Hansen Christian Fugl, Brodersen John Brandt, Krogsgaard Michael Rindom
Department of Orthopedic Surgery, Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Copenhagen University Hospital, Copenhagen, Denmark.
The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Knee Surg Sports Traumatol Arthrosc. 2025 Feb;33(2):555-566. doi: 10.1002/ksa.12393. Epub 2024 Aug 5.
The existing knee-specific pediatric patient-reported outcome measures (PROMs) lack content and construct validity for children with anterior cruciate ligament (ACL) injury. This impairs their accuracy which can lead to false interpretations of data and inaccurate clinical guidelines. The purpose of this study was to develop a content-valid PROM for children with an ACL injury.
The process adhered to the COnsensus-based Standards for the selection of health Measurement INstruments guidelines for PROM development. Informants were children with ACL deficiency and sampled based on age, sex, and treatment. Semistructured interviews were conducted exploring themes within the International Classification of Functioning, Disability and Health model. Interviews continued beyond data saturation. By thematic analysis and by probing items from the adult PROM 'KNEES-ACL', new themes and items emerged. Content coverage, relevance and understandability were continuously evaluated. All interviews were recorded and transcribed verbatim. The NVivo 12 software was used for data analysis and coding of items.
A PROM of 60 items across nine subscales was formed. From cognitive interviews, 19 new items emerged. Forty-one of 55 items from KNEES-ACL were endorsed as relevant; however, all required rewording to ensure understandability. Substantial differences in the psychosocial impact between adults and children were observed. The children experienced a more considerable negative psychosocial impact caused by a loss of participation in sports, lower self-confidence and loss of social networks. This resulted in four new domains. The physical issues were similar to adults, with few exceptions.
The 'KIDS-KNEES-ACL' 1.0 (qualitative version) was developed. This version will be subjected to psychometric analysis, resulting in adequate measurement properties of the final KIDS-KNEES-ACL 2.0. As the only adequate pediatric ACL-specific PROM, its use in clinical trials and databases will enhance PROM data quality, and strengthen clinical guidelines and thus the treatment of children with ACL injury.
Not applicable.
现有的针对膝关节的儿科患者报告结局测量工具（PROMs）对于前交叉韧带（ACL）损伤的儿童缺乏内容效度和结构效度。这损害了它们的准确性，可能导致对数据的错误解读以及不准确的临床指南。本研究的目的是为ACL损伤的儿童开发一种具有内容效度的PROM。
该过程遵循基于共识的健康测量工具选择标准指南进行PROM开发。信息提供者为ACL功能不全的儿童，并根据年龄、性别和治疗情况进行抽样。进行了半结构化访谈，探讨国际功能、残疾和健康分类模型中的主题。访谈持续到数据饱和之后。通过主题分析以及对成人PROM“KNEES - ACL”中的项目进行探究，出现了新的主题和项目。持续评估内容覆盖范围、相关性和可理解性。所有访谈均进行录音并逐字转录。使用NVivo 12软件进行数据分析和项目编码。
形成了一个包含9个分量表、共60个项目的PROM。通过认知访谈，出现了19个新项目。“KNEES - ACL”的55个项目中有41个被认可为相关；然而，所有项目都需要重新措辞以确保可理解性。观察到成人和儿童在心理社会影响方面存在显著差异。儿童因参与体育活动受限、自信心降低和社交网络丧失而经历了更严重的负面心理社会影响。这导致了四个新领域。身体问题与成人相似，仅有少数例外。
开发了“KIDS - KNEES - ACL”1.0（定性版本）。该版本将进行心理测量分析，从而使最终的KIDS - KNEES - ACL 2.0具有足够的测量属性。作为唯一适用的针对儿科ACL的PROM，其在临床试验和数据库中的使用将提高PROM数据质量，并加强临床指南，进而改善ACL损伤儿童的治疗。
不适用。
