Increasing value and reducing waste in stroke research

Berge, Eivind; Salman, Rustam Al-Shahi; Worp, H. Bart van der; Stapf, Christian; Sandercock, Peter; Sprigg, Nikola; Macleod, Malcolm; Kelly, Peter; Nederkoorn, Paul J.; Ford, Gary A.; Arnold, Marcel; Díez‐Tejedor, Exuperio; Jatužis, Dalius; Krieger, Derk; Weimar, Christian

doi:10.1016/s1474-4422(17)30078-9

Cited by 34 publications

(33 citation statements)

References 94 publications

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“…Research priorities of patients, health care professionals and key stakeholders are unknown. Involvement of these stakeholders in shaping the research agenda is important to ensure that research is relevant and applicable to the users of research and, therefore, more likely to be implemented in practice [ 29 ]. It is also important to promote partnership with these stakeholders and encourage engagement with research [ 29 ].…”

Section: Introductionmentioning

confidence: 99%

“…Involvement of these stakeholders in shaping the research agenda is important to ensure that research is relevant and applicable to the users of research and, therefore, more likely to be implemented in practice [ 29 ]. It is also important to promote partnership with these stakeholders and encourage engagement with research [ 29 ]. Furthermore, Chalmers et al [ 30 ] suggests that there is often a mismatch between the priorities of researchers and the priorities of the end users of researchers.…”

Section: Introductionmentioning

confidence: 99%

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Establishing research priorities relating to the long-term impact of TIA and minor stroke through stakeholder-centred consensus

et al. 2018

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Plain English summary What is the problem and why is this important? Mini-strokes are similar to full strokes, but symptoms last less than 24 h. Many people (up to 70%) have long-term problems after a mini-stroke, such as anxiety; depression; problems with brain functioning (like memory loss); and fatigue (feeling tired). However, the current healthcare pathway only focuses on preventing another stroke and care for other long-term problems is not routinely given. Without proper treatment, people with long-term problems after a mini-stroke could have worse quality of life and may find it difficult to return to work and their social activities. What is the aim of the research? We wanted to understand the research priorities of patients, health care professionals and key stakeholders relating to the long-term impact of mini-stroke. How did we address the problem? We invited patients, clinicians, researchers and other stakeholders to attend a meeting. At the meeting people discussed the issues relating to the long-term impact of mini-stroke and came to an agreement on their research priorities. There were three stages: (1) people wrote down their individual research suggestions; (2) in smaller groups people came to an agreement on what their top research questions were; and (3) the whole group agreed final research priorities. What did we find? Eleven people attended who were representatives for patients, GPs, stroke consultants, stroke nurses, psychologists, the Stroke Association (charity) and stroke researchers, The group agreed on eleven research questions which they felt were the most important to improve health and well-being for people who have had a mini-stroke.The eleven research questions encompass a range of categories, including: understanding the existing care patients receive (according to diagnosis and geographical location); exploring what optimal care post-TIA/minor stroke should comprise (identifying and treating impairments, information giving and support groups) and how that care should be delivered (clinical setting and follow-up pathway); impact on family members; and education/training for health care professionals.AbstractBackground Clinical management after transient ischaemic attack (TIA) and minor stroke focuses on stroke prevention. However, evidence demonstrates that many patients experience ongoing residual impairments. Residual impairments post-TIA and minor stroke may affect patients’ quality of life and return to work or social activities. Research priorities of patients, health care professionals and key stakeholders relating to the long-term impact of TIA and minor stroke are unknown.Methods Our objective was to establish the top shared research priorities relating to the long-term impact of TIA and minor stroke through stakeholder-centred consensus. A one-day priority setting consensus meeting took place with representatives from different stakeholder groups in October 2016 (Birmingham, UK). Nominal group technique was used to establish research priorities. This involved three stag...

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Establishing research priorities relating to the long-term impact of TIA and minor stroke through stakeholder-centred consensus

et al. 2018

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“…There is a current drive to reduce research waste in clinical trials, particularly through the REWARD campaign, which lists regulation and management[ 17 ] and efficient design, conduct and analysis[ 18 ] as areas to be addressed, as well as specifically targeting stroke research as an area to reduce waste through the European Stroke Organisation Trials Network Committee[ 19 ]. The campaign recommends that we ‘streamline and harmonise the laws, regulations, guidelines … and ensure that they are proportionate to the plausible risks associated with the research’ and calls for ‘additional research to learn how efficiency can be increased’[ 17 ].…”

Section: Introductionmentioning

confidence: 99%

Central adjudication of serious adverse events did not affect trial’s safety results: Data from the Efficacy of Nitric Oxide in Stroke (ENOS) trial

et al. 2018

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Background and purposeCentral adjudication of serious adverse events (SAEs) can be undertaken in clinical trials, especially for open-label studies where outcome assessment may be at risk of bias. This study explored the effect of central adjudication of SAEs on the safety results of the Efficacy of Nitric Oxide in Stroke (ENOS) Trial.MethodsENOS assigned patients with acute stroke at random to receive either transdermal glyceryl trinitrate (GTN) or no GTN and to Stop or Continue previous antihypertensive treatment. SAEs were reported by local investigators who were not blinded to treatment allocation. Central adjudicators, blinded to treatment allocation, reviewed the investigators reports and used evidence available to confirm or re-categorise the classification of event, likely causality, diagnosis and expectedness of event.ResultsOf 4011 patients enrolled in ENOS, 1473 SAEs were reported by local investigators; this was reduced to 1444 after the review by adjudicators, with 29 re-classified as not an SAE. There was fair agreement between investigators and adjudicators regarding likely causality, with 808 agreements and 644 disagreements (56% crude agreement, weighted kappa, κ = 0.31). Agreement increased upon dichotomisation of the causality categories, with 1432 agreements and 20 disagreements (99% crude agreement, kappa = 0.54). Repeating the main trial safety analysis with investigator reported events showed that adjudication had no effect on the main trial safety conclusions.ConclusionsIn a large trial, with many SAEs reported, central adjudication of these events did not affect trial conclusions. This suggests that adjudication of SAEs in a clinical trial where the intervention already has a well-established safety profile may not be necessary. Potential efficiency savings (financial, logistical) can be made through not adjudicating SAEs.

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“…Berge et al also identify that data collection forms can be too complex and burden centres with a requirement to collect data items that are never analysed or reported. 18 Refine the template to be readily understood and operational. In the final template of CRF, every variable should be clear.…”

Section: Discussionmentioning

confidence: 99%

“…Berge et al also identify that data collection forms can be too complex and burden centres with a requirement to collect data items that are never analysed or reported. 18 …”

Section: Discussionmentioning

confidence: 99%

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study

et al. 2017

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ObjectivesDespite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research.SettingThe setting for this research was a major academic institution in Beijing, China.ParticipantsThe target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts.MethodsUsing a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research.ResultsOur analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly.ConclusionThese results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive planning procedures such as those used by expert clinical researchers.

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Increasing value and reducing waste in stroke research

Cited by 34 publications

References 94 publications

Establishing research priorities relating to the long-term impact of TIA and minor stroke through stakeholder-centred consensus

Establishing research priorities relating to the long-term impact of TIA and minor stroke through stakeholder-centred consensus

Central adjudication of serious adverse events did not affect trial’s safety results: Data from the Efficacy of Nitric Oxide in Stroke (ENOS) trial

How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study

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