Introduction Long COVID (LC), the persistent symptoms ≥12 weeks following acute COVID-19, present... more Introduction Long COVID (LC), the persistent symptoms ≥12 weeks following acute COVID-19, presents major threats to individual and public health across countries, affecting over 1.5 million people in the UK alone. Evidence-based interventions are urgently required and an integrated care pathway approach in pragmatic trials, which include investigations, treatments and rehabilitation for LC, could provide scalable and generalisable solutions at pace. Methods and analysis This is a pragmatic, multi-centre, cluster-randomised clinical trial of two components of an integrated care pathway (Coverscan™, a multi-organ MRI, and Living with COVID Recovery™, a digitally enabled rehabilitation platform) with a nested, Phase III, open label, platform randomised drug trial in individuals with LC. Cluster randomisation is at level of primary care networks so that integrated care pathway interventions are delivered as “standard of care” in that area. The drug trial randomisation is at individual l...
ABSTRACTIntroductionLong COVID (LC), the persistent symptoms ≥12 weeks following acute COVID-19, ... more ABSTRACTIntroductionLong COVID (LC), the persistent symptoms ≥12 weeks following acute COVID-19, presents major threats to individual and public health across countries, affecting over 1.5 million people in the UK alone. Evidence-based interventions are urgently required and an integrated care pathway (ICP) approach in pragmatic trials, which include investigations, treatments and rehabilitation for LC, could provide scalable and generalisable solutions at pace.Methods and analysisThis is a pragmatic, multi-centre, cluster-randomised clinical trial of two components of an ICP (Coverscan™, a multi-organ MRI, and Living with COVID Recovery™, a digitally enabled rehabilitation platform) with a nested, Phase III, open label, platform randomised drug trial in individuals with LC. Cluster randomisation is at level of primary care networks so that ICP interventions are delivered as “standard of care” in that area. The drug trial randomisation is at individual level and initial arms are riv...
Additional file 1. WORKWELL Trial: contents of the: Work Self-help Information Pack; WORKWELL Job... more Additional file 1. WORKWELL Trial: contents of the: Work Self-help Information Pack; WORKWELL Job Retention Vocational Rehabilitation intervention; Participant Information Sheet and Consent Form.
Background Urinary incontinence affects around half of stroke survivors in the acute phase, and i... more Background Urinary incontinence affects around half of stroke survivors in the acute phase, and it often presents as a new problem after stroke or, if pre-existing, worsens significantly, adding to the disability and helplessness caused by neurological deficits. New management programmes after stroke are needed to address urinary incontinence early and effectively. Objective The Identifying Continence OptioNs after Stroke (ICONS)-II trial aimed to evaluate the clinical effectiveness and cost-effectiveness of a systematic voiding programme for urinary incontinence after stroke in hospital. Design This was a pragmatic, multicentre, individual-patient-randomised (1 : 1), parallel-group trial with an internal pilot. Setting Eighteen NHS stroke services with stroke units took part. Participants Participants were adult men and women with acute stroke and urinary incontinence, including those with cognitive impairment. Intervention Participants were randomised to the intervention, a system...
International Journal of Environmental Research and Public Health
Objective: To examine changes in leisure participation following stroke/transient ischaemic attac... more Objective: To examine changes in leisure participation following stroke/transient ischaemic attack (TIA) and explore its relationship to modifiable and non-modifiable participant characteristics. Design: An observational study design with self-report questionnaires collected at two time points (baseline and 6-months). Setting: The study was conducted across 21 hospital sites in England, Wales, and Northern Ireland. Participants: Participants were aged 18+ and had experienced a first or recurrent stroke or TIA and had a post-stroke/TIA modified Rankin score (mRS) of ≤3. Procedure: Research practitioners at each site approached potential participants. Individuals who agreed to participate completed a baseline questionnaire whilst an inpatient or at a first post-stroke/TIA clinic appointment. A follow-up questionnaire was posted to participants with a freepost return envelope. Two questionnaires were developed that collected demographic information, pre-stroke/TIA mRS, social circumsta...
Research Methods in Medicine & Health Sciences
Background Retention is considered the second highest trial methods priority in the UK after recr... more Background Retention is considered the second highest trial methods priority in the UK after recruitment. There is limited evidence on whether notifying trial participants that a follow-up questionnaire will be sent soon (‘pre-notification’) affects retention. Methods This Study Within a Trial (SWAT) evaluated whether sending a pre-notification letter or email around 2 weeks before sending a self-report questionnaire increased retention, in terms of provision of the host trial primary outcome. The SWAT was a randomised, two-arm, parallel-design (1:1 allocation ratio) trial, controlled by ‘no pre-notification letter’. It was embedded within the WORKWELL host trial, which evaluated the impact of job retention vocational rehabilitation on work-related and health-related outcomes of employed people with inflammatory arthritis. The SWAT primary outcome was a valid response for the WORKWELL primary outcome. Results Two hundred forty-four trial participants took part in the SWAT. All were ...
