Moore P, Jackson C, Mutch K, Methley A, Pollard C, Hamid S, Jacob A
Department of Clinical Neuropsychology, The Walton Centre NHS Foundation Trust, Liverpool, UK.
Department of Clinical Neuropsychology, The Walton Centre NHS Foundation Trust, Liverpool, UK Department of Clinical Psychology, University of Liverpool, Liverpool, UK.
BMJ Open. 2016 Sep 30;6(9):e011142. doi: 10.1136/bmjopen-2016-011142.
This study outlines the development of a patient-reported outcome measure (PROM), an instrument to obtain self-reported health status for neuromyeltis optica (NMO), a disabling neurological condition.
Development was conducted in accordance with international guidance for PROMs including systematic review of existing literature, item generation guided by qualitative interviews, health-related quality of life conceptual framework and clinical expert panel and cognitive interviews with NMO patients.
Participants were identified through a national NMO clinic in a tertiary NHS neurosciences service.
15 individuals with NMO participated in cognitive interviews requiring review and ranking of proposed PROM items and qualitative feedback on content, layout and response options.
Participants endorsed the draft instrument as reflecting their experience of the condition and as being easy to understand. Rating and ranking of item relevance and importance reduced the draft instrument from 106 to 48 items. Participant feedback on overlapping items eliminated a further 2 items and resulted in a preliminary instrument of 46 items. As a direct result of participant feedback ordering of the 10 domains was revised, a 4 option Likert scale was employed and a 4-week recall period for impact of symptoms was selected.
A 46-item instrument developed in accordance with international PROM development guidelines through literature review, developed by subject matter experts and refined through pretesting examining content validity provides a preliminary measure for assessing patient-report of health status in NMO. Further evaluation is proposed including sensitivity to clinical change, and international contributions to evaluating the measure are encouraged.
本研究概述了一种患者报告结局量表（PROM）的开发，该量表是一种用于获取视神经脊髓炎（NMO，一种致残性神经系统疾病）患者自我报告健康状况的工具。
根据PROM的国际指南进行开发，包括对现有文献的系统综述、基于定性访谈生成条目、健康相关生活质量概念框架和临床专家小组的指导以及对视神经脊髓炎患者的认知访谈。
通过英国国民健康服务体系（NHS）三级神经科学服务中的一家全国性视神经脊髓炎诊所确定参与者。
15名视神经脊髓炎患者参与了认知访谈，要求他们对视神经脊髓炎患者报告结局量表的拟议条目进行审查和排序，并就内容、布局和回答选项提供定性反馈。
参与者认可该量表草案反映了他们的病情经历且易于理解。对条目相关性和重要性的评分和排序将量表草案从106项减少到48项。参与者对重叠条目的反馈又消除了2项，从而形成了一个46项的初步量表。由于参与者的反馈，对视神经脊髓炎患者报告结局量表10个领域的顺序进行了修订，采用了4级李克特量表，并选择了4周的症状影响回忆期。
通过文献综述，根据国际患者报告结局量表开发指南开发，由主题专家编制，并通过预测试检验内容效度进行完善的46项量表，为评估视神经脊髓炎患者报告的健康状况提供了初步手段。建议进行进一步评估，包括对临床变化的敏感性，并鼓励国际社会为评估该量表做出贡献。
