Smith Alexander, Pennington Anna, Carter Ben, Gething Stephanie, Price Michelle, White James, Dewar Richard, Hewitt Jonathan
Aneurin Bevan University Health Board, South Wales, UK.
Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Trials. 2018 Jul 3;19(1):349. doi: 10.1186/s13063-018-2694-4.
UK-wide national clinical guidelines promote routine 6-month post-stroke follow-up assessment. However, as part of this 6-month assessment little information is gathered from the patient's perspective. The means of collecting this patient-centred information might be served best by a patient-reported outcome measure (PROM) at the 6-month assessment time point. Currently, four different methods of 6-month follow-up assessment occur; the most common being face-to-face interview followed by telephone interview, postal questionnaire and online questionnaire. Therefore, this study will investigate if the acceptability of telephone, online or postal administration of a PROM at the 6-month post-stoke time point is not inferior to face-to-face administration.
METHODS/DESIGN: A UK multicentre, blinded (analyst and researcher), pragmatic, non-inferiority study, with 80% power using a 2.5% non-inferiority margin was designed to compare the acceptability of three modes of administration (telephone interview, postal questionnaire and online questionnaire) compared with face-to-face interview administration of a PROM. We plan to approach and randomise a minimum of 808 potentially eligible participants, 202 participants per group.
The aim of this ongoing research is to understand if there is a difference between face-to-face administration and the other three methods of administering a PROM as a patient-centred supplement to the 6-month review for stroke survivors. In utilising a pragmatic design, it is believed that this study will offer UK wide generalisable results, of the acceptability of the methods under investigation, to inform clinicians and commissioners of stroke services.
ClinicalTrials.gov: NCT03177161 . Registered on 6 June 2017.
全英国范围的国家临床指南提倡在中风后进行常规的6个月随访评估。然而，在这6个月的评估中，从患者角度收集的信息很少。在6个月评估时间点采用患者报告结局量表（PROM）可能是收集这种以患者为中心信息的最佳方式。目前，有四种不同的6个月随访评估方法；最常见的是面对面访谈，其次是电话访谈、邮寄问卷和在线问卷。因此，本研究将调查在中风后6个月时间点通过电话、在线或邮寄方式进行PROM评估的可接受性是否不低于面对面评估。
方法/设计：一项英国多中心、双盲（分析人员和研究人员）、实用、非劣效性研究，设计为使用2.5%的非劣效性界值，检验效能为80%，旨在比较三种评估方式（电话访谈、邮寄问卷和在线问卷）与PROM面对面访谈评估的可接受性。我们计划纳入并随机分配至少808名潜在符合条件的参与者，每组202名参与者。
这项正在进行的研究的目的是了解作为中风幸存者6个月复查以患者为中心的补充内容，面对面评估与其他三种PROM评估方法之间是否存在差异。通过采用实用设计，相信本研究将提供全英国范围内关于所研究方法可接受性的可推广结果，为中风服务的临床医生和管理人员提供参考。
ClinicalTrials.gov：NCT03177161。于2017年6月6日注册。
