A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors

BMC Medicine

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[1] 0000 0001 0581 7464, grid.464526.7, Aneurin Bevan University Health Board, Newport, South Wales, UK;0000 0001 0807 5670, grid.5600.3, Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK;0000 0001 2322 6764, grid.13097.3c, Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK;0000 0004 0648 9863, grid.415187.e, Prince Charles Hospital, Cwm Taf NHS Trust, Prince Charles Hospital, CF47 9DT, Merthyr Tydfil, UK;Ynys Y Plant, Plantation Lane, SY16 1LH, Newtown, UK;

关键词: Stroke;    Follow-up method;    Online assessment;    Non-inferiority;   

DOI  :  10.1186/s12916-019-1350-5

来源: publisher

【 摘 要 】

BackgroundRecovery following a stroke is a long and ongoing process. Post-stroke follow-up after leaving the hospital is recommended. Methods for follow-up patients include face-to-face, via the telephone, post or online (internet). However, there is a debate which method is preferred by patients. This study aimed to determine whether telephone interview, online questionnaire and postal questionnaire were as acceptable as face-to-face follow-up.MethodsIn a blinded, UK-wide, multi-centre, Zelen’s designed, 4-arm (postal, online, telephone, compared to face-to-face), pragmatic non-inferiority randomised controlled trial of the mode of administration, stroke survivors were randomised to postal, online, telephone and face-to-face assessment, in an equal ratio (1:1:1:1). The primary outcome was the proportion of participants that responded to the three allocation groups, compared to the face-to-face group. Subgroup analyses for age, aphasia and type and severity of stroke were carried out. A non-inferiority margin of 0.025 was used, and Holm-Bonferroni multiplicity adjustment was made.ResultsOf the 2074 eligible patients randomised, 55% were male (1142/2074), with an average age of 73.0 years old (SD = 13.2). Of those randomised, 22% (116/525), 9% (47/515) and 20% (101/513) responded in postal, online and telephone, respectively, compared to 17% (89/521) in the face-to-face group. The reduction in the online response rate compared to face-to-face was found to be both inferior and not non-inferior and estimated as an 8% reduction (95% CI 3.9 to 12.0%; p < 0.001). The association with lower online completion was present regardless of age, stroke type (haemorrhage or infarct) and stroke severity. In haemorrhagic stroke, the reduction in response online, compared to face-to-face, was 21% (95% CI 10 to 32%; p value = 0.002). A secondary analysis found non-aphasic stroke survivors preferred postal completion adjusted odds ratio of 1.43 (95% CI 1.04 to 1.95; p = 0.026).ConclusionsThe study found that fewer stroke survivors completed follow-up assessment using an online method, compared to face-to-face. This finding was present in all age groups. Caution should be employed when considering online follow-up methods in stroke survivors, particularly in those who have experienced a cerebrovascular haemorrhage.Trials registrationClinicalTrials.gov, NCT03177161. Registered on 6 June 2017.

【 授权许可】

CC BY