The University of Southampton
University of Southampton Institutional Repository

Reporting of participant compliance in randomized controlled trials of nutrition supplements during pregnancy

Kehoe, Sarah H., Chheda, Purvi S., Sahariah, Sirazul A., Baird, Janis and Fall, Caroline H.D. (2009) Reporting of participant compliance in randomized controlled trials of nutrition supplements during pregnancy Maternal and Child Nutrition, 5, (2), pp. 97-103. (doi:10.1111/j.1740-8709.2008.00178.x).

Record type: Article


Randomized controlled trials (RCT) are widely considered to be the gold standard for demonstrating intervention effects. Adequacy of reporting of participant compliance in RCTs affects the interpretation of study results. Our aims were two-fold: first, to assess the adequacy of reporting of participant compliance in RCTs investigating the effect of maternal nutritional supplements on infant outcomes; and second, to examine authors' adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines on participant flow. Papers reporting trials of nutritional supplementation during pregnancy, and published after revision of the CONSORT recommendations, were identified using a search of medical databases. Two researchers systematically reviewed the papers to assess the reporting of participant compliance according to specified criteria, and the presentation of participant flow data recommended in the CONSORT guidelines. The literature search identified 58 papers. Almost a third (n = 18) did not describe how participant compliance was assessed. Nearly half of the papers (n = 27) failed to report participant compliance numerically (absolute numbers or percentage) and differences in compliance data between treatment arms were not reported in 52% of papers (n = 28). The majority (83%) gave no information on whether the study protocol included any researcher input aimed at maximizing compliance. In addition to inadequate reporting of compliance, two of the CONSORT requirements (eligibility criteria and numbers discontinuing the intervention) were inadequately reported in 69% and 60% of papers, respectively. We conclude that participant compliance in nutrition trials is frequently inadequately reported. 'False negative' results from RCTs with poor compliance could wrongly influence policy and inhibit further research concerned with nutritional supplementation for women of child-bearing age. We suggest that changes to the CONSORT guidelines may improve RCT reporting.

Full text not available from this repository.

More information

Published date: April 2009
Keywords: randomized controlled trial, consort, compliance, trial reporting, pregnancy, maternal nutrition, supplement


Local EPrints ID: 69456
ISSN: 1740-8695
PURE UUID: 315ddbf0-95c1-43b2-b15d-dc9dab3fad4f
ORCID for Janis Baird: ORCID iD

Catalogue record

Date deposited: 17 Nov 2009
Last modified: 19 Jul 2017 00:12

Export record



Author: Sarah H. Kehoe
Author: Purvi S. Chheda
Author: Sirazul A. Sahariah
Author: Janis Baird ORCID iD

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton:

ePrints Soton supports OAI 2.0 with a base URL of

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.