BibTex format
@article{Jarrold:2020:10.1001/jamapediatrics.2020.0578,
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, RJ},
doi = {10.1001/jamapediatrics.2020.0578},
journal = {JAMA pediatrics},
pages = {874--881},
title = {Guidance for the conduct and reporting of clinical trials of breast milk substitutes},
url = {http://dx.doi.org/10.1001/jamapediatrics.2020.0578},
volume = {174},
year = {2020}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - Importance: Breast milk 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 that arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance does not fully address issues specific to BMS trials. Objectives: To establish new methodological criteria to guide the design, conduct, analysis, and reporting of BMS trials and 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 was conducted, involving 3 rounds of anonymous questionnaires and a face-to-face consensus meeting between January 1 and October 24, 2018. Participants were 23 experts in BMS trials, BMS regulation, trial methods, breastfeeding support, infant feeding research, and medical publishing, and were 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 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 54 essential criteria and 4 recommended criteria. An 18-point checklist summarizes the criteria that are specific to BMS trials. Key themes emphasized 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, prot
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,RJ
DO - 10.1001/jamapediatrics.2020.0578
EP - 881
PY - 2020///
SN - 2168-6203
SP - 874
TI - Guidance for the conduct and reporting of clinical trials of breast milk substitutes
T2 - JAMA pediatrics
UR - http://dx.doi.org/10.1001/jamapediatrics.2020.0578
UR - https://www.ncbi.nlm.nih.gov/pubmed/32391870
UR - https://jamanetwork.com/journals/jamapediatrics/fullarticle/2765822
VL - 174
ER -