Hughes Anastasia, Matus Gonzalez Andrea, Amir Noa, Arancibia Garcia Macarena, Caskey Fergus J, Cervantes Lilia, Cho Yeoungjee, Cazzolli Rosanna, Dobrijevic Ellen, Elliott Meghan J, Farragher Janine, Ferreiro Alejandro, Greenwood Sharlene, Guha Chandana, Howell Martin, Huuskes Brooke M, Lampo Mauro, Levin Adeera, Lorca Eduardo, Malvar Ana, Manera Karine, Mascheroni Claudio A, Mellado Haydee, Molina Soledad, Monkowski Matias, Recabarren Silva Javier, Sautenet Bénédicte, Scholes-Robertson Nicole, Sepulveda Alejandro, Sluiter Amanda, Sola Laura, Teixeira-Pinto Armando, Trimarchi Herman, van Zwieten Anita, Gutiérrez Ventura Jorge, Viecelli Andrea K, Wang Bill, Weng Linda, Wong Germaine, Wu Rebecca, Jaure Allison
Sydney School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.
Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, New South Wales, Australia.
Clin J Am Soc Nephrol. 2025 Jun 26;20(8):1041-1050. doi: 10.2215/CJN.0000000724.
Patients, caregivers, and health professionals support the use of standardised outcomes in nephrology - life participation as the core outcome measure for life participation in patients with CKD. Further work is needed to pilot and validate the standardised outcomes in nephrology - life participation measure in patients with CKD before the need for KRT. A core outcome measure will support consistent reporting of life participation in trials in patients with CKD.
Life participation is of critical importance to patients with CKD not requiring KRT, their caregivers, and health professionals. However, life participation is rarely and inconsistently assessed in trials in CKD. The aim was to establish a core outcome measure for life participation in patients with CKD not requiring KRT.
An online (English language) and an in-person (Spanish language) consensus workshop, 1 hour in length, were held in March and April 2024, respectively, and were held to discuss and establish a meaningful, relevant, and feasible core patient-reported outcome measure for life participation for trials in CKD. Transcripts were analyzed thematically.
Workshops included 130 participants, including 74 patients and caregivers, and 56 health professionals, from 18 countries. Four themes were identified. included considering relevance to patients' own priorities, capturing key life activities common to all patients, reflecting the goal of leading a fulfilling life, acknowledging the variability and multiplicity of domains, and facilitating linguistic and cultural translation. meant covering the spectrum of CKD stages and diagnoses and allowing comparison across treatment stages. entailed minimizing burden of administration and completion, establishing psychometric robustness, seeking endorsement to legitimize the measure, and ensuring accessibility and acceptability across different settings. captured promoting person-centered clinical care and generating ideas for novel interventions to improve life participation.
A core outcome measure for life participation in patients with CKD should enable a patient to interpret life participation in their own context, have applicability across the CKD population, and be psychometrically robust and feasible to implement. Measuring life participation in a consistent and meaningful way across trials can better support patient-centered decision making and outcomes.
患者、护理人员和医疗专业人员支持在肾脏病学中使用标准化结局——将生活参与作为慢性肾脏病（CKD）患者生活参与的核心结局指标。在CKD患者需要肾脏替代治疗（KRT）之前，需要进一步开展工作，对肾脏病学标准化结局——生活参与指标进行试点和验证。核心结局指标将有助于在CKD患者的试验中对生活参与情况进行一致的报告。
生活参与对不需要KRT的CKD患者、他们的护理人员和医疗专业人员至关重要。然而，在CKD试验中，生活参与很少被评估，且评估方式不一致。目的是为不需要KRT的CKD患者建立一个生活参与的核心结局指标。
分别于2024年3月和4月举办了一次为期1小时的在线（英语）和一次面对面（西班牙语）共识研讨会，以讨论并建立一个有意义、相关且可行的核心患者报告结局指标，用于CKD试验中的生活参与评估。对会议记录进行了主题分析。
研讨会有来自18个国家的130名参与者，包括74名患者和护理人员以及56名医疗专业人员。确定了四个主题。包括考虑与患者自身优先事项的相关性、涵盖所有患者共有的关键生活活动、反映过上充实生活的目标、承认领域的多样性和多重性以及促进语言和文化翻译。意味着涵盖CKD各个阶段和诊断范围，并允许在不同治疗阶段进行比较。需要尽量减少管理和完成的负担，建立心理测量学稳健性，寻求认可以使该指标合法化，并确保在不同环境中的可及性和可接受性。促进以患者为中心的临床护理，并为改善生活参与的新型干预措施提出想法。
CKD患者生活参与的核心结局指标应使患者能够在自身背景下解读生活参与情况，适用于整个CKD人群，并且在心理测量学上稳健且易于实施。在各项试验中以一致且有意义的方式衡量生活参与情况，可以更好地支持以患者为中心的决策和结局评估。
