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Publications

The publications listed below include those relating to:
i) Analysis of INTERVAL data and samples to answer the trial’s main questions about optimum donation intervals
ii) Results of other studies that INTERVAL participants have been involved in
iii) Findings of research involving the use of samples and data collected during the INTERVAL trial and conducted to advance scientific understanding of donor and public health-related questions.

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The INTERVAL trial – MAIN RESULTS

Efficiency and safety of varying the frequency of whole blood donation (INTERVAL): a randomised trial of 45000 donors. Lancet (2017)
This paper describes the main findings of the INTERVAL trial. For a copy of the paper, please click here. For a copy of the press release, please click here.

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The INTERVAL trial 

1. 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. Trials (2014)
This paper describes the background and aims of the INTERVAL trial and explains how it has been carried out. To view a copy of the protocol paper, please click here.

2. Recruitment and representativeness of blood donors in the INTERVAL randomised trial assessing varying inter-donation intervals. Trials (2016)
In this paper we describe recruitment to INTERVAL and investigate how representative the trial participants were of the general donor population. To view a copy of this paper, please click here.

3. INTERVAL trial – statistical analysis plan for principal paper (2016)
This document describes the main statistical analyses that will be carried out at the end of the INTERVAL trial. To view a copy of this, please click here.

Other studies involving INTERVAL participants 
1. Information and Risk Modification Trial (INFORM): design of a randomised controlled trial of communicating different types of information about coronary heart disease risk, alongside lifestyle advice, to achieve change in health-related behaviour. BMC Public Health (2015)
After completing their 2-year involvement in INTERVAL, a subset of INTERVAL participants were invited to the University of Cambridge-led INFORM study. The aim of INFORM is to see whether providing people with different types of information about their individual risk of a heart attack in the next 10 years motivates them to change their lifestyle (for example to eat a healthier diet, exercise more, or stop smoking).. This paper describes the background and aims of the INFORM study and explains how it has been carried out. To view a copy of this paper, please click here.

Research involving the use of INTERVAL data and samples
1. Distinct genetic architectures for syndromic and nonsyndromic congenital heart defects identified by exome sequencing. Nature Genetics (2016)
INTERVAL donors were used as healthy controls to compare against patients who were born with heart defects. By looking at the genes of both groups (using a technique called whole-exome sequencing), the investigators discovered that syndromic and non-syndromic defects appear to be caused by different patterns of genetic variation. To view a copy of this paper, please click here.

2. Rare loss-of-function variants in SETD1A are associated with schizophrenia and developmental disorders. Nature Neuroscience (2016)
INTERVAL donors were used as healthy controls to compare against patients with schizophrenia. By looking at the genes of both groups (using a technique called whole-exome sequencing), the investigators identified genetic variants in the SETD1A gene to be an important cause of schizophrenia and other developmental disorders. To view a copy of this paper, please click here.

3. The Allelic Landscape of Human Blood Cell Trait Variation and Links to Common Complex Disease. Cell (2016)
The extensive blood profiling of INTERVAL donors was combined with their genetic information to identify genes and genetic variants that affect blood cell traits (eg, the number of red blood cells in a litre of blood). By combining results from INTERVAL with ~130,000 participants from the UK Biobank study, the investigators were able to identify 2706 associated genetic variants! These variants were then used to understand how genes influence blood cell traits and how blood cell traits influence major diseases. To view a copy of this paper, please click here.

4. The contribution of rare variants to risk of schizophrenia in individuals with and without intellectual disability. Nature Genetics (2017)
INTERVAL donors were used as healthy controls to compare against patients with schizophrenia. By looking at the genes of both groups (using a technique called whole-exome sequencing), the investigators discovered that there are many very rare genetic variants that predispose individuals to developing schizophrenia, both with and without intellectual disability. To view a copy of this paper, please click here.

5. Genome-wide association study of primary sclerosing cholangitis identifies new risk loci and quantifies the genetic relationship with inflammatory bowel disease. Nature Genetics (2017)
INTERVAL donors were used as healthy controls to compare against patients with primary sclerosing cholangitis (PSC), a rare inflammatory disorder. The investigators identified 4 new regions of the genome that affect a person’s risk of having PSC and explored the links between PCS and inflammatory bowel disease using the genetic data. To view a copy of this paper, please click here.