Publication Recommendations to Report Laboratory Data of Neonates - a Modified Delphi Approach.

BACKGROUND: Clinical and analytical information on laboratory data of neonates in scientific publications is sparse and incomplete. Furthermore, interpreting neonatal laboratory data can be complex due to their time-dependent and developmental physiology, and paucity of well-established age-appropriate reference ranges for neonates. This study aims to develop publication recommendations to report laboratory data of neonates to enhance the quality of these data in research and clinical care. METHODS: A modified Delphi approach was used to develop recommendations in cooperation with the International Neonatal Consortium. A Core Group, including different stakeholders, was responsible for developing the recommendations, in collaboration with a Reflection Group, responsible for providing additional input. RESULTS: The recommendations were classified into three categories: 'Clinical Characteristics', 'Bio-analytical Information' and 'Data-analytical Information'. These were each divided into 'Core Data' (always to be reported) and 'Supplemental Considerations' (to be reported when considered relevant to the study). CONCLUSION: Our recommendations provide guidance on standardization of neonatal laboratory data in publications. This will enhance the comparison, replication, and application of study results in research initiatives and clinical practice. Furthermore, these recommendations also serve as foundational work to develop reference ranges for neonatal laboratory values by standardizing the quality of information needed for such efforts. IMPACT: Standardized reporting of neonatal laboratory data in scientific publications will enhance the comparison, replication, and application of study results in research initiatives and clinical practice, as well as improve reporting to regulatory agencies. To integrate multistakeholder perspectives, a modified Delphi approach was used to develop publication recommendations which strengthens the applicability of the recommendations. Implementation of standardization will likely improve the overall quality of neonatal clinical research and neonatal healthcare. In addition, these recommendations are foundational to develop reference ranges for neonatal laboratory values by standardizing the quality of information needed for such efforts.

Considerations for applying emerging technologies in paediatric laboratory medicine.

Emerging technology in laboratory medicine can be defined as an analytical method (including biomarkers) or device (software, applications, and algorithms) that by its stage of development, translation into broad routine clinical practice, or geographical adoption and implementation has the potential to add value to clinical diagnostics. Paediatric laboratory medicine itself may be considered an emerging area of specialisation that is established relatively recently following increased appreciation and understanding of the unique physiology and healthcare needs of the children. Through four clinical (neonatal hypoglycaemia, neonatal hyperbilirubinaemia, sickle cell disorder, congenital adrenal hyperplasia) and six technological (microassays, noninvasive testing, alternative matrices, next generation sequencing, exosome analysis, machine learning) illustrations, key takeaways of application of emerging technology for each area are summarised. Additionally, nine key considerations when applying emerging technology in paediatric laboratory medicine setting are discussed.

Minimum retesting intervals in practice: 10 years experience.

Background: Minimum retesting intervals (MRI) are a popular demand management solution for the identification and reduction of over-utilized tests. In 2011 Association of Clinical Biochemistry and Laboratory Medicines (ACB) published evidence-based recommendations for the use of MRI. Aim: The aim of the paper was to review the use of MRI over the period since the introduction of these recommendations in 2011 to 2020 and compare it to previous published data between 2000-2010. Methods: A multi-source literature search was performed to identify studies that reported the use of a MRI in the management or identification of inappropriate testing between the years prior to (2000-2010) and after implementation (2011-2020) of these recommendations. Results: 31 studies were identified which met the acceptance criteria (2000-2010 n=4, 2011-2020 n=27). Between 2000 and 2010 4.6% of tests (203,104/4,425,311) were identified as failing a defined MRI which rose to 11.8% of tests (2,691,591/22,777,288) in the 2011-2020 period. For those studies between 2011 and 2020 reporting predicted savings (n=20), 14.3% of tests (1,079,972/750,580) were cancelled, representing a total saving of 2.9 M Euros or 2.77 Euro/test. The most popular rejected test was Haemoglobin A1c which accounted for nearly a quarter of the total number of rejected tests. 13 out 27 studies used the ACB recommendations. Conclusions: MRI are now an established, safe and sustainable demand management tool for the identification and management of inappropriate testing. Evidence based consensus recommendations have supported the adoption of this demand management tool into practice across multiple healthcare settings globally and harmonizing laboratory practice.