Introduction Long COVID (LC), the persistent symptoms ≥12 weeks following acute COVID-19, present... more Introduction Long COVID (LC), the persistent symptoms ≥12 weeks following acute COVID-19, presents major threats to individual and public health across countries, affecting over 1.5 million people in the UK alone. Evidence-based interventions are urgently required and an integrated care pathway approach in pragmatic trials, which include investigations, treatments and rehabilitation for LC, could provide scalable and generalisable solutions at pace. Methods and analysis This is a pragmatic, multi-centre, cluster-randomised clinical trial of two components of an integrated care pathway (Coverscan™, a multi-organ MRI, and Living with COVID Recovery™, a digitally enabled rehabilitation platform) with a nested, Phase III, open label, platform randomised drug trial in individuals with LC. Cluster randomisation is at level of primary care networks so that integrated care pathway interventions are delivered as “standard of care” in that area. The drug trial randomisation is at individual l...
ABSTRACTIntroductionLong COVID (LC), the persistent symptoms ≥12 weeks following acute COVID-19, ... more ABSTRACTIntroductionLong COVID (LC), the persistent symptoms ≥12 weeks following acute COVID-19, presents major threats to individual and public health across countries, affecting over 1.5 million people in the UK alone. Evidence-based interventions are urgently required and an integrated care pathway (ICP) approach in pragmatic trials, which include investigations, treatments and rehabilitation for LC, could provide scalable and generalisable solutions at pace.Methods and analysisThis is a pragmatic, multi-centre, cluster-randomised clinical trial of two components of an ICP (Coverscan™, a multi-organ MRI, and Living with COVID Recovery™, a digitally enabled rehabilitation platform) with a nested, Phase III, open label, platform randomised drug trial in individuals with LC. Cluster randomisation is at level of primary care networks so that ICP interventions are delivered as “standard of care” in that area. The drug trial randomisation is at individual level and initial arms are riv...
Additional file 1. WORKWELL Trial: contents of the: Work Self-help Information Pack; WORKWELL Job... more Additional file 1. WORKWELL Trial: contents of the: Work Self-help Information Pack; WORKWELL Job Retention Vocational Rehabilitation intervention; Participant Information Sheet and Consent Form.
Background Urinary incontinence affects around half of stroke survivors in the acute phase, and i... more Background Urinary incontinence affects around half of stroke survivors in the acute phase, and it often presents as a new problem after stroke or, if pre-existing, worsens significantly, adding to the disability and helplessness caused by neurological deficits. New management programmes after stroke are needed to address urinary incontinence early and effectively. Objective The Identifying Continence OptioNs after Stroke (ICONS)-II trial aimed to evaluate the clinical effectiveness and cost-effectiveness of a systematic voiding programme for urinary incontinence after stroke in hospital. Design This was a pragmatic, multicentre, individual-patient-randomised (1 : 1), parallel-group trial with an internal pilot. Setting Eighteen NHS stroke services with stroke units took part. Participants Participants were adult men and women with acute stroke and urinary incontinence, including those with cognitive impairment. Intervention Participants were randomised to the intervention, a system...
International Journal of Environmental Research and Public Health
Objective: To examine changes in leisure participation following stroke/transient ischaemic attac... more Objective: To examine changes in leisure participation following stroke/transient ischaemic attack (TIA) and explore its relationship to modifiable and non-modifiable participant characteristics. Design: An observational study design with self-report questionnaires collected at two time points (baseline and 6-months). Setting: The study was conducted across 21 hospital sites in England, Wales, and Northern Ireland. Participants: Participants were aged 18+ and had experienced a first or recurrent stroke or TIA and had a post-stroke/TIA modified Rankin score (mRS) of ≤3. Procedure: Research practitioners at each site approached potential participants. Individuals who agreed to participate completed a baseline questionnaire whilst an inpatient or at a first post-stroke/TIA clinic appointment. A follow-up questionnaire was posted to participants with a freepost return envelope. Two questionnaires were developed that collected demographic information, pre-stroke/TIA mRS, social circumsta...
Research Methods in Medicine & Health Sciences
Background Retention is considered the second highest trial methods priority in the UK after recr... more Background Retention is considered the second highest trial methods priority in the UK after recruitment. There is limited evidence on whether notifying trial participants that a follow-up questionnaire will be sent soon (‘pre-notification’) affects retention. Methods This Study Within a Trial (SWAT) evaluated whether sending a pre-notification letter or email around 2 weeks before sending a self-report questionnaire increased retention, in terms of provision of the host trial primary outcome. The SWAT was a randomised, two-arm, parallel-design (1:1 allocation ratio) trial, controlled by ‘no pre-notification letter’. It was embedded within the WORKWELL host trial, which evaluated the impact of job retention vocational rehabilitation on work-related and health-related outcomes of employed people with inflammatory arthritis. The SWAT primary outcome was a valid response for the WORKWELL primary outcome. Results Two hundred forty-four trial participants took part in the SWAT. All were ...
Uploads
Papers by Denise Forshaw