Ivana Holloway - Academia.edu (original) (raw)

Papers by Ivana Holloway

Research paper thumbnail of Can follow-up reminders from postal questionnaires help determine the mechanism of missing data in trials?

Research paper thumbnail of The Implementation of Dementia Care Mapping in a Randomized Controlled Trial in Long-Term Care: Results of a Process Evaluation

American Journal of Alzheimers Disease and Other Dementias, May 5, 2019

Research paper thumbnail of Dementia Care Mapping™ to reduce agitation in care home residents with dementia: the EPIC cluster RCT

Health Technology Assessment, Mar 1, 2020

Research paper thumbnail of The DARS (Dopamine Augmented Rehabilitation in Stroke) trial: protocol for a randomised controlled trial of Co-careldopa treatment in addition to routine NHS occupational and physical therapy after stroke

Research paper thumbnail of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Research Square (Research Square), Nov 5, 2020

Research paper thumbnail of Using routine healthcare data to evaluate the impact of the Medicines at Transitions Intervention (MaTI) on clinical outcomes of patients hospitalised with heart failure: protocol for the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomis...

BMJ Open

IntroductionHeart failure affects 26 million people globally, approximately 900 thousand people i... more IntroductionHeart failure affects 26 million people globally, approximately 900 thousand people in the UK, and is increasing in incidence. Appropriate management of medicines for heart failure at the time of hospital discharge reduces readmissions, improves quality of life and increases survival. The Improving the Safety and Continuity Of Medicines management at Transitions (ISCOMAT) trial tests the effectiveness of the Medicines at Transition Intervention (MaTI), which aims to enhance self-care and increase community pharmacy involvement in the medicines management of heart failure patients.Methods and analysisISCOMAT is a parallel-group cluster randomised controlled trial, randomising 42 National Health Service trusts with cardiology wards in England on a 1:1 basis to implement the MaTI or treatment as usual. Around 2100 patients over the age of 18 admitted to hospital with heart failure with at least moderate left ventricular systolic dysfunction within the last 5 years, and plan...

Research paper thumbnail of Efficacy and safety of co-careldopa as an add-on therapy to occupational and physical therapy in patients after stroke (DARS): a randomised, double-blind, placebo controlled trial

Research paper thumbnail of Effectiveness of Dementia Care Mapping™ to reduce agitation in care home residents with dementia: an open-cohort cluster randomised controlled trial

Aging & Mental Health, 2020

Research paper thumbnail of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Background: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising inc... more Background: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e., usual NHS rehabilitation) is more clinically and cost effective for supporting post-stroke RTW, than UC alone.Methods: 760 stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants’ ho...

Research paper thumbnail of Dementia Care Mapping™ to reduce agitation in care home residents with dementia: the EPIC cluster RCT

Health Technology Assessment, 2020

Background The quality of care for people with dementia in care homes is of concern. Intervention... more Background The quality of care for people with dementia in care homes is of concern. Interventions that can improve care outcomes are required. Objective To investigate the clinical effectiveness and cost-effectiveness of Dementia Care Mapping™ (DCM) for reducing agitation and improving care outcomes for people living with dementia in care homes, versus usual care. Design A pragmatic, cluster randomised controlled trial with an open-cohort design, follow-up at 6 and 16 months, integrated cost-effectiveness analysis and process evaluation. Clusters were not blinded to allocation. The primary end point was completed by staff proxy and independent assessors. Setting Stratified randomisation of 50 care homes to the intervention and control groups on a 3 : 2 ratio by type, size, staff exposure to dementia training and recruiting hub. Participants Fifty care homes were randomised (intervention, n = 31; control, n = 19), with 726 residents recruited at baseline and a further 261 recruited ...

Research paper thumbnail of Treatment of irritable bowel syndrome with diarrhoea using titrated ondansetron (TRITON): study protocol for a randomised controlled trial

Research paper thumbnail of Exploring adults’ experiences of sedentary behaviour and participation in non-workplace interventions designed to reduce sedentary behaviour: a thematic synthesis of qualitative studies

Research paper thumbnail of Safety and efficacy of co-careldopa as an add-on therapy to occupational and physical therapy in patients after stroke (DARS): a randomised, double-blind, placebo-controlled trial

The Lancet Neurology, 2019

Research paper thumbnail of The DARS (Dopamine Augmented Rehabilitation in Stroke) trial: protocol for a randomised controlled trial of Co-careldopa treatment in addition to routine NHS occupational and physical therapy after stroke