Brexit poses serious threats to the availability and affordability of food in the United Kingdom.

Brexit will have profound implications for health and health policy yet, while much attention has focused on health professionals, medicines and health protection, the risk of food insecurity, and thus health, has received less attention. We identify five major threats to the availability and affordability of food supplies. These are a lack of regulatory alignment restricting ability to import foods from the EU and beyond, a shortage of agricultural labour in the UK, increased prices of imported foods due to tariffs, damage to supply chains, for example, due to customs delays and loss of interoperability of transportation, and damage to agricultural production and food flows in Ireland.

Beyond the Golden Era of public health: charting a path from sanitarianism to ecological public health.

The paper considers the long-term trajectory of public health and whether a 'Golden Era' in Public Health might be coming to an end. While successful elements of the 20th century policy approach need still to be applied in the developing world, two significant flaws are now apparent within its core thinking. It assumes that continuing economic growth will generate sufficient wealth to pay for the public health infrastructure and improvement needed in the 21st century when, in reality, externalised costs are spiralling. Secondly, there is evidence of growing mismatch between ecosystems and human progress. While 20th century development has undeniably improved public health, it has also undermined the capacity to maintain life on a sustainable basis and has generated other more negative health consequences. For these and other reasons a rethink about the role, purpose and direction of public health is needed. While health has to be at the heart of any viable notion of progress the dominant policy path offers new versions of the 'health follows wealth' position. The paper posits ecological public health as a radical project to reshape the conditions of existence. Both of these broad paths require different functions and purposes from their institutions, professions and politicians. The paper suggests that eco-systems pressures, including climate change, are already adding to pressure for a change of course.

A qualitative, cross cultural examination of attitudes and behaviour in relation to cooking habits in France and Britain.

Food campaigners, policy makers, journalists and academics continue to debate an alleged decline in home cooking, a corresponding increase in individualised eating habits and the impact of such trends upon public health. The focus of this research was to examine and compare current domestic food practices in Britain with those of another country, namely France. In-depth interviews with 27 members of the public drawn from both countries enabled the researchers to explore people's actual cooking practices in the home. Analysis of the data revealed that respondents from both countries often lacked time to cook and increasingly relied on a mix of both raw and convenience-type foods to varying degrees. A range of cooking skills was employed in the home, although confidence in relation to cooking was more varied with the French respondents who demonstrated a greater willingness to 'cook from scratch'. There was some evidence of men on both sides of The Channel engaging with cooking in the home although this often formed part of a leisure activity undertaken at weekends and for special occasions.

The planet on our plates: approaches to incorporate environmental sustainability within food-based dietary guidelines.

For many decades, food-based dietary guidelines (FBDGs) were only health-oriented. This changed post-2009 when gradually, an increasing number of countries began to include environmental sustainability considerations in their guidelines. International organisations such as the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) have stated that governments should include environmental sustainability in future FBDGs. However, methodologies on how this should be done are lacking. Therefore, through workshops and discussions with experts, we analysed a selection of methodologies and classified them into six groups: (1) health first; (2) additional advice; (3) demonstrating synergies; (4) modelling impact; (5) combining strategies; (6) systems first. We then assessed how innovative each approach was and their potential for transformative impact. Of the 6 approaches investigated, only approaches 5 and 6 could be considered as disruptive innovations and leading to major changes. Adding environmental sustainability into FBDGs is a policy innovation and has become a debate between old and new multi-criteria guidelines for eating. With the addition of environmental sustainability in FBDGS, a new or emerging set of multi-criteria guidelines for judging food are being proposed that challenges past norms and governance. Today, there is growing scientific consensus that diets that are good for human health are also good for the environment. There is also a growing recognition that food system change is inevitable and desirable. We see this as a positive opportunity to collaborate on FBDGs that are more appropriate for the 21st century and ambitious enough to meet the environmental challenges at hand.

An approach to conflicts of interest in UK food regulatory institutions.

The history of food is replete with examples of food scandals leading to institutional and procedural reforms intended to rebuild trust. For trust to be sustainable, systems need to be trustworthy. Food regulatory institutions are at the interface of science and policy, and they should have robust and reliable mechanisms for identifying and addressing commercial conflicts of interest (COIs) among the membership of their boards and advisory committees. Here we provide a detailed estimate, analysis and critique of COIs within the United Kingdom's food regulatory institutions. This exercise was facilitated by the United Kingdom's rule requiring declarations of COIs, which are published. Institutions that require and publish declarations of COIs are probably more trustworthy than those that do not, while institutions that exclude all individuals with COIs could be even more trustworthy.

