Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7A, UK.
BMC Med Res Methodol. 2019 Feb 11;19(1):30. doi: 10.1186/s12874-019-0672-5.
Self-management support programmes are effective in a range of chronic conditions however there is limited evidence for their use in the treatment of chronic headaches. The aim of this study was to test the feasibility of four key aspects of a planned, future evaluative trial of a new education and self-management intervention for people with chronic headache: 1) recruiting people with chronic headache from primary care; 2) a telephone interview for the classification of chronic headaches; 3) the education and self-management intervention itself; and 4) the most appropriate patient reported outcomes (PROMS).
Participants were identified and recruited from general practices in the West Midlands of the UK. We developed a nurse-led chronic headache classification interview and assessed agreement with an interview with headache specialists. We developed and tested a group based education and self-management intervention to assess training and delivery receipt using observation, facilitator, and participant feedback. We explored the acceptability and relevance of PROMs using postal questionnaires, interviews and a smartphone app.
Fourteen practices took part in the study and participant recruitment equated to 1.0/1000 registered patients. Challenges to recruitment were identified. We did 107 paired headache classification interviews. The level of agreement between nurse and doctor interviews was very good. We piloted the intervention in four groups with 18 participants. Qualitative feedback from participants and facilitators helped refine the intervention including shortening the overall intervention and increasing the facilitator training time. Participants completed 131 baseline questionnaires, measurement data quality, reliability and validity for headache-specific and generic measures was acceptable.
This study indicated that recruiting people with chronic headache from primary care is feasible but challenging, our headache classification interview is fit for purpose, our study intervention is viable, and that our choice of outcome measures is acceptable to participants in a future randomised controlled trial (RCT).
ISRCTN, ISRCTN79708100. Registered 16th December 2015, http://www.isrctn.com/ISRCTN79708100.
自我管理支持计划在一系列慢性疾病中是有效的，但在治疗慢性头痛方面的证据有限。本研究的目的是测试未来对新的教育和自我管理干预措施进行评估的试验的四个关键方面的可行性：1）从初级保健中招募慢性头痛患者；2）电话采访用于慢性头痛的分类；3）教育和自我管理干预本身；4）最合适的患者报告结局（PROMS）。
参与者是从英国西米德兰兹的普通诊所中确定并招募的。我们开发了一种由护士主导的慢性头痛分类访谈，并评估了其与头痛专家访谈的一致性。我们开发并测试了一种基于小组的教育和自我管理干预措施，通过观察、主持人和参与者反馈来评估培训和交付效果。我们使用邮寄问卷、访谈和智能手机应用程序探索了 PROMS 的可接受性和相关性。
有 14 家诊所参与了该研究，参与者招募相当于每 1000 名登记患者中有 1.0 名。发现了招募方面的挑战。我们进行了 107 对头痛分类访谈。护士和医生访谈之间的一致性非常好。我们在四个小组中对 18 名参与者进行了干预试验。参与者和主持人的定性反馈有助于改进干预措施，包括缩短整体干预时间和增加主持人培训时间。参与者完成了 131 份基线问卷，头痛特异性和通用测量的测量数据质量、可靠性和有效性是可以接受的。
本研究表明，从初级保健中招募慢性头痛患者是可行的，但具有挑战性，我们的头痛分类访谈是合适的，我们的研究干预是可行的，并且我们选择的结局测量在未来的随机对照试验（RCT）中是可以接受的。
ISRCTN，ISRCTN79708100。于 2015 年 12 月 16 日注册，http://www.isrctn.com/ISRCTN79708100。