Research paper thumbnail of A cluster randomised controlled trial and economic evaluation of a structured training programme for caregivers of inpatients after stroke: the TRACS trial

Health technology assessment (Winchester, England), 2013

The majority of stroke patients are discharged home dependent on informal caregivers, usually fam... more The majority of stroke patients are discharged home dependent on informal caregivers, usually family members, to provide assistance with activities of daily living (ADL), including bathing, dressing and toileting. Many caregivers feel unprepared for this role and this may have a detrimental effect on both the patient and caregiver. To evaluate whether or not a structured, competency-based training programme for caregivers [the London Stroke Carer Training Course (LSCTC)] improved physical and psychological outcomes for patients and their caregivers after disabling stroke, and to determine if such a training programme is cost-effective. A pragmatic, multicentre, cluster randomised controlled trial. Stratified randomisation of 36 stroke rehabilitation units (SRUs) to the intervention or control group by geographical region and quality of care. A total of 930 stroke patient and caregiver dyads were recruited. Patients were eligible if they had a confirmed diagnosis of stroke, were medi...

Research paper thumbnail of Can follow-up reminders from postal questionnaires help determine the mechanism of missing data in trials?

Research paper thumbnail of Dopamine Augmented Rehabilitation in Stroke (DARS): a multicentre double-blind, randomised controlled trial of co-careldopa compared with placebo, in addition to routine NHS occupational and physical therapy, delivered early after stroke on functional recovery

Efficacy and Mechanism Evaluation, 2019

Background Dopamine is a key modulator of striatal function and learning, and may improve motor r... more Background Dopamine is a key modulator of striatal function and learning, and may improve motor recovery after stroke. Seven small trials of dopamine agonists after stroke have provided equivocal evidence of the clinical effectiveness of dopamine agonists in improving motor recovery. Design Dopamine Augmented Rehabilitation in Stroke was a multicentre, randomised, double-blind, placebo-controlled trial with stroke patients randomised to receive 6 weeks of co-careldopa (Sinemet®, Merck Sharp & Dohme Ltd) or placebo in combination with occupational and physical rehabilitation. Methods The primary outcome measure was the proportion of patients walking independently at 8 weeks [Rivermead Mobility Index (RMI) score of ≥ 7 points and ‘yes’ to item 7 on the RMI]. Secondary outcome measures assessed physical functioning, pain, cognition, mood, fatigue and carer burden at 8 weeks, 6 months and 12 months. Results Between May 2011 and March 2014, 593 patients (mean age 68.5 years) and 165 care...

Research paper thumbnail of Ondansetron for irritable bowel syndrome with diarrhoea: randomised controlled trial

Efficacy and mechanism evaluation, Sep 30, 2023

Criteria for inclusion in the Efficacy and Mechanism Evaluation journal Reports are published in ... more Criteria for inclusion in the Efficacy and Mechanism Evaluation journal Reports are published in Efficacy and Mechanism Evaluation (EME) if (1) they have resulted from work for the EME programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors. EME programme The Efficacy and Mechanism Evaluation (EME) programme funds ambitious studies evaluating interventions that have the potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or longterm care. Within these studies, EME supports research to improve the understanding of the mechanisms of both diseases and treatments. The programme supports translational research into a wide range of new or repurposed interventions. These may include diagnostic or prognostic tests and decision-making tools, therapeutics or psychological treatments, medical devices, and public health initiatives delivered in the NHS. The EME programme supports clinical trials and studies with other robust designs, which test the efficacy of interventions, and which may use clinical or well-validated surrogate outcomes. It only supports studies in man and where there is adequate proof of concept. The programme encourages hypothesis-driven mechanistic studies, integrated within the efficacy study, that explore the mechanisms of action of the intervention or the disease, the cause of differing responses, or improve the understanding of adverse effects. It funds similar mechanistic studies linked to studies funded by any NIHR programme.

Research paper thumbnail of A Multidimensional Approach to Assessing Factors Impacting Health-Related Quality of Life after Pediatric Traumatic Brain Injury

This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY

Research paper thumbnail of Can follow-up reminders from postal questionnaires help determine the mechanism of missing data in trials?

