Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.
Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Rd., Toronto, ON, M4G 1R8, Canada.
BMC Pediatr. 2021 Sep 29;21(1):428. doi: 10.1186/s12887-021-02861-3.
Although chronic pain is common in children with cerebral palsy (CP), little is known about short-term pain fluctuations and their impact on children's well-being. High-quality cohort studies are needed to understand the clinical course of pain in this population. We aimed to determine the feasibility of conducting a multicentre cohort study. In this pilot study we assessed: 1) study processes, 2) resource and 3) management indicators including recruitment and follow-up rates, data completeness, participant characteristics, and successes and barriers in the study conduct.
A multi-centre pilot cohort study was conducted with 10 Canadian children/youth with CP attending one of two children's rehabilitation centers. We collected self-reported pain intensity (Faces Pain Scale-Revised [FPS-R], Numeric Rating Scale [NRS]); pain interference (PROMIS PI); pain location (pain diagram); physical and psychological well-being (KIDSCREEN-27), sleep characteristics, preceding months' interventions, and some clinical characteristics at baseline. Average pain intensity was reported weekly for five weeks. Well-being, sleep and interventions were measured at baseline and again at five weeks. We used feasibility indicators to evaluate:1) study processes (e.g. recruitment, attrition rates); 2) resources (e.g. data completion, budgetary challenges); and 3) management (e.g. data optimization, variability of participants and pain scores).
Between March and May 2019, 24 children and their parents/guardians were contacted and 20 met eligibility criteria. Of those, 10 agreed to in-person screening (50%) and were subsequently enrolled. The follow-up rate was 90% and self-reported missing data was minimal. Ninety percent of participants chose e-questionnaire follow-ups versus mailed paper questionnaires. Sixty percent required reminders to complete e-follow-ups. Participants were aged 8-17 years, five were female, GMFCS levels I-IV (none with level V), 90% had spastic CP and 80% reported having pain in the preceding week. Pain intensity (FPS-R) between participants ranged from 0-8/10 at baseline and 0-6/10 across all four weekly follow-ups.
This pilot study demonstrates the feasibility of conducting a multicentre cohort study to identify short-term pain trajectories and measure their association with well-being in children and youth with CP. Additional strategies to improve recruitment and accessibility for those with GMFCS levels V should be implemented in future studies.
尽管脑瘫（CP）患儿常伴有慢性疼痛，但对于其短期疼痛波动及其对患儿健康的影响知之甚少。需要高质量的队列研究来了解该人群的疼痛临床过程。我们旨在确定开展多中心队列研究的可行性。在这项初步研究中，我们评估了：1）研究过程；2）资源和 3）管理指标，包括招募和随访率、数据完整性、参与者特征，以及研究过程中的成功和障碍。
对 2 家儿童康复中心的 10 名加拿大 CP 儿童/青少年进行了多中心初步队列研究。我们收集了自我报告的疼痛强度（修订面部疼痛量表[FPS-R]、数字评分量表[NRS]）；疼痛干扰（PROMIS PI）；疼痛位置（疼痛图）；身体和心理健康（KIDSCREEN-27）；睡眠特征；前几个月的干预措施以及基线时的一些临床特征。平均疼痛强度每周报告 5 次，共 5 周。健康状况、睡眠和干预措施在基线和 5 周时进行了测量。我们使用可行性指标来评估：1）研究过程（例如，招募、失访率）；2）资源（例如，数据完整性、预算挑战）；和 3）管理（例如，数据优化、参与者和疼痛评分的变异性）。
2019 年 3 月至 5 月期间，共联系了 24 名儿童及其家长/监护人，其中 20 名符合入选标准。符合入选标准的 10 名儿童中有 5 名同意接受现场筛查（50%），随后入组。随访率为 90%，自我报告的缺失数据很少。90%的参与者选择电子问卷随访，而非邮寄纸质问卷。60%的参与者需要提醒才能完成电子随访。参与者年龄为 8-17 岁，5 名女性，GMFCS 分级 I-IV（无 V 级），90%为痉挛型 CP，80%在前一周报告有疼痛。基线时参与者之间的疼痛强度（FPS-R）范围为 0-8/10，四次每周随访时的范围为 0-6/10。
这项初步研究表明，开展多中心队列研究以确定 CP 儿童和青少年短期疼痛轨迹并测量其与健康相关的情况是可行的。应在未来的研究中实施提高 GMFCS 分级 V 患者招募和可及性的额外策略。
