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

Jonathan Hewitt, Anna Pennington, Alexander Smith, Stephanie Gething, Michelle Price, James White, Richard Dewar, Ben Carter, Jonathan Hewitt, Anna Pennington, Alexander Smith, Stephanie Gething, Michelle Price, James White, Richard Dewar, Ben Carter

Abstract

Background: Recovery 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.

Methods: In 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.

Results: Of 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).

Conclusions: The 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 registration: ClinicalTrials.gov, NCT03177161 . Registered on 6 June 2017.

Keywords: Follow-up method; Non-inferiority; Online assessment; Stroke.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The completion rates for postal, online and telephone follow-up methods, compared to face-to-face are shown with the associated 95% confidence intervals. The solid horizontal line is the line of no difference, and the non-inferiority margin (NIM) is shown with the broken horizontal line

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Source: PubMed

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