Discussion
respiratory tract infections, infection
RESPIRATORY TRACT INFECTIONS, VIRUS, INFECTION
We implemented a novel efficient trial design which was also the first RCT where follow-up was conducted entirely within a TRE. We did not find any consistent overall evidence that the intervention impacted rates of respiratory tract infections or other health outcomes. Similarly, we found no evidence that higher user rates were associated with changes in health outcome rates at a practice level, although there was evidence that more relevant symptoms within a practice were associated with more website uptake.Although by comparison to many other trial interventions the reach of the Germ Defence intervention was extremely large (it was accessed more than 300,000 times across England during the trial period), we could only confirm that it was accessed by patients from 16% of the general practices approached, below the 25% of GP practices assumed in the sample size considerations. Therefore, it is hard to draw conclusions from our trial data. While we expected that using Germ Defence would improve infection control behaviours and reduce household virus transmission [However, these findings should not downplay the importance of the efficient trial design that allowed us to conduct a large-scale prospective randomised controlled evaluation of an active behavioural intervention during a pandemic. Our design allowed us to safely recruit GP practices in England during a national pandemic, and we used several novel techniques to minimise practice burden: (i) we recruited practices en masse via email, removing the lengthy process of contacting individual practices (although to avoid overwhelming practices this method should only be used when rapid enrolment is necessary), (ii) we set up intervention access links that were individualised to practices (meaning that practices merely had to use the intervention and we could remotely track their ‘enrolment’), (iii) we used national routinely collected patient record data (accessed through a secure TRE, OpenSAFELY) to analyse electronic health records and (iv) we recorded anonymous digital intervention analytics to understand how many individual patients used the intervention and how they used it.There was no indication that the use of Germ Defence was impacted by any factors related to deprivation. Generally, this is encouraging news that digital interventions have potential to support healthcare across the socioeconomic spectrum. However, despite substantial effort to ensure accessibility (such as translation, using infographics), we did see that practices with more patients from minority ethnic groups were less likely to have high levels of use. This needs to be examined in more detail to ensure that scalable digital solutions do not lead to digital exclusion for some groups.