Research paper thumbnail of The Implementation of Dementia Care Mapping in a Randomized Controlled Trial in Long-Term Care: Results of a Process Evaluation

American Journal of Alzheimers Disease and Other Dementias, May 5, 2019

Research paper thumbnail of Dementia Care Mapping™ to reduce agitation in care home residents with dementia: the EPIC cluster RCT

Health Technology Assessment, Mar 1, 2020

Research paper thumbnail of The DARS (Dopamine Augmented Rehabilitation in Stroke) trial: protocol for a randomised controlled trial of Co-careldopa treatment in addition to routine NHS occupational and physical therapy after stroke

Research paper thumbnail of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Research Square (Research Square), Nov 5, 2020

Research paper thumbnail of Using routine healthcare data to evaluate the impact of the Medicines at Transitions Intervention (MaTI) on clinical outcomes of patients hospitalised with heart failure: protocol for the Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT) cluster randomis...

BMJ Open

IntroductionHeart failure affects 26 million people globally, approximately 900 thousand people i... more IntroductionHeart failure affects 26 million people globally, approximately 900 thousand people in the UK, and is increasing in incidence. Appropriate management of medicines for heart failure at the time of hospital discharge reduces readmissions, improves quality of life and increases survival. The Improving the Safety and Continuity Of Medicines management at Transitions (ISCOMAT) trial tests the effectiveness of the Medicines at Transition Intervention (MaTI), which aims to enhance self-care and increase community pharmacy involvement in the medicines management of heart failure patients.Methods and analysisISCOMAT is a parallel-group cluster randomised controlled trial, randomising 42 National Health Service trusts with cardiology wards in England on a 1:1 basis to implement the MaTI or treatment as usual. Around 2100 patients over the age of 18 admitted to hospital with heart failure with at least moderate left ventricular systolic dysfunction within the last 5 years, and plan...

Research paper thumbnail of Efficacy and safety of co-careldopa as an add-on therapy to occupational and physical therapy in patients after stroke (DARS): a randomised, double-blind, placebo controlled trial

Research paper thumbnail of Effectiveness of Dementia Care Mapping™ to reduce agitation in care home residents with dementia: an open-cohort cluster randomised controlled trial

Aging & Mental Health, 2020

Research paper thumbnail of An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Background: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising inc... more Background: Return to work (RTW) is achieved by less than 50% of stroke survivors. The rising incidence of stroke among younger people, the UK economic forecast, and clinical drivers highlight the need for stroke survivors to receive support with RTW. However, evidence for this type of support is lacking. This randomised controlled trial (RCT) will investigate whether Early Stroke Specialist Vocational Rehabilitation (ESSVR) plus usual care (UC) (i.e., usual NHS rehabilitation) is more clinically and cost effective for supporting post-stroke RTW, than UC alone.Methods: 760 stroke survivors and their carers will be recruited from approximately 20 NHS stroke services. A 5:4 allocation ratio will be employed to randomise participants to receive ESSVR plus UC, or UC alone. The individually tailored ESSVR intervention will commence within 12 weeks of stroke onset and be delivered for up to 12 months as necessary by trained RETAKE occupational therapists in the community, participants’ ho...

Research paper thumbnail of Dementia Care Mapping™ to reduce agitation in care home residents with dementia: the EPIC cluster RCT

Health Technology Assessment, 2020

Background The quality of care for people with dementia in care homes is of concern. Intervention... more Background The quality of care for people with dementia in care homes is of concern. Interventions that can improve care outcomes are required. Objective To investigate the clinical effectiveness and cost-effectiveness of Dementia Care Mapping™ (DCM) for reducing agitation and improving care outcomes for people living with dementia in care homes, versus usual care. Design A pragmatic, cluster randomised controlled trial with an open-cohort design, follow-up at 6 and 16 months, integrated cost-effectiveness analysis and process evaluation. Clusters were not blinded to allocation. The primary end point was completed by staff proxy and independent assessors. Setting Stratified randomisation of 50 care homes to the intervention and control groups on a 3 : 2 ratio by type, size, staff exposure to dementia training and recruiting hub. Participants Fifty care homes were randomised (intervention, n = 31; control, n = 19), with 726 residents recruited at baseline and a further 261 recruited ...

