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

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

BMC Medicine, Volume: 17, Issue: 1

Swansea University Author: Alexander Smith Orcid Logo

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DOI (Published version): 10.1186/s12916-019-1350-5

Abstract

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. T...

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Published in: BMC Medicine
ISSN: 1741-7015
Published: Springer Science and Business Media LLC 2019
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URI: https://cronfa.swan.ac.uk/Record/cronfa67745
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fullrecord <?xml version="1.0" encoding="utf-8"?><rfc1807 xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns:xsd="http://www.w3.org/2001/XMLSchema"><bib-version>v2</bib-version><id>67745</id><entry>2024-09-19</entry><title>A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors</title><swanseaauthors><author><sid>a7a45e9adb57476de1eb1ae5613d2098</sid><ORCID>0000-0001-9656-6751</ORCID><firstname>Alexander</firstname><surname>Smith</surname><name>Alexander Smith</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2024-09-19</date><deptcode>HSOC</deptcode><abstract>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 &lt; 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. 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spelling v2 67745 2024-09-19 A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors a7a45e9adb57476de1eb1ae5613d2098 0000-0001-9656-6751 Alexander Smith Alexander Smith true false 2024-09-19 HSOC 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. Journal Article BMC Medicine 17 1 Springer Science and Business Media LLC 1741-7015 Stroke, Follow-up method, Online assessment, Non-inferiority 2 7 2019 2019-07-02 10.1186/s12916-019-1350-5 COLLEGE NANME Health and Social Care School COLLEGE CODE HSOC Swansea University Another institution paid the OA fee Unrestricted competitive funding was obtained from the Stroke Implementation Group of the Welsh Government. 2024-10-21T16:29:15.6430432 2024-09-19T15:19:15.4552817 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Therapies Jonathan Hewitt 0000-0002-7924-1792 1 Anna Pennington 2 Alexander Smith 0000-0001-9656-6751 3 Stephanie Gething 4 Michelle Price 5 James White 6 Richard Dewar 7 Ben Carter 8 67745__32666__d80e9f6d87a34b25a60e1531e4ee05f3.pdf 67745.VoR.pdf 2024-10-21T16:28:19.0781946 Output 1066018 application/pdf Version of Record true © The Author(s). 2019 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License. true eng http://creativecommons.org/licenses/by/4.0/
title A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors
spellingShingle A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors
Alexander Smith
title_short A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors
title_full A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors
title_fullStr A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors
title_full_unstemmed A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors
title_sort A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors
author_id_str_mv a7a45e9adb57476de1eb1ae5613d2098
author_id_fullname_str_mv a7a45e9adb57476de1eb1ae5613d2098_***_Alexander Smith
author Alexander Smith
author2 Jonathan Hewitt
Anna Pennington
Alexander Smith
Stephanie Gething
Michelle Price
James White
Richard Dewar
Ben Carter
format Journal article
container_title BMC Medicine
container_volume 17
container_issue 1
publishDate 2019
institution Swansea University
issn 1741-7015
doi_str_mv 10.1186/s12916-019-1350-5
publisher Springer Science and Business Media LLC
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care - Therapies{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Therapies
document_store_str 1
active_str 0
description 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.
published_date 2019-07-02T16:29:14Z
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