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

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.Peer reviewe

Adiposity and hepatic lipid in healthy full-term, breastfed, and formula-fed human infants: a prospective short-term longitudinal cohort study

Background: The effect of mode of infant feeding on adiposity deposition is not fully understood. Objective: The objective was to test the hypothesis that differences in total and regional adipose tissue content and intrahepatocellular lipid (IHCL) arise in early infancy between breast- and formula-fed infants and to describe longitudinal changes. Design: This prospective longitudinal cohort study was performed in 2 hospitals in the United Kingdom. Healthy, full-term, appropriate weight-for-gestational age infants were recruited; adipose tissue volume and distribution were directly quantified by using whole-body magnetic resonance imaging; IHCL was assessed by in vivo proton magnetic resonance spectroscopy. Measurements were performed after birth (median age: 13 d) and at 6–12 wk of age. Method of infant feeding was recorded prospectively by using maternally completed feeding diaries. Breastfed was defined as >80% of feeds consisting of breast milk at both points; formula-fed was defined as >80% of feeds consisting of formula milk at both points. Results: Longitudinal results were obtained from 70 infants (36 breastfed, 9 mixed-fed, and 25 formula-fed). No differences were found in total or regional adipose tissue or IHCL between breastfed and formula-fed infants. In pooled analyses including all feeding groups, IHCL and total adipose tissue approximately doubled between birth and 6–12 wk: IHCL after birth (median: 0.949; IQR: 0.521–1.711) and at 6–12 wk (1.828; 1.376–2.697; P < 0.001) and total adipose tissue after birth (0.749 L; 0.620–0.928 L) and at 6–12 wk (1.547 L; 1.332–1.790 L; P < 0.001). Increasing adiposity was characterized by greater relative increases in subcutaneous than in internal adipose tissue depots. Conclusions: No differences were detectable in adipose tissue or IHCL accretion between breastfed and formula-fed infants up to 2 mo. The substantial increase in IHCL seen over this period in both breastfed and formula-fed infants is a novel observation, which suggests that hepatic storage of lipids may be physiologic up to 2 mo. This trial was registered at www.clinicaltrials.gov as NCT02033005

The NCSBN National Simulation Study: A Longitudinal, Randomized, Controlled Study Replacing Clinical Hours with Simulation in Prelicensure Nursing Education

Providing high-quality clinical experiences for students has been a perennial challenge for nursing programs. Short patient length of stays, high patient acuity, disparities in learning experiences, and the amount of time instructors spend supervising skills have long been issues. More recently, other challenges have emerged: more programs competing for limited clinical sites, faculty shortages, facilities not granting students access to electronic medical records, and patient safety initiatives that decrease the number of students allowed on a patient unit or restrict their activity to observing care

The Role of Technology in Health Professions Education During the COVID-19 Pandemic.

The COVID-19 pandemic has sparked radical shifts in the ways that both health care and health professions education are delivered. Before the pandemic, some degree programs were offered fully online or in a hybrid format, but in-person learning was considered essential to the education and training of health professionals. Similarly, even as the use of telehealth was slowly expanding, most health care visits were conducted in-person. The need to maintain a safe physical distance during the pandemic rapidly increased the online provision of health care and health professions education, accelerating technology adoption in both academic and professional health care settings. Many health care professionals, educators, and patients have had to adapt to new communication modalities, often with little or no preparation. Before the pandemic, the need for cost-effective, robust methodologies to enable teaching across distances electronically was recognized. During the pandemic, online learning and simulation became essential and were often the only means available for continuity of education and clinical training. This paper reviews the transition to online health professions education and delivery during the COVID-19 pandemic and provides recommendations for moving forward

The Role of Technology in Health Professions Education During the COVID-19 Pandemic

The COVID-19 pandemic has sparked radical shifts in the ways that both health care and health professions education are delivered. Prior to the pandemic, some degree programs were offered fully online or in a hybrid format, but in-person learning was considered essential to the education and training of health professionals. Similarly, even as the use of telehealth was slowly expanding, most health care visits were conducted in-person. The need to maintain a safe physical distance during the pandemic rapidly increased the online provision of health care and health professions education, accelerating technology adoption in both academic and professional health care settings. Many health care professionals, educators, and patients have had to adapt to new communication modalities, often with little or no preparation. Before the pandemic, the need for cost-effective, robust methodologies to enable teaching across distances electronically was recognized. During the pandemic, online learning and simulation became essential and were often the only means available for continuity of education and clinical training. This paper reviews the transition to online health professions education and delivery during the COVID-19 pandemic and provides recommendations for moving forward

Flowchart of the search strategy used in the review.

<p>The relevant number of papers at each point is provided.</p

Studies examining the association between breast milk ghrelin concentrations and maternal BMI.

<p>ELISA: Enzyme-linked immunosorbent assay; GDM: Gestational Diabetes; HPLC: High Performance Liquid Chromatography; P-GDM: Pre-Gestational Diabetes; PP: post-partum; RIA: radioimmunoassay.</p><p>*Data are given as means and standard deviations unless stated otherwise.</p><p>Studies examining the association between breast milk ghrelin concentrations and maternal BMI.</p