The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial

Moore, Carmel; Sambrook, Jennifer; Walker, Matthew R.; Tolkien, Zoe; Kaptoge, Stephen; Allen, David L.; Mehenny, Susan; Mant, Jonathan; Angelantonio, Emanuele Di; Thompson, Simon G.; Ouwehand, Willem H.; Roberts, David; Danesh, John

doi:10.1186/1745-6215-15-363

Cited by 122 publications

(181 citation statements)

References 33 publications

(30 reference statements)

Supporting

Mentioning

178

Contrasting

Unclassified

Order By: Relevance

“…Many new cohort studies request participants to consent to be recalled for subsequent sub-studies, such as GBR trials. In the UK, for example, the UK Biobank (N~500,000)24, INTERVAL (N~50,000)25, and NIHR BioResource (N~20,000–100,000)26 are all designed with future GBR studies in mind. Similar initiatives are underway in other countries.…”

Section: Discussionmentioning

confidence: 99%

Statistical power considerations in genotype-based recall randomized controlled trials

Atabaki‐Pasdar

Ohlsson

Shungin

et al. 2016

Sci Rep

View full text Add to dashboard Cite

Randomized controlled trials (RCT) are often underpowered for validating gene-treatment interactions. Using published data from the Diabetes Prevention Program (DPP), we examined power in conventional and genotype-based recall (GBR) trials. We calculated sample size and statistical power for gene-metformin interactions (vs. placebo) using incidence rates, gene-drug interaction effect estimates and allele frequencies reported in the DPP for the rs8065082 SLC47A1 variant, a metformin transported encoding locus. We then calculated statistical power for interactions between genetic risk scores (GRS), metformin treatment and intensive lifestyle intervention (ILI) given a range of sampling frames, clinical trial sample sizes, interaction effect estimates, and allele frequencies; outcomes were type 2 diabetes incidence (time-to-event) and change in small LDL particles (continuous outcome). Thereafter, we compared two recruitment frameworks: GBR (participants recruited from the extremes of a GRS distribution) and conventional sampling (participants recruited without explicit emphasis on genetic characteristics). We further examined the influence of outcome measurement error on statistical power. Under most simulated scenarios, GBR trials have substantially higher power to observe gene-drug and gene-lifestyle interactions than same-sized conventional RCTs. GBR trials are becoming popular for validation of gene-treatment interactions; our analyses illustrate the strengths and weaknesses of this design.

show abstract

Section: Discussionmentioning

confidence: 99%

Statistical power considerations in genotype-based recall randomized controlled trials

Atabaki‐Pasdar

Ohlsson

Shungin

et al. 2016

Sci Rep

View full text Add to dashboard Cite

show abstract

“…Briefly, INFORM is a parallel-group, open randomised trial in which male and female blood donors with no previous history of CVD aged 40–84 years from across England, who took part in the INTERVAL study [42], were allocated to either no intervention (control group, group 1), or to one of three active intervention groups: lifestyle advice only (group 2); lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic characteristics (group 3); and lifestyle advice plus information on estimated 10-year CHD risk based on phenotypic and genetic characteristics (group 4). Lifestyle advice consisted of three sessions of interactive, tailored web-based information [41].…”

Section: Methodsmentioning

confidence: 99%

The response to receiving phenotypic and genetic coronary heart disease risk scores and lifestyle advice – a qualitative study

et al. 2016

View full text Add to dashboard Cite

BackgroundIndividuals routinely receive information about their risk of coronary heart disease (CHD) based on traditional risk factors as part of their primary care. We are also able to calculate individual’s risk of CHD based on their genetic information and at present genetic testing for common diseases is available to the public. Due to the limitations in previous studies further understanding is needed about the impact of the risk information on individual’s well-being and health-behaviour. We aimed to explore the short term response to receiving different forms of CHD risk information and lifestyle advice for risk reduction.MethodsWe conducted fourty-one face-to-face interviews and two focus groups across England with participants from the INFORM trial who received a combination of individualised phenotypic and genotypic CHD risk scores and web-based lifestyle advice. Risk scores were presented in different formats, e.g. absolute 10 year risk was presented as a thermometer and expressed as a percentage, natural frequency and ‘heart age’. Interviews and focus groups explored participants’ understanding and reaction to the risk scores and attempts to change lifestyle during the intervention. We tape-recorded and transcribed the interviews and focus groups and analysed them using thematic analysis.ResultsThree main themes were identified: limitations of risk scores to generate concern about CHD risk; the advantages of the ‘heart age’ format of risk score presentation in communicating a message of sub-optimal lifestyle; and intentions and attempts to make moderate lifestyle changes which were prompted by the web-based lifestyle advice.ConclusionsThere are a number of limitations to the use of risk scores to communicate a message about the need for a lifestyle change. Of the formats used, the ‘heart age’, if noticed, appears to convey the most powerful message about how far from optimal risk an individual person is. An interactive, user friendly, goal setting based lifestyle website can act as a trigger to initiate moderate lifestyle changes, regardless of concerns about risk scores.Trial registrationCurrent Controlled Trials ISRCTN17721237. Registered 12 January 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-016-3867-2) contains supplementary material, which is available to authorized users.

show abstract

“…Good donor management, not solely considering them as resource material, must safeguard donors of blood, cells, tissues, and organs. 286 Achievements of transfusion medicine (non-remunerated donors, good manufacturing practice, traceability, and hemovigilance) can support quality management of new cellular products for immunotherapy and repair treatment. 287 …”

Section: Evidence-based Indications Of Virtually All (Individualmentioning

confidence: 99%

The European Hematology Association Roadmap for European Hematology Research: a consensus document

et al. 2016

View full text Add to dashboard Cite

T he European Hematology Association (EHA) Roadmap for European Hematology Research highlights major achievements in diagnosis and treatment of blood disorders and identifies the greatest unmet clinical and scientific needs in those areas to enable better funded, more focused European hematology research. Initiated by the EHA, around 300 experts contributed to the consensus document, which will help European policy makers, research funders, research organizations, researchers, and patient groups make better informed decisions on hematology research. It also aims to raise public awareness of the burden of blood disorders on European society, which purely in economic terms is estimated at €23 billion per year, a level of cost that is not matched in current European hematology research funding. In recent decades, hematology research has improved our fundamental understanding of the biology of blood disorders, and has improved diagnostics and treatments, sometimes in revolutionary ways. This progress highlights the potential of focused basic research programs such as this EHA Roadmap. The EHA Roadmap identifies nine 'sections' in hematology: normal hematopoiesis, malignant lymphoid and myeloid diseases, anemias and related diseases, platelet disorders, blood coagulation and hemostatic disorders, transfusion medicine, infections in hematology, and hematopoietic stem cell transplantation. These sections span 60 smaller groups of diseases or disorders. The EHA Roadmap identifies priorities and needs across the field of hematology, including those to develop targeted therapies based on genomic profiling and chemical biology, to eradicate minimal residual malignant disease, and to develop cellular immunotherapies, combination treatments, gene therapies, hematopoietic stem cell treatments, and treatments that are better tolerated by elderly patients.

show abstract

The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial

Cited by 122 publications

References 33 publications

Statistical power considerations in genotype-based recall randomized controlled trials

Statistical power considerations in genotype-based recall randomized controlled trials

The response to receiving phenotypic and genetic coronary heart disease risk scores and lifestyle advice – a qualitative study

The European Hematology Association Roadmap for European Hematology Research: a consensus document

Contact Info

Product

Resources

About