Guidance for the Conduct and Reporting of Clinical Trials of Breast Milk Substitutes

被引：7
|
作者：
Jarrold, Katharine [1 ]
Helfer, Bartosz [1 ]
Eskander, Mona [2 ]
Crawley, Helen [3 ,4 ]
Trabulsi, Jillian [5 ]
Caulfield, Laura E. [6 ]
Duffy, Gillian [7 ]
Garcia-Larsen, Vanessa [6 ]
Hayward, Deborah [2 ]
Hyde, Matthew [8 ]
Jeffries, Suzan [1 ,9 ]
Knip, Mikael [10 ,11 ]
Leonardi-Bee, Jo [12 ]
Loder, Elizabeth [13 ,14 ]
Lodge, Caroline J. [15 ]
Lowe, Adrian J. [15 ]
McGuire, William [16 ]
Osborn, David [17 ]
Przyrembel, Hildegard [18 ]
Renfrew, Mary J. [19 ]
Trumbo, Paula [20 ]
Warner, John [1 ]
Schneeman, Barbara [21 ]
Boyle, Robert J. [1 ,22 ]
机构：
[1] Imperial Coll London, Natl Heart & Lung Inst, Norfolk Pl,Wright Fleming Bldg, London, England
[2] Hlth Canada, Food Directorate, Bur Nutr Sci, Ottawa, ON, Canada
[3] First Steps Nutr Trust, London, England
[4] WHO, Sci & Tech Advisory Grp Inappropriate Promot Food, Geneva, Switzerland
[5] Univ Delaware, Dept Behav Hlth & Nutr, Newark, DE USA
[6] Johns Hopkins Bloomberg Sch Publ Hlth, Ctr Human Nutr, Baltimore, MD USA
[7] Food Stand Australia New Zealand, Dept Publ Hlth Nutr Stand, Canberra, Australia
[8] Imperial Coll London, Sect Neonatal Med, London, England
[9] Int Board Certified Lactat Consultant Examiner, Fairfax, VA USA
[10] Univ Helsinki, Helsinki Univ Hosp, Childrens Hosp, Helsinki, Finland
[11] Univ Helsinki, Fac Med, Res Program Clin & Mol Metab, Helsinki, Finland
[12] Univ Nottingham, Med Stat, Nottingham, England
[13] British Med Journal, London, England
[14] Harvard Med Sch, Dept Neurol, Cambridge, MA 02115 USA
[15] Univ Melbourne, Allergy & Lung Hlth Unit, Melbourne Sch Populat & Global Hlth, Melbourne, Vic, Australia
[16] Univ York, Ctr Reviews & Disseminat, York, N Yorkshire, England
[17] Univ Sydney, Div Obstet Gynaecol & Neonatol, Sydney, NSW, Australia
[18] Fed Inst Risk Assessment, Dept Food Safety, Berlin, Germany
[19] Univ Dundee, Mother & Infant Res Unit, Sch Nursing & Hlth Sci, Dundee, Scotland
[20] US FDA, Nutr Programs, Rockville, MD 20857 USA
[21] Univ Calif Davis, Dept Nutr, Davis, CA 95616 USA
[22] Univ Nottingham, Ctr Evidence Based Dermatol, Nottingham, England
来源：
JAMA PEDIATRICS | 2020年 / 174卷 / 09期
基金：
英国医学研究理事会;
关键词：
INFANT FORMULA; MARKETING CLAIMS; DELPHI; WASTE;
D O I：
10.1001/jamapediatrics.2020.0578
中图分类号：
R72 [儿科学];
学科分类号：
100202 ;
摘要：
Question What is the best way to ensure the validity of clinical trials of breast milk substitutes while protecting trial participants? Findings Through a Delphi consensus project, guidance was developed to address issues specific to trials of breast milk substitutes assessing growth and tolerance, as well as trials of breast milk substitutes with other objectives. This consensus guidance summarizes best practice for the design, conduct, analysis, and reporting of trials of breast milk substitutes. Meaning Use of this guidance, in conjunction with existing clinical trial regulations, should enhance the quality and validity of trials of breast milk substitutes, protect trial participants, and support the evidence base for infant nutrition recommendations. This consensus guidance summarizes best practice for the design, conduct, analysis, and reporting of trials of breast milk substitutes. 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, protect BMS trial participants, and better inform the infant nutrition community about BMS products.
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页码：874 / 881
页数：8
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