New study reveals how electronic health records can benefit clinical trials

May 16, 2018, Swansea University
A new study by Swansea University academics has indicated that the Secure Anonymised Information Linkage (SAIL) Databank can provide a simple, cost-effective way to follow-up after the completion of randomised controlled trials (RCTs). Credit: SAIL

The study entitled "Long term extension of a randomised controlled trial of probiotics using electronic health records" led by researchers in the Swansea University Medical School and the College of Human and Health Sciences, was published in Scientific Reports.

The findings demonstrate the potential of using anonymised routinely collected , such as those linked in SAIL, for more complete trial results. Results showed that SAIL can help track trial participants, with long term monitoring of medical interventions and health outcomes, and new insights into population health.

Typically, RCTs are relatively short term, and due to costs and resources, have limited opportunity to be re-visited or extended which means the effects of treatments cannot be scrutinised beyond the duration of the study, typically 1-2 years.

With patients' consent, data analysts can match patients to their records and access data quickly. As a result, the cost of follow-up using routine data is potentially relatively small and does not increase with the number of participants.

The study

The original RCT investigated the impact of probiotics taken during pregnancy on childhood asthma and eczema in a group of children at 6 months and then 2 years of age.

Professor Sue Jordan of Swansea University's College of Human and Health Science who led the study said: "In this study we reported on the feasibility and efficiency of electronic follow up, and compared it with traditional trial follow up. We gained new insights from outcomes electronically recorded 3 years after the end of the trial, and could then identify the differences between trial data and electronic data."

The use of electronic databases in clinical trials has been hailed as one of the major benefits of a nationwide electronic health records system. However, few studies have demonstrated this benefit, or formally assessed the relationship between traditional trial data and electronic health records databases."

A new study by Swansea University academics has indicated that the Secure Anonymised Information Linkage (SAIL) Databank can provide a simple, cost-effective way to follow-up after the completion of randomised controlled trials (RCTs). Credit: SAIL

Key research findings

  • Using SAIL, the retention of children from lower socio-economic groups was improved which helped reduce volunteer bias.
  • Results from the electronic follow up were more reliable due to reduced risk of bias, unreliability or inaccuracy in participants' recall.
  • New insights were gained from the electronic five year follow up, particularly for asthma, which typically appears after 2 years of age
  • For the electronic follow up at five years, retention was still high and free of bias in socio-economic status
  • Any future extension of the trial is straightforward.

Follow up of trial participants on anonymised routine electronic health care databases such as SAIL offers great potential to maximise the economic efficiency of and allow access to a fuller range of health information.

SAIL Associate Professor Kerina Jones is the academic lead for data governance and public engagement. She said: "SAIL is a world-class, privacy-protecting data linkage system that securely brings together routinely-collected health data.

SAIL is part-funded by the Welsh Government, and makes person-based health data available for genuine research purposes only where there is a potential for benefit. Because SAIL removes the identities of participants to protect their privacy and holds only anonymised data, researchers carry out their work without knowing the identities of the individuals."

Professor Jordan said: "The number of participants volunteering for RCTs is decreasing, particularly amongst the most economically disadvantaged. Trial data are vulnerable to misunderstandings of questionnaires or definitions of illness."

Professor Michael Gravenor, who led the data analysis for the study said: "These results lead us to conclude that using electronic records have benefits relating to the cost-effective, long term monitoring of complex interventions which could have a positive impact for future clinical trial design."

Explore further: Protecting your electronic health records

More information: Gareth Davies et al, Long term extension of a randomised controlled trial of probiotics using electronic health records, Scientific Reports (2018). DOI: 10.1038/s41598-018-25954-z

Related Stories

Protecting your electronic health records

February 19, 2018
(HealthDay)—An electronic health record, or EHR, is the digital version of the paper records documenting your health care. These online records are an advance in health management in many ways.

Medicare claims show long-term prostate cancer prevention benefits of finasteride

March 20, 2018
Men who take the medication finasteride get a prostate cancer prevention benefit that can last 16 years - twice as long as previously recorded, according to SWOG clinical trial analysis published in the Journal of the National ...

Study: How to get patients to share electronic health records

November 28, 2017
Education is the key to getting patients to share their medical records electronically with health care providers, according to a new study from the University at Buffalo School of Management.

Better use of electronic health records makes clinical trials less expensive

July 11, 2014
Using electronic health records to understand the best available treatment for patients, from a range of possible options, is more efficient and less costly for taxpayers than the existing clinical trial process, a new study ...

Researchers call for better quality and consistency of electronic health record studies

June 15, 2017
We need improved quality of recording asthma diagnosis and events if the UK is to effectively use the very considerable potential locked within electronic health records to promote improvements in asthma care and catalyse ...

Recommended for you

New study shows higher formaldehyde risk in e-cigarettes than previously thought

May 21, 2018
Portland State University researchers who published an article three years ago in the New England Journal of Medicine about the presence of previously undiscovered forms of formaldehyde in e-cigarette vapor revisited their ...

Insufficient sleep, even without extended wakefulness, leads to performance impairments

May 21, 2018
Millions of individuals obtain insufficient sleep on a daily basis, which can lead to impaired performance and other adverse physiological outcomes. To what extent these impairments are caused by the short sleep duration ...

Sleep better, parent better: Study shows link between maternal sleep and permissive parenting

May 21, 2018
Research has shown that consistently not getting enough sleep, or getting poor quality sleep, can put you at risk for a number of health conditions. But how does sleep, or the lack of it, affect how you parent?

Mediterranean diet may blunt air pollution's ill health effects

May 21, 2018
Eating a Mediterranean diet may protect people from some of the harm of long-term exposure to air pollution, and reduce their risk of dying from heart attacks, stroke and other causes of death, according to new research presented ...

Autism is not linked to eating fish in pregnacy

May 21, 2018
A major study examining the fish-eating habits of pregnant women has found that they are not linked to autism or autistic traits in their children.

Improving heart health could prevent frailty in old age

May 21, 2018
New research has shown that older people with very low heart disease risks also have very little frailty, raising the possibility that frailty could be prevented.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.