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 P White; Richard Dewar; Ben Carter

doi:10.1186/s12916-019-1350-5

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 P White, Richard Dewar, Ben Carter

Biostatistics & Health Informatics

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Abstract

Background Recovery following a stroke is a long and ongoing process. Post stroke follow up after leaving hospital is recommended. Methods for follow up patients include face to face, via the telephone, post or online (internet). However, there is 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; 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 2,074 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, 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.

Original language	English
Article number	111
Journal	BMC Medicine
Volume	17
Issue number	1
Early online date	2 Jul 2019
DOIs	https://doi.org/10.1186/s12916-019-1350-5
Publication status	Published - 11 Jul 2019

Keywords

Follow-up method
Non-inferiority
Online assessment
Stroke

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10.1186/s12916-019-1350-5Licence: CC BY

A multi-centre, UK-based_HEWITT_Accepted24May2019Publishedonline2July2019_GOLD VoR (CC BY)Final published version, 1.02 MBLicence: CC BY

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@article{0bd9845a069b4e8ebcab463c34e677cf,

title = "A multi-centre, UK based, non-inferiority randomised controlled trial of 4 follow up assessment methods in Stroke Survivors",

abstract = "Background Recovery following a stroke is a long and ongoing process. Post stroke follow up after leaving hospital is recommended. Methods for follow up patients include face to face, via the telephone, post or online (internet). However, there is 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{\textquoteright}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; 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 2,074 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, 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. ",

keywords = "Follow-up method, Non-inferiority, Online assessment, Stroke",

author = "Jonathan Hewitt and Anna Pennington and Alexander Smith and Stephanie Gething and Michelle Price and White, {James P} and Richard Dewar and Ben Carter",

year = "2019",

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doi = "10.1186/s12916-019-1350-5",

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T1 - A multi-centre, UK based, non-inferiority randomised controlled trial of 4 follow up assessment methods in Stroke Survivors

AU - Hewitt, Jonathan

AU - Pennington, Anna

AU - Smith, Alexander

AU - Gething, Stephanie

AU - Price, Michelle

AU - White, James P

AU - Dewar, Richard

AU - Carter, Ben

PY - 2019/7/11

Y1 - 2019/7/11

N2 - Background Recovery following a stroke is a long and ongoing process. Post stroke follow up after leaving hospital is recommended. Methods for follow up patients include face to face, via the telephone, post or online (internet). However, there is 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; 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 2,074 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, 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.

AB - Background Recovery following a stroke is a long and ongoing process. Post stroke follow up after leaving hospital is recommended. Methods for follow up patients include face to face, via the telephone, post or online (internet). However, there is 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; 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 2,074 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, 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.

KW - Follow-up method

KW - Non-inferiority

KW - Online assessment

KW - Stroke

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U2 - 10.1186/s12916-019-1350-5

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JF - BMC Medicine

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

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