Professor Charlotte Beaudart, Clinical Pharmacology and Toxicology Research Unit (URCP), Namur Research Institute for Life Sciences (NARILIS), Department of Biomedical Sciences, Faculty of Medicine, University of Namur, Namur, Belgium, Email:
J Frailty Aging. 2024;13(3):224-232. doi: 10.14283/jfa.2024.47.
Current interventions targeting sarcopenia are diverse, incorporating a blend of nutritional, exercise, and pharmacological strategies. Although muscle mass, muscle strength, or functional performance typically serve as the primary endpoints, regulatory agencies have recently emphasized integrating Patient-Reported Outcome Measures (PROMs) as primary or secondary outcomes in interventional studies. This shift acknowledges the importance of PROMs and Patient-Reported Experience Measures (PREMs) in assessing intervention effectiveness and aligns with patient-centered healthcare models. The aims of this systematic review are 1) to identify all sarcopenia-designed interventional studies that used PROMs/PREMs as the primary or secondary outcome, 2) to identify the different PROMs/PREMs used within those studies, and 3) to summarize the effects of sarcopenia-designed interventions on PROMs/PREMs of sarcopenic participants. For that, a systematic search of databases (Medline, EMBASE, Review- Cochrane Central of Register of Controlled Trials, and PsychINFO (Via Ovid)) was conducted in September 2023. The review followed the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement, and the protocol was registered on Open Science Framework (https://osf.io/zxgwm/). The systematic review identified 17 RCTs as sarcopenia-designed interventional studies reporting PROMs. PROMs covered the assessment of various aspects, including quality of life, depressive symptoms, loneliness/social isolation, daytime sleepiness, insomnia impact, and sleep quality/disturbance. Only one sarcopenia-specific PROM, namely the SarQoL, was reported. The effect of sarcopenia-designed interventions on PROMs showed considerable heterogeneity, underscoring the need for standardization in sarcopenia research by developing a Core Outcome Set (COS). COS in sarcopenia studies would ensure consistent and comparable findings, ultimately enhancing the reliability and effectiveness of interventions.
目前针对肌肉减少症的干预措施多种多样,综合了营养、运动和药物等策略。虽然肌肉质量、肌肉力量或功能表现通常作为主要终点,但监管机构最近强调在干预研究中纳入患者报告结局(PROs)作为主要或次要结局。这种转变承认了 PROs 和患者报告体验测量(PREMs)在评估干预效果中的重要性,并与以患者为中心的医疗保健模式保持一致。本系统评价的目的是:1)确定所有使用 PROs/PREMs 作为主要或次要结局的肌肉减少症设计干预研究,2)确定这些研究中使用的不同 PROs/PREMs,3)总结肌肉减少症设计干预对肌肉减少症参与者的 PROs/PREMs 的影响。为此,我们于 2023 年 9 月对数据库(Medline、EMBASE、Cochrane 中心对照试验注册库和 PsychINFO(通过 Ovid))进行了系统检索。本研究遵循系统评价和荟萃分析的 Preferred Reporting Items(PRISMA)声明,并在 Open Science Framework(https://osf.io/zxgwm/)上进行了方案注册。本系统评价确定了 17 项 RCT 作为肌肉减少症设计的干预研究,报告了 PROs。PROs 涵盖了各种方面的评估,包括生活质量、抑郁症状、孤独/社会隔离、白天嗜睡、失眠影响和睡眠质量/障碍。仅报告了一种肌肉减少症特异性 PRO,即 SarQoL。肌肉减少症设计干预对 PROs 的影响存在相当大的异质性,这突出表明需要通过制定核心结局集(COS)来标准化肌肉减少症研究。在肌肉减少症研究中使用 COS 将确保一致和可比的发现,最终提高干预措施的可靠性和有效性。