Parslow Roxanne M, Shaw Alison, Haywood Kirstie L, Crawley Esther
Centre for Academic Child Health (CACH), Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, Bristol, BS8 1NU, UK.
Centre for Primary Care Research, Bristol Medical School, University of Bristol, Canynge Hall, Bristol, BS8 2PS, UK.
J Patient Rep Outcomes. 2019 Nov 9;3(1):67. doi: 10.1186/s41687-019-0156-8.
There is a lack of patient derived, child specific outcome measures to capture what health outcomes are important to children with Chronic Fatigue Syndrome/ Myalgic Encephalopathy (CFS/ME). We developed a new Patient Reported Outcome Measure (PROM) for paediatric CFS/ME through qualitative research with children. This study aimed to pre-test the new measure through cognitive interviews with children with CFS/ME.
Cognitive interviews were undertaken in children's homes or over Skype. The Three-Step Test-Interview (TSTI) method was used to assess the quality of the draft PROM with children with CFS/ME to identify problems with initial content and design and test modifications over subsequent interview rounds. Children were purposively sampled from a single specialist paediatric CFS/ME service in England.
Twenty-four children and their parents took part. They felt the new measure captured issues relevant to their condition and preferred it to the generic measures they completed in clinical assessment. Changes were made to item content and phrasing, timeframe and response options and tested through three rounds of interviews.
Cognitive interviews identified problems with the draft PROM, enabling us to make changes and then confirm acceptability in children aged 11-18. Further cognitive interviews are required with children 8-10 years old to examine the acceptability and content validity and provide evidence for age related cut offs of the new PROM to meet FDA standards. This study demonstrates the content validity of the new measure as relevant and acceptable for children with CFS/ME. The next stage is to undertake a psychometric evaluation to support the reduction of items, confirm the structure of the PROM and provide evidence of the data quality, reliability and validity.
缺乏源自患者的、针对儿童的特定结局指标来衡量慢性疲劳综合征/肌痛性脑脊髓炎（CFS/ME）对儿童而言哪些健康结局是重要的。我们通过对儿童进行定性研究，为儿童CFS/ME开发了一种新的患者报告结局指标（PROM）。本研究旨在通过对CFS/ME患儿进行认知访谈来对新指标进行预测试。
在儿童家中或通过Skype进行认知访谈。采用三步测试访谈（TSTI）方法，与CFS/ME患儿一起评估PROM草案的质量，以识别初始内容和设计方面的问题，并在后续访谈轮次中测试修改情况。从英国一家专门的儿科CFS/ME服务机构中进行目的抽样选取儿童。
24名儿童及其父母参与其中。他们认为新指标涵盖了与自身病情相关的问题，并且比起他们在临床评估中填写的通用指标，更喜欢这个新指标。对条目内容和措辞、时间范围和回答选项进行了修改，并通过三轮访谈进行了测试。
认知访谈发现了PROM草案存在的问题，使我们能够做出修改，然后在11 - 18岁儿童中确认其可接受性。还需要对8 - 10岁儿童进行进一步的认知访谈，以检查其可接受性和内容效度，并为新PROM的年龄相关临界值提供证据，以符合美国食品药品监督管理局（FDA）的标准。本研究证明了新指标的内容效度与CFS/ME患儿相关且为他们所接受。下一阶段是进行心理测量学评估，以支持条目精简、确认PROM的结构，并提供数据质量、可靠性和效度的证据。
