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EHRs enhance clinical trial follow-up

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Researcher at a computer

Electronic health records (EHRs) can enhance results from randomized controlled trials (RCTs), according to research published in Scientific Reports.

Researchers found EHRs could be used to track trial participants, enabling long-term monitoring of medical interventions and health outcomes and providing new insights into population health.

“In this study, we reported on the feasibility and efficiency of electronic follow-up and compared it with traditional trial follow-up,” said study author Sue Jordan, PhD, MB BCh, of Swansea University in Swansea, UK.

“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.”

Dr Jordan and her colleagues followed up on RCT participants using EHRs in the Secure Anonymised Information Linkage (SAIL) databank at Swansea University Medical School.

In this RCT, investigators had assessed the impact of probiotics on asthma and eczema in children born from 2005 to 2007. The trial had 2 years of traditional fieldwork follow-up.

Dr Jordan and her colleagues compared field results to EHR results at 2 years in 93% of trial participants.

The researchers said EHRs improved retention of children from lower socio-economic groups, which helped reduce volunteer bias.

The team also performed electronic follow-up at 5 years, which provided the “first robust analysis of asthma endpoints.”

The researchers said the asthma endpoints are “generally more reliable” in the 5-year EHR data for 2 reasons. The first is that the children are older, and asthma typically appears after 2 years of age.

The second reason is that, with the fieldwork follow-up, parents or guardians may have mistakenly identified symptoms as asthma without a child actually having an asthma diagnosis.

“Trial data are vulnerable to misunderstandings of questionnaires or definitions of illness,” Dr Jordan noted.

She and her colleagues also pointed out that retention was still high (82%) and free of bias in socio-economic status with the 5-year EHR data.

“These results lead us to conclude that using electronic health 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,” said study author Michael Gravenor, DPhil, of Swansea University.

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Photo by Darren Baker
Researcher at a computer

Electronic health records (EHRs) can enhance results from randomized controlled trials (RCTs), according to research published in Scientific Reports.

Researchers found EHRs could be used to track trial participants, enabling long-term monitoring of medical interventions and health outcomes and providing new insights into population health.

“In this study, we reported on the feasibility and efficiency of electronic follow-up and compared it with traditional trial follow-up,” said study author Sue Jordan, PhD, MB BCh, of Swansea University in Swansea, UK.

“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.”

Dr Jordan and her colleagues followed up on RCT participants using EHRs in the Secure Anonymised Information Linkage (SAIL) databank at Swansea University Medical School.

In this RCT, investigators had assessed the impact of probiotics on asthma and eczema in children born from 2005 to 2007. The trial had 2 years of traditional fieldwork follow-up.

Dr Jordan and her colleagues compared field results to EHR results at 2 years in 93% of trial participants.

The researchers said EHRs improved retention of children from lower socio-economic groups, which helped reduce volunteer bias.

The team also performed electronic follow-up at 5 years, which provided the “first robust analysis of asthma endpoints.”

The researchers said the asthma endpoints are “generally more reliable” in the 5-year EHR data for 2 reasons. The first is that the children are older, and asthma typically appears after 2 years of age.

The second reason is that, with the fieldwork follow-up, parents or guardians may have mistakenly identified symptoms as asthma without a child actually having an asthma diagnosis.

“Trial data are vulnerable to misunderstandings of questionnaires or definitions of illness,” Dr Jordan noted.

She and her colleagues also pointed out that retention was still high (82%) and free of bias in socio-economic status with the 5-year EHR data.

“These results lead us to conclude that using electronic health 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,” said study author Michael Gravenor, DPhil, of Swansea University.

Photo by Darren Baker
Researcher at a computer

Electronic health records (EHRs) can enhance results from randomized controlled trials (RCTs), according to research published in Scientific Reports.

Researchers found EHRs could be used to track trial participants, enabling long-term monitoring of medical interventions and health outcomes and providing new insights into population health.

“In this study, we reported on the feasibility and efficiency of electronic follow-up and compared it with traditional trial follow-up,” said study author Sue Jordan, PhD, MB BCh, of Swansea University in Swansea, UK.

“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.”

Dr Jordan and her colleagues followed up on RCT participants using EHRs in the Secure Anonymised Information Linkage (SAIL) databank at Swansea University Medical School.

In this RCT, investigators had assessed the impact of probiotics on asthma and eczema in children born from 2005 to 2007. The trial had 2 years of traditional fieldwork follow-up.

Dr Jordan and her colleagues compared field results to EHR results at 2 years in 93% of trial participants.

The researchers said EHRs improved retention of children from lower socio-economic groups, which helped reduce volunteer bias.

The team also performed electronic follow-up at 5 years, which provided the “first robust analysis of asthma endpoints.”

The researchers said the asthma endpoints are “generally more reliable” in the 5-year EHR data for 2 reasons. The first is that the children are older, and asthma typically appears after 2 years of age.

The second reason is that, with the fieldwork follow-up, parents or guardians may have mistakenly identified symptoms as asthma without a child actually having an asthma diagnosis.

“Trial data are vulnerable to misunderstandings of questionnaires or definitions of illness,” Dr Jordan noted.

She and her colleagues also pointed out that retention was still high (82%) and free of bias in socio-economic status with the 5-year EHR data.

“These results lead us to conclude that using electronic health 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,” said study author Michael Gravenor, DPhil, of Swansea University.

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