Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials.

BACKGROUND: Pandemic events often trigger a surge of clinical trial activity aimed at rapidly evaluating therapeutic or preventative interventions. Ensuring rapid public access to the complete and unbiased trial record is particularly critical for pandemic research given the urgent associated public health needs. The World Health Organization (WHO) established standards requiring posting of results to a registry within 12 months of trial completion and publication in a peer reviewed journal within 24 months of completion, though compliance with these requirements among pandemic trials is unknown. METHODS: This cross-sectional analysis characterizes availability of results in trial registries and publications among registered trials performed during the 2009 H1N1 influenza, 2014 Ebola, and 2016 Zika pandemics. We searched trial registries to identify clinical trials testing interventions related to these pandemics, and determined the time elapsed between trial completion and availability of results in the registry. We also performed a comprehensive search of MEDLINE via PubMed, Google Scholar, and EMBASE to identify corresponding peer reviewed publications. The primary outcome was the compliance with either of the WHO's established standards for sharing clinical trial results. Secondary outcomes included compliance with both standards, and assessing the time elapsed between trial completion and public availability of results. RESULTS: Three hundred thirty-three trials met eligibility criteria, including 261 H1N1 influenza trials, 60 Ebola trials, and 12 Zika trials. Of these, 139 (42%) either had results available in the trial registry within 12 months of study completion or had results available in a peer-reviewed publication within 24 months. Five trials (2%) met both standards. No results were available in either a registry or publication for 59 trials (18%). Among trials with registered results, a median of 42 months (IQR 16-76 months) elapsed between trial completion and results posting. For published trials, the median elapsed time between completion and publication was 21 months (IQR 9-34 months). Results were available within 24 months of study completion in either the trial registry or a peer reviewed publication for 166 trials (50%). CONCLUSIONS: Very few trials performed during prior pandemic events met established standards for the timely public dissemination of trial results.

Promotion, Protection, and Support of Breastfeeding as a Human Right: A Narrative Review.

Background: Despite the benefits of breastfeeding, there are significant disparities in rates among various racial, social, and economic groups. Society poses various barriers to breastfeeding, threatening the child's access to a basic human right. Exploring and understanding these issues can ensure that effective interventions are implemented. Objective: To present situations in which the mother's and child's basic human right to breastfeeding is threatened and to highlight opportunities to uphold their rights within social and health care systems. Methods: A literature search of relevant articles was performed via PubMed regarding (1) rights to optimal protections for breastfeeding, (2) situations in which the rights of breastfeeding parents are threatened, and (3) challenges in providing inclusive and equitable breastfeeding care along with strategies to uphold the human right to breastfeed. Results: Maternity leave of at least 12 weeks was associated with higher breastfeeding rates, whereas mandated breaks in the workplace resulted in either positive or inconclusive effects. Peer counseling, institutional initiatives, and mass media campaigns were among the most effective interventions; however, effects on breastfeeding varied among different racial groups. Conclusions: There are clear benefits of breastfeeding for mothers and infants, which highlight the importance of prioritizing breastfeeding as a basic human right. Regardless, there are numerous societal barriers to providing equitable breastfeeding care. Although there are interventions that have proven to be helpful in breastfeeding promotion, protection, and support, further standardized research will be beneficial in identifying effective and inclusive interventions.

Human Milk Sharing in the United States: A Scoping Review.

Background: Human milk is the optimal form of infant nutrition. If mother's own milk is unavailable, families may seek alternative sources of human milk through milk sharing, despite potential health and safety risks with this practice. Objective: The purpose of this scoping review was to synthesize the current literature on human milk sharing in the United States to help health care professionals better understand how families may use this practice for infant nutrition. Methods: A systematic search was conducted in June 2021 using Ovid MEDLINE, Embase, CINAHL, ProQuest Central, Web of Science, and Google Scholar. Articles were included if the primary outcome was milk sharing, excluding milk banks and preterm hospitalized infants. Results were limited to studies conducted in the United States and published in English after January 1, 2000. Results: From 2,124 articles, 34 met inclusion criteria and were reviewed. Study designs were largely observational (30/34), and participants were predominantly white, married, and middle-income women experiencing lactation problems or in possession of excess breast milk. Milk sharing, not for profit, was often facilitated through the internet but exchanged in person. Conversely, for-profit milk sharing often involved shipping and studies found evidence of milk contamination. No studies documented infant harm. Conclusions: There is limited research on the milk quality and relative risks of milk sharing, and no research on clinical outcomes in infants fed shared milk. Clinicians have opportunities to engage in open conversations about this practice to guide risk mitigation, however, research on recipient infant outcomes are urgently needed to inform best practices.

Academy of Breastfeeding Medicine Position Statement: Breastfeeding As a Basic Human Right.

A central goal of the Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. The Academy of Breastfeeding Medicine recognizes that not all lactating individuals identify as women. Using genderinclusive language, however, is not possible in all languages and all countries and for all readers. The position of the Academy of Breastfeeding Medicine (https://doi.org/10.1089/bfm.2021.29188.abm) is to interpret clinical protocols within the framework of inclusivity of all breastfeeding, chestfeeding, and human milk-feeding individuals.

Discrepancies between ClinicalTrials.gov recruitment status and actual trial status: a cross-sectional analysis.

OBJECTIVES: To determine the accuracy of the recruitment status listed on ClinicalTrials.gov as compared with the actual trial status. DESIGN: Cross-sectional analysis. SETTING: Random sample of interventional phase 2-4 clinical trials registered between 2010 and 2012 on ClinicalTrials.gov. PRIMARY OUTCOME MEASURE: For each trial which was listed within ClinicalTrials.gov as ongoing, two investigators performed a comprehensive literature search for evidence that the trial had actually been completed. For each trial listed as completed or terminated early by ClinicalTrials.gov, we compared the date that the trial was actually concluded with the date the registry was updated to reflect the study's conclusion status. RESULTS: Among the 405 included trials, 92 had a registry status indicating that study activity was either ongoing or the recruitment status was unknown. Of these, published results were available for 34 (37%). Among the 313 concluded trials, the median delay between study completion and a registry update reflecting that the study had ended was 141 days (IQR 48-419), with delays of over 1 year present for 29%. In total, 125 trials (31%) either had a listed recruitment status which was incorrect or had a delay of more than 1 year between the time the study was concluded and the time the registry recruitment status was updated. CONCLUSIONS: At present, registry recruitment status information in ClinicalTrials.gov is often outdated or wrong. This inaccuracy has implications for the ability of researchers to identify completed trials and accurately characterise all available medical knowledge on a given subject.