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

Sci Rep. 2018 May 16;8(1):7668. doi: 10.1038/s41598-018-25954-z.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Asthma / prevention & control*
  • Child, Preschool
  • Double-Blind Method
  • Eczema / prevention & control*
  • Electronic Health Records / statistics & numerical data*
  • Female
  • Humans
  • Infant, Newborn
  • Mothers / statistics & numerical data*
  • Pregnancy
  • Probiotics / therapeutic use*
  • Quality of Life

Associated data

  • ISRCTN/ISRCTN26287422