive evidence base.
患者报告的结局测量（PROM）在识别患者在临床接触中的需求和目标方面可以发挥重要作用，改善与临床医生的沟通和决策，使护理更加以患者为中心。在单一随机对照试验（RCT）中缺乏关于 PROM 是有效干预措施的综合证据。
使用与临床护理环境和患者报告的结局相关的受控词汇进行系统搜索。如果一项 RCT 将 PROM 作为患者人群的干预措施，并纳入了英语语言研究，则将其纳入研究。使用 Cochrane 偏倚风险工具对纳入的研究进行分析和评估其方法学质量。该方案已在 PROSPERO（CRD42016034182）上注册。
最初确定的 4302 篇文章中，有 115 篇进行了全文审查，最终有 22 项研究报告了 25 项比较。纳入的研究大多在美国（11 项）进行，针对癌症患者（11 项），仅纳入成年参与者（20 项）。在护理过程（2 项）和医疗保健（3 项）的预定结局方面，报告了统计学上显著且稳健的改善。此外，在护理过程、健康和患者满意度结局方面，分别报告了五个、八个和三个统计学上显著但可能不稳定的发现。
总体而言，将 PROM 与标准护理进行比较的研究报告了积极的效果，或者没有足够的能力发现预定的差异。有理由将 PROM 作为标准护理的一部分使用，但需要在不同情况下进一步进行足够有力的研究，以提供更全面的证据基础。
