Long term extension of a randomised controlled trial of probiotics using electronic health records



Davies, Gareth, Jordan, Sue, Brooks, Caroline J, Thayer, Daniel, Storey, Melanie, Morgan, Gareth, Allen, Stephen ORCID: 0000-0001-6675-249X, Garaiova, Iveta, Plummer, Sue and Gravenor, Mike
(2018) Long term extension of a randomised controlled trial of probiotics using electronic health records. SCIENTIFIC REPORTS, 8 (1). 7668-.

[thumbnail of Long term extension of a randomised controlled trial of probiotics using electronic health records.pdf] Text
Long term extension of a randomised controlled trial of probiotics using electronic health records.pdf - Published version

Download (1MB) | Preview

Abstract

Most randomised controlled trials (RCTs) are relatively short term and, due to costs and available resources, have limited opportunity to be re-visited or extended. There is no guarantee that effects of treatments remain unchanged beyond the study. Here, we illustrate the feasibility, benefits and cost-effectiveness of enriching standard trial design with electronic follow up. We completed a 5-year electronic follow up of a RCT investigating the impact of probiotics on asthma and eczema in children born 2005-2007, with traditional fieldwork follow up to two years. Participants and trial outcomes were identified and analysed after five years using secure, routine, anonymised, person-based electronic health service databanks. At two years, we identified 93% of participants and compared fieldwork with electronic health records, highlighting areas of agreement and disagreement. Retention of children from lower socio-economic groups was improved, reducing volunteer bias. At 5 years we identified a reduced 82% of participants. These data allowed the trial's first robust analysis of asthma endpoints. We found no indication that probiotic supplementation to pregnant mothers and infants protected against asthma or eczema at 5 years. Continued longer-term follow up is technically straightforward.

Item Type: Article
Uncontrolled Keywords: Humans, Asthma, Eczema, Double-Blind Method, Mothers, Pregnancy, Quality of Life, Probiotics, Child, Preschool, Infant, Newborn, Female, Electronic Health Records
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Faculty Management Office
Depositing User: Symplectic Admin
Date Deposited: 22 Dec 2022 16:55
Last Modified: 22 Dec 2022 16:55
DOI: 10.1038/s41598-018-25954-z
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3166766