UK food policy: implications for nutritionists.

Implications of the 'changing world' for nutrition and nutritionists are considered, using the UK within a global context as an illustration. The first section summarises the slow recognition by policy makers of the significance of the changing world of food and nutrition. The second section 'Food system stress is now at a critical level' considers the present scale of global food system stress and the failure so far sufficiently to narrow the gap between evidence and policy change. The year 2021 was earmarked when three major UN conferences had the opportunity to chart food changes ahead. The third section 'Multi-criteria analysis helps frame 21st century nutrition science' proposes that multi-criteria analysis is an essential methodology for nutrition within this more complex policy world; nutrition studies can no long exclude social and environmental criteria. The penultimate section 'Nutrition science can reconnect its life science, social and environmental nutrition traditions to contribute to new paradigm formation' suggests that nutrition science can now recombine three traditions within its own history to address this complexity: social nutrition, environmental nutrition and life sciences. The final section 'Priorities ahead' concludes that this multi-criteria approach to nutrition offers new routes for science and policy influence. Five priorities are identified: (1) clarification of the features of a good food system; (2) new sustainable dietary guidelines which integrate different determinants of sustainability; (3) helping consumer engagement with change; (4) developing improved policy frameworks and (5) contributing to professional channels in these processes. In the UK, while the challenge of narrowing the gap between evidence, policy and change remains daunting, the risks of not attempting to improve the transition to an ecologically sound public health nutrition are even greater.

Understanding the policy discourse within the formulation of the 2013 Indian National Food Security Act.

India was the third country in the world to enact into law a constitutional commitment to the right to food, following Brazil and South Africa. The 2013 National Food Security Act (NFSA) was the latest in a long line of post-Independence food policies aimed at tackling hunger. This paper explores the range of discourses among NFSA policy-makers, their views and disagreements, from drafting to the final Act. The research used mixed methods. Elite semi-structured interviews were conducted with 32 individuals who were either directly involved in NFSA formulation or food security specialist observers. Policy documents covering the period from before the Act and during the Act's passage were critically analysed. Significant intra-governmental disagreements were apparent between two broad positions. A 'pro-rights' position sought to formulate a law that was as comprehensive and rights-based as possible, while a 'pro-economy' policy position saw the NFSA as a waste of money, resources and time, although recognising the political benefits of a food security law. These disagreements were consistent throughout the formulation of the NFSA, and in turn cast the Act as a product of compromise. Although there was broad consensus for a food security act, there was surprisingly little agreement exactly how that Act should look, what it should contain, and whom it should target. There was little consensus even on the right to food approach itself. The article contributes to the understanding of policy formulation in India specifically, and in developing countries in general, as well as to lend credence to the suitability of policy analysis to developing nations, otherwise normally grounded in Western traditions. The paper highlights a lack of cross-government cooperation in policy formulation, with the continued pressure of a short-term economic rationale undermining the policy goal of lessening hunger, despite some success.

Impact of COVID-19 on Pediatric Laboratory Medicine: An IFCC C-ETPLM, SSIEM, ISNS Global Survey.

Objective: Pediatric laboratory medicine is a unique practice serving a vulnerable group of patients including highly specialized testing aiming to detect and treat inherited conditions early to avoid adverse outcomes. Data on the actual impact of COVID-19 pandemic on this speciality is lacking. Methods: A survey was conducted by the IFCC Committee on Emerging Technologies in Pediatric Laboratory Medicine in partnership with the Society for the Study of Inborn Errors of Metabolism and International Society for Neonatal Screening, to assess the impact on the clinical service provision during the initial wave (January to July 2020) of the COVID-19 pandemic and to gather experiences learned in order to improve laboratory preparedness for future outbreaks. Results: 217 survey responses were received from 69 regions. Sixty-three laboratories (29%) reported a restriction or suspension of service for a median period of four months. The common tests/ services suspended were new-born screening program, body fluids and sweat testing. The reasons for the suspension were related to bio-safety risks of COVID-19 transmission, manpower constraints and supplies disruption. A minority (9-10%) of laboratories did observe delayed/missed diagnoses or a more severe presentation of a clinical disorder. The critical operational decisions that helped manage the initial wave of COVID-19 included modifying work shift patterns, split-teams arrangement, use of personal protection equipment and social distancing. Conclusion: The provision and delivery of pediatric laboratories services were affected during the initial wave of the COVID-19 pandemic. Manpower preparedness for future potential disruptions to pediatric laboratory services is a key finding and recommendation from this survey.

