1. A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors
- Author
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James W. C. White, Benjamin Richard Carter, Michelle A. Price, Anna Pennington, Richard Dewar, Stephanie Gething, Alexander Smith, and Jonathan Hewitt
- Subjects
Male ,medicine.medical_specialty ,lcsh:Medicine ,Computer-assisted web interviewing ,Risk Assessment ,law.invention ,Non-inferiority ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Aphasia ,Surveys and Questionnaires ,Medicine ,Humans ,030212 general & internal medicine ,Survivors ,Follow-up method ,Stroke survivor ,Stroke ,Aged ,Response rate (survey) ,business.industry ,lcsh:R ,General Medicine ,Odds ratio ,medicine.disease ,R1 ,United Kingdom ,Telephone interview ,Physical therapy ,RC0321 ,Female ,medicine.symptom ,Online assessment ,business ,030217 neurology & neurosurgery ,Research Article ,Follow-Up Studies - 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
- Published
- 2019
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