Palermo Tonya M, Walco Gary A, Paladhi Unmesha Roy, Birnie Kathryn A, Crombez Geert, de la Vega Rocio, Eccleston Christopher, Kashikar-Zuck Susmita, Stone Amanda L
Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, WA, United States.
Department of Anesthesiology & Pain Medicine, University of Washington School of Medicine, Seattle, WA, United States.
Pain. 2021 Oct 1;162(10):2539-2547. doi: 10.1097/j.pain.0000000000002241.
Appropriate outcome measures and high-quality intervention trials are critical to advancing care for children with chronic pain. Our aim was to update a core outcome set for pediatric chronic pain interventions. The first phase involved collecting providers', patients', and parents' perspectives about treatment of pediatric chronic pain to understand clinically meaningful outcomes to be routinely measured. The second phase was to reach consensus of mandatory and optional outcome domains following the OMERACT framework. A modified Delphi study with 2 rounds was conducted including 3 stakeholder groups: children with chronic pain (n = 93), their parents (n = 90), and health care providers who treat youth with chronic pain (n = 52). Quantitative and qualitative data from round 1 of the Delphi study were summarized to identify important outcomes, which were condensed to a list of 10 outcome domains. Round 2 surveys were analyzed to determine the importance of the 10 domains and their relative ranking in each stakeholder group. A virtual consensus conference was held with the steering committee to reach consensus on a set of recommended outcome domains for pediatric chronic pain clinical trials. It was determined, by unanimous vote, that pain severity, pain interference with daily living, overall well-being, and adverse events, including death, would be considered mandatory domains to be assessed in all trials of any type of intervention. Emotional functioning, physical functioning, and sleep were important but optional domains. Last, the research agenda identifies several important emerging areas, including biomarkers. Future work includes selecting appropriate validated measures to assess each outcome domain.
合适的结局指标和高质量的干预试验对于推进慢性疼痛儿童的护理至关重要。我们的目标是更新儿科慢性疼痛干预的核心结局指标集。第一阶段包括收集医疗服务提供者、患者及其父母对儿科慢性疼痛治疗的看法，以了解常规测量的具有临床意义的结局。第二阶段是遵循OMERACT框架就强制性和可选结局领域达成共识。我们进行了一项两轮的改良德尔菲研究，包括三个利益相关者群体：慢性疼痛儿童（n = 93）、他们的父母（n = 90）以及治疗青少年慢性疼痛的医疗服务提供者（n = 52）。总结了德尔菲研究第一轮的定量和定性数据，以确定重要结局，这些结局被浓缩为10个结局领域的列表。对第二轮调查进行分析，以确定这10个领域的重要性及其在每个利益相关者群体中的相对排名。与指导委员会举行了一次虚拟共识会议，就一套儿科慢性疼痛临床试验推荐的结局领域达成共识。经一致投票决定，疼痛严重程度、疼痛对日常生活的干扰、总体幸福感以及包括死亡在内的不良事件将被视为所有类型干预试验中都要评估的强制性领域。情绪功能、身体功能和睡眠是重要但可选的领域。最后，研究议程确定了几个重要的新兴领域，包括生物标志物。未来的工作包括选择合适的经过验证的测量方法来评估每个结局领域。
