Hareendran Asha, Mannix Sally, Skalicky Anne, Bayliss Martha, Blumenfeld Andrew, Buse Dawn C, Desai Pooja R, Ortmeier Brian G, Sapra Sandhya
Evidera, Metro Building, 6th Floor, 1 Butterwick, London, W6 8DL, UK.
Evidera, Bethesda, MD, USA.
Health Qual Life Outcomes. 2017 Nov 17;15(1):224. doi: 10.1186/s12955-017-0799-1.
Adults with migraine experience substantial reductions in quality of life during and in-between migraine attacks. Clinical and regulatory guidelines encourage the inclusion of patient reported outcomes for the evaluation of benefits of interventions for migraine.
The conceptual framework and items for a new patient-reported outcome (PRO) instrument, the Migraine Physical Function Impact Diary (MPFID), were developed using scientific methods recommended to ensure content validity of PRO instruments. The MPFID was developed to measure the impact of migraine on physical functioning based on themes raised in concept elicitation (CE) interviews (conducted previously) with adults with migraine. Cognitive interviews were conducted with adults with migraine to further explore content validity. The instrument was modified following an interim analysis of a first round of cognitive interviews, to assess comprehensiveness and clarity of items, instructions, and response options. Refinements were subsequently tested in additional cognitive interviews.
The conceptual framework included impacts on physical functioning experienced by most adults with migraine and deemed clinically relevant for measuring the outcome of an intervention for migraine. Concepts in the framework included the impact of migraine on physical impairments (acts) and ability to complete day-to-day activities and perform everyday activities (tasks). MPFID items were generated to evaluate functioning over the past 24 h and to collect data daily, to capture experiences on days with migraine as well as the days in-between migraines. Items asked about needing to rest or lie down; ability to get out of bed, stand up, bend over, walk, perform household chores, do tasks outside the home, keep routines or schedules, get ready for the day, do activities that require concentration or clear thinking; difficulty moving head and body, doing activities requiring physical effort; avoiding interacting with others. Initial modifications based on the first round of cognitive interviews (n = 8) included clarifying instructions, updating three items to enhance specificity and clarity, and revising one item to include gender-neutral language. The second round of interviews (n = 9) confirmed acceptability of revisions and supported content validity.
The results provide qualitative evidence supporting the content validity of the MPFID for evaluating outcomes of interventions for migraine.
偏头痛成年患者在偏头痛发作期间及发作间期生活质量大幅下降。临床和监管指南鼓励纳入患者报告结局，以评估偏头痛干预措施的疗效。
采用推荐的科学方法开发了一种新的患者报告结局（PRO）工具——偏头痛身体功能影响日记（MPFID）的概念框架和条目，以确保PRO工具的内容效度。MPFID旨在根据之前对偏头痛成年患者进行的概念激发（CE）访谈中提出的主题，测量偏头痛对身体功能的影响。对偏头痛成年患者进行了认知访谈，以进一步探讨内容效度。在对第一轮认知访谈进行中期分析后，对该工具进行了修改，以评估条目的全面性和清晰度、说明及回答选项。随后在更多的认知访谈中对改进内容进行了测试。
概念框架包括大多数偏头痛成年患者所经历的对身体功能的影响，且被认为在临床上与测量偏头痛干预措施的结局相关。框架中的概念包括偏头痛对身体损伤（行为）以及完成日常活动和执行日常任务（事务）能力的影响。MPFID条目旨在评估过去24小时内的功能，并每天收集数据，以捕捉偏头痛发作日以及发作间期的经历。条目询问了是否需要休息或躺下；起床、站立、弯腰、行走、做家务、外出做事、保持日常安排或时间表、为一天做好准备、进行需要集中注意力或清晰思考的活动的能力；头部和身体移动困难、进行需要体力的活动困难；避免与他人互动。基于第一轮认知访谈（n = 8）的初步修改包括澄清说明、更新三个条目以提高特异性和清晰度，以及修改一个条目以纳入中性语言。第二轮访谈（n = 9）确认了修改的可接受性，并支持内容效度。
结果提供了定性证据，支持MPFID在评估偏头痛干预措施结局方面的内容效度。
