Reporting of participant compliance in randomized controlled trials of nutrition supplements during pregnancy
Reporting of participant compliance in randomized controlled trials of nutrition supplements during pregnancy
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.
randomized controlled trial, consort, compliance, trial reporting, pregnancy, maternal nutrition, supplement
97-103
Kehoe, Sarah H.
534e5729-632b-4b4f-8401-164d8c20aa26
Chheda, Purvi S.
a0c37330-3fe5-4331-b843-8913822b28d3
Sahariah, Sirazul A.
0a6a058e-735c-44e0-9ab2-8462376ef36b
Baird, Janis
f4bf2039-6118-436f-ab69-df8b4d17f824
Fall, Caroline H.D.
7171a105-34f5-4131-89d7-1aa639893b18
April 2009
Kehoe, Sarah H.
534e5729-632b-4b4f-8401-164d8c20aa26
Chheda, Purvi S.
a0c37330-3fe5-4331-b843-8913822b28d3
Sahariah, Sirazul A.
0a6a058e-735c-44e0-9ab2-8462376ef36b
Baird, Janis
f4bf2039-6118-436f-ab69-df8b4d17f824
Fall, Caroline H.D.
7171a105-34f5-4131-89d7-1aa639893b18
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 & Child Nutrition, 5 (2), .
(doi:10.1111/j.1740-8709.2008.00178.x).
Abstract
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.
This record has no associated files available for download.
More information
Published date: April 2009
Keywords:
randomized controlled trial, consort, compliance, trial reporting, pregnancy, maternal nutrition, supplement
Identifiers
Local EPrints ID: 69456
URI: http://eprints.soton.ac.uk/id/eprint/69456
ISSN: 1740-8695
PURE UUID: 315ddbf0-95c1-43b2-b15d-dc9dab3fad4f
Catalogue record
Date deposited: 17 Nov 2009
Last modified: 14 Mar 2024 02:47
Export record
Altmetrics
Contributors
Author:
Purvi S. Chheda
Author:
Sirazul A. Sahariah
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
