LSTM Home > LSTM Research > LSTM Online Archive

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


Downloads per month over past year

Davies, Gareth, Jordan, Sue, Brooks, Caroline J, Thayer, Daniel, Storey, Melanie, Morgan, Gareth, Allen, Stephen ORCID:, Garaiova, Iveta, Plummer, Sue and Gravenor, Mike (2018) 'Long term extension of a randomised controlled trial of probiotics using electronic health records.'. Scientific Reports, Vol 8, Issue 1, p. 7668.

Scientific Reports_Long term extension of a randomised contolled trial of probiotics.pdf - Published Version
Available under License Creative Commons Attribution.

Download (1MB) | Preview


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
Subjects: QU Biochemistry > Vitamins > QU 145.5 Nutritive values of food
QW Microbiology and Immunology > QW 4 General works. Classify here works on microbiology as a whole.
WX Hospitals and Other Health Facilities > Hospital Administration > WX 173 Medical records
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):
SWORD Depositor: JISC Pubrouter
Depositing User: Stacy Murtagh
Date Deposited: 29 May 2018 12:41
Last Modified: 12 Sep 2019 13:28


View details

Actions (login required)

Edit Item Edit Item