Imperial College London
Alternate

Dr Robert Boyle

Faculty of Medicine, National Heart & Lung Institute

Reader in Paediatric Allergy
 
 
 
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Contact

 

+44 (0)20 3312 7892r.boyle Website

 
 
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Location

 

Paediatric Research UnitQueen Elizabeth the Queen Mother Wing (QEQM)St Mary's Campus

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Summary

 

Publications

Citation

BibTex format

@article{Jarrold:2019,
author = {Jarrold, K and Helfer, B and Eskander, M and Crawley, H and Trabulsi, J and Caulfield, LE and Duffy, G and Garcia-Larsen, V and Hayward, D and Hyde, M and Jeffries, S and Knip, M and Leonardi-Bee, J and Loder, E and Lodge, CJ and Lowe, AJ and McGuire, W and Osborn, D and Przyrembel, H and Renfrew, MJ and Trumbo, P and Warner, J and Schneeman, B and Boyle, R},
journal = {JAMA Pediatrics},
title = {Guidance for the conduct and reporting of clinical trials of breastmilk substitutes: a Delphi consensus statement},
url = {http://hdl.handle.net/10044/1/76466},
year = {2019}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Importance: Breastmilk substitutes (BMS) are important nutritional products evaluated in clinical trials. Concerns have been raised about the risk of bias in BMS trials, the reliability of claims which arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance68 does not fully address issues specific to BMS trials. Objective: To establish new methodological criteria to guide the design, conduct, analysis and reporting of BMS trials. To support clinical trialists designing and undertaking BMS trials, editors and peer reviewers assessing trial reports for publication, and regulators evaluating the safety, nutritional adequacy and efficacy of BMS products. Design, Setting, and Participants A modified Delphi method involving 3 rounds of anonymous questionnaires and a face-to-face consensus meeting between January and October 2018. Participants were 23 experts in BMS trials, BMS regulation, trial methodology, breastfeeding support, infant feeding research and medical publishing, affiliated with institutions across Europe, North America and Australasia. Guidance development was supported by an industry consultation, analysis of methodological  issues in a sample of published BMS trials, and consultations with BMS trial 81 participants and a research ethics committee. Results: An initial 73 criteria, derived from the literature, were sent to the experts.  The final consensus guidance contains a total of 54 essential and 4 recommended criteria. An 18-point checklist summarizes those criteria which are specific to BMS 5 trials. Key themes emphasised in the guidance are research integrity and transparency of reporting, supporting breastfeeding in trial participants, accurate description of trial interventions and use of valid and meaningful outcome measures. Conclusions and Relevance: Implementation of this guidance should enhance the quality and validity of BMS trials, protect BMS trial particip
AU  - Jarrold,K
AU  - Helfer,B
AU  - Eskander,M
AU  - Crawley,H
AU  - Trabulsi,J
AU  - Caulfield,LE
AU  - Duffy,G
AU  - Garcia-Larsen,V
AU  - Hayward,D
AU  - Hyde,M
AU  - Jeffries,S
AU  - Knip,M
AU  - Leonardi-Bee,J
AU  - Loder,E
AU  - Lodge,CJ
AU  - Lowe,AJ
AU  - McGuire,W
AU  - Osborn,D
AU  - Przyrembel,H
AU  - Renfrew,MJ
AU  - Trumbo,P
AU  - Warner,J
AU  - Schneeman,B
AU  - Boyle,R
PY  - 2019///
SN  - 2168-6203
TI  - Guidance for the conduct and reporting of clinical trials of breastmilk substitutes: a Delphi consensus statement
T2  - JAMA Pediatrics
UR  - http://hdl.handle.net/10044/1/76466
ER  -
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