Research paper thumbnail of Treatment of irritable bowel syndrome with diarrhoea using titrated ondansetron (TRITON): study protocol for a randomised controlled trial

Research paper thumbnail of Exploring adults’ experiences of sedentary behaviour and participation in non-workplace interventions designed to reduce sedentary behaviour: a thematic synthesis of qualitative studies

Research paper thumbnail of Safety and efficacy of co-careldopa as an add-on therapy to occupational and physical therapy in patients after stroke (DARS): a randomised, double-blind, placebo-controlled trial

The Lancet Neurology, 2019

Research paper thumbnail of The DARS (Dopamine Augmented Rehabilitation in Stroke) trial: protocol for a randomised controlled trial of Co-careldopa treatment in addition to routine NHS occupational and physical therapy after stroke

Research paper thumbnail of A cluster randomised controlled trial and economic evaluation of a structured training programme for caregivers of inpatients after stroke: the TRACS trial

Health technology assessment (Winchester, England), 2013

The majority of stroke patients are discharged home dependent on informal caregivers, usually fam... more The majority of stroke patients are discharged home dependent on informal caregivers, usually family members, to provide assistance with activities of daily living (ADL), including bathing, dressing and toileting. Many caregivers feel unprepared for this role and this may have a detrimental effect on both the patient and caregiver. To evaluate whether or not a structured, competency-based training programme for caregivers [the London Stroke Carer Training Course (LSCTC)] improved physical and psychological outcomes for patients and their caregivers after disabling stroke, and to determine if such a training programme is cost-effective. A pragmatic, multicentre, cluster randomised controlled trial. Stratified randomisation of 36 stroke rehabilitation units (SRUs) to the intervention or control group by geographical region and quality of care. A total of 930 stroke patient and caregiver dyads were recruited. Patients were eligible if they had a confirmed diagnosis of stroke, were medi...

Research paper thumbnail of Can follow-up reminders from postal questionnaires help determine the mechanism of missing data in trials?

Research paper thumbnail of Dopamine Augmented Rehabilitation in Stroke (DARS): a multicentre double-blind, randomised controlled trial of co-careldopa compared with placebo, in addition to routine NHS occupational and physical therapy, delivered early after stroke on functional recovery

Efficacy and Mechanism Evaluation, 2019

Background Dopamine is a key modulator of striatal function and learning, and may improve motor r... more Background Dopamine is a key modulator of striatal function and learning, and may improve motor recovery after stroke. Seven small trials of dopamine agonists after stroke have provided equivocal evidence of the clinical effectiveness of dopamine agonists in improving motor recovery. Design Dopamine Augmented Rehabilitation in Stroke was a multicentre, randomised, double-blind, placebo-controlled trial with stroke patients randomised to receive 6 weeks of co-careldopa (Sinemet®, Merck Sharp & Dohme Ltd) or placebo in combination with occupational and physical rehabilitation. Methods The primary outcome measure was the proportion of patients walking independently at 8 weeks [Rivermead Mobility Index (RMI) score of ≥ 7 points and ‘yes’ to item 7 on the RMI]. Secondary outcome measures assessed physical functioning, pain, cognition, mood, fatigue and carer burden at 8 weeks, 6 months and 12 months. Results Between May 2011 and March 2014, 593 patients (mean age 68.5 years) and 165 care...

Research paper thumbnail of Ondansetron for irritable bowel syndrome with diarrhoea: randomised controlled trial

Efficacy and mechanism evaluation, Sep 30, 2023

Criteria for inclusion in the Efficacy and Mechanism Evaluation journal Reports are published in ... more Criteria for inclusion in the Efficacy and Mechanism Evaluation journal Reports are published in Efficacy and Mechanism Evaluation (EME) if (1) they have resulted from work for the EME programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors. EME programme The Efficacy and Mechanism Evaluation (EME) programme funds ambitious studies evaluating interventions that have the potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or longterm care. Within these studies, EME supports research to improve the understanding of the mechanisms of both diseases and treatments. The programme supports translational research into a wide range of new or repurposed interventions. These may include diagnostic or prognostic tests and decision-making tools, therapeutics or psychological treatments, medical devices, and public health initiatives delivered in the NHS. The EME programme supports clinical trials and studies with other robust designs, which test the efficacy of interventions, and which may use clinical or well-validated surrogate outcomes. It only supports studies in man and where there is adequate proof of concept. The programme encourages hypothesis-driven mechanistic studies, integrated within the efficacy study, that explore the mechanisms of action of the intervention or the disease, the cause of differing responses, or improve the understanding of adverse effects. It funds similar mechanistic studies linked to studies funded by any NIHR programme.

Research paper thumbnail of A Multidimensional Approach to Assessing Factors Impacting Health-Related Quality of Life after Pediatric Traumatic Brain Injury

This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY