Pain and Exercise Research, Universitat zu Lubeck Sektion Medizin, Lubeck, Germany
Department of Human Movement Science, University of Hamburg, Hamburg, Germany.
BMJ Open. 2020 Feb 12;10(2):e029855. doi: 10.1136/bmjopen-2019-029855.
The aim of this Delphi survey was to establish an international consensus on the most useful outcome measures for research on the effectiveness of non-pharmacological interventions for migraine. This is important, since guidelines for pharmacological trials recommend measuring the frequency of headaches with 50% reduction considered a clinically meaningful effect. It is unclear whether the same recommendations apply to complementary (or adjunct) non-pharmacological approaches, whether the same cut-off levels need to be considered for effectiveness when used as an adjunct or stand-alone intervention, and what is meaningful to patients.
University-initiated international survey.
The expert panel was chosen based on publications on non-pharmacological interventions in migraine populations and from personal contacts. 35 eligible researchers were contacted, 12 agreed to participate and 10 completed all 3 rounds of the survey. To further explore how migraine patients viewed potential outcome measures, four migraine patients were interviewed and presented with the same measurement tools as the researchers.
The initial Delphi round was based on a systematic search of the literature for outcome measures used in non-pharmacological interventions for headache. Suggested outcome measures were rated by each expert, blinded towards the other members of the panel, for its usefulness on a 5-point Likert scale ranging from definitely not useful to extremely useful. Results were combined using median values and IQRs. Tools rated overall as definitely or probably not useful were excluded from subsequent rounds. Experts further suggested additional outcome measures that were presented to the panel in subsequent rounds. Additionally, experts were asked to rank the most useful tools and provide information on feasible cut-off levels for effectiveness for the three highest ranked tools.
Results suggest the use of the Migraine Disability Assessment (MIDAS), Headache Impact Test (HIT-6) and headache frequency as primary outcome measures. Patient experts suggested the inclusion of a measure of quality of life and evaluation of associated symptoms and fear of attacks.
Recommendations are for the use of the MIDAS, the HIT-6 and headache frequency, in combination with an outcome measure for quality of life. Associated symptoms and fear of attacks should also be considered as secondary outcomes, if relevant for the individual target population. The cut-off level for effectiveness should be lower for non-pharmacological interventions, especially when used as an adjunct to medication.
German Register of Clinical Trials (DRKS00011777).
本德尔菲调查旨在就非药物干预偏头痛有效性研究中最有用的结果测量指标达成国际共识。这一点很重要，因为药物试验指南建议使用头痛发作频率减少 50%作为衡量临床意义的指标。目前尚不清楚对于补充（或辅助）非药物方法是否同样适用这些建议，当作为辅助或独立干预措施使用时，是否需要考虑相同的截止值，以及对患者而言什么是有意义的。
大学发起的国际调查。
专家小组根据偏头痛人群中非药物干预的出版物以及个人联系进行选择。联系了 35 名符合条件的研究人员，其中 12 人同意参与，10 人完成了所有 3 轮调查。为了进一步探讨偏头痛患者如何看待潜在的结果测量指标，对 4 名偏头痛患者进行了访谈，并向他们展示了与研究人员相同的测量工具。
第一轮德尔菲调查基于系统检索非药物干预头痛文献中使用的结果测量指标。每位专家根据其在 5 点李克特量表上的有用性对每个建议的结果测量指标进行评分，范围从绝对没有用到非常有用。结果使用中位数和 IQR 进行组合。总体上被评为绝对或可能没有用的工具被排除在后续轮次之外。专家们进一步提出了其他额外的结果测量指标，并在后续轮次中提交给小组。此外，专家们被要求对最有用的工具进行排名，并提供有关三种排名最高的工具的有效性的可行截止值的信息。
结果表明，使用偏头痛残疾评估（MIDAS）、头痛影响测试（HIT-6）和头痛频率作为主要结果测量指标。患者专家建议纳入生活质量衡量指标以及相关症状和对发作的恐惧评估。
建议使用 MIDAS、HIT-6 和头痛频率，同时结合生活质量的结果测量指标。如果与特定目标人群相关，还应考虑相关症状和对发作的恐惧作为次要结果。非药物干预的有效性截止值应较低，特别是当作为药物的辅助治疗时。
德国临床试验注册处（DRKS00011777）。
