Methods to improve patient recruitment and retention in stroke trials

Berge, Eivind; Stapf, Christian; Salman, Rustam Al-Shahi; Ford, Gary A.; Sandercock, Peter; Worp, H. Bart van der; Petersson, Jesper; Dippel, Diederik W.J.; Krieger, Derk; Lees, Kennedy R.

doi:10.1177/1747493016641963

Cited by 30 publications

(38 citation statements)

References 24 publications

(49 reference statements)

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“…fatigue, exercise tolerance, communication difficulties, being physically and psychological overwhelmed and memory difficulties), which are identified and acknowledged in the literature as barriers to recruitment and retention in stroke clinical trials [ 8 ]. These barriers have been carefully considered by utilising relevant literature [ 4 ] and resources such as Clinical Research Networks and people who have suffered stroke, their relatives and stroke specialist therapists to facilitate inclusion of people with severe stroke. Additionally, the qualitative component will provide the opportunity to explore the impact of the functional standing frame programme intervention, being randomised into the usual physiotherapy group, recruitment and retention.…”

Section: Discussionmentioning

confidence: 99%

Standing Practice In Rehabilitation Early after Stroke (SPIRES): a functional standing frame programme (prolonged standing and repeated sit to stand) to improve function and quality of life and reduce neuromuscular impairment in people with severe sub-acute stroke—a protocol for a feasibility randomised controlled trial

Logan

Freeman

Kent

et al. 2018

Pilot Feasibility Stud

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BackgroundThe most common physical deficit caused by a stroke is muscle weakness which limits a person’s mobility. Mobility encompasses activities necessary for daily functioning: getting in and out bed, on/off toilet, sitting, standing and walking. These activities are significantly affected in people with severe stroke who typically spend most of their time in bed or a chair and are immobile. Immobility is primarily caused by neurological damage but exacerbated by secondary changes in musculoskeletal and cardiorespiratory systems. These secondary changes can theoretically be prevented or minimised by early mobilisation, in this case standing up early post-stroke.Standing up early post-stroke has been identified as an important priority for people who have suffered a severe stroke. However, trials of prolonged passive standing have not demonstrated any functional improvements. Conversely, task-specific training such as repeated sit-to-stand has demonstrated positive functional benefits. This feasibility trial combines prolonged standing and task-specific strength training with the aim of determining whether this novel combination of physiotherapy interventions is feasible for people with severe stroke as well as the overall feasibility of delivering the trial.Methods/designThis is a pragmatic multi-centre parallel single-blinded two-armed feasibility randomised controlled trial. Fifty people with a diagnosis of severe stroke will be randomly allocated to either the functional standing frame programme or usual physiotherapy. All patient participants will be assessed at baseline and followed up at 3 weeks, then 3, 6 and 12 months post-randomisation. Trial objectives are to determine the feasibility according to the following indicators:: (i) Process: recruitment and retention rate, ability to consent, eligibility criteria, willingness/ability of physiotherapists to recruit, willingness of patients to be randomised, and acceptability of the intervention; (ii) Resource: burden and potential costs; (iii) Management: treatment fidelity, participant adherence, acceptability and completeness of outcome measures, impact and management or orthostatic hypotension; and (iv) Safety: number and nature of adverse and serious adverse events.DiscussionThe functional standing frame programme addresses a key concern for people who have suffered a severe stroke. However, several uncertainties exist which need to be understood prior to progressing to a full-scale trial, including acceptability and tolerance of the functional standing frame programme intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties.Trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN15412695. Registration on 19 December 2016.Electronic supplementary materialThe online version of this article (10.1186/s40814-018-0254-z) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Standing Practice In Rehabilitation Early after Stroke (SPIRES): a functional standing frame programme (prolonged standing and repeated sit to stand) to improve function and quality of life and reduce neuromuscular impairment in people with severe sub-acute stroke—a protocol for a feasibility randomised controlled trial

Logan

Freeman

Kent

et al. 2018

Pilot Feasibility Stud

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“…Under the IHR core capacities, pandemic preparedness and response at a national level include having an identified role and action for the public security sector and the need for formal platforms of com munication between public health and public security sectors. 8,9 However, in many countries there are considerable gaps in these core capacities. The lack of attention to this cross-sector approach to pandemic preparedness and response contrasts with planning for other large-scale disasters and ignores the interface between public security agencies and operational and geographical aspects of emerging and re-emerging Harnessing synergies at the interface of public health and the security sector by the UK and Scottish Stroke Research Networks, and had a pragmatic trial design.…”

Section: Fluoxetine and Recovery After Strokementioning

confidence: 99%

“…However, onsite monitoring is labour-intensive, expensive, and, importantly, of unproven effectiveness in investigator-initiated trials. 7,8 The requirement of onsite monitoring is probably disproportionate in trials testing treatments with a well established and favourable safety profile such as fluoxetine, and might even have the risk of impeding rather than promoting successful completion of such trials. In this respect, FOCUS serves as an example to clinical trialists and regulators.…”

Section: Fluoxetine and Recovery After Strokementioning

confidence: 99%

Fluoxetine and recovery after stroke

Worp

2019

The Lancet

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“…For example, there is still many questions about the best ways to increase patient recruitment and retention (68), and to analyse data from stroke trials (50). In order to understand what is best practice in these areas, and to learn whether best practices are followed, we need more methodological research.…”

Section: Conclusion and Future Perspectivesmentioning

confidence: 99%

Increasing value and reducing waste in stroke research

Berge

Salman

Worp

et al. 2017

The Lancet Neurology

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SummaryStroke represents a major burden to patients and society, and resources spent on stroke research must be used efficiently and produce good value in terms of improvements in human health.However, there are many examples of poor value from stroke research funding, which result from the way in which stroke research has been chosen, designed, conducted, analysed, regulated, managed, disseminated, or reported. In a project including a survey and a symposium and involving stroke researchers in the European Stroke Organisation we have sought to identify sources of inefficiency and waste, recommended approaches to increase value, and highlighted examples of best practice in stroke research. Recent evidence suggests that progress has been made, but there is room for much improvement, and stroke researchers, funders and other stakeholders might consider our recommendations when planning new research. Policy View 3

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Methods to improve patient recruitment and retention in stroke trials

Abstract: Many interventions have been used with the aim of improving recruitment and retention of patients in stroke studies, but only a minority has been evaluated. We have identified methods that could be tested, and propose that such evaluations may be nested within on-going clinical trials.

Cited by 30 publications

References 24 publications

Fluoxetine and recovery after stroke

Increasing value and reducing waste in stroke research

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