Randomized control trials have been the bedrock of the scientific process for generations, but they are far from infallible.  A number of tech-based approaches have been tested in recent years to try and improve them, whether in improving access, making data more reliable or providing personalized medicines as a result.

A recent study from Swansea University suggests that the humble electronic medical record might also play a part.  The researchers began their study after being frustrated at the difficulties inherent in following up on the studies that typically results in them being relatively short term.  This makes analyzing the effectiveness of treatments over a longer time-frame difficult.

Enter the electronic medical record, which the researchers believe can allow data analysts to quickly and efficiently follow-up on the wellbeing of participants via the data entered into their records.

Affordable follow-up

The researchers analyzed the data that is routinely collected and stored in the Secure Anonymised Information Linkage (SAIL) database at the university to follow up on patients who had participated in a trial on the impact of probiotics during pregnancy on the likelihood of the children developing asthma and eczema.

The researchers were able to locate 96% of participants in the trial in the SAIL database, with the majority of these followed up at both two years, which was within the timeframe of the clinical trial, and five years, which was not.

The findings illustrate the significant potential of using anonymized data from electronic medical records to allow trial results to be much more robust, providing researchers with 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,” the authors explain. “We gained new insights from outcomes electronically recorded three years after the end of the trial, and could then identify the differences between trial data and electronic data.”

The team believe that the rollout of electronic medical records could bring significant benefits to the clinical trial process, and that their study is one of the first to have explicitly illustrated the potential for them to augment traditional trial data.

The research also came to a number of other key findings, including:

• 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 two 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 trial follow-up would be straightforward.

“These results lead us to conclude that using electronic health records has benefits relating to the cost-effective, long term monitoring of complex interventions, which could have a positive impact for future clinical trial design,” the authors conclude.