Sodium and Health: Old Myths and a Controversy Based on Denial.

PURPOSE OF REVIEW: The scientific consensus on which global health organizations base public health policies is that high sodium intake increases blood pressure (BP) in a linear fashion contributing to cardiovascular disease (CVD). A moderate reduction in sodium intake to 2000 mg per day helps ensure that BP remains at a healthy level to reduce the burden of CVD. RECENT FINDINGS: Yet, since as long ago as 1988, and more recently in eight articles published in the European Heart Journal in 2020 and 2021, some researchers have propagated a myth that reducing sodium does not consistently reduce CVD but rather that lower sodium might increase the risk of CVD. These claims are not well-founded and support some food and beverage industry's vested interests in the use of excessive amounts of salt to preserve food, enhance taste, and increase thirst. Nevertheless, some researchers, often with funding from the food industry, continue to publish such claims without addressing the numerous objections. This article analyzes the eight articles as a case study, summarizes misleading claims, their objections, and it offers possible reasons for such claims. Our study calls upon journal editors to ensure that unfounded claims about sodium intake be rigorously challenged by independent reviewers before publication; to avoid editorial writers who have been co-authors with the subject paper's authors; to require statements of conflict of interest; and to ensure that their pages are used only by those who seek to advance knowledge by engaging in the scientific method and its collegial pursuit. The public interest in the prevention and treatment of disease requires no less.

Key questions about the future of laboratory medicine in the next decade of the 21st century: A report from the IFCC-Emerging Technologies Division.

This review advances the discussion about the future of laboratory medicine in the 2020s. In five major topic areas: 1. the "big picture" of healthcare; 2. pre-analytical factors; 3. Analytical factors; 4. post-analytical factors; and 5. relationships, which explores a next decade perspective on laboratory medicine and the likely impact of the predicted changes by means of a number of carefully focused questions that draw upon predictions made since 2013. The "big picture" of healthcare explores the effects of changing patient populations, the brain-to-brain loop, direct access testing, robots and total laboratory automation, and green technologies and sustainability. The pre-analytical section considers the role of different sample types, drones, and biobanks. The analytical section examines advances in point-of-care testing, mass spectrometry, genomics, gene and immunotherapy, 3D-printing, and total laboratory quality. The post-analytical section discusses the value of laboratory medicine, the emerging role of artificial intelligence, the management and interpretation of omics data, and common reference intervals and decision limits. Finally, the relationships section explores the role of laboratory medicine scientific societies, the educational needs of laboratory professionals, communication, the relationship between laboratory professionals and clinicians, laboratory medicine financing, and the anticipated economic opportunities and outcomes in the 2020's.

The molecular basis of pyruvate carboxylase deficiency: mosaicism correlates with prolonged survival.

Pyruvate carboxylase (PC) deficiency (OMIM, 266150) is a rare autosomal recessive disease. The revised PC gene structure described in this report consists of 20 coding exons and four non-coding exons at the 5'-untranslated region (5'-UTR). The gene codes for three transcripts due to alternative splicing: variant 1 (NM_000920.3), variant 2 (NM_022172.2) and variant 3 (BC011617.2). PC deficiency is manifested by three clinical phenotypes-an infantile form (Type A), a neonatal form (Type B), and a benign form (Type C). We report the molecular basis for eight cases (one Type A, five Type B and two Type C) of PC deficiency. Eight novel complex mutations were identified representing different combinations of missense mutations, deletions, a splice site substitution and a nonsense mutation. The classical phenotypes (A, B and C) correlated poorly with clinical outcomes. Mosaicism was found in five cases (one Type A, three Type B and one Type C) and four of these cases had prolonged survival. Death in the fifth case resulted from unrelated medical complications. The discrepancy between the current findings and the existing classification system should be addressed to accommodate these new observations.