Mayo Clinic, Scottsdale, AZ, USA.
Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
Headache. 2018 Oct;58(9):1358-1372. doi: 10.1111/head.13426.
OBJECTIVE: This study aimed to identify the essential content and amount of information to be collected from people with migraine via a patient-facing smartphone-based migraine tracker for them to share with clinicians during live discussions to assist in optimizing migraine management. The proposed tracker is intended for use in non-interventional research to evaluate disease burden in episodic migraine and chronic migraine patients as assessed by demographic and clinical characteristics and health resource utilization in an integrated delivery network setting. The proposed tracker is not intended for commercial purposes. BACKGROUND: Epidemiological studies suggest migraine is underdiagnosed and undertreated. Studies of patient-clinician interactions suggest that effective medical communication may help address these issues. METHODS: Four migraine practice leaders, an epidemiologist with extensive migraine experience, and a measurement expert took part in a modified Delphi panel process to identify data elements that could be collected from people with migraine through a smartphone-based migraine tracker. Importantly, the proposed tracker would not be intended to replace the patient-clinician encounter but to support the encounter through enabling the patient to document migraine symptoms and experiences in a timely and accurate manner for sharing with a clinician as part of a broader face-to-face discussion. The panel reviewed questions derived from the existing migraine diaries in the public domain, those used in clinical trials, and patient-centric surveys assessing the impact of migraine on physical function and other related concepts. Key considerations included identification of the most clinically useful data elements for a shared communication tool for people with migraine under the care of a clinician. The panel also identified numerous functionality requirements for such a tool and provided recommendations on the most effective way to present results to a clinician. RESULTS: The expert panel opined that people with migraine may value the ability to capture a relatively broad range of information for their own migraine-tracking purposes, while clinicians will likely find greater value in a small set of data relevant to the management of migraine. The panel identified the 3 most essential concepts in categories of data for a clinician, for which they coined the term "The 3 Fs": Frequency of days with headache; Frequency of acute medication usage; and Functional impairment. Information on the frequency of days with headache was felt to combine with the information on the frequency of acute medication usage to provide essential insights into current migraine management strategy and its outcomes, and to assist considerations of preventive measures. Functional impairment was treated as an effective surrogate for headache severity and was assessed based on the following: degree of difficulty in performing activities of daily living, impact on absenteeism (taking leave from work or cancelling/avoiding other activities) and presenteeism (performing work or other daily activities, with reduced productivity/capability), and amount of rest required as a result of a migraine attack. The modified Delphi panel process resulted in the selection of 13 questions in 8 categories to elicit sufficient and meaningful data comprising headache occurrence, symptoms, daily/preventive and as-needed/acute medication usage, triggers, ability to concentrate, and functional impairment. The panel also agreed that the tracker should generate 2 distinct reports: one for people with migraine that would include a wider range of data about symptoms and perceived triggers, and a targeted report for the clinician that would place prime emphasis on the 3 Fs for aggregating the results of each headache occurrence and the trend over time. CONCLUSIONS: A system that easily captures critical data elements about migraine, with specific feedback displays for patients to share with clinicians during live discussions, may offer some benefit to people with migraine and their clinicians by facilitating more objective communication and optimizing management. The tracker's output may enable people with migraine to track a wide range of data for their own purposes, allowing them to better understand their condition, while a synthesized view of the selected data may support more informed clinical decision-making for the clinician and individualized, evidence-based discussion with the patient. As a result, this shared decision-making tool may enable patients to more accurately convey essential migraine information during live patient-clinician discussions to drive improved management and patient outcomes.
目的:本研究旨在确定从偏头痛患者那里通过面向患者的智能手机偏头痛追踪器收集的基本内容和信息量,以便在实时讨论中与临床医生共享,以帮助优化偏头痛管理。拟议的追踪器旨在用于非干预性研究,以评估在综合交付网络环境中,发作性偏头痛和慢性偏头痛患者的疾病负担,评估人口统计学和临床特征以及卫生资源利用情况。拟议的追踪器不用于商业目的。
背景:流行病学研究表明偏头痛的诊断和治疗不足。对患者-临床医生互动的研究表明,有效的医学沟通可能有助于解决这些问题。
方法:四名偏头痛实践负责人、一位具有丰富偏头痛经验的流行病学家和一位测量专家参加了一项改良德尔菲小组流程,以确定可以通过基于智能手机的偏头痛追踪器从偏头痛患者那里收集的数据元素。重要的是,拟议的追踪器不会替代医患会面,而是通过使患者能够及时准确地记录偏头痛症状和体验,以便与临床医生共享,作为更广泛的面对面讨论的一部分,从而支持会面。该小组审查了从公共领域现有的偏头痛日记、临床试验中使用的问题以及评估偏头痛对身体功能和其他相关概念影响的以患者为中心的调查中得出的问题。关键考虑因素包括为在临床医生护理下的偏头痛患者确定用于共享通信工具的最具临床意义的数据元素。该小组还确定了此类工具的许多功能要求,并就向临床医生展示结果的最有效方式提供了建议。
结果:专家小组认为,偏头痛患者可能会重视为自己的偏头痛跟踪目的捕获相对广泛的信息的能力,而临床医生可能会发现与偏头痛管理相关的少量数据更有价值。该小组确定了临床医生类别中数据的 3 个最重要概念,他们将其命名为“3 Fs”:头痛天数的频率;急性药物使用频率;以及功能障碍。头痛天数的信息被认为与急性药物使用频率的信息相结合,为当前偏头痛管理策略及其结果提供了重要见解,并有助于考虑预防措施。功能障碍被视为头痛严重程度的有效替代指标,并根据以下内容进行评估:日常生活活动的困难程度、对旷工(休假或取消/避免其他活动)和在职出勤(执行工作或其他日常活动,生产力/能力降低)的影响,以及偏头痛发作后需要休息的程度。改良德尔菲小组流程导致选择了 8 个类别中的 13 个问题,以获取包含头痛发作、症状、日常/预防性和按需/急性药物使用、诱因、集中注意力能力以及功能障碍的足够和有意义的数据。该小组还同意,该追踪器应生成 2 份不同的报告:一份供偏头痛患者使用,其中将包括有关症状和感知诱因的更广泛的数据,另一份针对临床医生的有针对性的报告,将重点放在 3 Fs 上,以汇总每次头痛发作的结果和随时间的趋势。
结论:一个易于捕获偏头痛关键数据元素的系统,并为患者提供特定的反馈显示,以便在实时讨论中与临床医生共享,可能会通过促进更客观的沟通和优化管理,为偏头痛患者及其临床医生带来一些好处。该追踪器的输出可能使偏头痛患者能够跟踪广泛的数据用于自己的目的,使他们能够更好地了解自己的病情,而所选数据的综合视图可能为临床医生提供更明智的临床决策,并为患者提供个性化、基于证据的讨论。因此,这种共享决策工具可以使患者在实时的医患讨论中更准确地传达偏头痛的重要信息,以改善管理和患者的结果。
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